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China-based Livzon Pharmaceutical Group Inc. (HKG: 1513) has obtained approval from the National Medical Products Administration (NMPA) for its JP-1366 injection to conduct clinical studies in the treatment of peptic ulcer bleeding. This is a significant step forward for the company in the field of gastrointestinal therapeutics. About JP-1366JP-1366 is…
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China-based Degron Therapeutics, a developer of molecular glue-based drugs, announced that the U.S. Food and Drug Administration (FDA) has granted clinical clearance for DEG6498, its molecular glue degrader (MGD) targeting human antigen R (HuR). The drug will enter early-stage trials to assess its safety and efficacy in solid tumors. Drug…
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China’s Bio-Thera Solutions Ltd (SHA: 688177) has received clinical trial approval from the National Medical Products Administration (NMPA) for BAT1006, its recombinant humanized monoclonal antibody, in combination with trastuzumab and chemotherapy for HER2-positive unresectable or metastatic breast cancer patients previously treated with antibody-drug conjugates (ADCs). Drug ProfileBAT1006 targets the extracellular…
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA) has approved a clinical trial for its small molecule drug HLX99 in amyotrophic lateral sclerosis (ALS). The trial will assess the drug’s potential to treat this neurodegenerative disease through neuroprotective mechanisms. Drug ProfileHLX99 is an…
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing in a Phase II study of HLX43, its antibody-drug conjugate (ADC) targeting programmed death-ligand 1 (PD-L1), for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in China. The drug, designed for advanced/metastatic solid tumors, has no comparable approved products…
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China’s CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA) has approved clinical trials for its Category 1 chemical drug candidate SYH2039, a selective phosphodiesterase 4B (PDE4B) inhibitor, for advanced malignant tumors. The drug is also under study in China for interstitial lung diseases.…
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China-based Changchun GeneScience Pharmaceutical Co., Ltd announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its GenSci120 in rheumatoid arthritis (RA). The monoclonal antibody (mAb) was previously approved for studies in adult systemic lupus erythematosus, adult primary Sjogren’s syndrome, and inflammatory bowel…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its mRNA vaccine SYS6017. The trial will focus on herpes zoster, a painful condition caused by the reactivation of the varicella zoster virus (VZV).…
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for its BL-M07D1. The randomized, controlled trial will assess BL-M07D1 versus trastuzumab emtansine as a postoperative adjuvant treatment for HER2-positive breast cancer…
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II study assessing its polypeptide drug candidate RAY1225 in obese and overweight patients. This marks a significant step forward in the global development of…
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) is poised to initiate a clinical study for its interleukin-17 (IL-17) monoclonal antibody (mAb) HB0017 in hidradenitis suppurativa (HS) after receiving approval from the National Medical Products Administration (NMPA). This marks a significant step forward in the development of novel treatments for…
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China’s Hotgen Biotech Co., Ltd (SHA: 688068) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody (mAb) AA001. The drug is intended for the treatment of mild cognitive impairment caused by Alzheimer’s disease (AD) and mild to moderate AD. This…
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US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced the initiation of the pivotal Phase III waveLINE-010 study. This study is designed to assess zilovertamab vedotin, an investigational antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), in combination with rituximab plus cyclophosphamide, doxorubicin, and…
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China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III study assessing its Epidaza (chidamide) combined with CHOP in naive, peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH). This approval marks a significant step…
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Chinese partners Alphamab Oncology (HKG: 9966) and CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that they have received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for JSKN003 versus trastuzumab emtansine in HER2-positive advanced breast cancer. This approval marks a significant milestone in…
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Beijing-based gene therapy specialist Gene Cradle announced that it has received tacit clinical approval from the National Medical Products Administration (NMPA) for its GC310, an adeno-associated virus (AAV) gene therapy for hepatolenticular degeneration, also known as Wilson’s disease. This approval marks a significant step forward in the development of a…
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China-based Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HX044. This follows the initiation of a Phase I study for the CTLA-4 bispecific antibody (BsAb) in Australia. The approval marks a significant step in the global…
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Beijing-based cell therapy developer Likang Life Sciences announced that it has received approval from the US Food and Drug Administration (FDA) to conduct clinical trials for its LK101, an mRNA neoantigen vaccine. This marks a significant milestone in the development of personalized cancer treatments. Innovative Vaccine TechnologyLK101 is an innovative…
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China-based biotech Akeso Inc. (HKG: 9926) announced the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) assessing its PD-1/VEGF bispecific antibody (BsAb) ivonescimab. The trial compares ivonescimab combined with platinum-based chemotherapy to PD-1 inhibitor tislelizumab in combination with platinum-based chemotherapy in first-line squamous non-small cell lung…