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Daiichi Sankyo and AstraZeneca’s Datopotamab Deruxtecan Earns FDA Breakthrough Therapy Designation
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Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced that their co-developed TROP-2-targeted antibody drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA). The designation is based on the positive results from the Phase II…
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Shanghai Pharmaceuticals and Sichuan Kelun-Biotech Partner to Expand Sacituzumab Tirumotecan Market Access
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Shanghai Pharmaceuticals (SHA: 601607; SPH) has entered into a strategic partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990). The collaboration aims to leverage the advantageous resources of both companies to deepen market access, explore innovative financial payments, and other services for sacituzumab tirumotecan, a TROP2-targeted antibody drug conjugate (ADC)…
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China Medical System’s Methylthioninium Tablets Receive First Prescriptions for Colonoscopy Use
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China Medical System Holdings (CMS; HKG: 0867) has announced that the first prescriptions have been issued in China for its methylthioninium enteric coated sustained-release tablets. These tablets are designed to enhance the visualization of colorectal lesions in adult patients undergoing colonoscopy screening or monitoring. Methylthioninium’s Multi-Matrix Technology and MechanismMethylthioninium utilizes…
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Dizal Pharmaceutical Unveils Promising Data on DZD8586 for B-NHL at ASH Annual Meeting
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has presented new data from a pooled safety and efficacy analysis of DZD8586, a non-covalent blood-brain barrier (BBB) penetrant dual inhibitor targeting LYN and BTK, in patients with B-cell non-Hodgkin lymphoma (B-NHL) at the 66th American Society of Hematology (ASH) Annual Meeting. Clinical…
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AbbVie’s Tavapadon Shows Positive Results in Phase III TEMPO-2 Study for Parkinson’s Disease
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US-based pharmaceutical company AbbVie (NYSE: ABBV) has revealed positive top-line results from the pivotal Phase III TEMPO-2 study for its tavapadon, the world’s first and only D1/D5 partial agonist under investigation as a once-daily treatment for Parkinson’s disease (PD). TEMPO-2 Trial Design and OutcomesThe TEMPO-2 trial assessed the efficacy, safety,…
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Eli Lilly’s Jaypirca Demonstrates Superiority in BRUIN CLL-321 Study for CLL/SLL Treatment
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US pharmaceutical major Eli Lilly and Company (NYSE: LLY) unveiled the latest data from the Phase III BRUIN CLL-321 study for its Jaypirca (pirtobrutinib), an oral, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor, at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. BRUIN CLL-321 Study Design and Primary…
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CDE Releases 89th Batch of Reference Preparations for Generic Quality Consistency
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The Center for Drug Evaluation (CDE) in China has announced the selection of the 89th batch of reference preparations for the purpose of generic quality and consistency evaluation (GQCE). This process is crucial for ensuring that generic drugs meet the same high standards of quality and efficacy as their branded…
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Jiangsu Hengrui Pharmaceuticals Plans Secondary Listing on Hong Kong Stock Exchange
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has confirmed reports regarding its intention to make a secondary listing on the Hong Kong Stock Exchange. According to a statement released on the Shanghai Stock Exchange, the Chinese pharmaceutical company is poised to engage Ernst & Young as its auditor, following approval…
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Keymed Biosciences Presents CM336 Data for Relapsed Multiple Myeloma at ASH Annual Meeting
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China-based Keymed Biosciences Inc., (HKG: 2162) has announced the presentation of the latest data from the Phase I/II study for its bispecific antibody (BsAb) CM336, used for treating relapsed or refractory multiple myeloma (R/R M/M), at the 66th American Society of Hematology (ASH) Annual Meeting. Phase I/II Study Design and…
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Antengene’s Xpovio Showcases Positive Results in Phase III BENCH and Phase I/II TOUCH Studies at ASH 2024
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China-based Antengene Corporation Limited (Antengene, HKG: 6996) announced the presentation of the latest results from two clinical studies for its Xpovio (selinexor) at the 2024 American Society of Hematology Annual Meeting (ASH 2024). Phase III BENCH Study ResultsThe Phase III BENCH study evaluated the efficacy and safety of the selinexor,…
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Lee’s Pharmaceutical Receives NMPA Approval for Generic Glaucoma Treatments
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic versions of Pfizer’s Xalatan (latanoprost), Novartis/ Alcon’s Travatan (travoprost), and Novartis/ Alcon’s Duotrav (travoprost, timolol). All three generic drugs…
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NMPA Proposes Draft for Simplified Registration of Traditional Chinese Medicines from Hong Kong and Macao
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The National Medical Products Administration (NMPA) has issued the “Notification on Simplifying the Registration and Approval of Traditional Oral Traditional Chinese Patent Medicines Listed in Hong Kong and Macao in mainland China (draft proposal)”, and is soliciting public feedback until December 24, 2024. This move signifies a step towards streamlining…
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China’s NHSA and NHC Issue Guidelines to Enhance Volume-based Procurement Mechanism
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The National Healthcare Security Administration (NHSA) and National Health Commission (NHC) of China have released the “Notice on Improving the Working Mechanism for Volume-based Procurement (VBP) and its Implementation.” The notice outlines refined measures for hospital access, use, monitoring, examination, and feedback in relation to VBP drugs and consumables. Urging…
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CSPC Pharmaceutical Group’s SYHX2011 for Metastatic Breast Cancer Accepted for NMPA Review
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that the National Medical Products Administration (NMPA) of China has accepted a marketing filing for its Category 2.2 chemical drug, SYHX2011. The drug is indicated for the treatment of metastatic breast cancer that has failed combined chemotherapy or has relapsed…
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GSK’s Nucala Receives FDA Review for COPD Indication Based on MATINEE Study Data
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UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review data from the MATINEE study. The study seeks an indication approval for GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) who exhibit…
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Hantech Medical Device Co., Ltd Acquires BD’s Villamarzana Factory to Expand Manufacturing
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China-based Hantech Medical Device Co., Ltd, a Contract Development Manufacturing Organization (CDMO) specializing in medical consumables, has announced the buyout of Becton, Dickinson and Company’s (BD) factory located in Villamarzana, Italy. This acquisition includes all assets such as land, factory buildings, and equipment. Concurrently, the US major has reached an…
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Precision Biotech and T&L Biotechnology Form Partnership to Advance Cell and Gene Therapies
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China-based Precision Biotech has announced a strategic partnership with compatriot firm T&L Biotechnology Co., Ltd. to collaborate on the development and supply of cell sorting magnetic bead reagents. This alliance aims to enhance the research and development (R&D) and commercialization efforts in the field of cell and gene therapies (CGT),…
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MicroPort Scientific Corp. Launches FireFalcon Balloon for Coronary Interventions with NMPA Approval
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Shanghai-based medical device giant MicroPort Scientific Corp., (HKG: 0853) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its FireFalcon coronary spinous process balloon, a novel device designed to enhance vascular dilation in coronary intervention therapy. Challenges of Traditional Balloon Dilation TechniquesBalloon dilation…
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HuidaGene Therapeutics Initiates HERO Trial for RNA-Editing Therapy HG204 in MECP2 Duplication Syndrome
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Shanghai-based HuidaGene Therapeutics has announced the first subject dosing of the HERO clinical trial, which is evaluating HG204, an RNA-editing therapy, for the treatment of MECP2 duplication syndrome (MDS). CRISPR RNA-Editing Therapy and Its MechanismThe CRISPR RNA-editing therapy utilizes a single adeno-associated virus vector to deliver HuidaGene’s proprietary high-fidelity RNA…
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Simcere Pharmaceutical’s SIM0508 Reaches First Patient Dosing in Global Clinical Study
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China-based Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary, Simcere Zaiming, has announced the first patient dosing in a global clinical study for its Pol θ inhibitor, SIM0508, which targets advanced solid tumors. Global Phase I Study Design and ApprovalThe global multi-center, open-label Phase I study is designed to assess the…
