"Myopia miracle drug" atropine on the shelves to attract the rush to buy, some companies to the Internet medical treatment in advance to sell drugs

As soon as the "myopia miracle drug" Atropine has been blown, it has received social attention.

Recently, the reporter of the Compliance and Development Research Group of Nandu Pharmaceutical Enterprises noted that at the end of last year, 0.01% atropine sulfate eye drops (hereinafter referred to as low-concentration atropine) were listed in two public hospitals in Henan and Shandong, and after being listed in the form of in-hospital preparations, it caused parents to queue up for "crazy robbery".

According to nandu reporter, because it can help control the growth of the eye axis, delay the progression of myopia, reduce myopia-related complications, etc., atropine is considered to be a "miracle drug" for the treatment of myopia, especially for minors who are not suitable for myopia surgery, delaying the progression of myopia is equivalent to the possibility of surgery in adulthood. However, because drug-related clinical trials are still in progress, atropine has not yet been approved for marketing in China as a "national drug approval word".

However, under the huge demand, atropine "sword to the side" in the hospital preparation (that is, the hospital's self-developed and formulated drugs, used to solve the shortage of some drugs in the market) into the market, of which the listed company Xingqi eye medicine has become the beneficiary of this method, and the performance has also been pushed up. However, Nandu reporter noted that with more and more preparations in the hospital being approved and the advancement of clinical trials, the market position of Xingqi eye drugs may be greatly affected.

The "myopia miracle drug" that still has no definite conclusion

Wearing glasses and correcting myopia in adulthood are the two major ways to deal with myopia at present, but low concentrations of atropine seem to point to a "third way" for myopia treatment.

As a drug for gastrointestinal diseases, low concentrations of atropine were found to be able to treat myopia, stemming from the preliminary results of atom2 (atropine myopia treatment study 2) published by the National Eye Centre of Singapore in 2016.

Atom2 was randomized with atropine 0.5%, 0.1%, and 0.01 through 400 enrolled children, and conducted studies for up to 5.5 years, of which low concentrations of atropine were initially used as a placebo. However, as clinical trials continue to progress, researchers have found that low concentrations of atropine have produced "both effective and minimal adverse reactions" results in controlling myopia.

However, Nandu reporter found that in addition to ATOM2, as of now, there has been no strict randomized double-blind clinical trial worldwide, which can accurately indicate that low concentrations of atropine eye drops have the effect of controlling myopia. At the same time, in some trials, low concentrations of atropine also caused side effects in subjects.

For the indication that low concentrations of atropine can declare myopia, domestic clinical trials are also underway.

"As far as I know, the current registered clinical trial of atropine to control adolescent myopia was approved by the national clinical trial 3 years ago, and the multi-center clinical registration trial is currently being carried out nationwide, and this process has not yet been completed." From clinical to registered, the whole process of the drug takes at least 5 years. ”

Yang Xiao, chief physician of the Department of Refractive and Low Vision of Zhongshan Eye Center of Sun Yat-sen University, introduced to Nandu reporters that atropine has not been officially listed so far, mainly because of the time required for necessary clinical trials. "According to the latest clinical trial guidelines, the drug for the prevention and control of myopia in adolescents needs to be stopped for a period of time in the clinical trial stage to observe its side effects or whether it rebounds."

According to the data of the National Health Commission, the myopia rate of children and adolescents in China will reach 52.7% in 2020. Among myopic students, nearly 10% are highly myopic, 1.5% of 6-year-olds are highly myopic, and 17.6% in high school. Some experts believe that for adolescents who are not suitable for myopia surgery, low concentrations of atropine may be one of the means to inhibit the progression of myopia, "which also increases the probability of their future acceptance of myopia surgery."

However, Yang Xiao reminded that the use of low-concentration atropine has contraindications and professional technical requirements, and parents should not use it without authorization.

Hospital preparation + Internet medical treatment has become a breakthrough in "selling drugs in advance"

Even if the drug has not yet been approved for marketing by the "national medicine permit word", the huge myopic population has spawned a market demand for low-concentration atropine, which also makes the low-concentration atropine "curve listing" in the form of hospital preparations to fill the market gap. However, because the preparations in the hospital need to be prescribed by the doctor in the hospital, the hospitals in Henan and Shandong have caused parents to queue up to buy them after they are on the shelves.

Nandu reporter noted that the hospital preparation has also become a method for some listed companies to "run in advance" in the market of low concentration atropine, of which Xingqi eye medicine is one of the representatives.

On January 28, 2019, Xingqi Eye Medicine, through its subsidiary Xingqi Eye Hospital, listed low-concentration atropine eye drops as the hospital's in-hospital preparation; in December of the same year, Xingqi Eye Hospital obtained the qualification of Internet hospital and realized the issuance and sale of low-concentration atropine prescriptions through Internet medical methods. This also means that the low concentration of atropine of Xingqi eye medicine bypasses the way of "national medicine quasi-word" to enter the market in advance.

Of course, this has pushed the performance of Xingqi Eye Hospital up to a higher level.

According to the announcement disclosed by Nandu reporter through Xingqi eye drugs, based on the listing of low-concentration atropine in 2019, the net profit of Xingqi Eye Hospital in 2019, 2020 and January to July 2021 was -19.226 million yuan, 16.5108 million yuan and 26.9837 million yuan, respectively, and in the same reporting period, drug sales accounted for 88%, 94% and 96% of the revenue of Xingqi Eye Hospital. Nandu reporter also noted that in 2019, the hospital's drug sales revenue was 14.0124 million yuan, and in 2020, it became 114 million yuan. It can be seen that the hospital preparation + Internet medical treatment makes the low concentration atropine become the "cash cow" of Xingqi Eye Hospital. In addition, if the 66.8% equity of Xingqi Eye Drug Control is converted, the latter will theoretically bring a net profit of 11.0292 million yuan to the listed company in 2020, accounting for 12.5% of the net profit of the listed company in the current period.

Nandu reporter noted that the low concentration of atropine has an indirect boosting effect on the performance of Xingqi eye drugs. In the first three quarters of 2019, 2020 and 2021, the net profit attributable to the shareholders of the listed company increased by 162.79%, 145.11% and 190.45% respectively year-on-year.

In terms of stock price, Xingqi Eye Medicine opened a rising channel in April 2019, rising sharply from about 19 yuan, and once hit a record high of 226.2 yuan on July 24, 2020, and as of the close of trading on January 20, Xingqi Eye Medicine reported 122.98 yuan down 5.03%.

"Hidden worries" have begun to appear?

Although the performance is promoted by the use of low concentrations of atropine, the hidden worries of Xingqi eye medicine have gradually emerged.

Nandu reporter noted that Xingqi eye medicine through the Internet medical treatment, to achieve the hospital preparations sold to the outside, this behavior compliance has been questioned by the industry all the way. But in addition, the hidden concern of its low concentration of atropine comes from Xingqi eye medicine itself, and when the low concentration of atropine was listed in the form of hospital preparations in January 2019, Xingqi eye medicine also declared a clinical trial of low concentration atropine. According to the disclosure of Xingqi Eye Drug, the phase III clinical trial of low-concentration atropine was still in progress in November last year.

However, it is worth noting that if the low concentration of atropine in Xingqi Eye Medicine obtains the qualification of national medicine, according to the current drug administration regulations, the in-hospital preparations of Xingqi Eye Hospital will not be allowed to be sold on the market. However, in view of the relevant situation, Xingqi Eye Medicine clearly stated on the investor platform that its hospital preparation atropine eye drops was approved as NITM (transient myopia induced by close work), which is different from its indications for delaying the development of myopia in children, so it will not be affected in the future.

In addition to its own hidden concerns, the market position of the low concentration atropine of Xingqi eye medicine has also been challenged.

For example, the low-concentration atropine recently listed in a public hospital in Shandong is priced at only half the price of Xingqi Eye Hospital's products, which also leads to a sharp decline in the stock price of Xingqi Eye Medicine from the end of 2021 to the beginning of 2022. In addition, xingqi eye medicine's "peer" Aier ophthalmology has been on the shelves of low-concentration atropine in early 2021. The industry believes that although the competition for low-concentration atropine is still limited to the coverage of in-hospital preparations, the market position of Xingqi Eye Medicine, which was previously almost "monopolized", will be affected.

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How effective are low concentrations of atropine compared to other ways of delaying myopia? Or may be an alternative to some behavioral intervention

According to Nandu reporter, in response to children's myopia, there are OK lenses (that is, orthokeratology lenses) and behavioral interventions in medicine to intervene and delay, so how effective is low-concentration atropine compared with these methods?

"From the current clinical experience, the effect of low concentration atropine can replace part of the behavioral intervention, for example, 1 to 2 hours of outdoor activity during the day, is effective in delaying myopia, then after the use of low concentration atropine, if combined with outdoor activities for half an hour, the effect of myopia prevention and control may be better."

Yang Xiao, chief physician of the Department of Refractive and Low Vision of Zhongshan Eye Center of Sun Yat-sen University, told Nandu reporter that for the comparison of the effects of OK mirrors and low concentrations of atropine, the Zhongshan Eye Center of Sun Yat-sen University has carried out a two-year prospective clinical control trial (the results are still being sorted out), and the subjects are divided into four groups, respectively, giving the use of OK mirrors alone, the use of low concentration atropine alone, OK mirror and low concentration atropine combination treatment, and no intervention, "After two years of observation, We found that the effects of combination therapy were the most pronounced."

At the same time, Yang Xiao also found through experiments that the use of more 0.01% concentration of atropine is mainly better for children over 10 years old, but the benefits for children under 10 years old are not too high, through comparison, the research team found that 0.05% of atropine is more effective for young children, but side effects such as photophobia are more obvious, "combined with the results of the study, we think that children aged 8 to 10 years old still consider the first choice of OK lenses, or take combination therapy."

Produced by Nandu Pharmaceutical Enterprise Compliance and Development Research Group

Written by Nandu reporter Bei Bei Li Wen