Rendering of new 409,000 square foot facility in Dunkirk, NY

We have internalized key components of the supply chain, which we believe are integral to minimizing the risks of potential disruptions associated with a high potency oncology supply chain.

Polymed/Taihao

We acquired Polymed (Polymed Therapeutics Inc.) and Taihao (Chongqing Taihao Pharmaceutical Co. Ltd.) in 2015 to secure API for our clinical and future proprietary commercial supply. Taihao is a cGMP manufacturer of high potency oncology API based in Chongqing, China and Polymed is the U.S. marketing entity for Taihao’s API in North America and Europe. Polymed supplies API for our proprietary and 503B drugs and also sells API to large multi-national pharmaceutical companies.

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Athenex Pharma Solutions

In 2014, we acquired one of our contract manufacturers, Athenex Pharma Solutions (formerly QuaDPharma) in Clarence, New York, to obtain better control over our supply of high potency oncology drugs for our global clinical studies. APS currently manufactures clinical supply for our clinical trials worldwide, and also manufactures 503B and FDA shortage drug products as part of our commercial operation. We will be leveraging the cGMP systems and operating procedures at APS for use in our large scale cGMP manufacturing plants under development in both the U.S. and China.

 

Facilities, Manufacturing and Quality Assurance

We own and lease a variety of manufacturing, R&D, distribution, packaging, laboratory, office and warehouse space, with facilities in the U.S., China, and Hong Kong. Our cGMP operating facilities in the US and China are inspected by the FDA.

Our manufacturing facilities in Buffalo and Dunkirk, New York and Chongqing, China are supported through public-private partnerships, and will be used by us exclusively at below-market rates for the foreseeable future. These facilities are described further in the descriptions of our public-private partnerships below.

In the US, our plans include a 409,000 sq ft cGMP fill-finish high potency oncology plant capable of manufacturing sterile injectable and oral solid dosage forms. Our public-private partnership with New York State was announced in 2016.

In Chongqing China, where we have an existing active pharmaceutical ingredient plant, we are designing a new, expanded active pharmaceutical ingredient plant of approximately 440,000 sq.ft. and potentially also a fill-finish plant. These facilities will provide us valuable and necessary access to the Chinese cancer market. Our public-private partnership with Chongqing was announced in 2015.