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Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Files for New Indication with China’s NMPA
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that the National Medical Products Administration (NMPA) in China has accepted for review another indication approval filing for its sacituzumab tirumotecan (SKB264/MK-2870). The new indication is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC)…
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Akeso Biopharma Initiates Phase III Clinical Trial for PD-1/VEGF Bispecific Antibody Combination
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China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first patient in a randomized, controlled, multicenter Phase III clinical study (AK117-302), assessing the combination of the innovative PD-1/VEGF bispecific antibody ivonescimab and its next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive…
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AbbVie Reports Q3 2024 Revenue Growth, Strength in Immunology and Neuroscience
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US pharmaceutical company AbbVie (NYSE: ABBV) has announced its financial results for the third quarter ended September 30, 2024, with net revenues of USD 14.46 billion, marking a 4.9% increase year-on-year at constant exchange rates. The US market contributed USD 11.148 billion in sales, while the International Market (excluding the…
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Shanghai Henlius and Organon Submit Biosimilar Application for Denosumab to FDA
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Shanghai Henlius Biotech Inc. (HKG: 2696) and its US partner Organon (NYSE: OGN) have jointly announced that the Biologic License Application (BLA) for HLX14, an investigational biosimilar of Amgen’s (NASDAQ: AMGN) Prolia/Xgeva (denosumab), has been accepted for review by the US Food and Drug Administration (FDA). Denosumab, a recombinant anti-RANKL…
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Pfizer Reports Strong Q3 Results, Boosts 2024 Guidance to $61-$64 Billion
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Pfizer Inc. (NYSE: PFE) released its Q3 2024 financial results, reporting revenues of $17.702 billion for the third quarter, a 32% year-on-year (YOY) increase at constant exchange rates. For the first nine months of the year, revenues totaled $45.864 billion, reflecting a 3% YOY growth. This strong performance has prompted…
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AIM Vaccine Secures NMPA Approval for mRNA Vaccine Targeting RSV
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AIM Vaccine Co., Ltd (HKG: 6660), based in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its mRNA vaccine targeting respiratory syncytial virus (RSV). RSV is a leading cause of mortality in infants under one year old and significantly contributes to respiratory infections and…
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Acotec Secures NMPA Approval for Acotrace Disposable Catheter Sheath
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Acotec Scientific Holdings Ltd (HKG: 6669), based in China, has received marketing approval from the National Medical Products Administration (NMPA) for its Acotrace, a disposable catheter sheath group. The Acotrace is designed for the insertion of medical devices, including guide wires and catheters, into blood vessels, facilitating percutaneous puncture access…
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Innovent’s Fortvita Stake Sale Sparks Controversy, Shares Plummet Nearly 13%
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Innovent Biologics, Inc. (HKG: 1801), headquartered in China, has announced a subscription agreement in which its wholly owned subsidiary Fortvita will sell a 20% stake to Lostrancos Ventures Ltd. for USD 20.5 million. This news has sparked market controversy, with some investors criticizing the valuation of Fortvita as being too…
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Sino Medical Reports Five-Year PIONEER Study Results for HT Supreme Stent System
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Sino Medical Sciences Technology Inc. (SHA: 688108), based in China, has announced the five-year follow-up results from the Phase III PIONEER study for its first-in-class HT Supreme drug-eluting stent system across the United States, Japan, and Europe. The HT Supreme system represents a significant milestone as the first cardiac stent…
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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…
