来凯医药(02105) - 2025 - 中期财报

Definitions Company Information Business Highlights Advancing Clinical Trials LAE102 (ActRIIA monoclonal antibody) Phase I SAD study for obesity completed in China, showing good tolerability and sustained pathway blockade, with Phase I MAD study initiated in China and a Phase I clinical trial started in the US in collaboration with Eli Lilly - LAE102 Phase I SAD study completed in China, showing good tolerability, no serious adverse events reported, and dose-dependent increase in Activin A levels, indicating sustained pathway blockade[14][15] - LAE102 Phase I MAD study initiated recruitment in China by end of March 2025, aiming to assess safety, tolerability, pharmacokinetics, and pharmacodynamics[16] - Clinical collaboration agreement signed with Eli Lilly, with Lilly responsible for the US Phase I clinical trial, the Group retaining global rights, and the first subject dosed in the US Phase I clinical trial in May 2025[16] ActRII Product Portfolio Beyond LAE102, the company is developing LAE103 (ActRIIB selective antibody) and LAE123 (ActRIIA/IIB dual antagonist monoclonal antibody), both with IND-enabling studies initiated, LAE103 received FDA IND approval for Phase I, and LAE123 is planned for Phase I in 2026 - LAE103 (ActRIIB selective antibody) and LAE123 (ActRIIA/IIB dual antagonist monoclonal antibody) initiated IND-enabling studies in 2024[17] - LAE103's IND application submitted to US FDA by end of June 2025, received IND approval in July 2025, with Phase I clinical study planned for H2 2025[19] - Preclinical results for LAE102, LAE103, and LAE123 show them to be high-affinity functional antagonists, inhibiting ligands causing muscle atrophy and fat accumulation; LAE102 demonstrates excellent potential in weight management, and LAE123 can treat diseases requiring complete ActRIIA and ActRIIB inhibition[18] LAE002 (afuresertib) + Fulvestrant for HR+/HER2– Breast Cancer, Phase III LAE002 (afuresertib) combined with fulvestrant for HR+/HER2– breast cancer Phase III clinical trial AFFIRM–205 has initiated recruitment in China, with subject enrollment planned for Q4 2025 and NDA submission in H1 2026 - LAE002 (afuresertib) combined with fulvestrant for HR+/HER2– locally advanced or metastatic breast cancer Phase III clinical trial AFFIRM–205 initiated recruitment in China in May 2024[20] - Subject enrollment is planned for completion in Q4 2025, with New Drug Application (NDA) submission to China CDE in H1 2026[20] LAE002 (afuresertib) + LAE001/Prednisone for mCRPC, Phase II LAE002 (afuresertib) combined with LAE001 for mCRPC Phase II international multi-center clinical trial completed, showing a median rPFS of 8.1 months, good efficacy, and tolerability, with FDA approval for Phase III pivotal trial protocol - LAE002 (afuresertib) combined with LAE001 for mCRPC Phase II international multi-center clinical trial completed in 2024[21] - Median rPFS was 8.1 months, a significant improvement compared to 2-4 months for standard treatment, with the combination therapy generally well-tolerated[21] - The Group received FDA approval for the LAE201 Phase III pivotal trial protocol in mCRPC patients after SOC treatment[21] Preclinical Candidate (PCC) Progress In addition to ActRII series drugs, the company has multiple PCC advancements in oncology, including PI3Kα mutant selective inhibitor LAE118 entering IND-enabling studies, USP1 inhibitor LAE120's IND application submitted and approved by FDA, and WRN mutant selective inhibitor LAE122 completing PCC confirmation - PI3Kα mutant selective inhibitor LAE118 entered IND-enabling study phase in Q4 2024[22] - USP1 inhibitor LAE120's IND application submitted to FDA in January 2025, and a 'Study May Proceed' letter received in February 2025[22] - WRN mutant selective inhibitor LAE122 completed PCC confirmation in March 2025[22] Expected Milestones in H2 2025 The company expects to complete subject recruitment for AFFIRM–205 China Phase III trial, initiate LAE103 Phase I clinical study, and announce key results from LAE102 China Phase I MAD study and US Phase I clinical trial in H2 2025 - Complete subject recruitment for AFFIRM–205 China Phase III trial[23] - Initiate LAE103 Phase I clinical study[24] - Announce key results from LAE102 China Phase I MAD study and US Phase I clinical trial[25] Financial Summary Financial Summary for the Six Months Ended June 30, 2025 | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | Change (RMB thousands) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | 105,192 | 126,148 | (20,956) | -16.6% | | Administrative Expenses | 42,321 | 30,380 | 11,941 | 39.3% | | Loss for the Period | 129,637 | 143,706 | (14,069) | -9.8% | | Total Comprehensive Loss for the Period | 133,399 | 138,548 | (5,149) | -3.7% | - The decrease in R&D expenses was primarily due to a RMB 17.8 million milestone payment related to the AFFIRM-205 Phase III clinical trial incurred in H1 2024, with no such expense in the current reporting period[26] - The increase in administrative expenses was mainly due to higher equity-settled share-based payment expenses[26] Management Discussion and Analysis Company Overview and Strategic Focus The company is a clinical-stage biopharmaceutical company focused on metabolic diseases, cancer, and liver fibrosis, with seven clinical trials initiated, an experienced management and R&D team, a comprehensive ActRII and cancer pipeline, and plans to seek strategic collaborations for accelerated development and commercialization - The company is a science-driven, clinical-stage biopharmaceutical company focused on metabolic diseases, cancer, and liver fibrosis[27] - As of June 30, 2025, seven clinical trials have been initiated for LAE102, LAE002 (afuresertib), LAE001, and LAE005[27] - The company has an excellent R&D team of 60 employees, including 11 PhDs and 33 Masters[27] - A comprehensive ActRII product portfolio (LAE102, LAE103, LAE123) and oncology pipeline (LAE002 (afuresertib), LAE001, and seven other preclinical candidates) has been established[28][29] - Plans to seek strategic partners to accelerate the development and commercialization of candidate drugs[30] Market Opportunity Analysis Global obesity patients are projected to exceed 1.2 billion by 2030, driving urgent treatment demand for associated diseases, while significant unmet medical needs persist in cancer treatment, particularly for HR+/HER2- metastatic breast cancer, mCRPC, PROC, and TNBC, where existing therapies are limited and suboptimal - The global obese population is