Shanghai’s State Medical Products Administration announced that GSK plc has been banned from participating in volume-based procurement tenders until April 29, 2024, after failing a good manufacturing practices (GMP) inspection at a contract manufacturing plant in Poland that makes products for China.
Nearly six months after ditching its phase II/III COVID-19 vaccination study to chase a booster strategy, Inovio Pharmaceuticals Inc. is now ditching the heterologous booster.
China’s National Medical Products Administration (NMPA) established new medical device regulations earlier in the year aimed at spurring innovation and creating regulatory incentives, and although the regulation has shortened review and approval timelines, other benefits are less clear, experts said.
Ariemedi Medical Technology (Beijing) Co. Ltd. has completed a series A+ round to further develop its medical devices for minimally invasive surgeries. The round was co-invested by Haining Hairui Investment Management Co. Ltd. and Haier Capital.
Jiangsu Cowin Biotech Co. Ltd. has raised ¥1.14 billion (US$156 million) in a listing on the Shanghai STAR Market. Its shares opened at ¥42.96 apiece, plunged over 13% by the middle of the day but closed at ¥43.62 on the first trading day on Oct. 25.
Suzhou Zelgen Biopharmaceuticals Co. Ltd. reported a phase III trial testing the company’s deuterium-substituted sorafenib derivative donafenib in patients with progressive locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer met its primary endpoint following a preplanned interim analysis which found the drug significantly prolonged median progression-free survival vs. a placebo.
Biocytogen Pharmaceuticals Co. Ltd. subsidiary Eucure Biopharma Co. Ltd. has formed a partnership with Syncromune Inc. to combine Eucure’s YH-002 and two other active ingredients with Syncromune’s Syncrovax platform technology.
Inxmed Co. Ltd. has formed a partnership with Shanghai Huaota Biopharmaceutical Co. Ltd. to combine the former’s IN-10018 and the latter’s HB-0030 for the treatment of solid tumors by jointly running preclinical studies and clinical trials.
Suzhou Zelgen Biopharmaceuticals Co. Ltd. reported a phase III trial testing the company’s deuterium-substituted sorafenib derivative donafenib in patients with progressive locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer met its primary endpoint following a preplanned interim analysis which found the drug significantly prolonged median progression-free surviva vs. a placebo.
Inxmed Co. Ltd. has formed a partnership with Shanghai Huaota Biopharmaceutical Co. Ltd. to combine the former’s IN-10018 and the latter’s HB-0030 for the treatment of solid tumors by jointly running preclinical studies and clinical trials.
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