"Nine phase one" listed 10 days sold out? Lvgu pharmaceutical has greater "ambition"

"The first batch of drugs has been sold out, and the second batch will arrive soon." On January 8, 2020, according to Pharma news, the first batch of ganlute sodium capsule (trade name: phase 9, code: gv-971), a new Alzheimer's drug of Lvgu pharmaceutical, has been sold out in pharmacies all over the country And that's only 10 days before it officially goes on sale Does the annual cost exceed 40000 yuan, and the price is not friendly to the people? The dispute has not been resolved, and the "nine phase one" has entered the market On December 29, 2019, Green Valley pharmaceutical announced that "phase 9, phase 1" was officially listed in China, and patients can buy it by virtue of doctor's prescription "From time to time, some of the patients who have recently been visited have come to inquire about the new drug, phase 9-1," said some neurophysicians in this context It is reported that "nine phases one" has been put on the shelves of 151 professional pharmacies (DTP pharmacies) in 25 provinces in China Take ordinary people's pharmacy for example At present, "nine phases one" is sold in its first 35 authorized stores, mainly in Anhui, Jiangsu, Zhejiang, Guangdong, Hubei, Tianjin and other provinces Huang Xiuxiang, vice president of Hunan Branch of China Pharmacy Management College, said in an interview with the daily economic news, "DTP pharmacies need manufacturer authorization to sell this drug, and the requirements are relatively high, so it is difficult for ordinary pharmacies to obtain manufacturer authorization." However, the pricing of "nine phase one" is also controversial "The price of a single box of drugs (150mg, 14 capsules and 3 plates) is 895 yuan If the drugs are taken according to the drug instructions, the monthly drug cost is about 3580 yuan, and the annual drug cost is about 42000 yuan." Lu Songtao, chairman of Lvgu pharmaceutical, said in the media meeting after the listing of "phase 9-1" that the price of the drug was determined by employing internationally renowned consulting companies and combining various factors such as purchasing power, nursing fee and comprehensive medical cost of Chinese people Lu Songtao said that the biggest burden of ad to society lies in the care and care of patients The cost of care for an AD patient in the United States is as high as US $40000 per year In China, the cost of care is 130000 yuan per year, of which over 67% is indirect medical expenses Therefore, in terms of the improvement of patients' condition and the cost of care saved, the family burden of patients was reduced However, some media learned from the relevant neurophysicians that at present, the combination of "donepezil + memantine" commonly used in the clinical treatment of Alzheimer's disease in China only needs to bear a medical fee of about 1800 yuan per month Lu Songtao hopes that in the future, "nine phase one" will have the opportunity to enter the national medical insurance "The national health insurance can pay a part, and the patients themselves can pay a part I think in general, the price is acceptable for the patients." However, Huang Xiuxiang said, "in the future, if this drug enters the medical insurance, the related costs may be reduced, and the burden of patients will be reduced accordingly However, even if it is included, the cost of medical insurance is not low, which may exceed 10000 yuan per year, which is also a factor that will be considered practically in the future." As for the future sales situation of "nine phase one", Shi lichen, founder of Beijing Dingchen Management Consulting Co., Ltd., said frankly that the future sales situation of "nine phase one" is not easy to predict, the key lies in the extent of the product's effect As the relevant data has not yet been fully supplemented, it is difficult to make the following positive conclusion, and it will take time to observe the follow-up sales situation According to a $3 billion plan, there are about 50 million Alzheimer's patients in the world in 2018 In China, there are about 10 million people in this group, and the number of patients is expected to exceed 40 million by 2050 In this context, the "nine phase one" is called "filling in the gap of no new drugs in the field of Alzheimer's disease treatment in the past 17 years", with an effective rate of 78% However, since it was approved to be listed conditionally in November 2019, there have been continuous doubts about the "nine phase one" Firstly, the follow-up time required for Alzheimer's disease was compared for about 2 years, and the clinical effect of "nine phases one" was questioned because it was only 9 months; the "nine phases one" was also considered as a single research index, and the biomarkers were not clear; in addition, Geng Meiyu, the main R & D personnel of "nine phases one" was also pointed out that the paper was suspected of fraud, including improper cutting of pictures, multiple use of one picture, etc Title For a long time, this medicine has been doubting "and" doubting is completely understandable " In the whirlpool, Lu Songtao seems to be more peaceful He even threw out a plan of up to $3 billion According to the report, Lvgu pharmaceutical said it would invest 3 billion US dollars to support the real world research after the listing of "nine phases one", the international multi center three phase clinical research "green memory", the expansion of indications research and in-depth mechanism research, etc In this plan, it will complete the international multi center clinical trials in 2024 and the global registration application of new drugs in 2025 Among them, the international multicenter phase 3 clinical research will be led by the winner of the Lifetime Achievement Award (2018) of the Alzheimer's Association of the United States and serve as the chief scientist AI kunwei, the world's largest pharmaceutical clinical trial business company, is responsible for clinical trial management It will take more than 2000 patients with mild and moderate Alzheimer's disease as the object, 200 clinical trials in North America, EU, Eastern Europe, Asia Pacific and other regions The bed center carried out a double-blind test for 12 months and an open test for 6 months However, the general concern of the industry is, where does the $3 billion come from? On this issue, Lu Songtao's response is: the money will come from the sales of existing products, plus the sales after the listing of the "nine phase one", as well as a variety of financing channels and cooperation ways "There are a lot of sources in the next decade and we are very confident," he said Previously, in an interview with the media, LV Songtao said that the sales volume of Danshen polyphenolate injection, the main product of Lvgu pharmaceutical, reached 3 billion yuan to 4 billion yuan in 2014 and 2015, and the profit accumulated by this product reached 3 billion yuan, and the whole product has been put into "phase 9, phase 1" However, according to an EMIS report obtained by the media "Time Bureau 1", the performance of Lvgu pharmaceutical is far from what LV Songtao said Data sources of revenue and net profit of Lvgu pharmaceutical in the past four years: in the report of EMIS, from 2015 to 2018, Shanghai Lvgu Pharmaceutical Co., Ltd achieved operating revenue of 162 million US dollars, 188 million US dollars, 204 million US dollars and 171 million US dollars, about 1.06 billion yuan, 1.24 billion yuan, 1.37 billion yuan and 1.19 billion yuan, respectively The net profits were $7.257 million, $0.204 million, $29.011 million and $25.14 million, respectively, about RMB 50.79 million, - 1.428 million, 203 million and 176 million That is to say, in the last four years, the average annual net profit of Lvgu pharmaceutical is only about 100 million yuan In addition, Lvgu pharmaceutical still needs to face the reality of "conditional listing" According to Caijing magazine, the State Food and Drug Administration agreed to "conditionally approve the listing of phase 9 and phase 1" because the official report of 104 week carcinogenic toxicity test of rats has not been submitted in the application materials of new drugs At the time of declaration, the above carcinogenic test was also completed, but the information was not ready Based on the urgent needs of the patients, it is required to submit the above report within three months, otherwise the qualification of new drug certificate will be cancelled In response, Geng Meiyu disclosed the report of 104 week carcinogenic toxicity test of rats, which had been submitted on December 26 "Because the drug is conditionally approved for marketing, we should continue to supplement relevant experimental or clinical data later, and the relevant data will also be strictly reviewed." Shi lichen in an interview with the media analysis What will be the fate of the "nine phase one"? It's all up to time Penicillin is the reprinted content of yaozhi.com, and the copyright belongs to the original author The purpose of reprinting is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.