Chinese biotech building facility to make biosimilars

Clover Biopharmaceuticals expects its new biologics facility in Changxing, Zhejiang, in China to be up and running by the end of 2018.

A Chinese biotech expects to have a biologics manufacturing facility built by the end of the year where it intends to produce an etanercept (Enbrel) biosimilar for the Chinese market.

Clover Biopharmaceuticals has turned to General Electric for one of its FlexFactory facilities, which use single-use technology, GE announced today. The prefabricated facility, which will be located in China’s biopharma industrial cluster in Changxing, Zhejiang, will include two 2,000-liter bioreactors and is slated to be up and running in the second half of 2018. Terms of the deal were not released.

“Adopting high-quality technologies and driving innovation in our manufacturing operations is important for Clover Biopharmaceuticals,” Peng Liang, co-founder and president of Clover Biopharmaceuticals, said in a statement. “The first therapeutic product produced using this biomanufacturing platform is SCB-808, a prefilled syringe formulation Enbrel biosimilar candidate for the treatment of rheumatoid arthritis.”

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Clover in December completed a Series A financing that raised RMB 62.8 million ($9.5 million). It says it will use the funds to push its pipeline work along, including plans to enter clinical testing in China in mid-2018 with its prefilled syringe formulation of etanercept. 

RELATED: First prefab biologics plant goes up in China, in 11 days

GE built one of its prefab biologics factories in China two years ago for JHL Biotech, a company founded by U.S. biotech veterans working on biosimilars. The components for the plant were built at a factory in Germany and shipped to Wuhan, China, where they were assembled in 11 days. GE also erected one of its biomanufacturing facilities at JHL's Research Center and manufacturing plant in Hsinchu, Taiwan.

GE pointed out that China's biopharmaceutical market, which was valued at about $13 billion in 2015, had been projected to grow at an annual rate of about 13% for the next several years.

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