Clinical Development Strategies for Western Biotech Companies in China


China’s evolving regulatory reforms have greatly impacted review and approval timelines, streamlined processes, and expedited the development of innovative drugs. Notably, the IND/CTA review timeline set at 60 working days, in addition to the centralized and simultaneous review by the NMPA and EC has greatly reduced the time required for initiating trials in China. Furthermore, the new regulations allow Chinese regulators to accept overseas early phase clinical data to conduct late stage or pivotal trials, and overseas pivotal trial data for NDA approval. In recent years, Chinese regulators have implemented accelerated approval pathways to introduce new and life-saving drugs, updated the marketing authorization holder (MAH) system, and adopted ICH GCP guidelines to improve clinical trial quality which are beneficial for overseas biotech companies.

The improved regulatory environment along with incentives by the Chinese government offer a variety of benefits to western biotech companies for clinical development of their drug in China. Overseas biotechs can access large patient populations, leverage large and growing networks of qualified hospitals, skilled laboratory and clinical trial professionals, and world-class infrastructure for conducting high standard clinical trials at lower costs and in reasonable timelines. With China now accepting the overseas data for initiating late-stage clinical development, other locations, such as Australia, can be leveraged for accelerating early phase trials prior to late-stage development in China. This reduces the overall clinical development timeline in China. Partnerships with local biotech companies or CROs will simplify and ease the execution of clinical development projects. Identifying the right CRO could be challenging, and partnering with a CRO having local expertise and an international mindset is critical for a successful clinical development.

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