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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its pipeline candidate LAE002 (afuresertib) in combination with fulvestrant. This new treatment regimen targets HR+/HER2- locally advanced or metastatic breast cancer. The multi-center, randomized,…
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Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a pivotal Phase III clinical study. The multi-center, randomized, double-blinded, placebo-controlled trial is designed to evaluate the efficacy of QX005N, a monoclonal antibody (mAb) targeting IL-4Rα for the…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II/III study for its Category 1 product candidate, jacktinib tablets. The study will focus on adolescent and adult patients suffering from non-segmental vitiligo.…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and HRS9531. SHR0302, a highly selective Janus kinase 1 (JAK1) inhibitor, has…
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Full-Life Technologies Ltd, a globally integrated radiotherapeutics company with a presence in Belgium, Germany, and China, has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its investigational drug ²²⁵Ac-FL-020 in patients with metastatic castration-resistant prostate cancer (mCRPC). ²²⁵Ac-FL-020 is a PSMA (prostate-specific…
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Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, SGC001. SGC001, a monoclonal antibody (mAb) co-developed with Capital Medical University, is intended for the emergency…
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Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its innovative drug candidate, SGC001. SGC001 is an investigational monoclonal antibody (mAb) co-developed with Capital Medical University, designed for the…
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate, 177LuLNC1010. This investigational therapy is a somatostatin receptor 2 (SSTR2) targeted radioactive drug designed for the…
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Kexing Pharmaceutical (SHA: 688136), based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study targeting childhood growth hormone deficiency. The clinical trial will investigate a Category I innovative product candidate, an Fc fusion protein designed as a long-acting growth hormone. This molecule…
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidates BAT6005 in combination with BAT1308 for the treatment of locally advanced or metastatic solid tumors. BAT6005…
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Roche (SWX: ROG)’s Genentech, a leading biotechnology company based in Switzerland, has received approval to initiate a clinical study in China for its Category 1 drug vixarelimab. The drug will be evaluated as a potential treatment for ulcerative colitis (UC). Vixarelimab is a selective, fully human monoclonal antibody that targets…
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NK CellTech, a Shanghai-based developer of natural killer (NK) cell therapies, has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its proprietary genetically modified NK-cell therapy. This marks a significant milestone as the company’s molecule is set to be assessed as a treatment…
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Laekna Therapeutics Shanghai Co., Ltd, a biopharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its drug combination LAE001 and LAE002 (afuresertib) in patients with metastatic castration-resistant prostate cancer (mCRPC) who…
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Changchun High & New Technology Industries (Group) Inc. (SHE: 000661), a leading biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 biologic product, jinnamab. This marks a significant milestone for the…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its investigational bispecific antibody-drug conjugate (ADC), BL-B01D1. This in-house developed molecule is designed to target locally advanced, recurrent, or metastatic HR+/HER2- breast cancer. The…
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company, has announced that the first patient has been dosed in a Phase I clinical study for JSKN016, its innovative antibody-drug conjugate (ADC) targeting both HER3 and TROP2 in patients with solid tumors. The open-label, multi-center Phase I study is designed to conduct a…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent Chinese pharmaceutical company, announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 product, SHR1905. This product is a hymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb) intended for…
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for timdarpacept (IMM01), the first SIRPαFc fusion protein targeting CD47 to be designed in China. The study will evaluate the safety and efficacy…
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Bayer AG (ETR: BAYN), a multinational pharmaceutical company based in Germany, has this week commenced an early-stage trial for its targeted radionuclide therapy, 225Ac-PSMA-Trillium. The trial is focused on treating advanced metastatic castration-resistant prostate cancer (mCRPC). This innovative therapeutic candidate incorporates a PSMA-targeting small molecule designed to deliver an alpha…
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China-based Roc Rock Biotechnology Co., Ltd. has announced that it has received ethical approval from the Medical Ethics Committee of the Affiliated Hospital of Xuzhou Medical University for its chimeric antigen receptor macrophages (CAR-M) therapy in the treatment of ovarian cancer. This marks a significant step forward for the company…