医药行业周专题：心衰：Pipeline激烈竞争的潜在大市场

Industry Investment Rating - The report maintains a "Positive" rating for the pharmaceutical and biotechnology industry [2] Core Views - The heart failure (HF) market has significant potential, with improving patient prognosis being the core focus [3] - HF is characterized by high morbidity and mortality rates, with approximately 12.1 million HF patients in China in 2017 [3] - HF is classified into three types based on left ventricular ejection fraction (LVEF): HFrEF (35.6%), HFmrEF (20.6%), and HFpEF (43.8%) [3] - Chronic HF treatment has evolved from the "RASI+BB+MRA" golden triangle to the "RASI+BB+MRA+SGLT2i" quadruple therapy, with SGLT2i showing better prognosis improvement [3] - There is a lack of effective treatments for HFmrEF and HFpEF, with only SGLT2i receiving IA-level guideline recommendations [3] Unmet Needs and Competitive Landscape - Despite advancements, the 3-year all-cause mortality rate for HF patients in China remains high at 28.2%, indicating significant unmet needs [4] - Overseas companies dominate the chronic HF pipeline, with nearly 30 drugs in Phase II or later globally, including 5 domestic candidates [4] - Promising new drugs in development include Omecamtiv Mecarbil (OM), finerenone, tirzepatide, and semaglutide, with finerenone and tirzepatide showing potential as new treatment options [4] - Domestic candidates like S086 (sacubitril/valsartan) and recombinant human neuregulin are progressing rapidly, with S086 and neuregulin in Phase III trials [4] Investment Recommendations - Chronic HF, with its large patient base and long-term medication needs, is expected to see rapid market growth due to aging populations [5] - The market is driven by multi-drug combination therapies and the approval of new mechanism drugs [5] - Domestic companies like Salubris and Hengrui are recommended for attention due to their progress in HF drug development [5] Market Overview - HF is a chronic, progressive disease requiring long-term medication, with the Chinese HF drug market growing from 5.1 billion yuan in 2019 to 7.4 billion yuan in 2023 [26] - The global HF drug market is projected to grow from $3.7 billion in 2018 to $22.1 billion in 2028, with a CAGR of 19.5% [31] Treatment Evolution - HFrEF treatment has evolved from the "RASI+BB+MRA" golden triangle to the "RASI+BB+MRA+SGLT2i" quadruple therapy, with SGLT2i improving patient prognosis [32] - ACEIs were the first class of drugs proven to reduce mortality in HFrEF patients [33] - ARNIs, particularly sacubitril/valsartan, are recommended for HFrEF patients with NYHA class II/III symptoms [38] - SGLT2 inhibitors like dapagliflozin and empagliflozin have shown significant benefits in reducing HF hospitalization and cardiovascular death risks [50][55] Pipeline Highlights - Omecamtiv Mecarbil (OM) has shown mixed results in Phase III trials, with no significant reduction in cardiovascular mortality [71] - Finerenone has demonstrated positive results in HFmrEF and HFpEF patients, potentially becoming a new treatment option [72] - Semaglutide and tirzepatide have shown promise in reducing cardiovascular risks in obese and diabetic HFpEF patients [78][83] - Domestic candidates like S086 and recombinant human neuregulin are progressing well, with neuregulin showing potential in improving heart function [88][90]