21 Health News Daily|The 2024 medical insurance fund flight inspection work plan was released, and the first in vitro full magnetic levitation artificial heart in China was approved for marketing

This is "21 Health News", welcome to pay attention to the latest events in the pharmaceutical and health industry with the 21st Century Business Herald New Health Team!

Policy Trends

●The State Food and Drug Administration issued the "Measures for the Administration of Cosmetics Inspection"

On April 29, the website of the State Food and Drug Administration issued the "Announcement on the Issuance of the Administrative Measures for the Inspection of Cosmetics".

In order to strengthen the supervision and management of cosmetics and standardize the inspection of cosmetics, in accordance with the "Regulations on the Supervision and Administration of Cosmetics", "Measures for the Administration of Cosmetics Registration and Filing", "Measures for the Supervision and Administration of Cosmetics Production and Operation" and other laws and regulations, the State Food and Drug Administration has organized and formulated the "Measures for the Administration of Cosmetics Inspection", which is hereby promulgated and will come into force on November 1, 2024.

●The four departments issued the "2024 Medical Security Fund Unannounced Inspection Work Plan"

On April 28, the National Health Insurance Administration, together with the Ministry of Finance, the National Health Commission, and the State Administration of Traditional Chinese Medicine, issued the "2024 Medical Security Fund Unannounced Inspection Work Plan" (hereinafter referred to as the "Work Plan") to launch the 2024 Medical Security Fund Unannounced Inspection (hereinafter referred to as the "Unannounced Inspection") nationwide.

In 2024, the national flight inspection will adhere to the following principles in terms of covering regions and institutions: First, adhere to wide geographical coverage. Unannounced inspections will achieve full coverage of all provinces across the country, and further increase the scope of random inspection cities. In principle, the number of cities to be inspected in each province has increased from one to two per province per year, and the capital cities of each province must be checked. The second is to insist on full coverage of institutional types. Each province will simultaneously inspect a certain number of public designated medical institutions, private designated medical institutions and designated retail pharmacies. The third is to carry out "looking back" for the first time. This year, a certain percentage of the designated medical institutions that have been inspected by flights in previous years will be selected for a "retrospective". The main consideration of this measure is to avoid the institutions that have been checked that they will not be checked again in a few years, and there will be slack ideas in standardizing the use of medical insurance funds, and guiding designated institutions to strengthen internal management and standardize the use of funds as active awareness and conscious action.

Focus on inspecting the use and management of the medical insurance fund and the construction and implementation of relevant internal control systems during the period from January 1, 2022 to December 31, 2023, and retrospectively inspect previous years or extend inspections to 2024 if necessary.

For designated medical institutions. Focus on five aspects: First, focus on the fields of critical care medicine, anesthesia, lung tumors, etc., investigate and deal with the illegal use of medical insurance funds, and focus on investigating and dealing with fraud and insurance fraud. The second is to focus on cardiovascular medicine, orthopedics, blood purification, rehabilitation, medical imaging, clinical testing and other areas that have been key to inspection and self-examination and self-correction in previous years, and check whether they are self-inspected and rectified as required. The third is to focus on whether the problems found in the previous annual inspection still exist and whether the rectification is in place. The fourth is to focus on the online procurement of drug consumables, focusing on whether public medical institutions purchase all the required drug consumables on the provincial centralized procurement platform in accordance with the regulations. Fifth, for patients who are admitted to other provinces and places for medical treatment, check whether there is any illegal use of medical insurance funds.

For designated retail pharmacies. Focus on investigating and dealing with three aspects: First, false drug purchases. Falsifying prescriptions or expense lists, emptying or stealing medical insurance cards or medical insurance electronic vouchers. The second is to participate in the resale of medical insurance drugs. The third is to exchange drugs. Replace drugs or other commodities that are not paid by the medical insurance fund with medical insurance drugs for medical insurance settlement, and forge or alter the bills and accounts of "purchase, sale and storage" of medical insurance drugs.

Approval of drugs and devices

●The first in vitro full magnetic levitation artificial heart in China was approved for marketing

Recently, the National Medical Products Administration (NMPA) approved the registration application of "Extracorporeal Ventricular Assist Device" and "Extracorporeal Ventricular Assist Pump Head and Tubing" innovative products of Xinqing Medical (Suzhou) Co., Ltd.

The extracorporeal ventricular auxiliary equipment is composed of a magnetic levitation motor, a control host and accessories, and an extracorporeal ventricular auxiliary pump head and a pipe route are composed of a centrifugal pump head, a side hole through joint, a luer cap, a pipe clamp and a cable tie. The two products are used in combination to form a side loop branch connected to the blood vessels, and the impeller in the pump head is driven to rotate in suspension by controlling the host and magnetic levitation motor, providing kinetic energy for blood pressurization, which is used for temporary extracorporeal mechanical circulation assistance for patients after cardiac surgery.

The product adopts full magnetic levitation blood pump technology, which has anti-vibration, anti-torsion performance and better blood flow field design, which can effectively reduce the average incidence of hemocompatibility-related complications.

It is worth mentioning that this product is the first in vitro ventricular auxiliary equipment and special consumables with full magnetic levitation technology in China, and the approval of the listing represents another new breakthrough in domestic high-end medical devices.

●Pfizer's gene therapy was approved by the FDA

On April 27, Pfizer announced that the U.S. FDA has approved its developed one-time gene therapy Beqvez (fidanacogene elaparvovec) for the treatment of adult patients 18 years of age or older with moderate to severe hemophilia B, who are receiving coagulation factor IX (FIX) prophylaxis, or who have current or past life-threatening bleeding, or who have recurrent severe spontaneous bleeding events. Neutralizing antibodies targeting the adeno-associated virus serotype Rh74var (AAVRh74var) capsid were not detected in the U.S. FDA-approved test in these patients.

capital market

●Shenzhen established a synthetic biology industry fund

Recently, Shenzhen Synthetic Biology Industry Private Equity Investment Fund Partnership (Limited Partnership) was established with a registered capital of 1.5 billion yuan.

It is reported that the synthetic biology industry fund is located in Guangming District, Shenzhen, which is an important gathering area for synthetic biology enterprises in Shenzhen.

According to the equity penetration of the enterprise investigation, the partnership is jointly held by Shenzhen Guidance Fund Investment Co., Ltd. and Shenzhen Hongqi Venture Capital Co., Ltd. The executive partner is Shenzhen Capital Laterite Private Equity Fund Management (Shenzhen) Co., Ltd., which is wholly owned by Shenzhen Capital Group. From the perspective of capital contribution, the synthetic biology industry fund is mainly funded by Shenzhen Guidance Fund and Shenzhen Capital Group, with subscription ratios of 40% and 39% respectively. Other funders also include a number of district-level guidance funds in Shenzhen, such as Guangming District Guidance Fund and Dapeng New Area Guidance Fund.

●Innosys, a CRO company, submitted for registration on the Science and Technology Innovation Board

On April 26, according to the official website of the Shanghai Stock Exchange, Shanghai Innosys Biotechnology Co., Ltd. (hereinafter referred to as Innosys Biotechnology) submitted for registration on the Science and Technology Innovation Board, and its sponsor is Haitong Securities, which intends to raise funds of 1.602 billion yuan.

As one of the earliest companies in China with GLP certification of NMPA, GLP certification of OECD and GLP inspection of the US FDA, it is in line with international standards and has competitive international service capabilities in the industry, providing a full range of new drug research services that meet domestic and international application standards for global pharmaceutical companies and scientific research institutions.

●Baize Medical Group submitted a listing application on the Hong Kong Stock Exchange

On April 26, according to the official website of the Hong Kong Stock Exchange, Baize Medical Group submitted an application for listing on the Hong Kong Stock Exchange, with CMB International as the sponsor.

According to the prospectus, Baize Medical Group is a leading oncology medical group in China mainly engaged in investment and provision of medical-related services. As of the Latest Practicable Date, Baize Medical Group operated and managed eight hospitals in Beijing, Tianjin, Shanxi, Anhui and Henan provinces through direct equity ownership of six private for-profit hospitals and management rights of two private non-profit hospitals, focusing on the provision of full-cycle oncology medical services.

Industry events

●The domestic "blood flow directing dense mesh stent" has brought the treatment of intracranial aneurysm into the era of "automatic gear".

Recently, at the 2024 Zhongguancun Forum Annual Meeting, Eco Medical unveiled its core product Lattice®. It is reported that the new weapon "Lattice® Blood Flow Directing Dense Mesh Stent" independently developed by Eco for the treatment of intracranial aneurysms has been approved for marketing by the national innovative medical device green channel, which is currently the largest approved indication range of similar products, and for the first time, the indication scope of dense mesh stent has been extended to the treatment of small and medium-sized aneurysms in the vertebral artery, filling the gap in clinical needs.

An internal aneurysm is known as a "ticking time bomb" in the brain, and it is an abnormal bulge in the wall of an intracranial artery that can rupture at any time and cause intracranial hemorrhage. Data show that in China's 35~75-year-old population, the prevalence of unruptured aneurysms is as high as 7.0%, with nearly 100 million affected people. The case fatality rate of the first hemorrhage is about 35%, and the case fatality rate of the second hemorrhage is 60%~80%.

Lattice® is a thin-mesh stent that is used to treat intracranial aneurysms through close-mesh stent implantation. Compared with the traditional intraaneurysm tamponade surgery, the process is more optimized, the operation time is greatly shortened, the efficacy is more satisfactory and durable, and the safety is higher. It is worth noting that Lattice's® mechanical balloon delivery system and MIROR surface modification technologies are both world's firsts. Thanks to the breakthrough innovation of the mechanical balloon, Lattice® can accurately locate and release in situ after entering the intracranial diseased blood vessels, and keep the distal guidewire not displaced while assisting the stent to open throughout the whole process, effectively solving the problems of stent kinking, difficult or failed opening, and vascular damage caused by complex operations during surgery, realizing the precise positioning and smooth release of the stent, and truly making the treatment of intracranial aneurysms enter the era of "automatic gear".

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