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港股异动 | 中国抗体-B(03681)涨超15% 公司临床试验及管线开发取得重要进展 上半年收入约980.2万元
智通财经网· 2025-09-03 06:47
Core Viewpoint - China Antibody-B (03681) has seen a significant stock price increase of over 15%, currently trading at 2.7 HKD, with a transaction volume of 6108.39 HKD, following the release of its interim performance announcement for the period ending June 30, 2025 [1] Financial Performance - The total other income and revenue for the reporting period is approximately 9.802 million RMB, representing a year-on-year increase of 126.95% [1] - Research and development costs amounted to 32.74 million RMB, with a reduction in losses by 40.8 million RMB, primarily due to decreased expenses related to the preparation for the BLA of Shuxili monoclonal antibody and reduced hiring costs [1] Clinical Development - The company has made significant progress in its clinical trial projects and pipeline development, particularly with its two core products, Shuxili monoclonal antibody and SM17 [1] - Shuxili monoclonal antibody has achieved breakthrough results in preclinical studies for the treatment of systemic lupus erythematosus (SLE), demonstrating unique advantages in regulating the autoimmune network and protecting against organ damage [1] - The product has shown a significant reduction in anti-double-stranded DNA (anti-dsDNA) antibody levels and has outperformed existing drugs in improving proteinuria and renal pathological damage associated with lupus nephritis (LN) [1]
中国抗体-B涨超15% 公司临床试验及管线开发取得重要进展 上半年收入约980.2万元
Zhi Tong Cai Jing· 2025-09-03 06:46
Group 1 - The core point of the article highlights that China Antibody-B (03681) has seen a significant stock price increase of over 15%, reaching a rise of 18.42% to HKD 2.7, with a trading volume of HKD 6108.39 million [1] - The company reported a total other income and revenue of approximately RMB 9.802 million for the period ending June 30, 2025, representing a year-on-year increase of 126.95% [1] - Research and development costs amounted to RMB 32.74 million, with a reduction in losses by RMB 40.8 million, attributed to decreased expenses related to the preparation for the BLA of Shuxili monoclonal antibody and reduced hiring costs [1] Group 2 - The announcement indicates significant progress in the company's clinical trial projects and pipeline development, particularly for its two core products, Shuxili monoclonal antibody and SM17 [1] - Recently, Shuxili monoclonal antibody achieved breakthrough results in preclinical studies for treating systemic lupus erythematosus (SLE) [1] - The unique advantage of Shuxili monoclonal antibody lies in its ability to significantly reduce anti-double-stranded DNA (anti-dsDNA) antibody levels and demonstrate superior efficacy in improving proteinuria and renal pathological damage in lupus nephritis (LN) compared to existing medications [1]
核心管线取得突破性进展,早期研发后劲十足,财务结构明显优化,中国抗体处在投资价值爆发的前夜
Ge Long Hui· 2025-09-01 15:24
Core Insights - The company, China Antibody (03681.HK), has made significant progress in its drug pipeline, particularly with its core products SM03 and SM17, which have achieved breakthrough advancements in clinical research [1][2][4] Group 1: Core Drug Developments - SM03 (Suciraslimab) is a first-in-class anti-CD22 monoclonal antibody showing promising organ protection effects in systemic lupus erythematosus (SLE) models, particularly in reducing proteinuria and kidney damage [2][3] - The company has strategically withdrawn the application for SM03's use in rheumatoid arthritis to focus on SLE, which is seen as a more advantageous indication [2] - SM17, a first-in-class humanized IgG4 monoclonal antibody targeting IL-25, has shown positive results in treating moderate to severe atopic dermatitis (AD), with high rates of itch relief and skin lesion recovery [4][5] Group 2: Research and Development Pipeline - The company has a robust pipeline with several innovative candidates, including an anti-CGC antibody for autoimmune diseases and a bispecific antibody targeting RANKL for osteoporosis [6][7] - Additional candidates include SM06, a second-generation anti-CD22 antibody, and SN1011, a reversible covalent BTK inhibitor for multiple autoimmune conditions [7] Group 3: Research Platforms - China Antibody has established five strategic research platforms that support the development of innovative drug candidates, enhancing its ability to deliver new therapies [9][10] - These platforms focus on B-cell therapies, alarmin pathway treatments, selective T-cell therapies, neurodegenerative diseases, and antibody humanization [9] Group 4: Financial Performance - The company reported a significant reduction in losses for the first half of 2025, with a loss of RMB 49.8 million, down approximately 45% from RMB 90.6 million in the same period of 2024 [12] - The reduction in losses is attributed to decreased R&D and administrative expenses, as well as increased foreign exchange gains [12] - The company successfully raised approximately HKD 1.24 billion and HKD 3.7 billion through share placements, enhancing its cash reserves for clinical advancements [12] Group 5: Market Position and Future Outlook - The company is positioned at a critical juncture with clinical trial breakthroughs, a strong pipeline, improved financial health, and ample cash reserves, indicating a favorable environment for growth [14] - The global market for innovative antibody drugs is recovering, providing an advantageous backdrop for the company's strategic growth initiatives [14]
中国抗体-B(03681)发布中期业绩 研究及开发成本3274万元 两款核心药物管线均取得突破式进展
智通财经网· 2025-08-29 13:27
Core Insights - China Antibody-B (03681) reported a significant increase in other income and revenue, reaching 9.802 million RMB, a year-on-year increase of 126.95% [1] - The company’s flagship product, Suciraslimab (SM03), has achieved breakthrough results in preclinical studies for treating systemic lupus erythematosus (SLE), demonstrating unique advantages in regulating the autoimmune network and protecting organ damage [1][2] - The total value of license-out transactions for Chinese innovative drugs reached 66 billion USD in the first half of 2025, a 36% year-on-year increase, indicating strong international recognition of early-stage innovations from China [1] Financial Performance - Other income and revenue for the company amounted to 9.802 million RMB, reflecting a substantial increase of 126.95% compared to the previous year [1] - Research and development costs were reported at 32.74 million RMB [1] Product Development - Suciraslimab is the world's first monoclonal antibody targeting the CD22 site, showing significant efficacy in reducing anti-double-stranded DNA antibody levels and improving proteinuria and renal pathology in lupus nephritis [1] - The company is optimistic about the further validation of Suciraslimab and SM17 in upcoming clinical trials, aiming to address unmet medical needs for SLE and atopic dermatitis (AD) patients [2] Regulatory Environment - The National Medical Products Administration has reduced the clinical trial approval time for innovative drugs from 14 months to 30 days, which is expected to boost the innovative drug market in China [2] - The National Healthcare Security Administration's "Sixteen Policies for Innovative Drugs" supports the expansion of payment channels, further promoting the recovery of the innovative drug market [2] Strategic Positioning - As the first biopharmaceutical company based in Hong Kong listed under the 18A category, the company aims to maintain innovation as its core competitive advantage while commercializing existing drug pipelines and developing new ones [2] - The central government's "New Quality Productive Forces" strategy provides a favorable environment for the company's innovative research and development efforts [2]
中国抗体-B发布中期业绩 研究及开发成本3274万元 两款核心药物管线均取得突破式进展
Zhi Tong Cai Jing· 2025-08-29 13:23
Core Insights - China Antibody-B (03681) reported a significant increase in other income and revenue, reaching 9.802 million RMB, a year-on-year increase of 126.95% [1] - The company’s flagship product, Suciraslimab (SM03), has achieved breakthrough results in preclinical studies for treating systemic lupus erythematosus (SLE), demonstrating unique advantages in regulating the autoimmune network and protecting organ damage [1][2] - The total value of license-out transactions for Chinese innovative drugs reached 66 billion USD in the first half of 2025, a 36% year-on-year increase, indicating strong international recognition of early-stage innovations from China [1] Financial Performance - Other income and revenue for the first half of 2025 amounted to 9.802 million RMB, reflecting a 126.95% increase compared to the previous year [1] - Research and development costs were reported at 32.74 million RMB [1] Product Development - Suciraslimab is the world's first monoclonal antibody targeting the CD22 site, showing significant efficacy in reducing anti-dsDNA antibody levels and improving proteinuria and renal pathology in lupus nephritis [1] - The company is optimistic about the further validation of Suciraslimab and SM17 in upcoming clinical trials, aiming to address unmet medical needs for SLE and atopic dermatitis (AD) patients [2] Regulatory Environment - The National Medical Products Administration has reduced the clinical trial approval time for innovative drugs from 14 months to 30 days, facilitating a more favorable environment for innovation [2] - The National Healthcare Security Administration's "Sixteen Policies for Innovative Drugs" is expected to expand payment support, contributing to the recovery of the Chinese innovative drug market [2]
中国抗体(03681) - 2025 - 中期业绩
2025-08-29 12:38
[Executive Summary](index=2&type=section&id=Executive%20Summary) This report period saw significant progress in clinical trial projects and pipeline development, with flagship product Suciraslimab (SM03) showing breakthrough preclinical results in Systemic Lupus Erythematosus (SLE) treatment, and key product SM17 achieving positive Phase 1b results for Atopic Dermatitis (AD) [Business Summary](index=2&type=section&id=Business%20Summary) The company made significant progress in clinical trials and pipeline development, with SM03 showing breakthrough preclinical results in SLE and SM17 achieving positive Phase 1b results for AD - Suciraslimab (SM03) achieved breakthrough preclinical results in in vitro studies for SLE treatment, showing potential to reduce proteinuria and alleviate Lupus Nephritis (LN), with three competitive advantages: "non-depleting B-cell modulation," "dual mechanism and bidirectional regulation," and "organ protection"[4](index=4&type=chunk) - The company strategically withdrew the Biologics License Application (BLA) for Suciraslimab in Rheumatoid Arthritis (RA) and decided to fully accelerate its clinical development for SLE treatment[4](index=4&type=chunk) - SM17 achieved positive topline results in a Phase 1b study for moderate-to-severe Atopic Dermatitis (AD), with clinical data showing faster and more significant itch relief, superior lesion recovery, and better safety than JAK inhibitors, positioning it as a potential first-in-class and best-in-class therapy for AD[4](index=4&type=chunk) - The Investigational New Drug (IND) application for anti-CGC antibody (the world's first humanized anti-γc antibody) for Alopecia Areata treatment has been initiated, with submission expected as early as 2026[4](index=4&type=chunk) - During the reporting period, the company published two academic papers in *The Journal of Immunology* and *Journal of Neuroinflammation*, revealing the role of anti-γc antibody hC2 in autoimmune diseases and the dual mechanism of Suciraslimab in Alzheimer's disease, respectively[5](index=5&type=chunk)[6](index=6&type=chunk) [Financial Summary](index=3&type=section&id=Financial%20Summary) For the six months ended June 30, 2025, the company significantly reduced losses, primarily due to lower R&D and employment costs, while successfully raising substantial funds through new share subscriptions Key Financial Indicators Comparison (For the six months ended June 30) | Indicator | 2025 (RMB million) | 2024 (RMB million) | Change (RMB million) | Change Rate | Primary Reason | | :--- | :--- | :--- | :--- | :--- | :--- | | Loss for the Period | 49.8 | 90.6 | (40.8) | -44.9% | R&D laboratory consumables and trial costs decreased; R&D and administrative employee employment costs decreased | | Total Available Funds (Period End) | 125.7 | 141.4 (Dec 31, 2024) | (15.7) | -11.1% | Repayment of bank borrowings, capital expenditure, and net cash outflow from operating activities offset by proceeds from share issuance | Share Subscription Financing Details | Subscription Event | Net Proceeds Raised (HKD million) | Completion Date | | :--- | :--- | :--- | | May 2025 | 124.0 | May 2025 | | August 2025 | 369.5 | August 2025 | - The Board has resolved not to declare an interim dividend for the reporting period[7](index=7&type=chunk) [Business Operations and R&D Progress](index=4&type=section&id=Business%20Operations%20and%20R%26D%20Progress) The company operates in the "Biotech 3.0 Era," focusing on differentiated innovation and achieving breakthrough progress in two core drug pipelines for immune-related diseases [Industry Background and Company Strategy](index=4&type=section&id=Industry%20Background%20and%20Company%20Strategy) The biopharmaceutical industry is in the "Biotech 3.0 Era," characterized by innovation, multidisciplinary integration, and precision, aligning with the company's differentiated innovation strategy - The biopharmaceutical industry is entering the "Biotech 3.0 Era," characterized by innovation-driven development, multidisciplinary integration, intelligence, and precision[8](index=8&type=chunk) - The company's strategy focuses on differentiated innovation, aiming for "first-in-class" and "best-in-class" as core R&D goals, specializing in innovative therapies for immune-related diseases[8](index=8&type=chunk) [Flagship Product: Suciraslimab (SM03)](index=4&type=section&id=Flagship%20Product%3A%20Suciraslimab%20(SM03)) SM03, a first-in-class anti-CD22 monoclonal antibody, showed breakthrough preclinical results in SLE, leading to the strategic withdrawal of its RA BLA to accelerate SLE clinical development and explore Alzheimer's disease potential - SM03 achieved breakthrough results in SLE preclinical studies, significantly reducing anti-dsDNA antibody levels and showing superior kidney protection in improving Lupus Nephritis (LN) proteinuria and renal pathological damage compared to existing drugs, by modulating B-cell interactions and organ damage protection[9](index=9&type=chunk) - Over **5 million** global SLE patients, with over **1 million** in China, approximately **50%** progressing to LN; SM03 is expected to address unmet needs regarding "long-term medication safety risks" and "lack of actual organ damage protective benefits"[10](index=10&type=chunk) - SM03 for RA showed good efficacy and safety in Phase 3 clinical data, with ACR20 response rates of approximately **50%** at 24 weeks and over **70%** at 104 weeks, with no new safety risks identified[11](index=11&type=chunk) - The company strategically withdrew the BLA for SM03 in RA and is fully accelerating its clinical development for SLE treatment, while also initiating Phase 2 clinical project planning for SLE[12](index=12&type=chunk)[13](index=13&type=chunk) - SM03 also shows potential in Alzheimer's disease, by modulating microglial cell function, it is expected to become the world's first Alzheimer's immunotherapy with both efficacy and safety, with IND application preparations underway[13](index=13&type=chunk) [Key Product: SM17](index=5&type=section&id=Key%20Product%3A%20SM17) SM17, a first-in-class anti-IL-25 receptor antibody, achieved breakthrough Phase 1b topline results for moderate-to-severe AD, demonstrating rapid itch relief, superior lesion recovery, and favorable safety, with formulation bridging studies underway - SM17 is the world's first humanized monoclonal antibody targeting the IL-25 receptor, achieving rapid itch relief and lesion recovery by inhibiting downstream factors of the Type II inflammatory pathway and blocking the IL-25 receptor[14](index=14&type=chunk) SM17 Phase 1b Clinical Results for Moderate-to-Severe AD (High-Dose Group) | Indicator | Result | | :--- | :--- | | Itch Relief (NRS–4) | 91.7% of patients achieved | | Lesion Recovery (EASI 75) | 75% of patients achieved | | Complete/Near-Complete AD Symptom Clearance (IGA0/1) | 41.7% of patients achieved | - SM17 data significantly outperforms IL4/IL-13 class monoclonal antibodies, and its safety and tolerability are notably superior to JAK inhibitors, positioning it as potentially the first AD treatment to simultaneously offer rapid itch relief, lesion recovery, and safety[14](index=14&type=chunk) - Over **230 million** global AD patients, with over **70 million** in China; SM17's triple advantages (rapid itch relief, potent lesion recovery, high safety) are expected to address unmet needs of existing treatment options[15](index=15&type=chunk) - The company is advancing SM17's formulation bridging clinical study, expected to be completed by Q1 2026[15](index=15&type=chunk) [Other Pipeline Drugs and Expansion](index=6&type=section&id=Other%20Pipeline%20Drugs%20and%20Expansion) The company is expanding its R&D pipeline with anti-CGC antibody and bispecific antibodies targeting IND submission by 2026, while SM06 is in IND research and SN1011 shows positive clinical results for pMN through collaboration - Anti-CGC antibody, a proprietary humanized anti-γc antibody, is a potential drug for Alopecia Areata, Vitiligo, and other autoimmune diseases, with IND submission expected in 2026[16](index=16&type=chunk) - Bispecific antibody product targeting RANKL and Sclerostin for osteoporosis treatment, with IND submission expected in 2026[16](index=16&type=chunk) - SM06, a second-generation anti-CD22 antibody and a humanized variant of Suciraslimab, is in IND research, with internal studies suggesting potentially stronger efficacy and longer half-life[27](index=27&type=chunk) - SN1011, a third-generation reversible covalent BTK inhibitor, has received **4** NMPA IND approvals, including for SLE, Pemphigus, MS, and NMOSD[28](index=28&type=chunk) - The company collaborates with Everest Medicines on SN1011 for kidney diseases; Everest Medicines announced positive latest results from its Phase 1b/2a clinical trial for primary Membranous Nephropathy (pMN) in July 2025[28](index=28&type=chunk) Company Product Pipeline Overview | Product Line | Indication | Region | IND Stage | Phase 1 | Phase 2 | Phase 3 | BLA | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | SM03 (Suciraslimab) | SLE | China | | | Planning | | | | (Anti-CD22 Monoclonal Antibody) | RA | China | | | | Completed | Withdrawn | | | MCI, Alzheimer's Disease | China | IND Application Preparation | | | | | | SM17 (Humanized Anti-IL-25 Receptor Monoclonal Antibody) | AD | China/US | | Completed | Proof of Concept Completed | | | | | Asthma, IPF | China/US | IND Approved | | | | | | SN1011 (BTK Inhibitor) | SLE, Pemphigus, MS, NMOSD | China/Global | IND Approved | Completed | Positive Results | | | | SM06 (Humanized Anti-CD22 Monoclonal Antibody) | Autoimmune Diseases | China | CMC Optimization | | | | | | Anti-CGC Antibody | Alopecia Areata, Vitiligo | China | CMC Optimization | | | | | | Bispecific Antibody Candidate (bsAb) | Osteoporosis | Global | CMC Optimization | | | | | | SM09 (Humanized Anti-CD20 Monoclonal Antibody) | NHL, Autoimmune Diseases | China | R&D | | | | | [Strategic Partnerships and R&D Platforms](index=6&type=section&id=Strategic%20Partnerships%20and%20R%26D%20Platforms) The company signed a strategic cooperation agreement with SYSU-IAS, leveraging its facilities and Oxford University's expertise, while exploring AI for drug target identification to enhance R&D efficiency - The company signed a comprehensive strategic cooperation agreement with Sun Yat-sen University Hong Kong Advanced Institute (SYSU-IAS) to accelerate innovative drug development and global scientific research translation into clinical applications[18](index=18&type=chunk)[60](index=60&type=chunk) - The cooperation agreement allows the company to use SYSU-IAS's laboratory facilities and scientific research resources (including primate and non-primate experimental animals) and gain access to expertise provided by Oxford University[18](index=18&type=chunk)[55](index=55&type=chunk)[56](index=56&type=chunk) - The company is actively exploring the feasibility of using Artificial Intelligence (AI) technology for drug target identification to enhance new drug R&D efficiency and shorten development cycles[18](index=18&type=chunk) - The company will provide SYSU-IAS with **HKD 1,000,000** quarterly, of which SYSU-IAS will pay **HKD 1,000,000** annually to Oxford University, to support joint laboratory research activities and talent exchange[57](index=57&type=chunk) [Manufacturing and Intellectual Property](index=19&type=section&id=Manufacturing%20and%20Intellectual%20Property) The company operates a manufacturing base in Haikou and is building a second commercial-scale base in Suzhou, while evaluating a shift to an asset-light model and continuously expanding its intellectual property portfolio for core drugs - The company has a manufacturing base in Haikou with a capacity of **1,200 liters**, which completed GMP inspection in January 2024[64](index=64&type=chunk) - Construction of the second manufacturing base in Suzhou was completed by the end of 2024 and is expected to pass completion acceptance by the end of 2025, serving as a commercial-scale manufacturing base[65](index=65&type=chunk)[79](index=79&type=chunk) - The company is evaluating the feasibility of transitioning to an asset-light model, considering outsourcing manufacturing to CDMOs for cost advantages and operational flexibility[63](index=63&type=chunk) - The company holds invention patents for several core drugs including Suciraslimab (SM03), SN1011, and SM09, and continuously submits new PCT applications and pending patent applications[66](index=66&type=chunk)[67](index=67&type=chunk) Intellectual Property and R&D Personnel Overview | Indicator | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Number of Invention Patents Owned by the Group* | 92 | 91 | | Total R&D Personnel | 33 | 40 | | - PhD Degree | 5 | 6 | | - Master's Degree | 21 | 24 | | - University Degree or Below | 7 | 10 | *Includes pending and granted patents [Internal Strategic R&D Platforms](index=27&type=section&id=Internal%20Strategic%20R%26D%20Platforms) The company has established five internal strategic R&D platforms, including B-cell, Alarmins Pathway, Selective T-cell, Neurological Disease, and Antibody Framework Reshaping Humanization platforms, to identify drug targets and expand its autoimmune disease pipeline - The company has established five internal strategic platforms: B-cell Therapy Platform, Alarmins Pathway Therapy Platform, Selective T-cell Therapy Platform, Neurological Disease Platform, and Antibody Framework Reshaping Humanization Platform[78](index=78&type=chunk) - The B-cell Therapy Platform developed anti-CD22 antibodies (SM03, SM06), anti-CD20 antibody (SM09), and BTK inhibitor (SN1011)[88](index=88&type=chunk) - The Alarmins Pathway Therapy Platform developed SM17, a humanized IgG4-κ monoclonal antibody targeting the IL-25 receptor (IL-17RB), for treating diseases such as asthma, AD, and IPF[87](index=87&type=chunk) - The Selective T-cell Therapy Platform developed humanized anti-γc antibodies for treating autoimmune diseases such as Alopecia Areata and Vitiligo[89](index=89&type=chunk)[90](index=90&type=chunk) - The Neurological Disease Platform utilizes anti-CD22 antibodies (SM03/SM06) to treat Alzheimer's disease by promoting Aβ protein internalization and anti-inflammatory effects[91](index=91&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) - The Antibody Framework Reshaping Humanization Platform employs a new "framework reshaping" method to achieve functional humanization, with SM06 and SM09 antibodies utilizing this proprietary technology[94](index=94&type=chunk) [Future Outlook and Strategy](index=6&type=section&id=Future%20Outlook%20and%20Strategy) The company benefits from a rapidly growing Chinese innovative drug market and supportive policies, aiming to be a global leader in immune disease therapies by advancing its pipeline and commercialization efforts [Industry Opportunities and Policy Support](index=6&type=section&id=Industry%20Opportunities%20and%20Policy%20Support) China's innovative drug market is rapidly growing with increased outbound licensing, supported by accelerated NMPA approvals, expanded medical insurance coverage, and the "new quality productive forces" strategy - In H1 2025, China's innovative drug outbound licensing (License-out) transactions totaled **USD 66 billion**, a **36%** year-on-year increase, exceeding the total for full-year 2024[19](index=19&type=chunk) - The National Medical Products Administration (NMPA) reduced innovative drug clinical trial approval time from 14 months to **30 days**, and the National Healthcare Security Administration's "16 Measures for Innovative Drugs" supports payment expansion, promoting the recovery of China's innovative drug market[20](index=20&type=chunk) - The central government's "new quality productive forces" strategy provides a favorable environment for the company's innovative R&D[20](index=20&type=chunk) [Company Vision and Core Competitiveness](index=7&type=section&id=Company%20Vision%20and%20Core%20Competitiveness) As Hong Kong's first biopharmaceutical IPO, the company aims to be a global leader in innovative immune disease therapies, leveraging innovation to commercialize existing pipelines and develop new ones, with SM03 and SM17 expected to validate their best-in-class potential - The company's vision is to become a global leader in innovative therapies for immune and other debilitating diseases[70](index=70&type=chunk) - The company will continue to leverage innovation as its core competitiveness, driving the commercialization of existing drug pipelines and the R&D of new ones[20](index=20&type=chunk) - The company believes Suciraslimab and SM17 will further validate their best-in-class characteristics in subsequent clinical trials, addressing unmet medical needs for SLE and AD patients[20](index=20&type=chunk) [Clinical Development and Commercialization Plans](index=22&type=section&id=Clinical%20Development%20and%20Commercialization%20Plans) The company plans to advance SM03 clinical trials for SLE and neuroimmune diseases, and SM17's formulation bridging study and IPF IND, while expanding its marketing team and seeking strategic partnerships for commercialization - The company will advance Suciraslimab (SM03) clinical trials for SLE and other autoimmune diseases, and plans to initiate IND applications for Alzheimer's disease and Phase 2 proof-of-concept clinical studies for SLE in China[74](index=74&type=chunk) - SM17's Phase 1b clinical trial achieved positive topline results; the company is advancing its formulation bridging clinical study, expected to be completed by Q1 2026, and plans to submit IND applications for SM17 in IPF in the US and China[75](index=75&type=chunk) - The company will continue to expand its marketing team and actively seek cooperation and/or partnership opportunities, including in-licensing and out-licensing, to maximize the commercial value of its assets[80](index=80&type=chunk) [Market Overview](index=25&type=section&id=Market%20Overview) Global and Chinese markets for SLE, AD, asthma, and RA are large and growing, with significant unmet medical needs, providing vast market potential for the company's innovative therapies Key Disease Market Size Forecast | Disease | Market Size (2024) | Forecast Market Size (2030/2037) | CAGR | | :--- | :--- | :--- | :--- | | SLE (Global) | >USD 2.4 billion | >USD 6.37 billion (2037) | >7.8% | | AD (Global) | - | USD 27.7 billion (2030) | - | | AD (China) | USD 1.5 billion | USD 4.3 billion (2030) | - | | RA (China) | - | RMB 83.3 billion (2030) | 16.8% | - China has approximately **1.0349 million** SLE patients, projected to increase to **1.0947 million** by 2030[81](index=81&type=chunk) - China had approximately **65.7 million** AD patients in 2019, projected to increase to **81.7 million** by 2030, with **30%** being moderate-to-severe patients[82](index=82&type=chunk) - The number of global asthma patients is increasing annually, projected to reach approximately **860 million** by 2030, with China's patient count reaching **78.1 million**[83](index=83&type=chunk) - China has approximately **5 million** Rheumatoid Arthritis patients; the market share of biologics is expected to increase from **43.4%** in 2024 to **59.8%** by 2030[84](index=84&type=chunk) [Financial Review](index=29&type=section&id=Financial%20Review) The company's net loss significantly decreased for the six months ended June 30, 2025, driven by optimized R&D and administrative expenses, with stable financial costs and no income tax expense [Income Statement Analysis](index=29&type=section&id=Income%20Statement%20Analysis) For the six months ended June 30, 2025, the company's net loss decreased by 44.9% to RMB 49.8 million, due to reduced R&D and administrative expenses, increased other income, and no income tax Condensed Interim Consolidated Income Statement Summary (For the six months ended June 30) | Indicator | 2025 (RMB thousand) | 2024 (RMB thousand) | Change (RMB thousand) | Change Rate | | :--- | :--- | :--- | :--- | :--- | | Revenue | 2,026 | - | 2,026 | N/A | | Cost of Sales | - | (1,483) | 1,483 | N/A | | Gross Profit | 2,026 | 543 | 1,483 | 273.1% | | Other Income and Gains | 9,802 | 4,319 | 5,483 | 127.0% | | R&D Costs | (32,740) | (55,035) | 22,295 | -40.5% | | Administrative Expenses | (23,734) | (34,205) | 10,471 | -30.6% | | Finance Costs | (2,990) | (3,287) | 297 | -9.0% | | Other Expenses | (159) | (2,957) | 2,798 | -94.6% | | Loss Before Tax | (49,821) | (90,622) | 40,801 | -44.9% | | Loss for the Period | (49,821) | (90,622) | 40,801 | -44.9% | - Other income and gains increased by approximately **RMB 5.5 million**, primarily due to an increase of approximately **RMB 7.4 million** in foreign exchange gains and approximately **RMB 1.0 million** in government grants, offset by a decrease of approximately **RMB 2.9 million** in bank interest income[95](index=95&type=chunk) - R&D costs decreased by approximately **RMB 22.3 million**, mainly due to reduced expenditure on laboratory consumables and trial costs in preparation for SM03 BLA and commercialization, and lower R&D employee employment costs[97](index=97&type=chunk) - Administrative expenses decreased by approximately **RMB 10.5 million**, mainly due to optimized administrative personnel costs and the reversal of share-based non-cash payment expenses[98](index=98&type=chunk) - No income tax expense for the period, as neither the company nor its mainland China subsidiaries generated assessable profits[139](index=139&type=chunk) [Cash Flow and Liquidity](index=30&type=section&id=Cash%20Flow%20and%20Liquidity) For the six months ended June 30, 2025, the company saw reduced net cash outflow from operating activities, net cash inflow from investing and financing activities, and improved financial health with a significantly lower debt-to-asset ratio Condensed Interim Consolidated Cash Flow Statement Summary (For the six months ended June 30) | Indicator | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Net Cash Flows Used in Operating Activities | (26,906) | (70,587) | | Net Cash Flows From/(Used in) Investing Activities | 35,230 | (76,390) | | Net Cash Flows From Financing Activities | 38,263 | 93,446 | | Net Increase/(Decrease) in Cash and Cash Equivalents | 46,587 | (53,531) | | Cash and Cash Equivalents at Period End | 101,034 | 153,617 | Total Available Funds (Period End) | Indicator | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Cash and Cash Equivalents | 101,034 | 61,900 | | Pledged and Restricted Deposits | 13,879 | 66,002 | | Wealth Management Products | 10,738 | 13,523 | | **Total Available Funds** | **125,651** | **141,425** | Bank Borrowings and Debt-to-Asset Ratio | Indicator | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Outstanding Borrowings (RMB million) | 354.4 | 419.3 | | Effective Annual Interest Rate | 3.00% to 3.90% | 3.15% to 3.90% | | Unutilized Bank Facilities (RMB million) | 321.7 | - | | Debt-to-Asset Ratio | 104.1% | 185.3% | - The company pledged land use rights and construction in progress with a carrying value of approximately **RMB 338.2 million** to secure bank loans[104](index=104&type=chunk) [Significant Events: Share Subscriptions and Fund Utilization](index=32&type=section&id=Significant%20Events%3A%20Share%20Subscriptions%20and%20Fund%20Utilization) The company successfully raised substantial funds through multiple share subscriptions in and after the reporting period, primarily for SM17 R&D, new drug preclinical studies, IND preparation, and general working capital, with prior subscriptions fully utilized Utilization of Net Proceeds from May 2025 Share Subscription (As of June 30, 2025) | Purpose | Intended Use (HKD million) | Actual Use (HKD million) | Unutilized (HKD million) | Expected Timeline | | :--- | :--- | :--- | :--- | :--- | | SM17 R&D and Clinical Projects | 55.781 | 8.375 | 47.406 | Before end of 2026 | | Preclinical Research and IND Application Preparation for New Drug Candidates | 24.791 | - | 24.791 | Before end of 2026 | | Group Working Capital and General Corporate Purposes | 43.385 | 10.726 | 32.659 | Before end of 2025 | | **Total** | **123.957** | **19.101** | **104.856** | | - Proceeds from the 2023 share subscription (net approximately **HKD 73.18 million**) and the 2022 share subscription (net approximately **HKD 50.89 million**) have been fully utilized as intended[109](index=109&type=chunk)[113](index=113&type=chunk) - The company or any of its subsidiaries did not purchase, sell, or redeem any of the company's listed securities during the reporting period[117](index=117&type=chunk) [Events After Reporting Period](index=40&type=section&id=Events%20After%20Reporting%20Period) After the reporting period, the company completed a significant share subscription in July 2025, raising approximately HKD 369.5 million, and granted share options to employees and service providers [July 2025 Share Subscription](index=40&type=section&id=July%202025%20Share%20Subscription) On July 22, 2025, the company entered into subscription agreements with 23 subscribers to issue 182,072,400 new ordinary shares at HKD 2.03 per share, raising approximately HKD 369.5 million net proceeds - On July 22, 2025, the company entered into subscription agreements with **23** subscribers to issue a total of **182,072,400** new ordinary shares at a subscription price of **HKD 2.03** per share[120](index=120&type=chunk) - The net proceeds from the July 2025 share subscription amounted to approximately **HKD 369,461,972**[120](index=120&type=chunk) - These subscribed shares represent approximately **15.12%** of the issued shares immediately prior to the subscription and approximately **13.13%** of the enlarged issued shares after the allotment and issuance of the subscription shares[120](index=120&type=chunk) [Grant of Share Options](index=40&type=section&id=Grant%20of%20Share%20Options) On July 24, 2025, the company granted a total of 46,585,862 share options to 20 employees and 2 service providers under its share option scheme - On July 24, 2025, the company granted a total of **46,585,862** share options to **20** employees and **2** service providers to subscribe for a total of **46,585,862** new shares of the company[122](index=122&type=chunk) [Corporate Governance](index=40&type=section&id=Corporate%20Governance) The company adheres to high corporate governance standards, applying principles of the Listing Rules, with the Board deeming the combined Chairman and CEO role appropriate due to the individual's extensive business knowledge and the Board's independent composition - The company has applied the principles and code provisions of the Corporate Governance Code set out in Appendix C1 to the Listing Rules[124](index=124&type=chunk) - The roles of Chairman and Chief Executive Officer are held by Dr. Liang Rui'an, deviating from Code Provision C.2.1 of the Corporate Governance Code[125](index=125&type=chunk) - The Board considers this deviation appropriate, as Dr. Liang has extensive business knowledge, and the Board comprises one executive director, four non-executive directors, and five independent non-executive directors, ensuring a high degree of independence and balance of power[125](index=125&type=chunk) [Interim Dividend](index=42&type=section&id=Interim%20Dividend) The Board resolved not to declare an interim dividend for the six months ended June 30, 2025, consistent with the prior year - The Board has resolved not to declare an interim dividend for the six months ended June 30, 2025 (2024: nil)[127](index=127&type=chunk) [Notes to Financial Statements](index=42&type=section&id=Notes%20to%20Financial%20Statements) The financial statements, prepared under HKAS 34, show a reduced net loss and improved net assets, with detailed notes on income, cash flow, and balance sheet items, reflecting the company's financial position and recent capital activities [Condensed Interim Consolidated Income Statement](index=42&type=section&id=Condensed%20Interim%20Consolidated%20Income%20Statement) For the six months ended June 30, 2025, the company reported a net loss of RMB 49,821 thousand, significantly narrowed from the prior year, with revenue from capsule sales and reduced R&D and administrative expenses Condensed Interim Consolidated Income Statement (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Revenue | 2,026 | - | | Cost of Sales | - | (1,483) | | Gross Profit | 2,026 | 543 | | Other Income and Gains | 9,802 | 4,319 | | R&D Costs | (32,740) | (55,035) | | Administrative Expenses | (23,734) | (34,205) | | Finance Costs | (2,990) | (3,287) | | Other Expenses | (159) | (2,957) | | Loss Before Tax | (49,821) | (90,622) | | Income Tax Expense | - | - | | **Loss for the Period** | **(49,821)** | **(90,622)** | | Loss per Share Attributable to Ordinary Equity Holders of the Parent (RMB) | (0.05) | (0.08) | [Condensed Interim Consolidated Statement of Comprehensive Income](index=43&type=section&id=Condensed%20Interim%20Consolidated%20Statement%20of%20Comprehensive%20Income) For the six months ended June 30, 2025, the company's total comprehensive loss for the period narrowed to RMB 57,398 thousand, primarily comprising the net loss and exchange differences from currency translation Condensed Interim Consolidated Statement of Comprehensive Income (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Loss for the Period | (49,821) | (90,622) | | Exchange differences arising from translation of presentation currency | (7,577) | 3,664 | | **Total Comprehensive Loss for the Period** | **(57,398)** | **(86,958)** | [Condensed Interim Consolidated Statement of Financial Position](index=44&type=section&id=Condensed%20Interim%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2025, the company's total assets less current liabilities were RMB 533,605 thousand, with net assets of RMB 243,289 thousand, showing growth from the prior period, despite a net current liability position Condensed Interim Consolidated Statement of Financial Position (As of June 30) | Item | June 30, 2025 (RMB thousand) | December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | **Total Non-Current Assets** | **558,810** | **567,763** | | Property, Plant and Equipment | 482,506 | 484,108 | | Right-of-Use Assets | 59,099 | 66,614 | | **Total Current Assets** | **163,283** | **185,337** | | Cash and Cash Equivalents | 101,034 | 61,900 | | Pledged and Restricted Deposits | 13,879 | 66,002 | | Financial Assets at Fair Value Through Profit or Loss | 42,063 | 44,978 | | **Total Current Liabilities** | **188,488** | **203,498** | | Interest-bearing Bank Borrowings (Current) | 105,156 | 112,639 | | **Net Current Liabilities** | **(25,205)** | **(18,161)** | | **Total Assets Less Current Liabilities** | **533,605** | **549,602** | | **Total Non-Current Liabilities** | **290,316** | **356,691** | | Interest-bearing Bank Borrowings (Non-Current) | 249,209 | 306,647 | | **Net Assets** | **243,289** | **192,911** | | **Total Equity** | **243,289** | **192,911** | [Explanatory Notes](index=45&type=section&id=Explanatory%20Notes) The financial statements, prepared under HKAS 34 on a going concern basis, show current liabilities exceeding current assets, but with sufficient working capital from unutilized facilities and post-period share subscriptions, with revenue from BTK inhibitor capsule sales and an improved debt-to-asset ratio - The condensed interim consolidated financial information is prepared in accordance with Hong Kong Accounting Standard 34 "Interim Financial Reporting" and on a going concern basis[133](index=133&type=chunk)[134](index=134&type=chunk) - As of June 30, 2025, the Group's current assets were **RMB 163,283 thousand**, current liabilities were **RMB 188,488 thousand**, and a net loss of **RMB 49,821 thousand** was incurred for the period[134](index=134&type=chunk) - Revenue primarily derived from BTK inhibitor capsule sales, supplied and recognized in April 2024[137](index=137&type=chunk) - Basic loss per share attributable to ordinary equity holders of the parent was **RMB 0.05** (2024: **RMB 0.08**), with no diluted adjustment due to the anti-dilutive effect of share options[143](index=143&type=chunk) - Total interest-bearing bank borrowings were **RMB 354,365 thousand** (December 31, 2024: **RMB 419,286 thousand**), with effective annual interest rates ranging from **3.00%** to **3.90%**[145](index=145&type=chunk) - Share capital increased due to the issuance of **112,810,817** new ordinary shares in May 2025, with net settlement proceeds of approximately **RMB 108,238 thousand**[147](index=147&type=chunk) [Review of Interim Results](index=51&type=section&id=Review%20of%20Interim%20Results) Ernst & Young, the independent auditor, reviewed the interim condensed consolidated financial information, and the Audit Committee confirmed compliance with accounting standards, laws, and regulations, with appropriate disclosures - Independent auditor Ernst & Young reviewed the condensed interim consolidated financial information in accordance with Hong Kong Standard on Review Engagements 2410[148](index=148&type=chunk) - The Audit Committee, together with management and the independent auditor, reviewed accounting principles and policies, confirming that the interim results comply with applicable accounting standards, laws, and regulations, and that appropriate disclosures have been made[149](index=149&type=chunk) [Publication of Interim Results and Report](index=51&type=section&id=Publication%20of%20Interim%20Results%20and%20Report) This interim results announcement is published on the HKEX and company websites, with the full 2025 interim report to be dispatched to shareholders and/or published online as required by Listing Rules - This interim results announcement is published on the HKEX website (www.hkexnews.hk) and the company's website (www.sinomab.com)[150](index=150&type=chunk) - The 2025 interim report, containing all information required by the Listing Rules, will be dispatched to shareholders and/or published on the HKEX and company websites in due course[150](index=150&type=chunk)
中国抗体-B(03681.HK)完成根据一般授权发行2496.54万股认购股份
Ge Long Hui· 2025-08-29 11:11
Group 1 - The company China Antibody-B (03681.HK) announced the completion of the subscription of a total of 24,965,400 shares according to the terms and conditions of the relevant subscription agreements with subscribers H and O on August 29, 2025 [1]
中国抗体-B完成发行2496.54万股认购股份
Zhi Tong Cai Jing· 2025-08-29 11:07
Group 1 - The company China Antibody-B (03681) has completed the issuance of 24.9654 million subscription shares as of August 29, 2025 [1] - The subscription price for each share was set at HKD 2.03 [1]
中国抗体(03681) - 翌日披露报表
2025-08-29 10:55
FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | | 證券代號 (如上市) | 03681 | 說明 | 普通股 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | | | 已發行股份(不包括庫存股份)變動 | | 庫存股份變動 | | | | | 事件 | | 已發行股份(不包括庫存股份)數 目 | 佔有關事件前的現有已發 行股份(不包括庫存股 份)數目百分比 (註3) ...
中国抗体(03681) - 完成根据一般授权认购新股份
2025-08-29 10:53
香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 的 內 容 概 不 負 責,對其準確性或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部 或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 下表說明(i)緊接餘下認購事項完成前;及(ii)緊隨餘下認購事項完成後本公司的股 權架構: SinoMab BioScience Limited 中 國 抗 體 製 藥 有 限 公 司 (於香港註冊成立的有限公司) (股份代號:3681) 完成根據一般授權認購新股份 董 事 會 欣 然 宣 佈 , (i) 本 公 司 與 認 購 人 H 及 (ii) 本 公 司 與 認 購 人 O 有 關 認 購 合 共 24,965,400股認購股份的認購事項已根據各相關認購協議的條款及條件於二零二 五年八月二十九日完成。 緒言 茲提述中國抗體製藥有限公司(「本公司」)日期為二零二五年七月二十二日及二零 二五年八月十五日的公告( 統稱「該等公告」),內容有關( 其中包括 )根據一般授權 認購本公司新股份及完成若干認購事項。除另有所指外,本公告所用詞彙與 ...