Qilu Pharmaceutical's Pazopanib Tablets Nears First-to-File Generic Approval in China

Text | Baihuawen

On August 24, the marketing application for pazopanib tablets, a new Class 4 generic drug submitted by Qilu Pharmaceutical, entered the “under review” stage, with expectations of imminent approval as the first generic version.

Pazopanib is a multi-targeted tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3; platelet-derived growth factor receptors (PDGFR)-α and -β; fibroblast growth factor receptors (FGFR)-1 and -3; cytokine receptor (Kit); interleukin-2 receptor-inducible T-cell kinase (Itk); leukocyte-specific protein tyrosine kinase (Lck); and transmembrane glycoprotein receptor tyrosine kinase (c-Fms).

Pazopanib received FDA approval in October 2009, and its currently approved indications include renal cell carcinoma and soft tissue sarcoma. In February 2017, the drug’s indication for the treatment of renal cell carcinoma was approved in China, and it was subsequently included in the Class B list of the National Reimbursement Drug List following the 2018 national reimbursement negotiations. Pazopanib was originally a product of GlaxoSmithKline (GSK) but was divested as part of the asset swap transaction between GSK and Novartis in 2014. The drug’s sales revenue amounted to USD 755 million in 2019.

Renal Cell Carcinoma (RCC) is a common malignant tumor worldwide, with its incidence and mortality accounting for approximately 2%-3% of all systemic tumors. Among urological malignancies, its incidence ranks second only to bladder cancer and shows a逐年 increasing trend year by year. In recent years, targeted therapies have made significant progress in the treatment of advanced renal cell carcinoma. Since 2005, multiple drugs have been approved globally and have become the standard of care for advanced RCC.

The current incidence rate of renal cell carcinoma (RCC) in males in China is 4.7 per 100,000, while in females it is approximately 3 per 100,000. The annual incidence rate of kidney cancer is increasing by about 2.5%. Drugs approved by the National Medical Products Administration for the treatment of RCC include sunitinib (Pfizer), sorafenib (Bayer), everolimus (Novartis), axitinib (Pfizer), anlotinib (Chia Tai Tianqing), and sunitinib (Pfizer), among others.