On May 24, 2021 Akeso, Inc. (HKEx: 9926.HK) reported that Penpulimab (research and development code: AK105), an PD-1 monoclonal antibody drug co-developed by the Company with Sino Biopharmaceutical Limited (HKEx: 1177.HK), 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 (Press release, Akeso Biopharma, MAY 24, 2021, View Source [SID1234580510]).

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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.

According to the annual report of Akeso, Penpulimab is expected to receive NDA approval in China in 2021 for treatment of relapsed or refractory classical Hodgkin’s lymphoma, meanwhile the Company is accelerating approval progress of Penpulimab in the United States.

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

Penpulimab’s BLA submitted to the FDA will be reviewed under the new policy of RTOR, which aims to accelerate the process of drug approval. 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 ("U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program"), there were a total of 20 drugs approved under the RTOR by the FDA as of April 2020. 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. It is currently the fastest track for FDA drug approval.

The first immuno-oncology therapy 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.

Up to now, 3 Chinese PD-1 developers have submitted BLA to the FDA, including previously Innovent Biologics, Inc. and Shanghai Junshi Biosciences Co., Ltd.. Akeso is expected to expedite its BLA submission to the FDA under the new policy of RTOR. It is worth looking forward to when Chinese PD-1 will obtain the first approval overseas.

INFORMATION ABOUT PENPULIMAB

Penpulimab (AK105, PD-1 mAb) 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 (1177.HK) . Penpulimab is possibly one of the most innovative PD-1 monoclonal antibody drug candidates of the Company in advanced clinical development stage that can be differentiated from other products. Penpulimab’s Fc receptor and complement mediated effector are completely removed by Fc mutations; it also has a slower antigen binding off rate 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.