Phase 3 trial

Innovent Biologics’ dual GCG/GLP-1 agonist mazdutide demonstrated significant weight loss (14.84% vs. 0.47% placebo) in a Phase 3 trial (GLORY-1) with 610 Chinese adults with obesity over 48 weeks, published in *NEJM*. Over 50% achieved ≥15% weight reduction, alongside improved cardiovascular and liver health. Safety aligned with GLP-1 therapies, with transient gastrointestinal effects. This marks the first NEJM-published metabolic therapy trial from China, signaling the nation’s rise in drug innovation. Experts emphasized mazdutide’s potential in addressing China’s obesity crisis under “Healthy China 2030.” Partnerships with Eli Lilly and ongoing trials aim to expand its use in metabolic diseases.

Mineralys Therapeutics’ lorundrostat, a novel aldosterone synthase inhibitor, demonstrated strong Phase 3 results in treating resistant hypertension across 1,000+ patients. The trial showed sustained systolic reductions of 19.0 mmHg (11.7 mmHg vs placebo) at 12 weeks and a favorable safety profile with 0.1% serious adverse events. Exceeding FDA efficacy benchmarks, the therapy achieved dual Phase 3 validation and potentially reduces cardiovascular risk by 20-40%. With patent protection through 2041 and a projected $10B+ market opportunity, Mineralys plans Q1 2026 regulatory submission. The company’s $1.2B market cap signals growth potential amid rising global demand for precision hypertension treatments.

Savara Inc. announced positive Phase 3 trial results for molgramostim in autoimmune pulmonary alveolar proteinosis (aPAP) at ATS 2025. In 157 patients, the therapy significantly reduced radiological surfactant burden (mean GGO score decrease 2.1 vs. 1.1; P=0.0004) and need for rescue whole-lung lavage (7.4% vs. 13.3%). Molgramostim improved respiratory quality of life metrics (St. George’s Respiratory Questionnaire, P=0.0084) and reduced breathing difficulties (P=0.0305 and P=0.0049 at Weeks 24/48). By addressing impaired GM-CSF signaling, this inhaled therapy could redefine aPAP treatment, offering a non-invasive alternative to current procedures. Trial data supports future regulatory submissions for rare disease approval pathways.