Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Apitope, Bio-Thera Solutions, Biovaxys, China Medical System, Cyclica, Cytodyn, D&D Pharmatech, Destiny, Eli Lilly, Elicio, Eurocine Vaccines, Geneuro, Gtreebnt, HLB Group, Immunic, Impact, Intract, Mirum, Model Medicines, Moderna, Mosaic Immunoengineering, Regenerx, SAB Biotherapeutics, Shenzhen Salubris, Takeda, Tonix, Twist, Worg.
Just months after the controversial FDA approval of Alzheimer’s disease drug Aduhelm (aducanumab), partners on that medicine, Eisai Co. Ltd. and Biogen Inc., are advancing a BLA for another possible AD therapy, lecanemab. Formerly known as BAN-2401, the Bioarctic AB-originated antibody is designed to neutralize and eliminate soluble, toxic amyloid beta for the treatment of early AD. The rolling submission, in pursuit of an accelerated approval, was primarily based on data from a phase IIb trial in people with early AD and confirmed amyloid pathology.
Denmark’s Union Therapeutics A/S has begun a strategic collaboration with Innovent Biologics Inc. over orismilast, a next-generation oral PDE4 inhibitor for inflammatory dermatology conditions that could compete directly with Amgen Inc.’s psoriasis blockbuster, Otezla (apremilast). At the same time, the company is looking for partners in the medium term to develop the drug in the rest of the world as it bids to take on Amgen and other dermatology players such as Bristol-Myers Squibb Co.
Astellas Pharma Inc. and Seagen Inc. received approval through a priority review from Japan's Ministry of Health, Labour and Welfare for Padcev (enfortumab vedotin) to treat radically unresectable urothelial carcinoma that has progressed after chemotherapy. The green light for the antibody-drug conjugate is based on the global phase III EV-301 clinical trial, which included sites in Japan.
Cstone Pharmaceuticals Co. Ltd. released positive data from the phase III trial, Gemstone-302, of sugemalimab plus chemotherapy for the first-line treatment of patients with stage IV squamous and non-squamous non-small cell lung cancer.
Imugene Ltd.’s recent win with a patent granted in Japan with its HER-Vaxx immunotherapy, in development for HER2-positive gastric cancer, represented a smallish but significant win in the HER2/neu space, where plenty of other players are busy, with Greenwich Life Sciences Inc. a strong emerging name.
Biogen Inc. and Samsung Bioepis Co. Ltd. gained FDA clearance for Byooviz (ranibizumab-nuna), a biosimilar that references the VEGF therapy Lucentis (ranibizumab) from Roche Holding AG, as a treatment for wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.
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