NORTHLAND Obtains Drug Registration Certificate for "Sodium Hyaluronate Eye Drops"

Category:

2023-05-09


Recently, our company’s generic drug project, “Sodium Hyaluronate 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. H20233521, making this the first ophthalmic product our company has been approved to market under the Marketing Authorization Holder (MAH) system. This product is classified as a Class 4 chemical drug, with a specification of 0.1% (5 ml: 5 mg). The manufacturer of this drug is Beijing Huonland Pharmaceutical Co., Ltd., a subsidiary controlled by our company.

Sodium hyaluronate eye drops are a major product in the ophthalmic market and serve as a first-line treatment for dry eye syndrome. According to data from Yaorongyun’s nationwide hospital database, sodium hyaluronate ophthalmic preparations represent the best-selling product in the hospital market for dry eye disease, accounting for over 25% of the entire dry eye disease market share. PDB data show that during the period from 2015 to 2021, the compound annual growth rate of sodium hyaluronate eye drops was 17.6%. Among these, the multi-dose formulation at a concentration of 0.1% continues to hold the largest share of the sodium hyaluronate market. According to the “Clinical Consensus on Diagnosis and Treatment of Dry Eye (2020)” and existing epidemiological studies in China, the global prevalence of dry eye ranges from approximately 5.5% to 33.7%, while in China, the prevalence is estimated to be between 21% and 30%. With the prolonged use of smartphones and computers, coupled with factors such as air pollution, the number of dry eye patients has been rising sharply. In 2020, the number of dry eye patients in China reached 240 million.

The successful approval of this product further enriches NORTHLAND Group’s ophthalmic product pipeline and fully demonstrates the group’s coordinated resource management and efficient utilization across its enterprises. In accordance with the MAH (Marketing Authorization Holder) system requirements, the company will ensure robust quality control throughout the contract manufacturing process. Moreover, the company will continue to leverage the group’s resource advantages, fostering synergy between the parent company and its subsidiaries, and steadily advance on the path toward integrated pharmaceutical R&D, production, and sales within the group framework.

Share to: