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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…
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RemeGen’s Telitacicept Shows Positive Results in Phase II Myasthenia Gravis Study
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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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Immunochina Pharmaceuticals Raises Funds for Gene Therapy Development
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Beijing-based gene therapy specialist Immunochina Pharmaceuticals has reportedly raised “hundreds of millions” of renminbi in a Series D+ financing round, following a Series D financing round at the same scale in November 2021. The round was led by ZGC Science City and Beijing Innovation Industry Investment. The proceeds will be…
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BGI Genomics Receives NMPA Approval for Chromosome Aneuploidy Detection Kit
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China-based genomics firm BGI Genomics Co., Ltd (SHE: 300676), the Shenzhen-listed subsidiary of BGI Group, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its chromosome aneuploidy detection kit (combined probe anchoring polymerization sequencing method). This marks a significant milestone in the company’s efforts to advance…
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NMPA Suspends GSK’s Avodart Amid Inspection Findings
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The National Medical Products Administration (NMPA) has decided to suspend the import, sales, and use of GlaxoSmithKline’s (GSK, NYSE: GSK) Avodart (dutasteride) in China. The drug had previously won a spot during the fifth round of volume-based procurement (VBP). However, recent overseas non-on-site inspections revealed that not all batches of…
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Antengene’s ATG-017 Gets FDA Approval for Phase I Clinical Study
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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 Grand’s STC3141 Reaches Primary Endpoint in ARDS Phase Ib Study
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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…
