On the evening of October 28, sapace announced that the quality and efficacy consistency evaluation of the company’s core product benzyl amino acid eye drops (i.e., sapace eye drops) may not be completed within the time limit required by the State Food and drug administration, and has applied to the State Food and drug administration through Zhejiang drug Administration for extension.
as to why novel coronavirus pneumonia is not completed on time, Ssha F Ai Faith has thrown the pot into the new crown pneumonia epidemic. “Due to the novel coronavirus pneumonia epidemic, the work of the research institutes is suspended or slow, the ethical examination and contract review time is longer and the test cycle is longer. The company is not expected to report the evaluation results to the SFDA drug evaluation center within the original deadline.” Sapace said. < / P > < p > if the application for extension is not approved, the drug approval number of benzylamine eye drops may be cancelled or will not be re registered after expiration, resulting in the failure to continue production and sales of the product. It was a blow to sapace. In the first three quarters of 2020, sapace achieved a revenue of 240 million yuan, a year-on-year decrease of 40.61%, and a loss of 28.0564 million yuan in net profit attributable to its parent. “< p > < p >” cataract, can’t see clearly, sapace’s eyes “,” fuzzy drops, double shadow drops, black shadow drops “, these once bombarded advertisements are extremely inspiring to the elderly people who are suffering from cataract. Behind this, sapace eye drops have been selling well for many years, with the highest sales of nearly 30 million per year. < / P > < p > on December 2, 2017, an article entitled “crazy sales of 750 million yuan of brain washing drugs a year, please let go of the elderly in China” was posted on the Internet, pointing out that there were false publicity and delayed treatment of sapace eye drops. Originally only “alleviates the cataract progress” the benzyl amino acid, is promoted by sapace to be able to cure the cataract, the effectiveness of this “miracle drug” was subsequently bombarded by ophthalmologists in the medical field. < / P > < p > on December 6, 2017, the former State Food and Drug Administration issued a document requiring sapace to “start the clinical efficacy test as soon as possible 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, and report the evaluation results to the drug evaluation center of the State Food and drug administration within three years”. < p > < p > sapace said that the company has set up a leading group including the chairman of the board of directors to evaluate the consistency of benzylamine eye drops and spare no effort to promote the relevant work. In fact, sapace started the consistency evaluation of benzylamine eye drops as early as 2016, and commissioned Hangzhou Baicheng Pharmaceutical Technology Co., Ltd. to carry out the consistency evaluation of benzylamine eye drops. < / P > < p > in recent years, although sapace disclosed the progress in the evaluation of the consistency of the eye drops every year in its annual report, it has always been “thunder but no rain”. In more than four years, the project has been in the preclinical stage, until the deadline is approaching, the clinical stage is pushed forward in a hurry. < p > < p > on October 31, Liu Ming (pseudonym), who has been engaged in drug development for many years, told the times weekly that the process of generic drug consistency evaluation usually includes the selection and acquisition of reference preparation, comparative study of in vitro dissolution and bioequivalence study. Compared with traditional drug development, it is relatively simple, and the number of people required to join the group is also small, and the time from declaration to approval is convenient Usually no more than 2 years. < p > < p > Guotai Junan once made a statistics in July 2019. Among the 222 generic drugs that had passed the consistency evaluation at that time, the average review period was about 213 days, the shortest was only 51 days, and the longest was only 481 days. < p > < p > “consistency evaluation is to compare the generic drug with the original drug to evaluate whether its quality and efficacy are consistent with the original drug. According to the regulatory requirements, benzylamine eye drops need to prove not only whether they are consistent with the original drug, but also the effectiveness of the product itself. ” Liu Ming pointed out to the times weekly. < p > < p > from the domestic drug clinical trial registration and information publicity platform, sapace registered a clinical efficacy trial on April 10, 2020, called “randomized, double-blind, placebo-controlled, multicenter post marketing clinical study on the effectiveness of benzylamine eye drops in delaying early senile cataract”. According to the public information, 500 cataract patients aged 50-70 years were enrolled in the study. However, up to now, only one subject has been recruited for the project, and it was just enrolled in July. According to the National Pharmaceutical Administration’s basic schedule of 2020, the clinical trial of saproxobin may not be completed within 2020. < / P > < p > “it usually takes a few months from the submission of clinical trial application to clinical admission. It took several years for the project to be approved for clinical trials. It may be that the preliminary data are not very optimistic, or the re evaluation work may be delayed intentionally or unintentionally. ” Liu Ming thinks. < p > < p > at the end of December 2017, the former State Food and Drug Administration once issued a document requiring the manufacturers of benzylamine eye drops to start clinical efficacy test as soon as possible, and report the evaluation results to the drug evaluation center of the general administration within three years. From the official website of the State Food and drug administration, the reporter of the times weekly found that there were 8 domestic manufacturers of benzylamine eye drops, with 11 approval numbers in total, involving well-known companies such as Yuanda pharmaceutical and United Laboratories (03933. HK). It was first developed by Angelini Pharmaceutical Group and was listed in Italy in 1983. However, at present, there is no drug for the treatment of cataract in the world, and Angelini’s benzylamine eye drops are only used as auxiliary drugs for anti cataract. But in China, benazeprine eye drops are packaged as a best-selling drug for cataracts, and it is Chen Dekang, the actual controller of sapace, behind the package. Chen Dekang, a native of Zhejiang Province, has been the director of Pinghu pharmaceutical factory since 1985. At that time, Pinghu pharmaceutical factory only produced general medicine, and did not have its own trump card products. Chen Dekang, who was trying to find “unique” products, took a fancy to the business of the elderly. In 1991, he started to copy benzylamine eye drops jointly with Jiangsu Pharmaceutical Research Institute. < p > < p > in 1997, sapace obtained the class II new drug certificate and became the first manufacturer of benzylamine eye drops in China. At first, the product was marketed as a prescription drug in hospitals. However, doctors usually treat cataract patients with surgery, so sales have not improved. In December 2004, the State Food and Drug Administration approved the conversion of benzylamine to OTC. With the sales channel from hospitals to pharmacies, sapace’s marketing promotion is “let go”. In particular, after its listing on the main board in 2014, the advertising expenses of sapace in the straight-line year accumulated about 950 million yuan, while the R & D investment in the same period was only 117 million yuan. And since its launch, its new drug project has not made any progress. < / P > < p > data shows that in 2019, the sales volume of sapace’s benzylamine eye drops has shrunk to 230 million yuan, but the gross profit still accounts for 62.08%; in the first three quarters of 2020, the sales revenue of the product is 86.82 million yuan, accounting for 62.4% of the total. < / P > < p > “it’s no surprise to delay the re evaluation work. Sapais has become the abandoned son of the Chen family, and the focus of the” Putian system “that takes over the dishes is not on the medicine.” On October 31, a medical researcher from an institution in Shanghai told the times weekly. At the end of 2018, Chen Dekang transferred his 9.66% shares of sapace to Shanghai Yanghe Investment Management Co., Ltd. (hereinafter referred to as “Yanghe investment”). In January 2020, Chen Dekang transferred 7.24% of the shares to the maintenance and investment party at a price of 420 million yuan, giving up the voting right of the remaining 21.73% shares, and said that he would continue to transfer 5.43% of the shares to the maintenance and investment party in 2021. < p > < p > since then, Yanghe investment has become a major shareholder. Lin Hongli and Lin Hongyuan have become the actual controllers of sapace, and his father Lin Chunguang is one of the representatives of “Putian system” medical capital. Chen Weiping and his board of directors were completely replaced in August this year. < p > < p > after the Lin family became the owner, the first thing they did was to purchase 100% equity of Taizhou women’s and children’s Hospital controlled by themselves with 500 million yuan in cash. According to the data, the hospital’s revenue in 2019 and from January to July in 2020 will be 172 million yuan and 84.01 million yuan respectively, and the net profit will be 28.79 million yuan and 17.74 million yuan respectively. In addition to the above hospitals, the Lin family also controls many hospitals such as Shanghai Tianlun hospital and Chongqing Guobin maternity hospital. Whether these hospitals will continue to inject sapace has become a topic of general concern to investors. < p > < p > the purpose of this article reprinted by China net finance and economics is to convey more information, which does not represent the views and positions of the website. The content of this paper is for reference only and does not constitute investment advice. Investors operate accordingly and bear their own risks.