Market investigation and analysis of 4 domestic cancer new drugs approved by FDA


Entering the year of 2022, a large number of new drugs are speeding up their clinical approval and marketing.Recently, a number of domestic cancer drugs came to the US FDA clinical approval of good news.1. Preclinical study results of ZG19018 tablets showed that ZG19018 tablets had significant pharmacodynamic effects on inhibiting the growth and cell proliferation of KRAS G12C mutated tumors, with long drug half-life, high oral bioavailability and pharmacokinetic characteristics, and high drug concentration in tumors and brain tissues.This product is expected to become an innovative drug for the treatment of KRAS G12C mutated tumors.2. HG030HG030 is a novel, potent and highly selective oral small-molecule inhibitor of troposin ii receptor kinase (Trk), which is clinically intended for first-line treatment of NTRK or ROS1 gene fusion tumors, as well as solid tumor patients with acquired mutations resistant to first-generation drugs.3. According to the disclosure, JAB-2485 is A highly selective small molecule Aurora A inhibitor, which can inhibit Aurora A activity, induce cell apoptosis and inhibit tumor growth at the cellular level.4. APS03118APS03118 mainly targets patients with non-small cell lung cancer, thyroid cancer, pancreatic cancer, breast cancer, ovarian cancer, colorectal cancer and other advanced solid tumors caused by RET gene alteration, as well as patients with resistance to first-generation selective RET inhibitors.Preclinical studies have shown that APS03118 shows significant inhibition of various RET fusion and mutated proteins at the nanomolar level compared to first-generation selective RET inhibitors currently on the market.APS03118 showed strong antitumor activity and good safety in mouse model, especially for goalkeeper V804M/L/E and solvent frontier G810R/S/C mutations leading to selective RET inhibitor resistance.In addition, in the brain tumor model, APS03118 can completely disappear the brain tumor, and all animals survived after treatment, indicating that APS03118 is a potential Best in class selective RET inhibitor for patients with brain metastases.In the drug development of various diseases, the research and development of anti-tumor drugs is the field with the largest investment and the fastest new drug launch.According to the report “2021-2026 China’s Anti-tumor Drug Industry Development Prospects and Investment Risk Forecast analysis report” by PWC Research Institute, analysis of anti-tumor drug market survey From the distribution of drug categories, China’s pharmaceutical market and the global pharmaceutical market has a great difference.In China, traditional Chinese medicine, anti-metabolites, plant alkaloids and other natural drugs are the main drugs, while targeted drugs share a small share.In China’s cancer drug market, these drugs with good efficacy of monoclonal antibodies and small molecule targeting drugs are mostly monopolized by imported drug companies, especially tumor targeting drugs, and there are few domestic companies.The oncology drug market continues to grow, driven by factors such as an aging population and a growing cancer population.From 2016 to 2020, the sales volume of anti-tumor drugs in China continued to rise from 86.362 billion yuan to 145.874 billion yuan, with a compound growth rate of 14.00%. It is one of the drug categories with rapid growth in China.Malignant tumor is a serious threat to human life in the world, and is one of the top killers of human health. The number of cancer patients in China ranks the first in the world, and the morbidity and mortality have been rising in recent years.The National Cancer Center released the latest edition of national cancer statistics, reporting that on average, more than 10,000 people are diagnosed with cancer every day, and seven people are diagnosed with cancer every minute.With the accelerated development and marketing of new antibody drugs, the continuous expansion of indications, the continuous improvement of domestic demand and affordability, and the continuous expansion of medical insurance coverage, the domestic immunotherapy market is stimulating the demand of over 100 billion dollars, and the global tumor immunotherapy market scale is over 100 billion dollars.The global oncology drug market is expected to continue to grow and reach us $244.4 billion by 2024, with a CAGR of 11.2% from 2019 to 2024.To reach 391.3 billion US dollars by 2030, with a cagR of 8.2% from 2024 to 2030.Fosun Pharma and Insilicon Intelligence announced a collaboration to use artificial intelligence to drive drug r&d cooperation for four designated targets provided by Fosun Pharma.Under the agreement, Insilicon Intelligence will be responsible for nominating preclinical drug candidates for the QPCTL program and advancing the candidates to the preclinical phase, after which Fosun Pharma will conduct clinical phase studies and jointly promote the development of the program worldwide.Current AI companies may have an early advantage, with relatively sufficient data collection and well-proven platforms.Or have unique advantages, differentiation strategy, focus on deep cultivation in a specific field.In the future, the accuracy and capability of the AI platform can be further optimized and improved, and the end-to-end AI platform for drug development can be improved according to the demand, such as the construction of new AI platforms such as accelerated drug metabolism stability prediction, kinase selectivity prediction, and compound inverse synthesis route design.What are the prospects for 2022?For more detailed industry analysis, please click on the Development Prospect and Investment Risk Forecast Analysis Report of China’s Antineoplastic Drug Industry (2021-2026) published by PriceWaterhousecoopers Research Institute.

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