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Huadong Medicine Gets NMPA Green Light for Clinical Study of Ryzodeg Biosimilar
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its biosimilar version of Novo Nordisk’s (NYSE: NVO) Ryzodeg (insulin degludec, insulin aspart), intended for the treatment of adults with type 2 diabetes.…
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Bio-Thera Solutions Gets NMPA Green Light for PD-1 Inhibitor BAT1308 in Endometrial Cancer
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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) in China to initiate a clinical study for its programmed death-1 (PD-1) inhibitor, BAT1308, in the treatment of endometrial cancer. BAT1308 is an internally developed…
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3D Medicines Initiates Phase III Trial for Envafolimab in NSCLC Patient
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3D Medicines (HKG: 1244), a China-based oncology specialist, has announced the enrollment of the first patient in a Phase III clinical study for its PD-L1 monoclonal antibody (mAb), envafolimab. The randomized, controlled, double-blinded, multi-center trial will evaluate envafolimab in combination with chemotherapy as a neoadjuvant/adjuvant therapy for patients with resectable…
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China Medical System Gets NMPA Green Light for Phase III Vitiligo Study with Ruxolitinib Cream
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for its Opzelura (ruxolitinib) cream for the treatment of non-segmental vitiligo. Opzelura, a topical Janus kinase (JAK) inhibitor, was approved in the…
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Clover Biopharmaceuticals Commences Phase I Trial for RSV Vaccine in Australia
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced the successful enrollment of the first batch of subjects in a Phase I clinical study in Australia for its pipeline candidate, SCB-1019, a respiratory syncytial virus (RSV) PreF trimeric subunit candidate vaccine. The randomized, placebo-controlled Phase I study aims to assess the…
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HutchMed’s Elunate-Tyvyt Combination Study for Renal Cell Carcinoma Completes Enrollment
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China-based HutchMed (NASDAQ: HCM) has announced the completion of patient enrollment in its Phase II/III clinical study for Elunate (fruquintinib) in combination with Tyvyt (sintilimab) for the treatment of second-line locally advanced or metastatic renal cell carcinoma (RCC). The randomized, open-label controlled study aims to compare the efficacy and safety…
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BMS Advances TIGITxCD96 Bispecific Antibody into Phase II Dose Expansion
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Bristol Myers Squibb (BMS; NYSE: BMY) has advanced its development program for the TIGITxCD96 bispecific antibody (BsAb) BMS-986442 into a Phase II dose expansion trial. The candidate was licensed from Agenus (NASDAQ: AGEN) in 2021, and as part of the agreement, Agenus will receive a USD 25 million cash payment,…
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Staidson Pharmaceutical Initiates Clinical Study for ARDS Treatment STSA-1002
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a Chinese pharmaceutical company, has announced the dosing of the first patient in a Phase Ib/II clinical study for its injectable STSA-1002, an anti-human complement protein C5a (hC5a) monoclonal antibody (mAb). The drug candidate is under evaluation as a potential treatment for acute…
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Skyline Therapeutics’ Gene Therapy SKG0201 for SMA Gets Green Light from China’s NMPA
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Skyline Therapeutics has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its proprietary AAV gene therapy, SKG0201 injection, which is being developed as a treatment for type I spinal muscular atrophy (SMA). SKG0201 is an SMN1 gene replacement therapy that is administered through a single intravenous…
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Chinese Biotech Precision Biotechnology Gets NMPA Green Light for Advanced Cancer Therapies
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Chongqing Precision Biotechnology Co., Ltd, a Chinese biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for C-13-60 cell preparations as a local treatment in the abdominal cavity for CEA+ advanced malignant tumors, including a range of cancers such as colorectal, esophageal, gastric,…
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Mabwell Secures NMPA Approval for Phase III Study of ADC 9MW2821 in Urothelial Carcinoma
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Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III clinical study for its antibody-drug conjugate (ADC), 9MW2821, which targets Nectin-4. The randomized, open-label, controlled, multi-center Phase III trial aims to evaluate the efficacy…
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Changchun BCHT Secures NMPA Approval for Freeze-Dried Human Rabies Vaccine Trials
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Changchun BCHT Biotechnology Co., Ltd. (SHA: 688276), based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its freeze-dried human rabies vaccine, developed using human diploid/MRC-5 cells. This innovative vaccine utilizes human diploid cells, which are widely recognized in international…
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Shanghai Pharmaceuticals Gains NMPA Approval for WST04 Clinical Trials in Oncology
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607), a leading pharmaceutical distribution company in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its oral probiotic preparation, WST04, aimed at treating advanced malignant solid tumors. Preclinical studies indicate that WST04 significantly enhances the anti-tumor efficacy of…
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Ascletis Pharma’s Denifanstat Advances to Phase III for Severe Acne Vulgaris Treatment
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Ascletis Pharma Inc., (HKG: 1672) a China-based biotechnology company, has announced the commencement of a Phase III trial for its drug candidate denifanstat (ASC40), intended to assess its efficacy in treating severe acne vulgaris. The trial, a randomized, double-blind, placebo-controlled, and multi-center study, will be conducted at hospitals across China,…
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Yantai Dongcheng Pharmaceutical Gets NMPA Green Light for FAP-Targeting Radiotherapeutic Drug
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to proceed with a clinical study for its radiotherapeutic drug, 177Lu-LNC1004, which targets advanced solid tumors. The drug is designed to treat fibroblast activation protein (FAP)-positive…
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Simcere Pharmaceutical’s SIM0501 Receives FDA Approval for Advanced Solid Tumor Clinical Trial
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Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its cancer drug candidate SIM0501, which targets advanced solid tumors. The company’s clinical filing was previously accepted for review by China’s National Medical Products Administration (NMPA) in…
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Worg Pharmaceuticals Gets FDA Approval for Phase II Graves’ Disease Study
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Worg Pharmaceuticals, a Hangzhou-based developer of allergic drugs, has received the green light from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its drug candidate WP1302 in the treatment of Graves’ disease. Graves’ disease, a prevalent autoimmune condition, impacts an estimated 10…
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CARsgen Therapeutics Secures U.S. FDA Approval for CT071 Clinical Trials in Multiple Myeloma
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), based in China, has announced that it has received clinical trial approval from the U.S. FDA for its chimeric antigen receptor (CAR)-T cell product, CT071, aimed at treating recurrent/refractory multiple myeloma (R/R MM) and primary plasma cell leukemia (PCL). CT071 is developed using the…
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TG ImmunoPharma Secures U.S. FDA IND Approval for Promising mAb TGI-5 Targeting Multiple Cancers
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TG ImmunoPharma Co., Ltd, based in China, has announced that it has received Investigational New Drug (IND) approval from the U.S. FDA for its proprietary monoclonal antibody (mAb), TGI-5. While the specific target of this molecule remains undisclosed, the company claims it could be a potential global first-in-class treatment. TGI-5…
