Recently, Qilu Pharmaceutical announced that its Moxifloxacin Hydrochloride Eye Drops, an ophthalmic anti-infective drug submitted under Chemical Drug Class 4, has been approved for marketing by the National Medical Products Administration (NMPA) and is deemed to have passed the consistency evaluation.
As of now, Qilu Pharmaceutical has a total of 84 products that have passed or are deemed to have passed the consistency evaluation, 37 of which are the first in China.
Bacterial conjunctivitis is a common infectious ocular disease that often causes varying degrees of damage to ocular tissues. Conjunctivitis caused by highly virulent bacteria, such as Neisseria gonorrhoeae, can threaten vision and even lead to blindness.
In 2019, Qilu Pharmaceutical initiated research on Moxifloxacin Hydrochloride Ophthalmic Solution. This drug belongs to the latest generation of quinolone-class ophthalmic anti-infective agents. It exerts its bactericidal effect by inhibiting the activity of bacterial DNA gyrase subunit A and topoisomerase IV, thereby blocking DNA replication. Clinically, it is primarily used for the treatment of bacterial conjunctivitis caused by susceptible microorganisms.
Compared with most currently available therapeutic agents, Moxifloxacin Hydrochloride Ophthalmic Solution offers advantages such as a broad antibacterial spectrum, high potency, a low resistance potential, a simplified dosing regimen, and an excellent safety profile. It features a rapid onset of action, is preservative-free, and is suitable for patients of all ages, including neonates, representing a new option for ocular anti-infective therapy.
It is reported that in the Chinese market, only Moxifloxacin Hydrochloride Eye Drops, registered by Novartis Pharmaceuticals Corporation and manufactured by Alcon Laboratories, Inc., was approved for registration by the National Medical Products Administration (NMPA) at the end of 2018.
In 2021, the approval of ophthalmic products in China experienced a surge. By 2019, the sales scale of ophthalmic preparations at the terminal market of public medical institutions in China had already risen to nearly RMB 7 billion. In 2020, 13 new products produced in China were approved for market launch, and from 2021 to date, 8 additional new products have received approval. As pharmaceutical companies in China continue to intensify their efforts, the ophthalmic preparations market is steadily expanding.
Moreover, Xingqi Ophthalmic, Qilu Pharmaceutical, and Jiangxi Kelun Pharmaceutical have recently had new eye drop products approved. In March this year, Haohai Biotech and CR Zizhu also became among the first domestic manufacturers in China to complete the generic drug application and registration for this product. This underscores the immense potential of the 7-billion-yuan ophthalmic market.
In recent years, Qilu Pharmaceutical has strategically introduced high-quality products in the ophthalmology niche market, continuously expanding its ophthalmic product portfolio. The portfolio encompasses glaucoma therapeutics, ophthalmic anti-infectives, and medications for dry eye disease and visual fatigue. To date, multiple products including Wenkeming®, Qibituo®, Zhuoliping®, Dianshu®, and Runyi® have been approved for marketing. We look forward to Qilu Pharmaceutical bringing us more exciting innovations.
References:
1. Qilu Pharmaceutical Official Website
2.https://www.163.com/dy/article/G7VF0EHN0519QIKK.html