English | 简体中文 | 繁體中文 | 한국어 | 日本語
Wednesday, 1 August 2018, 18:35 HKT/SGT
Share:
Ascletis' NDA for Its All-oral HCV Treatment Accepted by CFDA

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 © 2018 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

 

Latest Press Releases
DENSO's Second Founding: Company Shift in Strategy to Craft the Core Technologies for the Future of Mobility  
Oct 19, 2018 17:34 HKT/SGT
Toyota Yaris WRC Set for a Crucial Test on Both Gravel and Asphalt  
Oct 19, 2018 17:17 HKT/SGT
BGC (SET:BGC) Begins Trading on the Stock Exchange of Thailand  
Oct 19, 2018 16:00 HKT/SGT
card complete Service Bank AG and JCBI enable contactless acceptance in Europe  
Oct 19, 2018 16:00 HKT/SGT
Fujitsu Develops Cooling Control Technology to Substantially Reduce Datacenter Energy Consumption  
Oct 19, 2018 12:41 HKT/SGT
Mazda Publishes Mazda Sustainability Report 2018 and Annual Report 2018  
Oct 19, 2018 12:28 HKT/SGT
Mazda Included in Dow Jones Sustainability Indices for Second Year Running  
Oct 19, 2018 12:15 HKT/SGT
Eisai: Discovery of Candidate Compound as Potential Treatment for Parkinson's Disease Using iPS Cells  
Oct 19, 2018 11:18 HKT/SGT
Novotech and CNS deal expands CRO services for Biopharma Clients across Asia-Pacific  
Oct 19, 2018 07:00 HKT/SGT
Macau Theme Park and Resort Limited Unveils the First Macau-Themed Integrated Resort LISBOETA   
Oct 18, 2018 18:00 HKT/SGT
More Press release >>
Copyright © 2018 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Privacy Policy | Terms of Use | RSS
US: +1 800 291 0906 | Beijing: +86 10 8405 3688 | Hong Kong: +852 2217 2912 | Singapore: +65 6304 8926 | Tokyo: +81 3 6721 7212

Connect With us: