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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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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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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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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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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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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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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, 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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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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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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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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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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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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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 (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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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, 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…
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China-based innovative drug company Chipscreen Biosciences (SHA: 688321) has announced the completion of the analysis of results from the Phase III clinical trial for its drug candidate chiauranib, used as a monotherapy for third-line and above small cell lung cancer (SCLC). The independent review committee (IRC) has assessed the trial’s…
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Immunofoco, a biotechnology company specializing in immunotherapy, has announced that its self-developed autologous CAR-T product, IMC002, targeting CLDN 18.2, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). This designation is for the treatment of patients with unresectable locally advanced, recurrent, or metastatic CLDN…
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Shanghai Juncell Therapeutics has announced that the National Medical Products Administration’s Center for Drug Evaluation (CDE) has approved the first pivotal Phase II registration clinical trial for its GC101 TIL injection. The trial, designated as NCT06703398, is for the treatment of advanced melanoma patients who have progressed or are intolerant…