Recently, ACEA Pharma has announced that Ogrelvir Sodium Capsule (brand name: Oveinin®), its independently developed oral antiviral agent, has been selected to the Nature Reviews Drug Discovery 2025 Top Novel Target Drugs List. This achievement marks the first time a Chinese innovative drug has earned a spot on this globally recognized authoritative ranking.
Medicilon, a long-term strategic partner of ACEA Pharma,provided preclinical R&D support for Ogrelvir Sodium Capsule, covering compound synthesis, early-stage process scale-up and toxicology batch preparation.Medicilon’s rigorous technical services underpinned the successful preclinical development and commercial launch of this world-first dual-target oral anti-COVID-19 drug.
Nature-Accredited Innovation:
Ogrelvir Sodium Establishes a New Benchmark for Target Discovery
Nature Reviews Drug Discovery, a leading authoritative journal in global pharmaceutical research. All listed therapies represent first-in-class breakthroughs with transformative implications for clinical practice.
According to the journal’s 2025 industry analysis, four major global regulatory bodies — the U.S. FDA, EU EMA, Japan PMDA and China NMPA — collectively approved 94 new drugs with well-defined mechanism-of-action targets in 2025. Of these approvals, only 11 targets are completely novel with no prior marketed therapies, corresponding to merely 10 first-in-class innovative drugs of exceptional technical rarity and research value.
Distinguished by its proprietary dual-target mechanism, Ogrelvir Sodium Capsule verifies the originality, scientific validity and global competitiveness of its therapeutic pathway. This accolade not only underscores ACEA Pharma’s core prowess in innovative drug R&D but also places China’s anti-coronavirus drug development firmly within the global innovation elite.
Shifting COVID-19 Landscape Drives Demand for Domestic Innovative Therapeutic Solutions
With ongoing viral mutation, COVID-19 has transitioned from an acute public health emergency to an endemic respiratory infectious disease. Elderly populations and patients with underlying comorbidities continue to face elevated risks of severe disease and long COVID complications.
Traditional antiviral therapies are frequently limited by drug-drug interactions, combination restrictions and emerging drug resistance, rendering them inadequate for complex clinical scenarios. Innovative antiviral agents with broad-spectrum activity, superior safety profiles and flexible administration have therefore become an essential component of long-term post-pandemic public health preparedness.
Dual-Target Mechanism Delivers Safer, More Efficient COVID-19 Treatment
As the world’s first oral antiviral drug designed to concurrently block SARS-CoV-2 entry and replication, Ogrelvir Sodium Capsule integrates unparalleled advantages in target innovation, clinical applicability and evidence-based efficacy.
Proprietary Dual-Target Mechanism: Dual Protection Against Viral Invasion and Proliferation
Unlike conventional single-pathway anti-COVID-19 therapies, Ogrelvir Sodium Capsule acts on two validated targets: Cathepsin L (CTSL) and 3CL protease (3CLpro). The CTSL mechanism works by modulating host cellular protease activity to prevent viral entry into human cells, rather than targeting the virus directly. Complementarily, the drug inhibits 3CLpro, a critical enzyme for viral replication, effectively halting in-vivo viral propagation.
Standalone Monotherapy Resolves Medication Challenges for High-Risk Patients
Ogrelvir Sodium Capsule enables ritonavir-free monotherapy, overcoming a key limitation of mainstream anti-COVID-19 drugs that rely on ritonavir boosting. This design eliminates the risk of adverse drug-drug interactions (DDIs), substantially improving clinical safety and broadening patient eligibility, particularly for elderly users and patients with chronic underlying conditions.
Peer-Reviewed Clinical Data Proves Rapid Symptom Resolution and Favorable Safety
The Phase III clinical trial results of Ogrelvir Sodium Capsule, published in NEJM Evidence, were derived from 1,218 enrolled participants. Trial outcomes demonstrated that the drug significantly shortened the duration of 11 core COVID-19 symptoms (including fever, cough and fatigue), delivering a 2.44-day faster clinical recovery compared with the placebo group.
Superior therapeutic benefits were observed in high-risk patient subgroups. Patients aged 60 and above experienced a 33% reduction in core symptom duration, while individuals with cardiovascular disease risks achieved a 46% shorter recovery timeframe, highlighting enhanced efficacy for vulnerable populations.
Safety assessments confirmed a favorable tolerability profile. The majority of treatment-emergent adverse events (TEAEs) associated with Ogrelvir Sodium were Grade 1 or 2 in severity, with no single adverse event (AE) occurring at an incidence above 5%. The trial also recorded a lower rate of Grade 3+ TEAEs in the treatment group versus placebo, with no Grade 4 drug-related adverse events reported.
As a flagship novel-target innovative drug of 2025, Ogrelvir Sodium Capsule offers a safe, efficient and DDI-free therapeutic option for COVID-19 patients, especially high-risk groups with advanced age or comorbidities. The agent delivers a state-of-the-art Chinese pharmaceutical solution to strengthen global public health defense systems.
Medicilon’s Preclinical Platform Empowers Anti-Pandemic Drug Innovation
Boasting over two decades of specialized preclinical R&D experience, Medicilon operates a end-to-end integrated service platform spanning drug discovery, pharmaceutical development and preclinical studies. Medicilon’s facilities and quality systems are certified by NMPA, FDA, OECD GLP and AAALAC international standards.
Medicilon’s antiviral research capabilities are supported by dedicated ABSL-2 and BSL-2 laboratories, enabling controlled experimentation on Class III pathogenic microorganisms, viral culture, virulence quantification and a full spectrum of in-vitro pathogen assays. Its comprehensive service portfolio covers compound activity screening, tumor cell biology studies, tumorigenicity evaluation, vaccine potency testing and PK/PD analysis for antimicrobial agents, supporting preclinical development for novel therapies including AAV gene therapeutics. To date, Medicilon has facilitated the clinical advancement of 9 anti-COVID-19 drugs and vaccines.
Moving forward, Medicilon will leverage its one-stop preclinical R&D platform to accelerate the development and commercialization of more first-in-class drugs with novel mechanisms. Medicilon will continue to advance the upgrading of global biomedical industry and contribute localized R&D expertise to global major disease prevention and treatment.
