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]

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].

Investment Highlights - Company is a global biopharmaceutical technology firm focusing on metabolic and oncology diseases, recognized as a new player in the domestic fat loss and muscle gain sector [1] - 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 [1] Product Development - GLP-1RA weight loss may lead to muscle loss, with studies indicating that over 40% of weight lost may come from lean body mass, raising concerns about muscle loss [2] - Targeting ActRII shows potential for fat loss and muscle gain, addressing the clinical need for higher quality weight loss solutions [2] - Company’s LAE102, a monoclonal antibody targeting ActRIIA, is in Phase I clinical trials in China and the US, with preliminary data expected by September 2025 [2] Market Positioning - Company differentiates itself from market expectations by focusing on the potential of ActRII for fat loss and muscle gain, with LAE102 expected to offer advantages in selectivity, administration convenience, and safety [3] - Anticipated catalysts include data readouts from LAE102's multi-dose escalation studies and overseas clinical data [3] Financial Projections - Company forecasts net losses of RMB 289 million and RMB 309 million for 2025 and 2026, respectively [3] - Based on DCF valuation, the company is rated as outperforming the industry with a target price of HKD 27.02, indicating a potential upside of 43.7% from the current stock price [3]

Group 1 - The report highlights the strong growth potential of coconut water as a new consumer product, with a projected market size of nearly 200 billion yuan by 2029, reflecting a compound annual growth rate (CAGR) of approximately 20% over the next five years [25][26] - The coconut water market has transitioned from a niche luxury juice to a mainstream health beverage, with sales increasing from less than 2 billion yuan before 2022 to 7.8 billion yuan in 2024, driven by health trends and consumer education [25][26] - Key players in the coconut water market include IFBH, which has become the largest single product in China, and Huanyoujia, which is leveraging its supply chain advantages to expand its market presence [26][27] Group 2 - The report discusses the significant advancements in China's marine economy, emphasizing the strategic importance of marine economic development in the context of national modernization [10][12] - The central government has outlined five key principles for promoting high-quality marine economic development, including innovation-driven growth and efficient collaboration, which are expected to lead to a series of supportive policies [10][11] - Investment opportunities in the marine economy are identified in sectors such as marine technology, marine renewable energy, and marine biomedicine, with a focus on deep-sea materials and equipment [12][13] Group 3 - The report analyzes the performance of the Hong Kong Stock Connect Technology ETF, which tracks the performance of technology-related companies listed in Hong Kong, highlighting its cost advantages and growth potential [15][18] - The technology sector within the Hong Kong Stock Connect index is primarily driven by information technology, with significant contributions from software services and hardware sectors, indicating strong market potential [16][17] - The report notes that the technology index is currently at a historically low price-to-earnings ratio, suggesting potential for future growth as the market recovers [18]

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]

Summary of Key Points from the Conference Call Industry Overview - The conference call focused on the healthcare sector, specifically the developments in diabetes treatment and related biopharmaceuticals in China, particularly in relation to the upcoming ADA'25 conference. Core Insights and Arguments 1. **China's Presence at ADA'25**: Chinese biotech companies are expected to present significant data at ADA'25, including: - Ascletis's ASC30 (oral GLP-1) in Phase 1, showing mild to moderate adverse events (AEs) with no serious adverse events (SAEs) reported [1][2] - Laekna's LAE102 (muscle-preserving drug) in Phase 1, demonstrating dose-dependent increases in serum concentration and no serious AEs [2][3] - Innovent's Mazdutide (GLP-1/GCG) in Phase 3, showing superior results compared to placebo in HbA1c reduction and weight loss [2][3] 2. **Anticipated Outcomes**: There are low expectations for major surprises from Chinese players at ADA'25, as many oral GLP-1 and amylin candidates are still in early stages of development [4]. 3. **Key Data Points**: - **Ascletis's ASC30**: 70.3% of AEs were mild, and 29.7% were moderate, with pharmacokinetic analysis supporting once-daily oral dosing [2]. - **Laekna's LAE102**: No serious AEs or treatment-emergent adverse events (TEAEs) leading to study discontinuation were reported, with increased activin A levels maintained over a 28-day follow-up [2]. - **Innovent's Mazdutide**: At week 24, the mean HbA1c change from baseline was -1.43% for MAZ 4 mg and -2.02% for MAZ 6 mg, with significant proportions of patients achieving HbA1c <7.0% and weight reduction ≥5% [2]. Additional Important Content 1. **Company Valuations and Risks**: - **Eli Lilly & Co**: Price target supported by DCF valuation, with risks including commercial, regulatory, and clinical factors [7]. - **Hengrui**: Price target of Rmb80.0 based on DCF methodology, with risks related to negotiations and market competition [8]. - **Innovent Biologics Inc**: Price target of HK$40.0 derived from DCF methodology, with various operational and regulatory risks [9]. 2. **Development Phases of Key Products**: A detailed table outlines the development phases of various products presented by Chinese companies at ADA'25, including their indications and target mechanisms [6]. 3. **Market Dynamics**: The report highlights the competitive landscape and the potential for intensified market competition as more players enter the diabetes treatment space [8]. This summary encapsulates the critical insights and data points discussed in the conference call, providing a comprehensive overview of the current state and future outlook of the healthcare sector, particularly in diabetes treatment in China.

Core Insights - The 85th American Diabetes Association Scientific Sessions highlighted the escalating competition in the GLP-1 drug market, particularly between major players Novo Nordisk and Eli Lilly [1][2] - Novo Nordisk's STEP UP trial demonstrated a significant average weight reduction of 21% in obese patients without diabetes using a higher dose of Wegovy, while Eli Lilly's ACHIEVE-1 trial showed orforglipron effectively lowered A1C levels by 1.3% to 1.6% in type 2 diabetes patients [1][3][4] Company Developments - Novo Nordisk reported sales of its GLP-1 products, with Ozempic generating approximately $17.47 billion, Rybelsus around $3.38 billion, and Wegovy about $8.45 billion in 2024, totaling approximately $29.3 billion [3] - Eli Lilly's tirzepatide contributed nearly $16.5 billion to its revenue in 2024, accounting for about 36% of its total income [3] - Novo Nordisk plans to submit a label update for a higher dose of Wegovy in the EU by late 2025, while Eli Lilly is expected to file for orforglipron's weight management approval by the end of this year [4][5] Market Trends - The global market for GLP-1 drugs is projected to reach approximately $60 billion by 2025 and could grow to $80 billion or more by 2030, driven by increasing obesity rates and demand for effective treatments [2][6] - The competitive landscape is evolving, with 179 GLP-1 candidates in clinical stages from 45 companies, indicating a potential influx of new products by 2029 [6][8] Innovations and Research - Domestic companies are making significant strides in GLP-1 drug development, with innovative products like IBI362 and HRS9531 showing promising results in clinical trials [6][7] - The introduction of Ecnoglutide, a novel GLP-1 drug from a Chinese company, demonstrated a weight reduction of 15.1% in clinical trials, marking a significant advancement in the field [7] - The focus is shifting towards improving drug safety and tolerability, with companies expected to invest more in these areas to enhance patient experience and treatment outcomes [2][9]

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 ...

Core Insights - The 85th American Diabetes Association (ADA) conference showcased innovative metabolic drugs, particularly focusing on weight loss medications, with GLP-1 agonists being a prominent research area [1][2] - Novo Nordisk reported that a higher dose of Wegovy (semaglutide 7.2 mg) resulted in an average weight reduction of 21% for obesity patients, with one-third of participants losing 25% or more of their body weight [1][4] - The competitive landscape includes multiple companies, with Novo Nordisk leading in the number of obesity drug pipelines, followed by Eli Lilly and several domestic firms [1][6] Company Developments - Novo Nordisk's STEP UP trial demonstrated significant weight loss effects with the higher dose of semaglutide, maintaining safety profiles consistent with existing GLP-1 medications [2][4] - Eli Lilly announced positive results for its oral small molecule GLP-1 receptor agonist, Orforglipron, showing significant reductions in A1C levels and an average weight loss of 7.3 kg in the highest dose group [5] - Novo Nordisk plans to submit a label update for the higher dose of Wegovy in the EU by mid-2025, while Eli Lilly aims to submit Orforglipron for weight management approval by the end of this year [4][5] Industry Trends - The focus on innovative mechanisms for weight loss drugs includes long-acting, oral, multi-target, and muscle-preserving approaches, indicating a shift towards more effective treatment options [6][8] - The dual and triple-target GLP-1 agonists are gaining traction, with Eli Lilly's Retatrutide leading in global development, while several Chinese companies are advancing their products into clinical phases [7][8] - The market is seeing a growing number of combination therapies, with 13 dual-target and 9 multi-target combinations currently in development, totaling 88 related investigational drugs [7]

Investment Rating - The report does not explicitly state an investment rating for the industry or specific companies involved in the ADA 2025 meeting presentations [2]. Core Insights - The upcoming American Diabetes Association (ADA) meeting is expected to showcase significant presentations from Chinese pharmaceutical companies, particularly focusing on diabetes and obesity treatments [1][3]. - Innovent is anticipated to present data on its Phase 3 study of Mazdutide for Type 2 Diabetes (T2D) and preclinical data for a multi-target candidate involving GLP-1, GIP, GCG, and PCSK9 [1][3]. - There is a growing interest from large pharmaceutical companies in the obesity treatment space, suggesting potential for increased collaborations following the generation of more clinical data [1]. Summary by Sections Presentations at ADA 2025 - Innovent will present the DREAMS-1 Phase 3 study results for Mazdutide and preclinical data for a novel antibody-peptide conjugate targeting multiple receptors [3]. - Huadong will showcase a Phase I study of HDM1005, a dual GLP-1/GIP receptor agonist, focusing on safety and tolerability [3]. - Sciwind Biosciences is set to present data on Ecnoglutide, a GLP-1 analog for obesity, in a Phase 3 study [3]. - HighTide will present findings from a Phase 3 study of HTD1801, a berberine-based treatment for T2D [3]. - BrightGene Bio-Medical will discuss a Phase 2 trial of BGM0504, a GIPR/GLP-1R dual agonist for T2D [3]. Poster Sessions - Huadong will present a Phase 1b study of HDM1002 for obesity, targeting Activin Type II receptors [4]. - Laekna will showcase monoclonal antibodies LAE102, LAE103, and LAE123 as candidate therapeutics for muscle growth and fat reduction [4]. - Guanadona will present data on RAY1225, a GIPR/GLP-1R agonist, in studies for both obesity and T2D [4].