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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…
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Novartis’ Scemblix Demonstrates Superior MMR Rates in Phase III ASC4FIRST Study
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Swiss pharmaceutical giant Novartis (NYSE: NVS) unveiled longer-term results from the pivotal Phase III ASC4FIRST study for its Scemblix (asciminib) at the 66th American Society of Hematology (ASH) annual meeting. The study demonstrated superior major molecular response (MMR) rates for Scemblix at week 96 compared to standard-of-care (SoC) tyrosine kinase…
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Tecvayli (Teclistamab) Demonstrates Positive Results in MajesTEC-5 and MajesTEC-4 Trials
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Janssen-Cilag International NV, a subsidiary of US healthcare giant Johnson & Johnson (J&J; NYSE: JNJ), announced the presentation of results from the MajesTEC-5 and MajesTEC-4 studies for its bispecific antibody (BsAb) Tecvayli (teclistamab) at the 66th American Society of Hematology (ASH) annual meeting. The studies focused on patients with newly…
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SinoPep-Allsino Biopharmaceutical Partners with Spraying Systems Co. for Peptide API Manufacturing
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Jiangsu-based Contract Development and Manufacturing Organization (CDMO) Sinopep-Allsino Biopharmaceutical Co., Ltd (SHA: 688076) has announced a strategic partnership with US-based Spraying Systems Co. to collaborate on the application of electrostatic spray drying technology in the commercial manufacturing of peptide active pharmaceutical ingredients (APIs). Enhancing Market Advantages in Peptide ManufacturingThe collaboration,…
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Merck’s Zilovertamab Vedotin Shows 100% CR Rate in Phase II Study for DLBCL: ASH Presentation
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US pharmaceutical giant Merck (NYSE: MRK) has revealed promising data from the Phase II waveLINE-007 study for its antibody drug conjugate (ADC) zilovertamab vedotin at the 66th American Society of Hematology (ASH) annual meeting. Zilovertamab Vedotin’s Potential in Treating DLBCLZilovertamab vedotin, an ADC that targets receptor tyrosine kinase-like orphan receptor…
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Medtide Inc. Submits Second IPO Application to Hong Kong Stock Exchange
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Medtide Inc., a Contract Research, Development, and Manufacturing Organization (CRDMO) specializing in polypeptides and based in Hangzhou, has filed for an initial public offering (IPO) with the Hong Kong Stock Exchange for the second time. This move comes after the company’s initial attempt in May of this year, with the…
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AstraZeneca’s Calquence Combo Shows 35% Reduced Risk in CLL: AMPLIFY Phase III Results
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At the 66th American Society of Hematology (ASH) annual meeting, UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) revealed the latest results from the Phase III AMPLIFY study for its drug Calquence (acalabrutinib) in combination with venetoclax for adult patients with chronic lymphocytic leukaemia (CLL). AMPLIFY Study Design and FindingsThe AMPLIFY…
