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.
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.
China’s NMPA granted a green light to China Medical System Holdings Ltd.’s tildrakizumab injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sold under the brand name Ilumetri, tildrakizumab is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor to block the release of pro-inflammatory cytokines and chemokines.
The U.S. FDA approved the temporary importation of the unapproved chemotherapy drug cisplatin from Qilu Pharmaceutical Co. Ltd. to help address a shortage of drugs used in cancer treatments in the U.S. The decision opened the possibility of more Chinese drugs making their way to the U.S. market, but some warned that this decision would be likely be a one-off.
Lynk Pharmaceuticals Co. Ltd. raised ¥200 million (US$28 million) in a series C1 financing round to accelerate the clinical development of its second-generation and third-generation JAK inhibitors for cancer and autoimmune diseases.
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.
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere.
In a deal potentially worth $392 million, C4 Therapeutics Inc. signed with Betta Pharmaceuticals Co. Ltd. to develop and market an orally bioavailable BiDAC degrader for non-small-cell lung cancer (NSCLC).
After a steep drop in biopharmaceutical IPOs in the first half of 2023, investors have come to expect that the slowdown in new listings of Chinese companies will continue for some time. Without the key influx of cash that equity financing can generate, biopharma companies are ramping up other activities to generate cash, particularly by out-licensing drugs with the potential for global expansion.
Gracell Biotechnologies Inc. is initiating two clinical trials in China in refractory systemic lupus erythematosus for lead candidate GC-012F, a CD19/B-cell maturation antigen dual-targeting CAR T.
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