New Drug Application for Penpulimab Monoclonal Antibody (PD-1) for Third-Line Treatment of Metastatic Nasopharyngeal Carcinoma Accepted by NMPA

[HONG KONG, 5 Aug 2021] Akeso, Inc. (9926.HK, the “Company”) announced that the new drug application (“NDA”) of Penpulimab (AK105), a PD-1 monoclonal antibody drug co-developed by the Company with Sino Biopharmaceutical Limited (1177.HK), for third-line treatment of metastatic nasopharyngeal carcinoma, had been submitted and was accepted by the National Medical Products Administration of China (the “NMPA”). This is the fourth indication of Penpulimab of which the NDA was successfully submitted in China and the United States.


Penpulimab is a new PD-1 monoclonal antibody that applies the immunoglobulin G1 (IgG1) subtype, modified by fragment crystallizable (Fc) segment, which has a slower antigen binding off-rate. Analysis shows that its crystal structure has unique binding epitope which continuously blocked the binding of PD-1/PD-L1, thus differentiates it from other PD-1 products in the market, which allows Penpulimab to enhance its immunotherapy efficacy and reduce immune-related adverse effects.


According to the introduction from Prof. Hu Chaosu, the principal research scientist of this study, who is also the deputy director of the Radiation Therapy Center of Fudan University Cancer Hospital, as well as the chief expert of the Multidisciplinary Comprehensive Diagnosis and Nasopharyngeal Cancer Treatment Team of Fudan University Cancer Hospital, nasopharyngeal carcinoma is a malignant tumor with a high incidence in localized areas. He added that the patients with recurrent or metastatic nasopharyngeal carcinoma have a poor prognosis, with a median overall survival period of less than 20 months, and no effective treatment option is available after failure of second-line therapy. Penpulimab has demonstrated a considerably high rate of sustained tumor remission and longer survival benefit in patients with metastatic nasopharyngeal carcinoma who have failed prior multiline therapy, and its efficacy in patients with refractory nasopharyngeal carcinoma with liver metastases is impressive. Penpulimab has been proved safe and well-tolerated, with a low incidence of overall immune-related adverse effects. The Company anticipates the approval of Penpulimab will provide patients with better treatment options.


Previously, Penpulimab has submitted two NDAs in China and one biologics license application (BLA) in the United States:


July 2021

NDA of Penpulimab in combination with chemotherapy for first-line treatment of locally advanced or metastatic squamous non-small-cell lung cancer was submitted and was accepted by NMPA.


May 2021

Penpulimab for third-line treatment of metastatic nasopharyngeal carcinoma has been submitted to the Food and Drug Administration of the United States (FDA) for a Biologics License Application (BLA) through the Real-Time Oncology Review (RTOR) program.


May 2020

NDA of Penpulimab for treatment of patients with classical Hodgkin’s lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL) was submitted and accepted by NMPA.



Information about Penpulimab Monoclonal Antibody (PD-1)

Penpulimab (PD-1 monoclonal antibody, AK105) is jointly developed and commercialized by a joint venture established by the Company and Chia Tai-Tianqing Pharmaceutical Group Co., Ltd. (Chia Tai-Tianqing), a subsidiary of Sino Biopharm. Penpulimab's Fc receptor and complement mediated effector are completely removed by mutations of Fc region, it also has a slower antigen binding offrate compared with the PD-1 antibodies that are already launched in foreign market. These features have made Penpulimab more effective in blocking the activity of the PD-1 pathway and evaded the T-cell anti-tumor activity, thus it has the potential to become an anti-PD-1 drug that can achieve better clinical efficacy.


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 bi-specific 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 bi-specific 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 (''R&D') 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 scope covering the entire industry value chain including various pharmaceutical R&D platforms, intelligent production and strong sales system. Its products include numerous kinds of biopharmaceutical and chemical medicines, and have gained a competitive foothold in different kinds of 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, as well 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.