China Bispecific Antibodies Market and Clinical Pipeline Insight 2028

Report Highlights:

• Research Methodology
• China Bispecific Antibodies Market Opportunity: > USD 5 Billion
• China Bispecific Antibodies Clinical Pipeline By Company, Indication and Phase
• Clinical Insight On Bispecific Antibodies Clinical Pipeline: > 250 Bispecific Antibodies
• China Drug Regulatory Framework
• Indigenously Developed Bispecific Antibodies Available For Licensing: > 50 Bispecific Antibodies

China has evolved exponentially in the last few years with respect to its pharmaceutical field, and as a result, many modern therapeutic approaches, such as immunotherapies, have made their way into the nation’s drugs market. Monoclonal antibodies were the first immunotherapy to enter China’s pharmaceutical market, which laid the foundation for the development of further immunotherapeutic modalities. One of these is bispecific antibodies, which have now become a hot topic in the region’s pharmaceutical market, as also being seen at the global level. The bispecific antibodies market is still in its nascent stage in China, with only few NMPA approved candidates of this drug class in the market. However, the market is poised to grow and expand at exceptional rates in the coming years considering the rich clinical and preclinical landscape of bispecific antibodies under development.

The development of Cadonilimab was technology driven exceptional transformative step in China’s pharmaceutical market because this antibody was the world’s first PD-1 CTLA-4 bispecific immunotherapy to be developed. Moreover, it was completely developed by Akeso, which validates the company’s research, development and manufacturing capabilities. Cadonilimab is indicated for the treatment of relapsed or metastatic cervical cancer, and is yet to receive approval by other regulatory bodies, including FDA.

Similar to Cadonilimab, many other first-in-class bispecific candidates have been entering the clinical pipelines in China, largely driven by the absence of candidates targeting the unique protein combinations as well as the title of being the first candidate to target a pair of targetable proteins. In this aspect, technological platforms have played a key role in letting companies identify the most effective protein combinations to target, as well as by allowing the construction of bispecific antibodies having binding arms specific for the chosen epitopes.

Novel inventions are being seen in the development of such platforms as well. For instance, Alphamab's CRIB platform, which has been designed to overcome the chemistry, manufacturing and control issues faced during development of bispecific antibodies, represents an excellent Fc -based heterodimer bispecific platform. The CRIB technology represents the 3rd generation of Fc-based bispecific platforms in engineering the Fc domain of antibodies and enables the formation of a bispecific antibody with identical format and size of a regular antibody. CRIB has been used to construct KN026, an anti-HER2 bispecific antibody, in early phase trials for HER2-positive solid cancers.  

The emerging market for bispecific antibodies has attracted several investors, and many startups are coming up in China, blessed with novel ideas and expertise of their founders. Sanyou Biopharmaceuticals is one of these, having launched the “Sanyou Super Trillion Common Light Chain Antibody Discovery Platform” in June 2023, which can be used to generate lead antibodies that can then be designed into bispecific antibodies with ideal properties. Sanyou offers contract research and development services, and its platform has been designed to aid customers in overcoming the challenges of bispecific antibody drug research and development.

The continuously expanding bispecific antibodies market has also seen several research and clinical collaborations, as well as licensing and technology transfer deals pertaining to bispecific antibodies, in the last year, signifying the rapid speed at which bispecific antibodies are taking over the immunotherapy market in China. Collaborations between Biotheus and BioNTech, and Chime Biologics and Hanxbio are only a few of these. Such collaborations allow the transfer of knowledge and expertise, and sometimes even technologies and patented ideas, which often lead to the creation of bispecific antibodies with novel functionalities.

Thus, the market for bispecific antibodies is expanding and emerging at a rapid speed, led by companies like Akeso at the forefront, who have made their names at a global level thanks to their innovative clinical candidates. The trend is anticipated to continue in the near future as more companies venture into this drug class area. In addition, China also has a strong network of contract development and manufacturing organizations, which have their own ways to support growth of the bispecific antibody market of the country.