China FDA approval for Sinovac's EV71

4 January 2016
2019_biotech_test_vial_discovery_big

Chinese vaccine maker Sinovac Biotech (Nasdaq: SVA) today announced that the China Food and Drug Administration (CFDA) issued the new drug certificate and production license for its Enterovirus 71 ("EV71") vaccine.

The CFDA completed its Good Manufacturing Practices (GMP) inspection simultaneously with the site inspection of the EV71 vaccine production facility in October 2015, and will issue the GMP license after the new drug certificate and production license are issued. Sinovac expects to receive the GMP license in early 2016 and will start commercial production of EV71 vaccine immediately afterwards. The company expects to deliver the vaccine to the market within four to five months after commercial production begins.

Sinovac's EV71 vaccine production facility is located in Beijing with an expected production capacity of 20 million doses annually. This vaccine will target children aged six-35 months, with each child requiring a total of two doses one month apart from another.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology