4:41 PM
 | 
Apr 19, 2019
 |  BioCentury  |  Product Development

Companies poised to take Chinese checkpoints global

Three companies poised to answer Pazdur’s call for Chinese PD-1 inhibitors

Editor's Note: This article was updated on Apr 22, 2019 at 7:19 AM PDT

At least three companies are well positioned to answer FDA Oncology chief Richard Pazdur’s call to bring Chinese PD-1/PD-L1 inhibitors to the U.S. to compete on price.

Two Chinese drugmakers and one U.S. company globally developing therapies from China have plans underway to bring Chinese PD-1 inhibitors to the U.S.

Shanghai Junshi Biosciences Co. Ltd. and Innovent Biologics Inc. each market domestically developed PD-1 inhibitors in China, and each have U.S. development plans that should lead to discounted products.

In China, both of the anti-PD-1 mAbs are priced below Keytruda pembrolizumab from Merck & Co. Junshi sells Tuoyi toripalimab at an 83% discount, and Innovent Biologics Inc. sells Tyvyt sintilimab (IBI308) at a 56% discount.

Behind them is Apollomics Inc., a Bay Area-based company whose mission is to globalize Chinese innovations. Apollomics is working out U.S. development plans for its anti-PD-1 mAb APL-501, which is in Phase II testing in China through its partner Genor Biopharma Co. Ltd., a subsidiary of Walvax Biotechnology Co. Ltd.

Apollomics spun out of Chinese CRO Crown Bioscience International Inc. as CBT Pharmaceuticals Inc. in 2016, and rebooted as Apollomics earlier this year with a $100 million series B round from the China Merchants Bank subsidiary CBM International (CMBI), OrbiMed and other investors.

Apollomics’ strategy bucks the bigger trend of biopharma companies aiming to capitalize on Chinese markets by bringing Western innovations East, but doing the opposite could allow the company to undercut U.S. prices.

The strategy was validated by remarks from Pazdur, FDA’s Oncology Center of Excellence director, at last month’s American Association for Cancer Research meeting.

In a session titled “East meets West: Chinese pharma explores Western markets,” Pazdur encouraged Chinese companies to bring PD-1/PD-L1 inhibitors to the U.S. market, where multinational pharmas haven’t moved on price. He noted FDA would accept good quality clinical data from China in applications, and proposed a development strategy mimicking the pharmas’ studies (see

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