Shenzhen Salubris Pharmaceuticals Co. Ltd. received marketing approval from China’s NMPA for enarodustat as a treatment for anemic patients with chronic kidney disease that are not on dialysis.
The World Health Organization (WHO) recently gave an emergency use listing for SK Bioscience Ltd.’s COVID-19 vaccine called Skycovione, a self-assembled nanoparticle vaccine that targets the SARS-CoV-2 spike protein.
After raising AU$4 million (US$2.6 million), Argenica Therapeutics Pty. Ltd. is gearing up to begin phase II trials in ischemic stroke for ARG-007, a glutamate receptor modulator that is believed to reduce brain tissue death after stroke.
Itabmed Ltd. received an IND approval to start a phase I trial of its CD3-activating bispecific antibody A-337 for the treatment of patients with advanced solid tumors.
Sino Biopharmaceutical Ltd. formed a partnership with Gmax Biopharm International Ltd. to develop obesity candidate GMA-106. As part of the $57 million deal, Sino Biopharm acquired greater China rights to develop and commercialize the drug, in exchange for up-front and milestone payments to Gmax.
Astellas Pharma Inc. has agreed to pay Cullgen Inc. up to $1.9 billion-plus to jointly develop multiple protein degraders. Under the agreement, Tokyo-based Astellas will pay Cullgen, of San Diego, $35 million up front, and an additional $85 million if it decides, during the initial stages of development, to jointly commercialize and promote Cullgen’s lead program, a cell cycle protein degrader for the treatment of breast cancer and other solid tumors, in the U.S.
Sirnaomics Ltd. is advancing lead siRNA candidate STP-705 for the treatment of squamous cell carcinoma in situ into late-stage clinical testing after sharing encouraging phase II trial results with the U.S. FDA in an end-of-phase II meeting. The company plans to move forward in 2023 with a single-dose study as a subgroup of subjects in a large phase III study. Positive results will provide the basis for completion of this large registrational phase III trial.
Curocell Inc. is inching closer to realizing Korea’s first domestically developed CAR T therapy, presenting “encouraging” interim phase II trial results for anbalcabtagene-autoleucel at the International Conference on Malignant Lymphoma in Lugano, Switzerland.
Cellusion Inc. raised ¥2.83 billion (US$21 million) in a series C round to progress its lead therapy, CLS-001, an iPS cell-derived therapy to treat bullous keratopathy.
Cutia Therapeutics Ltd. raised HK$465 million (US$65 million) in a Hong Kong IPO on June 12, with almost half of the proceeds going toward furthering its lead product to treat adipose accumulation. Cutia’s shares moved a little higher on the first day of trading, opening at HK$21.80, rising 0.46% and closing at HK$21.95.
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