Hengrui, Qilu, and Kelun Advance into the RMB 7-billion Ophthalmic Market with New Drug Approvals and Filings

On April 15, the NMPA website updated its drug approval information, with new ophthalmic drop products approved for Xingqi Eye Medicine, Qilu Pharmaceutical, and Jiangxi Kelun Pharmaceutical. On April 16, Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui Medicine, submitted an application for clinical trial approval of HR19034 eye drops as a Class 2.4 new drug, which was accepted... Recently, the ophthalmic preparation market has seen a series of positive developments, with a promising market potential of RMB 7 billion.

Figure 1: Ophthalmic preparations recently approved for market launch

Source: NMPA Official Website

Moxifloxacin Hydrochloride Eye Drops are primarily indicated for the treatment of bacterial conjunctivitis caused by susceptible microorganisms. The originator product, developed by Novartis, was approved for entry into the Chinese market in 2018 and was included as a new addition in the 2019 National Reimbursement Drug List (NRDL). In the 2020 NRDL, its reimbursement was restricted to “second-line therapy.” The approval of domestic generic versions surged in 2021. Previously, Shanghai Sine Jingzhu Pharmaceutical, China Resources Zizhu Pharmaceutical, and Zhuhai Essex Bio-Pharmaceutical had obtained marketing approvals for Class 4 generics. With the recent approvals granted to Shenyang Xingqi Pharmaceutical and Kelun Pharmaceutical, a total of five domestic pharmaceutical companies have received marketing authorizations, which are considered equivalent to passing the quality consistency evaluation. As moxifloxacin eye drops appeared on the reported volume list for the fifth national centralized procurement circulated within the industry earlier, the upcoming bidding for this national procurement is expected to be highly competitive.

Figure 2: Sales of Brimonidine Tartrate Eye Drops

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

Brimonidine Tartrate Eye Drops are indicated for lowering intraocular pressure in patients with open-angle glaucoma and ocular hypertension, and are included in the National Reimbursement Drug List. Data from Menet shows that sales of Brimonidine Tartrate Eye Drops have been steadily increasing in recent years at terminals comprising Chinese urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (collectively referred to as Chinese public medical institutions). In the first half of 2020, it entered the TOP 20 list of ophthalmic preparations for the first time. Currently, the market leader is Allergan (USA), with a market share exceeding 80%. Domestic companies that had previously obtained approval include Nanjing Hengsheng Pharmaceutical, Beijing Hui'en Lande Pharmaceutical, and Lunan Better Pharmaceutical. Qilu Pharmaceutical has recently received approval for its generic version under Class 4 classification, becoming the first company to pass the consistency evaluation.

Figure 3: New drugs submitted by Chengdu Shengdi Pharmaceutical for clinical trial approval

Source: CDE Official Website

Data from Menet shows that the sales volume of ophthalmic preparations at public medical institution terminals in China rose to nearly RMB 7 billion in 2019. In 2020, 13 new domestically produced products were approved for market launch (based on approval dates), and eight new products have been approved since 2021. With continuous efforts by domestic pharmaceutical companies, the ophthalmic preparation market is expanding steadily.

Sources: NMPA Official Website, CDE Official Website, Menet Data

Review data statistics are as of April 19. Please point out any errors or omissions.