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. Read More
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. Read More
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. Read More
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). Read More
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). Read More
A team at the Broad Institute of Harvard and MIT has developed a genome editing method that could, in principle, correct 90% of the roughly 75,000 currently known genomic changes that are associated with genetic diseases. Read More
HONG KONG – South Korea's biopharmaceutical venture Genome & Co. Ltd. recently secured KRW30.2 billion (US$25.2 million) in series C investment with an IPO and global clinical trial plans for next year. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific. Read More
