Blue Sail Medical Co.Ltd(002382)
Report of the board of directors in 2021
In 2021, in strict accordance with the company law of the people’s Republic of China (hereinafter referred to as the “company law”), the Blue Sail Medical Co.Ltd(002382) articles of Association (hereinafter referred to as the “articles of association”), the rules of procedure of the board of directors and other relevant provisions, the board of directors of the company earnestly performed the duties of the board of directors entrusted by the general meeting of shareholders, further standardized and optimized the corporate governance structure of the company, and ensured the scientific decision-making and standardized operation of the board of directors. With the support of all shareholders, the board of directors of the company led the management and all employees to actively respond to the complex business environment and promote the sustainable, stable and healthy development of the company. The work of the board of directors in 2021 is reported as follows:
1、 Review of the company’s operation in 2021
Since 2018, the “a + X” strategy determined by the company has set sail in an all-round way. Relying on the development path of both endogenous and extension, the company has continued to enter a number of carefully selected “low, medium and high value” medical device consumables tracks. Today, the company’s “a + X” strategy is basically implemented, and has become a multinational leading medical device enterprise with a complete layout of low-value consumables and high-value consumables. At the end of 2021, the company launched a comprehensive strategic upgrade, redefined “new medical treatment + great health”, and accelerated the transformation to high-quality and innovative development. According to the business nature of the subdivided fields, the company divides its business segments into protection division, cardio cerebrovascular division and nursing division. The company has developed into the forefront of the industry in all subdivided fields, and has fully possessed the platform, resources and foundation for high-quality development.
1. Protection Division: at present, its main business is the production and sales of medical and protective gloves, including disposable medical gloves, household gloves, etc., which are mainly used in medical inspection and protection, food processing, electronic industry, etc. At present, the company has a full range of medical and protective gloves, the main products are nitrile gloves, PVC gloves, latex gloves and TPE gloves / CPE gloves.
In view of the fact that the epidemic situation around the world has not subsided, the demand for the company’s main products such as health protection gloves and other health protection products has increased again all over the world. Covid-19 epidemic has also structurally improved the awareness and concept of health protection of various countries, societies and institutions, and began to improve the emergency capacity system. Based on the operating results in 2020, the company continues to increase the construction of medical and protective gloves projects. On the basis of continuously optimizing the design of production line, innovating non-standard self-developed equipment and improving the operation efficiency and stability of production line, the company continues to promote the combination of self-developed innovation of new non-standard equipment and new process technology, improve the utilization rate of raw and auxiliary materials and compress the comprehensive timeliness of water reuse through scientific positioning and deployment of intelligent sensors, drivers, visual inspection, cooperation Siasun Robot&Automation Co.Ltd(300024) and other methods, Further reduce production and manufacturing costs, build a more energy-saving, environmental friendly, efficient and flexible protective glove production line, and build an industrial integrated automatic production plant in line with the new situation.
At the same time, the company adheres to the objectives of “carbon neutralization” and “carbon peak”, actively carries out the certification of green factory and energy management system with a high sense of responsibility and mission, establishes and improves energy management system and realizes low-carbon production; Increase capital investment and adopt practical and effective technical means, such as the use of clean energy, new waste heat recovery facilities, equipment upgrading and transformation, so as to achieve low-carbon emission.
During the reporting period, the company’s “200 million pairs / year surgical gloves project”, the first phase of 60 million pairs / year surgical gloves project, the second phase of 60 million pairs / year surgical gloves project, the annual output of 7.5 billion health protection (nitrile gloves) project, the annual output of 4.5 billion PVC health protection gloves project and the annual output of 10 billion high-end health protection nitrile gloves project “were completed and put into operation, and the” 800 million PVC gloves project “in Vietnam has been successfully completed, The production of the above projects has further enriched and improved the company’s health protection product line, effectively supported the release of production capacity, better met customer needs, further consolidated the international and Chinese market share and consolidated the company’s comprehensive competitiveness.
2. Cardio cerebrovascular Division: Currently, it is mainly engaged in the R & D, production and sales of cardiac stents and interventional cardiac surgery related instruments. The main products include drug-eluting stents, drug coated stents, balloon catheters, implantation devices for transcatheter aortic valve replacement (TAVR) and other supporting products for interventional cardiac surgery. At present, drug coated balloon (DCB) is undergoing clinical trials. The new generation TAVR products are planned to carry out clinical trials in Europe, Southeast Asia and China in 2022. The products under research also include solutions for total coronary calcification / CTO lesions, transcatheter mitral valve repair and replacement and other projects.
(1) Cardiac interventional device products
① Cardiac coronary stent
In June 2021, the registration of biofreedomtm, the world’s first uncoated drug stent developed by the company, was approved in China. This product is the first stent in the world that can reduce the postoperative time of taking dual antisectorlet drugs from one year to one month, which fundamentally prevents the bleeding risk of patients. It has become the only imported drug stent approved by the China food and Drug Administration for dapt for patients with high bleeding risk for one month, It is an important milestone in the development of the company’s cardiac stent interventional devices. As of December 2021, biofreedomtm products have been online in more than half of China’s provinces. The company’s new product, biofreedom ultra, obtained the European CE certification in October 2020. As of December 2021, it has been sold in 28 European and South American countries such as Spain, Italy, France, the United Kingdom, Chile, the Czech Republic, Austria and Germany, and has been highly recognized in these markets; Since then, biofreedom ultrawas approved in Thailand in December 2020 and South Korea in February 2021. At present, it has entered seven different countries and regions in Southeast Asia and North Asia, benefiting more patients day by day. In 2021, Parkson international and its exclusive agent Kaneka won the first place in Indonesia’s national balloon collection and achieved 50% of the local balloon market share. On the whole, Parkson international and its subsidiaries occupy an important position in the markets outside China.
On November 5, 2020, the state implemented the policy of centralized procurement of coronary stents, resulting in a sharp decline in the terminal sales price of cardiac stents in the Chinese market. Under this policy situation, the company took advantage of the historic opportunity of winning the bid in this centralized procurement, realized the coverage of more hospitals, and expanded the sales network to more than 2300 hospitals at one stroke, The winning heart leaptm (excrossal) stent has become the most widely used cardiac stent in Chinese hospitals. By December 2021, the sales volume of Xinyue TM (excrossal) stents had exceeded 350000, an increase of more than 330% over the same period last year. According to the statistics of implantation volume, the company’s use of coronary stents has risen to the second place in China, and China’s market share has increased significantly.
National volume procurement is another milestone on the road of deepening medical reform, which will have a far-reaching impact on the industry. The mechanism of volume purchase gives the enterprise clear sales commitment and expectation, increases the company’s sales volume, saves intermediate sales expenses, shortens the payment time, improves the operation efficiency of the winning enterprise and promotes the growth of the endogenous capacity of the enterprise.
② Coronary intervention balloon
Cardiac interventional device products also involve drug coated balloon catheter, balloon dilation catheter, self owned or agent catheter, guide wire and other interventional cardiac surgery related device products, with drug coated balloon catheter, PTCA coronary balloon catheter (biostream), balloon dilation catheter (powerline, rise NC) as the core products. In June 2021, the RISE NC balloon catheter made by the company’s Biosensors Europe SA was certified by the State Administration of drug supervision and approval, which further enriched the company’s cardiovascular interventional product structure in Chinese mainland.
In August 2021, the graceful moss coated coronary artery balloon dilation catheter developed by Gewei medical, a subsidiary of the company, was approved by the Innovation Medical Management Co.Ltd(002173) device special review procedure of the State Drug Administration, which is also the only moss drug balloon product suitable for small vascular diseases in the Chinese market. The drug balloon adopts the company’s exclusive patented drug BA9, which has 10 times higher lipophilicity than ordinary rapamycin. It can reduce the drug loss during delivery, accelerate the drug absorption at the lesion, and has a tissue half-life of up to 20 days. It is the best choice for coated drugs. Gemway medical uses patented technology to crystallize graceful mousse to improve drug stability, and cooperate with exclusive coating technology to further reduce drug loss during delivery, so as to give full play to the advantages of graceful mousse in drug balloon application.
The company’s products under development also include the overall solution of total calcified lesions / CTO lesions, such as CTO balloon, notch balloon and IVL products.
(2) Structural heart disease interventional valve products
NVT has three generations of products in the field of aortic valves. Its first generation product Allegra obtained EU CE in March 2017 and approved the indication of “valve in valve” in Europe in 2020. The first generation product once again proves its excellent safety with its very low mortality of 1.2% in the real-world multicenter short-term clinical results; The second generation of products is planned to carry out clinical trials in Europe and China at the same time in 2022; The third generation products are planned to start clinical trials in Europe and China in 2023. At the same time, the company has reserved its next generation of aortic valve technology products and carried out pre research work on products in the fields of mitral valve and tricuspid valve repair and replacement.
During the reporting period, in order to optimize the overall business framework of the company, the company internally restructured all subsidiaries and business entities of the cardiovascular and cerebrovascular business division, realizing the complete integration of coronary artery business and structural heart disease business from the perspective of equity structure and management structure. At present, the marketing, sales, clinical registration and other teams of nvtag in Europe have completed preliminary integration with the team of Parkson international in Europe, and can share the sales channels and customer resources of coronary artery and valve. NVT’s main products have been sold in Germany, Italy, Spain, Portugal, the United Kingdom, Ireland, Switzerland, Austria, the Netherlands and Finland through the sales network of Parkson international in Europe. The cardiovascular and cerebrovascular business department will give full play to the synergistic advantages of market promotion and penetration, provide strong guarantee for the rapid market development of follow-up products, and lay a solid foundation for the long-term strategic development, next operation and capital planning of the company’s high-value consumables business segment.
The company will continue to adhere to the combination of investment, M & A and innovative R & D, continue to develop and M & a new products with core technology and adapt to market demand, and accelerate the overall planning and layout of cardiovascular and cerebrovascular sector. In terms of investment and M & A, we will make full use of professional teams through industrial funds, investment, M & A and other forms; In terms of innovative R & D, the company has set up eight global R & D and clinical registration platforms in Singapore, the United States, Switzerland, Germany, Shandong, Beijing and Shanghai, and built a global 24-hour R & D system. Relying on the global R & D platform, the company has carried out innovative R & D of dozens of heavy new products on many high-value consumables tracks such as coronary artery, valve, nerve intervention and peripheral intervention, so as to become a new engine for the company’s sustainable development in the future.
3. Nursing department: at present, its main business is to develop, produce and sell all kinds of emergency rescue products and disposable health protection products mainly medical first-aid bags. The main products include vehicle first-aid kits, medical first-aid kits, family disaster prevention emergency kits and other first-aid kits, reflective vests, masks, medical dressings and so on. Wuhan bikele makes full use of network platform resources, develops Wuxi Online Offline Communication Information Technology Co.Ltd(300959) business simultaneously, and actively develops new channels, new markets, new customers and new products. In 2021, Wuhan bikaier will sell more than 10million sets of first-aid kits, nearly 70million masks and more than 1.6 million reflective vests. Wuhan bikele’s products are sold to Germany, Britain and other countries around the world. While constantly exploring foreign markets, it actively develops products that meet the needs of the Chinese market.
On January 30, 2021, the company invested 800 million yuan to build the headquarters of medical and nursing business department, medical emergency rescue Industrial Park, medical care and disease control and infection protection industrial park. The new 10 million sets of medical first aid kits, 60000 tons of high-grade spunlaced nonwoven new material production capacity and deep processing project of downstream medical and nursing series products were officially launched in Tuanfeng County, Hubei Province. The company will build an intelligent and lean smart factory, comply with the new development pattern of double circulation, seize the strategic development opportunities of the construction of the Yangtze River economic belt and the rise of central China, undertake the Wuhan economic circle and the urban agglomeration in the middle reaches of the Yangtze River, build an upstream and downstream whole industry chain integrating medical basic materials, medical care products and medical care product portfolio products, and form a new pattern of aggregation and cluster development along the chain.
During the reporting period, the company achieved an operating revenue of 8108586500 yuan, a year-on-year increase of 3.04%; The operating profit was 1390548000 yuan, a year-on-year decrease of 31.79%; The total profit was 1347358 million yuan, a year-on-year decrease of 33.25%; The net profit attributable to the shareholders of the listed company was 11557092 million yuan, a year-on-year decrease of 34.28%; After deducting non recurring profits and losses, the net profit attributable to the shareholders of the listed company was 621252 million yuan, a year-on-year decrease of 96.43%; The net cash flow from operating activities was 2245545700 yuan, a year-on-year decrease of 38.84%.
As China’s China has one belt, one road and the international influence of China, the state has provided good opportunities for China’s medical device enterprises to develop in the 14th Five-Year. The company will further actively assume social responsibility, actively give back to the society, firmly follow the path of innovation driven high-quality development, comply with the new development pattern of China’s international double cycle, and vigorously cultivate and serve the Chinese market. 2、 Affairs of the board of directors during the reporting period
Convene the annual meeting of the board of directors in strict accordance with the provisions of the company law and the relevant laws and regulations of the people’s Republic of China, and carefully perform their duties in accordance with the situation of the company and the relevant laws and regulations of the people’s Republic of China, so as to damage the interests of the company; There was no illegal operation. (I) board meeting
In 2021, the board of directors held 10 meetings, the main contents of which are as follows:
Meeting date and resolution
On February 5, 2021, the 5th board of directors deliberated and adopted the proposal on not redeeming “lanfan convertible bonds” in advance.
Eleventh meeting
1. Deliberated and passed the proposal on foreign investment and related party transactions;
