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Hainan Poly Pharm’s Generic ProHance Wins FDA Approval in US
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China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) announced that the US Food and Drug Administration (FDA) has approved its generic version of Bracco’s ProHance (gadoteridol), making it the first and currently only ProHance generic available in the US. The approved strengths include 1.3965 g/5 mL, 2.793 g/10 mL, 4.1895…
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Kexing Biopharm and Bio-Thera Solutions Form Alliance for Global Expansion
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China-based Kexing Biopharm (SHA: 688136) and Bio-Thera Solutions Ltd (SHA: 688177) have formed a strategic alliance to explore international pharmaceutical markets. The partnership aims to leverage the companies’ respective strengths in research and development, manufacturing, and commercialization. Financial details were not disclosed. Bio-Thera’s PortfolioBio-Thera has four marketed biologic drugs: Two…
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MicroPort MedBot’s Toumai Surgical Robot Wins NMPA Approval for Single-Hole Laparoscopy
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) announced that the National Medical Products Administration (NMPA) has granted market approval for its Toumai single-arm single-hole laparoscopic surgical robot. The device is designed to perform minimally invasive surgeries through a single incision, offering clinical benefits such as reduced scarring and faster…
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Novartis to Acquire Anthos Therapeutics for $3.1B, Boosting Factor XI Inhibitor Portfolio
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Swiss pharma giant Novartis (NYSE: NVS) announced plans to acquire Anthos Therapeutics, Inc., a cardiometabolic-focused biopharma co-founded with Blackstone Life Sciences in 2019, in a deal valued at up to USD 3.1 billion. The transaction underscores Novartis’ commitment to expanding its pipeline in thrombosis and cardiovascular diseases. Acquisition TermsAnthos shareholders…
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J&J’s Rybrevant and Talvey Win Separate NMPA Approvals in China
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US pharma giant Johnson & Johnson (J&J, NYSE: JNJ) announced receiving marketing approvals from China’s National Medical Products Administration (NMPA) for two of its biologics: Rybrevant (amivantamab) for non-small cell lung cancer (NSCLC) and Talvey (talquetamab) for multiple myeloma. The approvals mark J&J’s latest expansion in China’s oncology market. Rybrevant…
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Degron Therapeutics’ DEG6498 Receives FDA Clearance for Clinical Trials
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China-based Degron Therapeutics, a developer of molecular glue-based drugs, announced that the U.S. Food and Drug Administration (FDA) has granted clinical clearance for DEG6498, its molecular glue degrader (MGD) targeting human antigen R (HuR). The drug will enter early-stage trials to assess its safety and efficacy in solid tumors. Drug…
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Roche Transfers InterMune and Esbriet to Legacy Pharma in IP Deal
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Swiss pharma giant Roche (SWX: ROG) has transferred US-based InterMune, Inc., acquired for USD 8 billion in 2014, and the intellectual property (IP) rights to Esbriet (pirfenidone) in the US to Legacy Pharma Inc. SEZC. Financial terms were undisclosed. FinancialsEsbriet, an idiopathic pulmonary fibrosis (IPF) drug, saw peak sales of…
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Bio-Thera Solutions’ BAT1006 Wins NMPA Approval for HER2+ Breast Cancer Trial
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China’s Bio-Thera Solutions Ltd (SHA: 688177) has received clinical trial approval from the National Medical Products Administration (NMPA) for BAT1006, its recombinant humanized monoclonal antibody, in combination with trastuzumab and chemotherapy for HER2-positive unresectable or metastatic breast cancer patients previously treated with antibody-drug conjugates (ADCs). Drug ProfileBAT1006 targets the extracellular…
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China Resources Double-Crane Pharmaceutical Co., Ltd Receives NMPA Approval for Generic Purinethol
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Stason Pharmaceuticals Inc.’s Purinethol (mercaptopurine). The drug, classified as a Category 2.2 chemical drug, is now approved for the treatment of children with…
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Henlius Biotech’s HLX99 Receives FDA Approval for ALS Clinical Study
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA) has approved a clinical trial for its small molecule drug HLX99 in amyotrophic lateral sclerosis (ALS). The trial will assess the drug’s potential to treat this neurodegenerative disease through neuroprotective mechanisms. Drug ProfileHLX99 is an…
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Henlius Biotech Doses First Patient in HLX43 Phase II Study for Esophageal Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing in a Phase II study of HLX43, its antibody-drug conjugate (ADC) targeting programmed death-ligand 1 (PD-L1), for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in China. The drug, designed for advanced/metastatic solid tumors, has no comparable approved products…
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Bayer Files for Eylea 8 mg EMA Approval to Extend AMD, DME Treatment Intervals
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Bayer (ETR: BAYN) has submitted a marketing application to the European Medicines Agency (EMA) for Eylea 8 mg (aflibercept 8 mg), seeking to extend anti-VEGF injection intervals to 6 months in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The filing builds on positive data from the PULSAR…
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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…
