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Magenta Medical's Self-Developed Weixin Jie™ Intracranial Electrolytic Detachable Coil Approved for Marketing

Magenta Medical's Subsidiary Viestar Applies for Medical Device Registration and Gets Accepted

Magenta Medical BVB2000 Series Ophthalmic Optical Biometer Receives Class II Medical Device Registration Certificate

On July 30, 2024, WuXi AppTec released its financial report for the first half of 2024. The report indicated that in H1 2024, WuXi AppTec achieved revenue of 17.24 billion yuan, a year-on-year decrease of 8.6%, or a decrease of 0.7% year-on-year excluding COVID-19 impacts; the company's net profit attributable to shareholders was 4.24 billion yuan, a year-on-year decrease of 20.2%, and the adjusted net profit attributable to shareholders was 4.37 billion yuan, a year-on-year decrease of 14.2%.

On the evening of July 25, 2024, United Imaging Healthcare issued an announcement stating that it plans to invest 120 million yuan of its own funds in Sichuan Jiuyiyuan Particle Technology Co., Ltd., acquiring 10% of its equity after the capital increase. Given that Shanghai United Investment Co., Ltd. (hereinafter referred to as Shanghai United) is a legal entity directly holding more than 5% of United Imaging Healthcare's shares, Shanghai United also plans to acquire 5% of Jiuyiyuan’s equity after the capital increase with its own funds. This transaction constitutes a joint investment with related parties.

On July 25, 2024, Xintai Medical announced that its wholly-owned subsidiary, Shanghai Shape Memory Alloy Materials Co., Ltd., had obtained the medical device registration certificate for the RF-Lance® disposable radiofrequency atrial septal puncture needle product from the National Medical Products Administration of the People's Republic of China.

Recently, Siemens Healthineers Plans to Close Its Rapid Diagnostics Unit and Cut About 90 Jobs; Demand Peaked During the COVID-19 Pandemic but Has Since Dropped Significantly. Siemens Healthineers stated that due to a significant decline in demand, it plans to close its rapid diagnostics unit, becoming the latest medtech company to make cuts this year. The unit was "a small player in the molecular diagnostics space" and contributed "only a small portion of Siemens Diagnostics' total revenue." The closure of this unit will affect approximately 90 employees, most of whom work in Luxembourg. Siemens has already implemented layoffs in the U.S. as part of a broader restructuring and plans to complete the closure by September.

Recently, the National Medical Products Administration approved the innovative product registration application of "Bioabsorbable Rapamycin-Eluting Coronary Stent System" by Shanghai MicroPort Medical (Group) Co., Ltd. Firesorb (Huo Niao) is the world's first next-generation fully bioabsorbable cardiac stent independently developed by Shanghai MicroPort. The product began its research and development in 2009, making it a 15-year journey so far, and entered the special review process for innovative medical devices, known as the "green channel," in May 2016. Firesorb (Huo Niao) continues the targeted drug-eluting technology of the first-generation product Firehawk (Huo Ying), achieving precise drug positioning through aerospace-grade intelligent targeting and positioning systems, combined with ultra-precision processing equipment and techniques using precision micro-dosing spray control systems. This ensures that the drug coating is applied only on the side of the stent facing the vessel wall, reducing the effective drug load to one-fourth of the typical amount while maintaining the same therapeutic efficacy.

Recently, Roche Diagnostics' series of cerebrospinal fluid (CSF) assay kits for Alzheimer's disease (including Elecsys® β-Amyloid (1-42) CSF II, Elecsys® Phospho-Tau (181P) CSF, Elecsys® Total-Tau CSF assay reagents, as well as 9 products such as matching calibrators and quality control materials) have officially been approved by the Hainan Provincial Drug Administration. As urgently needed imported clinical medical devices, they will soon be implemented at Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine.

Recently, GoLight Medical's stock price surged over 9% as two dry eye diagnostic devices received medical device registration certificates, meeting the growing demand of patients with dry eye syndrome. The company turned its 2023 financial performance from loss to profit. GoLight innovated these two dry eye diagnostic devices, which provide a more comprehensive solution for dry eye diagnosis, enabling quick and non-invasive full dry eye examinations while significantly improving patient comfort and data accuracy during testing.

Recently, Haier Group has transformed and laid out in the medical field. By acquiring and establishing hospitals and medical device companies, it is building a medical empire. It has completed the acquisition of Shanghai RAAS, a blood products giant, and now owns three listed companies. This acquisition of Shanghai RAAS by Haier Medical is already its third controlling stake in a listed company. Shanghai RAAS is a leading blood products manufacturing enterprise in China with a reasonable industrial structure, comprehensive product categories, and high plasma utilization. Its products cover three major categories: albumin, immunoglobulin, and coagulation factors.

Recently, New Industries announced that the company had received two Medical Device Registration Certificates issued by the Guangdong Provincial Drug Administration. The product names are: Anti-β2-Glycoprotein 1 Antibody IgA Assay Kit (Magnetic Particle Chemiluminescence Method) and Prealbumin Assay Kit (Immunoturbidimetry). New Industries is a biomedical company specializing in the research, production, and sales of "clinical laboratory analytical instruments and in vitro diagnostic reagents." It has now formed a strong professional team: Reagent Research and Production Center, Instrument Research and Manufacturing Center, and Marketing Center. It has a 19-year history in the field of quantitative immunoassay.

Recently, Zhonghong Medical announced that its subsidiary, Jiangxi Kelun Medical Device Manufacturing Co., Ltd. (referred to as "Kelun Medical"), has recently obtained the "Medical Device Registration Certificate" issued by the National Medical Products Administration. The medical device registration certificate for the disposable intravenous indwelling needle applied by Kelun Medical has been approved.

Recently, Contec Medical announced that its wholly-owned subsidiary, Changsha Contec Medcore Biotechnology Co., Ltd., has recently received three "Medical Device Registration Certificates of the People's Republic of China" issued by the Hunan Provincial Drug Administration, including two for glucose meters and one for a lipid analyzer.

Recently, Sanyou Medical announced that the company has recently received the "Medical Device Registration Certificate of the People's Republic of China" issued by the National Medical Products Administration for its 3D-printed "Metal Additive Manufacturing Cervical Fusion Cage." The fusion cage is designed and independently developed by the company based on the theory of porous bone ingrowth. This product features excellent anatomical scaffold functionality, manufactured through an additive manufacturing process, consisting of a porous structure and support framework, with outstanding biomechanical performance. Additionally, the porous structure mimicking bone trabeculae can better achieve bone fusion effects. The additive manufacturing process allows for a high degree of customization of interbody fusion cages and can quickly meet clinical needs, helping doctors improve treatment outcomes.

Recently, the 2024 Yangtze River Delta Region Medical Device Collaborative Supervision Work Conference was held in Qingpu District, Shanghai. This conference was jointly organized by the drug regulatory authorities of Shanghai, Jiangsu, Zhejiang, and Anhui provinces, aiming to promote the coordinated development of medical devices in the Yangtze River Delta region, strengthen regional regulatory cooperation, and enhance overall regulatory efficiency. The conference focused on discussing the necessity, feasibility, and related content of cross-provincial off-site warehouse supervision pilots for third-party logistics enterprises of medical devices in the Yangtze River Delta region. The conference concluded that carrying out this pilot work is a beneficial exploration and practice to implement the spirit of "further promoting the integrated development of the Yangtze River Delta," support high-quality integrated development in the Yangtze River Delta, and serve third-party logistics enterprises of medical devices in the Yangtze River Delta region in conducting cross-regional industrial chain supply chain division and cooperation.

Recently, the Device Supervision Department of the National Medical Products Administration held a symposium on the investigation and handling of medical device cases in Yinchuan, Ningxia. The meeting heard reports from 11 provincial medical product administrations including Ningxia, Hebei, Jiangsu, Zhejiang, Fujian, Hubei, Shaanxi, Gansu, Qinghai, Xinjiang, and the Xinjiang Production and Construction Corps regarding their progress in handling medical device cases. Participants exchanged experiences, analyzed challenges, and discussed plans for key case investigations. The meeting emphasized that drug regulatory authorities at all levels must follow the requirements of the national drug regulation symposium, further enhance their political awareness, strictly implement the "four most stringent" requirements, adhere to bottom-line thinking, increase efforts in investigating leads, and handle violations according to laws and regulations to ensure public safety in the use of medical devices.

Recently, in order to strengthen the supervision and management of medical devices and ensure the safety and effectiveness of medical device product quality, the National Medical Products Administration organized a quality supervision inspection of 10 varieties including electrocardiographs, soft contact lenses, and Helicobacter pylori antibody detection reagents. Thirteen batches (units) of products were found to be non-compliant with standard regulations. Regarding the non-compliant products discovered during the inspection, the National Medical Products Administration has required provincial medical products administration departments where the relevant companies are located to promptly make administrative decisions according to requirements and disclose them to the public. Provincial medical products administration departments must urge companies to conduct risk assessments on non-compliant products, determine the recall level based on the severity of the medical device defects, proactively recall the products, and publicly disclose the recall information.

Recently, the National Medical Products Administration issued the "Guiding Principles for On-site Inspection of Quality Management Standards for Medical Device Operations." These "Guiding Principles" apply to on-site inspections for medical device operation permits (including changes and renewals), post-filing on-site inspections, and other types of supervisory inspections. During the inspection process, medical device operating enterprises can determine reasonable missing items based on their mode of operation, scope of operations, types of products operated, and other characteristics, providing written justification for these determinations, subject to confirmation by the inspection team of the drug regulatory authority. For on-site inspections of medical device operation permits (including changes and renewals), the inspection results are determined based on the proportion of non-conforming key items (marked with “※”). Enterprises must complete rectifications within 30 working days after the completion of the on-site inspection and submit a rectification report to the original inspection department in one submission.

Recently, the General Office of the Shanghai Municipal People's Government issued several opinions on supporting the full-chain innovative development of the biopharmaceuticals industry. According to these opinions, the Shanghai municipal government will provide up to 3 million yuan in financial support for products entering the special review procedures for innovative medical devices at the national and municipal levels. In addition, for the aforementioned products that obtain registration certificates for the first time and are produced locally, support will be provided according to regulations, amounting to no more than 40% of R&D investment, with a maximum of 8 million yuan. The maximum cumulative support amount each entity can receive annually is 30 million yuan. These measures aim to promote the innovative development of Shanghai’s biopharmaceuticals industry, enhance the R&D level and market competitiveness of medical devices. By providing financial support, companies are encouraged to increase R&D investment, accelerate the development process of innovative medical devices, and improve the technological content and added value of products.