中国抗体(03681) - 2024 - 中期业绩

Performance Summary Business Highlights During the reporting period, the Group achieved significant progress in clinical trials and pipeline development, with flagship product Suciraslimab (SM03) nearing NMPA approval and key product SM17 advancing in clinical trials in both the US and China, while its intellectual property portfolio nearly doubled - The Biologics License Application (BLA) for flagship product Suciraslimab (SM03) for rheumatoid arthritis (RA) has entered the final review stage with China's National Medical Products Administration (NMPA), with necessary on-site inspections completed in January 2024[2] - Key product SM17 (anti-IL-25 receptor antibody) demonstrated good safety, tolerability, and pharmacokinetic (PK) profiles in its Phase I first-in-human clinical trial in the US, with the first patient dosed in the China Phase 1b clinical trial on June 5, 2024[2] - The Group achieved significant intellectual property progress, with the number of authorized and pending invention patents nearly doubling by June 30, 2024, compared to the beginning of the reporting period, primarily due to new preclinical candidate discoveries[2] Financial Highlights During the reporting period, the Group's loss significantly narrowed to RMB 90.6 million, a 32.4% year-on-year reduction, primarily due to effective control over R&D and administrative expenses, and reduced exchange losses, with total available funds at period-end of RMB 220.0 million supported by net financing cash inflow Financial Performance Summary | Metric | H1 2024 (RMB million) | H1 2023 (RMB million) | Change | | :--- | :--- | :--- | :--- | | Loss for the Period | 90.6 | 134.1 | ↓ 32.4% | | Total Available Funds (Period-end) | 220.0 | - | - | | Net Cash from Financing Activities | 93.4 | - | - | - The reduction in loss was primarily due to: (i) decreased laboratory consumables and trial costs in R&D following the acceptance of the Suciraslimab BLA and receipt of the SM17 Phase I report; (ii) a reduction of approximately RMB 7.5 million in share-based non-cash payments; and (iii) a decrease of approximately RMB 17.1 million in net exchange losses[3] - Completed 15 subscription agreements in January 2024, raising net proceeds of approximately HKD 73.2 million[3] - The Board resolved not to declare an interim dividend[3] Management Discussion and Analysis Business Review and Outlook The company adheres to the philosophy of discovering and developing first-in-class drugs, focusing on innovative treatments for immunological diseases, with flagship product Suciraslimab (SM03) nearing commercialization and key product SM17 making significant progress, while remaining optimistic about future profitability and shareholder value creation - The company positions itself in the new era of Biotechnology 3.0, focusing on drug development for prevalent diseases such as age-related conditions, autoimmune diseases, and mental health disorders[4] - The BLA application for flagship product Suciraslimab (SM03) is in the final review stage with the NMPA, with its Phase III extension trial demonstrating durable efficacy and long-term sustainable benefits[4] - Key product SM17 has achieved significant progress in treating atopic dermatitis (AD), with preclinical study results published in a prestigious journal and Phase 1b clinical trials initiated[5] - Looking ahead, the company anticipates commercial profitability upon Suciraslimab's market approval and aims to confirm SM17's differentiated advantages over existing therapies[6] Product Pipeline and Clinical Progress The company has established a robust product pipeline focused on immunological diseases, with flagship product Suciraslimab (SM03) for RA nearing commercialization, and key products SM17 and SN1011 showing positive clinical development progress across multiple indications, complemented by preclinical-stage investigational drugs Product Pipeline Overview | Product | Target/Type | Key Indications | Latest Progress | | :--- | :--- | :--- | :--- | | Suciraslimab (SM03) | Anti-CD22 mAb (First-in-class) | Rheumatoid Arthritis (RA) | China BLA application in final review stage | | SM17 | Anti-IL-25R mAb (First-in-class) | Atopic Dermatitis (AD), Asthma | US Phase I completed, China Phase 1b initiated | | SN1011 | Third-gen BTK Inhibitor | Systemic Lupus Erythematosus (SLE), Pemphigus, etc. | 4 IND approvals from NMPA | | SM06 | Second-gen Anti-CD22 mAb | Systemic Lupus Erythematosus (SLE), etc. | IND-enabling stage, CMC optimization | | SM09 | Anti-CD20 mAb | Non-Hodgkin Lymphoma (NHL) | Preclinical research optimization | Flagship Product: Suciraslimab (SM03) SM03 is a first-in-class anti-CD22 monoclonal antibody for rheumatoid arthritis (RA) and other immunological diseases, with its Phase III clinical study meeting primary endpoints and BLA application accepted by the NMPA in September 2023, positioning it as the company's first potential commercialized drug following completed GMP inspections - SM03's BLA application for RA was accepted by the NMPA in September 2023, nearing commercialization, with clinical site and GMP inspections completed in January 2024[15][8] - Phase III extension trial data indicate SM03 offers durable efficacy, with response rates continuously increasing over time, demonstrating long-term sustainable benefits superior to conventional biologics[14] Key Product: SM17 SM17 is a first-in-class humanized monoclonal antibody targeting the IL-25 receptor, with potential for treating atopic dermatitis (AD), asthma, and idiopathic pulmonary fibrosis (IPF), demonstrating good safety and PK profiles in its US Phase I trial and successfully dosing its first patient in China's Phase 1b clinical trial for AD in June 2024 - The US Phase I clinical trial report, obtained in Q1 2024, indicated SM17 demonstrated good overall safety, tolerability, and PK profiles[18][9] - China's Phase 1b clinical trial for AD completed its first patient dosing on June 5, 2024, aiming to explore preliminary efficacy and safety[18] - Preclinical study results published in Allergy journal demonstrated SM17 was as effective as JAK1 inhibitors in treating mouse AD[18][9] Key Product: SN1011 SN1011 is a third-generation reversible covalent BTK inhibitor targeting various autoimmune diseases, including systemic lupus erythematosus (SLE), pemphigus, and multiple sclerosis (MS), having shown good safety and PK profiles in its Phase I studies in Australia and China, and currently holding four IND approvals from the NMPA for different indications - SN1011 has received 4 IND approvals from the NMPA for the treatment of SLE, pemphigus, MS, and NMOSD, respectively[20][9] Manufacturing, Intellectual Property, and Collaborations The company operates a 1,200-liter capacity manufacturing facility in Haikou, which has completed GMP inspections supporting the SM03 BLA application, while a second commercial-scale facility is under construction in Suzhou, intellectual property holdings have significantly increased to 67 patents, and active collaborations with LifeArc and Everest Medicines are accelerating drug development and commercialization - The Haikou manufacturing facility completed GMP inspections in January 2024, supporting SM03's BLA approval, with the new Suzhou manufacturing base expected to pass completion acceptance in late 2024[24][25] Invention Patents Owned | Item | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Number of Invention Patents Owned* | 67 | 35 | - Collaborated with UK-based LifeArc for the development and commercialization of SM17, and partnered with Everest Medicines to license global development rights for SN1011 for kidney diseases[23] Market Overview and Strategic Platforms The company focuses on the autoimmune disease sector with significant market potential, projecting the Chinese RA market to reach RMB 83.3 billion and the global AD market USD 27.7 billion by 2030, and has established five internal strategic R&D platforms to continuously identify innovative targets and develop new drugs for competitive advantage - Broad market prospects: The Chinese RA market is projected to reach RMB 83.3 billion by 2030, and the global AD market is expected to reach USD 27.7 billion[39][40] - The company has established five internal strategic R&D platforms to support continuous drug innovation: - B-cell Therapy Platform (producing SM03, SM06, SM09, SN1011) - Alarmins Pathway Therapy Platform (producing SM17) - Selective T-cell Therapy Platform - Neurological Diseases Platform - Antibody Framework Remodeling Humanization Platform (for SM06, SM09)[42][43][44][45][46][47] Financial Review During the reporting period, the Group's financial position showed positive changes, with R&D costs decreasing 17.5% year-on-year to RMB 55.0 million and administrative expenses decreasing 31.9% year-on-year to RMB 34.2 million due to cost optimization and reduced non-cash expenses, while total available funds were RMB 220.0 million and the gearing ratio increased to 73.6% Expense Analysis | Expense Item | H1 2024 (RMB million) | H1 2023 (RMB million) | Reason for Change | | :--- | :--- | :--- | :--- | | Research and Development Costs | 55.0 | 66.8 | Decreased trial costs after SM03 BLA acceptance and SM17 Phase I report | | Administrative Expenses | 34.2 | 50.2 | Reduced share-based payments and depreciation/amortization | Liquidity and Capital Position | Liquidity and Capital | June 30, 2024 (RMB million) | December 31, 2023 (RMB million) | | :--- | :--- | :--- | | Total Available Funds | 220.0 | 233.1 | | Interest-bearing Bank Borrowings | 423.8 | 391.4 | | Gearing Ratio | 73.6% | 53.5% | - During the reporting period, net cash outflow from operating activities was RMB 70.6 million, net cash outflow from investing activities was RMB 76.4 million, and net cash inflow from financing activities was RMB 93.4 million[54] Use of Proceeds The company adjusted the use of net proceeds from the global offering, reallocating HKD 15.0 million to working capital and general corporate purposes, with HKD 98.0 million of IPO proceeds remaining unutilized as of June 30, 2024, and detailed the usage of funds from 2022 and 2023 share subscriptions primarily for core product R&D and clinical studies - The Board resolved to change the use of listing proceeds, reallocating HKD 15.0 million to 'working capital, expansion of internal capabilities, and other general corporate purposes'[62] Proceeds Utilization Summary | Source of Funds | Net Proceeds (HKD million) | Used as of 2024/6/30 (HKD million) | Unused as of 2024/6/30 (HKD million) | | :--- | :--- | :--- | :--- | | Global Offering (IPO) | 1,272.8 | 1,174.8 | 98.0 | | 2022 Share Subscription | 50.9 | 38.4 | 12.5 | | 2023 Share Subscription | 73.2 | 8.4 | 64.8 | Interim Condensed Consolidated Financial Statements Interim Condensed Consolidated Statement of Profit or Loss For the six months ended June 30, 2024, the company recorded revenue of RMB 2.0 million and gross profit of RMB 0.5 million, with a significantly narrowed loss for the period of RMB 90.6 million compared to RMB 134.1 million in the prior year, resulting in a basic loss per share of RMB 0.08 Statement of Profit or Loss | Item (RMB thousands) | H1 2024 (Unaudited) | H1 2023 (Unaudited) | | :--- | :--- | :--- | | Revenue | 2,026 | 1,365 | | Gross Profit | 543 | 422 | | Research and Development Costs | (55,035) | (66,750) | | Administrative Expenses | (34,205) | (50,200) | | Loss for the Period | (90,622) | (134,096) | | Loss Per Share (RMB) | (0.08) | (0.13) | Interim Condensed Consolidated Statement of Financial Position As of June 30, 2024, the company's total assets were RMB 841.8 million, total liabilities were RMB 564.9 million, and net assets were RMB 276.9 million, with non-current assets primarily consisting of property, plant, and equipment, and liabilities mainly composed of interest-bearing bank borrowings Statement of Financial Position | Item (RMB thousands) | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | Total Non-Current Assets | 575,746 | 577,603 | | Total Current Assets | 266,056 | 270,183 | | Of which: Cash and Cash Equivalents | 153,617 | 203,664 | | Total Current Liabilities | 202,696 | 172,646 | | Total Non-Current Liabilities | 362,176 | 379,557 | | Net Assets | 276,930 | 295,583 | | Total Equity | 276,930 | 295,583 | Other Information Corporate Governance and Dividends The company is committed to high standards of corporate governance, applying the principles of the Corporate Governance Code despite a deviation where Dr. Liang Ruian serves as both Chairman and CEO, an arrangement the Board deems in the company's best interest, and has resolved not to declare an interim dividend for the six months ended June 30, 2024 - The company deviates from Corporate Governance Code Provision C.2.1, where the roles of Chairman and Chief Executive Officer are combined and held by Dr. Liang Ruian. The Board believes this arrangement is in the Group's best interest, given Dr. Liang's founder status and extensive business knowledge[76] - The Board has resolved not to declare an interim dividend for the six months ended June 30, 2024[78][3] - The company's independent auditor, Ernst & Young, has reviewed the interim condensed consolidated financial information. The Audit Committee, in conjunction with management and the auditor, has reviewed and deemed the interim results to be in compliance with applicable accounting standards[97]