Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: AB Science, Adagene, Anji, Arca, Arch Biopartners, Astrazeneca, Betterlife, Bonus Biogroup, Daiichi Sankyo, First Wave, Hepagene, Humanigen, Hummingbird, I-Mab, Immutep, Insilico Medicine Hong Kong, Kyowa Kirin, Lintonpharm, Longeveron, Lynk, Mei, Merck, Nrx, Ose Immunotherapeutics, Pulmotect, RDIF, Revive, Ridgeback, Starpharma, Zai Lab.
PERTH, Australia – Neuren Pharmaceuticals Ltd.’s stock nearly doubled on positive top-line phase III results for trofinetide in Rett syndrome, meeting all primary and secondary endpoints in the pivotal phase III trial run by partner Acadia Pharmaceuticals Inc.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Alphamab Oncology, Ascentage, Beigene, Biontech, Carsgen, Glaxosmithkline, Janssen-Cilag, Johnson & Johnson, Kintor, Merck, Moderna, Novavax, Pfizer, RDIF, Relief, Seqirus, Takeda.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Biotron, Bone, Ix, Link Health, Merck, NLC, Pfizer, Qurient, Ranok, RDIF, Seelos, Shenzhen Pregene, Simcere, Sosei-Heptares, Todos Medical, Tonix, Valneva.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Akston, Arctic Vision, Astrazeneca, Beigene, Biontech, Daiichi Sankyo, Hutchmed, Innovent, Oncotelic, Pfizer, Pulmonem, Syneurx, Tennor.
Ascentage Pharma Group International’s olverembatinib has received marketing approval from China’s NMPA for the treatment of patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CMP-AP) harboring a T315I mutation. The Suzhou, China-based firm said the decision marks the country’s first approved third-generation BCR-ABL inhibitor for the treatment of TKI-resistant CML.
Ildong Pharmaceutical Co. Ltd. inked a partnership with Shionogi & Co. Ltd. to co-develop S-217622, the latter’s orally administered 3CL protease inhibitor treating COVID-19 and has obtained an IND for a phase II/III trial in South Korea to enroll more than 200 patients who are asymptomatic or suffering from mild to moderate COVID-19.
Alphamab Oncology Co. Ltd. has won conditional marketing approval from China’s NMPA for KN-035 (envafolimab), the world’s first PD-1/PD-L1 antibody to be administered by subcutaneous injection. The drug was cleared for use in treating adult patients with advanced solid tumors who have unresectable or metastatic advanced microsatellite instability-high phenotype/mismatch-repair deficiency. That includes patients with advanced colorectal cancer who have experienced disease progression after previous therapy with fluorouracil, oxaliplatin and irinotecan.
Biopharmas in Asia-Pacific raising money in public or private financings: Ablaze, Beigene, Bionomics, Greenlight, Help, Incannex Healthcare, Neurophth, Serum Institute of India.
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