Chinese drug regulators approved Chi-Med's VEGFR inhibitor fruquintinib for the treatment of metastatic colorectal cancer, providing the first unconditional approval for a homegrown new drug in China that has been tested in randomized clinical trials.

Although industry has long been ramping up its investments in China, many of the early ventures were focused on outsourcing chemistry and manufacturing services. Some firms have been building end-to-end drug discovery capabilities in China as well (Nat. Rev. Drug Discov. 16, 443–446; 2017). Chi-Med, one such company, has now scored a landmark approval that they hope will prove their ability to discover and develop follow-on drug contenders with best-in-class potential.

First-generation VEGFR inhibitors like Bayer and Amgen's sorafenib are multikinase inhibitors with broad binding profiles and toxicity liabilities. Chi-Med by contrast designed its anti-angiogenesis agent fruquintinib to act as a hyperselective VEGFR inhibitor, with the aims of minimizing off-target toxicities, improving tolerability and providing more consistent target coverage. For now, the drug is only approved in China for patients who have failed at least two prior lines of therapy, and the company has yet to prove its best-in-class status. But further clinical trials are underway, including a phase I trial in the US.

A few China-based R&D teams are also pursuing potential first-in-class, discovered-in-China drugs. Novartis's anticancer drug MAK683, an EED inhibitor that was discovered in China, is in a phase I/II trial that is set to wrap up next year. Roche's capsid inhibitor RO7049389 (also known as RG7907) and its TLR7 agonist RO7020531 (RG7854) are in phase I trials for hepatitis B virus infection.