Zhongsheng Pharmaceutical Advances Pediatric Angladivir Granules to Phase III for Influenza A Treatment
Key Insights
Guangdong Zhongsheng Pharmaceutical (search) has completed enrollment and dosing of the first participant in a Phase III clinical trial for Angladivir (search) granules targeting influenza A (search) in children aged 2-11 years.
The granule formulation is designed to facilitate medication use among children and patients with swallowing difficulties, building on positive Phase II results demonstrating efficacy and safety.
Angladivir (search) represents the world's first Class I innovative drug targeting the PB2 subunit (search) of influenza A (search) virus RNA polymerase (search), with the tablet form already approved for adult treatment in May 2025.
Guangdong Zhongsheng Pharmaceutical (search) Co., Ltd. has reached a significant milestone in pediatric influenza treatment development, completing enrollment and dosing of the first participant in a Phase III clinical trial for Angladivir (search) granules in children aged 2-11 years with simple influenza A (search).
The granule formulation represents a strategic expansion of the company's Angladivir (search) platform, specifically developed to address medication challenges in pediatric populations and patients with swallowing difficulties. This formulation builds on the success of Angladivir tablets, which achieved regulatory approval as the world's first Class I innovative drug targeting the PB2 subunit (search) of the RNA polymerase (search) of the influenza A (search) virus.
Clinical Development Progress
The Phase III trial for Angladivir (search) granules is being conducted under the guidance of the Principal Investigator at Beijing Children's Hospital (search) affiliated with Capital Medical University. According to the company, Phase II clinical trial results for the granule formulation demonstrated positive efficacy and good safety with ideal outcomes, providing the foundation for advancing to the pivotal Phase III study.
Concurrently, Zhongsheng Pharmaceutical is advancing a separate Phase III clinical trial of Angladivir (search) tablets for treating simple influenza A (search) in adolescents aged 12-17 years. This trial is being conducted under the guidance of the Principal Investigator at Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, with participant enrollment proceeding smoothly.
Mechanism and Market Position
Angladivir (search) tablets, marketed under the brand name Anruiwei, received approval from the National Medical Products Administration in May 2025 for treating adult patients with simple influenza A (search). The drug features rapid action, potent efficacy, and low resistance characteristics, positioning it as a first-in-class therapeutic option targeting the influenza A virus RNA polymerase (search) PB2 protein.
The PB2 subunit (search) represents a novel therapeutic target in influenza treatment, distinguishing Angladivir (search) from existing antiviral approaches and potentially offering advantages in terms of resistance profiles and treatment outcomes.
Broader Pipeline Development
Beyond the Angladivir (search) program, Zhongsheng Pharmaceutical is advancing Phase III clinical trials for RAY1225 injection, targeting both obese/overweight patients and type 2 diabetes (search) patients in separate studies. This diversified clinical portfolio reflects the company's commitment to addressing multiple therapeutic areas with unmet medical needs.
Development Outlook
The company has committed to advancing both Angladivir (search) Phase III trials with high quality, accelerated timelines, and scientifically standardized approaches according to regulatory requirements. However, the company acknowledges that clinical trial progress, review and approval results, and future market competition patterns for innovative drug development projects carry inherent uncertainties.
The commercialization outlook for approved products will be influenced by various factors including market dynamics, policy changes, widespread adoption of preventive vaccines, successive approvals of competing treatments, and market promotion efforts for follow-up products.