#China #Ningbo #TL-001 #TrueLab Biopharmaceutical #Bionyra Pharma

TrueLab Biopharmaceutical and Bionyra Pharma Form Strategic Partnership

In a groundbreaking move, TrueLab Biopharmaceutical, a leader in immunology innovation, has unveiled an exclusive licensing agreement with Bionyra Pharma, a newly established biopharmaceutical company focused on advancing clinical stage therapies. The agreement centers on the development of TL-001 and TL-003, two next-generation monoclonal and bispecific antibodies targeting immune-mediated inflammatory diseases, with a potential worth of up to $985 million.

Details of the Licensing Agreement

Under the terms of this partnership, Bionyra Pharma has secured worldwide exclusive rights (excluding Greater China) for the exploration, development, production, and marketing of TL-001 and TL-003. TrueLab stands to receive up to $985 million, which encompasses upfront payments and milestone rewards tied to development, approval, and commercialization stages. Furthermore, the agreement includes tiered royalties on future net sales, and upon completion of a Series A funding round, TrueLab is set to acquire a minority stake in Bionyra Pharma.

Dr. Francis Fan, the Founder, Chairman, and CEO of TrueLab, expressed enthusiasm about the strategic alliance, stating, "We are incredibly excited to collaborate with Bionyra Pharma to advance TL-001 and TL-003—two distinct immunological programs that possess the potential to revolutionize treatment for inflammatory bowel diseases (IBD) and other immune-mediated inflammatory conditions. This partnership represents a significant endorsement of our TrueForge™ platform, which integrates translational science and advanced antibody engineering to systematically discover and develop next-generation biologics. Ultimately, our collaboration aims to transform scientific opportune into globally competitive clinical resources benefiting patients worldwide."

Financial Insights and Market Implications

Bionyra Pharma recently completed a Series A funding round, raising $165 million from major investors such as Jeito Capital and Sofinnova Partners, alongside participation from Arkin Capital, Sanofi Ventures, Sixty Degree Capital, Vives Partners, and Apollo Health Ventures. This influx of capital will bolster their efforts in developing new treatments based on TrueLab's advanced antibody technologies.

Dr. Frédéric Marrache, Bionyra's Founder and CEO, noted, "TrueLab's antibody development and optimization expertise is remarkable. We are thrilled to seize this opportunity for collaboration, bringing our capacities in immunology and global clinical development to the table. We firmly believe that this partnership will prove to be highly productive."

Continued Development Initiatives

TrueLab is actively leveraging its AI-driven discovery platform, TrueForge™, to create differentiated next-generation biologics tailored for immune-mediated inflammatory diseases. With robust research and development capabilities, TrueLab is building a diverse pipeline of high-quality drug candidates and is committed to transforming scientific advances into commercially viable therapeutic resources worldwide.

About TL-001 and TL-003

TL-001 (also known as BYN-002) is a humanized monoclonal IgG1 antibody designed with an extended half-life aimed at blocking the human tumor necrosis factor-like cytokine 1A (TL1A) signaling pathway—a well-validated mechanism involved in various immune-mediated disorders, including IBD. Clinical recruitment for Phase I trials in Australia has been completed, with plans to assess single and multiple ascending doses.

TL-003 (also referred to as BYN-003) is a novel bispecific antibody structured to bind both human TL1A and Interleukin-23 (IL-23) with high affinity, either individually or concurrently. TL-003 is currently undergoing evaluation in a Phase I clinical study in Australia, marking a significant step forward in treating IBD by addressing the roles of TL1A and IL-23.

About TrueLab Biopharmaceutical

TrueLab Biopharmaceutical is dedicated to immunology-focused therapies, seeking to innovate treatments for immune-mediated inflammatory diseases. The company utilizes its proprietary TrueForge™ platform, alongside strong internal development capabilities, to create a robust pipeline of monoclonal, bispecific, and multispecific antibodies. TrueLab's commitment lies in fulfilling substantial unmet medical needs through pioneering scientific advancements.

About Bionyra Pharma

Bionyra Pharma is a clinical-stage biopharmaceutical firm developing next-generation biologics for severe immune-mediated inflammatory diseases. With an emphasis on groundbreaking monoclonal and multispecific antibodies, Bionyra is focused on targeting novel immune pathways to achieve profound and durable disease control, initially concentrating on atopic dermatitis and inflammatory bowel diseases. Founded with backing from Sofinnova Partners and led by Dr. Frédéric Marrache, a former Sanofi executive with immunology expertise, Bionyra is set on redefining treatment paradigms by offering patient-centric solutions aimed at enhanced efficacy and improved comfort, leading to better and more sustainable outcomes.