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.
Vaxxas Pty. Ltd. and the Coalition for Epidemic Preparedness Innovations (CEPI) signed a partnership agreement to develop Vaxxas’ vaccine-patch delivery technology in a project that could end the need for frozen storage of mRNA vaccines.
India’s drug regulatory system is under the lens again after the World Health Organization’s (WHO) latest medical product alert on two substandard cough syrups manufactured in the country, varieties of which have led to the deaths of scores of children in late 2022.
CAR T specialist Carsgen Therapeutics Holdings Ltd. out-licensed commercial rights for its B-cell maturation antigen (BCMA) CAR T therapy, CT-053, in mainland China to Huadong Medicine Co Ltd. in a deal worth up to $152 million.
Hadasit Medical Research Services and Development Ltd. and BIRAD – Research & Development Company Ltd. have inked a development deal with Immix Biopharma Inc. for tissue specific therapeutics based on their jointly developed anti-B-cell maturation antigen CAR T cells targeting plasma cell technology.