随着近期各大跨国药企2025年一季度财报相继披露，司美格鲁肽再次火出圈。报告期内，诺和诺德的司 美格鲁肽销售额达557.76亿丹麦克朗（按1丹麦克朗=0.1506美元计算，下同，合约84亿美元）,同比增长 32%，反超默沙东的帕博利珠单抗（俗称"K药"）。后者2023年、2024年连续两年登顶"药王"，今年一 季度销售额72.05亿美元。随着今年一季度司美格鲁肽的反超，谁能成为今年"药王"成为关注点。 "药王"宝座的交替更迭，也映射出了背后的激烈竞争，不管是在全球还是在中国市场，在"群狼环伺"的 竞争环境中，无论是K药还是司美格鲁肽，拓展适应症、提升产品竞争力、优化营销策略、加强产能建 设等，都是需要发力之处。 从销售额来看，降糖及减重适应症均晚于司美格鲁肽获批的替尔泊肽，正奋起直追。礼来披露的2025年 一季报数据显示，替尔泊肽销售放量推动了礼来报告期内业绩高速增长，其中，降糖版替尔泊肽 Mounjaro第一季度销售额38.4亿美元，同比增长113%；减重版替尔泊肽Zepbound第一季度收入23.1亿美 元，而去年同期为5.17亿美元。按此计算，替尔泊肽今年一季度凭借两大适应症合计为礼来贡献61.5亿 美 ...

证券研究报告 健友股份 (603707 CH) 原料药阶段承压，类似药驱动向好 | 华泰研究 | | | 公告点评 | | --- | --- | --- | --- | | 2025 年 | 5 月 | 08 日│中国内地 | 化学制药 | 公司发布 2024/1Q25 业绩：1）2024 年营收/归母净利润/扣非净利润分别为 39.24/8.26/7.82 亿元（营收-0.20%yoy，利润扭亏）；其中，4Q24 营收/归 母净利润/扣非净利润分别为 8.36/2.20/2.34 亿元（营收+5.84%yoy，利润 扭亏）。2）1Q25 营收/归母净利润/扣非净利润分别为 8.85/0.85/0.75 亿元 （-11.85/-52.19/-56.05%yoy）。公司年报业绩符合业绩预告。我们看好公司 生物类似药业务驱动全年业绩改善，维持"买入"评级。 制剂：稳增长延续，非肝素制剂出口持续发力 2024 年，公司制剂（含生物类似药）实现收入 30.50 亿元（+10%yoy），其 中非肝素制剂 14.67 亿元（+24%yoy）；1Q25，公司制剂收入同比+18%， 制剂出口仍为强力增长驱动。海外来看：1） ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 61.59 per share, compared to the current price of HKD 37.85 [6]. Core Insights - The company is entering a harvest period for its innovation and internationalization efforts, following significant progress in its pipeline and global expansion after privatization [1]. - The company has achieved historical profitability in the first half of 2023, with a revenue of HKD 25.01 billion, marking a year-on-year increase of 93.9% [6][25]. - The innovative drug segment, particularly the differentiated PD-1 drug, is expected to drive significant revenue growth in the medium term [4][6]. Summary by Sections 1. Commercialization and Innovation - The company has established itself as a pioneer in biosimilars, with its first product, Rituximab, approved in 2019, and is now focusing on expanding its innovative drug portfolio [14][15]. - The revenue from biosimilars reached HKD 36.3 billion in 2024, while the innovative drug segment generated HKD 13.1 billion, accounting for 22.86% of total sales [29]. 2. HLX43: Potential in PD-L1 ADC - HLX43 is the second PD-L1 ADC drug to enter clinical trials globally, showing significant potential as a future pillar in the company's pipeline [2]. - The drug is currently in clinical phase II and has demonstrated promising data, indicating a strong confidence from the company in its development [2]. 3. HLX22: Potential to Change HER2 Positive Gastric Cancer Treatment - HLX22 has shown superior clinical benefits compared to standard treatments in HER2 positive gastric cancer, with ongoing international phase III trials [3]. - The drug has received orphan drug designation in the US, highlighting its potential in the gastric cancer treatment landscape [3]. 4. Differentiated PD-1 Drug: Surulitinib - Surulitinib is positioned to address unmet clinical needs in small cell lung cancer, with expected rapid market uptake upon approval [4]. - The drug has shown optimal data in clinical trials, indicating a strong commercial potential in various indications [4]. 5. Internationalization and Market Expansion - The company has a strong track record in internationalization, with significant licensing agreements and expected revenue growth from overseas markets starting in 2025 [5]. - The company aims to leverage its first-mover advantage in biosimilars and innovative drugs to maximize market value domestically and internationally [5]. 6. Profit Forecast - Revenue projections for 2025-2027 are estimated at HKD 58.73 billion, HKD 59.70 billion, and HKD 71.25 billion, with corresponding net profits of HKD 8.27 billion, HKD 7.97 billion, and HKD 11.22 billion [6]. - The company is expected to continue its upward trajectory in profitability, driven by its innovative pipeline and effective cost management strategies [6][32].

Investment Rating - The investment rating for the company is "Buy" with a target price of HKD 61.59 per share, maintaining the rating from previous assessments [6]. Core Views - The report emphasizes that the company is entering a harvest period for its innovation and internationalization efforts, following significant progress in its pipeline and global expansion after privatization [1]. - The company has achieved historical profitability in the first half of 2023, with a notable increase in revenue and net profit, indicating strong growth potential [6][25]. Summary by Sections 1. Commercialization and Innovation - The company has established itself as a pioneer in biosimilars, with its first product, Rituximab, being the first biosimilar approved in China [14]. - The company is focusing on innovative drugs and has seen significant sales growth, with projected revenues of HKD 57.24 billion in 2024, reflecting a year-on-year increase of 6.06% [25][29]. 2. HLX43: PD-L1 ADC Development - HLX43 is the second PD-L1 ADC to enter clinical trials globally, showing promising potential for treating patients who do not respond to PD-1/PD-L1 therapies [2]. - The report highlights the urgent clinical need for effective treatments in EGFR wild-type NSCLC, where current therapies primarily rely on chemotherapy [37]. 3. HLX22: HER2 Positive Gastric Cancer - HLX22 has demonstrated significant clinical benefits in treating HER2 positive gastric cancer, with ongoing international trials expected to enhance its market position [3]. - The drug has received orphan drug designation in the US, indicating its potential as a key revenue driver for the company [3]. 4. Differentiated PD-1 SruLi monoclonal antibody - The company is advancing its differentiated PD-1 monoclonal antibody, SruLi, targeting unmet clinical needs in small cell lung cancer, with expected revenue of HKD 13.13 billion in 2024 [4]. - The report notes that SruLi has shown superior efficacy in clinical trials compared to existing treatments, positioning it for rapid market uptake [4]. 5. Internationalization and Market Expansion - The company has a strong track record in internationalization, with successful licensing agreements and product approvals in various global markets [5]. - The anticipated approval of SruLi in Europe and the US is expected to drive overseas revenue growth starting in 2025 [5]. 6. Financial Forecast - The company is projected to achieve revenues of HKD 58.73 billion, HKD 59.70 billion, and HKD 71.25 billion for the years 2025 to 2027, with corresponding net profits of HKD 8.27 billion, HKD 7.97 billion, and HKD 11.22 billion [6]. - The report indicates a significant improvement in the company's financial health, with a historical achievement of breakeven in 2023 [6][25].

第一节重要提示 7、 董事会决议通过的本报告期利润分配预案或公积金转增股本预案 公司2024年度利润分配预案为：不进行利润分配，不进行资本公积金转增股本。以上利润分配预案已经 公司第二届董事会第二十四次会议审议通过，尚需公司股东大会审议通过。 1、 本年度报告摘要来自年度报告全文，为全面了解本公司的经营成果、财务状况及未来发展规划，投 资者应当到http://www.sse.com.cn/网站仔细阅读年度报告全文。 2、 重大风险提示 公司已在本报告中详细阐述公司核心竞争力风险、经营风险、行业风险和宏观环境风险等因素，敬请查 阅本报告第三节"管理层讨论与分析"之"四、风险因素"。 3、 本公司董事会、监事会及董事、监事、高级管理人员保证年度报告内容的真实性、准确性、完整 性，不存在虚假记载、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 4、 公司全体董事出席董事会会议。 5、 立信会计师事务所（特殊普通合伙）为本公司出具了标准无保留意见的审计报告。 6、 公司上市时未盈利且尚未实现盈利 □是 √否 8、 是否存在公司治理特殊安排等重要事项 □适用 √不适用 第二节公司基本情况 1、 公司简介 1.1 公 ...

H药目前已在欧洲、东南亚和中国等30多个国家获批上市。 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，复宏汉霖（2696.HK）于近日公布了产品最新进展。2月5日，公司宣布，H药汉 斯状（斯鲁利单抗，欧洲商品名：Hetronifly）获欧盟委员会（EC）批准上市，用于联合卡铂和依 托泊苷用于广泛期小细胞肺癌（ES-SCLC）成人患者的一线治疗，H药成为了首个且唯一在欧盟获 批上市用于ES-SCLC治疗的抗PD-1单抗。截至目前，H药已在欧洲、东南亚和中国等30多个国家 获批上市，惠及超过90,000位患者。 此外，公司在研的Perjeta（帕妥珠单抗）生物类似药HLX11的生物制品许可申请（BLA）也于近日 获FDA受理。目前Perjeta已在多个国家和地区获批，适应症包括联合曲妥珠单抗和化疗用于HER2 阳性、局部晚期、炎性或早期乳腺癌患者的新辅助治疗，以及部分HER2阳性早期乳腺癌患者的辅助 治疗等。 迄今为止，复宏汉霖已有已有6款产品在中国获批上市，4款产品在国际获批上市，4个上市申请分别 获中国药监局、美国FDA和欧盟EMA受理。 突破差异化临床需求，H ...

有望为国内银屑病患者提供更可负担的用药选择。 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，11月5日，华东医药（000963.SZ）发布公告，其下属杭州中美华东制药有限公 司（下称"中美华东"）收到国家药监局（NMPA）核准签发的《药品注册证书》，由中美华东与荃 信生物（2509.HK）联合开发的乌司奴单抗注射液赛乐信（研发代码：HDM3001/QX001S）的上 市许可申请获得批准，用于治疗成年中重度斑块状银屑病，成为国内首个乌司奴单抗注射液生物类似 药。 赛乐信是原研产品Stelara（喜达诺，乌司奴单抗注射液）的生物类似药，为一款白介素IL-12/23 单抗药物。据强生公司2023年报，2023年Stelara在全球的销售额为108.58亿美元（约767.29亿 元人民币）。米内网数据显示，2023年喜达诺在中国的销售额为13.22亿元人民币。 此次赛乐信获批上市，有望为国内银屑病患者带来更可负担的用药选择。 本文由公众号IPO早知道（ID：ipozaozhidao）原创撰写，如需转载请联系C叔↓↓↓ QX001S最初由荃信生物自主研发，2020年8月， ...