Chinese regulators granted a first approval for general use to a COVID-19 vaccine to China National Biotec Group’s (CNBG) BBIBP-CorV. “The NMPA granted conditional approval to the vaccine on Dec. 30,” said Chen Shifei, deputy head of the National Medical Products Administration (NMPA) during a Dec. 31 press conference. The company is required to continue with phase III trials as planned, submit subsequent data and report any adverse reactions.
HONG KONG – Hutchison China Meditech Ltd. (Chi-Med) earned approval from China’s National Medical Products Administration (NMPA) for Sulanda (surufatinib) for the treatment of non-pancreatic neuroendocrine tumors (NETs).
HONG KONG – With the sale of a group of noncore assets to a little-known Chinese company, Takeda Pharmaceutical Co. Ltd. took another step in a multibillion-dollar string of divestitures that is part of a plan to cut debt and focus on five key business areas. Takeda announced on Dec. 21 the sale of a portfolio of noncore prescription drugs marketed in China to Hasten Biopharmaceutic Co. Ltd. (China).
HONG KONG and BEIJING – China’s Sinovac Biotech Ltd. delayed releasing trial data from its Coronavac COVID-19 vaccine while the National Medical Products Administration (NMPA) accepted an NDA from China National Biotec Group (CNBG) for its own vaccine, BBIBP-CorV.
China has added 119 new drugs to its national reimbursement drug list (NRDL) with an average price cut of 50.64%, a move that biopharmaceutical insiders said will further encourage drug innovation at home, despite lower drug prices. More innovative drugs, notably all homegrown PD-1 inhibitors, are included in the latest NRDL that will take effect from March 1, 2021 to the end of 2023.
HONG KONG – Shanghai Junshi Biosciences Co. Ltd.’s toripalimab has reached its prespecified primary endpoint of progression-free survival at the interim analysis of a phase III study in non-small-cell lung cancer (NSCLC), as efforts to expand approval of the anti-PD-1 antibody into other cancer types are underway.
Shares in Chinese drug developer Jacobio Pharmaceuticals Group Co. Ltd. (HK:1167) rose 3% on their first day of trading in Hong Kong. The company, which develops small-molecule drug candidates to modulate enzymes by binding to their allosteric sites, raised HK$1.35 billion (US$174.1 million) in its IPO, pricing 96 million shares at HK$14. Shares closed at HK$14.42 on Dec. 21 after rising as high as HK$16.50.
Kintor Pharmaceutical Ltd. said it's "actively initiating" multiregional phase II/III trials to test a combination of GT-90001 (ascrinvacumab) and Opdivo (nivolumab) for advanced hepatocellular carcinoma.
BEIJING – Denovo Biopharma LLC closed a series D financing round to raise nearly ¥300 million (US$46 million), just six months after its $83.5 million series C round.
Scineuro Pharmaceuticals, based in Shanghai and Philadelphia, launched with a $100 million series A financing to focus on tackling central nervous system diseases. CEO Min Li told BioWorld the startup is “building a CNS portfolio through a combination of internal R&D and strategic collaborations.” Lilly Asia Ventures Fund and Arch Venture Partners co-led the round.
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