SinoMed Sinks After China Withholds Marketing Approval for New Brain Artery Stent
Tang Shihua
DATE:  Oct 29 2025
/ SOURCE:  Yicai
SinoMed Sinks After China Withholds Marketing Approval for New Brain Artery Stent SinoMed Sinks After China Withholds Marketing Approval for New Brain Artery Stent

(Yicai) Oct. 29 -- Shares of Sino Medical Sciences Technology plunged after Chinese regulators turned down the medical device maker's application to market a new brain artery stent.

After sinking by as much as its 20 percent daily trading limit in Shanghai today, SinoMed [SHA: 688108] closed 18.6 percent lower at CNY20.51 (USD2.89) a share. The stock fell 9.4 percent yesterday prior to the announcement.

The National Medical Products Administration notified Sinomed Neurovita Technology that its application to market the Cometiu self-expanding drug-coated intracranial stent had been denied, the unit’s Tianjin-based parent firm announced late yesterday. It did not say why the regulator had rejected the application.

SinoMed will continue to communicate with the NMPA to push forward the registration process for Cometiu in China and further promote the product’s global commercialization, it added.

Cometiu is the world's first innovative medical device for treating intracranial atherosclerotic stenosis, according to SinoMed. It expands the internal width of the blood vessels to improve blood flow, shortening surgery time and lowering the corresponding risks, it said.

SinoMed noted that Cometiu received Breakthrough Device Designation from the US Food and Drug Administration in August and was authorized to proceed directly with a pivotal confirmatory clinical study in the United States, allowing the stent to be initially marketed through the FDA's pre-market approval process

SinoMed said it will host an investors’ meeting on the Shanghai Stock Exchange’s online roadshow platform at 3.30 p.m. tomorrow, during which Chairman and General Manager Sun Jianhua and other executives will answer questions about the matter.

Editor: Martin Kadiev

Follow Yicai Global on
Keywords:   Registration Application Denied,I National Medical Products Administration,Intracranial Drug-Eluting Stent,COMETIU™,Intracranial Atherosclerotic Stenosis,Breakthrough Device Designation,Sinocare Medical Technology