Innovation breakthrough! Xingyue Biotechnology's "Joint Cartilage Regeneration Bracket" has been approved to enter the special review process for national innovative medical devices, and the listing process has been fully accelerated

2025-11-14

Recently, the National Medical Products Administration (NMPA) released the "Announcement of the Results of the Special Review Application for Innovative Medical Devices", which shows that the "Joint Cartilage Regeneration Stent" independently developed by Xingyue Biotechnology has officially passed the NMPA review and been approved to enter the "Innovative Medical Device Special Review Procedure" (hereinafter referred to as the "Innovation Channel"). This not only reflects the technological originality and significant clinical application value of the product, but also marks that the product's technology has reached the international leading level.


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The "Innovation Channel" is known as the "Green Channel" for medical device product registration, aiming to promote innovation through regulatory reform, encourage medical device research and innovation, promote the promotion and application of new technologies, and drive the development of the medical device industry. Mainly targeting products with core technology patents, domestic innovation, and outstanding clinical value, we provide early intervention and dedicated personnel to significantly shorten the product approval cycle and accelerate the launch of advanced medical device products; At the same time, in market promotion, products that enter the "innovation channel" approval will be linked with supporting policies such as DRG exclusion payment and hospital admission green channel to improve the efficiency of product market access.


This successful entry into the "innovation channel" not only marks a milestone in the research and development process of "joint cartilage regeneration scaffold" by Xingyue Biotechnology, but also an authoritative recognition of Xingyue Biotechnology's corporate philosophy of "technology caring for health, technology radiating beauty".


In the future, enterprises will take this opportunity to enter the special review process for innovative medical devices, fully rely on this policy advantage, actively and efficiently promote product follow-up research and registration work under the professional guidance of regulatory authorities, and fully accelerate its listing process. At the same time, the company will continue to deepen its research and development of medical device innovation, contributing wisdom and strength to support the construction of a "Healthy China" and benefit global patients!


Zhejiang Xingyue Biotechnology Co., Ltd. was founded in 2010 and is a national high-tech enterprise jointly established by a team of overseas returnees and China Xingyue Group. It is located in Hangzhou Future Science and Technology City (one of the four major future science and technology cities in China). The company is positioned to integrate Chinese civilization (silk materials) and regenerative technology (regenerative medicine), benefiting human health and economic development, and developing, producing, and selling high-end medical products using silk fibroin as raw material.


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