Release Date: 16-Feb-2023
In recent years, with exponential increase in clinical research and development activities, China has developed as one of the biggest pharmaceutical industries in the world. The robust pipeline of research and development activities that cover various therapeutic areas and diseases, the country has also emerged in terms of scientific growth. China has now eventually started testing their bispecific antibodies in preclinical and clinical trials. Although comparatively late, the country has still managed to pull through with the emerging trend of bispecific antibodies and both the local and international players have started seeking research and development opportunities seeing the exponential increase in clinical trials activities in China.
The emergence of monoclonal antibodies sparked a worldwide interest and a range of significant treatment options were born from it. Similar, to monoclonal antibodies, the newly emerging bispecific antibodies is yet another rising star in the field of antibody treatment. Recently, Akeso Biopharma announced that the centre for drug evaluation of the China national Medical Products Administration (NMPA) granted the breakthrough therapy designation for Ivonescimab (AK112) which is a PD-1/VEGF targeting bispecific antibody in combination with docetaxel for the treatment of locally advanced or metastatic non-small cell lung cancer. This marks the third breakthrough therapy designation (BTD) for AK112 for NSCLC patients and is the only drug candidate granted BTD for PDL-1 resistant lung cancer treatment in China.
Bispecific antibodies have gathered significant attention and efforts towards research and development as drugs for cancer treatment from pharmaceutical companies in China. Currently, there are more than 100 bispecific antibodies undergoing clinical trials in China. Pharma companies in China have also started to develop their own proprietary technologies like YBODYandreg;, CRIBandtrade;, ITabandtrade;, FIT-Igandtrade;, WuXiBodyandtrade;, and SMABandtrade; are some of the platforms which have been developed by Chinese companies. Key players in China’s bispecific antibody market include; Alphamab oncology, BioPharma, EpimAb and BeiGene.
There are three bispecific antibodies which are approved by China’s regulatory body, the National medical Products Administration (NMPA). These include Blincyto, Hemlibra and Cadonilimab, out of which Cadonilimab is the only bispecific antibody which was independently developed by domestic researchers at Akeso which shows that China is slowly but progressing and making its way into the global bispecific antibody market. Getting a license agreement from Amgen, BeiGene can commercialize its FDA approved Blincyto in China.
The overall regulatory environment of China is favorable for bispecific antibody research and development. With increase in partnerships among domestic and multinational companies is driving the commercial growth of bispecific antibody therapy market in China. North America and Europe are the major regions for bispecific antibodies market, however, with the emerging Asia Pacific region; China is setting its foot in the market as well.
Among all the domestic bispecific antibodies developing companies in China, Akesobio has established an encircling drug delivery and development system. The company’s exclusive Tetrabody technology provides druggable bispecific antibodies tackling major challenges in clinical studies. So far, the company independently has developed several leading bispecific antibody products including the global first-in-class PD-1/CTLA-4 bispecific antibody Cadonilimab, PD-1/VEGF bispecific antibody (AK112), PD-1/CD73 bispecific antibody (AK131) and PD-1/LAG3 bispecific antibody (AK129).
The research and development on bispecific antibodies has gained momentum globally and the Chinese government is actively introducing new policies and making changes in already existing regulations so as to attract more and more pharmaceutical companies in the country encouraging the regional market of China for bispecific antibody therapy. Multiple factors play in the favorable growth of China’s market and research publication describes the driving factors and challenges that cause a shift in the country’s regional market. With much overseas collaboration seen with domestic Chinese pharmaceutical companies, the market is expected to grow exponential. Additionally, with the robust investments done in the region, it is expected that the clinical trials for bispecific antibodies in China are expected to rapidly shift from preclinical studies to clinical trials. This research publication summarizes the bispecific antibody therapy market of China giving significant highlights about the reach of existing bispecific therapies and the possible wave of new bispecific therapies.