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 © 2019 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

 

Latest Press Releases
China Dynamics and Eastern Ferry Sign Mou for Strategic Cooperation to Jointly Promote Green Marine Transport  
May 20, 2019 19:45 HKT/SGT
DENSO and Aisan Start Studying the Possibility of Strengthening Competitiveness in Powertrain and Future Growth Areas  
May 20, 2019 17:40 HKT/SGT
Honda Begins Joint Research with Center for Information and Neural Networks (CiNet) to Strengthen its Study of Humans in the Areas of Mobility and Robotics  
May 20, 2019 17:30 HKT/SGT
LT Game's First-Ever Self-Developed Slot Machines Approved by the Macau Gaming Authority  
May 20, 2019 16:32 HKT/SGT
Lexus LC Takes 24th Position Overall at QF Race for Nurburgring 24 Hours Endurance Race  
May 20, 2019 16:07 HKT/SGT
Mabpharm Announces Proposed Listing on the Main Board of the Hong Kong Stock Exchange  
May 20, 2019 07:00 HKT/SGT
Pacific Green Appoints KPMG LLP as Its Auditor  
May 18, 2019 03:00 HKT/SGT
Local biotech start-ups begin to target mass market  
May 17, 2019 17:00 HKT/SGT
"Science Based Targets (SBT) Initiative" Approves Eisai's Greenhouse Gas Reduction Targets  
May 17, 2019 15:34 HKT/SGT
Toyota Rolls Out New Supra  
May 17, 2019 14:49 HKT/SGT
More Press release >>
 Events:
More events >>
Copyright © 2019 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: +86 400 879 3881 | Hong Kong: +852 8192 4922 | Singapore: +65 6653 1210 | Tokyo: +81 3 6859 8400