Myopia is a major public health problem in the world, especially in China. The number of myopia patients in China has exceeded 600 million, and the incidence of myopia is nearly 50%. The prevention and control of children's myopia has also become an important task in the field of health in China.
At present, there is no official approval of drugs that can delay children's myopia in China and even the world, but many Chinese listed companies are developing new drugs for the prevention and control of children's myopia.
The latest entrant is Zhaoke Ophthalmology, a Hong Kong listed company. According to the information of China drug clinical trial registration and information publicity platform, the company recently launched a phase III clinical trial of atropine sulfate eye drops to delay the progression of myopia in children in China on February 17.
multiple phase III clinical launches
The first financial reporter inquired about the records of the clinical trial registration platform. At present, there are six clinical trials of atropine sulfate in low concentration in China. In addition to the two studies of Zhaoke Ophthalmology, there is also a phase III global multicenter clinical trial launched by oukangweishi, a Hong Kong listed company, and three phase III clinical trials in China of Shenyang Xingqi Pharmaceutical Co.Ltd(300573) A-share listed company.
Atropine sulfate eye drops with low concentration is a myopia drug prevention and control method officially recognized by who. At present, this drug is mainly used as prescription drugs in hospitals in China and is not sold on the market. A number of clinical trials in China have helped to promote the market popularization of low concentration atropine drugs, which is of positive significance for the prevention and control of myopia in children.
Among the projects that have entered the phase III clinical trial, Zhaoke ophthalmology has obtained the authorization of American Nevada company, which is also the first company to start the clinical trial in the world. At present, it has completed the enrollment in the world. The newly approved phase III clinical trial of Zhaoke ophthalmology will recruit 526 patients in China, To evaluate the safety and efficacy of two low concentrations of atropine sulfate (0.01% and 0.02%).
Dr. Li Xiaoyi, founder of Zhaoke Ophthalmology, told the first financial reporter: "the clinical cycle of atropine sulfate will be relatively long. We will do two clinical trials, one for one year and one for two years. We hope to graft the data of the United States."
Li Xiaoyi revealed that the results of the phase III clinical trial of Nevada in the United States are expected to be released this year. The data may be disclosed by 2023. It is expected to give a complete scheme and seek approval for listing by 2024.
Shenyang Xingqi Pharmaceutical Co.Ltd(300573) a phase III clinical trial launched last year aimed at the safety and efficacy of atropine sulfate with different concentrations (0.02% - 0.04%) plans to recruit 800 patients, 124 of whom have been enrolled, and the first subject was enrolled in December last year. In addition, Shenyang Xingqi Pharmaceutical Co.Ltd(300573) launched two clinical trials of low concentration atropine sulfate eye drops as early as 2020, which are still in progress.
great clinical difficulty long cycle
Shenyang Xingqi Pharmaceutical Co.Ltd(300573) the first two phase III clinical trials in China Professor Qu Jia of the optometry Hospital Affiliated to Wenzhou Medical University told the first financial reporter: "the clinical trial of myopia prevention and control drugs is difficult because the clinical trial lasts a long time. According to the guiding principles for clinical research technology of drugs to control the progress of myopia issued by the State Food and Drug Administration in 2020 , it takes up to two years of clinical trials. Considering the high shedding rate of patients in clinical trials, we are also conducting several clinical trials at the same time. We hope to shorten the time of Unblinding, such as Unblinding once a year to see the effectiveness data of medication in a year. "
He further said that in theory, low concentration atropine sulfate is safe, but due to the long-term use of drugs, the long-term impact on children's health still needs to be observed through clinical trials; In addition, this drug is not applicable to all children, so it needs to be studied for its effectiveness.
Previously, Shenyang Xingqi Pharmaceutical Co.Ltd(300573) Xingqi ophthalmic hospital low concentration atropine sulfate has been used in the prevention and control of children's myopia in Liaoning Province in the form of hospital preparation approval, and sold to patients as prescription drugs in Internet clinics. This kind of "edge ball" approach has made high profits for the company. More than 80% of the revenue of Xingqi ophthalmic hospital comes from the sales of atropine sulfate.
This also pushed up the share price of Shenyang Xingqi Pharmaceutical Co.Ltd(300573) ten times last year. The price earnings ratio of the company has soared to more than 1300 times, but it has fallen sharply, with a market value of less than 10 billion yuan.
Although the experts told the first financial reporter that the approval of the drug for in-hospital preparation also goes through a strict clinical review process, some hostages suspected that the approval qualification of in-hospital preparation usually means that it can only be sold in the hospital. If it is sold externally, it needs to be adjusted within or across provinces.
Now Shenyang Xingqi Pharmaceutical Co.Ltd(300573) to speed up the phase III clinical process is also to get out of the "gray area" as soon as possible. Only after the clinical data are officially listed after being approved by the State Food and drug administration, can the company not only meet the public demand, but also reap as much profit as possible from atropine, the "miracle drug" for myopia. Of course, it will also face fierce market competition.
Qu Jia told the first financial reporter that at present, clinical trials of atropine sulfate eye drops are being carried out all over the world, and the competition is very fierce. If China's clinical progress is slow, Europe and the United States may reach the end point ahead of time. "China is a big country with myopia. We certainly hope that China can make a difference in myopia prevention and control and provide solutions for the world." Qu Jia told the first financial reporter.
