Junlian Medical Enterprise Development Update · Issue 8, 2024

Ansucon Completes New Round of Financing Worth Hundreds of Millions

Accelerate the Implementation of Host-Free Ultrasonic Scalpel

Recently, Ansucon Medical (Suzhou) Co., Ltd. ("Ansucon"), an innovative medical device R&D manufacturer, announced the completion of a new round of financing worth 100 million yuan. The funds will mainly be used for the market promotion of wireless ultrasonic scalpels, the development of a brand-new energy platform, and production capacity preparation.

Ansucong is an innovative medical device company based on its own core technology system, established in Suzhou in 2020. It is committed to providing Chinese medical workers with better and more convenient medical devices. The company's founder, Zhang Tao, has extensive industry experience at Hill-Rom, Johnson & Johnson, and local Chinese medical device companies. He led the team to develop the world’s first split-type wireless ultrasonic scalpel, which ranks first globally in related technical fields. It is also the only domestically produced brand in the ultrasonic scalpel field that surpasses foreign brands in highly integrated technology. It is reported that this product obtained a Class III medical device registration certificate issued by the National Medical Products Administration in November 2022 and officially launched sales in the second quarter of 2023. As of the first half of this year, the number of hospitals awarded through centralized procurement has exceeded 100, and the total number of hospitals adopting the product has surpassed 200.

China's First KRAS G12C Inhibitor

Innovent Bio's Dabot® Approved for Marketing

August 21, 2024, San Francisco, USA, and Suzhou, China — Innovent Bio (01801.HK), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major disease areas such as oncology, autoimmune disorders, metabolic diseases, and ophthalmology, announced that Dabot® (Fuzoradenib tablets, KRAS G12C inhibitor) has been approved by the National Medical Products Administration (NMPA) of China for marketing. It is indicated for adult patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation who have received at least one prior systemic therapy. Dabot® is the first approved KRAS G12C inhibitor in China and the eleventh product from Innovent Bio, benefiting lung cancer patients with the KRAS G12C mutation. In September 2021, Innovent Bio and GenFleet Therapeutics announced a global exclusive licensing agreement, granting Innovent Bio the rights to develop and commercialize Fuzoradenib tablets (Innovent's R&D code: IBI351; GenFleet's R&D code: GFH925) in China (including mainland China, Hong Kong, Macau, and Taiwan). Fuzoradenib tablets were designated as a breakthrough therapy by the CDE in January 2023 and May 2023, intended for treating patients with advanced non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation who have received at least one prior systemic therapy and patients with advanced colorectal cancer (CRC) harboring the KRAS G12C mutation who have received at least two prior systemic therapies.

Innostellar Biotherapeutics LX102 Completes Enrollment for Phase II Clinical Trial

New Hope for nAMD Treatment

On August 1, 2024, Innostellar Biotherapeutics Co., Ltd. announced that LX102 Injection, developed by its subsidiary Innostellar Biotherapeutics (Suzhou) Co., Ltd., has successfully completed patient enrollment for its Phase II clinical trial. This milestone marks the successful advancement of the first multicenter, randomized, controlled study in China for gene therapy targeting neovascular age-related macular degeneration (nAMD). The Phase II clinical trial received active participation from several well-known medical institutions across China. The trial aims to further evaluate the safety and efficacy of subretinal injection of LX102 in treating nAMD, providing solid data support for upcoming confirmatory clinical trials. LX102 Injection received clinical trial approval from China’s National Medical Products Administration (NMPA) in December 2022 and from the U.S. FDA in December 2023. Leveraging Innostellar Biotherapeutics' innovative R&D capabilities in ophthalmic gene therapy, LX102 has successfully completed the enrollment and treatment of all subjects in its Phase I clinical trial in China, with preliminary results showing good safety and tolerability.

Lynk Pharmaceuticals Announces

LNK01004 in the treatment of atopic dermatitis

Positive Results Achieved in Phase 1b Clinical Study

On August 13, 2024, LinkMed (Hangzhou) Co., Ltd. — an innovative drug development company in the clinical stage — announced positive results from its Phase 1b clinical study of LNK01004 (a topical pan-JAK inhibitor), a Class 1 innovative drug independently developed by the company for the treatment of atopic dermatitis. This study is a randomized, double-blind, placebo-controlled multicenter clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic profile of LNK01004 after multiple topical administrations in adult subjects with mild to moderate atopic dermatitis. The trial results showed that topical administration of LNK01004 ointment for up to four weeks demonstrated good safety and tolerability, with no significant skin irritation observed and no subjects discontinuing the trial. Notably, the LNK01004 1.0% dose group exhibited the most promising efficacy outcomes, with EASI-75, IGA 0/1, and PP-NRS4 response rates at week 4 being 63%, 50%, and 75%, respectively (compared to 17%, 17%, and 33% in the placebo group). The positive outcomes achieved in this study lay a solid foundation for the subsequent clinical development of this product.

Deep Faith Biologics mRNA Drug

IN016 Granted FDA Orphan Drug Designation

Hong Kong, Shenzhen, Nanjing, July 30, 2024 – Innorna (“Innorna”), a clinical-stage biopharmaceutical company focused on lipid nanoparticle (LNP) delivery technology and the development of innovative RNA therapies, announced that its investigational mRNA drug IN016 has received Orphan Drug Designation (ODD) from the U.S. FDA, following the Rare Pediatric Disease Designation (RPDD) granted on July 10, 2024 (Eastern Time). IN016 is being developed for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC), a life-threatening genetic disorder. The simultaneous granting of RPDD and ODD will significantly accelerate the clinical development and market approval process of IN016, benefiting patients sooner. Founded in 2019, Innorna is committed to developing a world-leading LNP delivery technology platform and innovative RNA therapies to address unmet clinical needs. Innorna has built a Diversity-Oriented LNP Library (DOLL) containing more than 5,000 ionizable lipids, which can be applied to the development of various innovative therapies, including mRNA vaccines and drugs, gene editing therapies, and cell therapies. Based on its proprietary mRNA and LNP technology platforms, Innorna has established multiple internal R&D pipelines in the fields of infectious disease vaccines, rare diseases, and cancer immunotherapy, while collaborating with several domestic and international biopharmaceutical companies to explore the broader therapeutic potential of this technology.

FDA Lifts Hold on Yilian Biologics' YL202/BNT326

Partial Hold in Clinical Trials

August 19, 2024 - Medilink Therapeutics (Suzhou) Co., Ltd. ("Medilink Therapeutics"), a clinical-stage biotechnology company, announced on August 15, 2024, that it had received official notification from the U.S. Food and Drug Administration (FDA) lifting the Partial Hold on the Phase I clinical trial (NCT05653752) of YL202/BNT326. YL202/BNT326 is an investigational antibody-drug conjugate targeting HER3 (Human Epidermal Growth Factor Receptor 3), currently under co-development by Medilink Therapeutics and BioNTech SE (Nasdaq: BNTX, "BioNTech"). The clinical trial will continue with patient recruitment and focus on dose levels of 3.0 mg/kg and below, which have demonstrated excellent efficacy and manageable safety. YL202/BNT326 is a next-generation antibody-drug conjugate (ADC) product targeting human epidermal growth factor receptor 3 (HER3), developed based on Medilink Therapeutics' TMALIN® technology. HER3 is highly expressed in multiple cancer types, including non-small cell lung cancer and breast cancer, and is closely associated with tumor metastasis and disease progression. Additionally, HER3 expression is further upregulated following frontline drug treatments, making it a highly promising target for cancer therapy. Medilink Therapeutics has entered into an overseas collaboration and licensing agreement with BioNTech for YL202/BNT326, which is currently in Phase I/II clinical development.

Tianxing Medical ENT Electrode Approved for Marketing

Tianxing Medical's Self-Developed ENT "Single-Use Plasma Surgical Electrode (Blade)" Receives NMPA Approval for Market Launch (Registration Certificate No.: Guo Xie Zhu Zhun 20242010405)

Changde Medical®EF-Salween®

Peripheral Thrombus Aspiration System Approved for Marketing

Recently, the EF-Salween® Peripheral Thrombus Aspiration System, independently developed by Shanghai Changde Medical Technology Co., Ltd., has officially received approval from the National Medical Products Administration (NMPA) for market launch. The EF-Salween® Peripheral Thrombus Aspiration System is suitable for removing thrombi in the peripheral vascular system. Established in November 2021, Changde Medical's founder and core team possess extensive experience in interventional device R&D, clinical registration, and commercialization, with a deep understanding of the focused industry. Adhering to the core concept of innovative R&D, Changde Medical is committed to efficiently providing a comprehensive solution that meets the needs of minimally invasive treatment for vascular diseases. The company focuses on areas such as lower limb arterial stenosis intervention, thrombus management, venous disease intervention, and chronic disease management, and has launched several products including peripheral vascular constraining balloon dilation catheters and intermittent pulse compression therapy devices.

Stellar Sea Medical Single-Use Hysteroscope

FDA Approved

Starsea Medical's Single-Use Hysteroscope SeleneView® Receives FDA 510(k) ClearanceStarsea Medical's SeleneView® single-use hysteroscope, which features a finer endoscope, allows for surgery without cervical dilation or anesthesia, effectively reducing patient anxiety and discomfort while improving surgical success rates. The single-use hysteroscope will have a positive impact on gynecology by providing healthcare professionals with the most advanced tools to enhance patient care and treatment outcomes. Established in October 2020 and headquartered at Nantai Cloud Innovation Valley in Guangming District, Shenzhen, Starsea Medical is an innovative medical technology company specializing in single-use endoscopic interventional diagnosis and treatment, integrating R&D, production, sales, and service. Its product portfolio covers urology, ICU, gynecology, emergency medicine, and anesthesia. The founding team of Starsea comes from leading domestic and international medical device companies, with over a decade of extensive experience in endoscope product development, global marketing, and production management.

Yipu Run, a wholly-owned subsidiary of Puyi Bio

Pedom® Silicone Rubber Uterine Drug Delivery Stent System Approved

Recently, the Peduo® Silicone Rubber Uterine Drug Delivery Stent System, developed by Yipu Run (Shanghai) Biotechnology Co., Ltd., has received registration approval from the National Medical Products Administration (NMPA) (Registration No. 20243181461). The product is intended for placement in the uterine cavity of patients with moderate to severe intrauterine adhesions after hysteroscopic lysis of adhesions, assisting in the prevention of recurrent intrauterine adhesion. The product's registration clinical trial was a randomized controlled trial (RCT). Compared with the standard treatment recommended by clinical guidelines, the clinical trial results of this product demonstrated superior efficacy. It is an innovative product that is "China-originated and world-first," effectively promoting endometrial growth, preventing intrauterine adhesions, protecting female fertility, and addressing global women’s health issues while providing a new and better therapeutic option for clinical practice. Yipu Run (Shanghai) Biotechnology Co., Ltd. is a wholly-owned subsidiary of Puyi (Shanghai) Biotechnology Co., Ltd. Relying on advanced bio-medical material transformation processes and cutting-edge drug-controlled release technologies, Puyi Biotech and Yipu Run have developed multiple innovative pipelines and built up a portfolio of high-end implantable and interventional products.

China-produced Self-developed Spectrum Medical Sonico-CX®

Intravascular Lithotripsy System Successfully Goes Global

Recently, in line with the strategy of implementing "Belt and Road" healthcare cooperation, the domestically developed Sonico-CX® Intravascular Lithotripsy (IVL) System successfully made its way overseas! It achieved two breakthrough IVL cases in Bangkok, Thailand, and completed the first IVL procedure in Indonesia. This marks another practical step in deepening the joint construction of “Belt and Road” healthcare cooperation and represents a solid stride for innovative Chinese medical devices going global. The Coronary Shockwave Therapy System consists of the Sonico-CX® disposable coronary intravascular lithotripsy catheter (NMPA approval No. 20243010464) and the intravascular lithotripsy treatment device (NMPA approval No. 20243010505). It is currently the only domestically self-developed coronary intravascular shockwave therapy product to have received an invention patent and successfully overcome technical bottlenecks faced by similar foreign technologies.

Terry Pharmaceutical's Gefitinib Tablets Exported to Indonesia

Embarking on the International Journey of Formulations

On August 2, 2024, Suzhou Terui Pharmaceutical Co., Ltd. shipped Gefitinib Tablets to Indonesia. Suzhou Terui Pharmaceutical Co., Ltd. signed a cooperation agreement with Indonesian biotechnology company PT Etana Biotechnologies Indonesia (Etana) to jointly promote the marketing approval and market promotion of Gefitinib Tablets (Indonesian trademark: GETANA) in Indonesia. After reaching the cooperation with Etana, Gefitinib Tablets successfully passed the review by Indonesia's pharmaceutical regulatory authority BPOM in terms of pharmaceuticals, clinical trials, and GMP compliance at the manufacturing plant, and were approved. Exporting finished dosage forms is an important development strategy for Terui Pharmaceutical, marking a breakthrough from active pharmaceutical ingredients to finished dosage form exports. Terui Pharmaceutical adheres to a "global perspective," steadily advancing in its development process.

Guoke Saifu Approved to Establish Provincial Engineering Research Center

Accelerating Innovation in the Non-Clinical Evaluation of CGT Drugs

Recently, 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 Guo Ke Saifu Hebei Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Guo Ke Saifu") has been officially included in the 2024 preparation plan of the Hebei Provincial Development and Reform Commission. Guo Ke Saifu will use this platform to further deepen innovation in pharmaceutical R&D technology, explore the frontiers of cell and gene therapy product development, strengthen industry-university-research cooperation, accelerate the industrialization of scientific research achievements, and contribute to promoting innovation in China's biopharmaceutical industry and local economic prosperity.

Haiskell iLivTouch® Full Series Products

Included in the 10th List of Excellent Domestic Medical Device Products

Recently, Hisky iLivTouch® Full Series Products Passed the Selection of the 10th Batch of Excellent Chinese Medical Device Products Directory. This is also another inclusion of the series into the list of excellent medical devices in China. "Excellent Chinese Medical Devices" are strictly selected by relevant experts from the China Association of Medical Equipment under the commission of the Planning Development and Information Department of the National Health Commission. The aim is to select a group of outstanding domestic equipment that meets clinical needs, with advanced technology and high quality, providing references for the equipment configuration work of medical and health institutions at all levels in China, while significantly promoting the high-end development of domestic medical devices. The iLivTouch® full series products independently developed by Hisky have won unanimous recognition from expert reviewers due to their advanced technology, excellent performance, rich clinical value, and wide market application. The iLivTouch® series mainly includes Max, Plus, Pro, Mini, and other product lines. Based on advanced Transient Elastography (TE) technology, it only takes 2 minutes to detect liver stiffness measurement (LSM) and ultrasound attenuation parameter (UAP). Equipped with cutting-edge algorithm technology, the measurement results are more accurate. Additionally, with artificial intelligence technology, personalized reports can be automatically generated for examinees. Compared with traditional detection technologies, it can quickly, non-invasively, and quantitatively complete the detection of two indicators. Currently, it has been recommended by many domestic and international societies, guidelines, and consensuses such as the Chinese Medical Association, WHO, AASLD, and EASL.

Haihe Biomarker CNAS Certification Field Deepens Expansion

Upgrade and Leap in Laboratory Testing Capabilities

Recently, Tianjin Haihe Benchmark Testing Technology Co., Ltd., a subsidiary of Haihe Biotechnology, achieved significant updates and expansions in its certification scope from CNAS (China National Accreditation Service for Conformity Assessment). In this update, multiple new testing items were successfully included, marking that Haihe Benchmark not only expanded its business scope but also advanced its comprehensive service capabilities to a new level. The expansion and update of the CNAS certification scope is a significant move, covering various series, dozens of projects, and multiple standards. Haihe Benchmark is committed to providing professional and independent third-party testing services in the fields of medical devices, pharmaceuticals, ophthalmic care products, and disinfectant products, offering testing services and validation solutions throughout the product lifecycle. The team members at Haihe Benchmark cover specialties such as chemical analysis, mechanical properties, veterinary medicine, and pathology, with extensive work experience to meet clients' unique needs. To date, it has obtained national CMA certification, China CNAS and U.S. ANAB laboratory accreditation, U.S. FDA GLP and OECD GLP laboratory recognition, as well as AAALAC accreditation from the International Association for Assessment and Accreditation of Laboratory Animal Care, ensuring global applicability through one test. Dedicated to providing global one-stop solutions, Haihe Benchmark is a trustworthy partner for enterprises.

N1 Life Partners with XtalPi

Co-create for nucleic acid and macromolecular drugs

Non-invasive Ophthalmic Drug Delivery Platform

On August 8, N1 Life, which focuses on innovative drug delivery technologies, and XtalPi (2228.HK) announced a technical collaboration to combine peptide molecule design with artificial intelligence (AI), high-throughput, and automated screening platforms for ophthalmic diseases. This partnership aims to develop safer and more efficient drug delivery systems for macromolecular drugs and nucleic acid drugs. Both parties will jointly utilize the peptide carrier library developed by N1 Life over years of research at Stanford University and XtalPi's mature peptide molecule design and screening platform to achieve AI-powered platform-type drug delivery peptide carrier design. This will enhance the druggability of macromolecules like RNA and accelerate the development process of novel ophthalmic drugs. In this collaboration, XtalPi will use its mRNA display peptide library and screening technology to co-design a peptide library with N1 Life and perform high-throughput screening based on N1 Life’s established tissue delivery screening model. The goal is to build a peptide delivery system with strong targeting, good stability, and high delivery efficiency, addressing key challenges in intravitreal macromolecular drug delivery. Additionally, this effort seeks to explore more advanced and efficient R&D models for macromolecular drug delivery across more disease areas, aiming to open up entirely new development pathways for drugs that are otherwise difficult to formulate.

Lingfu Bio and Heze Technology Reach Strategic Cooperation

Promote the Innovative Development of Brain-Computer Interface Technology

Recently, Beijing Lingfu Biotechnology Co., Ltd. ("Lingfu Bio") and Heze Qiyuan (Beijing) Technology Co., Ltd. ("Heze Tech") officially announced a strategic partnership. This collaboration aims to combine Heze Tech's brain-computer interface technology with Lingfu Bio's expertise in model animals to jointly advance the innovative development of brain-computer model animals in life sciences and biomedicine. This cooperation marks the joint exploration of cutting-edge technologies by the two companies, with expectations to bring breakthroughs to future medical treatment and scientific research. As a technical service platform focusing on model animals and the R&D of innovative drugs and devices, Lingfu Bio boasts abundant experimental animal resources, professional modeling techniques, and model animal experiments, providing one-stop services to customers and committing to delivering high-quality model animals and related services for life science research. Heze Tech holds leading R&D capabilities in the field of brain-computer interface technology, with its innovative products showing great potential across various application scenarios. This strategic partnership will organically combine the strengths of both parties, with Lingfu Bio leveraging its expertise in model animals to support Heze Tech in testing and validating brain-computer interface technology for broader biomedical applications. Both parties will jointly promote the innovative application of brain-computer interface technology in multiple fields such as neuroscience, drug development, and disease model construction, further exploring the potential applications of this technology and facilitating continuous progress in scientific research.

Tongxin Zhiyi Selected for Publication by the Ministry of Industry and Information Technology and the National Medical Products Administration

"Winning Units of the Artificial Intelligence Medical Device Innovation Task List"

On August 9, 2024, the Science and Technology Department of the Ministry of Industry and Information Technology and the Medical Device Registration Management Department of the National Medical Products Administration announced the "Winning Units of the AI Medical Device Innovation Task Leaderboard," comprising 104 entities (67 key industry enterprises and 37 authoritative medical institutions). The AI medical device "Task Leaderboard Initiative" has officially achieved "industry leadership." Among them, UnityMed's product "Development of an Intelligent Auxiliary Treatment System for Intracranial Aneurysms (also known as: Intracranial Aneurysm Auxiliary Treatment Software)" was successfully selected as a winning unit in the "Intelligent Auxiliary Treatment Products" category based on its profound technical expertise. The featured product, "Development of an Intelligent Auxiliary Treatment System for Intracranial Aneurysms (also known as: Intracranial Aneurysm Auxiliary Treatment Software)," is independently developed by Kunming UnityMed Technology Co., Ltd., a wholly-owned subsidiary of UnityMed. It utilizes advanced image recognition technology specifically designed for analyzing images of intracranial aneurysms. By automatically analyzing the morphological characteristics of unruptured intracranial aneurysms and their parent vessels, it provides clinicians with precise data analysis. Additionally, based on the analysis results, it intelligently recommends suitable specifications for initial embolization coils used in interventional treatment, addressing the lack of preoperative planning and surgical strategy solutions for unruptured intracranial aneurysms in China. This offers robust decision-making support for clinicians during preoperative planning for intracranial aneurysms.

VirtueMed Wins Award from the Chinese Invention Association

Second Prize of the 2024 "Invention and Entrepreneurship Award for Innovation"

Recently, the China Association of Inventions officially announced the list of winners for the 2024 "Invention and Entrepreneurship Award – Innovation Award." Wezual, in collaboration with the Chinese People's Liberation Army General Hospital and the University of Science and Technology Beijing, received the second prize for their groundbreaking achievement: "An Efficient Application Strategy of Artificial Intelligence, Mixed Reality, and Precision Navigation and Positioning Technologies in Digital Surgery." This award highlights the company's profound strength and forward-looking vision in the field of medical technology. Since its establishment in 2005 with the approval of the Ministry of Science and Technology, the "Invention and Entrepreneurship Award – Innovation Award" from the China Association of Inventions has become a shining star in China’s invention and innovation sector — representing the highest national recognition for inventors and their achievements, and serving as a significant driving force for promoting technological innovation and industrial integration. This award not only affirms Wezual's technical innovation capabilities but also highly commends its contributions to advancing the digital transformation of healthcare and improving the quality of medical services.

Cloud Boat Biotech Selected

"Guangdong Provincial Single Champion Enterprise in Manufacturing Industry"

Recently, the Guangdong Provincial Department of Industry and Information Technology announced the list of provincial-level manufacturing single champion enterprises in Guangdong Province for 2024. Cloud Boat Biotech has made a strong entry into the list with its "high-throughput customized gene vector" product. Since its establishment, Cloud Boat Biotech has consistently focused on the research and application of gene delivery technology. Gene delivery technology is crucial for accelerating life science research and the clinical application of gene drugs, and it is expected to make gene drugs the third major pillar of the biopharmaceutical industry, following small-molecule chemical drugs and large-molecule antibody protein drugs. Cloud Boat Biotech innovatively developed the online gene vector design and ordering platform VectorBuilder (VectorBuilder), and created an offline "Lego-style" high-throughput vector production platform, streamlining the entire process from vector design to preparation, achieving modular and standardized production of gene vectors, greatly enhancing research efficiency, and providing strong support for global life science research. At the same time, Cloud Boat Biotech has extended its business scope downstream, creating an all-encompassing industrial chain service system that includes scientific research vectors, gene delivery CRO, and gene vector CDMO services. Forward-looking layout and strong innovation capabilities have enabled Cloud Boat Biotech to build up significant business barriers and secure a leading position in the field of gene delivery.

Hanchen Light Wing Successfully Recognized as

"2024 Sichuan Provincial Enterprise Technology Center"

On August 21, 2024, the Sichuan Provincial Department of Economy and Information Technology released the "Public Notice on the Proposed List of Sichuan Provincial Enterprise Technology Centers for 2024." After undergoing multiple stages including independent application, city-level recommendation, preliminary system evaluation, expert review, and on-site verification, Hanchen Optoelectronics was successfully recognized as a Sichuan Provincial Enterprise Technology Center for 2024. This honor represents full recognition by authorities at all levels of Hanchen Optoelectronics' technological innovation capabilities, innovative mechanisms, management standards, development potential, and contributions to industry technological advancement. Hanchen Optoelectronics, established in 2016 and headquartered in Chengdu Tianfu International Bio-Town, focuses on the life sciences field. It is committed to developing high-throughput automated molecular detection equipment with independent innovation to serve global biotech customers and promote the application and development of molecular detection technologies in medical testing, modern agriculture, health management, drug research and development, and other fields.

Beizhuo Medical Honored

Medical Device Quality Management System Certification

Recently, Beizhuo Medical was awarded the GB/T 42061-2022 idt ISO 13485:2016 Medical Device Quality Management System Certification. This authoritative certification not only recognizes Beizhuo Medical’s high standards and strict requirements across the entire chain of product development, production management, and quality control but also demonstrates to the world the firm steps of "Made in China" transforming into "Quality Made in China." As a globally recognized standard for medical device quality management systems, every detail of ISO 13485:2016 represents a solemn commitment to patient safety. Using this as a benchmark, Beizhuo Medical ensures that every product, from design to delivery, can withstand the most rigorous safety and efficacy tests, allowing the warmth of medical technology to reach every corner in need. Beizhuo Medical's core business focuses on the field of neuroscience. By integrating resources from medical-engineering complexes to digitally empower this field, it collaborates with top clinical research institutions in China to transform research outcomes, forming two R&D pipelines: high-end leadership and rapid implementation. These cover digital surgical systems and 5G remote applications, brain network neuromodulation technologies, and electrophysiological monitoring traceability technologies.

Gloria Tech Collaborative R&D Project Honored

Third Prize of Jiangsu Provincial Science and Technology Award General Projects

Recently, the Jiangsu Provincial Department of Science and Technology announced the comprehensive review results of the 2023 Jiangsu Provincial Science and Technology Awards. The project "Research and Application of Multi-Agent Key Technologies in Emergency Search, Rescue, and Treatment," jointly completed by Genvict Technology, the General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army, Nanjing University of Information Science & Technology, and others, was awarded the third prize in the General Projects category of the Jiangsu Provincial Science and Technology Award. The project "Research and Application of Multi-Agent Key Technologies in Emergency Search, Rescue, and Treatment" aims to meet the search-rescue-treatment-transport needs for casualties during major natural disasters, accidents, and other public emergencies. It developed multi-agent devices such as dual-mode drones for emergency search and rescue, casualty transport pods, unmanned flying rescue boats, and multi-parameter health monitoring and diagnostic all-in-one machines. It achieved breakthroughs in a series of key technologies including rapid detection and positioning of casualties, on-site emergency treatment, safe transport of severely injured patients, and intelligent monitoring of vital signs. It solved major challenges such as integrating diverse and heterogeneous equipment, providing rapid on-site treatment, safely evacuating casualties, and enabling real-time monitoring of vital signs, thereby improving the timeliness, precision, efficiency, and safety of casualty search-rescue-treatment-transport under harsh emergency conditions.