Qilu Pharmaceutical Reaps Rewards in Ophthalmic Drug Segment with Successful Product 'Outbound' to Europe

　　【Pharmaceutical Network Enterprise NewsIn recent years, with the aggravation of population aging and the frequent use of electronic products, the prevalence of ophthalmic diseases has been continuously increasing, bringing a large development space to the ophthalmic drug market. According to Frost & Sullivan data, from 2016 to 2020, the scale of China's ophthalmic drug market grew from 15.1 billion yuan to 18.8 billion yuan, with a compound annual growth rate of 5.7%. It is expected that by 2025, this market will reach 44 billion yuan, and by 2030 it will increase to 116.6 billion yuan. In order to tap into the blue ocean of the billion-yuan ophthalmic drug market, pharmaceutical companies at home and abroad are actively making arrangements, and progress updates are constantly being reported.
 

News on January 15: Qilu Pharmaceutical announced that its Ranibizumab Injection (Rimmyrah) has received marketing approval from the European Medicines Agency (EMA), becoming the first ophthalmic biologic agent produced in China to "go global." The product is mainly used for the treatment of wet (neovascular) age-related macular degeneration, vision impairment caused by diabetic macular edema, and diabetic retinopathy.
 

It is reported that age-related macular degeneration, diabetic macular edema, and retinal vein occlusion are often causes of vision loss in patients. Ranibizumab injection is a recombinant anti-VEGF (vascular endothelial growth factor) humanized monoclonal antibody Fab fragment that specifically inhibits human vascular endothelial growth factor A (VEGF-A). Ranibizumab can prevent the proliferation of vascular endothelial cells, formation of new blood vessels, and vascular leakage by binding to and blocking VEGF receptors, while also promoting the regression of existing new blood vessels.
 

In China, the marketing application for the ranibizumab injection submitted by Qilu Pharmaceutical in January 2023 has been accepted by the Center for Drug Evaluation of the National Medical Products Administration and is currently under review. If successfully approved, this product will offer a new treatment option for patients with related eye diseases in China.
 

In addition to the news that Regeneron's aflibercept injection has been approved by the EMA, on December 18, 2023, the National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical Co., Ltd.'s ophthalmic drug, aflibercept intravitreal injection solution, has been approved for marketing in China. Reportedly, the indications for aflibercept intravitreal injection solution are neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME) in adults. Public data indicates that aflibercept is a VEGF inhibitor. The original research drug, aflibercept intravitreal injection solution (Eylea), was jointly developed by Bayer and Regeneron and received FDA approval in the United States as early as 2011. It has now been approved in multiple countries and regions, including China.
 

As early as June 2023, Qilu Pharmaceutical's Bromfenac Sodium Eye Drops received approval from the National Medical Products Administration (NMPA) for marketing in China and were considered to have passed the consistency evaluation. Bromfenac sodium, as a brand-new generation of non-steroidal anti-inflammatory drugs, exhibits stronger anti-inflammatory activity. It exerts its anti-inflammatory and analgesic effects by inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), thereby blocking the synthesis of prostaglandins. Due to its excellent anti-inflammatory activity, pain-relieving properties, and medication safety, Bromfenac Sodium Eye Drops are gradually becoming a drug of choice for treating ocular inflammation.
 

Public data shows that currently, Qilu Pharmaceutical's ophthalmic drugs have covered major treatment areas such as ocular anti-infection, ocular inflammation, glaucoma, anti-allergy, and eye fatigue (dry eye syndrome). The company adheres to an innovation-driven strategy, continuously increasing R&D investment. In 2022, Qilu Pharmaceutical's R&D investment reached 3.89 billion yuan, accounting for 10.4% of sales revenue. It is estimated that in 2023, this proportion will reach 12% of the group's revenue, providing momentum for the continuous development of new drugs.
 

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