Qilu Pharmaceutical Files for First-to-File Generic Nilotinib Capsules Targeting $2 Billion Anticancer Drug Market

On October 21, Qilu Pharmaceutical Co., Ltd. submitted a Class 4 generic drug marketing application for nilotinib capsules. This product is a second-generation BCR-ABL tyrosine kinase inhibitor developed by Novartis, with global sales approaching $2 billion in 2020. Suzhou Terui Pharmaceutical submitted the first marketing application for this drug in September this year. Qilu is not significantly behind in terms of timing and still has the opportunity to secure the first generic approval.

Figure 1: Application Status of Qilu Pharmaceutical's Nilotinib Capsules

Source: CDE Official Website

Figure 2: Sales of Novartis' Nilotinib in China (Unit: 10,000 RMB)

Source: MENET Database

Novartis's nilotinib was approved for marketing in China in July 2009 and is currently included in the 2020 National Reimbursement Drug List (NRDL) negotiation catalog. Data from Menet shows that in 2020, its combined sales at China's public medical institutions (urban public hospitals, county-level public hospitals, urban community health centers, and township health centers) and physical retail pharmacies in urban China reached nearly RMB 900 million. The product has been growing rapidly in the retail market, with 2021 sales projected to exceed RMB 300 million. Following the comprehensive implementation of the "dual-channel" policy, its sales growth rate is expected to continue accelerating.

In September 2021, Suzhou Tairui Pharmaceutical’s marketing authorization application for nilotinib capsules, submitted under the Class 4 generic pathway, was formally accepted by the CDE, making it the first applicant in China. Qilu Pharmaceutical submitted its application one month later but still holds the potential to overtake it and secure the first generic approval.

Table: Overview of Generic Drugs Filed for Marketing Approval by Qilu Pharmaceutical Since 2021

Source: Menet MED2.0 China Drug Evaluation Database

Since 2021, Qilu Pharmaceutical has filed 22 chemical generic drugs for marketing approval, 10 of which are poised to compete for first-generic status. Among them, apremilast, emtricitabine/tenofovir alafenamide, and nilotinib are blockbuster drugs with global sales exceeding $1 billion, holding substantial market potential upon regulatory approval and commercial launch.

Source: CDE Official Website, Menet Database

Review data statistics are as of October 22. Please kindly point out any errors or omissions.