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Junshi Biosciences Gets Green Light for Global Phase III Study of Tifcemalimab Combination Therapy in LS-SCLC
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877), a leading biotech company based in China, has received approval from the Pharmaceuticals and Medical Devices Agency of Japan to initiate a global multi-center Phase III study. The study will be a randomized, double-blind, placebo-controlled trial investigating the combination of tifcemalimab (TAB004/JS004) and…
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Bristol Myers Squibb’s Krazati Trial Yields Positive Phase III Results in NSCLC
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Last week, Bristol Myers Squibb (BMS; NYSE: BMY) unveiled preliminary results from a Phase III confirmatory trial for its KRAS inhibitor Krazati (adagrasib) in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying a KRASG12C mutation. This encouraging data reinforces BMS’s strategic 2023 acquisition of original…
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AstraZeneca’s AKT Inhibitor Truqap Approved in Japan for HR+, HER2- Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, has registered with Japan’s Ministry of Health, Labour, and Welfare (MHLW) its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with endocrine therapy Faslodex (fulvestrant). This combination therapy is intended for the treatment of unresectable or recurrent PIK3CA-, AKT1-, or PTEN-altered HR-positive, HER2-negative…
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Gilead Strikes Deal with Xilio Therapeutics for Tumor-Activated IL-12 Candidate
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Gilead Sciences (NASDAQ: GILD) has announced an in-licensing agreement with fellow US biotechnology company Xilio Therapeutics (NASDAQ: XLO) to acquire an early-stage tumor-activated interleukin 12 (IL-12) for the treatment of solid tumors. Gilead will pay an initial sum of USD 43.5 million for the exclusive development and global commercialization rights…
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Jiangsu Hengrui’s SHR-A1921 Earns FDA Fast-Track Status for Platinum-Resistant Ovarian Cancer Therapies
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a distinguished pharmaceutical entity, has announced that it has been granted Fast-Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for its proprietary antibody-drug conjugate (ADC), SHR-A1921. This designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube…
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IASO Biotherapeutics Gets NMPA Go-Ahead for BCMA-Targeted CAR-T Therapy Clinical Trial
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IASO Biotherapeutics, a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidate CT103A, known as equecabtagene autoleucel. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR) T cell therapy designed for patients…
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Genor Biopharma’s Lerociclib Accepted for Review by China’s NMPA for Breast Cancer Treatment
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China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced that the market filing for its cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, lerociclib (GB491), has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for the treatment of hormone receptor (HR) positive, human epidermal…
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BeiGene and GenFleet Join Forces for DLBCL Trial Combining Brukinsa and GFH009
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a China-based biotechnology company, has entered into a clinical research and drug supply cooperation agreement with fellow Chinese firm GenFleet Therapeutics. The partnership will kick off a Phase Ib/II clinical trial to evaluate the safety and efficacy of a combination regimen featuring…
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HutchMed’s Orpathys Files for Expanded Indication in NSCLC Treatment in China
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that the National Medical Products Administration (NMPA) in China is currently reviewing a new market approval filing for Orpathys (savolitinib), a MET inhibitor co-developed with AstraZeneca. The company is seeking a new indication for the drug as a first-line treatment for…
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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…
