Avance Clinical Client Immunic, Inc. Announced Dosing of First Healthy Volunteer in Phase 1 Clinical Program of IMU-856, Targeting Restoration of Intestinal Barrier Function

Adelaide, AUS, Sep 4, 2020 – (ACN Newswire) – The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical is pleased to share the news that its client Immunic Therapeutics has announced dosing of the first healthy volunteer in the company's phase 1 clinical program of IMU-856, an novel treatment for patients suffering from gastrointestinal diseases, including diarrhea-predominant irritable bowel syndrome, ulcerative colitis and Crohn's disease.

Immunic Therapeutics (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company developing selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases.

According to the public announcement released by Immunic Therapeutics on 20 August 2020:

> IMU-856, an orally available, small molecule modulator, serves as a transcriptional regulator of intestinal barrier function. Based on preclinical data, the compound appears to represent a novel and potentially paradigm-shifting approach to the treatment of gastrointestinal diseases by potentially restoring intestinal barrier function while maintaining immunocompetency.

> Immunic's Australian subsidiary, Immunic Australia Pty Ltd., received approval from the Bellberry Human Research Ethics Committee in Australia to conduct a phase 1 clinical trial of IMU-856 under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutic Goods Administration (TGA). The phase 1 clinical program includes single and multiple ascending dose parts in healthy volunteers. Subsequently, Immunic also plans to extend this program to assess biomarker, safety and drug trough levels in patients with diarrhea-predominant irritable bowel syndrome, ulcerative colitis and Crohn's disease.

Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, noted, "Current treatments for many gastrointestinal conditions focus on inhibiting inflammation and do not directly address impaired intestinal barrier function. In contrast, IMU-856 appears to have a unique targeted ability to strengthen and thereby normalize this function, potentially avoiding the bacterial triggers which can occur when the intestinal barrier is impaired. Moreover, because this approach appears to avoid any detrimental effects on the immune system, we believe that IMU-856 has the potential to change the treatment paradigm for gastrointestinal diseases."

Avance Clinical Chief Scientific Officer Gabriel Kremmidiotis PhD, BSC Hon said, "We consider ourselves fortunate to be working with Immunic on this exciting project. IMU-856 is the second compound that Immunic has selected Avance Clinical as their CRO. Our engagement in these projects has been from early planning, study design, preparation of the investigator brochures and clinical trial protocols. Working with the Immunic team and the Bellberry Human Research Ethics Committee, we have been able to design clinical trials which include careful data informed adaptive elements aimed at expediting the transition of these promising products from healthy volunteers to the patient populations."

See full announcement here: https://tinyurl.com/y5rvh7fa

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, including relapsing-remitting multiple sclerosis, ulcerative colitis, Crohn's disease, and psoriasis. Immunic is developing three small molecule products: its lead development program, IMU-838, is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect; IMU-935 is an inverse agonist of RORrt; and IMU-856 targets the restoration of the intestinal barrier function. On August 2, 2020, Immunic announced positive top-line results from its phase 2 EMPhASIS trial of IMU-838 in patients with relapsing-remitting multiple sclerosis, reporting achievement of both primary and key secondary endpoints with high statistical significance, indicating activity for IMU-838 in this indication. IMU-838 is also in phase 2 clinical development for ulcerative colitis and COVID-19, with an additional phase 2 trial considered in Crohn's disease. An investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary sclerosing cholangitis is ongoing at the Mayo Clinic. For further information, please visit: www.imux.com.

About Avance Clinical

Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.
Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.
Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Visit http://www.avancecro.com for more information.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons

Media Contact:
media@avancecro.com
Chris Thompson

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

Moms on Watch Condemns Lack of Diversity at Prolacta; Demands Prolacta’s Leadership Team Reflect the Communities it Serves

LOS ANGELES, CA., Sep 2, 2020 – (ACN Newswire) – Moms on Watch, a watchdog group dedicated to making mother's milk safe, affordable, and accessible, is demanding that the leadership of Prolacta Biosciences Inc. reflect the communities it serves.

Moms on Watch highlights the following statistics:

– It appears that there is only 1 woman serving on the 8-person Board of Directors
– Out of 17 people listed as Executives on the Prolacta website, only 4 are women
– It does not appear that there is even ONE person of color on either the Board of Directors or Executive Team

Moms on Watch had the following statement:

"It is shocking that Prolacta, a billion dollar company with hundreds of millions in revenue in the business of selling breast milk has an executive team that would fit well in the world of Mad Men. And if you look at the allegations against Prolacta: anti-competitive business practices, labor standard violations, sexual harassment, anti-LGBT discrimination; it is clear that they operate like an old boys club right out of the 1950s. Our group of moms believe that at the root of all of these allegations is a male-dominated chauvinist culture which emphasizes short term profits over all else and where wealthy and powerful men can engage in misconduct with impunity. Prolacta must join the 21st Century."

Moms on Watch is aware of the following allegations against Prolacta:

1. A lawsuit (LA Superior Court Docket 19STCV37738) filed in October of 2019 by a former Director of Human Resources, Jacqueline Roeder, points to a systemic culture of racist, sexist and homophobic comments. These include allegations that VP of Operations made fun of an employee for being a lesbian and, together with CEO Scott Elster, declined to hire a candidate due to his sexual orientation. The lawsuit also cites pay disparities between male and female employees and a culture of inappropriate remarks by top executives.

2. The lawsuit from that same former HR Director also alleges an even more disturbing and potentially fraudulent practice of using milk donors' DNA for research without their authorization. These allegations, if true, potentially amount to fraud.

3. Prolacta is currently in late stage litigation with a small Oregon based milk bank called Ni-Q LLC based on allegations that Prolacta fraudulently obtained bogus patents (US District Court of Oregon, Case No. 3:17-cv-934-SI).

4. Some of the reviews on job site Glassdoor again point to disturbing comments made by executives and a toxic good ol boy network where friends of Scott Elster are promoted over more qualified candidates. Accounts of inappropriate comments aren't even limited to Glassdoor. One former employee recalls Scott Elster telling her that her "pregnant belly was disgusting" and that she shouldn't have another baby.

5. Prolacta has sued Medolac, a Public Benefit corporation, in a case legal observers have called frivolous and predatory. This case appears like an attempt for Prolacta to silence competition and bury a smaller competitor in legal fees.

"Moms on Watch believes that companies, like people, should be given a presumption of innocence. Each individual allegation or battle may have a reasonable explanation but taken together there does not appear to be any reasonable explanation for a company of Prolacta's size being allegedly engaged in anti-competitive business practices, sexual harassment, discrimination, and misuse of DNA. Prolacta's deafening silence amidst these mounting allegations combined with the seeming failure of board members to start an independent investigation illustrates that the company isn't even trying to seem like a good corporate citizen anymore."

Moms on Watch is aware that a class action attorney is investigating allegations of Prolacta's misuse of breastmilk donor DNA.

Alan Romero of ROMERO LAW in Pasadena, CA can be reached at (626) 396-9900 or on his cellphone at (626) 383-3391.

Contact Information:
Ciera Jefferson
Email: MomsonWatch2020@gmail.com
https://www.momsonwatch.org/
Phone: 310 862-2377

This news release was issued through EmailWire – the global newswire with press release distribution services: http://www.emailwire.com.

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

Jacobson Pharma Collaborates with Fosun Pharma Group to Supply Potentially 10 Million Doses of BioNTech SE’s COVID-19 Vaccine Candidate in Hong Kong and Macau

HONG KONG, Aug 27, 2020 – (ACN Newswire) – Jacobson Pharma Corporation Limited ("Jacobson Pharma" or "the Group"; Stock Code: 2633.HK), a leading company engaged in the research, development, production, marketing and sale of essential medicines and branded healthcare products in Hong Kong, today announced the signing of a letter of intent ("Letter of Intent") with Fosun Industrial Co. Ltd., a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma Group"; Stock Code: 600196.SH, 02196.HK) to market and supply potentially 10 million doses of BioNTech SE's BNT162 mRNA-based vaccine candidate (the "COVID-19 Vaccine") against SARS-CoV-2 in Hong Kong Special Administrative Region (SAR) and Macau SAR (the "Region").

In the collaboration, Jacobson Pharma will provide all relevant support services to Fosun Pharma Group for the marketing, sales and distribution of the COVID-19 Vaccine in Hong Kong and Macau SAR regions through its extensive sales and distribution network amongst the hospital and medical clinic sectors in the region.

Mr Derek Sum, Chairman and Chief Executive Officer of Jacobson Pharma, said, "We much look forward to joining forces with Fosun Pharma Group to market and supply a potentially safe and effective COVID-19 vaccine product to effectively turn the tide of this pandemic in Hong Kong and Macau SAR regions. We will leverage our distribution network and technical resources to ensure swift accessibility of this novel mRNA-based vaccine product to answer the needs of healthcare professionals and the general public. Jacobson is particularly gratified with the opportunity to contribute and play a part in the fight against this COVID-19 pandemic."

BioNtech SE is one of the leading mRNA-based biopharmaceutical companies in the world and is currently listed in US Nasdaq (NASDAQ: BNTX). BioNTech SE will supply the vaccines from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech SE and Fosun Pharma Group announced their strategic collaboration on March 13, 2020. Based on the agreement, the two companies are working jointly on the development and commercialization of potential COVID-19 vaccine products based on BioNTech SE's mRNA technology platform in Greater China i.e. Mainland China, Hong Kong and Macau Special Administration Regions as well as Taiwan. The vaccine candidate is a prophylactic biological product, aiming to prevent COVID-19 in adults. A phase 1 trial has already been initiated in China and the treatment of the first participants with one of the vaccine candidates from the BNT162 program, BNT162b1, was announced on August 5, 2020. All 144 participants have already been enrolled in the Phase 1 study.

About Jacobson Pharma Corporation Limited (Stock Code: 2633)
Jacobson Pharma is a leading generic drug company in Hong Kong. The Group also carries a portfolio of proprietary brands, notably Po Chai Pills, Ho Chai Kung TjiThung San, Contractubex Scar Gel, Flying Eagle Woodlok Oil, Tong Tai Chung Woodlok Oil, Doan's Ointment, Saplingtan, Shiling Oil and Col-gan Tablet, which have been widely recognised by the market. In the strategic expansion of its branded healthcare business platform, the Group has introduced health and wellness brands and products such as Dr. FreemanFlu/RSV Combo, SmartfishHealth Nutrition Products, Dr.Freeman Infection Control Product Series and Dr Freeman COVID-19 Rapid Test Kit, among other reputable brands represented in overseas markets such as Excilor and Weisen-U.

The Group aims at the continued strategic enrichment of both of its generic drug and branded healthcare portfolios through the addition of high value-added products. With its corporate headquarters based in Hong Kong, the Group has also established its operating subsidiaries in China, Macau, Taiwan, Singapore and Cambodia forming a regional commercial platform to tap the market potential in the Asia Pacific and Greater China region. Jacobson Pharma has been a constituent stock of MSCI Hong Kong Micro Cap Index since 1 June 2017. For more details about Jacobson Pharma, please visit the Group's website: http://www.jacobsonpharma.com

For media enquiries, please contact:
Strategic Financial Relations Limited
Vicky Lee Tel: (852) 2864 4834 Email: vicky.lee@sprg.com.hk
Stephanie Liu Tel: (852) 2864 4852 Email: stephanie.liu@sprg.com.hk
Rachel Ko Tel: (852) 2864 4806 Email: rachel.ko@sprg.com.hk
Fax: (852) 2527 1196

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

Lee’s Pharm Announces 2020 Interim Results

HONG KONG, Aug 27, 2020 – (ACN Newswire) – Lee's Pharmaceutical Holdings Limited ("Lee's Pharm" or the "Group", Stock Code: 950), an integrated research-driven and market-oriented pharmaceutical group in China, today announced its interim results for the six months ended 30 June 2020 (the "period under review").

The Group's revenue for the second quarter of this year was HK$283,732,000, represented a decrease of 12.6% over the same quarter last year but a sequential increase of 3.9% over the first quarter of 2020. Revenue for the first half of 2020 was HK$556,716,000, represented a decrease of 8.4% over same period last year when Renminbi currency has been weakened by 5.1% year on- year. Sales of licensed-in products accounted for 60.9% (1H 2019: 55.4%) of the Group's revenue while sales of proprietary and generic products contributed 39.1% (1H 2019: 44.6%) of the Group's revenue.

Drugs for surgical use such as Livaracine and Slounase have been affected most as the hospitals were still inclined to postpone elective surgeries amid novel coronavirus ("COVID-19") resurgence fears during the quarter under review but began to show improvement on a quarter-to-quarter comparison. The sales of Livaracine and Slounase dropped 31.8% and 23.5%, respectively, during the period under review as compared to the same period last year, and were improved from decrease in the first quarter of 33.1% and 34.8%, respectively. Yallaferon was categorised by the Department of Economic and Information Technology of Anhui Province as one of the critical materials for the COVID-19 pandemic prevention and control during the period under review, and the sale thereof was comparatively less affected, declined by 13.4% as compared to the same period last year. On the other hand, the demand for chronic disease medications remains intact during the period under review. Revenue of Carnitene and Zanidip recorded a growth of 18.6% and 1.6%, respectively, and revenue of Ferplex decreased by 14.0%. The timely approved generic Treprostinil Injection in March 2020 has instantly made contribution to the revenue since the end of first quarter of this year and partially compensated for the loss of revenue following the termination of distribution of Remodulin by end of 2019.

Following the slowdown in the first quarter amid COVID-19 pandemic, the Group's research and development ("R&D") activities for new drugs have been resumed gradually in the second quarter and HK$151,136,000 was spent in R&D activities during the first half of 2020, representing 27.1% to the corresponding revenue during the period under review.

During the period under review, the product license of Zanidip which would be originally expired on 31 December 2021 was early terminated in return for compensation. Given the availability of several generic lercanidipines in China, the Group believes that the early termination of this product at this juncture not only brings short term financial benefit but also paves the way for the Group to launch its generic version in the near future for long term prosperity. Net profit attributable to the owners of the Company in the first half of 2020 was HK$96,982,000, increased by 153.3% over the same period last year.

Dr. Benjamin Li, Executive Director and Chief Executive Officer of the Group, said, "Given the backdrop of the volatile global macro environment, 2020 was the year not without its challenges. The market was in a slowing growth situation but inflationary pressure in raw material costs, manufacturing and administrative overhead remained high during the period under review. Together with the tensions between China and the U.S. attained an all-time high and the negative impact arising from the outbreak of a COVID-19 persisted, the business operating environment was stayed tough in China during the period under review. The Group continued to impose stringent cost-control measures in order to mitigate cost pressures in other areas. The Group has allocated more resources to the sales and marketing team during the period under review in order to explore new distribution channels and to prepare for the roll-out of new products."

From the aspect of manufacturing facilities and production capabilities, following the completion of the upgrading of facilities for APIs such as Nadroparin Calcium, there are more upgrading works in progress in Hefei site such as the upgrading of Yallaferon production facilities and pre-filled syringe production facilities in order to improve the capacity and efficiency. In Nansha site, the manufacturing of Tecarfarin tablet batch samples for GMP application and clinical trials is actively moving forward in good progress. In addition, the three new manufacturing facilities in the Nansha premise for Staccato fentanyl, oral cytotoxic drugs and continuous glucose monitor have been erected. Clinical sample of Staccato fentanyl for inhalation for the treatment of cancer breakthrough pain has been successfully produced and the submission of Investigational New Drug ("IND") will be made in September 2020. The equipment installation for the production of oral cytotoxic drugs and continuous glucose monitor is ongoing and full commission is expected during the second half of 2020.

With respect to New Drug Application ("NDA"), the Group's R&D pipeline includes over 60 projects from early-to late-stage development in various therapeutics areas. The Group's commitment to R&D persisted and measurable progress has been made during the period and up to date. The Group's applications for Import Drug License ("IDL"), namely Trazodone, INOmax, Zingo and Teglutik, were under review by the Centre for Drug Evaluation (the "CDE"). The New Drug Application ("NDA") of INOmax has been granted priority review for pediatric orphan disease by China's National Medical Products Administration ("NMPA"). The Group's applications for Abbreviated New Drug Application ("ANDA"), namely Fondaparinux, Sodium Phenylbutyrate Granule, Sodium Phenylbutyrate Tablet and Bimatoprost, were also in good progress during the period under review and up to date.

In the area of ophthalmology, China Ophthalmology Focus Limited ("COPFL"), the Company's indirect non-wholly owned subsidiary, has agreed the Phase III protocol of the Cyclosporine A Ophthalmic Gel trial with CDE for the treatment of dry eye in China. The application of ethical clearance is currently in progress and the pivotal Phase III study is expected to initiate patient recruitment in September 2020. In-licensing strategy is the Group's preferred mode of its business development, and here are two in-licensing deals which involve three new ophthalmic products. On 25 June 2020, Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited ("ZKO"), an indirectly non-wholly owned subsidiary of the Company, and PanOptica, Inc. ("PAN"), a U.S.-based ophthalmology focused pharmaceutical company developing a topical eye drop for the treatment of sight-threatening eye diseases caused by abnormal or leaky blood vessels, entered into a binding letter of intent for exclusive rights to develop, manufacture and commercialise PAN-90806 in China, Hong Kong, Macau, South Korea and other countries of Southeast Asia. On 24 July 2020, following the binding letter of intent signed in May 2020, ZKO, and IACTA Pharmaceuticals, Inc. ("IACTA"), a U.S.-based ophthalmology focused pharmaceutical company developing drugs with novel mechanisms of action that treat diseases in areas of significant unmet medical need, entered into a license agreement for exclusive rights to develop, manufacture and commercialise IC-265 and IC-270 in China and other countries of Southeast Asia.

One of the Group's strategic investments has reached a milestone during the period under review. On 20 May 2020, Windtree Therapeutics, Inc. ("Windtree") has successfully uplisted its common shares from the OTC Markets to the Nasdaq Capital Market after the completion of financing via public offering. The proceeds therefrom provide additional resources for Windtree to advance its clinical studies and create value.

Regarding corporate development, in view of the spread of the COVID-19 worldwide and the demand for masks has surged significantly, Powder Pharmaceuticals Incorporated, an associated company of the Group, is currently operating two fully automatic face mask production machines in its cleanroom which meets the ISO-8 class 100,000 requirements. To date, the production volume of masks has been ramped up to approximately 40,000 pieces daily, and is selling online at vmask.com.hk.

Looking forward, Dr. Benjamin Li, Executive Director and Chief Executive Officer of the Group said, "the tensions arising from inflationary, the challenging situations may continue for an extended period, and the Group foresees the tough environment will be persisted throughout this year. Nevertheless, the Group will continue to stay focus on its new drug development, sales organisation reform and expansion, and cost containment. With the good progress is being made on the development of new drugs, evidenced by the encouraging results from clinical trials achieved and the number of NDA approvals obtained during the period under review and up to date, the Group is confident that all these works to be done will eventually drive growth therefor. In addition, with the increasing maturity of the Chapter 18A regime introduced by The Stock Exchange of Hong Kong Limited since 2018 which support biotech companies to go public and raise capital in their pre-revenue stage, the Group is actively considering a possible spin-off and separate listing of its ophthalmology project in the near future. The Group believes that the spin-off of R&D arms, such as ophthalmology and oncology projects, into standalone companies will in turn drive the market to recognise the value of its robust R&D pipelines. Beyond the present headwinds, the Group will continuously monitor the changing situations and make timely responses and adjustments as needed. As always, the operation and management team will continue to make its unremitting efforts to achieve additional uplift on the performance in the upcoming quarters."

About Lee's Pharmaceutical Holdings Limited
Lee's Pharm is a research-based and market-oriental biopharmaceutical company listed in Hong Kong with over 25 years' operation in China's pharmaceutical industry. It is fully integrated with solid infrastructures in drug development, manufacturing, sales and marketing. It has established extensive partnerships with over 20 international companies and currently has 23 products in the market place. Lee's Pharm focuses on several key disease areas such as cardiovascular, woman health, pediatrics, rare diseases, oncology, ophthalmology, dermatology, obstetrics and urology. Lee's Pharm more than 60 products under different development stages stemming from both internal research and development as well as from the licensing of development, commercialisation, and manufacturing rights from various United States, European and Japanese companies. The mission of Lee's Pharm is to become a successful biopharmaceutical group in Asia providing innovative products to fight diseases and improve health and quality of life.

Additional information about Lee's Pharm is available at www.leespharm.com.

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

Universal Medical Announced its 2020 Interim Results

HONG KONG, Aug 26, 2020 – (ACN Newswire) – The board (the "Board") of directors (the "Directors") of Genertec Universal Medical Group Company Limited (the "Company" or "Universal Medical") is pleased to announce the interim results of the Company and its subsidiaries (together, the "Group") for the 6 months ended 30 June 2020.

2020 INTERIM RESULTS HIGHLIGHTS
– The revenue amounted to approximately RMB4,024.2 million, representing an increase of 25.9% as compared with that of approximately RMB3,195.4 million for the corresponding period of 2019.
– The profit for the period amounted to approximately RMB861.0 million, representing a decrease of 1.3% as compared with that of approximately RMB872.5 million for the corresponding period of 2019.
– The profit for the period attributable to owners of the parent amounted to approximately RMB793.4 million, representing a decrease of 2.3% as compared with that of approximately RMB812.0 million for the corresponding period of 2019.
– The total assets amounted to approximately RMB59,199.2 million, representing an increase of 2.3% as compared with that of approximately RMB57,852.5 million as at 31 December 2019.
– The equity attributable to owners of the parent amounted to approximately RMB9,851.0 million, representing an increase of 3.8% as compared with that of approximately RMB9,489.3 million as at 31 December 2019.
– For the six months ended 30 June 2020, the return on equity was 16.41% and the return on total assets was 2.94%.

In the first half of 2020, Universal Medical was actively engaged in epidemic prevention and control of the new novel coronavirus (COVID-19) epidemic. A total of 23 member medical institutions were identified as designated hospitals for treatment and isolation, and all Grade II Class A and above hospitals have established fever clinics and participated in the joint prevention and control work of communities, stations, terminals, and airports. Additionally, the headquarters of the Group has implemented various medical supplies for the hospitals and strived to ensure the smooth development of the epidemic prevention and control work in the hospitals. Universal Medical orderly promoted the resumption of work and production and minimize the impact of the epidemic as much as possible, while adapting to the new normal of ongoing epidemic control. In the first half of 2020, the operating results of the Group were generally stable.

Maintained Steady Financial Performance and Proceed with Hospital Group Business
The Group recorded revenue of RMB4,024.2 million, representing an increase of 25.9% as compared to the corresponding period of the previous year, as a result of more medical institutions being consolidated into the Group's financial statements in the second half of 2019 and the first half of 2020; recorded profit for the period of RMB861.0 million, representing a slight decrease of 1.3% as compared to the corresponding period of the previous year due to the impact of the epidemic; recorded profit for the period attributable to the owners of the parent of RMB793.4 million, representing a slight decrease of 2.3% as compared to the corresponding period of the previous year; and recorded total assets of RMB59,199.2 million as of 30 June 2020, representing an increase of 2.3% as compared to the end of 2019, with asset quality generally safe and controllable.

Hospital group is the most essential resources of building a medical and health conglomerate. In the first half of 2020, the Group continued to actively participate in the integration and takeover of medical institutions of SOEs, and build up a tightly-knit medical networks surrounding key regions and cities across China. As of 30 June 2020, the Group had entered into contracts in relation to takeover of 48 medical institutions (including 5 Grade III Class A hospitals and 24 Grade II hospitals) with actual capacity of over 15,000 beds. Meanwhile, the Group continued to improve the post-investment management of our medical institutions, and comprehensively improved the medical technology, management efficiency and service capabilities of our medical institutions by focusing on discipline construction, operation management, organization management innovation, service system construction, hospital digitalization, supply chain management, hospital renovation and expansion, so as to ensure their sound and orderly development.

Affected by the epidemic control in the first half of 2020, the number of outpatient visits of the medical institutions decreased by approximately 15% as compared to the corresponding period of the previous year, the number of inpatient visits decreased by approximately 18% as compared to the corresponding period of the previous year, and the number of medical examination services decreased by approximately 25% as compared to the corresponding period of the previous year, resulting in varying degrees of decline in the income of medical institutions of the Group and their profit contribution to the Group. The Group believes that the impact of the epidemic on the business of member medical institutions is temporary. With the epidemic under control in the second quarter, the number of patient visits of the medical institutions of the Group has rebounded significantly. Since May 2020, the overall monthly income has basically recovered to the same level for the corresponding period of the previous year, and the monthly income of most medical institutions in June 2020 has exceeded the level of the corresponding period of the previous year.

Steady Develop Finance and Advisory Business with Safe and Controllable Asset Quality
The Group's finance business, which is the cornerstone underpinning the Group's steady development and mainly provides finance lease services for county level public hospitals, and provides financial support for the Company, was affected by the epidemic control policies. The development of the Group's finance and advisory business and collection of receivables from hospital customers relatively slowed down. Meanwhile, due to the continued and steady downward adjustment of the national monetary policies after the Loan Prime Rate (LPR) reform, the interest rate of the Group's new leasing business decreased accordingly. Therefore, the average yield dropped as compared to the corresponding period of the previous year, and the operating performance of the finance and advisory business experienced short term fluctuations. During the reporting period, the finance and advisory business of the Group recorded revenue of RMB2,480.5 million, increased by 0.4% as compared to the corresponding period of the previous year; recorded gross profit of RMB1,521.5 million, decreased by 1.7% as compared to the corresponding period of the previous year. Finance lease business recorded revenue of RMB2,049.7 million, increased by 8.3% as compared to the corresponding period of the previous year; recorded gross profit of RMB1,090.7 million, increased by 10.9% as compared to the corresponding period of the previous year; the net interest spread was 3.55% and the net interest margin was 4.13%, still a high ranking among domestic competitors. As at 30 June 2020, the Group's interest-bearing assets reached RMB50,869.6 million, representing an increase of 2.2% as compared with the beginning of the year; non-performing assets ratio was 0.98% and the overdue ratio (30 days) was 0.92%. The Group strictly controlled the operating risks, and continuously enhanced internal management. Although the non-performing assets ratio and the overdue ratio (30 days) slightly increased due to the epidemic, the overall asset quality was safe and controllable and continued to maintain its leading position in the industry.

Layout the Health Industry Chain and Explore New Opportunities in the Health Industry
In the first half of 2020, the Group continued to promote model exploration, pilot projects and layout in various fields of the health industry chain based on our hospital group, and focused on the Internet medical business. As of 30 June 2020, 4 member medical institutions of the Group, namely XD Group Hospital, Genertec Universal Xi'an Aero-Engine Hospital, Xianyang Caihong Hospital and Yantai Port Hospital, were approved for conducting Internet hospital business. A total of 13 member medical institutions went online based on the Internet platform, with the offline to online conversion rate reaching 5.1% within 4 months, over 30% of online patients showing needs for offline medical services and the patient satisfaction rate reaching 99%. In addition, based on full evaluation of our existing advantages, market prospects and our talent strategies, the Group actively developed businesses of equipment sales and maintenance, and third-party inspection center through various cooperation modes, such as acquisition of majority interest, investment in minority interest and strategic alliance, to build a health industry ecosystem and realize win-win results enjoyed by all.

Prospect for the Future
In the future, the Group will continue to uphold the philosophy of whole industry chain and whole life cycle, which is centered on medical services and supported by financial services, to build a shared and win-win health industry ecosystem, strive for a trustworthy medical and health group, and contribute to construction of "Healthy China".

About Genertec Universal Medical Group Company Limited
Genertec Universal Medical Group Company Limited ("Universal Medical") is a listed subsidiary (Stock code: HK.02666) of China General Technology (Group) Holding Co., Ltd ("Genertec"), one of the backbone SOEs directly administrated by the central government. Universal Medical is a diversified healthcare company focused on China's rapidly evolving healthcare industry. With reliance on modern management concepts, professional teams, high-quality medical resources, solid financial strength and inclusive corporate culture, Universal Medical upholds the philosophy of whole industry chain and whole life cycle, which is centered on medical services and supported by financial services, to build a shared and win-win health industry ecosystem, strive for a trustworthy medical and health group, and contribute to construction of "Healthy China".

This press release is issued by Institutional Capital Advisory (Asia) Limited on behalf of Genertec Universal Medical Group Company Limited.

For further information, please contact:
Institutional Capital Advisory (Asia) Limited
E-mail: unimedical@icaasia.com

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

INDONESIA: BUMN Go Global is the Accurate Strategy in Midst of Pandemic

JAKARTA, Aug 21, 2020 – (ACN Newswire) – Christovita Wiloto, Founder of IYE! Indonesian Young Entrepreneurs, believes that the BUMN Go Global strategy issued by the Minister of State Owned Enterprises (BUMN) is exactly what Indonesia needs right now, especially in the midst of a global economic recession due to the Covid-19 pandemic.

State-Owned Enterprises (BUMN) Minister Erick Thohir(R) and BUMN Deputy Minister Budi Gunadi Sadikin in Jakarta, Wed (8/19/20). (Antara Photos / Adam Bariq)

Indonesia Young Entrepreneurs, otherwise known as IYE!, is a global network of young Indonesians with entrepreneurial spirit across all industries. With over 50,000 members based all around the world, this organization acts as a platform to bring together young minds that are resilient and have integrity.

"The launch of the BUMN Go Global strategy as we enter a world recession due to the Covid-19 pandemic is very timely. Even countries as strong as the United States and China have been overwhelmed by this mega disruption. These new circumstances level the playing field so that countries are now in a position of equal opportunities within the global business playing field," explained Christovita Wiloto.

Known as a reliable global entrepreneur with an extensive international network, BUMN Minister Erick Thohir is believed to be able to direct BUMNs to be more active on a global scale.

"Under the leadership of Erick Thohir, the opportunities for SOEs to be more active at the global level has widened through the BUMN Go Global program," Christov said.

BUMN Minister Erick Thohir and Minister of Foreign Affairs Retno Marsudi initiated the BUMN Go Global economic diplomacy program. The goal of the program is to improve Indonesia's supply chain. BUMNs are encouraged to acquire foreign companies, many of which are beginning to stagger during this time of global recession.

State-Owned Enterprises Minister Erick Thohir explained that the BUMN GO Global program is an effort to develop and uplift the Indonesian business world towards the international level. He said there were two big goals of the program, which includes marketing BUMN products as well as improving supply chains in Indonesia.

"So this is not a program that is just for show. But it really has to be able to improve the ecosystem of our nation," said Erick.

From the marketing side, Erick said that Indonesia's state-owned companies currently already have various products that are recognized by various countries. Examples of products that are already well known in other countries include vaccines produced by Biofarma as well as products of the defense industry, and these can be improved even more.

Christov also observed that there are actually quite a number of Indonesian state-owned companies that have already successfully penetrated the global market. These companies include Telkomcel, PT Bank Negara Indonesia (Persero) Tbk, Bank BRI, Bank Mandiri, PT Semen Indonesia (Persero) Tbk., PT Pertamina (Persero), PT Wijaya Karya (Persero) Tbk., Kimia Farma Dawaa, and many more.

"But it is not enough that BUMN Go Global, we also want to participate in improving the supply chain in Indonesia. We know that, so far, Indonesia has only been a market for other global companies, but how long will this go on? What we can expect from acquiring several global companies overseas is a simple objective, namely to improve Indonesia's supply chain," Erick asserted.

Erick further said that Indonesia actually has two advantages, namely a large market and rich natural resources. However, on the other hand, Indonesia is still facing challenges related to logistics and technology. For that reason, these are the areas that he intends to fix.

For more information, please contact:
PowerPR | Indonesia Investment Forum
christhaliawiloto@powerpr.co.id
www.powerpr.co.id/IIFNYC2021

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

Bayer and Hua Medicine announce commercialization agreement and strategic partnership for investigational first-in-class novel diabetes treatment dorzagliatin in China

Beijing and Shanghai, China, Aug 17, 2020 – (ACN Newswire) – Bayer and Hua Medicine, a leading innovative drug development company, today announced a commercialization agreement and strategic partnership for dorzagliatin, a novel diabetes treatment, in China. The agreement aims to provide Chinese diabetes patients with access to a new treatment option, building on Bayer's existing strength and leadership in diabetes management in China and the innovation capabilities of Hua Medicine.

On behalf of Bayer and Hua Medicine, Wei Jiang (Left) and Dr. Li Chen (Right) signed agreement on strategic partnership in China

"Bayer has been long committed to Chinese patients living with diabetes and diabetic macular edema (DME) by offering innovative treatment options including Glucobay and Eylea," said Wei Jiang, Executive Vice President and President of Bayer Pharmaceuticals Region China & APAC and President of Bayer Group Greater China. "In the face of significantly increasing challenges caused by diabetes to public health in China, our collaboration with Hua Medicine will further address unmet medical needs of Chinese patients living with diabetes. By leveraging Bayer's well-established products as well as the upcoming continuous glucose monitoring system under the partnership with WaveForm, we will be able to provide integrated solutions ranging from prevention, diagnosis, treatment and complication management."

Type 2 diabetes continues to be an important health challenge. According to the China Mainland National Cross Sectional Study in the British Medical Journal, the prevalence rate of T2DM for adults in China is 11.2%, but the proportion of patients who have their hemoglobin A1c (HbA1c) levels controlled is 49.4%(1). Among patients taking oral anti-diabetic drugs, fasting plasma glucose and 2-hour postprandial plasma glucose level lower than or equal to target were only achieved by 51.3% and 53.4%, respectively. These observations from real-world data highlights the unmet medical needs in diabetes, and are the reasons why biotech companies continue to explore novel therapies to improve diabetes management. With a novel mechanism of action, dorzagliatin is an investigational first-in-class glucokinase activator ("GKA") targeting the restoration of glucose homeostasis in T2DM patients by addressing the defect of the glucose sensor function in the pancreas. A recently completed phase III clinical study of dorzagliatin monotherapy by Hua Medicine showed positive 52-week efficacy data. In addition, 24-week topline results were announced recently: The phase III metformin combination clinical trial met the primary efficacy endpoint.

"We are very excited to have this great opportunity, joining forces with Bayer to bring a first-in-class diabetes medicine, dorzagliatin, to Chinese patients," said Dr. Li Chen, CEO of Hua Medicine. "Bayer has been a leader in diabetes treatment for the past 10 years in China and will be a great partner for Hua Medicine to advance diabetes care. T2DM currently affects approximately 463 million patients worldwide, 116 million of which are in China(2). Over the last ten years, Hua Medicine has translated the novel concept of glucose homeostasis management into a breakthrough T2DM therapy that aspires to cure diabetes. For the first time, a drug has demonstrated, in clinical trials, the potential ability to improve glucose metabolism and Bata-cell function in T2DM patients. The partnership between Hua Medicine and Bayer will bring this medical innovation to a broader patient population in China even faster."

Under the terms of the agreement, Hua Medicine as the market authorization holder shall be responsible for clinical development, registration, product supply and distribution, whilst Bayer as the promotion service provider shall be responsible for marketing, promotion and medical education activities in China. Hua Medicine will receive an upfront payment of RMB 300 million and additional payments could reach up to RMB 4.18 billion if certain milestones are met. Bayer receives the exclusive rights to commercialize the product in China and will receive tiered service fee based on the net sales. Initially, both parties will share equally in sales derived from China net sales, with adjusting sales percentages based on agreed China net sales thresholds.

"China is a key focus of Bayer's partnering efforts and we are continuously looking for assets and health technologies to help address significant unmet medical needs of patients," said Marianne De Backer, PhD, Member of the Executive Committee and Head of Strategy and Business Development & Licensing, Pharmaceuticals Division of Bayer AG. "Through this new partnership, we further expand treatment options for millions of Type 2 diabetes patients in China by leveraging our commercial expertise and diabetes leadership position in China and combining it with the external know-how of a strong partner."

The Pharmaceuticals Business Development & Licensing team of Bayer facilitated this collaboration.

(1). British Medical Journal. Prevalence of diabetes recorded in China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. https://www.bmj.com/content/369/bmj.m997
(2). International Diabetes Federation. 9th Edition of IDF Diabetes Atlas. https://www.diabetesatlas.org/en/

About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in patients with T2DM. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with T2DM and serve as a standard-of-care therapy for the treatment of the disease, or as a combination therapy with currently approved anti-diabetes drugs. For more information, please go to www.huamedicine.com

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.com.

About Hua Medicine
Hua Medicine is a leading, clinical-stage innovative drug development company in China focused on developing novel therapies for the treatment of diabetes to satisfy unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA-enabling stage and is currently evaluating the therapy in adults with diabetes in two Phase III trials in China and various earlier stage clinical trials in China and the United States. Dorzagliatin has achieved its primary endpoint in both of its Phase III monotherapy and combination trials in China over the 24-week trial period, and completed its 52-week Phase III monotherapy trial. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.

Contact Bayer:
Bayer China Communications – Pharmaceuticals
Tel No.: (86)10-5921-8499
Email: pharma.china.comm@bayer.com

Contact Hua Medicine
Investors: ir@huamedicine.com
Media: pr@huamedicine.com

Bayer Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Hua Forward-Looking Statements
This press release may contain statements that constitute "forward-looking statements", including, but not limited to, statements relating to the implementation of strategic initiatives, and other statements relating to Hua Medicine's future business development and economic performance. While these forward-looking statements represent Hua Medicine's judgments and future expectations concerning the development of business, a number of risks, uncertainties and other statutory requirements may render actual developments and results to differ materially from our expectations. For more information, go to www.huamedicine.com.

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