HANGZHOU, China – April 15, 2025 – TJ Biopharma (“TJ Bio” or “Company”), a fully integrated biotech company focusing on discovery, development, manufacturing and commercialization of innovative biologics in the areas of autoimmune diseases, oncology and metabolic disorders, today announced completion of patient enrollment in the Phase 2 stage of its ongoing Phase 2/3 clinical study evaluating uliledlimab, a differentiated CD73 antibody, in combination with toripalimab (doublet study) as first-line treatment for non-small cell lung cancer (NSCLC). The Company anticipates topline data readout in the first half of 2025 and intends to initiate a Phase 3 registrational study of the doublet study as planned.

“Despite multiple challenges, our team successfully managed to complete the patient enrollment on track, demonstrating TJ Bio’s exceptional clinical operations capabilities,” said Dr. Jingwu Zang, Founder and Chairman of TJ Bio. “The development of uliledlimab,  a cornerstone of our staged pipeline, is accelerating steadily. We’re confident in the clinical value of this therapy and look forward to upcoming data analysis results as we prepare for the Phase 3 study launch, aiming to provide more effective and innovative treatment options for lung cancer patients.”

Earlier this year, TJ Bio initiated and dosed the first patient in another Phase 2 clinical study evaluating uliledlimab in combination with sintilimab and chemotherapy (triplet study) as first-line treatment for NSCLC. The Company is actively advancing both studies in China as planned.

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About Uliledlimab

Uliledlimab (also known as TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine, in turn, binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in the tumor microenvironment. Uliledlimab is expected to offer clinical benefits by suppressing tumor growth in concert with checkpoint therapies such as PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties, as evident in preclinical and clinical studies.

Positive results from the Phase 1b/2 clinical study (NCT04322006) of uliledlimab in combination with toripalimab as first-line treatment for advanced non-small cell lung cancer (NSCLC) were presented at ASCO 2023: The combination therapy showed a 31% response rate in treatment-naïve NSCLC patients; notably, in patients with high CD73 expression and PD-L1 positivity, the response rate reached 63%. Biomarker analysis revealed a strong correlation between high tumor CD73 expression and treatment response, further supporting the potential of CD73 expression as a predictive biomarker. In September 2024, TJ Bio and Sanofi entered into strategic partnership for the development, manufacturing and commercialization of uliledlimab in Greater China.

About TJ Biopharma

TJ Biopharma is a fully integrated biotech company at the forefront of pioneering cutting-edge therapies for autoimmune diseases, immuno-oncology and metabolic disorders. Through its R&D and manufacturing establishments in China, including comprehensive R&D centers in Shanghai and Beijing and a state-of-the-art GMP manufacturing facility in Hangzhou, TJ Biopharma has developed a differentiated and advanced pipeline of innovative clinical products and pre-clinical assets, with its first group of advanced clinical products now progressing toward market approval. Over the years, the Company has established a series of development and commercialization partnerships with Jumpcan, CSPC, Sanofi, and others to commercialize its pipeline products. TJ Biopharma is committed to driving excellence in drug innovation and development through a diverse and sustainable revenue model comprising global asset transactions, contract manufacturing services and future sales revenues. For more information, please visit: TJBio.com.