从政策破冰到 CRO 供需重塑，把握预期差带来的布局机会 20250709 摘要 CRO 行业经历产能快速扩张后，面临同质化竞争加剧和盈利能力削弱的 挑战。创新药融资受阻和医药政策变化导致 CRO 企业订单需求降低，行 业正处于艰难的去产能阶段，小型企业面临生存危机，头部企业则通过 结构调整实现转型升级。 国家药品审评中心数据显示，2024 年中国药物临床试验数量同比增长 16%，三期临床试验增速达 31%，反映国内药企在创新药研发后期阶 段加速推进。但 BE 实验占比接近 50%，一期实验占比下降，表明早期 临床试验推动放缓。 CRO 企业人均创收及人均创利在 2023 年至 2024 年均出现下滑，订单 价格下行背景下，大型企业虽未大规模裁员，但仍面临效益压力。头部 公司如昭衍新药、泰格等员工人数保持增长，表明其在价格压力下仍扩 充市场份额。 CDMO 行业中，大单品对业绩拉动显著。新冠药物商业化订单曾对药明 康德、凯莱英和博腾股份等企业业绩有明显推动作用。2021 至 2023 年，这三家公司大订单销售额合计实现 42 亿美元收入，利润达 17 亿美 元。 Q&A 如何看待 CRO 行业的当前发展状况及 ...

阳光诺和 20250708 摘要 阳光诺和转型创新药研发，1.1 类新药 STC007（术后镇痛、尿毒症瘙 痒）、SPC008（肿瘤恶病质）进入临床阶段，与易妙神州合作 CAR-T 疗法 ZM001（系统性红斑狼疮）也处于临床一期，SE 幺九预计明年提 交 IND。 STC007 术后镇痛二期临床数据显著，计划启动三期，有望成全球首款 非成瘾性阿片类镇痛药，正积极推进海外申报及销售合作。NHKC 杠 1 等改良型新药临近 NDA 申报，特殊制剂凝胶贴膏即将获批。 阳光诺和引入华为大模型加速多肽药物开发，商业化团队由经验丰富的 医药代表组成，对 STC007 产品充满信心，以较高估值购买部分权益， 利于产品市场推广。 STC007 三期临床试验方案遵循指导原则，包括优效安慰剂对照和与曲 马多头对头比较，预计年内启动患者入组。瘙痒适应症二期临床预计年 底或明年初完成，同步准备海外申报及出海合作。 公司正与国内药企洽谈 STC007 瘙痒适应症产品权益合作，瘙痒适应症 BD 方案与镇痛适应症不同，将侧重肾病科能力强的团队合作。 Q&A 阳光诺和公司目前的运营状况和未来发展规划是怎样的？ 关于 007 药物的瘙痒适应 ...

Core Viewpoint - The rapid development of the global innovative drug industry has led to a significant opportunity for the CDMO (Contract Development and Manufacturing Organization) sector, with Shanghai Haoyuan Pharmaceutical Co., Ltd. positioning itself as a leader in the ADC (Antibody-Drug Conjugate) niche [1][2]. Group 1: Company Strategy and Market Position - Haoyuan Pharmaceutical has identified ADC as a key area for growth, establishing core competencies and positioning itself in the first tier of CDMO providers in this field [1][2]. - The company has successfully undertaken over 110 ADC projects in 2024, with 12 small molecule products related to ADC having completed FDA filings [2]. - The company reported a revenue of 2.254 billion yuan in 2024, a year-on-year increase of 20.62%, and a net profit of 202 million yuan, up 58.17% year-on-year [2]. Group 2: Technological Advancements - ADC technology, which combines antibodies, linkers, and cytotoxic drugs, allows for targeted cancer treatment, minimizing damage to normal tissues [2]. - Haoyuan Pharmaceutical has developed proprietary technologies in ADC, having been a pioneer in this field since its establishment in 2006 [3]. - The company has collaborated with AI pharmaceutical firms to enhance drug development processes, establishing an AI Drug Exploration Joint Laboratory with East China Normal University [3]. Group 3: International Expansion - The company is actively expanding its international market presence, having serviced numerous ADC "outbound" orders, with nine overseas licensing transactions reported in the first half of the year [4]. - Haoyuan Pharmaceutical has established a CDMO base in Chongqing, which is the largest of its kind in Southwest China, and has passed EU quality audits to facilitate international market expansion [4][5]. - The company has set up business warehousing centers in the US, Europe, and India, serving over 13,000 pharmaceutical companies and research institutions globally [5]. Group 4: Future Prospects - Haoyuan Pharmaceutical is not only focusing on ADC but is also exploring emerging fields such as PDC (Peptide-Drug Conjugates), RDC (Radioisotope-Drug Conjugates), and ApDC (Aptamer-Drug Conjugates) [5]. - The company aims to create a full-chain service model that integrates technology research, industrialization, and global service, thereby establishing competitive barriers [5].

编辑丨王多鱼 排版丨水成文 电压门控钠 （ Na v ） 通道通过介导膜去极化时钠离子 （ Na + ） 的快速内流来控制神经元和肌肉的膜兴奋性。这些功能由核 心的 Na v 结构驱动，该结构由一 个中央孔道结构域 （PD） 和四个环绕的电压感受结构域 （VSD） 组成。 在人类的九种 Na v 亚型 （Na v 1.1 - 1.9） 中，由 SCN8A 基因编码的 Na v 1.6 在中枢神经系统中广泛表达，尤其在轴突远端起始段的密度极高，其功能紊乱 与 癫痫 等神经疾病密切相关。然而，Na v 1.6 虽然功能强大，但靶向药物极少，开发其精准、特异性强的新型分子一直是神经药理领域的一大挑战。 2025 年 7 月 4 日 ， 深圳医学科学院 颜宁 / 黄健 团队在 Cell Research 期刊发表了题为： Phrixotoxin-3 binds to three distinct antagonistic sites on human Na v 1.6 的研究论文。 该研究首次揭示了 蜘蛛毒素 Phrixotoxin-3 （PaurTx3） 通过三位点协同调控人源电压门控钠通道 Na v 1.6 ，为 ...

连续7年扣非净利润亏损的翰宇药业（300199.SZ），终在2025年上半年迎来转机。 6月30日晚，翰宇药业发布2025年半年度业绩预告，预计净利润1.42亿-1.62亿元，同比扭亏（去年同期亏损1035.88万元）。公司将此归因于利拉鲁肽注射液 在美国获批上市并放量销售、原料药出口增长及成本控制。 利拉鲁肽这款用于治疗2型糖尿病的GLP-1类药物，因兼具减重效果成为翰宇药业翻盘的关键。2024年12月，其利拉鲁肽注射液获FDA批准，随即在2025年1 月完成近140万支发货。截至去年年底，公司已收到美国合作方Hikma累计4639.63万美元订单。 但这款"救命药"的国内故事已画上句号。2023年6月，翰宇药业主动撤回利拉鲁肽国内上市申请，并于同年11月终止项目，全额计提减值5298.82万元。去 年，翰宇药业又将司美格鲁肽的国内权益转让给三生制药（01530.HK）旗下三生蔓迪。两个选择背后，是公司对国内GLP-1市场未来价格战的预判，同时也 吹响公司全力押注海外市场的号角。 翻盘全靠利拉鲁肽 公开资料显示，翰宇药业成立于2003年，2011年登陆深交所创业板，主营多肽制剂及原料药，主要产品包括多肽原料 ...

Core Viewpoint - Hanyu Pharmaceutical has signed strategic investment and cooperation agreements with Shenzhen Carbon Cloud Peptide Pharmaceutical Technology Co., Ltd to enhance collaboration in peptide drug development and industrialization [1][2] Group 1: Agreements and Collaborations - The agreements include a strategic investment in Carbon Cloud Peptide and a strategic cooperation for CRDMO services in innovative drugs [1] - Previous collaboration began with a framework agreement in 2024, focusing on leveraging Hanyu's capabilities in peptide drug industrialization and Carbon Cloud's advanced technology in peptide screening using AI [1][2] - A joint development agreement for a GLP-1R/GIPR/GCGR triple agonist innovative drug project was established in May 2025, laying a solid foundation for further cooperation [1] Group 2: Project Development and Support - Hanyu Pharmaceutical will utilize its CRDMO technical platform and industrialization advantages to support multiple innovative drug projects under Carbon Cloud, including PDC peptide conjugated drugs and AI antibacterial peptides [2] - The cooperation encompasses the entire process from preclinical research to commercialization, covering key aspects such as active pharmaceutical ingredient process optimization, formulation development, quality research, registration, and large-scale production [2] - Industry analysts believe this collaboration will strengthen Hanyu's industrial synergy in the peptide CRDMO service chain and accelerate the commercialization of innovative products for Carbon Cloud, achieving resource sharing and complementary advantages [2]

近期，港股创新药接连大涨，医药新股表现也相当不俗。值此档口，港股新股也即将迎来一家颇具辨识的药企泰德医药。 6月25日中午12时，泰德医药(03880.HK)招股阶段正式结束。 据悉，此次泰德医药全球发售涉及1680万股H股，其中香港发售股份数目为168万股H股，国际发售股份数目为1512万股H股，最高发售价定为每股H股30.60 港元。 眼下来看，港股IPO市场热络之际，对于每只新上市的药企，都值得多看一眼，不妨就此来挖掘下泰德医药的机会所在。 1、黄金赛道的头部选手，持续受益市场扩容 泰德医药是一家专注于多肽领域的CRDMO企业，其向药企提供多肽的研究、开发及制造等服务。 多肽药物可以说是近年来医药行业当之无愧的风口。此前减肥"明星药"司美格鲁肽、替尔泊肽相继"出圈"，将多肽药物这一细分领域推向了前所未有的高 度。 从市场规模来看，全球多肽药物市场正处于爆发性增长前夜。 据弗若斯特沙利文的资料，按销售收入计，全球多肽类药物市场从2018年的607亿美元增长至2023年的895亿美元，复合年增长率为8.1%，并预计将进一步 增长至2032年的2612亿美元，复合年增长率为12.6%。 （来源：公司招股书） ...

Core Viewpoint - Shengnuo Biotech (688117.SH) has reported significant growth in its half-year performance for 2025, with net profit expected to increase by 253.54% to 332.1% year-on-year, driven by strong performance in its peptide raw material business [1][3]. Financial Performance - The company anticipates a net profit of between 77.03 million yuan and 94.14 million yuan for the first half of 2025, with a year-on-year increase of 253.54% to 332.1% [1][3]. - The expected non-deductible net profit is projected to be between 77.35 million yuan and 94.53 million yuan, reflecting a year-on-year increase of 304.49% to 394.38% [1][3]. - In 2024, Shengnuo Biotech reported revenue of 456 million yuan, a year-on-year growth of 4.84%, while net profit decreased by 28.88% to 50.02 million yuan due to increased R&D investment and other factors [2]. Business Operations - Shengnuo Biotech is actively expanding its production capacity to meet market demand, with projects such as the "Annual Production of 395 kg Peptide Raw Material Production Line" and the expansion of raw material workshops [3]. - The company has successfully launched its 106 workshop and is in the equipment validation phase for workshops 107 and 108 [3]. Market Expansion - The global peptide CDMO market is projected to reach $11.8 billion by 2030, with the domestic market expected to reach 18.5 billion yuan, indicating a higher CAGR than the global market [4]. - Shengnuo Biotech's overseas revenue reached 148 million yuan in 2024, a significant increase of 73.93%, while domestic revenue decreased by 12.51% to 303 million yuan [4]. - The proportion of overseas revenue has increased to 32.52%, up 12.92 percentage points from 2023, reflecting the company's focus on expanding its international sales channels [4]. R&D and Product Development - The company is collaborating with external firms to develop various peptide products and has significantly increased its R&D investment, with expenses rising from 13.75 million yuan in 2021 to 49.17 million yuan in 2024 [5]. - Shengnuo Biotech provides CDMO services for over 40 peptide innovation drug projects, with two products approved for commercialization and two in the production application stage [5].

公司主要提供(i)CRO服务，即多肽NCE发现合成;及(ii)CDMO服务，即多肽CMC开发以及商业化生产。 公司的服务主要专注于向客户提供API，而非药品。然后，公司的客户会将API与辅料混合，形成药品 的最终剂型，并确定适当的剂型、给药途径及配方，然后将最终药品用于其临床试验或商业销售。公司 已在超过50个国家建立稳定的客户关係和服务范围，其中包括中国、美国、日本、欧洲、韩国及澳大利 亚等主要市场。公司为客户提供符合全球主要市场监管规定的多肽类药物开发、生产、CMC申报支持 服务。 公司已与基石投资者签订基石投资协议，基石投资者同意遵照若干条件，以若干投资金额按发售价认购 或促使其指定实体认购(视情况而定)。假设发售价为29.50港元(即本招股章程所载发售价范围的中位 数)，则基石投资者将认购的发售股份总数将为266.08万股发售股份，相当于(i)根据全球发售提呈发售 的H股的约15.84%，及(ii)紧随全球发售完成后公司已发行股本总额的约1.88%，基石投资者的总认购金 额将约为1000万美元。 泰德医药(03880)于2025年6月20日至6月25日招股，公司拟发售1680万股，香港发售占10%，国 ...

公司报告 | 年报点评报告 蓝晓科技（300487） 证券研究报告 吸附材料弥补提锂项目下滑，生命科学、超纯水突破 事件：蓝晓科技公布 2024 年年报，公司 2024 年实现营业收入 25.54 亿元， 同比+2.6%，实现归母净利润 7.87 亿元，同比+9.8%；其中第四季度实现营 业收入 6.62 亿元，同比-27.4%，环比+10.89%，实现归母净利润 1.91 亿元， 同比-4.0%，环比-0.79%。公司公布 2025 年一季报，一季度实现营业收入 5.77 亿元，同比-8.6%，环比-12.91%，实现归母净利润1.93 亿元，同比+14.2%， 环比+1.22%。 吸附材料收入保持较快增长，提锂项目下滑拖累系统装置下滑 按照业务模式：吸附材料业务保持增长，系统装置同比下滑拖累较大：离 子交换树脂/系统装置/技术服务 2024 年分别实现营业收入 19.86/4.69/0.64 亿元，同比分别+27.61%/-43.13%/-1.61%。其中吸附材料业务中，按照下游 应用划分，金属资源/生命科学/水处理与超纯化/节能环保/食品加工/化工 与催化六大应用领域收入分别为 2.56/5.68/6. ...