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3SBio Acquires Licensing Rights to Duality Biologics’ HER2-Targeting ADC DB-1303
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China-based 3SBio Inc. (HKG: 1530) has entered into a strategic partnership with Duality Biologics, a leading antibody conjugate drug (ADC) developer with operations in the United States and China. The collaboration centers on the licensing rights to Duality Biologics’ promising ADC, DB-1303, which targets the HER2 protein. Agreement DetailsPursuant to…
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CSPC Pharmaceutical’s ADC Pipeline Advances with SYS 6041 Approval
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has reported significant progress in its antibody drug conjugate (ADC) pipeline. The company’s latest product, SYS 6041, has recently been cleared for study in advanced solid tumors in China. This approval marks a crucial step in the development of CSPC’s ADC portfolio,…
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Henlius Biotech Gains NMPA Clearance for HLX43 ADC Study
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that it has received clearance from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) drug HLX43, combined with the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10), in patients with advanced/metastatic solid…
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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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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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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…
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MediLink and Zai Lab Collaborate on LRRC15-Targeted ADC Drug ZL-6201
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Chinese biotechs MediLink Therapeutics (Suzhou) Co., Ltd and Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) have entered into a collaboration and license agreement. MediLink’s TMALIN antibody drug conjugate (ADC) platform will be utilized to develop ZL-6201, a novel LRRC15-targeted ADC drug discovered by Zai Lab, for the treatment of solid…
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Astellas’ Padcev and Keytruda Combo Cleared by NMPA for Urothelial Cancer
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced marketing clearance by China’s National Medical Products Administration (NMPA) for its Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) to treat adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination offers a new therapeutic option to patients in China,…
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Mabwell’s 9MW2821 Granted Breakthrough Therapy Designation by CDE for Urothelial Carcinoma
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to its 9MW2821, an antibody drug conjugate (ADC) targeting Nectin-4. The designation is for the use of 9MW2821 in combination…
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Araris Biotech and Chugai Pharmaceutical Collaborate on Novel ADC Development
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Switzerland-based oncology biotech Araris Biotech AG has announced a research collaboration and option to license agreement with Chugai Pharmaceutical Co., Ltd. The partnership will utilize Araris’ proprietary linker-conjugation platform, AraLinQ, to generate novel antibody drug conjugates (ADCs) using antibodies against undisclosed targets provided by the Japanese firm. Deal Terms and…
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Avenzo Therapeutics Licenses Duality Biologics’ EGFR/HER3 Bispecific ADC AVZO-1418/DB-1418
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US-based oncology-focused biotech Avenzo Therapeutics, Inc. has signed a licensing agreement with Duality Biologics, an antibody conjugate drug (ADC) developer operating out of the United States and China, for AVZO-1418/DB-1418, a potential best-in-class EGFR/HER3 bispecific ADC. Drug Profile and DevelopmentAVZO-1418/DB-1418 is an EGFR/HER3 dual-targeting ADC based on a topoisomerase-1 inhibitor.…
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Boehringer Ingelheim and Sutro Achieve Commercial-Scale Manufacturing of Luvelta
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Boehringer Ingelheim BioXcellence and Sutro Biopharma Inc. have announced the successful application of Sutro’s proprietary cell-free expression technology on a commercial scale to manufacture luveltamab tazevibulin (luvelta). This marks the first time Sutro’s cell-free protein synthesis platform has scaled from small-scale Good Manufacturing Practice (GMP) production to large-scale GMP production.…
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CSPC Pharmaceutical Group Receives NMPA Approvals for ADC SYS6045 and PDE4B Inhibitor SYH2059
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) SYS6045 and small molecule inhibitor SYH2059. These approvals mark significant milestones in the development of both drug candidates. SYS6045: Antibody…
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Kelun-Biotech’s Anti-HER2 ADC A166 Receives NMPA Review for Expanded Indication
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that another indication approval filing for its anti-HER2 antibody drug conjugate (ADC), trastuzumab botidotin (A166), has been accepted for review by the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The Chinese company is seeking approval for the…
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Hansoh and GSK’s HS-20093 Receives FDA Breakthrough Therapy Designation for Osteosarcoma
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China-based Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692) and its UK partner GSK plc (LON: GSK, NYSE: GSK) have announced that they have received another breakthrough therapy designation (BTD) from the US FDA for their B7-H3-targeted antibody drug conjugate (ADC), HS-20093 (GSK5764227). The indication this time is for the drug’s…
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Innovent Biologics Strikes Licensing Deal with Roche for IBI3009 ADC
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced a significant licensing agreement with Swiss pharmaceutical giant Roche (SWX: ROG). The agreement grants Roche global exclusive development, manufacturing, and commercialization rights to Innovent’s IBI3009, a DLL3-targeted antibody drug conjugate (ADC) that is anticipated to offer new treatment options for patients with…
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Alphamab Oncology’s JSKN033 Advances to Phase III Trial for Platinum Resistant Ovarian Cancer
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China-based Alphamab Oncology (HKG: 9966) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase III study for its drug candidate JSKN033. The study will compare JSKN033 against the investigator’s choice of chemotherapy in…
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BeiGene Secures Global Rights to Duality Biologics’ B7H4 Targeted ADC DB1312/BG-C9074
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Duality Biologics, a developer of antibody conjugate drugs (ADCs) with operations in the United States and China, has announced that BeiGene Ltd. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has exercised its exclusive option to secure global development, manufacturing, and commercialization rights to Duality’s B7H4 targeted antibody-drug conjugate (ADC), DB1312/BG-C9074. Terms…
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Hengrui Pharmaceuticals and IDEAYA Biosciences Ink Licensing Deal for SHR-4849
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced a significant licensing agreement with US-based IDEAYA Biosciences Inc., (NASDAQ: IDYA). Under this agreement, Hengrui will grant IDEAYA development, manufacturing, and commercialization rights to its novel DLL3-targeting Topo-I-payload antibody drug conjugate (ADC), SHR-4849, for markets worldwide outside of Greater China. Financial…
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Daiichi Sankyo and AstraZeneca Withdraw EU Application for Datopotamab Deruxtecan in Lung Cancer
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Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced the voluntary withdrawal of the marketing authorization application (MAA) in the European Union for their co-developed drug, datopotamab deruxtecan (Dato-DXd). This decision pertains to the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell…
