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Antengene Launches Phase I CLINCH Study for ATG-022 in Australia
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China-based Antengene Corporation Ltd (HKG: 6996) has received approval from Australia’s Therapeutic Goods Administration (TGA) to commence the Phase I CLINCH study for its antibody-drug conjugate (ADC) ATG-022. The study targets advanced or metastatic solid tumors, with a focus on gastric cancer patients expressing Claudin 18.2. ATG-022: Mechanism and Preclinical…
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Kelun’s SKB264 Receives Breakthrough Therapy Designation for Lung Cancer
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE). The designation is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung…
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RemeGen and Allist Partner to Assess ADC and EGFR Inhibitor Combination in NSCLC
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China-based RemeGen Ltd (HKG: 9995) and Allist Pharmaceuticals Inc. (SHA: 688578) have announced a clinical cooperation agreement to evaluate the safety, tolerability, efficacy, and pharmacokinetics of RemeGen’s antibody drug conjugate (ADC) RC108 in combination with Allist’s epidermal growth factor receptor (EGFR) inhibitor furmonertinib. The collaboration aims to assess the potential…
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Keymed Biosciences’ CMG901 Shows Promising Results in Phase Ia Study for Solid Tumors
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China-based Keymed Biosciences Inc. (HKG: 2162) has revealed the latest data update from a Phase Ia dosage escalation study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of its CMG901. The study focuses on CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) for advanced solid tumors. The data…
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Bliss Bio Raises RMB 100 Million in Series B+ Financing for Oncology Pipeline
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Hangzhou-based oncology-focused clinical-stage biotech Bliss Bio has reportedly raised over RMB 100 million (USD 14.7 million) in a Series B+ financing round. The round was led by In Capital, with contributions from Oriental Fortune Capital and Sherpa Healthcare Partners. The proceeds will be used to advance clinical studies for BB-1701,…
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Roche’s Polivy Approved by China’s NMPA for Lymphoma Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the National Medical Products Administration (NMPA) has approved its antibody-drug conjugate (ADC) Polivy (polatuzumab vedotin for injection). Polivy is the world’s first ADC targeting CD79b and is designed for use as a first-line treatment for diffuse large B-cell lymphoma…
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Kelun-Biotech’s SKB264 Approved for Phase II Study in EGFR-Mutant NSCLC
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its drug candidate SKB264. The antibody-drug conjugate (ADC) targets trophoblast cell-surface antigen 2 (TROP2) and will be evaluated in combination with AstraZeneca’s (AZ, NASDAQ: AZN)…
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Luye Pharma’s BA1301 Receives CDE Approval for Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its antibody-drug conjugate (ADC) BA1301. The drug is indicated for use in Claudin18.2 (CLDN18.2)-positive advanced solid tumors, including advanced gastric cancer, adenocarcinoma of the gastroesophageal junction, and pancreatic cancer. This…
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Duality Biologics Licenses ADC Platform to Denmark’s Adcendo for Mesenchymal Tumor Program
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Duality Biologics, a developer of novel modality drugs operating in the United States and China, has announced a technology license agreement with Denmark-based Adcendo ApS. Under the agreement, Adcendo has been granted a license to use Duality’s antibody drug conjugate (ADC) platform, DITAC, in its mesenchymal tumor product uPARAP program.…
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RemeGen’s RC48 Gains NMPA Approval for Phase II Study in Bladder Cancer
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China – based biopharmaceutical company RemeGen Ltd (HKG: 9995) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II study of its antibody – drug conjugate (ADC) candidate RC48 (disitamab vedotin). The study will assess the efficacy and safety of RC48…
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RemeGen’s RC108 Receives FDA Go-Ahead for Phase I Clinical Study
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China-based biopharma RemeGen Ltd (HKG: 9995) has announced receiving approval from the US FDA to initiate a Phase I clinical study for its antibody drug conjugate (ADC) RC108 in c-Met positive advanced solid tumors. This marks a significant step forward in the global development of RC108, building on its existing…
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Biosion Completes Series B Financing Round Led by Guangfa Xinde Investment
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Biosion, a global, clinical-stage biotech committed to developing antibody-based therapies targeting immune and oncologic diseases, has announced the completion of a Series B financing round at upwards of RMB 100 million (USD 14.33 million). The funding was led by Guangfa Xinde Investment, with contributions from FangFund, Addor Capital, and Suxin…
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Jiangsu Chia Tai Tianqing’s TQB2102m Gains NMPA Clinical Approval
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Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd’s (CTTQ) Category 1 biologic product TQB2102m, an HER2 targeted antibody drug conjugate (ADC), has obtained clinical approval from the National Medical Products Administration (NMPA). The targeted indication is advanced malignant tumors, with no similar product currently approved for marketing anywhere in the world.…
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WuXi XDC Partners with GeneQuantum for ADC Development
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China-based WuXi XDC, a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has announced a partnership with compatriot firm GeneQuantum Healthcare (Suzhou) Co., Ltd in relation to antibody-drug conjugate (ADC) development. The collaboration aims to advance the development and…
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Biosion and ImmunoGen Collaborate on Cancer ADCs
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China-based Biosion Inc. announced an exploratory research collaboration to create antibody-drug conjugates (ADCs) for the treatment of cancer with US firm ImmunoGen, Inc. (Nasdaq: IMGN). Biosion will leverage its proprietary SynTracer high-throughput (HT) endocytosis platform to generate highly selective antibodies to targets allocated by each company, and ImmunoGen will provide…
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Henlius Biotech Partners with Medilink for Global ADC Development
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced a strategic partnership with Suzhou-based Medilink Therapeutics, obtaining global development, manufacturing, and commercialization rights to antibody conjugate drugs (ADCs) based on the latter’s ADC technology platform, focusing on two designated, undisclosed targets. No financial details were revealed. Medilink’s ADC TechnologyMedilink Therapeutics boasts the…
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RemeGen’s RC118 Receives Orphan Drug Designations for Gastric and Pancreatic Cancers
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China-based RemeGen Ltd announced that its antibody drug conjugate (ADC) drug candidate RC118 has obtained two orphan drug designations (ODD) from the US FDA, for the therapy’s potential use against gastric and pancreatic cancers. RC118: Mechanism and DevelopmentRC118, a novel ADC drug candidate co-developed with contract research organization (CRO) Biocytogen,…
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Enhertu Confirmed as New Standard of Care for Breast Cancer in Phase III Study
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AstraZeneca PLC (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) released the latest data supporting the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) as a new standard of care for breast cancer. An update from the DESTINY-Breast03 Phase III study assessing Enhertu head-to-head against Roche’s Kadcyla (trastuzumab emtansine, TDM-1) in patients with…
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Daiichi Sankyo Doses First Patient in Global Phase III TROPION-Lung08 Study
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Japan-based Daiichi Sankyo Inc. (TYO: 4568) announced the first patient dosed in the global multi-center Phase III TROPION-Lung08 study in China. The trial is assessing the efficacy and safety of Dato-DXd combined with pembrolizumab in treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC) with high expression of PD-L1 without…
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Biocytogen and ADC Therapeutics Enter Evaluation and Option Agreement
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd has announced an evaluation and option agreement with Swiss firm ADC Therapeutics SA. Under the agreement, Biocytogen will grant ADC Therapeutics a license to evaluate its proprietary antibodies against three tumor targets. ADC Therapeutics will have the option to license selected antibodies at a…
