The China Securities Regulatory Commission (CSRC) has issued draft rules to permit U.S. auditors to examine U.S.-listed Chinese companies on April 2, 2022, following a provisional list by the U.S. SEC.
Elix Inc. has teamed up with Shionogi & Co. Ltd. to validate a retrosynthetic analysis model for drug discovery that will employ chemical reaction data from Shionogi to explore various routes to synthesizing new molecules.
Innovent Biologics Inc. has acquired exclusive rights to commercialize Eli Lilly and Co.’s oncology drugs Cyramza (ramucirumab) and Retsevmo (selpercatinib) in mainland China, where it will be responsible for the pricing, importation, marketing, distribution and sales of the two products.
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
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.
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax.
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.
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.
Nec Corp. has acquired all of Vaximm AG’s neoantigen program assets. Tokyo-based Nec will conduct the acquisition via its subsidiary, Nec Oncoimmunity AS.
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.
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