Aptorum Group Joins the BEAM Alliance To Combat Antimicrobial Resistance

HONG KONG, Sep 8, 2020 – (ACN Newswire) – Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group"), a biopharmaceutical company focused on novel therapeutics including the development of next-generation therapeutics targeting antimicrobial resistance, today announced it joined the Biotech companies in Europe combating Antimicrobial Resistance Alliance based in Europe (the "BEAM Alliance") as full member.

The BEAM Alliance is a network of approximately 70 small and medium-sized European companies involved in developing innovative products and kits to tackle antimicrobial resistance ("AMR"), including small molecule antibiotics, biologics, products with a prophylaxis indication, microbiome-based and phage-based therapies, immune targeting therapies, anti-biofilm agents, and medical devices, including in-vitro diagnostics.

"We are pleased to join the BEAM Alliance and strengthen our European network with the AMR community. The aims of the alliance and the pharmaceutical community are particularly synergistic with one of our core focus in infectious disease research, culminating the development of our ALS-4 and ALS-2/3 programs, to address global antimicrobial resistance against deadly bacteria such as methicillin-resistant staphylococcus aureus ("MRSA") and others. Being a part of the BEAM Alliance will further facilitate the exchange of information and potential establishment of collaborating partners within this AMR field and we look forward to contributing our efforts for global preparedness against AMR," said Mr. Darren Lui, President and Executive Director of Aptorum Group.

About Aptorum Group Limited
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a pharmaceutical company dedicated to the discovery, development and commercializing of therapeutic assets to treat diseases with unmet medical needs, particularly infectious diseases and cancers (including orphan oncology indications). The pipeline of Aptorum is also enriched through the establishment of drug discovery platforms that enable the discovery of new therapeutics assets through, e.g. systematic screening of existing approved drug molecules, and microbiome-based research platform for treatments of metabolic diseases. In addition to the above main focus, we are also pursuing therapeutic and diagnostic projects in neurology, gastroenterology, metabolic disorders, women's health and other disease areas. We also have projects focused on surgical robotics and natural supplement for women undergoing menopause and experiencing related symptoms.

For more information about Aptorum Group, please visit www.aptorumgroup.com.

For further general presentation, please visit: https://ir.aptorumgroup.com/static-files/ca36cc65-6f23-4105-895e-f5f234ecca1e

About the BEAM Alliance
BEAM represents European biopharmaceutical companies involved in developing innovative products to tackle antimicrobial resistance. BEAM collaborates with the existing community of stakeholders dedicated to implementing tangible strategies. BEAM gives its members a unique voice to propose and support policies and incentives in antimicrobial research and development in Europe. BEAM recommends bold incentives that warrant action by policymakers to stimulate much-needed innovation.

For more information about BEAM Alliance, please visit https://beam-alliance.eu/

Disclaimer and Forward-Looking Statements
This press release does not constitute an offer to sell or a solicitation of offers to buy any securities of Aptorum Group.

This press release includes statements concerning Aptorum Group Limited and its future expectations, plans and prospects that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential," or "continue," or the negative of these terms or other similar expressions. Aptorum Group has based these forward-looking statements, which include statements regarding projected timelines for application submissions and trials, largely on its current expectations and projections about future events and trends that it believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions including, without limitation, risks related to its announced management and organizational changes, the continued service and availability of key personnel, its ability to expand its product assortments by offering additional products for additional consumer segments, development results, the company's anticipated growth strategies, anticipated trends and challenges in its business, and its expectations regarding, and the stability of, its supply chain, and the risks more fully described in Aptorum Group's Form 20-F and other filings that Aptorum Group may make with the SEC in the future, as well as the prospectus that received the French Autorite des Marches Financiers visa n20-352 on 16 July 2020.

As a result, the projections included in such forward-looking statements are subject to change and actual results may differ materially from those described herein. Aptorum Group assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

This announcement is not a prospectus within the meaning of the Regulation (EU) n2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n2019/980 of 14 March 2019 and n2019/979 of 14 March 2019.

This press release is provided "as is" without any representation or warranty of any kind.

Contacts
Investor relations
Aptorum Group Limited
Investor Relations Department:
Tel: +44 020 80929299
Email: investor.relations@aptorumgroup.com

Redchip – Financial Communications United States
Investor relations
Dave Gentry
dave@redchip.com
+1 407 491 4498

Actifin – Financial Communications Europe
Investor relations
Ghislaine Gasparetto
ggasparetto@actifin.fr
+33 1 56 88 11 22



Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Aptorum Group Announces Further Positive Data on ALS-4 against MRSA Wound Infection and MRSA Bacteraemia against Linezolid and Vancomycin Respectively in In Vivo Models

HONG KONG, Sep 1, 2020 – (ACN Newswire) – Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) ("Aptorum Group"), a biopharmaceutical company focused on novel therapeutics including the development of next-generation approach therapeutics targeting antimicrobial resistance, announced two sets of positive data showing both significant in vivo activities of its lead compound ALS-4 against Methicillin-Resistant Staphylococcus aureus (MRSA, one of the "super-bugs") in wound infected and bacteraemia mouse models, respectively when compared to prevailing antibiotics.

ALS-4 is currently undergoing final stages of IND enabling studies, which involves a 14-Day oral toxicity in rats and dogs, a functional observation battery study in rats and a cardiovascular telemetry and respiratory study in dogs. Subject to the final IND-enabling studies results, ALS-4 is on track to target the regulatory submission in Q4 2020 subject to which to commence Phase I clinical trials in Canada.

"Despite the two current mainstay treatments, vancomycin and daptomycin, being the only FDA approved antibiotics for MRSA bacteraemia thus far, patient mortality, morbidity and recurrence rates remain significant1. With the fragile antibiotic pipeline being at risk globally, antimicrobial resistance issues continue to gain significant attention from global bodies including the World Health Organization and the FDA, as well as the pharmaceutical industry. We believe that our oral ALS-4 drug based on a novel first-in-class anti-virulence concept can potentially tackle a variety of infections related to MRSA, including (but not limited to) bacteraemia and skin & soft tissue infections, subject to the respective clinical trials. We are greatly encouraged by the data because ALS-4 appears to be effective against MRSA superbug and could be a potential alternative and sustainable treatment for different MRSA indications including, but not limited to, MRSA bacteraemia and skin infections. ALS-4's anti-virulent properties are a novel approach in tackling antimicrobial resistance issues as encouraged by recent global action plans. We are also pleased to report that our IND enabling studies are also at their final stages and we remain on track to target regulatory submission to commence phase 1 clinical trials," said Mr. Darren Lui, President and Executive Director of the company.

Efficacy of ALS-4 in a MRSA Wound Infection Mouse Model
A recent study, conducted by a third party contract research organization, assessed ALS-4's effect in the healing of open wounds infected with MRSA in a mouse model. Compared with topical dosing of 2% Mupirocin and oral dosing of Linezolid at 100mg/kg twice a day, oral dosing of ALS-4 at 30mg/kg twice a day showed statistically significant improvement in wound healing. Specifically, at the end of the study on Day 7, ALS-4 exhibited 63.8% of wound closure compared with 48.4% for oral Linezolid and 43.2% for topical Mupirocin 2%. The results are further illustrated in the graph below.

Efficacy of ALS-4 in a Bacteraemia Mouse Model
In a further round of in vivo studies, conducted by a third party contract research organization, in a non-lethal MRSA bacteraemia mouse model, the mice were orally administered with different doses of ALS-4 from 0.3 to 30mg/kg twice a day for 7 days, compared to those who received vancomycin only group (3mg/kg of vancomycin administered intravenously) and a no treatment control group.

At the conclusion of the study on Day 7, ALS-4 brought a statistically significant reduction in bacterial counts in major organs such as the kidneys, lungs, liver and spleen compared with the no drug control and vancomycin only groups (unpaired student's t-test, p<0.05). This is in addition to the previous in vivo results announced in February 2020, whereby ALS-4 demonstrated on a statistically significant basis better survival rates (56% vs 0% control group) in the lethal MRSA bacteraemia rat model and higher reduction of bacterial load (by 99.5% against the control group) in the non-lethal MRSA bacteraemia rat model.

About ALS-4
As part of Aptorum Group's Acticule infectious disease platform, ALS-4 is a novel first-in-class small molecule developed in oral form based on an anti-virulence approach targeting Methicillin resistant Staphylococcus aureus (MRSA). ALS-4 targets the antimicrobial resistant properties of S. aureus and render the bacteria to become highly susceptible to the host's immune clearance and also potentially other existing antibiotics, as shown in the preclinical data.

About Aptorum Group Limited
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a pharmaceutical company dedicated to developing and commercializing novel therapeutics to tackle unmet medical needs. Aptorum Group is pursuing therapeutic projects in orphan diseases, infectious diseases, metabolic diseases, woman's health and other disease areas.

For more information about Aptorum Group, please visit www.aptorumgroup.com.

For further general presentation, please visit: https://ir.aptorumgroup.com/static-files/ca36cc65-6f23-4105-895e-f5f234ecca1e

Disclaimer and Forward-Looking Statements

This press release does not constitute an offer to sell or a solicitation of offers to buy any securities of Aptorum Group.

This press release includes statements concerning Aptorum Group Limited and its future expectations, plans and prospects that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential," or "continue," or the negative of these terms or other similar expressions. Aptorum Group has based these forward-looking statements, which include statements regarding projected timelines for application submissions and trials, largely on its current expectations and projections about future events and trends that it believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions including, without limitation, risks related to its announced management and organizational changes, the continued service and availability of key personnel, its ability to expand its product assortments by offering additional products for additional consumer segments, development results, the company's anticipated growth strategies, anticipated trends and challenges in its business, and its expectations regarding, and the stability of, its supply chain, and the risks more fully described in Aptorum Group's Form 20-F and other filings that Aptorum Group may make with the SEC in the future, as well as the prospectus that received the French Autorite des Marches Financiers visa n20-352 on 16 July 2020.

As a result, the projections included in such forward-looking statements are subject to change and actual results may differ materially from those described herein. Aptorum Group assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

This announcement is not a prospectus within the meaning of the Regulation (EU) n2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n2019/980 of 14 March 2019 and n2019/979 of 14 March 2019.

This press release is provided "as is" without any representation or warranty of any kind.
1 https://link.springer.com/article/10.1186/s13054-017-1801-3

Contacts
Investor relations
Aptorum Group limited
Investor Relations Department:
Tel: +44 020 80929299
Email: investor.relations@aptorumgroup.com

Redchip – Financial Communications United States
Investor relations
Dave Gentry
dave@redchip.com
+1 407 491 4498

Actifin – Financial Communications Europe
Investor relations
Ghislaine Gasparetto
ggasparetto@actifin.fr
+33 1 56 88 11 22



Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Aptorum Group Announces Further Positive Data on SACT-1 Against Neuroblastoma and Other Potential Tumor Types

HONG KONG, Sep 1, 2020 – (ACN Newswire) – Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) ("Aptorum Group"), a biopharmaceutical company focused on the development of novel therapeutics including orphan diseases and oncology indications, announced further positive data from its latest in vivo studies showing significant activity against neuroblastoma tumor reduction when treated with its lead compound SACT-1 in combination with standard of care (SOC) chemotherapy. Separately, SACT-1 was also screened for its in vitro activity against over 300 cancer cell lines and showed positive results in a number of cancer types including in particular colorectal cancer, leukemia and lymphoma, etc.

Our repurposed drug candidate, SACT-1 is undergoing preparation for IND submission and is on track for regulatory application to target to commence phase 1b/2a clinical trials under the US FDA's 505(b)(2) pathway.

"Neuroblastoma is one of the most prevailing solid tumor cancers in children, representing 8% – 10% of all childhood tumors, accounting for c. 15% of all cancer related deaths in the pediatric population1. For the high-risk patient group, the 5-year survival rate of this condition is around 40-50% as observed by the American Cancer Society2 based on existing treatment. We are delighted to see the progress of our SACT-1, one of our first assets from our SMART-ACT platform. We are extremely excited to observe SACT-1's significant effect on tumor shrinkage when used in combination with standard of care chemotherapy in our latest in vivo studies. Moreover, we believe that SACT-1 may have potential applications in a number of other cancer types, including non-orphan cancers, which we will be continuing to investigate further for its wider application," said Dr. Clark Cheng, the Chief Medical Officer and Executive Director of the company.

Summary of our in vivo assessment against neuroblastoma and in vitro assessment against other cancers are discussed below.

Neuroblastoma In Vivo Assessment
Based on the initial 22 day data of a recent study we conducted in a xenograft mouse model of neuroblastoma, SACT-1 was orally administered daily at 60mg/kg in combination of SOC chemotherapy brought a statistically significant tumor shrinkage (unpaired student's t-test, p<0.01) from Day 15 to Day 22, compared to the control group which received SOC only. Indeed, the combination reduced the tumor size by up to 54.2% in the first 22 days compared with the control (SOC only). SACT-1 appears to be effective in accelerating the effect of the SOC in early time points (from Day 1 – 7 vs control). This further supports our earlier in vitro observation that SACT-1 promotes tumor DNA damage and tumor cell death.

Other Cancer Types In Vitro Assessment
In addition, SACT-1 was also screened for in vitro activity in a panel of over 300 cancer cell lines. Similar to our previous findings against neuroblastoma cell lines, SACT-1 exhibits similar anti-tumor efficacy across one or more other major cancer types, including but not limited to colorectal cancer, leukemia and lymphoma cell lines. As a result, in addition to treating neuroblastoma, SACT-1 may have potential applications in the treatment of other cancers. Based on this discovery, the company plans to carry out further in vivo studies to study the efficacy of SACT-1 over other types of cancers to maximize the potential of SACT-1.

About SACT-1
As part of Aptorum Group's SMART-ACT platform, SACT-1 was discovered from our SMART-ACT platform focused on orphan and unmet diseases. SACT-1 is a repurposed drug targeted for the treatment of neuroblastoma (and potentially other cancer types) especially in combination with SOC chemotherapy. SACT-1's mechanism has been demonstrated in vitro to enhance DNA damage and tumor cell death.

About Aptorum Group Limited
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a pharmaceutical company dedicated to developing and commercializing novel therapeutics to tackle unmet medical needs. Aptorum Group is pursuing therapeutic projects in orphan diseases, infectious diseases, metabolic diseases, woman's health and other disease areas.

For more information about Aptorum Group, please visit www.aptorumgroup.com.

For further general presentation, please visit: https://ir.aptorumgroup.com/static-files/ca36cc65-6f23-4105-895e-f5f234ecca1e

Disclaimer and Forward-Looking Statements

This press release does not constitute an offer to sell or a solicitation of offers to buy any securities of Aptorum Group.

This press release includes statements concerning Aptorum Group Limited and its future expectations, plans and prospects that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential," or "continue," or the negative of these terms or other similar expressions. Aptorum Group has based these forward-looking statements, which include statements regarding projected timelines for application submissions and trials, largely on its current expectations and projections about future events and trends that it believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions including, without limitation, risks related to its announced management and organizational changes, the continued service and availability of key personnel, its ability to expand its product assortments by offering additional products for additional consumer segments, development results, the company's anticipated growth strategies, anticipated trends and challenges in its business, and its expectations regarding, and the stability of, its supply chain, and the risks more fully described in Aptorum Group's Form 20-F and other filings that Aptorum Group may make with the SEC in the future, as well as the prospectus that received the French Autorite des Marches Financiers visa n20-352 on 16 July 2020.

As a result, the projections included in such forward-looking statements are subject to change and actual results may differ materially from those described herein. Aptorum Group assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

This announcement is not a prospectus within the meaning of the Regulation (EU) n2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n2019/980 of 14 March 2019 and n2019/979 of 14 March 2019.

This press release is provided "as is" without any representation or warranty of any kind.
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668791/#:~:text=Neuroblastoma%20is%20the%20most%20common,deaths%20in%20the%20pediatric%20population.
2 https://www.cancer.org/cancer/neuroblastoma/detection-diagnosis-staging/survival-rates.html

Contacts
Investor relations
Aptorum Group limited
Investor Relations Department:
Tel: +44 020 80929299
Email: investor.relations@aptorumgroup.com

Redchip – Financial Communications United States
Investor relations
RedChip Companies, Inc.
dave@redchip.com
+1 407 491 4498

Actifin – Financial Communications Europe
Investor relations
Ghislaine Gasparetto
ggasparetto@actifin.fr
+33 1 56 88 11 22



Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Aptorum Group Limited Reports Financial Results and Business Update for the Six Months Ended June 30, 2020

HONG KONG, Sep 1, 2020 – (ACN Newswire) – Aptorum Group Limited (NASDAQ: APM, Euronext Paris: APM) ("Aptorum Group"or the "Company"), a biopharmaceutical company focuses on the development of novel therapeutics to address global unmet medical needs, today provided a business update and announced financial results for the six months ended June 30, 2020.

"I am pleased with the developments that were achieved during the first half of 2020 despite the challenges presented by the COVID-19 pandemic," said Mr. Ian Huen, Chief Executive Officer and Executive Director of Aptorum Group. "Throughout the COVID-19 crisis, we remained focused on advancing the development of our therapeutic programs. As announced today, further positive data showing significant in vivo activities of ALS-4 (for MRSA wound healing and MRSA bacteraemia) and also in vitro and in vivo studies of SACT-1 (for neuroblastoma and other potential tumor types). Also, as an emerging company, we have been expanding our global strategic presence. In July, Aptorum Group became the first Nasdaq listed biopharmaceutical company admitted to trading on Euronext Paris. We are also delighted about 3 new appointments we made to support the development of our various programs. Looking forward, we remain committed to accelerating the Company's commercial growth and transformation into a biopharmaceutical company with exciting clinical stage assets being developed."

Clinical Pipeline Update and Upcoming Milestones
SACT-1-lead program of the Smart-ACTTM platform, a repurposed drug for neuroblastoma and others: Undergoing preparation and on track for IND submission to commence Phase 1b/2a human clinical trials targeting the US FDA's 505(b)(2) pathway. Further in vitro screening to assess SACT-1's potential effect on over 300 cancer cell lines has been completed and showed promising effect on including, but not limited to, colorectal cancer, leukemia and lymphoma.

ALS-4-lead program of the Acticule platform, a small drug molecule candidate for methicillin resistant Staphylococcus aureus ("MRSA" superbug): ALS-4 is undergoing final stages of IND enabling studies and is targeted for regulatory submission in Q4 2020 to commence a Phase 1 human clinical trial thereafter.

CLS-1-lead program of the Claves platform, a macromolecule approach for obesity: Currently in lead optimization stage, aimed for IND enabling studies to commence in 2021.

NLS-2 NativusWell-a dietary supplement for woman's health, including menopause and osteoporosis: Undergoing registration in the United Kingdom, Europe and Asia, aimed for distribution to market in 2020.

Corporate Highlights
Commenced trading on Euronext Paris stock exchange:
Aptorum Group became the first Nasdaq listed biopharmaceutical company admitted to trading on Euronext Paris. The Class A Ordinary Shares of Aptorum Group have commenced trading on the Professional Compartment of Euronext in Paris under the Euronext ticker symbol "APM" and ISIN Code: KYG6096M1069 on 24 July 2020.

Three new personnel appointed to Aptorum Group's team:
– Dr. Herman Weiss, M.D., Chief Executive Officer and Executive Director of Claves Life Sciences Limited and Senior Medical Advisor of Aptorum Group
– Dr. Kira Sheinerman, Senior Strategic Consultant of Aptorum Group
– Dr. Robbie Majzner, Scientific Advisor of Aptorum Group

Financial Results for the Six Months Ended June 30, 2020
Aptorum Group reported a net loss of $7.0 million for the six months ended June 30, 2020 compared to $9.6 million for the same period in 2019. The decrease in net loss in current period was driven by decrease in interest expenses, net of $3.6 million, partly offset by the increase in research and development expenses by $1.6 million.

Research and development expenses were $4.3 million for the six months ended June 30, 2020 compared to $2.7 million for the same period in 2019. The increase was primarily due to the increase in consultation service provided by our consultants, advisory and contracted research organization as a result of the progress of our projects' development.

General and administrative fees were $2.1 million for the six months ended June 30, 2020 compared to $3.2 million for the same period in 2019. The decrease was mainly driven by the decrease in bonus related expenses to our directors, employees, external consultants and advisors. Also, there was a significant decrease in business trips and sponsoring conference in 2020 due to the outbreak of COVID-19.

Legal and professional fees were $1.5 million for the six months ended June 30, 2020 compared to $2.0 million for the same period in 2019. The decrease in legal and professional fees was mainly due to the decrease of consultancy service fees during the period.

Interest expenses, net were $0.1 million for the six months ended June 30, 2020 compared to $3.7 million for the same period in 2019. The decrease in interest expenses, net was mainly due to the convertible debts were fully repaid in 2019. The interest expenses, net for the six month ended June 30, 2019 contained $3.1 million amortization of beneficial conversion feature of our convertible debts.

As of June 30, 2020, cash, restricted cash and marketable securities totaled approximately $4.4 million and total equity was approximately $17.5 million.

Aptorum Group expects that its existing cash, restricted cash and marketable securities, together with undrawn line of credit facility from related parties, will enable it to fund its operating and capital expenditure requirements to the end of 2021.

About Aptorum Group Limited
Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a pharmaceutical company dedicated to developing and commercializing novel therapeutics to tackle unmet medical needs. Aptorum Group is pursuing therapeutic projects in orphan diseases, infectious diseases, metabolic diseases, woman's health and other disease areas.

For more information about Aptorum Group, please visit www.aptorumgroup.com.

For further general presentation, please visit: https://ir.aptorumgroup.com/static-files/ca36cc65-6f23-4105-895e-f5f234ecca1e

Disclaimer and Forward-Looking Statements

This press release does not constitute an offer to sell or a solicitation of offers to buy any securities of Aptorum Group.

This press release includes statements concerning Aptorum Group Limited and its future expectations, plans and prospects that constitute "forward-looking statements" within the meaning of the US Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential," or "continue," or the negative of these terms or other similar expressions. Aptorum Group has based these forward-looking statements, which include statements regarding projected timelines for application submissions and trials, largely on its current expectations and projections about future events and trends that it believes may affect its business, financial condition and results of operations.

These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions including, without limitation, risks related to its announced management and organizational changes, the continued service and availability of key personnel, its ability to expand its product assortments by offering additional products for additional consumer segments, development results, the company's anticipated growth strategies, anticipated trends and challenges in its business, and its expectations regarding, and the stability of, its supply chain, and the risks more fully described in Aptorum Group's Form 20-F and other filings that Aptorum Group may make with the SEC in the future and the prospectus that received the French Autorite des Marches Financiers visa n20-352 on 16 July 2020. As a result, the projections included in such forward-looking statements are subject to change and actual results could be materially different from those described herein.

Aptorum Group assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

This announcement is not a prospectus within the meaning of the Regulation (EU) n2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n2019/980 of 14 March 2019 and n2019/979 of 14 March 2019.

This press release is provided "as is" without any representation or warranty of any kind.

Contacts
Investor relations
Aptorum Group limited
Investor Relations Department
Tel: +44 020 80929299
Email: investor.relations@aptorumgroup.com

Redchip – Financial Communications United States
Investor relations
RedChip Companies, Inc.
dave@redchip.com
+1 407 491 4498

Actifin – Financial Communications Europe
Investor relations
Ghislaine Gasparetto
ggasparetto@actifin.fr
+33 1 56 88 11 22




Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Hepalink Announces 2020 Interim Results

HONG KONG, Aug 31, 2020 – (ACN Newswire) – Shenzhen Hepalink Pharmaceutical Co., Ltd. (Stock Code: 9989.HK; "Hepalink" or the "Group") today announced the unaudited consolidated results for the first half year of 2020 ("1H2020") ended June 30, 2020 (the "Reporting Period").

Financial Highlights
For the six months ended 30 June 2020, the Group recorded:
– Total revenue was RMB2,635.6 million, an increase of 24.3% over the first half of 2019 ("YoY");
– Gross profit was RMB1,085.8 million, an increase of 47.9% YoY;
– Gross margin amounted to 41.2%, an increase of 6.6 percentage point YoY;
– On a non-IFRS basis, net profit attributable to equity holders of the Group (net of non-recurring profit or loss) was RMB505 million, increased by 668.8%;
– The adjusted net profit attributable to equity holders of the Group after deduction of non-recurring profit or loss (excluding the listing expenses after tax of RMB32 million) was approximately RMB 532 million.

In the first half of 2020, the sudden outbreak of COVID-19 has impacted many industries in varying degree. During the Reporting Period, the Group maintained sound revenue growth and profitability. For the six months ended June 30, 2020, the Group's total revenue amounted to RMB2,635.6 million, representing a year-on-year increase of 24.3%, while the gross profit of the Group increased 47.9% to RMB1,085.8 million; and recorded net profit attributable to equity holders of the Group (net of non-recurring profit or loss) of RMB505 million, representing a year-on-year increase of 668.8%.

Outstanding Performance of Our Businesses
The revenue from finished dose pharmaceutical products business increased by 37.1% to RMB631.3 million for the first half of 2020 on a year-on-year basis and accounted for 24.0% of the Group's total sales revenue. Gross profit increased by 31.1% to RMB272.8 million, with a gross margin of 43.2%. During the Reporting Period, as the major market of enoxaparin finished dose, Europe was affected by the unexpected COVID-19 epidemic, and the Group encountered varying degrees of challenges. The Group proactively strengthened its marketing efforts by further promoting hospital sales channels in European countries and building our pharmacy channels with a spillover effects from hospital to pharmacy. In June 2020, the Group's enoxaparin finished doses obtained the approval for marketing in Switzerland, which marked as an important step for the Group in EU market. The access to the Swiss market is a recognition of our excellence in the quality of products, and further accelerate the Group to achieve full coverage of European market.

The sale of heparin API business, which accounted for 55.4% of the Group's total sales revenue, amounted to approximately RMB 1,459.1 million, representing a year-on-year increase of 30%. The gross profit increased by 67.9% to RMB656.3 million, with a gross margin increased to 45% from 34.7% compared to the same period in 2019. The API business achieved outstanding growth and profit performance in the first half of 2020, which was primarily driven by the effectiveness of new pricing scheme formulated by the Group and its customers. This enabled the effective transmission of upstream cost fluctuations, and the gross profit level of the heparin API business improved significantly as compared to the same period of last year.

The CDMO business increased by 11% to RMB 386.8 million, and accounted for 14.7% of the Group's total sales revenue. The gross profit increased by 49% to RMB123.2 million, with the gross margin increased by 8.1 percentage point to 31.9% compared to the same period in 2019. The simultaneous enhancement of the Group's production capacity in the microbial fermentation and mammalian cell culture business lines, the further enhancement of its operational capabilities, as well as the successful cooperation with multinational companies and the maintenance of revenue growth contributed to the development of CDMO business. The gross profit margin of CDMO business was improved because of the increased utilization of scientific research and development.

Development of New Drugs is Progressing Steadily
During the Reporting Period, the Group anchored its efforts on research and development of innovative drugs. The Group made remarkable progress in the research and development of its two new drugs, Oregovomab and RVX-208. Oregovomab, the world's first immunotherapy drug, can be used to treat advanced ovarian cancer; the PFS of the phase I clinical trial group is 41.8 months, which was nearly 3.5 times in compared to the control group (12.2 months). The Group is making strenuous preparations for the III phase of the clinical trial, and it is expected that Oregovomab will become the most effective first-line treatment for advanced ovarian cancer after the completion of the phase III. Besides, RVX-208, which is intended to reduce major adverse cardiovascular events among high-risk cardiovascular disease patients with type 2 diabetes mellitus, was granted Breakthrough Therapy Designation by the FDA in February 2020. Its phase III clinical protocol was reapproved by the FDA in June 2020, indicating that the new drug pipeline of the Group was recognized and supported by the regulatory authorities.

Mr. Li Li, the Chairman of the Board of Shenzhen Hepalink Pharmaceutical Co., Ltd. stated, "The outbreak of COVID-19 is expected to have a significant impact on every industry this year. We believe it is confronted with the opportunities and challenges. We achieved high growth from pharmaceutical products, development of innovative drugs and CDMO business, which were primarily driven by our long-term competitiveness. The COVID-19 pandemic poses significant risks to public health, many countries start to implement policies on reservation of medical resources and equipment, which is expected to drive the demand in the medium to long term. In light of these uncertainties, we will continue to closely monitor the market and utilize our advantage of global operating model in order to seize the market opportunities and strengthen cooperation with customers." With regard to the plans for the second half of 2020, he added, "We will remain flexible and adjust our strategies from time to time to ensure that the Group can deliver steady growth. At the same time, the Group will continue to execute its strategies and plans to reach our annual targets and to achieve our goal of becoming a leading international pharmaceutical enterprise in the future."

About Shenzhen Hepalink Pharmaceutical Co., Ltd.
Shenzhen Hepalink Pharmaceutical Co., Ltd. is a global pharmaceutical company with business spanning the manufacture and sale of pharmaceutical products, development of innovative drugs and CDMO services. The Company's sales of pharmaceutical products consists of finished does pharmaceutical products which include enoxaparin sodium injection; active pharmaceutical ingredient ("API") products including heparin sodium API and enoxaparin sodium API; and other products mainly including pancreatin API. The Company has obtained exclusive development and commercial rights in Greater China for clinical stage innovative drug candidates which are being developed for the treatment of disease with an immune system axis. The Company are also developing a self-discovered proprietary drug candidate currently at preclinical stage. The Company operate a CDMO business providing R&D, manufacturing, quality management and program management services, through the Company's wholly-owned subsidiaries Cytovance Biologics, Inc. (the "Cytovance"), which specializes in the development and manufacture of recombinant pharmaceutical products and critical non-viral vectors and intermediates for gene therapy, and SPL Acquisition Corp. (the "SPL"), which provides services in the development and manufacture of naturally derived pharmaceutical products.


Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Junshi Biosciences Announces Financial Results for Six Months Ended June 30, 2020 and Provides Corporate Updates

HONG KONG, Aug 31, 2020 – (ACN Newswire) – Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced its financial results for the six months ended June 30, 2020 and provided corporate updates.

First Half 2020 Financial Highlights

– Total revenues reached RMB575 million in the first half year of 2020, representing an 86% increase compared with the first half year of 2019. Sales of Toripalimab was RMB426 million, out of which RMB254 million was generated in the second quarter, representing recovery from the initial outbreak of COVID-19 in early 2020. Gross margin increased slightly to approximately 90% due to capacity utilization and productivity improvement. Sub-licensing and service income was RMB149 million. Junshi entered into a research collaboration and license agreement with Lilly and granted Lilly a license to conduct research, development and commercialization of JS016, an innovative drug for the treatment and prevention of COVID-19 in May 2020.

– The research and development ("R&D") expenses were RMB709 million in the first half year of 2020, representing an increase of 92% compared to RMB369 million for the same period in 2019. The increase was primarily due to progress of key clinical trials, more R&D collaboration and license-in activities expanding our pipelines to small molecule drugs, antibody drug conjugates (ADCs) and JS016.

– The property, plant and equipment ("PPE") by the end of June 2020 increased 11% to RMB2,026 million compared with the end of year 2019. The significant growth of the PPE was primarily due to the construction of the Lingang Production Base, which will enhance our current production capacity by ten folds.

– Total comprehensive expense for the Reporting Period was RMB593 million, representing an increase of 105% compared to first half of 2019, mainly due to profit generated from Toripalimab sales, service income and sub-licensing income but offset by the increase in R&D expenses and administrative and selling expenses.

– As of 30 June 2020, our bank and cash balances decreased to RMB676 million from RMB1,214 million as of 31 December 2019. The decrease was mainly due to: 1) investment in ongoing R&D projects, new R&D collaboration and license-in projects; 2) investment in and acquisition of companies in the pharmaceutical sector; and 3) investment in the production bases especially the Lingang Production Base. Subsequently, in July 2020, the company completed a public offering of A shares on the STAR Market of the Shanghai Stock Exchange and received gross proceeds of approximately RMB483.6 million.

Business Highlights

During the Reporting Period, we achieved significant progress with respect to our product commercialization, clinical trials and pipeline expansion. The Company's products concentrated on self-developed biological products with original innovation. At the same time, through co-development and technology transfer/license-in, we further expanded our product pipeline. As of the end of the Reporting Period, we had 21 drug candidates, including 19 innovative drugs and 2 biosimilars, covering five major therapeutic areas including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases and infectious diseases.

– During the Reporting Period, 15 pivotal registered clinical trials for Toripalimab were being conducted, in which 2 pivotal registered clinical trials were applied for NDA to the National Medical Products Administration ("NMPA") and included in the process of priority review, covering a broad spectrum of indications, including: melanoma, urothelial carcinoma, nasopharyngeal carcinoma, non-small cell lung carcinoma, esophageal carcinoma, small cell lung carcinoma, triple negative breast carcinoma, hepatocellular carcinoma, gastric carcinoma and renal cell carcinoma.
— In March 2020, Toripalimab in combination with Axitinib for treatment of mucosal melanoma was granted the orphan-drug designation by the US Food and Drug Administration ("FDA").
— In April and May 2020, the supplemental NDAs in respect of Toripalimab as a treatment for recurrent/metastatic NPC after failure of second-line and above systemic treatment and for locally advanced or metastatic urothelial carcinoma who received previous treatment were accepted by the NMPA, marking a new stage in the layout of indications in the segmented areas of Toripalimab. The two supplemental NDAs had been included in the process of priority review by the NMPA in July 2020.
— In June 2020, the Company and Merck KGaA entered into clinical trial collaboration in respect of the use of Toripalimab in combination with Cetuximab (Erbitux) for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck.

– The Company's drug candidate TAB004/JS004 (a recombinant humanized anti-BTLA monoclonal antibody for injection) was approved for clinical trials in China by the NMPA, and the first patient was dosed in a Phase I clinical study in April 2020. In addition, its Phase I clinical study in the United States has completed dose-escalation study and entered dose-expansion stage.

– The first subject was dosed in a Phase I clinical study of JS005 (a recombinant humanized anti-IL-17A monoclonal antibody for injection) in China in May 2020. At present, the Phase I clinical study has completed random enrollment.

– In March 2020, the Company and the Institute of Microbiology, Chinese Academy of Sciences ("IMCAS") entered into a project cooperation agreement to jointly develop and produce novel coronavirus neutralizing antibody JS016 (a recombinant fully human anti-SARS-CoV-2 monoclonal antibody for injection), an innovative drug for the treatment and prevention of COVID-19.
— In May 2020, the Company and Lilly entered into an agreement to collaborate on research, develop and commercialize potential preventive and therapeutic antibody therapies for COVID-19, and Lilly was granted an exclusive license to conduct research, develop and commercialize JS016 outside Greater China.
— In May 2020, the international authoritative journal "Nature" published the results of JS016 pre-clinical research, which reported for the first time that the neutralizing antibody of SARS-CoV-2 can significantly inhibit novel coronavirus infection in the test on non-human primate rhesus monkeys, showing the dual effect of treatment and prevention.
— In June 2020, JS016 was approved to conduct Phase I clinical trial in China, and the enrollment of subjects in the Phase I clinical trial was completed in July 2020. The international multi-center clinical trial was a randomized, double-blind and placebo controlled Phase I clinical study, aiming at evaluating the tolerability and safety of single-dose intravenous infusion of JS016 in healthy subjects. We plan to recruit 40 healthy subjects (including both male and female) as the world's first novel coronavirus neutralizing antibody clinical trial conducted in healthy subjects. We are conducting Phase Ib international multi-center clinical studies for patients with mild/normal novel coronavirus pneumonia. And we expect to commence Phase II/III clinical study for patients with severe and critical novel coronavirus pneumonia as soon as possible. At the same time, the Company will also conduct follow-up studies on groups who are at high risks of the novel coronavirus to evaluate the preventive effect of JS016 on novel coronavirus infection.

After the Reporting Period, we continued to make significant progress in business operations including the following:

– The Company applied to The Stock Exchange of Hong Kong Limited (the "Hong Kong Stock Exchange") and obtained approval for the dis-application of Rules 18A.09 to18A.11 of the Rules Governing the Listing of Securities on the Hong Kong Stock Exchange (the "Hong Kong Listing Rules") (the "Relevant Rules") to the Company. As a result of the dis-application of the Relevant Rules, the "B" marker ceased to be affixed to the Company's stock name and stock short name from 15 July 2020.

– The Company completed the issue of A shares. The A shares of the Company were listed and commenced trading on the STAR Market of the Shanghai Stock Exchange on 15 July 2020.

– The Company entered into a research collaboration and license agreement with Revitope Oncology, Inc. to develop next generation of T-cell engaging cancer immunotherapies that utilize Revitope's proprietary dual-antigen targeting technology platform together with the Company's antibody technology platform. Revitope will be responsible for designing up to 5 unique T-cell immunotherapeutic drugs against targets selected by the Company. The Company will be granted a world-wide exclusive license on products that result from such agreement.

– The Company's recombinant humanized anti-Trop2 monoclonal antibody – Tub196 conjugate for injection (product code: JS108), obtained the Clinical Trial Approval issued by the NMPA.

– The Company and IMPACT Therapeutics entered into a joint venture agreement for the formation of a joint venture company (the "JV Company"). The JV Company will mainly engage in the R&D and commercialization of small molecule anti-tumor drugs. IMPACT Therapeutics will contribute for its equity interests by way of injection of a PARP inhibitor Senaparib (IMP4297) as an asset within mainland China, Hong Kong and the Macau Special Administrative Regions. The Company and IMPACT Therapeutics will each own 50% equity interests in the JV Company. Both parties will cooperate in conducting clinical trials, manufacturing, and commercialization preparations for various indications of the IMP4297 project within the above territory.

About Junshi Biosciences
Junshi Biosciences (HKEX: 1877; SSE: 688180) was co-established in December 2012 by alumni of famous universities of China and the United States. The founding team has extensive and solid experience in the cross-border transformation of scientific and technological achievements and substantial expertise in the pharmaceutical industry.

Our priority is researching and developing therapeutic antibodies. We are committed to researching, developing, and industrializing innovative monoclonal antibody drugs and other therapeutic protein drugs. The company has established a diversified R & D pipeline comprising 19 innovative candidate drugs and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune diseases, metabolic diseases, neurologic diseases, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for PD-1 monoclonal antibody and clinical trial approval for anti PCSK9 monoclonal antibody from NMPA. The world's first in human anti-BTLA antibody for solid tumors was officially approved for drug clinical trials by the FDA and NMPA. From this year onwards, Junshi Biosciences pooled its efforts with Chinese science institutions to co-develop JS016, China's first neutralizing human monoclonal antibodies against SARS-Cov-2, that has entered clinical trial, part of our continuous innovation for disease control and prevention in China and beyond. We have about 2,000 employees in San Francisco and across Maryland in the United States, as well as Shanghai, Suzhou, Beijing, and Guangzhou, China. For more information, please visit: http://junshipharma.com.

Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800


Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Sino Biopharm Announces 2020 Interim Results

HONG KONG, Aug 28, 2020 – (ACN Newswire) – Sino Biopharmaceutical Limited ("Sino Biopharm" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading, innovative research and development ("R&D") driven pharmaceutical conglomerate in the PRC, has announced its unaudited interim results for the six months ended 30 June 2020 (the "review period").

Results Highlights
– Sino Biopharm ranked 133rd among the Top 500 Chinese Listed Companies in terms of market capitalization in 2020 published by 21 Data News Laboratory in March, up 87 positions when compared to last year.
– According to the index review results announced by the Hang Seng Indexes Company Limited in March, the weighting of Sino Biopharm in the Hang Seng Index increased from 0.88 to 0.96, while the weighting of Sino Biopharm in Hang Seng China Enterprises Index rose from 1.41 to 1.51. The changes took effect after the market close on 6 March.
– On 23 March, the Hang Seng Indexes Company Limited announced the launch of the Hang Seng Stock Connect Biotech 50 Index. Sino Biopharm has been included in the index and was ranked second among the top 10 weighted constituents on that day. The index reflects the overall performance of the 50 largest biotech companies in terms of market capitalization that are listed in Hong Kong or Mainland China and are eligible for trading through the Stock Connect Scheme.
– In May 2020, the China Healthcare Consulting and CITIC Securities jointly issued the "2019 China Healthcare Industry Investment and Financing Honor List". Sino Biopharm was named as one of Top 10 Best Listed Biopharm Companies in 2019.
– On 8 June, Sino Biopharm was included among the Hang Seng China (Hong Kong-listed) 25 Index, becoming the only pharmaceutical stock selected by the Index.
– On 12 June, PharmExec, a pharmaceutical magazine in the US, announced a compilation of the top 50 global biopharm players in 2020. The Group again made the list this year, ranking 42nd with a revenue of US$3.373 billion.
– The Group's Budesonide Suspension for Inhalation (brand name: Tianqingsuchang) has obtained approval and has become the first nebulized budesonide generic drug in China. This product is an inhaled glucocorticoid with strong focal anti-inflammatory effect, given through a nebulizer. It can fight inflammation through various ways, not only countering inflammatory cells, but also suppressing glandular secretion, thus reducing exudation from inflammation and sputum, and boasts excellent clinical efficacy for asthma and chronic respiratory patients. It also has a higher technological entry barrier, which requires huge investments in R&D, testing and equipment. Previously, the market only had the branded product of AstraZeneca. In 2019, a sales amount of approximately RMB6 billion was recorded at the specimen hospitals. With high R&D standards, the quality of Tianqingsuchang is as good as the branded product but with differentiation in areas of safety, speed, efficacy, effective duration, etc. The launch of Tianqingsuchang marks a breakthrough for domestic medicine in a product category with a high entry barrier, and offers a new choice to ease the financial burden of local patients.
– Nanjing Chia Tai Tianqing has been included in the Top 100 Innovative Patents of Nanjing Companies published by the Nanjing Municipal Intellectual Property Administration. CT Qingjiang has been named as a National IP Exemplary Enterprise by the National Intellectual Property Administration, PRC.

Results
During the review period, the Group recorded revenue of approximately RMB12,648 million, representing an increase of approximately 1.0% over the same period last year. Profit attributable to the owners of the parent was approximately RMB1,213 million, approximately 16.0% lower than that of the same period last year, which was mainly impacted by the non-cash fair value loss of and effective interest expenses from the EUR750 million zero coupon convertible bonds due 2025 that the Group issued in February 2020. Excluding the impact of (i) amortization expenses of new identifiable intangible assets arising from the acquisition of 24% interests in Beijing Tide (net of related deferred tax and non-controlling interests), (ii) the unrealized fair value losses (net) on equity investments and financials assets, (iii) fair value loss of convertible bond embedded derivative component and (iv) effective interest expenses of convertible bond debt component, underlying profit was approximately RMB1,761 million, approximately 5.2% higher than that of the same period last year. Based on underlying profit, the earnings per share were approximately RMB13.99 cents, approximately 5.2% higher than that of the same period last year. The Group has maintained a strong financial position with cash and bank balances reaching approximately RMB17,091 million at the period end.

The Board of Directors has declared the payment of a second quarterly dividend of HK2 cents per share. Together with the dividend of HK2 cents already paid in the first quarter, the total dividends for the first half of 2020 amounted to HK4 cents (first half of 2019: HK4 cents).

Business Highlights
During the review period, the implementation of the prices in the National Reimbursement Drug List after negotiation and the centralized drug procurement policy had a bigger influence on the Group's revenue and profit. The rapid growth of new products became the main drivers: Qingkeshu (Abiraterone Acetate Tablet), Anxian (Lenalidomide Capsules), Tianqingsuchang (Budesonide Suspension for Inhalation), Leweixin (Bendamustine Hydrochloride for Injection), Tianming (Caspofungin Acetate for Injection), Weishou (Azacitidine for Injection), Shanqi (Fosaprepitant Dimeglumine for Injection) and Qingliming (Iodixanol Injection). All of these new products have quickly grown into new business drivers, reflecting the value created by the Group's high R&D investments over the years, and the outstanding abilities of its marketing teams developing new products in different sectors.

The Group capitalized on the success of Anlotinib, a blockbuster innovative oncology medicine, and concentrated its human and financial resources on the oncology sector through creating effective synergies. Apart from the oncology drugs mentioned above, other drugs including Yinishu (Dasatinib Tablets), Qianping (Bortezomib for Injection) and Yijiu (Bortezomib for Injections) also delivered substantial growth. Contributions from the oncology medicines sector to the Group's growth already exceeded that from hepatitis medicines and cardio-cerebral medicines sectors which were previously key revenue contributors of the Group.

Benefitting from the Group's deployment in chronic disease management over the years, respiratory system medicine Tianqingsule (Tiotropium Bromide Powder for Inhalation) showed healthy growth. The brilliant performance of Tianqingsuchang (Budesonide Suspension for Inhalation) after its launch also demonstrated the Group's expertise and competitive strength in respiratory medicines sector. Several subsequent respiratory products of the Group are also in the final stage of clinical trial.

As a result of the increasing use of anti-infectious respiratory medicines during the COVID-19 pandemic and the Group's stronger promotion of its anti-infectious products, antibiotics products including Tianjie (Tigecycline for Injection), Tianli (Linezolid and Glucose Injection) and Fengruineng (Moxifloxacin Hydrochloride and Sodium Chloride Injection) achieved satisfactory growth. During the pandemic, the Group quickly engaged in different modes of effective communications and consultations with doctors and patients and provided information services via various network technology platforms, which brought about positive impact on its sales.

During the review period, the sales performance of the Group's major medicine types are as below:

– The sales of oncology medicines amounted to approximately RMB4,018 million, representing approximately 31.8% of the Group's revenue.

– The sales of hepatitis medicines amounted to approximately RMB2,249 million, representing approximately 17.8% of the Group's revenue.

– The sales of orthopedic medicines amounted to approximately RMB1,018 million, representing approximately 8.0% of the Group's revenue.

– The sales of anti-infectious medicines amounted to approximately RMB753 million, representing approximately 6.0% of the Group's revenue.

– The sales of respiratory system medicines amounted to approximately RMB597 million, representing approximately 4.7% of the Group's revenue.

– Sales of others amounted to approximately RMB4,013 million, representing approximately 31.7% of the Group' revenue.

R&D
The Group has continued to focus its R&D efforts on new hepatitis, oncology, respiratory system and cardio-cerebral medicines. During the second quarter, the Group was granted 8 clinical trial approvals, 6 production approvals, and 3 approvals for Consistency Evaluation, and made 20 clinical trial applications, 1 application for Consistency Evaluation and 17 production applications. The production approvals included Bortezomib for Injections (additional specification), Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, Clopidogrel Hydrogen Sulphate Tablets, Invert Sugar Injection (two concentrations) and Vildagliptin Tablets. During the first half of 2020, it obtained 12 production approvals, Consistency Evaluation approval for 9 products (including those deemed to have passed the Consistency Evaluation) and 22 clinical trial approvals. The Group also submitted 19 production applications, 29 clinical trial applications and 4 applications for Consistency Evaluation. Cumulatively, a total of 438 pharmaceutical products had obtained clinical trial approval, or were under clinical trial or applying for production approval. Out of these, 38 were for hepatitis medicines, 189 for oncology medicines, 22 for respiratory system medicines, 24 for endocrine, 35 for cardio-cerebral medicines and 130 for other medicines.

The Group also emphasizes on the protection of intellectual property rights. During the second quarter, the Group has received 83 authorized patent notices (61 invention patents, 5 utility model patents and 17 apparel design patents) and filed 150 new patent applications (143 invention patents, 3 utility model patents and 4 apparel design patents). During the review period, the Group has also obtained 82 invention patent approvals and has filed 263 new invention patent applications. It also obtained 7 utility model patents and made 3 utility model patent applications. Cumulatively, the Group has obtained 848 invention patent approvals, 30 utility model patents and 109 apparel design patents.

Prospects
The main purpose of the government's efforts to deepen medical insurance reform is to maintain fundamental benefits and expand coverage. Going forward, adjustments to the categories and prices in the NRDL and Essential Drug List are expected to cover drugs in all categories, and reducing the price of medicines through centralized drug procurement will become a normal practice. The launch of the total amount control payment policy such as payment categorized under Diagnosis-Related Groups and the medical representative registration system will further increase the difficulty of marketing in the pharmaceutical industry. The Consistency Evaluation of injections will accelerate the elimination of uncompetitive generic drugs manufacturers and drive the transformation of generic drug manufacturers boasting R&D capability to develop new medicines. The new drug evaluation and approval mechanism encourages innovation and speeds up the introduction of new medicines. Enterprises with strong innovation and R&D capabilities and diversified market operation models will be able to enjoy greater advantages.

Observing the government's active promotion of the "Internet + healthcare" policy, the trial launch of initial medical consultation via the Internet in some of the provinces and cities and medical insurance payment relating to Internet healthcare, the Group will pay close attention to the impact of these initiatives on the medical model and modes of marketing in the pharmaceutical industry, as well as explore related opportunities.

About Sino Biopharmaceutical Limited (HKEX:1177)
Sino Biopharmaceutical Limited is a leading, innovative R&D driven pharmaceutical conglomerate in the PRC. Its business encompasses a fully-integrated chain which covers an array of R&D platforms, a line-up of intelligent production and a strong sales system. The Group's products have gained a competitive foothold in various therapeutic categories with promising potentials, comprising a variety of biopharmaceutical and chemical medicines for treating liver diseases, tumors, orthopedic diseases, anti-infections and respiratory system diseases.

Sino Biopharmaceutical is a constituent stock of the following indices: MSCI Global Standard Indices – MSCI China Index, Hang Seng Index, Hang Seng Index – Commerce & Industry, Hang Seng Composite Index, Hang Seng Composite Industry Index – Consumer Goods, Hang Seng Composite LargeCap Index, Hang Seng Composite LargeCap & MidCap Index, Hang Seng China (Hong Kong-listed) 100 Index, Hang Seng Stock Connect Hong Kong Index and Hang Seng China (Hong Kong-listed) 25 Index. Sino Biopharm was ranked as one of "Asia's Fab 50 Companies" by Forbes Asia for three consecutive years in 2016, 2017 and 2018.



Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Novotech the Asia-Pacific CRO Leader – Awarded ‘2020 Frost & Sullivan Asia-Pacific CRO Company of the Year’

SYDNEY, Aug 26, 2020 – (ACN Newswire) – Novotech, the largest biotech specialist CRO in the Asia-Pacific region, was awarded the '2020 Frost & Sullivan Asia-Pacific CRO Company of the Year' in an overnight virtual global ceremony. This is the fourth consecutive year Novotech has been recognized with the prestigious CRO regional award.



Yooni Kim accepting the award



Accepting the award at the ceremony last night, Novotech's Executive Director Asia Operations Yooni Kim said:

"On behalf of Novotech I am extremely pleased the company has again been recognized as the CRO leader in the region. Novotech is growing rapidly due to its reputation for specialist teams on the ground across the Asia region with local knowledge, partnerships and expertise. Our staff numbers have grown by over 20% over the last 12 months. We now have over 750 Novotech people delivering excellence in clinical research management, biometrics and monitoring. Novotech helps biotechnology companies progress their R&D programs by investing in upfront regulatory and clinical consulting, continued focus on developing site relationships across the region, and a commitment to creating an exceptional workplace. Everyone at Novotech is very proud of our recent successes. So once again many thanks to the Frost & Sullivan jury for selecting Novotech for this award and congratulations to all nominees!"

Award recipients are selected after extensive research and market analysis by the Frost & Sullivan industry team.

Senior Industry Analyst Transformational Health Frost & Sullivan Khushbu Jain said:

"Novotech's commitment to offering its customers unparalleled value has guided its investments in IT infrastructure such as CTMS upgrade, Medidata Rave coding systems and developing its clinical consulting capabilities through BioDesk. In addition, the company's strong understanding of cultures, language and regulatory requirements has uniquely positioned Novotech in APAC to offer a level of service comparable to that of global CROs, but with the local flexibility and scale that appeal to biotech companies."

Novotech has been delivering clinical research excellence in the Asia-Pacific for US, EU and APAC biotechs for more than 24 years with its specialist Novotech teams across 11 countries, and supported by more than 30 partnerships with major health institutions.

Novotech is always hiring the best people in the region – please see our careers page here. https://novotech-cro.com/careers

Watch the ceremony here. https://youtu.be/qslO6K0XlYk

About Novotech – https://novotech-cro.com

Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific. Novotech has been instrumental in the success of over a thousand Phase I – IV clinical trials for biotechnology companies. Novotech was established in 1996, with offices in 11 locations across the region, and site partnerships with major health institutions.

Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.

For RFP enquiries: Please fill out the form available at https://novotech-cro.com/talk-to-an-expert

Media Contact
David James
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Sihuan Pharmaceutical Announces 2020 Interim Results

HONG KONG, Aug 25, 2020 – (ACN Newswire) – Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460 "Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") is pleased to announce its interim results for the 6 months ended 30 June 2020 (the "Period").

Financial Summary

Under the influence of pharmaceutical policies and COVID-19 during the Period, the Group recorded a revenue of approximately RMB1,054.5 million, representing a year-on-year decrease of 36.4%. Gross profit amounted to approximately RMB786.1 million, decreased 42.4% year-on-year. Gross profit margin is 74.5%, decreased 7.9 p.p. from the same period last year. The lower gross profit margin was resulted from decreased sales of drugs which had better profit margin but were captured in the Key Monitoring Drug List during the Period. Profit attributable to owners of the Company for the Period amounted to approximately RMB170.5 million.

During the Period, revenue from CCV products recorded approximately RMB609.6 million, decreased 58.0% year-on-year, accounting for 57.8% of the Group's total revenue. The sales decline was mainly due to the drop in patient flow in hospital during the COVID-19 pandemic and products exclusion from PRDL and NRDL starting from the second half of last year.

Revenue from non-CCV products sharply by 114.6% year-on-year to approximately RMB444.9 million, accounting for 42.2% of the Group's total revenue. This sales growth was mainly attributable to the group's strong sales platform, hospital coverage has sharply increased.

The Group maintained strong financial position during the Period, with net cash of approximately RMB4,336.0 million recorded as at 30 June 2020. The Group's net cash-to-equity ratio is 50.3%, and debt-to-equity ratio is 7.1%.

An interim cash dividend of RMB0.1 cents per share and special cash dividend of RMB3.0 cents per share were declared by the Board.

Strategic planning

The Group values the development of innovative drug R&D center, generic drug R&D center and high-quality production enterprises as its core: During the Period, innovative drug R&D center Xuanzhu Biopharmaceutical spun off and became independent. WIth the support of the Group, it is able to quickly develop innovative drugs that are differentiated, effective and safe, and with global intellectual property rights, therefore achieves the goal of solving the huge and unmet clinical needs in oncology, metabolic diseases and anti-infective field, etc. Jilin Huisheng Biopharmaceuticals, a biopharmaceutical R&D center, is committed to building a full product-line platform in the field of diabetes, covering products from biosimilar insulin products to oral preparations and compound preparations. It is actively introducing other varieties and plans to become an independent spin-off and get listed in the future. Beijing Aohe Research Institute, a generic drug R&D center which has very mature technology, and is looking for varieties with high-tech barriers in APIs, dosage forms, and preparation processes in key therapeutic areas for R&D process. In addition, Beijing Sihuan, Jilin Sihuan, Jilin Jinsheng and other manufacturing companies will rely on their high-efficiency, low-cost, modern production lines for unique formulations and dosage forms and experienced production technical teams. The Group's superior sales teams will support the above-mentioned companies, and quickly promote product commercialization. As a result, Sihuan Pharmaceutical will thus become a group which integrates production, sales, and research.

Innovation-driven, imitation and creation co-exist

Significant progress has been made in multiple R&D platforms that are carefully incubated by the Group. Xuanzhu Biopharmaceutical is one of the few domestic innovative drug companies that have a complete R&D industry chain, and with more than ten innovative products, mainly covering oncology, diabetes, metabolic diseases, digestive system, male reproduction, anti-infection and other fields for product line R&D layout. Some of the products have already entered their late clinical stage. The key product Birociclib, a CDK4/6 inhibitor for advanced breast cancer, has successfully carried out multiple clinical trials. Another blockbuster product, Janagliflozin, an SGLT-2 inhibitor for the treatment of diabetes, can reduce blood sugar while protecting the heart and kidneys, and has entered clinical phase III and is expected to bring hope to patients in China. Biopharmaceutical R&D platform, Jilin Huisheng Biological Co., Ltd. focuses on the treatment of diabetes and complications, covering biological drugs and chemical drugs, and has a comprehensive product pipeline. Currently, the products under research include insulin and its analogues, GLP-1 analogues and oral solid preparations. In addition, Beijing Aohe Generic Drug R&D Center, a generic drug R&D platform has obtained many product approvals: rivastigmine hydrogen tartrate capsule and levetiracetam tablets have obtained pharmaceutical production approval, midazolam oromucosal solution has been granted drug registration, ibuprofen injection has been granted production approval, and the paediatric compound amino acid injection (18AA-II) also obtained drug registration approval.

At the same time, the Group is actively enhancing international business cooperation through investment and mergers and acquisitions, with businesses covering multiple therapeutic areas with huge clinical needs. In 2020, the Group became equity investment partners with Zhongrui and Chempion to ensure the stable supply of the Group's related preparations and raw materials and strengthen the Group's R&D capabilities in high-tech barrier raw materials, continuous flow processes, and enzymatic processes. The Group also reached a cooperation framework agreement with HETETO, India to cooperate in the R&D of high-end generic drugs in the field of cardiovascular and cerebrovascular, central nervous system and anti-infection.

Focus on the rapid developing therapeutic fields, lay out the investment and optimization of APIs

Oncology, diabetes, metabolic, non-alcoholic hepatitis and other diseases have become the fastest growing therapeutic areas in global pharmaceutical market, especially in China pharmaceutical market. The Group focuses on products layout in these areas, including independently developed innovative products, biosimilars and generic drugs with huge clinical demand.

On the premise of ensuring science and quality, the Group will reduce operating and production costs, especially the in investment and optimization of APIs, so as to increase the competitiveness and product profits of future products, and thus to create greater value. The Group also values the unique sales model and marketing network which have rich experience, high performance and extensive hospital coverage, as well as a multi-dimensional international business cooperation platform.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group said, "Sihuan Pharmaceutical values innovative drug R&D center, generic drug R&D center and high-quality manufacturing companies as its core value, supplemented with investment, mergers, incubation, holdings, spin-offs, etc., for a group of independently operating subsidiary companies. The Company will realize the initiative of each sub-enterprise through the introduction of capital, CMO and other independent operations, and to improve the efficiency and competitiveness of Sihuan Pharmaceutical, therefore adapt to MAH and a series of policy changes and industry competition patterns. At the same time, the Company will help the subsidiaries to be able to land in the capital market soon, also add value to the parent company. This dual approach of strategic planning and core values will enable Sihuan Pharmaceutical to focus on global level, focus on the pharmaceutical field, and form the most competitive, international and professional pharmaceutical group enterprise.

Future prospects

With regard to existing products on sale, the Group will continue to improve the evidence-based research system, promote key products to be included in the diagnosis and treatment guidelines, and evaluate the launched exclusive and major products. At the same time, giving full play to the advantages of diversified product structure, actively promote products in the growth period through refined market management, and strengthen the Group's pipeline layout and market advantages in the fields of cardiovascular, oncology and diabetes, and establish a sustainable drug product line. The group will also increase its resources for drug R&D projects and establish a sustainable drug product line, adjust the product structure through mergers and acquisitions and international cooperation. In order to enrich the project resources and optimize the product portfolio continuously, domestic and overseas mergers and acquisitions will be the Group's sustainable strategy to provide short-, medium- and long-term growth engines. Several products are expected to be launched on the market in the next year or two, including leading generic drugs, such as midazolam oromucosal solution and rivastigmine hydrogen tartrate capsule, specialty drugs, such as quetiapine fumarate SR tablet, and innovative drugs, such as Janagliflozin and Anaprozole sodium.The Group also conforms to policies and market trends, seizes policy opportunities, studies and judges market development directions, focuses on business synergy and resource integration, accelerates the cultivation of new businesses, and continuously improves the Group's core competitiveness by adjusting the business structure and encouraging model innovation. Under the assistance of the Group's experienced, high-performance, and comprehensive hospital coverage professional sales team and marketing network, and under the leadership of an international management team, Sihuan Pharmaceutical will steadily enhance its competitive advantage in the pharmaceutical industry.

About Sihuan Pharmaceutical Holdings Group Ltd.
Founded in 2001, Sihuan Pharmaceutical is a pharmaceutical group with 21 subsidiaries and integrated R&D, production and marketing and sales capabilities. It is one of the China's largest suppliers of cardiovascular and cerebrovascular prescription drugs. Sihuan Pharmaceutical integrates production, R&D, and marketing. It has an excellent and professional marketing model, a nationwide distribution network, and a diversified product portfolio with great market potential. The Group continues to increase investment in R&D every year. Because of the continuing efforts over the past decade, Sihuan Pharmaceutical has a R&D platform with over 1,000 researchers conducting more than 110 pharmaceutical research projects currently. More than 300 patents on innovative drugs were granted in China and over 80 are PCT patents, covering pipeline projects including important areas of diabetes, oncology, anti-infectives and non-alcoholic steatohepatitis etc.

For more information about Sihuanpharm, please visit the company website https://www.sihuanpharm.com/.



Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Ivermectin Triple Therapy Protocol for COVID-19 Released to Australian GPs for Infected Elderly and Frontline Workers

SYDNEY, Aug 19, 2020 – (ACN Newswire) – Triple therapy specialist Professor Thomas Borody, famous for curing peptic ulcers using a triple antibiotic therapy saving millions of lives, today released the COVID-19 treatment protocol to Australian GPs, who can legally prescribe it to their COVID-19 positive patients, and can also prescribe it as a preventative medication. Borody says this could be the fastest and safest way to end the pandemic in Australia within 6-8 weeks.



The Centre for Digestive Disease (CDD) Medical Director Professor Thomas Borody



Professor Thomas Borody MB, BS, BSc(Med), MD, PhD, DSc, FRACP, FACP, FACG, AGAF, FRS(N) said:
"The three medications are on chemist shelves right now. GPs can email GP@CDD.com.au to obtain the dosing protocol and COVID-19 treatment information for their patients.

"GPs can legally prescribe the therapy today as an "off label" treatment according to Australian Guidelines – a standard practice in medicine. In fact more than 60% of prescriptions in Australia are "off-label". It's not a new concept. It's happening every day to manage diseases and save lives."

Professor Borody continued:
"We have a therapy that can fight COVID-19. The medications have been around for 50 years, they are cheap, FDA and TGA approved and have an outstanding safety profile. Why are we just waiting around for a vaccine? To save lives we should be using whatever is safe and available right now. We could lead the world in this fight.

"Australia has some of the best medical and science people in the world – indeed the Ivermectin connection was first discovered by Dr Kylie Wagstaff's team at Monash University in April. How long do we need to wait before Australian politicians get behind Australian medical science and use 'war room' tactics with safe and approved medications."

Professor Borody, an internationally regarded physician with 4 FDA approved drugs on the US and Australian markets, is famous for developing the triple therapy that cured peptic ulcers, saving more than 18,000 lives just in Australia and millions internationally. [See Professor Borody's published research at ORCID: http://orcid.org/0000-0002-0519-4698]

"No trial has shown Ivermectin-based therapy to be ineffective. In-fact, international data reports an almost 100% cure rate and a symptom improvement within 4-6 days. We should share Australian findings from this triple therapy with the world," said Professor Borody.

"An Ivermectin tablet can cost as little as $2 – which could make it by far the cheapest, safest, and fastest cure for Australians and the Australian economy. This needs to be available for aged care facilities and frontline health workers today.

"We have written the Federal Health Minister Greg Hunt and Victorian Premier Daniel Andrews for an urgent medical briefing to bypass the raft of 'advisors' who need to know TGA-approved medicines do not require animal studies and prolonged clinical trials already done to approve them in the first place.

"The Government could end the pandemic by openly encouraging GPs to prescribe these TGA approved medications. Those who test positive, are identified in contact tracing, as well as those in high-risk groups like the elderly and healthcare workers, can then access the therapy quickly," said Professor Borody.

Ivermectin was discovered in the 1970s and is on the World Health Organization (WHO) list of essential medicines.
"There is mounting worldwide clinical literature pointing to a 100% cure rate using Ivermectin Triple Therapy," he said.

There are currently 28 COVID-19 Ivermectin treatment studies running globally. Research papers include:

WHO:
Mass treatment with ivermectin: an underutilized public health strategy
https://www.who.int/bulletin/volumes/82/8/editorial30804html/en/

ResearchSquare:
A Randomized Trial of Ivermectin-Doxycycline and Hydroxychloroquine-Azithromycin therapy on COVID19 patients
https://www.researchsquare.com/article/rs-38896/v1

MedRxiv:
Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (Pilot Trial)
https://www.medrxiv.org/content/10.1101/2020.07.07.20145979v1

Journal of Antibiotics:
Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen
https://www.nature.com/articles/s41429-020-0336-z

ResearchGate:
A Case Series of 100 COVID-19 Positive Patients Treated with Combination of Ivermectin and Doxycycline
https://www.researchgate.net/publication/343305357 _A_Case_Series_of_100_COVID-19_Positive_Patients_Treated_with_Combination_of_Ivermectin_and_Doxycycline

Journal of Bangladesh College of Physicians and Surgeons:
A Case Series of 100 COVID-19 Positive Patients Treated with Combination of Ivermectin and Doxycycline
https://www.banglajol.info/index.php/JBCPS/article/view/47512

Journal of Bangladesh College of Physicians and Surgeons:
Comparison of Viral Clearance between Ivermectin with Doxycycline and Hydroxychloroquine with Azithromycin in COVID-19 Patients
https://www.banglajol.info/index.php/JBCPS/article/view/47514

MedRxiv:
ICON (Ivermectin in COvid Nineteen) study: Use of Ivermectin is Associated with Lower Mortality in Hospitalized Patients with COVID19
https://www.medrxiv.org/content/10.1101/2020.06.06.20124461v2

ChemRxiv:
Has Ivermectin Virus-Directed Effects against SARS-CoV-2? Rationalizing the Action of a Potential Multitarget Antiviral Agent
https://chemrxiv.org/articles/preprint/12782258 Has_Ivermectin_Virus-Directed_Effects_against_SARS-CoV-2_Rationalizing_the_Action_of_a_Potential_Multitarget_Antiviral_Agent/12782258

Professor Borody says his research has led him to a triple therapy of Ivermectin, zinc and an antibiotic – which are all TGA and FDA approved. The therapy comprises:

1. Ivermectin – TGA and FDA approved as an anti-parasitic therapy with an established safety profile since the 1970s. Known as the "Wonder Drug" from Japan.
2. Zinc
3. Doxycycline – TGA and FDA approved tetracycline antibiotic that fights bacterial infections, eg. acne or urinary tract infections, viral and malarial infections.

Professor Borody is involved in a Phase 2 study in the US to potentially develop the triple therapy as a single "blister pack" compliance product. He says, "Our study in the US is looking at developing the triple therapy as a single product which requires FDA approval, even though all 3 medications separately are already approved." [US clinical trial: https://clinicaltrials.gov/ct2/show/NCT04482686?term=Ivermectin+borody]

About the Centre for Digestive Diseases (CDD)

The Sydney-based Centre for Digestive Diseases (CDD) provides patients with innovative therapies not available in the rest of the world. The Hospital features cutting-edge technologies enabling our specialists to provide world-class treatments. Visit https://centrefordigestivediseases.com.

Professor Borody is best known internationally for his work in gut and its mircobiome infections and re-purposing antimicrobial drugs for new diseases including the triple therapy cure for peptic ulcers. His discoveries prevented premature deaths in over 18,000 people and saved the Federal Government a reported $10 billion. [THEMA Report]

Professor Borody developed a triple therapy for the treatment for Crohn's Disease, and has developed 4 FDA approved pharmaceuticals for the USA and international markets.

For interviews please contact:
Kate Newton, Digital Mantra Group
E: team@DMGPR.com; AU: +61 2 8218 2144
US: +1 415 951 3228; ASIA: +65 3159 3427


Copyright 2020 ACN Newswire. All rights reserved. http://www.acnnewswire.com