China, New Products

Bristol-Myers wins the frenzied race to a first approval for a PD-1/L1 checkpoint in China as regulators hustle up a quick OK

Bristol-Myers’ $BMY Opdivo may be about to cede its top place in the PD-1/L1 world to Merck, but in China today, they’re number 1.

The China Drug Administration has approved Opdivo for second line treatment of non-small cell lung cancer, marking the first official entry of a checkpoint pioneer into the booming healthcare market.

Bristol-Myers, which has been fighting a losing war with Merck for dominance in the NSCLC field in the US, wrapped their Phase III with a predominantly Chinese group of patients late last year, hustling the positive results to regulators as they looked to flank their rivals in Asia.

Chinese officials responded with a fast-paced approval that took only six months to achieve, highlighting a thorough regulatory shakeup that has brought a host of top developers into the market. Their announcement included a note that the checkpoint extended overall survival by “around three months” in patients with an advanced case.

In a statement from the agency, authorities noted:

BMS initiated and completed clinical trials for Opdivo in advanced NSCLC patients whose cancer progressed after platinum-based chemotherapy, and used that to submit their imported new drug application. The CDA accelerated the assessment using the priority review pathway, including technical evaluation and auditing of clinical trial data, and approved registration on June 15, 2018.

Merck, though, isn’t far behind. Bristol-Myers’ big rival field for their approval in February, which could leave them just a step behind Bristol-Myers, if regulators continue to act with a sense of urgency. Both foreign and home grown biopharmas see China as one of the big growth areas, particularly in oncology, as AstraZeneca has helped highlight recently with its own set of rising numbers.


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