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Daiichi Sankyo Launches Datroway in Japan for HR Positive, HER2 Negative Breast Cancer
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Japan-based Daiichi Sankyo (TYO: 4568) has announced the launch of Datroway (datopotamab deruxtecan) in Japan. The drug is approved for treating adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer who have undergone prior chemotherapy. First TROP2-Directed Therapy…
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Menarini Group Partners with VisualDx to Enhance BPDCN Identification Using AI/ML Tools
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Italy’s Menarini Group, through its subsidiary Stemline Therapeutics Inc., has formed a partnership with US-based VisualDx. This alliance aims to enhance the identification of individuals who may have blastic plasmacytoid dendritic cell neoplasm (BPDCN) by introducing artificial intelligence/machine learning (AI/ML) tools. Understanding BPDCNBPDCN is an aggressive orphan hematologic malignancy with…
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Junshi Biosciences Receives NMPA Approval for JS212 in Advanced Solid Tumors
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its JS212, a bispecific antibody drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). This marks a…
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Fosun’s Henlius Receives FDA Orphan Drug Designation for HER2-Targeting HLX22
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On March 19, 2025, Fosun Pharmaceutical (SHA: 600196) announced that its subsidiary, Henlius, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for HLX22, a monoclonal antibody targeting HER2, for the treatment of gastric cancer (GC). This designation marks a significant milestone in the development of…
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Joyo Pharma’s JYP0035 Receives Clinical Trial Approval for Breast Cancer Treatment
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On March 14, 2025, Joyo Pharma announced that its independently developed next-generation, highly selective Class 1 new drug, the PI3Kα inhibitor JYP0035 capsule, received clinical trial approval from the National Medical Products Administration (NMPA). This marks a significant step forward in the development of targeted therapies for breast cancer patients…
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Servier and Black Diamond Therapeutics Ink Global Deal for BDTX-4933
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French pharmaceutical company Servier and US-based Black Diamond Therapeutics, Inc. (NASDAQ: BDTX) announced a strategic global licensing agreement for BDTX-4933 on March 19, 2025. This collaboration aims to advance the development of BDTX-4933, a potential best-in-class targeted therapy for solid tumors. Drug ProfileBDTX-4933 is uniquely designed by Black Diamond to…
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AstraZeneca’s Imfinzi Approved in EU for Limited-Stage Small Cell Lung Cancer
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UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has received approval from the European Union (EU) for its PD-L1 inhibitor Imfinzi (durvalumab) as a monotherapy for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). Clinical Need and Approval SignificanceSCLC is a highly…
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Hengrui Pharmaceuticals Receives NMPA Clearance for HRS-6213 in Solid Tumor Diagnosis
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its HRS-6213. This novel agent is designed for PET imaging to diagnose and evaluate solid tumors, marking a significant step forward in oncology diagnostics. Mechanism and ApplicationHRS-6213…
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Alphamab Oncology’s JSKN033 Receives Breakthrough Therapy Designation for Platinum Resistant Ovarian Cancer
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China-based Alphamab Oncology (HKG: 9966) announced receiving Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) for its JSKN033, a HER2-targeted antibody drug conjugate (ADC) for the treatment of platinum-resistant recurrent epithelial ovarian cancer (PROC), primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels. Drug…
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AstraZeneca Licenses Alteogen’s ALT-B4 for Subcutaneous Cancer Therapies
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UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has entered into a licensing agreement with South Korea-headquartered Alteogen Inc. to develop and commercialize subcutaneous versions of an undisclosed cancer drug using Alteogen’s recombinant hyaluronidase enzyme, ALT-B4. This collaboration aims to expand AstraZeneca’s oncology portfolio by leveraging Alteogen’s innovative technology for improved drug…
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ROBO Medical’s Innovative Gastrointestinal Endoscopic Instrument Gains NMPA Approval
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China’s National Medical Products Administration (NMPA) has approved ROBO Medical’s gastrointestinal endoscopic surgical instrument control equipment, an innovative product now eligible for clamping and pulling diseased tissues during submucosal dissection of esophagus and stomach endoscopy. Product InnovationThis product, the first home-grown digestive endoscopic integrated robot in China, features a flexible…
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Akeso Biopharma’s Penpulimab Approved for First-Line NPC Treatment
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China-based Akeso Biopharma (HKG: 9926) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its PD-1 inhibitor penpulimab (AK105). The drug is now approved for use in combination with chemotherapy for first-line recurrent or metastatic nasopharyngeal carcinoma (NPC). Commercialization and Market PresencePenpulimab, a differentiated PD-1 therapy,…
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BioCity and MSD Enter Clinical Collaboration for BC3195 and Keytruda Combination Trial
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China-based BioCity Biopharmaceutics Co., Ltd. announced a clinical collaboration agreement with US-based giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK). The partnership will initiate a global Phase I/II study to evaluate the safety and efficacy of BioCity’s BC3195 in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) for patients with…
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CSPC Pharmaceutical Group Receives FDA Approval for SYH2051 Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its in-house developed Category 1 chemical drug SYH2051. This ATM inhibitor will be assessed for use in general solid tumors, an indication previously approved for trials…
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Zai Lab Submits TIVDAK BLA to China’s NMPA for Cervical Cancer Treatment
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Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) announced that a Biological License Application (BLA) for TIVDAK (tisotumab vedotin-tftv), an antibody-drug conjugate (ADC) originated by Seagen Inc., has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in making this innovative therapy available…
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MindRank Ltd Receives FDA Clearance for MRANK-106 Clinical Study in Solid Tumors
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China-based artificial intelligence (AI)-enabled drug developer MindRank Ltd announced receiving clearance from the US Food and Drug Administration (FDA) to initiate a clinical study for its MRANK-106, a dual inhibitor of WEE1 and YES1 kinases. This marks a significant milestone for the company as it expands its innovative oncology pipeline…
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AstraZeneca’s Imfinzi Approved by NMPA for Early-Stage NSCLC Treatment
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UK-based giant AstraZeneca (NASDAQ: AZN) received approval from China’s National Medical Products Administration (NMPA) for a new indication for its PD-L1 inhibitor Imfinzi (durvalumab). The approval allows Imfinzi to be used in combination with chemotherapy for adults with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC), specifically for patients without…
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Genmab’s HexaBody-CD38 Clinical Development Halted After J&J Opt-Out
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Denmark-based Genmab A/S (NASDAQ: GMAB) announced that US giant Johnson & Johnson (J&J, NYSE: JNJ) has decided not to exercise its option to obtain a worldwide license for the development, manufacturing, and commercialization of HexaBody-CD38 (GEN3014). Consequently, clinical development of the drug will be terminated. The decision was based on…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4602 Clinical Study in Advanced Solid Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-4602 in combination with SHR-A2102, with or without adebrelimab (SHR-1316), in advanced solid tumors. This marks a significant step forward in the development of innovative…
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Jiangsu Cowin Biotech Obtains NMPA License for Gene Methylation Detection Kit
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China-based Jiangsu Cowin Biotech Co., Ltd. (SHA: 688426) announced receiving a Category III medical device license from the National Medical Products Administration (NMPA) for its human Septin9, SDC2, and NDRG4 gene methylation detection kit (fluorescence PCR method). This approval marks a significant step forward in the company’s efforts to provide…
