Medical equipment approved for marketing

Recently, Weitai Medical Devices (Hangzhou) Co., Ltd. (hereinafter referred to as "Weitai Medical") submitted a prospectus to the Hong Kong Stock Exchange, intending to be listed on the main board of Hong Kong.

Founded on 20 1 1, Weitai Medical is a high-tech enterprise engaged in the research and development of medical devices in the field of diabetes, aiming to reshape the monitoring, treatment and management mode of diabetes through a closed-loop solution that can dynamically monitor and control blood sugar levels. According to the consulting report of burning knowledge, Weitai Medical is the only company in the world that has both an approved patch insulin pump and a calibration-free continuous blood glucose monitoring system.

According to the prospectus, in 20 19 and 2020, the operating income of Weitai Medical was 5018.63 million yuan and 75.277 million yuan respectively, the corresponding R&D expenditure was 50.06 million yuan and 82.009 million yuan respectively, and the corresponding annual losses were 78614,000 yuan and/kloc respectively.

Like many innovative biotechnology enterprises, Weitai Medical has no profit, and the loss is mainly caused by the financial treatment of equity incentive payment.

Diabetes is one of the chronic diseases with the highest incidence in the world. As a populous country, the number of diabetic patients has been increasing in recent years.

According to the consulting report, the global incidence of diabetes in 20 19 was 486.9 million, and it is expected to reach 607.6 million in 2030. According to the same data source, in 20 19 years, the incidence of diabetes in China was1190,000, and it is expected to reach1430,000 in 2030.

Product Layout of>& gt& gt& gt Sticky Insulin Pump

As early as the 1960s, some people tried to simulate physiological insulin secretion by continuous subcutaneous insulin infusion. By the late 1970s, a mechanical insulin delivery device was used, which was also the embryonic form of an insulin pump.

Up to now, there are two main types of insulin pumps: pipeline type and pipeline-free paste type. Among them, the adhesive insulin pump not only has the advantages of small size and portability, but also avoids many problems caused by catheter and increases the compliance of patients with treatment plans.

The traditional pipeline insulin pump is equipped with a pumping mechanism and an insulin reservoir, which delivers insulin to an infusion device worn by the body through a long tube. Usually, it has a large size and a large dose button, which allows users to correct blood sugar level by injecting large doses of insulin during meals or when blood sugar is high, or set the basal rate of insulin infusion, or suspend insulin infusion when necessary. Medtronic, SOOIL and other products adopt pipeline insulin pump design.

The invention is more compact, eliminates the inconvenience caused by the external pipeline of the traditional pipeline insulin pump, and reduces the treatment risk caused by kinking, bending and pulling of the external pipeline.

However, due to the high comprehensive barrier, the SMD insulin pump involves the fields of machinery, electronics, software, materials, sensors, general integration and so on. This product belongs to therapeutic equipment and requires high reliability and safety. In recent years, many companies and teams at home and abroad have tried this, but they have failed repeatedly.

In the layout of diabetes management, Weitai Medical has long been aiming at the research and development of patch insulin pump, focusing on breaking through the research and development difficulties of this insulin pump, successfully developing the core product Equil and realizing commercialization. It is understood that Equil is the second commercial semi-throwing insulin pump in the world, and it is also the first domestic insulin pump approved by China and the European Union.

At present, the first patch insulin pump on the market is Omnipod series launched by Insulet. Different from the disposable design of Omnipod, Weitai Equil adopts semi-throwing design.

& gt& gt& gt& gt Product Layout of Blood Glucose Monitoring

Judging from the vision of Weitai Medical to reshape diabetes management, the layout of Weitai Medical is obviously not only reflected in the single diabetes control, but also reflected in the product layout of Weitai Medical as an important means of blood sugar management for diabetic patients.

In fact, as early as 20 13, Weitai Medical launched a blood sugar monitoring system, but this product is not much different from the existing blood sugar system on the market. With the concept of continuous blood glucose monitoring (CGM) put forward, Weitai Medical began to lay out in this direction, and in 20 18, the clinical trial of AiDEX G7, a calibration-free, real-time continuous blood glucose monitoring product, was officially launched.

Compared with traditional blood glucose monitoring products, continuous blood glucose monitoring system (CGMS) can continuously and dynamically monitor the changes of blood glucose throughout the day and provide reliable and comprehensive blood glucose information. In terms of use, CGMS simplifies the process of blood sugar monitoring and management, which is painless in the whole process, and improves the compliance of diabetic patients with treatment plans to some extent.

It is understood that AiDEX G7 is the second commercial calibration-free, real-time continuous blood glucose monitoring system in the world. Since its introduction, AiDEX G7 has shown various advantages over the traditional blood glucose monitoring system, which has the characteristics of real-time monitoring, reducing the risk of high/low blood sugar and improving the compliance of treatment plan (without routine finger blood measurement).

Although AiDEX G7 has not been approved in China at this stage, due to its excellent performance and use effect, it was officially certified by CE in September 2020, and the application for domestic registration certificate is also being actively promoted.

In view of the fact that the blood glucose meter market is the Red Sea market, Weitai Medical only regards the continuous blood glucose monitoring system as a part of the all-round management of diabetes. In contrast, the patch insulin pump is a more important product of Weitai Medical, which overcomes some disadvantages of conventional injection methods and has the advantages of more convenience and more accurate infusion than the traditional pipeline pump. The semi-throwing insulin pump still belongs to the blue ocean market in China.

In 65438+February last year, Weitai Medical announced the completion of 575 million yuan Series D financing, which was led by Taikang Ganzhen Fund under Taikang Investment, led by Tencent and IDG Capital, and followed by Everbright Holdings, Jinzhong Pucheng and Sanzheng Health. The original shareholders' venture capital, Lilly Asia Fund, Capital and Guofang Parent Fund continued to participate in the investment.

According to the information in the prospectus, Weitai Medical has previously completed three rounds of financing in A, B and C on 20 16, 20 17 and 20 18, with financing amounts of 310000000 yuan,12 million yuan and/kloc respectively.

Weitai Medical can continue to be favored by capital, which is obviously inseparable from its excellent research and development capabilities and the successful research and development of high-quality products.

In terms of team, the founder and core R&D members of Weitai Medical have many years of R&D experience in the industry. The R&D team brings together interdisciplinary talents such as mechanical engineering, electrical engineering, software engineering, biomedical engineering and artificial intelligence.

From the perspective of R&D investment, the R&D expenditure of Weitai Medical in 20 19 and 2020 is 50.06 million yuan and 82.009 million yuan respectively, both exceeding 35% of the total expenditure, and this figure is still rising.

In terms of product coverage, in the past decade, Weitai Medical has developed a strong and comprehensive product portfolio, covering a number of product lines, such as patch insulin pump and continuous blood glucose monitoring system (providing the basis for closed-loop artificial pancreas), IVD equipment (such as blood glucose monitoring system and instant detection equipment).

On the basis of the launched Equil and AiDEX G7 products, Weitai Medical is still improving the assembly line layout of the products, and plans to expand the application scope of the products, including closed-loop artificial pancreas, second-generation attached insulin pump, AiDEX and IVD equipment.

In the research and development of artificial pancreas, Weitai Medical has completed the relevant market and feasibility study in the first quarter of 20021,and it is expected that the engineering verification of artificial pancreas will be completed in the first half of 2022.

In addition to the diversified product portfolio, Weitai Medical has also developed a series of diabetes management solutions, striving to establish a diabetes management platform based on cloud big data, and integrating the company's products by means of big data and artificial intelligence.

At present, the revenue growth of Weitai Medical mainly benefits from the sales growth of its core product Equil. Since the listing of 20 18, Equil has been sold or distributed to 747 hospitals in China. In 20 19 and 2020, the sales revenue from Equil accounted for 47.6% and 46.2% of the total revenue of Weitai Medical respectively.

Compared with the traditional pipeline pump, Equil adopts a lightweight design without catheter, which enables users to manage diabetes privately, conveniently and safely. Other functions include the vibration alarm that the user can feel under the clothes, and the insulin infusion large dose button of the pump body, which can be activated even when the wireless PDA is not around to facilitate infusion. In addition, due to its higher safety, better accuracy and semi-throwing use, Equil has the performance equivalent to or better than the main similar products.

From September 2065438 to September 2007, Equil obtained the marketing license for adults from the National Medical Products Administration in China, and obtained the EU CE mark in the same year. As of the last actual date (May 5, 20021year), Equil has been successfully sold in more than 15 countries in Asia Pacific, Europe, Middle East, Africa and Latin America. In February, 20021,Weitai Medical submitted a pre-marketing notice of 5 10(k) to FDA, which is expected to be approved by FDA in 2022.

At the same time, Weitai Medical is developing the second-generation patch insulin pump, which will be fully optimized in terms of product size, waterproof performance, adaptability to different sizes of insulin storage and user experience. It is believed that in the next period of time, the sales of Equil will still be an important driving factor for the growth of Weitai medical income.

In addition, AiDEX G7 is also an important part of the company's income.

As a company with commercial products in both patch insulin pump and calibration-free continuous monitoring system, Weitai Medical's product portfolio can bring diabetes management mode integrating monitoring and treatment to patients, and also lay the foundation for the company to develop closed-loop artificial pancreas.

Artificial pancreas has always been regarded as one of the subversive solutions for diabetes monitoring, treatment and management, that is, insulin pump and continuous blood sugar monitoring system are effectively combined through a series of control algorithms to realize continuous monitoring, treatment and management of blood sugar level.

In the application process, the artificial pancreas can automatically adjust the dosage of insulin according to the continuous monitoring of blood sugar level, which reduces the risk of hyperglycemia or hypoglycemia and minimizes the manual operation of patients. In the future, if Weitai Medical can successfully launch the product of artificial pancreas, it will surely usher in greater development space for the company.

From the revenue data of Weitai Medical in 20 19 and 2020, it can be seen that although the investment of R&D accounts for most of the company's total expenditure, the company has also invested a lot of resources in the sales layout, and the investment is increasing.

As disclosed in the prospectus, as of February 30, 2020, Weitai Medical has 370 dealers. As of the last actual date, the company has 65,438+020 internal sales and marketing personnel, and its products are sold in 30 provinces, municipalities, autonomous regions and 60 overseas countries in China. With a strong dealer network, Weitai Medical has spread all over the world, including Asia-Pacific region, Europe, Middle East, Africa and Latin America.

In terms of sales methods, Weitai Medical regards distribution as an important sales model. By the end of 20 19 and 2020, and the end of 12.30, the total sales of Weitai Medical to dealer customers were 512510,000 yuan and 73.277 million yuan, accounting for 98.8% and 97.3% of the revenue respectively.

At present, Weitai Medical is in the initial stage of market promotion of pasted insulin pump and continuous blood glucose monitoring system. According to the information in the prospectus, Weitai Medical is also making new attempts to expand the sales path.

At present, Weitai Medical is actively building communication channels with product users and implementing a sales strategy based on user-centered and clinical data, which will also help Weitai Medical develop more products based on patient experience.

In addition, Weitai Medical is actively establishing cooperative relations with commercial insurance companies to help Weitai Medical's products enter the market more efficiently from the perspective of broadening promotion channels, and further improve the penetration rate of products among diabetic people.

Judging from the revenue data, although Weitai Medical has not yet achieved profitability at this stage, its revenue has increased by 45% from 20 19 to 2020, and the R&D investment is also increasing. In the long run, when more products follow, the company's investment in R&D will enter a payback period. With a strong sales network, Weitai Medical has the ability to occupy a high position in the future market.