Shenyao Is In A Terrible Situation! Product Consistency Evaluation Delayed, Or Will Sapace ACE ACE Eye Drops Be Discontinued?

Now, when she looks at the cataract, she is in trouble.

On the evening of October 28, sapace announced that the consistency evaluation of the company's core product, benadrysine eye drops (i.e., sapace eye drops), due to the great impact of the new crown epidemic, the relevant work of each research unit was suspended or the progress was slow, the ethical review and contract audit time of each hospital was long, and the test cycle was long, so it was expected that the evaluation results could not be reported to the national drug administration within the original time limit The drug administration has completed the evaluation of consistency.

? ? ? Sapace stressed that "the quality and efficacy consistency evaluation of Benz lysine eye drops may not be completed within three years in accordance with the requirements of the State Food and drug administration; or the company may apply to delay the completion of the consistency evaluation work, or even though the quality and efficacy consistency evaluation of bendalalysine eye drops has been completed and reported to the drug review of the State Food and drug administration In case of the above situation, the approval number of the company's Benzyl lysine eye drops may be cancelled or will not be re registered after the expiration, resulting in the failure to continue production and sales of the product, which will have a significant impact on the company's business. "

For sapace, it was a blow in the head.

Since it was questioned in 2017 by we media's article "crazy sale of 750 million brainwashing pills a year, please let go of the Chinese elderly", the consistency evaluation seems to be the last card for sapace to prove her innocence. However, the delay of the consistency evaluation has left many question marks for sapace's survival.

Revenue contribution of "trump" products shrank from 77% to 36%

Sapace landed on the Shanghai Stock Exchange on July 2, 2014. Its main products include sapace eye drops, large infusion and cefixime products.

In the annual report of its first year on the market, sapace described it as "an anti cataract drug developed by the company in cooperation with Jiangsu Provincial Institute of medicine. It has been listed in the national Torch Program project and the national key new product plan. In 1997, it was awarded the national ophthalmic class II New drug certificate, and it is the only domestic product with the commercial name of benzyl lysine eye drops. Sapace eye drops are in the leading position in the market of anti cataract drugs. "

The 21st century economic reporter combed the financial reports over the years and found that since it was put into the market, benadrysine eye drops have always been the "trump card" product of sapace.

From 2014 to 2017, sapace eye drops achieved revenue of 507 million yuan, 664 million yuan, 754 million yuan and 685 million yuan respectively, accounting for 66.19%, 72.02%, 77.02% and 72.95% of that year's revenue, especially in 2016, which accounted for 77% of the total revenue.

In addition, the gross profit margin of sapace eye drops is quite considerable. From 2014 to 2019, the gross profit rates of sapace eye drops were 94.68%, 95.29%, 94.59%, 93.55%, 92.65% and 92.13%, respectively, exceeding 92%.

On December 2, 2017, the article "selling 750 million brain washing drugs every year, please let go of the Chinese elderly" broke the legend of this "miracle drug" and questioned the efficacy and advertising of sapace eye drops (i.e. bendalamine eye drops).

The article said that "sapace eye drops" to prevent and treat cataracts is a big lie; it is a brainwashing advertising marketing to "entrap" the elderly, causing them to delay treatment and have the risk of blindness. The article emphasizes that "ophthalmologists often joke that if anyone can develop a drug to treat cataract, it will be OK to win a Nobel Prize."

Despite the urgent clarification made by sapace at that time, "the company believes that 0.5% benzidine lysine eye drops have a certain effect on delaying the development of senile cataract and improving or maintaining eyesight, and the curative effect is exact". It still couldn't stop the stock price from plummeting, and finally fell for 9 consecutive trading days, including two days of drop limit.

Since then, the State Food and Drug Administration and the Zhejiang food and drug administration asked sapace to carry out advertising self-examination and other related work.

According to the annual report of 2017, after self-examination, sapace has voluntarily suspended the advertising of approved benzaldehyde lysine eye drops since December 12, 2017, and will strictly comply with the relevant provisions on drug advertising review and the new requirements of the State Food and Drug Administration and Zhejiang food and drug administration, re produce the company's advertising and perform the relevant approval and filing procedures for advertising release.

Even in the second year (2018), sapace eye drops still contributed 325 million yuan to the company's revenue, accounting for more than 50% of that year's revenue.

However, the impact of the crisis is slow.

With the rectification of sapace eye drops advertising, its crazy investment in advertising model is no longer exist.

From 2014 to 2017, the total advertising promotion and sales expenses of sapace were 235 million yuan, 304 million yuan, 324 million yuan and 308 million yuan respectively. However, in 2018, its advertising promotion and sales expenses dropped to 182 million yuan, and further reduced to 147 million yuan in 2019.

Another group of data shows that from January to September of 2019-2020, the revenue of sapace eye drops will drop to 232 million yuan and 87 million yuan, and the revenue contribution will be reduced to 44.6% and 36.25% successively.

In the annual report of 2019, sapace explained that the total operating revenue of that year was RMB 515 million, a decrease of RMB 91.4809 million compared with the same period of 2018, with a year-on-year decrease of 15.06%, which was mainly due to the year-on-year decrease in the sales volume of eye drops in this period.

Among them, the revenue of eye drops decreased by 28.51% in 2019.

The consistency evaluation has been delayed for a long time

The evaluation of the quality of ACE's eye drops determines whether or not ace's eye drops can survive.

According to public information, the generic name of sapacil is bendalalysine eye drops. The manufacturer claims that its indication is early senile cataract and belongs to over-the-counter drug (OTC).

The 21st century economic report reporter combed the annual reports over the years and found that sapace had already started the quality and efficacy consistency evaluation of Benadryl lysine eye drops in 2016, and entrusted Hangzhou Baicheng Pharmaceutical Technology Co., Ltd.

In view of the General Administration of food administration of China (No In accordance with the "Drug Administration Law of the people's Republic of China" and the relevant provisions on the quality and efficacy consistency evaluation of generic drugs, the drug administration urged the manufacturers of Benz lysine eye drops in the administrative region to start the clinical efficacy test as soon as possible, and report the evaluation results to the drug evaluation center of the State Food and drug administration within three years.

In the annual reports since then, sapace also disclosed the progress in the evaluation of the consistency of the eye drops.

In 2018, the Forum on post marketing evaluation of benzaldehyde lysine eye drops and seminar on post marketing clinical research scheme of benzaldehyde lysine eye drops were held successively; the company entrusted professional cro company to organize and implement the post marketing clinical research of benzaldehyde lysine eye drops, and the research scheme was further consulted with relevant experts and reported to relevant departments. By the end of 2018, the research on the formulation and quality analysis of the original drug, the study of API, the prescription screening of eye drops, the investigation of optimization of preparation process and the comparative study of packaging materials have been basically completed. The quality indicators of laboratory samples are basically consistent with those of the original research drugs, and no abnormal conditions have been found.

In 2019, the progress of the conformance evaluation of bendazole lysine eye drops: in March 2019, the center for drug evaluation of the State Drug Administration (CDE) organized and held a communication meeting of bendazole lysine eye drops (sapace), and invited a number of well-known national experts and professors to conduct in-depth discussion on the clinical research program and other related issues.

In August 2019, the medical ethics committee of Sun Yat sen University Sun Yat Sen Ophthalmic Center held a meeting to review and approve the post marketing clinical research protocol of bendalalysine eye drops (sapace), and agreed to carry out clinical research according to the program.

In October 2019, the post marketing clinical trial researchers' meeting of bendazole lysine eye drops (sapace) was held, which fully exchanged and discussed how to implement the clinical research plan well.

In December 2019, relevant technical personnel from 9 units from 9 provinces (cities) participated in the clinical research in Guangzhou, and participated in the relevant business training organized by Zhongshan Ophthalmic Center of Sun Yat sen University, so as to ensure the consistency of specific operations of each clinical research unit.

According to the latest third quarter report of 2020, seven units, including Zhongshan eye center of Sun Yat sen University, have passed the examination of the ethics committee.

In addition, 21st century economic reporter inquired the official website of China clinical trial registration center and found that there was indeed a "randomized, double-blind, placebo-controlled, multi center post marketing clinical study on the effectiveness of bendalamine eye drops in delaying early senile cataract". The registration date was April 10, 2020, the applicant was sapace, and the research implementation time was from April 16, 2020 From December 30, 2022 to December 30, 2022, the study was conducted in Zhongshan Eye Center, Sun Yat sen University.

It can be seen that from 2016 to now, four years later, the evaluation of the consistency of sapezinyl lysine eye drops is still in the stage of clinical research, and the clinical research was officially launched only in April 2020.

As for the consistency of sapacil benzidine lysine eye drops, the person in charge of drug research and development of a listed company in China told the reporter of 21st century economic news that "the consistency evaluation of sapace's bendalalysine eye drops has not been completed for such a long time, it should be that the evaluation experiment has encountered problems that are difficult to overcome, and the probability is that the curative effect data is not significant."

The person in charge further said, "generally, after more than four years, the generic drug consistency evaluation has been completed." The implication is obviously that, as the company's mature ace blockbuster product, the efficacy consistency evaluation for such a long time is extremely abnormal. (Editor: Zhu Yimin)

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