Akeso Penpulimab Monoclonal Antibody (PD-1) Submitted BLA in the United States

On May 24, 2021, Akeso, Inc. (9926.HK) jointly announced with Sino Biopharmaceutical Limited (stock code: 1177. HK) that Penpulimab (research and development code: AK105), an PD-1 monoclonal antibody drug co-developed by the two companies, has submitted a Biologics License Application (BLA) to the Food and Drug Administration of the United States (FDA) for third-line treatment of metastatic nasopharyngeal carcinoma.


Penpulimab is expected to get NDA approval domestically in China in 2021 for treatment of relapsed or refractory classical Hodgkin’s lymphoma, meanwhile the company is accelerating NDA approval progress of Penpulimab in the United States.


Previously, based on the promising clinical data of Penpulimab, it has obtained designated breakthrough therapy and fast track designation from the FDA for third-line treatment of metastatic nasopharyngeal carcinoma.


What is worth mentioning is that the FDA will review the BLA under the new policy of Real-Time Oncology Review (RTOR), which aims to accelerate the process of drug approval. This is the first Chinese PD-1 drug being BLA reviewed by the FDA under RTOR.


RTOR is a major and innovative new oncology drug approval policy issued by the Oncology Center of Excellence (OCE) of the FDA. It is faster than the priority review and aims to accelerate the process of drug approval, so as to facilitate a safe and effective treatment of cancer patients as early as possible.


According to publicly available information, up to April 2020, in total 20 drugs have been approved under the RTOR by the FDA. The average time of these drugs from application submission to getting approval is 3.3 months, with the fastest of 0.4 month and slowest 5.9 months. This means the new drug approval time under RTOR is way faster than fast track designation, breakthrough therapy or orphan drugs, being so far fastest track for FDA drug approval.


The first oncological immunotherapy approved by the FDA under the RTOR is Keytruda, a PD-1 immunotherapy drug by MSD. The approval time for treatment of endometrial carcinoma by Keytruda in combination with Lenvima was ahead of expectation for 3 months.


It is worth looking forward to regarding when Chinese PD-1 will obtain the first NDA overseas.



Penpulimab (PD-1 monoclonal antibody, AK105) is jointly developed and commercialized by a joint venture established by Akeso, Inc. and Chia Tai-Tianqing Pharmaceutical Group Co., Ltd. (“Chia Tai-Tianqing”), a subsidiary of Sino Biopharm. Penpulimab’s fragment crystallisable (“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.



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 Akeso’s establishment, Akeso 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. Akeso has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). Akeso 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). Akeso’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.



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.



Chia Tai-Tianqing is an innovative pharmaceutical company with integrated R&D, manufacturing and sales capabilities. It is a renowned R&D and manufacturing base in China targeting drugs on liver diseases and oncology treatment. It is a key high technology enterprise, as well as the highlighted Lianyungang new medical industry base under the State Torch Program. It ranked 16th on the list of the “Top 100 Pharmaceutical Enterprises in China” in 2018, and was the Chinese pharmaceutical enterprise with the best drug pipeline in 2019 (by the China National Pharmaceutical Industry Information Center). With more than 12,000 employees, Chia Tai-Tianqing’s products focus on six core therapeutic areas, including oncology, liver diseases, respiratory diseases, infection, endocrine and cardiocerebral. Apart from liver diseases, Chia Tai-Tianqing has formed its unique product line in the oncology field. “Anlotinib Hydrochloride Capsules”, a category 1 new drug, has been proven to treat three major indications including non-small cell lung cancer, small cell lung cancer and soft tissue sarcoma. It was a designated Orphan Drug for treatment of ovarian cancer and soft tissue sarcoma by the FDA. Multiple clinical trials are ongoing for other indications.

Chia Tai-Tianqing has over 1,500 R&D staff. It invests 10% to 12% of its annual sales revenue in R&D every year. There are more than 250 projects in its product pipeline.