Recently, the Phase III clinical study for pediatric indication of Deunoxavir Marboxil granules, an innovative anti-influenza drug jointly developed by Simcere Pharmaceutical and AnDiConBio, has completed the full patient enrollment and follow-up. Deunoxavir Marboxil granules represent China's first new generation pediatric anti-influenza medication to enter Phase III clinical trials and the first to complete full patient enrollment, offering patients the promising prospect of achieving "cure with a single sachet".
This Phase III clinical study is a multi-center, randomized, double-blind, double-dummy, active-controlled study of Deunoxavir Marboxil granules conducted across 35 clinical study sites nationwide in China, led by Professor Ni Xin and Professor Zhao Chengsong, President and Vice President of Beijing Children's Hospital, Capital Medical University, as the principal investigators. The trial compares Deunoxavir Marboxil granules head-to-head with several marketed and mainstream influenza antiviral drugs and aims to evaluate the safety, pharmacokinetics, and efficacy of Deunoxavir Marboxil granules in pediatric patients aged 2 to 11 years with influenza.
Previously, Phase II/III clinical studies of Deunoxavir Marboxil tablets for the treatment of uncomplicated acute influenza in adolescents and adults successfully met their primary endpoints. The median time to alleviation of all influenza symptoms was improved by 26.543% compared to the placebo group, demonstrating favorable safety with a statistically significant difference (P < 0.0001). Clinical data have shown that "a single oral tablet" of Deunoxavir Marboxil may effectively manage the entire course of influenza, with the potential to halt viral replication within 24 hours and achieve a "negative" test result in just one day. The smooth progress of the Phase III clinical trial for new indication of Deunoxavir Marboxil granules for patients aged 2 to 12 years brings hope for a new drug achieving "cure with a single sachet" for pediatric influenza in clinical practice.
About Deunoxavir Marboxil
Deunoxavir Marboxil functions as a cap-dependent endonuclease inhibitor specifically designed to target the influenza virus. By inhibiting the virus's cap-dependent endonuclease, it effectively blocks the transcription of the virus's mRNA, thereby disrupting its ability to replicate. Available study data have demonstrated that Deunoxavir Marboxil exhibits significant antiviral activity and favorable safety against avian influenza A, B, and highly pathogenic viruses. Moreover, compared with similar drugs, this candidate drug also offers the advantages of oral efficacy not affected by food intake and a higher safe dose.
About AnDiConBio
Led by a number of academicians and focusing on the fields of respiratory anti-infection and pain, AnDiConBio's technology innovation team has established a new drug R&D system based on metabolic differentiation leveraging the DMPK platform. In addition to its new anti-influenza drug Deunoxavir Marboxil (ADC189), the company's product pipeline also covers multiple innovative drugs, including the ADC308 tablet for the treatment of endometriosis and uterine fibroids, a new non-addictive drug for pain (ADC558 tablet), and a new anti-mycoplasma super antibiotic (ADC101 suspension). AnDiConBio completed a Pre-Series A financing of 100 million yuan in 2022, received a strategic investment of tens of millions yuan from Simcere Pharmaceutical Group (2096.HK) in 2023, and completed a Series A financing of over 200 million yuan in early 2024.