NINGBO, China, June 22, 2026 /PRNewswire/ -- TrueLab Biopharmaceutical, an immunology-driven innovator leveraging a proprietary, AI-powered R&D platform to develop transformative therapies for immune-mediated inflammatory diseases, today announced that it has entered into an exclusive license agreement with Bionyra Pharma, a newly launched clinical-stage biopharmaceutical company, for TL-001, an anti-TL1A monoclonal antibody, and TL-003, a TL1A × IL-23p19 bispecific antibody.
Under the terms of the agreement, Bionyra has been granted exclusive worldwide rights, excluding Greater China, to research, develop, manufacture, and commercialize TL-001 and TL-003. TrueLab is eligible to receive up to $985 million in total consideration related to TL-001 and TL-003, including the upfront payment as well as development, regulatory, and commercial milestone payments. The agreement also includes tiered royalties on future net sales. In addition, TrueLab is granted a single-digit equity stake in Bionyra Pharma following completion of its Series A financing.
The collaboration further provides Bionyra with the opportunity to advance additional preclinical programs from TrueLab within a similar framework.
In connection with the agreement, Bionyra Pharma has completed a $165 million Series A financing co-led by Jeito Capital and Sofinnova Partners, with participation from Arkin Capital, Sanofi Ventures, Sixty Degree Capital, Vives Partners, and Apollo Health Ventures.
"We are delighted to partner with Bionyra Pharma to advance TL-001 and TL-003 programs, two differentiated immunology programs with the potential to transform the treatment landscape for inflammatory bowel disease (IBD) and other immune-mediated inflammatory diseases." said Dr. Francis Fan, Founder, Chairman and CEO of TrueLab Biopharmaceutical, "This collaboration represents a significant validation of our TrueForge platform, which integrates translational science, advanced antibody engineering to systematically discover and develop next-generation biologics. More importantly, it demonstrates our ability to consistently generate high-value therapeutic candidates and translate scientific innovation into globally competitive clinical assets that can ultimately benefit patients worldwide."
"TrueLab technologies and expertise in the field of antibody engineering and development are impressive. We are very happy to have the opportunity to work together. Bionyra will provide its expertise in immunology and global clinical development and we strongly believe our partnership will be very productive" said Dr. Frédéric Marrache, Founder and CEO of Bionyra Pharma.
TrueLab continues to leverage its TrueForge AI-powered discovery platform to generate differentiated next-generation biologics for immune-mediated inflammatory diseases. Supported by strong internal research and development capabilities, TrueLab is building a diversified pipeline of high-value therapeutic candidates and translate scientific innovation into globally competitive clinical assets.
About TL-001 (BYN-002)
TL-001 (also known as BYN-002) is an extended half-life, humanized IgG1 monoclonal antibody targeting human tumor necrosis factor-like cytokine 1A (TL1A). It is designed to block TL1A-mediated signaling by inhibiting the interaction between TL1A and its receptor, a well-validated pathway implicated in the pathogenesis of multiple immune-mediated inflammatory diseases, including IBD. TL-001 has the potential to be a best-in-class therapy for IBD and other TL1A-relevant indications. TrueLab has completed enrollment for a Phase I clinical trial in Australia, including both single ascending dose and multiple ascending dose cohorts.
About TL-003 (BYN-003)
TL-003 (also known as BYN-003) is a novel, extended half-life, bispecific antibody designed to bind both human TL1A and interleukin-23 (IL-23) with high affinity, either individually or simultaneously. Through dual targeting of TL1A and IL-23, TL-003 has the potential to be a best-in-class therapy for IBD and other TL1A and IL-23 relevant immune-mediated inflammatory diseases. TL-003 is currently being evaluated in a Phase I Clinical Trial in Australia, with enrollment initiated in 2026.
About TrueForge AI-powered discovery platform
TrueForge is TrueLab's proprietary R&D platform that integrates translational science, antibody engineering, and data-driven technologies, including machine learning and generative AI, to enhance and accelerate drug discovery. By integrating multi-omic biological data with proprietary analytical models, the platform enables identification of novel therapeutic targets and supports rational design of antibody modalities with optimized developability and pharmacokinetic properties, including improved binding affinity and extended half-life.
Rather than replacing core scientific expertise, TrueForge functions as an enabling layer that strengthens TrueLab's internal capabilities, bridging deep biological insight with efficient therapeutic discovery and development to advance transformative therapies for patients.
About TrueLab Biopharmaceutical
TrueLab Biopharmaceutical is an immunology-driven biopharmaceutical company focused on discovering and developing differentiated therapies for immune-mediated inflammatory diseases. Leveraging deep expertise in disease biology, antibody engineering and drug development, the Company advances innovative therapeutics from discovery through early clinical development. Through its TrueForge AI-powered R&D platform and strong internal discovery capabilities, TrueLab is building a diversified pipeline of next-generation monoclonal, bispecific, and multispecific antibodies designed to address significant unmet medical needs worldwide.
Since its inception, TrueLab has completed multiple rounds of financing totaling $53 million, with participation from Han Kang Capital, Bayland Capital, Legend Capital, Huagai Capital, Loyal Vally Capital, Tencent Investment, Xiamen C&D Group and HongPei Capital.
About Bionyra Pharma
Bionyra Pharma is a clinical-stage biopharmaceutical company developing next-generation biologics for severe immune-mediated inflammatory diseases. Bionyra's best-in-class mono and multispecific antibodies target novel immune pathways, enabling deeper and more durable disease control, with an initial focus on atopic dermatitis and inflammatory bowel disease. Seed financed by Sofinnova Partners, Bionyra was co-founded by Sofinnova Partners and Frédéric Marrache, MD, PhD, MBA, a former Sanofi R&D executive with deep immunology expertise. The company is committed to overcoming the limitations of existing therapies by delivering patient-optimized treatments with greater efficacy and improved convenience, offering better and longer-lasting outcomes.
Contacts:
Business development: bd@truelab-bio.com
Investors & Media: ir@truelab-bio.com
General Inquiries: info@truelab-bio.com
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