Shanghai, China, May 12, 2026 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. ("ImmuneOnco"; HKEX Stock Code: 01541.HK) today announced that the Investigational New Drug (IND) application for its independently developed amourofavfop alfa (IMM0306) for the indication of primary Sjögren's syndrome (pSS) has been officially approved by the National Medical Products Administration (NMPA) of China. This milestone marks another significant breakthrough in ImmuneOnco's innovative drug development landscape within the field of autoimmune diseases.

Primary Sjögren's syndrome (pSS) is a chronic, systemic autoimmune disease characterized primarily by lymphocytic infiltration of exocrine glands, which severely impacts patients' quality of life. Currently, there remains a substantial unmet clinical need in the treatment of pSS, with an urgent demand for safe and highly effective innovative therapies. The approval of the IND for IMM0306 in the pSS indication brings new hope for treatment to patients in this field.

Amourofavfop alfa (CD47xCD20, IMM0306) is the world's first CD47xCD20 dual-target specific molecule to enter the clinical stage, developed based on ImmuneOnco's proprietary "mAb-Trap" technology platform. ImmuneOnco has comprehensively laid out the development of this product. Data from the Phase Ib/II clinical study in systemic lupus erythematosus (SLE), released in 2025, demonstrated outstanding performance in the improvement of key biomarkers and safety. No cytokine release syndrome (CRS) or significant infectious events were observed, fully validating its robust therapeutic potential and favorable safety profile.

The approval of the IND for the pSS indication represents another significant achievement in ImmuneOnco's strategy of "comprehensively advancing its autoimmune pipeline." Clinical studies of IMM0306 for multiple blockbuster indications, including systemic lupus erythematosus (SLE) and IgG4-related disease (IgG4-RD), are steadily progressing. The Phase Ib clinical data for SLE will be presented at the 2026 EULAR meeting. In recent years, leveraging the powerful extensibility of the "mAb-Trap" technology platform, ImmuneOnco has built a rich and deep product pipeline in the field of autoimmune diseases.

Dr. Tian Wenzhi, Chairman, CEO, and CSO of ImmuneOnco, stated:

"The clinical needs of patients with primary Sjögren's syndrome have long been inadequately met. The rapid advancement of IMM0306 in this indication reflects our firm commitment to translating innovative therapies into tangible benefits for patients. This series of breakthroughs, spanning from early-stage research to late-stage clinical development, fully validates the powerful extensibility and commercial potential of ImmuneOnco's technology platform. Moving forward, we will continue to accelerate the clinical development process, looking forward to providing more effective, safer, and more convenient treatment options for patients with autoimmune diseases worldwide through continuous formulation innovation and clinical exploration."

Dr. Wu Zhuli, Chief Medical Officer of ImmuneOnco, stated:

"The pathogenesis of primary Sjögren's syndrome is closely related to the abnormal activation of B cells and the production of autoantibodies. As an innovative bispecific fusion protein, IMM0306 can simultaneously target CD47 and CD20, enabling the highly efficient clearance of pathogenic B cells and plasmablasts. This 'dual-strike' mechanism holds the promise of breaking through the efficacy bottlenecks of existing single-target drugs. Based on the data of rapid onset, deep remission, and orderly B-cell reconstruction observed in our studies of other autoimmune indications such as systemic lupus erythematosus, we are confident in further validating the immense potential of IMM0306 in improving patients' glandular function and inducing clinical remission in the upcoming pSS clinical trials, providing a highly effective and safe therapeutic solution for this refractory disease."