HONG KONG, Apr 21, 2022 – (ACN Newswire) – EC Healthcare (the "Company", which together with its subsidiaries is referred to as the "Group", SEHK stock code: 2138), the largest non-hospital medical group in Hong Kong*, is pleased to announce that the expected performance of the Group's sales volume for the Year ended 31 March 2022 (the "Year").

Benefiting from the diversified business portfolio and continuous improvement in operation efficiency, the Group's business grew steadily against market headwinds. During the 104 business days of compulsory closure, the Group was able to boost sales in the local market and in Mainland China through proactive client engagement via online channel and e-commerce campaigns; stimulate cross-selling among different medical disciplines; actively expand anti-epidemic related medical services and complete acquisitions of certain medical establishments to expand the Group's market share in healthcare market. The Group also expanded business via organic growth and M&A so as to further consolidate its leading position.

Despite the adverse economic conditions resulting from the fifth outbreak of COVID-19 with continuous travel restrictions, social distancing restrictions and the compulsory closure of all beauty parlors, the Group's business performance remains stable. The Group expects to record sales volume of no less than HK$3 billion for the Year, representing a no less than 35% Year-on-Year ("Y-o-Y") increase. The overall sales performance of the Group for the second half of Year is expected to record a no less than 15% Y-o-Y increase.

Benefiting from the strong demand on medical services and the Group's effective integration of medical assets, the sales volume of medical services offered by the Group is expected to record a no less than 55% Y-o-Y increase for the Year, despite the absence of medical tourists due to the lockdown. The sales volume of medical services in Hong Kong offered by the Group for the second half of Year is expected to record a no less than 25% Y-o-Y increase.

Mainland China authorities have been tightening the regulation of the medical aesthetic market. Leveraging the Group's leading position and strong brand strength in the medical aesthetic market, the Group was able to further consolidate the market. The Group's sales volume in Mainland China is expected to record a no less than 18% Y-o-Y increase for the Year, and a no less than 8% Y-o-Y increase for the second half of the Year.

Mr. Eddy Tang, Chairman, Executive Director and Chief Executive Officer of EC Healthcare said, "Looking ahead, the Group is optimistic about its business performance, which is expected to benefit from the government electronic consumption voucher scheme and the prevalence and increasing demand for anti-epidemic medical services. The Group will also benefit from the strong demand after the business reopening under the easing of COVID-19 prevention measures on 21 April 2022 by the Hong Kong Government. The Group will continue to fully support and cooperate with the Hong Kong Government's anti-epidemic policy, also implement new strategies to seize opportunities and expand the scope of healthcare services, continue to develop its businesses through organic growth and mergers & acquisitions, with particular focus on information technology, branding and service so as to increase the Group's market share."

About EC Healthcare
EC Healthcare is Hong Kong's largest non-hospital medical service provider*, leveraging its core businesses of preventive and precision medicine, and committed to developing medical artificial intelligence by integrating its multi-disciplinary medical services. The move, which is supported by the Group's high-end branding and quality customer services, is aimed at offering customers safe and effective healthcare and medical services with professionalism. The Group is a constituent stock of the Hang Seng Composite Index and the MSCI Hong Kong Small Cap Index.

The Group principally engages in the provision of one-stop medical and health care services in Greater China. The Group provides a full range of services and products under its well-known brands, including those of its one-stop aesthetic medical solutions provider DR REBORN which has ranked first in Hong Kong by sales for Years, primary care clinics jointly established with Tencent Doctorwork, chiropractic services centre SPINE Central, New York Spine and Physiotherapy Center NYMG, health management centre re:HEALTH, a vaccine centre Hong Kong Professional Vaccine HKPV, a comprehensive dental centre UMH DENTAL CARE, a diagnostic and imaging centre HKAI, an oncology treatment centre reVIVE, a day procedure centre HKMED, a specialty clinic SPECIALISTS CENTRAL and NEW MEDICAL CENTER, obstetrics and gynaecology specialist ZENITH MEDICAL CENTER AND PRENATAL DIAGNOSIS CENTRE, specialists central, a paediatric center PRIME CARE, cardiology center HONG KONG INTERNATIONAL CARDIOLOGY CENTER, PathLab Medical Laboratories, a professional hair care center HAIR FOREST, Ophthalmology Center VIVID EYE and EC Veterinary Hospital and Imaging Center.

*According to independent research conducted by Frost and Sullivan in terms of revenue in 2019 and 2020

For further information, please contact:
iPR Ogilvy Limited
Callis Lau / Lorraine Luk / Charmaine Ip
Tel: (852) 2136 6952 / 2169 0467 / 3920 7649
Fax: (852) 3170 6606
Email: ech@iprogilvy.com


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

HONG KONG, Apr 20, 2022 – (ACN Newswire) – As the pandemic continued to affect the market, China Biotech Services (08037), which owns one of the largest nucleic acid testing laboratories in Hong Kong, recently announced its 2021 annual report.

According to the annual report, China Biotech Services recorded revenue of HK$624 million and net profit of HK$133 million during the reporting period due to strong demand for nucleic acid testing, as a result of the ongoing epidemic in Hong Kong. Thanks to the overall decline in the cost of materials used for nucleic acid testing, the Company's gross profit margin increased by 5.69 percent to 57.4%.

In order to expand the business capabilities of the testing business segment, China Biotech Services increased its expenditure during the reporting period, which, combined with greater R&D investment, placed pressure on its net profit margin. Excluding investments in new product launches and R&D, the Company's actual net profit would have exceeded that of 2020.

With the advent of the post-pandemic era in view, the Company's development path has become clearer. While enriching the product pipeline of the testing business and providing diversified testing services to generate stable cash flow, it has strengthened its investment in the latest precision radiotherapy technology and CAR-T innovative drugs to create new growth drivers and laid a solid foundation for the Company's rapid growth in the future and raise its intrinsic value.

Precision testing enriches product lines, with channels expanded to accelerate business development

Committed to becoming the world's leading integrated platform for cancer treatment, China Biotech Services has formed three business segments, namely precision testing, precision treatment, and all-round precision targeted drug research and development, through both in-house R&D initiatives and patent introduction. The synergistic development of the sectors has continued to enhance the core competitiveness of the platform.

Among them, precision testing is the "ballast" for the Company's steady development, not only because it is the main source of income, but also because the profits generated from this business play a key role in the cultivation and incubation of the other two major businesses. In order to ensure the continuous and stable development of the precision testing business in the post-pandemic era, China Biotech Services has made a multi-dimensional layout.

Regarding the Sunrise Diagnostic Center (SDC), the fifth wave of the COVID-19 epidemic in Hong Kong has not yet subsided, with around 2,000 new cases reported on this 10th and 11th April. Although the peak has passed, the number of infections has not yet dropped to a comfortably low level. Hong Kong Chief Executive Mrs Carrie Lam Cheng Yuet Ngor previously said that universal COVID-19 testing would still be considered if the timing was right.

At the same time, SDC offers testing services at a number of major immigration control points. It has been stationed at Hong Kong International Airport, Shenzhen Bay Port and HZMB Hong Kong Port, and offers testing services to China-Hong Kong cross-border drivers. According to the Zhitong Caijing APP, Hong Kong lifted flight bans on nine countries since this 1st April. With the continuous resumption of flights, Hong Kong, as one of the largest airports with the highest passenger flow in the world, will significantly drive the demand for nucleic acid testing. Moreover, the border between Hong Kong and the Mainland is about to open, which will surely drive the demand for nucleic acid testing.

In addition to nucleic acid testing, SDC has been cooperating with the government to develop large-scale screening for public health programs including HPV and colorectal cancer, thus expanding the testing product lines. In the meantime, SDC has also made efforts at the service channelfront. In March 2022, it established a joint venture laboratory with Town Health International (03886) to achieve complementary advantages. Through Town Health International's clinic network, SDC's testing services can be quickly introduced to the market and facilitate the sustainable development for theGroup's testing businesses.

The Asia Molecular Diagnostic Laboratory (AMDL), which provides cancer precision testing and concomitant diagnostic services, established a strategic partnership with Pillar Biosciences, Inc., a clinical cancer diagnostic company based in Boston, MA and Shanghai, China in 2019. We jointly provide tumor precision diagnostic products and services to Hong Kong, Macau, Great Bay Area, South Korea and Southeast Asia markets, and has built a high-throughput sequencing innovation laboratory at Hong Kong Science & Technology Park.

Recently, the laboratory has passed the NGSST-B 2021 (Next-Generation Sequencing Solid Tumor) external quality assessment conducted by the College of American Pathologists ("CAP") with a perfect score. This demonstrates that the laboratory's professionalism and capability in data analysis and interpretation of tumor high-throughput sequencing have reached an advanced international level.

Meanwhile, AMDL owns the first & sole commercialization rights of the Pillar Biosciences FDA-approved NGS companion diagnostic (CDx) test for lung and colorectal cancers which guides the prescription of targeted therapies. The CDx test will soon be launched in Hong Kong, where around 37,200 cancer patients seek medical treatment every year, and the demand of cancer diagnostic testing is still rising. Currently, the FDA approved CDx test conducted in Hong Kong are currently sent to the US for test diagnosis, resulting in long-turn around time and high costs (ranging from HK$45,000 to HK$100,000). Moreover, AMDL continues to develop various genetic tests in the fields like tumor mutational burden (TMB), microsatellite instability (MSI), homologous recombination deficiency (HRD) detection and minimal residual disease (MRD) monitoring.

As the exclusive test provider and cancer diagnostic products distributor of Pillar Biosciences's FDA approved CDx kits in Hong Kong, AMDL boasts a clear monopolistic advantage. Its upcoming testing services are expected to provide at a reasonable price which aims to provide an accurate and robust cancer diagnostic test service to clinicians and their cancer patients for appropriate targeted therapies. The services are also expected to quickly penetrate the markets in Hong Kong and the Mainland and even the surrounding Southeast Asian markets.

With a development history of more than 50 years and high brand recognition, PHC Medical Diagnostic Centre (PHC), one of the largest third-party medical testing centers in Hong Kong, captures a stable market share in traditional testing services. Zhitong Caijing learned that, in addition to introducing the latest WHO-recognized neutralizing antibody test targeting the Omicron variant, PHC has also cooperated with internationally renowned pharmaceutical companies for a contract period of five years to provide testing services for clinical trials. PHC will also continue to contribute stable income and cash flow to theGroup.

It is foreseeable that, through the deployment of new growth drivers such as SDC and AMDL, as well as the stable development of PHC, China Biotech Services' precision testing business is expected to grow steadily and continue to play a key role in establishing a solid foundation.

BNCT project commences construction, expected to be operational in 2024

If precision testing is the main growth driver of current results performance, the boron neutron capture therapy (BNCT) segment is expected to become the new growth driver for China Biotech Services in the medium to long term. It is reported that BNCT therapy, which was introduced from Japan by China Biotech Services, is the world's first BNCT technology to be approved for marketing and inclusion on the National Reimbursement Drug List.

Compared with other particle therapies, BNCT therapy can kill tumor cells and tissues with only one radiotherapy treatment, and the course of treatment is significantly shortened. Therefore, the therapy is regarded as a "crown jewel" in the field of radiotherapy and is widely recognized by the industry as a new generation tumor treatment with great development potential.

In November 2021, China Biotech Services' BNCT project officially passed the admission assessment of the International Medical Tourism Pilot Zone of Boao Hope City in Hainan, and an agreement for the entry into the pilot zone was signed on 28 February 2022, marking the official commencement of the project's construction. The project is expected to be completed by the end of 2023, and will be ready to start operation and receive patients in 2024.

Upon completion, the BNCT Center will become China's first boron neutron treatment facility able to provide commercialized treatment services. It will also become the first cancer center in China to provide BNCT, meeting the BNCT treatment needs of cancer patients nationwide, in Southeast Asia countries and even globally.

In terms of market capacity, according to the 2017 Eighth National Radiotherapy Survey Report issued by the (Report of the 8th National Radiation Therapy Survey in 2017) of the Chinese Medical Association, China's radiotherapy equipment was 1.57 units per million people, far less than the 12.4 units per million people in the US, and also falling short of WHO's recommendation of two to four units per million people. Based on 0.5 BNCT devices per 1,000,000 people, the corresponding market demand in China is 700 sets.

Compared with 33 proton radiotherapies, BNCT therapy has a higher pricing power thanks to the convenience and safety of only one radiotherapy treatment. The cost of one treatment can be around RMB 300,000 to RMB 400,000, which is still very attractive. Assuming China Biotech Services opens five treatment centers in the future with 10 devices installed and treats 10,000 people a year (in 2020, there were 4.57 million new cancer cases in China and cases of head and neck cancers alone already exceeded 140,000), it can realize an income of RMB 3 to 4 billion in a year, with obvious room for growth.

Clinical trials progressing steadily, first subject dosing successfully completed

The continued advancement of cell therapy clinical trials has also increased the Group's intrinsic value. On 21 January 2021, the IND application for LY007 Cellular Injection developed by Shanghai Longyao Biotech, a subsidiary of China Biotech Services, was officially approved by the National Medical Products Administration of China. This is the first CD20-targeted chimeric antigen receptor T-cell ("CAR-T") product filed and approved in China.

It is reported that LY007 introduces an independent co-stimulatory signaling receptor OX40 into the structure of CAR, which is experimentally proven to reduce T-cell exhaustion, enhance the proliferation and killing ability of CAR-T cells and facilitate the release of more effector molecules, thereby improving the performance of CAR-T in terms of both safety and effectiveness. Given these mechanisms, LY007 has the potential to treat solid tumors, for which the majority of existing CAR-T cell therapies have no significant efficacy.

On 25 January and 27 January 2022, the launch event for Phase I registered clinical trial of LY007 for the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma was successfully held at Shanghai Ruijin Hospital and Jiangsu People's Hospital, respectively. The trial is co-hosted by Zhao Weili, Vice President of Ruijin Hospital, and Li Jianyong, Head of the Department of Hematology at Jiangsu People's Hospital.

On 1 March 2022, the first subject was enrolled in the LY007 Phase I registered clinical program at Shanghai Ruijin Hospital, and on this 7th April, the infusion of cells for the first subject was completed. The infusion process was generally smooth, and the subject was in good condition following the procedure. The Company expects to compile the preliminary data by the end of September 2022, and the interim data will be released by the first half of 2023. The Phase II clinical trial application is expected to be approved in the first half of next year and will be completed in the second half of 2024, according to China Biotech Services.

As we all know, the disclosure of clinical data is a key factor in determining the real value of drug R&D companies. Once the data meet the expectations, the Company's intrinsic value will grow exponentially, and the market has been eagerly awaiting the data of the Phase I clinical trial by Shanghai Longyao Biotech.

Moreover, Shanghai Yaolong and the Affiliated Hospital of Xuzhou Medical University officially launched clinical research on an innovative CAR-T (LY011) for treating pancreatic cancer and gastric cancer in October 2021, and four patients have been enrolled. The safety, PK characteristics and preliminary efficacy findings suggest that the LY011 is worthy of further research and development.

From the capital market perspective, China Biotech Services has been significantly undervalued. According to data released by China Merchants Securities (Hong Kong), the market value of comparable clinical-stage CAR-T companies listed on main board of The Stock Exchange of Hong Kong is more than US$1.2 billion, while the market value of comparable CAR-T companies listed on NASDAQ is more than US$6 billion. The current market value of China Biotech Services is actually less than US$200 million, which means that the market's perception of China Biotech Services is still limited to precision testing, and the market value only reflects the valuation of the precision testing segment.

Nonetheless, China Biotech Services' model of using the profits and cash flow from the testing business to incubate other new growth drivers has proved effective. The BNCT segment and CAR-T cell therapy have been steadily progressing and have become the Company's new growth drivers in the medium to long term, laying a solid foundation for sustainable growth in the future. With the implementation of the BNCT project and the announcement of the clinical trial of the LY007 injection, the intrinsic value of China Biotech Services will be greatly enhanced and is expected to be reflected in its market value, and the present moment is probably the best time to formulate a development plan.

In addition, China Biotech Services has achieved profitability for two consecutive years. According to its current operating trend, its performance is expected to maintain stable growth. After achieving profitability this year, the factors restricting the transfer of its listing to the main board will be eliminated, and the Company's financial position will meet the conditions required for the transfer of its listing from the GEM to the main board. Once the transfer is successful, the increase in liquidity will lead to a restoration in valuation. At that time, the Company's market value is expected to rise sharply under the allocation of passive investment funds, and the valuation is expected to be on a par with comparable companies.

Source: Zhitong Caijing


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

HONG KONG, Apr 20, 2022 – (ACN Newswire) – SinoMab BioScience Limited ("SinoMab" or the "Company", together with its subsidiaries, the "Group", stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, on 19 April 2022 (after trading hours), an Investigational New Drug application ("IND", for multiple sclerosis) for SN1011 was approved by the National Medical Products Administration of China (the "NMPA"). The IND approval would enable the Company to initiate the Phase II clinical study to evaluate the efficacy and safety of SN1011 in patients with multiple sclerosis in China. The planned first patient enrollment is in the fourth quarter of 2022.

SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy and improved safety for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety.

The Phase I study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated good safety and pharmacokinetics profile. Currently, the IND application for SN1011 in the treatment of systemic lupus erythematosus (SLE), pemphigus vulgaris (PV) and multiple sclerosis (MS) have been approved by NMPA, the Company plans to launch the Phase II clinical study for pemphigus in the third quarter of 2022. In addition to the approval of this IND, the Company is planning an IND submission for multiple sclerosis (MS) in the U.S. in the second quarter of 2022, thereby accelerating the initiation of a global phase II trial in the third quarter of 2022.

MS is a demyelinating disease, which potentially damages the patient's brain and spinal cord. MS may cause a wide range of symptoms, including but not limited to vision problems and movement disorders. Global MS prevalence reached 2.7 million people in 2018 and is expected to increase to 3.1 million people in 2023 at a CAGR of 2.8% from 2018, and 3.7 million people in 2030 at a CAGR of 2.7% from 2023. Global MS market expanded to US$23.0 billion in 2018, and is expected to reach US$30.8 billion in 2023 at a CAGR of 6.0% from 2018, and US$48.9 billion in 2030 at a CAGR of 6.8% from 2023.

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "The IND application for MS for SN1011 was accepted by the NMPA at the beginning of the year, and was approved only three months later, which fully reflects the NMPA's recognition of the Company's candidate products, and also confirms the efficient execution of the Company's new drug R&D program. The approval of this IND application is the third indication of SN1011 in China following the approval of IND application for SLE and pemphigus, fully demonstrating the great potential of our innovative BTK inhibitor in the field of the treatment of autoimmune diseases. We are absolutely confident in the enormous prospects of SN1011's clinical development, we will also accelerate clinical trials and continuously expand the scope of potential indications. In the future, we will accelerate our R&D projects implementation, devote to the vision of independent innovation, further expand the product portfolio and potential indications, dedicate to exploring safe and effective treatments for patients suffering from autoimmune diseases worldwide."

About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company's flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin's lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.


Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

NEW JERSEY, the U.S. and HANGZHOU, China, Sep 8, 2021 – (ACN Newswire) – Adlai Nortye, a global biopharmaceutical company focused on developing innovative oncology drugs, today announced that the first patient has been dosed in the Phase Ia clinical trial in the U.S. to evaluate the triple combination of AN2025 (buparlisib, oral pan-PI3K inhibitor), AN0025 (oral EP4 antagonist) and atezolizumab (PD-L1 inhibitor) in patients with locally advanced/metastatic tumors.

This trial (AN2025S0101) is an open-label, multicenter, Phase Ia study to evaluate the safety, tolerability, pharmacokinetics ("PK") and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with atezolizumab in patients with locally advanced/metastatic tumors. The study consists of three dose-limiting toxicity ("DLT") Observation Periods, Observation I, II and III. Observations I and II are double combination treatments, which will be conducted in parallel, whereas Observation III (the triple combination treatment) will be initiated only after a thorough review of the safety data from Observations I and II. Each Observation period will last 3 weeks. This study plans to recruit approximately 63 patients. The first patient was dosed at Florida Cancer Specialists – Lake Mary Cancer Center, while the study is also going to recruit patients from the University of Colorado Cancer Center, Rutgers Cancer Institute of New Jersey and Stephenson Cancer Center in Oklahoma.

AN2025 targets not only PI3K mediated tumorigenesis (e.g. via inhibition of PI3Ka/PIK3CA mutants) but also the immunosuppression of the tumor microenvironment (e.g. via inhibition of PI3Ko and PI3Ky). According to the Frost & Sullivan Report, PIK3CA alterations are found in approximately 13% of all solid tumors globally, including 25% to 40% of cervical cancer, 30% to 40% of breast cancer, 30% to 35% of endometrial cancer, 30% of ovarian cancer, 24% of urothelial cancer, 20% of colorectal cancer and 10% to 20% of head and neck squamous cell carcinoma ("HNSCC") globally. The global incidence of PIK3CA mutant solid tumors reached approximately 2.3 million in 2020 and is expected to reach approximately 2.9 million in 2030, indicating a substantial overall addressable market and significant commercial potential.

Adlai Nortye aspires to develop differentiated cancer immunotherapy medicines for global markets. The Company's Cocktail therapy strategy represents the third wave of immuno-oncology therapy, featuring the combination of an immune checkpoint inhibitor with two or more additional cancer therapies. The Company expects it to achieve significantly higher overall response rates than present combination therapies. The triple combination of AN2025 (targeted therapy), AN0025 (immuno-oncology therapy) and atezolizumab (immuno-oncology therapy) exemplifies the cocktail therapy strategy of Adlai Nortye.

"Results from preclinical studies of the triple combination of AN2025, AN0025 and an anti-PD1 antibody have demonstrated encouraging antitumor activity. We believe that this triple combination potentially could develop into a novel anti-cancer immune therapy by exquisitely and systemically targeting the suppressive tumor microenvironment and thus permitting enhanced host immune responses against the tumor." said Dr. Lars Birgerson, Chief Medical Officer of Adlai Nortye, "We expect to identify the recommended Phase II dose of this Phase I clinical trial in the second half of 2022 as a step in a planned development program to bring this therapy to patients worldwide. Adlai Nortye is strongly committed to improve the lives of patients and their families by continuously developing our pipeline in oncology through our cocktail therapy strategy."

About AN2025S0101
This is an open-label, multicenter, Phase Ia study to evaluate the safety, tolerability, PK and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with atezolizumab in patients with locally advanced/metastatic tumors. This study consists of three DLT Observation Periods, Observation I, II and III. Observations I and II are double combination treatments, which will be conducted in parallel, whereas Observation III (the triple combination treatment) will be initiated only after a thorough review of the safety data from Observations I and II. Each Observation period will last 3 weeks.

About AN2025 (Buparlisib)
AN2025 (buparlisib) is an oral pan-PI3K inhibitor that targets all class I PI3K isoforms and is active in both hematologic malignancies and solid tumors. In the global randomized Phase II clinical trial for the treatment of recurrent or metastatic HNSCC with buparlisib in combination with paclitaxel, the median overall survival was as high as 10.4 months. Buparlisib was granted Fast-Track designation for this indication from the FDA. The ongoing study is the first global Phase III clinical trial conducted by Adlai Nortye.

About AN0025 (EP4 Antagonist)
AN0025 is a potentially first-in-class oral EP4 antagonist that blocks prostaglandin E2 from binding to its subtype 4 receptor (EP4) changing the immunosuppressive character of the tumor microenvironment. Based on preliminary results, it is well tolerated in patients with solid tumors in combination with radiotherapy/chemoradiotherapy ("RT/CRT"). A Phase Ib study of AN0025 in combination with the standard of care in a neoadjuvant setting for locally advanced rectal cancer showed excellent results, with 20% of patients achieving clinical complete remission and 16% achieving pathological complete remission in this study.

About Adlai Nortye
Adlai Nortye is a global biopharmaceutical company focused on developing innovative oncology drugs, with its R&D and clinical operation centers in both China and the United States. With a strategic emphasis on oncology, the Company has built a global pipeline through collaborations and internal discovery with more than 10 drug candidates in development. Currently, four of them are being investigated in clinical trials. With fast-track designation from the FDA, AN2025 (buparlisib), in combination with paclitaxel, is initially developed to be the drug of choice for 2L treatment of metastatic HNSCC after anti-PD-1 treatment (Phase III multi-center clinical trial). AN0025 is a clinical-stage, potential first-in-class EP4 antagonist designed to modulate tumor microenvironment. AN1004 (pelareorep), with fast-track designation from the FDA, is a registrational trial-stage, potential first-in-class intravenously delivered oncolytic virus for treating hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. AN4005, the Company's clinically most advanced drug candidate from in-house discovery, is a potential first-in-class, orally available, small-molecule PD-L1 inhibitor.

The Company has assembled an experienced management team, built its proprietary drug research and development platforms and partnered with multiple leading pharmaceutical companies to promote innovation. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. The mission of the Company is to transform deadly cancer into a chronic and eventually a curable disease. For more information, please visit: www.adlainortye.com.


Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

HONG KONG, Aug 31, 2021 – (ACN Newswire) – Zhong Ji Longevity Science Group Limited ("Zhong Ji Longevity Science", together with its subsidiaries, the "Group"; stock code: 0767.HK) is pleased to announce its unaudited interim results for the six months ended 30 June 2021 ("Period under Review").

During the Period under Review, the Group has been expediting the development of its longevity science business. In addition to operating and managing it existing businesses of money lending, securities and other investment, financial and investment advisory and property investment, the Group accelerated its business transformation by deploying more resources in its operations through five key divisions, namely, longevity science research, longevity medical testing, longevity biological products, longevity management services and member division. The Group has strived to map out its blueprint in the field of longevity science through a number of mergers and acquisitions as well as establishment of strategic cooperations, and managed to achieve breakthroughs.

The Group was principally engaged in the business of money lending, securities and other investments and financial and investment advisory during the Period under Review. Given the unstable market environment and sentiment, and to mitigate the volatility risk, the management of the Group took a rather prudent approach in operating these businesses which has directly caused the slowdown in the business performance. In addition, the Group's grant of share options to relevant consultants further deteriorated the performance of the Group on the overall basis. Nevertheless, the newly ventured longevity science business recorded a pretty impressive set of results for the Group in the first half of 2021. During the Period under Review, the Group recorded a total revenue of HK$16,112,000 (2020: HK$20,956,000), with loss for the period amounted to HK$20,851,000 (2020: profit for the period of HK$16,039,000). The additional share options grant amounting to HK$13.1 million contributed to the overall loss of HK$20.9 million in the Period under Review. Nevertheless, the contribution of longevity science business served as a cushion to alleviate the overall losses incurred. The basic loss per share and diluted loss per share were HK$0.54 cents (2020: basic and diluted earnings per share were HK$0.41 cents and HK$0.11 cents respectively).

Mr. YAN Li, Chairman of the Board and Executive Director of Zhong Ji Longevity Science, said, "Since the change of company name, the Group has been focusing on expanding its longevity science business. During the Period under Review, we have spearheaded strategic transformation venturing into the field of longevity science in an exhaustive and diversified manner to continuously improve its industry and product chains riding on our existing finance-related businesses. Through our innovative longevity healthcare solutions, we are committed to realising our vision of 'helping people live longer and healthier lives', thereby building a world's leading ecosystem platform in longevity science."

Business Review
During the Period under Review, the Group advanced its transformation of longevity science business from all fronts. The revenue of the segment amounted to approximately HK$7,171,000, of which, approximately HK$3,136,000 was generated from diagnostic consultation and medical testing, and approximately HK$4,035,000 was contributed by the sales of longevity biological products, with segmental profit of approximately HK$2,839,000.

Strengthening in-house R&D and production capabilities
During the Period under Review, the Group focused on strengthening its hard and soft capabilities. The Group recruited a seasoned team of biotechnology and management talents, including Nobel laureates in Physiology or Medicine, which has immensely enhanced the Group's research and development ("R&D") capability, enabling the Group to achieve its strategic goals. In addition, the Group resolved in May to adopt a share award scheme, which aims to recognise employees and individuals who have contributed to the Group's development and business growth as well as to attract talents in the industry. Perpetual Master Limited ("Perpetual Master"), a wholly-owned subsidiary of the Group, has leased a 36,000-square-foot production plant in California, the United States, ensuring stable support to the production and technology of the Group's flagship products. Given its high start-up cost compounded with the effect of COVID-19 in California, the management of the Group has decided to subcontract the operation to an independent third party to manufacture the longevity biological products on the Group's behalf. The decision made was in line with the Group's goal of operational efficiency and effectiveness.

Proactively identifying suitable acquisition opportunities to perfect industry chain
In order to enhance and enrich existing business during the Period under Review, the Group has been proactively identifying suitable acquisition targets. Blooming Faith Development Limited, a wholly-owned subsidiary of the Group, acquired two examination centres, namely Irving Weissman International Advanced Medical Testing Centre and Asian Advanced Medical Testing Centre. The two testing centres commenced their operations in May this year in Shenzhen. In terms of longevity science R&D and longevity management services, Perpetual Master entered into a memorandum of understanding ("MOU") with China International Osteoarticular Medical Group earlier this year to acquire one of the world's largest FDA-registered international auto-immune cell banks, Asian Integrated Cell Laboratory Limited. In August this year, the Group acquired the entire equity interest of Banderland Development Investment Holdings Limited ("Banderland Development") at a consideration of RMB154 million. Banderland Development indirectly holds 55% equity interest in Hangzhou Chenghui, which in turns directly holds the entire interest of Hangzhou Chengnan Hospital. The Group will collaborate with Hangzhou Chengnan Hospital to establish Zhejiang Zhongji Longevity Medical Testing Centre and Zhejiang Zhongji Longevity Cloud Centre.

Striving to expand and enhance longevity biological products
During the Period under Review, the Group has commenced the development and production of its flagship NMN product "ZJ1" and VC sustained-release tablets, as well as other longevity biological products. The Group's products are currently sold worldwide and well received by high-net-worth individuals. During the Period under Review, the Group's scientific research team boosted the R&D progress of "ZJ1" to the seventh generation. In terms of marketing and sales strategy, the Group will capitalise the existing customer base, marketing network and sales channels of ZJ1 International Medical Group (Hong Kong) to gradually set up the "Internet + Healthcare" longevity system platform – Zhong Ji Longevity Cloud.

Establishing partnerships with world-class companies
The Group entered into a MOU in relation to forming a strategic partnership with Thermo Fisher Scientific (Hong Kong) Limited, a forerunner in the field of life sciences. Thermo Fisher will priorities the Group in the provision of its latest life sciences technology, software and solution. The Group has also entered into an investment cooperation framework agreement with Hubei Mailyard Share Co., Ltd. (Stock Code: 600107.SH). A joint venture, Mailyard Health Group (Hubei) Company Limited, was incorporated in April to focus on the development of advanced medical services such as cancer prevention and early screening, longevity medical testing and cell management, as well as the distribution of longevity biological products, provision of longevity management services and longevity solutions.

Prospect
It is expected that longevity science industry will embrace bright prospects, leading the development of Zhong Ji Longevity Science to bear fruits in future. The Group will continue to establish longevity medical testing centres in 18 first and second-tier cities of China through mergers and acquisitions and strategic cooperation in the coming three years, aiming at providing customers with world's leading services of cancer prevention and early screening, longevity medical testing and longevity management. It is expected that the Group's early screening services will reduce the incidence and mortality rates of cancer by benefiting more people at high risk of cancer and other critical illnesses. In terms of longevity biological products, the Group will fully leverage its expertise in the cellular field and continuously enhance its R&D and production level to introduce higher quality and more effective longevity biological products, with a focus on catering public's desire for longevity and ultimately further increase the Group's market share of global healthcare products. In terms of R&D in longevity science and longevity management services, the Group will focus on the development and related applications of cell and gene therapy, and the provision of cell testing, cell banking and storage, optimisation as well as cell therapy services. The Group plans to provide longevity healthcare solutions for its members. The Group will also continuously enhance the coordination and operation of its longevity system platform "Zhong Ji Longevity Cloud" and gradually improve its "Internet + Healthcare" longevity system platform.

Mr. YAN Li concluded, "As a pioneer in the field of longevity science, Zhong Ji Longevity Science will invest more resources to build its technology platform in the field of longevity science, striving for enlarging its scope and deepening its foothold, so as to continuously enhance the industry and product chains, as well as to further enhance its brand awareness. The management is confident about the Group's business performance in the second half of the year, and believes that its longevity science business will gradually support the Group's revenue growth and become a growth driver in the future, thereby creating long-term returns for its shareholders."

About Zhong Ji Longevity Science Group Limited
Zhong Ji Longevity Science Group Limited (0767.HK) is principally engaged in longevity science, money lending, securities and other investments, financial and investment advisory, as well as property investment. As the world's leading ecosystem platform in the field of longevity science, the Group is dedicated to making contribution to human health and longevity. With operations of five major divisions, the Group's longevity scientific research division involves research and development through NK, CBNK and CAR-NK technology platforms, CAR-T technology platform, MSC technology platform as well as longevity biological product technology platform; its longevity medical detection division provides data related to human health and longevity assessment; its longevity biological products division includes production and sales of longevity biological products such as NMN and Vitamin C time-release tablets; its longevity management division offers scientific solutions in terms of human health and longevity, while its member division provides construction and operations of the World Longevity Science and Healthcare Association and Longevity Cloud.

For more information, please visit: https://www.irasia.com/listco/hk/zhongjilongevity/



Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

SUZHOU, CHINA, Aug 30, 2021 – (ACN Newswire) – Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced its 2021 interim results and released an update on its recent progress in clinical development, commercialization (including license-out and production capacity expansion), and activities in Hong Kong capital market.

Dr.Youzhi Tong, Founder, Chairman, and CEO of Kintor Pharma, commented,
"In the first half of 2021, Kintor Pharma has made great progress in areas including research, clinical operations, and business cooperation with reputable partners. More specifically, proxalutamide, an innovative androgen receptor antagonist for the treatment of COVID-19 infection, is in three phase III multi-regional clinical trials (MRCT) approved by regulators in the United States, Brazil, and other countries. Recently, in a major milestone, proxalutamide was granted its first emergency use authorization (EUA) by the Paraguay. Looking further out, our company is accelerating the global clinical development of existing products pipeline and remains focused on creating value at the clinical stage, while pursuing new treatment for patients with unmet needs. At the same time, we continue to strive to create value for shareholders."

First EUA Granted for Proxalutamide for Treating COVID-19 Inpatients
Proxalutamide is a nonsteroidal antiandrogen – specifically, a selective high-affinity silent antagonist of the androgen receptor (AR). The compound has a dual mechanism of action: It inhibits the androgen receptor competitively and decreases the expression of AR, effectively lowering the expression of the proteins ACE2 and TMPRSS2, which the novel coronavirus uses to invade host cells. Thus, proxalutamide prevents the coronavirus from infecting normal host cells, prevents viral replication and reproduction, and appears to treat novel coronavirus infections effectively. In addition, proxalutamide also promotes the clearance of pathogens and decreases inflammation by activating the Nrf2 pathway, which activates several antioxidative genes and proteins and reduces the intensity of the cytokine response, which is of clinical benefit to the most seriously ill COVID-19 patients.

Kintor Pharma has been studying the use of proxalutamide for the treatment of COVID-19 infection since early 2020, at the beginning of the COVID-19 pandemic. So far, the in vitro studies in the P3 laboratory have demonstrated that proxalutamide can effectively inhibit infections caused by the Alpha and Delta variants. The outcome of genome sequencing on COVID-19 inpatients in Brazil has shown that proxalutamide has effectively treated inpatients infected by Gamma variant.

In 2021, Kintor Pharma received greenlight from the U.S. Food and Drug Administration (FDA) and the approval from Brazilian Health Regulatory Agency (ANVISA) to conduct phase III clinical trials with proxalutamide in patients with COVID-19. The company is conducting two phase III MRCT of proxalutamide for the treatment of COVID-19 outpatients, and one phase III MRCT for COVID-19 inpatients in countries and regions including the United States, South America (including Brazil), the Europe, and Asia.

Most recently, the Ministry of Public Health and Social Welfare (MSPBS) of Paraguay granted Kintor Pharma an EUA for proxalutamide to treat hospitalized patients with COVID-19.

Pyrilutamide and GT20029 for Hair Loss and Acne
Androgenic alopecia (AGA) is a common form of hair loss in both men and women. Acne vulgaris is common in teenagers and young adults. Both AGA and acne affect people worldwide. Kintor Pharma has made progress in developing products for these two conditions.

Kintor Pharma's pyrilutamide is a topical AR antagonist with a specific target that can inhibit the combination of AR and androgen in hair follicle sebaceous glands, treating both AGA and acne.

Pyrilutamide is undergoing phase II clinical trials in China for AGA. As of this writing, the trial data is being analyzed, and we expect to announce results soon. In April 2021, the first batch patients of pyrilutamide's phase I/II clinical trial in China for acne vulgaris were enrolled and successfully dosed. Separately, the FDA approved pyrilutamide's US-based phase II clinical trial for AGA in July 2021.

Kintor Pharma developed protein degradation chimera (PROTAC) compounds. The first, GT20029, can effectively block the AR pathway and physiological function by degrading the AR protein.

In April and July 2021, Kintor Pharma received clearance from the CDE and FDA to conduct phase I clinical trials with GT20029 for the treatment in AGA and acne in China and U.S.

In July, Kintor Pharma announced that the first subjects had been enrolled and dosed in a phase I clinical trial of GT20029 for the treatment in AGA and acne in China. GT20029 is the world's first topical AR-PROTAC compound to enter the clinical stage.

We look forward to reporting progress on pyrilutamide and GT20029 soon.

Exploring Innovative Combination Therapies for Multiple Solid Tumor Types
In February 2018, Kintor Pharma obtained from Pfizer Inc. an exclusive license for GT90001, a fully humanized monoclonal, potential first-in-class antibody that inhibits ALK-1/TGF-beta signal transduction and tumor angiogenesis. GT90001 has the potential as a treatment in multiple solid tumor types.

GT90001 is now in phase II clinical trials in Taiwan (China) as a second-line combination therapy with Nivolumab, a PD-1 inhibitor, for metastatic hepatocellular carcinoma (HCC). The preliminary data from the ongoing Taiwan (China) phase II trial was released at ASCO GI 2021 and showed positive efficacy and safety results. Eight of 20 assessable patients had partial remission (PR), with an objective remission rate of 40 percent.

In February 2021, the U.S. FDA granted Kintor Pharma an investigational new drug (IND) application of GT90001 for a multi-regional phase II clinical trial for the combination treatment of GT90001 and Nivolumab for the second-line treatment of HCC.

The first patient with advanced or refractory solid tumors in a phase Ib/II clinical trial of GT90001 in combination with KN046, a PD-L1/CTLA-4 bispecific antibody developed by Alphamab Oncology, expects to be dosed soon. Tumor types being targeted include HCC, gastric carcinoma (GC), gastroesophageal junction adenocarcinoma (GEJ), urothelial carcinoma (UC), and esophageal square cell carcinoma (ESCC).

In addition, Kintor Pharma has entered into a partnership agreement with US-based Gensun for its PD-L1/TGF-beta dual-targeting antibody. Kintor Pharma's clinical trial application for PD-L1/TGF-beta was recently accepted by the China Center for Drug Evaluation (CDE).

Meanwhile, Kintor Pharma is working on designing clinical trials for combination therapy of ALK-1/VEGF dual-targeting antibody for solid tumor types.

Continuous Expansion of Diversified Products Pipeline
Kintor Pharma's products pipeline consists of innovative, small-molecule drugs, biologics, and combination therapies. At present, seven of Kintor Pharma's new drug programs are in clinical development:

— Two AR antagonists (proxalutamide and pyrilutamide)
— ALK-1 monoclonal antibody
— mTOR kinase targeting inhibitor
— Hedgehog/SMO inhibitor
— AR-PROTAC compounds, and
— PD-L1/TGF-beta dual-targeting antibody

Kintor Pharma's other products – c-Myc inhibitors and ALK-1/VEGF dual-targeting antibody, among others – are under pre-clinical study.

Collaboration with Reputable Partners Globally
Kintor Pharma has partnered with the Medical College of the University of Michigan and the Beijing Proteome Research Center on pre-clinical research to study further the proxalutamide's mechanism of action against the SARS-CoV-2 virus causing the COVID-19 pandemic. In addition to the three phase III MRCT of proxalutamide for COVID-19, Kintor Pharma has been working with several international CROs to advance clinical progress.

We have expanded production capacity at our own GMP factory and entered into a strategic partnership with Hainan Visum Pharmaceutical Limited to expand the production capacity of proxalutamide. At the same time, we entered into a licensing agreement with Shanghai Fosun Pharmaceutical Development Ltd. ("Fosun Pharma Development") on the commercialization of proxalutamide for the treatment of COVID-19 infection in India and 28 African countries. In addition, Kintor Pharma has also partnered with PT Etana to commercialize proxalutamide to treat COVID-19 infection in Indonesia. We believe these efforts will make a valuable contribution in the global fight against the COVID-19 pandemic.

Robust Performance in Capital Market
On June 2, 2021, Kintor Pharma completed the top-up placement and raised HK$1.16 billion($150 million) from reputable long-only funds, healthcare specialist funds and hedge funds.

On August 20, 2021, Hang Seng Indexes Company Limited announced the Hang Seng Composite Index (HSCI) results as of June 30, 2021. Kintor Pharma was included in the HSCI, with relevant changes taking effect on September 6, 2021. Being included in the HSCI means that Kintor Pharma's stock is eligible for inclusion in the Hong Kong Stock Connect program, which will help increase the stock's liquidity and expand investors base.

2021 Interim Financial Performance
For the six months ended June 30,2021, the company's R&D costs increased by 90.2% to RMB282.2 million, mainly attributable to the increase in clinical research expenses primarily paid to hospitals and CROs for the clinical trials advancing proxalutamide for the treatment of COVID-19 infection, and the increase in R&D employee expenses primarily due to the expansion of our R&D personnel and the grant of RSUs to certain of our R&D employees under the Employee Incentive Scheme.

Our adjusted loss after adding back the listing expenses (which is applicable to the six months ended 30 June 2020 only) and share-based compensation expenses for the Employee Incentive Scheme increased by RMB136.2 million or approximately 83.2% from RMB163.7 million for the six months ended 30 June 2020 to RMB299.9 million for the six months ended 30 June 2021.

The company's cash and cash equivalents consisted of deposits (including time deposit) with banks and cash on hand. As of June 30, 2021, cash and cash equivalents (including time deposit) increased from RMB1,388.9 million on December 31, 2020 to RMB1,755.3 million. The increase was primarily attributable to the net cash proceeds of approximately HK$1.16 billion Kintor Pharma received from the placement.

As of June 30, 2021, we had utilized bank facilities of RMB137.7 million and unutilized bank facilities of RMB112.3 million.

About Kintor Pharmaceutical Limited
Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of small molecule and biological drugs for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia and acne. For more information, visit www.kintor.com.cn.




Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

HANGZHOU, Aug 21, 2021 – (ACN Newswire) – New Horizon Health (6606.HK) (the "Company"), the first public listed cancer screening company in China, has today announced its financial report for the first half year ended 30 June 2021.

In the first half of 2021, the Company's total revenue was RMB43.9 million, a year-on-year increase of 317%. Gross profit was RMB24.7 million, up 1,000.2% from the same period of 2020. Gross profit margin also climbed from 21.3% in the same period of 2020 to 56.2%.

ColoClear, the first and only molecular cancer screening test approved by National Medical Products Administration (NMPA) in China, realized revenue of RMB14.2 million in the first half of 2021, an increase of 149% year-on-year. Its shipment volume was about 121,500 units in the first half of the year, a rise of 392% over the same period last year, and its gross profit margin increased from 33.9% in the same period of 2020 to 56.6%. Pupu Tube, the first and only self-conducted fecal immunochemical test (FIT) screening product approved by NMPA in China, recorded revenue of RMB29.6 million in the first half of 2021, representing year-on-year growth of 623.7%. The product's gross profit margin also increased from 26.4% in the same period of 2020 to 59.0%.

The latest report issued by the International Agency for Research on Cancer (IARC) predicts that new cases of breast cancer and colorectal cancer around the world will increase the most in the next 50 years. The penetration rate for colorectal cancer screening in China was only 16.4% in 2019, while that in the United States reached 60.1%. The social and economic value of early cancer screening has quickly received attention and recognition from various domestic sectors in 2021, and the market is entering the fast lane at full speed.

Mr. Yeqing Zhu, Executive Director and CEO of New Horizon Health, said, "The year 2021 marks the first year for the regulation, innovation and evolution of China's early cancer screening industry. As progress relies on strength, New Horizon Health has just opened a new chapter of growth. The strong sales growth of ColoClear and Pupu Tube proves that home-based cancer screening tests have successfully gained recognition from target groups and addressed the urgent needs of consumers in upgrading their health. The improvement in gross profit margin was driven by the rapid and determined execution of our diversified commercial layout in the first half of the year, which significantly increased the average selling price of both products. The higher sales volume has also enabled more efficient management of our operating facilities, further reducing our unit operating cost."

Mr. Zhu added, "The recognition from clinical experts and doctors is the cornerstone of our market expansion and product development. In January and April this year, the Company's proprietary multi-target stool-based FIT-DNA test technology was included within the first national 'Guidelines for Prevention and Treatment of Colorectal Cancer' and 'Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines' initiated by the National Cancer Center of China. The FIT-DNA test is the only molecular cancer screening and genetic testing technology presently included in national guidelines. Meanwhile, our marketing team has also expanded by 137% to 270 people in the first half of 2021. The launch of ColoClear to public hospitals across various provinces and cities has progressed smoothly. As a pioneer and leader in cancer screening in China, we are committed to investing in awareness and compliance education for cancer screening. Pupu Tube, an entry-level product for home-based self-testing for cancer detection costing less than RMB100 per unit, has become the vanguard of market education and sinking the vast grassroots. In the second half of the year, we will continue to build up our professional team structure and strengthen our cooperation and promotion with medical check-up centers, insurance organizations, online medical consultation platforms, pharmacies, and other authorized institutions. ColoClear will soon see an explosion of promotion".

Continues to promote early cancer screening compliance advantages and build a diversified business presence

The "First Certificate for Early Cancer Detection in China" approved by the NMPA of China on 9 November 2020 has set a benchmark for compliance in the cancer screening industry. Capitalizing on its advantageous position as the first cancer screening compliant company in China, after its successful listing in Hong Kong, New Horizon Health has quickly established in-depth strategic partnerships with leading brands across several sectors. Such cooperation accelerated the implementation of diversified business presence and promoted ColoClear and Pupu Tube to become the exclusive promotional products of various strategic cooperation platforms.

The cooperation with AstraZeneca China has strongly supported the Company's expansion into China's digestive disease prevention and treatment sector and consolidated its advantages in the in-hospital clinical market. The partnership with JD Health has realized the in-depth alignment of the platforms of New Horizon Health and JD.com and the Company's user service system, an important step forward for its conducting e-commerce marketing. While the cooperation with Ping An Healthcare has enabled the first closed-loop solution integrating Internet medical and healthcare in China, marking a major advance from online diagnosis and treatment to cancer prevention and screening. The cooperation with China Post has filled the gap in intestinal screening, and cancer prevention and treatment in China's grassroots market while educating the user in the vast township market. The partnership with PICA Health has empowered three million village doctors to promote intestinal health and prevent intestinal diseases in remote rural areas with severe deficiencies of diagnosis and treatment resources and shortage of colonoscopy equipment.

The only stool-based FIT test included in two medical guidelines and commercialized to clinical markets

Hospital market access and clinician education are the keys to the promotional efforts to hospitals for New Horizon Health. The multi-target stool-based FIT-DNA testing technology developed by New Horizon Health has become the sole colorectal cancer screening and DNA test technology recommended by two medical guidelines in January and April 2021: The "China Guidelines for the Screening, Early Detection and Early Treatment of Colorectal Cancer" was compiled by the National Health Commission and published by the National Cancer Center; and the latest edition of the "Guideline for Diagnosis and Treatment of Colorectal Cancer" was published by the Chinese Society of Clinical Oncology (CSCO).

With the implementation of colorectal cancer early screening standards and regulations, negative predictive value (NPV) and sensitivity have become the industry standards for the selection and performance evaluation of early cancer screening products. New Horizon Health's clinical team has aggressively conducted a series of academic seminars and clinical trials to continuously promote the multi-target stool-based FIT-DNA testing technology into the existing clinical segment and implement the technology into the practice and application of clinically-related fields.

Striving its utmost to invest in popular science education for early cancer screening in multiple formats across platforms and in pursuit of continuous innovation

As a leader in the early cancer screening industry, New Horizon Health has always adhered to spare relentless effort in investing in market education. In the first half of the year, New Horizon Health continued to promote early cancer screening education to the general public.

On 15 April 2021, the Committee of Colorectal Cancer of the Chinese Anti-Cancer Association and the People's Daily Health App co-launched China's first-ever "Early Cancer Screening Day" during the "Nationwide Promotion Week for Popular Science Education on Oncology", making early cancer screening an important event in China's strategic public health campaign. Subsequently, New Horizon Health has organized its first branded health awareness day with the theme of "Changing Life Trajectory" inviting seven industry national clinical experts. The live streaming of the event recorded 5 million views. During the 618 Festival, New Horizon Health teamed with Kuaishou Health and Xiaohe Health to launch a popular science short video campaign featuring intestinal health, early screening, and cancer prevention. More than 80 million views were recorded by the two platforms. During the same period, New Horizon Health ranked No. 1 in industry sales in the DNA test category segment and in sales of a single product on JD.com as well as No. 1 in terms of spending in the healthcare product list on 18 June.

R&D pipeline progresses as planned, while overseas cooperation and business expansion focuses on building future pipeline capacity

The approval of the UU Tube is progressing on schedule, and preparations for the kickoff of the clinical trial of CerviClear is proceeding smoothly. New Horizon Health is accelerating its R&D in multiple product pipelines, and has heavily invested in the development of biomarker R&D capability for, and the building of, the next-generation sequencing technology platform. The Company continues to make additional investments, expand automated production lines, and enhance production and testing capabilities to meet the fast-growing demand.

Moreover, New Horizon Health has officially commenced overseas strategic cooperation, actively introducing advanced technologies and focusing on future new pipeline layout and capacity expansion. The listed company New Horizon Health contributed US$30 million to the establishment of NHH Venture Fund, L.P. Fundraising for the first phase of the Fund was completed on 20 August 2021. The Fund is to focus on investing in molecular diagnostic technology to promote disease screening and early testing for cancer and other serious diseases. In July 2021, New Horizon Health and Proteomedix have forged a partnership for R&D cooperation and investment in its convertible debt. In addition, in August 2021, New Horizon Health and Epigenomics AG have signed an asset purchase agreement.

About New Horizon Health
Founded in 2015, New Horizon Health is the pioneer and market leader in China's cancer screening sector focusing on early detection of high-incidence cancers at home. It aims to promote innovation in cancer screening technology and expedite the widespread take-up of cancer screening technology in China. On 18 February, 2021, New Horizon Health was successfully listed on the Stock Exchange of Hong Kong under the stock code of 6606.HK, becoming the "first cancer screening stock in China".

New Horizon Health's two colorectal cancer screening products, ColoClear and Pupu Tube have been approved by the National Medical Products Administration (NMPA) and have commercialized. ColoClear is the first and only cancer screening product approved by the NMPA in China. In addition, the Company also has two pipeline candidates for gastric and cervical cancer screening respectively. The Company holds global rights in all its marketed and pipeline products. New Horizon Health has a 100,000-grade clean production workshop accredited with ISO13485 international certification, and third-party medical laboratories in Beijing, Hangzhou and Guangzhou, that are certified and licensed to practice by the local Health Care Commission, with an annual testing capacity of 2 million samples, and extensive cooperation with hundreds of hospitals, medical check-up centers, insurance companies, pharmacies and online channels.


Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

SHANGHAI, CHINA, Aug 19, 2021 – (ACN Newswire) – Hua Medicine (the "Company", Stock Code: 2552.HK), today announces the consolidated results of the Company and its subsidiaries for the six months ended June 30, 2021 (the "Reporting Period"). During the Reporting Period, the New Drug Application (NDA) of the first glucokinase activator (GKA) dorzagliatin, has been accepted by The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and has become the first GKA globally to submit a NDA for the treatment of diabetes. During the Reporting Period, the Company incurred approximately RMB165.1 million in total expenditures, of which approximately RMB98 million was research and development expenses. As of June 30, 2021, the Company's cash position was approximately RMB846.9 million, to be used for the commercialization of dorzagliatin and innovative drug R&D.

In the first half of 2021, Hua Medicine reached a breakthrough milestone in preparing for dorzagliatin's commercialization. The Company submitted the NDA for dorzagliatin, the first-in-class oral drug for the T2DM in March 2021 and was accepted by NMPA on April 23, 2021. To accelerate the potential launch of dorzagliatin, the Company is actively preparing for the review and approval of the relevant clinical, production and R&D on-site inspection. In anticipation of dorzagliatin commercialization, subject to approval of its NDA, in addition to its CMO partnerships, Hua Medicine has also established Hua Medicine drug manufacture company at Shanghai Lingang Special Area for ensuring adequate dorzagliatin commercial supply.

Hua Medicine has also made remarkable achievements in clinical R&D. In June 2021, the Company presented the latest clinical research analysis data of dorzagliatin at the 81st American Diabetes Association (ADA) Annual Scientific Sessions. Clinical trial HMM0111, dorzagliatin in combination with sitagliptin (a DPP-4 inhibitor), demonstrated clear synergistic effects. Dorzagliatin regulates GLP-1 release and insulin secretion in T2D patients, and in combination with sitagliptin, increases circulating active GLP-1. The results strongly demonstrate the clinical value of dorzagliatin in combination with DPP-4 inhibitors.

During the research and development of dorzagliatin, Hua Medicine was the first to put forward the scientific concept of "repair the sensor, restore homeostasis, and treat the underlying cause of diabetes" globally, as well as realize the potential of this drug, new mechanism of action, new targets, new structures, new technology and new clinical benefits. Dorzagliatin sets out to target the fundamental cause of T2D, and through clinical trials, has demonstrated that dorzagliatin significantly improves beta-cell function and reduces insulin resistance by repairing the damaged glucokinase sensor function in diabetic patients with T2D. It is expected to potentially control the progression of T2D and has therapeutic prospects in patients with diabetic nephropathy (DKD).

In the second half of the year, the Company will initiate research on the combination of dorzagliatin with existing antidiabetic drugs, including dorzagliatin in combination with dapagliflozin (a SGLT-2 inhibitor), insulin and GLP-1, to explore new opportunities in the areas of diabetic nephropathy, metabolic syndrome diabetes, advanced diabetes, and diabetes cognitive impairment. The Company will also initiate clinical research in the United States for Type 1 diabetes patients. In the future, the Company plans to further advance its fixed-dose combination pipeline for dorzagliatin for the treatment of diabetes and related diseases.

"In the first half of 2021, Hua Medicine made important achievements in clinical research and development, while pushing forward on commercialization preparations. Hua Medicine's commercialization team is taking shape, and has established closer corporation with Bayer, which has strengthened Hua Medicine's confidence in curing diabetes in the future. With dorzagliatin as a cornerstone, in combination with existing drugs, Hua Medicine will systematically and precisely treat diabetes and control the occurrence and development of diabetic complications, contributing to Healthy China 2030." said Dr. Li Chen, founder, CEO and CSO of Hua Medicine.

Clinical and Commercialization Highlights:
— In March 2021, the Company submitted the NDA for dorzagliatin for the treatment of T2D to NMPA, which was accepted by the NMPA in April 2021.
— Presented the 52-week data of two Phase III registration clinical trials, the SEED trial (dorzagliatin monotherapy trial) and the DAWN trial (dorzagliatin combined with metformin) at the 2021 ADA Annual Scientific Sessions. The Company also reported data of the clinical trial HMM0112 (dorzagliatin in combination with empagliflozin).
— Presented data of clinical trial HMM0111 (dorzagliatin in combination with sitagliptin) at the 2021 ADA Annual Scientific Sessions, demonstrating that dorzagliatin regulates secretion of endogenous GLP-1.
— In anticipation of dorzagliatin commercialization, subject to approval of its NDA, in addition to its CMO partnerships, Hua Medicine has also established Hua Medicine drug manufacture company at Shanghai Lingang Special Area for ensuring adequate dorzagliatin commercial supply.

Financial Highlights:
For the year ended June 30, 2021
— Cash position was approximately RMB846.9 million as of June 30, 2021.
— Total expenditures incurred by the Company for the six months ended June 30, 2021 was approximately RMB165.1 million, of which approximately RMB98.0 million was attributable to research and development expenses. Research and development expenses decreased by approximately RMB14.3 million or approximately 12.7% to approximately RMB98.0 million for the six months ended June 30, 2021, compared with the six months ended June 30, 2020.
— Loss before tax decreased by approximately RMB8.2 million or approximately 4.7% to approximately RMB165.3 million for the six months ended June 30, 2021, compared with the six months ended June 30, 2020.
— Loss and other comprehensive expense for the period decreased by approximately RMB8.4 million or approximately 4.8% to approximately RMB165.3 million for the six months ended June 30, 2021, compared with the six months ended June 30, 2020.

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 Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired insulin and GLP-1 secretion of patients with Type 2 diabetes and serve as a cornerstone therapy targeting the root cause of the disease. Two Phase III registration trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin have been completed in China, as well as studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submitted its NDA to the National Medical Products Administration, so as to realize the "First in Global, Start from China" mission objective for the benefit of diabetic patients worldwide.

About Hua Medicine
Hua Medicine is a leading, innovative biotechnology company in China focused on developing novel therapies for diseases with 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 stage and it has successfully completed two Phase III registration trials in China for dorzagliatin. 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.

Forward-looking Statement
This article contains the statements regarding the future expectation, plan and prospects for Hua Medicine and the investigational product. The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect as a result of various risks, uncertainties or other legal requirements.

For more information
Hua Medicine
Website: www.huamedicine.com

Investors
Email: ir@huamedicine.com

Media
Email: pr@huamedicine.com

Porda Havas International Finance Communications Group
Mr. Bunny Lee +852 3150 6707 bunny.lee@pordahavas.com
Ms. Louisa Chen +86 75523807432 louisa.chen@pordahavas.com
Ms. Karen Chiu +852 3150 6726 karen.chiu@pordahavas.com
Ms. Winnie Tan +852 15915975512 winnie.tan@pordahavas.com


Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com