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On July 3, China's National Medical Products Administration (NMPA) officially approved Gensci Pharma's Class 1 innovative drug—fusincimab (brand name: Jinbeixin®). As China's first independently developed fully human anti-IL-1β monoclonal antibody, its approval fills the gap for precision-targeted therapies in China's gout treatment landscape. As Gensci's long-term partner, Pristine Pharma leveraged its expertise in clinical trial design and execution to expedite the R&D journey of this blockbuster drug, bringing new hope to over 14.66 million Chinese gout patients.
According to the 2021 China Hyperuricemia and Gout Trends White Paper, China has 177 million hyperuricemia patients and over 14.66 million gout sufferers—making it the second-largest metabolic disease after diabetes. Despite widespread use of traditional treatments, nearly half of patients experience inadequate pain relief, and ~60% suffer recurrent attacks within a year. Fusincimab's approval offers a novel therapeutic option for adults with acute gouty arthritis.
As a specialized CRO with 22 years of clinical research expertise, Pristine Pharma has built a data-centric end-to-end service system spanning "trial design → data management → statistical analysis → regulatory submission." Its core biostatistics team averages 17+ years of industry experience, having contributed to 2,200+ projects and 210+ product approvals, with deep expertise in endpoint design and data standards for diseases like gout.
Throughout fusincimab’s 4-year development cycle (2021–2025)—covering Phase I, II, III, and ISS studies—Pristine served as the core biostatistics partner, steering a complex program of 6 interlinked trials. Facing multi-phase (I/II/III/ISS) challenges, we demonstrated exceptional resource integration and dynamic management:
Mobilized a 152-member cross-functional team spanning 12 critical roles (data management, biostatistics, CDISC experts, etc.)
Dedicated 18,706.9 hours (including 912.5 overtime hours)
Executed 107 key submissions (IND, interim analyses, NDA, ISS, DSUR)
This underscores Pristine's prowess in managing long-term, multi-phase R&D programs.
Fusincimab's launch marks China's entry into precision-targeted gout therapy. As a fully human IL-1β monoclonal antibody, it directly inhibits the core inflammatory mechanism by blocking IL-1β/receptor binding. Unlike symptomatic treatments, it addresses both acute flares and intercritical periods, providing long-term anti-inflammatory protection. Clinical data show:
Rapid onset: 6 hours post-dose
Analgesic efficacy matching corticosteroids at 6–72 hours
87% lower recurrence risk vs. compound betamethasone at 24 weeks
85.3% of patients achieved zero recurrence
No drug-related serious adverse events observed
China's gout drug market is projected to reach ¥10.8 billion by 2030. As the nation's first approved IL-1β mAb, fusincimab is poised to become the largest single product in China's autoimmune therapy sector. Gensci is actively expanding its indications:
Connective tissue disease-associated interstitial lung disease: Phase II trials ongoing
Pristine will continue providing robust support—through professional trial design, efficient data management, and advanced statistical analysis—to accelerate approval of additional indications.
As fusincimab's indications grow, Pristine remains committed to empowering innovation, accelerating breakthrough therapies to patients, and advancing China's biopharmaceutical industry toward higher-quality development.
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