华东医药 20250718 摘要 华东医药口服 GLP-1 小分子药物完成一、二期临床，安全性良好，三期 临床入组预计 7 月完成，有望成为首批上市产品，凭借内分泌领域优势， 预计市场份额可观。 三靶点 GLP-1 注射剂针对高血脂和脂肪肝，二期临床数据积极，肝脏脂 肪含量显著下降，优于安慰剂组，且在降血脂和胰岛素抵抗方面表现良 好，或优于竞争对手产品。 公司创新产品管线丰富，超 80 项，聚焦内分泌、自身免疫及肿瘤领域， 授权品种如苏明托西单抗、利那西普陆续上市，自研品种德谷门冬胰岛 素、迈华替尼进展迅速。 华东医药自研 ADC 平台进展迅速，RO-1 ADC 已进入一期临床，预计 2025 年 Q3 完成，Q4 交流数据，CDH17 ADC 等其他品种也显示自研 能力，并获得中美临床批准。 工业微生物业务预计 2025-2026 年保持 30%-40%增速，利润率提升； 医美业务国内市场有望双位数增长，少女针、曼丽玻尿酸及重组肉毒毒 素预计年底或明年初获批。 Q&A 华东医药在创新药品方面的布局和进展如何？ 华东医药作为国内领先的制药公司之一，在创新药品方面取得了显著进展，尤 其是在 GLP-1 领域。公 ...

Core Viewpoint - The National Medical Products Administration (NMPA) has announced five typical cases of illegal activities in the pharmaceutical sector and issued compliance and consumer reminders [1] Group 1: Illegal Activities - Two cases involve illegal procurement of drugs through unauthorized channels, including a pharmacy in Guangdong that faced penalties of 1.3 million yuan and a pharmacy in Jiangxi that was fined 224,100 yuan for purchasing drugs from unqualified individuals [2] - A case in Zhejiang involved a pharmacy that failed to conduct proper prescription reviews when dispensing prescription drugs, resulting in a fine of 40,000 yuan [3] - An individual in Guangxi was penalized for selling unregistered medical products through WeChat, with fines totaling 17,400 yuan [3] - A clinic in Sichuan was found selling prohibited drugs online without permission, leading to a fine of 50,000 yuan [3] Group 2: Compliance and Consumer Reminders - The NMPA emphasizes that pharmaceutical businesses should purchase drugs from licensed manufacturers and maintain accurate sales records, adhering to quality management standards [4] - Consumers are advised to buy drugs from licensed pharmacies and to be cautious when purchasing online, ensuring that relevant licenses are displayed prominently [4] - It is recommended that consumers provide valid prescriptions when purchasing prescription drugs and report any illegal activities related to counterfeit or substandard drugs to regulatory authorities [4]

国家药监局今天（6月19日）公布5起药品经营环节"清源"行动违法违规典型案例，包括药店非法渠道购 进药品案、微信无证销售未经注册注射用A型肉毒毒素案等。 一、广东省惠州市惠东县稔山镇燕记药店非法渠道购进药品案 四、张某某通过微信无证销售未经注册注射用A型肉毒毒素案 2025年2月，广西壮族自治区桂林市七星区市场监督管理局依据检察机关移交的线索立案调查，发现张 某某通过微信，从非法渠道购进、销售未经注册的医疗用毒性药品"BOTATOX注射剂A型肉毒毒素"。 当事人上述行为违反《中华人民共和国药品管理法》第二十四条、第五十一条规定。2025年3月，桂林 市七星区市场监督管理局依据《中华人民共和国药品管理法》第一百一十五条、第一百二十四条，《中 华人民共和国行政处罚法》第三十二条，《市场监管总局关于规范市场监督管理行政处罚裁量权的指导 意见（2022）》第十四条规定，对当事人处以没收涉案药品、没收违法所得、罚款1.74万元的行政处 罚。 五、四川省成都市双流众康行续荣诊所违规销售网络禁售药品案 2024年11月，四川省成都市双流区市场监督管理局根据线上巡查线索，对成都双流众康行续荣诊所有限 责任公司进行现场检查，发 ...

Core Viewpoint - Lepu Medical's self-developed polylactic acid facial filler has received approval from the National Medical Products Administration (NMPA), marking its entry into the regenerative aesthetic market, despite ongoing performance declines [1][2][4] Product Approval and Market Position - The approved product is the seventh domestic and fifth local "youthful needle" filler, indicating a significant step into the aesthetic medicine sector [1] - The product is classified as a Class III medical device, which has a high approval threshold, positioning the company in the second tier among domestic products [2] - The regenerative aesthetic filler market in China is projected to reach 11.52 billion yuan by 2027, with a compound annual growth rate of 31.2% [2] Product Pipeline and Strategy - Lepu Medical's aesthetic pipeline includes botulinum toxin type A and various hyaluronic acid formulations, creating a comprehensive product chain covering "regenerative filling - wrinkle repair - facial shaping" [1][2] - The company is expanding its aesthetic product line, with multiple hyaluronic acid products in the registration phase and a focus on maintaining core technology autonomy to control costs and build brand barriers [4][5] Financial Performance and Challenges - Lepu Medical's financial performance has been under pressure, with a 23.52% decline in revenue to 6.103 billion yuan in 2024 and an 80.37% drop in net profit to 247 million yuan, marking the worst performance since its listing in 2009 [6] - The core business segments, including medical devices and pharmaceuticals, have faced significant revenue declines, with the medical device segment down 9.47% and pharmaceuticals down 42.25% [6] Management Changes and Strategic Shift - The company has undergone management changes, with a new general manager implementing marketing reforms and workforce reductions to enhance operational efficiency [7] - The shift towards aesthetic medicine is seen as a strategic response to pressures from traditional pharmaceutical operations, with the potential for financial recovery hinging on successful product commercialization and market adaptation [7]

Group 1 - The core viewpoint is that Lepu Medical has officially entered the aesthetic medicine market with the approval of its self-developed polylactic acid facial filler, marking a significant strategic move into consumer healthcare [1][2] - The newly approved product is expected to fill a gap in the dermatology field and is seen as a milestone for the company, with anticipated positive contributions to its performance [2][3] - The company is facing declining growth in its main business, with a reported revenue of 1.736 billion yuan in Q1 2024, down 9.67% year-on-year, and a net profit of 379 million yuan, down 21.44% year-on-year, indicating a need for new growth avenues [3] Group 2 - Lepu Medical's ambitions in the aesthetic field extend beyond the facial filler, as its subsidiary has submitted an application for a botulinum toxin product, targeting a domestic market worth over 6 billion yuan [4] - The aesthetic medicine market is becoming increasingly competitive, with several existing products already in the market, including those from competitors like Aimeike and Sihuan Pharmaceutical [2][5] - The entry of major pharmaceutical companies into the aesthetic market indicates a shift towards a more robust and competitive landscape, where Lepu Medical's experience in medical device development may provide a commercial advantage [5]

Core Viewpoint - The recent adjustment of the Hong Kong Stock Connect list has led to a significant impact on the stock price of Kedi-B (02487), which experienced a notable decline followed by a recovery, supported by strong financial performance and market sentiment towards its new product developments [1][3][6]. Stock Performance - Kedi-B's stock price fell by 20.60% over six trading days after being removed from the Hong Kong Stock Connect [1]. - Following a brief recovery, the stock saw a dramatic drop of 26.88% on April 7 due to market volatility, creating a potential buying opportunity [1]. - The stock hit a low of 3.64 HKD on April 9 but rebounded significantly, reaching a peak of 7.62 HKD by May 20, surpassing pre-removal levels [1][3]. Financial Performance - Kedi-B reported total revenue of approximately 280 million RMB for 2024, a year-on-year increase of about 103% [6][7]. - Gross profit for the same period was around 144 million RMB, reflecting a 102% increase year-on-year, while net loss narrowed by 77.91% to approximately 434 million RMB [6][7]. - The company achieved a gross margin of 51.3%, up from 50.6% in the previous year, driven by improved product lines and cost management [8]. Product Line and Market Strategy - The revenue growth was primarily attributed to increased sales of hair care and skincare products, with hair care revenue exceeding 160 million RMB and skincare revenue surpassing 110 million RMB [8]. - Kedi-B plans to enter a second growth phase in 2025 with three significant prescription drugs, including treatments for acne and hair loss, which are expected to drive future revenue growth [9]. - The company is also involved in the development of a botulinum toxin product, CU-20101, which has received approval in South Korea, showcasing its technical capabilities [10][12]. Market Context - The domestic medical aesthetics market is under pressure, with many companies reporting declines in Q1 2025, yet Kedi-B's stock performance indicates positive market sentiment towards its product developments [11]. - The botulinum toxin market in China is projected to reach 11.4 billion RMB by 2025, with a compound annual growth rate of 23.9% from 2020 to 2025, indicating strong growth potential [12][14]. - Kedi-B's entry into the botulinum toxin market, particularly with innovative product forms, positions it well against established competitors [14].

思宇年度活动回顾： 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 即将召开： 君合盟生物制药（杭州）有限公司 （以下简称"君合盟"）成立于2020年11月，总部位于浙江省杭州市钱塘 区和享科技中心。公司是一家专注于 重组蛋白创新药物及合成生物学领域创新产品开发 的生物科技公司，致 力于推进创新重组蛋白药物在内分泌、神经治疗、皮肤抗衰和新一代生物医用材料等方面的应用。公司由 冷 春生博士 创立，其凭借多年的重组蛋白药物研发及产业化经验，形成了覆盖产品开发全流程的核心技术、平 台及人才积淀。 君合盟的核心业务聚焦于严肃医疗和消费医疗双赛道，产品管线包括 重组I型人胶原蛋白、重组III型人胶原蛋 白、重组A型肉毒毒素、重组人生长激素和长效生长激素 等。公司拥有多个国内外首创的重组蛋白表达及分离 纯化平台，技术水平及产业化进展处于国内领先。其 重组I/III型人胶原蛋白产品 与天然人胶原蛋白结构高度 一致，已实现规模化放大，商业化规模生产车间已建成投产。 融资历程 欢迎企业积极参与思宇组织的大会↓ 2025年6月12日，首届全球医美科技大会 2025年6月12日，首届全球医美科技大会 2025年7月 ...

公司重组肉毒素在严肃医学领域的探索有望与石药国方产生更强的协同效应。 本文为IPO早知道原创 作者｜C叔 微信公众号｜ipozaozhidao 据 IPO早知道消息， 近日 ，君合盟生物制药（杭州）有限公司（ 下称 "君合盟" ）完成数千万元 战略融资，由石药国方基金独家投资，凯乘资本连续担任独家财务顾问。 本轮融资将用于推进公司 在研产品管线开发，深化在严肃医疗及消费医疗领域的技术布局，加快公司产品管线临床进展、申报 进程及市场推广。 君合盟成立于 2020年11月，是一家专注于重组蛋白创新药物及合成生物学领域创新产品开发的生 物科技公司， 基于 多年的重组蛋白药物研发及产业化经验，实现了覆盖产品开发全流程的核心技 术、平台及人才的积淀，形成了一套完整的技术及产品开发体系。 公司的研发管线 布局围绕严肃医疗、消费医疗、代谢等拥有广阔市场的前沿蛋白药物领域 ，已实现 包括重组 I/III型人胶原蛋白原液及制剂、重组A型肉毒毒素等在内的高端重组蛋白产品的规模化放 大，技术水平及产业化进展处于国际领先水平。其中， 核心产品重组人生长激素注射液已完成 III期 临床；重组A型肉毒毒素已于近日完成成人中重度眉间纹适应 ...

Core Insights - The company Junhe Alliance has completed a strategic financing round of several tens of millions, exclusively funded by Shiyao Guofang Pioneer Fund [2] - The financing will be used to advance the development of the company's product pipeline, deepen its technological layout in serious medical and consumer healthcare fields, and accelerate clinical progress, application processes, and market promotion [3] Company Overview - Junhe Alliance Biopharmaceuticals (Hangzhou) Co., Ltd. was established in November 2020, focusing on the development of innovative recombinant protein drugs and synthetic biology products [3] - The company has accumulated core technologies, platforms, and talent covering the entire product development process, forming a complete technical and product development system [3] Product Pipeline - The research and development pipeline is centered around serious medical, consumer healthcare, and metabolic fields, which have vast market potential [3] - The company has achieved large-scale production of high-end recombinant protein products, including recombinant type I/III human collagen solutions and formulations, as well as recombinant type A botulinum toxin [3] - The core product, recombinant human growth hormone injection, has completed Phase III clinical trials; the recombinant type A botulinum toxin has recently completed the first dosing of Phase III clinical trials for moderate to severe glabellar lines and is nearing the end of Phase II clinical trials for post-stroke upper limb spasticity [3] Future Outlook - The CEO of Junhe Alliance, Xu Kui, emphasized the company's focus on unmet clinical needs in serious medical and consumer healthcare since its inception, with independent research and development as the core driving force [4] - The company aims to continue deepening innovative technological breakthroughs and accelerate the development and market application of its product pipeline, striving to become a leader in the recombinant protein drug field [4]

近日,致力于成为全球领先专业皮肤学公司的瑞士高德美(SIX:GALD)公布了 2025 年第一季度的财务业 绩 ·净销售额:实现净销售额11.29亿美元,按固定汇率计算同比增长8.3%,主要得益于销量增长驱动,并受益于 有利的产品组合。 ·业绩超预期:得益于高度聚焦的执行力、注射美学产品顺利推进以及奈莫利珠单抗上市初期表现超出预 期,推动净销售额超出市场预期。 ·全面增长:各产品品类和地区均实现强劲增长,按固定汇率计算,注射美学产品同比增长 9.9%,日常护肤产 品同比增长 7.8%,皮肤治疗产品同比增长 4.9%,其中奈莫利珠单抗(nemolizumab)实现净销售额为 3900 万 美元。 ·在创新、科学和教育方面持续引领:凭借奈莫利珠单抗和新型液态A型肉毒毒素(RelabotulinumtoxinA)两 款具备重磅潜力的新产品上市,进一步巩固了在皮肤科领域的领先地位,并在各品类中发布新的科学数据, 积极出席关键行业会议。 ·财务实力提升:成功发行首支欧元债券及瑞士法郎双期债券,此前获得惠誉给予公司投资级别评级"BBB 级,前景稳定"。 ·确认2025 年全年业绩指引:预计净销售额全年按固定汇率增长 10 ...