According to the China Medical Device Innovation and Priority Approval Database, one innovative medical device has entered the special review process in a public announcement released by local drug regulatory authorities nationwide: the disposable endoscopic anastomosis clip system of Guangzhou Yulin Pharmaceutical Technology Co., Ltd. (hereinafter referred to as Yulin Pharmaceutical).

Accelerate the process of domestic substitution
Yulin Pharmaceutical was founded in 2011 and is a technology-based medical enterprise that integrates research and development, production, sales, and after-sales service. Currently, it holds one US invention patent and more than ten domestic utility model and design patents. The factory is equipped with a 100000 level sterile production workshop and complete production facilities. Focusing on the field of obstetrics and gynecology, we are committed to providing simple and convenient clinical consumables.

According to Yaozhi Patent Communication, currently Yulin Medicine has 8 authorized patents and 5 patents in the approval process, covering fields such as surgical instruments, protective equipment, gynecological and respiratory intervention devices. Based on multiple patents, its product pipeline also focuses on surgical instruments, respiratory intervention instruments, protective equipment, drug delivery and flushing devices, etc.

It is worth mentioning that in the authorized patents of Yulin Medicine, a matching clip kit for soft endoscopes relates to the field of surgical auxiliary instrument technology, including: handwheel, puller, clip cap, matching clip, and release wire. Among them, the release wire is wound around the cable puller so that the release wire can be pulled when the handwheel drives the cable puller to rotate; The handwheel triggers the release line to drive the anastomotic clip forward and disengage from the clamping cap, so that the anastomotic clip can elastically return to bite forward. This technology is a matching clip kit for soft endoscopes, which can further improve the smoothness of the clip kit during surgical operations and make it more convenient to use.

The disposable endoscopic anastomosis clip system that has entered the special examination procedure this time, or combined with the patented technology of Yulin Pharmaceutical, is expected to fill the gap of domestic high-end endoscopic anastomosis instruments, compete with imported products (such as the ENDO GIA series from the United States), and accelerate the process of domestic substitution.

Domestic high-end stapler products accelerate breakthrough
It is reported that traditional open surgery can no longer meet the needs of patients due to its characteristics of large surgical trauma, heavy bleeding, and slow patient recovery. Minimally invasive surgical procedures can be assisted by surgical instruments such as endoscopic staplers and endoscopes, which can achieve disease treatment while minimizing patient damage and improving surgical safety and efficiency.

The stapler is a medical device that replaces manual excision and suturing, and has the characteristics of safety and convenient operation. Currently, it is widely used in the field of minimally invasive surgery. It is reported that staplers can be divided into two categories: open staplers and endoscopic staplers. With the development of minimally invasive surgery, endoscopic staplers are gradually replacing open staplers.

In recent years, the market size of staplers in China has shown an accelerating growth trend. According to data, the market size of Chinese staplers reached 8.63 billion yuan in 2022, a year-on-year increase of 12.8%, and it is expected that by 2030, the market size of Chinese staplers will grow to 20.5 billion yuan.

However, for a long time, China's stapler market has been dominated by imported brands, especially high-end production lines. According to Frost&Sullivan data, in the domestic electric endoscope stapler market in 2022, Johnson&Johnson and Medtronic together accounted for 78% of the market share. However, with the further development of technology in our country, the process of domestic substitution has accelerated, and a number of domestic high-end stapler products have emerged, achieving a new breakthrough in domestic high-end stapler products.

According to the data from the China Medical Device Screening System, there are currently 1822 stapler series products on the market in China, with 5 innovative and 5 priority approved products. Among them, Class II medical devices are the majority, accounting for 1750 types, and Class III medical devices have 72 types. However, starting from 2024, the series of staplers that have obtained Class III medical device registration certificates in the local market will enter a period of explosive growth, with an increase of 112.5% compared to 2023, among which electric endoscope linear cutting staplers are the most common. Moreover, among Class III stapler products, the number of domestic and imported products is basically the same, with 37 domestic products accounting for 51.39% and 35 imported products accounting for 48.61%.

Moreover, centralized procurement of stapler consumables is a frequent occurrence in volume based procurement. After multiple rounds of provincial-level volume based procurement, due to factors such as production costs and tariffs, the price reduction space for imported brands has been significantly reduced, and the localization rate of the stapler market will continue to increase. In the future, with the deepening of centralized procurement price reduction and technological breakthroughs of domestic enterprises, domestic brands will further seize market share with higher cost-effectiveness advantages.

Conclusion
With the support of policies and the promotion of continuous technological development, the "gold content" of domestic medical devices is becoming increasingly high, and local medical devices are continuously shining with new brilliance.

Source: https://news.yaozh.com/archive/45071.html