Edigene Inc. has obtained nonexclusive, global rights to technology from Boston Children’s Hospital for technology related to increasing fetal hemoglobin levels by disrupting B-cell lymphoma/leukemia 11A (BCL11A) expression at the genomic level to treat hemoglobinopathies.
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.
The NMPA’s Center for Drug Evaluation (CDE) published a draft document named the Pilot Work Procedure to Speed Up the Review of Innovative Drug NDAs in February 2022. It aims to accelerate the review of new drug applications (NDAs) 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.
Salubris Biotherapeutics Inc. has raised $32 million in financing from its parent company, Shenzhen Salubris Pharmaceuticals Co. Ltd., for the development of its cardiovascular candidate. Funds will be used to continue efforts in an ongoing phase Ib trial and to initiate two additional phase Ib studies in 2022, as well as to expand the company’s pipeline.
Bridge Biotherapeutics Inc. has signed an exclusive option-to-license agreement for Cellionbiomed Inc.’s preclinical ion channel modulator, BBT-301, thus adding a second idiopathic pulmonary fibrosis (IPF) candidate to its fibrotic diseases portfolio. The company hopes to enter the clinic with the drug in the U.S. by the end of 2022.
Three U.S.-listed China-based biopharmas were among five companies named this week by the U.S. SEC for reportedly failing to submit necessary accounting reports under the Holding Foreign Companies Accountable Act (HFCAA).
The U.S. Securities and Exchange Commission (SEC) recently issued a provisional list of five U.S.-listed Chinese companies that reportedly failed to submit necessary accounting reports required under Holding Foreign Companies Accountable Act. The list included three biopharmas: Beigene Ltd., Hutchmed Ltd., and Zai Lab Ltd.
Chinese state-owned enterprise China Meheco Group Co. Ltd. has signed a deal with Pfizer Inc. to be its mainland China partner for the commercialization of the COVID-19 pill Paxlovid (nirmatrelvir and ritonavir), which won conditional approval from China’s NMPA earlier this year.
Huadong Medicine Co. Ltd.’s wholly owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd. has acquired Asia-Pacific rights to two drugs from Kiniksa Pharmaceuticals Ltd. in a deal worth up to $662 million. “This collaboration aims to bring Kiniksa’s therapeutics to patients in the Asia Pacific Region suffering from severe autoimmune and inflammatory diseases,” said Sanj Patel, chairman and CEO of Kiniksa. “The collaboration also provides nondilutive capital, cost-sharing, and resources for clinical trials to accelerate our drug development and commercialization efforts.”
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