Qilu Pharmaceutical's Olaparib, China's First Generic PARP Inhibitor, Gains Market Approval

On May 17, the official website of the National Medical Products Administration showed that Qilu Pharmaceutical's Olaparib Tablets have been approved for marketing. This is the first domestically produced generic Olaparib to be approved for marketing in China.

Poly (ADP-ribose) polymerase (PARP) inhibitors can suppress the repair process of DNA single-strand damage, thereby converting it into double-strand damage during DNA replication. If tumor cells have BRCA1/2 mutations, their DNA damage repair function is limited, resulting in irreparable double-strand damage, which increases the sensitivity of cancer cells to PARP inhibitors, disrupting tumor cell synthesis to achieve anti-tumor purposes.

Olaparib is the world's first approved PARP inhibitor. On December 19, 2014, Olaparib was approved by the FDA for the treatment of ovarian cancer. To date, Olaparib has successively obtained indications for ovarian cancer, breast cancer, castration-resistant prostate cancer, pancreatic cancer, fallopian tube cancer, and peritoneal cancer.

Since its launch, the sales of Olaparib have been increasing year by year. According to AstraZeneca's 2022 financial report, the full-year sales of Olaparib reached 2.638 billion US dollars.

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