NORTHLAND Approved for Registration Certificate of Class 4 Brimonidine Tartrate Eye Drops
Recently, our company’s independently developed ophthalmic formulation, “Bromothymol Eye Drops,” has received the “Drug Registration Certificate” approved and issued by the National Medical Products Administration. The approval number is: National Drug Approval No. H20243152, marking a splendid start to work after the Spring Festival in the Year of the Dragon.
The bromothymol blue eye drops approved this time are available in a 0.2% formulation (5 ml: 10 mg) and belong to Class 4 of chemical drugs. They represent the first domestically developed multi-dose product that has been approved following consistency evaluation requirements aligned with those for reference preparations. This product is indicated for lowering intraocular pressure in patients with open-angle glaucoma and ocular hypertension. It is the third ophthalmic product approved under our company’s status as the Marketing Authorization Holder (MAH), and commercial production will be entrusted to our controlled subsidiary, Huonland.
Glaucoma is a group of eye diseases characterized by damage to the optic nerve and visual field defects. It can impair the optic nerve and its visual pathways, ultimately leading to impaired vision or even blindness. Glaucoma is the world’s leading cause of irreversible blindness. According to data from Frost & Sullivan, China had approximately 18.5 million glaucoma patients in 2016, a figure that rose to 20 million by 2020, representing a compound annual growth rate of 1.9%. As the population ages, the prevalence of glaucoma in China is expected to increase year by year. The Chinese market for anti-glaucoma drugs grew from 1.6 billion yuan in 2016 to 2 billion yuan in 2020, with a compound annual growth rate of 5.4%. By 2025 and 2030, the market size for anti-glaucoma drugs is projected to reach 4.5 billion yuan and 10.9 billion yuan, respectively.
Currently, the treatment options for glaucoma include medication, laser therapy, and surgical intervention. For open-angle glaucoma, medication is the most fundamental treatment approach. Brimonidine tartrate eye drops belong to the α... 2 - Adrenergic receptor agonists possess a dual mechanism for lowering intraocular pressure: they reduce aqueous humor production and enhance its outflow via the uveoscleral pathway. While effectively reducing intraocular pressure, these agents also offer neuroprotective effects on the optic nerve. Moreover, due to their low lipid solubility, they hardly cross the blood-brain barrier and have virtually no impact on cardiovascular function. In clinical practice, they can be used alone or in combination with other drugs for the treatment of glaucoma, making them one of the mainstream medications currently employed in glaucoma therapy and the preferred choice for combination therapies.
The four types of brimonidine tartrate eye drops recently approved will gradually replace the original six varieties, helping the company to deepen its presence in the glaucoma drug market. After years of cultivation and development, NORTHLAND Group’s ophthalmic product pipeline has become increasingly diverse, and its business performance has continued to grow. Currently, the company holds a total of eight ophthalmic drug registration approvals covering six varieties: sodium hyaluronate eye drops, olopatadine hydrochloride eye drops, brimonidine tartrate eye drops, moxifloxacin hydrochloride eye drops, dexamethasone sodium phosphate eye drops, and balanced salt solution, among others. And there are many more... During the development process, this product line covers multiple indications, including dry eye syndrome, anti-allergy treatments, glaucoma management, antibacterial agents, and irrigation solutions for ophthalmic surgeries. Our outstanding R&D capabilities, advanced production lines, comprehensive quality management system, and professional service expertise have significantly enhanced our competitiveness in the ophthalmology market. Our company will continue to leverage the Group’s strengths in resource integration, deepen our focus on ophthalmic drug R&D and CMO/CDMO services, and, through the sustained operation and performance improvement of our ophthalmic products, support the R&D, industrialization, and commercialization of our innovative biopharmaceuticals, thereby achieving the company’s sustainable development.



