Amberstone Biosciences and Henlius Enter into Collaboration and License Agreement for Conditionally Activated T-Cell Engagers for Solid Tumors

IRVINE, Calif., Sept. 24, 2026 /PRNewswire/ -- Amberstone Biosciences, Inc., a preclinical-stage oncology company developing pH-gated, tumor-activated T-cell engagers (TCEs), today announced a collaboration and license agreement with Shanghai Henlius Biotech, Inc., a commercial-stage biopharmaceutical company (2696.HK). Under the agreement, Amberstone will work with Henlius to apply its proprietary T-MATE™ (Tumor Microenvironment Activated ThErapeutics) platform technology to generate preclinical candidates against up to two targets selected by Henlius. Henlius will lead subsequent research, development, manufacturing, and commercialization activities worldwide.

T-cell engagers redirect a patient's T cells to kill cancer cells, but their development in solid tumors has been constrained by cytokine release syndrome and on-target, off-tumor toxicity. T-MATE is designed to address these limitations through reversible pH gating, reducing T-cell activation in the circulation and healthy tissues while retaining therapeutic activity across a broad range of pH conditions found in solid tumors. Preclinical studies have shown potent tumor-cell killing under tumor-like pH conditions with markedly reduced activity at physiological pH. Amberstone's self-developed lead T-MATE TCE asset is expected to enter clinical development in the first half of 2027.

Under the agreement, Amberstone will receive an upfront payment and research funding, and is eligible to receive up to US$440 million in potential development, regulatory, and sales milestones for each target, plus tiered royalties on net sales.

About Amberstone Biosciences

Amberstone Biosciences, Inc. is a preclinical-stage oncology company based in Irvine, California, developing tumor-activated antibody therapeutics through internal innovation and strategic partnerships. Its proprietary T-MATE™ platform uses reversible, pH-sensitive activation and is designed to widen the therapeutic window of T-cell engagers and beyond, by reducing activity in blood and normal tissues while preserving efficacy in the tumor microenvironment. The company's lead candidate is in IND-enabling development with additional internal programs in the discovery.

About Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. Founded in 2010, Henlius has established an integrated platform spanning R&D, clinical operations, regulatory affairs, manufacturing, and commercialization. To date, 10 Henlius products have received regulatory approvals across more than 60 countries and regions, including four products approved by the U.S. FDA and five by the European Commission. Henlius is advancing more than 50 early-stage innovative assets across  immune checkpoint inhibitors, antibody-drug conjugates, and AI-enabled discovery programs, with more than 50 clinical trials ongoing globally. Henlius also operates a biologics manufacturing network with 84,000 L of total capacity and GMP certifications from regulatory authorities in China, Europe, and the United States. To learn more about Henlius, visit the website at Henlius.com or LinkedIn at Henlius Linkedin.

Media and Business Development Contact

George Wu, Amberstone Biosciences, Inc., 15300 Barranca Parkway, Suite 100, Irvine, CA 92618
Email: [email protected]

Forward-Looking Statements: This press release contains forward-looking statements, including statements regarding the collaboration, anticipated research and development activities, and potential milestones. Drug development is subject to substantial risks and uncertainties, and actual results may differ materially from those expressed or implied by these statements.

SOURCE Amberstone Biosciences