Yantai, China-based biologics developer Remegen Ltd. launched the biggest pre-revenue biotech IPO in Hong Kong this year by raising HK$3.99 billion ($514.5 million) on Nov 9. With this IPO, Remegen’s CEO Jianmin Fang told BioWorld in an exclusive interview, the company aims to take its assets abroad.
Taiwan’s FDA rolled out two new supplementary regulations on periodic safety updates and adverse event notifications for medical devices in October. They are part of its Medical Device Management Law that was reported on Jan. 15. As Taiwan is stepping up innovation of and regulation for medical devices, the nation for the first time decided to separate the regulation of medical devices from pharmaceutical products.
Gracell Biotechnologies Inc. has closed a $100 million series C financing round to advance its CAR T-cell therapy candidates, including autologous product candidate, GC-012F, and allogeneic product candidate, GC-027. Both candidates are in investigator-initiated phase I trials in China.
CAR T therapy developer JW Therapeutics Co. Ltd. launched a HK$2.325 billion (US$300 million) IPO in Hong Kong by issuing 97.7 million shares at HK$23.8 apiece on Nov 3. The listing is set to help the company’s march toward the goal of winning the first CAR T product approval in China.
Precision oncology company Genetron Holdings Ltd. has entered an exclusive licensing agreement for Seq-MRD, a diagnostic assay for detecting and monitoring minimal residual disease (MRD) in select hematologic cancers from med-tech startup Hangzhou Immuquad Biotechnologies Co. Ltd.
Gracell Biotechnologies Inc. has closed a $100 million series C financing round to advance its CAR T-cell therapy candidates, including autologous product candidate, GC-012F, and allogeneic product candidate, GC-027. Both candidates are in investigator-initiated phase I trials in China.
Tencent Holdings Ltd. has launched two med-tech solutions to facilitate data sharing and management with artificial intelligence capabilities, marking an additional step into the smart health care realm for the company. The Chinese tech giant unveiled the two products at the 83rd China International Medical Device Expo Oct. 20.
Chinese pharma giant Huadong Medicine Co. Ltd. has licensed rights to mirvetuximab soravtansine, an antibody-drug conjugate (ADC) for ovarian cancer, from Immunogen Inc., marking its first step into a realm embraced by a growing number of Chinese biopharma player: innovative medicines.
The Chinatrials roundtable went virtual this year and drew clinical trial experts to discuss state-of-the-art clinical trial design strategies, which are increasingly important in a more competitive clinical landscape.
Chinese drugmaker Simcere Pharmaceutical Group Ltd. raised HK$3.57 billion ($460.6 million) in Hong Kong by issuing 261 million shares at HK$13.7 apiece on Oct 27. Its debut hit a setback, with its share price (HKEX:2096) dropping over 20% in mid-morning and extending losses to nearly 24% to close at HK$10.46.
