Medical support not in line with “blue sail”

With the arrival of the first round of nationwide coronary stent procurement, the pattern of high-value medical consumables industry has changed, and medical device manufacturers are more than happy and worried. High value medical consumables, like drugs, directly act on human body and have strict safety requirements. For a long time, the clinical use of high-value medical consumables, large quantities, high prices, increased the burden of the masses. But different from drugs, the types of high-value medical consumables are complex. For the varieties with the same indications, the production process is different, and the price is often huge. Taking coronary stents as an example, the unit prices of domestic coronary stents ranged from 9000 yuan to 11000 yuan, and the unit prices of imported coronary stents were more than 15000 yuan. < / P > < p > since the general office of the State Council issued the “reform plan for governance of high-value medical consumables” in July 2019, a series of changes on the production quality, circulation links, prices and use standards of high-value medical consumables have been vigorously promoted. In the view of the industry, a series of reforms will purify the market environment of high-value medical consumables, promote the import substitution of high-value medical consumables, and reshape the industry pattern. When the wind direction of the industry changes, the old medical device manufacturer lanfan Medical Co., Ltd. (hereinafter referred to as “lanfan medical”, 002382. SZ) has suffered many troubles due to its subsidiary company of coronary stent. < p > < p > in 2010, lanfan Medical Co., Ltd. initially mainly produced PVC medical gloves, health protection gloves and other low-value consumables. In 2018, lanfan medical spent nearly 6 billion yuan to acquire 93.37% of the shares of Singapore medical device manufacturer parson international, which involved in the field of high-value consumables such as cardiac stents and interventional heart surgery related equipment products. < / P > < p > according to the latest financial report of lanfan medical, “Parkson international is the fourth largest heart stent R & D, production and sales enterprise in the world, ranking second only to Abbott, Boston science and Medtronic. Its subsidiary company, Jiwei medical, focuses on the R & D, production and sales of cardiac stents and minimally invasive interventional heart surgery related equipment products, develops and launches the world’s first biodegradable coated drug-eluting stent exel-8 (ex-cel), occupying an important share of China’s cardiac drug eluting stent (DES) market, with a market share of up to 20% for many years, firmly occupying the Chinese cardiac stent brand The top three. ” < / P > < p > after the merger and acquisition, Parkson international and its subsidiary, Jiwei medical, have become the pillar of performance of lanfan medical. In 2019, the overall revenue of lanfan medical is 3.476 billion yuan, and the non net profit attributable to shareholders of listed companies is 473 million yuan. In that year, the revenue of Jiwei medical was 824 million yuan, and the net profit was 400 million yuan. < p > < p > on October 10, the notice on flight inspection of medical devices issued by the verification center of the State Food and drug administration showed that the inspection center organized the flight inspection of medical device manufacturers from August to September 2020, and found that there were five non-compliance items in the plant and facilities, production management and quality control. It includes: the parameters such as the axial speed range of the drug automatic coating machine have been adjusted, but the adjustment has not been verified; the cleaning operation procedures of metal stents stipulate that the acid washing solution should be used for washing, and after air drying, the stents should be dried. The cleaning operation records of a batch of metal stents were checked, and the process of washing and drying with purified water was not recorded. < p > < p > according to the notice of the inspection center of the State Food and drug administration, in view of the problems found in the inspection, the relevant provincial (autonomous region, municipality directly under the central government) drug administration shall instruct the enterprise to rectify within a time limit, require the enterprise to assess the product safety risk, and recall the relevant products in accordance with the provisions of the administrative measures for recall of medical devices. After the enterprise has completed the rectification, the relevant provincial drug administration shall timely organize the follow-up review, and timely report the follow-up review to the food and drug audit and inspection center of the State Drug Administration. < p > < p > in October 2016, due to coronary heart disease and acute anterior myocardial infarction, Wang went to Xuzhou Central Hospital for treatment. The cardiac stent was produced by GeV medical. < p > < p > in October 2018, Mr. Wang was admitted to Xuzhou Central Hospital for treatment again. During the operation, stent separation was found. Through talking with the attending doctor, Wang learned that the common understanding of the sign of separation is heart stent rupture. As a result, Wang believed that the heart stent implanted during the first hospitalization was a defective medical product, and sued Jiwei medical and Xuzhou central hospital. < / P > < p > the first instance judgment: the batch inspection report, production record and other evidence submitted by Jiwei medical are not enough to prove that the medical products involved in the case have no defects. In the case that the cause of the fracture cannot be determined by appraisal, the compensation liability of the case is determined by the distribution of the burden of proof. In August this year, Xuzhou intermediate people’s Court of Jiangsu Province issued the second instance civil judgment on medical damage liability dispute between Shandong Jiwei Medical Products Co., Ltd. and Wang Yuansong and Xuzhou Central Hospital, which showed that “since the evidence provided by Jiwei company in compliance with compulsory standards is not sufficient, Wang Yuansong has also initially completed the burden of proof for defective medical products The court of first instance found that the defects of the heart stents involved were not improper. The appeal was dismissed and the original judgment was upheld. This judgment is final. ” < / P > < p > the reporter asked lanfan medical about the progress of the rectification of Jiwei medical and whether the company would appeal the above cases again. As of the time of publication, no reply was received. < p > < p > according to the annual report of lanfan medical in 2019, in the domestic market, lanfan medical and its subsidiary Jiwei medical have established a wide range of penetration and coverage in different departments in the domestic market. < p > < p > in August this year, Suzhou Gusu District People’s Court published the criminal judgment of Chen Jianchang’s bribery crime in the first instance. Before the Spring Festival of 2016, Hu, a medical consumables agent, bribed Chen Jianchang, who was then the director of cardiovascular department of the Second Affiliated Hospital of Suzhou University, bribed Chen Jianchang with a total of 100000 yuan before the Spring Festival of 2016. Later, Jiwei medical stent entered Suzhou University Learn from the Second Affiliated Hospital. After the case, Chen Jianchang was sentenced to seven years’ imprisonment for accepting bribes from several agents, which constituted the crime of bribery. < / P > < p > in fact, consumables and surgery are inseparable, and the use of consumables depends on the choice of hospitals and doctors. In order to maintain their sales channels, the profit chain of consumables rebate is intertwined, which indirectly leads to the virtual high price of medical consumables. According to the data of the National Health Insurance Bureau, the market scale of medical consumables in China is 320 billion yuan, including 150 billion yuan of high-value consumables. < / P > < p > on October 16, the joint purchasing office of high value medical consumables of the state organization issued the procurement document of centralized volume of coronary stents organized by the state. Tianjin pharmaceutical procurement center undertakes the daily work of the joint procurement office and initiates negotiation invitation to relevant enterprises. In this nationwide centralized procurement, domestic coronary stents accounting for 80% of the total number of coronary stents purchased in the first year were 1.0747 million, and the reference price was 2850 yuan, which raised the price of cardiac stents from 10000 yuan to 1000 yuan. In this regard, lanfan medical said in the latest financial report: “the value of leading enterprises in the medical device industry will become more and more prominent by promoting the purchase of high-value consumables in a large range, forming a situation in which the strong are always strong, which is conducive to the rise and healthy development of the whole industry. The company will give full play to the advantages of wide market coverage in the intracardiac PCI stent market, as well as the product combination advantages of Axel 8 (Excel) stent and Xinyue TM (ex-cross SAL) stent. The company will adopt the strategy of providing lower price for Axel 8 (Excel) stent and higher price strategy for Xinyue TM (excel-sal) stent to meet the needs of different customers and patients. ” < / P > < p > Disclaimer: the purpose of this article reprinted by china.com finance and economics is to convey more information and does not represent the views and positions of the website. The content of this paper is for reference only and does not constitute investment advice. Investors operate accordingly and bear their own risks. < p > < p > Chinanet is a national key news website under the leadership of the Information Office of the State Council and managed by China foreign language publishing and Distribution Bureau. Through 11 versions in 10 languages, the website releases information 24 hours a day, which is an important window for China to carry out international communication and information exchange.