On December 16, 2025, the Phase III Clinical Trial Summary and Inspection Coordination Meeting of Extracts from Rabbit Skin Inflamed by Vaccinia Virus Tablets was successfully convened. Sponsored by Vanworid Pharmaceutical (Rugao) Company Limited, led by Zhujiang Hospital of Southern Medical University as the lead research center, and undertaken by Guangzhou Haibote Pharmaceutical Technology Co., Ltd. (hereinafter referred to as Haibote) as the CRO, the meeting fully summarized the efficacy and safety data of the product for low back pain induced by lumbar degenerative disorders, and held in-depth exchanges on key points of clinical trial data inspection to be carried out by the National Medical Products Administration (NMPA).

Specialists and institutional representatives from nine national clinical centers attended the milestone event, including Zhujiang Hospital of Southern Medical University, Guangzhou First People’s Hospital, Affiliated Hospital of Zunyi Medical University, The Second Affiliated Hospital of Zhengzhou University, Gaozhou People’s Hospital, The Seventh Affiliated Hospital of Southern Medical University, The First Affiliated Hospital of Henan University, The Third People’s Hospital of Yunnan Province, and The Third Xiangya Hospital of Central South University. Also present were relevant management staff from sponsor Vanworid Pharmaceutical and the Haibote project team.

The meeting was presided over by Professor Zhu Lixin, Director of the Orthopedic Center and Department of Spinal Surgery at Zhujiang Hospital of Southern Medical University (the lead center). Liu Chi, Deputy General Manager of Vanworid Pharmaceutical (Rugao) Company Limited, delivered an opening speech. Professor Zhu Lixin gave a systematic report on the overall outcomes of the clinical trial. The meeting also invited He Shuai, Director of the GCP Office at Zhujiang Hospital of Southern Medical University, to deliver a special presentation on regulatory requirements for clinical trial data inspection.

Joint Analysis of Clinical Data to Accelerate Project Progress

Released study results showed that Extracts from Rabbit Skin Inflamed by Vaccinia Virus Tablets achieved non-inferior efficacy to the positive control drug in alleviating low back pain in patients with lumbar degenerative disorders, with a more favorable declining trend in pain scores. Its safety profile was generally consistent with that of the control drug, and no new safety risks were identified.

Attending experts had practical discussions on data sorting and inspection preparation. Director Ni Suiqin from Guangzhou First People’s Hospital stressed the need to further clarify the judgment logic for causal correlation between severe adverse events and the investigational drug. Director Deng Li from Gaozhou People’s Hospital pointed out that inspectors would focus on the consistency of subjective evaluation indicators and the rigor of medical history documentation. Director Liu Wei from The First Affiliated Hospital of Henan University shared systematic experience of institutional inspection readiness and underscored the significance of standardized procedures and team collaboration.

In-depth R&D: Continuing the Innovative Journey of a Classic Medicine

Since its launch in 2004, Extracts from Rabbit Skin Inflamed by Vaccinia Virus for Injection has been widely applied to treat and relieve various types of neuropathic pain. To offer a more convenient administration route, Vanworid Pharmaceutical (Rugao) Company Limited launched the R&D of its oral tablet formulation and advanced clinical verification after years of research.

This Phase III trial adopted a multi-center, randomized, double-blind, parallel positive-controlled design to scientifically evaluate the efficacy and safety of the oral tablets for low back pain, generating critical evidence to support its new drug application.

Full-cycle Support from Haibote for High-quality Clinical Trial Implementation

As the CRO for this project, Haibote leveraged extensive experience in clinical trial organization and management to coordinate resources across all research centers throughout the trial, ensuring standardized trial procedures and authentic, reliable data. The smooth running of this summary meeting demonstrates Haibote’s comprehensive capabilities in multi-party coordination, professional technical support and event planning.

Moving forward, Haibote will continue to cooperate with the sponsor and research institutions to steadily advance follow-up work for this product, delivering new safe and effective therapeutic options to more patients.

Thank you for following the official platform of Vanworld! We are committed to providing you with professional, reliable and cutting-edge medical and health information.

Kind Reminder: All content released on this platform is for popular science of health knowledge only, intended to share more health-related information, and shall not replace professional medical diagnosis. Please be sure to consult a qualified doctor and strictly follow medical advice for specific diagnosis and treatment plans.

Disclaimer: Reposted from Haibote for industry information sharing. Contact us for any copyright issues; we will amend or remove content after verification. Thanks for your support.