[exclusive] selling 750 million brainwashing drugs

In recent days, a 750 million God eye medicine has been sold by Dr Xiang's wechat to brush the circle of friends Dr Xiang's analysis is more from the perspective of doctors Today, we look at it from the perspective of drugs: cataracts, according to statistics, more than 65% of the elderly over 60 years old in China suffer from this disease Although there are a large number of people, few people know that the only effective way to treat cataracts is the common sense of surgery Most of the elderly "are believed" to be a magic eye potion - sapais (benzyl lysine eye drops) In 2016 alone, I used RMB 260 million advertising fee to swipe the screen, and every day I chanted in the old man's ear, "cataract, can't see clearly, SAPS drops", how did it come into being? We closely follow the data of Yaozhi to dig up its "past life and present life" According to the data from "Weizi" to "Guozi", the earliest approved benzyl lysine was developed by Nanjing Pharmaceutical Research Institute and produced by Zhejiang Pinghu pharmaceutical factory The drug was jointly developed in accordance with the requirements of new drugs (Western Medicine) class II, and was listed in the national "Eighth Five Year Plan" scientific and technological research project On September 2, 1997, it obtained the new drug certificate and production approval, among which the approval number of benzyl lysine eye drops was (97) Wei Yao Shi Zi X-37 (refer to figure 1 for specific information) In 1998, the new drug was approved to be put into production (the previous new drug had a trial period), and the trade name was changed from baidake to sapais (the trade name can also be changed, but I haven't seen it yet) After restructuring, Zhejiang Pinghu Pharmaceutical Co., Ltd is now renamed "Zhejiang sharplove Pharmaceutical Co., Ltd." and successfully listed on a share of Shanghai Stock Exchange on July 2, 2014 Fig 1 data source: it should be noted that the approval number of the drug was initially "(97) wjtz X-37" In this regard, we can first understand the development of the measures for the administration of drug registration in China On July 1, 1985, the Ministry of Health issued the measures for the examination and approval of new drugs, which clearly stipulates that new drugs can be divided into traditional Chinese medicine and Western medicine, each of which includes five categories The second category of Western medicine declared by benzyl lysine is "raw materials and preparations approved for production abroad but not listed in the Pharmacopoeia" After the clinical research of new drugs is completed, if production is required, an application must be submitted to the Department (bureau) of health of the province, autonomous region or municipality directly under the central government where the new drugs are to be produced After examination and approval, the application shall be transferred to the Ministry of health for examination and approval, and the "new drug certificate" and approval number shall be issued by the Ministry of health Since it's a new class II drug, it must have been on the market abroad Let's see which countries this drug has been on the market (not some people say it's exclusive to China) The benzyl lysine contained in sapais eye drops is an aldose reductase inhibitor, which can inhibit the activity of aldose reductase It was first listed in Italy by Angelini Pharmaceutical Group in 1983 (trade name: bendaline), and also listed in several small countries Figure 2 data source: drug intelligence data: the key to the efficacy of a drug is to look at clinical trials As a second-class new drug, SAPS eye drops also carried out clinical trials In the clinical trials of 7.22 drugs in 2015, most of the clinical trials were withdrawn due to fraud or non-standard How about the clinical trials of drugs more than 20 years ago? It is not mentioned that it is very difficult to evaluate the effect of cataract treatment at this stage by looking at the results of the test alone We found that the lens of patients has not changed significantly by using objective evaluation indicators, and only by using subjective indicators (looking at the vision chart) can we see some effect Conclusion a large number of long-term clinical observations are needed for verification (now is the time for CFDA to ask for re clinical verification) With the instruction and OTC, I started to swipe the screen at ease According to the notice on the task of the second batch of unified instruction of Chemicals issued by CFDA on August 10, 2001, the indication of the instruction of bendalalysine eye drops is: it is suitable for early senile cataract However, it is understood that lysine eye drops at this time as prescription drugs are sold in the hospital channel, with poor effect and are not popular with doctors On December 1, 2004, CFDA issued the notice on the conversion of 34 kinds of drugs such as naftopin hydrochloride cream into over-the-counter drugs, which converted 34 kinds of drugs such as benzyl lysine eye drops (including 11 kinds of chemicals and 23 kinds of Chinese patent drugs) into over-the-counter drugs That is to say, this paper has made a great change in the fate of the eye drops of benzyl lysine After switching to OTC drugs in 2004, benzyl lysine eye drops began to be sold in pharmacies However, as of 2007, the annual sales volume is about 300000, and the annual sales volume is only around 10 million The sales performance of 750 million in 2016 is far from satisfactory In 2007, Zhejiang sharplove pharmaceutical entrusted Guangdong Phoenix Legend integrated media Co., Ltd to carry out brand consultation and planning work, and the cooperation between the two sides has continued to this day The rising performance is accompanied by the high cost of screen advertising Interestingly, in the database of Chinese clinical trials of Yaozhi, we found that the bendalalysine capsule declared by Zhejiang Pinghu sapais Pharmaceutical Co., Ltd is undergoing phase 2 clinical trials Its indication is diabetic nephropathy and the target population is type 2 diabetic patients (see Figure 5 and Figure 6 for details) What kind of medicine will this be? We'll see Fig 5 Fig 6