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Genmab’s Tivdak Approved in Japan for Advanced Cervical Cancer Treatment
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Denmark-based Genmab A/S (NASDAQ: GMAB) has secured approval from the Japan Ministry of Health, Labour and Welfare for its Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that has progressed on or after chemotherapy. Drug Profile and TechnologyTivdak is an antibody-drug conjugate (ADC) comprising Genmab’s human monoclonal antibody…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-9803 and SHR-A2102 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its anti-tumor drugs SHR-9803 and SHR-A2102. This marks a significant step forward in the development of these promising therapies. SHR-9803: Targeting Regulatory T CellsSHR-9803, a Category 1 biologic…
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Luye Pharma’s BA1302 Receives FDA Orphan Drug Designation for Lung and Pancreatic Cancer
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary Shandong Boan Biotechnology Co., Ltd (HKG: 6955) has announced receiving orphan drug designation (ODD) from the US FDA for its novel antibody drug conjugate (ADC) BA1302. The designation covers two indications: squamous non-small cell lung cancer and pancreatic cancer. Innovative ADC DevelopmentBA1302,…
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Insilico Medicine Collaborates with Mabwell Bio to Enhance ADC R&D with AI
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China’s generative artificial intelligence (AI)-driven biotech Insilico Medicine has entered into a collaboration with compatriot firm Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) to enhance antibody drug conjugate (ADC) product research and development (R&D). The partnership leverages the respective technical advantages of both companies in AI and ADC R&D fields,…
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Sichuan Kelun-Biotech Gains NMPA Approval for SKB107 Bone Metastasis Trial
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate SKB107, formerly known as TBM-001. The study will focus on advanced solid tumor bone metastasis. Drug Development and MechanismSKB107 is a radionuclide…
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Sichuan Kelun-Biotech Reports 25.5% Revenue Growth with Key Drug Approvals
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has released its 2024 financial report, recording revenues of RMB 1.933 billion (USD 266 million), representing a 25.5% year-on-year (YOY) increase. This growth includes USD 147.5 million in cooperation payments from US partner Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK), UK-based…
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AbbVie Sues Genmab Over Alleged Trade Secret Misappropriation in ADC Development
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US pharmaceutical giant AbbVie (NYSE: ABBV) has filed a lawsuit in the U.S. District Court for the Western District of Washington, D.C., naming Genmab A/S (NASDAQ: GMAB), Profound Bio US Co., ProfoundBio (Suzhou) Co., Ltd., and former AbbVie employees as defendants. The lawsuit alleges misappropriation of AbbVie’s trade secrets related…
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Innovent Biologics Doses First Patient with IBI354 in HeriCare-Ovarian01 Study
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China-based Innovent Biologics, Inc. (HKG: 1801) has administered the first dose of its antibody-drug conjugate (ADC) IBI354 to a subject in the HeriCare-Ovarian01 study. This Phase III trial is a randomized, controlled, multicenter study designed to evaluate the safety and efficacy of IBI354 compared to chemotherapy in patients with HER2-expressing…
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CSPC Pharmaceutical Group Gains NMPA Approval for SYS6040 Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational antibody-drug conjugate (ADC) SYS6040. The trial will focus on evaluating the safety and efficacy of SYS6040 in patients with advanced solid tumors. Promising Pre-Clinical…
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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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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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Hengrui’s Trastuzumab Rezetecan Nears 8th Breakthrough Therapy Designation
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its trastuzumab rezetecan (SHR-A1811), an HER2-targeted antibody-drug conjugate (ADC), is on course to receive its 8th Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is recurrent or metastatic…
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Taiho Pharmaceutical to Acquire Araris Biotech for USD 400 Million, Expanding ADC Portfolio
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Japan-based Taiho Pharmaceutical Co., Ltd. announced plans to fully acquire Araris Biotech AG, a Swiss biotech company specializing in antibody drug conjugates (ADCs). The acquisition, valued at USD 400 million with potential additional milestone payments of up to USD 740 million, is expected to close during the first half of…
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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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Doma Biopharmaceutical’s HER3-MUC1 Targeted ADC DM002 Receives NMPA Clinical Approval
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China-based Doma Biopharmaceutical (Suzhou) Co., Ltd announced receiving clinical approval from the National Medical Products Administration (NMPA) for its Category 1 drug DM002. This marks a significant milestone in the development of the company’s innovative bispecific antibody drug conjugate (ADC) targeting human epidermal growth factor receptor 3 (HER3) and mucin…
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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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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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WuXi XDC and AbTis Partner to Advance Antibody-Drug Conjugate Innovation
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA (a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259)), has entered into a memorandum of understanding (MOU) with South Korea-based biotech company AbTis. This collaboration aims to enhance innovation in antibody-drug conjugate (ADC) therapeutics and…
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Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Wins New NMPA Approval for NSCLC
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its sacituzumab tirumotecan (SKB264/MK-2870). The approval allows the use of this TROP2-targeted antibody drug conjugate (ADC) in adult patients with EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell…
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Huadong Medicine Seeks Regular Approval for Elahere in Ovarian Cancer Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its application for converting conditional to regular approval for Elahere (mirvetuximab soravtansine) has been accepted by the National Medical Products Administration (NMPA). This antibody drug conjugate (ADC) targets folate receptor α (FRα) and represents a significant step forward in the treatment…
