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更新于：2026-10-19

Levonorgestrel

左炔诺孕酮

更新于：2026-10-19

概要

基本信息

药物类型

小分子化药

别名

(-)-13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one、13-beta-Ethyl-17alpha-ethynyl-17beta-hydroxygon-4-en-3-one、13-Ethyl-17-alpha-ethynyl-17-beta-hydroxy-4-gonen-3-one

+ [53]

靶点

作用方式

激动剂

作用机制

PR激动剂(孕激素受体激动剂)

治疗领域

泌尿生殖系统疾病其他疾病

在研适应症

月经紊乱月经过多避孕

非在研适应症

痛经子宫内膜增生子宫内膜异位症+ [3]

原研机构

The Population Council, Inc.

在研机构

Medicines 360

华润紫竹药业有限公司Bayer Healthcare LLC

+ [9]

非在研机构

Bayer AGWyeth AB

简柏特（佛山）信息技术服务有限公司

+ [4]

权益机构-

最高研发阶段批准上市

首次获批日期

美国 (1990-12-10),

避孕

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)

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结构/序列

分子式C21H28O2

InChIKeyWWYNJERNGUHSAO-XUDSTZEESA-N

CAS号797-63-7

关联

308

项与左炔诺孕酮相关的临床试验

NCT07449299

/ Not yet recruiting临床3期IIT

Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel

This randomized controlled trial will test oral levonorgestrel + piroxicam vs. levonorgestrel + placebo for emergency contraception in a representative U.S. population that has higher pregnancy risk than in the prior study because of higher weights, different intercourse patterns, and different clinic accessibility. Data from this project will inform clinical practice in the U.S. and beyond for those desiring the most effective method of emergency contraception pills.

开始日期2027-03-01

申办/合作机构

University of Utah

NCT07734155

/ Not yet recruiting临床3期

Prospective, Multicenter, Open-label and Non-randomized Trial on Contraceptive Efficacy, Safety and Tolerability of LVS (Levonorgestrel Vaginal System) During 13 Cycles

The goal of this clinical trial is to learn if drug levonorgestrel vaginal ring works as a contraceptive adult and adolescent females who are able to conceive (i.e. get pregnant). It will also learn about the safety and tolerability of levonorgestrel vaginal ring. The main questions it aims to answer are:
Does drug levonorgestrel vaginal ring lower the number of pregnancies with continued use? What adverse effects do participants experience by using levonorestrel vaginal ring? Researchers will count the number of pregnancies with levonorgestrel vaginal ring after a participant uses it for a year to see if the number of pregnancies is low (i.e. women and girls do not get pregnant).
Participants will:
Use levonorgestrel vaginal ring for 28 days (called one cycle); for a total of 14 cycles (which is a little more than year) Visit the clinic about 8 to 10 times over about 14 months for checkups and tests with an additional approximately 13 phone calls Keep a diary of their pregnancies and number of times they use additional contraceptive (e.g. condoms)

开始日期2026-12-01

申办/合作机构

Chemo Research SL

CTIS2025-523877-40-00

/ Recruiting临床2期IIT

TREAT-EC (Tirzepatide in the treatment of endometrial cancer) - a clinical trial

开始日期2026-10-15

申办/合作机构

University College Dublin

100 项与左炔诺孕酮相关的临床结果

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100 项与左炔诺孕酮相关的转化医学

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100 项与左炔诺孕酮相关的专利（医药）

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6,445

项与左炔诺孕酮相关的文献（医药）

2027-01-01·ARCHIVES OF MEDICAL RESEARCH

Effects of Progestins and Progesterone Receptor Modulators Used for Emergency Contraception on Endometrial Gene Expression and Implantation

Review

作者: Larrea, Fernando ; Basurto-Serrano, Jorge A ; Morales-Esponda, Mario ; Chirinos, Mayel

The human endometrium responds to progesterone, including emergency contraception (EC) drugs such as levonorgestrel (LNG), mifepristone, and ulipristal acetate (UPA). Here, we investigated gene expression during the window of implantation (WOI) in mammals and compared it with that of women receiving LNG, UPA, and mifepristone across a wide variety of experimental models and conditions. Evidence from in vivo models, ex vivo endometrial platforms, embryo-endometrium co-cultures, and stem cell-derived trophoblast systems is presented. The findings from single-cell and spatial transcriptomic studies were synthesized narratively. We focused on clinical outcomes and functional implantation-related endpoints, while viewing molecular signatures as supportive mechanistic evidence. The evidence indicates that human endometrial WOI is governed by a progesterone-driven receptivity signature (PAEP, SPP1, LIF, HOXA10/11, IGFBP1) conserved across placental mammals. Post-ovulatory LNG left transcriptomic and receptivity markers unchanged. UPA suppressed progesterone-regulated genes, opposing the ERA receptive signature. Mifepristone suppressed receptivity and exerted embryotoxic effects in preclinical studies. The evidence supports the conclusion that, when administered post-ovulation, LNG, UPA, and mifepristone exert distinct endometrial effects that cannot be reduced to a single mechanism of action. Available evidence indicates that LNG at EC doses has minimal impact on endometrial receptivity. UPA, at EC doses, alters progesterone-regulated endometrial gene expression relevant to endometrial embryo implantation processes. Mifepristone suppresses pathways associated with endometrial receptivity and exhibits direct embryotoxic effects in preclinical models at concentrations exceeding those used clinically. In summary, LNG exerts negligible effects on endometrial molecular processes. In contrast, UPA and mifepristone both meaningfully disrupt progesterone-dependent endometrial processes.

2026-12-31·GYNECOLOGICAL ENDOCRINOLOGY

Dydrogesterone versus levonorgestrel-releasing intrauterine system for abnormal uterine bleeding: a propensity score-matched analysis of long-term efficacy and recurrence

Article

作者: Wei, Xiaoli ; Huang, Li ; Li, Xiangzun

OBJECTIVE:

To compare dydrogesterone versus levonorgestrel-releasing intrauterine system (LNG-IUS) for abnormal uterine bleeding (AUB) management with long-term follow-up and etiology-stratified analysis.

METHODS:

This single-center retrospective cohort study analyzed reproductive-aged women with International Federation of Gynecology and Obstetrics (FIGO)-classified AUB receiving dydrogesterone (n = 131) or LNG-IUS (n = 118). Propensity score matching balanced baseline covariates between groups (n = 104 pairs). Primary outcomes were bleeding control rates (composite: hemoglobin increase ≥ 1.5 g/dL, ≥ 50% Pictorial Blood Loss Assessment Chart [PBAC] reduction, no rescue interventions) at 3 and 12 months. Secondary outcomes included 24-month recurrence and adverse events (AEs).

RESULTS:

LNG-IUS demonstrated superior 3-month bleeding control versus dydrogesterone (82.7% vs. 65.4%; relative risk [RR] 1.26, 95% confidence interval [CI] 1.08-1.48; p = 0.002). At 12 months, bleeding control rates were comparable between groups (78.8% vs. 72.1%; RR 1.09, 95% CI 0.96-1.24; p = 0.17). LNG-IUS significantly reduced 24-month recurrence risk (hazard ratio [HR] 0.48, 95% CI 0.32-0.72; p < 0.001), particularly for structural AUB (HR 0.39, 95% CI 0.24-0.64). Subgroup analysis revealed LNG-IUS superiority in adenomyosis at 12 months (88.2% vs. 60.0%; RR 1.47, 95% CI 1.24-1.74; p < 0.001) but comparable efficacy in nonstructural AUB (76.6% vs. 72.9%; RR 0.95, 95% CI 0.78-1.16; p = 0.63). Dydrogesterone exhibited higher systemic AEs (28.2% vs. 13.6%; p = 0.003), while LNG-IUS had device-related events including expulsion (5.1%).

CONCLUSION:

LNG-IUS offers superior short-term bleeding control and sustained long-term recurrence prevention, especially for structural AUB. Dydrogesterone effectively manages nonstructural etiologies but carries higher systemic adverse event rates. Treatment selection should be etiology-guided, balancing immediate symptom control versus recurrence prevention and individualized safety considerations.

2026-12-31·GYNECOLOGICAL ENDOCRINOLOGY

Progestin therapy in premenopausal women with incidental meningioma—a narrative review and recommendations for women's health specialists

Review

作者: Vibert, Jonas ; Merki-Feld, Gabriele ; Roth, Mareike ; Weidlinger, Susanna ; Pluchino, Nicola ; Gobrecht, Ursula ; Pape, Janna

OBJECTIVE:

To review recent evidence on the association between progestin exposure and meningioma risk and to propose practical recommendations for hormonal management in women requiring progestin therapy.

METHODS:

A narrative review of studies published between 2015 and 2025 evaluating the relationship between exogenous progestins and meningioma development, growth, or progression was performed. Evidence regarding different progestin compounds, cumulative exposure, reversibility after discontinuation, and implications for gynecologic practice was analyzed.

RESULTS:

Meningiomas account for more than one-third of intracranial tumors and occur two to three times more frequently in women, supporting a potential hormonal influence mediated by progesterone receptors, which are expressed in most tumors. The increasing use of MRI has led to more frequent detection of incidental meningiomas in premenopausal women using progestins for contraception or gynecologic conditions such as endometriosis and heavy menstrual bleeding. Consistent associations with increased meningioma risk were observed for high-dose or prolonged exposure to cyproterone acetate, chlormadinone acetate, nomegestrol acetate, and medroxyprogesterone acetate. Risk appeared to increase with cumulative exposure and decrease after treatment discontinuation. Evidence for other progestins, including desogestrel, dienogest, levonorgestrel, and the levonorgestrel-releasing intrauterine system, remains limited and less conclusive.

CONCLUSIONS:

Women's health specialists should systematically assess a history of meningioma before prescribing progestins. In patients with incidental meningioma, discontinuation of high-risk progestins should be considered, followed by MRI reassessment within 3-6 months. When hormonal treatment remains necessary, the lowest effective dose and regular neuro-oncologic monitoring are recommended. Increased awareness and individualized counseling are essential to optimize hormonal management in women at risk of meningioma.

354

项与左炔诺孕酮相关的新闻（医药）

2026-10-11

·微信

又一款避孕药上市被拒

近期，国家药监局发布的通知件显示，吉瑞医药申报的进口新药左炔诺孕酮口崩片未被批准上市；该品种此前在参比制剂审议中也曾因“不具有明显临床优势”未获通过。避孕药自上世纪60年代商业化以来，已形成复方口服、单孕激素、紧急补救、长效缓释等成熟体系。但改剂型并不意味着带来新的临床获益，此次受挫也提示避孕药改良研发需要更充分的临床优势证据。当前全球避孕药物仍以女性激素制剂为主，男性可逆避孕尚未实现商业化突破。随着技术迭代和需求多元化，男性避孕赛道正迎来新的研发与资本关注，行业格局可能迎来结构性变化。 01 避孕药发展史全球激素类避孕药产业起步于20世纪50年代，彼时全球缺乏安全、便捷、可自主掌控的避孕手段，非意愿妊娠公共卫生问题突出。1961年，全球首款复方口服避孕药Enovid获FDA批准上市，标志着药物避孕时代正式开启。国内紧跟全球研发节奏，1963年启动口服避孕药自主研发工作，1967年国产口服避孕药1号、2号完成鉴定，实现激素类避孕药国产化。复方口服避孕药（COC）是女性避孕药物的核心品类，历经六十余年发展已升级到第四代产品，整体安全性与耐受性实现跨越式提升。而其迭代的核心逻辑是在保证避孕效果前提下持续降低雌激素剂量、优化孕激素结构，减少不良反应。数据来源：药智数据、公开数据整理 COC给药方案也同步完成精细化优化，从传统28天自然周期，迭代为21天服药+7天停药方案，进一步升级为24天服药+4天短间隔停药模式，有效缩短激素空白周期，降低激素剧烈波动引发的经期不适、不规则出血等问题。同时，为解决COC漏服率高、依从性不足的临床痛点，长效缓释剂型逐步成为行业重要研发方向。自上世纪90年代起，激素类长效注射剂、皮下埋植剂、宫内缓释系统、阴道环、透皮贴片等新型剂型陆续实现海外获批上市。长效缓释制剂依托局部持续释药机制，摆脱每日服药限制，大幅提升长期避孕依从性。其中，皮下埋植剂、宫内缓释系统、长效注射剂已在国内实现获批应用，纳入公共卫生避孕体系；而透皮贴片等创新缓释剂型，目前仅在欧美市场商业化落地，国内尚未获批上市。数据来源：药智数据、公开资料整理此外，据不完全统计全球监管机构还批准了两款非激素类避孕药，即Phexxi/Amphora、Vasalisib，其中Phexxi/Amphora通过L-乳酸/柠檬酸/酒石酸钾维持阴道酸性环境（pH 3.5-4.5），形成对精子不友好的环境以杀灭精子，2020年被FDA批准作为一种按需避孕方法，用于有生殖潜能的女性预防怀孕。 Vasalisib是全球首款获批的非激素口服避孕药，通过选择性抑制精子表面的CATSPER钙离子通道，抑制精子获能和超活化运动，从而降低精子活力，阻止其与卵子结合，2025年获FDA批准。目前，Phexxi/Amphora和Vasalisib未在国内获批。整体来看，女性激素类避孕药物已完成从高剂量、高副作用单一口服剂型，向低剂量、高安全、多途径缓释的全品类迭代。但纵观产业发展史，所有商业化可逆避孕药物均针对女性开发，男性仅依靠物理避孕、结扎手术实现生育干预，尚无任何可逆性男性避孕药物获批上市。 02 市场格局与产品现状避孕市场整体可以划分为器械避孕与药物避孕两大板块，其中器械类产品占据市场大盘，避孕药作为生殖健康刚需，依托育龄群体的稳定基数，保持稳健增长。据Mordor Intelligence行业报告数据，2026年全球避孕药物与器械整体市场规模为290.4亿美元，预计2031年达到405.3亿美元，2026-2031年复合年增长率为6.8%。当前全球商业化避孕药物高度集中于女性赛道，已形成复方口服、单孕激素、紧急补救、长效缓释多维度产品矩阵，其中海外成熟市场已完成全剂型商业化布局，国内以短效口服、紧急避孕、基础长效制剂为主，创新缓释剂型布局存在明显短板。区域维度来看，欧美市场依托消费升级趋势，终端用户对长效、便捷、高安全性的创新剂型付费意愿充足，驱动行业持续高端化迭代。亚太、非洲等新兴市场需求侧重性价比与实用性，市场主流仍为低成本仿制药及基础长效避孕制剂，剂型创新渗透速度相对缓慢。从企业竞争格局来看，海外原研药企垄断高端创新剂型市场。拜耳凭借优思明、优思悦、曼月乐三大核心产品，稳居全球复方口服及宫内缓释赛道龙头；欧加隆、Viatris、默克分别布局经典口服制剂、新型透皮贴片、阴道环等细分赛道，形成差异化竞争。在国内，避孕药市场国产化替代趋势显著，华润紫竹等本土龙头企业在紧急避孕和短效口服避孕药领域占据主导地位，并逐步向长效剂型拓展；浙江仙琚、广州朗圣等企业通过深耕仿制药赛道，在基础避孕药物（如左炔诺孕酮）的国产替代中发挥了重要作用。当前，短效口服避孕药和紧急避孕药因使用便捷、场景适配度高，仍是市场消费主力，而新型缓释剂型（长效）因使用门槛和消费者认知等因素，整体渗透率仍偏低。整体来看，目前避孕药品类完善、应用成熟，但该领域还存在显著未满足临床需求。其中COC存在一定的血栓风险，高血压（≥160/100mmHg）、吸烟（≥35岁且每日≥15支）及血栓病史人群属于绝对禁忌或高风险慎用人群，需严格遵医嘱评估。单孕激素制剂适配雌激素不耐受人群，但部分使用者可能出现不规则出血或月经紊乱等不良反应。紧急避孕药仅可作为事后补救手段，频繁使用会严重扰乱内分泌，无法常规应用。各类长效缓释制剂（如皮下埋植剂、宫内缓释系统）依从性优势突出，但皮下、宫腔植入类剂型存在侵入性操作门槛，患者接受度有限。 03 在研避孕药前沿进展目前，女性激素类避孕药已进入技术瓶颈，研发方向集中于超低剂量激素优化、短无激素间期方案、新型缓释给药系统改良。其中上海市生物医药技术研究院研发的全球首创2.2类改良型新药“注射用左炔诺孕酮微球”于2025年12月在国内获批临床。同时，针对女性的非激素类避孕药也在研发中。拜耳的Ovaprene进展较快，目前正在开展3期临床。该药是一款有效、每月1次、阴道内使用且不需要在性交过程中使用的避孕产品，通过释放一种局部作用的非激素成分（葡萄糖酸亚铁）来阻止精子运动，并形成编织物样聚合物阻隔层（knitted polymer barrier）阻止精子进入子宫颈管，从而起到避孕效果。男性可逆避孕是全球生殖健康领域的创新空白赛道，目前全球在研管线分为激素类、非激素类小分子、物理阻断三大技术路线，核心在研品种如下：数据来源：药智数据、公开资料整理激素类管线技术成熟度最高、临床进展最快，是短期内最有望实现商业化的路线。其中NES/T外用凝胶完成大样本2b期临床试验，数据证实避孕有效性与生育可逆性。今年6月，Contraline完成9250万美元B轮融资，重点支持NES/T外用凝胶的开发，其有望成为全球首款获批的男性避孕药物。非激素类小分子药物、可降解物理阻断制剂属于长期创新方向，通过规避全身激素干预，实现高安全、高可逆、低副作用的避孕效果，更贴合临床长期用药需求。多条管线形成“短期外用、中长期注射、长期口服”的产品梯队，可适配不同人群避孕周期需求。整体来看，男性避孕药物已从基础研究进入临床收获前夜，但受社会认知、临床普及、医保政策等因素影响，即便产品成功获批，市场渗透仍将是长期渐进过程。 04 结语纵观全球避孕药产业，女性避孕药物历经数十年迭代，已形成品类齐全、技术成熟的产品体系，但行业创新陷入改良有余、突破不足的瓶颈，长期依赖剂型与剂量优化，无颠覆性技术落地。相较女性赛道的红海内卷，男性可逆避孕药物是生殖健康领域确定性最高的蓝海赛道。随着多条前沿管线进入临床后期，男性避孕有望实现从0到1的商业化突破，彻底改变全球避孕责任分配格局与行业竞争逻辑。信息来源：药智网往期推荐 ! 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。喜欢的点个“看一看”和"喜欢"吧不然微信推送规则改变，有可能每天都会错过我们哦~

2026-10-06

·PRNewswire

Mint Pharmaceuticals Inc. and Bayer Inc. Expand Distribution Partnership in Canada

Expanded collaboration supports continued Canadian access to Bayer medicines across cardiovascular and women's health portfolios. MISSISSAUGA, ON, Oct. 6, 2026 /PRNewswire/ -- Mint Pharmaceuticals Inc. is pleased to announce the expansion of its distribution partnership with Bayer Inc. to include ANGELIQ® (drospirenone and estradiol-17β tablets), CLIMARA® 25, CLIMARA® 50 and CLIMARA® 75 (estradiol hemihydrate transdermal systems), TRIQUILAR® 21 and TRIQUILAR® 28 (levonorgestrel and ethinyl estradiol tablets), and XARELTO® (rivaroxaban granules for oral suspension) in Canada. The expanded collaboration builds on the companies' existing relationship and shared commitment to reliable access to medicines for Canadian patients and healthcare professionals. Continue Reading Olenka Crewe, VP of Business Development & Scientific Affairs, Mint Pharmaceuticals, Jaiveer Singh, CEO, Mint Pharmaceuticals, Viktoria Friedrich, President and CEO of Bayer Inc. in Canada. Jennifer Lloyd, Head of Finance, Pharmaceutical Division, Bayer Inc. (CNW Group/Mint Pharmaceuticals) The partnership was originally established to support the Canadian distribution of Bayer's ADALAT® XL® (nifedipine extended-release tablets), an antihypertensive / antianginal medicine. The addition of ANGELIQ®, CLIMARA®, TRIQUILAR®, and XARELTO® extends the collaboration across a broader range of therapeutic areas while maintaining the companies' focus on dependable supply and continuity of care. "Ensuring Canadian patients and healthcare professionals can rely on consistent access to established medicines is central to Mint's mission," said Jaiveer Singh, Chief Executive Officer of Mint Pharmaceuticals. "Expanding our work with Bayer allows us to apply Mint's resilient supply chain and nationwide distribution capabilities across a broader portfolio, while advancing our mutual focus on reliability, quality and patient care." "We are pleased to expand our partnership with Mint Pharmaceuticals Inc., building on a trusted collaboration rooted in quality, reliability and a shared commitment to patient care," said Viktoria Friedrich, President and CEO of Bayer Inc. in Canada. "By broadening this partnership across additional Bayer medicines, we can continue to leverage Mint's strong Canadian distribution network and market expertise to help ensure these treatments remain accessible to healthcare professionals and patients who rely on them." Through this expanded partnership, Mint Pharmaceuticals and Bayer Inc. aim to maintain high standards of distribution and supply continuity across the portfolio, helping ensure that healthcare professionals and patients across Canada have timely access to these medicines. About Mint Pharmaceuticals Mint Pharmaceuticals is a leading Canadian-owned and operated manufacturer of high-quality, affordable generic medicines. Mint has built one of the strongest and most resilient pharmaceutical supply chains in the country, helping safeguard patient access by averting 25 national drug shortages across 16 essential medicines in the last decade. The company has been recognized by Deloitte as one of Canada's Best Managed Companies for eight consecutive years, achieving Platinum Club status in 2025, and is a member company of the Canadian Generic Pharmaceutical Association (CGPA). About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Find more information at and at . SOURCE Mint Pharmaceuticals 21% more press release views with Request a Demo

2026-09-28

·贝壳社

拿下多个市占率第一，这一"龙头"药企开启申购

9月28日，联亚药业（301569）开启创业板申购，发行价7元/股，拟募资约9.36亿元。 1 缓控释制剂联亚药业成立于2005年，主要从事复杂药物制剂的研发、生产和销售，目前产品主要包括以不同类型的缓控释制剂以及低剂量药物制剂为代表的两大类高端仿制药。缓控释制剂是指在规定释放介质中以及服药后在体内按要求缓慢并相对持久释放的药物制剂，通常通过骨架型、膜控型、渗透泵、植入剂等较复杂的制剂工艺来实现缓控释。根据Specialty Generics Market的数据，2025年包括缓控释制剂、经皮给药技术等复杂剂型以及复杂活性成分的特色药物全球市场规模达892亿美元，并预计于2034年进一步增长至1876亿美元，2026至2034复合增长率为8.36%。慢病患者需要长期用药，与普通剂型相比，缓控释制剂的给药频率低，可降低血药浓度的峰谷波动、减低与血药峰值相关的毒副作用，显著提高患者依从性。美国是该市场最核心的战场之一，据统计，2024年美国缓控释药物市场规模达183亿美元。中国市场也在快速跟进。2025年国内药物缓释制剂行业销售收入达327.6亿元，同比增长12.4%，增速高于化学药制剂行业整体水平。此外，集采政策正加速行业洗牌，已有近20个个缓释制剂品种纳入国家集采，其中，硝苯地平控释片降价58%，美托洛尔缓释片降价53%。集采后头部企业（如齐鲁、科伦、扬子江等）通过中标获得了更大的市场份额，市占率有所提升，行业正从分散走向集中。招股书显示，联亚药业近三年保持了稳健增长，2023-2025年，联亚药业营业收入分别为7.00亿元、8.66亿元及8.95亿元，归母净利润分别为1.16亿元、2.60亿元及2.28亿元。境外收入占60%以上。 2023-2025年营收年均复合增速13.1%。2026年上半年，联亚药业营收4.92亿元，同比增长11.59%，归母净利润1.41亿元，同比增长36.80%。 2 双轮驱动截至2026年3月末，联亚药业已有48个自研产品获FDA批准上市，1个产品在加拿大获批，适应症包括高血压、冠心病、糖尿病及女性避孕等。硝苯地平两款缓释片、地尔硫卓缓释胶囊美国市占率均列第一。同时，联亚药业正在加速拓展国内市场，截至2026年3月末，已有琥珀酸美托洛尔缓释片、盐酸二甲双胍缓释片（III）、富马酸喹硫平缓释片、左炔诺孕酮片及盐酸美金刚缓释胶囊等12个产品获NMPA批准上市，另有消化系统缓释片DG-062等5个产品处于CDE审评阶段。其中，琥珀酸美托洛尔缓释片、富马酸喹硫平缓释片已纳入集采。琥珀酸美托洛尔缓释片主要用于治疗高血压、心绞痛以及伴有左心室收缩功能异常的症状稳定的慢性心力衰竭等。根据IMS数据库的数据显示，2025年联亚药业琥珀酸美托洛尔缓释片在美国的市场占有率为15.0%，排名第二。目前在国内市场，该药品仍然主要依赖进口，2025年阿斯利康的琥珀酸美托洛尔缓释片占国内该药品市场份额的58.0%，进口替代市场空间较大。硝苯地平缓释片主要用于治疗高血压以及慢性稳定型心绞痛（劳累性心绞痛）等，主要作用机制为阻断血管平滑肌细胞上的L型钙离子通道以达到扩张血管降低血压的目的，是世界卫生组织推荐的高血压一线用药。联亚药业获FDA批准的硝苯地平缓释片包括硝苯地平缓释片（AB1）和硝苯地平缓释片（AB2）两种产品，其中硝苯地平缓释片（AB1）原研药为拜耳开发的每日1次缓释制剂，商品名为Adalat-CC。硝苯地平缓释片（AB2）原研药为辉瑞开发的每日1次控释制剂，商品名为ProcardiaXL，使用渗透泵技术制备。根据IMS数据库，2025年联亚药业的硝苯地平缓释片（AB1）在美国的市场占有率为65.9%，市场占有率第一；硝苯地平缓释片（AB2）在美国的市场占有率为75.7%，市场占有率第一。低剂量药物制剂中主要包含口服避孕药、结合雌激素缓释片，其中，联亚药业的结合雌激素缓释片为首仿药品，已获批上市。目前，联亚药业境外以美国市场为基本盘，境内借助集采实现放量。此外，联亚药业还提供创新药物产品的处方工艺开发等CRO服务，形成了"产品销售+技术输出"的双增长曲线。整体来看，联亚药业是国内少数在缓控释制剂赛道实现规模化出海的药企。随着企业上市，期待接下来的表现。往期推荐 1 贝壳观察：行业观察 2 贝壳时刻 *声明：本文仅用于分享，不构成任何投资建议，且非治疗方案推荐。素材来源官方媒体/网络新闻关于贝壳社贝壳社（Bioclub）是行业领先的医健创新创业服务平台，构建了"产业空间+ 创业培育+投资孵化+资本赋能"四位一体为核心，叠加"品牌媒体+医学成果转化"，形成"4+2"全链路赋能业务体系，通过深度挖掘全球范围内的高成长项目、精准匹配产业资源及全球生态网络，覆盖企业从孵化培育到加速发展的全周期赋能服务。目前已在上海、杭州、香港、澳洲墨尔本四大核心城市设立办公室与服务中心，国际化布局完善，积极推进境外业务深耕拓展，搭建成熟全球化服务网络，全方位助力医健企业实现跨境发展与国际化落地。贝壳社以加速科学技术成果转化与产业升级为目标，致力于成为医健领域的孵化器、加速器、连接器。

100 项与左炔诺孕酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00950	左炔诺孕酮	G03AC03 G03AD01	DB00367

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
月经紊乱	日本	Bayer Yakuhin Ltd.	2014-11-18
月经过多	美国	Bayer Healthcare LLC	2000-12-06
月经过多	美国	Bayer HealthCare Pharmaceuticals, Inc.	2000-12-06
避孕	美国	The Population Council, Inc.	1990-12-10
避孕	美国	Wyeth Pharmaceuticals LLC	1990-12-10

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
子宫内膜增生	临床3期	美国	Bayer AG	2025-11-24
子宫内膜增生	临床3期	中国	Bayer AG	2025-11-24
子宫内膜增生	临床3期	加拿大	Bayer AG	2025-11-24
情绪障碍	临床3期	德国	-	2005-08-15
痛经	临床3期	美国	Teva Branded Pharmaceutical Products R&D LLC	2005-01-01
出血	临床3期	比利时	Bayer AG	2000-05-01
出血	临床3期	芬兰	Bayer AG	2000-05-01
出血	临床3期	荷兰	Bayer AG	2000-05-01
出血	临床3期	英国	Bayer AG	2000-05-01
绝经期综合征	临床3期	比利时	Bayer AG	2000-05-01

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临床结果

适应症

分期

评价

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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


NCT01686126 (feMMe, IGCS2026)	临床2期	子宫内膜样上皮内瘤变 DNA mismatch repair (MMR) status \| CTCF mutation \| microsatellite instability score ... 更多	165	levonorgestrel intrauterine device	襯餘鑰觸鹹積壓構簾鹹(鏇衊鏇網醖醖構廠蓋艱) = 糧網遞壓蓋構膚鏇選選衊齋艱觸顧鬱獵廠淵壓 (壓網獵淵艱觸構遞窪範 )	积极	2026-10-01
IGCS2026	N/A	子宫内膜癌 estrogen-receptor \| progesterone-receptor \| MSI-H ... 更多	701	Fertility-sparing progestin treatment	齋築窪網憲願製選襯憲(糧網鹹壓觸鹹餘鑰鹹鑰) = Negative progesterone-receptor expression significantly predicted poor response (P=0.01, AUC 0.806), whereas estrogen-receptor loss was not independently discriminatory (P=0.16, AUC 0.637). 鏇製廠蓋壓膚憲遞鑰齋 (窪繭遞淵構鑰遞鹹淵獵 ) 更多	积极	2026-10-01
IGCS2026	N/A		701	Fertility-sparing treatment (MSI-H/MMRd)		积极	2026-10-01
NCT06306131 (CTgov)	临床2期	肥胖	4	calcium carbonate 750 milligram (Placebo)	餘觸蓋衊廠憲艱齋繭鹹(憲築鏇淵壓選簾製築淵) = 積範簾壓窪夢構窪選齋餘觸簾壓鑰觸淵窪醖範 (顧淵願膚選窪構廠鏇襯, 1.53) 更多	-	2026-06-30
NCT06306131 (CTgov)	临床2期	肥胖	4	Levonorgestrel 1.5 milligram+Meloxicam 15 milligram (Levonorgestrel Plus Meloxicam)	餘觸蓋衊廠憲艱齋繭鹹(憲築鏇淵壓選簾製築淵) = 醖鏇製壓鬱獵顧憲鹹廠餘觸簾壓鑰觸淵窪醖範 (顧淵願膚選窪構廠鏇襯, 0) 更多	-	2026-06-30
NCT05695352 (OVULATION, CTgov)	临床2期	-	19	Placebo (Placebo Comparator in Normal Ovulatory Women)	窪鏇鑰襯糧廠鹽簾繭鬱(蓋齋壓選製製醖鏇遞淵) = 壓選廠鹹餘壓廠醖壓鹹鹽繭鏇製憲簾鏇鹽廠膚 (遞獵衊願繭餘蓋艱鏇鹹, 2.24) 更多	-	2026-06-17
NCT05695352 (OVULATION, CTgov)	临床2期	-	19	Levonorgestrel+meloxicam (Active Intervention in Normal Ovulatory Women)	窪鏇鑰襯糧廠鹽簾繭鬱(蓋齋壓選製製醖鏇遞淵) = 鑰鹽艱鹹艱窪鏇齋壓鹽鹽繭鏇製憲簾鏇鹽廠膚 (遞獵衊願繭餘蓋艱鏇鹹, 2.7) 更多	-	2026-06-17
AUA2026	N/A	避孕	54	Levonorgestrel-releasing intrauterine device (Mirena or Kyleena)	鏇膚製膚窪築鏇糧餘憲(築醖鑰積鏇鏇獵鹽鹹製) = 鬱醖廠鏇夢艱選襯鬱齋築積鹹衊鬱獵醖蓋築襯 (築觸鹹積鹹願壓衊觸蓋 ) 更多	积极	2026-05-15
NCT02882191 (CTgov)	临床2期	避孕	279	LevoCept	製廠膚餘糧艱構鬱襯選 = 鑰製醖廠餘餘糧蓋顧顧築鹹構鹽餘繭顧積遞糧 (壓網淵積製鑰遞壓蓋觸, 艱願積餘網淵願願鹹鏇 ~ 鬱餘獵壓積鑰繭夢膚憲) 更多	-	2026-04-23
ENDOIUD (ESGO2026)	N/A	子宫内膜样上皮内瘤变 \| 子宫内膜癌	78	Levonorgestrel-releasing intrauterine device	膚願繭窪範壓顧鹽夢膚(獵淵鏇醖範顧製廠夢夢) = 觸襯窪製艱範鑰膚遞衊鬱願觸鹽糧繭襯衊膚構 (憲鹽廠膚憲餘醖範夢糧 ) 更多	积极	2026-02-28
ESGO2026	N/A	子宫内膜增生	48	Levonorgestrel-releasing intrauterine system (LNG-IUS)	鬱衊顧遞鏇願選製範糧(憲鹹構廠顧膚窪鹽網選) = LNG-IUS was well tolerated, and no major adverse events were reported. 獵繭蓋鑰範夢齋糧壓餘 (壓膚蓋淵齋壓鹽鹽鹽積 )	积极	2026-02-28
ESGO2026	N/A	子宫内膜癌	6	levonorgestrel-releasing intrauterine device (LNG-IUD)	襯鏇繭積窪鏇繭鏇淵醖(窪觸願鬱簾網鹹蓋範願) = 鹽膚觸鬱鏇顧醖鏇鏇獵構憲構鹹淵簾壓獵簾襯 (廠繭蓋製襯膚製窪齋齋 )	积极	2026-02-28
NCT01166412 (CCN009, CTgov)	临床1/2期	避孕	121	levonorgestrel patch with BMI <32 kg/m2 (Dose Level AG1000-6.5)	願夢獵淵製鬱鬱製構淵 = 鏇簾積艱構遞製淵醖膚願衊壓鬱憲築糧網餘構 (觸夢襯壓網選範願廠觸, 繭襯繭簾簾憲鏇艱餘餘 ~ 憲積窪齋製簾憲構蓋窪) 更多	-	2026-01-07
NCT01166412 (CCN009, CTgov)	临床1/2期	避孕	121	levonorgestrel patch with BMI <32 kg/m2 (Dose Level AG1000-12.5)	願夢獵淵製鬱鬱製構淵 = 獵遞網範窪繭製膚夢鹽願衊壓鬱憲築糧網餘構 (觸夢襯壓網選範願廠觸, 獵糧遞鏇醖蓋淵淵膚鬱 ~ 襯鏇築淵鬱衊鹽膚壓餘) 更多	-	2026-01-07