China Cancer Antibodies Market Trends and Clinical Trials Insight 2023 Report Highlights:
Ever since the Chinese government revised its policies regarding pharmaceutical sector, the country has not held back on the development and clinical investigation of locally made drugs. Antibodies, especially, now make up for a major portion of the pharmaceutical candidates developed in China, and many of these are now available in the international market as well. Clinical research and development activities has allowed for the rapid expansion of the country’s drugs pipeline, with many pharmaceutical and biotechnology companies contributing to it. The current antibodies pipeline in China is still in expansion phase as both domestic and international drug developers are continuously foraying into the market.
At present, multiple cancers are dominating the antibodies clinical trials landscape in China similar to other developed pharmaceutical markets. The burden of cancer in China is among the highest in the world, which has led to the research and development of novel treatments methodologies driven by success achieved by antibody therapeutics in other markets. At present, several companies are involved in developing antibodies in China. These include BeiGene, Incyte, Zai Lab, Innovent Bio, Akeso, RemeGen, HengRui Medicine, Henlius Biotech, CStone and Mabtech many more. All these mentioned companies have antibody candidates in phase III of clinical trials, which are anticipated to get approval in the next couple of years, adding to the ever-expanding pipeline of antibodies developed and commercialized in China. These antibodies have been mainly developed for different solid cancers considering the patients suffering from solid cancer make up for a significant portion of the cancer patients population in China.
With only five months into 2023, China’s drug regulatory authority National Medical Products Administration (NMPA) has already begun approving drugs made by the domestic drug developers for different cancer indications. Recently, in January 2023, the agency approved Hansizhuang (serplulimab injection) developed by Shanghai Henlius Biotech. Hansizhuang is a monoclonal antibody targeting the PD-1 immune checkpoint protein and has been approved for the treatment of extensive stage small cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide. Another penpulimab, co-developed by Akeso and Sino Biopharmaceutical was approved in the same month by the drug regulator for treating locally advanced or metastatic squamous non-small cell lung cancer. This added to the list of indications for which penpulimab has received approved for, the first being classic Hodgkin's lymphoma.
Apart from these marketing approvals, many companies also received approvals for their filed investigational new drug (IND) applications. For instance, Transcenta received the NMPA approval for the IND application fled for its candidate TST003, a monoclonal antibody targeting Gremlin1 (GREM1), andTHORN;veloped for the treatment of prostate cancer
All these success stories would not have been possible without collaborations between different companies because sharing of resources hastens the drug development process. This also allows western companies to mark their presence in China’s competitively growing pharmaceutical industry. Sanofi and Innovent entered into a partnership in August 2022 to carry out clinical trials for two of a Sanofi’s assets in combination with Tyvyt, a PD-1 inhibitor developed jointly by Innovent and Eli Lilly. Likewise, Chinese pharmaceutical giant BeiGene also entered into a clinical trial agreement with Immune-Onc to evaluate the combination of their drug candidate to improve clinical outcomes in patients with solid tumors.
China’s antibodies market is a booming segment that has been expanding rapidly in the last few years with efforts from the major market players and the government authorities, who have created a welcoming environment for western companies to venture into the domestic market to boost their antibody development process. More growth is estimated in the coming years, as the driving factors keep getting stronger with market restraining factors being slowly conquered by the market players.