Another Ophthalmic Drug Approved, Set to Compete for the Original Manufacturer's RMB 6 Million Market

　　【Pharmaceutical Network Industry DynamicsNorthland announced on the evening of May 31 that its subsidiary, Beijing Huonland Pharmaceutical Co., Ltd., received the "Drug Registration Certificate" issued by the National Medical Products Administration. The company's Moxifloxacin Hydrochloride Eye Drops have been approved and will be qualified for production and sales in the Chinese market.
 

Moxifloxacin Hydrochloride Ophthalmic Solution is applicable for the treatment of bacterial conjunctivitis caused by susceptible microorganisms. Bacterial conjunctivitis is a common ophthalmic disease, with clinical manifestations including scleral congestion, redness of the surrounding skin, accompanied by mucous or purulent discharge.
 

This drug belongs to the fourth-generation quinolone class and is an "8-methoxy fluoroquinolone" compound that inhibits topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is involved in bacterial DNA replication, transcription, and repair; topoisomerase IV is essential for bacterial chromosome segregation during cell division. Therefore, moxifloxacin exhibits a broad-spectrum antibacterial effect and is effective againstMacrolidesPathogens that develop resistance to aminoglycosides and tetracyclines still exhibit antibacterial activity and do not produce cross-resistance with the aforementioned products.
 

The original research and development manufacturer of Moxifloxacin Hydrochloride Eye Drops is Novartis. From the perspective of the registration application for Moxifloxacin Hydrochloride Eye Drops, there have been 48 registration applications since 2016. Among them, there are 13 registration applications this year, with applying companies including Beijing Huonland Pharmaceutical Co., Ltd., Jiangsu Wango, Shaanxi Bosson, Chengdu Pushi, etc.
 

Currently, this product has a total of 13 marketing approvals, involving local pharmaceutical companies such as Shenyang Xingqi, Zhuhai Yisheng, Qilu Pharmaceutical, Jiangxi Kelun, Shanghai Haohai/Shanghai Xinyi Jinzhu, as well as the original developer Novartis.
 

In addition, from the perspective of the market pattern, Novartis' Moxifloxacin Hydrochloride Eye Drops entered the Chinese market at the end of 2018 and were included in the medical insurance in 2019. Data from MiNet shows that currently, only the original 5ml specification of Moxifloxacin Hydrochloride Eye Drops is available for sale in China. In 2020, the sales revenue of this product in sample public medical institutions reached 6 million yuan, and it continued to grow in 2021. In contrast, the retail market is relatively small, with sales exceeding 300,000 yuan in 2020.
 

The industry believes that as numerous domestic and foreign pharmaceutical companies, such as Beijing Huonland Pharmaceutical Co., Ltd., are applying for the new classification of generic drugs, a large number of products will be approved for marketing. This will lead to the division of the market currently occupied by original research, making market competition even more intense.
 

Public information shows that Northland is an innovative biopharmaceutical company. Currently, the project with relatively rapid progress in the company's research and development (R&D) pipeline is NL003, a product indicated for the treatment of critical limb ischemia. It is at a key stage transitioning from R&D to commercialization. Meanwhile, Northland is enhancing its self-sustaining capabilities by engaging in the eyedrops business, fully supporting the R&D and commercialization of innovative drugs.