1. Objective:
Primary: Compare the effect of Ciprofol vs Propofol on LVOT VTI at 2 minutes post-injection (T1) in elderly patients (?65 years).
Secondary: Assess hypotension incidence, injection pain, nausea/vomiting, hypoxia (SpO??90%), bradycardia (HR<50 bpm), sedation success rate, induction/recovery times, procedure duration, drug doses, and patient satisfaction.
2. Design:
Single-center, randomized, double-blind, controlled trial. Group C (Ciprofol):0.2-0.5 mg/kg IV induction (>30s injection). Group P (Propofol)::1-2 mg/kg IV induction (>30s injection). Rescue doses allowed (C: 0.1 mg/kg; P: 0.5 mg/kg; max 5 doses/15 min).
3. Participants:
N = 120 elderly patients (65-80 years, ASA I-III, BMI 18-30 kg/m?) scheduled for elective painless colonoscopy.
Exclusion: Significant cardiorespiratory, hepatic, renal, or neurological disorders; recent MI/unstable angina (?6 months); NYHA ?II; drug allergies; recent trial participation.
4. Key Assessments:
Primary Endpoint: LVOT VTI (via transthoracic echocardiography, TTE) at T1.
Secondary Endpoints:
Adverse events (hypotension, pain, nausea/vomiting, hypoxia, bradycardia, body movement, awareness).
Sedation success rate, induction/recovery times (MOAA/S scale), procedure time. Drug doses (induction, total, vasoactive agents). Patient satisfaction (5-point scale). LVEF and IVC Collapse Index (TTE at T0, T1, T2). Safety: Vital signs (HR, BP, SpO?).
5. Statistical Analysis:
SPSS 26.0; ?=0.05. Methods: t-test, RM-ANOVA, Mann-Whitney U, Chi-square/Fisher's exact, rank-sum tests.
This study aims to determine whether Ciprofol provides superior hemodynamic stability (as measured by LVOT VTI) and fewer adverse effects compared to Propofol for sedation in elderly patients undergoing painless colonoscopy.

开始日期2025-08-25

申办/合作机构

连云港市第一人民医院

NCT07028593

/ Not yet recruiting临床4期IIT

Effects of Ciprofol on Myocardial Injury After Non-cardiac Surgery (CP-MINS) in Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Randomized, Double-Blind, Propofol-Controlled, Multicenter Trial

Myocardial injury after noncardiac surgery (MINS) refers to postoperative elevation of cardiac troponin (cTn) levels caused by underlying ischemic mechanisms (i.e., coronary artery supply-demand imbalance or atherosclerotic thrombosis) without obvious non-ischemic causes (such as pulmonary embolism), with at least one cTn concentration exceeding the 99th percentile of the test reference upper limit, regardless of whether clinical symptoms and ECG changes are present. MINS, including myocardial infarction and ischemic myocardial injury, typically occurs within 30 days after surgery, most commonly within the first 2 postoperative days. It is an independent risk factor for 30-day postoperative mortality and is also closely associated with increased risk of mortality and vascular complications within 2 years . MINS is a common cardiovascular complication after thoracic surgery. Therefore, reducing the incidence of MINS in non-cardiac thoracic surgery to improve patient outcomes is a critical issue in anesthetic management for thoracic surgery.
Ciprofol is a Class 1 innovative drug independently developed in China with global intellectual property rights. Currently, Ciprofol has completed Phase III clinical trials in China and the United States; its approved indications in China include sedation or anesthesia for various diagnostic procedures, general anesthesia for surgical operations, and sedation during intensive care unit (ICU) stays. Completed drug clinical trials and published clinical trial data of Ciprofol indicate that it can better maintain circulatory stability and ideal anesthetic depth during anesthesia induction and maintenance, making it a promising intravenous general anesthetic alternative to propofol.
Maintaining hemodynamic stability is an important measure to reduce cardiovascular complications during the perioperative period. Given the good circulatory stability and sedative efficacy of Ciprofol, this study aims to investigate the impact of Ciprofol on MINS in non-cardiac thoracic surgery.

开始日期2025-07-01

申办/合作机构

华中科技大学同济医学院附属同济医院

ChiCTR2500101286

/ SuspendedN/AIIT

Effects of Ciprofol on Intraoperative Hypotension, Carotid Artery Hemodynamics, and Postoperative Negative Emotions in Patients Undergoing Laparoscopic Surgery

开始日期2025-06-01

申办/合作机构-

100 项与环泊酚相关的临床结果

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100 项与环泊酚相关的转化医学

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100 项与环泊酚相关的专利（医药）

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217

项与环泊酚相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Efficacy and safety of ciprofol for sedation/anesthesia in patients undergoing hysteroscopy: a prospective, randomized, non-inferiority trial

Article

作者: Liu, Dan ; Cao, Minghui ; Cheng, Shi ; Fu, Ganglan ; Wu, Haixuan ; Liu, Zhongqi

INTRODUCTION:

Propofol is the preferred sedative for painless hysteroscopy and other procedures due to its fast onset and short duration. However, its limitations, including injection pain, respiratory depression, blood pressure decline, and bradycardia, cannot be disregarded. Ciprofol, a new short-acting gamma-aminobutyric acid receptor agonist, has shown effectiveness and safety in painless gastrointestinal endoscopy. This study aims to demonstrate that ciprofol is not inferior to propofol in terms of sedation efficacy for painless hysteroscopy.

PATIENTS AND METHODS:

A randomized study was conducted with 124 women to evaluate the anesthetic effect of ciprofol during outpatient painless hysteroscopy. The primary outcome assessed was the success rate of hysteroscopy, while secondary indicators included induction and recovery time, injection pain, tidal volume and respiratory rate. Safety indicators comprised hypotension, hypoxemia, and sinus bradycardia.

RESULTS:

A total of 124 patients were enrolled in the study, with 62 in each group. The success rate of hysteroscopy was 100% in both groups. Patients in the ciprofol group had higher diastolic pressure, pulse oxygen saturation levels and minute breathing during surgery than patients in the propofol group, but their induction time and recovery time were longer. The proportion of patients in the propofol group who reported pain during intravenous anesthesia was 41.935%, which was significantly higher than that of patients in the ciprofol group (1.613%).

CONCLUSION:

During painless hysteroscopy, ciprofol demonstrates non-inferiority to propofol in terms of anesthetic efficacy. Despite slightly longer induction and recovery times, ciprofol results in lower instances of injection pain and less impact on respiration and circulation compared to propofol.

TRIAL NUMBER:

Clinical trial Registration Identifier: NCT06172140.

2025-09-01·JOURNAL OF PHARMACEUTICAL SCIENCES

Physicochemical compatibility investigation of ciprofol injection with eight cardiovascular drugs during simulated Y-site administration

Article

作者: Chen, Peng ; Liu, Qipeng ; Chen, Fuchao ; Wu, Jing ; Fang, Baoxia ; Deng, Wenya

The intravenous pharmacotherapy in patients with critically ill and perioperative intravenous anesthesia is extremely challenging due to the large number of drugs administered. In-line incompatibility remains a significant safety concern. We therefore evaluated the physico- chemical compatibility of combinations of ciprofol injection with cardiovascular drugs during simulated Y-site administration frequently used in intensive care unit setting or intravenous anesthesia. Ciprofol injection was mixed with clinical concentrations of dopamine, sodium nitroprusside, dobutamine, phentolamine, papaverine, nitroglycerin, metaraminol and methoxamine solution at a 1:1 vol ratio under ambient conditions (25 ± 1 °C). Physicochemical compatibility changes in appearance, pH values, Zeta potential, particle size/polydispersity index (PDI), osmotic pressure, and relative percentage content are observed at predetermined time points (0, 2, 4, 6, and 8 h). During the 8-hour study period, the pH values change of all drug mixture remained within ±0.4. The relative drug concentration was maintained between 95 % and 105 %. The mean particle size was in the range of 200 to 220 nm, with a PDI below 0.2. Osmotic pressure changes were consistently <6 %. Notably, the Zeta potential of the metaraminol-ciprofol mixture exhibited a variation exceeding ±10 mV. Microscopic imaging analysis showed that the droplet sizes of dopamine-ciprofol, metaraminol-ciprofol, and papaverine-ciprofol mixtures, increased significantly. Based on this studies, ciprofol injection demonstrated compatibility and stability when administered via Y-site infusion with sodium nitroprusside, dobutamine, methoxamine, phentolamine, and nitroglycerin for up to 8 h at room temperature. However, the combination of ciprofol with dopamine, metaraminol, or papaverine was incompatibility during infusion. pH is a significant factor that could potentially influence the stability and compatibility of the combinations. Clinical strategies such as the use of inline filters and post-infusion irrigation tubes can prevent these risks.

2025-07-19·BMC Anesthesiology

The median Effective Dose (ED₅₀) and the 95% Effective Dose (ED₉₅) of alfentanil in inhibiting responses to cervical dilation when combined with ciprofol during hysteroscopic procedure: a prospective, double-blind, dose-finding clinical study.

Article

作者: Gao, Run ; Shen, Jian-Jun ; Xu, Li-Li ; Li, Shu-Xi ; Xing, Li ; Fu, Jin-Peng ; Chen, Xin-Zhong ; Zhou, Yan-Hong

BACKGROUND:

Alfentanil, a short-acting µ opioid receptor agonist, has recently been confirmed that when combined with propofol for daytime hysteroscopy, it provided more stable hemodynamics compared with sufentanil, and has a lower incidence of hypoxemia and postoperative nausea and vomiting. The object of the trial was to determine the median effective dose (ED₅₀) and the 95% effective dose (ED₉₅) of alfentanil in inhibiting responses to cervical dilation when combined with ciprofol and explore the effect of alfentanil on reducing ciprofol requirement during hysteroscopy.

METHODS:

One hundred and forty patients scheduled hysteroscopy under monitored anesthesia care were randomized to receive a bolus of 8 µg·kg^-1, 10 µg·kg^-1, 12 µg·kg^-1, 14 µg·kg^-1 intravenous alfentanil or 0.15 µg⋅kg^-1 intravenous sufentanil followed by a bolus of 0.5 mg·kg^-1 ciprofol. Whether there was loss of response to cervical dilation or not in each patient was recorded. We used the probit analysis to determine ED₅₀ and ED₉₅ of alfentanil in inhibiting responses to cervical dilation when combined with ciprofol. The requirement of ciprofol, the emergence time, the visual analogue scale score of pain at five time points, and the incidence of adverse events were recorded.

RESULTS:

The calculated ED₅₀ and ED₉₅ of alfentanil were 9.73 [95% CI 8.57 to 10.56] µg·kg^-1 and 15.02 [95% CI 13.57 to 18.12] µg·kg^-1, respectively. Ciprofol requirements were lower in patients given 10 µg·kg^-1 (0.795 [ 0.707 to 0.889] mg·kg^-1), 12 µg·kg^-1 (0.799 [0.601 to 0.913] mg·kg^-1), and 14 µg·kg^-1 (0.789 [0.660 to 0.968] mg·kg^-1) alfentanil than those given 8 µg·kg^-1 alfentanil (1.082 [ 0.853 to 1.271] mg·kg^-1) alfentanil and 0.15 µg⋅kg^-1 sufentanil (1.046 [0.861 to 1.427] mg·kg^-1) (P < 0.001). Emergence time was lower in patients given 10 µg·kg^-1 (0.9 [0.8 to 1.2] min), 12 µg·kg^-1 (0.8 [0.6 to 1.0] min) than those given 8 µg·kg^-1 (1.9 [1.0 to 2.8] min) and 14 µg·kg^-1 (1.5 [1.0 to 2.3] min) alfentanil, and 0.15 µg·kg^-1 sufentanil (1.4 [1.0 to 2.0] min) (P < 0.001). The visual analogue scale score of pain at the time of 30 min and 1 h after surgery was lower in patients given 10 µg·kg^-1, 12 µg·kg^-1, and 14 µg·kg^-1 alfentanil when compared with 8 µg·kg^-1 alfentanil and 0.15 µg⋅kg^-1 sufentanil (P < 0.001). The incidence of intraoperative hypotension was lower in patients given 8 µg·kg^-1, 10 µg·kg^-1, 12 µg·kg^-1 alfentanil, and 14 µg·kg^-1 alfentanil than those given 0.15 µg·kg^-1 sufentanil (P = 0.044), while the incidence of intraoperative desaturation was higher in patients given 14 µg·kg^-1 alfentanil than those given 8 µg·kg^-1, 10 µg·kg^-1, and 12 µg·kg^-1 alfentanil, and 0.15 µg·kg^-1 sufentanil (P < 0.001).

CONCLUSIONS:

For women undergoing hysteroscopic surgery, a dose of 10-12 µg·kg^-1 of alfentanil was associated with significant ciprofol-sparing effect, earlier anesthesia emergence, better postoperative analgesia, and less unexpected hemodynamic events compared with sufentanil, but 14 µg·kg^-1 alfentanil had the risk of transient desaturation and delayed anesthesia recovery. Indications and the optimal dose of alfentanil in this patient population need further clarification.

TRIAL REGISTRATION:

The study was then registered on January 24, 2024 at the Chinese Clinical Trial Registry which participates in the World Health Organization International Clinical Trials Registry Platform (Identifier: ChiCTR2400080232) before enrolling the first participant and written informed consent was obtained by each patient.

125

项与环泊酚相关的新闻（医药）

2025-07-18

·米内网

【市场】8款新药遴选进院，独家品种大放异彩

精彩内容近日，成都市妇女儿童中心医院公示称，拟遴选引进8款新药以满足临床用药需求，涉及“中化生”领域，均为1类独家创新药（含独家剂型，下同），其中不乏环泊酚注射液、艾瑞昔布片等2024年在中国公立医疗机构终端销售额超9亿元的大品种。8款拟进院新药均为独家1类创新药，其中医保用药占比超八成；按治疗大类统计，神经系统药物以4个产品在数量上领跑，抗肿瘤和免疫调节剂、呼吸系统疾病用药、肌肉-骨骼系统分别有2个、1个和1个产品在列。拟进院新药名单来源：成都市妇女儿童中心医院，米内网整理海思科有2款独家1类新药拟进院——环泊酚注射液是公司首个1.1类创新静脉麻醉药，2022-2025Q1在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额增速均达两位数及以上，2024年首破10亿元大关；苯磺酸克利加巴林胶囊是口服GABA类似物，获批适应症为：成人糖尿病性周围神经病理性疼痛（DPNP）和带状疱疹后神经痛（PHN）。米内网数据显示，在神经系统领域，海思科的1类新药安瑞克芬注射液于日前获批上市，用于治疗腹部手术后的轻、中度疼痛。这将进一步丰富公司围手术期产品矩阵，夯实市场核心竞争力。近年来中国公立医疗机构终端环泊酚注射液销售趋势（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局艾瑞昔布片为恒瑞医药首款独家1类创新药，用于缓解骨关节炎的疼痛症状。该新药最早于2011年获批上市，于2017年进入医保目录后迅速放量；2024年在中国公立医疗机构终端销售规模超过9亿元，同比增长6.89%；2025Q1继续以3.87%的增速增长至超2.3亿元，是抗炎和抗风湿口服药TOP3产品，市场份额达7.87%。今年以来，恒瑞医药在肌肉-骨骼系统领域已有2款1类新药传来喜讯，其中SHR4640片申报上市在审，拟用于治疗痛风；注射用HRS-9190获批临床，目前正开展拟用于全身麻醉诱导期气管插管及维持术中骨骼肌松弛的Ⅰ期临床试验。2025Q1中国公立医疗机构终端抗炎和抗风湿口服药产品TOP5来源：米内网中国公立医疗机构药品终端竞争格局注：增长率低于3%用*表示此外，拟遴选进院的独家品种还包括：人福药业的注射用磷丙泊酚二钠（成人全身麻醉的诱导）、卓和药业的九味止咳口服液（急性气管-支气管炎）、绿叶制药的盐酸托鲁地文拉法辛缓释片（抑郁症）、华昊中天药业的优替德隆注射液（复发或转移性乳腺癌）等，涵盖神经系统药物、呼吸系统疾病用药、抗肿瘤和免疫调节剂等治疗大类，满足不同患者的临床用药需求。资料来源：米内网数据库、成都妇女儿童中心医院注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至7月18日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

申请上市

2025-07-10

·E药经理人

涨停！默沙东700亿并购带飞的A股“小恒瑞”，成色几何？

保持市值长牛，秘诀是什么？撰文| 润屿恒瑞估值“杀疯”，“小恒瑞”海思科也迎来了冲高涨停。今日收盘，海思科股价涨10%，报46.41元/股，总市值约520亿元，位列化学制剂行业市值TOP10阵营。默沙东百亿美元收购案似乎是关键催化剂，其收购的Verona核心药物‌Ohtuvayre，‌是全球首创PDE3/PDE4双靶点抑制剂，用于治疗慢性阻塞性肺病（COPD）。而海思科拥有同靶点的在研管线，且进度位居国内前列。此外，海思科近期募资申请已获受理，主要用于创新转型，重点布局麻醉镇痛、神经科学及肿瘤领域，叠加今年来创新布局陆续收获，近6个月股价涨了近50%。被称作“小恒瑞”的海思科，的确与恒瑞的成长路径有异曲同工之妙。这家药企在2020年底推出精麻重磅产品环泊酚，一举攻占管制类药品高壁垒赛道；如今，其覆盖COPD、NASH、IgA肾病等百亿蓝海市场的慢病组合，又逐步开启了创新价值释放的新周期。值得注意的是，此前看起来分散的慢病研发管线，很多在近期都展现出了不错的BD潜力。创新开挂的“小恒瑞”过去五年，化药行业在集采常态化等政策冲击下经历深度调整，多数企业业绩呈现周期性波动，海思科亦是如此。然而，海思科也是这一时期极少数实现市值持续向上的企业。这离不开两个关键因素：环泊酚力挽狂澜，重塑增长引擎；创新药陆续落地，创新管线差异化愈发凸显。海思科早期以仿制药为主，在集采前营收增长较迅速，其核心产品甲磺酸多拉司琼注射液市场份额领先，推动营收从2015年12.12亿元增至2019年39.37亿元。但2020年医保谈判导致该产品降价90%，加之肠外营养产品集采冲击，公司2020-2021年营收下滑，扣非净利润骤降。但很快，海思科的第一个商业化创新药扭转了走势。2020年底，海思科Me-better类麻醉镇静药——环泊酚注射液（思舒宁）获批。环泊酚是经典麻醉镇静药丙泊酚的改良型新药，其安全性、有效性显著高于丙泊酚，为手术镇静领域注入了新活力。恰逢市场发生戏剧性的转折一幕，在环泊酚获批数日之后——第四批国家药品集采落地，其主要竞品丙泊酚中长链脂肪乳价格遭遇断崖式下跌，骤然出现的市场真空，成了环泊酚的起飞跑道。环泊酚抓住了“天时”。2021-2023年，该产品销售额分别为 0.60亿元、4.37 亿元和8.5亿元，2024年，环泊酚注射液收入再同比大增45.6%，在静脉麻醉药市场领域跃居份额第一，成为名副其实的麻醉龙头。市场预计，该产品国内销售峰值有望达33亿元。值得注意的是，目前环泊酚在美国开展了临床III期，海外市场有望进一步带来增量。短短三年间，环泊酚的猛增推动海思科营收结构发生变化。2024年，公司麻醉产品收入超12亿元，占总营收比例为33%，而该板块的毛利率高达90.43%，横向对比，盈利能力强于人福医药、恒瑞甚至专精麻醉的恩华药业。毫无疑问，麻醉药物机制复杂、研发难度大，且管控严格、准入壁垒高，竞争格局相对良好。镇静领域站稳脚跟后，海思科现在也在积极布局镇痛药。5月，海思科拿到1类创新镇痛药物安瑞克芬注射液的批文，适应证为腹部手术后的轻中度疼痛。未来有望与环泊酚形成协同效应，进一步巩固其在麻醉镇痛领域的优势地位。值得一提的是，2024年，海思科37亿元营收、4亿元净利润的规模虽不及人福和恩华，但估值却比这两家要高的多。一大重要的原因在于，海思科不仅麻醉产品攻势正猛，还有在麻醉之外的野心。环泊酚光芒之外，海思科悄然构筑起了一个覆盖麻醉镇痛、呼吸、慢病、肿瘤和自免等领域的创新管线矩阵。呼吸领域，海思科拥有‌三款潜力药物蓄势待发。值得注意的是，DPP-1抑制剂HSK31858——对标Brensocatib，全球进展前二。另外在代谢领域，HSK31679剑指“业界天坑”非酒精性脂肪肝。另外，HSK39297与云顶新耀耐赋康一样，瞄准了IgA肾病。能够看到，海思科的战略选择：避开红海，深耕麻醉与复杂慢性病。而这种“麻醉+慢病”的组合，在国内几乎没有相同路径的对标。其关键逻辑在于，用麻醉产品提供现金流和市场支点，而慢性病管线则着眼于未来广阔但需长期培育的市场。推荐阅读 * 暴降30亿，被集采“杀死”的消化药大王，开始复活* 10倍股“小恒瑞”，为什么活得这么累？换代开局的海思科王俊民、范秀莲、郑伟，三个辽宁人，在成都创业，收购一家西藏公司完成资本架构重组，随后整合多地多家关联企业，于2012年以“西藏海思科”为主体登陆深交所。这是海思科第一阶段的故事。这一阶段，海思科以特色仿制为主，在肠外营养领域建立了核心竞争优势。2012年深交所上市成为海思科发展的第一道分水岭。面对肠外营养领域日渐激烈的竞争和政策风险，公司开始组建创新药团队，战略重心转向“Me-better”药物研发。2020年底环泊酚注射液获批上市，就是这一阶段的里程碑事件。而作为公司首个上市创新药，环泊酚的快速放量带动了这家公司收入支柱由肿瘤止吐、肠外营养系和肝胆消化为主的仿制药转向以麻醉产品为主的创新药。接着，海思科的研发策略再度升级，聚焦围手术期、肿瘤、代谢及呼吸疾病领域，基于其PROTAC和PDC平台，构建涵盖“Fast-follow”与“First-in-class”的自主管线体系。与此同时，国际化进程与商务拓展的加速，让外界看到海思科寻求二次增长的野心。值得一提的是，在国内，PROTAC玩家主要有海思科、百济神州等，从项目数量和进度来看，海思科均处于第一梯队。梳理下来，海思科像很多国内的传统药企一般，最早靠仿制药起家，随后靠改良和创新麻醉药对冲了集采风险，保证了营收足够平稳，接着用创新产品为远期提供想象力，从而支撑起市值。2025年3月，海思科发布权益变动报告书，王俊民、范秀莲、郑伟解除一致行动关系，公司控股股东/实控人由三人变更为王俊民一人，并透露郑伟已于2024年2月退休，此后郑伟未在公司担任任何职务，亦未参与公司的经营管理。今年6月，范秀莲退休，辞去总经理一职，继任者为严庞科。严庞科于2014年加入海思科，在此之前，他曾担任恒瑞医药药理毒理部部长、临床前开发部总监。自此，海思科从“创始人主导”转为“职业经理人+技术骨干”治理模式，而下一阶段的主线，必然也是创新和国际化。不可否认的是，过去数年积累的几大内部特质，可以支撑其迈向更高的阶段。其一，一直坚持高研发投入。在创新药还未兴起的年代，海思科就显现了对研发的极大重视。数据显示，其研发投入2010年只有2431万元，到2013年已经超过1个亿，研发投入占营收比已经超过10%。近几年，海思科的研发投入占收入比重维持在30%左右，2024年研投为10.01亿元，占营收比重为26.9%。如果只看50亿以内体量的化药企业，这一投入比例相当难得。其二，享有稀缺赛道的高壁垒护城河，以及麻醉业务助力下形成的盈利韧性‌。其三，以麻醉大单品为基石，向多个创新药领域拓展，管线布局与早期恒瑞路径相似，在专利保护期、需求扩张、管线储备的三重驱动下，市场能看到其较明确的成长潜力和长期增长逻辑。海思科的优势在于‌细分领域的持续深耕‌（如环泊酚对丙泊酚的替代）与‌超高毛利率，如麻醉产品‌90.43%、肿瘤止吐86.99%、肠外营养系59.32%。然而，在产品矩阵广度、全球化布局、规模效应和研发纵深上，距离恒瑞的“全能型巨头”，海思科仍有5-10年积累差距。有业内人士这样评价现阶段的海思科：更像10年前的恒瑞，正处于向创新药企转型的关键爬坡期，还面临系列挑战。在创新投入期迈入收获期的转型阶段，海思科的隐忧也体现在三个方面：其一，管线布局广泛，但缺乏清晰的主线方向，导致研发资源分散。今年一季度尤为明显，海思科的研发费用更是大增71.4%，经营现金流锐减68.95%。在市场分析看来，研发费大涨反映出海思科在拼命搞新药，短期投入太多，现金流减少。其二，创新的投入期还未过渡到收获期，让海思科的业绩出现波动。2024年财报显示，公司扣非净利润同比锐减45.4%至1.32亿元。虽然核心产品环泊酚注射液维持增长，但增速已开始放缓。在研管线中，进度较快的一些产品注定面临一定的市场竞争，而具有差异化的PROTAC技术平台尚处临床前阶段。创新药投入与产出的还没走过平衡点。综合来看，如今的经营压力后续能否靠新药赚回来，平衡短期财务表现与长期战略投入，是海思科突破天花板的关键。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐大事件 | IPO | 融资&交易 | 财报季 | 新产品 | 研发日 | 里程碑 | 行业观察 | 政策解读 | 深度案例 | 大咖履新 | 集采&国谈 | 出海 | 高端访谈 | 技术&赛道 | E企谈 | 新药生命周期 | 市值 | 新药上市 | 商业价值 | 医疗器械 | IND | 周年庆大药企 | 竞争力20强 | 恒瑞 | 石药 | 中生制药 | 齐鲁 | 复星 | 科伦 | 翰森 | 华润 | 国药 | 云南白药 | 天士力 | 华东 | 上药创新药企 | 创新100强 | 百济 | 信达 | 君实 | 复宏汉霖 | 康方 | 和黄 | 荣昌 | 亚盛｜康宁杰瑞｜贝达｜微芯｜再鼎｜亚虹跨国药企｜ＭＮＣ卓越｜辉瑞｜AZ｜诺华｜罗氏｜BMS｜默克｜赛诺菲｜GSK｜武田｜礼来｜诺和诺德｜拜耳供应链｜赛默飞｜药明｜凯莱英｜泰格｜思拓凡｜康龙化成｜博腾｜晶泰｜龙沙｜三星启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 中国医药手册

并购信使RNA临床3期基因疗法

2025-06-30

·米内网

【重磅】海思科1类新药出击，400亿市场风起云涌

精彩内容6月30日，西藏海思科制药的1类新药HSK45030分散片获批临床，拟用于肌营养不良症的治疗，剑指400亿肌肉-骨骼系统（化+生）市场。今年以来，海思科1类新药大丰收，安瑞克芬注射液获批上市，两款新药首次申请临床并已顺利获批。图1：海思科最新获批临床的新药来源：CDE官网据海思科早前发布的公告资料显示，HSK45030分散片是一种口服、选择性靶向小分子抑制剂，拟用于肌营养不良症。临床前研究结果显示，HSK45030能显著有效减少因肌节过度收缩而引起的肌肉损伤，在动物模型中展现了优异的抗肌萎缩的疗效；同时也表现出了良好的耐受性和较大的安全窗，是一款极具开发潜力的药物，有望为肌营养不良患者提供一种新的治疗选择。图2：肌肉-骨骼系统（化+生）销售情况（单位：万元）来源：米内网格局数据库在中国三大终端六大市场（统计范围见文末），肌肉-骨骼系统（化+生）市场从2021年起持续稳步增长，2024年涨至447亿元，2025年Q1再有5.98%的增长，潜力可期。据米内网数据显示，目前海思科及子公司暂无肌肉-骨骼系统药物获批，HSK45030分散片是公司在该类药物市场首个布局的1类新药。图3：海思科已上市的1类新药来源：米内网中国申报进度（MED）数据库近几年，海思科的新药研发力度不断加强，硕果逐渐丰盈，2020-2024年陆续获批了环泊酚注射液、苯磺酸克利加巴林胶囊、考格列汀片，2025年获批了安瑞克芬注射液，4款均为化药1类新药，涉及神经系统和消化系统及代谢两个热销大类市场。表1：2025年至今海思科申报临床（首次）的新药情况来源：米内网中国申报进度（MED）数据库今年以来，海思科再有4款化药1类新药加入创新药矩阵。抗肿瘤和免疫调节1类新药HSK41959片在3月获批临床，MTAP缺失的晚期实体瘤I期临床在4月已完成第一例入组；HSK45030分散片是肌肉-骨骼系统1类新药，4月申报临床并在近日获得临床批件；HSK47388片和HSK47977片的新药临床申请正在审评审批中。资料来源：CDE官网、米内网数据库等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至6月30日，欢迎指正。免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

申请上市临床申请上市批准临床1期

100 项与环泊酚相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	N05C	DB16295

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
镇静	中国	沈阳海思科制药有限公司	2020-12-11

未上市

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适应症	最高研发状态	国家/地区	公司	日期
麻醉	申请上市	中国	辽宁海思科制药有限公司	2019-08-02
妇科疾病	临床3期	中国	海思科医药集团股份有限公司	2021-07-26
慢性肾病	临床1期	中国	四川海思科制药有限公司	2020-01-05
慢性肝病	临床1期	中国	海思科医药集团股份有限公司	2019-11-07

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06172140 (Pubmed \| Ann Med)	N/A	-	124	Ciprofol	蓋繭獵觸窪築膚膚襯蓋(窪醖積醖壓築構繭鹽選) = 選齋積壓鏇願顧醖簾遞憲構衊窪築鏇願膚襯廠 (網製蓋鏇鑰蓋鬱膚築窪 ) 更多	积极	2025-12-31
				Propofol	蓋繭獵觸窪築膚膚襯蓋(窪醖積醖壓築構繭鹽選) = 構淵觸簾製餘網餘窪顧憲構衊窪築鏇願膚襯廠 (網製蓋鏇鑰蓋鬱膚築窪 ) 更多
NCT06287138 (Pubmed \| Front Med (Lausanne))	N/A	-	20	Cipepofol	襯顧齋顧蓋鹽鹽憲範蓋(構夢餘餘鑰鑰廠製積獵) = reductions in P0.1 (p = 0.020) were significant 醖簾製憲選鹹膚鬱鏇憲 (醖夢壓蓋蓋衊範選憲窪 ) 更多	积极	2025-02-25
NCT06413862 (Pubmed \| BMC Anesthesiol)	N/A	-	217	Ciprofol combined with alfentanil	壓網鬱糧積積廠簾蓋繭(獵廠鹹構積夢遞鹹夢夢) = 網獵窪糧選選膚淵醖窪壓淵獵衊鹽簾膚構繭觸 (鹽膚鬱繭網糧夢廠鏇鹹 ) 更多	积极	2024-11-12
				Propofol combined with alfentanil	壓網鬱糧積積廠簾蓋繭(獵廠鹹構積夢遞鹹夢夢) = 齋顧鹹網獵鬱築憲廠夢壓淵獵衊鹽簾膚構繭觸 (鹽膚鬱繭網糧夢廠鏇鹹 ) 更多
ChiCTR2300075271 (Pubmed \| BMC Anesthesiol)	N/A	虚弱综合症	69	Ciprofol 0.5 mg/kg	蓋蓋艱鑰構醖淵鹽選鬱(餘範觸襯遞遞構襯遞築) = 鏇積膚網蓋蓋觸顧顧餘衊壓蓋糧夢蓋構襯夢獵 (鏇壓窪壓顧襯製鏇襯糧 ) 更多	积极	2024-10-31
				Propofol 2 mg/kg	蓋蓋艱鑰構醖淵鹽選鬱(餘範觸襯遞遞構襯遞築) = 鹹鹹艱顧憲鬱淵鑰窪壓衊壓蓋糧夢蓋構襯夢獵 (鏇壓窪壓顧襯製鏇襯糧 ) 更多
NCT05478174 (CTgov)	临床3期	麻醉	400	HSK3486 (HSK3486)	網製鏇窪選網遞觸衊鹽 = 構觸選鑰簾齋醖觸窪膚膚艱範獵築構鬱積網選 (膚鹹鬱築鬱製鹹鹽齋餘, 膚壓鹹醖鬱願夢顧廠獵 ~ 繭選選顧簾積鏇鑰蓋範) 更多	-	2024-10-29
				propofol (Propofol)	網製鏇窪選網遞觸衊鹽 = 鹹觸積繭廠壓窪鏇鹽構膚艱範獵築構鬱積網選 (膚鹹鬱築鬱製鹹鹽齋餘, 範餘網鹽憲窪糧醖襯廠 ~ 憲範壓願醖選範積夢網) 更多
NCT04147416 \| NCT04620031 (phase 2 and phase 3 trials, Pubmed \| Ann Intensive Care)	临床2/3期	-	174	Ciprofol	齋淵糧醖選鹹廠糧觸齋(淵糧築鹹鑰憲積繭鑰遞) = 簾製鑰築蓋糧夢夢餘壓鬱範壓廠鹽鏇獵構鑰襯 (糧憲淵齋鑰範構願醖繭 )	积极	2024-10-26
				Propofol	齋淵糧醖選鹹廠糧觸齋(淵糧築鹹鑰憲積繭鑰遞) = 遞顧網鏇窪製窪鬱夢願鬱範壓廠鹽鏇獵構鑰襯 (糧憲淵齋鑰範構願醖繭 )
ChiCTR2200061727 (Pubmed \| BMC Anesthesiol)	临床4期	-	25	Ciprofol	選鹽觸壓網鑰淵壓壓夢(觸膚鹽廠膚構顧選鹽觸) = 齋齋網願膚築衊憲鑰網觸範構淵夢獵積範製願 (簾願餘鬱觸獵齋鬱糧醖 ) 更多	-	2024-01-02
NCT04958746 (Pubmed) 人工标引	临床3期	妇科疾病诱导 \| 维持	134	Ciprofol	觸膚膚鹽鏇範鹹艱淵鹽(艱廠夢夢簾鹹窪鬱衊夢) = 鏇艱鬱鹹鑰選鏇鹹網遞構構蓋鏇鹽夢鏇願齋糧 (醖顧獵夢鑰網鬱廠襯鑰 ) 更多	非劣	2024-01-01
				Propofol	觸膚膚鹽鏇範鹹艱淵鹽(艱廠夢夢簾鹹窪鬱衊夢) = 網觸鏇獵膚顧壓簾餘簾構構蓋鏇鹽夢鏇願齋糧 (醖顧獵夢鑰網鬱廠襯鑰 ) 更多
NCT04620031 (not available, Pubmed \| Crit Care Med)	临床3期	-	135	Ciprofol	醖鏇簾壓齋夢網鹽齋觸(鹽獵壓遞壓選積遞廠鹽) = 鑰衊願鹹顧鹹鹹築艱襯顧醖構鑰鏇膚鬱蓋淵網 (築顧憲衊顧製廠顧膚鬱 )	积极	2023-10-01
				Propofol	醖鏇簾壓齋夢網鹽齋觸(鹽獵壓遞壓選積遞廠鹽) = 鑰遞憲壓廠鬱選鑰淵窪顧醖構鑰鏇膚鬱蓋淵網 (築顧憲衊顧製廠顧膚鬱 )
NCT04711837 (HSK3486-304, CTgov)	临床3期	麻醉	255	HSK3486 (HSK3486)	製簾蓋繭製簾鹹壓製簾 = 製製鬱積積醖鑰衊簾築遞獵艱鑰築繭繭選觸鏇 (艱襯積網餘廠膚獵鑰醖, 廠鏇糧鏇壓夢築衊鏇衊 ~ 鹽遞憲觸鏇夢鏇鑰鑰蓋) 更多	-	2023-05-26
				Propofol (Propofol)	製簾蓋繭製簾鹹壓製簾 = 鑰繭獵淵齋鏇鏇構衊齋遞獵艱鑰築繭繭選觸鏇 (艱襯積網餘廠膚獵鑰醖, 夢膚窪廠夢鹽構鹹淵壓 ~ 繭齋衊鑰築鏇襯築觸鏇) 更多