The Zhitong Finance App learned that Guojin Securities released a research report saying that on March 11, the official website of the State Drug Administration showed that Sinqi Pharmaceutical (300573.SZ) atropine sulphate eye drops were approved for sale on March 5, 2024. Atropine sulphate eye drops have good safety and compliance for use. At this stage, there is a high incidence of myopia among children and adolescents in China, and demand for myopia prevention and control is strong. Atropine sulphate eye drops are expected to be released quickly with strong product strength. It is recommended to continue to pay attention to companies that are progressing rapidly in research and development in the field of atropine sulphate eye drops. Key recommendations: Sinqi Pharmaceutical, Hengrui Pharmaceutical (600276.SH), Okanvision Bio-B (01477), etc.

Incident: On March 11, the official website of the State Drug Administration revealed that Sinqi Pharmaceutical's atropine sulphate eye drops were approved for marketing on March 5, 2024. According to the company's announcement, the approved clinical indication is to delay the progression of myopia in children aged 6 to 12 with a spherical degree of -1.00D to -4.00D (astigmatism ≤ 1.50D, refractive error ≤ 1.50D).

Guojin Securities reviews are as follows:

The product is safe and has strong patient compliance.

Atropine sulphate eye drops are ophthalmic preparations with atropine sulfate as the active ingredient. It is an improved new drug and is mainly used to slow the progression of myopia in children. According to phase III clinical trial data conducted by Sinqi Eye Medicine and Singapore National Ophthalmology Centre (SNEC), 406 children aged 6-12 were observed for 1 year of medication and followed up for 0.5 years after discontinuation. Compared with the placebo group, the atropine sulfate eye drop group had statistically significant differences in the main efficacy indicators, and the atropine sulphate eye drop group was safe, and patients were well compliant with use.

There is a high incidence of myopia among young people, and there is a strong demand for myopia prevention and control.

The population base of myopic patients in China is large. In 2020, the overall myopia rate of children and adolescents in China was 52.7%, of which 14.3% were 6-year-olds, 35.6% were elementary school students, 71.1% were middle school students, and 80.5% were high school students. Under the high base of myopic children, we believe that based on the good compliance of atropine sulphate eye drops, the product is expected to usher in rapid dosage after launch.

The marketing process for new drugs is long, and products that have already been marketed are expected to establish a first-mover advantage.

The product launch process is long. According to Pharmaceutical Rubik's Cube data, Sinqi Pharmaceutical's atropine sulfate eye drops are the first eye drops to slow myopia in children to be marketed in China, and have a strong first-mover advantage. Furthermore, by the end of '22, Sinqi Pharmaceutical had a sales team of 862 people. Combined with rich academic promotion experience and brand advantages, strong channel capabilities are expected to help rapidly release atropine sulfate eye drops after marketing.

Risk warning: risk of policy changes; risk of developing indications less than expected; risk of product marketing falling short of expectations; risk of increased market competition; risk of price reduction caused by the collection of ophthalmic products, etc.