Qilu Pharmaceutical Nears Approval for Tenofovir Alafenamide Fumarate Tablets as Originator Drug Surpasses RMB 100 Million in H1 Sales

Recently, Qilu Pharmaceutical’s Class 4 generic application for Tenofovir Alafenamide Fumarate Tablets has entered the “under review” status, with positive news expected in the near future. Developed by Gilead Sciences and hailed as the “most potent hepatitis B drug in history,” Tenofovir Alafenamide Fumarate Tablets were approved for the Chinese market in November 2018. In the first half of 2020, sales at public healthcare institutions in China exceeded RMB 100 million, representing a remarkable growth rate of 1,952.93%.

Figure 1: Registration Progress of Qilu Pharmaceutical's Tenofovir Alafenamide Fumarate Tablets

Source: NMPA Official Website

Tenofovir Alafenamide Fumarate (TAF) is a potent antiviral agent for the treatment of chronic hepatitis B in adults and adolescents. As a nucleos(t)ide analogue, it belongs to the same class as Tenofovir Disoproxil Fumarate (TDF) and Entecavir (ETV), and is recognized as one of the three first-line therapies recommended by global clinical practice guidelines for hepatitis B. Tenofovir Alafenamide Fumarate tablets were developed by Gilead Sciences, with global sales reaching USD 488 million in 2019.

Figure 2: Sales of Tenofovir Alafenamide Fumarate Tablets

Source: Menet - Competitive Landscape at the Terminal of China's Public Medical Institutions

The original research product was approved for entry into the Chinese market in November 2018. After being included in the National Reimbursement Drug List through price negotiations in 2019, its sales rapidly increased. Data from Menet shows that in the first half of 2020 (2020H1), sales of tenofovir alafenamide at terminals of Chinese public medical institutions—including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—exceeded RMB 100 million.

Figure 3: Current Approval Status of Tenofovir Alafenamide Fumarate Tablets

Source: Menet One-Click Search

In October this year, Chengdu Better Pharmaceutical’s application for market approval of its generic Tenofovir Alafenamide Fumarate Tablets (Class 4) was approved and considered as having passed the consistency evaluation, making it the first domestic generic version. If Qilu Pharmaceutical obtains approval smoothly, it will become the second domestic manufacturer. Currently, other companies with Class 4 generic marketing applications for this product under review include Kelun, Yuandong Bio-pharmaceutical, HEC Pharm, Yangtze River Pharmaceutical, and Nanjing Chia Tai Tianqing.

Table 1: Overview of Generic Drugs Approved for Qilu Pharmaceutical and Its Subsidiaries from 2020 to Present

Source: Menet MED2.0 China Drug Evaluation Database

Data from Menet shows that since 2020, Qilu Pharmaceutical and its subsidiaries have obtained approval for the market launch of 14 generic drug products (with 27 approval documents). Among them, aprepitant capsules achieved the distinction of being the “first generic version approved” and the “first to pass quality consistency evaluation.” Oxaliplatin injection, leflunomide tablets, pregabalin capsules, and bivalirudin for injection were the first to pass the quality consistency evaluation, marking significant achievements.

Source: NMPA Official Website, Menet Database