The Company and all the members of the Board warrant that the contents of the announcement are true, accurate, and complete without any false record, misleading statement, or material omission.
Lepu Medical Technology (Beijing) Co., Ltd. (hereinafter referred to as "Lepu Medical "or" the Company") has submitted the application of medical device registration to the State Food and Drug Administration for the blockbuster product of the Company, NeoVasTM, the bioabsorbable drug-eluting (rapamycin) stent system. The registration has been accepted on August 8th, 2017. (Accepted number: CQZ1700369)
This product will be in accordance with the Innovative Medical Device Special Approval Process (Trial) for registration approval, and the registration process will be given priority. Lepu medical is expected to become the first domestic company to receive the registration certificate on the bioabsorbable coronary stent.
The research and development of bioabsorbable coronary stent are considered as the fourth revolution of interventional treatment for coronary heart disease. It achieved the technological transformation from vascular recanalization to vascular revascularization, which is of epoch-making significance.
In 2009, Lepu Medical started the R&D program of a bioabsorbable coronary stent. The design, development, examination, animal experiment, clinical trial and other R&D works were in accordance with the laws and regulations of China's medical device industry. The result showed that the performance of NeoVasTM bioabsorbable coronary stent reached the leading level of the world, and it has comparable clinical effects with Abbott's XIENCE metal drug-eluting stent, which fully confirmed the safety and efficacy of NeoVasTM.
According to registration requirements for the Class III medical device, the new product will be reviewed by the Medical Device Technical Review Center of the National Food and Drug Administration after receiving the acceptance of registration. If the product passes the review, a registration certificate will be issued. According to the above provisions, the time period of registration review and the review result of the "bioabsorbable drug-eluting (rapamycin) stent system" is still uncertain. The company will disclose the related information of the process timely. Please pay attention to the investment risk.
Notice is hereby given.
Board of Lepu Medical Technology (Beijing) Co., Ltd.
August 9th, 2017