Global Phase 3 study met its primary endpoint demonstrating clinically meaningful improvement in progression-free survival, positioning HBI-8000 plus nivolumab as a potential new frontline treatment option for patients with advanced melanoma.
SAN DIEGO, July 14, 2026 /PRNewswire/ — HUYABIO International today announced statistically significant and clinically meaningful topline results from its global Phase 3 clinical trial evaluating HBI-8000 in combination with nivolumab for patients with advanced melanoma, bringing the company one step closer to a potential new frontline treatment option for one of the deadliest forms of skin cancer.
The study met its primary endpoint, with patients receiving HBI-8000 in combination with nivolumab achieving a median progression-free survival of 11.7 months, compared with 7.4 months for patients receiving nivolumab plus placebo, a statistically significant improvement in progression-free survival of 58%. Further statistical analysis is in progress to identify in detail the strong efficacy advantage of HBI-8000.
The randomized global Phase 3 trial enrolled 404 patients across 15 countries, representing HUYABIO’s largest oncology study to date. HBI-8000 is an oral drug that has received regulatory approval for lymphoma in China and Japan. It has been prescribed to over 90,000 patients and so has a well established safety record.
“These results represent an exciting milestone for patients and the future of melanoma treatment,” Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said. “Although immunotherapy has dramatically improved outcomes, many patients still need better options. We believe HBI-8000 will become an important addition to the standard of care, helping physicians improve outcomes while bringing new hope to patients and their families.”
Data from HBI-8000-303 will be presented at future medical meetings.
HUYABIO International
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan and China, the company has become a partner of choice to accelerate product development and maximize value globally.
For more information, visit www.huyabio.com.
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SOURCE HUYABIO International