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Speaking during the 2021 China Pharmaceutical Innovation 100 Summit, industry insiders called for more regulatory talent and even an organizational revamp to clear innovative products faster and support the global development strategies of Chinese drugmakers.
SHANGHAI – China’s regulatory environment has evolved to encourage drug innovation, but despite remarkable progress, mounting pricing pressure from the government and a weak insurance sector remain as barriers.
HONG KONG – In a surprisingly candid statement, the director of China’s Centers for Disease Control conceded that the efficacy of Chinese coronavirus vaccines is "not high" and may require improvements. George Gao, the director of China’s CDC, stated that Chinese vaccines “don’t have very high protection rates” at the National Vaccines and Health conference in the southwestern city of Chengdu on Saturday.
Zai Lab Ltd., China rights holder for the Deciphera Pharmaceuticals Inc. drug Qinlock (ripretinib), has obtained NMPA approval for the therapy, a treatment for adults with advanced gastrointestinal stromal tumors (GIST) previously treated with three or more kinase inhibitors, including imatinib, sunitinib and regorafenib.
Lianbio Co. Ltd. has inked a $200 million deal with Tarsus Pharmaceuticals Inc. for greater China rights to the phase IIb/III-stage candidate, TP-03 (lotilaner ophthalmic solution, 0.25%), designed to treat Demodex blepharitis and Meibomian gland disease (MGD). Lianbio will pay $15 million up front and up to $185 million in development and commercialization milestones.
PERTH, Australia – Analytica Ltd. signed a joint venture agreement with Hebei Nacol Bio-Technology Co. Ltd. and Shijiazhuang Biosphere Pty Ltd., of Hebei Province, China, to manufacture and distribute its Pericoach device for urinary incontinence in China, Macau, Hong Kong and Taiwan.
Zai Lab Ltd., China rights holder for the Deciphera Pharmaceuticals Inc. drug Qinlock (ripretinib), has obtained NMPA approval for the therapy, a treatment for adults with advanced gastrointestinal stromal tumors (GIST) previously treated with three or more kinase inhibitors, including imatinib, sunitinib and regorafenib.
Lianbio Co. Ltd. has inked a $200 million deal with Tarsus Pharmaceuticals Inc. for greater China rights to the phase IIb/III-stage candidate, TP-03 (lotilaner ophthalmic solution, 0.25%), designed to treat Demodex blepharitis and Meibomian gland disease.
Suzhou-China based Cstone Pharmaceuticals Co. Ltd., which in-licensed RET inhibitor pralsetinib from Blueprint Medicines Corp. in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and the country’s first selective RET inhibitor.
The continuing politicization of COVID-19 vaccines is undermining medical science and the international response to the pandemic. “Vaccine nationalism is very troubling,” Jeremy Levin, chair of BIO's executive committee, told BioWorld.
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