Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory multiple myeloma.
SK Bioscience Ltd. and Sanofi Pasteur SA announced June 30 positive results from a phase II study for its 21-valent pneumococcal conjugate vaccine (PCV) candidate called GBP-410, or SP-0202 under Sanofi.
Although the highest dose of Bioxcel Therapeutics Inc.’s BXCL-501 hit the primary endpoint in the phase III Tranquility II trial for acute agitation in Alzheimer’s disease patients, shares fell dramatically on June 29 by 64% when investors learned the company received an FDA warning letter over infractions at a trial site.
South Korea’s JW Pharmaceutical Corp. announced a redo of its IND application to the Taiwan FDA on June 27 for its phase III trial on gout treatment URC-102 (epaminurad). The second filing comes in response to a regulatory rejection in March citing a problem with the proposed reference drug.
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.
Eubiologics Co. Ltd. said it would file for regulatory approval for its COVID-19 vaccine called Eucorvac-19 in the Philippines, after announcing positive interim phase III trial results on June 27.
Aslan Pharmaceuticals Pte Ltd. said it inked a licensing deal with Zenyaku Kogyo Co. Ltd. for its atopic dermatitis-targeting monoclonal antibody, eblasakimab, that could reach $138.5 million in up-front and milestone payments.
Edding Group Co. Ltd. announced June 23 it filed for an IPO on the Hong Kong Exchange – news that comes amid a steep drop in China’s biopharma IPO market forecasting sluggish activity in a near-frozen “capital winter.”
Hanmi Pharmaceutical Co. Ltd. presented early results for two candidates for short bowel syndrome (SBS) and hyperinsulinemia, two diseases with limited approved therapies, at the recent annual meeting of the Endocrine Society (ENDO 2023) in Chicago.
Aslan Pharmaceuticals Pte Ltd. said it inked a licensing deal with Zenyaku Kogyo Co. Ltd. for its atopic dermatitis-targeting monoclonal antibody, eblasakimab, that could reach $138.5 million in up-front and milestone payments.
