On December 7, 2021, Qingdao Haitai Xinguang Technology Co., Ltd. announced that it signed a joint venture cooperation memorandum with China Medical Devices Co., Ltd. (hereinafter referred to as "Sinopharm"). Through the establishment of a joint venture company, the medical endoscope system is the entry point to quickly obtain evidence and sell.
On November 15, 2021, Aohua Endoscopy officially landed on the Science and Technology Innovation Board, opening a new chapter in the development of domestic endoscopy. It publicly issued 33.34 million shares at an issue price of 22.5 yuan per share. On the same day, the stock price of Aohua Endoscopy rose by 73%, with a market value of nearly 5.2 billion yuan. Endoscope faucet successfully launched
On September 27, 2021, Xinguangwei Medical, a domestic endoscopy company, also submitted a prospectus to the Hong Kong Stock Exchange, and plans to be listed on the Hong Kong Main Board. Morgan Stanley and CICC are its joint sponsors.
1. Endoscope and its classification Endoscope generally refers to medical instruments that enter the human body through various pipes to observe the internal conditions of the human body. It integrates traditional optics, ergonomics, precision machinery, modern electronics, mathematics, software, etc. one. And its inspection is called endoscopy (Endoscopy) or endoscopy (surgery). Some endoscopes also have therapeutic functions, such as cystoscopy, gastroscope, colonoscopy, bronchoscopy, laparoscopy, etc.
According to the application site, endoscopes can be divided into: gastrointestinal endoscopy, respiratory endoscopy, urology endoscopy, female reproductive system endoscopy, closed body endoscopy (cutting a small hole for inspection), endoscopy during pregnancy.
Endoscopy technology is mainly divided into endoscopic technology and laparoscopy technology. Endoscopy generally completes inspection, diagnosis and treatment through the large natural orifice of the human body, such as gastroenteroscopy, endoscopic ultrasonography, endoscopic mucosal resection, etc.; The technology mainly enters the sterile chamber of the human body through a sterile environment or surgical incision, such as laparoscopy, thoracoscopy, arthroscopy, etc.
In terms of products, endoscopes can be divided into flexible endoscopes, rigid endoscopes, endoscopic diagnosis and treatment instruments, minimally invasive surgical instruments and accessories.
2. Domestic substitution and technological innovation of endoscopes Recently, the Ministry of Industry and Information Technology has made a detailed plan for the key development and breakthrough directions of medical equipment in the "Medical Equipment Industry Development Plan (2021-2025)", which includes key breakthroughs in medical equipment. The strategic goal of imaging diagnostic equipment such as endoscopes.
In October this year, the Ministry of Finance and the Ministry of Industry and Information Technology jointly issued a notice on the "Guiding Standards for the Review of Government Procurement of Imported Products" (2021 version), which clearly stipulated that all 137 medical devices require 100% domestic procurement; 12 medical devices require 75% procurement Domestically produced; 24 types of medical devices require 50% domestic purchases; 5 types of medical devices require 25% domestic purchases. In addition to provincial documents, Guangzhou, Hangzhou and other places have also released more detailed documents to help domestic equipment open up the market.
In terms of supporting the R&D and innovation of domestic medical devices and giving tax incentives, the state's support has been increasing since the beginning of this year. In February, the Ministry of Industry and Information Technology of the People's Republic of China drafted the "Medical Equipment Industry Development Plan (2021-2025)" (Draft for Comment), which requires the optimization of the registration review process of innovative medical equipment, and supports the possession of invention patents. The technology is a domestic initiative and has significant clinical application value. Priority approval of medical equipment to promote product promotion and application. In June, the State Administration of Taxation issued the "Administrative Measures for the Refund of Value-Added Tax on the Purchase of Domestic Equipment by R&D Institutions", which clarified that all qualified R&D institutions purchasing domestic equipment will fully refund the value-added tax. In September, the State Administration for Market Regulation issued the "Guiding Opinions on Further Deepening Reforms and Promoting the Inspection and Testing Industry to Be Better and Stronger", clearly proposing to establish an "import substitution" verification and evaluation system for domestic instruments and equipment, and to promote the quality improvement of instruments and equipment and "importation". substitute".
Endoscopy has always been a field with a low rate of localization of medical devices. The domestic endoscope market is highly concentrated and is basically monopolized by foreign manufacturers. According to the data of China's medical device industry development report, in the field of rigid endoscope equipment, the top three companies of Karlstos, Olympus and Stryker occupy more than 80% of the market share.
The technical barriers of flexible endoscopes are relatively high, mainly the three manufacturers of Japanese brand Olympus (more than 60% of the market share), Pentax and Fuji, which almost monopolize the domestic flexible endoscope market.
According to the statistics of Zhongcheng Medical Equipment Big Data Platform, by the end of 2020, there were 61 domestic endoscope manufacturers. However, there are fewer listed companies in the industry. At present, domestic endoscope manufacturers are mainly concentrated in developed coastal provinces, such as Zhejiang, Shanghai, and Guangdong. In particular, Tonglu County, Zhejiang Province, is a gathering place for domestic endoscopes.
After the epidemic, when most of the energy and market are concentrated in China, according to the revenue of the two companies in the first half of the year, the proportion of domestic endoscopes in the domestic soft mirror market in 2021 may approach 10%. At present, my country's medical endoscopes have gotten rid of the situation of relying solely on imports, and the domestic medical endoscope market accounts for about 30%. While the domestic market share has increased, domestic endoscopes have also been exported. At present, the medical endoscope industry is in a period of rapid development.
At present, endoscopes are developing in the direction of miniaturization, multi-function and high image quality. Thanks to state support and supply chain innovation, the domestic endoscope industry will usher in its rapid development period in terms of product innovation and market expansion. Domestic brand marketing gradually covers medical institutions at all levels, and the market share is also getting higher and higher. Through higher cost-effective advantages, the curtain of domestic substitution is opened. A quick overview of the representative manufacturers of endoscopes ~ abroad
Olympus, Japan: Founded in 1919, it is one of the representative companies of precision and optical technology in Japan and the world. In 1950, it was the first in the world to develop endoscopes that play an extremely important role in the field of cancer prevention and treatment. Business areas include medical, life science, imaging equipment, etc.
Fujifilm of Japan: Fujifilm has now become a global leader in the field of imaging and information. As the world's largest manufacturer of photosensitive materials, it is world-renowned and has won the trust and praise of users around the world. Medical imaging business is one of the company's main businesses.
Japan's Pentax (PENTAD): is the world's oldest and most authoritative optical manufacturer. In the field of medical devices, Pentax launched the first fiberoptic bronchoscope in 1977 with its powerful optical technology, which was very popular in the market. After continuous development, Pentax formed two major fields of fiberoptic and electronic endoscopes It has developed a complete product system and has become a well-known endoscope manufacturer in the market.
Stryker: Founded in 1941 and headquartered in Klamazoo, Michigan, Stryker is a leader in the global medical device industry with a wide range of product lines in the medical field. The company continuously promotes the development of endoscopy technology, and took the lead in developing the first digital three-chip camera system and the first high-definition (High Definition) camera system. As an industry leader, Stryker's endoscopic system is gradually promoting the development of minimally invasive surgery.
KarlStorz, Germany: Founded in 1945 and headquartered in Turingen, Germany, it is one of the world's largest manufacturers of minimally invasive surgical endoscopy equipment and instruments, with products covering ENT, stomatology , neurosurgery, plastic surgery, cardiovascular surgery, thoracic surgery, urology, anorectal surgery, gynecology and many other departments of minimally invasive medical devices.
German Wolf Brand (RICHARDWOLF): Founded in 1947, it is one of the world's leading manufacturers of endoscopy diagnostic and therapeutic products, with more than 1,400 employees, 7 subsidiaries and 120 regional offices worldwide, with products involving Otolaryngology, neurosurgery, orthopedic surgery, thoracic and abdominal surgery, urology, gynecology, gastroenterology, etc.
Domestic Aohua Endoscopy (688212): Founded in 1994, the company's products provide three major endoscopic solutions: flexible endoscopic solutions, rigid endoscopic solutions, and endoscopic consumables solutions. After 27 years of focus and innovation, Aohua endoscopy products have been used in gastroenterology, surgery, respiratory, otolaryngology, gynecology, emergency department, ***************** * Department, ICU and other departments. Kaili Medical (300633): Since its establishment in 2002, it has been committed to the research and development and manufacturing of medical equipment. The products cover three product lines: ultrasonic diagnostic system, electronic endoscopy system and in vitro diagnostic series. The HD550 series of high-definition endoscope products launched by Kaili Medical gradually narrowed the gap between product performance and foreign investment, and received good feedback from the hospital. It fills the gap of domestic high-definition endoscopes, and is expected to further accelerate the development of domestic high-end endoscope products. Kangji Medical (09997.HK): Founded in 2004, it is mainly engaged in the research and development, production and sales of medical devices for endoscopic minimally invasive surgery. Specific products include disposable trocars, disposable ligation clips, disposable forceps, repetitive forceps and repetitive trocars. The main application scenarios are general surgery, obstetrics and gynecology, urology, thoracic surgery and other operations. Shenyang Shenda: Founded in the 1980s, it is one of the earliest R&D and production enterprises of medical rigid endoscopes in China. It mainly produces various endoscopes and supporting products for clinical diagnosis and minimally invasive surgery. The company is now Some products are represented by the urology series, and cover the fields of gynecology, general surgery, orthopedics, ENT, anorectal and industrial production. Nanwei Medicine (688029.SH): Founded in 2000. Engaged in R&D, manufacturing and sales of minimally invasive medical devices. Digestive endoscopic diagnosis and treatment equipment: including varicose, polyp/EMR/ESD treatment, biopsy, expansion, ERCP, EUS products. Respiratory endoscopic diagnosis and treatment equipment, including tracheal stent, disposable airway tertiary balloon dilation catheter, disposable airway cytobrush, disposable airway spray tube, disposable airway guide wire, and covered tracheal stent. Mindray Medical (300760): It is a leader in my country's medical device industry. Its main products cover three major areas: life information and support, in vitro diagnosis and medical imaging. In addition to the three main business areas, Mindray is actively cultivating business in the field of minimally invasive surgery. In 2012, Mindray Medical acquired Hangzhou Guangdian, whose main business is hard mirrors. At present, Mindray's minimally invasive surgical products include surgical endoscopic camera systems, cold light sources, pneumoperitoneum machines, optical endoscopes, minimally invasive surgical instruments and surgical consumables. Xinguangwei Medical: a high-tech innovative medical device R&D and production enterprise involving optical diagnosis and treatment, multi-dimensional imaging, high-performance materials and precision manufacturing. Its product matrix now covers soft mirrors and hard mirrors. Pusheng Medical: Founded in Zhuhai in 2014, it obtained the registration certificate of disposable flexible ureteroscope in June 2020. It has passed CE and FDA certification in the early stage and started overseas sales. The company's future product line also includes disposable nasopharyngoscope, disposable bronchoscope, disposable cystoscope, etc. Ruipai Medical: Founded in Guangzhou International Bio Island in 2015, it is a global provider of overall solutions for one-time minimally invasive surgery. Its product development plans cover urology, gynecology, ENT, gastroenterology, respiratory, and general surgery. Wait. In 2020, Ruipai Medical was approved the registration certificate of disposable flexible ureteroscope and disposable electronic cystoscope. Innovich: Founded in Shanghai in 2009, it mainly focuses on the R&D and sales of high-value consumables related to digestive endoscopy and urology. In 2014, the subsidiary Anqing Medical was established, focusing on medical endoscopy. It is expected that endoscopic equipment and consumables can form a closed loop to provide an overall solution for minimally invasive surgery. Happiness Factory: Founded in 2017, it has a R&D technology platform for disposable electronic endoscopes, and is mainly engaged in the R&D and production of disposable electronic flexible ureteroscopes, flexible cystoscopes, etc.
