China is reportedly approving its 6th PD-1(L)1 drug in just over a year and Amgen will be pleased with this one.
The OK for tislelizumab would be the first marketed product to be developed by BeiGene, the eminent Beijing-based biotech that Amgen recently took a $2.7 billion stake in. Chinas Center for Drug Evaluation has completed technical review and sent the NDA to the National Medical Products Administration with a recommendation to approve, Chinese media outlet Jiemian reported.
BeiGene is all set to hit the ground running. Having partnered with Celgene to hawk Revlimid, Abraxane and Vidaza in China, the drugmaker has built a 700-strong commercialization team. The Amgen deal also puts them in charge of selling Xgeva (denosumab), Kyprolis (carfilzomib) and Blincyto (blinatumomab) provided the last two come through after Phase III development.
Following the initial indication of chronic Hodgkins lymphoma, BeiGene has already filed an sNDA to use tislelizumab in urothelial carcinoma.
While Celgene once held rights to the drug outside China, BeiGene regained global rights after its US partner broke off the pact in the wake of a buyout by Bristol-Myers Squibb, the maker of Opdivo.
The fast pace reflects just how rapidly the checkpoint market has evolved in China. Junshi and Innovent scored the first approvals for their homegrown therapies, Tuoyi and Tyvyt, though according to Jiemian its Mercks Keytruda that racked up the most sales: RMB$2 billion ($280 million) since last July. The numbers for Junshis Tuoyi and Innovents Tyvyt are RMB$332 million ($47 million) and RMB$308 million ($43 million), respectively.
Given that competitive some would say commoditized landscape, BeiGene is looking to make a name for itself through zanubrutinib, a BTK inhibitor positioned to challenge the dominance of Imbruvica. The drug is under review at the FDA after nabbing breakthrough status.
Read the rest here:
Ahead of FDA decision on BTK drug, Amgen-partnered BeiGene is one step closer to China OK for PD-1 - Endpoints News
Recommendation and review posted by G. Smith
