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歌礼制药-B(01672.HK):海外临床进展顺利 远期管线成功概率提升
Ge Long Hui· 2025-08-17 17:01
Core Viewpoint - The company has shown strong progress in its core pipelines and financial performance in the first half of 2025, with significant revenue growth and promising clinical data expected in the near future [1][2][3] Financial Performance - The company's main operating revenue for H1 2025 was 1.08 million, primarily from R&D services [1] - R&D expenses for H1 2025 were 146 million, a year-on-year increase of 10.9%, with effective pipeline adjustments and cost optimizations [1] - Cash and cash equivalents at the end of H1 2025 reached 1.58 billion, a year-on-year increase of 361.9%, mainly due to the maturity of time deposits [1] Pipeline Development - ASC30, the company's core small molecule GLP-1 pipeline, demonstrated a 6.5% weight loss in a 4-week Phase I trial in the U.S., outperforming Eli Lilly's small molecule GLP-1 [1] - The company is currently conducting a Phase IIa trial for ASC30, with top-line data expected in Q4 2025 [1] - ASC47, a new THR-β target pipeline, is in Phase I clinical trials in the U.S., with top-line data anticipated in Q4 2025 [2] - ASC50, an oral small molecule for IL-17, is also in Phase I clinical trials, with top-line data expected by the end of 2025 [2] - The oral small molecule FASN inhibitor, Denifasita, is projected to submit a market application in China by 2026 based on excellent Phase III data [2] Profit Forecast and Investment Rating - The company’s pipeline progress aligns with expectations, increasing the likelihood of successful product launches [3] - Revenue forecasts for 2025-2027 have been adjusted to 0.02 billion, 0.64 billion, and 2.03 billion respectively [3] - The target price has been raised to 29.26 HKD, maintaining a "buy" rating based on improved pipeline success rates [3]
歌礼制药-B(01672):2025 年中报点评:海外临床进展顺利,远期管线成功概率提升
Soochow Securities· 2025-08-16 09:16
Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The report highlights that the company has made significant progress in its overseas clinical trials, which enhances the probability of success for its long-term pipeline [1] - The revenue forecast for 2025 has been adjusted upwards to 0.02 billion, 0.64 billion, and 2.03 billion for the years 2025, 2026, and 2027 respectively, indicating a positive outlook [1] - The target price has been raised to 29.26 HKD, reflecting increased confidence in the company's pipeline success [1] Financial Performance Summary - Total revenue for 2023 is projected at 56.69 million, with a year-on-year growth of 4.81% [1] - The net profit attributable to the parent company is expected to be negative at (144.72) million for 2023, with a year-on-year increase of 54.04% [1] - The earnings per share (EPS) for 2025 is estimated at (0.43) HKD, with a price-to-earnings (P/E) ratio of (18.70) [1] Pipeline Development - ASC30, the company's core GLP-1 pipeline, is currently in Phase IIa clinical trials in the US, with expected top-line data release in Q4 2025 [1] - ASC47, a new THR-β target pipeline, is also in clinical trials, with data expected in Q4 2025 [1] - ASC50, an oral small molecule for psoriasis, is in Phase I clinical trials, with top-line data anticipated by the end of 2025 [1] - The company has a strong cash position of 1.58 billion at the end of H1 2025, which supports ongoing research and development [1]
歌礼制药-B(1672.HK):美国临床进展顺利 期待临床数据读出
Ge Long Hui· 2025-08-16 01:00
Core Viewpoint - Songlei Pharmaceutical-B has announced the completion of the Phase IIa study for its small molecule oral GLP-1R agonist ASC30, targeting obesity or overweight subjects, indicating rapid clinical advancement in a competitive market [1][2]. Group 1: Clinical Progress - ASC30 is the first and only small molecule GLP-1R agonist developed by the company that can be administered either orally once daily or via subcutaneous injection once monthly. The company initiated the Phase IIa clinical trial in early July and enrolled 125 subjects in just over a month, showcasing high efficiency. The treatment period lasts for 13 weeks, with top-line data expected in Q4 2025. Currently, the fastest progress in the global small molecule GLP-1 development pipeline is by Eli Lilly with Orforglipron, which has submitted an FDA application, while Pfizer has abandoned its small molecule GLP-1 pipeline, placing ASC30 in a competitive catch-up position [1]. Group 2: Potential and Safety Profile - ASC30 demonstrates potential to become a Best in Class (BIC) treatment due to its safety profile and rapid weight loss capabilities. According to data presented at the ADA conference from the Phase I MAD study, the average weight loss after four weeks was 6.4%. No severe adverse reactions, such as hepatotoxicity, were observed, and treatment-emergent adverse events (TEAEs) were mild, with no vomiting reported at doses of 2mg and 5mg. This positions ASC30 favorably in the market [1]. Group 3: ASC47 Development - ASC47, another small molecule THRβ agonist developed by the company, is designed for monthly injection and is currently in clinical trials in combination with semaglutide for treating obesity. ASC47 targets adipose tissue and is expected to provide synergistic effects when used with GLP-1, helping to reduce muscle loss while enhancing weight loss efficacy. The design of ASC47 allows for convenient monthly administration alongside GLP-1 [2]. Group 4: Financial Forecast - The company anticipates increased overseas clinical investment, projecting R&D expenses of 415 million, 487 million, and 540 million yuan for 2025, 2026, and 2027, respectively. The net profit attributable to the parent company is forecasted to be -372 million, -467 million, and -562 million yuan for the same years. Given the rapid clinical progress of ASC30 and ASC47, the company is positioned to achieve Best in Class potential in the small molecule weight loss drug development space, leading to a "Buy" investment rating [2].
歌礼制药:上半年净亏损8795.1万元,同比收窄32.5%
Ge Long Hui A P P· 2025-08-15 09:44
格隆汇8月15日丨歌礼制药-B(1672.HK)在港交所发布中期业绩报告,上半年收入1.04亿元,同比增加 111.4%;净亏损8795.1万元,同比收窄32.5%。 ...
歌礼制药:2025上半年收入1.04亿元 同比增加111.4%
Mei Ri Jing Ji Xin Wen· 2025-08-15 09:24
每经AI快讯,8月15日,歌礼制药-B(01672.HK)在港交所发布中期业绩报告,上半年收入1.04亿元,同 比增加111.4%;净亏损8795.1万元,同比收窄32.5%。 ...
歌礼制药-B(01672)发布中期业绩,股东应占亏损8795.1万元 同比收窄32.5%
智通财经网· 2025-08-15 09:15
Core Viewpoint - The company reported significant revenue growth and advancements in its drug pipeline, particularly in obesity treatment, indicating strong research and development capabilities and a commitment to addressing unmet clinical needs [1][2]. Financial Performance - Total revenue reached RMB 104 million, representing a year-on-year increase of 111.4% [1] - Research and development costs amounted to RMB 147 million, up 10.9% year-on-year [1] - Loss attributable to equity shareholders was RMB 87.95 million, a decrease of 32.5% compared to the previous year [1] - Loss per share was 9.14 cents [1] Drug Development Progress - ASC30, an oral medication for obesity, showed a significant average weight reduction of 6.5% after 28 days in a U.S. Phase Ib study, positioning it as a potential best-in-class treatment for obesity [1] - The company rapidly enrolled 125 participants in a U.S. Phase IIa study for ASC30, demonstrating efficient execution in clinical trials [2] - ASC30 also showed a 36-day half-life in a single subcutaneous injection study, supporting less frequent dosing [2] - ASC47, another obesity treatment, exhibited a 40-day half-life and has completed participant enrollment for a study combining it with semaglutide [2] - ASC50, an oral IL-17 inhibitor, has entered Phase I clinical trials with initial dosing completed [2] - ASC40, a daily oral FASN inhibitor for acne treatment, demonstrated statistically significant improvements in all primary and secondary endpoints in a Phase III study, indicating its potential for a breakthrough in acne treatment [2] Research and Development Commitment - The achievements highlight the company's strong R&D capabilities and commitment to developing best-in-class and first-in-class drugs to meet long-term clinical needs [2]
歌礼制药-B(01672):公司事件点评报告:美国临床进展顺利,期待临床数据读出
Huaxin Securities· 2025-08-15 09:13
Investment Rating - The report assigns a "Buy" investment rating for the company, indicating a positive outlook for its stock performance [11]. Core Insights - The company is making rapid progress in its clinical trials, particularly with its small molecule GLP-1R agonist ASC30, which has shown promising results in weight loss and safety [6][7]. - ASC30 is positioned to potentially become a "Best in Class" treatment due to its efficacy in weight reduction and low adverse effects [7]. - The company is also developing ASC47, a small molecule THRβ agonist, which is expected to work synergistically with GLP-1 treatments to enhance weight loss while minimizing muscle loss [8]. Clinical Development - The company initiated its first phase IIa clinical trial for ASC30 in early July, successfully enrolling 125 participants within a month [6]. - The expected timeline for top-line data from the ASC30 trial is Q4 2025 [6]. Financial Projections - The report forecasts the company's R&D expenses to increase to 415 million, 487 million, and 540 million RMB for the years 2025 to 2027, respectively [9]. - The projected net profit attributable to the parent company is expected to be -372.9 million, -467.09 million, and -562.67 million RMB for the years 2025 to 2027 [9][13]. - Revenue projections for 2021 to 2023 are not specified, but the report indicates a significant decline in revenue for 2024 [9][13]. Financial Statements Overview - The company's total assets are projected to decrease from 2,491.01 million RMB in 2023 to 571.46 million RMB by 2027 [14][16]. - The report highlights a significant drop in operating income, with a forecast of 1.28 million RMB in 2024 and no revenue expected in 2025 and 2026 [13][16]. - The cash flow statement indicates negative cash flow from operating activities, with projections of -555.17 million RMB in 2025 [15].
歌礼制药-B发布中期业绩,股东应占亏损8795.1万元 同比收窄32.5%
Zhi Tong Cai Jing· 2025-08-15 09:12
Core Viewpoint - The company reported significant revenue growth and advancements in its drug pipeline, particularly in obesity treatment, indicating strong research and development capabilities and a commitment to addressing unmet clinical needs [1][2]. Financial Performance - The company achieved total revenue of RMB 104 million, representing a year-on-year increase of 111.4% [1] - Research and development costs amounted to RMB 147 million, reflecting a year-on-year increase of 10.9% [1] - The loss attributable to equity shareholders was RMB 87.95 million, a decrease of 32.5% year-on-year [1] - The loss per share was 9.14 cents [1] Drug Development Progress - The ASC30 oral tablet for obesity showed a significant average weight reduction of up to 6.5% after 28 days of treatment in a U.S. Phase Ib study, positioning it as a potential best-in-class candidate for obesity treatment [1] - The company rapidly enrolled 125 participants in a U.S. Phase IIa study for ASC30, demonstrating efficient execution in clinical trials [2] - ASC30 also showed a 36-day half-life in a single subcutaneous injection study, supporting less frequent dosing [2] - ASC47, another obesity treatment, demonstrated a 40-day half-life and has completed participant enrollment for a combination study with semaglutide [2] - ASC50, an oral small molecule IL-17 inhibitor, has completed initial dosing in a U.S. Phase I clinical study [2] - The FASN inhibitor, denifasirt, showed statistically significant improvements in all primary and secondary endpoints in a Phase III study for acne treatment, indicating its potential for a major breakthrough in acne therapy [2]
歌礼制药(01672) - 2025 - 中期业绩
2025-08-15 08:40
[Financial Summary](index=1&type=section&id=%E8%B4%A2%E5%8A%A1%E6%A6%82%E8%A6%81) Provides a concise overview of the company's financial performance for the six months ended June 30, 2025 Financial Summary for the Six Months Ended June 30, 2025 (Unaudited) | Metric | For the Six Months Ended June 30 (Unaudited) | Change (%) | | :--- | :--- | :--- | | | **2025 (RMB thousands)** | **2024 (RMB thousands)** | | | **Total Revenue** | 103,577 | 49,004 | 111.4% | | **R&D Costs** | (146,812) | (132,382) | 10.9% | | **Administrative Expenses** | (43,302) | (41,356) | 4.7% | | **Loss Before Tax** | (87,951) | (130,318) | -32.5% | | **Loss for the Period** | (87,951) | (130,318) | -32.5% | | **Loss Per Share (Basic and Diluted)** | (9.14) cents | (12.82) cents | -28.7% | [Company Overview and Business Progress](index=2&type=section&id=%E5%85%AC%E5%8F%B8%E6%A6%82%E8%A7%88%E4%B8%8E%E4%B8%9A%E5%8A%A1%E8%BF%9B%E5%B1%95) Details the company's strategic vision, overall business advancements, and pipeline development across key therapeutic areas [Company Profile and Vision](index=2&type=section&id=%E5%85%AC%E5%8F%B8%E7%AE%80%E4%BB%8B%E4%B8%8E%E6%84%BF%E6%99%AF) Ascletis aims to be a world-class innovative biopharmaceutical company addressing unmet global medical needs in metabolic diseases - Company vision: To be the most innovative world-class biopharmaceutical company, dedicated to addressing unmet global medical needs in metabolic diseases[5](index=5&type=chunk) [Overall Business Overview](index=2&type=section&id=%E6%95%B4%E4%BD%93%E4%B8%9A%E5%8A%A1%E6%A6%82%E8%A7%88) The company made significant pipeline progress in metabolic and immune diseases, narrowing its loss for the period despite increased R&D investment - The company achieved significant progress in its R&D pipeline across multiple disease areas, including: - **Obesity treatment**: ASC30 oral tablet showed up to **6.5% weight loss** in a US Ib study; ASC30 subcutaneous formulation had a half-life of 36 days, supporting monthly dosing; muscle-sparing candidate ASC47 completed enrollment for combination study with semaglutide - **Immune diseases**: Oral small molecule IL-17 inhibitor ASC50 initiated Phase I clinical study in the US - **Expanded indications**: FASN inhibitor denifanstat (ASC40) for acne achieved all primary endpoints in Phase III study[6](index=6&type=chunk) Financial Performance and Cash Position | Metric | 2025 H1 | 2024 H1 | Change | | :--- | :--- | :--- | :--- | | **Loss for the Period** | approx. 88.0 million RMB | approx. 130.3 million RMB | -32.5% | | **R&D Costs** | approx. 146.8 million RMB | approx. 132.4 million RMB | +10.9% | | **Cash and Equivalents** | approx. 1,827.9 million RMB | approx. 2,117.2 million RMB | - | - As of June 30, 2025, the Group's cash and equivalents reserves were approximately **1.828 billion RMB**, projected to support R&D and operations until 2029[7](index=7&type=chunk) [R&D Pipeline](index=3&type=section&id=%E7%A0%94%E5%8F%91%E7%AE%A1%E7%BA%BF) The company maintains three core pipelines: metabolic diseases, immune diseases, and expanded indications, with global or Greater China rights for various drug candidates - **Metabolic Disease Pipeline**: Core products for obesity, ASC30 (oral/subcutaneous) and ASC47 (subcutaneous), both with global rights and in clinical Phase IIa or Ib[8](index=8&type=chunk) - **Immune Disease Pipeline**: Core product, oral small molecule IL-17 inhibitor ASC50, for psoriasis and other immune diseases, with global rights, in clinical Phase I[9](index=9&type=chunk) - **Expanded Indication Pipeline**: Core product, oral small molecule FASN inhibitor ASC40, for acne, with Greater China rights, in Phase III[10](index=10&type=chunk) [Management Discussion and Analysis](index=4&type=section&id=%E7%AE%A1%E7%90%86%E5%B1%82%E8%AE%A8%E8%AE%BA%E4%B8%8E%E5%88%86%E6%9E%90) Provides an in-depth review of the company's operational performance, financial results, and future outlook [Business Review](index=4&type=section&id=%E4%B8%9A%E5%8A%A1%E5%9B%9E%E9%A1%BE) The company detailed clinical progress and key data for its core pipeline products, with notable advancements in metabolic disease drugs and strategic project adjustments [Metabolic Diseases](index=4&type=section&id=%E4%BB%A3%E8%B0%A2%E6%80%A7%E7%96%BE%E7%97%85) Significant progress in obesity drug pipeline, with ASC30 showing up to 6.5% weight loss and ASC47 demonstrating potential for healthy weight reduction - **ASC30 Oral Tablet**: In a US Phase Ib study, after 4 weeks of treatment, the placebo-adjusted average weight loss was up to **6.5%**, with good tolerability. Its 13-week Phase IIa study has completed enrollment of 125 patients, with top-line data expected in Q4 2025[13](index=13&type=chunk)[14](index=14&type=chunk) - **ASC30 Subcutaneous Injection**: In a US Phase Ib study, an ultra-long-acting formulation showed a half-life of **36 days** in obese patients, supporting monthly or less frequent dosing. Phase IIa study has completed dosing of the first subjects[16](index=16&type=chunk)[17](index=17&type=chunk) - **ASC47 (Muscle-Sparing)**: A single subcutaneous injection in obese patients showed a half-life of **40 days**, supporting monthly to bi-monthly dosing. The combination study with semaglutide has completed enrollment of all 28 subjects[18](index=18&type=chunk)[19](index=19&type=chunk) [Immune Diseases](index=6&type=section&id=%E5%85%8D%E7%96%AB%E7%96%BE%E7%97%85) The company's self-developed novel oral small molecule IL-17 inhibitor ASC50 has initiated a Phase I clinical trial in the US for psoriasis - The novel oral small molecule IL-17 inhibitor **ASC50** has initiated a Phase I clinical trial in the US for psoriasis, with potential to be a best-in-class daily oral drug[21](index=21&type=chunk) - ASC50 is the company's first immunology candidate developed through its structure-based **AI-assisted drug discovery (AISBDD) platform**[22](index=22&type=chunk) [Expanded Indications and Others](index=7&type=section&id=%E6%8B%93%E5%B1%95%E6%80%A7%E9%80%82%E5%BA%94%E7%97%87%E5%8F%8A%E5%85%B6%E4%BB%96) FASN inhibitor denifanstat (ASC40) successfully completed Phase III trials for acne, while the rGBM project was terminated, and out-licensing opportunities are being sought for other assets - **ASC40 for Acne**: Phase III clinical trial achieved success, with all endpoints showing highly statistically significant improvements and good safety. Efficacy was superior to FDA-approved drugs like sarecycline and doxycycline. The company plans to seek commercial partnerships in 2025[24](index=24&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) - **Project Termination and Out-licensing**: Based on study results, the company decided to terminate the ASC40 project for recurrent glioblastoma (rGBM). For ASC40 in MASH and ASC61 for solid tumors, the company will seek opportunities to maximize project value, including out-licensing[27](index=27&type=chunk)[28](index=28&type=chunk)[30](index=30&type=chunk) [Preclinical Discovery](index=8&type=section&id=%E4%B8%B4%E5%BA%8A%E5%89%8D%E5%8F%91%E7%8E%B0) The company continues to leverage its AI-assisted drug discovery (AISBDD) and ultra-long-acting drug development (ULAP) platforms to strengthen early-stage R&D - The company continues to strengthen early-stage discovery by leveraging its two core platforms (AISBDD and ULAP) to develop more globally competitive small molecule and peptide pipeline products[31](index=31&type=chunk) [Future and Outlook](index=9&type=section&id=%E6%9C%AA%E6%9D%A5%E5%8F%8A%E5%89%8D%E6%99%AF) The company's H2 2025 strategy focuses on advancing core clinical programs, obtaining key data, strengthening early R&D, and pursuing out-licensing opportunities - Key Outlook for H2 2025: - **Obtain Key Clinical Data**: Expected top-line data from US clinical studies for ASC30 oral tablet (obesity), ASC47 combination therapy (obesity), and ASC50 (psoriasis) - **Advance Clinical Enrollment**: Complete enrollment for all subjects in the US Phase IIa study of ASC30 monthly subcutaneous injection (obesity) - **Strengthen Early R&D**: Accelerate peptide pipeline clinical trials using the ULAP platform - **Seek Out-licensing**: Actively pursue collaboration opportunities with global pharmaceutical companies[35](index=35&type=chunk) [Financial Position Analysis](index=10&type=section&id=%E8%B4%A2%E5%8A%A1%E7%8A%B6%E5%86%B5%E5%88%86%E6%9E%90) The company's total revenue increased significantly, driven by fair value gains and government grants, while R&D expenses rose, and financial ratios improved, indicating a robust financial position [Revenue and Other Income](index=10&type=section&id=%E6%94%B6%E5%85%A5%E4%B8%8E%E6%94%B6%E7%9B%8A) Total revenue increased by 111.4% to 103.6 million RMB, primarily due to higher fair value gains from financial assets and increased government grants - Total revenue (revenue, other income and gains) increased by **111.4%** from **49.0 million RMB** to **103.6 million RMB**, primarily due to an increase in other income and gains[37](index=37&type=chunk) Details of Other Income and Gains (RMB thousands) | Item | 2025 H1 | 2024 H1 | | :--- | :--- | :--- | | Bank interest income | 30,037 | 48,076 | | Government grants | 34,175 | 12,226 | | Net fair value gain/(loss) on financial assets | 39,151 | (10,735) | | Gain on dilution of interest in an associate | – | 21,147 | | Loss on remeasurement of interest in an associate | – | (24,546) | | **Total** | **102,496** | **49,004** | [Costs and Expenses](index=11&type=section&id=%E6%88%90%E6%9C%AC%E4%B8%8E%E5%BC%80%E6%94%AF) R&D expenses increased by 10.9% to 146.8 million RMB, mainly due to increased investment in the metabolic disease pipeline, while administrative expenses slightly rose - R&D expenses increased by **10.9%** to **146.8 million RMB**, primarily due to increased investment in the metabolic disease product pipeline[43](index=43&type=chunk)[44](index=44&type=chunk) R&D Costs by Product Pipeline (RMB thousands) | Product Pipeline | 2025 H1 | 2024 H1 | | :--- | :--- | :--- | | Metabolic Diseases | 42,640 | 27,037 | | Expanded Indications - Acne | 43,970 | 47,182 | | Expanded Indications - Oncology | 15,259 | 15,807 | | Preclinical | 38,023 | 14,486 | | **Total** | **146,812** | **132,382** | - Administrative expenses increased by **4.7%** to **43.3 million RMB**, primarily due to higher staff costs and benefits[41](index=41&type=chunk)[42](index=42&type=chunk) [Key Balance Sheet Items](index=13&type=section&id=%E5%85%B3%E9%94%AE%E8%B5%84%E4%BA%A7%E8%B4%9F%E5%80%BA%E8%A1%A8%E9%A1%B9%E7%9B%AE) Inventories, trade receivables, and financial assets increased, with non-current financial assets significantly rising due to fair value gains on listed equity securities, while other payables decreased - Non-current financial assets at fair value through profit or loss increased from **53.5 million RMB** to **79.3 million RMB**, primarily due to an increase in the fair value of investments in NASDAQ-listed equity securities[59](index=59&type=chunk) - Total other payables and accrued expenses decreased from **145.2 million RMB** to **119.9 million RMB**, with provisions reduced by **11.2 million RMB** due to arbitration settlement[64](index=64&type=chunk)[66](index=66&type=chunk) [Liquidity and Capital Resources](index=18&type=section&id=%E6%B5%81%E5%8A%A8%E8%B5%84%E9%87%91%E4%B8%8E%E8%B5%84%E6%9C%AC%E8%B5%84%E6%BA%90) The company held 1.828 billion RMB in cash and equivalents, with net cash outflow from operating activities and net inflow from investing activities, primarily from maturing time deposits Condensed Consolidated Cash Flow Statement Summary (RMB thousands) | Item | 2025 H1 | 2024 H1 | | :--- | :--- | :--- | | Net cash flow (used in) operating activities | (172,990) | (203,415) | | Net cash flow from investing activities | 904,605 | 261,633 | | Net cash flow (used in) financing activities | (14,485) | (45,455) | | **Net increase in cash and cash equivalents** | **717,130** | **12,763** | - Net cash inflow from investing activities was primarily due to a decrease of approximately **864 million RMB** in time deposits with original maturity over three months[71](index=71&type=chunk) - Net cash outflow from financing activities was primarily due to share repurchases totaling approximately **12.8 million RMB**[72](index=72&type=chunk) [Key Financial Ratios](index=22&type=section&id=%E5%85%B3%E9%94%AE%E8%B4%A2%E5%8A%A1%E6%AF%94%E7%8E%87) The company's liquidity improved, with current and quick ratios increasing, and the debt-to-asset ratio decreasing, indicating a more robust financial structure Key Financial Ratios | Ratio | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Current Ratio | 14.6 | 12.9 | | Quick Ratio | 14.5 | 12.8 | | Debt-to-Asset Ratio | 6.5% | 7.5% | - The increase in current and quick ratios and the decrease in the debt-to-asset ratio were primarily due to a **reduction in current liabilities**[82](index=82&type=chunk) [Other Information](index=21&type=section&id=%E5%85%B6%E4%BB%96%E4%BF%A1%E6%81%AF) The company disclosed litigation updates with Viking Therapeutics, including provisions for ITC fines, and detailed its employee structure and compensation policy [Litigation and Contingent Liabilities](index=21&type=section&id=%E8%AF%89%E8%AE%BC%E4%B8%8E%E6%88%96%E7%84%B6%E8%B4%9F%E5%80%BA) The company disclosed litigation with Viking Therapeutics, making provisions for an ITC fine of approximately $567,000 while actively defending the ongoing USDC lawsuit - Regarding the litigation with Viking Therapeutics, the ITC's recommended judgment imposed a fine of approximately **$567,000**, for which the company has made provisions[76](index=76&type=chunk) - The lawsuit filed with the USDC is ongoing, and the company will actively defend it, with no provisions made as of the end of the reporting period[77](index=77&type=chunk) [Employees and Remuneration Policy](index=23&type=section&id=%E9%9B%87%E5%91%98%E5%8F%8A%E8%96%AA%E9%85%AC%E6%94%BF%E7%AD%96) As of June 30, 2025, the Group had 208 employees, with 65.9% in R&D, reflecting its research-centric strategy, and total employee costs increased Number of Employees by Function (as of June 30, 2025) | Function | Number of Employees | % of Total | | :--- | :--- | :--- | | Management | 4 | 1.9% | | R&D | 137 | 65.9% | | Manufacturing | 29 | 13.9% | | Operations | 38 | 18.3% | | **Total** | **208** | **100.0%** | - For the six months ended June 30, 2025, total employee costs were approximately **82.1 million RMB**, compared to **76.8 million RMB** in the prior period[84](index=84&type=chunk) [Consolidated Financial Statements](index=24&type=section&id=%E7%BB%BC%E5%90%88%E8%B4%A2%E5%8A%A1%E6%8A%A5%E8%A1%A8) Presents the company's consolidated financial performance and position, including the income statement and balance sheet [Consolidated Statement of Profit or Loss](index=24&type=section&id=%E7%BB%BC%E5%90%88%E6%8D%9F%E7%9B%8A%E8%A1%A8) For the six months ended June 30, 2025, the company reported revenue of 1.08 million RMB and a loss of 87.95 million RMB, a 32.5% reduction from the prior year Summary of Consolidated Statement of Profit or Loss (RMB thousands) | Item | 2025 H1 | 2024 H1 | | :--- | :--- | :--- | | Revenue | 1,081 | – | | Other income and gains | 102,496 | 49,004 | | R&D costs | (146,812) | (132,382) | | Administrative expenses | (43,302) | (41,356) | | **Loss before tax** | **(87,951)** | **(130,318)** | | **Loss for the period** | **(87,951)** | **(130,318)** | [Consolidated Statement of Financial Position](index=26&type=section&id=%E7%BB%BC%E5%90%88%E8%B4%A2%E5%8A%A1%E7%8A%B6%E5%86%B5%E8%A1%A8) As of June 30, 2025, the company reported total assets of 1.997 billion RMB, total liabilities of 129.0 million RMB, and net assets of 1.868 billion RMB, indicating strong liquidity Summary of Consolidated Statement of Financial Position (RMB thousands) | Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total non-current assets** | 173,899 | 153,790 | | **Total current assets** | 1,822,936 | 1,970,782 | | **Total assets** | **1,996,835** | **2,124,572** | | **Total current liabilities** | 125,125 | 153,053 | | **Total non-current liabilities** | 3,873 | 5,357 | | **Total liabilities** | **129,000** | **158,410** | | **Net assets** | **1,867,837** | **1,966,162** | [Notes to Interim Financial Report](index=28&type=section&id=%E4%B8%AD%E6%9C%9F%E8%B4%A2%E5%8A%A1%E6%8A%A5%E5%91%8A%E9%99%84%E6%B3%A8) Provides detailed explanations and disclosures supporting the interim financial statements, covering accounting policies, revenue, capital, and dividends [Company Information and Basis of Preparation](index=28&type=section&id=%E5%85%AC%E5%8F%B8%E8%B5%84%E6%96%99%E4%B8%8E%E7%BC%96%E8%A3%BD%E5%9F%BA%E5%87%86) This unaudited interim financial report, reviewed by KPMG, details the company's primary engagement in drug R&D and its listing on the HKEX - This interim financial report is unaudited but has been reviewed by **KPMG** in accordance with Hong Kong Standard on Review Engagements 2410[96](index=96&type=chunk) - The company is an investment holding company, with subsidiaries primarily engaged in drug R&D. Its shares were listed on the Main Board of the Stock Exchange of Hong Kong on August 1, 2018[93](index=93&type=chunk)[94](index=94&type=chunk) [Revenue and Segment Reporting](index=29&type=section&id=%E6%94%B6%E5%85%A5%E5%8F%8A%E5%88%86%E9%83%A8%E6%8A%A5%E5%91%8A) Revenue for the period was 1.08 million RMB, primarily from R&D services, with the company managed as a single operating segment and revenue mainly from Hong Kong - Revenue for the reporting period was **1,081 thousand RMB**, primarily from providing R&D services (**1,054 thousand RMB**)[100](index=100&type=chunk) - The company operates as a **single operating segment**, thus no segment information is presented[102](index=102&type=chunk) [Capital, Reserves and Dividends](index=33&type=section&id=%E8%B5%84%E6%9C%AC%E3%80%81%E5%82%A8%E5%A4%87%E5%8F%8A%E8%82%A1%E6%81%AF) The board did not recommend an interim dividend, while the company repurchased 3.44 million shares and issued new shares from option exercises, also canceling repurchased shares - The Board does not recommend the payment of any dividend for the six months ended June 30, 2025[113](index=113&type=chunk) - During the interim period, the company repurchased shares on the Stock Exchange of Hong Kong for a total consideration of **13.81 million HKD** (equivalent to **12.76 million RMB**)[115](index=115&type=chunk) - During the reporting period, the company cancelled **44,896,790 shares**[117](index=117&type=chunk) [Other Disclosure Information](index=35&type=section&id=%E5%85%B6%E4%BB%96%E6%8A%AB%E9%9C%B2%E4%BF%A1%E6%81%AF) Covers corporate governance practices, details of securities transactions including share repurchases, and the review process for interim results [Corporate Governance](index=35&type=section&id=%E4%BC%81%E4%B8%9A%E7%AE%A1%E6%B2%BB) The company adheres to the Corporate Governance Code, with the only deviation being Dr. Wu holding both Chairman and CEO roles for efficient leadership - The company has complied with the Corporate Governance Code during the reporting period, except that the roles of Chairman and Chief Executive Officer are not separate, both held by Dr. Wu. The Board believes this arrangement provides more efficient leadership[120](index=120&type=chunk) [Securities Transactions and Share Repurchases](index=35&type=section&id=%E8%AF%81%E5%88%B8%E4%BA%A4%E6%98%93%E4%B8%8E%E8%82%A1%E4%BB%BD%E5%9B%9E%E8%B4%AD) The company repurchased 3.44 million shares for 13.559 million HKD to enhance shareholder value and holds treasury shares for its share award scheme Details of Share Repurchases During the Reporting Period | Month of Transaction | Number of Shares Repurchased | Highest Price Per Share (HKD) | Lowest Price Per Share (HKD) | Total Consideration (HKD) | | :--- | :--- | :--- | :--- | :--- | | January 2025 | 2,640,000 | 4.13 | 2.94 | 9,301,470.00 | | April 2025 | 800,000 | 6.74 | 4.57 | 4,257,980.00 | - As of June 30, 2025, the company held **5,784,210 treasury shares** for its 2025 share award scheme[123](index=123&type=chunk) [Review of Interim Results](index=36&type=section&id=%E4%B8%AD%E6%9C%9F%E4%B8%9A%E7%BB%A9%E5%AE%A1%E9%98%85) KPMG, the independent auditor, reviewed the interim financial information, and the Audit Committee confirmed its compliance with accounting standards and regulations - The company's independent auditor, **KPMG**, has reviewed the interim financial information[125](index=125&type=chunk) - The Audit Committee, comprising three independent non-executive directors, has reviewed the interim results and found them to be in compliance with applicable accounting standards and regulations[125](index=125&type=chunk)
化学制药:创新药动态更新:GLP-1 小分子:口服 GLP-1 小分子受体激动剂达到三期临床终点,国产潜在 BIC 管线在美国临床展示减重潜力
Shanxi Securities· 2025-08-13 09:15
Investment Rating - The report maintains an investment rating of "Leading the Market-B" for the chemical pharmaceutical industry [1]. Core Insights - The oral GLP-1 small molecule receptor agonists are positioned as effective treatments for type 2 diabetes and obesity, with advantages such as no dietary restrictions and low chemical synthesis supply difficulties. The oral small molecule GLP-1 RA Orforglipron has reached phase III clinical endpoints and is set to apply for market approval [1][2]. - The potential BIC pipeline from Geely Pharmaceutical shows promising weight loss potential in the U.S. clinical trials, demonstrating superior half-life, drug exposure, and activity compared to Orforglipron [1][3]. - In clinical trials, Orforglipron has shown significant reductions in A1C levels and weight loss, with 65% of patients achieving A1C values ≤6.5% and a weight reduction of -7.9% after 40 weeks of treatment [2]. - In a separate obesity trial, Orforglipron demonstrated a weight loss of -12.4% after 72 weeks, with 59.6% of patients losing ≥10% of their body weight [3]. - ASC30, another oral GLP-1 RA, has shown superior pharmacokinetic and pharmacodynamic characteristics, with a drug exposure 2.2 times higher than Orforglipron and a faster dose titration, which may enhance long-term efficacy [3]. Summary by Sections Market Performance - The chemical pharmaceutical industry has shown a strong market performance over the past year, particularly in the area of innovative drugs [1]. Drug Evaluation - The report highlights the successful clinical outcomes of Orforglipron and ASC30, emphasizing their potential in treating type 2 diabetes and obesity, with favorable safety profiles and tolerability [1][2][3]. Clinical Trial Results - Orforglipron's phase III trials have demonstrated significant efficacy in reducing A1C levels and body weight, while ASC30's early clinical results indicate its potential for superior performance compared to existing treatments [2][3].