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Alphamab Oncology Partners with ArriVent BioPharma for Global ADC Development and Commercialization
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has entered into a research and development (R&D) and commercialization cooperation agreement with ArriVent BioPharma, Inc. (NASDAQ: AVBP), a U.S. biopharmaceutical firm. The collaboration aims to jointly discover, develop, and commercialize innovative antibody-drug conjugates (ADCs) for oncology treatments. According to…
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Jiangsu Hengrui’s HER2 Targeted ADC SHR-A1811 Poised to Earn Breakthrough Designation in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its HER2 targeted antibody-drug conjugate (ADC), SHR-A1811, is on track to receive breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of HER2…
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Huadong Medicine’s ROR1-Targeting ADC HDM2005 Cleared for Clinical Trials by China’s NMPA
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Huadong Medicine Co., Ltd (SHE: 000963), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for HDM2005, an antibody-drug conjugate (ADC) that targets the recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1). The molecule…
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Gilead’s Trodelvy Misses Overall Survival Endpoint in Late-Stage Urothelial Cancer Study
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Gilead (NASDAQ: GILD) has announced that a late-stage study for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) did not meet the primary endpoint of overall survival (OS) in patients with previously treated locally advanced or metastatic urothelial cancer (mUC). This result casts uncertainty over the drug’s accelerated approval indication in…
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Full-Life Technologies Receives FDA Green Light for ²²⁵Ac-FL-020 Clinical Study in mCRPC
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Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its investigational drug ²²⁵Ac-FL-020 in patients with metastatic castration-resistant prostate cancer (mCRPC). ²²⁵Ac-FL-020 is a PSMA (prostate-specific…
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Medilink Therapeutics Partners with BioNTech to Develop ADC Products Using TMALIN Technology
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Medilink Therapeutics, based in Suzhou, has entered into another partnership agreement with German biotechnology company BioNTech SE (NASDAQ: BNTC). This collaboration allows BioNTech to utilize Medilink’s TMALIN ADC technology platform for the development of specific antibody drug conjugate (ADC) products. According to the terms of the deal, BioNTech will make…
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Jiangsu Hengrui’s SHR-A1921 Anticipated to Gain NMPA Breakthrough Designation for Ovarian Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that its drug candidate SHR-A1921 is on track to receive breakthrough therapy designation (BTD) from the National Medical Products Administration (NMPA) for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. SHR-A1921 is an antibody…
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Chinese Pharma Companies Set to Showcase Cancer Treatments at ASCO 2024
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The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 31 to June 4 in Chicago, will feature updates from Chinese pharmaceutical companies Ascentage Pharma (HKG: 6855), Lepu Biotechnology Co., Ltd (HKG: 2157), Transcenta Holding Ltd, and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) on their…
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RemeGen’s Disitamab Vedotin on Track for Breakthrough Designation in Muscle Invasive Bladder Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), is poised to receive breakthrough therapy designation (BTD) in China. This designation underscores the molecule’s potential in treating perioperative treatment of muscle invasive bladder cancer (MIBC) with HER2 expression,…
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AstraZeneca Sets Sights on $80 Billion Revenue Target and 20 New Molecular Entities by 2030
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At its recent investor day, AstraZeneca plc (NASDAQ: AZN), a prominent UK pharmaceutical company, articulated its long-term objectives to shareholders. The company outlined an ambitious plan to achieve revenues of $80 billion by 2030, which is nearly double the $45.8 billion reported in 2023. This target will be pursued by…
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Sichuan Biokin’s BL-B01D1 Advances to Phase III for HR+/HER2- Breast Cancer
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its investigational bispecific antibody-drug conjugate (ADC), BL-B01D1. This in-house developed molecule is designed to target locally advanced, recurrent, or metastatic HR+/HER2- breast cancer. The…
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Alphamab Oncology’s JSKN016 Begins Phase I Clinical Trial for Solid Tumor Treatment
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical study for JSKN016, its innovative antibody-drug conjugate (ADC) targeting both HER3 and TROP2 in patients with solid tumors. The open-label, multi-center Phase I study is designed to conduct a…
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AstraZeneca Commits $1.5 Billion to Build Singapore-Based ADC Manufacturing Facility
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UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced plans for a $1.5 billion greenfield investment to establish a manufacturing presence in Singapore with the construction of a state-of-the-art antibody-drug conjugate (ADC) production site. This facility will be the company’s first end-to-end manufacturing hub, handling all stages of ADC production,…
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Genmab CEO Cites China’s Biotech as a ‘Mind-Boggling’ Source of Innovation
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Jan van de Winkel, CEO of Denmark-based biotech Genmab (NASDAQ: GMAB), has expressed optimism about the potential of China’s biotech industry to drive innovation for multinational corporations (MNCs). This sentiment comes in the wake of Genmab’s significant foray into the Chinese market with the acquisition of Sino-US antibody-drug conjugate (ADC)…
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Mabwell’s 9MW2821 ADC for Triple Negative Breast Cancer Accepted for Review by NMPA
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for its pipeline candidate, 9MW2821. This antibody drug conjugate (ADC) targets Nectin-4 and is planned to be assessed in combination…
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Sichuan Biokin Pharmaceutical Advances BL-B16D1 to Clinical Trial for Advanced Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its in-house developed bispecific antibody drug conjugate (ADC), BL-B16D1, in patients with advanced solid tumors. Biokin Pharma,…
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Bio-Thera Solutions’ PD-1 and ADC Combo Gets NMPA Approval for Clinical Trial in Solid Tumors
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Bio-Thera Solutions, Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for a combination therapy of BAT1308 and BAT8006 in patients with advanced solid tumors. BAT1308 is an in-house developed programmed death-1 (PD-1) monoclonal…
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Mabwell Bioscience’s 9MW2821 Earns Orphan Drug Status from FDA for Esophageal Cancer
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its pipeline candidate, the antibody-drug conjugate (ADC) 9MW2821. This designation is for the drug’s potential in treating esophageal…
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Innovent Biologics’ CLDN18.2 ADC IBI343 Receives Breakthrough Designation in China
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC), IBI343, targeting CLDN18.2, has been granted breakthrough therapy designation (BTD) status in China. This designation highlights the potential of IBI343 as a third-line treatment option for patients with advanced gastric or…
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Sichuan Biokin’s EGFR/HER3 ADC Expands Phase II Clinical Program with NMPA Approval
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct seven Phase II clinical studies for its antibody-drug conjugate (ADC), BL-B01D1, in combination with a PD-1 inhibitor, with or without chemotherapy. The combo therapy, previously approved for…
