Clinical Manufacturing
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Since our inception, we have established an internal CMC team which is currently led by Dr. Zhifeng Long, our Chief Development Officer and China Chief Medical Officer. Our CMC capabilities include: delivery platform research and development and optimization; formulation development; and analytical sciences. Our analytical science team implements a science-driven, phase-appropriate, and commercial oriented approach to the development and application of both classic and state-of-the-art analytical techniques and tools throughout the development life cycle of each of our product candidates, This includes but is not limited to development and validation of analytical methods for drug substance and drug product: technical transfer of process and analytical methods; establishment of specifications; testing and releasing of each batch of drug product; and quality control and assurance. With a well-documented and comprehensive quality system, the quality control and assurance team is responsible for testing and verifying the product quality with predefined standards to assure the quality of all the batches, manufactured at every stage of manufacturing/processing drug substance and drug products.

We currently work with qualified CMOs to manufacture product candidates for preclinical and clinical supply. We have established GMP-compliant manufacturing processes in the U.S. with CMOs accredited by the U.S. FDA and with an annual capacity of approximately two million vials per year. We have adopted procedures to ensure that the production qualifications, facilities and processes of our CMOs comply with the relevant regulatory requirements and our internal guidelines. We select our CMOs by reviewing a number of factors, including their qualifications, relevant expertise, production capacity and product quality. 

We recently completed building our pilot manufacturing facility in Guangzhou, which is expected to have an anticipated annual production capacity of 50,000 vials of lyophilized doses for injection, which we expect to be sufficient to support all clinical trials we have in our current planning. Our Guangzhou facility will be capable of GMP-compliant manufacturing of our pipeline products, including formulation, fill and finish, test and release and will be sufficient to support our clinical trials in China, and potentially to supply our clinical trials globally in the future.

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