At present, the research and development of anti-tumor drugs in China is in a rapid development stage, and the expectations for drug safety, treatment experience and quality of life are higher. The strength of domestic drug research and development has been enhanced, and local pharmaceutical companies have successively laid out global hot tumor targets. In 2022, the research and development of hot tumor targets will definitely be held in by going up one flight of stairs.
Rong Yun has integrated the whole database, combing the acceptance of domestic 1 new drug applications, the targets involved and the latest research and development progress during the period of 20 16-202 1. And classify them, sort out the history of hot targets, the statistics of target distribution of new drugs in the main treatment fields in recent 6 years, and the latest research and development progress of the five hot targets in the world; Based on the global and China innovative drug targets above IND, the most potential "China New" target and popular target top30 in tumor field are sorted out. ......
Finally, the above contents are organized into "China? White paper on the target of the first kind of new drugs.
Analysis of competition pattern in tumor field
The tumor trajectory is "involuted" seriously, and the research and development of new drugs is "wasted".
Looking back from 20 16 to 202 1 year, the number of targets involved in the domestic tumor field and the amount of new drugs accepted ranked first; In the acceptance of new drugs, tumor target accounts for 44%, and tumor field accounts for 62% of drugs. It is not difficult to see that the homogenization of popular targets in China is serious at present, mainly in the field of cancer. The indications of clinical trials of biological drugs and chemical drugs are mainly anti-tumor. Some insiders have analyzed that the phenomenon of "homogenization" will cause some waste of clinical resources. When choosing diseases and targets, it is like choosing a track, choosing the right diseases and targets, and the speed of research and development.
China 1 New Drug Targets White Paper by Rong Yun.
Hot spots in the field of cancer are clustered together, and homogenization competition is serious.
According to Rong Yun's "China 1 White Paper on New Drug Targets", from 20 16 to 202 1 year, the target data of the top 30 domestic new drugs in China's tumor field was crowded and the homogenization competition was serious.
Since 20 16-202 1, PD- 1 has been the most marketed drug. The number of PD-L 1 is the largest before clinical practice, and only two new drugs of 202 1 have passed the marketing application. Among the 30 most popular targets in the field of cancer, more than half of domestic new drugs have not yet been listed.
In the field of tumor, EGFR, PD-L 1, PD- 1, VEGFR, HER2, CD 19, FGFR and so on involve a large number of new drugs.
China 1 New Drug Targets White Paper by Rong Yun.
EGFR: At present, EGFR is the most popular tumor target. Lung cancer has long occupied the 1 th place in the incidence and mortality of malignant tumors in China, ranking first among the "big cancers" in China. Non-small cell lung cancer (NSCLC) accounts for 80%~85% of the total lung cancer, while the total mutation rate of EGFR in patients with NSCLC in China is about 50%. According to the Rong Yun database of drugs, there are 348 kinds of drugs under research in the world, which are seriously homogenized. There are many factors to consider when choosing the target, one of which is the competition of research and development, and the homogenization factor should be avoided.
PD-(L) 1: The domestic track is crowded, which is one of the most "involuted" objects in the medical circle. According to the database of Rong Yun, 20 18 was approved to be listed in China, and now it has been approved as 12 PD-(L) 1 inhibitor, with 44 indications in China. The number of clinical trials in the world reached 347 1, of which 675 were registered in China (CDE), accounting for 9.5% of the global total. Moreover, in the national medical insurance negotiations, the price has been greatly reduced and included in the medical insurance catalogue, and the competitive pressure is increasing, and domestic enterprises have adjusted their strategies.
VEGFR: Most small molecule inhibitors VEGFR:VEGFR is a multi-target inhibitor with a wide range of indications, including gastric cancer, liver cancer, renal cell carcinoma and so on. VEGFR small molecule inhibitors have a wide range of indications, and it has an important influence on the promotion of sales by choosing suitable fields. For example, the first indication of erlotinib is third-line non-small cell lung cancer, which was almost a blank market before, and the drug sales increased rapidly.
HER2: From the market results, it is more economical to develop drugs for breast cancer with HER2 positive and low incidence than for breast cancer with HR positive and high incidence. This is why many top pharmaceutical companies have invested in research and development in the field of rare diseases:
Relatively speaking, it is more difficult to get effective drugs for rarer diseases, and patients are willing to pay more.
This is a secret that the pharmaceutical industry is not convenient to tell. Once a drug becomes a "generic drug" after the patent protection period, large multinational pharmaceutical companies often choose to give up and invest heavily in research and development to update more top-notch drugs in order to seek greater market benefits.
CD 19: Monoclonal antibodies, monoclonal antibodies, ADC and CAR-T drugs against CD 19 have been listed one after another, providing various treatment schemes for patients with advanced B-cell lymphoma. However, behind the lively R&D, there are also views that the R&D of CD 19 is too crowded, whether there is a bubble behind the fiery track, and the homogenization of R&D is worth pondering.
FGFR: Whether it is a pan-FGFR inhibitor or an accurate subtype of FGFR highly selective inhibitor, it has its clinical value and market prospect. Multi-target inhibitors and pan-FGFR inhibitors have achieved good results in clinical research and are still important choices for disease treatment. However, in view of the current adverse drug events, constantly improving drug safety, overcoming drug resistance and improving clinical benefits are also the driving force for the continuous progress of drug research. We look forward to the further breakthrough of FGFR subtype selector in clinic and provide better treatment experience for patients.
"involution", "cluster" and "red sea" ... these words have been repeatedly mentioned in the mouths of innovative drug players in China in the past 202 1 year. Whether EGFR, PD-L 1, PD- 1, VEGFR, HER2, etc. Familiar targets are being confirmed.
The promulgation of medical policy has brought about real innovation.
The Drug Trial Center of the State Administration of Pharmaceutical Products has publicly solicited opinions on the Guiding Principles of Clinical Research and Development of Antitumor Drugs Oriented by Clinical Value, which has been formally promulgated and implemented. Among them, in the research and development of anti-tumor drugs, we should pay attention to and constantly improve the matching degree between patients and therapeutic drugs, and constantly improve the accuracy of anti-tumor treatment so that tumor patients can receive more suitable therapeutic drugs. We have also made some adjustments in our policies, advocating that everyone should be guided by clinical value and really solve clinical problems, so as to make effective research.
When these policies come out, they pose a challenge to the current domestic "involution" serious R&D situation, and are also regarded as a powerful squeeze on the clustered R&D "bubble". At present, the innovative drug research and development of cancer drugs in China is in a rapid development stage, and there is a higher expectation for drug safety, treatment experience and quality of life. Innovative drugs in the future put forward higher requirements for my too/Meo better. Only truly original and innovative drugs or drugs with better therapeutic effects can win the favor of the market. With the current medical reform, only the real me is better, not worse, will it promote the market and even enter the national medical insurance.
Combined with tumor hot spot target and medical policy, the situation of tumor field in 2022 is predicted.
1, scientific and technological progress accelerates the pace of innovation: scientific and technological progress promotes significant progress in key areas of tumor drugs, such as tumor immunotherapy and targeted therapy. The combined application of two or more drugs is one of the important trends in cancer drug research and development. According to industry data, only 2% of cancer patients received combination therapy in 2000, while the proportion of patients receiving combination therapy in 20 18 was 44%. Another research and development trend of tumor therapy is cell gene therapy (CGT). There are more than 300 clinical trials of CAR-T therapy in the world, and the clinical trials of gene therapy are also increasing. With the increase in the number of approvals, these new therapies will fundamentally change the treatment mode of many cancers.
2. Policy-oriented to improve drug quality: The opinion of Guiding Principles for Clinical Research and Development of Anti-tumor Drugs Oriented by Clinical Value was officially promulgated and implemented, which raised higher expectations for drug safety, effectiveness, treatment experience and quality of life, and prompted innovative drugs to put forward higher requirements for future Me too/Meo. Only drugs that are truly innovative from the source or have more therapeutic effects can win the favor of the market.
3. Seeking breakthroughs in hot targets: The gap between domestic research and development of new cancer drugs and foreign clinics is narrowing further, but problems such as target aggregation, concentrated indications, "surplus" and "shortage" still exist. From the perspective of clinical R&D and evaluation, innovation and R&D oriented by clinical value is always a core issue.
The domestic cancer market has a large base. With the improvement of living standards and ability to pay, people have higher requirements for new drugs that can improve their quality of life and have definite curative effects. However, the homogenization competition in the field of tumor targets is serious, and drugs can be developed for some potential targets. Combined with Rong Yun database, we can accurately, efficiently and quickly grasp the new targets, the proportion of different stages of global drug research and development, applications, patents, prescription technology, raw material consumption, market information and other information. , and inquire about the main fields, markets, patents, raw materials and other information developed for these targets, and then select potential targets for further research through epidemiological data and strategic adaptability with the company itself.