Qilu Pharmaceutical Races for First-to-File Status with Three Ophthalmic Drops Targeting a RMB 10-Billion Market

On November 28, data from the CDE website showed that Qilu Pharmaceutical’s Class 4 generic marketing application for brimonidine tartrate and timolol maleate eye drops was accepted. This product is indicated for lowering intraocular pressure in patients with open-angle glaucoma and ocular hypertension. Currently, only Allergan (USA) has obtained approval for importation into the Chinese market, making Qilu Pharmaceutical the first pharmaceutical company to file a generic marketing application for this product in China.

Figure 1: Brimonidine Tartrate and Timolol Maleate Eye Drops Submitted by Qilu Pharmaceutical

Source: CDE Official Website

Figure 2: Market Size of Ophthalmic Drugs

Source: Menet’s Competitive Landscape of China’s Public Medical Institution Terminal Market

Data from Menet shows that in 2019, the market size of ophthalmic drugs 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 10 billion. The sales growth rate from 2017 to 2019 was over 10% each year, but it decreased by 8.10% in the first half of 2020 due to the impact of the pandemic. Among the top 20 companies ranked, Qilu Pharmaceutical ranked 18th with a market share of 1.17% in the first half of 2020, an increase of 0.07% compared to 2019.

Table 1: Overview of Approved Marketing Applications for Ophthalmic Drugs by Qilu Pharmaceutical from 2017 to Present

Source: Menet MED2.0 China Drug Review Database

Table 2: Status of Ophthalmic Drug Marketing Applications Under Review by Qilu Pharmaceutical

Source: MENET MED2.0 China Drug Review Database

Since 2017, Qilu Pharmaceutical has had three generic ophthalmic drugs approved for market launch in China. Among them, the latanoprost-timolol eye drops represent the first domestic generic version; following its market entry, the originator Pfizer’s market share declined to 93.91% in the first half of 2020. Currently, in addition to the newly filed brimonidine-timolol eye drops, Qilu has two additional high-end generic ophthalmic products under regulatory review and approval, namely cyclosporine eye drops (II) and brimonidine tartrate eye drops.

Source: CDE Official Website, Menet Database

The review data statistics are current as of November 30, 2020. Please point out any errors or omissions.