AstraZeneca's Olaparib Set to Become China's First Approved PARP Inhibitor

Text | Jian Shi Ju, Feng Chenchen

Edited by Shirely

Recently, AstraZeneca's olaparib tablets have completed the review and approval process for their domestic marketing application in China and are expected to be approved for market launch.

This means that it may become the first PARP inhibitor to be marketed in China, filling a nearly 30-year gap in the field of targeted therapy for ovarian cancer in the country.

And this occurred just eight months after its application for domestic import and marketing approval was accepted by the Center for Drug Evaluation (CDE) in December 2017.

This is attributable to the advancement of accelerated approval policies for new drugs urgently needed in clinical practice in China.

In January 2018, AstraZeneca’s olaparib tablets were included in the public notice list of the 26th batch of drug registration applications proposed for priority review by the Center for Drug Evaluation (CDE), on the grounds that they demonstrated “significant therapeutic advantages over existing treatment options.” Thereafter, olaparib tablets officially entered the “fast track” for market approval.

It is reported that global sales of PARP inhibitors reached $462 million in 2017, with olaparib alone contributing $297 million, accounting for more than half of the total.

To date, there are three PARP inhibitors approved globally: in addition to AstraZeneca’s olaparib, they include rucaparib from Clovis Oncology and niraparib from TESARO and Merck & Co. However, as of now, neither rucaparib nor niraparib has submitted a registration application for market approval in China.

In addition, there are currently eight domestic pharmaceutical companies in China whose investigational PARP inhibitor products have been approved for clinical trials in China, including BeiGene, Zai Lab, Jiangsu Hansoh Pharmaceutical, Qingfeng Pharmaceutical, Humanwell Healthcare, Hengrui Medicine, Shanghai Chuannuo Pharmaceutical, and the Shanghai Institute of Materia Medica, Chinese Academy of Sciences.