Qilu Pharmaceutical Enters the $1.9 Billion Tenofovir Alafenamide Market, Competing with Chengdu Biotech for First-to-File Generic

On June 7, Qilu Pharmaceutical submitted a Category 4 generic marketing application for Emtricitabine and Tenofovir Alafenamide Tablets (I) and Emtricitabine and Tenofovir Alafenamide Tablets (II). Currently, only the originator drug was approved for import in China in 2018, and no domestic generic drugs have been approved yet.

Figure 1: Overview of Products Submitted for Approval by Qilu Pharmaceutical

Figure 2: Global Sales of Gilead's Emtricitabine/Tenofovir Alafenamide (Unit: million USD)

Source: MENET Multinational Listed Companies Sales Database

Gilead's emtricitabine/tenofovir alafenamide is indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older and weighing at least 35 kg). This fixed-dose combination was approved by the FDA in 2016, and its global sales reached nearly USD 1.9 billion in 2020.

Figure 3: Sales of Emtricitabine/Tenofovir Alafenamide in the Chinese Market (Unit: 10,000 RMB)

Source: MENET Database

In 2018, the NMPA approved Gilead’s fixed-dose combination emtricitabine/tenofovir alafenamide tablets (I: emtricitabine 200 mg/tenofovir alafenamide 10 mg; II: emtricitabine 200 mg/tenofovir alafenamide 25 mg) for the treatment of HIV. According to MENET data, in 2020, the sales growth rate of emtricitabine/tenofovir alafenamide at the sales terminals of urban public hospitals, county-level public hospitals, urban community health centers, and township health centers in China (collectively referred to as Chinese public medical institutions) reached 487.61%, while the growth rate at urban physical pharmacy terminals also surged to 177.78%. The rapid sales volume expansion of the originator product in the domestic market has also attracted keen attention from domestic pharmaceutical companies.

Figure 4: Review Timeline of Chengdu Bright Pharmaceutical's Emtricitabine and Tenofovir Alafenamide Tablets

Source: MENET MED2.0 Drug Review Database

Chengdu Better Pharmaceutical submitted a Class 4 generic marketing application for emtricitabine and tenofovir alafenamide tablets (Acceptance No. CYHS1900772) in November 2019, which is currently under review and approval. Based on the acceptance date, Qilu Pharmaceutical appears to be at a slight disadvantage; however, we will continue to follow up and report on whether it can ultimately reverse the situation.

Source: CDE official website and MENET database

Review data statistics are current as of June 7. Please kindly point out any errors or omissions.