Rundu Pharma(SZ:002923)2025-06-18 07:32Group 1: Product Development and Regulatory Status - The registration application for the innovative drug, Sodium Deoxycorticosterone Injection, is progressing smoothly, with the company having submitted the necessary documentation to the National Medical Products Administration (NMPA) [1] - The company completed supplementary research work in April 2025, following a notification from the NMPA regarding additional data requirements [1] Group 2: Market Potential and Commercialization - Sodium Deoxycorticosterone is a partial agonist of adrenal β receptors, used for myocardial perfusion imaging (MPI) to assist in diagnosing and evaluating myocardial ischemia [3] - In the U.S., approximately 4.57 million MPI tests were conducted in 2023, representing 22.3% of the 20.5 million coronary heart disease patients [3] - The company plans to actively promote the product through its marketing team and is open to collaborations with experienced partners for commercialization [4] Group 3: Clinical Safety and Efficacy - The Phase IIIb clinical trial for Sodium Deoxycorticosterone Injection, led by Peking Union Medical College Hospital, showed good safety with mild adverse reactions that resolved quickly after discontinuation [5] Group 4: Future Plans and Market Expansion - The company has not yet considered international commercialization rights for Sodium Deoxycorticosterone Injection [6] - The Jingmen facility has seen significant growth in total output value, with multiple products achieving stable supply, enhancing the company's integrated supply chain advantages [6] - The company aims to increase market coverage and capacity utilization to enhance competitiveness [6]