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On August 20, the official website of CDE showed that BeiGene's PD-1 tislelizumab new indication was accepted
On May 21 this year, BeiGene announced that, as recommended by the Independent Data Testing Committee, a tislelizumab combined with chemotherapy versus placebo combined with chemotherapy is used for the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) The Phase 3 RATIONALE309 clinical trial of the therapy reached the primary endpoint in the interim analysis
RATIONALE 309 is a randomized, double-blind, placebo-controlled phase 3 clinical trial (NCT03924986), which aims to compare Bezeran® combined with gemcitabine and cisplatin with placebo combined with gemcitabine and cisplatin as the first-line treatment for recurrent or metastatic NPC Effectiveness and safety
A total of 263 Asian patients were enrolled in the trial, and they were randomized to the Bazaan® combined chemotherapy test arm or placebo combined chemotherapy test arm at a ratio of 1:1
BeiGene's tislelizumab sold approximately 800 million yuan in the first half of this year, a year-on-year increase of 148%
Moreover, in the upcoming medical insurance negotiations in the second half of this year, BeiGene has also expanded the scope of payment for indications for levilizumab
Product indications in the BeiGene medical insurance catalogue and application for adjustment of payment scope
If this year's medical insurance negotiations go smoothly, I believe that with the inclusion of major indications in medical insurance, tislelizumab will bring stronger growth momentum
At present, tislelizumab has 5 approved indications and 4 indications for marketing in China.