Qilu Pharmaceutical Submits the World's First Generic Olaparib NDA

Source: PharmaCube Info

Author: Shi Bei

On October 28, the official website of the Center for Drug Evaluation (CDE) showed that the marketing authorization application for Qilu Pharmaceutical's olaparib generic drug, filed under Class 4, has been accepted by the National Medical Products Administration (NMPA). This marks the first marketing authorization application for a generic version of this product, as well as the first for a PARP inhibitor generic drug in China.

Olaparib is the first FDA-approved oral poly(ADP-ribose) polymerase (PARP) inhibitor. By inhibiting PARP enzymatic activity and preventing PARP dissociation from DNA, it exploits defects in DNA damage repair to kill tumor cells. Originally developed by AstraZeneca, the product was first approved for marketing in the European Union and the United States in 2014 under the brand name Lynparza.

Olaparib was first approved for marketing by the NMPA in August 2018, becoming the first PARP inhibitor to be marketed in China. It has been previously approved in China for the treatment of: ① maintenance treatment of adult patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy. ② first-line maintenance treatment of advanced ovarian cancer with BRCA mutation. ③ maintenance treatment of advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer harboring BRCA mutations. ④ monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) harboring germline or somatic BRCA mutations (gBRCAm or sBRCAm) whose disease has progressed following prior therapy (including a novel hormonal agent).

According to the PharmaGo database, only Qilu Pharmaceutical in China has submitted a generic drug application for olaparib, while nine other Chinese companies, including Hansoh Pharma, Chia Tai Tianqing, and Shandong Luoxin, have filed clinical trial applications for this product.

According to the NextPharma database by PharmCube, there are currently six PARP inhibitors approved globally: olaparib (AstraZeneca/MSD), niraparib (GSK/Zai Lab), rucaparib (Clovis), talazoparib (Pfizer), fluzoparib (Hengrui), and pamiparib (BeiGene). The global market size for PARP inhibitors in 2020 was USD 3.135 billion, with olaparib accounting for the largest share at 79.8%.

Currently, four innovative PARP inhibitors have been approved for marketing in China, namely olaparib, niraparib, fluzoparib, and pamiparib.