The 0.1% sodium hyaluronate eye drops (0.4 ml: 0.4 mg), developed by our company’s controlled subsidiary, Beijing Huonland Pharmaceutical Co., Ltd., were reclassified from prescription drugs to OTC products through post-marketing change filing on July 3, 2023. The filing number is Jing Bei 2023020205. The product is indicated for dry eye syndrome and helps relieve dry eye symptoms. This marks Huonland’s first OTC eye drop formulation to receive approval.

Drug management is based on the principles of drug safety, efficacy, and ease of use. Depending on their variety, specifications, indications, dosage, and route of administration, drugs are categorized and managed separately as prescription drugs and over-the-counter (OTC) drugs. The national drug regulatory authority designates drugs with significant pharmacological effects, capable of treating serious conditions, and prone to adverse reactions as prescription drugs. Patients must purchase and use these drugs under the supervision and guidance of a physician. In contrast, OTC drugs are intended for consumers’ self-care; they are used to quickly and effectively relieve minor ailments. These drugs do not require a physician’s prescription and can be selected, purchased, and used independently by consumers based on their own judgment. Drugs listed as OTC generally undergo extensive and thorough evaluation over an extended period, boasting advantages such as safe use, stable quality, proven efficacy, minimal toxic side effects, convenience in application, and ease of storage.

The sodium hyaluronate eye drops with a concentration of 0.1% are thinner than the 0.3% formulation, providing a more comfortable sensation after instillation into the eye. They are suitable for patients with mild to moderate dry eye and can also be used by wearers of contact lenses and orthokeratology lenses. Additionally, this 0.1% sodium hyaluronate eye drop formulation can be employed as an initial treatment for patients with moderate to severe dry eye. These eye drops are single-dose, disposable products that contain no preservatives, effectively preventing the cumulative toxicity associated with long-term use of preservatives and safeguarding corneal health.

According to relevant data, China’s dry eye syndrome market was valued at 3.743 billion yuan in 2022, with the number of dry eye patients reaching 240 million. With the prolonged use of smartphones and computers, as well as factors such as air pollution, the number of dry eye patients is showing a sharp upward trend. The global dry eye disease market is projected to grow at a CAGR of 6.18% during the forecast period and is expected to reach RMB 43.324 billion by 2028. Sodium hyaluronate eye drops are first-line medications for the treatment of dry eye disease, with a compound growth rate of 17.6% from 2015 to 2021. Among these, the 0.1% dosage form accounts for the largest share of the sodium hyaluronate market.

This time, the 0.1% sodium hyaluronate eye drops have successfully been approved as an OTC drug, marking the official entry of the company’s ophthalmic products into the OTC market and opening up a new avenue for enhancing the company’s business performance. China’s “Administrative Measures for the Classification of Prescription Drugs and Over-the-Counter Drugs (Trial)” explicitly stipulates: “Over-the-counter drugs, after approval, may be advertised through mass media.” The company will fully leverage its first OTC product to officially enter the OTC market. By increasing advertising investment and adopting an “online + offline” approach, it aims to expand its market share, establish a strong brand for its ophthalmic products, and enhance its corporate image.

Faced with numerous challenges such as frequent changes in pharmaceutical industry policies and shifting market conditions, NORTHLAND has consistently adhered to pioneering innovation, proactively planned its product pipeline, and continuously strengthened its self-sustaining capabilities. In the field of ophthalmic drug development, the group company has already obtained drug registration certificates for six products, and several more are under review or in development, forming a robust product pipeline that covers a wide range of indications, including dry eye syndrome, glaucoma, anti-allergy, antibacterial treatments, and balanced salt solutions (for irrigation) used in ocular surgery. While advancing pharmaceutical R&D, we leverage the resource advantages of our group company, take advantage of the MAH system, and rely on the advanced, safe, reliable, and effective ophthalmic drug manufacturing facilities and quality control systems of our subsidiaries to simultaneously provide CMO/CDMO services. As a result, we enjoy a clear competitive edge and an excellent industry reputation in the fields of ophthalmic drug R&D and manufacturing.

In the future, the company will continue its efforts, adhering to the corporate mission of “creating value and serving health,” and remain committed to developing more high-quality, clinically accessible drugs. We will pursue integrated advancement in R&D, manufacturing, and sales, achieving high-quality enterprise development, generating positive economic and social benefits, and rewarding our shareholders and society.