November 30, 2018

Chi-Med, Innovent Enter Global Cancer Partnership

Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM) and Innovent Biologics Inc. (HKSE:1801) will take advantage of China’s new foreign data guidelines and enter into a global partnership to develop fruquintinib in combination with sintilimab to treat advanced solid tumors.

The companies said the new foreign data guidelines, which allow companies to submit foreign clinical data to support Chinese regulatory submissions, could expedite the path to a China launch (see “China Accelerates Drug Review Timelines for Rare, Life-Threatening Diseases”).

Innovent’s sintilimab, an anti-PD-1 mAb, is under review in China to treat relapsed or refractory classical Hodgkin lymphoma.

Elunate fruquintinib is approved in China to treat metastatic colorectal cancer (mCRC). According to Chi-Med, the inhibitor of VEGF receptors 1, 2 and 3 is the first China-discovered and developed product for an oncology indication to receive unconditional approval based on a randomized clinical trial (see “Chi-Med Scores a China First with Approval of Fruquintinib”).

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