Innovent Biologics Inc. announced June 27 that it gained National Medical Products Administration’s (NMPA) approval of mazdutide as a new weight loss therapy for obese or overweight patients in China. Mazdutide is a dual glucagon/glucagon-like peptide-1 (GCG/GLP-1) receptor agonist originally discovered by Eli Lilly and Co., of Indianapolis.
China’s National Medical Products Administration (NMPA) has accepted for review Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), an autologous CAR T candidate targeting Claudin18.2 for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Just one day earlier, Carsgen announced that it had submitted the satri-cel NDA to the NMPA.
Innovent Biologics Inc. announced a HKD$4.3 billion (US$547 million) placement on the Hong Kong Stock Exchange to advance its R&D projects and to fund its global expansion.
Just a month after laying off 147 employees and announcing plans to mull “strategic alternatives,” Vor Biopharma Inc. reported raising $175 million in private placement in public equity financing and inking a new $4.23 billion license deal for Yantai Rongchang Biotechnologies (Remegen) Co. Ltd.’s telitacicept, a dual-target fusion protein drug approved in China for three autoimmune indications. The news was disclosed after U.S. market hours June 25. Vor’s shares (NASDAQ:VOR) gained 34 cents, or 60.5%, to close June 26 at 89 cents. The company’s shares had risen for eight consecutive trading days since June 17.
Harbour Biomed is out-licensing its B-cell maturation antigen and CD3 bispecific T-cell engager HBM-7020 for autoimmune diseases to Otsuka Pharmaceutical Co. Ltd. in a deal worth up to $670 million.
Keymed Biosciences Co. Ltd. has raised HK$982 million (US$125 million) in a placement on the Hong Kong Stock Exchange (HKEX:2162) to commercialize its IL-4Rα monoclonal antibody CM-310 branded as Stapokibart, and to advance its larger pipeline.
Transthera Sciences Inc. debuted on the Hong Kong stock exchange June 23 with a HK$200.95 million (US$25.6 million) IPO, becoming the latest in a string of mainland Chinese biopharmaceutical firms to turn to the Hong Kong market for capital.
Shanghai Yao Yuan Biotechnology Ltd., also known as Drug Farm, is advancing a portfolio of immune-modulating therapies for various indications including hepatitis B virus, hepatocellular cancer and a relatively new rare genetic disease called ROSAH, an acronym for retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and headache.
Using informed consent to do what Congress couldn’t, the U.S. FDA is flexing its regulatory authority to halt clinical trials that involve sending cells from American patients to China or other adversarial nations for genetic engineering and subsequent infusion back into the patient.
Transthera Sciences Inc. debuted on the Hong Kong stock exchange June 23 with a HK$200.95 million (US$25.6 million) IPO, becoming the latest in a string of mainland Chinese biopharmaceutical firms to turn to the Hong Kong market for capital.
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