The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study.
Zai Lab Ltd. has shared positive top-line data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint.
Shouyao Holdings Co. Ltd. raised ¥1.48 billion ($233 million) in a listing on the Shanghai STAR Market to support the company’s ongoing clinical programs, led by a second-generation anaplastic lymphoma kinase inhibitor. Company shares (SHA:688197) debuted at ¥39.90, then fell 19.5% to close at ¥32.11 on March 23.
Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA.
After securing $70 million in series B funding, Chinese biotech Medilink Therapeutics Co. Ltd. is gearing up to enter the clinic with its next-generation antibody-drug conjugates (ADCs).
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).
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