In a crowded thyroid eye disease (TED) space, Innovent Biologics Inc. reported positive late-stage findings for its TED therapy, IBI-311, spurring the Suzhou, China-based biopharma to file for regulatory approval in China. Read More
San Francisco-based Xyphos Biosciences Inc. is pooling technology platforms with Boston’s Kelonia Therapeutics Inc. in a novel immuno-oncology (I-O) drug discovery deal that could fetch more than $800 million. Xyphos and Kelonia will collaborate to develop a maximum of two in vivo CAR T-cell therapy programs, utilizing both Kelonia’s in vivo gene placement system called iGPS and Xyphos’ Accel technology platform. Read More
Ono Pharmaceutical Co. Ltd. inked deals with Shattuck Labs Inc. and Numab Therapeutics AG aimed at bolstering its pipeline in oncology and autoimmune and inflammatory diseases. Ono struck a drug discovery collaboration and option agreement with Shattuck Labs to generate bifunctional fusion proteins for pathways involved in autoimmune and inflammatory diseases. It also signed a global research, development and commercialization deal with Numab for its NM-49, a multispecific antibody designed to activate tumor-associated macrophage phagocytosis for treating cancers. Read More
Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group. Read More
South Korean biopharmaceutical firm GNT Pharma Co. Ltd. on Feb. 13 reported positive findings from a domestic phase III trial of its neuroprotectant therapy, nelonemdaz (NEU-2000), for patients with acute ischemic stroke. Read More
After Lianbio Co. Ltd. turned away a $465 million acquisition offer from Concentra Biosciences LLC, the China and U.S.-based biotech announced it was selling off its assets and shutting down the company. Read More
Palo Alto, Calif.-based Bridgebio Pharma Inc. will hand over development and sales of its rare bone growth disorder therapy, infigratinib, in Japan to Kyowa Kirin Co. Ltd. under its latest exclusive licensing deal. Read More
Otsuka Pharmaceutical Co. Ltd.’s AVP-786 missed the primary endpoint for a third time in a phase III trial for agitation associated with dementia due to Alzheimer’s disease (AD). Two previous phase III trials also failed to show statistical significance for AVP-786. Read More
The U.S. FDA has accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan (dato-dxd) to treat adults with locally advanced or metastatic nonsquamous non-small-cell lung cancer who have received prior systemic therapy. Read More
Hong Kong’s Hutchmed (China) Ltd. reported mixed phase III results of fruquintinib as a second-line combination therapy for advanced gastric cancer on Feb. 6, with the oral vascular endothelial growth factor receptor inhibitor hitting just one co-primary endpoint. Read More
CSL Ltd. will review the data further to see if there is a path forward for CSL-112 (human apolipoprotein A-I) after the phase III AEGIS-II trial failed to meet the primary efficacy endpoint in reducing the risk of major adverse cardiovascular events in patients following an acute heart attack. Read More
Biopharma deals in January reached $26.97 billion, marking the sixth-highest month in BioWorld’s records going back to 2016. It is an increase of nearly 25% from the $21.64 billion in deals in January 2023 and also is up from December. Value the first month of the year is more than 2023’s average monthly value of $18.14 billion, and likewise more than the average monthly value of any previous year. Read More
Citing national security and intellectual property (IP) concerns, a bipartisan group of U.S. lawmakers is calling on three federal departments to investigate China’s Wuxi Apptec’s ties, and that of its subsidiary, Wuxi Biologics, to the Chinese Communist Party and the country’s People’s Liberation Army.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Alterity, Hutchmed, Iregene, Kyowa Kirin, Olix, Opthea, Otsuka, Takeda. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Acepodia, Ascentage, Caliway, GSK, Fermion, Innovent, Takeda. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Aiolos Bio, Alvogen, Astrazeneca, Biocon, Bridgebio, C-Biomex, GSK I-Mab Biopharma, Hengrui, Kowa, Kyowa Kirin, Lianbio, Lotus Pharmaceuticals, Nicox, Nippon Shinyaku, NRX, Numab, Ono Pharmaceutical, PT Etana, QSAM, Recce Pharmaceuticals, Shattuck Labs, Sandoz, Telix, Vicor Pharm, Yiviva Read More
