Boehringer, BeiGene enter manufacturing pact for PD-1 drug
- In the first biopharmaceutical marketing authorization project in China, Boehringer Ingelheim GmBH has hooked up with biopharma BeiGene Ltd. to manufacture the Chinese company's PD-1 antibody tislelizumab.
- Under the terms of the commercial supply agreement, Boehringer Ingelheim will manufacture the compound in its biopharmaceutical facility in Shanghai in an exclusive and extendable multi-year agreement.
- BeiGene gains certain preferred rights for future capacity expansion by Boehringer Ingelheim in China.
BeiGene, in collaboration with Celgene Corp., is dipping its toe into an increasingly crowded PD-1/L1 market, but the difference is that BeiGene's focus is on the domestic market. According to the company, tislelizumab, previously known as BGB-A317, is the first PD-1 antibody that has moved into clinical trials and is being developed in China under the domestic regulatory pathway.
The drug is in Phase 3 trials in liver cancer, two Phase 2 trials in Hodgkin lymphoma and urothelial cancer in China, and in a global Phase 3 trial in non-small cell lung cancer.
In a preliminary study presented at the 20th Annual Meeting of the Chinese Society of Clinical Oncology in Xiamen, China last September, the drug was well-tolerated and showed early evidence of anti-tumor activity.
"As we advance tislelizumab towards potential regulatory approval and commercialization in China, we are pleased to have secured our commercial product supply," said John V. Oyler, founder, CEO and chair of BeiGene.
The company believes that tislelizumab has potential both as a monotherapy and as a combination therapy in hematologic and solid cancers. The drug is likely to follow a similar development route to the existing PD-1/L-1 agents already on the market.
As well as working with Boehringer Ingelheim, BeiGene is building a manufacturing facility for biologic commercial supply in Guangzhou, China, in a joint venture with the Guangzhou Development District. This will expand capacity for tislelizumab and other biologics in the company's pipeline.
Under the terms of the global collaboration with Celgene, BeiGene retains exclusive rights in China.
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