SBP GROUP - VOLUNTARY ANNOUNCEMENT - ACCEPTANCE OF NEW DRUG APPLICATION FOR M701 "CD3/EpCAM BISPECIFIC ANTIBODY"

(Incorporated in the Cayman Islands with limited liability)

Website: www.sbpgroup.com

(Stock code: 1177)

VOLUNTARY ANNOUNCEMENT

ACCEPTANCE OF NEW DRUG APPLICATION FOR

M701 "CD3/EpCAM BISPECIFIC ANTIBODY"

The board of directors (the "Board") of Sino Biopharmaceutical Limited (the "Company", together with its subsidiaries, the "Group") announces that a new drug application for M701 "CD3/EpCAM Bispecific Antibody", a national Category 1 innovative drug jointly developed by Chia Tai Tianqing Pharmaceutical Group Co. Ltd. ("CTTQ"), a subsidiary of the Group, for the treatment of malignant ascites (MA) caused by advanced epithelial malignancies, has been submitted to and accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration.

M701 is China's first independently developed CD3/EpCAM bispecific antibody, capable of simultaneously targeting EpCAM on tumor cells and CD3 on immune T cells. By forming a bridge between tumor cells and immune T cells through dual-target binding, it activates T cells to kill tumor cells. M701 is currently undergoing multiple clinical trials in China. Among these, a pivotal Phase III clinical trial for MA caused by epithelial solid tumors has been completed, and its marketing application has been formally accepted by the CDE. Additionally, a Phase II clinical trial for malignant pleural effusion (MPE) caused by non-small cell lung cancer has completed patient enrollment.

Malignant effusion is a common complication of mid- to late-stage malignant tumors, with MPE and MA being the most prevalent. Statistics indicate that approximately 50% of patients with advanced malignant tumors develop MPE or MA during disease progression, directly impacting patients' quality of life and survival[1]. Currently, there is no established standard of care for managing MPE and MA. Treatment primarily relies on paracentesis or thoracentesis combined with intraperitoneal or intrapleural administration of therapeutic agents. Options for regional therapeutic agents are limited, and their use lacks guidance from expert consensus or support from large-scale clinical studies. Patients experience poor quality of life and short survival times, indicating a significant unmet medical need. Compared to current primary clinical treatment regimens, M701 demonstrates superior safety and efficacy, positioning it as a potential standard of care for the management of MPE and MA.

This acceptance is based on a Phase III clinical trial (M70104) of M701 conducted in China. The study enrolled patients with MA caused by epithelial malignancies and aimed to evaluate the efficacy and safety of intraperitoneal infusion of M701 in patients with advanced epithelial malignancies presenting with moderate to massive MA. The relevant study data are planned to be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

Source:

[1] Chen, Y., Xu, X., Chen, J., Yin, M., Chen, J., Qi, Z., Shi, M., Su, W. (2026). Fluid-Derived Organoids from Pleural Effusion and Ascites: Emerging Models for Drug Resistance and Personalized Oncology. Journal of Cancer, 17(3), 614- 625.

By order of the Board

Sino Biopharmaceutical Limited Tse, Theresa Y Y

Chairwoman

Hong Kong, 7 May 2026