Ascletis'' NDA for Its All-oral HCV Treatment Accepted by CFDA
(firmenpresse) - Hangzhou and Shaoxing, China , Aug 1, 2018 - (ACN Newswire) - Ascletis announced today it has received the acceptance letter from the China Food and Drug Administration (CFDA) for Ravidasvir (RDV) new drug application (NDA). Ravidasvir in combination with Ganovo (RDV/DNV Regimen) is the first all-oral interferon-free HCV regimen developed by a domestic company in China. Phase II/III clinical trial has shown that RDV/DNV Regimen demonstrated a cure rate of 99 % ( SVR12) with a short treatment duration of 12 weeks in genotype 1 patients. In patients with baseline NS5A resistance mutations, RDV/DNV Regimen demonstrated a cure rate of 100% (SVR12).
"Ascletis was successfully listed this morning on Hong Kong Exchange as the first ever pre-revenue biotech. The NDA for our all-oral HCV regimen was accepted by CFDA in the afternoon." Jinzi J. Wu, Ph.D., Ascletis'' founder, President and CEO, commented, "Two significant accomplishments on the same day reflect our unremitting effort to provide affordable and effective HCV cures to the patients and to fulfill our commitment to the investors."
Ganovo Regimen, Ascletis'' first breakthrough HCV regimen, was approved on June 8 and launched on June 27, 19 days after the approval. The acceptance of the NDA for its all-oral HCV regimen enables Ascletis soon to provide two HCV treatment options for Chinese patients, strengthening its leading position in China''s HCV field.
Topic: Press release summary
Sectors: Daily Finance, Daily News, BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 02.08.2018 - 03:57 Uhr
Sprache: Deutsch
News-ID 1539295
Anzahl Zeichen: 1756
contact information:
Contact person:
Town:
Hangzhou and Shaoxing, China
Phone:
Kategorie:
Healthcare & Medical
Typ of Press Release: bitte
type of sending: Veröffentlichung
Date of sending:
Anmerkungen:
Diese Pressemitteilung wurde bisher 381 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Ascletis'' NDA for Its All-oral HCV Treatment Accepted by CFDA
"
steht unter der journalistisch-redaktionellen Verantwortung von
Ascletis (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
