Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, today announced that it has entered into a collaboration agreement with Shanghai Henlius Biotech, Inc., (2696.HK) (“Henlius”) to develop innovative cancer immunotherapy with an engineered cytokine.

Under the terms of the agreement, Forlong will fuse a monoclonal antibody against a specific target selected by Henlius in a site-specific manner, with an engineered cytokine. In exchange, Forlong will receive an undisclosed upfront sponsor fee and research milestone payments, and upon reaching a predetermined development milestone, further licensing fee payments.

Forlong has developed a portfolio of engineered cytokines aiming to activate specific subpopulations of the immune system. FL115 is an interleukin-15 (IL-15) superagonist to stimulate natural killer (NK) cells and memory T cells, showing favorable safety profile and preliminary clinical responses in multiple Phase I studies in China and US, and is currently being advanced to combo therapy with PD-(L)1 antibodies in Phase I for patients with advanced solid tumors and combo therapy with Bacillus Calmette-Guérin (BCG) in Phase II for patients with nonmuscle invasive bladder cancer (NMIBC). FL116 is a human anti-programmed cell death protein 1 (PD-1) antibody site-specifically fused to an interleukin-18 (IL-18) variant with minimal binding affinity to the IL-18 binding protein (IL-18BP), to preferentially activate T cells expressing both PD-1 and IL-18 receptors, and is in Preclinical Development Candidate Stage. Early research programs include cytokine-fusion proteins to activate naïve T cells and others being developed with proprietary Syntokine^® Synthetic Cytokine Platform and AI-driven Intelligent Biomolecular Discovery Platform.

“Recent progress in cancer immunotherapy has shown tremendous advancement in harnessing power of engineered cytokines through fusion with target proteins to activate desired segments of the immune system with precision,“ said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, “we are very excited by this collaboration, and will continue to further develop cytokine fusion proteins for target-specific immunostimulatory activity to significantly improve therapeutic outcome, through our internal programs such as FL115 and FL116 as well as additional partnership in the future”.

"We are pleased to collaborate with Forlong Biotech to explore new frontiers in cancer immunotherapy," said Jijun Yuan, Ph.D., Chief Scientific Officer of Henlius. "By leveraging Forlong's synthetic cytokine platform for engineered cytokines and Henlius' profound expertise in the ​full-cycle​development of biologics, we will join forces to accelerate the development of novel therapies that can bring clinical benefits to cancer patients."

About Forlong Biotechnology

Forlong Biotechnology is a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs. It has established four proprietary synthetic immunology platforms: Fbody^® Long-acting Technology Platform, Fc engineering platform, Syntokine^® Synthetic Cytokine Platform and AI-driven Intelligent Biomolecular Discovery Platform. Its lead candidate FL115 is interleukin-15 (IL-15) super agonist with best-in-class potential, currently being advanced to combo therapy with PD-(L)1 antibodies in Phase I for patients with solid tumors and combo therapy with Bacillus Calmette-Guérin (BCG) in Phase II for patients with nonmuscle invasive bladder cancer (NMIBC). Its second candidate FL116 is a human anti-programmed cell death protein 1 (PD-1) antibody site-specifically fused to an interleukin-18 (IL-18) variant with minimal binding affinity to the IL-18 binding protein (IL-18BP), and has demonstrated potent tumor-killing efficacy in multiple in vivo tumor models sensitive or resistant to immune checkpoint inhibitors.

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 9 products have been approved for marketing worldwide, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab Bildyos® and Bilprevda®. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251022986359/en/