Manufacturing News

BeiGene wins approval for commercial manufacturing of antibody

Chinese biotech company BeiGene Ltd announced on Thursday the approval from the China National Medical Products Administration to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, Guangdong province.

With the currently approved capacity of 8,000 liters of biologics for commercial supply, the wholly owned facility will immediately begin production to ensure supply of tislelizumab to the market.

The approval enhanced the company's independent production capacity of innovative biopharmaceuticals, and indicated the company has realized its layout alongside the whole value chain from research and development to production and commercialization, marking a milestone in the development of the company, said John Oyler, founder, chairman and CEO of BeiGene.

The facility has a total investment of 2.54 billion yuan ($387.78 million). An additional phase of construction currently in progress is expected to shore up the facility coverage to 158,000 square meters.

In 2022, the facility's capacity will increase to 64,000 liters, from 54,000 liters currently. The final capacity is to reach 200,000 liters, making the facility one of the largest domestic biopharmaceutical manufacturing hubs in China or even in Asia.

Wu Xiaobin, president of the company, said commercialization will be a key priority of the company in 2021.

The approval of the production could fully guarantee the company's supply of drugs after they are listed and included into the national reimbursement drug list, ensuring patient accessibility, he said.

BeiGene is the first pharmaceutical company in the world using off-the-shelf biomanufacturing facility, KUBio, for large-scale commercial production of drugs.

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