View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. Comment
July 23, 2019

Beigene’s Tislelizumab receives second priority review by China’s NMPA

The incidence of bladder cancer is ranked sixth by the National Central Cancer Registry (NCCR) of China.

By GlobalData Healthcare

Recently, the National Medical Product Administration (NMPA, formerly known as the China Food and Drug Administration, or CFDA) has been issuing guidelines and reforms to accelerate the drug development process in China.

Bladder cancer treatment

BeiGene’s Tislelizumab (BGB-A317), an investigational Fc engineered anti-PD-1 antibody, has received priority review for its recent supplemental New Drug Application (sNDA) for patients with previously treated locally advanced or metastatic urothelial carcinoma (UC). This implies a need for this drug, as the incidence of bladder cancer is ranked sixth by the National Central Cancer Registry (NCCR) of China.

According to Wendy Yan, SVP, and head of regulatory affairs at BeiGene, it is the second priority granted by the NMPA for Tislelizumab. Following the acceptance of the sNDA for Tislelizumab in patients with previously treated locally advanced or metastatic urothelial carcinoma in May 2019, the NMPA gave the application a Priority Review designation in early July 2019. This decision was supported by the clinical, non-clinical, and Chemistry Manufacturing and Control (CMC) results from the Phase II pivotal trial (CTR20170071). This will be the first solid tumour and the first PDL1/PD-1 antibody in China to receive Priority Review. Previously, Tislelizumab’s NDA received Priority Review process for relapsed/refractory (R/R) classical Hodgkin’s lymphoma (cHL).

Tislelizumab is also being tested as a monotherapy and in a combination with sitravatinib, a small molecule tyroskine kinase inhibitor, for a wide variety of solid tumours and hematologic cancers.

Some highlights from the current ongoing trials for this drug are given in the table below.

With 15 ongoing clinical trials for Tislelizumab, BeiGene’s regulatory team is constantly working with the NMPA as it reviews BeiGene’s application to treat patients with solid tumours and hematologic cancers.

BeiGene owns the full developmental and commercialisation rights of Tislelizumab worldwide and has formed a strategic relationship with Celgene for its development outside Asia (except Japan).

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU