Quanta Therapeutics Inc. has gained IND clearance from the FDA for QTX-3544, an oral multi-KRAS inhibitor with G12V-preferring activity and dual ON/OFF state.
CSPC Pharmaceutical Group Ltd.’s antibody-drug conjugate SYS-6045 has been granted clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials.
Naya Biosciences Inc. has expanded its bifunctional antibody pipeline to include NY-500, a novel PD-1 x VEGF tetravalent bifunctional antibody for the treatment of hepatocellular carcinoma (HCC) and other solid tumors.
Simcere Zaiming Pharmaceutical Co. Ltd. has announced clinical trial approvals in China and the U.S. for its CDH6-targeting antibody-drug conjugate (ADC), SIM-0505, for advanced solid tumors. A global clinical study will evaluate SIM-0505 in various malignant tumors, including ovarian cancer and renal cancer.
Cstone Pharmaceuticals Co. Ltd. has filed a clinical trial application in Australia seeking to initiate a first-in-human study of CS-2009 for solid tumors. The company plans to initiate a multi-regional trial for CS-2009 in Australia early next year, followed by expansion into China and the U.S.
Radiopharm Theranostics Ltd. has been granted Belberry Human Research Ethics Committee (HREC) approval in Australia to initiate a first-in-human phase I therapeutic study of 177Lu-labeled RAD-202 (177Lu-RAD-202) for the treatment of HER2-expressing solid tumors, including breast and gastric cancers.
CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials of antibody-drug conjugates (ADCs) SYS-6005 and SYS-6043.
Ottimo Pharma Ltd. is equipped to file an IND and take its lead bifunctional antibody into phase II development, after closing a $140 million series A. The round will accelerate development of jankistomig, which targets the PD-1 immune checkpoint whilst inhibiting tumor angiogenesis by neutralizing vascular endothelial growth factor (VEGF).
Inceptor Bio LLC and Shenzhen Grit Biotechnology Co. Ltd. have established a strategic partnership to advance IB-T101, a CAR T therapy targeting solid tumors.
Beigene Ltd. struck a global licensing deal with CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd. worth up to $1.5 billion for its phase I selective methionine adenosyltransferase 2A (MAT2A) inhibitor, SYH-2039, which is being explored for solid tumors.
