SUNSHINE PHARMA (06887): Clinical trial application for the new drug HEC-921 injection targeting LY6G6D/4-1BB dual-specific antibody has been accepted by the National Drug Administration.

SUNSHINE PHARMA (06887) announced that on June 18, 2026, the China National Medical Products Administration's Center for Drug Evaluation (CDE) officially accepted the clinical trial application for the targeted LY6G6D/4-1BB bispecific antibody new drug HEC-921 injection submitted by the Group, and is expected to formally start Phase I clinical research in 2026. HEC-921 is a bispecific antibody drug independently developed by the company, intended for the treatment of advanced solid tumors, with LY6G6D-positive colorectal cancer as the main development direction. HEC-921 is designed for tumor-targeted immunotherapy by utilizing LY6G6D to achieve tumor tissue-specific enrichment and regional immune activation in the tumor microenvironment through the 4-1BB pathway, exerting anti-tumor effects. To the best of the company's knowledge and available public information, as of the date of this announcement, there are no similar products applied for clinical trials domestically or internationally. As of the date of this announcement, HEC-921 has completed the key research work required to support the clinical trial application, including pharmaceutical (CMC), pharmacological, pharmacokinetic, and animal safety evaluations. Preclinical studies have shown excellent anti-tumor activity in multiple animal models, synergistic effects with anti-PD-1 antibodies and chemotherapy, and good safety in cynomolgus monkeys. Colorectal cancer is one of the most common malignant tumors worldwide, and there is still a significant unmet clinical need in patients with advanced stages of the disease. HEC-921, with its innovative LY6G6D/4-1BB bispecific antibody design, is expected to improve efficacy while enhancing safety, and has important clinical development value. The Group continues to focus on innovative oncology drug development, with a forward-looking layout in the field of cancer immunotherapy and precision treatment, and has successfully established the TCE technology platform centered on 4-1BB. Currently, the HEC-921 project, which is progressing rapidly, has been accepted for clinical trial application. In addition, leveraging this technology platform, the Group is concurrently advancing multiple preclinical pipelines, such as the 4-1BB/CDH17 bispecific antibody, as planned, and expects to gradually submit applications for clinical trials in the future.