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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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Dartsbio Licenses Potential First-in-Class BsAb DS005 to Duality Biologics
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China-based Dartsbio Pharmaceuticals, Ltd has announced a licensing deal with Duality Biologics, a novel modality drug developer operating out of the United States and China. The agreement grants Duality Biologics global rights to Dartsbio’s in-house developed, potential first-in-class bispecific antibody (BsAb) DS005 to develop a new antibody drug conjugate (ADC).…
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Fosun Pharma Terminates Equity Transfer Deal with OncoCare Medical
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the termination of an equity transfer deal with OncoCare Medical Pte. Ltd. The decision follows the inability to fulfill all preconditions for the transaction within the agreed period. Deal OverviewIn June this year, Fosun Pharma had agreed to…
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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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Sino Medical Sciences’ Non-Compliant Balloon Catheter Approved by NMPA
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced receiving market approval from the National Medical Products Administration (NMPA) for its non-compliant balloon dilation catheter. This approval marks a significant step forward in the company’s efforts to enhance cardiovascular treatment options. Product ProfileThe non-compliant balloon dilation catheter is now…
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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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Baidu Health Partners with Shanghai Epiprobe for Cancer Early Screening
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China Internet giant Baidu’s Health Internet Hospital unit has announced a partnership with Shanghai Epiprobe Biotechnology Co., Ltd. The collaboration aims to enhance the promotion and popularization of universal cancer early screening in clinics. No financial details were disclosed. Partnership ObjectivesThe partnership will leverage the respective strengths of both companies…
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Pharmaniaga Partners with JD.com to Enter China Market
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Malaysia-based pharma company Pharmaniaga Berhad (Pharmaniaga) is planning to bring its products into mainland China through a partnership with JD.com, one of China’s largest e-commerce platforms. The company has signed a memorandum of understanding (MoU) with JD.com subsidiary JDMAS Commerce Sdn Bhd to commercialize its over-the-counter (OTC) products, with plans…
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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 Hexaell’s HepaCure Biocolumn Receives IND Approval for HBV-Induced Liver Failure
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China-based Yiming (Beijing) Cell Biotechnology Co., Ltd (also known as Ubrigene) and its partner Shanghai Hexaell Biotech Co., Ltd have received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) for their in-house developed HepaCure Biocolumn. This bioartificial liver product is designed to treat chronic acute liver…
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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…
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LianBio’s TP-03 Begins Phase III Trial for Demodectic Blepharitis in China
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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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Ascletis Files IND Application for COVID-19 Oral Inhibitor ASC11 with FDA
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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…
