U.S. biotech focused on China to build manufacturing facility there

China flag against blue sky
Hepatitis B drug entecavir is among a portfolio of ANDAs that CASI Pharmaceuticals bought from Sandoz and intends to sell in China. (Pixabay)

A U.S. biotech that bought a portfolio of nearly 30 generic drugs from Sandoz in January says it has plans to build its first manufacturing facility in China, where it has focused much of its drug development efforts.  

Rockville, Maryland-based CASI said on Friday that it “has entered into framework agreements” to build a manufacturing site at the Wuxi Huishan Economic Development Zone in Jiangsu Province, China.

CASI provided no details about the agreements in terms of cost or size of a facility, saying only that it expects construction to begin in the middle of 2019 and the facility will be able to handle large-scale production.

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“We are excited about moving forward with building our own manufacturing site as part of our supply chain,” CASI Executive Chairman Wei-Wu He, Ph.D., said in a statement. “The facility will be a core component of our long-term growth strategy as it will give us significantly greater capacity in order to meet the company’s commercial needs, and also will allow us greater control over quality, cost of goods and to accelerate production schedules.”

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CASI, which has acquired a number of drugs for development in China, announced in January that it had bought a portfolio of ANDAs from Novartis' Sandoz, including 25 approved drugs and four pipeline ANDAs that are pending FDA approval. Among those is entecavir, an antiviral treatment for hepatitis B, which is a significant problem in China.

Sandoz sold off hundreds of its U.S.-approved generics this year as prices in the U.S. have crashed, making it difficult to earn a margin on many copies. 

But CASI has other plans for the Sandoz portfolio. It expects to take advantage of China’s recent regulations accepting Western pharmaceutical and clinical data to get drugs approved there, which it believes will allow it to quickly get some of these medicines into the massive Chinese market.  

In June, the biotech announced it had a struck a long-term contract manufacturing deal with a subsidiary of Shijiazhuang Yiling Pharmaceutical to produce entecavir as well as cilostazol for the Chinese market.

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