Chinese Drugmaker BeiGene And Novartis Move Out From Second Cancer Drug Pact

BeiGene Ltd BGNE said it would regain rights to develop, manufacture, and commercialize Tevimbra (tislelizumab), its cancer drug, from Novartis AG NVS.

Under the agreement signed in 2021, the companies were jointly developing the drug tislelizumab.

BeiGene has launched more than 20 potentially registration-enabling trials with Tevimbra, of which 10 Phase 3 trials and four Phase 2 trials have already had positive readouts. 

Minutes later, BeiGene said the European Commission approved the checkpoint inhibitor, to be sold as Tevimbra, as a monotherapy for adults with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. 

The FDA also accepted the biologics license application for the first-line advanced ESCC treatment candidate. The FDA has assigned a target action date in the second half of 2024.

“Tevimbra is the cornerstone of BeiGene’s solid tumor portfolio. We believe having full control of the development and commercialization of Tevimbra will allow us to rapidly accelerate our plans and reach more patients worldwide,” Josh Neiman, BeiGene’s chief commercial officer for North America and Europe, said in a press release.

No royalty payments are due to Novartis.

In July, BeiGene mutually agreed to terminate a licensing deal with Novartis and regained global rights to develop, manufacture, and commercialize TIGIT inhibitor ociperlimab.

Price Action: BGNE shares are up 0.14% at $209.20 premarket on the last check Tuesday.