December 14, 2025 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter "ImmuneOnco", HKEX: 01541.HK) successfully convened the interim investigators' meeting for the "Phase Ib/II Clinical Study of Injectable IMC-002 (IMM0306) in Active Systemic Lupus Erythematosus (SLE)" in Beijing.

The meeting focused on summarizing encouraging clinical data and establishing consensus on efficacy evaluation, biomarker analysis, and corticosteroid regimens for the next phase.

Efficacy: The 24-week SRI-4 response rate was notable: 71.4% (5/7) in the 0.8 mg/kg cohort and 80% (4/5) in the 1.2 mg/kg cohort. Patients achieved complete resolution of arthritis, vasculitis, and alopecia, with significant improvements in key biomarkers including anti-dsDNA antibodies, 24-hour urinary protein, and complement C3/C4. Following deep B-cell depletion, 5 patients exhibited orderly B-cell reconstitution at 12–24 weeks (2 in the 0.8 mg/kg cohort, 3 in the 1.2 mg/kg cohort), predominantly with naïve B cells, supporting long-term immune balance.

Safety: Among 19 subjects, 73.7% reported TRAEs, mostly mild-to-moderate; only 2 cases had Grade ≥3 TRAEs (both thrombocytopenia, spontaneously resolved within 4–5 days). No DLT, CRS, or major infection events occurred. Immunoglobulin levels remained normal, with no dose adjustments or deaths due to TRAEs, demonstrating a favorable safety profile.

Led by Principal Investigator Professor Li Zhanguo (Peking University People's Hospital), a leading authority in rheumatology, the meeting gathered investigators and experts from premier research centers nationwide to discuss this dual-target candidate's clinical profile and development strategy in a vibrant academic atmosphere.

The meeting opened on December 14, chaired by Professor Li Zhanguo. Dr. Wenzhi Tian, Founder and Chairman of ImmuneOnco and Founder of ImmuneCare, and Dr. Qian Zheng, Co-founder and VP of ImmuneCare, delivered opening and closing remarks. Attendees included Ms. Wu Zhuli (CMO of ImmuneOnco), core investigators, sponsor medical/project teams, and CRO representatives, demonstrating exceptional professionalism and collaboration.

Professor Li noted substantial unmet needs in SLE and highlighted IMC-002's unique B-cell depletion and immune reconstitution mechanism as a promising dual-target CD47×CD20 innovation. He emphasized the importance of high-quality trial completion and called for collaborative efforts to bring new treatment options to patients.

Dr. Tian, as sponsor representative and CD47 pioneer, reviewed the study progress since first-patient-in (October 2024), underscoring the scientific value of the CD47×CD20 mechanism. He thanked research teams for their expertise and highlighted the molecule's validated deep B-cell depletion from lymphoma studies and promising SLE efficacy/immune reconstitution, confirming its potential in autoimmunity.

Under Professor Li's moderation, experts detailed process quality control mechanisms, reaching consensus on a three-tier system (CRA monitoring, project manager risk oversight, independent QC verification). They shared best practices on SLE-specific challenges: 24-hour urine collection protocols, corticosteroid taper compliance, and scale assessment consistency, agreeing to strengthen real-time lab-investigator communication.

A dedicated session on patient compliance covered CRC full-process follow-up, pre-scheduled blood draws, standardized infusion reaction prevention, and refined concomitant medication education to ensure data integrity at key timepoints (Weeks 12, 24, 52).

All attendees explored the B-cell reconstitution finding—subjects showed naïve B-cell dominance with 100% SRI-4 response. Experts agreed this "immune reconstitution" phenomenon warrants further investigation in Phase II.

ImmuneOnco will advance IMC-002 to Phase II post-Ib completion and submit an IND for the subcutaneous formulation. The company will also expand development across multiple autoimmune indications—strategies highly endorsed by experts.

The successful meeting marks IMC-002's entry into a new clinical development phase. The established consensus and collaboration framework will enhance execution efficiency and data quality, accelerating innovative SLE therapy development. ImmuneOnco sincerely thanks all investigators and partners and remains committed to advancing this program with scientific rigor to deliver tangible patient benefits and transform the global SLE treatment landscape.