Leritrelvir Tablets (Brand Name: 乐睿灵®) Receive Regular Approval from NMPA: A Leap from Conditional to Full Market Authorization
Raynovent, in collaboration with the Guangzhou Laboratory and the Guangzhou Institute of Respiratory Health, is pleased to announce that its Class 1 innovative chemical drug, Leritrelvir Tablets (brand name: 乐睿灵®), has received regular approval from the National Medical Products Administration (NMPA). This marks the transition from conditional to full market authorization for the treatment of mild to moderate COVID-19 in adult patients.
Leritrelvir Tablets become the world's first 3CL protease inhibitor monotherapy oral antiviral drug for COVID-19 to receive regular approval, signifying comprehensive recognition by regulatory authorities of its efficacy, safety, and quality controllability, achieving a milestone upgrade from conditional to full approval.
Product Information:
Drug Name: Leritrelvir Tablets (乐睿灵®)
Indication: For the treatment of mild to moderate COVID-19 in adult patients. For full prescribing information, please refer to the package insert.
Manufacturer: Raynovent
Pack Size: 30 tablets
01 From Conditional to Regular Approval: Full Evidence Chain Validates Definitive Efficacy
Leritrelvir Tablets were initially granted conditional approval by the NMPA in March 2023. Since its market launch, Raynovent has rigorously fulfilled the post-marketing requirements stipulated in the approval certificate, completing a series of clinical pharmacology studies, including mass balance, pharmacokinetics in patients with hepatic/renal impairment and the elderly, and drug-drug interaction studies. Additionally, the company conducted a large-scale real-world study. Results demonstrated that Leritrelvir Tablets significantly reduced the risk of progression to severe/critical illness or death in mild to moderate COVID-19 patients. The risk of disease progression was notably reduced in subgroups including elderly patients aged 65 and above, those with comorbidities, and high-risk populations. No new safety signals were identified. The complete clinical evidence chain fully substantiates the drug's definitive efficacy and favorable safety profile.
02 Monotherapy 3CL Protease Inhibitor, No Need for Ritonavir: Enabling the Most Vulnerable Populations to Access and Safely Use Treatment
Pharmacokinetically, Leritrelvir dissociates from the protease inhibitor complex approximately 12 times slower than Nirmatrelvir—the target residence time for Nirmatrelvir is 9 minutes, while for Leritrelvir it is extended to 104 minutes. This unique property significantly improves the elimination half-life of Leritrelvir, allowing it to maintain higher plasma concentrations for a longer duration, fundamentally addressing the major clinical issue of requiring co-administration with Ritonavir.
The core differentiating advantage of Leritrelvir Tablets lies in its ability to achieve potent antiviral efficacy as a monotherapy, without the need for concomitant Ritonavir. Traditional 3CL protease inhibitors require Ritonavir as a boosting agent, but Ritonavir has significant drug-drug interactions with numerous commonly used medications, including antihypertensives, lipid-lowering agents, anticoagulants, and immunosuppressants. This creates a clinical dilemma: the very populations who most need antiviral therapy—elderly patients, those with cardiovascular disease, hepatic/renal impairment, or immunosuppression—often face safety risks with Ritonavir-boosted regimens. Leritrelvir Tablets overcome this challenge mechanistically: no dose adjustment is required for elderly patients, nor for patients with mild to moderate hepatic impairment or mild to severe renal impairment. This provides a safe and convenient treatment option for fragile populations with multiple comorbidities and long-term polypharmacy.
03 Regular Approval Enables Broader Accessibility: Benefiting More Patients
Currently, COVID-19 infection remains at a moderate level of activity with periodic fluctuations, and the need for antiviral therapy among high-risk populations persists. With regular approval, Leritrelvir Tablets will gain access to a wider range of distribution channels, including various levels of medical institutions, primary healthcare facilities, and retail pharmacies. This will facilitate easier clinical prescribing and patient access, effectively improving the accessibility of this innovative drug. It will enable more patients, especially vulnerable populations, to receive timely, standardized antiviral therapy in the early stages of infection, thereby reducing disease burden and contributing to the development of a public health emergency response system.
Dr. Xiaoxin Chen, CEO of Raynovent, stated:
"The regular approval of Leritrelvir Tablets represents authoritative recognition by the national drug regulatory authority of the complete evidence chain and clinical value of this product. It is also the fruit of collaborative efforts between industry, academia, and research institutions to serve national strategic needs. Leritrelvir Tablets have been included in the 2025 National Reimbursement Drug List and are recommended as a '1A' level therapy in the 'Expert Consensus on the Clinical Application of Small Molecule Antiviral Drugs Against SARS-CoV-2'.
In clinical practice, we continuously receive real-world feedback that further confirms the irreplaceable value of this drug for special populations. For example, a patient with chronic renal failure was unable to use Ritonavir-boosted alternatives due to medication restrictions. Under the evaluation and guidance of their physician, the patient was treated with Leritrelvir Tablets, and the treatment course proceeded smoothly. The patient's family expressed gratitude: 'We thank the doctor for promptly recommending this monotherapy option, and it also gives us the opportunity to share the hope of this treatment with other patients in urgent need.' At the same time, clinicians have also expressed interest in the drug's accessibility, hoping to offer this option to more emergency patients. These cases deeply impress upon us that the monotherapy design, which eliminates the need for Ritonavir, effectively addresses the medication challenges faced by high-risk populations.
Looking ahead, the company will continue to advance the supply assurance and academic promotion of this product across all channels, ensuring that this Chinese-originated innovative drug benefits a broader range of patients, contributing to public health and the national strategic reserve of therapeutics for major infectious diseases."