The first therapeutic antibody was approved by the FDA in 1986; thirty years later, there are over 70 approved monoclonal antibodies, and hundreds currently in clinical trials. China has been a relative latecomer to this field but is advancing rapidly. In March 2018, the FDA approved the first antibody originating in China: ibalizumab-uiyk (Trogarzo) for treatment-resistant HIV infection. Thirteen other biologics developed in China are currently in clinical trials.
Most companies developing therapeutic antibodies are targeting cancer, and companies in China are no exception. It is noted about half of the CAR-Ts in clinical trials are sourced in China. Other than the medications above, the bispecific antibody and ADCs are other rising stars in the red-hot monoclonal antibody field.
In the face of more talent returning from overseas, China’s biologics research and development is maturing rapidly. Meanwhile, a host of supportive policies from CFDA is further driving China’s domestic mAb development forward. However, the path ahead is not all rosy; Chinese productions will certainly face a range of new challenges in the future. It is estimated China is about five years behind the global competition in development of antibodies for PD-1, PD-L1, and other targets, as well as for development of CAR-Ts for CD19, the most popular cancer cell targets.
Riding on the success of the meeting last time, Biologics Innovation and Frontier Technology (BIFT 2019) is the definitive conference in China for examining opportunities and challenges for the biologics development of in China, bringing together decision makers across C level management, top researchers and scientists in the realms of drug discovery, clinical trials, CMC, bio-manufacturing and QA/QC sectors.
This two day interactive show will provide you the opportunity to take home cutting edge strategies, case study examples, and regulatory guidelines with rich information on cell lines and process development, scale-up and downstream innovations, single-use technology; quality evaluation of biosimilars, frontier technology in biologics development and novel therapeutics etc. We welcome you to the meeting to establish and renew partnerships to help develop new products, acquire emerging process technologies, and establish new contract manufacturing relationships. It is a Summit not to be missed.