证券研究报告·海外公司深度·药品及生物科技(HS) 歌礼制药-B（01672.HK） 全新 GLP-1 减重不减肌，有潜力成为 Best- in-Class 买入（首次） | [Table_EPS] 盈利预测与估值 | 2022A | 2023A | 2024E | 2025E | 2026E | | --- | --- | --- | --- | --- | --- | | 营业总收入（百万元） | 54.09 | 56.69 | 0.00 | 0.00 | 0.00 | | 同比(%) | (29.66) | 4.81 | (100.00) | 0.00 | 0.00 | | 归母净利润（百万元） | (314.84) | (144.72) | (393.20) | (490.26) | (579.38) | | 同比(%) | (58.20) | 54.04 | (171.71) | (24.68) | (18.18) | | EPS-最新摊薄（元/股） | (0.33) | (0.15) | (0.41) | (0.51) | (0.60) | | P/E（现价&最新摊薄） | (25.36) | ( ...

证券研究报告·海外公司深度·药品及生物科技(HS) 歌礼制药-B（01672.HK） 全新 GLP-1 减重不减肌，有潜力成为 Best- in-Class 买入（首次） | [Table_EPS] 盈利预测与估值 | 2022A | 2023A | 2024E | 2025E | 2026E | | --- | --- | --- | --- | --- | --- | | 营业总收入（百万元） | 54.09 | 56.69 | 0.00 | 0.00 | 0.00 | | 同比(%) | (29.66) | 4.81 | (100.00) | 0.00 | 0.00 | | 归母净利润（百万元） | (314.84) | (144.72) | (393.20) | (490.26) | (579.38) | | 同比(%) | (58.20) | 54.04 | (171.71) | (24.68) | (18.18) | | EPS-最新摊薄（元/股） | (0.33) | (0.15) | (0.41) | (0.51) | (0.60) | | P/E（现价&最新摊薄） | (25.36) | ( ...

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 ...

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，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 本公告載有涉及風險及不確定因素的前瞻性陳述。除過往事實陳述以外的所有陳述均為前瞻性 陳述。該等陳述涉及已知及未知風險、不確定因素及其他因素，當中若干風險及因素並非本公 司所能控制，其可導致實際業績、表現或成果與該等前瞻性陳述所明示或暗示者存在重大差 異。 閣下不應依賴前瞻性陳述作為未來事件的預測。本公司概不承擔更新或修訂任何前瞻性 陳述的責任，無論是否由於新資料、未來事件或其他因素所致。 Ascletis Pharma Inc. 歌禮製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1672） 截至二零二四年十二月三十一日止年度之年度業績公告 及所得款項用途變更 董事會謹此宣佈，本集團截至二零二四年十二月三十一日止年度之經審核簡明綜 合年度業績連同截至二零二三年十二月三十一日止年度之比較數據如下。 財務概要 | | 二零二四年 | 二零二三年 | | --- | --- | --- | | | ...

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].

证 券 研 究 报 告 | --- | --- | --- | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 即时点评 | | 减重不减肌药研发 ...

歌 ascletis Ascletis Pharma Inc. 歌 禮 製 藥 有 限 公 司 ( 於開曼群島註冊成立的有限公司) 股份代號：1672 2024 中 期 報 告 20 目 錄 2 公司資料 4 財務概要 5 管理層討論與分析 30 其他資料 35 獨立審閱報告 36 綜合損益表 37 綜合損益及其他全面收益表 38 綜合財務狀況表 40 綜合權益變動表 42 簡明綜合現金流量表 43 未經審核中期財務報告附註 55 釋義 歌禮製藥有限公司 2024 中期報告 2 公司資料 | --- | --- | |---------------------|---------------------------| | | | | 董事會 | 註冊辦事處 | | 執行董事 | Walkers Corporate Limited | | | 190 Elgin Avenue | | 吳勁梓博士 | George Town | | （主席兼行政總裁） | Grand Cayman KY1-9008 | | 何淨島女士 | Cayman Islands | | （高級副總裁） | 中國公司總部 | | 獨立非執行 ...

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Financial Data and Key Metrics - The company's cash reserves as of June 30, 2024, exceeded RMB 2.1 billion, ensuring healthy operations and development for the next five years [1][2] - The company reported a loss of RMB 130 million in the first half of 2024, primarily due to increased R&D investments [1][2] - R&D personnel now account for 69% of the company's total workforce, reflecting a significant increase in R&D focus and efficiency [1][2] Business Line Data and Key Metrics - The company has focused on global BIC (Best-in-Class) and FIC (First-in-Class) pipeline development, particularly in metabolic diseases and oncology [1][2] - Key pipeline highlights include AAC40, which has successfully initiated Phase III trials, and AAC41, which showed promising Phase II results with 93.3% of patients achieving a 30% reduction in liver fat content [1][2] - The company has accelerated the development of global FIC and BIC candidates for metabolic diseases, with plans to continue this focus in the second half of 2024 [1][2] Market Data and Key Metrics - The company has engaged in extensive business development activities, including participation in major industry conferences such as the JP Morgan Healthcare Conference and the BioInnovation Biotechnology Innovation Organization's global PG conference [1][2] - A top-ten global chemical company expressed interest in the company's pipeline, selecting only 70 out of 1,000 biotech companies for meetings, with the company being one of the selected [1][2] Company Strategy and Industry Competition - The company's strategy is centered on global BIC and FIC pipeline development, avoiding "Me Too" drugs and focusing on top-tier competitive targets [1][2] - The company has increased its patent filings, with four new drug invention patents granted and 51 new applications filed in the first half of 2024, strengthening its competitive position [1][2] - The company plans to continue accelerating the development of global FIC and BIC candidates, particularly in metabolic diseases, to maintain its competitive edge [1][2] Management Commentary on Operating Environment and Future Outlook - Management emphasized the importance of healthy survival in a challenging industry environment, focusing on global BIC and FIC pipeline development and business development activities [1][2] - The company expects to complete key clinical milestones in the second half of 2024, including Phase III enrollment for AAC40 and Phase II completion for AAC41, with top-line data expected in the first half of 2025 [1][2] - Management expressed confidence in the company's cash reserves and R&D capabilities, aiming to maximize the value of its core pipelines before engaging in further business development activities [1][2] Other Important Information - The company has initiated a stock repurchase program, having already repurchased RMB 133 million worth of shares, with plans to continue repurchasing if cash reserves allow [1][2] - The company is exploring the potential of its AAC61 small molecule PD-L1 oral inhibitor, seeking potential partners following promising Phase I results [1][2] Summary of Q&A Session Question: What were the main projects driving the increase in R&D expenses in the first half of 2024? - The increase in R&D expenses was primarily driven by Phase III trials for AAC40, Phase II trials for AAC41, and the acceleration of global FIC and BIC candidate development for metabolic diseases [1][2] Question: When will the efficacy data for AAC40's Phase III trials be available? - Efficacy data for AAC40's Phase III trials is expected to be available in the first half of 2025, with safety follow-up data not impacting the efficacy data readout [1][2] Question: Is the company still working on the AS110 monkeypox project? - The company is conducting further internal evaluations of the AS110 monkeypox project, given the recent rise in monkeypox cases [1][2] Question: How does the company view the competition between its two NASH drugs and weight-loss drugs? - The company's NASH drugs (AAC40 and AAC41) are oral medications targeting liver fat reduction, while weight-loss drugs like GLP-1 are injectable and focus on weight management, indicating different market segments [1][2] Question: Will the company continue its stock repurchase program? - The company will prioritize R&D investments but may continue stock repurchases if cash reserves allow, with a focus on maintaining healthy operations and development [1][2] Question: When will the company form a commercialization team? - The company will consider forming a commercialization team once its pipelines receive regulatory approval, with a focus on global markets rather than domestic sales [1][2] Question: What are the company's future early-stage R&D pipeline plans? - The company's early-stage R&D pipeline will continue to focus on metabolic diseases, building on its current pipeline of AAC40 and AAC41 [1][2]