Around 3000 Cancer Drugs Are In Clinical Trials And More Than 150 Drugs Are Commercially Available In China
Over the years, China’s pharmaceutical industry has experienced a number of reforms to regulations that have made the country a hotspot for conducting clinical trials and elevated it to the status of a favored location. Its’ rapidly developing and growing clinical trials, together with the efforts of domestic pharmaceutical and biotechnology companies, have further supported this. Based on the current trends in clinical development and clinical trial patterns, pharmaceutical companies in China are primarily focused on developing drugs for cancer therapy. These drugs are highly attractive from a commercial standpoint, which is attributed to the rising incidence of cancer in China and other countries.
For the treatment of solid malignancies, which are quite common in China and include gastric, hepatic, lung, and colorectal cancers, the majority of cancer medications are now in early phase clinical trials. In addition to participation from major players in the domestic sector such as RemeGen, Nanjing Leads Biolabs, BeiGene, CSPC Pharmaceutical Group, Jiangsu Hengrui Medicine, Hansoh Pharmaceutical, etc., these trials involve candidates such as IMMH-010, IBB0979, HRS-2189, and LBL-033. According to Neeraj Chawla, Research Head at Kuick Research, there are around 300 cancer drugs under trials in china and most are being done by home grown Chinese companies.
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Our estimations indicate that the majority of drugs undergoing clinical trials for the treatment of cancer, both hematological and solid, are antibodies. This is a result of their novel modes of action and proven clinical effectiveness, as demonstrated by cancer antibodies that have received regulatory approval in the global cancer drugs market. The following antibodies are small molecule inhibitors of numerous proteins and enzymes involved in cancer formation, progression, and metastasis, as well as new cell treatments that target diverse cancer-associated antigens. Taken together, these three modalities account for more than half of the candidates in clinical trials in China.
Given the close knit nature of China’s clinical trials landscape and the abundance of opportunities in the domestic market, another noticeable trend in this domain is the increasing collaborations between domestic and international players, with the goal of regional expansion of cancer drugs both in and outside China. This is most clearly demonstrated by Amgen and BeiGene’s collaboration, which enabled the clinical evaluation and regulatory approval of Blincyto in China, making it the first bispecific antibody approved for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia in China.
The market has also seen an increase in the number of alliances and agreements targeted at providing pharmaceuticals for clinical studies of experimental drugs in China. For example, Innovent Biologics and Xuanzhu Biopharma signed a clinical trial collaboration and supply agreement in December 2023 to test the combination of KM-501, an investigational HER-2 bispecific ADC, with Innovent’s approved PD-1 inhibitor Sintilimab for the treatment of solid cancers in China.
Furthermore, the National Medical Products Administration (NMPA), China’s drug regulatory body, has expeditiously approved clinical trial applications, indicating that the country’s growing R&D endeavors have resulted in a rise in the quantity of cancer drugs undergoing clinical trials. For instance, CSPC Pharmaceutical Group reported in June 2024 that the NMPA had approved the conduct of clinical studies for SYS6020, a drug used to treat multiple myeloma. With this, this mRNA-lipid nanoparticle (LNP)-based chimeric antigen receptor (CAR)-T cell injection becomes the first to receive approval for use in clinical studies.
As a result, the landscape for cancer drug clinical trials in China is quite dynamic, influenced by a number of prominent trends as mentioned above. More trends are expected to emerge as the market opens up to both domestic and foreign businesses. These will help China catch up to the US in terms of clinical development and testing, which will improve its standing in the global market for cancer drugs.
