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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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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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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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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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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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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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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…
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Abbisko Therapeutics Presents Positive Phase II Results for Pimicotinib in cGvHD at ASH
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) announced the presentation of preliminary Phase II study results for pimicotinib (ABSK021) in patients with chronic Graft-versus-Host Disease (cGvHD) at the 66th American Society of Hematology (ASH) annual meeting. The study focused on patientszhe who have either progressed or not responded to…
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Jacobio Pharma’s BET Inhibitor JAB-8263 Shows Promising Results in Myelofibrosis Phase I Study
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Jacobio Pharma (HKG: 1167) has announced the presentation of preliminary results from the Phase I study of its bromodomain and extra-terminal domain (BET) inhibitor, JAB-8263, in the treatment of myelofibrosis (MF), at the 66th American Society of Hematology (ASH) annual meeting. JAB-8263 Demonstrates Good Tolerability and Efficacy in Phase IThe…
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Youcare Pharmaceutical Gets FDA Clearance for Herpes Zoster mRNA Vaccine YKYY026
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China-based Youcare Pharmaceutical Group (SHA: 688658) has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its mRNA vaccine candidate, YKYY026, aimed at preventing herpes zoster. YKYY026: An Innovative mRNA Vaccine with Proprietary Delivery SystemYKYY026 is a novel mRNA vaccine that utilizes Youcare…
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Duality Biologics’ DB-1311 ADC Shows Promising Results in Global Phase 1/2a Trial
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Duality Biologics, in partnership with BioNTech (NASDAQ: BNTX), has announced the initial data from the global 1/2a phase clinical trial of its B7H3-targeting antibody-drug conjugate (ADC), DB-1311 (BNT324). The trial marks a significant advancement in the treatment of patients with locally advanced or metastatic solid tumors who have previously received…
