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Perusahaan dan semua anggota papan menjamin bahwa isi pengumuman benar, akurat, dan lengkap tanpa catatan palsu, pernyataan menyesatkan, atau kekacauan.

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, NeoVas^TM, Sistem stent drug-eluting (rapamycin) bioabsorble. Pendaftaran telah diterima pada 8 Agustus 2017. (Nomor yang diterima: CQZ1700369)

Produk ini akan sesuai dengan proses persetujuan khusus perangkat medis yang inovatif (percobaan) untuk persetujuan pendaftaran, dan proses pendaftaran akan diberikan prioritas. Lepu medis diharapkan menjadi perusahaan domestik pertama yang menerima sertifikat registrasi pada stent koroner yang dapat diserap.

Penelitian dan Pengembangan bioabsorpsi yang dapat dipertimbangkan sebagai Revolusi keempat pengobatan intervensi untuk penyakit jantung koroner. Hal ini mencapai transformasi teknologi dari realistis vaskular menjadi revaskulalisasi vaskular, yang membuatnya sangat terperinci.

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 NeoVas^TM 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 NeoVas^TM.

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.

Pemberitahuan di sini dengan diberikan.

Papan teknologi medis Lepu (Beijing) Co., Ltd.
9 Agustus 2017