SINOMED: The domestic registration of the subsidiary's product COMETIU stent has not been approved
SINOMED's subsidiary, SINOMED Shenchang Medical Technology Co., Ltd., has not received approval from the National Medical Products Administration for the COMETIU stent registration application. The product applied for EU MDR certification from DEKRA Certification B.V. in 2024 and has passed the on-site audit, currently in the technical review stage. At the same time, the COMETIU stent received breakthrough medical device designation from the US FDA in 2025, becoming the world's first product for the treatment of intracranial atherosclerotic stenosis
According to the Zhitong Finance APP, SINOMED (688108.SH) announced that its controlling subsidiary SINOMED Shenchang Medical Technology Co., Ltd. ("SINOMED Shenchang") received the "Medical Device Registration Not Approved Notice" from the National Medical Products Administration on October 28, 2025. The registration application for the COMETIU self-expanding intracranial drug-coated stent system ("COMETIU Stent") was not approved by the National Medical Products Administration ("NMPA"), and the NMPA has publicly announced the results of the relevant registration application.
It is reported that the company submitted the EU MDR certification application for the COMETIU Stent to the international certification body DEKRA Certification B.V. in October 2024, and it has been accepted. As of the date of the announcement, the product has passed the MDR on-site quality system audit and is in the final stage of technical review. In addition, the COMETIU Stent and COMEX balloon microcatheter received breakthrough medical device designation from the U.S. FDA in August 2025. This product is the first intracranial atherosclerotic stenosis treatment product in the history of the U.S. FDA's breakthrough medical device program and is also the first neurointerventional device product in China to receive breakthrough medical device designation from the U.S. FDA
