blockpartycrypto| Pharmaceutical industry: IGA nephrology panorama: The domestic base of millions of patients and IGAN's road to gold mining is waiting to set sail

The epidemiology of IgA nephropathy varies greatly in different countries and regions.BlockpartycryptoThe incidence is high in Asia, and the domestic stock of patients is one million. IgA nephropathy is mainly characterized by the accumulation of immunoglobulin A (IgA) in the kidney. Asymptomatic hematuria with varying degrees of proteinuria is the most common clinical manifestation. IgA nephropathy is the most common primary glomerular disease in China, accounting for about 35% of primary nephropathy. In terms of the number of patients, according to Sullivan's report, the number of global IgA nephropathy patients increased from 8.8 million in 2015 to 9.3 million in 2020, of which China accounted for about 2.2 million; it is estimated that the number of patients in the world will reach 10.2 million in 2030 and about 2.4 million in China. IgA nephropathy is a rare disease in the United States, the patient base is small, only about 130000-150000 patients, by contrast, the stock of patients diagnosed with IgA nephropathy in China is millions, and the population base is large. At present, there is no specific treatment for IgA nephropathy, and the main goal is to control blood pressure and albuminuria and delay renal function and disease progression. The 2021 KDIGO guidelines indicate that for albuminuria > 0Blockpartycrypto.5g / d patients are recommended to be treated with angiotensin converting enzyme inhibitor ACEI or angiotensin receptor antagonist ARB for a long time. Patients with albuminuria 50ml/min can be treated with glucocorticoid for 6 months. However, due to many adverse reactions caused by long-term use of glucocorticoid, there is still some controversy in the treatment of patients with high risk of progression of IgA nephropathy. The guidelines are less recommended for the treatment of IgA nephropathy with immunosuppressants, only when IgA is associated with crescent formation and rapid decline in renal function. Currently, immunosuppressants used to treat IgA mainly include cyclophosphamide CTX, mycophenolate mofetil MMF, tacrolimus and so on. Starting from the pathogenesis of IgA nephropathy "quadruple strike hypothesis", innovative treatments for primary IgA nephropathy can be divided into four categories. At present, the pathogenesis of IgA nephropathy is not clear, and it is relatively recognized as the "quadruple blow hypothesis". According to the various steps of this hypothesis, the treatment of primary IgA nephropathy can be divided into several categories: (1) to inhibit excessive mucosal immune response and reduce the production of immunogen from the source. The representative drug is Nifukang, a listed product of Genting Xinyao (approved in the mainland in November 2023). The persistent decrease of proteinuria and the decrease of eGFR were observed in the third phase of the complete 2-year clinic. (2) B cytokine (BAFF/APRIL) inhibitors: eliminate antibody-producing b cells and reduce the production of autoantibodies. Late-stage projects include Tetacil (BAFF&APRIL dual inhibitor, Rongchang Biological, Clinical Phase 3), BAFF&APRIL dual inhibitor, vera Pharmaceutical, Clinical Phase 3), zigakibart (single target APRIL, Novartis, Clinical Phase 3), sibeprenlimab (single target APRIL,Otsuka). Clinical phase 3), povetacicept (BAFF&APRIL dual inhibitor, Vertex, 24H2 is expected to enter clinical phase 3). (3) Endothelin / angiotensin antagonist: dilate blood vessels and reduce blood pressure. Dual endothelin angiotensin receptor antagonist sparsentan (Travere) was accelerated in February 2023 in the United States, and a supplementary new drug application was submitted in March 2024. Atrasentan, an endothelin receptor antagonist acquired by Novartis Chinook, is expected to be submitted for listing in the United States in 2024. Domestic Zhikang Hongyi SC0062 entered the second phase of clinical practice. (4) complement system targeting therapy: inhibition of complement activation pathway and reduction of immune and inflammatory reactions. Among them, Novartis iptacopan (targeted CFB) clinical phase 3 reached the main end point of mid-term analysis, and the application for accelerated approval is expected to be submitted in the United States in 2024; AstraZeneca ravulizumab (targeted C5) is in the global phase 3; Hengrui HRS-5965 (targeted CFB), Conoya CM338 (targeted MASP2) and Hengrui SHR-2010 (targeted MASP2) are all in clinical phase 2. Investment advice: the incidence of IgA nephropathy in China is higher than that in other countries and regions in the world, and the domestic confirmed IgA stock is one million, and the current treatment of IgA nephropathy is mainly supportive treatment. Due to the large number of patients and unmet clinical needs, it is recommended to pay attention to the innovative pharmaceutical companies that are studying IgA nephropathy products, such as Genting Xinyao, Rongchang Biology, Konoya, Hengrui Pharmaceutical and so on. Risk hints: the risk of industry policy change; the risk that R & D progress is not as expected; the risk that competition intensifies; and the commercial performance of products after listing is not as expected. [disclaimer] this article only represents the views of a third party and does not represent the position of Hexun. Investors operate accordingly, at their own risk.

[disclaimer] this article only represents the views of a third party and does not represent the position of Hexun. Investors operate accordingly, at their own risk.