HK Stock Market Move | If LAEKNA-B(02105) rises by more than 4%, LAE103 will submit a new drug clinical trial application to the US FDA.

LAEKNA-B (02105) rose by more than 4%, reaching an increase of 4.2% at the time of the report, amounting to HK$17.38 with a turnover of HK$45.44 million. In terms of news, Lai Ke Pharmaceuticals recently announced that the group has submitted a new drug clinical trial application (IND) to the US Food and Drug Administration (FDA) for its independently developed LAE103 (a monoclonal antibody targeting ActRIIB), potentially for the treatment of patients with muscular dystrophy and muscle-related diseases. The group plans to evaluate the efficacy and safety of monoclonal antibodies targeting the ActRIIA and ActRIIB receptors in humans. The Pacific Securities report stated that domestic MAD studies of LAE102 (subcutaneous administration) and Phase 1 studies in the United States have already started, with data expected to be released in Q2 of 2025. The Phase I MAD study of LAE102 in China has begun, evaluating the safety, tolerability, PD, and PK of subcutaneous administration of LAE102 in 60 overweight/obese subjects, with data expected to be released in Q3 of 2025. In terms of overseas clinical trials, Lilly has started Phase 1 clinical trials in the United States, planning to enroll 32 healthy postmenopausal women, with single-dose escalating administration via subcutaneous and intravenous routes, with the first subject dosed in May and planning to complete the main research stage by September.