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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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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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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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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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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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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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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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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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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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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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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 (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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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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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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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…
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Shanghai-based biopharmaceutical company LianBio (OTCMKTS: LIANY) has announced the first patient dosing in a Phase III LIBRA study for its TP-03, targeting demodectic blepharitis in Chinese patients. This marks a significant step forward in addressing a prevalent eye disease in the region. Understanding Demodectic BlepharitisDemodectic blepharitis is a common eye…
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that the Investigational New Drug (IND) application for ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19, has been filed with the US FDA following a pre-IND consultation. This marks a significant step forward in the development of…
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has released data from a Phase II clinical study for its novel fusion protein telitacicept in Chinese patients with myasthenia gravis (MG), showing positive results. The study demonstrated significant improvements in patient conditions and good safety profiles. Study Design and ResultsThe multicenter,…
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Antengene Corporation has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its ATG-017, an extracellular regulated protein kinase 1/2 (ERK1/2) inhibitor. The Shanghai-based biotech company will commence the joint part of the Phase I ETASER study, assessing the safety,…
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that the Phase Ib clinical study (NCT05000671) for its drug candidate STC3141 in acute respiratory distress syndrome (ARDS) has reached its primary endpoint. This marks a significant step forward in the development of the drug for this critical condition. Phase Ib…