• Partnership combines TJ Bio’s innovative R&D capabilities with Sanofi's market leadership to develop and commercialize uliledlimab in Greater China, addressing unmet medical needs in oncology
• Agreement includes upfront and near-term milestone payments totaling €32 million (approximately $36 million), plus subsequent milestone payments; total potential value up to €213 million (approximately $238 million)
• TJ Bio will receive tiered royalties based on sales and additional milestone payments for new indications
• TJ Bio to lead clinical development and long-term manufacturing efforts; Sanofi to share partial development costs and lead commercialization

HANGZHOU, China – September 25, 2024 – TJ Biopharma (“TJ Bio” or “Company”), a fully integrated biotech company in China that develops, manufactures, and partners on innovative biologics for autoimmune diseases and oncology, today announced a strategic partnership with Sanofi for the development, manufacturing, and commercialization of uliledlimab, the Company’s proprietary differentiated CD73 antibody, in Greater China. This strategic partnership combines TJ Bio's innovative R&D and manufacturing capabilities with Sanofi's established commercial network in the Chinese market to address unmet medical needs in cancer treatment.

Uliledlimab, an innovative CD73 antibody that promotes stronger activation of patients’ immune systems against cancer cells, is currently being evaluated in a pivotal Phase 2/3 study in combination with toripalimab for treatment-naïve advanced non-small cell lung cancer (NSCLC) in China. Data from earlier studies of uliledlimab conducted in the U.S. and China, presented at ASCO 2023¹, demonstrated favorable safety profiles and positive efficacy signals in combination with toripalimab for patients with CD73^High NSCLC. Recent studies also show a strong correlation between high CD73 expression in tumors and better clinical response, particularly in patients with PD-L1 TPS≥1%, suggesting CD73’s potential role as a predictive biomarker.

Under the terms of the agreement, Sanofi will receive an exclusive license to develop, manufacture, and commercialize uliledlimab in mainland China, Hong Kong, Macau, and Taiwan. TJ Bio will receive an upfront payment and a series of milestone payments, including two near-term milestones.

 Key highlights of the partnership include:

• TJ Bio will lead clinical development for specific cancer indications and be responsible for clinical supply and long-term commercial manufacturing, while Sanofi will share partial development costs and lead commercialization efforts of uliledlimab in Greater China
• Sanofi will pay TJ Bio €32 million (approximately $36 million) in upfront and near-term milestone payments, plus specified regulatory and commercial milestone payments; total potential consideration up to €213 million (approximately $238 million)
• Upon commercialization, TJ Bio will be eligible to receive tiered royalties based on net sales of uliledlimab in Greater China, reaching up to double-digit percentages
• TJ Bio will receive additional milestone payments for each new indication of uliledlimab upon regulatory approval, beyond the aforementioned financial terms.

“This strategic partnership with Sanofi marks a significant milestone for TJ Bio in executing our new business strategy to maximize pipeline value through global partnerships, following the Company’s recent restructuring. Combined with our two scheduled BLA submissions this year, we are accelerating this business initiative to strengthen our diverse and sustainable revenue model,” said Dr. Jingwu Zang, Founder and Chairman of TJ Bio. “Sanofi’s leadership position in both global and China markets makes them an ideal partner for advancing uliledlimab’s development and commercialization to benefit cancer patients across the region. This collaboration not only highlights TJ Bio’s innovation capabilities but also underscores our proven track record of forging high-value partnerships with industry leaders.”

1. Zhou Q, et al. Uliledlimab and toripalimab combination therapy in treatment naive advanced NSCLC: Phase 1b/2 clinical trial results using CD73 as a potential predictive biomarker. J Clin Oncol. 2023;41(16_suppl):2570. doi:10.1200/JCO.2023.41.16_suppl.2570

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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 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.

About TJ Biopharma

TJ Biopharma is a fully integrated biotech company pioneering innovative biologics in autoimmune diseases and immuno-oncology. Committed to bringing life-changing immunotherapies from lab to patients worldwide, TJ Biopharma features a differentiated pipeline of advanced clinical assets, state-of-the-art GMP manufacturing capabilities, and a diverse, sustainable revenue model that drives value throughout the innovation pathway in China and globally. For more information, please visit: TJBio.com.