HONG KONG – Amid renewed interest in CD47 as an immuno-oncology target, Innovent Biologics Inc., of Suzhou, China, has received IND approval in China to start clinical trials of its monoclonal antibody (MAb), IBI-188. To further get ahead in the anti-CD47 race, Innovent will conduct clinical trials on IBI-188 at home and abroad simultaneously.
HONG KONG – China has seen a busy month of drug approvals, from Lenvima (lenvatinib, Eisai Co. Ltd. and Merck & Co. Inc.) on Sept. 5 to Elunate (fruquintinib, Hutchison China Meditech Ltd.) and Soliris (eculizumab, Alexion Pharmaceuticals Inc.) on Sept. 6. More notably, the three drugs, all accepted under the priority review pathway, were granted marketing approval in about a year.
HONG KONG – Shanghai-based Fosun Kite Biotechnology Co. Ltd. was granted approval from China's National Medical Products Administration (NMPA) to advance its gene therapy candidate, FKC-876, to clinical trials.
HONG KONG – Amid renewed interest in CD47 as an immuno-oncology target, Innovent Biologics Inc., of Suzhou, China, has received IND approval in China to start clinical trials of its monoclonal antibody (MAb), IBI-188. To further get ahead in the anti-CD47 race, Innovent will conduct clinical trials on IBI-188 at home and abroad simultaneously.
HONG KONG – China-based Hansoh Pharmaceutical Group Co. Ltd. has filed for an IPO in Hong Kong, making it the 11th biopharma company to seek a listing on the Hong Kong Stock Exchange (HKEX) since May and following Ascentage Pharma Group International's IPO a week earlier.
HONG KONG – Hong Kong-based gene therapy company Reflection Biotechnologies Ltd. received orphan drug designation from the U.S. FDA for its gene therapy, RBIO-101, to treat Bietti's crystalline dystrophy (BCD), an inherited eye disease affecting about 100,000 patients worldwide.
HONG KONG – South Korea's JW Pharmaceutical Corp. out-licensed its atopic dermatitis candidate, JW-1601, to Danish medical dermatologist Leo Pharma A/S, which has rights to develop and commercialize the drug worldwide, except in South Korea.
HONG KONG – Alexion Pharmaceuticals Inc.'s blockbuster drug, Soliris (eculizumab), was granted a rapid approval by China's drug regulator, the National Medical Products Administration (NMPA, formerly CFDA), for treating paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
HONG KONG – Hong Kong-based gene therapy company Reflection Biotechnologies Ltd. received orphan drug designation from the U.S. FDA for its gene therapy, RBIO-101, to treat Bietti's crystalline dystrophy (BCD), an inherited eye disease affecting about 100,000 patients worldwide.
HONG KONG – Alexion Pharmaceuticals Inc.'s blockbuster drug, Soliris (eculizumab), was granted a rapid approval by China's drug regulator, the National Medical Products Administration (NMPA, formerly CFDA), for treating paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
