Challenge $1 billion in sales: Why are these areas likely to produce heavy-duty bomb-grade drugs?

　　We have previously analyzed that domestic enterprises want to create "heavy bomb"-grade drugs, the first to solve the problem may be the research and development level, the second to solve, but also essential, is the global marketing capacity to improve In the last century, whenever one or a batch of important targets are found and confirmed, will be accompanied by the birth of a number of "heavy bomb" grade drugs, it can be seen that a drug in the sale of success, to a certain extent, is also a direct reflection of its clinical significance So where is the current area where heavy-bomb drugs are concentrated, and where is the next one that will give birth to heavy-bomb drugs? 　　In 2018, there were 141 brand products with global sales of over $1 billion Anti-tumor drugs remain a regular customer of "billion" dollar sales, with sales of 36 products over one billion, 12 for single-resistant and 8 for tinib One of the largest products in the market is Tonala, followed by PD-1 Navu monoantigen to nalamide for multiple myeloma (MM, multiple myeloma) at home and abroad the main guidelines recommended first-line, second-line preferred medication, preferred maintenance and continuous medication, is the main therapeutic drug Multiple myeloma is a blood malignant tumor, according to myeloma (myeloma.org), there are about 750,000 patients with multiple myeloma worldwide, GLOBOCAN 2018 reported that China's annual number of mm patients 2006 The above data can be preliminarily estimated that the total number of patients with multiple myeloma in China exceeds 100,000 100,000 people have been treated in a standardized form, and according to epidemiological estimates, the entire market size of myeloma drug use can be as high as 10 billion yuan but domestic sales of Lenado amine in general, in September 2017, Xinji its three anti-cancer products, including Theinamine operation rights, all transferred to Baiji Shenzhou According to the 2018 annual report, net revenue from the three products in 2018 was $131 million This is mainly due to the fact that the market for non-medicare was only approved for the market in January 2013, but was only included in the National Health Insurance Negotiating List on July 13, 2017, and the non-medicare market growth was limited until 2017 After entering health insurance, the original research price was also adjusted from 2799 yuan (25mg/grain) to 1101.99 yuan (25mg/granules) the november 2017 launch of a generic drug by Shuangyu Pharmaceuticals, the annual report of shuangyin pharmaceutical industry in 2018 did not mention the full-year sales of the drug, only in the 2018 half-year report shows that the sales revenue of Nadoamine in the first half of 2018 was more than 48 million yuan In 2019, another company is on the market with a generic drug from Datianqing and Qilu, and the product officially enters the price war Shanghai Sunshine Procurement Network announced on June 6 that Qilu's agreement purchase price for Rinnaamine was 189.5 yuan (25 mg/grain) Zhengda sunny June 13 in the future that degree amine Shandong Province hanging net price reduced to 188 yuan (25 mg / grain) Although not into the second batch of band procurement catalog, but with the increase of manufacturers through consistency evaluation, it is expected that it is difficult to re-create the glory of global sales in China, can be described as "foreign heavyweights, domestic dismal." 　　PD-1 is facing serious homogenization competition in China and each family has developed an expansion strategy to accelerate the development of indications, multi-target research and development, joint drug use and so on However, the 2019 report card shows that foreign have made a lot of gains in China, such as The Shasaeast PD-1 single anti-drug Keytruda (Paboli Pearl Mono-resistance) listed so far in china's sales have exceeded 2 billion yuan However, in the corresponding, Cinda in the 2019 semi-annual report published in the first half of 2019 PD-1 Cindy Single Anti-Sales Revenue of 332 million, which can be seen in the foreign heavy bomb and domestic metoo /mebetter in the domestic market with home-field advantage, domestic products may not be able to occupy a home-field advantage, even if Cindy single resistance by Lilly responsible for sales in addition, in the health insurance office 'negotiated drug part (i) Western medicine during the agreement period" list, PD-1 mono-resistance only Sindili single resistance shortlisted From 7838 yuan 10ml: 100mg/bottle) down to 2843 yuan (10ml: 100mg/bottle) It is estimated that the annual cost of treatment for patients with Sindili monoantigen has dropped from 160,000 yuan to less than 100,000 yuan from this case can be seen, when the domestic drug market approval and listing speed is more and more in line with foreign markets, the domestic metoo / mebetter new drugs in the home has not yet been able to PK out of imported pharmaceutical companies, not to mention our products want to win competition in foreign markets to become a heavy bomb want the cancer field to become a bombshell, first of all, the population of the disease is a wide number of people and there is no better drugs, such as small cell lung cancer Second, there is sufficient clinical basis to show that the efficacy of the product is superior to similar target products, which requires a large amount of clinical trial data accumulation Finally, there must be global marketing capabilities, especially products as far as possible in the United States - although China's cancer market is very broad, but the domestic market annual sales of more than 6 billion yuan of anti-tumor drugs basically no Some of the global sales of better scale but domestic sales of general indications are more need to be marketed in the United States, such as rheumatoid arthritis, psoriasis and other immune system medications 　　A total of 13 products of diabetes drugs are still heavy bombs, of which 7 are insulin, 2 GLP-1, 2 DDP-4, 1 SGLT-2 inhibitor, and one DDP-4 plus metformin Insulin is not easy to copy, the original drug products can maintain high sales for many years, the new mechanism and more clinical advantage spree products than listed products still have the opportunity to get heavy bombs one of the two exclusive products with annual sales of more than 6 billion yuan in China's Western medicine is Novo Nordisk's winter insulin To last a long period of time, a heavy bomb must establish a technical threshold that cannot be easily imitated traditional medicines, hypertension products have three original research products sold more than one billion U.S dollars, namely, ammonia chloritin, shattan, shatan and ammonia chloritin, ammonia chloritin original research income from China and Japan's contribution, with China's implementation of the belt , the global market size is expected to be affected high blood pressure can sell more than a billion basic drugs are expired, but if there is a new mechanism more clinical advantages and better safety of the new drug on the market, the new drug is expected to replace the market for heavy bombs, from the new diabetes mechanism drugs or can get the status of heavy bombs can confirm that traditional chronic diseases if there is a new target mechanism and more clinical advantages than the listed drugs, this kind of new drug new drugs want to "billion" of heavy bomb products difficult 　　HIV antiviral drugs have a total of 10 products of more than $1 billion, five of which come from Gilead, and are all fixed-dose compound preparations, such as enthofa-and-tinofweaola, en-titabin-tinofeola-libevelin, en-tretbin-fu-matacid tinofor This new crown outbreak is pinned on the high hopes of the product Redsiewe is also from Gilead, it can be seen that Gilead in the field of HIV accumulation, Gilead reservead a large number of antiviral compounds can play the complex combination of the turn respiratory areas such as chronic obstructive pulmonary disease also have six products entering the "Billion Dollar Club", with AstraZeneca and GlaxoSmithKline each having two AstraZeneca's Budinide, which also has revenues of Rmb6bn in China, has an indication that includes not only chronic obstructive pulmonary disease, but also asthma and allergic rhinitis Chronic obstructive pulmonary disease also has three fixed-dose compound preparations in excess of $1 billion three products with hepatitis C products of more than $1 billion, all of which are compound preparations, two from Gilead and one from AbbVie clinically requires a variety of different mechanisms at the same time drug treatment of indications, the development of the same drug pathway of fixed-dose compound preparation can improve patient compliance, however, this requires the patient has taken one of the single, which means that this unilateral is not a first-line conventional drug, or the enterprise has a strong market capacity for most patients to take their own products In addition, it is best for companies to have patents on the chemical composition and corresponding indications in compositions to avoid the risk of imitation by generic manufacturers and competitors dementia is due to a variety of causes caused by cognitive impairment as the main clinical manifestation, accompanied by mental behavior symptoms, leading to a decline in daily life ability of a group of acquired intelligence impairment, mostly in the elderly, the most common type is Alzheimer's disease (AD), followed by vascular cognitive impairment or dementia At the end of 2013, China's population over 65 years of age has reached 132 million, according to 7.8% of the prevalence of dementia and 4.8% of the AD prevalence estimates, China's dementia patients about 10 million, of which AD patients about 6 million estimates that there are 44 million AD patients worldwide and an estimated $604 billion a year in medical costs (including health care providers, carers, etc.) In developed countries, Alzheimer's disease is one of the major diseases that consume social financial assistance In the United States, for example, Alzheimer's is the sixth leading cause of death, with one diagnosis every 66 seconds, and the annual cost to society as a whole is $259 billion because of the enormous burden of Alzheimer's disease on patients and society, and there is still no effective treatment, the drugs approved are drugs to slow the clinical symptoms of Alzheimer's disease since 2002, pharmaceutical companies have invested more than 200 billion U.S dollars in aD new drug research and development, however, in more than 200 clinical studies, the successful market of Only one AD drug, drug research and development failure rate of 99.6% The reason for the failure of drug development is that the above-mentioned drugs are based on the amyloid theory Amyloid theory suggests that the accumulation of amyloid beta in the brain is the cause of dementia and cognitive impairment However, biogenetic tests and many other drug trials to prevent or remove amyloid protein have shown that even in early-stage Alzheimer's patients, cognitive ability has not been improved the pathogenesis is not clear, the pathogenesis is complex, the disease course is long and the pathogenesis is the main dilemma of AD drug research and development But in any case, any company in the world would be a "super bombshell" if it could develop a drug that slows the progression of AD 　　Non-alcoholic fat hepatitis (NASH) drug treatment has great potential Nash is often caused by obesity and belongs to a fatty liver disease More than 16 million people in the United States alone have the disease In addition, non-alcoholic fatty liver disease (NAFLD) is a precursor disease characterized by high levels of fat in the liver and can affect about 80 million people in the United States the incidence of disease in China has also increased in recent years, with epidemiological findings from Shanghai and Beijing showing that the prevalence of NAFLD in general adult Synostic diagnosis has risen from 15% to more than 31% in 10 years A biopsy confirmed that NASH accounted for 41.4% of NAFLD patients and 2% of patients with cirrhosis According to reports, there are about 240 million NAFLD population in China in 2016, and by 2030, the nAFLD population is expected to increase to about 310 million, of whom about 2.3 million will be suffering from cirrhosis 　　The main known major causes of NASH include metabolic syndromes such as obesity, type 2 diabetes, hyperlipidemia and hypertension But the industry's diagnosis of NASH still relies on liver biopsy assessments, and no treatment spree for the condition has yet to be available worldwide In terms of therapeutic purposes, the main purpose is to control the progression of obesity, type 2 diabetes and hyperlipidemia, and weight management is often selected as the primary treatment for NASH in recent years NASH new drugs have become a new hot spot in the industry, the industry believes that its market potential is $35 billion The NASH battle between domestic imported and domestic pharmaceutical companies is likely to be similar to the pD-1 war, with a first-mover advantage but only if it can be successfully listed in China 　　Ischemic stroke is a variety of reasons caused by the blocking of blood supply in the brain, resulting in limited or comprehensive brain function and/or structural damage, including transient cerebral ischemic attacks (TIA), cerebral infarction and embolism Stroke is the first cause of death in China more than 7 million existing stroke patients in China, ranking first among vascular diseases Each year, 1-2 million new cases were reported, the annual incidence rate of stroke after the correction of age was (116-219) / 100,000, the annual fatality rate (58-142) / 100,000, and 70-80% of the survivors were left with different degrees of disability the treatment of acute ischemic stroke is mainly based on conservative drug treatment, and its treatment strategy mainly focuses on the following two aspects: first, to improve cerebral blood circulation treatment, and second, the use of nerve protectors to protect the structure and function of nerve cells for the purpose of treatment However, there are very limited available drugs in clinical practice for these two treatment strategies measures to improve cerebral blood circulation mainly include thrombosis, antiplatelet, anticoagulant, defibre and expansion A total of six products will enter the Billion Club in 2018 The only effective treatment for ischemic stroke is the treatment of rt-PA thrombosis, but by its strict time window and indications, contraindications, china currently meets the rt-PA thrombosis treatment of less than 1% of patients the nerve protectors used in our clinical treatment of stroke are Ida la feng, nemodpine and Malayic acid cinnamon Although neuroprotective agents have been treating acute ischemic stroke for more than 30 years, the clinical results accumulated over the years are disappointing With the domestic neuroprotective agent as a key monitoring drug to control, the future of China's neuroprotective agent market will decline , if drugs can be developed that are better than those that have been put on the market for the treatment of acute ischemic stroke, the area is limited in treatable drugs and is very likely to become a bombshell.