NORTHLAND's subsidiary obtains the drug registration certificate for Olopatadine Hydrochloride Eye Drops.
Recently, our company’s holding subsidiary, Beijing Huonland Pharmaceutical Co., Ltd., has obtained the “Drug Registration Certificate” for “Olopatadine Hydrochloride Eye Drops,” approved and issued by the National Medical Products Administration. The drug approval number is Guoyao Zhunzi H20203419, with a specification of 0.1% (5 ml: 5 mg, calculated as C21H23NO3). The registration classification is Category 4 chemical drug. To date, the subsidiary has secured approval for three ophthalmic drugs, including two multi-dose eye drops (Bromothymol Blue and Olopatadine Hydrochloride) and one single-dose eye drop (Sodium Hyaluronate).
The olotadine hydrochloride eye drops recently approved are indicated for the treatment of signs and symptoms of allergic conjunctivitis. Allergic conjunctivitis is an allergic reaction of the conjunctiva caused by the contact of ocular surface tissues with allergenic antigens; it typically represents a type I hypersensitivity reaction mediated by IgE. Patients may experience symptoms such as intense itching of the eyes, tearing, photophobia, burning sensation, dry eyes, and general ocular discomfort. In severe cases, it can even lead to visual impairment. Olotadine is a novel selective antagonist of the histamine H1 receptor. It also stabilizes mast cells and inhibits the release of histamine, making it a dual-action anti-allergic drug that effectively suppresses type I immediate hypersensitivity reactions. This medication boasts advantages such as rapid onset of action, prolonged efficacy, and excellent safety profile, and is currently the primary drug used in clinical practice for the treatment of allergic conjunctivitis.
Allergic conjunctivitis is a common ocular surface disease in clinical practice. According to available data, approximately 85 million people in the United States suffer from allergic conjunctivitis each year, with treatment costs reaching 5.9 billion U.S. dollars—of which drug expenses account for 25%. Moreover, the annual growth rate of treatment costs has reached 25%. Currently, China lacks authoritative epidemiological data on allergic conjunctivitis. Based on expert estimates, the prevalence of allergic conjunctivitis in China is around 10% to 16%, affecting more than 100 million people. In 2019, sales of olopatadine hydrochloride at the terminal points of public medical institutions in China totaled 200 million yuan, representing a year-on-year increase of 45.49%. At present, the market is dominated by products from Novartis, which hold a market share of 76.77%. There are currently 10 domestic companies producing olopatadine hydrochloride. This time, Huonland’s olopatadine hydrochloride has been approved as a Class 4 generic drug, giving it certain market competitiveness.
Huonland is a subsidiary of NORTHLAND Holdings, specializing in the production and distribution of ophthalmic pharmaceutical products. The company boasts an advanced integrated BFS automated sterile production line and a comprehensive GMP management system. In the first half of 2020, the company achieved sales revenue exceeding 27 million yuan, entering a favorable operating phase. The company will continue to enhance its capabilities in pharmaceutical production, CMO/CDMO services, and pharmaceutical distribution. While building a high-level production base for ophthalmic pharmaceuticals, it will also create significant social and economic benefits.



