Innovent Announces the Approval of a First-Line Therapy for People with Hepatocellular Carcinoma in China

Goodwin
Contact

Goodwin

Innovent Biologics, Inc. announced that the National Medical Products Administration of China (“NMPA”) approved its supplemental New Drug Application for TYVYT®, a sintilimab injection, in combination with BYVASDA®, a bevacizumab biosimilar injection, as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma (“HCC”).  According to the press release, this is the first regulatory approval of a PD-1 inhibitor-based combination therapy for the first-line treatment of HCC.  The announcement indicated that this approval was based on the results of a randomized, open-label Phase 3 clinical trial (ORIENT-32).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:

Goodwin
Contact
more
less

Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide