Jiutai Think Tank Pharmaceutical and Medical Equipment Weekly Vol 03

Mondo International Updated on 2024-01-31

What's new.

[Industry dynamics].In 2023, a total of 61 innovative medical devices will be approved for marketing

According to the official website of the National Medical Products Administration (NMPA), a total of 61 innovative medical devices will be approved for marketing by the NMPA in 2023Year-on-year **13%.

Among the 61 innovative medical devices approved, 19 cardiovascular-related devices, 3 ophthalmic devices, 9 imaging devices, 10 surgical robot devices, 4 orthopedic implantable devices, and 16 other innovative medical devices were approved. The products cover patient monitors, hybrid closed-loop insulin infusion systems, hemodialysis urea clearance calculation software, etc.

In 2023, there will be 6 new listed companies in the field of medical devices. They are: Hangzhou Adicon Medical Laboratory Center, Harbin Fuerjia Technology Co., Ltd., Sichuan Gangtong Medical Equipment Group Co., Ltd., Chongqing Xishan Science and Technology Co., Ltd., Hangzhou AGS Medical Technology Co., Ltd., Shanxi Jinbo Biomedical Co., Ltd., and Shanxi Jinbo Biomedical Co., Ltd

Among them, there are 2 science and technology innovation boards, 1 main board, 2 gems, and 1 Beijing ** exchange. It is worth mentioning that since 2020-2022, the domestic medical device industry has experienced a listing boom, with the number of listed companies accounting for nearly half of the total in three years, and the number of listings in 2023 has dropped by 22% compared with 2022.

Henan Provincial ** Procurement Network issued a penalty announcement, saying that Henan Dong * Medical Technology * * participated in the bidding and won the bid for the critical medical resource construction equipment procurement project of Kaifeng Infectious Disease Hospital, but the company gave up the bid qualification after the project was completed and refused to sign a ** procurement contract with the purchaser. The Kaifeng Municipal Bureau of Finance included the company in the list of bad records, banned from participating in ** procurement activities within one year, and issued an administrative penalty of notification.

This kind of incident is not an isolated case, and the recent abandonment of medical device manufacturers has become the main reason for their loss of business opportunities. All localities have begun to comprehensively and strictly investigate and crack down on such illegal acts, and publicly report typical cases. According to statistics, in November 2023, China's ** procurement network updated a total of 75 information records involving serious illegal and untrustworthy behaviors, of which 13 were abandonment behaviors of refusing to sign a procurement contract with the purchaser or giving up the qualification to win the bid without a legitimate reason, accounting for about 173%。These behaviors have seriously disrupted the bidding process of ** procurement and disrupted the normal order of procurement activities.

Recently, eight departments, including the Hainan Provincial Medical Security Bureau, the Hainan Provincial Health Commission, and the Hainan Provincial Drug Administration, jointly issued the "Several Measures to Support the Development of Innovative Drugs and Devices in Hainan Province", proposing 24 measures to ensure that innovative drugs and devices are effectively connected with medical security systems after passing the review and approval, promoting the linkage and coordinated development of the "three medicines", and accelerating the listing and use of innovative drugs and devices through review and approval.

The Measures also propose to establish a first-class formation mechanism for newly approved innovative drugs and devices to enter the market. At the same time, the independent pricing mechanism of medical institutions during the trial period of the new medical service ** project will be optimized, and the fee can be charged after filing. Support and encourage patients to use innovative drugs and devices, and use payment innovation to promote industrial innovation. For eligible innovative drugs and devices, the application will be completed within 5 working days, and a green channel will be opened for major innovative projects that optimize the diagnosis and treatment plan for major diseases or fill the diagnosis and treatment gap, and the review will be completed within 10 working days after receiving the application and reported to the National Health Insurance Administration.

Recently, the seventh meeting of the Standing Committee of the 14th National People's Congress passed the "Amendment (12) to the Criminal Law of the People's Republic of China", which will come into force on March 1, 2024. The amendment clarifies that criminal liability will be strengthened in some serious cases of bribery. Those who offer bribes in areas such as ecology and environment, finance, production safety, food and drugs, disaster prevention and relief, social security, education, and medical care and carry out illegal and criminal activities will be severely punished. "Where the circumstances are especially serious, or where the interests of the state suffer especially heavy harm, a sentence of 10 or more years imprisonment or indefinite imprisonment is to be given, and a concurrent fine or confiscation of property. ”

【Enterprise dynamics】Endoscope platform enterprise Opmandi completed tens of millions of yuan of strategic financing

Guangdong Op Mandi Technology Co., Ltd. has completed tens of millions of yuan in strategic financing, led by Cinda Kunpeng, and Haoyue Capital has served as the exclusive financial advisor for several rounds.

Founded in 2013, as the world's leading endoscope platform innovation enterprise, Opmandi focuses on the R&D and production of high-end medical devices, including full-featured endoscope imaging platform, fluorescence laparoscope series, white light laparoscope series, electronic soft endoscope series, disposable scope series, fluorescent contrast agent, energy device consumables and other products, which continue to extend in the field of minimally invasive surgery, and has established a vertical integration of raw materials, production, R&D, warehousing and logistics to connect the global sales network** Chain system.

【Enterprise dynamics】Hannuo Medical, an innovative enterprise in the field of ECMO, has received another investment of more than 100 million yuan

Recently, Shenzhen Hannuo Medical Technology Co., Ltd. (hereinafter referred to as "Hannuo Medical") has received more than 100 million yuan in Series E investment, which is led by Guangdong Traditional Chinese Medicine Health ** managed by China Development Bank Capital and Guangdong Hengjian Holdings, and is also a new round of financing after Hannuo Medical completed hundreds of millions of yuan in Series D financing in early 2023. Founded in 2018, Hannuo Medical is a high-tech enterprise focusing on the research and development of high-end medical devices for acute and critical care extracorporeal life support, and on January 4, 2023, the company's self-developed first domestic extracorporeal membrane oxygenation system (ECMO) was approved for marketing, making China the fourth country with ECMO technology industrialization capabilities after the United States, Germany and Italy. Hannuo Medical has become the only enterprise in China that has mastered the R&D and production technology of a full set of ECMO monitoring system, blood pump system, membrane lung system and pipeline consumables. At the same time, the two products independently developed by Hannuo Medical have been approved one after another, breaking through the "stuck neck" technology again and filling the gap in China.

[Focus on AI].The AI giant has been accused of infringing intellectual property rights, and writers have filed a class action lawsuit

0penai and Microsoft have been massively sued for "stealing" someone else's work. Famous American ** writers have filed a class action lawsuit, accusing OpenAI and Microsoft of infringing the intellectual property rights of many writers by using massive amounts of copyrighted content, including plaintiffs' works, to train their large language models without permission.

This incident reminds us that in today's rapid development of artificial intelligence, although AI has brought a lot of convenience to our daily work, it has also raised concerns about copyright issues. The reasonable use of AI tools and the circumvention of copyright issues have become a difficult problem to be solved urgently, and the correct use method needs to attract the attention and attention of AI tool users.

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