Celloram Inc., the U.S. subsidiary of the Seoul, South Korea-based Medpacto Inc., signed a €160 million (US$175.88 million) licensing deal with Genfit SA to develop Celloram’s inflammasome inhibitor, CLM-022, for liver disease.
Hangzhou and New Jersey-based cancer biotech Adlai Nortye Ltd. – formerly Hangzhou Nuotai Pharmaceutical Co. Ltd. – announced plans to list on Nasdaq with its U.S. IPO filed on July 27.
Top-line results show a disappointing placebo effect that resulted in Sumitomo Pharma Co. Ltd./Otsuka Pharmaceutical Co. Ltd.’s ulotaront (SEP-363856) missing the primary endpoints in both the Diamond (Developing Innovative Approaches for Mental Disorders) 1 and Diamond 2 trials in schizophrenia.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Antengene, Arrowhead, Beigene, Daiichi Sankyo, Dong-A, Fosun Kite, Hutchmed, Junshi, Mabwell, Qihan, Scynexis, SN.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Biontech, Biotheus, Botanix, CASI, Cleave, Fresh Tracks.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Antengene, Biocity, Biogen, Gannex, Highfield, Kintor, Recce, Sathgen, Telix, Triastek, Zai.
Taking strides from its start as a Seoul National University laboratory, South Korea’s Cellid Co. Ltd. said July 24 that the MFDS approved an IND for the global phase III trial for its omicron variant-targeting COVID-19 vaccine called AdCLD-CoV19-1 OMI. Approval from the MFDS comes two months after Cellid filed the IND on May 23 for its adenovirus vector platform vaccine “capable of responding quickly to virus mutations,” the company said.
The HIV journey is a roller coaster of highs and lows for the patients living with HIV and their families and loved ones but also for the community of researchers and clinicians who pour their hearts and souls into the work they do, said speakers at the International AIDS Society (IAS) 2023 conference in Brisbane, Australia.
Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data.
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