BEIJING – CAR T-cell therapeutics developer Carsgen Therapeutics Co. Ltd., of Shanghai, won IND clearance from the FDA for its first-in-class CT-041 for advanced gastric and pancreatic cancers. The company said it is the first claudin18.2 (CLDN18.2)-targeted CAR T-cell therapy cleared for clinical trials in the world.
BEIJING – Androgen receptor (AR)-related disease specialist Kintor Pharmaceutical Ltd., of Suzhou, China, raised $240 million on the Hong Kong Stock Exchange (HKEX) on May 22 by issuing 92.3 million shares at HK$20.15 apiece. The IPO was oversubscribed by 551 times, showing the city’s biotech fever.
HONG KONG – Blockchain technology usually is associated with digital currencies. However, it’s now emerging as an important platform for COVID-19 management. It’s been a focus in China, where a top-down approach is key to driving sectors and technology.
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors.
HONG KONG –Shanghai-based Zai Lab Ltd. has won an approval for the first innovative treatment for glioblastoma approved by China in more than 15 years, with the National Medical Products Administration’s nod for Optune in combination with temozolomide for use in patients with newly diagnosed glioblastoma.
BEIJING – Shanghai-based bispecifc antibody startup Epimab Biotherapeutics Inc. entered a research collaboration and license agreement with Brisbane, Australia-based QIMR Berghofer Medical Research Institute to look for novel bispecific target combinations, a move that could expand the startup’s pipeline.
BEIJING – CAR T specialist Wuhan Bio-Raid Biotechnology Co. Ltd. said its BRD-01, an anti-CD30 CAR T therapy candidate, has been granted IND approval by China’s NMPA. It is the first CD30 candidate to enter the clinic stage amid an increasingly heated CAR T race dominated by candidates targeting CD19 and BMCA.
BEIJING – During the market downturn caused by COVID-19 disruptions, biotech and med-tech companies continue to attract investors at a time when medical solutions are needed more than ever. Qiming Venture Partners said that it has established a new $1.1 billion fund to target early stage health care and technology investments, the latest good news sector for biopharma and med-tech startups. Known as the Qiming Venture Partners Fund VII, this $1.1 billion fund draws most of its capital from endowments, foundations, family offices and private pensions.
Two phase III studies in China testing Gilead Sciences Inc.’s antiviral drug, remdesivir, in patients with COVID-19 infection have been halted after Chinese authorities reported a lack of eligible patients. Other studies, including trials sponsored by the Foster City, Calif.-based company, remain ongoing.
BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.