China Covid curbs push FDA to delay decision on BeiGene's cancer drug
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Drug developer BeiGene said on Thursday the FDA delayed its decision on the cancer drug, Tislelizumab, as the firm was unable to conduct inspections due to Covid-related travel curbs in the country.
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People enter a BeiGene Ltd building in Jiangsu province, China, on Nov. 22, 2019. (Photo: Reuters/Stringer)
Drug developer BeiGene (6160. HK) in China said, on Thursday the US Food and Drug Administration (FDA) has postponed a decision regarding its cancer drug following the Covid-19 curbs in the country that is preventing the regulator from carrying out inspections.
The FDA was supposed to decide on Tislelizumab by July 12; however, it has now delayed the move until the completion of inspections, the company said.
The postponement makes BeiGene the latest company based in China for which the FDA has cited pandemic travel curbs as an issue after similar problems with Hutchmed Ltd and the US-based Coherus BioSciences Inc (CHRS.O) along with its Chinese partner Shanghai Junshi Biosciences Co Ltd (688180. SS)
BeiGene and its Novartis are working to make the inspections easier so as to get the treatment approved, according to John Oyle, the Chairman and Chief Executive.
The company's application for Tislelizumab for second-line treatment of patients with esophageal cancer includes data from a late-stage trial of 512 patients in Europe, the United States, and Asia, the company said.
