China’s NMPA has given a green light for Walvax Biotechnology Co. Ltd.’s human papillomavirus (HPV) bivalent vaccine to be used against HPV types 16 and 18 to prevent cervical cancer.
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.
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.
Adagene Inc. has announced a research collaboration with Sanofi SA, to find “masked” monoclonal and bispecific antibodies that are safer than marketed drugs in oncology, in a deal worth up to $2.5 billion plus royalties. San Diego and Suzhou, China-based Adagene will generate masked versions of Sanofi antibodies, taking responsibility for early stage research activities using its Safebody technology.
LONDON – Antibody-drug conjugate specialist Heidelberg Pharma AG has secured a route into Asia and a fresh injection of much-needed capital, in a licensing and equity deal with Huadong Medicine Co. Ltd. worth up to €930 million (US$1.1 billion).
Odeon Therapeutics Inc. has acquired rights to two cancer candidates from Obi Pharma Inc. in a deal worth up to $200 million. The transaction gives Shanghai-based Odeon rights to develop, register, and commercialize the antibody-drug conjugate OBI-999 and a therapeutic cancer vaccine OBI-833 in mainland China, Hong Kong, and Macau.
Researchers at Inserm have developed a method to direct pre-existing antibodies toward new targets. Their bimodular fusion proteins could be a broadly useful method for expanding access to antibody therapy. In a study that appeared in the Feb. 11, 2022, issue of Science Advances, the teams showed that antibodies to Epstein-Barr virus (EBV), which are present in 95% of the global population, could be redirected to a target cell of their choosing by fusing an EBV antigen to a cellular targeting ligand.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China.
SCG Cell Therapy Pte. Ltd. has acquired rights to human induced pluripotent stem cell technology from Singapore’s Agency for Science, Technology and Research (A*STAR)’s Accelerate Technologies Pte. Ltd. to support the development of natural killer (NK) cell therapies for leukemia, liver cancer, gastric cancer and other solid tumors.