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CORXEL Gets CDE Green Light for Phase III Aficamten Study in nHCM
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CORXEL, formerly known as Ji Xing Pharmaceuticals, a China-based pharmaceutical company, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct the Phase III ACACIA-HCM study for its drug aficamten (CK-3773274) in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) in China. Aficamten, a next-generation cardiac myosin…
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Simcere Pharmaceutical Gets NMPA Approval for Clinical Study of Trispecific Antibody SIM0500
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SIM0500, a trispecific antibody targeting GPRC5D, BCMA, and CD3. This molecule is intended for the treatment of recurrent or…
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Fosun Pharmaceutical Gets NMPA Green Light for Phase I Study of Fibrosis Drug HLX6018
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its drug candidate HLX6018. This investigational compound is a GARP/TGF-β1 compound…
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Sinocelltech Gains NMPA Approval for Clinical Study of SCTB35 in B-Cell Non-Hodgkin’s Lymphoma
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Sinocelltech Group Ltd (SHA: 688520), based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational bispecific antibody (BsAb), SCTB35. This novel molecule targets both CD20 and CD3 and is being evaluated as a treatment for…
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Huadong Medicine Secures NMPA Approval for HDM1005, Targeting Type 2 Diabetes and Obesity
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Huadong Medicine Co., Ltd (SHE: 000963), based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HDM1005. This long-acting agonist targets both the GLP-1 and GIP receptors and is being developed for the treatment of type 2…
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Simcere Secures FDA Approval for Clinical Study of Trispecific Antibody SIM0500 in Multiple Myeloma
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Simcere Pharmaceutical Group (HKG: 2096), based in China, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its trispecific antibody, SIM0500, which targets GPRC5D, BCMA, and CD3. This innovative molecule is being evaluated as a treatment for recurrent or refractory multiple myeloma…
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Shanghai Fosun Pharma Gets NMPA Green Light for Universal NK Cell Therapy GCK-01 Clinical Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its universal NK cell therapy, GCK-01. This Category 1 innovative therapeutic…
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Shanghai Fosun Pharma Gets NMPA Green Light for XS-02 Solid Tumor Clinical Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate XS-02 in patients with advanced solid tumors. XS-02 is a…
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Shanghai RAAS Receives NMPA Approval to Initiate Clinical Trial for Hemophilia Preventive Treatment
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Shanghai RAAS (SHE: 002252), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical study for SR604. The drug candidate is intended as a preventive treatment for bleeding episodes in patients with hemophilia and…
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Bio-Thera Solutions Receives NMPA Approval for Three Cancer Treatments Including a Novel ADC
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for three of its drug candidates. These include BAT8010 in combination with BAT1006 for the treatment of locally advanced or metastatic solid tumors, as well as BAT7205 as…
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Luye Pharma Initiates Phase III Clinical Trial for Irinotecan Liposome Injection in Small-Cell Lung Cancer
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the enrollment of the first patient in a Phase III clinical study for its irinotecan liposome injection, LY01610. The Phase III study, which is multi-center, randomized, open-label, and parallel-designed, aims to evaluate the efficacy and safety of LY01610 in…
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Hengrui Pharmaceuticals Gets NMPA Green Light for KRAS G12C Inhibitor Clinical Trial in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for HRS-7058, an innovative and selective drug candidate, in patients with advanced solid tumors harboring the KRAS G12C mutation. This development marks a significant step for Hengrui Pharmaceuticals…
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HitGen Secures CDE Approval for Lipisense IND Filing, Advancing Development for Dyslipidemia Treatment
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HitGen Inc., (SHA: 688222) a China-based pharmaceutical company, has announced that the Investigational New Drug (IND) filing for its Lipisense (A24110He for injection) has received approval from China’s Center for Drug Evaluation (CDE). Lipisense, an innovative antisense oligonucleotide (ASO) drug originally developed by Swiss firm Lipigon Pharmaceuticals AB, is designed…
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AIM Vaccine Advances Pneumococcal Vaccine and Initiates Phase II Meningococcal Study
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AIM Vaccine Co., Ltd (HKG: 6660) has delivered a series of updates on the development progress of its vaccine candidates. The company has submitted a preliminary market filing for its 13-valent pneumococcal conjugate vaccine, designed to prevent invasive diseases caused by 13 pneumococcal serotypes, including bacteremic pneumonia, meningitis, sepsis, and…
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Shanghai Fosun Pharma’s GCK-01 CAR-NK Cell Therapy Gets Tacit Clinical Approval from China’s CDE
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The China Center for Drug Evaluation (CDE) website has indicated that Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), has received tacit approval for a Category 1 biologic preparation, GCK-01, to proceed with clinical trials. The therapeutic candidate is intended for the treatment of recurrent or refractory follicular…
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Astellas Launches Late-Stage Trial in Japan for Nonhormonal Menopause Treatment
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, last week initiated a late-stage trial in Japan for fezolinetant, a neurokinin B (NKB) blocker, as a potential treatment for vasomotor symptoms (VMS) associated with menopause in women. This placebo-controlled study aims to evaluate the efficacy and safety of the…
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Fosun Pharmaceutical Secures NMPA Approval for Phase II Study of FCN-338 and FCN-647 in Chronic Lymphocytic Leukemia
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its Bcl-2 inhibitor FCN-338 in combination with the BTK inhibitor FCN-647, targeting chronic lymphocytic leukemia/small lymphocytic lymphoma. FCN-338…
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Jiangsu Hengrui Receives NMPA Approval for HRS-1167 Clinical Trials in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276) has secured clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy HRS-1167, which will be evaluated in combination with SHR-A1921, bevacizumab, or abiraterone plus prednisone/prednisolone for the treatment of advanced solid tumors. HRS-1167 is a second-generation PARP inhibitor…
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Jenscare Scientific Achieves Milestone with First LuX-Valve Plus Implantation in Brazil
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Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer headquartered in Ningbo, China, has announced the successful completion of the first clinical implantation surgery using its transjugular tricuspid valve replacement product, LuX-Valve Plus, in Brazil. This milestone marks a significant advancement for the company in the…
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AstraZeneca’s AZD0486 Receives NMPA Greenlight for Clinical Study in B-Cell Leukemia
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AstraZeneca (NASDAQ: AZN), a leading UK pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its drug candidate AZD0486 (TNB-486) in patients with recurrent or refractory B-cell acute lymphoblastic leukemia. AZD0486 is a bispecific antibody (BsAb) that targets both…
