Oncology Drug Development Brings Momentum to the Development of Humanized Mouse Drug Evaluation Model

For companies and researchers, clinical research requires high costs. Once the trial fails, it not only faces the stranding of drug research, but also loses a lot of money. For cancer patients, the clinical trials of taking some new drugs are often their last hope. If the test fails, it will bring a huge blow to patients and their families.

Promissing preclinical research challenges

The problems faced by major new drug research and development institutions include the clinical efficacy of new drugs, the risk of time cost and the benefits. In modern drug development, from preclinical research to clinical research, and then to CFDA/FDA approval, the time is long, the cost is huge, and the probability of failure is quite high. Everything in the new drug development process always needs to face difficulties, and every link is crucial.

The R&D process requires many steps, such as drug design and screening, chemical synthesis and transformation, pharmaceutics and pharmacokinetic studies, processes and preparations, quality testing and control, safety and clinical evaluation, market feedback, and so on.

According to the different content of the work, the research and development of new drugs can be divided into four stages: discovery and screening, preclinical research, clinical research, new drug declaration and follow-up work. First, discovery and screening include basic and applied research (including drug preparation and primary screening) to identify and screen drug sources. Subsequent clinical studies include Phase I (Preliminary Clinical Pharmacology, Human Safety Studies), Phase II (Preliminary Evaluation of Treatment, Safety Studies), Phase III Clinical Trials and Preparations (Expanded Clinical Trials, Special Clinical Trials) , supplement clinical trials, adverse reactions observed). The final declaration and follow-up of new drugs includes new drug declarations and additional work required by the CFDA (National Food and Drug Administration) to review new drug declarations.

For companies and researchers, clinical research requires high costs. Once the trial fails, it not only faces the stranding of drug research, but also loses a lot of money. For cancer patients, the clinical trials of participating in some new drugs are often theirs. After a glimmer of hope, if the test fails, it will bring even greater blows to patients and their families.

Preclinical research has become a challenge in drug development. Preclinical research refers to chemical synthesis or natural product purification studies, drug analysis studies, pharmacodynamics, pharmacokinetics, toxicology, and pharmaceuticals. Learning research. Every year, a large number of new drugs are eliminated in the phase I clinical process. After all, animal experiments and human experiments are very different.

Whether it is animal or human drugs, the research and development of drugs will follow the method of using animal models to study diseases, and the use of animal experiments to verify the safety and effectiveness of new drugs. What kind of drugs can enter clinical trials is a headache for many researchers. For tumor immunity (CAR-T/Checkpoint), because its mode of action is to mobilize autoimmune to kill, it has a different effect from the past drug-targeted drug killing. Therefore, there is a need for a model to simulate the immune environment in the human body in the preclinical stage. If you have a good pre-clinical evaluation system, you can provide very valuable and meaningful experimental data for reference, such as the use of humanized mice models for new drug evaluation.

A valuable tool - a humanized mouse model

Because of the significant differences between human physiology and animal physiology, experimental results obtained using animal models sometimes cannot be applied to the human body. The human derived xenograft (PDX) mouse model enables the assessment of the safety and efficacy of new human-related drugs in animals, simulating human clinical trials.

In view of the particularity of tumor immunotherapy, Edmo independently developed a mouse model-HSC mouse suitable for tumor immunotherapy evaluation. This model realizes the remodeling of the immune system in mice by transplanting human hematopoietic stem cells. On the basis of this, transplanting human tumor tissue and obtaining a tumor-immunized double-sourced mouse model can not only help pharmaceutical companies improve the drug clinical trial pass rate. To help patients find a suitable treatment plan, it also provides a powerful tool for pre-clinical evaluation of human immune system and cellular immunotherapy.

Dr. Peng Siying, CEO and founder of Beijing Aidemo Biotechnology Co., Ltd., said that humanized immune reconstituted mice can be a powerful tool for promoting the development of new drugs, effectively shortening the clinical trial cycle of new drugs, greatly reducing the cost and risk of clinical trials, and thus accelerating The birth of domestic innovative drugs and new therapies.

In 2011, the global anti-cancer drug market was about $83 billion. In the past five years, the global anti-cancer drug market has grown at a compound annual growth rate of 7.6%, which is significantly higher than the 4.3% average growth rate of the global drug market. China's anti-tumor drug market is about 80 billion yuan, with an average annual growth rate of about 20%. In 2012, anti-tumor and immune drugs exceeded the 16.46% market share with 18.2% market share, making it a large domestic prescription drug category.

The huge demand for new drug development has also brought a huge market for humanized mouse drug evaluation models. According to Amy's research data, 70 new drugs for treating more than 20 tumor diseases have been published in the past five years. At present, there are more than 586 kinds of tumors in research, which has increased by 63% in the past 10 years, of which 87% are targeted drugs.

Advances in science and technology have led to the development of medicine. In the face of disease patients, there are more choices, new oncology drugs continue to appear, and Emers data shows that there are more than 586 kinds of tumors in research, and the growth rate has increased by 63% in the past 10 years. Drugs accounted for 87%. The late stage of oncology therapy includes 270 biological therapies, including 16 gene therapies, 86 new monoclonal antibodies and 15 biomolecules of listed monoclonal antibodies; late development products also include 74 for multiple tumors.

China's industrial research network released the 2016-2022 China anti-cancer drug industry research analysis and development trend forecast report that China, India, Brazil and Russia "BRIC" will become the global fast-growing anti-cancer drug market. In China, due to the rapid increase in the incidence of cancer, the anti-tumor drug market has broad prospects for development. At the same time, due to the limitations of current drug efficacy, the new anti-cancer drug market needs to be vigorously developed, and anti-cancer drug development has become a major factor in the pharmaceutical industry. Popular.

The development of oncology drugs will also bring more impetus to the development of humanized mice antibody production evaluation models.