The success rate of new drug research and development is only 8%

In five years, both China and the United States have doubled the cost of cancer treatment and drugs, ushering in a great leap forward At the same time, the number of new tumor drugs launched in 2018 has reached a record of 15, and the global tumor market is developing rapidly In China, through the negotiation of medical insurance, many tumor drugs have been included in the medical insurance, and many innovative drugs have been put on the market at an accelerated speed In the coming round of medical insurance negotiation, many pharmaceutical companies are calling for innovative drugs to enter the medical insurance, but in the game of quantity and price, some experts call for rational treatment In 2018, the number of new cancer drugs launched globally reached a record 15, and the global cancer treatment expenditure increased by 12.9% The world of cancer drugs saw a double-digit growth in 2018 Iqvia recently released the global cancer trend report 2019, which disclosed the above data 1 Leader in spending and growth: China's above-mentioned report points out that spending on cancer treatment reached nearly US $150 billion in 2018, up 12.9% year-on-year, achieving double-digit growth for five consecutive years China, on the other hand, leads in spending and growth, growing 24% in 2018 to $9 billion in total spending, despite a 10% decline in supportive care in China Iqvia predicts that the growth rate of treatment expenditure will reach 11% - 14% in the next five years, and the compound annual growth rate will bring the total market to US $20-23 billion In the past five years, China's cancer spending has more than doubled, mainly due to the increased use of existing brand drugs, while the contribution of new drugs is less In terms of per capita expenditure, China's per capita expenditure is only $4.5 per person, compared with $173 per person in the United States From a global perspective, the expenditure of anti-cancer drugs is highly concentrated, with the top 38 drugs accounting for 80% of the total expenditure In fact, the annual sales of more than half of the anti-cancer drugs are less than $143.6 million In terms of drug quantity and indications, in the past five years, 57 new tumor treatment drugs have been approved for a total of 89 indications, some of which treat multiple tumor types In the past five years, almost one-third of the approved indications have been hematological cancer, with 28 indications approved Among the solid tumors, lung cancer has the most, reaching 12, followed by breast cancer and melanoma, with 7 and 6 indications respectively, while other solid tumors mostly have 1-3 indications In addition, the global market launched a record number of new cancer drugs in 2018, bringing new treatment options to patients, and continues to change the treatment model generated by the introduction of immunotherapy less than five years ago In 2018, larotrecinib was approved to treat solid tumor patients carrying ntrk gene fusion, which is the first targeted treatment "unlimited cancer species" when approved 2 The steady growth of oncology R & D pipeline due to the increasing number of targeted therapies in the tumor pipeline, the number of drug pipelines in the late stage of R & D increased from 711 in 2017 to 849 in 2018, an increase of 19%, while compared with 2008, it increased by 77% In the late 2018 pipeline, 91% of treatments are targeted at small molecules or biological agents Targeted Biopharmaceutics increased by 30% over 2017, while targeted small molecule therapies increased by 14% In the later research and development of oncology, emerging biomedical companies play the only leading role At present, there are more than 700 companies in post oncology research and development in the world, including 29 academic research institutions, 626 emerging biomedical companies, 28 large pharmaceutical companies with global sales of more than 5 billion US dollars and 28 medium-sized companies At present, there are about 450 cancer immunotherapies in different stages of clinical research and development, and these therapies have more than 60 mechanisms of action There are 9 mechanisms of action in the 3-phase clinical phase of in-situ therapy, and 62 different mechanisms in the early research and development pipeline In 2018, 43 cancer types were treated by cancer immunotherapy in the R & D pipeline, of which 52 different mechanisms were involved in the research of 25 cancer types PD-1 / PD-L1 inhibitor types are used to treat 14 different cancer types, including blood cancer and solid tumor Nearly half of the 25 major types of cancer are blood cancer Among them, the in-depth treatment of acute myeloid leukemia (AML) includes 12 different types of new generation mechanisms, such as Indo inhibitors, OX40 receptor agonists and CD33 regulators Due to the increasing attention and investment in new approaches to treatment, there are nearly 100 next-generation biotherapeutics including gene therapy, cell therapy and nucleotide therapy in the R & D pipeline in late 2018, nearly doubling compared with 2013 and 32% higher than 2017 According to the report, PD-1 / PD-L1 checkpoint inhibitors are still the most successful immunotumor treatment methods, and the improvement of formula (such as oral) or immunotherapy combination and targeted treatment (such as TKIs) as well as the next generation of biotherapy drugs may promote the breakthrough of tumor treatment 3 The success rate of new drugs dropped to 1170 oncology clinical trials launched in 2018, an increase of 27% compared with 2017 The number of phase 1 clinical trials has increased significantly in the past three years, up 46% compared with 2015 The number of phase 2 and phase 3 clinical trials has increased steadily since 2013 Compared with 2013, the number of phase 2 clinical trials has increased by 100% and that of phase 3 clinical trials by 83% However, it is worth noting that the success rate of the development of new oncology drugs is still limited Although 15 oncology NASS were listed in 2018, the success rate of phase 1 clinical trials and phase 3 clinical trials has declined The success rate of new drug development is only 8%, down from 2017 It is still a slow process to develop new anticancer drugs In 2018, it will take an average of 10.5 years for new drugs to be developed from the initial patent application to the approval of new drugs for marketing This number is four years less than in 2017 and one year less than the average since 2007 The average duration of oncology trials in 2018 was 3.2 years at all trial stages, compared with 1.8 years for all other treatment areas, a difference of more than 40% Oncology therapy benefits from special qualification provided by regulatory agencies For example, an effective drug identified as breakthrough therapy can be approved after completing phase 1 or phase 2 clinical trials In 2018, the R & D time for the drugs recognized as breakthrough therapy was 10.1 years In terms of the accessibility of anti-cancer therapy, iqvia's research found that only patients from the United States, Germany, the United Kingdom, France, Italy, Canada and other nine countries can obtain the global anti-cancer drugs that have been listed recently 4 Medical insurance may be a double-edged sword report shows that the average annual expenditure of new drugs continues to rise In 2018, the expenditure of each drug is between $90000 and $300000, and the average expenditure of new drugs is $176000, lower than $209000 in 2017, but higher than the average expenditure of $143000 in 2012-2018 Cancer drug spending in the United States has doubled since 2013, spending more than $56 billion in 2018, with $9 billion in growth from the use of PD-1 / PD-L1 inhibitors In the past five years, China's spending on cancer treatment has also doubled However, this large amount of expenditure and the promotion of innovative medicine and health insurance by enterprises have attracted concerns "It's not good for pharmaceutical companies to advocate too much for cancer drugs to be covered by medical insurance." At a seminar on pharmaceutical policy held in Beijing in April, an expert from the development research center of the State Council warned the representatives of pharmaceutical companies present The expert believes that after too many high-priced tumor drugs enter the medical insurance, drug companies may face a stronger price reduction If the medical insurance eventually leads to the increase of drugs and the decrease of reimbursement ratio, "all parties" may not achieve anything " According to e drug managers, at present, innovative drugs in China are active in inclusion in medical insurance, many of the PD-1 listed are striving to enter the medical insurance catalog, and even some insiders say that domestic PD-1 will be able to enter the catalog through the medical insurance negotiation in 2019 Some foreign companies also said that more than 5 products will be considered to be included in medical insurance or ready to participate in negotiations this year In local health care, this positive attitude is more obvious At the end of 2018, Merck's PD-1 McAb coreda was included in the supplementary catalogue of medical insurance for serious and serious diseases in Shenzhen In the last month, Junshi biological trepril MAb (melanoma indication) and moshadong coreida (non-small cell lung cancer indication) were included in the drug catalog of cancer self financing drug project (the third batch) of Zhuhai supplementary medical insurance Eligible participants can enjoy the treatment of cancer self financing drug project Last year, 17 anti-cancer drugs were included in the medical insurance through negotiation, and 10 of them were all listed after 2017 However, there are comments that the pharmaceutical companies involved in the negotiation seem to have unspeakable "grievances" The lowest decline rate of 17 new anti-cancer drugs included in the medical insurance reached 31%, and the biggest one reached 80% Although in the negotiation, representatives of pharmaceutical enterprises have said that "maximize the social benefits of the negotiation results, so that the majority of the insured actually enjoy the dividend of medical insurance reform" But whether "price for volume" can bring the growth of volume sales or not, pharmaceutical companies still face different possibilities for some drugs that enter the Chinese market relatively short and are still in patent period The pressure of pharmaceutical companies is reflected in the game between R & D investment cost and "cost recovery" In addition, the will to control the cost of medical insurance has been shown in generic drugs If pharmaceutical companies call too much for high price innovative drugs to be included in the medical insurance, whether innovative drugs will also face the pressure of controlling the cost is intriguing.