Penpulimab, the Fifth Chinese PD-1 Monoclonal Antibody, was approved for Marketing

On August 5, penpulimab (AK105) developed by Akeso, Inc. was approved for marketing, which is used to treat patients with relapsed or refractory classic Hodgkin's lymphoma (r/r cHL) after second-line systemic chemotherapy. It is the fifth domestic PD-1 monoclonal antibody. In addition, all indications of penpulimab for third-line nasopharyngeal carcinoma and first-line squamous non-small cell lung cancer have been reported, and a number of indications of first-line liver cancer and first-line non-squamous non-small cell lung cancer are in phase III clinical stage. 

Penpulimab is an innovative and potentially best-in-class humanized antibody PD-1 monoclonal antibody independently developed by Akeso, Inc. At present, it is jointly developed and commercialized by the joint venture company-Chiatai Tianqing Akeso (jointly established by Akeso, Inc. and Chiatai Tianqing). 

The approval of penpulimab by National Medical Products Administration is based on a key clinical trial with multi-center, single-arm and open label. The enrolled patients with recurrent or refractory classic Hodgkin's lymphoma had received at least second-line systemic chemotherapy. 200 mg penpulimab was administered intravenously every 2 weeks until the disease progressed or unacceptable toxicity appeared. The study's primary endpoint was objective response rate (ORR). 

The results of research are as follows. 

1. The ORR reviewed by the Independent Radiology Review Committee (IRRC) was 89.4% (76/85). In all, 47.1% (40/85) of patients achieved complete response (CR). 

2. The median follow-up time was 15.8 months. The median duration of response (DoR) was not achieved, with a DoR of 74.9% in 12 months. The median progression-free survival (PFS) failed, and the 12-month PFS rate was 72.1%.Penpulimab is the only new PD-1 monoclonal antibody in the world that adopts IgG1 subtype and is modified by Fc segment. The structure of the antibody is stable, so that it is not easy to aggregate. The ADCC, ADCP and CDC effects were completely removed, and the ADCR effect was reduced. The crystal structure analysis showed that it had unique PD-1 binding epitopes, which had a slower dissociation rate with PD-1, and could permanently block the binding of PD-1/PD-L1. The differentiated characteristics of penpulimab compared with other marketed PD-1 products may result in better efficacy and safety. 

As a broad spectrum anticancer product, PD-(L)1 drug has been highly popular in the market in recent years. According to Frost & Sullivan's analysis, the global market scale of PD-(L)1 inhibitors was 16.3 billion US dollars in 2018 and is expected to reach 63.9 billion US dollars by 2023. While in China, the market scale of PD-(L)1 inhibitors is expected to reach 66.4 billion yuan in 2023 and grow to 98.8 billion yuan in 2030. 

Nowadays, the market of PD-(L)1 is relatively broad. There are not only imported O drugs and K drugs, but also strong domestic players such as Junshi, Innovent, Hengrui, BeiGene, as well as other dozens of clinical PD-1 drug companies. This makes people wonder whether the PD-1 products of Akeso, Inc. can still take a place. 

Fortunately, Akeso, Inc. chose the small indications of classic Hodgkin's lymphoma to apply for marketing. With the development of medicine and the continuous emergence of treatment methods, Hodgkin's lymphoma has become a cancer with good prognosis, but the survival rate of advanced patients will gradually decline. New treatment options and biological pharma products are still needed for these refractory or relapsed patients. 

Penpulimab of Akeso, Inc. was approved for listing and became the fifth domestic PD-1 monoclonal antibody. At present, there are 4 domestic PD-1 monoclonal antibodies in the production application stage, which are serplulimab of Henlius, geptanolimab of Genor Biopharma, pucotenlimab of Lepu Biopharma and zimberelimab of Gloria Pharmaceuticals. 

Although penpulimab injection is approved, it can be believed that it will also face fierce market competition. 

Reference:

1.Retrieved Aug 5, 2021, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20210805143041169.html；

2.Retrieved May 26, 2020, from https://pdf.dfcfw.com/pdf/H2_AN202005261380235157_1.pdf；

3.Retrieved Oct 28, 2020, from http://asia.blob.euroland.com/press-releases-attachments/1259822/HKEX-EPS_20201028_9485209_0.PDF.