Business Daily Media

Business Marketing

.

Ascletis' NDA for Its All-oral HCV Treatment Accepted by CFDA

  • Written by ACN Newswire
Wednesday, 1 August 2018, 18:35 HKT/SGT
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 summarySectors: Daily Finance, Daily News, BioTech[1][2][3] http://www.acnnewswire.com From the Asia Corporate News Network

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

References

  1. ^ Daily Finance (www.acnnewswire.com)
  2. ^ Daily News (www.acnnewswire.com)
  3. ^ BioTech (www.acnnewswire.com)

Read more http://www.acnnewswire.com/press-release/english/45184/

Popular

Why it is so important for Companies to understand their team members financial wellness

In a survey conducted by CoreData, they found that only 6% of employees they surveyed, classified themselves as ‘superstar savers’. This section was defined as having no concerns about their ability to pay their mortgage or ...

Travel DAZE

Travel DAZE is going to help you survive the apocalypse that is already rocking the boat in the tourism industry. Don't be left without a paddle! It's Australia's first-ever TED style ideas, marketing and strategy event for the tr...

How to capitalise on Kaseel Solar solar panels

The installation of solar panels has proven to be a continuous trend. Every day more homes and buildings use them for self-consumption, while business investment in this type of energy production continues to grow. One of the m...