Business Daily Media

The Times Real Estate

.

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/

UBH Group Pioneers Australia's Path to Nuclear Sovereignty

Sovereign technology company, UBH Group, has achieved a landmark milestone as the first organisation in the Southern Hemisphere to secure ISO 1944...

The unsung heroes: How MSPs can safeguard SMBs while boosting profitability

In Australia, small-to-medium-sized businesses (SMBs) form the backbone of the economy, accounting for 95% of all businesses. Yet, they remain pri...

Businesses grapple with wage compliance as new laws take effect

Australian businesses are navigating a landscape of rising compliance complexity as new wage theft laws under The Closing Loopholes Acts take hold...

Aerologix Partners with Soar to Create World’s Largest Digital Atlas

Australian drone technology pioneer Aerologix today announced a strategic partnership with digital mapping platform Soar to create what is set to ...

Five signs that AI is growing faster than the internet did

What do Aussie businesses need to do to keep up? There has been mounting chatter that AI is growing even faster than the rapid acceleration we sa...

Protecting Your Small Business from Cyber Threats This Holiday Season

The holiday season brings a surge of online activity for small and medium businesses (SMBs), with increased sales and customer inquiries offering ...

Sell by LayBy