Phase I/II trial results of sacituzumab tirumotecan (sac-TMT; Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.) published in Nature Medicine came a month after China’s National Medical Products Administration gave clearance to Kelun-Biotech’s supplemental NDA of sac-TMT to treat advanced non-small-cell lung cancer (NSCLC).
As new clinical trials regulations were signed into law in the U.K., an analysis of 4,616 submissions to conduct studies has highlighted what is required for the updated law to translate into a more efficient, streamlined and adaptable regulatory framework.
The BioWorld Cancer Index ended the first quarter (Q1) of 2025 down 4.74%, retreating after a promising start that saw the index rise 5.78% by the end of January. In the first quarter, 20 stocks declined in value while just nine posted gains.
After gaining 5.78% in January, the BioWorld Cancer Index reversed course, falling 4.74% year-to-date by the end of March. The index’s movement has closely tracked broader market trends. The Nasdaq Biotechnology Index climbed to 5.15% at the end of January but ended the first quarter down 1.54%. Similarly, the Dow Jones Industrial Average rose 4.7% in the first month of the year before slipping to a 1.28% loss through March.
China approved 48 first-in-class innovative drugs, as well as a significant number of medications for pediatric and rare diseases, thanks to measures aimed at enhancing review efficiency and accelerating patient access to novel therapies, according to a report released by China’s National Medical Products Administration.
ABL Bio Inc. announced April 7 that it sealed a potential £2.075 billion (US$2.65 billion) license deal with GSK plc, granting GSK global rights to use ABL’s blood-brain barrier (BBB) penetrating bispecific antibody platform, Grabody-B, to develop multiple programs in the neurodegenerative disease arena. Under the terms signed April 5, ABL agreed to transfer Grabody-B-related technology and know-how to GSK, upon which GSK will assume responsibility for preclinical and clinical development, manufacturing and commercialization.
Radiopharmaceuticals, including 16α-18F-fluoro-17β-estradiol (18F-FES) PET/CT, are emerging as powerful tools with new diagnostic and therapeutic potential in breast cancer diagnosis and treatment, Han Sang-won, professor from the department of nuclear medicine at Asan Medical Center, recently told BioWorld.
Last October, having chalked another trial failure with E-selectin antagonist uproleselan, Glycomimetics Inc. made known its acquisition plan for privately held, solid tumor-focused Crescent Biopharma Inc. – backed by $200 million from a syndicate of investors who liked the odds of success with CR-001, a preclinical VEGFxPD-1 bispecific antibody.
Beigene Ltd. said it is shutting down development of its anti-TIGIT antibody, ociperlimab (BGB-A1217), after the humanized IgG1-variant monoclonal antibody failed a phase III trial in lung cancer. The move is one of many in a string of anti-TIGIT immunotherapy failures.
Sumitomo Pharma Co. Ltd. announced that it will sell off two more of its subsidiaries, Sumitomo Pharma (China) Co. Ltd. and Sumitomo Pharma Asia Pacific Pte. Ltd. (and their subsidiaries), to Marubeni Global Pharma Corp. April 1, as the Japanese pharma continues restructuring efforts from last year.
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