The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
Ascentage Pharma Group Corp. Ltd. said two of its novel candidates have been included in the 2025 Chinese Society of Clinical Oncology Guidelines, including its in-house developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which is under review in China and could be the first domestically approved Bcl-2 inhibitor and the second global approval.
Orum Therapeutics Inc. on April 26 pulled the plug on a U.S.-based phase I study of ORM-5029, its lead oncology degrader antibody conjugate (DAC) asset, a decision that came months after the company first reported a patient death in November 2024.
Ono Pharmaceutical Co. Ltd. terminated development of CTX-177 (ONO-7018), its ex-oncology candidate in-licensed from Chordia Therapeutics Inc. in December 2020 for up to ¥52.9 billion (US$370.37 million).
Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange, winning clearance April 28 from the China Securities Regulatory Commission to float new H-shares.
The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.
First quarter earnings reports from Edwards Lifesciences Corp., Intuitive Surgical Inc. and Boston Scientific Corp. support trends seen earlier: Larger med-tech companies expect substantial tariff hits, but also have confidence that they can absorb the impact with fairly minor adjustments.
The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
Tightening of U.S. regulation and capital is leading Chinese biotechs to alternative and new models of financing, ranging from cross-border licensing deals, M&As, the so-called newco model and overseas listings.
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