Akesobio Announced NMPA Accepts its new drug Penpulimab (PD-1 Monoclonal Antibody) for the Treatment of relapsed or refractory Classic Hodgkin's Lymphoma

May 25, 2020, Akesobio (9926.HK) announced Center for Drug Evaluation(CDE), National Medical Products Administration (NMPA) has accepted the application for anti PD-1 monoclonal antibody drug(安尼可) penpulimab (AK105) for the treatment of recurrent or refractive classic Hodgkin's Lymphoma after at least second-line chemotherapy. Such drug was developed and commercialized by Akesobio (9926.HK) and China Biopharmaceutical Co. Ltd. (1177.HK).


Professor Zhu Jun, CO principal investigator of the lead unit Beijing Cancer Hospital said, " Through bioengineering technology, penpulimab completely eliminate the binding activity of Fc receptors and avoid the ADCC effect. At the same time, compared with other drugs (已上市)on the same target, it has a slower rate of antigen binding and dissociation, which makes the biological effect stronger and improves its anti-tumor activity. I am full of expectations for such a differentiated PD-1 mono-resistance? product developed by Akesobio.” Co-lead researcher Professor Song Yuqin, Director of lymphoma Department at Peking University Cancer Hospital, said, "In clinical trial, penpulimab was observed with gratifying therapeutic data and good safety, and as a clinician, it is hoped that penpulimab will become a high-quality, clinically proven innovative PD-1 monoclonal antibody that will bring good news to patients."


The Chairwoman and CEO of Akesobio Dr. Michelle Yu said, "Since the establishment of joint venture with Chia-Tai Tianqing (“CTTQ"), the principal subsidiary of Sino Biopharm to research and commercialize Penpulimab together, Penpulimab has continuously reached new milestone. We sincerely hope that, if approved, the monoclonal antibody drug Penpulimab will provide a meaningful and affordable treatment for Hodgkin's lymphoma patients."


About classical Hodgkin’s lymphoma

Classical Hodgkin lymphoma (cHL) is a B cell lymphoma, and is the most common malignancy among young people. The age incidence rate curve is single peak in China, and the peak incidence rate is about 40 years old[1]. cHL is one of the few curable tumors. Chemotherapy (such as ABVD) plus radiotherapy is usually used. More than 80% of the patients can reach a 5-year survival rate. Although the first-line chemotherapy has a high clinical cure rate, a considerable number of patients are not sensitive to chemotherapy, about 5% to 10% of patients have no response to the initial treatment, 10% to 30% of patients have progress or relapse after the first-line treatment reaches complete remission[2], the treatment of patients after relapse is still a big problem.

[1]Wenqi Jiang, Huaqing Wang, Fenzi Gao and others, Lymphoma diagnosis and treatment [M]. People's Medical Publishing House, 2017 ,293-307..

[2]Ansell, Stephen M. Hodgkin lymphoma: 2018 update on diagnosis, risk-stratification, and management[J]. American Journal of Hematology, 2018, 93(5):704-715.


About Penpulimab(AK105

Penpulimab (AK105, PD-1 antibody) is a late-stage, differentiated and potentially best-in-class humanized monoclonal antibody against PD-1. Penplulimab was engineered to eliminate FC receptor binding activity, particularly with respect to Fc γ R and effectively eliminates undesirable fragment crystallizable (Fc)-receptor-mediated effects, such elimination has been shown to improve the anti-tumor activity of PD-1 antibodies and slower antigen binding off-rate as compared with the currently marketed PD-1 antibodies. Akeso have forged partnership with Chia Tai Tianqing, the principal subsidiary of Sino Biopharm for the joint development and commercialization of Penpulimab, Penpulimab is the only PD-1 antibody that Sino Biopharm can use to develop PD-1-based monotherapy or combination therapy.


About Akeso

Akeso,Inc.(HKEX Code: 9926.HK) is a clinical-stage biopharmaceutical company committed to in-house discovery, development and commercialization of first-in-class and best-in-class therapies. The Company’s business is designed to drive success through both efficient and breakthrough R&D innovation. Since its inception, the Company has had the foresight to develop an end-to-end platform, Akeso Comprehensive Exploration platform (“ACE Platform”), encompassing comprehensive drug discovery and development functionalities, including target validation, antibody drug discovery and development, CMC, and GMP-compliant manufacturing.The Company dedicated to addressing global unmet medical needs in oncology, immunology and other therapeutic areas. Akeso’s vision is to become a global leader in developing, manufacturing and commercializing innovative, next-generation and affordable therapeutic antibodies for patients worldwide.


About Sino Biopharmaceutical Limited

Sino Biopharmaceutical Limited (“Sino Biopharm”) is a limited liability company incorporated in the Cayman Islands and was listed on the Main Board of the Stock Exchange (stock code: 1177) in 2003 and included as a constituent stock of the Hang Seng Index in 2018.


Sino Biopharm principally engages in the research and development as well as the manufacture and sales of pharmaceutical products. It is particularly recognized for a range of medicines for treating liver diseases, tumours, cardio-cerebral diseases, analgesia, respiratory system diseases and orthopedic diseases. According to PharmExec’s 2019 Top 50 Global Pharmaceutical Companies, Sino Biopharm was ranked No. 42 globally and No.1 in China by 2018 global sales of prescription drugs.  


About Chia-Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ)

CTTQ is a multinational pharmaceutical company with integrated R&D, manufacturing, marketing, sales and distribution capabilities. 

With more than 12,000 employees, CTTQ is the market leaders in both liver disease and oncology field in China. It was ranked 16th on the list of the “Top 100 Pharmaceutical Enterprises in China” in 2018, and among the Chinese pharmaceutical companies with the best drug pipeline in 2019.

At present, we manufacture over 50 prescription medicines in 6 core therapeutic areas, including liver diseases, oncology, respiratory diseases, antibiotics, endocrine and cardiovascular. The innovative oncology drug, Anlotinib, was designated Orphan Drug status for treatment of ovarian cancer and STS by FDA, and three indications of NSCLC, SCLC, and STS have been approved in China. Multiple clinical trials are ongoing for other indications.

CTTQ has a total of over 1500 employees. We invest 10-12% of our annual sales revenue in R&D every year. There are more than 250 projects in our product pipeline.