Qilu Pharmaceutical Enters the Over-3-Billion-Yuan Tacrolimus Market, Challenging Originator Dominance

The latest data from the MENET MED China Drug Review Database 2.0 indicates that Qilu Pharmaceutical’s tacrolimus ointment (application numbers CYHS1401006 and CYHS1401007) has completed the review and approval process for its Class 6 generic marketing application, with the current status listed as “Documents Issued,” making approval highly likely. In 2018, sales of tacrolimus at public medical institutions in China exceeded RMB 3.8 billion. How much market share will remain for the originator companies after Qilu’s entry into the market?

Figure 1: Sales of Tacrolimus at Public Medical Institution Terminals in China (Unit: 10,000 Yuan)

Source: Menet – Competitive Landscape at the Terminal of Chinese Public Medical Institutions

Figure 2: Corporate Landscape of Tacrolimus at Public Healthcare Institution Terminals in China, 2018

Source: Competitive Landscape of China’s Public Medical Institution Terminals, Menet

Currently, the tacrolimus formulations approved for marketing in the Chinese market include ophthalmic preparations, capsules, ointments, and injections. In 2018, the terminal sales of this product in China’s public medical institutions—comprising urban public hospitals, county-level public hospitals, urban community health centers, and township health centers—exceeded RMB 3.8 billion. In terms of dosage form distribution, capsules accounted for the largest share at 90.53%, followed by ointments at 8.16%, injections at 0.47%, and ophthalmic preparations at 0.85%.

The market leader for this product is Astellas Pharma, whose market share has declined sharply in recent years due to the impact of domestic generic drugs. Astellas Pharma’s market share was as high as 82.78% in 2013, but dropped to 67.53% by 2018. Among domestic companies, Hangzhou Zhongmei Huadong Pharmaceutical ranks among the top, with its market share rising to 25.20% in 2018.

Tacrolimus ointment is indicated for the short-term or intermittent long-term treatment of patients with moderate-to-severe atopic dermatitis who are not suitable for conventional therapies due to potential risks, have an inadequate response to conventional therapies, or cannot tolerate conventional therapies. In 2018, tacrolimus ointment ranked seventh among the top 20 dermatological products by sales at public medical institutions in China. Currently, the main competitors for tacrolimus ointment are Astellas Pharma, Sichuan Mingxin Pharmaceutical, and Zhejiang Wansheng Pharmaceutical. What is the potential of Qilu Pharmaceutical after entering this market? We await the outcome.

Source: Menet Database