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Med-Fine FamilyResearch and Development Progress
1. Covering East China, North China, Central China, and Southwest China,Juncell TherapeuticsObjectGC203 Sub-center Successfully Launched
On July 18, 2024, the Phase I clinical trial (KUNLUN-001) of Juncell Therapeutics' gene-modified TIL therapy GC203 was successfully launched at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. This marks the third center initiated for GC203 this month.Learn More
2. LanesseSpecialSuccessful Approval of Disposable Visual Nasogastric Enteral Nutrition TubeOn July 24, 2024, RyanSet's disposable visual nasogastric enteral nutrition tube was successfully approved. The disposable visual nasogastric enteral nutrition tube produced by RyanSet is used for entering the stomach, duodenum, and jejunum through the nasal cavity, delivering enteral nutrition fluids or performing gastrointestinal decompression. It allows for direct visualization during rapid tube placement and bedside operation without the need for X-ray or endoscopic assistance, improving the efficiency of tube placement.Learn More
3. SonoMicroSelf-developed New Generation 3D4K Fluorescence Electronic Thoracoabdominal Endoscopy System Receives Certification and LaunchesOn July 29, SonoMicro's self-developed next-generation 3D4K fluorescence electronic thoracoscopy and laparoscopy system was certified for marketing, with the registration number: Zhejiang Medical Device Registration No. 20242061623.Learn More4. Sinoway4K Fluorescence Endoscope Camera System Receives Certification and LaunchesOn July 22, Sinovation's 4K Fluorescence Endoscopic Camera System was certified for marketing, with the registration number: Zhejiang Medical Device Registration No. 20242061575.Learn More
5. Shuimu JihengNew Product Launch: Multiple Biochemical Controls & Lipid Controls & Urine Biochemical Controls & Urine Specific Protein ControlsMultiple Biochemical Quality Control Products Jing Medical Device Registration Approval 20242400358Lipid Quality Control Product Jing Medical Device Registration Approval 20242400359Urinary Biochemical Quality Control Product Jing Medical Registration Approval 20242400360Urinary Specific Protein Control Product Jing Medical Device Registration Approval 20242400361
6. Qiuzhen MedicalFull Marks in NCCL Tumor ctDNA High-Throughput Sequencing Proficiency TestingRecently, the National Center for Clinical Laboratories (NCCL) of the National Health Commission of China announced the results of the "2024 Quality Assessment for High-Throughput Sequencing of Tumor Cell-Free DNA Gene Mutations." The laboratories of Qiuzhen Medical in Beijing and Hangzhou both achieved zero false positives, zero false negatives, and zero deductions, passing the assessment with a perfect score of 100 points.Learn More
7. NCCL Releases mNGS External Quality Assessment Results for Central Nervous System InfectionsWILLINGMEDComprehensively Passed the National External Quality Assessment in Three Major Infection FieldsRecently, the National Center for Clinical Laboratories of the National Health Commission released the "Report on the Results of the Pre-research Activity for External Quality Assessment of Metagenomic High-throughput Sequencing for Central Nervous System Infections in China." WILLINGMED and several medical institutions using the PIseq® detection platform all passed this external quality assessment with full/high scores!Learn More
8. AnhuiCAS GenomicsSuccessfully Passed CNAS Laboratory AccreditationIn July 2024, Anhui Hongqiao Zhongke Gene Testing Technology Co., Ltd. successfully passed the evaluation by the China National Accreditation Service for Conformity Assessment and obtained the laboratory accreditation certificate, registration number: CNAS L21109.Learn More
9. Guoke Saifu (Shenzhen)Successfully Passed NMPA GLP CertificationSafuGene (Shenzhen) New Drug Research and Development Technology Co., Ltd. obtained the drug GLP certification (Certificate No. GLP020010199) issued by the National Medical Products Administration (NMPA) on July 4, 2024.Learn More
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Med-Fine FamilyBusiness Breakthrough
1. Libang PharmaceuticalsFirst Commercial Product, Meixinluo®, Prescribed for the First Time in ChinaRecently, the first prescription of Alebrin® in China was issued by Professor Ding Xiaoqiang from Zhongshan Hospital Affiliated to Fudan University. It is used to treat anemia caused by chronic kidney disease in patients receiving erythropoiesis-stimulating agent (ESA) therapy. Alebrin® has been included in the 2023 National Medical Insurance Drug Catalog, ushering in a new era for the treatment of renal anemia in China.Learn More
2. Guoke SaifuApproval for Establishment of Provincial Engineering Research Center Accelerates Innovation in Non-Clinical Evaluation of CGT DrugsRecently, the Hebei Provincial Development and Reform Commission issued the "Notice on Publishing the 2024 Provincial Engineering Research Center Preparation Plan List". The "Hebei Provincial Engineering Research Center for Non-clinical Evaluation of Cell and Gene Therapy Drugs" by Guoke Saifu Hebei Pharmaceutical Technology Co., Ltd. has been officially included in the 2024 preparation plan of the Hebei Provincial Development and Reform Commission.Learn More
3. Aikema MedicalGroundbreaking Ceremony of the Cardiac Electrophysiology Innovation Center Successfully Held in Shaoxing Binhai New AreaTo promote the high-end medical device industry cluster development in Shaoxing Binhai New Area and accelerate the realization of the goal of high-quality development and common prosperity, the Management Committee of Shaoxing Binhai New Area and Suzhou Aikangmai Medical Technology Co., Ltd. have agreed to invest in the construction of an Electrophysiology Innovation Center in Binhai New Area based on the principle of win-win cooperation. The project officially started on July 10th, with a groundbreaking ceremony held on the same day.Learn More
4. SonoMicroSoniCure® Ultrasonic Scalpel: Dual-Core Intelligent Technology Leads the Way in Self-Reliant and Controllable Health in ChinaRecently, the "China Medical Device Industry Data Report (2024)" compiled by the editorial board of *China Medical Equipment* magazine, in collaboration with industry regulatory agencies, Class A tertiary hospitals in China, top academic research institutions, and well-known medical device manufacturing and R&D enterprises, as well as industry experts and scholars, has been officially released. SoniCure® Ultrasonic Soft Tissue Cutting and Hemostasis Device, independently developed by Sinowave Medical, has been successfully included in this report thanks to its outstanding adaptive tissue technology and high-speed frequency tracking technology, showcasing its leading position and innovative strength in the field of medical devices.Learn More
5. YipinObtained ISO 18562 2024 Edition and Chemical Characterization CNAS Qualification CapabilityRecently, the Epshine Guiyang Laboratory successfully completed the CNAS qualification expansion for the ISO 18562 2024 edition series of standards and the study of medical device extractables and chemical characterization. The main standards are as follows:ISO 10993-18:2020/Amd.1:20226. YipinTwo Major Laboratories Simultaneously Gain New CMA Qualification CapabilitiesRecently, Suzhou Yipin and Hefei Yipin, two major laboratories under Yipin Group, have simultaneously obtained new CMA qualification capabilities!Yipin Group's CMA Qualification Expansion: In the field of active medical devices, the key focus was on expanding the capabilities for endoscopic product series standards, covering rigid endoscopes, camera systems, cold light sources, electronic endoscopes, and more. Additionally, the scope of capabilities was expanded to include multi-parameter monitoring devices and physical therapy products. In the field of passive medical devices, improvements were made to the dental implant systems and sports medicine product standards, while also increasing the comprehensive capabilities for bio-membranes and protein-based products.Learn More
7. Jiayin MedicalNew Product Launch: Mitochondrial Disease Hotspot Mutation Detection KitGENEINSIGHT Mitochondrial Disease Hotspot Mutation Detection Kit, independently developed by GENEINSIGHT and awarded the world's first certification, is simple and fast, accurately targeting high-frequency mutation sites of mitochondrial diseases, making treatment more targeted and effectively improving patient prognosis.Learn More
8. Kelubao GroupShining Brightly in the Field of Special Medical FoodsAt the 2024 CBME exhibition, Kelubao Group stood out as a remarkable highlight with its exceptional R&D capabilities, innovative product lines, and professional commercial promotion. During this exhibition, Kelubao not only showcased the outstanding achievements of its four special medical food registration certificates but also demonstrated its leading position in the field of formula foods for special medical purposes.Learn More
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Med-Fine FamilyBusiness Cooperation
1. Saifu MedicalMedicineSAL0120 Tablets, a Small Molecule Innovative Drug by Sinopharm Xinyitai, Approved for New Indication Clinical TrialsShenzhen Salubris Pharmaceutical Co., Ltd.'s Class 1 new drug SAL0120 tablets have been approved for a new indication of chronic kidney disease (CKD) clinical trials. Saifu Pharmaceuticals undertook the pharmacodynamics study of Salubris' small molecule innovative drug SAL0120 tablets project, assisting in the approval of the clinical trial application for the new indication of Salubris' small molecule innovative drug SAL0120 tablets.Learn More2. Saif PharmaceuticalAssisting Oncolmmune's MVR-T3011 Herpes Virus Injection in Gaining Approval for Intraperitoneal Administration to Enter Clinical Research
The Oncolytic Product MVR-T3011 Herpes Virus Injection of ImmunoViroTherapeutics has been Approved for Intraperitoneal Administration to Enter Clinical Research! Sino-Aura Pharma undertook the efficacy and non-clinical safety evaluation studies for the intraperitoneal administration of the MVR-T3011 project, assisting the oncolytic product MVR-T3011 herpes virus injection in gaining approval for intraperitoneal administration to enter clinical research.Learn More04
Med-Fine FamilyIndustry Honors
1. OrangeSail PharmaceuticalsAwarded the "Shanghai Pudong New Area Postdoctoral Innovation Practice Base" Plaque2. Xinqi MedicalAwarded Siyu MedTech "2024 Global Innovative Medical Device Award"3. ZD Medical®Product Selected for "Directory of Excellent Domestic Medical Device Products"4. Westlake OmicsCollaborative Project Research Awarded "Second Prize of Hubei Provincial Natural Science Award"5. BlueIslandCAS GenomicsAwarded the "Grand Prize" in the Rural Revitalization Innovation and Excellence Competition6. Walnut TechnologySelected as a "Data Technology Service Provider" by Beijing International Big Data Trading Co., Ltd.7. JINGZHUN MedicalSelected for "2024 Future Medical Technology Leaders · Brilliant 100 · Bio-detection"8. InnoVirus TherapeuticsSelected for "2024 Future Medical Technology Leaders · Brilliant 100 · Chemical Pharmaceuticals"
