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Novartis Secures FDA Accelerated Approval for Scemblix in Newly Diagnosed CML Patients
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Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that its drug Scemblix (asciminib) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). This accelerated approval is supported by the…
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MGI Tech Partners with OncoDNA to Enhance Precision Oncology Solutions
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MGI Tech Co., Ltd., (SHA: 688114) a China-based leader in gene sequencing, announced a strategic collaboration with Belgium’s OncoDNA, a company specializing in precision medicine for cancer and genetic diseases. The partnership integrates the OncoDEEP Kit’s comprehensive workflow—including sequencing, secondary analysis, and final interpretation of next-generation sequencing (NGS) data through…
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Mindray Reports Q3 2024 Financials: International Revenues Surge Over 18% Amid Domestic Challenges
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (SHE: 300760) reported its Q3 2024 financial results, revealing revenues of RMB 29.48 billion (USD 4.18 billion) for the first three quarters, reflecting a year-on-year increase of 7.99%. Net profit attributable to the parent company reached RMB 10.64 billion (USD 1.49 billion), up 8.16%…
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BeiGene CCO Yin Min Detained Amid Investigation; Company Affirms Compliance Standards
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On October 25, Yin Min, Chief Commercial Officer of BeiGene (NASDAQ: BGNE) Greater China, was taken into custody by regulatory authorities for cooperation with an ongoing investigation. Yin Min joined BeiGene in January 2022 after spending 15 years at AstraZeneca (AZ, NASDAQ: AZN), where she held several key positions, including…
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Biogen Partners with Neomorph to Develop Molecular Glue Degraders for Alzheimer’s and Rare Diseases
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U.S.-based Biogen Inc. (NASDAQ: BIIB) has announced a research collaboration with Neomorph to jointly develop molecular glue degraders targeting key areas in Alzheimer’s, rare neurological disorders, and immunological diseases. Leveraging Neomorph’s proprietary molecular glue discovery platform, the partnership aims to enhance the identification and validation of novel small-molecule therapeutic degraders…
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Yantai Dongcheng Pharma Secures FDA Fast-Track Designation for 177Lu-LNC1004 in Thyroid Cancer
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its investigational therapy, 177Lu-LNC1004, in patients with metastatic iodine-131 refractory differentiated thyroid cancer who have previously undergone treatment with at least one tyrosine kinase…
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Sunshine Guojian Pharmaceutical Secures NMPA Approval for Clinical Trials of SSGJ-626 in Lupus Indications
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA: 688336) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody, SSGJ-626. This BDCA2-targeted mAb will now enter trials for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), indications that have…
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Zai Lab Reports Positive Phase III Results for KarXT, Showcasing Efficacy in Psychiatric Conditions
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced encouraging topline results from its Phase III multi-center trial evaluating the safety and efficacy of KarXT (xanomeline and trospium chloride) within China. In line with prior global studies, this registrational bridging trial successfully met its primary endpoint, showing a…
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Sun-Novo Pharmaceuticals Gets Green Light for CAR-T Therapy Clinical Trial in Lupus Treatment
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Beijing Sun-Novo Pharmaceutical Research Co., Ltd. (SHA: 688621) has secured approval from China’s National Medical Products Administration (NMPA) to initiate clinical trials for ZM001, a CD19-targeted chimeric antigen receptor (CAR)-T therapy, in the treatment of systemic lupus erythematosus (SLE). The therapy, co-developed with Beijing-based gene therapy specialist Immunochina Pharmaceuticals, is…
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GSK Secures Global Rights to Chimagen Biosciences’ T Cell-Engager in $850 Million Deal
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UK pharmaceutical company GSK plc (NYSE: GSK) has entered into a licensing agreement with Chimagen Biosciences, securing all global rights to CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE). GSK will pay an upfront fee of USD 300 million and is committed to making success-based development and commercial…
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Fosun Pharmaceutical Reports Q3 2024 Revenue Growth and R&D Progress
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has released its financial report for the third quarter of 2024, highlighting overall revenues of RMB 30.912 billion (USD 4.33 billion) for the first three quarters, marking a 5.74% year-on-year (YOY) increase excluding COVID-19 related products. The company’s revenues for…
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Shanghai Pharmaceuticals Reports Q3 2024 Revenue Growth, Strengthens Drug Pipeline
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China’s Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) has announced its financial results for the third quarter of 2024, reporting a total revenue increase of 6.14% year-on-year (YOY) to RMB 209.629 billion (USD 29.42 billion). The pharmaceutical industry and pharmaceutical business segments achieved sales of RMB 18.284 billion (USD 2.56…
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Innovent Biologics’ Picankibart Shows 64.6% Skin Clearance in Phase II Psoriasis Study
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced encouraging results from the multi-center, open Phase II study of its picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection. The study focused on psoriasis patients with a poor response to prior biologic treatments, primarily IL-17 antibodies. After 16 weeks of treatment…
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Livzon Pharmaceutical’s Leuprorelin Acetate Microspheres Passes China’s GQCE
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China’s Livzon Pharmaceutical Group Inc., (HKG: 1513, SHE: 000513) has announced that its leuprorelin acetate microspheres for injection have successfully passed the generic quality consistency evaluation (GQCE) in China. Leuprolide, a gonadotropin-releasing hormone (GnRH) receptor agonist, is utilized in the treatment of prostate cancer and endometriosis. Originally developed by Japan’s…
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Xi’an Xintong Pharma’s Pradefavir Wins NMPA Nod for Chronic Hepatitis B Treatment
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The National Medical Products Administration (NMPA) has granted market approval for pradefavir, a Category 1 drug developed by Xi’an Xintong Pharmaceutical Research Co., Ltd., for the treatment of adult chronic hepatitis B virus (HBV) infection under the trade name XinShuMu. Pradefavir, a nucleoside liver-targeting drug, functions by inhibiting HBV DNA…
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Eli Lilly’s Mounjaro Approved in Hong Kong for Obesity and Type 2 Diabetes Treatment
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Eli Lilly & Co. (NYSE: LLY) has received market approval from Hong Kong’s Department of Health for its Mounjaro (tirzepatide) in KwikPen presentation, marking a significant step in the treatment of weight management and type 2 diabetes. Mounjaro is indicated for adults with obesity (BMI of 30 kg/m^2 or greater)…
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Clover Biopharmaceuticals Reports Strong Phase I Results for RSV Vaccine SCB-1019
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China-based Clover Biopharmaceuticals Ltd. (HKG: 2197) has announced encouraging additional immunogenicity and safety data from its Phase I trial of SCB-1019, a non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate. The trial assessed SCB-1019 against GSK (NYSE: GSK)’s AS01E-adjuvanted RSV vaccine, Arexvy, in elderly subjects. In the ongoing Phase…
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Merck and Moderna Launch Phase III Study for Individualized Neoantigen Therapy in Lung Cancer
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US pharmaceutical companies Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) and Moderna Inc. (NASDAQ: MRNA) have initiated the Phase III INTerpath-009 study to evaluate V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab). The study will focus on patients with resectable Stage…
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Merck’s Keytruda Gains Two Additional EU Indications for Gynecologic Cancer Treatment
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Merck, Sharp & Dohme Inc., known as MSD (NYSE: MRK), has received two additional indication approvals from the European Union for its immunotherapy drug Keytruda (pembrolizumab), increasing the total number of approved uses in the region to 30. The PD-1 inhibitor is now approved for use in combination with carboplatin…
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WuXi AppTec Reports Q3 2024 Revenues of RMB 10.46 Billion Amid Biosecure Act Challenges
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WuXi AppTec Co., Ltd (SHA: 603259), the China-based Contract Development and Manufacturing Organization (CDMO) facing potential restrictions under the Biosecure Act—set to ban drugmakers with U.S. government contracts from utilizing Chinese services post-2032—reported its financial results for the first three quarters of 2024. In the third quarter, revenues reached RMB…
