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Bristol-Myers Squibb’s Breyanzi Hits Primary Endpoint in Lymphoma Study
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Bristol-Myers Squibb (BMS, NYSE: BMY) reported positive results from the Phase II TRANSCEND FL study of Breyanzi (lisocabtagene maraleucel), its CD19-directed CAR T cell therapy, in adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL). The trial met its primary endpoint in the marginal zone lymphoma (MZL) cohort, demonstrating…
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CSPC Pharmaceutical’s SYH2039 Wins FDA Clinical Approval for Advanced Tumors
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China’s CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA) has approved clinical trials for its Category 1 chemical drug candidate SYH2039, a selective phosphodiesterase 4B (PDE4B) inhibitor, for advanced malignant tumors. The drug is also under study in China for interstitial lung diseases.…
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Boehringer Ingelheim’s Nerandomilast Hits Primary Endpoint in PPF Phase III Study
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German pharma giant Boehringer Ingelheim announced positive topline results from the Phase III FIBRONEER-ILD study of its investigational phosphodiesterase 4B (PDE4B) inhibitor nerandomilast, demonstrating a statistically significant improvement in forced vital capacity (FVC) at week 52 versus placebo in patients with progressive pulmonary fibrosis (PPF). Study DetailsThe trial met its…
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CSPC Pharmaceutical’s Omalizumab Biosimilar Wins NMPA Approval for Allergic Asthma
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received an additional indication approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’ Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). The latest approval is for the treatment of moderate to severe persistent allergic asthma,…
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Kelun-Biotech to Present SKB264/MK-2870 Data for Urothelial Carcinoma at ASCO-GU 2025
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China’s Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) will present efficacy and safety data from the Phase I/II KL264-01/MK-2870-001 study of its TROP2-targeted antibody-drug conjugate (ADC) sacituzumab tirumotecan (SKB264/MK-2870) at the ASCO-GU 2025 conference. The drug is being evaluated in patients with unresectable, locally advanced, or metastatic urothelial carcinoma (UC)…
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Sinopep-Allsino Wins NMPA Approval for Generic Liptruzet in China
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Jiangsu-based CDMO Sinopep-Allsino Biopharmaceutical Co., Ltd (SHA: 688076) has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Organon’s (NYSE: OGN) Liptruzet (ezetimibe, atorvastatin), becoming the first such product approved in China. The drug, used to treat hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH), was…
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R-Nanoablation Raises USD 13.7M in Series B+ to Advance Nanosecond Ablation Tech
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Hangzhou-based R-Nanoablation, a minimally invasive medical device developer, has raised over RMB 100 million (USD 13.7 million) in a Series B+ round led by Zhangjiang Haoheng Innovative Equity Investment and Jwell. The funds will accelerate clinical trials and commercialization of its nanosecond pulse electric field (nsPEF) technology platform. Funding DetailsProceeds…
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Bio-Thera Solutions Licenses BAT2506 to Intas Pharmaceuticals for US Market
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that it has entered into a licensing agreement with Intas Pharmaceuticals Ltd., granting the Indian firm exclusive commercialization rights to its BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab), in the United States. Details of the AgreementUnder the terms of the…
