• The Company’s Third Commercial-Stage Pipeline Product Enters Regulatory Review for Approval, Following Felzartamab and Eftansomatropin Alfa

Hangzhou, China – October 14, 2025 – TJ Biopharma (“TJ Biopharma” or the “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 that its partner CSPC Pharmaceutical Group (01093.HK, “CSPC”) has received formal acceptance from the China National Medical Products Administration (NMPA) for the Biologics License Application (BLA) of Efmedaglutide Alfa (also known as TJ103 or TG103) for the long-term management of overweight or obese adults. The BLA was submitted by CSPC’s subsidiary Baike (Shandong) Biopharmaceutical Co. Ltd (“CSPC Baike”).

Efmedaglutide Alfa is a recombinant human glucagon-like peptide-1 (GLP-1) Fc-fusion protein injection designed for once-weekly dosing. It selectively activates the GLP-1 receptor to suppress appetite and reduce food intake, resulting in significant weight reduction while improving glycemic control and metabolic parameters. The therapy has demonstrated favorable efficacy and safety profiles, offering a promising treatment option for patients with overweight and obesity.

In 2018, TJ Biopharma¹ and CSPC entered into a strategic collaboration, under which TJ Biopharma granted CSPC Baike the exclusive rights to develop, register, manufacture, and commercialize the product in Mainland China (excluding Hong Kong, Macau, and Taiwan). Under the licensing agreement, TJ Biopharma is eligible to receive development milestone payments and sales-based royalties. The NMPA acceptance of the BLA marks a major regulatory and commercial milestone for the product.

TJ Biopharma currently has a robust and well-balanced two-wave pipeline, including three products that are under regulatory review for approval and several others in Phase 3 or near-Phase 3 development, including Felzartamab (multiple myeloma and autoimmune diseases), Eftansomatropin Alfa, Efmedaglutide Alfa, Plonmarlimab, Uliledlimab, and Givastomig. Together, they span the Company’s three core therapeutic areas – autoimmune, immuno-oncology, and metabolic disorders. Through a diversified business model integrating product commercialization, business development partnerships, and CDMO services, TJ Biopharma has built a fully integrated value chain from discovery to production and commercialization, supporting long-term sustainable growth.

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About Efmedaglutide Alfa

Efmedaglutide Alfa (also known as TJ103 or TG103) is a long-acting GLP-1 receptor agonist developed based on an Fc-fusion protein platform. It is characterized by once-weekly dosing, an extended half-life, and favorable tolerability, enabling simultaneous weight reduction and glycemic improvement. In 2018, TJ Biopharma licensed the product to CSPC Pharmaceutical Group for exclusive development and commercialization in Mainland China (excluding Hong Kong, Macau, and Taiwan). Under the licensing agreement, TJ Biopharma is entitled to milestone payments and sales-based royalties. The product is currently being developed by CSPC, with its BLA for obesity accepted by NMPA in October 2025, and additional clinical studies underway in type 2 diabetes and other metabolic indications. 

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 established a differentiated two-wave pipeline, including three products (Felzartamab, Eftansomatropin Alfa, and Efmedaglutide Alfa) that are under regulatory review for approval, and additional Phase 3 or pre-Phase 3 assets with first-in-class potential advancing toward clinical entry. 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.

Note:

1. The original licensing agreement was signed between I-Mab Biopharma and CSPC. Following the Company’s restructuring completed in April 2024, the licensor was changed to TJ Biopharma, which remains entitled to receive all future milestone payments and royalties under the existing agreement.