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GSK’s Jemperli Receives FDA Breakthrough Therapy Designation for Rectal Cancer Treatment
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UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its drug Jemperli (dostarlimab). The designation is for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. Jemperli’s Background…
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Innovent Biologics Partners with Eli Lilly for Distribution of Jaypirca in China
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China-based Innovent Biologics, Inc. (HKG: 1801) has entered into a significant distribution and promotion agreement with US pharmaceutical giant Eli Lilly and Company (NYSE: LLY). The agreement pertains to Lilly’s non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, Jaypirca (pirtobrutinib). Financial details of the agreement have not been disclosed. Under the terms,…
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Innovent Biologics Initiates Phase I Trial for IBI3009 in Small Cell Lung Cancer and Neuroendocrine Tumors
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On December 13, 2024, Innovent Biologics, Inc. (HKG: 1801) registered a Phase I clinical trial for IBI3009 on the drug clinical trial registration and information public platform. The trial will investigate the efficacy of IBI3009 in treating small cell lung cancer (SCLC) and other neuroendocrine tumors. Exploring Biomarkers and Efficacy…
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Bayer AG Initiates Phase I Study Combining BAY3498264 with Sotorasib for KRAS-Mutated Tumors
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Germany-based pharmaceutical giant Bayer AG (ETR: BAYN) has announced the initiation of a Phase I study to assess the preliminary efficacy and safety of its BAY3498264, a selective SOS1 inhibitor, when combined with sotorasib in patients with advanced KRAS G12C-mutated solid tumors. BAY3498264: A Potential Therapeutic Agent for KRAS-Mutant CancersBAY3498264…
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Pfizer’s Ibrance Demonstrates Significant PFS Improvement in Phase III PATINA Trial
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US pharmaceutical major Pfizer Inc. (NYSE: PFE) and Alliance Foundation Trials, LLC (AFT) have announced positive results from the Phase III PATINA trial for Ibrance (palbociclib), a CDK4/6 inhibitor. The trial data indicated that incorporating Ibrance into the standard-of-care first-line maintenance therapy—following induction chemotherapy—resulted in a statistically significant and clinically…
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BeiGene Ltd Acquires Global Rights to CSPC’s MAT2A Inhibitor SYH2039
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BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has entered into a significant licensing agreement with CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093). The agreement secures BeiGene the global development, manufacturing, and commercialization rights to CSPC’s methionine adenosyltransferase 2A (MAT2A) inhibitor, SYH2039. Financial Details and Milestones of the AgreementAs per…
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Arvinas and Pfizer Present Positive TACTIVE-U Sub-Study Data at SABCS 2024
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Partners Arvinas, Inc. (NASDAQ: ARVN) and Pfizer Inc. (NYSE: PFE) have jointly presented preliminary data from the ongoing Phase Ib portion of the TACTIVE-U sub-study at the 2024 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. The study assesses vepdegestrant in combination with Verzenios (abemaciclib) in patients with…
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Legend Biotech’s Carvykti Demonstrates High MRD Negativity Rates in Phase III CARTITUDE-4 Trial
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China-based Legend Biotech Corporation (NASDAQ: LEGN) has released new data on minimal residual disease (MRD) negativity rates from the Phase III CARTITUDE-4 trial at the 66th Annual American Society of Hematology (ASH) Annual Meeting. The trial compared Carvykti (ciltacabtagene autoleucel; cilta-cel) with the standard of care (SoC) in treating multiple…
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Jiangsu Hengrui Pharmaceuticals Secures NMPA Approvals for SHR-4394 and HRS-3802 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for its two drug candidates, SHR-4394 and HRS-3802. SHR-4394: A Novel Therapeutic Biologic for Prostate CancerSHR-4394 is an in-house developed therapeutic biologic product, with its target undisclosed, currently under…
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Merck’s PD-1 Inhibitor Keytruda Approved by NMPA for Cervical Cancer Treatment in China
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US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its PD-1 inhibitor Keytruda (pembrolizumab). The approval allows the use of Keytruda in combination with chemotherapy for International Federation of Obstetrics and Gynecology (FIGO) 2014 stage III-IVA cervical…
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Wuhan YZY Biopharma’s M701 Shows Promise in Phase II Study for Malignant Pleural Effusion at ESMO ASIA 2024
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China-based Wuhan YZY Biopharma Co., Ltd (HKG: 2496) has announced the presentation of results from a Phase II clinical study for its M701, a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, at the ESMO ASIA Congress 2024. The study focused on patients with malignant pleural effusion…
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Immunofoco’s IMC002 Earns FDA Fast-Track Designation for CLDN 18.2-Positive Gastric Cancer
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Immunofoco, a leading developer in tumor immunotherapy based in Suzhou, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its IMC002. This chimeric antigen receptor (CAR)-T therapy targets CLDN 18.2 and is intended for the treatment of patients with unresectable locally…
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Dizal Pharmaceutical Unveils Promising Data on DZD8586 for B-NHL at ASH Annual Meeting
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has presented new data from a pooled safety and efficacy analysis of DZD8586, a non-covalent blood-brain barrier (BBB) penetrant dual inhibitor targeting LYN and BTK, in patients with B-cell non-Hodgkin lymphoma (B-NHL) at the 66th American Society of Hematology (ASH) Annual Meeting. Clinical…
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Keymed Biosciences Presents CM336 Data for Relapsed Multiple Myeloma at ASH Annual Meeting
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China-based Keymed Biosciences Inc., (HKG: 2162) has announced the presentation of the latest data from the Phase I/II study for its bispecific antibody (BsAb) CM336, used for treating relapsed or refractory multiple myeloma (R/R M/M), at the 66th American Society of Hematology (ASH) Annual Meeting. Phase I/II Study Design and…
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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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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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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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Chipscreen Biosciences’ Chiauranib Phase III Trial Results for SCLC Announced
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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…
