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CSPC Pharmaceutical Group’s SYHX2011 for Metastatic Breast Cancer Accepted for NMPA Review
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that the National Medical Products Administration (NMPA) of China has accepted a marketing filing for its Category 2.2 chemical drug, SYHX2011. The drug is indicated for the treatment of metastatic breast cancer that has failed combined chemotherapy or has relapsed…
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GSK’s Nucala Receives FDA Review for COPD Indication Based on MATINEE Study Data
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UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review data from the MATINEE study. The study seeks an indication approval for GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) who exhibit…
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Hantech Medical Device Co., Ltd Acquires BD’s Villamarzana Factory to Expand Manufacturing
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China-based Hantech Medical Device Co., Ltd, a Contract Development Manufacturing Organization (CDMO) specializing in medical consumables, has announced the buyout of Becton, Dickinson and Company’s (BD) factory located in Villamarzana, Italy. This acquisition includes all assets such as land, factory buildings, and equipment. Concurrently, the US major has reached an…
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Precision Biotech and T&L Biotechnology Form Partnership to Advance Cell and Gene Therapies
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China-based Precision Biotech has announced a strategic partnership with compatriot firm T&L Biotechnology Co., Ltd. to collaborate on the development and supply of cell sorting magnetic bead reagents. This alliance aims to enhance the research and development (R&D) and commercialization efforts in the field of cell and gene therapies (CGT),…
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MicroPort Scientific Corp. Launches FireFalcon Balloon for Coronary Interventions with NMPA Approval
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Shanghai-based medical device giant MicroPort Scientific Corp., (HKG: 0853) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its FireFalcon coronary spinous process balloon, a novel device designed to enhance vascular dilation in coronary intervention therapy. Challenges of Traditional Balloon Dilation TechniquesBalloon dilation…
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HuidaGene Therapeutics Initiates HERO Trial for RNA-Editing Therapy HG204 in MECP2 Duplication Syndrome
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Shanghai-based HuidaGene Therapeutics has announced the first subject dosing of the HERO clinical trial, which is evaluating HG204, an RNA-editing therapy, for the treatment of MECP2 duplication syndrome (MDS). CRISPR RNA-Editing Therapy and Its MechanismThe CRISPR RNA-editing therapy utilizes a single adeno-associated virus vector to deliver HuidaGene’s proprietary high-fidelity RNA…
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Simcere Pharmaceutical’s SIM0508 Reaches First Patient Dosing in Global Clinical Study
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China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced the first patient dosing in a global clinical study for its Pol θ inhibitor, SIM0508, which targets advanced solid tumors. Global Phase I Study Design and ApprovalThe global multi-center, open-label Phase I study is designed to assess the…
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Livzon Pharmaceutical Group Inks Influenza Vaccine Patent Deal with South China Vaccine Corporation
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China-based Livzon Pharmaceutical Group Inc. (HKG: 1513) has entered into a significant patent and technology transfer agreement with South China Vaccine Corporation Limited (SCVC) for the development of influenza recombinant protein vaccines. Terms of the AgreementUnder the terms of the agreement, SCVC will grant Livzon Pharma the rights to its…
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WuXi AppTec’s Subsidiary Invests EUR 20 Million in Jeito II S.L.P. for Growth Expansion
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China-based Contract Development and Manufacturing Organization (CDMO) WuXi AppTec Co., Ltd (SHA: 603259) has announced that its wholly owned subsidiary, WuXi PharmaTech Healthcare Fund I L.P., is set to invest EUR 20 million (USD 21.12 million) by subscribing to A shares of Jeito II S.L.P. Jeito II S.L.P. Fund Managed…
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TJ Biopharma and Jumpcan Pharmaceutical Announce NMPA Review of Eftansomatropin Alfa BLA
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Chinese partners TJ Biopharma and Jumpcan Pharmaceutical (SHA: 600566) have jointly announced that the National Medical Products Administration (NMPA) of China has accepted a Biologic License Application (BLA) for eftansomatropin alfa (TJ101) for review. This product, the first and currently only fusion protein long-acting growth hormone, is anticipated to offer…
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AstraZeneca’s Imfinzi Receives FDA Priority Review for Muscle-Invasive Bladder Cancer
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UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced that the US Food and Drug Administration (FDA) has accepted for review an additional indication filing for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The filing, which seeks approval for the treatment of muscle-invasive bladder cancer (MIBC), has also been…
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Amgen’s Blincyto Meets Primary Endpoint in Phase III AALL1731 Study for Pediatric B-ALL
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US-based biotechnology company Amgen (NASDAQ: AMGN) has published the results from the Phase III study (AALL1731) for its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) at the 66th American Society of Hematology (ASH) annual meeting. The study assessed the potential of adding Blincyto to chemotherapy to improve disease-free survival (DFS) in…
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Novartis’ Fabhalta Demonstrates Positive Results in APPULSE-PNH Phase IIIb Study
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Swiss pharmaceutical major Novartis (NYSE: NVS) has released positive topline results from the APPULSE-PNH Phase IIIb study for its complement inhibitor Fabhalta (iptacopan). This study marks a significant milestone in the evaluation of Fabhalta’s efficacy and safety in treating adult patients with paroxysmal nocturnal hemoglobinuria (PNH). APPULSE-PNH Study Design and…
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Jiaxing Pharbers Genesis Secures RMB 100 Million in Series A2 Financing for Radiopharmaceuticals Expansion
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China-based Jiaxing Pharbers Genesis has reportedly raised RMB 100 million (USD 13.74 million) in a Series A2 financing round. The round was led by the Beijing Isotope and Radiation Innovative Industry Investment Fund, which was initiated by China National Nuclear Corporation (CNNC) and China Isotope and Radiation Corporation, with participation…
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Novo Holdings’ Acquisition of Catalent Gets EU Nod, Paving Way for Novo Nordisk Expansion
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The acquisition of contract development and manufacturing organization (CDMO) Catalent (NYSE: CTLT) by Novo Holdings A/S, the controlling shareholder of Denmark’s major pharmaceutical company Novo Nordisk (NYSE: NVO), has been cleared by the European Commission (EC). This endorsement smooths the path for Novo Nordisk’s subsequent acquisition of three manufacturing sites…
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Johnson & Johnson’s Darzalex Faspro Showcases Clinical Efficacy in Multiple Myeloma at ASH 2024
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US healthcare conglomerate Johnson & Johnson (J&J, NYSE: JNJ) has presented results from several clinical studies for its Darzalex Faspro (daratumumab and hyaluronidase-fihj) at the 2024 American Society of Hematology (ASH) annual meeting. Darzalex Faspro, a CD38-directed antibody co-formulated with Halozyme’s ENHANZE drug delivery technology, has shown promising results in…
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AstraZeneca’s Imfinzi Demonstrates Positive Outcomes in PACIFIC-5 III Study for NSCLC
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UK-based pharmaceutical company AstraZeneca (AZ, NASDAQ: AZN) has announced positive results from the PACIFIC-5 III study for its programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab). The study focused on patients with unresectable stage III non-small cell lung cancer (NSCLC) who did not experience disease progression after receiving synchronous or sequential…
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Duality Biologics’ BNT324/DB-1311 Shows Positive Results in Global Phase I/IIa Study at ESMO Asia
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Duality Biologics, a developer of antibody conjugate drugs (ADCs) with operations in the United States and China, has unveiled the first batch of results from the global Phase I/IIa clinical study for its investigational next-generation antibody-drug conjugate (ADC), BNT324/DB-1311, targeting the transmembrane glycoprotein B7-H3. The data, presented during an oral…
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Innovent Biologics’ IBI343 Shows Promising Results in Phase I Study for Pancreatic Cancer at ESMO Asia
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China-based biopharmaceutical company Innovent Biologics, Inc. (HKG: 1801) presented updated data from the Phase I study of its IBI343, an innovative anti-CLDN18.2 antibody drug conjugate (ADC), for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) during an oral presentation at the ESMO Asia Congress 2024. Updated Data Highlights Efficacy and…
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Hainan Haiyao Secures Exclusive Rights for AFT Pharmaceuticals’ Nutritional Products in China
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China-based Hainan Haiyao Co., Ltd (SHE: 000566) has announced a significant licensing agreement with Australia-based AFT Pharmaceuticals Ltd (NZE: AFT, ASX: AFP). Through this agreement, Hainan Haiyao has obtained exclusive distribution rights to AFT Pharmaceuticals’ range of products in China, including Lipo-Sachets liposomal Vitamin C, Lipo-Sachets liposomal Vitamin D3, Ferro…
