Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Ascentage, Astrazeneca, Cansino Biologics, Eli Lilly, Henlius, Innovent, Kyowa Kirin, Mei, Neuren, Novavax, Takeda, Xcovery.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Adagene, AIDS Clinical Trials Group, Astrazeneca, Beigene, Bioheng, Biontech, Brii, Cstone, Medison, Moderna, Pfizer, Shionogi, Sinomab, Swedish Orphan Biovitrum.
Edigene Inc. has obtained nonexclusive, global rights to technology from Boston Children’s Hospital for technology related to increasing fetal hemoglobin levels by disrupting B-cell lymphoma/leukemia 11A (BCL11A) expression at the genomic level to treat hemoglobinopathies.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Akston, Ascletis, Bavarian Nordic, Biogen, Biolexis, Boston Children’s Hospital, Edigene, Eisai, Imugene, Innovation, Kukbo, Linkinvax, Lynk, Merck, Moderna, Nanomerics, Nuance, Pfizer, Pharmabcine, Redhill, Rnagene, Scripps Research, Simcere, Soligenix, Sorrento, Virpax, Washington University.
Shanghai Junshi Biosciences Co. Ltd. and Coherus Biosciences Inc. have disclosed positive data from a phase III trial of the anti-PD-1 antibody toripalimab in combination with chemotherapy in China.
The NMPA’s Center for Drug Evaluation (CDE) published a draft document named the Pilot Work Procedure to Speed Up the Review of Innovative Drug NDAs in February 2022. It aims to accelerate the review of new drug applications (NDAs) in China.
Inxmed Co. Ltd. has raised $50 million in a series B round to support clinical trials of its lead candidate, IN-10018, for the treatment of multiple cancers in both the U.S. and China. Inxmed plans to use the funds to invest in trials of IN-10018, bring more stroma-targeting candidates into clinic trials, and improve the firm’s R&D capabilities.
Salubris Biotherapeutics Inc. has raised $32 million in financing from its parent company, Shenzhen Salubris Pharmaceuticals Co. Ltd., for the development of its cardiovascular candidate. Funds will be used to continue efforts in an ongoing phase Ib trial and to initiate two additional phase Ib studies in 2022, as well as to expand the company’s pipeline.
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