BEIJING – Canbridge Pharmaceuticals Inc. last week won marketing approval in China for its first rare disease drug, the mucopolysaccharidosis II therapy Hunterase (idursulfase beta injection).
HONG KONG – Legend Biotech Corp. head Frank Fangliang Zhang has come under investigation by mainland Chinese law enforcement in relation to suspected violations of Chinese import and export regulations, the company said.
HONG KONG – Chinese biotech companies, long in-licensors of innovative biopharma assets for the region, have started to reverse the flow by out-licensing domestically generated candidates to global players.
BEIJING – Canbridge Pharmaceuticals Inc. last week won marketing approval in China for its first rare disease drug, the mucopolysaccharidosis II therapy Hunterase (idursulfase beta injection).
Favorable conditions in China encouraged biotech veterans Jerry Wang, Bing Yan and Lihua Zheng to co-found Anheart Therapeutics Co. Ltd. in November 2018 to focus on oncology. On Monday, the Chinese startup in-licensed a mIDH-1 inhibitor and an AXL inhibitor from Daiichi Sankyo Co. Ltd. to expand its pipeline, less than two years after it obtained the global rights of its first asset, AB-106 (taletrectinib), from the Japanese firm to establish its footing.
China’s provincial government for Hainan Province has two sets of medical devices going through the urgent medical device needs program, but leveraging this program for regulatory approval in China is still no small undertaking. One complication is that any real-world evidence gathered in Hainan might not suffice for nationwide regulatory approval, but patient recruitment is also difficult.
Precision oncology company Genetron Holdings Ltd. will help develop a liquid biopsy-based malignant tumor screening and early detection testing kit based on its mutation capsule technology.
Favorable conditions in China encouraged biotech veterans Jerry Wang, Bing Yan and Lihua Zheng to co-found Anheart Therapeutics Co. Ltd. in November 2018 to focus on oncology. On Monday, the Chinese startup in-licensed a mIDH-1 inhibitor and an AXL inhibitor from Daiichi Sankyo Co. Ltd. to expand its pipeline, less than two years after it obtained the global rights of its first asset, AB-106 (taletrectinib), from the Japanese firm to establish its footing.
HONG KONG – Xuanzhu (Shijiazhuang) Biopharmaceutical Co. Ltd., Beijing-based Sihuan Pharmaceutical Holdings Group Ltd.’s innovative drug R&D platform, has secured ¥800 million (US$117.2 million) in series A funding from the State Development and Investment Corp. (SDIC). CMG-SDIC Capital Co. Ltd. (CMG-SDIC) invested the entire ¥800 million, giving SDIC an 18.6% equity interest in the platform, a company spokesperson told BioWorld.
A nearly $2 billion global development and commercialization deal with Abbvie Inc. and a $418 million private placement have bolstered I-Mab Biopharma Co. Ltd.’s position globally. I-Mab framed the deal as being the largest out-licensing and global partnership transaction ever executed by a China-based biotech. Abbvie and I-Mab plan to develop and commercialize the anti-CD47 monoclonal antibody lemzoparlimab for treating multiple cancers globally, with the exception of China. Lemzoparlimab, also called TJC-4, is Shanghai-based I-Mab’s discovery and its lead cancer therapy. The company will get an up-front $180 million by licensing the highly differentiated antibody to Abbvie, along with a $20 million milestone payment based on phase I results.