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Astellas Pharma’s Padcev Combo Therapy Accepted for Review in China for Urothelial Carcinoma
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that China’s Center for Drug Evaluation (CDE) has accepted for review a supplementary Biologic License Application (sBLA) for its drug Padcev (enfortumab vedotin). The application seeks to expand the use of Padcev in combination with pembrolizumab for the…
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Zai Lab and Novocure Report Positive Phase III Results for TTFields in NSCLC Brain Metastases
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Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, and Novocure (Nasdaq: NVCR), a UK-based oncology innovator, have announced positive results from the Phase III METIS trial. The trial evaluated the efficacy of the Tumor Treating Fields (TTFields) therapeutic device in combination with supportive care for…
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Jiangsu Hengrui Receives NMPA Approval for SHR-7631 ADC Clinical Study in Solid Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 antibody drug conjugate (ADC), SHR-7631, in patients with advanced solid tumors. While the…
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Wuhan YZY Biopharma Initiates Phase II Study for M701 in Malignant Pleural Effusion Treatment
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its investigational drug M701. M701 is a recombinant anti-EpCAM and CD3 human murine chimeric bispecific antibody (BsAb) injection, currently under assessment as…
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Innovent Biologics Initiates Phase III Neoshot Study for MSI-H/dMMR Colon Cancer Treatment
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced the first subject dosing in the randomized, multi-center Phase III Neoshot study for its anti-CTLA-4 monoclonal antibody IBI310. The study combines IBI310 with the PD-1 inhibitor sintilimab as a neoadjuvant treatment for patients with resectable MSI-H/dMMR…
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Nuvation Bio to Acquire AnHeart Therapeutics in All-Stock Deal Amid Biotech Pressures
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U.S.-based biotech Nuvation Bio Inc. (NYSE: NUVB) has announced a definitive agreement to acquire China-based AnHeart Therapeutics Inc. in an all-stock transaction, which has received approval from the boards of both companies. The deal is contingent upon approval from AnHeart’s shareholders and is anticipated to close in the second quarter…
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FDA Grants Full Approval to AbbVie’s Elahere for Advanced Ovarian Cancer Treatment
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This week, the U.S. Food and Drug Administration (FDA) granted full approval to AbbVie’s (NYSE: ABBV) antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer following up to three prior therapies. This approval marks an upgrade from the 2022…
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Zylox-Tonbridge Secures NMPA Approval for Advanced Flow Diverter Targeting Intracranial Aneurysms
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Zylox-Tonbridge Medical Technology (HKG: 2190), a China-based developer of nerve and peripheral vascular interventional devices, has secured marketing approval from the National Medical Products Administration (NMPA) for its flow diverter (FD). This device represents a significant advancement in the treatment of intracranial aneurysms, particularly large and giant aneurysms. Notably, this…
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MSD’s Phase III Trial of Keytruda Plus Lynparza Misses Primary Endpoints in NSCLC
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced an unfavorable outcome for a Phase III trial combining Keytruda (pembrolizumab) and Lynparza (olaparib) in the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC). The study, which aimed to evaluate the efficacy of this combination therapy, was halted after…
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Shanghai Institute’s Biosimilar Rituximab Approved by NMPA for Lymphoma Treatments
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Shanghai Institute of Biological Products Co., Ltd has announced that its biosimilar version of Roche/Genentech’s Mabthera (rituximab) has received approval from the National Medical Products Administration (NMPA) for the treatment of Non-Hodgkin’s lymphoma, including follicular non-Hodgkin’s lymphoma and CD20 positive diffuse large B-cell non-Hodgkin’s lymphoma, as well as chronic lymphoblastic…
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Roche Invests EUR 90 Million in New Gene Therapy Center in Germany
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Swiss pharmaceutical giant Roche (SWX: RO) has inaugurated a new gene therapy development center in Germany, following an investment of EUR 90 million (USD 97.4 million). The expansive 2,500 square meter facility is designed to specialize in the production of gene vectors for clinical trials across various therapeutic areas, including…
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Grand Pharma Receives NMPA Approval for Global Phase III Study of RDC ITM-11 in GEP-NETs
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Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the COMPOSE study. This is a prospective, randomized, controlled, open-label, global multi-center Phase III study designed to assess the efficacy, safety,…
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NeuExcell Therapeutics Doses First Patient in Groundbreaking Clinical Trial for NeuroD1 Gene Therapy
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NeuExcell Therapeutics, a Shanghai-based developer of in vivo neural regenerative therapies, has announced the first patient dosing in a clinical trial for its first-in-class (FIC) NeuroD1 gene therapy product, NXL-004, targeting malignant glioma. This marks NXL-004 as the world’s first gene therapy of its kind to enter the clinical setting.…
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FDA Grants Accelerated Approval for Takeda’s Iclusig in Newly Diagnosed Ph+ ALL
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The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan’s Takeda Pharmaceutical Company (TYO: 4502) for its tyrosine kinase inhibitor (TKI) Iclusig (ponatinib) in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This follows the drug’s previous…
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Bayer and Thermo Fisher Partner to Develop Rapid Companion Diagnostics for Precision Oncology
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Germany’s Bayer (NYSE: BAYE) has entered into a strategic partnership with U.S. life sciences leader Thermo Fisher Scientific (NYSE: TMO) to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx) aimed at enhancing precision cancer therapies. Financial terms of the collaboration remain undisclosed. According to the press release, the diagnostic tests…
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BMS Reports Positive Phase III Results for Opdivo and Yervoy in Advanced HCC
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Bristol Myers Squibb (BMS; NYSE: BMY) announced this week that its Phase III study evaluating the combination of anti-PD-1 drug Opdivo (nivolumab) and anti-CTLA-4 biologic Yervoy (ipilimumab) as a first-line treatment for advanced hepatocellular carcinoma (HCC) has yielded promising top-line results. According to data from a pre-specified interim analysis, the…
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Antengene’s ATG-022 Advances to Dose Expansion Phase in Phase II CLINCH Study for Solid Tumors
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Antengene Corporation Ltd (HKG: 6996), a leading biopharmaceutical company based in China, has announced that ATG-022, an antibody drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), has progressed into the dosage expansion phase of the Phase II CLINCH study. This trial is evaluating ATG-022 as a monotherapy for advanced or metastatic…
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CSPC Pharmaceutical Secures NMPA Approval for Clinical Study of SYS6023 in Advanced Solid Tumors
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent China-based biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody drug conjugate (ADC) SYS6023 in patients with advanced solid tumors. SYS6023 is designed to target specific receptors on tumor surfaces, allowing…
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Jiangsu Hengrui Receives NMPA Approval for Phase Ib/II Study of HRS2398 in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II study. The study will assess the drug candidate HRS2398 in combination with HRS-1167 or adebrelimab…
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CSPC Pharmaceutical Gets NMPA Greenlight for SYH2039 Clinical Study in Advanced Malignant Tumors
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 chemical drug candidate, SYH2039, which targets advanced malignant tumors. SYH2039 is a potent inhibitor of methionine adenosine…
