Zhuhai Beihai Biotech Co. Ltd. has raised nearly ¥200 million (US$27.5 million) in a series B round slated to support clinical trials for its lead candidates as well as preparations to file an NDA for its core asset, BH-009.
Biocytogen Pharmaceuticals Co. Ltd.’s subsidiary Eucure Biopharma Co. Ltd. has granted Isu Abxis Co. Ltd. rights to use its humanized agonistic anti-CD40 antibody YH-003 to develop cancer drugs.
Broncus Holding Corp.’s disposable nebulizing microcatheter for an endoscope has been approved by China’s NMPA. The product Mist Fountain is the only nebulizing micro-catheter product available on the Chinese market to treat lung disease, according to the company.
Zhuhai Beihai Biotech Co. Ltd. has raised nearly ¥200 million (US$27.5 million) in a series B round slated to support clinical trials for its lead candidates as well as preparations to file an NDA for its core asset, BH-009, an injectable formulation of docetaxel that excludes polysorbate 80 (Tween 80), a surfactant that has been associated with increased risk of adverse events, including hypersensitivity. The company claims that no similar product is currently available worldwide.
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.
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