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Shanghai Escugen Initiates Phase III Clinical Trial for Breast Cancer Drug Candidate ESG401
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Shanghai Escugen, a biopharmaceutical company based in China, has announced the dosing of the first patient in a Phase III clinical study for its candidate drug ESG401. The study is assessing the efficacy of ESG401 in patients with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-)…
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Ipsen Strikes Global Licensing Deal with Foreseen Biotechnology for First-in-Class ADC FS001
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Ipsen (EPA: IPN; OTCMKTS: IPSEY), a French biopharmaceutical company, has announced a global licensing agreement with Chinese startup Foreseen Biotechnology for the latter’s lead pipeline candidate, FS001. This agreement grants Ipsen exclusive rights to develop, manufacture, and commercialize the antibody-drug conjugate (ADC) on a global scale. As per the terms…
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Sichuan Biokin Pharmaceutical Gets NMPA Approval for BL-M14D1 Clinical Trial in 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 initiate a clinical study for its antibody-drug conjugate (ADC), BL-M14D1, intended for the treatment of advanced solid tumors. BL-M14D1 leverages the same…
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Biokin Pharmaceutical Co., Ltd Eyes Secondary Listing on HKEX, Co-Sponsored by Goldman Sachs and Others
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a company listed on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR) since October 2022, is reportedly planning a secondary listing on the Hong Kong Stock Exchange (HKEX). The firm’s IPO is being co-sponsored by prominent investment banks Goldman Sachs, J.P. Morgan, and…
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Quantum Hi-Tech Partners with East China Normal University to Establish Advanced Drug Research Lab
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Quantum Hi-Tech (China) Biotechnology Co., Ltd, known as ChemPartner (SHE: 300149), has entered into a strategic partnership with Shanghai’s East China Normal University (ECNU). The collaboration aims to establish a state-of-the-art joint laboratory dedicated to advancing research in drug discovery, biochips, drug delivery systems, and drug conjugates (XDCs). Furthermore, the…
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CSPC Pharmaceutical’s SYS6023 Receives FDA Approval for Clinical Study in Advanced Solid Tumors
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its pipeline candidate SYS6023. The study will initially focus on patients with general advanced solid tumors.…
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Doma Biopharmaceutical’s Bispecific ADC DM001 Receives FDA Clearance for Clinical Trial
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its bispecific antibody drug conjugate (ADC), DM001. The molecule is set to be evaluated for safety, tolerability, and preliminary anti-tumor activity…
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Full-Life Technologies’ ²²⁵Ac-FL-020 Earns FDA Fast-Track Status for mCRPC
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Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has announced that the US Food and Drug Administration (FDA) has granted fast-track designation for its investigational drug ²²⁵Ac-FL-020 for the treatment of metastatic castration resistant prostate cancer (mCRPC). ²²⁵Ac-FL-020 is a PSMA-targeted radionuclide…
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Bristol-Myers Squibb Ends Collaboration with Eisai on Farletuzumab Eteribulin
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Bristol-Myers Squibb (BMS; NYSE: BMY), a prominent US pharmaceutical company, has decided to terminate its collaboration with Japanese pharmaceutical firm Eisai Co., Ltd, which was focused on the co-development of Eisai’s antibody drug conjugate (ADC) farletuzumab ecteribulin (FZEC; MORAb-202). According to a press release from Eisai, BMS’s decision is part…
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Innovent Biologics Presents Positive Phase I Results for IBI343 at ESMO GI Congress 2024
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the presentation of new results from a Phase I clinical study of its anti-CLDN18.2 antibody-drug conjugate (ADC), IBI343, at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024. The study focuses on advanced gastric and gastroesophageal junction…
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Huadong Medicine’s ROR1-Targeting ADC HDM2005 Receives FDA Clinical Trial Approval
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Huadong Medicine Co., Ltd (SHE: 000963), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HDM2005. This molecule targets recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1) and is intended…
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Shanghai’s Phrontline Biopharma Secures Over RMB 100 Million in Pre-Series A Funding for ADC Development
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Shanghai-based antibody drug conjugate (ADC) specialist Phrontline Biopharma has reportedly secured over RMB 100 million (USD 13.8 million) in a pre-Series A financing round, with funds exclusively provided by Decheng Capital. The capital raised will be directed towards bolstering research and development efforts, pre-clinical development, and the enhancement of its…
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Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
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Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
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Sichuan Biokin Pharmaceutical Gets NMPA Go-Ahead for BL-M17D1 Solid Tumor Clinical Study
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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 bispecific antibody drug conjugate (ADC), BL-M17D1, which is designed for the treatment of advanced solid tumors.…
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Day One Biopharmaceuticals Expands Pipeline with MabCare Therapeutics Licensing Deal
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Day One Biopharmaceuticals (NASDAQ: DAWN), a California-based biotech company that recently celebrated its first drug approval, has announced an expansion of its pipeline through a licensing agreement with Shanghai-based MabCare Therapeutics. Day One will acquire exclusive development, manufacturing, and commercialization rights to MTX-13, an antibody-drug conjugate (ADC) targeting protein-tyrosine kinase…
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Sichuan Kelun-Biotech Receives NMPA Clearance for SKB518 Clinical Trial in Solid Tumors
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received clearance from the National Medical Products Administration (NMPA) in China for a clinical trial filing of its pipeline candidate, SKB518. The novel antibody-drug conjugate (ADC) is slated for assessment in patients with general advanced solid tumors. Developed…
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BioNTech and MediLink’s HER3 ADC BNT326 Faces Partial Clinical Hold in the US
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BioNTech SE (NASDAQ: BNTX), a German biotechnology company, and its Chinese co-development partner MediLink Therapeutics (Suzhou) Co., Ltd, are facing a partial clinical hold in the U.S. for Phase I development of the HER3-targeted antibody drug conjugate (ADC) BNT326/YL202. The U.S. Food and Drug Administration (FDA) has decided to pause…
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RemeGen’s Disitamab Vedotin Shows Positive Results in Phase III Trial for HER2 Positive Breast Cancer
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced positive results from a Phase III clinical trial for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48), in patients with HER2 positive advanced breast cancer with liver metastasis, achieving the trial’s primary endpoint. The open, parallel-controlled, multi-center Phase…
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Innovent Biologics’ CLDN18.2-Targeted ADC IBI343 Earns FDA Fast-Track Status
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that the US Food and Drug Administration (FDA) has granted Fast-Track designation to its antibody-drug conjugate (ADC), IBI343. This CLDN18.2-targeted therapy has been previously cleared for clinical studies in patients with advanced unresectable or metastatic pancreatic…
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AbbVie’s Telisotuzumab Vedotin Earns Breakthrough Therapy Designation in China for c-Met Positive NSCLC
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AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company based in the U.S., has announced that its cutting-edge antibody-drug conjugate (ADC) telisotuzumab vedotin has been granted breakthrough therapy designation (BTD) in China. This designation is for the treatment of advanced or metastatic epidermal growth factor receptor (EGFR) wild-type (WT) non-squamous (NSq)…
