Lee's Pharmaceutical Factory (00950): Proprietary ADC project ZK2401 submitted a new drug clinical trial application in China and was accepted by the NMPA

According to Zhitong Finance App, Li's Pharmaceutical Factory (00950) announced that on July 29, 2026, the Group's New Drug Clinical Trial (IND) application for ZK2401 in China was accepted by the China National Drug Administration (NMPA) Drug Evaluation Center. ZK2401 is a proprietary antibody drug conjugate (ADC) project independently developed by Lee's Pharmaceuticals. Lee's Pharmaceuticals owns the complete global intellectual property rights for this molecule.

ZK2401 is based on the anti-PD-L1 antibody Socazolimab (Socazolimab) independently developed by Lee's Pharmaceuticals and combined with a novel topoisomerase I inhibitor load. As the first project of the ADC platform of Lee's Pharmaceuticals, ZK2401 marks an important starting point for the Group to advance the development of this platform. The ADC is designed to accurately identify and kill tumor cells, and has shown encouraging safety and efficacy in a number of preclinical in vitro and in vivo studies.

For this IND application, the Group adopted a pre-ethical review model and used the new national policy for the review and approval of clinical trials of innovative drugs. Based on the current review path, it is expected that the review period will take about 30 working days. It is expected that the clinical trial will be approved as early as September 2026, and the first patient will be enrolled as early as October 2026.

The Board believes that the submission of the IND application is an important milestone in the Group's innovation pipeline in the field of oncology. The project reflects Lee's pharmaceutical company's continuous independent R&D capabilities in fully independently developing innovative biological and ADC assets, and is in line with the Group's strategic focus, which is to focus on differentiated products with significant clinical potential and defensive competitive advantage based on patented technology.

Socazolimab (previously known as ZKAB001) is a wholly human anti-programmed death ligand 1 (anti-PD-L1) monoclonal antibody owned by China Oncology Medical Co., Ltd. (COF), a subsidiary of the Company. Up to now, socazolimab has been approved for marketing by the NMPA in China for two indications: (1) first-line treatment of extensive small cell lung cancer (ES-SCLC) in combination with chemotherapy, and (2) treatment of recurrent or metastatic cervical cancer.