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Alphamab and CSPC Gain NMPA Approval for JSKN003 Phase III Trial in HER2-Positive Breast Cancer
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Chinese partners Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that they have received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for JSKN003 versus trastuzumab emtansine in HER2-positive advanced breast cancer. This approval marks a significant milestone in…
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Hanx Biopharmaceuticals Gains NMPA Approval for HX044 Clinical Trials
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China-based Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HX044. This follows the initiation of a Phase I study for the CTLA-4 bispecific antibody (BsAb) in Australia. The approval marks a significant step in the global…
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Akeso Completes Enrollment for Global Phase III Trial of Ivonescimab in Lung Cancer
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China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) assessing its PD-1/VEGF bispecific antibody (BsAb) ivonescimab. The trial compares ivonescimab combined with platinum-based chemotherapy to PD-1 inhibitor tislelizumab in combination with platinum-based chemotherapy in first-line squamous non-small cell lung…
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Regeneron’s Q4 Financials Show 10% Revenue Growth, Driven by Eylea and Libtayo
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US-based biopharmaceutical company Regeneron (NASDAQ: REGN) released its Q4 2024 financial report, showing revenues up 10% year-on-year (YOY) to USD 3.79 billion. For the full year, sales grew by 8% to USD 14.2 billion. The results highlight the continued strength of Regeneron’s portfolio, particularly its top-selling products. Top Performers in…
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Eli Lilly’s Q4 Sales Soar 45% to $13.53B on Strength of GLP-1 Drugs
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Eli Lilly & Co. (NYSE: LLY) reported a robust finish to 2024, with Q4 revenues climbing 45% year-on-year (YOY) to reach USD 13.53 billion. The surge was primarily fueled by its GLP-1 drugs Mounjaro and Zepbound (tirzepatide). Excluding these incretin-focused drugs, Lilly’s overall portfolio still expanded by 20% YOY. For…
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FDA Approves Enhertu for HER2-Low and HER2-UltraLow Breast Cancer
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The US Food and Drug Administration (FDA) has approved Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow…
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Immunophage Partners with GoBroad Cancer Hospital for IPG1094 Phase II Study
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Nanjing-headquartered Immunophage Biotech Co., Ltd., a targeted therapy developer with operations in China, Australia, and the US, has announced a comprehensive partnership with Shanghai GoBroad Cancer Hospital and China Pharmaceutical University. The collaboration, which follows their initial alliance in December of last year regarding IPG7236, is focused on the Phase…
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Betta Pharmaceuticals Gains NMPA Approval for BPI-452080 Clinical Study
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its BPI-452080 in von Hippel-Lindau (VHL) syndrome-related tumors and solid tumors. This marks a significant step forward in the development of new treatments for…
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Junshi Biosciences Receives NMPA Approval for JS213 Clinical Trials
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its JS213 sterile powder for injection. The drug is intended for use in combination with other anti-tumor drugs or as a standalone treatment for advanced…
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Henlius’ Serplulimab Receives EU Approval for Extensive-Stage Small Cell Lung Cancer
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced that it has received marketing approval from the European Commission (EC) for its serplulimab, combined with carboplatin and etoposide, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) under the trade name Hetronifly. This approval marks serplulimab…
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IASO Bio’s CAR-T Therapy Fucaso Accepted for Review in Singapore
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China-based IASO Biotherapeutics has announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Health Sciences Authority (HSA) of Singapore. The therapy is intended for the treatment of relapsed/refractory multiple myeloma (R/R MM)…
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MediLink Therapeutics’ YL217 Receives FDA IND Clearance for Novel ADC Targeting Gastrointestinal Cancers
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MediLink Therapeutics, a clinical-stage biotech company, announced today that its internally developed antibody-drug conjugate (ADC), YL217, has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA). YL217 is the 11th ADC candidate to enter clinical development based on MediLink’s proprietary TMALIN® platform. YL217: A Novel…
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Enhertu Approved by FDA for HR-Positive, HER2-Low Breast Cancer
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Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) jointly announced that their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received FDA approval for the treatment of unresectable or metastatic hormone receptor (HR) positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2 ultra-low (IHC 0 with membrane staining) breast…
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Accuray’s Tomo C System Completes Treatment of First 100 Patients in China
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US-based medical device firm Accuray Inc. (NASDAQ: ARAY) has announced the completion of treating the first 100 patients using its Tomo C Radiation Treatment Delivery System at the Shandong Cancer Hospital and Institute. The milestone marks a significant achievement for the Tomo C System, which was developed through the CNNC-Accuray…
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Beijing Aosaikang’s ASKB589 Shows Promise in Phase I/II Study for Gastric Cancer
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China’s Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has unveiled the latest results from a Phase I/II study of its Category 1 biologic product candidate ASKB589, which is being evaluated as a first-line treatment for advanced gastric/esophagogastric junction (G/GEJ) adenocarcinoma. The study assessed the efficacy and safety of ASKB589 in…
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Shenzhen TargetRx Raises $50M in Series C Financing for Global Clinical Trials
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China-based Shenzhen TargetRx, Inc., a developer of small-molecule kinase inhibitors, has announced the completion of a Series C financing round, raising USD 50 million. The funds will be used to advance overseas clinical studies for multiple innovative drugs, positioning the company for global expansion. Company Background and PipelineFounded in 2014,…
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Akeso Biopharma Receives Development Payment for PD-L1 Monoclonal Antibody
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China-based Akeso Biopharma (HKG: 9926) has announced receiving a drug collaboration development payment from compatriot firm Kelun Pharmaceutical Research Institute, following the National Medical Products Administration’s (NMPA) approval of its programmed death ligand 1 (PD-L1) monoclonal antibody (mAb) tagitanlimab last month. Collaboration BackgroundAkeso entered into a collaboration agreement with Kelun…
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FDA Lifts Clinical Hold on Sanofi’s Cialis Over-the-Counter Trial
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France-based Sanofi’s (NASDAQ: SNY, EPA: SAN) Consumer Healthcare unit Opella has announced that the US FDA has lifted a clinical hold on its planned Actual Use Trial (AUT) for Cialis (tadalafil). This move allows Sanofi to initiate the AUT and potentially switch the PDE5 inhibitor from a prescription to an…
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CD Biopharma Initiates Phase I Trial for CD-001 in Advanced Solid Tumors
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Suzhou-based tumor immunotherapy specialist CD Biopharma has announced the first subject dosing of a Phase I study for its novel anti-tumor drug CD-001 in patients with advanced solid tumors. The patient is reported to be stable with all indicators being normal. This milestone marks the beginning of clinical evaluation for…
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Humanwell’s HWH340 Receives Clinical Approval for Prostate Cancer Treatment
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that its Class 1 chemical drug HWH340 has received clinical approval from the National Medical Products Administration (NMPA). The drug is indicated for use in combination with abiraterone acetate for the treatment of advanced prostate cancer. This approval marks a significant…
