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.
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.
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.
Qihan Biotechology Co. Ltd., a company known for its multiplexable genome editing technology, has yet again extended its series A financing, this time with a $67 million round that will support advancement of its allogeneic cell therapy candidates to IND in China. To date the company has raised more than $100 million.
HONG KONG – Bispecific antibody startup Epimab Biotherapeutics Inc. has completed a $120 million series C financing, bringing it closer to a potential IPO next year. The Shanghai-based company said the new funds would help it move EMB-01 into phase II testing this year.
Like its distinctive name, Dragon Boat Biopharmaceutical Co. Ltd., of Shanghai, raced to victory with the Chinese IND approval for its anti-CSF-1R monoclonal antibody candidate BC-006, marking an important milestone for the company as it embraces a growing focus on innovative medicines.
HONG KONG – Privately held Wugen Inc. of St. Louis has inked an exclusive deal with Shanghai-based Alpha Biopharma Ltd. to manufacture, develop and commercialize allogeneic cell products in Asia.
RSS
