Priority review granted to BeiGene’s Tislelizumab in China by NMPA
Category: #health  By Pankaj Singh  Date: 2019-07-08
  • share
  • Twitter
  • Facebook
  • LinkedIn

Priority review granted to BeiGene’s Tislelizumab in China by NMPA

BeiGene, Co., Ltd., a commercial-stage biotechnology company recently announced that China NMPA (National Medical Products Administration) has granted priority review status to the sNDA (supplemental new drug application) for an investigational Fc-engineered anti-PD1 antibody, tislelizumab, for patients with metastatic urothelial carcinoma.

For the record, BeiGene has been developing tislelizumab as a monotherapy and in combination with other therapies for the treatment of both solid & hematologic cancers. In 2018, a New Drug Application for the drug as a potential treatment of patients with R/R (Relapsed/Refractory) CHL (Classic Hodgkin’s Lymphoma) was accepted by the NMPA & was granted a priority review status in the same year.

Urothelial carcinoma, also known as TCC (transitional cell carcinoma) is the most common type of bladder cancer. In 2018, it was estimated that 82,270 incidences of bladder cancer cases were registered in China, accounting for 15% of all incidences worldwide. Although urothelial carcinoma is most common in the bladder, it can occur in other parts of the urinary system as well.

Wendy Yan, Senior VP, Global Head of Regulatory Affairs, at BeiGene, Co., Ltd., was reported to state that the company’s first priority review granted by the NMPA was for a solid tumor indication for a PD-1 antibody for bladder cancer & now, tislelizumab has become the second to receive priority review by the NMPA. Moreover, zanubrutinib was granted two priority reviews in China for treatment of various B cell malignancies.

BeiGene’s regulatory team has been closely working with the National Medical Products Administration, as NMPA reviews applications for treating patients with hematologic cancers & solid tumors. The company is looking forward to treating patients with metastatic urothelial carcinoma, with the new drug, Yen added.

Reportedly, the supplemental new drug application for tislelizumab as a potential treatment for patients with metastatic urothelial carcinoma was accepted by the NMPA in May 2019. The drug is reinforced by clinical, non-clinical & CMC data packages including the results from a pivotal Phase 2 study of the drug in 113 Chinese & Korean patients with metastatic urothelial carcinoma.

Source credits: http://ir.beigene.com/news-releases/news-release-details/priority-review-granted-beigenes-supplemental-new-drug



About Author

Pankaj Singh

Email: [email protected]   

Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

Read More

More News By Pankaj Singh

RADLogics obtains FDA's approval for AI-based chest X-Ray App
RADLogics obtains FDA's approval for AI-based chest X-Ray App
By Pankaj Singh

RADLogics Inc., a healthcare software company developing AI-powered solutions has reportedly received 510(k) clearance from the US FDA (Food and Drug Administration) for its latest AI-Powered chest X-ray pneumothorax a...

CDE of China NMPA clears I-Mab’s application for lemzoparlimab
CDE of China NMPA clears I-Mab’s application for lemzoparlimab
By Pankaj Singh

Clinical stage biopharmaceutical major, I-Mab, has reportedly announced that it has received the clearance of the Center for Drug Evaluation of the China National Medical Products Administration for its IND application...

Aoyuan Healthy to acquire 55% equity interest in Liantianmei
Aoyuan Healthy to acquire 55% equity interest in Liantianmei
By Pankaj Singh

Aoyuan Healthy Life Group Company Ltd., a renowned commercial property operation service and property management service provider based in China, has reportedly announced that Guangdong Xinyuerong Industrial Investment...