LAEKNA(02105)

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一年涨超300%,来凯医药-B中报下的全球雄心与商业化答卷
Jin Tou Wang· 2025-08-14 01:16
Core Viewpoint - The Hong Kong stock market's innovative pharmaceutical sector has rebounded strongly since 2025, with a cumulative increase of nearly 100%, and over 30 pharmaceutical companies have seen their stock prices double, making it a focal point in the capital market. The core driver of this trend is the revaluation of value, indicating that the sector's valuation remains attractive [1]. Group 1: Company Performance - Lai Kai Pharmaceutical has shown remarkable performance, with its stock price increasing over 300% in the past year, and multiple investment banks have set target prices above HKD 27 [2]. - The company has made significant breakthroughs in its core areas of metabolism and cancer treatment, showcasing its innovative research capabilities through the advancement of specific pipelines [5]. Group 2: Metabolic and Cancer Treatment Innovations - In the metabolic field, Lai Kai has built a comprehensive product portfolio centered around the ActRII pathway, gradually advancing these candidate drugs into clinical research to explore their therapeutic potential in muscle-related and other diseases [5]. - The LAE102 (ActRIIA monoclonal antibody) has demonstrated clear therapeutic value, with data from Eli Lilly showing that weight loss was entirely from fat, while muscle mass increased by 2.5% [5]. - LAE102 has shown better safety and tolerability compared to Bimagrumab, with no serious adverse events reported, indicating its potential as a best-in-class drug [6]. Group 3: Clinical Collaborations and Market Potential - Eli Lilly's acquisition of Bimagrumab for USD 1.925 billion and subsequent clinical collaboration with Lai Kai for LAE102 underscores the clinical value of LAE102 and accelerates its global development process [7]. - The LAE002 (afuresertib) is positioned to become the first domestic AKT inhibitor, with ongoing Phase III trials expected to complete recruitment by Q4 2023, aiming for a new drug application submission in mid-2026 [8]. Group 4: Long-term Growth Drivers - Lai Kai's growth is supported by its internationalization strategy and robust R&D system, which together create a solid foundation for sustainable development [9]. - The collaboration with Eli Lilly is expected to attract more multinational pharmaceutical companies, enhancing Lai Kai's position in the global innovative drug industry [10]. - The global obesity drug market is projected to exceed USD 100 billion by 2030, and LAE102 is well-positioned to capture a significant share of this market [10]. Group 5: R&D Advancements - Lai Kai continues to enhance its R&D capabilities, with multiple drug candidates progressing through various stages of development, including LAE103 and LAE120, which have received IND approvals [11]. - The company's strong innovation capabilities are translating into tangible R&D results, with its pipeline entering a phase of readiness for future growth [11]. Group 6: Financial Position - Lai Kai Pharmaceutical has a cash and bank balance of RMB 742 million, providing a solid financial foundation for ongoing innovative research and development [12]. - As innovative products like LAE002 and LAE102 approach commercialization, the market's recognition of Lai Kai's intrinsic value is expected to transition from growth expectations to value realization [12].
一年涨超300%,来凯医药-B(2105.HK)中报下的全球雄心与商业化答卷
Ge Long Hui· 2025-08-14 00:49
Core Viewpoint - The Hong Kong stock market's innovative pharmaceutical sector has rebounded strongly since 2025, with a cumulative increase of nearly 100%, and over 30 pharmaceutical companies have seen their stock prices double, indicating a significant capital market focus on this sector [1] Group 1: Company Performance - Lakai Pharmaceuticals has shown remarkable performance, with its stock price increasing over 300% in the past year, and multiple investment banks have set target prices above HKD 27 [2] - The company has made significant breakthroughs in the fields of metabolism and cancer treatment, showcasing its innovative research capabilities through the advancement of specific drug pipelines [5] Group 2: Metabolic Drug Development - Lakai Pharmaceuticals has established a comprehensive product portfolio centered around the ActRII pathway, gradually advancing these candidate drugs into clinical research to explore their therapeutic potential in muscle-related and other diseases [5] - The monoclonal antibody LAE102, targeting ActRIIA, has demonstrated clear therapeutic value, with data from Eli Lilly's Bimagrumab showing significant weight loss primarily from fat while preserving muscle mass [5][6] - LAE102's clinical trial results indicate good tolerability compared to Bimagrumab, with no serious adverse events reported, highlighting its potential as a best-in-class drug [6] Group 3: Strategic Collaborations - Eli Lilly's acquisition of Bimagrumab for USD 1.925 billion and subsequent clinical collaboration with Lakai Pharmaceuticals for LAE102 underscores the clinical value of LAE102 and accelerates its global development process [7] - The FDA has approved the clinical application of another ActRIIB monoclonal antibody, LAE103, which is set to initiate Phase I clinical trials in the second half of the year, further establishing Lakai's competitive advantage in the metabolic drug space [8] Group 4: Cancer Drug Development - In the oncology sector, LAE002 (afuresertib), an AKT inhibitor, is positioned to become the first domestic AKT inhibitor, with ongoing Phase III clinical trials for specific breast cancer patients [9] - The market potential for AKT inhibitors is significant, as evidenced by AstraZeneca's Capivasertib, which is projected to achieve global sales of USD 430 million in 2024 and potentially reach USD 1 billion in the future [9] Group 5: Long-term Growth Strategy - Lakai Pharmaceuticals' growth is driven by both international expansion and a robust self-research system, creating a solid foundation for sustainable development [10] - The collaboration with Eli Lilly not only validates the company's research capabilities but also opens up opportunities for further partnerships with multinational pharmaceutical companies [11] - The company is actively discussing strategic collaborations to accelerate the development and commercialization of the ActRII product portfolio, with expectations of significant market penetration [11] Group 6: Financial Position - Lakai Pharmaceuticals has a cash and bank balance of RMB 742 million, providing a stable financial foundation for ongoing innovative research and development [13] - The anticipated market recognition of the intrinsic value of Lakai Pharmaceuticals is expected to transition from growth expectations to value realization as innovative products reach the market [13]
来凯医药-B上半年核心管线临床进展显著 研发费用逾1亿元
Zhi Tong Cai Jing· 2025-08-13 09:35
来凯医药-B(02105)发布截至2025年6月30日止6个月的中期业绩,该集团取得其他收入人民币1990.8万元 (单位下同),同比增加40.7%;研发费用1.05亿元,同比减少16.61%;期内亏损1.3亿元,同比减少9.79%。 截至2025年6月30日,公司流动资产为7.62亿元,其中现金及现金等价物6.77亿元,定期存款6715.9万 元,资金储备充足,为后续研发项目推进提供有力支撑。 集团于2024年5月在中国启动LAE002(afuresertib,一种口服AKT抑制剂)联合氟维司群治疗 PIK3CA/AKT1/PTEN改变及HR+/HER2–局部晚期或转移性乳腺癌(LA/mBC)患者的III期临床试验 AFFIRM–205(III期临床试验AFFIRM–205)。III期临床试验AFFIRM–205是一项多中心、随机、双盲、安 慰剂对照的关键研究,旨在进一步评估该联合疗法的抗肿瘤疗效和安全性。研究招募工作正在进行中。 集团计划于2025年第四季度完成受试者入组并于2026年上半年向中国CDE提交新药上市申请(NDA)。集 团正在与潜在合作伙伴商讨战略合作,加速LAE002(afureserti ...
来凯医药-B(02105)上半年核心管线临床进展显著 研发费用逾1亿元
智通财经网· 2025-08-13 09:33
Core Viewpoint - The company reported a significant increase in other income due to government subsidies, while R&D expenses decreased, leading to a reduced loss compared to the previous year [1][2]. Financial Performance - Other income reached RMB 19.908 million, a year-on-year increase of 40.7% [1] - R&D expenses amounted to RMB 105 million, a decrease of 16.61% year-on-year [1] - The loss for the period was RMB 130 million, a reduction of 9.79% compared to the previous year [1] - As of June 30, 2025, current assets totaled RMB 762 million, with cash and cash equivalents at RMB 677 million, indicating strong financial reserves for future R&D projects [1] Clinical Development - LAE102, a monoclonal antibody targeting ActRIIA, has shown potential for muscle preservation and weight control, with successful completion of the single ascending dose part of Phase I clinical trials for obesity treatment in China by December 2024 [1] - The company initiated a Phase III clinical trial (AFFIRM-205) in May 2024 for LAE002 (afuresertib) in combination with Fulvestrant for HR+/HER2– locally advanced or metastatic breast cancer patients [2] - The Phase III trial is a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of the combination therapy, with plans to complete subject enrollment by Q4 2025 and submit a New Drug Application (NDA) in H1 2026 [2] - The company is in discussions with potential partners to accelerate the regulatory approval and commercialization of LAE002 and LAE001 [2] Future Plans - The IND application for LAE103 was submitted to the FDA by the end of June 2025, with plans to initiate Phase I clinical trials in the second half of 2025 [3] - The company aims to evaluate the efficacy and safety of monoclonal antibodies targeting ActRIIA and ActRIIB through the Phase I clinical study of LAE103 [3] - Plans are also in place to advance LAE123 to Phase I clinical trials in 2026 [3]
来凯医药-B(02105.HK)2025年中期业绩:计划寻求战略合作伙伴,加速候选药物的开发和商业化
Ge Long Hui· 2025-08-13 09:30
Core Viewpoint - The company, Lai Kai Pharmaceutical-B, reported a significant increase in other income and a reduction in losses for the first half of 2025, driven by government subsidies and ongoing clinical trials for its drug candidates targeting metabolic diseases and cancer [1]. Financial Performance - Other income for the first half of 2025 reached RMB 19.9 million, representing a year-on-year increase of 41.1% due to increased government subsidies [1]. - As of June 30, 2025, the company's cash and bank balance amounted to RMB 743.8 million [1]. Clinical Development - The company is focused on developing new therapies for metabolic diseases, cancer, and liver fibrosis, with seven clinical trials initiated for drug candidates LAE102, LAE002 (afuresertib), LAE001, and LAE005 [1]. - In the cancer sector, the company has established a comprehensive portfolio of drug candidates, including LAE002 (afuresertib), which is a potent AKT inhibitor targeting breast and prostate cancers [3]. Research and Development Team - The company has a skilled management team with extensive experience across the entire drug discovery and development cycle, supported by a research team of 60 employees, including 11 PhD holders and 33 master's degree holders [1]. Drug Candidates and Mechanism - LAE102 is positioned as a candidate drug for weight control by promoting muscle regeneration and fat reduction through the inhibition of the Activin-ActRII pathway [2]. - The company is also developing additional candidates, including LAE103 and LAE123, which are selective antibodies targeting ActRII receptors for muscle and other disease indications [2]. Strategic Partnerships - The company plans to seek strategic partnerships to accelerate the development and commercialization of its drug candidates, addressing significant unmet medical needs [3].
来凯医药(02105) - 2025 - 中期业绩
2025-08-13 09:02
[Business Summary](index=1&type=section&id=%E6%A5%AD%E5%8B%99%E6%91%98%E8%A6%81) The company achieved significant clinical progress with its core products and anticipates key milestones in the latter half of 2025 [Clinical Trial Progress](index=1&type=section&id=%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A9%97%E9%80%B2%E5%B1%95) The company achieved significant clinical progress during the reporting period, advancing core products LAE102 (obesity) and LAE002 (afuresertib) in various clinical trials, alongside preclinical candidates - The self-developed obesity drug LAE102 (an ActRIIA-targeting monoclonal antibody) successfully completed its Phase I SAD study in China, demonstrating **good tolerability**, **no serious adverse events**, and **sustained pathway blockade**, laying the foundation for further development[4](index=4&type=chunk)[5](index=5&type=chunk) - The company entered a clinical collaboration with **Eli Lilly** to accelerate LAE102's global development, with Lilly responsible for and bearing the costs of the US Phase I clinical trial, where the **first subject was dosed in May 2025**[7](index=7&type=chunk) - The Phase III clinical trial AFFIRM–205 of LAE002 (afuresertib) combined with fulvestrant for HR+/HER2- breast cancer is ongoing in China, with patient enrollment planned for completion by **Q4 2025** and an NDA submission targeted for **H1 2026**[11](index=11&type=chunk) - The company has established a comprehensive ActRII product portfolio, including LAE103 (ActRIIB selective antibody) and LAE123 (ActRIIA/IIB dual antagonist antibody) in addition to LAE102, actively advancing their clinical research for muscle and other diseases[8](index=8&type=chunk)[10](index=10&type=chunk) [LAE102 for Obesity, Phase I](index=1&type=section&id=LAE102%E6%B2%BB%E7%99%82%E8%82%A5%E8%83%96%E7%97%87%EF%BC%8CI%E6%9C%9F) - In the China Phase I SAD study, LAE102 demonstrated **good tolerability** after intravenous (IV) and subcutaneous (SC) administration, with no serious adverse events or treatment-discontinuing adverse events reported[5](index=5&type=chunk) - The Phase I multiple ascending dose (MAD) study was initiated in China in **March 2025**, and the first subject was dosed in the US Phase I clinical trial in collaboration with Eli Lilly in **May 2025**[6](index=6&type=chunk)[7](index=7&type=chunk) [LAE002 (afuresertib) + Fulvestrant for HR+/HER2– Breast Cancer, Phase III](index=3&type=section&id=LAE002%20%28afuresertib%29%20%2B%E6%B0%9F%E7%B6%AD%E5%8F%B8%E7%BE%A4%E6%B2%BB%E7%99%82HR%2B%2FHER2%E2%80%93%20%E4%B9%B3%E8%85%BA%E7%99%8C%EF%BC%8CIII%E6%9C%9F) - The AFFIRM–205 Phase III clinical trial was initiated in China in **May 2024**, with ongoing recruitment targeting completion by **Q4 2025**[11](index=11&type=chunk) [LAE002 (afuresertib) + LAE001/Prednisone for mCRPC, Phase II](index=4&type=section&id=LAE002%20%28afuresertib%29%20%2B%20LAE001%E2%88%95%E6%BD%91%E5%B0%BC%E6%9D%BE%E6%B2%BB%E7%99%82mCRPC%2C%20II%E6%9C%9F) - The international multi-center Phase II clinical trial completed in **2024** showed a median radiographic progression-free survival (rPFS) of **8.1 months**, a significant improvement over the 2-4 months for standard therapy, with the combination therapy being well-tolerated[12](index=12&type=chunk) - The company has received **US FDA approval** for the Phase III clinical trial protocol for this indication and plans to seek strategic partners to accelerate development and commercialization[13](index=13&type=chunk) [Preclinical Candidate Drugs (PCC)](index=4&type=section&id=%E8%87%A8%E5%BA%8A%E5%89%8D%E5%80%99%E9%81%B8%E8%97%A5%E7%89%A9%28PCC%29) - The IND application for LAE103 was submitted to the US FDA in **June 2025**, with a Phase I clinical study planned for initiation in **H2 2025**; LAE123 is projected to advance to Phase I clinical trials in **2026**[14](index=14&type=chunk) - In oncology, the USP1 inhibitor LAE120 received **FDA approval** for clinical trials in **February 2025**, and the WRN inhibitor LAE122 completed PCC confirmation in **March 2025**[14](index=14&type=chunk) [Expected Milestones in H2 2025](index=4&type=section&id=2025%E5%B9%B4%E4%B8%8B%E5%8D%8A%E5%B9%B4%E7%9A%84%E9%A0%90%E6%9C%9F%E9%87%8C%E7%A8%8B%E7%A2%91) The company anticipates key milestones in H2 2025, including announcing LAE102 Phase I results, completing AFFIRM–205 patient enrollment, and initiating LAE103 Phase I clinical studies - LAE102: Expected to announce **topline results** from the China Phase I MAD study and US Phase I clinical trial[15](index=15&type=chunk) - AFFIRM–205: Expected to complete **subject enrollment** for the China Phase III trial[16](index=16&type=chunk) - Other ActRII-targeted drugs: Expected to initiate **LAE103 Phase I clinical study**[17](index=17&type=chunk) [Financial Summary and Statements](index=5&type=section&id=%E8%B2%A1%E5%8B%99%E6%91%98%E8%A6%81%E8%88%87%E5%A0%B1%E8%A1%A8) This section details the company's financial performance, position, and cash flows for the reporting period, highlighting key changes in expenses and liquidity [Financial Summary](index=5&type=section&id=%E8%B2%A1%E5%8B%99%E6%91%98%E8%A6%81) For the six months ended June 30, 2025, R&D expenses decreased by 16.6% to RMB 105.2 million due to prior-period milestone payments, while administrative expenses increased by 39.1% to RMB 42.3 million, narrowing the period's loss to RMB 129.6 million Financial Summary (For the six months ended June 30) | Metric | 2025 (RMB '000) | 2024 (RMB '000) | Y-o-Y Change | | :--- | :--- | :--- | :--- | | R&D Expenses | 105,192 | 126,148 | -16.6% | | Administrative Expenses | 42,321 | 30,380 | +39.1% | | Loss for the Period | 129,637 | 143,706 | -9.8% | | Total Comprehensive Loss for the Period | 133,399 | 138,548 | -3.7% | - The decrease in R&D expenses was primarily due to a **RMB 17.8 million** milestone payment related to the AFFIRM-205 Phase III clinical trial in H1 2024, with no such expenses in the current reporting period[19](index=19&type=chunk) - The increase in administrative expenses was mainly attributable to higher **equity-settled share-based payment expenses**[20](index=20&type=chunk) [Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=6&type=section&id=%E7%B6%9C%E5%90%88%E6%90%8D%E7%9B%8A%E5%8F%8A%E5%85%B6%E4%BB%96%E5%85%A8%E9%9D%A2%E6%94%B6%E7%9B%8A%E8%A1%A8) During the period, other income grew 40.7% to RMB 19.91 million, operating loss narrowed to RMB 127.6 million from RMB 142.4 million, and net loss was RMB 129.6 million, with basic and diluted loss per share at RMB 0.35 Key Items from Consolidated Statement of Profit or Loss (For the six months ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Other Income | 19,908 | 14,149 | | Administrative Expenses | (42,321) | (30,380) | | R&D Expenses | (105,192) | (126,148) | | Loss from Operations | (127,605) | (142,383) | | Loss Before Tax | (129,637) | (143,706) | | Loss for the Period | (129,637) | (143,706) | | Basic and Diluted Loss Per Share (RMB) | (0.35) | (0.40) | [Consolidated Statement of Financial Position](index=7&type=section&id=%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E7%8B%80%E6%B3%81%E8%A1%A8) As of June 30, 2025, the company reported total assets of RMB 913.4 million, total liabilities of RMB 200.6 million, and net assets of RMB 712.9 million, with cash and cash equivalents increasing to RMB 676.6 million Key Items from Consolidated Statement of Financial Position | Item | As of June 30, 2025 (RMB '000) | As of Dec 31, 2024 (RMB '000) | | :--- | :--- | :--- | | **Assets** | | | | Non-current Assets | 151,048 | 146,636 | | Current Assets | 762,362 | 813,401 | | Of which: Cash and Cash Equivalents | 676,562 | 636,422 | | **Liabilities and Equity** | | | | Current Liabilities | 194,705 | 148,473 | | Non-current Liabilities | 5,849 | 6,772 | | Net Assets | 712,856 | 804,792 | | Total Equity | 712,856 | 804,792 | [Condensed Consolidated Statement of Cash Flows](index=8&type=section&id=%E7%B0%A1%E6%98%8E%E7%B6%9C%E5%90%88%E7%8F%BE%E9%87%91%E6%B5%81%E9%87%8F%E8%A1%A8) Net cash outflow from operating activities significantly decreased to RMB 74.15 million, while investing activities generated RMB 105.9 million net cash inflow, and financing activities generated RMB 10.84 million, increasing period-end cash and cash equivalents to RMB 674.5 million Condensed Consolidated Statement of Cash Flows (For the six months ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | (74,149) | (143,382) | | Net Cash From Investing Activities | 105,926 | 101,835 | | Net Cash From Financing Activities | 10,841 | 5,575 | | Net Increase/(Decrease) in Cash and Cash Equivalents | 42,618 | (35,972) | | Cash and Cash Equivalents at Beginning of Period | 634,323 | 440,815 | | Cash and Cash Equivalents at End of Period | 674,542 | 407,331 | [Management Discussion and Analysis](index=17&type=section&id=%E7%AE%A1%E7%90%86%E5%B1%A4%E8%A8%8E%E8%AB%96%E5%8F%8A%E5%88%86%E6%9E%90) This section provides an overview of the company's strategic pipeline, financial performance, liquidity, and future development plans, including the use of proceeds [Overview and Pipeline Review](index=17&type=section&id=%E6%A6%82%E8%A7%88%E8%88%87%E7%AE%A1%E7%B7%9A%E5%9B%9E%E9%A1%A7) The company is a science-driven clinical-stage biopharmaceutical firm focused on metabolic diseases, cancer, and liver fibrosis, actively advancing its ActRII product portfolio and AKT inhibitor afuresertib through clinical trials and strategic partnerships - The company has established a comprehensive ActRII product portfolio in the metabolic field, with LAE102 showing promise as a potential drug for **muscle-preserving weight loss**[51](index=51&type=chunk) - In oncology, the core product LAE002 (afuresertib) is one of only two AKT inhibitors globally in late-stage clinical development for breast and prostate cancer, with a **Phase III pivotal study initiated in China**[52](index=52&type=chunk) - The Phase II trial of LAE002 combined with LAE001 for mCRPC showed a median rPFS of **8.1 months**, significantly outperforming standard therapy[68](index=68&type=chunk) - In the Phase I trial of LAE002 combined with LAE005 and chemotherapy for triple-negative breast cancer (TNBC), the objective response rate (ORR) was **35.7%**, and the disease control rate (DCR) was **64.3%**[74](index=74&type=chunk) [Financial Review](index=24&type=section&id=%E8%B2%A1%E5%8B%99%E5%9B%9E%E9%A1%A7) During the period, other income increased by 41.1% due to government grants, administrative expenses rose by 39.1% from equity-settled share-based payments, and R&D expenses decreased by 16.6% primarily due to the absence of prior-period milestone payments R&D Expense Breakdown (For the six months ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Staff Costs | 41,806 | 34,580 | | R&D Research Expenses | 30,392 | 13,140 | | Clinical Development Expenses | 28,052 | 54,417 | | Clinical Trial Milestone Payments | – | 17,758 | | Other | 4,942 | 6,253 | | **Total** | **105,192** | **126,148** | [Liquidity and Financial Resources](index=25&type=section&id=%E6%B5%81%E5%8B%95%E8%B3%87%E9%87%91%E5%8F%8A%E8%B2%A1%E5%8B%99%E8%B3%87%E6%BA%90) As of June 30, 2025, the company held RMB 743.8 million in cash and bank balances, with current assets of RMB 762.4 million and current liabilities of RMB 194.7 million, resulting in a current ratio of 3.92 and a net cash position - As of June 30, 2025, cash and cash equivalents were **RMB 676.6 million**, a **6.3% increase** from **RMB 636.4 million** at the end of 2024[81](index=81&type=chunk) - As of June 30, 2025, the current ratio was **3.92**, compared to **5.48** as of December 31, 2024[85](index=85&type=chunk) - The company is in a **net cash position**, thus the debt-to-asset ratio is not applicable[86](index=86&type=chunk) [Use of Net Proceeds](index=27&type=section&id=%E6%89%80%E5%BE%97%E6%AC%BE%E9%A0%8D%E6%B7%A8%E9%A1%8D%E7%94%A8%E9%80%94) The company detailed the use of net proceeds from its global offering and placing, with HKD 489.8 million utilized from the HKD 724.4 million global offering and HKD 51.6 million from the HKD 230.4 million November 2024 placing, primarily for LAE102 and ActRII drug R&D Use of Net Proceeds from Global Offering (As of June 30, 2025) | Intended Use | Allocated Amount (HKD Million) | Cumulative Utilized (HKD Million) | Unutilized Amount (HKD Million) | | :--- | :--- | :--- | :--- | | Core Product Clinical Development | 407.8 | 269.7 | 138.1 | | Other Pipeline Product R&D | 150.7 | 144.4 | 6.3 | | Enhance Production Capacity and Manufacturing Capabilities | 71.7 | 4.9 | 66.8 | | Business Development Activities | 55.1 | 26.7 | 28.4 | | Working Capital and Other | 39.1 | 39.1 | – | Use of Net Proceeds from Placing (As of June 30, 2025) | Intended Use | Allocated Amount (HKD Million) | Cumulative Utilized (HKD Million) | Unutilized Amount (HKD Million) | | :--- | :--- | :--- | :--- | | Accelerate LAE102 and ActRII Drug R&D | 230.4 | 51.6 | 178.7 | [Future Developments](index=30&type=section&id=%E6%9C%AA%E4%BE%86%E7%99%BC%E5%B1%95) The company plans to expand its metabolic and oncology portfolios, focusing on ActRII product development, aiming to advance one candidate to clinical stage annually, and seeking strategic collaborations to accelerate clinical development and commercialization - The company will continue to build and expand its ActRII product portfolio to maximize the development value of ActRII receptor targeting[98](index=98&type=chunk) - The goal is to advance **one candidate drug into clinical stage annually** and continuously explore the potential for combination therapies[99](index=99&type=chunk)[100](index=100&type=chunk) - Following the collaboration with Eli Lilly, the company plans to establish **strategic partnerships with more global leading pharmaceutical companies** to accelerate asset clinical development and commercialization[101](index=101&type=chunk) [Corporate Governance and Other Information](index=31&type=section&id=%E4%BC%81%E6%A5%AD%E7%AE%A1%E6%B2%BB%E7%9B%B8%E9%97%9C%E8%B3%87%E6%96%99) This section outlines the company's adherence to corporate governance principles, the Audit Committee's review, and the Board's decision regarding interim dividends [Corporate Governance and Compliance](index=31&type=section&id=%E4%BC%81%E6%A5%AD%E7%AE%A1%E6%B2%BB%E8%88%87%E5%90%88%E8%A6%8F) The company adopted and complied with the Corporate Governance Code, with the exception of the Chairman and CEO roles being held by the same individual, Dr. Lu Xiangyang, an arrangement the Board believes benefits strategic execution - The company complied with all relevant provisions of the Corporate Governance Code during the reporting period, with **one deviation**[102](index=102&type=chunk) - The deviation is that the roles of Chairman and Chief Executive Officer are not separated, both held by founder **Dr. Lu Xiangyang**, an arrangement the Board believes benefits strategic execution and communication efficiency[103](index=103&type=chunk) [Audit Committee and Interim Results Review](index=32&type=section&id=%E5%AF%A9%E8%A8%88%E5%A7%94%E5%93%A1%E6%9C%83%E5%8F%8A%E4%B8%AD%E6%9C%9F%E6%A5%AD%E7%B8%BE%E5%AF%A9%E9%96%B1) The company's Audit Committee, comprising independent non-executive and non-executive directors, reviewed the unaudited interim financial information, which was also independently reviewed by KPMG - The Audit Committee has reviewed the Group's accounting principles, policies, and **unaudited interim financial information** with management[108](index=108&type=chunk) - Independent auditor **KPMG** has reviewed the interim financial information in accordance with Hong Kong Standard on Review Engagements 2410[108](index=108&type=chunk) [Dividends](index=32&type=section&id=%E8%82%A1%E6%81%AF) The Board did not recommend the payment of any interim dividend for the six months ended June 30, 2025 - The Board does not recommend the payment of any interim dividend for the six months ended June 30, 2025[110](index=110&type=chunk)
来凯医药-b(02105):首次覆盖报告:聚焦高质量减重增肌与未满足肿瘤需求
GUOTAI HAITONG SECURITIES· 2025-08-13 05:21
Investment Rating - The report assigns an "Accumulate" rating to the company, with a target price of HKD 29.19 [5][15]. Core Insights - The report highlights that the company focuses on high-quality fat reduction and muscle gain in weight loss, as well as unmet needs in oncology, indicating a globally competitive pipeline in these areas [2][10]. - The company is positioned as a science-driven, clinical-stage biopharmaceutical firm, aiming to provide innovative therapies for metabolic diseases, cancer, and liver fibrosis [20][19]. Financial Summary - The projected financials for the company indicate no revenue until 2025, with expected revenues of RMB 280 million in 2027. The net profit is forecasted to be negative in the coming years, with estimates of -RMB 369 million in 2023, improving to -RMB 190 million by 2027 [4][15]. - The company’s financial ratios show a significant increase in the price-to-book (PB) ratio from 9.66 in 2024 to 429.89 in 2027, reflecting the anticipated growth in valuation as the company progresses [4][11]. Pipeline and Market Focus - The company’s pipeline includes several clinical trials targeting obesity and cancer, with a focus on LAE102, LAE002 (afuresertib), and LAE001, which are positioned to address unmet medical needs in these therapeutic areas [23][24]. - The report emphasizes the growing global market for weight loss drugs, projected to exceed USD 115 billion by 2030, driven by increasing obesity rates and demand for effective treatments [34][32]. Management and Team Experience - The management team possesses extensive experience in the pharmaceutical industry, with key members having backgrounds in leading global pharmaceutical companies, which enhances the company’s capability in drug development and clinical trials [30][25]. Competitive Landscape - The report notes that the company is innovating in the "fat reduction + muscle gain" space, which is becoming a critical focus in the weight loss drug market, with several multinational corporations also investing in this area [45][48].
来凯医药(02105) - 截至二零二五年七月三十一日止之股份发行人的证券变动月报表
2025-08-05 11:01
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | | | 致:香港交易及結算所有限公司 公司名稱: 來凱醫藥有限公司 FF301 II. 已發行股份及/或庫存股份變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02105 | 說明 | | | | | | | | | 已發行股份(不包括庫存股份)數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 407,736,350 | | 0 | | 407,736,350 | | 增加 / 減少 (-) | | | 0 | | 0 | | | | 本月底結存 | | | 407,736,350 | | 0 | | 407,736,350 | 呈交日期: 2025年8月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | ...
中金:首予来凯医药-B跑赢行业评级 目标价27.02港元
Zhi Tong Cai Jing· 2025-08-04 02:35
Group 1 - The core viewpoint is that CICC has initiated coverage on Lai Kai Pharmaceutical-B (02105) with an "outperform" rating and a target price of HKD 27.02, indicating a potential upside of 43.7% from the current stock price, based on DCF valuation [1] - Lai Kai is a global biopharmaceutical company focusing on metabolic and oncology diseases, recognized as a rising player in the domestic fat loss and muscle gain sector [1] - The market perceives Eli Lilly's Bimagrumab data as strong, revealing the drug's potential for fat loss and muscle gain through targeting the ActRII receptor, which aligns with the clinical demand for higher quality weight loss solutions [2][3] Group 2 - The global market for GLP-1 receptor agonists (GLP-1RA) is rapidly expanding, projected to reach USD 14.7 billion in 2024, accounting for 86.6% of the global obesity drug market, with an expected increase to 93.9% by 2034, reaching USD 54.1 billion [2] - There are concerns regarding muscle loss associated with GLP-1RA weight loss drugs, as studies indicate that over 40% of the weight lost may come from lean body mass, highlighting the need for therapies that promote fat loss while preserving muscle [2] - LAE102, a monoclonal antibody developed by Lai Kai targeting ActRIIA, shows promise in promoting muscle regeneration and reducing fat, with ongoing Phase I clinical trials in China and the US [3]
中金:首予来凯医药-B(02105)跑赢行业评级 目标价27.02港元
智通财经网· 2025-08-04 02:31
Group 1: Company Overview - Company is a global biopharmaceutical technology firm focusing on metabolic and oncology diseases, recognized as a rising player in the domestic fat reduction and muscle gain sector [1] - Company’s LAE102 is a monoclonal antibody targeting ActRIIA, showing potential for muscle regeneration and fat reduction, with ongoing Phase I clinical studies in China and the US [4] Group 2: Market Insights - The global market for GLP-1 receptor agonists (GLP-1RA) is rapidly expanding, projected to reach $14.7 billion in 2024, accounting for 86.6% of the global obesity and overweight drug market, with an expected increase to 93.9% by 2034, reaching $54.1 billion [2] - Concerns regarding muscle loss associated with GLP-1RA weight loss drugs have emerged, highlighting the clinical need for targeted solutions like ActRII to achieve quality weight loss [3] Group 3: Clinical Development and Potential Catalysts - LAE102's multi-dose escalation study data is anticipated to be released, with overseas clinical data also expected to provide significant insights [4] - Company has signed an agreement with Eli Lilly to advance clinical trials for obesity in the US, with preliminary data from multi-dose escalation trials expected by September 2025 [4]