On October 28, the official website of China's CDE showed that Qilu Pharmaceutical's application for the generic drug listing of olaparib declared in Category 4 was accepted by the State Food and Drug Administration. This is the first application for the listing of a generic drug for this product and the first application for the listing of a generic PARP inhibitor in China.

Olapali is the first oral polyadenosine diphosphate ribose polymerase (PARP) inhibitor approved by the FDA. By inhibiting PARP enzyme activity and preventing PARP from dissociating from DNA, it cooperates with DNA damage to repair functional defects and kills tumor cells. . The original manufacturer is AstraZeneca. The product was approved to be listed in the European Union and the United States as early as 2014, under the trade name Lynparza.

Olaparib was first approved for marketing by China's NMPA in August 2018. It is the first PARP inhibitor to be marketed in China. It has previously been approved for treatment in China: ①Platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer or Maintenance treatment for adult patients with primary peritoneal cancer after platinum-containing chemotherapy has achieved complete or partial remission. ②First-line maintenance treatment for BRCA-mutated advanced ovarian cancer. ③Maintenance treatment of advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer with BRCA mutation. ④Single agent is used to treat adult patients with metastatic castration-resistant prostate cancer who carry germline or somatic BRCA mutations (gBRCAm or sBRCAm) and have failed previous treatments (including a new type of endocrine drug).

According to statistics, there are currently 6 PARP inhibitors currently on the market worldwide, namely olaparib (AstraZeneca/Mersk), Nirapali (GSK/Zai Lab), Lucapali (Clovis), talazoparib (Pfizer), fluzoparib (Hengrui), pamidril (BeiGene). The global market size of PARP inhibitors in 2020 is 3.135 billion U.S. dollars, with olaparib accounting for the highest proportion at 79.8%.

At present, 4 innovative PARP inhibitor drugs have been approved for marketing in China, namely olaparib, niraparib, fluzoparib, and pamiparib.