China, Pharma

China greenlights second homegrown PD-1 in 10 days as Innovent celebrates its first drug OK with Eli Lilly

You can count on the crowded pool of made-in-China checkpoint inhibitors to ripple fast.

Chinese regulators have handed an approval to Innovent and its partners at Eli Lilly for sintilimab, just 10 days after Junshi scored the historic OK for its own homegrown PD-1.

Michael Yu

Sintilimab is the fourth checkpoint to be approved in China and, so far, the only one jointly developed by a multinational drugmaker and a local biotech (the other two are Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo). Its manufacturing operations — a critical field in the marketing battles to come — is the largest in the country (at three 1000L lines currently) and has passed muster with Lilly, CEO Michael Yu told PharmCube in an interview.

The approval is based on a study of 96 patients with relapsed/refractory classical Hodgkin’s lymphoma, which hit a objective response rate of 79.2% and a disease control rate of 97.9%. Innovent filed the NDA in April and the newly dubbed National Medical Products Administration — or NMPA, successor to CFDA — issued a priority review designation to speed things up.

To be marketed as Tyvyt (Innovent’s first commercial product), sintilimab is also being tested in first- and second-line settings, with 20-plus clinical trials underway.

In November, the companies cited a Phase Ib success for non-small cell lung cancer that’s helping justify a Phase III program. Other potential indications include gastric cancer, liver cancer and esophageal cancer.

Innovent was among the leading PD-1 developers tipped for market launches in the first half of 2019 alongside BeiGene and Jiangsu Hengrui. But it was Junshi Biosciences — now publicly listed in Hong Kong — that won the race for the first made-in-China PD-1 OK for a melanoma drug. A recent count by PharmCube put the number of PD-1/L1 agents in development in China at 68, part of a big wave of new checkpoints now in the clinic around the world.

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Skyhawk Therapeutics Waltham, MA
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