Qilu Pharmaceutical Submits China's First Domestic Application for Aflibercept Intravitreal Injection, a Global Blockbuster with Over $9 Billion in Annual Sales

Recently, the marketing application for Aflibercept Ophthalmic Injection submitted by Qilu Pharmaceutical under the New Drug Category 3.3 has been accepted by the CDE, marking it as China's first reported Aflibercept biosimilar. According to data from Menet, the sales of Aflibercept Ophthalmic Injection in Chinese public medical institutions exceeded 600 million yuan in 2021, with a year-on-year growth of nearly 60%.

Source: CDE Official Website

Aflibercept, a VEGF inhibitor developed by Bayer/Regeneron, inhibits angiogenesis and reduces vascular permeability by blocking the signaling pathways mediated by VEGF-A, VEGF-B, and placental growth factor (PLGF). Aflibercept has been approved in multiple countries and regions for the treatment of neovascular age-related macular degeneration (wet AMD), retinal vein occlusion, diabetic macular edema, and vision impairment caused by pathological myopia-related choroidal neovascularization. According to Regeneron's financial report, global sales of aflibercept exceeded $9 billion in 2021.

Bayer's aflibercept intravitreal injection solution was approved to enter the Chinese market in February 2018 and was included in the Class B directory of the national medical insurance through negotiation in 2019. Data from MiNe Network shows that in recent years, the terminal sales of aflibercept intravitreal injection solution in Chinese urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics (referred to as Chinese public medical institutions) have been increasing year by year, exceeding 600 million yuan in 2021, with a year-on-year increase of nearly 60%.

Sales of Aflibercept Intravitreal Injection Solution in Chinese Public Medical Institutions (Unit: Ten Thousand Yuan)

Source: Terminal Competition Pattern of Public Medical Institutions in China, Menet

Currently, there is no biosimilar of Aflibercept approved in China, but several pharmaceutical companies have made strategic moves. Among them, the product from Qilu Pharmaceutical has been submitted for production, making it the first domestically produced option. In addition, Shandong Boan Biotech's LY09004 and Mabwell's 9MW0813 are both undergoing Phase III clinical trials.

Biological Medicines Layout by Qilu Pharmaceutical

Source: MiNeiNet Database

Biological drugs are a key focus area for Qilu Pharmaceutical. In terms of Class 1 new drugs, the injectable recombinant human thrombopoietin mimetic peptide-Fc fusion protein and VB4-845 injection have both entered Phase III clinical trials. Regarding biosimilars, Bevacizumab biosimilar and Recombinant Human Follitropin biosimilar have been approved, while Denosumab biosimilar and Romiplostim biosimilar have been submitted for marketing approval.

Source: MiNei Database, CDE Official Website, etc.

Note: Data statistics are as of May 5th. If there are any omissions, corrections are welcome!