The mainstream of new anti-tumor drugs - the current situation of targeted drug development and future market forecast

the | According to the 2018 National Cancer Report, malignant tumors (cancers) have become one of the major public health problems that seriously threaten the health of Chinese groups, according to the latest statistics, malignant tumor deaths account for 23.91% of all deaths among residents, and morbidity mortality of malignant tumors has been on the rise for more than a decade.
, targeted drugs to open a new era of tumor therapy target drug specificity is high, toxic side effects are small, for a variety of malignant tumors have significant efficacy, in the past decade has become the mainstream of new anti-tumor drugs.
In 1997, the FDA approved the first targeted tumor drug: lysiocytant, which ushered in a new era of tumor therapy; The proportion of targeted drugs approved by the FDA increased year by year between May 2017 and 2017, with 12 of the 14 anti-tumor drugs approved in 2015 and all approved in 2016 and 2017.
Figure 1 Number and type of cancer treatment drugs approved by the FDA for 1997-2017 Source: FDA, Firestone Creation and Finishing II, Targeting Drugs are drugs that are given Targeting capabilities or their preparations are the product of the fusion development of biotechnology and information technology. the rapid progress of
pharmacology, molecular biology and bioinsynatics has promoted the Human Genome Project, and the rapid development of functional genomes in the post-genome era has strongly promoted the development of target evidence and structural biology, as well as the design of precision drugs based on the target 3D structure.
November 1997, Lytoxi monoantigen (anti-CD20 monoclonal antibody) was the first monoclonal antibody targeted drug approved for the treatment of tumors.
October 2001, methyl sulfonate imatinib (tyrosine kinase inhibitor) became the first small molecularly targeted drug approved for the treatment of tumors.
targeted drugs can act on specific lesions, reducing damage to normal tissues and cells, mainly used in cancer treatment.
Is different from the traditional chemotherapy, radiotherapy carpet bombing, the target is not clear, tumor cells and normal human cells are defeated, targeted treatment is like a precision-guided cruise missile, targeted, can accurately hit the cancerous site.
This drug is given the ability to target specific lesions, accumulate or release active ingredients at the target site, form a relatively high concentration in the target area, improve the ability of the drug at the same time inhibit toxic side effects, reduce damage to normal tissues, cells.
According to different targeting therology can be divided into passive targeting, active targeting, physical targeting three categories, according to different target levels can be divided into tissue organ level, cell level and subcellular level three categories.
Figure 2 Target Drug Classification Photo Source: Firestone Creation III, Targeting Drugs Drive the Global Anti-Tumor Drug Market to Grow at a High Rate The Global Anti-Cancer Drug Market is large in size, and its growth rate is much higher than the average in the pharmaceutical industry market.
2017, the global cost of cancer treatment and ancillary treatment reached $133 billion, up about 12.5 percent year-on-year, according to Global Cancer Trends 2018.
the United States, Japan and five European countries (Germany, Britain, France, Italy, Spain) account for 74% of global cancer treatment costs, of which the United States accounted for 46%, cancer treatment costs and ancillary treatment costs total about $61 billion.
the global market for cancer drugs is expected to grow to $180-200 billion over the next five years as the quality of care in developing countries increases.
Figure 3 Global Cancer Treatment and Complementary Treatment Cost Data Source: Global Oncology Trends 2018 Targeted Drugs have significant efficacy in treating tumors due to their small toxic side effects and high specificity, and have been hailed by the medical community as the most promising cancer drugs, which have become the mainstream of new anti-tumor drugs in recent years.
in terms of the types of anti-cancer drugs, targeted drugs account for half of the total.
Statistics show that between 1997 and 2017, the FDA (U.S. Food and Drug Administration) approved 141 anti-tumor drugs (excluding ancillary drugs), including 35 biological products (including 2 ADCs), 106 chemicals, 50 conventional chemotherapy drugs, and 56 molecular targeted drugs (52.8 percent of anti-tumor chemicals).
4 Data on the classification of cancer drugs approved by the FDA in 1997-2017 Source: The National Drug Administration's top 10 anti-tumor drugs in the world in 2017 are all targeted, of which 6 large molecules are targeted at anti-tumor drugs (mono-anti-tumor drugs) Cytokines), 4 small molecules targeted anti-tumor drugs, the total sales of the top ten drugs in 2017 totaled $54.09 billion, an increase of 33.4% over the previous year, accounting for 47.9% of the global anti-tumor market share in 2017.
2017, global TOP10 oncology drugs achieved total sales of $52,252 million, of which 9 targeted drugs achieved sales of $47.718 billion, accounting for 91.32 percent of sales.
small-molecule drug lysamine has maintained rapid growth over the past few years, surpassing lysoxi monoantigen as the number one anti-tumor drug in sales in 2017; Qutoju single resistance occupies 2-4 positions; representatives of immunotherapy, PD-1 monoantitor of BMS listed in 2014, and Pam single resistance of Mercadon ranked 5th and 8th respectively.
the future, with the expiration of the lyxi monoantigen, beva bead monoantigen patent, the two drugs will have a high probability of exiting the list.
PD-1 monoantidrnamic narcissist, Pym monoantigen and CDK inhibitor Pabosini will hopefully carry the banner of the tumor drug market and become the new representative variety.
table 1 2017 global TOP10 oncology drugs (units: US$100 million) Source: State Drug Administration IV, China's targeted drug treatment started late, the future growth space is broad China is a large country with cancer incidence, the number of cases continues to rise year by year, And cancer is the largest cause of death among chinese residents, in 2017, the proportion of urban residents who died of malignant tumors in China was 26%, which is the largest cause of death;
Based on this, China's cancer treatment market continues to expand, according to public data show that in 2017 China's cancer drug market size of 126.8 billion yuan, an increase of 14.27% over the previous year, the future cancer drug market is expected to grow at a compound annual rate of 12.30%, in 2022 China's cancer drug market size will reach 226.461 billion yuan.
Figure 5 Proportion of major causes of death among residents in 2017 (outer circle: rural, inner circle: city) Data Source: Ping An Securities Figure 6 China's anti-tumor drug market size data source 2010-2022: Ping An Securities in 2005 developed by AstraZeneone became the first targeted drug to enter the Chinese market.
approved in 2011 by Ektini, developed by Beda Pharmaceuticals, to become the first small molecule in China to target cancer drugs with its own intellectual property rights.
2018 by Hutchison Whampoa Pharmaceuticals independently developed the market, becoming China's first from research and development to the new drug market applications are completed in the domestic mainstream anti-cancer new drugs.
target pharmaceutical enterprises represented by Beida Pharmaceuticals, Hengrui Pharmaceuticals, Zhengda Tianqing, etc. are concentrated in Jiangsu, Shanghai and other places.
target drug development mainly relies on the southeast coast of large-scale pharmaceutical enterprises.
by the end of 2017, CFDA had approved 160 anti-tumor drugs (excluding ancillary drugs), of which 120 were chemicals and 40 were biological products;
only one-third of the more than 90 FDA-approved targeted drugs are available in China, and there are still few new anti-tumor drugs available to cancer patients in China.
But with the speed of registration approval and the implementation of a series of policies to encourage the domestic listing of imported anti-cancer drugs, the pace of approval accelerated significantly in 2018, with the new approval of nine targeted anti-cancer drugs.
In the last two years, innovative targeted anti-tumor drugs have been included in the CDE "priority approval" list, in the third quarter of 2015-2018 alone, there were 117 declared CDE production or clinical (including original research drugs and generic drugs), in the next few years, China will have a large number of targeted drugs on the market. table
2 China's tumor-targeted drug innovation original research drug information source: Firestone creation according to public information finishing five, targeted drug future market forecast 1. Tumor-targeted drugs are global research and development hot spot IMS Health report shows that the global cancer drug market from 83.2 billion U.S. dollars in 2015 to 143.5 billion U.S. dollars in 2019, a compound annual growth rate of 14.6%, accounting for 7.5% and 10.8% of the global pharmaceutical market, respectively.
predicts that the global cancer drug market will exceed $150 billion by 2020, up nearly 50 percent from $83.2 billion in 2015.
The current global cancer drug market is 100 billion U.S. dollars, of which anti-tumor targeted drugs accounted for nearly 50%, 2011-2015 compound growth rate of 18%, significantly higher than hormone-type oncology drugs (5-year compound growth rate of 6%) and cell-toxic oncology drugs (5-year compound growth rate of 3%).
68 new anti-tumor drugs were approved for market in 2011-2016, with targeted drugs accounting for more than 80%.
A total of 631 research projects on follow-up oncology drugs in the research pipeline in 2016 were in Clinical Phase II/III, of which nearly 90% were targeted drugs, and the proportion of targeted biologic drugs increased from 21% in 2006 to 43% in 2016, which is expected to become the main force of future cancer drugs.
2015, nine of the world's TOP10 best-selling cancer drugs were targeted drugs, with a total sales of $42 billion, and the proportion of targeted drugs is expected to continue to climb in the future as follow-up targeted drugs are approved.
Figure 9 Global Cancer Drug Market Forecast 2010-2020 (US$100 million) Data Source: Firestone Creation Collates 2. Keep up with Hot Spots and Catch Up: The fast-growing market for domestic targeted anti-cancer drugs has prompted more and more domestic listed pharmaceutical companies to join the research and development of innovative anti-tumor drugs.
A-share listed companies, Hengrui Pharmaceuticals, Fosun Pharma, Lizhu Group, Beda Pharmaceuticals and other enterprises in the field of cancer layout.
despite entering the research and development relatively late, but closely follow the hot spot, focus on the field of targeted anti-tumor drugs, that is, targeting small molecules and monoantial, fusion protein and other biological products.
present, CFDA has approved 8 domestic 1 class 1 targeted anti-cancer drugs on the market, of which 6 are targeted small molecules anti-cancer drugs, 2 are bio-polymer drugs, most of which have achieved remarkable sales results.
approval time is reduced.
has long taken a long time to review new drugs in China, taking an average of 63 months from clinical application to market, well ahead of the average 10 months of approval for new drugs in the United States.
Since 2015, in order to speed up the review and approval, to meet the needs of clinical drug use, on the basis of the original drug registration special approval channel, and gradually establish a priority review and approval system, has not been listed in China and abroad innovative drugs, not listed in China, included in major new drugs, AIDS and other major diseases of new drugs into the priority review channel to encourage the development of innovative drugs to meet clinical needs.
health care policy support.
2019, a new edition of the National Health Insurance Drug Catalog was released, focusing on supporting innovative drugs, drugs for major diseases (such as cancer, diabetes, cardiovascular diseases, etc.), children's medicines, etc.
97 negotiating drugs were all included in the health insurance list of Class B drugs, with an average price reduction of 60%, involving more than 10 clinical treatment areas such as tumors, rare diseases, chronic diseases and children's medicines.
policy is good for cancer drug research and development and market expansion, the future policy on cancer drugs will continue, or related to supporting approval, market access, medical insurance reimbursement and other aspects.
has great potential for leading domestic enterprises.
the domestic and foreign cancer targeted drug market generation difference is obvious, the anti-tumor target drug field competition is low, the domestic leading enterprises have great potential.
Domestic new drug approval efficiency and Europe and the United States gap is large, there are currently 19 anti-tumor targeted small molecules (of which 3 are Chinese original research products) and 6 anti-tumor monoantigens (2 are original research products) listed in China, of which nearly 60% are overseas-listed varieties before 2010, nearly 85% of the market share occupied by foreign enterprises.
targeted drugs in the high-risk cancer layout will be the core of future corporate competition.
At present, the domestic treatment of small molecule target drugs for lung cancer is mainly the first substitute for nipple drugs, the treatment of breast cancer, liver cancer, stomach cancer of small molecule targeting drugs only Rapatini, Solafini and Apatini, and for colorectal cancer indications there is no small molecule targeting drugs, of which only Apatini is a domestic enterprise original research products.
The domestic single-resistance field is in the import phase, the market share is mostly occupied by Roche, domestic enterprises only Chengdu Huasseng's treatment of liver cancer iodine .
for tumor immunotherapy PD-1/PD-L1 monoantigen and ADC drugs, there are currently no products on the market in China.
china's oncology drug market is still mainstreamed on cytotoxyte drugs.
The United States and other developed countries market targeted drugs accounted for nearly 75%, but the domestic cancer drug market is still anti-metabolic drugs, plant drugs and alkanes as the representative of the cytotoxic drugs mainstream (nearly 50%), and may continue to dominate for some time to come.
First, the number of traditional tumor drugs, a broad anti-tumor spectrum, still more for the first-line anti-tumor treatment options preferred;
7 of the top 10 varieties of cancer drugs sold in sample hospitals in 2016 were cytotox drugs.
proportion of targeted drugs in China's tumor market will increase year by year.
the domestic cancer drug market is undergoing product upgrading, since 2005 the proportion of sales of traditional plant drugs and alkanes decreased year by year, targeting small molecules from 2.0% in 2005 to 8.9% in 2016, monoantigen from 3 in 2005