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Lancet-Validated Milestone: GCP ClinPlus' Biostatistics Team Elevates China's Influenza Drug Research onto the World Stage

Lancet-Validated Milestone: GCP ClinPlus' Biostatistics Team Elevates China's Influenza Drug Research onto the World Stage
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    Lancet article screenshot


    On 10 June, Guangzhou National Laboratory held a landmark press conference for onradivir. Academician Zhong Nanshan—recipient of the Medal of the Republic and Director of Guangzhou National Laboratory—announced that the world's first PB2-subunit inhibitor for influenza A, onradivir, received NMPA approval on 20 May. The pivotal Phase III results were simultaneously published in The Lancet. Representatives from Guangzhou Medical University First Affiliated Hospital, National Respiratory Medicine Center, National Clinical Research Center for Respiratory Diseases, Zhongsheng Ruichuang Biotech, and GCP ClinPlus (Beijing) attended the event.


    The study, titled "Efficacy and safety of onradivir in adults with acute uncomplicated influenza A infection in China: a multicentre, double-blind, randomised, placebo- and oseltamivir-controlled, phase 3 trial", is a watershed publication for Chinese innovation. Every complex statistical analysis, figure, and rigorous response to The Lancet's editorial queries was executed by GCP ClinPlus' veteran biostatistics and programming unit. Working around the clock against a tight journal deadline, the team delivered flawless, publication-ready outputs—proof of world-class professionalism and commitment. Phase II findings, also published in The Lancet, were hailed internationally as "a breakthrough against antiviral resistance". As the core clinical-research partner, GCP ClinPlus provided end-to-end, data-driven support that laid the scientific cornerstone for the first-in-class PB2 inhibitor.


    Full-spectrum, high-impact biostatistics



    A RMB 10-billion blue-ocean market


    China's anti-influenza market exceeded RMB 10 billion in 2023 and is projected to reach RMB 22.4 billion by 2027. With oseltamivir dominating and baloxavir marboxil emerging, PB2-targeting onradivir—backed by superior efficacy data—is poised to capture significant share.


    Scientific rigor powering global recognition


    By steering onradivir from trial design to Lancet publication, GCP ClinPlus has deepened its expertise in antiviral R&D and in meeting the exacting standards of top-tier journals. Going forward, we will continue to deliver internationally competitive biostatistics, data management and quality-assurance solutions that help Chinese innovators shine on the global stage.


    With onradivir's launch imminent, CITIC Securities forecasts Zhongsheng Pharma's net profit at RMB 300 million (2025), RMB 391 million (2026) and RMB 517 million (2027).


    Rooted in "Science, Precision, Efficiency, Innovation", GCP ClinPlus stands ready to partner with innovators worldwide—turning rigorous data into therapies that benefit patients everywhere and showcasing the rising power of Chinese pharmaceutical science.


    Lancet-Validated Milestone GCP ClinPlus’ Biostatistics Team Elevates China's Influenza Drug Research onto the World Stage

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