core point
Innovative drug policy: From the “14th Five-Year” development plan to industry norms, intellectual property rights, drug guidelines, etc., the main theme of developing the bio-economy and promoting bio-pharmaceutical innovation has remained unchanged. On June 20, 2022, the “Single-arm Clinical Trials The Draft for Comments on the Applicability of the Technical Guiding Principles for Supporting the Marketing Application of Antineoplastic Drugs also shows the state’s supportive attitude towards innovative drugs.
Drug conjugates: There are various types of drug conjugates, such as ADC, SMDC, PDC, ISAC, etc. Among them, the development of ADC is relatively mature. ADC has both high target specificity and potent lethality, and has undergone three generations of evolution and iteration. As of the reporting date, there are a total of 471 ADC clinical development projects in the world, and the top four targets of ADC drugs under research in the world are HER2, EGFR, TROP2 and CLDN18.2. Combing solid tumor ADCs: Among solid tumor ADCs, the more common targets include HER2, EGFR, TROP2, CLDN18.2, Nectin-4, c-MET, etc. The existing therapies for HER2 are mainly ADC and monoclonal antibody, and dual antibody/ Most of the three antibodies are in the clinical stage. Among the existing EGFR therapies, TKIs are relatively mature, and there is a broad space for ADCs. The existing therapy for Trop2 is ADC, and there are few other therapies. There is no mature therapy for CLDN18.2 currently on the market, and monoclonal antibody, double antibody, ADC, CAR-T, etc. are all in the research and development stage. Nectin-4 has launched an ADC worldwide, which is ahead of PDC, CART, monoclonal antibody and other therapies. Met inhibitors are more common in the existing C-MET therapy, and the highest development stage of ADC in the world is Phase III.
Hematological tumor ADC combing: Among the hematological tumor targets, the more common targets include CD19, CD20, CD22, CD33, CD30, BCMA, and CD79b. Among the research projects, CD20 has the largest number, followed by CD19.
Five elements of ADC design: mainly include target, antibody, linker, cytotoxin, and coupling method. Among them, the mainstream antibody is IgG1. At present, the most concerned linker is the enzyme cleavage linker, and the payload is a tubulin inhibitor. and DNA-damaging agents, the development of site-directed conjugation technology has better controlled DAR.
Summary of viewpoints: The pharmaceutical industry research and development is hot and steady, and the current innovation and progress of domestic medical diagnosis and treatment urgently needs the implementation of a new generation of drugs. In the domestic ADC field, from the launch of HER2 drugs by a few companies to the launch of foreign/existing foreign + domestic HER2 and Trop2 ADCs one after another this year, we believe that the change in medication for tumor treatment will set off a phenomenal wave.
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