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.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Antengene, Biontech, Canbridge, Daiichi Sankyo, Esperion, Lumosa, Pfizer, Synairgen, Takeda.
Biopharmas in Asia-Pacific raising money in public or private financings, including: Clarity, HBM, Junshi, Phathom, Revitope Oncology, Sellas Life Sciences, Takeda.
Amsterdam-based Uniqure NV’s regulatory hitch with its highly regarded hemophilia B program had analysts questioning during a conference call what the development might mean for the company’s deal with CSL Ltd.
HONG KONG – Peptidream Inc. inked a research collaboration with Amolyt Pharma SAS to test and optimize Peptidream’s growth hormone receptor antagonist (GHRA) peptides, with the aim of selecting a candidate to develop as a potential treatment for acromegaly.
HONG KONG – Hummingbird Bioscience Pte. Ltd. is collaborating with artificial intelligence (AI) company Tempus Labs Inc. to advance HMBD-001, a differentiated anti-HER3 neutralizing antibody developed using Hummingbird's Rational Antibody Discovery platform, into clinical trials in HER3-driven cancers.
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