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Qilu Regor’s RGT-264 Phosphate Tablets Approved for Phase I Study
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China-based biotech Qilu Regor Therapeutics Inc has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I study. The study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of its RGT-264 phosphate tablets in patients with advanced solid tumors. RGT-264 ProfileRGT-264 is a…
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Reforgene Medicine RM-001 Thalassemia Gene Editing
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China-based Guangzhou Reforgene Medicine Co., Ltd’s in-house developed β-thalassemia gene editing drug RM-001 (HBG gene modified autologous CD34+ hematopoietic stem cell injection) has obtained tacit clinical trial approval from the National Medical Products Administration (NMPA). This marks a significant milestone for the first thalassemia gene editing novel drug program in…
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Walvax Biotech Launches Phase IIIb Trial for mRNA COVID-19 Vaccine
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the initiation of a Phase IIIb clinical study with ethics approval. The study is designed to assess the immunogenicity and safety of its “novel coronavirus variant mRNA vaccine” (S protein chimera) in individuals aged 18 and above who have completed three…
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Guangdong Zhongsheng Initiates Phase III Study for RAY1216 in COVID-19
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the initiation of a randomized, double-blind, placebo-controlled Phase III study with ethics approval for its RAY1216 in mild and common SARS-CoV-2 infection. The study is expected to enroll 1,070 patients with mild and common COVID-19 infection, using placebo as the…
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Ascentage Pharma Announces Clinical Advances for Olverembatinib at ASH
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Suzhou-based Ascentage Pharma (HKG: 6855) announced the latest clinical development of its olverembatinib (HQP1351), a third-generation BCR-ABL-targeted tyrosine kinase inhibitor (TKI), Bcl-2 inhibitor lisaftoclax (APG-2575), and MDM2-p53 inhibitor alrizomadlin (APG115) at the 64th American Society of Hematology (ASH) annual meeting this year. Olverembatinib in CML and Ph+ALLOlverembatinib can overcome drug…
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Abbisko Enrolls First Patient in Phase II Study for ABSK091 in Urothelial Carcinoma
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China-based Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the enrollment of the first patient in a Phase II clinical study for its investigational pan-FGFR inhibitor ABSK091, in combination with BeiGene Ltd’s anti-PD-1 antibody tislelizumab, for the treatment of urothelial carcinoma (UC). This marks the first clinical combination trial of…
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Blue Shield Pharma’s LD013 CAR-T Therapy Approved for Clinical Trials
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China-based Blue Shield Biotech’s in-house developed LD013, an autologous chimeric antigen receptor (CAR)-T cell therapy, has obtained clinical trial approval from the National Medical Products Administration (NMPA). The intended indication is recurrent refractory ovarian cancer, a condition that poses significant challenges in treatment and management. Mesothelin as a TargetMesothelin (MSLN)…
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Akeso Biopharma Completes Enrollment for AK112 Phase III Study
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China-based Akeso Biopharma (HKG: 9926) has announced the completion of enrollment for its Phase III study of AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). The study aims to assess the drug in combination with chemotherapy for locally advanced or metastatic non-squamous non-small…
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Eccogene Gains FDA Approval for Phase I Study of ECC5004
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Shanghai-based Eccogene has announced receiving approval from the US FDA to initiate a Phase I clinical study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of ECC5004, a glucagon-like peptide 1 receptor agonist (GLP-1 RA) targeting type 2 diabetes mellitus (T2DM), in healthy participants and subjects with T2DM. GLP-1 Mechanism and…
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BeiGene’s Brukinsa Receives EU Marketing Approval for Marginal Zone Lymphoma
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China-based biotech BeiGene Inc. (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced receiving marketing approval from the European Committee (EC) for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The drug is now approved in the EU for the treatment of relapsed/refractory (R/R) marginal zone lymphoma (MZL) in patients who have…
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Antengene’s CD73 Inhibitor ATG-037 Greenlit for Phase I Study by NMPA
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China-based Antengene Corporation Limited (HKG: 6996) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I study assessing its ATG-037, a small molecule inhibitor of CD73, in patients with locally advanced or metastatic solid tumors. This marks a significant step forward in the development…
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Hengrui’s Pyrotinib Granted Breakthrough Therapy Designation by CDE
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The Center for Drug Evaluation (CDE) website indicates that China-based Hengrui Medicine Co., Ltd’s (SHA: 600276) pyrotinib has been granted breakthrough therapy designation (BTD) status for use in combination with trastuzumab plus docetaxel in recurrent or metastatic breast cancer that is human epidermal growth factor receptor 2 (HER2) positive in…
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NMPA Approves Humanwell’s Generic Clobazam for Lennox-Gastaut Syndrome
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China-based Yichang Humanwell Pharmaceutical Co., Ltd’s generic version (oral suspension) of Sanofi’s clobazam (trade name: Frisium) has been approved by the National Medical Products Administration (NMPA) to be assessed in a clinical study as a combination therapy for seizures in patients with Lennox-Gastaut syndrome (LGS) two years of age and…
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NMPA Approves Luye Pharma’s LY03005 for Depression Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that its Category 1 chemical drug LY03005 has been approved by the National Medical Products Administration (NMPA) for the treatment of depression. This marks a significant milestone in the company’s efforts to address the growing need for effective depression treatments. LY03005 ProfileLY03005…
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Shanghai SMPA Suspends HEC’s Linagliptin Procurement Over Patent Infringement
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The Shanghai Sunshine Medical Procurement All-in-One (SMPA) platform has revealed that it has suspended the procurement qualifications for HEC Group’s linagliptin (5mg × 7 boxes). HEC’s product is a generic version of German major Boehringer Ingelheim’s (BI) Trajenta. The decision was taken to ensure that intellectual property (IP) rights are…
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Shanghai Pharmaceuticals Gets NMPA Clearance for Sublingual Rasagiline
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Shanghai Pharmaceuticals (HKG: 2607, SHA: 601607) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its rasagiline (sublingual delivery) to treat primary Parkinson’s disease (PD) as a monotherapy and patients with drug end fluctuation combined with levodopa. This marks a significant step forward in the development…
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Eli Lilly’s Peresolimab and LOXO-783 Gain Tacit Clinical Trial Approvals in China
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The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approvals to two investigational drugs from US-based Eli Lilly (NYSE: LLY): peresolimab, a PD-1 agonist, and LOXO-783, a PI3Kα H1047R inhibitor. These approvals pave the way for further clinical development of the drugs in China. Peresolimab: Targeting…
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Hua Medicine Launches Dorzagliatin, a First-in-Class Diabetes Drug, in China
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China-based Hua Medicine has announced the commercial launch of its Category 1 drug, dorzagliatin, with the first prescription issued in Shanghai. Priced at RMB 420 (USD 59.00) per box, the drug is now available in pharmacies across multiple locations in China. This marks a significant milestone for the company and…
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Yiming and Vitalgen’s Gene Therapy VGR-R01 Receives CDE Approval for Bietti Crystalline Dystrophy
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China-based Yiming (Beijing) Cell Biotechnology Co., Ltd (also known as Ubrigene) and its partner Shanghai Vitalgen Biomed Co., Ltd have received tacit clinical trial approval from the Center for Drug Evaluation (CDE) for their in-house developed gene therapy drug VGR-R01. This marks the second gene therapy from the company to…
