Wisdom News APP learned that CSC Securities has released a research report stating that the patient population of self-immune diseases and type II inflammation is rapidly growing. Although the market size is only second to that of cancer drugs, it is still in an accelerating development period. Existing drugs still have great room for improvement in efficacy and safety. In recent years, new drugs have emerged continuously, with endless new target points or new mechanisms of action. This team's research involves a large number of R&D pipelines for indications such as asthma, psoriasis, inflammatory bowel disease, and atopic dermatitis. Psoriasis, asthma, chronic obstructive pulmonary disease, and inflammatory bowel disease are difficult to treat and the market size of alopecia areata is rapidly developing.

This article mainly introduces self-immune diseases involving respiratory, skin, and intestinal tracts, and discusses the hot targets and drugs for treatment. This article detailedly introduces 11 diseases such as asthma, psoriasis, and atopic dermatitis, and also lists the pipeline progress of treatment drugs in detail and analyzes the competition pattern of key indications. It involves basic company information and specific in-pipeline data, as well as summarizing the catalyst events of the global key self-immune company pipeline this year. The relevant self-immune companies include Jiangsu Hengrui Pharmaceuticals, Innovent Bio, Akeso, Connoah, Zelgen Pharmaceuticals, Hutchmed (China), Remegen, Innocare, Zai Lab, Acepodia, Sunshine Guojian Pharmaceutical, CMS, Livzon Pharmaceutical Group Inc., Yifang Bio and Simcere Pharma.

China's self-immune market is mainly focused on psoriasis and ankylosing spondylitis, and is expected to reach 24.7 billion US dollars by 2030. Among self-immune diseases, the prevalence rate of psoriasis is the highest, reaching 2.7%, ankylosing spondylitis is close to rheumatoid arthritis, and the prevalence rate of ulcerative colitis and Crohn's disease is lower. Type II inflammatory diseases are mainly atopic dermatitis and asthma.

Biologics are gradually becoming a front-line treatment. Traditional drugs (such as glucocorticoids and calcineurin inhibitors) still occupy a mainstream position in self-immune treatment due to reasons such as price, onset time, efficacy, and administration method. Although various types of innovative drugs mainly serve as additional treatments for traditional drugs or substitutes for treatment failures, they are also constantly challenging more advanced treatment positions. For example, the Global Initiative for Asthma (GINA) recommends that patients with eosinophilic polyps should use biologics such as IgE antibodies, IL5 antibodies, IL4 antibodies, and TSLP antibodies; the 2023 China Psoriasis Diagnosis and Treatment Guidelines will list the aromatase Inhibitor Berdimonas Recommended for topical drugs; crystalline boron and lukotinib are also included in the front-line treatment plan for patients with mild-to-moderate atopic dermatitis in the US guidelines.

IL6, IL17, IL23, OX40 / OX40L, TL1A, JAK1/TYK2, and integrins (ITG) are new development targets. At the beginning of the 21st century, traditional self-immune targets represented by TNF-α and CD20 marked the beginning of biologic treatment of self-immune diseases. New targets such as IL12/23, IgE, and TSLP that emerged around 2010 further improved the treatment of self-immune diseases. In recent years, drugs with better efficacy such as IL17 antibodies, IL23p19 antibodies, new JAK1/TYK2 inhibitors with high safety, and integrin antibodies targeted at tissues have become hot areas of drug development.

Bispecific/multispecific antibodies are one of the future directions for asthma treatment. Among respiratory system diseases, asthma has the largest number of patients and the largest market share. IL13 antibodies such as mepolizumab, omalizumab, dupilumab, and TSLP antibodies such as tezepelumab have good therapeutic effects. The IL5 antibody mepolizumab has good efficacy in eosinophilic asthma. At present, one of the development directions of asthma biologics is to combine with TSLP bispecific/multispecific antibodies, which may include targets such as IL13 and IL4R.

IL17 and IL23 antibodies are effective in psoriasis, and PDE4 inhibitors cover more patients. IL-4/13 antibodies work better in atopic dermatitis. JAK inhibitors are effective for both diseases. In skin system diseases, atopic dermatitis and psoriasis occupy the main market position. Drugs targeting upstream targets such as IL17 and IL23 have played a good role in the treatment of psoriasis. Among them, IL17 antibodies work faster and have the same long-term effectiveness as IL23 antibodies, but there is a risk of weakening intestinal barriers causing inflammatory bowel disease. PDE4 inhibitors such as apremilast have been expanded to mild to moderate patients and children due to their good safety. In atopic dermatitis, drugs targeting downstream targets such as IL-4/13 are more effective. JAK1/TYK2 inhibitors have good effects on both diseases, and new products have emerged in recent years, such as Hengrui Pharmaceuticals' upcoming Emma Citinib. OX40/OX40L is an emerging target for the treatment of atopic dermatitis, and Sanofi is currently leading in progress.

Inflammatory bowel disease biologics are mainly limited to moderate to severe patients, and TNF-α antibodies are the most widely used. JAK inhibitors have good efficacy but have safety risks. TL1A is the most popular target in early targets. In the digestive system, inflammatory bowel disease occupies a major position and can be divided into ulcerative colitis and Crohn's disease. Currently, TNF-α antibodies are still the most classic drugs, and the IL-12/23 target (such as ustekinumab) is also relatively mature. However, the above drugs all have certain safety issues. Antibodies targeting IL23 p19, such as risankizumab, do not affect the IL12 pathway and reduce interference with the immune system. Whole-linker (ITG) class antibodies target intestinal cells, have good tissue specificity, and have high safety but slow onset. Although JAK inhibitors have applications, products already on the market such as tofacitinib have high safety risks. The tumor necrosis factor family member TL1A has become a hot early clinical target in recent years, and there have been many medical transactions.

Investment advice: CSC Securities believes that the accelerated development of the self-immunity market scale will promote the improvement and efficiency of the domestic innovative drug industry, and promote the incubation of a large number of excellent pipelines to produce advanced drugs that meet the clinical needs of patients.