Global First Dual-Target COVID-19 Drug Olgotrelvir Sodium Capsules Approved by China’s NMPA
Recently, the National Medical Products Administration (NMPA) granted conditional approval for Olgotrelvir Sodium Capsules, a Class I innovative drug developed by Zhejiang ACEA Pharmaceutical Co., Ltd.
✨ The drug represents the world’s first dual-target oral small-molecule therapy for COVID-19, indicated for adult patients with mild to moderate infections.
A Breakthrough in China’s Independent Drug Innovation
Developed entirely in China with global intellectual property rights, Olgotrelvir Sodium Capsules mark a major milestone in the nation’s antiviral drug innovation.
💊 As the first Class I innovative drug originating from Quzhou, Zhejiang Province, it highlights China’s growing capabilities in biopharmaceutical research and development, contributing to global efforts in COVID-19 prevention and treatment.
Dual-Target Mechanism Enhances Efficacy and Safety
👉 Olgotrelvir Sodium Capsules feature a unique dual-target antiviral mechanism.
✅ The drug inhibits both the viral 3CL protease—blocking viral replication—and the host Cathepsin L enzyme, preventing viral entry into epithelial and immune cells.
Unlike existing antiviral regimens, olgotrelvir can be administered as a standalone therapy, eliminating the need for ritonavir boosting.
This significantly reduces the risk of drug–drug interactions, particularly benefiting elderly and high-risk patients with underlying conditions.
Clinical Data Demonstrate Strong Therapeutic Benefits
💡 In May 2024, NEJM Evidence published the results of the Phase III clinical trial for olgotrelvir sodium capsules.
Conducted across 25 clinical centers in China with 1,218 mild to moderate COVID-19 patients, the study demonstrated that:
- The median time to sustained symptom recovery was 205 hours (≈8.6 days), significantly shorter than 264 hours (≈11 days) in the placebo group (P<0.001).
- Viral load reduction was greater in the Olgotrelvir group, decreasing by 2.20 log₁₀ copies/mL by Day 4 (P<0.0001).
- Efficacy was consistent across both primary and recurrent infection groups, with notable benefits observed in patients aged ≥60 and those at high risk of severe disease.
- The treatment demonstrated a favorable safety profile, with most adverse events being Grade 1–2 and no serious drug-related events.
Driving Pharmaceutical Innovation and Global Collaboration
The approval of Olgotrelvir Sodium Capsules represents a landmark achievement for Zhejiang ACEA Pharmaceutical and underscores China’s commitment to advancing antiviral innovation.
👉 As a Hong Kong Department of Health–certified Chinese pharmaceutical distributor, Hong Kong DengYue Medicine will continue to follow the market launch of Olgotrelvir Sodium Capsules
👉And actively support the global distribution of China’s innovative medicines, expanding access to safe and effective therapies worldwide.
