China Biopharmaceutical (01177): LM-364 “NECTIN-4TMEADC” clinical trial application approved by NMPA and FDA

Zhitong Finance App News, China Biopharmaceutical (01177) announced that the national Class 1 innovative drug LM-364 “Nectin 4TMEADC” independently developed by Lixin Pharmaceutical Technology (Shanghai) Co., Ltd. (Lixin Pharmaceutical), a wholly-owned subsidiary of the Group, has obtained implied clinical trial approval from the China National Drug Administration (NMPA) to treat advanced solid tumors. In April of this year, LM-364 obtained clinical trial approval from the US Food and Drug Administration (FDA) and officially launched clinical trials in Australia. The Group is accelerating the global clinical development of the drug.

Nectin-4 is an important ADC target that has been clinically proven, and is highly expressed in various solid tumors such as urothelial cancer, triple-negative breast cancer, cervical cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma; however, traditional ADCs may also bind to Nectin-4 in normal tissues while identifying tumor cells, causing dose-limiting toxicity such as rash and neurotoxicity, which has become a bottleneck in clinical development.

LM-364 is a next-generation Nectin-4 ADC developed by Lixin Pharmaceutical based on the self-developed tumor microenvironment (TME) antibody-conjugation drug (ADC) platform. It aims to avoid the risk of target toxicity and off-target toxicity (on-target/off-target) common in traditional ADC therapies. Its core design concept is to use biological differences between tumor microenvironment and normal tissue to show TME-dependent regulation of target binding ability, that is, to achieve conditional high affinity activation under tumor microenvironment conditions. Based on the above mechanism, LM-364 can concentrate its anti-tumor activity on the tumor site while reducing normal tissue exposure, providing a new technical path for reducing the toxicity associated with traditional Nectin-4 ADC and broadening the treatment window.