Forlong Biotechnology Receives Milestone Payment as Partner's Fbody® Fusion Protein Therapy Advances to IND Submission
核心洞察
Forlong Biotechnology (搜索) received its first milestone payment following a partner's IND submission to China's NMPA for a protein therapy using the company's proprietary Fbody® technology platform.
The milestone stems from licensing and collaboration agreements with Shell BioTech (搜索) and a third party, originally established in 2020 and restructured in 2025 to include upfront payments, milestones, and royalties.
Fbody® technology is designed to optimize protein half-life and biodistribution by maintaining FcRn (搜索) affinity while eliminating binding of FcγRs (搜索) and complement systems.
Forlong Biotechnology (搜索), a clinical-stage biotech company developing cytokine therapies, announced it has received the first milestone payment under its licensing and collaboration agreements following a partner's IND submission for a protein therapy incorporating the company's proprietary Fbody® technology platform to China's National Medical Products Administration.
Partnership Evolution and Financial Structure
The milestone payment represents a significant development in Forlong's collaboration strategy that began in 2020. Initially, Forlong partnered with Shell BioTech (搜索), a Chinese CDMO, to leverage the Fbody® Technology Platform for developing long half-life peptide therapy for a third party. In 2025, the partnership evolved into a formal licensing agreement with the third party for selected protein therapy candidates incorporating Fbody®, with restructured terms including upfront payments, milestone payments, and royalties on future product sales.
Fbody® Technology Platform
Fbody® Long-acting Technology represents one of Forlong's synthetic immunology platforms. The technology features a single-chain Fc engineered to maintain FcRn (搜索) affinity while eliminating binding of FcγRs (搜索) and complement systems, specifically designed to optimize protein half-life and biodistribution.
Clinical Pipeline Progress
Forlong's lead clinical candidate FL115, an interleukin-15 (搜索) (IL-15 (搜索)) superagonist incorporating Fbody®, is currently in multiple clinical studies across China and the United States. The therapy has demonstrated a favorable safety profile and preliminary clinical responses in patients with advanced solid tumors (搜索). FL115 is advancing to combination therapy with PD-(L)1 (搜索) antibodies in Phase I trials for patients with advanced solid tumors and combination therapy with Bacillus Calmette-Guérin (搜索) (BCG) in Phase II trials for patients with nonmuscle invasive bladder cancer (搜索) (NMIBC (搜索)).
The company's second candidate, FL116 (搜索), is a human anti-programmed cell death protein 1 (PD-1 (搜索)) antibody site-specifically fused to an interleukin-18 (搜索) (IL-18 (搜索)) variant with minimal binding affinity to the IL-18 binding protein (IL-18BP). This candidate has demonstrated potent tumor-killing efficacy in multiple in vivo tumor models sensitive or resistant to immune checkpoint inhibitors.
Strategic Validation
"We are excited to see another Fbody® fusion protein therapy advancing into clinic, a significant milestone for our synthetic immunology platforms," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology (搜索). "FL115's best-in-class potential in the challenging IL-15 (搜索) superagonist class first showcased unique properties of Fbody®, and this milestone further validates its ability to enhance profiles for variety of proteins beyond cytokines, and success of our out-licensing strategy and its ability to drive real-world impact through partnerships."
Technology Platform Portfolio
Forlong has established four proprietary synthetic immunology platforms: the Fbody® Long-acting Technology Platform, Fc engineering platform, Syntokine® Synthetic Cytokine Platform, and AI-driven Intelligent Biomolecular Discovery Platform. This diversified approach positions the company to address various therapeutic challenges in cytokine therapy development.