Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

PD-1 Inhibitor Market Poised For A New Round Of Expansion: After GSK’s Jemperli Approval, US FDA Still Has Three Novel Candidates Under Review

Executive Summary

Agenus’ recent submission of balstilimab joins novel checkpoint inhibitors from Incyte expecting FDA action this year; Junshi and Coherus’ ongoing rolling BLA for toripalimab is the first from the multiple PD-1/L1 inhibitor candidates developed in China that are vying to enter the US market.

You may also be interested in...



After ODAC: The State Of Accelerated Approval At The US FDA

US FDA’s Accelerated Approval process has always been a deceptively simple idea. After a three-day public review of ‘dangling’ applications, the underlying complexity remains.

Keeping Track: US FDA Says Yes To AZ’s Farxiga In CKD And ADC’s Zynlonta, But No To Leo’s Tralokinumab, Chiesi’s Pegunigalsidase

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

China Inc. Shines In Latest Batch Of Approvals

Chinese domestic firms have gained a flurry of novel drug approvals at home, including the first globally for an anti-PD-1 antibody for nasopharyngeal carcinoma.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS144217

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel