01
Med-Fine FamilyFinancing Progress
1. EccogeneReceived a $60 million milestone payment from AstraZenecaOn October 23, 2024, Eccogene announced the receipt of a $60 million milestone payment from AstraZeneca. This milestone was triggered by the dosing of the first patient in the Phase 2b clinical trial of the small molecule GLP-1 receptor agonist ECC5004/AZD5004.Learn More02
Med-Fine FamilyResearch and Development Progress
1. Nanjing Aimeifei Biomedical Technology Co., LtdGlobally Innovative Drug IPG8294 Receives FDA Clinical Approval in the United StatesRecently, Aimeifei Pharmaceutical announced that its self-developed IPG8294, the world’s first small-molecule oral drug targeting NAD+ hydrolase, has received clinical approval from the U.S. Food and Drug Administration (FDA). This is another innovative drug clinical trial approval following three globally innovative drugs — IPG1094, IPG7236, and IPG11406 — that have entered clinical trials, marking the fourth innovative drug by Aimeifei to obtain a clinical trial entry ticket.。Learn More
2. MabworksOral Presentation of Continuous Research Data on MIL62 for the Treatment of Primary Membranous Nephropathy at the CSN Annual Academic Conference for Two Consecutive YearsBeijing Mabworks Biotechnology Co., Ltd. announced that during the 2024 Academic Annual Meeting of the Chinese Society of Nephrology (CSN), held from October 16 to 20, 2024, an oral presentation updated the continuous research data for at least 76 weeks of follow-up in the Phase Ib/II clinical trial of the third-generation CD20 antibody MIL62 for treating primary membranous nephropathy. The clinical research data were presented by Professor Cui Zhao from Peking University First Hospital and marked the second consecutive year of oral presentations on this clinical trial at the CSN annual meeting, following the oral report in 2023, continuously sharing the latest findings of this study.Learn More
3. The first in China,Juncell TherapeuticsTILClinical Trial for Lung Cancer Treatment Officially LaunchedOn October 14, 2024, the kick-off meeting for the clinical trial "An Open-Label, Single-Arm, Phase Ib Study to Evaluate the Safety and Efficacy of Autologous Natural Tumor-Infiltrating Lymphocyte Injection (GC101 TIL) in Patients with Advanced Non-Small Cell Lung Cancer (MIZAR-005)" sponsored by Juncell Therapeutics was successfully held at the Shanghai Chest Hospital in both online and offline formats.Learn More
4. SonoMedAnother Breakthrough, China's First Approved 7mm Integrated Ultrasonic ScalpelRecently, the 7mm integrated ultrasonic scalpel (disposable ultrasonic soft tissue surgical blade) independently developed by Synowave has been officially approved for a Class III medical device registration certificate by the National Medical Products Administration (NMPA), becoming the first approved 7mm integrated ultrasonic scalpel produced in China to enter the market.Learn More
5. SinowaySelf-developed "NanoKnife" Receives FDA Approval for Market Launch, Leading the Reverse Output of High-end Domestic Tumor Ablation TechnologyRecently, Dophi®N3000, a new-generation irreversible electroporation device independently developed by SonoWe, has been approved for marketing by the U.S. Food and Drug Administration (FDA). The product is suitable for intraoperative soft tissue ablation. This not only confirms the product's innovative strength, clinical value, and international competitiveness but also lays a solid foundation for China-produced high-end tumor ablation technology to move from the East to the West.Learn More
6. Jingzhun MedicalCYP3A5 Gene Detection Kit (Fluorescence PCR Method) Officially Approved by NMPA for Market LaunchOn October 16, 2024, Jingzhun Medical's self-developed CYP3A5 Gene Detection Kit (Fluorescence PCR Method) officially received NMPA approval for marketing (Registration Certificate No.: 20243402031). This is the eleventh Class III medical device registration certificate obtained by Jingzhun Medical.Learn More
03
Med-Fine FamilyBusiness Breakthrough
1. Juncell TherapeuticsGC203 Receives Positive Feedback from Clinical ParticipantsRecently, Juncell Therapeutics' gene-modified TIL therapy GC203 completed the first patient cell infusion at the Chongqing University Cancer Hospital, a sub-center of the Phase I clinical trial (KUNLUN-001). The patient was successfully discharged on October 25. Both the trial participant and the clinical researchers highly praised the clinical safety and operational simplicity of GC203.Learn More
2. Jiajian MedicineFull Marks in NCCL 2024 Inter-Laboratory Quality Assessment for Chromosomal Genome Structural AbnormalitiesRecently, the National Center for Clinical Laboratories (NCCL) under the National Health Commission of China announced the statistical results of the 2024 External Quality Assessment (EQA) for chromosomal genomic structural abnormalities. Jiajian Medical Laboratory achieved a perfect score in this EQA, demonstrating its high-quality standards in testing and further confirming the reliability and accuracy of the test results provided to customers.Learn More3. Jiayan MedicineFull Marks in NCCL 2024 Newborn Hearing Loss Gene Detection (Second Round) External Quality AssessmentRecently, the National Center for Clinical Laboratories (NCCL) under the National Health Commission of China announced the statistical results of the 2024 external quality assessment for neonatal deafness gene testing. Jiajian Medical Laboratory achieved an outstanding performance in this evaluation, with all tested samples meeting the expected results and achieving a perfect score. This accomplishment once again demonstrates the high standard of quality control in DNA sequencing at Jiajian Medical Laboratory, ensuring the reliability and accuracy of test results provided to customers.Learn More
4. ChasingMedFull marks achieved in the two external quality assessments organized by CAP and NCCL both domestically and internationally.Recently, the College of American Pathologists (CAP) announced the results of the NEO-B 2024 Neoplastic Cellularity Program inter-laboratory quality assessment. ChosenMed's test results were in complete agreement with the CAP official standard answers, achieving a perfect score once again in this competency certification. In the subsequent release by the National Center for Clinical Laboratories (NCCL) under the National Health Commission of China regarding the 2024 national inter-laboratory quality assessment for high-throughput sequencing detection of somatic mutations in solid tumors, ChosenMed’s laboratories in Beijing and Hangzhou both achieved perfect scores.Learn More
5. HebeiGeneseekSuccessfully Passed CNAS Laboratory AccreditationIn October 2024, Hebei Jicai Zhongke Gene Technology Co., Ltd. successfully passed the evaluation by the China National Accreditation Service for Conformity Assessment and obtained the laboratory accreditation certificate, registration number: CNASL21756.Learn More
04
Med-Fine FamilyBusiness Cooperation
1. CoGIN BiotechStrategic Cooperation Agreement Reached with Nanjing University Research Institute in Wuxi
In the golden autumn of October, Wuxi Co-Gene Biotechnology Co., Ltd. signed a "Strategic Cooperation Agreement" with Wuxi Nanjing University Xishan Applied Biotechnology Research Institute.The CRISPR3.0 precise gene insertion technology platform independently developed by CoGent Biotech will be applied to the regenerative medicine and tissue engineering platforms of Nanjing University's Wuxi Institute, achieving medical transformation and benefiting more patients. Bi Feng, the executive deputy director of Nanjing University’s Wuxi Institute, stated: "CoGent Biotech's CRISPR/AAV technology platform is precise, safe, and efficient. The cooperation between both parties will accelerate the implementation of innovative achievements in cell and gene therapy, forming a complete solution from technology development to application transformation, and assisting in the treatment of major diseases."Learn More
2. Pengli BioRui Feng Bio's Usher Syndrome New Drug IND Approved by U.S. FDAOn September 17, 2024, local time in the United States, the U.S. Food and Drug Administration (FDA) officially approved the IND application for RM-101, an innovative drug developed by Ruifeng Bio for Usher syndrome. Pengli Bio provided preclinical research services for Ruifeng Bio's RM-101 innovative drug product, including long-term expression effect studies of different doses and evaluation of changes in retinal function and structure after administration. Studies evaluating changes in retinal function and structure were conducted on genome-modified C57BL/6 mice following subretinal or intravitreal injection of different doses of RM-101. Terminal collection of retinal tissues was performed to analyze differences in expression effects, scientifically demonstrating the intraocular expression effects post-injection as well as the impact of dosing on retinal structure and function.Learn More3. Pengli BioAssisting Hengrui's "Class 1 New Drug for Heart Failure" in Gaining Clinical Approval
According to the CDE official website, Hengrui Medicine's Class 1 new drug SHR-6934 Injection has received clinical trial implied permission, intended for the treatment of heart failure.PharmAbilities Provided Pharmacodynamic Evaluation Services for Hengrui Medicine’s SHR-6934 Injection in Heart Failure Models for Clinical Submission. During the research and development process, PharmAbilities utilized an isoproterenol-induced animal heart failure model to evaluate the pharmacological effects of SHR-6934 Injection on animals with heart failure. Observations and analyses were conducted at various levels, including cardiac function and histopathology. PharmAbilities thoroughly completed the pharmacodynamic evaluation of SHR-6934 Injection in improving heart failure in animals and scientifically demonstrated its efficacy in preventing and treating heart failure, assisting Hengrui Medicine in efficiently advancing the rapid transition of its product pipeline from preclinical to clinical stages.Learn More
4. Saifu PharmaceuticalsAssisting Bintie Bio in obtaining the implied permission for clinical trials from the National Medical Products Administration for "IX001 TCR-T Injection"Saifu Pharmaceutical undertook a one-stop evaluation service for the pharmacodynamics, pharmacokinetics, and non-clinical safety of Bintie Biotech's TCR-T cell therapy product "IX001 TCR-T Injection," assisting Bintie Biotech in obtaining approval from the National Medical Products Administration (NMPA) for the Investigational New Drug (IND) application of this project.Learn More
5. Shuimu JinshengAssisting Sichuan Yu'an Zhikang in Obtaining Class II Medical Device Registration CertificateRecently, Beijing Shuimu Jinsheng Medical Technology Services Co., Ltd. assisted Sichuan Yu'an Zhikang Medical Technology Co., Ltd. in obtaining a Class II medical device registration certificate issued by the Sichuan Provincial Drug Administration for its independently developed cognitive function assessment and training software.In the cooperation process with Yu An Zhi Kang this time, Shui Mu Jin Sheng provided full-process services, including: software compliance R&D services, software cybersecurity capability assessment services, clinical evaluation services, and registration technical services. These covered all compliance service modules throughout the software's entire lifecycle from compliant R&D to pre-registration certification.Learn MoreMed-Fine FamilyIndustry Honors
1. Hanyu MedicalSuccessfully Selected for the "New and Excellent Pharmaceutical and Medical Device Products Catalog" of Shanghai's Biomedical Industry2. SinowayTwo-in-One Energy Platform Awarded "Top Ten Scientific and Technological Achievement Transformation Projects in China"3. BeijingZhongguancun Shuimu MedicalContinuously Recognized as a "Specialized, Precise, Unique, and Innovative" Small and Medium-sized Enterprise in Beijing4. BeijingShuimu JinshengMedical Technology Services Co., Ltd. Awarded the Title of "High-Quality Institution for Medical Device R&D Services"
