Qilu Pharmaceutical declares the world's first generic drug ``Olapali''

Article source: Medical Rubik's Cube Info

Author: Shi Bei

On October 28, the CDE official website 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
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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.

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Olaparib was first approved for marketing by NMPA in August 2018.
It is the first PARP inhibitor to be marketed in China.
It has been approved for treatment in China before: ①Platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer or primary Maintenance treatment for adult patients with peritoneal cancer after platinum-containing chemotherapy has achieved complete or partial remission
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According to the PharmaGo database of Medicine's Cube, only Qilu Pharmaceutical has declared a generic drug for olaparib in China, and 9 domestic companies including Hausen Pharmaceutical, Chia Tai Tianqing and Shandong Luoxin have applied for clinical trials of this product
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According to NextPharma, the medical Rubik’s Cube database, there are currently 6 PARP inhibitors on the market worldwide, namely olaparib (AstraZeneca/Mersk), Nirapali (GSK/Zai Lab), and Lucapali (Clovis).
), talazoparib (Pfizer), fluzoparib (Hengrui), and Pamiparib (BeiGene)
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At present, 4 innovative PARP inhibitor drugs have been approved for marketing in China, namely olaparib, niraparib, fluzoparib, and pamiparib