Itabmed Ltd. received an IND approval to start a phase I trial of its CD3-activating bispecific antibody A-337 for the treatment of patients with advanced solid tumors.
Sino Biopharmaceutical Ltd. formed a partnership with Gmax Biopharm International Ltd. to develop obesity candidate GMA-106. As part of the $57 million deal, Sino Biopharm acquired greater China rights to develop and commercialize the drug, in exchange for up-front and milestone payments to Gmax.
Astellas Pharma Inc. has agreed to pay Cullgen Inc. up to $1.9 billion-plus to jointly develop multiple protein degraders. Under the agreement, Tokyo-based Astellas will pay Cullgen, of San Diego, $35 million up front, and an additional $85 million if it decides, during the initial stages of development, to jointly commercialize and promote Cullgen’s lead program, a cell cycle protein degrader for the treatment of breast cancer and other solid tumors, in the U.S.
The U.S. FDA greenlighted Highfield Biopharmaceuticals Co. Ltd.’s IND, paving way for the Chinese immunotherapy firm to begin clinical testing its immunoliposome cancer therapy.
Sirnaomics Ltd. is advancing lead siRNA candidate STP-705 for the treatment of squamous cell carcinoma in situ into late-stage clinical testing after sharing encouraging phase II trial results with the U.S. FDA in an end-of-phase II meeting. The company plans to move forward in 2023 with a single-dose study as a subgroup of subjects in a large phase III study. Positive results will provide the basis for completion of this large registrational phase III trial.
Curocell Inc. is inching closer to realizing Korea’s first domestically developed CAR T therapy, presenting “encouraging” interim phase II trial results for anbalcabtagene-autoleucel at the International Conference on Malignant Lymphoma in Lugano, Switzerland.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Anthos, Astellas, Biogen, Eisai, Itabmed.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Daewoong, Hanall, Idorsia, Vincere.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Astellas, Beigene, Harbour, Lianbio, Ractigen, Vivavision.