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太平洋医药日报:酶替代疗法LOARGYS获FDA批准
Xin Lang Cai Jing· 2026-02-26 08:34
Market Performance - The pharmaceutical sector increased by 0.84% on February 25, 2025, outperforming the CSI 300 index by 0.24 percentage points, ranking 14th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, other biological products (+2.39%), hospitals (+2.04%), and medical consumables (+1.58%) showed the best performance, while offline pharmacies (+0.32%), in vitro diagnostics (+0.33%), and medical research outsourcing (+0.34%) lagged behind [1] - Top three gainers in individual stocks were Changchun High-tech (+10.00%), Aidi Te (+9.03%), and Changshan Pharmaceutical (+8.87%); top three losers were Frontier Biotech (-4.09%), Baile Tianheng (-3.62%), and Shuoshi Biotech (-2.97%) [1] Industry News - Immedica announced that the FDA has accelerated the approval of Loargys for the treatment of hyperargininemia in patients aged 2 years and older with arginase 1 deficiency (ARG1-D), based on positive results from the Phase 3 PEACE trial [2] - The trial showed that the geometric mean of plasma arginine (pArg) in patients treated with Loargys decreased significantly from 354.0 μmol/L to 86.4 μmol/L by week 24 [2] - Loargys is a recombinant human arginase that can rapidly and sustainably lower plasma arginine and its toxic metabolites while improving clinical symptoms; it has already been approved in the EU and the UK [2] Company News - Sino Medical (688108) reported a revenue of 525 million yuan for 2025, a year-on-year increase of 14.53%, with a net profit attributable to shareholders of 47 million yuan, up 3057.05%, and a net profit of 34 million yuan after deducting non-recurring items, up 293.82% [3] - United Imaging (688271) announced a revenue of 13.821 billion yuan for 2025, a 34.18% increase year-on-year, with a net profit of 1.888 billion yuan, up 49.60%, and a net profit of 1.788 billion yuan after deducting non-recurring items, up 77.01% [3] - Huyou Pharmaceutical (688553) received notification from the FDA that its new drug applications for etoposide injection and fluorouracil injection have been approved, facilitating the company's expansion into the U.S. market [3] - Aibo Medical (688050) announced plans to acquire 68.31% of Demai Medical for 683 million yuan, with Demai Medical being a leading company in sports medicine; this acquisition will make it a subsidiary of Aibo Medical [3]