Will the deadline go to cataract "god medicine" Shapps eye drops or will it be discontinued?

Pharmaceutical Network October 30, October 28, Sapp Ace Pharmaceutical Co., Ltd. (hereinafter referred to as Sapp Ace) issued a notice that the company had received the former Zhejiang Food and Drug Administration on December 7, 2017 "forwarded to the State Food and Drug Administration The notice document on the matter related to Shapps eye drops requires the company to "start clinical effectiveness trials as soon as possible in accordance with the relevant provisions of the Drug Administration Law of the People's Republic of China and the consistent evaluation of the quality and efficacy of generic drugs, and to report the evaluation results to the Drug Review Center of the State Food and Drug Administration within three years".
However, due to the impact of the new crown epidemic, the research units related to the suspension or slow progress, the hospital ethics review and contract review time is longer, the trial cycle is long, the company is not expected to be able to report the evaluation results to the State Drug Administration Drug Review Center within the original time limit.
company has applied to the State Drug Administration through the Zhejiang Provincial Drug Administration for an extension to complete the consistency evaluation related work.
announcement shows that there is a possibility that the evaluation of the quality and efficacy of dicin hydrants can not be completed within three years as required by the State Drug Administration, or that there is a risk that the company's application for extension of the completion of the consistency evaluation work will not be approved, or that the quality and efficacy of dicta/lysine eye drops will be completed and reported to the Drug Review Center of the State Drug Administration.
In the above, the Company's approval number for the Lysine eye drops drug may be cancelled or not re-registered after expiration, resulting in the product not being able to continue production and sales."
on the other hand, Shapps also said that the company will continue to accelerate the progress of consistency evaluation-related work, take measures to urge CRO to further accelerate clinical research, and actively communicate with the group leader to speed up clinical progress.
and actively report and communicate with the drug regulatory authorities to obtain approval for the company's delay in the completion of consistency evaluation of the company's pentasine/lysine eye drops.
However, according to the interface report, there are industry insiders analysis that Sapp Ace basically determined that the above-mentioned consistent evaluation work can not be completed within the specified time, its only in April this year to launch the market after evaluation of clinical research, planned to 2022.
according to the official website of the China Clinical Trial Registration Center, there is a randomized, double-blind, placebo parallel control and multi-center post-market clinical study entitled "The effectiveness of cylindrical cataracts in early geriatrics," according to the official website of the China Clinical Trials Registry.
Photo Source: China Clinical Trial Registration Center's official website, Ida/Lysine eye drops, or Sapp Ess eye drops, completed Phase II clinical trials in December 1995, obtained a new drug certificate in 1997, obtained production approvals after the completion of Phase III. Phase III clinical trials in August 1998, is the exclusive domestic product, is Sapp Ace's Fist products, which are also one of the main revenue varieties, according to performance data, in 2019, Shapps eye drops accounted for 44.6% of operating income, gross profit accounted for 62.08 percent, in January-September 2020, operating income accounted for 36.15 percent, gross margin accounted for 62.4 percent.
photo source: Sapp Ace's announcement comes after a controversial brainwashing ad that "can't see Shapps' eyes clearly because of cataracts", "fuzzy drops, ghost drops, dark shadow drops" and "a little pain insists on drops", December 2, 2017. A year to sell 750 million brainwashing drugs, please let go of the Chinese elderly" article, the article quoted a number of ophthalmologists and authoritative literature, to prove that "Sapp Ais eye drops" prevention and treatment of cataracts is a big lie, is the use of brainwashing advertising marketing "pit harm" the elderly, so that it delayed treatment, there is a risk of blindness.
There have been clinical trials that have confirmed that whether it is eye drops to treat cataracts or internal medications, surgical treatment is still the most effective means of cataracts, but for some of the initial stages there is a necessary effect to slow down some trends.
On December 6, 2017, the former State Administration of Food and Drug Administration issued the Notice on Matters Related to Sapp Ace Eye Drops, which clearly states that in view of the fact that some doctors in the medical profession have questioned the efficacy of Shapps Eye Drops, the former Zhejiang Food and Drug Administration, in accordance with the relevant provisions of the Drug Administration Law of the People's Republic of China and the consistent evaluation of the quality and efficacy of generic drugs, urged Shapps to start clinical effectiveness trials as soon as possible and to report the results to the State Administration of Food and Drug Administration within three years.
in order to prevent misleading consumers, the drug approval advertisement shall be expressed in strict accordance with the written expression stipulated in the instruction manual adaptation, and shall not contain any text content that goes beyond the instruction manual adaptation.
On December 28, the State Food and Drug Administration again named Anhui Province Shuangke Pharmaceutical Co., Ltd., Hubei Yuanda Tianming Pharmaceutical Co., Ltd., Hebei Medical University Pharmaceutical Factory, Hangzhou Minsheng Pharmaceutical Co., Ltd., Ningxia Kangya Pharmaceutical Co., Ltd., Changchun Puhua Pharmaceutical Co., Ltd., Zhuhai Federal Pharmaceutical Co., Ltd. Zhongshan Branch and other 7 enterprises also need to do a consistent evaluation of lysine hydrants.
Photo Source: Pharmaceutical Intelligence Data Although the original "God's drug storm" had a major impact on Sapp Ace, and then in order to get out of the "God's Medicine" storm, Sapp Ace in the first half of 2018 low-key launch of the 10 full complement pills, lock Yang New sales product varieties such as solid sperm pills, but according to pharmaceutical data enterprise version of hospital sales data show that in 2019, the market share of the hospital is still as high as 30.48 percent, second only to Changchun PwC Pharmaceuticals.
In this reason, Sapp Ess made it clear in its announcement that pyrethroide/lysine eye drops are the company's core products and that failure to continue production and sales of pentax/lysine eye drops will have a significant impact on the company's production and operations.