恒星集团(中国)

(HONG KONG, 9 August 2021) Akeso, Inc. (9926.HK, the “Company”) announces that at the European Society for Medical Oncology Congress of 2021 (ESMO 2021) on September 16-21, a study on the mechanism of 安尼可^® (Penpulimab, PD-1 monoclonal antibody, AK105) will be published in the form of oral presentation, while a clinical trial of Cadonilimab (PD-1/CTLA-4 bi-specific antibody, AK104) in combination with Anlotinib for first-line treatment of non-small cell lung cancer (NSCLC) and a clinical trial of 安尼可^® (Penpulimab) for treatment of nasopharyngeal carcinoma will be published in the form of posters. Summary of the abstracts and electronic posters will be posted on the website of Akeso at http://www.mxcysc.com after ESMO 2021 is held.

Details of the three researches are as follows:

Information about Cadonilimab (PD-1/CTLA-4 Bispecific Antibody, AK104)

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bispecific PD-1/ CTLA-4 immuno-oncology backbone drug independently developed by the Company, and its major indications include liver cancer, cervical cancer, lung cancer, gastric cancer, esophageal squamous cell cancer and nasopharyngeal carcinoma. The preliminary research data of cervical cancer, gastric cancer and other tumors shows that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrated    promising       safety     profile     and  efficacy.

Information about 安尼可^®(Penpulimab, PD-1 Monoclonal Antibody, AK105)

Penpulimab (PD-1 monoclonal antibody, AK105, 安尼可^®) is jointly developed and commercialized by a joint venture established by the Company and Chia Tai Tianqing Pharmaceutical Group Co., Ltd., a subsidiary of Sino Biopharmaceutical Limited. Penpulimab is a new PD-1 monoclonal antibody with IgG1 subtype and Fc segment modification, which is structurally stable and less prone to aggregation. Antibody-dependent cell-mediated cytotoxicity (ADCC), acoustic doppler current profiler (ADCP) and complement dependent cytotoxicity (CDC) is avoided entirely, and antibody-drug conjugate reaction (ADCR) is lessened. Crystal structure analysis reveals a unique PD-1 binding epitope with a slower dissociation rate from PD-1 for durable blockade of PD-1/PD-L1 binding. This differentiation from other PD-1 products on the market may lead to a better efficacy and safety profile for the Penpulimab antibody.

Information about Akeso, Inc.

Akeso, Inc. is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable to patients worldwide. Since the Company’s establishment, the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system, encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant scale production. The Company has also successfully developed a bispecific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors, autoimmune diseases, inflammation and metabolism diseases, 13 of which have entered clinical stage, including two first-in-class bispecific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). The Company’s vision is to become a global leading biopharmaceutical company through research and development of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.

Information about Sino Biopharm

Sino Biopharm is a leading R&D-based pharmaceutical group in China, with business covering the entire industry chain including various pharmaceutical R&D platforms, intelligent production and strong sales system. Its products include various kinds of biopharmaceutical and chemical medicines, and have gained a competitive foothold in various therapeutic categories with promising potentials, including tumors, liver diseases, cardiocerebral diseases, analgesic medicines, respiratory system medicines and orthopedic diseases.

Information about Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (‘‘Chia Tai Tianqing’’)

Chia Tai Tianqing is an innovative pharmaceutical company with integrated pharmaceutical R&D, manufacturing and commercialization capabilities. With more than 14,000 employees, it is a leading pharmaceutical company in China in the fields of oncology, liver diseases and respiratory diseases. It ranked 15th place in the list of the top 100 pharmaceutical companies in China in 2020, and has been awarded as the best industrial company in China in terms of pharmaceutical R&D product pipeline in 2021.

Chia Tai Tianqing takes technological innovation as its important strategy for sustainable development, making unremitting efforts to actively research and develop innovative and high- quality pharmaceutical products, Chia Tai Tianqing has formed its production in the six core therapeutic sectors, including oncology, liver diseases, respiratory diseases, infection, endocrine and cardiocerebral. Chia Tai Tianqing has invested 10% to 12% of its annual sales revenue in research and development. It has 196 ongoing research projects, including 82 new drugs. It has undertaken over 30 major national specialized projects, and has applied for over 1,500 patents in China, including over 500 patents announced in China, and over 200 patents announced overseas.