来凯医药-B(02105)早盘涨超7%，截至发稿，涨8.42%，报13.9港元，成交额3424.37万港元。 财通证券（601108）此前指出，ActRII通路作为肌肉调控的关键通路，吸引多家跨国药企布局，公司围 绕ActRII通路布局三款增肌产品：LAE102目前已完成SAD研究，安全性较好，目前正在开展MAD研 究；2024年11月公司与礼来签订LAE102的临床合作协议，由礼来负责在美国开展1期临床并承担相关费 用，公司保留LAE102的全球权益，体现出礼来对LAE102产品看好，已启动美国1期临床。此外，公司 计划分别于2Q2025/3Q2025提交LAE103/LAE123临床试验申请。 消息面上，来凯医药宣布，完成发行3600万股配售股份，每股配售股份16.30港元，所得款项净额约5.77 亿港元。拟将用于ActRII产品组合的研发开支；临床前候选药物的持续研发开支；一般及企业用途。董 事会预计，额外资金对于推进集团ActRII产品组合的持续研发活动以及支持持续进行的临床前研发活动 而言至关重要。 ...

消息面上，来凯医药宣布，完成发行3600万股配售股份，每股配售股份16.30港元，所得款项净额约5.77 亿港元。拟将用于ActRII产品组合的研发开支；临床前候选药物的持续研发开支；一般及企业用途。董 事会预计，额外资金对于推进集团ActRII产品组合的持续研发活动以及支持持续进行的临床前研发活动 而言至关重要。 财通证券此前指出，ActRII通路作为肌肉调控的关键通路，吸引多家跨国药企布局，公司围绕ActRII通 路布局三款增肌产品：LAE102目前已完成SAD研究，安全性较好，目前正在开展MAD研究；2024年11 月公司与礼来签订LAE102的临床合作协议，由礼来负责在美国开展1期临床并承担相关费用，公司保留 LAE102的全球权益，体现出礼来对LAE102产品看好，已启动美国1期临床。此外，公司计划分别于 2Q2025/3Q2025提交LAE103/LAE123临床试验申请。 智通财经APP获悉，来凯医药-B(02105)早盘涨超7%，截至发稿，涨8.42%，报13.9港元，成交额3424.37 万港元。 ...

Summary of the Conference Call for LaiKai Pharmaceuticals Company Overview - LaiKai Pharmaceuticals is focused on developing innovative therapies, particularly in the fields of obesity and cancer treatment, with several core products in various stages of clinical development [2][4][5]. Financial Performance - Cash reserves decreased from 700 million RMB in the same period last year to approximately 633 million RMB in the first half of this year, with net cash around 630 million RMB [2][4]. - The net loss slightly reduced from 173 million RMB to 129 million RMB year-over-year [4]. Core Products and Clinical Development - **LQA102**: Currently in Phase I clinical trials, expected to complete MAD (Multiple Ascending Dose) studies by the end of September [2][5]. - **LQA103**: Recently received FDA IND approval, with plans to initiate human trials in the second half of the year [2][5]. - **LAE123**: In the IND enabling stage, with human trials planned for next year [2][5]. - **LAE002**: An AKT inhibitor in Phase III trials for breast cancer in China, with patient enrollment expected to complete in Q4 this year and data readout in the first half of next year [2][5]. Key Clinical Data and Insights - **Bimagrumab**: Data from Eli Lilly indicates a weight loss of over 10% with bimagrumab alone, and over 22% when combined with semaglutide, validating the efficacy of receptor antibodies for obesity treatment [2][8]. - **L2Q a (LQA102)**: Demonstrated significant advantages in weight loss and muscle preservation, with over 41% fat reduction in three weeks during preclinical studies [3][10]. - **AKT Pipeline**: The AKT pipeline is positioned for breast and prostate cancer, with expectations for NDA submission in Q2 next year [12][29]. Market Interest and Strategic Positioning - International market interest is high, as evidenced by Eli Lilly's acquisition of bimagrumab for $1.925 billion and Merck's acquisition of Acero Farm for $11.5 billion, indicating the potential of LaiKai's product portfolio [2][9]. - Multiple multinational corporations (MNCs) are exploring opportunities in the weight loss sector post-ADA conference [9]. Future Directions and Collaborations - LaiKai is actively pursuing partnerships and collaborations, particularly for the 102 and 103 projects, which are expected to enhance business development (BD) opportunities and transaction sizes [18][34]. - The company is also focusing on the development of combination therapies with GLP-1 drugs to address muscle loss associated with obesity treatments [21][27]. Safety and Efficacy Considerations - The MAD study for LQA102 is designed to assess safety and efficacy, with no new safety signals observed thus far [13][14]. - Long-term safety of bimagrumab has shown positive metabolic outcomes, including significant reductions in waist circumference and inflammatory markers [32][33]. Conclusion - LaiKai Pharmaceuticals is positioned at the forefront of innovative drug development in obesity and cancer treatment, with a strong pipeline and significant market interest. The company is focused on advancing its clinical trials and exploring strategic partnerships to maximize shareholder value [35].

Core Viewpoint - The company, LaiKai Pharmaceuticals, focuses on high-quality fat reduction and muscle gain in weight loss, addressing unmet needs in the oncology field, and possesses globally competitive pipelines [1][2]. Group 1: Investment Highlights - LaiKai Pharmaceuticals is a science-driven, clinical-stage biopharmaceutical company expected to enter a revenue-generating phase, with projected revenues of 0, 0, and 280 million yuan for 2025, 2026, and 2027 respectively, and net profits of -300 million, -313 million, and -190 million yuan for the same years [1]. - The company is assigned a target price of 29.19 HKD using DCF absolute valuation method and is rated as a buy [1]. Group 2: Research and Development Focus - The focus on fat reduction and muscle gain is a key research area in the future weight loss drug sector, with a need for differentiated innovation in "fat reduction + muscle gain" to address high muscle loss during weight loss and rebound weight gain [1]. - LaiKai Pharmaceuticals has established a comprehensive pipeline targeting the ActRII signaling pathway, including LAE102, LAE103, and LAE123 [1]. Group 3: Oncology Pipeline - The core pipeline LAE002 (afuresertib) is one of only two late-stage clinical AKT inhibitors globally targeting breast and prostate cancer, offering higher efficacy, better drug action, and improved safety [2]. - LAE002 addresses unmet medical needs in oncology, covering indications such as breast cancer, prostate cancer, ovarian cancer, and PD-1/PD-L1 resistant solid tumors [2]. Group 4: Management Team - The management team of LaiKai Pharmaceuticals has extensive experience and a deep understanding of relevant target pathways, with the chairman, Dr. Lü Xiangyang, being a co-inventor of Bimagrumab and having over 20 years of experience in the ActRII pathway [2]. - Key members of the board, including Dr. Ge Xiangju and Director Xie Ling, have backgrounds in international pharmaceutical companies like Novartis, specializing in new drug discovery, clinical development, and registration [2].

Core Viewpoint - The company reported a significant increase in other income and a reduction in R&D expenses, while also showing a decrease in losses, indicating a positive trend in financial performance and ongoing development of promising drug candidates [1][2][3] Financial Performance - The company achieved other income of RMB 19.908 million for the six months ending June 30, 2025, representing 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 net loss for the period was RMB 130 million, which is a 9.79% reduction compared to the previous year [1] - As of June 30, 2025, the company had current assets of RMB 762 million, including cash and cash equivalents of RMB 677 million, indicating strong financial reserves for future R&D projects [1] Drug Development - LAE102, a monoclonal antibody targeting ActRIIA, has shown potential for muscle regeneration and weight control, with successful completion of the single ascending dose part of Phase I clinical trials for obesity treatment in China by the end of 2024 [1] - The company initiated a Phase III clinical trial (AFFIRM-205) in May 2024 for LAE002 (afuresertib), an oral AKT inhibitor, 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 anti-tumor 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 has submitted an IND application for LAE103 to the FDA as of June 30, 2025, with plans to initiate Phase I clinical trials in the second half of 2025 [3]

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]

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].

Core Viewpoints - The company showcased multiple early clinical products at the 2025 ADA conference, demonstrating excellent early data, particularly for LAE102, which showed good safety and pharmacokinetic properties [1][2] - The clinical and preclinical studies of LAE102, LAE103, and LAE123 indicate promising fat reduction and muscle gain effects, with LAE102 outperforming LAE103 [1][3] Events - On June 23, 2025, the company announced the clinical and preclinical research results of LAE102, LAE103, and LAE123 at the 2025 ADA conference [1] Safety and Efficacy - LAE102 demonstrated good safety with no serious adverse events (SAE) reported in both intravenous and subcutaneous administration groups, and no cases of diarrhea were noted [2] - Initial efficacy signals were observed for LAE102, with a significant increase in Actvin A levels correlating with drug dosage, indicating promising pharmacokinetic and pharmacodynamic effects [2] Clinical Pipeline - The company has a balanced pipeline focused on cancer and metabolic diseases, with several candidates in various stages of development, including LAE103 and LAE123, both in the IND application stage [3] - LAE001 and LAE005 are also in clinical trials, with LAE001 having completed Phase I trials and LAE005 showing potential in treating triple-negative breast cancer [3] Financial Projections - The company has a globalized and integrated approach to its cancer and metabolic drug development, with expectations for LAE102 to meet market demand upon commercialization [4] - Revenue projections for 2025, 2026, and 2027 are estimated at 0, 0, and 169 million respectively, with a target valuation of 16.85 billion HKD and a revised target price of 41.30 HKD [4]

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。 （於開曼群島註冊成立之有限公司） （股份代號：2105） 來凱醫藥有限公司 Laekna, Inc. 本公司董事（「董事」）會（「董事會」）宣佈：(i)用於治療肥胖症的LAE102（ 一種針對 Act RI IA 的 單 克 隆 抗 體 ）的 I 期 單 劑 量 遞 增 (SAD ) 研 究 結 果 ； 以 及 (ii) LAE102 、 LAE103（ 一種針對Act RIIB的單克隆抗體 ）及LAE123（ 一種針對Act RIIA / IIB雙靶點 的單克隆抗體 ）作為增肌減脂療法的臨床前研究結果，已於美國糖尿病協會(ADA) 第85屆科學年會上公佈。 相關海報詳情如下： 海報編號1 – 1 – 摘要編號： 2205 -LB 標題： LAE102在健康志願者中的首次人體研究：評估其安全性、耐受 性、藥代動力學及藥效學 時間： 202 ...

Group 1 - The core announcement is that 来凯医药 will present multiple research results in the field of muscle gain and fat loss at the 85th Annual Scientific Sessions of the American Diabetes Association (ADA) [1] - The company will showcase preclinical data for three monoclonal antibodies targeting ActRII: LAE102, LAE103, and LAE123, along with initial human study data for LAE102 [1] - LAE102 has shown significant effects in preclinical models, increasing muscle and reducing fat, with strong target inhibition indicated by elevated activin A levels in completed Phase I trials in China [1] Group 2 - The company is advancing its research on the ActRII pathway, with LAE103 and LAE123 entering IND supportive research stages, aimed at exploring innovative therapies for muscle and critical illness [2] - The poster presentations will take place on June 22, 2025, at the McCormick Place Convention Center in Chicago, Illinois [2] - The first human study of LAE102 will assess its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers [2]