Hello NMPA: China Approval For Astellas's Xtandi, Keytruda Set For Fourth Indication
Astellas’s Xtandi gets its latest approval in China, where Merck’s Keytruda is set for another win.
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Beijing-based BeiGene is set to score two big wins in a row as it pursues innovation. After securing US approval for its BTK inhibitor zanubrutinib for mantle cell lymphoma, its PD-1 inhibitor has sailed through a technical review in China.
Japanese firm unveils new capital investment program for novel biologics including antibodies and cell therapies as it ups full-year forecasts on strong US and global growth for Xtandi after a solid first half.
China has signaled that it will offer a more level playing field to foreign players as part of a bid to join a major regional trade pact but some see the gesture as offering little real relief and high hurdles remain.