歌礼制药-B（01672.HK） ASC40痤疮适应症 III期临床达到所有终点， 疗效数据优秀 证券研究报告·海外公司点评·药品及生物科技(HS) 买入（维持） | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入（百万元） | 56.69 | 1.28 | 0.00 | 40.00 | 100.00 | | 同比(%) | 4.81 | (97.74) | (100.00) | | 150.00 | | 归母净利润（百万元） | (144.72) | (300.94) | (454.44) | (469.72) | (445.21) | | 同比(%) | 54.04 | (107.95) | (51.01) | (3.36) | 5.22 | | EPS-最新摊薄（元/股） | (0.15) | (0.31) | (0.47) | (0.48) | (0.46) | | P/E（现价&最新摊薄） | (54.06) | (26.00) | ...

智通财经APP讯，歌礼制药-B(01672)发布公告，同类首创(first-in-class)、每日一次口服小分子脂肪酸合成酶(FASN)抑制剂地尼法司他(ASC40)治疗中重度寻 常性痤疮的 III期临床试验(NCT06192264)达到所有主要、关键次要及次要终点。 主要、关键次要及次要终点可见表2。主要终点包括治疗成功百分比(治疗成功的定义为在第12周时，研究者总体评估(Investigator's Global Assessment，IGA) 评分较基线下降至少2分，且IGA分级为0分(光洁)或1分(几乎光洁))、总皮损计数相对基线百分比下降，以及炎性皮损计数相对基线百分比下降。第12周时， 地尼法司他治疗组治疗成功百分比为33.2%，而安慰剂组为14.6%，p <0.0001;地尼法司他治疗组总皮损计数相对基线百分比下降是57.4%，而安慰剂组为 35.4%，p <0.0001;以及，地尼法司他治疗组炎性皮损计数相对基线百分比下降是63.5%，而安慰剂组为43.2%，p <0.0001。第12周时，非炎性皮损计数相对 基线百分比下降(关键次要终点)，地尼法司他治疗组为51.9%，而安慰剂组为28.9 ...

分析师：胡博新 SAC编号：S1050522120002 分析师：吴景欢 SAC编号：S1050523070004 医 药 行 业 观 点 证 券 研 究 报 告 行业周报 关税短期冲击减弱，出海仍是主要趋势 医药行业周报 | 投资评级： | 推荐 （ 维持 ） | | --- | --- | | 报告日期： | 2025年05月19日 | 1. 出海仍是主要趋势，关税短期冲击减弱 根据医保商会统计，2025年Q1，医药出口额为266.32亿美元，同比增长4.39%，其中对美出口46.39亿美元，同比增长 9.6%，美国仍为中国出口的第一大单体市场，占比17.4%。医药虽然有部分被豁免，但仍非豁免品种受到关税的冲击，5月 12日之后，美国订单有望显著恢复。医药交易方面，根据医药魔方数据，2025年Q1，中国医药交易数量同比增加34%，交 易总金额同比增加222%。美国制药企业也是全球医药交易的主要受让方，美国市场是全球最大的创新药市场，未来增长可 能受到政策的干扰，但考虑美国商业保险模式占据主导，而且医疗体制改革需要长周期布局，创新药高度市场化定价机制 仍将维持。近年来，中国创新药的研发效率和质量得到迅速提升 ...

Group 1 - The Hang Seng Index closed up 0.93%, while the Hang Seng Tech Index rose by 1.91% [1] - Apple-related stocks led the gains, with Sunny Optical Technology rising over 10% and AAC Technologies increasing by more than 9% [1] - The innovative drug sector experienced declines, with Genscript Biotech falling over 8% and BeiGene dropping more than 7% [1]

对此，世界卫生组织独家回应《人民财讯》称，自2022年以来，世卫组织一直在针对不同年龄组制定一 套关于肥胖预防、护理和治疗的新指南。 有传闻称"世卫组织计划首次将减肥药纳入基本药物目录以治疗成人肥胖症"。 目前，关于使用GLP-1 RA和GLP-1 RA/GIP双受体激动剂治疗成年肥胖患者的指南，正按照指南审查委 员会的程序进行全面制定，预计在2025年8月或9月会出台最终方案。 该指南的目的在于明确GLP 1 RAs的临床适应症、应用以及规划方面的考量，包括这类药物如何以及在 何时能够作为包括临床干预和生活方式干预的慢性病管理模式的一部分加以应用。 另外，上述药物目前正由世界卫生组织基本药物选择与使用专家委员会进行评审。该专家委员会的评审 流程独立于指南制定程序，旨在评估多种药物是否应纳入《世界卫生组织基本药物标准清单》和《世界 卫生组织儿童基本药物标准清单》。 这两份清单为国家或地区采购机构提供指导，帮助其选择符合人群优先健康需求的药物。 中信证券研报认为，海外巨头的业绩持续超预期以及国内研发进展的加速，减肥药的产业趋势有望进一 步明确。预计后续海外巨头业绩预期指引&重磅药物销售数据超预期、海外GLP-1 ...

Group 1 - Zhengrong Real Estate (06158.HK) has appointed joint liquidators by its controlling shareholder, and trading of its shares will resume from 9 AM on Wednesday, with business operations continuing as usual [1] - XPeng Motors (09868.HK) plans to hold a board meeting on May 21 to approve its first-quarter results [1] - Xiehe New Energy (00182.HK) reported a total equity generation of 3,330.69 GWh in the first four months, a year-on-year decrease of 2.24%, with April's generation at 809.84 GWh, down 6.48% year-on-year [1] Group 2 - Touyun Biotechnology (01332.HK) plans to sell 70% of its stake in Weidao International for 13 million yuan [1] - Gilead Sciences (01672.HK) will present early research findings on its obesity candidate drug ASC47 at the 32nd European Congress on Obesity (ECO 2025) through oral and poster presentations [1] - Yuanda Pharmaceutical (00512.HK) has successfully reached clinical endpoints in its Phase II clinical study of the global innovative product STC3141 for the treatment of sepsis in China [1] Group 3 - Shanggao New Energy (01250.HK) reported a cumulative operational generation of approximately 1.0196 million MWh in the first two months, representing a year-on-year increase of about 13.1% [1]

Core Insights - The company will present research results on its obesity candidate drug ASC47 at the 32nd European Congress on Obesity [1] - The oral presentation is scheduled for May 13, 2025, and the poster presentation will take place on May 14, 2025, in Malaga, Spain [1] - ASC47 is a thyroid hormone receptor β selective small molecule agonist that targets fat and is designed for subcutaneous injection with a long duration of action [1] - The drug achieves dose-dependent high drug concentrations in adipose tissue [1] - The FDA has approved the clinical trial application for ASC47 in combination with semaglutide for the treatment of obesity [1]

Group 1 - The Hang Seng Index closed up by 0.51% [1] - The Hang Seng Tech Index increased by 1.35% [1] - The Hong Kong Tech ETF (159751) rose by 1.44% [1] - The Hang Seng Hong Kong Stock Connect ETF (159318) gained 0.58% [1] Group 2 - Meitu Inc. saw a rise of over 10% [1] - Chow Tai Fook Jewelry Group increased by over 8% [1] - Lao Poo Gold experienced a decline of over 5% [1] - Genscript Biotech Corporation (B) fell by over 4% [1]

Financial Performance - The company reported a revenue of RMB 1,283 thousand for the fiscal year 2024, a significant increase compared to RMB 56,596 thousand in 2023[15]. - The gross profit for 2024 was RMB 735 thousand, showing a recovery from a gross loss of RMB 24,692 thousand in 2022[15]. - The net loss margin for 2024 was reported at -23,455.7%, a significant increase from -255.7% in 2023, reflecting ongoing challenges[15]. - Total assets decreased to RMB 2,124,572 thousand in 2024 from RMB 2,332,756 thousand in 2023, indicating a reduction in financial resources[15]. - The annual loss increased from RMB 144.7 million for the year ended December 31, 2023, to RMB 300.9 million for the year ending December 31, 2024, primarily due to increased R&D expenditures for obesity and other metabolic diseases[19]. - Other income and gains decreased by 35.1% from approximately RMB 184.7 million for the year ended December 31, 2023, to approximately RMB 119.8 million for the year ended December 31, 2024[58]. - 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, due to strategic adjustments in response to the easing of the COVID-19 pandemic[55]. Research and Development - Research and development costs increased to RMB 302,394 thousand in 2024, up from RMB 216,781 thousand in 2023, indicating a strong focus on innovation[15]. - R&D expenses increased by 39.5% from approximately RMB 216.8 million for the year ended December 31, 2023, to approximately RMB 302.4 million for the year ending December 31, 2024[19]. - R&D costs for metabolic diseases surged to RMB 99,237 thousand in 2024 from RMB 12,290 thousand in 2023, reflecting a significant focus on this area[66]. - The company plans to initiate a 13-week IIa phase clinical study for ASC30 in the U.S. in 2025[28]. - The company expects to announce topline results from the Ib phase clinical study of ASC30 in the U.S. in 2025[32]. - The ASC30 subcutaneous injection, administered monthly or less frequently, is expected to show promising results as a first-in-class treatment for obesity, with interim data anticipated by March 2025[10]. - The ASC47 subcutaneous injection, also targeting obesity, demonstrated a half-life of up to 40 days in patients, indicating potential for effective weight loss without muscle loss[10]. - The ASC30 is a new chemical entity (NCE) with patent protection in the U.S. and globally until 2044, showing strong competitive potential for obesity treatment[27]. - The ASC47 single-agent Ib phase study in Australia showed positive topline results, with an average weight loss of 1.7% at peak after a single injection[33]. Strategic Decisions and Initiatives - The company has made strategic decisions to terminate multiple plans and optimize R&D resources to focus on globally competitive pipeline products[11]. - The company remains committed to sustainability initiatives aimed at reducing its carbon footprint while enhancing operational efficiency[11]. - The management emphasized a commitment to sustainability, with plans to reduce carbon emissions by 30% by 2025[1]. - The company is exploring partnerships with leading universities to accelerate drug development processes[1]. - The company has decided to terminate the ASC22 project for chronic hepatitis B functional cure based on strategic planning and resource optimization[37]. Cash and Financial Position - As of December 31, 2024, the group's cash and cash equivalents are approximately RMB 1,980.8 million, down from RMB 2,299.4 million as of December 31, 2023, sufficient to support R&D activities until 2029[19]. - Cash and cash equivalents increased to approximately RMB 864.3 million as of December 31, 2024, from RMB 330.1 million as of December 31, 2023, reflecting a net increase of RMB 533.8 million[97]. - Net cash used in operating activities for the year ended December 31, 2024, was approximately RMB 341.6 million, primarily due to an operating loss of approximately RMB 355.4 million before changes in working capital[99]. - 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 approximately RMB 866.0 million[100]. - 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 approximately RMB 98.5 million[101]. Employee and Operational Insights - The total employee cost for the year ending December 31, 2024, was approximately RMB 136.1 million, down from RMB 144.0 million for the year ending December 31, 2023[116]. - The company has 231 employees as of December 31, 2024, with 69.7% in R&D and over 81.3% holding a bachelor's degree or higher[116]. - The company recognizes the importance of attracting and retaining quality employees and provides regular training programs, including onboarding, technical, professional, and safety training[146]. Shareholder and Equity Information - As of December 31, 2024, the total number of issued shares was 1,012,758,000, including treasury shares[168]. - Dr. Wu holds 514,393,664 shares through JJW12 Limited, representing 50.79% of the company's equity[162]. - The company repurchased a total of 41,692,000 shares as treasury shares, authorized by shareholders at the annual general meeting on May 23, 2024[168]. - The company has decided to reallocate 30.8% of the unutilized proceeds to support the development of metabolic disease candidates such as ASC47 and ASC30[188]. - The board of directors did not recommend the payment of any final dividend for the year ending December 31, 2024[177]. Compliance and Risk Management - The company has established compliance procedures to ensure adherence to applicable laws and regulations that significantly impact its operations[144]. - The company has identified key risks, including regulatory approval for drugs in development and the ability to attract and retain senior management and key research staff[149]. - The company has received confirmation from its controlling shareholder regarding compliance with non-competition commitments during the reporting period[157].

该行续指，24年公司开展多个肥胖相关I期临床，包括：1)ASC30每日口服治疗肥胖患者，治疗28天后 两个队列患者体重相对基线平均下降4.2%和6.2%(经安慰剂调整)；2)ASC30每月一次或更低频率皮下注 射治疗肥胖患者，此前在动物模型内其半衰期长达40天；3)ASC47每月一次或更低频率皮下注射治疗肥 胖患者，I b期试验中展现长半衰期(健康受试者26天，肥胖患者40天)，单次皮下注射90mg后，肥胖患 者第 50天峰值减重达 1.7%，且未出现肌肉流失。公司口服与皮下注射减肥产品初步展现出优异的减重 效果与长半衰期，在同类竞品中具备独特优势。 光大证券发布研报称，2024年，歌礼制药对于公司管线做出重大战略调整。公司决定终止病毒性疾病治 疗管线，包括慢乙肝、HIV、RSV在研产品，以及终止MASH治疗产品ASC41的临床推进。同时公司新 增肥胖及代谢性疾病临床管线，分别是GLP受体激动剂ASC30与THR-β激动剂ASC47，截至24年末，二 者在海外均已推进至临床I期。24年公司研发开支同比增长39.5%至3.02亿元，其中代谢性疾病研发开支 近1亿元，痤疮治疗产品因进入临床3期产生研发开支近8千万 ...