Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific.
There has been a flurry of news flowing from companies developing new antibiotics during the month and the BioWorld Infectious Diseases index, after languishing for the past several months, is tracking up 5% for October. The activity comes against the backdrop of the completion of the AMR Challenge.
BEIJING – Cancer and autoimmune specialist Innocare Pharma Ltd., of Beijing, is seeking a pre-revenue listing on the Hong Kong Stock Exchange (HKEX) to raise capital to advance its BTK inhibitor, ICP-022, to an NDA filing in China by the end of this year.
BEIJING – Cell therapies specialist Nanjing Iaso Biotherapeutics Co. Ltd. became the latest Chinese biotech to enter the country's fierce CAR T race, after China regulators granted an IND approval to CT-103A, a fully human BCMA CAR T for treating relapsed or refractory multiple myeloma.
The FDA's Antimicrobial Drugs Advisory Committee last week backed by a large margin cefiderocol for treatment of complicated urinary tract infections (cUTIs), despite the mortality disparity found by Shionogi & Co. Ltd. among critically ill drug-treated patients in the descriptive phase III trial in severe infections called Credible-CR.
HONG KONG - China and U.S.-based I-Mab Biopharma Co Ltd. has won two IND clearances for TJ-202/MOR-202 from China's National Medical Products Administration (NMPA).
HONG KONG – South Korea's Helixmith Co. Ltd. has announced the results of a phase III trial extension testing VM-202 (donaperminogene seltoplasmid), a regenerative plasmid DNA gene therapy candidate, in diabetic peripheral neuropathy (DPN).
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