Core Insights - The announcement from Yuan Da Pharmaceutical regarding the new specification (20ml: 50mg) of its drug, Qufei Lianer injection, received approval from the National Medical Products Administration on September 22, indicating a significant development in the treatment of pulmonary arterial hypertension (PAH) [1] - Qufei Lianer injection is the only drug in China that can be administered subcutaneously and intravenously for PAH treatment, which is a first-line medication and a foundational drug in targeted therapy regimens [1][5] - The PAH market is projected to grow significantly, with an estimated global market size of approximately $8.06 billion in 2024, expected to reach around $13.5 billion by 2034, reflecting a compound annual growth rate (CAGR) of 5.3% [5] Company Insights - Qufei Lianer is a synthetic prostacyclin analog that promotes vasodilation and inhibits platelet aggregation, effectively treating PAH symptoms [5] - The drug has demonstrated long-term efficacy and safety in clinical studies, with one-year and four-year survival rates of 88% and 70%, respectively, indicating a significant improvement in patient prognosis [5] - The sales revenue of Qufei Lianer has consistently exceeded $100 million annually, achieving approximately $517 million in global sales in 2020 [5][6] - In China, the sales growth of Qufei Lianer injection was remarkable, with a year-on-year increase of 186.89% in 2021 [6] Industry Insights - PAH is a rare cardiovascular disease with a high mortality rate, historically referred to as "the cancer of the cardiopulmonary system," with a median survival of only 2.8 years before the advent of targeted therapies [2] - The prevalence of PAH has nearly doubled globally from 1990 to 2021, with an incidence rate of approximately 2.4 per million person-years and a prevalence rate of about 15 per million [1][2] - The five-year survival rate for PAH patients has improved from 34% in 1991 to nearly 57% in recent years, with an average survival time of 6.2 years [2]
远大医药曲前列尼尔注射液新规格国内获批上市 Go Global战略持续推进