Medical News Morning Briefing | New Priority Review List for Medical Devices Released; Germany's Largest Biotech M&A Deal Approved

1. NMPA Incorporates 15 Testing Methods, Including Toothpaste pH Testing, into the Cosmetics Safety Technical Specification

Recently, the National Medical Products Administration organized the drafting of 15 testing methods, including the "Testing Method for Toothpaste pH Value." These methods were reviewed and approved at the plenary session of the Cosmetic Standards Expert Committee and have been officially released. The 15 testing methods, including the "Testing Method for Toothpaste pH Value," are newly added toothpaste testing methods and have been incorporated into the "Cosmetic Safety Technical Specification (2015 Edition)." Starting from December 1, 2024, the testing for toothpaste registration, filing, and sampling inspections must adopt the testing methods announced in the notice. (National Medical Products Administration)

2. CMDE Announces New Review Results for Priority Approval Applications of Medical Devices

Recently, according to the former China Food and Drug Administration's "Priority Review Procedure for Medical Devices" (Announcement No. 168 of 2016), the Center for Medical Device Evaluation reviewed the applications for priority approval of medical device registrations. It was determined that certain projects meet the criteria for priority approval, and they have been proposed for priority review and public announcement. The selected product is the toric intraocular lens produced by Henan Saimeishi Biotechnology Co., Ltd., a medical device used in ophthalmic surgeries to replace damaged or missing natural lenses in patients' eyes. The reason for selection is that the product falls under the category of medical devices "included in the National Key Research and Development Program." (Center for Medical Device Evaluation)

3. Beijing Municipal Health Commission Releases "Beijing 2024 Work Plan for Improving Medical Services"

Recently, the Beijing Municipal Health Commission released the "Beijing 2024 Work Plan for Improving Medical Services," requiring all secondary-level and above medical institutions in Beijing to implement a comprehensive appointment system for non-emergency visits, with appointment times accurate to within 30 minutes. The plan also calls for optimizing the unified appointment registration platform for Beijing and improving the appointment registration services of second- and third-tier hospitals, aiming to connect over 200 such hospitals directly to the platform for resource sharing this year. Online intelligent or manual triage services will be provided to help patients accurately choose the appropriate departments for registration. The registration process will be streamlined by simplifying steps such as identity information binding. Additionally, interpretation services for test results will be enhanced within corresponding treatment units after the results are returned. (The Paper)

4. Yeasen Withdraws Application for STAR Market IPO

Recently, according to the disclosure by the Shanghai Stock Exchange (SSE), due to Yisheng Biotechnology (Shanghai) Co., Ltd. and its sponsor withdrawing the application for issuance and listing, in accordance with the relevant provisions of Article 63 of the "SSE Stock Issuance and Listing Review Rules," the SSE has terminated its issuance and listing review. Yeasen is a biotechnology company driven by protein engineering and enzyme evolution technologies, focusing on core raw materials upstream in the life science industry chain. It engages in the research, development, production, and sales of molecular, protein, and cell biological reagents. Its core products cover qPCR series, NGS series, reverse transcription series, nucleic acid extraction and purification series, PCR series, molecular cloning series, in vitro transcription series, antibodies, etc. Previously, the company planned to raise 1.109 billion yuan (CNR).

5. Johnson & Johnson partners with NVIDIA to develop AI surgical system

Recently, Johnson & Johnson Medical Technologies announced a partnership agreement with Nvidia. The two parties will jointly develop new artificial intelligence applications. According to the agreement, Johnson & Johnson will gain access to Nvidia’s IGX edge computing platform and Holoscan edge AI platform. The aim is to leverage Nvidia's computing platforms and AI technologies to support real-time data analysis for surgical software and devices in operating rooms, thereby enhancing surgical performance. The two sides also plan to apply AI technology to medical imaging analysis and disease diagnosis, helping to make faster and more accurate diagnostic and treatment decisions. The collaboration will also extend to the field of medical education and training. By utilizing Nvidia’s virtual reality and augmented reality technologies, medical students and doctors can undergo more realistic and effective training. (Financial World)

6. Gene Sequencing Technology Developer Insight Tech Completes Tens of Millions in Financing

Recently, Guangzhou Insight Technology Co., Ltd. announced the completion of an angel round of financing worth tens of millions of yuan. This round of financing was led by Forcefield Ventures (IMO Ventures), with participation from Tiantu Capital, Yae Capital, and other institutions.

Insight Technology was founded in January 2022 by several doctoral graduates from Stanford University in the United States and Imperial College London in the United Kingdom. Based on solid-state nanopore single-molecule detection technology, the company has independently developed accurate, fast, low-cost, and miniaturized biomacromolecule detection equipment and gene sequencers, along with supporting reagents and consumables. Its engineering prototype has been successfully built. This round of financing will be used for the research and development of solid-state nanopore detection equipment and the expansion of application scenarios. A solid-state nanopore sequencer targeting the scientific research market is expected to be launched in the second half of this year. (Yiou)

7. "World's First" Compliance Digital Product - "Compliance Connect"

Since the full implementation of Good Manufacturing Practice (GMP) for medical devices in 2018, the regulation of medical devices has become increasingly stringent. Industry professionals now face routine spot checks, regular unannounced inspections, and the normalization of information disclosure. To assist medical device companies in addressing risks during the compliance process and achieving compliance objectives, OrthoMed, a globally leading service provider and regional operator in the medical device industry, has independently developed and launched "CompliancePass," a "world-first" digital compliance product. CompliancePass serves as a guide to the regulatory requirements throughout the entire lifecycle of medical device products and ensures comprehensive compliance in corporate operations and product development. It intelligently presets compliance standards, provides real-time feedback on compliance status, proactively screens for compliance risks, and delivers precise guidance for compliance responses. (Compiled by OrthoMed)

8, 21.2 Billion! The Largest Acquisition in German Biotech Industry Approved

Recently, the German antitrust authority, the Federal Cartel Office, issued a statement approving the acquisition of German biotech company MorphoSys by Swiss pharmaceutical giant Novartis. On February 5, 2024, Novartis announced that it would acquire MorphoSys for €68 per share, or a total of €2.7 billion (approximately 21.2 billion RMB) in cash. Once completed, this transaction will be the largest acquisition in the German biotech sector. The focus of Novartis' acquisition is Pelabresib, a self-developed product by MorphoSys and currently the most advanced BET inhibitor globally. This acquisition will further expand and complement Novartis' product portfolio in its priority therapeutic area of oncology, while strengthening Novartis' global presence in hematology. (Investment Community)