• Following the obesity indication, the BLA for Efmedaglutide Alfa for glycemic control in adults with type 2 diabetes has been accepted by China’s National Medical Products Administration, further expanding the product’s indication coverage in metabolic diseases

• With Efmedaglutide Alfa, Eftansomatropin Alfa and Felzartamab all entering regulatory review or key commercialization stages, TJ Bio’s near-commercial product portfolio is positioned for forthcoming value realization

Hangzhou, China – June 22, 2026 – TJ Biopharma (“TJ Bio” 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 Limited (01093.HK, “CSPC”), through its subsidiary CSPC Baike (Shandong) Biopharmaceutical Co., Ltd., has received acceptance from China’s National Medical Products Administration (NMPA) for the Biologics License Application (BLA) of Efmedaglutide Alfa (also known as TJ103 or TG103), for glycemic control in adults with type 2 diabetes. The product was submitted as a Class 1 therapeutic biologic. Previously, the BLA for Efmedaglutide Alfa for the long-term management of overweight or obese adults was accepted by the NMPA in October 2025.

Efmedaglutide Alfa is a recombinant human glucagon-like peptide-1 (GLP-1) Fc-fusion protein injection designed for once-weekly dosing. The product selectively binds to and activates the GLP-1 receptor, promoting insulin secretion and inhibiting glucagon release in a glucose-dependent manner to help lower blood glucose steadily. It can also suppress appetite and reduce food intake, supporting weight management while potentially improving cardiovascular and metabolic parameters.

The BLA is primarily supported by two pivotal Phase 3 clinical studies, which evaluated the efficacy and safety of Efmedaglutide Alfa as monotherapy and in combination with metformin in Chinese patients with type 2 diabetes. Results from the studies showed that:

• Efmedaglutide Alfa delivered comprehensive benefits in glycemic control, weight reduction and multiple metabolic parameters;

• The product demonstrated rapid onset of action, with clear effects observed after four weeks of treatment. By week eight, HbA1c reductions from baseline exceeded 1%, and efficacy was maintained through 52 weeks;

• In patients receiving background metformin therapy, Efmedaglutide Alfa demonstrated better long-term glycemic control compared with dulaglutide;

• Among patients with higher baseline HbA1c levels, Efmedaglutide Alfa achieved greater HbA1c reductions, reaching more than 2%;

• The product was generally well tolerated, with lower rates of gastrointestinal adverse events and treatment discontinuation due to adverse events compared with marketed drugs in the same class. Its dose-escalation regimen is also faster and simpler, requiring only four weeks to reach the target maintenance dose.

In 2018, the Company¹ and CSPC entered into a strategic collaboration, under which CSPC Baike was granted exclusive rights to develop, register, manufacture and commercialize Efmedaglutide Alfa in Mainland China. Under the licensing agreement, TJ Biopharma is eligible to receive development milestone payments and sales-based royalties. The NMPA acceptance of the second BLA reflects CSPC’s continued execution in clinical development and regulatory advancement, and further enhances the product’s potential clinical and commercial value in metabolic diseases.

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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 glycemic improvement and weight reduction while potentially delivering broader metabolic benefits. 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.

Efmedaglutide Alfa is currently being developed and registered by CSPC. The product’s BLA for the long-term management of overweight or obese adults was accepted by the NMPA in October 2025, and its second BLA for glycemic control in adults with type 2 diabetes was accepted in June 2026.

About TJ Biopharma

TJ Biopharma is a fully integrated biotech company advancing next-generation therapies in autoimmune diseases, immuno-oncology and metabolic disorders.

Anchored by comprehensive R&D centers in Shanghai and Beijing and a state-of-the-art GMP manufacturing facility in Hangzhou, the Company has built a clearly differentiated two-wave pipeline. The first wave includes products currently under regulatory review, together with additional late-stage assets in registrational or pre-Phase 3 development, while the second wave comprises novel antibody conjugates with first-in-class potential powered by the Company’s proprietary Antibody^PLUS technology platforms, with programs advancing through Phase 1 studies or preparing for clinical entry. Over the years, TJ Biopharma has established a robust network of development and commercialization partnerships with Jumpcan, CSPC, Sanofi, Biogen and other leading industry players. The Company is committed to delivering innovation through a diversified and sustainable revenue model that integrates global asset transactions, contract manufacturing services, and future product sales. or more information, please visit TJBio.com or follow us on LinkedIn.

References:

1. The original licensing agreement was signed between I-Mab Biopharma and CSPC in 2018. 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.