Acotec Scientific Holdings Limited (Stock Code: 6669) announced that on November 13, 2025, it obtained registration approval from the PRC National Medical Products Administration for its Coronary Over-the-Wire Balloon Dilatation Catheter Jingyi. According to the announcement dated November 18, 2025, Jingyi is indicated for dilating coronary artery or coronary artery bypass vessels stenosis to improve myocardial perfusion; the balloon diameter configurations ranging from 2.0 to 5.0mm are also approved for post-stent dilation.
Jingyi is described as a semi-compliant balloon dilatation catheter featuring a smaller distal tip profile and balloon folding profile, along with an optimized delivery system for enhanced crossability and pushability. It is intended to address complex lesions such as chronic total occlusion and severe calcification. Its Over-the-Wire design is noted to further improve procedural efficiency and safety, and the company intends to pursue marketing activities in the PRC when appropriate.
The announcement states that the company may not ultimately succeed in marketing Jingyi and advises shareholders and potential investors to exercise due care when dealing in its shares.