Investment Rating - The report maintains a "Buy" rating for the company [6] Core Insights - The company has undergone a strategic transformation focusing on the development of metabolic drugs, particularly in the obesity treatment sector, with promising clinical data [1][2] - In 2024, the company reported a significant decline in revenue to 1.283 million (down 97.7% year-over-year) and a net loss of 301 million, attributed to reduced income post-COVID and increased R&D expenditures in the metabolic disease area [1][2] - The company has terminated its viral disease treatment pipeline and shifted its focus to obesity and metabolic disease clinical pipelines, with two new clinical candidates, ASC30 and ASC47, advancing to Phase I trials [2] Financial Summary - The company’s R&D expenses increased by 39.5% year-over-year to 302 million, with nearly 100 million allocated to metabolic disease research [2] - The projected net losses for 2025 and 2026 have been revised down to -493.14 million and -417.02 million respectively, reflecting a significant downward adjustment of 57.5% and 29.5% from previous estimates [3] - The company has approximately 1.98 billion in cash and equivalents, expected to support operations until 2029 [2] Clinical Development Highlights - The company has reported strong efficacy results for its obesity drugs, with ASC30 showing an average weight reduction of 4.2% and 6.2% after 28 days of treatment in two cohorts [3] - ASC47 demonstrated a long half-life in Phase Ib trials, with a peak weight loss of 1.7% observed on day 50 after a single injection [3]

Investment Rating - The report assigns a "Buy" rating for the company, with a target price of 11.37 CNY, indicating potential upside from the current stock price [9][11]. Core Insights - The company is advancing into the weight loss market with its self-developed GLP-1 drugs, particularly ASC30 and ASC47, which show promising clinical data and potential to outperform existing treatments [9][11]. - ASC30 is the first product in the weight loss segment, being the only GLP-1 receptor agonist available in both oral and injectable forms, with early clinical trials indicating superior efficacy compared to competitors [9][11]. - ASC47 targets the clinical need for weight loss without muscle loss, showing promising results in preclinical studies [9][11]. Summary by Sections Company Overview - The company, founded in 2013 and listed in 2018, focuses on innovative drug development for metabolic diseases, with a strong management team experienced in the pharmaceutical industry [9][14][15]. - The core pipeline includes small molecule GLP-1 receptor agonists ASC30 and ASC47, which are expected to address unmet medical needs in the weight loss market [9][14]. Product Pipeline - ASC30 is positioned as a dual-action weight loss drug, with both long-acting injectable and oral formulations, currently undergoing Phase I clinical trials in the U.S. [9][20][24]. - ASC47 is designed to reduce weight without muscle loss, addressing a significant gap in the current market for weight loss medications [9][20][24]. Clinical Data and Competitive Landscape - Early clinical data for ASC30 shows it has a significantly longer half-life and better efficacy compared to existing GLP-1 drugs, suggesting a strong competitive advantage [9][28][30]. - The global landscape for weight loss drugs is competitive, with major players focusing on both peptide and small molecule approaches, highlighting the importance of clinical trial outcomes and speed of development [9][39][42]. Financial Projections - The company anticipates no revenue from its commercialized products in the near term, with ASC30 and ASC47 expected to launch by 2029 [9][11]. - Financial forecasts indicate a significant increase in net losses over the next few years, reflecting the investment in R&D and the long timeline to market for new products [9][11].

Investment Rating - The report assigns a "Buy" rating for the company, with a target price of 11.37 CNY, indicating potential upside from the current stock price [9][11][40]. Core Insights - The company is advancing into the weight loss market with its self-developed GLP-1 drugs, particularly ASC30 and ASC47, which show promising clinical data and potential advantages over existing treatments [9][11][40]. - ASC30 is the first product in the company's pipeline aimed at weight loss, featuring a unique dual administration method (both oral and injection) and demonstrating superior efficacy in early clinical trials compared to competitors [9][11][40]. - ASC47 targets the clinical need for weight loss without muscle loss, showing promising results in preclinical studies against existing treatments [9][11][40]. Summary by Sections Company Overview - The company, founded in 2013 and listed in 2018, focuses on innovative drug development for metabolic diseases and has a strong management team with extensive experience in the pharmaceutical industry [9][11][40]. - The company's major pipeline includes small molecule GLP-1 receptor agonists ASC30 and ASC47, which are expected to launch by 2029 [9][11][40]. Product Pipeline - ASC30 is a long-acting GLP-1 receptor agonist that can be administered both orally and via injection, with clinical trials showing it has 2-3 times the efficacy of existing treatments [9][11][40]. - ASC47 is designed to reduce weight without losing muscle mass, addressing a significant gap in the current weight loss drug market [9][11][40]. Financial Projections - The company anticipates no revenue from its commercialized products in the first half of 2024, with significant losses projected until the new products are launched [9][11][40]. - The financial outlook includes a projected net profit loss of 393.20 million CNY in 2024, increasing to 579.38 million CNY by 2026 [9][11][40].

在Ib期研究中，ASC30皮下注射剂总体耐受性良好，安全性良好。未报告严重不良事件(SAE)，且未观 察到3级或以上不良事件。大多数胃肠道相关不良事件(AE)为轻度(1级)。包括丙氨酸氨基转移酶 (ALT)、天冬氨酸氨基转移酶(AST)及总胆红素(TBL)在内的肝酶指标未升高。实验室检查、生命体徵、 ECGs(心电图，包括按心率校正的QT间期(QTc))及体格检查均未见异常。大部分的ASC30注射部位反应 均为轻度。未发生3级或以上注射部位反应。 由歌礼自主研发的ASC30是首款也是唯一一款既可每日一次口服也可每月一次或更低频率皮下注射的用 于治疗肥胖症的试验阶段小分子GLP-1R激动剂。 在评估的三种制剂中，其中一种制剂在接受单次皮下注射的肥胖症患者中显示出36天的半衰期，支持每 月一次或更低频率给药。此外，该制剂是一种皮下注射的无菌溶液，在中性pH值附近保持稳定，为与 其他药物或候选药物开发复方制剂及联合给药方案提供可能性。该小分子ASC30皮下注射制剂正在推进 至进一步的临床试验，旨在评估100毫克以上剂量的临床疗效。 另两种制剂与上述制剂的理化性质不同，在肥胖症患者中也显示出了超长效的潜力。 智通财经 ...

这些成就彰显了集团强大的研发能力，以及其长期以来致力于发现和开发具有全球竞争力的差异化管线 产品的决心。 公告称，亏损扩大主要由于肥胖症及其他代谢性疾病的研发开支增加。集团拥有充足的资金以支持其未 来五年的创新研发。 于报告期间及直至本公告日期，集团已就其代谢性疾病管线取得重大进展：(i)每日一次服用ASC30口服 片用于治疗肥胖症：在用于治疗肥胖症患者方面，显示出有望成为同类最佳特性，在治疗28天后，体重 相对基线平均下降最多达6.3%;(ii)每月一次或更低频率的皮下注射ASC30用于治疗肥胖症：作为针对已 验证靶点的小分子GLP-1R偏向激动剂，在用于治疗肥胖症患者方面显示出有望成为同类首创的特性。 其期中数据预计将于2025年3月底公布;及(iii)每月一次或更低频率的皮下注射ASC47用于治疗肥胖症(减 重不减肌)：作为针对新型靶点的脂肪靶向的小分子甲状腺激素受体β(THRβ)激动剂，显示出有望成为 同类首创的特性，有望实现减重不减肌地治疗肥胖症。ASC47在肥胖症患者体内显示出了长达40天的半 衰期。 歌礼制药-B(01672)发布年度业绩 股东应占亏损3.01 亿元 同比扩大107.95% 智通 ...

Financial Performance - For the fiscal year ending December 31, 2024, the company reported total revenue of RMB 1,283,000, a significant decrease of 97.7% compared to RMB 56,596,000 for the previous year[3]. - The basic and diluted loss per share increased to RMB 30.05 from RMB 13.47 in the previous year[3]. - The net loss for the year rose to RMB 300.9 million, up from RMB 144.7 million in the previous year, primarily due to increased R&D expenditures related to obesity and other metabolic diseases[6]. - The total revenue decreased from approximately RMB 566 million for the year ended December 31, 2023, to RMB 1.3 million for the year ended December 31, 2024, primarily due to strategic adjustments in response to the easing of the COVID-19 pandemic[32]. - The company's gross profit for the same period was RMB 735,000, down from RMB 25,990,000 in 2023, indicating a decline of about 97.17%[79]. - The company incurred an operating loss of RMB 295,419,000 in 2024, compared to a loss of RMB 124,296,000 in 2023, marking an increase in losses of about 138.56%[79]. - The company reported a basic loss per share of RMB 0.30 for 2024, compared to RMB 0.14 for 2023, based on a weighted average of 1,001,588,704 shares issued[109]. Research and Development - The company's research and development expenses increased by 39.5% from approximately RMB 216.8 million in the previous year to approximately RMB 302.4 million for the current year[6]. - The company emphasizes its commitment to developing a differentiated pipeline of globally competitive products in the metabolic disease sector[5]. - ASC30, a small molecule GLP-1R agonist, shows strong competitive potential for obesity treatment with unique properties allowing both subcutaneous and oral administration[12]. - The company is developing ASC30 and ASC47 for obesity treatment, with ASC30 showing potential best-in-class characteristics and ASC47 targeting a novel mechanism for weight loss without muscle loss[5][7]. - The company has established a comprehensive pipeline for metabolic diseases with key clinical stage assets and plans to announce results from various clinical studies in 2025[30]. - The company plans to announce interim data for ASC30's monthly injection formulation by the end of March 2025[5]. - The company plans to announce topline results from the ASC30 Phase Ib study in the U.S. by 2025[15]. Clinical Trials and Product Development - The company achieved promising interim results for ASC30, showing an average weight reduction of up to 6.3% relative to baseline after 28 days of treatment in the second cohort of a clinical trial[5][11]. - The Phase Ib clinical study for monthly or less frequent subcutaneous ASC30 injections in obesity patients has made significant progress, involving 76 patients across 8 cohorts[14]. - ASC47, a fat-targeting obesity treatment, has shown positive topline results in an Ib study in Australia, with a half-life of up to 40 days supporting monthly dosing[16]. - ASC47 demonstrated an average weight loss of 1.7% by day 50 after a single 90 mg injection, with good tolerability and no serious adverse events reported[16]. - The company has obtained exclusive rights for ASC40 in the Greater China region, which targets fatty acid synthase for acne treatment[8]. - The company plans to complete Phase III clinical studies for ASC40 targeting moderate to severe acne by 2025 and seek commercial partnerships[26]. Financial Position and Cash Flow - The cash and cash equivalents as of December 31, 2024, were approximately RMB 1,980.8 million, down from RMB 2,299.4 million the previous year, which is expected to support R&D activities until 2029[6]. - The net cash used in operating activities was approximately RMB 341.6 million, primarily due to an operating loss of about RMB 355.4 million before changes in working capital[61]. - The net cash generated from investing activities for the year ended December 31, 2024, was approximately RMB 978.9 million, mainly due to a decrease in time deposits of about RMB 866.0 million[62]. - The net cash used in financing activities for the year ended December 31, 2024, was approximately RMB 103.5 million, primarily attributed to the repurchase of shares at a total cost of about RMB 98.5 million[63]. - Cash and cash equivalents, along with time deposits, decreased from approximately RMB 2.27 billion as of December 31, 2023, to approximately RMB 1.94 billion as of December 31, 2024[55]. Corporate Governance and Strategic Decisions - The board does not recommend any dividend payment for the year ending December 31, 2024, consistent with 2023[120]. - The company has decided to terminate the ASC22 project for chronic hepatitis B and the ASC10 project for RSV based on strategic evaluations[19][20]. - The company is actively seeking suitable opportunities for licensing its clinical assets while developing its metabolic disease pipeline[29]. - The company maintains high standards of corporate governance to protect shareholder interests and enhance corporate value[130]. - The audit committee, consisting of three independent non-executive directors, reviewed the annual performance for the year ending December 31, 2024, and recommended approval to the board[135].

Investment Rating - The report maintains a "Buy" rating for the company [4][3]. Core Insights - ASC47, in combination with semaglutide, shows superior weight loss effects in preclinical studies compared to semaglutide alone, with weight reductions of 36.2% and 35.9% for the 3 mg/kg and 9 mg/kg groups respectively [1]. - The company is actively advancing clinical trials for ASC47 in Australia, with a Phase I single ascending dose study showing good tolerability and a half-life of 21 days [2]. - The company is also progressing multiple obesity-related drug candidates, including ASC30, which is undergoing Phase I trials in the US [8]. Financial Forecasts and Valuation - The company has adjusted its net profit forecasts for 2024 and 2025 to -261 million and -313 million CNY respectively, improving from previous estimates of -284 million and -340 million CNY [3]. - The net profit for 2026 is projected at -322 million CNY, reflecting effective cost control measures [3]. Market Data - The total market capitalization of the company is approximately 28.15 billion HKD, with a total share capital of 1.013 billion shares [19]. - The stock has experienced a 1-year high of 2.93 HKD and a low of 0.76 HKD [19]. Earnings Performance - The company reported a revenue of 54 million CNY in 2022, with a projected revenue of 0 CNY for 2024 and beyond [11]. - The earnings per share (EPS) is forecasted to be -0.26 CNY in 2024, worsening to -0.32 CNY by 2026 [11]. Cash Flow Analysis - The operating cash flow is expected to decline from -142 million CNY in 2022 to -292 million CNY by 2026 [21]. - The cash and cash equivalents are projected to decrease from 404 million CNY in 2022 to 98 million CNY by 2026 [21].

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Financial Performance - Total revenue for the six months ended June 30, 2024, was zero, a decrease of 100% from RMB 46.5 million in the same period of 2023, primarily due to reduced market demand for Ritonavir products following effective control of COVID-19 in mainland China [3]. - The total revenue decreased by 59.7% to approximately RMB 49.0 million for the six months ended June 30, 2024, from approximately RMB 121.5 million in the same period of 2023 [5]. - Total revenue for the period was RMB 49,004,000, down from RMB 75,041,000 in the previous year, indicating a decline of about 34.7% [86]. - The company reported a total comprehensive loss of RMB 121,630,000 for the period, compared to a total comprehensive income of RMB 37,253,000 in the previous year [88]. - The company reported a loss attributable to ordinary equity shareholders of RMB 130,318,000 for the six months ended June 30, 2024, compared to a loss of RMB 16,559,000 for the same period in 2023 [111]. Research and Development - Research and development expenses increased by 43.5% to approximately RMB 132.4 million for the six months ended June 30, 2024, compared to RMB 92.3 million for the same period in 2023 [5]. - The company announced positive interim results from the Phase II clinical trial of ASC41 for treating NASH patients confirmed by liver biopsy [5]. - ASC40's Phase IIb FASCINATE-2 clinical trial for treating NASH also reported positive topline results, indicating progress in metabolic disease treatment [5]. - The company has made significant advancements in internal drug discovery for metabolic diseases during the reporting period [5]. - The company is focusing on ten key clinical stage assets targeting viral diseases, metabolic diseases, and tumors [25]. Cash and Liquidity - Cash and cash equivalents, along with other liquid assets, amounted to approximately RMB 2,117.2 million as of June 30, 2024, compared to RMB 2,516.4 million as of June 30, 2023, expected to support R&D activities until 2028 [5]. - As of June 30, 2024, the company had cash and cash equivalents of approximately RMB 2,117.2 million, sufficient to support R&D activities until 2028 [26]. - The company's cash and cash equivalents stood at RMB 342,994,000 as of June 30, 2024, compared to RMB 330,117,000 at the end of 2023, showing a slight increase of about 3.6% [89]. Clinical Trials and Product Development - ASC22 for chronic hepatitis B has shown a significant HBsAg decline with 21.1% (4 out of 19) of patients achieving HBsAg clearance after 24 weeks of treatment [12]. - ASC10, an oral prodrug for RSV, has demonstrated an EC50 of 0.51 to 0.6 µM against two clinical strains in vitro, indicating strong efficacy [13]. - ASC40, an oral small molecule targeting FASN for NASH, has received fast track designation from the US FDA [9]. - The Phase III trial for ASC40 in rGBM has completed patient enrollment, targeting approximately 180 patients for progression-free survival analysis [18]. - The company plans to submit Phase II data for ASC40 in 2024 and discuss registration trials with regulatory authorities [16]. Shareholder and Corporate Governance - The company’s chairman and CEO positions are held by the same individual, which the board believes enhances efficiency [65]. - The company confirmed compliance with corporate governance codes during the reporting period [65]. - The company did not recommend the payment of an interim dividend for the six months ending June 30, 2024 [79]. - The independent auditor, KPMG, reviewed the interim financial information and found it compliant with applicable accounting standards [78]. Employee and Management Costs - The total employee cost for the six months ended June 30, 2024, was approximately RMB 76.8 million, an increase from RMB 55.3 million for the same period in 2023, primarily due to payments made to R&D personnel [61]. - Total remuneration for key management personnel for the six months ended June 30, 2024, was RMB 44,544,000, significantly up from RMB 14,842,000 in the same period last year [130]. Legal and Regulatory Matters - The company has ongoing litigation with Viking Therapeutics regarding candidate drugs ASC41 and ASC43F, with no provisions made as of June 30, 2024 [128]. - The company incurred litigation expenses of RMB 20,459,000 for the six months ended June 30, 2024, compared to RMB 6,013,000 for the same period in 2023 [108]. Future Outlook and Strategy - The company plans to enhance its digital marketing strategies, aiming for a 20% increase in online engagement by the end of 2024 [135]. - The company is expanding its market presence in the Greater China region, targeting a market share increase of CC% by the end of 2024 [133]. - The company has established partnerships with leading research institutions to accelerate the development of its pipeline products [134].

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