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 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 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]

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。 Act RII信號失調與多種疾病包括肥胖症、肌肉減少症和其他嚴重疾病相關。我們 將探索LAE123作為治療嚴重威脅生命的疾病，如肺動脈高壓和脊髓性肌萎縮症的 新療法。 關於LAE123 LAE123是本集團自主研發的單克隆抗體，可同時抑制由其配體誘導的Act RIIA和 Act RIIB信號，包括肌生長抑制素、激活素（ 如激活素A、激活素B、激活素AB、 激活素C和激活素E ）及生長╱分化因數（ GDF，如GDF3和GDF11 ）。Act RII信號失 調與多種疾病，包括肥胖症、肌肉減少症和其他嚴重疾病相關。 – 1 – （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. 自願公告 LAE123針對重症療法的IND支持性研究(IND -enabling study)已經啟動 本 公 告 由 ...

10月16日及17日，来凯医药股价涨幅分别为8.44%和16.21%。 已全面布局ActRII通路。 本文为IPO早知道原创 作者｜罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，10月16日，来凯医药（2105.HK）宣布其自主研发的LAE102（ActRIIA单克隆 抗体）针对超重/肥胖在中国开展的I期临床试验单次剂量递增（SAD）研究的皮下注射（SC）部分 已启动。 该I期临床系一项随机、双盲、安慰剂对照、单次和多次给药剂量递增研究，旨在通过静脉输注 （IV）和皮下注射（SC）两种给药方式，评价LAE102注射液在健康成年受试者及超重/肥胖受试者 中的安全性、耐受性及药代动力学。 截至2024年9月30日，已有过半数的静脉输注队列完成了给药，并在低剂量组中就观察到靶点结合 的早期迹象和预期的PD生物标志物变化。此次启动的为皮下注射研究部分，2024年底前有望完成单 次剂量递增研究。 LAE102是来凯医药自主研发、全球首创的一种单克隆抗体，针对参与调控肌肉再生和脂代谢的重要 靶点ActRIIA。临床前研究显示，可增加肌肉并减少脂肪 。 LAE102 与 GLP-1 受体激动剂联用，可 进 ...