gist
ADC drugs lead the second wave of innovative drugs in China. ADC drugs integrate the culmination of modern pharmaceutical industry, open up a new frontier for tumor treatment, and announce that the era of three-dimensional tumor immunity has come. ADC is composed of three parts: monoclonal antibody, linker and drug carrier. The monoclonal antibody specifically binds to the highly expressed target antigen on the surface of tumor cells, forms ADC-antigen complex, and then internalizes into tumor cells to release cytotoxic carrier. drugs to kill tumor cells. ADC drugs have both the high specificity of antibodies and the high anti-tumor activity of cytotoxics, and at the same time, their safety is more controllable due to their directional release characteristics. In addition, since the essence of ADC is the cross-combination of small molecule drugs and biological macromolecular drugs, this will cause the number of candidate drug molecules to increase exponentially, making this field full of huge imagination space. After 100 years of development, ADC has gradually entered a mature stage. 14 ADC drugs have been approved in the world. In 2021, the global sales will exceed 5 billion US dollars. The market will reach $20.7 billion. As one of the hot research directions in the field of tumor treatment, the global ADC-related transactions and financing continue to rise. Due to the complex pharmacokinetic characteristics, unavoidable side effects, aggregation, tumor targeting and payload release, immunogenicity and drug resistance of the current ADC research and development facing many unsolved challenges, both global and The development of ADCs in China has shown a trend of clustering of targets and indications.
Where should ADC drug development go in the post-DS-8201 era? The high drug loading, high toxicity, high homogeneity of DS-8201, the “bystander effect” caused by the cleavable linker, and the targeting of the pan-cancer HER2 target make it useful in the treatment of breast and gastric cancers. CUHK has been successful, and gratifying progress has also been made in the clinical research and development of other solid tumors such as non-small cell lung cancer and colorectal cancer. Therefore, since the launch of DS-8201, which is known for its extensive and excellent clinical efficacy, it has brought great pressure to the major ADC development pharmaceutical companies in the world. But when we look at DS-8201 critically, we will find that it is not perfect. The first is the safety risk. DS-8201 has been found to cause interstitial pneumonia in multiple indications, which is lethal and has been black boxed by the FDA. Warning; secondly, the price is unfriendly. According to Deep Blue View, the purchase of the drug in Hong Kong is 70,000-80,000 yuan per month, which discourages the vast majority of domestic patients. The defects of DS-8201 have made other pharmaceutical companies see the light of day. How to seize the innovation wave of the pan-coupling era in the post-DS-8201 era has become a major issue for global pharmaceutical companies to think about. We believe that the domestic innovation environment in terms of policies, capital, technology, and talents is no longer the same as the first wave of innovative drugs, and there are already some signs of competition with DS-8201. The road to differentiation. In terms of specific strategies, we believe that we can diversify targets (including conventional competitive targets, mutant protein targets, and dual targets), and diversify indications (including avoiding “crash” with DS-8201, front-line and back-line treatment Comprehensive flowering, accurate matching of the indication population), combination therapy (including anti-angiogenic agents, anti-antigen expression drugs, drugs with complementary or synthetic lethal effects with the drug load, drugs that promote the recruitment of activated immune effector cells such as anti-PD-1 monoclonal drugs Anti-), pan-coupling exploration and other perspectives.
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