China’s NMPA granted conditional approval for a COVID-19 oral pill to treat adult patients with mild to moderate cases of the virus to a unit of Guangdong Zhongsheng Pharmaceutical Co. Ltd. RAY-1216 is a peptidomimetic inhibitor of SARS-CoV-2 main protease (Mpro), which is also known as a 3C-like protease (3CLpro).
Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK-021), is advancing from phase I trials to pivotal phase III trials in patients with tenosynovial giant cell tumors (TGCT) in the U.S. and China following clearance from both regulators.
Health Guard Biotechnology Inc. raised ¥294 million (US$43 million) in an IPO on the SME-focused Beijing Stock Exchange, with the funds going to push the development of its HPV vaccines.
Livzon Pharmaceutical Group Inc. licensed rights to zastaprazan, a gastroesophageal reflux disease (GERD) treatment candidate, from Onconic Therapeutics Inc. in a $127.5 million deal. Under the agreement, Livzon, which is based in Guangdong, China, obtains the exclusive rights to develop, license, manufacture and commercialize the candidate in greater China. In turn, Seoul, Korea-based Onconic will obtain a $15 million up-front payment, and up to $112.5 million in development, licensing and commercialization milestone payments.
Hanall Biopharma Co Ltd.’s batoclimab met the primary and key secondary endpoints in a pivotal phase III trial in generalized myasthenia gravis (gMG) in China, marking the first positive phase III data for the candidate globally.
South Korean biotech peers Celltrion Healthcare Co. Ltd. and Liscure Biosciences Co. Ltd. signed a deal to co-develop microbiome-based oral live biotherapeutic products for Parkinson's disease. Under the agreement, Celltrion, of Incheon, South Korea, will provide Seoul-based Liscure with research funding as well as additional payments as the project progresses. Liscure will lead discovery of the novel candidates, and Celltrion will be responsible for further clinical and regulatory development.
Bridge Biotherapeutics Inc.’s small-molecule Pellino-1 inhibitor, BBT-401, failed to meet the primary efficacy endpoint in a phase II trial in ulcerative colitis (UC). The phase II mid-to-high dose cohort study included 38 patients with active UC enrolled at 37 clinical sites across the U.S., New Zealand, South Korea, Poland and Ukraine.
South Korea’s GI Innovation Inc. announced its IPO on the Kosdaq market with plans to raise up to $34 million in March 2023. Funds raised from the IPO will go toward phase I/II clinical trials of immunotherapy agent GI-101 in the U.S. and Korea, and a phase I trial of allergy treatment GI-301 (also known as YH-35324) in Korea.
Sirnaomics Ltd. is gearing up to start either an expanded phase IIb or a phase III clinical trial for its lead siRNA candidate, STP-705, for the treatment of two non-melanoma skin cancers: squamous cell carcinoma in situ and basal cell carcinoma. STP-705 comprises two siRNA oligonucleotides that inhibit transforming growth factor beta 1 and cyclooxygenase-2 gene expressions and is delivered via injection using what the company describes as a polypeptide nanoparticle-enhanced delivery mechanism.
ABVC Biopharma Inc is headquartered in San Francisco but it has its roots in Taiwan where it is digging into traditional medicine and validating it for the modern world. “There are a number of drugs that can’t be synthesized in the lab,” ABVC CEO Howard Doong told BioWorld, so he is going back to the original source of traditional Chinese medicines to validate them using traditional drug development models.
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