China’s National Medical Products Administration (NMPA) approved Zhejiang Jingxin Pharmaceutical Co. Ltd.’s dimdazenil (EVT-201) for short-term treatment of insomnia. Jingxin filed the NDA in China in April 2022.
Prescient Therapeutics Pty Ltd.’s PTX-100 met primary safety endpoints and showed preliminary efficacy in a phase Ib trial in patients with relapsed and refractory T-cell lymphomas that exceeded the standard of care, and the company hopes to advance to a phase II registrational study in 2024, Prescient CEO Steven Yatomi-Clarke told BioWorld.
As South Korea awaits potential changes to drug pricing policies for generics and novel ultra-expensive therapies like Novartis AG’s Kymriah (tisagenclecleucel), the domestic pharmaceutical industry is proactively voicing concerns about some policies that could do more harm than good.
BioWorld spoke with Dave Bearss, CEO of Halia Therapeutics Inc., Vimal Mehta, CEO of Bioxcel Therapeutics Inc., Paul Lammers, CEO at Triumvira Immunologics Inc., Chris Pirie, COO of HDT Bio Corp., Thijs Spoor, CEO of Perspective Therapeutics Inc., and Shelley Hartman, CEO of Aegl Therapeutics Corp. They offered insights brought about by years of hard-won experience.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Ascletis, Bionomics, Innovent, Merck, Neuren, Qulu, Ribomic, Technoderma.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Antengene, Bio-Thera, Carsgen, Cstone, Engenic, Junshi, Ractigen, Zhejiang Jingxin.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Akeso, Bionix Solutions, Concentra, Coya, Cytomed, Immutep, Lianbio, Dr. Reddy’s, Taiwan Bio Therapeutics.
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Systimmune Inc. and Bristol Myers Squibb Co. have joined hands in a co-development deal for bispecific antibody drug conjugate (ADC) BL-B01D1 in a deal worth up to $8.4 billion. The deal falls on the heels of BMS acquiring Mirati Therapeutics in October 2023 for $4.8 billion to add to its oncology pipeline.
Systimmune Inc. and Bristol Myers Squibb Co. have joined hands in a co-development deal for bispecific antibody drug conjugate (ADC) BL-B01D1 in a deal worth up to $8.4 billion. The deal falls on the heels of BMS acquiring Mirati Therapeutics in October 2023 for $4.8 billion to add to its oncology pipeline.
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