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Pfizer’s Sasanlimab Shows Positive Results in Phase III CREST Study
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US-based Pfizer Inc. (NYSE: PFE) has reported positive topline results from its pivotal Phase III CREST study. The study evaluated sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).…
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NMPA Approves J&J’s FGFR Kinase Inhibitor Balversa for Urothelial Carcinoma
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China’s National Medical Products Administration (NMPA) has approved Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) for the treatment of adult patients with unresectable locally advanced or metastatic urothelial carcinoma (UC). The drug is indicated for patients who carry susceptible FGFR3 gene mutations and have undergone at…
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Doma Biopharma Receives FDA Clearance for DM002 Phase I Study-Fineline Info & Tech
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China-based Doma Biopharmaceutical (Suzhou) Co., Ltd has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study. The study will assess the safety, tolerability, and preliminary anti-tumor activity of its Category 1 drug DM002 in multiple solid tumors. This…
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GSK’s Shingrix Prefilled Syringe Accepted for FDA Review
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UK-headquartered GlaxoSmithKline (GSK; NYSE: GSK) has announced that a market filing for a prefilled syringe presentation of its recombinant zoster vaccine Shingrix has been accepted for review by the US Food and Drug Administration (FDA). This development marks a significant step towards enhancing the convenience and efficiency of vaccine administration.…
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NHSA Launches Nationwide Self-Inspection Campaign on Medical Insurance Fund Usage
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China’s National Healthcare Security Administration (NHSA) released a notification last weekend, mandating designated medical institutions to conduct self-inspections and self-corrections regarding the illegal and irregular use of medical insurance funds. This initiative aims to enhance the integrity and efficiency of fund utilization within the healthcare sector. Expansion of Campaign ScopeThis…
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China’s NHSA Implements New Regulations for Medical Insurance Payment Qualifications
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China’s National Healthcare Security Administration (NHSA) has released the “Regulations on the Management of Medical Insurance Payment Qualifications for Personnel in Medical Security Designated Medical Institutions.” These regulations aim to enhance the rational use of medical insurance funds and maintain fund security through improved management efforts. The document came into…
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Shenzhen Oculgen Secures Over RMB 100 Million in Series A Funding
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Shenzhen Oculgen Biomedical Technology Co., Ltd. has successfully completed a Series A financing round, raising over RMB 100 million (USD 14.46 million). The round was led by LongRiver Jiangyuan Investment, with additional participation from Nanshan Zhanxin Investment, Junshi Venture Capital, Boyuan Capital, and Qingsong Capital. Existing investor Genesis Venture also…
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Fosun Pharmaceutical’s FCN-437c Accepted for NMPA Review for Breast Cancer Treatment
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Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) has announced that another market approval filing for its FCN-437c has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment option for patients with hormone receptor (HR)…
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Hengrui’s SHR4640 Accepted for NMPA Review for Gout and Hyperuricemia Treatment
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that a market filing for its SHR4640 as a long-term treatment for primary gout with hyperuricemia has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of a new treatment…
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Keymed Biosciences Licenses CM313 to Timberlyne Therapeutics for Global Development
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China-based Keymed Biosciences Inc. (HKG: 2162) has entered into a licensing agreement with US firm Timberlyne Therapeutics, Inc., granting the startup biopharma exclusive development, manufacturing, and commercialization rights to its CM313, a CD38-targeted monoclonal antibody (mAb). The agreement covers global rights, excluding mainland China, Hong Kong, Macau, and Taiwan. Financial…
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Biocytogen and SOTIO Biotech Partner on Colorectal Cancer ADC Candidate SOT109
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China-based Biocytogen (HKG: 2315) has announced an option and licensing agreement with SOTIO Biotech, allowing the Czech Republic firm to use its tumor-targeted fully human antibodies to develop SOT109, SOTIO’s new antibody drug conjugate (ADC) candidate. The ADC is intended for the treatment of colorectal cancer and other gastrointestinal (GI)…
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Novo Nordisk and Valo Health Expand Partnership to Develop Treatments for Obesity and Diabetes
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Partners Novo Nordisk (NYSE: NVO) and Valo Health have announced an expanded partnership, aiming to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular disease. The collaboration leverages Valo’s extensive human dataset and computation powered by artificial intelligence (AI) to accelerate the development of innovative therapies. Initial…
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Immunochina Pharmaceuticals Raises Series E Funding for CAR-T Therapy IM19
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Beijing-based biotech Immunochina Pharmaceuticals has reportedly raised “hundreds of millions” of renminbi in a Series E financing round. The round was led by BTH Coordinated Development Industrial Investment Fund, with contributions from Taiping Medical and Health Industry Equity Investment Fund, Beijing Science and Technology Innovation Group, Beijing Sun-Novo Pharmaceutical Research…
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Sinogen’s SalMet-Vec Receives FDA Orphan Drug Designation for Pancreatic Cancer
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China’s oncology specialist Guangzhou Sinogen Pharmaceutical Co., Ltd. has announced receiving Orphan Drug Designation (ODD) from the US FDA for its SalMet-Vec in pancreatic cancer. This oncolytic bacteria drug has previously earned ODD statuses from the agency for osteosarcoma, hepatocellular carcinoma, and small cell lung cancer. Drug Profile and MechanismSalMet-Vec…
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SynCardia’s Next-Generation Artificial Heart Granted Patent in China
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US-based SynCardia Systems, LLC., a global leader in total artificial heart technology, has announced that the China National Intellectual Property Administration has granted a patent for its next-generation total artificial heart, Emperor. This patent covers novel technology designed to eliminate external drive mechanisms by fully integrating the pumping mechanism within…
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Zai Lab and MediLink Therapeutics Partner to Develop LRRC15 ADC Drug ZL-6201 for Solid Tumors
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On January 10, Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced a new strategic cooperation and global licensing agreement with MediLink Therapeutics. The partnership aims to utilize MediLink’s TMALIN® antibody-drug conjugate (ADC) platform to develop a novel LRRC15 ADC drug, ZL-6201, targeting solid tumors. The antibody for this product was…
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Danaher Corporation Partners with Innovaccer to Enhance Healthcare AI Solutions
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US-based science and tech services giant Danaher Corporation (NYSE: DHR) has announced an investment partnership with Innovaccer Inc., a leading Silicon Valley-based healthcare artificial intelligence (AI) company. The alliance is designed to improve patient prognosis and experience through innovative digital solutions. Innovaccer’s SolutionsInnovaccer offers a suite of software solutions designed…
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Sanofi’s Sarclisa Meets Co-Primary Endpoints in Phase III IRAKLIA Study for Multiple Myeloma
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French pharmaceutical giant Sanofi (NASDAQ: SNY, EPA: SAN) has announced that the Phase III IRAKLIA study for its Sarclisa (isatuximab) met its co-primary endpoints when administered subcutaneously (SC) via an on-body delivery system (OBDS) in patients with multiple myeloma (MM). This marks a significant step forward in the treatment of…
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FDA Grants Priority Review to Johnson & Johnson’s Nipocalimab for Myasthenia Gravis
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US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced that the US FDA has granted priority review status to the Biologics License Application (BLA) for its portfolio drug nipocalimab. This priority status is based on results from the Phase III Vivacity-MG3 study and is awarded for the product’s potential use…
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Boehringer Ingelheim Licenses ADC Technology from Synaffix to Boost Portfolio
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German giant Boehringer Ingelheim has announced the licensing of antibody drug conjugate (ADC) technology from Synaffix B.V., a subsidiary of Switzerland’s Lonza (SWX: LONN). This strategic deal is expected to significantly enhance Boehringer’s ADC portfolio, driven by its subsidiary, NBE Therapeutics. Agreement DetailsUnder the terms of the agreement, Synaffix will…
