China’s National Medical Products Administration (NMPA) has accepted Ascentage Pharma Group Corp. Ltd.’s NDA for its in-house-developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which could be the first domestically approved Bcl-2 inhibitor in China and the second global approval.
With two approved radioligand therapies on its commercial roster and a recent plan to boost its manufacturing for radiotherapeutics, Novartis AG tapped Ratio Therapeutics Inc. in a potential $745 million collaboration aimed at developing a somatostatin receptor 2 radiotherapeutic for cancer.
Syndax Pharmaceuticals Inc. won U.S. FDA approval – the company’s second this year – for menin inhibitor Revuforj (revumenib) with a black box warning for differentiation syndrome. “We’ve long expected that would be the case,” said CEO Michael Metzger. For “the last six years or so” the agency has had a “heightened awareness” of the problem, and he predicted all drugs in the class would bear similar cautionary language. But there’s also a warning about QT prolongation and a requirement for monitoring.
Keymed Biosciences Co. Ltd. is out-licensing global rights, excluding China, for its bispecific antibody, CM-336, to Platina Medicines Ltd. in a deal worth up to $626 million plus sales royalties.
Merck & Co. Inc. has in-licensed Lanova Medicines Ltd.’s PD-1/VEGF bispecific antibody LM-299 in a deal worth up to $2.7 billion in a move to bolster its Keytruda (pembrolizumab) fortress. Under terms of the deal, Merck (known as MSD outside the U.S.) gains an exclusive global license to develop, manufacture and commercialize LM-299 in exchange for an up-front payment of $588 million. Shanghai-based Lanova is eligible to receive up to $2.7 billion in milestone payments associated with the technology transfer, development, regulatory approval and commercialization of LM-299 across multiple indications.
Celltrion Inc. said it would acquire Iqone Healthcare Switzerland SA in the fourth quarter of 2024 for about ₩30 billion (US$21.34 million) to expand its European business. “This move represents a strategic shift in our growth strategy,” Taehun Ha, Celltrion vice president and Europe head, said in a statement Nov. 15.
Despite government efforts to prop up biopharma and med-tech research toward creating women’s health products, companies must eventually reach out to the private markets to bring their inventions to the next stage of development. Anna Zornosa-Heymann, a women’s health investor, serves as a part-time contractor with the U.S. NIH’s SEED (Small business Education & Entrepreneurial Development) office, where she helps companies move from government to external funding. Government funds are “excellent to pay for research … but those funds don’t allow you to build a first-class team and to develop a sales apparatus,” she told BioWorld.
Biontech SE is extending its relationship with Biotheus Inc. from a licensing deal to a full-scale acquisition, agreeing to pay $800 million cash and up to $150 million in milestone payments for the Chinese oncology specialist.
On the heels of U.S. FDA approval of its first T-cell therapy, Adaptimmune Therapeutics plc reported positive results from a pivotal study for its second candidate, letetresgene autoleucel, expected to support a rolling BLA submission in 2025 that could bolster the firm’s offerings as it narrows its focus on the rare sarcoma space.
Syros Pharmaceuticals Inc.’s phase III failure with oral retinoic acid receptor alpha agonist tamibarotene in myelodysplastic syndrome (MDS) meant not only severe stock damage but also defaulting on the loan facility with Oxford Finance LLC, which means an obligation may be accelerated for the company of about $43.6 million, including principal, interest, and other amounts, according to an SEC filing.
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