维立志博-B(09887) - 2025 - 中期业绩

Company Information and Announcement Statement This section provides disclaimers and outlines the company's interim results announcement, reviewed by the audit committee Disclaimer Hong Kong Exchanges and Clearing Limited makes no representation as to the accuracy or completeness of this announcement and expressly disclaims any liability for losses arising from reliance on its contents - Hong Kong Exchanges and Clearing Limited assumes no responsibility for the accuracy or completeness of this announcement[1] Company Overview and Announcement Purpose Nanjing Leads Biolabs Co., Ltd. (the Company) is pleased to announce its unaudited interim condensed consolidated results for the six months ended June 30, 2025, which have been reviewed by the Company's audit committee - The Company announces its unaudited interim condensed consolidated results for the six months ended June 30, 2025[3] - The interim results have been reviewed by the Company's audit committee[3] Business Highlights The company achieved significant pipeline and operational progress, with core product LBL-024 showing promising clinical results and other products advancing Overall Business Progress The Company was listed on the Stock Exchange on July 25, 2025, and has made significant progress in advancing pipeline candidates and business operations during the reporting period and up to the announcement date - The Company was listed on the Stock Exchange on July 25, 2025[4] - During the reporting period and up to the announcement date, the Company made significant progress in advancing pipeline candidates and business operations[4] Core Product Progress Core product Opatisumab (LBL-024) has achieved significant progress in both monotherapy and combination therapy clinical trials for various solid tumors, demonstrating encouraging efficacy and safety, especially in the treatment of extra-pulmonary neuroendocrine carcinoma - LBL-024 is the world's first 4-1BB targeted candidate to reach the registrational clinical stage for extra-pulmonary neuroendocrine carcinoma[5] - In August 2025, patient enrollment for the single-arm pivotal registrational clinical trial of LBL-024 monotherapy for extra-pulmonary neuroendocrine carcinoma was completed[5] - In the Ib/II phase clinical trial of LBL-024 combined with chemotherapy for first-line extra-pulmonary neuroendocrine carcinoma, the Objective Response Rate (ORR) reached 75.0% and the Disease Control Rate (DCR) reached 92.3%[5] Opatisumab (PD-L1/4-1BB Bispecific Antibody LBL-024) LBL-024 as monotherapy showed an Objective Response Rate of 33.3% and a Disease Control Rate of 51.1% in patients with advanced extra-pulmonary neuroendocrine carcinoma, with good safety; combination with chemotherapy also demonstrated high Objective Response Rate and Disease Control Rate in extra-pulmonary neuroendocrine carcinoma and small cell lung cancer, with plans to expand to more solid tumor indications - In the Phase I/IIa trial of LBL-024 monotherapy for extra-pulmonary neuroendocrine carcinoma, the Objective Response Rate (ORR) was 33.3% and the Disease Control Rate (DCR) was 51.1% among 45 evaluable patients[5] - In the Ib/II phase clinical trial of LBL-024 combined with chemotherapy for first-line extra-pulmonary neuroendocrine carcinoma, the Objective Response Rate (ORR) was 75.0% and the Disease Control Rate (DCR) was 92.3% among 52 efficacy-evaluable patients[5] - Phase II studies of LBL-024 combined with standard therapy for cholangiocarcinoma, hepatocellular carcinoma, melanoma, and ovarian cancer are planned to commence in the third quarter of 2025, with a Phase II study for triple-negative breast cancer to start in the second half of the year[6] Progress of Other Selected Clinical-Stage Products The Company's multiple clinical-stage products have achieved positive progress, with LBL-034 demonstrating a high Objective Response Rate in multiple myeloma, LBL-007 showing significant combination efficacy in nasopharyngeal carcinoma, LBL-033 achieving disease stabilization in advanced malignant tumors, LBL-047 having submitted an FDA IND application, and LBL-051 entering into a collaboration with Oblenio Bio - In the Phase I/II trial of LBL-034 monotherapy for relapsed/refractory multiple myeloma, the Objective Response Rate (ORR) reached 82.1% at the 400-800 μg/kg dose level[7] - In the Phase II trial of LBL-007 combined with tislelizumab and chemotherapy for nasopharyngeal carcinoma, the Objective Response Rate (ORR) reached 83.3% and the Disease Control Rate (DCR) reached 97.6%[9] - LBL-047 has submitted an IND application to the FDA, with approval expected in August 2025[10] - LBL-051 has entered into a collaboration, exclusive option, and license agreement with Oblenio Bio, Inc., targeting an IND submission to the FDA in the first quarter of 2026[10] LBL-034 (GPRC5D/CD3 Bispecific Antibody) LBL-034 demonstrated an 82.1% Objective Response Rate in the high-dose group (400-800 μg/kg) in Phase I/II trials for relapsed/refractory multiple myeloma, with good safety; updated data is planned for presentation at the 2025 ASH annual meeting, and Phase II patient enrollment has commenced - In the 400 μg/kg dose group (n=18) of LBL-034, the Objective Response Rate (ORR) was 77.8%, the rate of ≥Very Good Partial Response (VGPR) was 61.1%, and the rate of ≥Complete Response (CR) was 44.4%[7] - In the 800 μg/kg dose group (n=10) of LBL-034, the Objective Response Rate (ORR) reached 90.0%, with rates of ≥Very Good Partial Response (VGPR) and ≥Complete Response (CR) at 60.0% and 50.0%, respectively[7] - Updated data on LBL-034's comprehensive efficacy, safety, pharmacokinetics/pharmacodynamics, biomarkers, and exposure-response results are planned for presentation at the 2025 American Society of Hematology (ASH) annual meeting[7] - The Company enrolled the first patient in the Phase II trial of LBL-034 in August 2025[7] LBL-007 (LAG3 Monoclonal Antibody) In the Phase II trial of LBL-007 combined with tislelizumab and chemotherapy for nasopharyngeal carcinoma, the Objective Response Rate reached 83.3% and the Disease Control Rate reached 97.6% among 42 evaluable patients, with a median Progression-Free Survival of 15.8 months and good safety - In the Phase II trial of LBL-007 combined with tislelizumab and chemotherapy for nasopharyngeal carcinoma, the Objective Response Rate (ORR) reached 83.3% (including 3 complete responses) and the Disease Control Rate (DCR) reached 97.6%[9] - The median Progression-Free Survival (PFS) was 15.8 months, and the median Duration of Response (DoR) was 14.7 months[9] LBL-033 (MUC16/CD3 Bispecific Antibody) In the Phase I/II trial of LBL-033 monotherapy for advanced malignant tumors, 5 out of 20 evaluable patients achieved disease stabilization, with 1 maintaining stability for over 9 months; the maximum tolerated dose was not reached, and most adverse events were Grade 1 or 2 - In the Phase I/II trial of LBL-033 monotherapy for advanced malignant tumors, 5 out of 20 evaluable patients achieved disease stabilization, with 1 patient maintaining stability for over 9 months[9] - Only one dose-limiting toxicity was observed at the 10 mg/kg dose, and the maximum tolerated dose was not reached[9] LBL-049 (GDF15 Monoclonal Antibody) LBL-049 completed Dose Range Finding (DRF) studies and cell line development in August 2025, and the Company is actively seeking global collaborations to enhance its clinical and commercial value - LBL-049 completed Dose Range Finding (DRF) studies and cell line development in August 2025[9] - The Company is actively seeking global partnerships with leading pharmaceutical companies to fully enhance the clinical and commercial value of LBL-049[9] LBL-054-ADC (CDH17 ADC) LBL-054-ADC completed the identification of preclinical candidate (PCC) molecules in July 2025 - LBL-054-ADC completed the identification of preclinical candidate (PCC) molecules in July 2025[9] LBL-054-TCE (CDH17/CD3 Bispecific Antibody) LBL-054-TCE completed the identification of preclinical candidate (PCC) molecules in July 2025 - LBL-054-TCE completed the identification of preclinical candidate (PCC) molecules in July 2025[9] LBL-058 (DLL3/CD3 ADC) LBL-058 validated the TCE-ADC platform through in vitro and in vivo studies in July 2025 and is currently undergoing lead compound optimization - LBL-058 validated the TCE-ADC platform through in vitro and in vivo studies in July 2025[9] - Lead compound optimization is currently underway[9] LBL-061 (EGFR/PD-L1 ADC) LBL-061 entered the IND-enabling stage in July 2025 - LBL-061 entered the IND-enabling stage in July 2025[9] LBL-047 (Anti-BDCA2/TACI Bispecific Fusion Protein) LBL-047 has submitted an IND application to the FDA, with approval expected in August 2025, and the Company is actively seeking global collaborations to enhance its clinical and commercial value - LBL-047 has submitted an IND application to the FDA, with approval expected in August 2025[10] - The Company is actively seeking global partnerships with leading pharmaceutical companies to fully enhance the clinical and commercial value of LBL-047[10] LBL-051 (CD19/BCMA/CD3 Trispecific Antibody) In November 2024, the Company entered into a collaboration agreement with Oblenio Bio, Inc. to jointly develop and commercialize LBL-051, targeting an IND submission to the FDA in the first quarter of 2026 - On November 5, 2024, the Company entered into a collaboration, exclusive option, and license agreement with Oblenio Bio, Inc. (a newly formed US company by Aditum Bio) to develop and commercialize LBL-051[10] - Toxicology studies and CMC development for the IND-enabling stage are currently progressing on schedule, targeting an IND submission to the FDA in the first quarter of 2026[10] Financial Highlights The company's loss for the period decreased, driven by lower administrative expenses despite increased R&D costs for pipeline advancement Key Financial Metrics For the six months ended June 30, 2025, the Company's loss decreased by 7.8% year-on-year to RMB 166.4 million, primarily due to a significant 39.0% decrease in administrative expenses, though R&D costs increased by 56.9% due to clinical progress of LBL-024 and LBL-034 Key Financial Metrics for the Six Months Ended June 30 | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Research and development costs | (131,811) | (83,999) | | Administrative expenses | (35,826) | (58,759) | | Fair value change of share repurchase obligation | – | (42,084) | | Loss for the period | (166,393) | (180,399) | - Loss for the period decreased by RMB 14.0 million (7.8%) from RMB 180.4 million in the same period of 2024 to RMB 166.4 million in the same period of 2025[11] - Research and development costs increased by 56.9% to RMB 131.8 million, primarily due to BLA preparation for LBL-024 and accelerated clinical progress of LBL-024 and LBL-034[11] - Administrative expenses decreased by 39.0% to RMB 35.8 million, mainly due to a reduction in share-based payment expenses, partially offset by an increase in listing expenses[12] Management Discussion and Analysis Management discusses core strategies, product pipeline progress, proprietary technology platforms, and future development plans to address unmet clinical needs Overview and Core Strategies The Company is a pioneer in next-generation immuno-oncology therapies, committed to transforming 'cold tumors' into 'hot tumors' by deploying various combination therapeutic strategies, including bispecific antibodies, T-cell engagers (TCEs), and antibody-drug conjugates (ADCs), to address the limitations of PD-1/PD-L1 inhibitors, and has established proprietary technology platforms such as X-body™ and LeadsBody™ - The Company is committed to addressing the limitations of PD-1/PD-L1 inhibitors through a core scientific strategy of transforming 'cold tumors' into 'hot tumors'[13] - Three major therapeutic strategies are deployed: utilizing agonists to deliver co-stimulatory signals (e.g., 4-1BB) to activate exhausted T cells; leveraging CD3-mediated activation of broad non-tumor-specific T cells; and actively targeting other resistance pathways (e.g., LAG-3)[13][14] - Proprietary technology platforms including X-body™ (validated by LBL-024) and LeadsBody™ (validated by LBL-034 and LBL-033) have been established[13] Product Pipeline The Company has 1 core product, LBL-024, and 13 other candidate drugs, of which 6 have entered clinical stages, covering oncology and autoimmune fields, and continues to advance multiple clinical trials and IND applications - As of June 30, 2025, the Company has 1 core product, LBL-024, and 13 other candidate drugs, of which 6 have successfully entered clinical stages[15] Development Status of Selected Candidate Drugs (As of Announcement Date) | Category | Project | Target (Drug Type) | Line of Therapy/Indication | Current Status/Next Milestone | | :--- | :--- | :--- | :--- | :--- | | Oncology Clinical | LBL-024 | PD-L1/4-1BB (Bispecific Antibody) | Third-line and above extra-pulmonary neuroendocrine carcinoma | Patient enrollment completed in August 2025; BLA submission expected in Q3 2026 | | Oncology Clinical | LBL-034 | GPRC5D/CD3 (Bispecific Antibody) | Fourth-line and above multiple myeloma | Phase II trial patient enrollment initiated in August 2025 | | Oncology Clinical | LBL-007 | LAG3 (Monoclonal Antibody) | First-line nasopharyngeal carcinoma | Phase II trial expected to conclude in Q4 2025; collaboration with BeiGene terminated, global rights recovered | | Oncology Clinical | LBL-033 | MUC16/CD3 (Bispecific Antibody) | Second-line and above solid tumors | Phase I trial expected to conclude in Q3 2025 | | Preclinical | LBL-061 | EGFR/PD-L1 (ADC) | Non-small cell lung cancer, head and neck squamous cell carcinoma, and nasopharyngeal carcinoma | Entered IND-enabling stage in July 2025 | | Autoimmune | LBL-047 | BDCA2/TACI (Fusion Protein) | Autoimmune diseases | IND application submitted to FDA, approval expected in August 2025 | | Autoimmune | LBL-051 | CD19/BCMA/CD3 (Trispecific Antibody) | Autoimmune diseases | IND submission to FDA expected in Q1 2026 | Business Review The Company continues to advance the development of multiple candidate drugs, with core product LBL-024 demonstrating encouraging efficacy and safety in both monotherapy and combination therapies for extra-pulmonary neuroendocrine carcinoma and small cell lung cancer. LBL-034 showed a high Objective Response Rate in multiple myeloma. Following the termination of the collaboration with BeiGene for LBL-007, the Company has regained its global development rights. Several preclinical products have also entered IND-enabling stages or completed PCC identification - LBL-024, as a core product, has demonstrated potential efficacy and safety in clinical trials for various solid tumors, including extra-pulmonary neuroendocrine carcinoma and small cell lung cancer[28] - In the Phase I/II trial of LBL-034 for relapsed/refractory multiple myeloma, the high-dose group (400-800 μg/kg) observed an Objective Response Rate (ORR) of 82.1%, without additional safety risks[44] - The collaboration with BeiGene regarding LBL-007 was terminated on May 18, 2025, and the Company has regained full global rights to develop, manufacture, and commercialize LBL-007[55] - Preclinical products such as LBL-061, LBL-054-ADC, and LBL-054-TCE have entered the IND-enabling stage or completed PCC identification[57][59] Core Product: Opatisumab (LBL-024) LBL-024, as the world's first 4-1BB targeted drug to enter registrational clinical stage, has demonstrated significant efficacy and good safety in both monotherapy and combination chemotherapy for extra-pulmonary neuroendocrine carcinoma, with plans to expand to various solid tumors including non-small cell lung cancer, cholangiocarcinoma, and hepatocellular carcinoma - LBL-024 is the world's first registrational clinical-stage 4-1BB targeted candidate for extra-pulmonary neuroendocrine carcinoma, with patient enrollment for the single-arm pivotal registrational clinical trial completed in August 2025[28] - LBL-024 demonstrated superior efficacy compared to historical benchmarks in previously treated advanced neuroendocrine carcinoma patients, with an Objective Response Rate (ORR) of 33.3% and a Disease Control Rate (DCR) of 51.1%[30] - LBL-024 combined with chemotherapy for first-line extra-pulmonary neuroendocrine carcinoma achieved an Objective Response Rate (ORR) of 75.0% and a Disease Control Rate (DCR) of 92.3%[40] - LBL-024 combined with chemotherapy for first-line small cell lung cancer achieved an Objective Response Rate (ORR) of 86.5% and a Disease Control Rate (DCR) of 96.2%[43] Monotherapy Efficacy and Safety Data LBL-024 monotherapy in 45 patients with second-line/third-line or above extra-pulmonary neuroendocrine carcinoma showed an Objective Response Rate of 33.3%, a Disease Control Rate of 51.1%, a median Overall Survival of 11.9 months, and no dose-limiting toxicities observed Efficacy Data Observed in Phase I/IIa Trial of LBL-024 Monotherapy for Second-line/Third-line or Above Extra-pulmonary Neuroendocrine Carcinoma (N=45) | Response | Complete Response n (%) | Partial Response n (%) | Stable Disease n (%) | Progressive Disease n (%) | Not Evaluable n (%) | Objective Response Rate n (%) | Disease Control Rate n (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total (n=45) | 3 (6.6)* | 12 (26.7) | 8 (17.8) | 21 (46.7) | 1 (2.2) | 15 (33.3) | 23 (51.1) | - As of June 3, 2025, the median Overall Survival (OS) for the patient population with second-line or above extra-pulmonary neuroendocrine carcinoma was 11.9 months[34] - No dose-limiting toxicities were observed at the highest tested dose of 25.0 mg/kg, and the maximum tolerated dose was not reached; most adverse events were Grade 1 or 2 and manageable[28] Combination Therapy Efficacy and Safety Data LBL-024 combined with chemotherapy for first-line extra-pulmonary neuroendocrine carcinoma showed an Objective Response Rate of 75.0% and a Disease Control Rate of 92.3%; for first-line small cell lung cancer, the Objective Response Rate was 86.5% and the Disease Control Rate was 96.2%, with good safety and no dose-limiting toxicities observed - In the Ib/II phase trial of LBL-024 combined with chemotherapy for first-line extra-pulmonary neuroendocrine carcinoma, the Objective Response Rate (ORR) was 75.0% and the Disease Control Rate (DCR) was 92.3% among 52 efficacy-evaluable patients[40] - The Objective Response Rate (ORR) reached 79.2% in the 15 mg/kg dose group, and 83.3% in the Phase II dose optimization stage[40] - In the Phase II trial of LBL-024 combined with chemotherapy for first-line small cell lung cancer, the Objective Response Rate (ORR) was 86.5% and the Disease Control Rate (DCR) was 96.2% among 52 efficacy-evaluable patients[43] - No dose-limiting toxicities were observed during the Phase Ib dose escalation stage, and the maximum tolerated dose was not reached, with no unexpected safety signals identified[43] Key Product: LBL-034 (GPRC5D/CD3 Bispecific Antibody) LBL-034 demonstrated an 82.1% Objective Response Rate in the high-dose group (400-800 μg/kg) in Phase I/II trials for relapsed/refractory multiple myeloma, also performing well in patients previously treated with BCMA CAR-T and other therapies, with manageable safety and the maximum tolerated dose not reached - In the Phase I/II trial of LBL-034 monotherapy for relapsed/refractory multiple myeloma, the Objective Response Rate (ORR) reached 82.1% at the 400-800 μg/kg dose level[44] LBL-034 Efficacy Results (Percentage of Responding Patients) | Dose Group | ORR | | :--- | :--- | | ≤80μg/kg (N=8) | 25.0% | | 200μg/kg (N=7) | 57.2% | | 400μg/kg (N=18) | 77.8% | | 800μg/kg (N=10) | 90.0% | | 1,200μg/kg (N=6) | 83.3% | - LBL-034 also demonstrated good efficacy in patients previously treated with BCMA CAR-T, BCMA-targeted therapies, or autologous stem cell transplantation[47] - No dose-limiting toxicities were observed at the highest dose of 1,200 μg/kg, and the maximum tolerated dose was not reached[49] Monotherapy Efficacy and Safety Data In patients with relapsed/refractory multiple myeloma, LBL-034's high-dose group (400-800 μg/kg) achieved an Objective Response Rate of up to 90.0%, showing significant clinical benefit even in heavily pre-treated patients, with good safety, most adverse events being Grade 1 or 2, and incidence significantly decreasing in subsequent treatment cycles - In the 400 μg/kg dose group (n=18) of LBL-034, the Objective Response Rate (ORR) was 77.8%, the rate of ≥Very Good Partial Response (VGPR) was 61.1%, and the rate of ≥Complete Response (CR) was 44.4%[44] - In the 800 μg/kg dose group (n=10) of LBL-034, the Objective Response Rate (ORR) reached 90.0%, with rates of ≥Very Good Partial Response (VGPR) and ≥Complete Response (CR) at 60.0% and 50.0%, respectively[44] - Most treatment-emergent adverse events were Grade 1 or 2, with almost all events occurring in the first cycle, and incidence significantly decreasing in subsequent treatment cycles[51] Key Product: LBL-007 (LAG3 Monoclonal Antibody) LBL-007 combined with tislelizumab and chemotherapy as first-line treatment for recurrent/metastatic nasopharyngeal carcinoma showed an Objective Response Rate of 83.3% and a Disease Control Rate of 97.6%, with a median Progression-Free Survival of 15.8 months and good safety. The collaboration with BeiGene has been terminated, and the Company has regained global rights to LBL-007 - In the Phase II trial of LBL-007 combined with tislelizumab and chemotherapy for nasopharyngeal carcinoma, the Objective Response Rate (ORR) reached 83.3% and the Disease Control Rate (DCR) reached 97.6% among 42 patients[55] - The median Progression-Free Survival (PFS) was 15.8 months, and the median Duration of Response (DoR) was 14.7 months[55] - On May 18, 2025, the Company's collaboration with BeiGene regarding LBL-007 was terminated, and the Company has regained full global rights to develop, manufacture, and commercialize LBL-007[55] Key Product: LBL-033 (MUC16/CD3 Bispecific Antibody) In the Phase I/II trial of LBL-033 monotherapy for advanced malignant tumors, 5 out of 20 evaluable patients achieved disease stabilization, with 1 maintaining stability for over 9 months, and good safety, with most common adverse events being Grade 1 or 2 - In the Phase I/II trial of LBL-033 monotherapy for advanced malignant tumors, 5 out of 20 evaluable patients achieved disease stabilization, with 1 patient maintaining stability for over 9 months[56] - Only one dose-limiting toxicity was observed at the 10 mg/kg dose, and the maximum tolerated dose was not reached; the most common adverse events were Grade 1 or 2[56] Other Clinical-Stage Products (LBL-019, LBL-015) LBL-019 (TNFR2 monoclonal antibody) is being developed for solid tumors, promoting T-cell proliferation by activating downstream signaling pathways. LBL-015 (PD-1/TGF-βR2 fusion protein) is a dual-function therapeutic designed to enhance anti-tumor immune responses by dually blocking the PD-1/PD-L1 axis and TGF-β signaling pathway - LBL-019, by binding to TNFR2, preferentially stimulates CD8+ T cell expansion by over 200% and increases CD4+ T cells by 30%[56] - LBL-015 is designed as a dual-function therapeutic, capable of effectively binding to PD-1 and TGF-β1, blocking PD-1/PD-L1 and PD-1/PD-L2 interactions, as well as the TGF-β signaling pathway[57] Preclinical Stage Products (LBL-061, LBL-054-ADC, LBL-054-TCE, LBL-058, LBL-043, LBL-049) Multiple preclinical products have advanced: LBL-061 entered IND-enabling stage; LBL-054-ADC and LBL-054-TCE completed PCC identification; LBL-058 validated the TCE-ADC platform and is undergoing lead compound optimization; LBL-043 and LBL-049 completed DRF studies and cell line development - LBL-061 (EGFR/PD-L1 ADC) entered the IND-enabling stage in July 2025[57] - LBL-054-ADC (CDH17 ADC) completed the identification of preclinical candidate (PCC) molecules in July 2025[57] - LBL-054-TCE (CDH17/CD3 bispecific antibody) completed the identification of preclinical candidate (PCC) molecules in July 2025[59] - LBL-058 (DLL3/CD3 ADC) validated the TCE-ADC platform through in vitro and in vivo studies in July 2025 and is currently undergoing lead compound optimization[58] - LBL-049 (GDF15 monoclonal antibody) completed Dose Range Finding (DRF) studies and cell line development in August 2025[61] Autoimmune Products (LBL-051, LBL-047) LBL-051 (CD19/BCMA/CD3 trispecific antibody) aims to treat B-cell and autoantibody-driven autoimmune diseases and has partnered with Oblenio Bio. LBL-047 (anti-BDCA2/TACI bispecific fusion protein) has submitted an IND application to the FDA, with approval expected in August 2025, for the treatment of autoimmune diseases such as systemic lupus erythematosus - LBL-051 (CD19/BCMA/CD3 trispecific antibody) is designed to treat B-cell and autoantibody-driven autoimmune diseases and has entered into a collaboration agreement with Oblenio Bio, Inc.[61] - LBL-047 (anti-BDCA2/TACI bispecific fusion protein) has submitted an IND application to the FDA, with approval expected in August 2025, for the treatment of systemic lupus erythematosus, cutaneous lupus erythematosus, IgA nephropathy, and scleroderma[61] Proprietary Technology Platforms The Company has developed three proprietary technology platforms: LeadsBody™ (CD3 T-cell engager), X-body™ (4-1BB engager), and TOPiKinectics™ (ADC), utilizing advanced antibody engineering to achieve highly specific, low-toxicity, and efficient drug design to address unmet clinical needs - The Company has developed the LeadsBody™ platform (CD3 T-cell engager platform), X-body™ platform (4-1BB engager platform), and TOPiKinectics™ platform (ADC platform)[62] - The LeadsBody™ platform optimizes the ratio and affinity of tumor-associated antigens to the CD3 binding domain, enabling conditional T-cell redirection and activation, thereby reducing off-target toxicity[62] - The X-body™ platform designs bispecific antibodies with a 2:2 structure, balancing affinity to achieve conditional 4-1BB activation within the tumor microenvironment, thereby reducing systemic toxicity[66] - The TOPiKinectics™-ADC platform incorporates innovations such as Fc-silent antibodies, stable conjugates, cleavable/hydrophilic linkers, and Exatecan, aiming to improve therapeutic index, stability, and pharmacokinetic properties[66] LeadsBody™ Platform (CD3 T-cell Engager Platform) The LeadsBody™ platform employs diverse molecular designs to optimize the ratio and affinity of tumor-associated antigens to the CD3 binding domain, enabling conditional T-cell redirection and activation, effectively killing target cells while reducing cytokine secretion, and has successfully developed LBL-034 and LBL-033 - The LeadsBody™ platform allows for diverse modifications to the molecular design of CD3-targeting bispecific antibodies, including controlling binding strength, fine-tuning CD3 affinity, conditional T-cell redirection and activation mechanisms, and different spatial structures[62] - Advantages of this platform include optimizing the ratio and affinity of antigen to CD3 binding domains to reduce off-target toxicity, structural optimization to minimize cytokine secretion, and demonstrating durable anti-tumor effects in both in vitro and in vivo studies[62] - Through the LeadsBody™ platform, LBL-034 (GPRC5D/CD3 bispecific antibody) and LBL-033 (MUC16/CD3 bispecific antibody) have been successfully developed[62] X-body™ Platform (4-1BB Engager Platform) The X-body™ platform utilizes advanced antibody engineering to design bispecific antibodies with a 2:2 structure, balancing the affinity between tumor-associated antigens and 4-1BB to achieve conditional activation of 4-1BB receptors in the tumor microenvironment, enhancing immune response while reducing systemic toxicity, and has successfully developed core product LBL-024 - The X-body™ platform utilizes advanced antibody engineering to create differentiated bispecific antibodies with a 2:2 structure, featuring high yield, high purity, and excellent developability[66] - This platform can balance the affinity between tumor-associated antigens and 4-1BB, promoting 4-1BB receptor cross-linking and activation only when bound to antigens at the tumor site, thereby reducing systemic toxicity[66] - Through the X-body™ platform, Opatisumab (4-1BB/PD-L1 bispecific antibody LBL-024) has been successfully developed[66] TOPiKinectics™ Platform (ADC Platform) The TOPiKinectics™-ADC platform aims to overcome the resistance and safety challenges of existing ADCs through innovations such as Fc-silent antibodies, stable conjugates, cleavable/hydrophilic linkers, and more potent topoisomerase I inhibitor Exatecan, enhancing therapeutic index, stability, and pharmacokinetic properties - The TOPiKinectics™-ADC platform aims to overcome the resistance of existing ADCs and improve patients' quality of life[66] - This platform incorporates several key innovations, including Fc-silent antibodies, stable conjugates, cleavable/hydrophilic linkers, and Exatecan (a more potent topoisomerase I inhibitor with lower sensitivity to multi-drug resistance)[66] - TOPiKinectics™-ADC features an improved therapeutic index, excellent stability, and enhanced pharmacokinetic properties[66] Future Developments The Company will continue to advance its product pipeline, with a particular focus on rapidly expanding the indications for core product LBL-024. It will adhere to an asset-light strategy, combining its own pilot production facilities with CDMO collaborations, and actively seek global partnerships to maximize product market value, with future plans to establish an internal sales team in China and strengthen global business development capabilities - The Company will continue to advance its preclinical assets and clinical-stage products, with a particular focus on rapidly expanding the indications for core product LBL-024[67] - It will adhere to an asset-light strategy, combining its own GMP-compliant pilot production facilities with collaborations with reputable Contract Development and Manufacturing Organizations (CDMOs)[67][68] - It will continue to focus on forging partnerships with leading global industry players to leverage their international clinical development capabilities, distribution channels, and sales and marketing capabilities[69] - In the long term, plans include establishing an internal sales and marketing team in the domestic Chinese market and potentially initiating selected clinical trials in the United States to generate high-quality data[69] Financial Review A detailed review of financial performance, including revenue, expenses, loss, capital structure, and employee-related costs Revenue For the six months ended June 30, 2025 and 2024, the Group recorded zero revenue - For the six months ended June 30, 2024 and 2025, the Group recorded zero revenue[71] Other Income and Gains For the six months ended June 30, 2025, other income and gains amounted to RMB 5.6 million, a slight decrease from RMB 5.8 million in the same period of 2024, primarily due to reduced government grants and the absence of net foreign exchange gains, though bank interest income increased Other Income and Gains (For the Six Months Ended June 30) | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Government grants related to income | 164 | 520 | | Bank interest income | 5,425 | 4,402 | | Net foreign exchange gains | – | 914 | | Total | 5,589 | 5,836 | - Other income and gains decreased from RMB 5.8 million in the same period of 2024 to RMB 5.6 million in the same period of 2025[73] Research and Development Costs For the six months ended June 30, 2025, research and development costs significantly increased by 56.9% year-on-year to RMB 131.8 million, primarily due to BLA preparation for LBL-024 and accelerated clinical progress of LBL-024 and LBL-034 Research and Development Costs (For the Six Months Ended June 30) | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Clinical trial expenses | 33,877 | 17,147 | | Staff costs | 28,936 | 30,797 | | Preclinical and CMC expenses | 41,395 | 13,268 | | Depreciation and amortization expenses | 9,214 | 11,862 | | Materials and consumables costs | 8,949 | 3,120 | | Share-based payment expenses | 1,289 | 1,058 | | Others | 8,151 | 6,747 | | Total | 131,811 | 83,999 | - Research and development costs increased by 56.9% from RMB 84.0 million in the same period of 2024 to RMB 131.8 million in the same period of 2025[76] - The primary reasons for the increase include higher CMC development milestone expenses (related to LBL-024 BLA preparation) and increased clinical development expenses (due to accelerated patient enrollment and clinical progress for LBL-024 and LBL-034)[76] Administrative Expenses For the six months ended June 30, 2025, administrative expenses decreased by 39.0% year-on-year to RMB 35.8 million, primarily due to a reduction in share-based payment expenses, partially offset by an increase in listing expenses Administrative Expenses (For the Six Months Ended June 30) | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Professional service fees | 14,755 | 6,687 | | Staff costs | 11,864 | 10,318 | | Share-based payment expenses | 3,749 | 36,720 | | Depreciation and amortization expenses | 1,676 | 1,661 | | General office expenses | 1,445 | 2,088 | | Lease charges | 222 | 186 | | Others | 2,115 | 1,099 | | Total | 35,826 | 58,759 | - Administrative expenses decreased by 39.0% from RMB 58.8 million in the same period of 2024 to RMB 35.8 million in the same period of 2025[77] - The primary reason for the decrease was a reduction in share-based payment expenses, partially offset by an increase in listing expenses incurred in the first half of 2025[77] Finance Costs For the six months ended June 30, 2025, finance costs increased to RMB 3.6 million, primarily due to a RMB 1.0 million increase in interest expenses resulting from a moderate growth in bank borrowings - Finance costs increased from RMB 2.4 million in the same period of 2024 to RMB 3.6 million in the same period of 2025[78] - Primarily due to a RMB 1.0 million increase in interest expenses resulting from a moderate growth in bank borrowings[78] Income Tax Expense For the six months ended June 30, 2025 and 2024, the Group recognized no income tax expense, as neither the Company nor its subsidiaries had estimated taxable profits - For the six months ended June 30, 2024 and 2025, the Group recognized no income tax expense[79] Loss for the Period For the six months ended June 30, 2025, the Group's loss decreased from RMB 180.4 million in the same period of 2024 to RMB 166.4 million, primarily due to the combined impact of increased research and development costs and decreased administrative expenses - The Group's loss decreased from RMB 180.4 million in the same period of 2024 to RMB 166.4 million in the same period of 2025[80] Non-IFRS Measures The Company uses adjusted loss as a non-IFRS measure to eliminate the impact of fair value changes in share repurchase obligations, share-based payment expenses, and listing expenses, providing investors with a clearer comparison of operating performance. As of June 30, 2025, the adjusted loss was RMB 148.6 million, an increase from RMB 94.4 million in the same period of 2024 - The Company uses adjusted loss as a non-IFRS measure to eliminate the impact of fair value changes in share repurchase obligations, share-based payment expenses, and listing expenses[81] Reconciliation of Loss to Adjusted Loss (For the Six Months Ended June 30) | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Loss for the period | (166,393) | (180,399) | | Add: Fair value change of share repurchase obligation | – | 42,084 | | Add: Share-based payment expenses | 5,038 | 37,778 | | Add: Listing expenses | 12,796 | 6,095 | | Adjusted loss for the period | (148,559) | (94,442) | Significant Acquisitions and Disposals During the reporting period, the Group did not undertake any significant acquisitions or disposals of subsidiaries, associates, or joint ventures - During the reporting period, the Group did not undertake any significant acquisitions or disposals of subsidiaries, associates, or joint ventures[85] Capital Structure, Liquidity and Financial Resources As of June 30, 2025, the Company's cash and cash equivalents and financial assets at fair value through profit or loss totaled RMB 451.7 million, a decrease from RMB 538.7 million at the end of 2024, primarily due to cash outflows for R&D, operations, and listing expenses, partially offset by new bank borrowings. The Company's net current assets decreased from RMB 197.97 million at the end of 2024 to RMB 36.78 million - As of June 30, 2025, cash and cash equivalents and financial assets at fair value through profit or loss totaled RMB 451.7 million, a decrease from RMB 538.7 million as of December 31, 2024[86] - Net current assets decreased from RMB 197.97 million as of December 31, 2024, to RMB 36.78 million as of June 30, 2025[116] - As of June 30, 2025, the Company had unutilized bank loan facilities of approximately RMB 150.0 million[87] Gearing Ratio As of June 30, 2025, the Company was in a net cash position, thus the gearing ratio is not applicable - As of June 30, 2025, the Company was in a net cash position, thus the gearing ratio is not applicable[89] Indebtedness As of June 30, 2025, the Company's unsecured bank borrowings increased to RMB 280.2 million, with all borrowings bearing fixed interest rates ranging from 2.4% to 3.1%. Lease liabilities increased to RMB 19.4 million, primarily due to new lease contracts and renewed leases - As of June 30, 2025, unsecured bank borrowings amounted to RMB 280.2 million, an increase from RMB 255.2 million as of December 31, 2024[90] - All bank borrowings bear fixed interest rates ranging from 2.4% to 3.1%[90] - Lease liabilities increased from RMB 11.3 million as of December 31, 2024, to RMB 19.4 million as of June 30, 2025, primarily due to new lease contracts and renewed leases[91] Capital Commitments As of June 30, 2025, the Company's contracted but unprovided capital commitments amounted to RMB 0.7 million, an increase from RMB 0.1 million at the end of 2024, primarily for the acquisition of property, plant and equipment, and other intangible assets - As of June 30, 2025, contracted but unprovided capital commitments amounted to RMB 0.7 million, an increase from RMB 0.1 million as of December 31, 2024[92] Contingent Liabilities As of June 30, 2025, the Group had no contingent liabilities - As of June 30, 2025, the Group had no contingent liabilities[93] Pledge of Assets As of June 30, 2025, the Group had no pledge of assets - As of June 30, 2025, the Group had no pledge of assets[94] Foreign Exchange Risk The Group's financial assets and liabilities are exposed to foreign currency risk, with no current foreign currency hedging policy, but management monitors and considers hedging significant foreign currency risks when necessary - Certain financial assets and liabilities of the Group are denominated in foreign currencies of the respective Group entities, exposing them to foreign currency risk[95] - The Company currently has no foreign currency hedging policy, but management monitors foreign exchange risk and will consider hedging significant foreign currency risks when necessary[95] Significant Investments Held As of June 30, 2025, the Group held no significant investments - As of June 30, 2025, the Group held no significant investments[96] Employees and Remuneration Policy As of June 30, 2025, the Group had 192 employees, with total employee benefit expenses of RMB 49.0 million, a year-on-year decrease primarily due to reduced share-based payment expenses. The Company offers competitive salaries, bonuses, and share incentives, along with continuous education and training programs for employees - As of June 30, 2025, the Group had a total of 192 employees[97] - Total employee benefit expenses for the six months ended June 30, 2025, amounted to RMB 49.0 million, a decrease from RMB 82.0 million in the same period of 2024, primarily due to a reduction in share-based payment expenses[97] - The Company provides employees with competitive salaries, bonuses, and share-based payment remuneration, and has made contributions to social security insurance funds and housing provident funds in accordance with applicable laws[98] Corporate Governance The company maintains compliance with corporate governance standards, with specific disclosures on board structure and securities trading Compliance with Corporate Governance Code The Company has complied with the Corporate Governance Code since its listing date, with one deviation where Dr. Kang serves as both Chairman and CEO. The Board believes this arrangement ensures consistent internal leadership and decision-making efficiency and will review it in due course - Since the listing date and up to the date of this announcement, the Board believes the Company has complied with all applicable code provisions of the Corporate Governance Code, except for a deviation from code provision C.2.1 (roles of Chairman and Chief Executive should be separate)[100] - Currently, Dr. Kang serves as both Chairman of the Board and Chief Executive Officer, an arrangement the Board believes ensures consistent internal leadership for the Group, leading to more effective and efficient overall strategic planning[101] Compliance with Model Code The Company has adopted a code of conduct for securities transactions no less exacting than the Model Code. Since the listing date, all Directors and Supervisors have confirmed compliance with this code, and the Company has not identified any non-compliance by employees - The Company has adopted a code of conduct for securities transactions by Directors, Supervisors, and employees, with terms no less exacting than the required standards set out in the Model Code[103] - Since the listing date and up to the date of this announcement, all Directors and Supervisors have individually confirmed compliance with the Company's code of conduct for securities transactions by Directors, Supervisors, and employees[104] Other Corporate Changes Mr. Du Yilong was appointed as the Lead Independent Non-executive Director, and Ms. Du Jiliu was appointed as a member of the Nomination Committee, both effective from the listing date - Mr. Du Yilong has been appointed as the Lead Independent Non-executive Director of the Company, effective from the listing date[105] - Independent Non-executive Director Mr. Du Yilong is no longer a member of the Nomination Committee; Independent Non-executive Director Ms. Du Jiliu has been appointed as a member of the Nomination Committee, effective from the listing date[105] Other Important Information Key information on global offering proceeds, audit committee review, significant post-reporting events, and interim dividend policy Use of Proceeds The Company was listed on July 25, 2025, with net proceeds from the global offering (after accounting for the over-allotment option and full exercise of the greenshoe option) of approximately HKD 1,363.1 million, to be used for purposes outlined in the prospectus. As of the end of the reporting period, the net proceeds had not yet been utilized - Net proceeds from the global offering (after accounting for the over-allotment option and full exercise of the greenshoe option) of approximately HKD 1,363.1 million will be used for the purposes set out in the prospectus[107] - As of June 30, 2025, the Company had not yet been listed on the Stock Exchange, thus the net proceeds from the global offering were not utilized during the reporting period[107] Audit Committee The Audit Committee, comprising three members, has reviewed the accounting principles and practices adopted by the Group and discussed internal controls, risk management, and financial reporting matters with management, concluding that the interim results comply with relevant accounting standards and are appropriately disclosed - The Audit Committee comprises three members: Ms. Du Jiliu (Chairperson), Dr. Chen Renhai, and Mr. Du Yilong[108] - The Audit Committee has reviewed the interim financial results for the six months ended June 30, 2025, and is of the opinion that they comply with relevant accounting standards, rules, and regulations, and have been appropriately disclosed[108] Events After Reporting Period After the reporting period, the Company's shares were listed on the Main Board of the Stock Exchange on July 25, 2025, with net proceeds from the global offering of approximately HKD 1,179.3 million. On August 6, 2025, the over-allotment option was fully exercised, generating additional net proceeds of approximately HKD 183.8 million. Furthermore, LBL-024 completed patient enrollment, preclinical products LBL-061, LBL-054-ADC, and LBL-054-TCE advanced to IND-enabling stages, and LBL-047 received FDA IND approval - On July 25, 2025, the Company's shares were listed on the Main Board of the Stock Exchange, with net proceeds from the global offering of approximately HKD 1,179.3 million[109] - On August 6, 2025, the over-allotment option was fully exercised, and the Company received additional net proceeds of approximately HKD 183.8 million from the issuance of over-allotted shares[109] - In August 2025, patient enrollment for the registrational single-arm pivotal clinical trial of LBL-024 for extra-pulmonary neuroendocrine carcinoma was completed[110] - In July and August 2025, preclinical products such as LBL-061, LBL-054-ADC, and LBL-054-TCE advanced to the IND-enabling stage, and LBL-047 received FDA IND approval[110] Purchase, Sale or Redemption of Listed Securities As the Company was not listed during the reporting period, relevant disclosures are not applicable. Since the listing date, neither the Company nor any of its subsidiaries has purchased, sold, or redeemed any of its listed securities - As the Company was not listed on the Stock Exchange during the reporting period, relevant disclosures are not applicable[111] - Since the listing date and up to the date of this announcement, neither the Company nor any of its subsidiaries has purchased, sold, or redeemed any of the Company's securities listed on the Stock Exchange[111] Interim Dividend The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2025 - The Board does not recommend the payment of an interim dividend for the six months ended June 30, 2025 (six months ended June 30, 2024: nil)[112] Publication of Interim Results and Interim Report This interim results announcement has been published on the Stock Exchange website and the Company's website. The interim report will be dispatched to shareholders and published on the Stock Exchange and Company websites in due course - This interim results announcement is published on the Stock Exchange website (www.hkexnews.hk) and the Company's website (www.leadsbiolabs.com)[113](index=113&type=chunk) - The Company's interim report for the six months ended June 30, 2025, will be dispatched to the Company's shareholders and published on the Stock Exchange and the Company's website in due course[113] Acknowledgement The Board, on behalf of the Company, sincerely thanks shareholders and business partners for their trust and support, and employees for their tireless efforts and dedication - The Board sincerely thanks shareholders and business partners for their continuous trust and support, and employees for their tireless efforts and dedication[114] Financial Statements Presents the interim condensed consolidated financial statements, including profit or loss, financial position, and explanatory notes Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2025, the Company recorded a loss for the period of RMB 166.4 million, a narrowing from RMB 180.4 million in the prior year's corresponding period, primarily due to the combined impact of increased research and development costs and decreased administrative expenses Interim Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income (For the Six Months Ended June 30) | Metric | 2025 (RMB thousands) | 2024 (RMB thousands) | | :--- | :--- | :--- | | Other income and gains | 5,589 | 5,836 | | Research and development costs | (131,811) | (83,999) | | Administrative expenses | (35,826) | (58,759) | | Fair value gains on financial assets at fair value through profit or loss | 470 | 1,006 | | Finance costs | (3,632) | (2,399) | | Other expenses | (1,183) | – | | Fair value change of share repurchase obligation | – | (42,084) | | Loss before tax | (166,393) | (180,399) | | Income tax expense | – | – | | Loss for the period | (166,393) | (180,399) | | Other comprehensive income for the period (Exchange differences on translation of overseas operations) | 666 | 12 | | Total comprehensive loss for the period | (165,727) | (180,387) | | Loss per share (basic and diluted) | (1.06) | (1.22) | - Loss for the period was RMB 166,393 thousand, a decrease from RMB 180,399 thousand in the same period of 2024[115] - Basic and diluted loss per share was RMB (1.06), an improvement from RMB (1.22) in the same period of 2024[115] Interim Condensed Consolidated Statement of Financial Position As of June 30, 2025, the Company