LaNova Medicines Receives CDE Approval to Initiate Phase II Trial of LM-24C5 (Anti-CEACAM5/4-1BB BsAb)

Shanghai, August 7, 2025 – LaNova Medicines Ltd. announced that its internally developed CEACAM5/4-1BB bispecific antibody, LM-24C5, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China to initiate a Phase II clinical trial. The trial will evaluate LM-24C5 in combination with other anti-tumor agents in patients with CEACAM5-positive advanced solid tumors.

 CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5) is highly expressed in various solid tumors—including non-small cell lung cancer, colorectal cancer, and gastric cancer—making it a promising target for cancer therapy^[1]. LM-24C5 is a conditionally activated bispecific antibody engineered using LaNova's proprietary 4-1BB agonist platform. It is designed to simultaneously bind CEACAM5 on tumor cells and 4-1BB on immune cells, thereby directing and activating immune responses within the tumor microenvironment while minimizing off-target immune activation and associated systemic toxicities.

Preclinical studies have demonstrated that LM-24C5 can induce durable anti-tumor immune memory and exhibits synergistic effects when used in combination with other immunotherapeutic agents. These results support its potential to become a first-in-class immunotherapy.

LM-24C5 is currently in Phase I/II clinical development in the United States.

Reference:

[1] Clin Cancer Res; 26(24) December 15, 2020; Clin Cancer Res. 2021 March 01; 27(3): 759–774; The Human Protein Atlas