Testosterone Undecanoate

作者：高恒 当股价涨停，背后却是一种“隐秘疾病”：长春高新与一个没人愿公开谈论的市场。 2月25日，长春高新涨停，报97.26元/股；2月26日午间，公司股价继续上行至100.89元/股，总市值411.57亿元。触发资金情绪的，并不是业绩反转，也不是并购，而是一份药监局批件——子公司金赛药业的GenSci141双氢睾酮软膏获国家药监局批准开展临床试验，适应症为儿童小阴茎。 如果只看资本市场，这是一条典型“创新药进展”新闻。但真正值得注意的是：这并不是一个新药赛道，而是一个此前几乎没有被商业化的医疗需求第一次被正式定义。 儿童小阴茎并非舆论想象中的罕见状况。医学定义为在生殖器结构正常的前提下，阴茎伸展长度低于同年龄平均值2.5个标准差以上。根据《中国小儿隐匿性阴茎临床处理专家共识（2023）》，近十年门诊观察显示国内发病率呈上升趋势；相关研究还发现，62.7%的患者在儿童期即出现焦虑，37.3%在青春期才明显焦虑。若在青春期前未纠正，成年后可能出现持续的性心理障碍。 关键问题在于治疗路径。当前治疗手段包括手术、心理干预及药物，其中核心是外源性雄激素（睾酮及其衍生物），如庚酸睾酮、十一酸睾酮、双氢睾酮凝胶。但一个决定性的事实是：这些用药长期属于“超说明书使用”，即临床在用，却没有任何药物专门获批该适应症。 这正是市场关注GenSci141的原因。双氢睾酮对雄激素受体亲和力高于睾酮，且不会被芳香化，不会促进骨成熟和男性乳房发育，从理论上可避免高剂量睾酮的不良反应。更重要的是，目前全球范围内尚无针对儿童小阴茎的获批药物。分析师普遍判断，如果研发顺利，它可能成为全球首个对应适应症产品。当然，从临床试验到上市仍需完成Ⅰ、Ⅱ、Ⅲ期试验与审评审批，研发不确定性依然很高。 资本之所以敏感，还因为公司正处于业绩压力期。2022—2024年，长春高新营收分别为126.27亿元、145.66亿元、134.66亿元；归母净利润分别为41.4亿元、45.32亿元、25.83亿元。2024年净利润同比下滑43.01%。公司预计2025年归母净利润仅1.5亿—2.2亿元，同比下降约91%—94%。 原因并不复杂：过去十多年，公司依赖生长激素业务。金赛药业的长效生长激素“金赛增”曾拥有近十年市场独占期，但随着集采政策与竞争加剧，增长逻辑开始动摇。弗若斯特沙利文数据显示，中国生长激素市场规模已由2018年的40亿元增长至2023年的116亿元，但竞争者也在进入，诺和诺德、特宝生物、维昇药业的长效产品已陆续获批。 另一方面，在国内创新药企BD（商务拓展）出海热潮下，2025年12月，金赛药业全资子公司赛增医疗与美国生物医药公司Yarrow Bioscience, Inc.正式签署独家许可协议，Yarrow获得金赛药业自主研发的人源化促甲状腺激素受体（TSHR）拮抗型单克隆抗体GenSci098（YB-101）在大中华区以外的全球独家开发、生产及商业化权利。 根据协议，赛增医疗将获得1.2亿美元首付款及近期开发里程碑款项，其中包含7000万美元不可退还、不可抵扣的首付款，以及后续5000万美元的近期开发里程碑款项；若GenSci098在临床开发、注册及商业化等阶段达到预期目标，赛增医疗最多可额外获得13.65亿美元里程碑付款，产品上市后还可享受超过净销售额10%的销售提成。换句话说，市场真正押注的是一件事：一家依赖单一重磅产品的公司，能否通过创新药重新建立增长逻辑。 这条新闻的特殊之处在于，它既是医药研发事件，也是社会心理事件。一个长期被隐匿的儿童发育问题被医学正式命名、被资本定价。当某种焦虑被纳入临床诊断，它就不再只是个体困扰，而成为医疗体系的一部分。 股价涨停，表面是药物进展，深层则是资本对“未被满足需求”的预期投票。

SALT LAKE CITY, Feb. 18, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the last patient has completed the final study visit (Last Patient Last Visit) in its Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). The randomized, double-blind, placebo-controlled study enrolled a total of 90 patients with severe PPD, having an average baseline Hamilton depression rating scale (HAM-D) of 28.3. LPCN 1154 has shown a positive safety profile, with all reported nervous system adverse events being mild to moderate in severity. Furthermore, there were no instances of drug discontinuation, excessive sedation, loss of consciousness, or drug-related serious adverse events. "We are encouraged by the high study drug compliance and safety profile observed in this study. which we believe to be attributable to the short, 48-hour treatment duration, coupled with the regimen's ease of use and tolerability," said Mahesh Patel, CEO of Lipocine. "Provided the efficacy results are positive, the established safety profile could promote greater willingness among healthcare professionals to prescribe LPCN 1154 as a patient-centric treatment option for women suffering from postpartum depression." Postpartum depression is a serious condition affecting a significant number of new mothers and can be life-threatening if left untreated. Existing treatment options are often limited by access to care, burdensome administration, or tolerability challenges, and may take weeks to months to provide relief. LPCN 1154 is designed to address these limitations with a differentiated profile that may deliver faster symptom relief, a shorter course of treatment, and better tolerability in a convenient oral medication taken at home. The Phase 3 trial design is informed by a strong foundation of clinical and translational evidence. Brexanolone has demonstrated established antidepressant efficacy in multiple intravenous infusion studies, including the pivotal Phase 3 program that supported approval of Zulresso™ for PPD. LPCN 1154 achieved bio-equivalent systemic exposure to the intravenous Brexanolone. In addition, the current study aligns closely with the Zulresso registrational trials with respect to patient population (women with severe PPD and similar baseline HAM-D scores), treatment duration, sample size, and the primary efficacy endpoint (change from baseline in HAM-D score at Hour 60). About the Phase 3 Study The pivotal, randomized, double-blind study is evaluating LPCN 1154 compared to placebo in women aged 15 years and older diagnosed with severe PPD. Following feedback from the U.S. Food and Drug Administration (FDA), this single confirmatory trial was conducted in an outpatient setting and administration of LPCN 1154 does not require medical monitoring by a healthcare provider. Nineteen clinical sites across the United States participated. Data from this Phase 3 trial are expected to support a 505(b)(2) NDA submission for LPCN 1154 in 2026. For more information about the phase 3 study, refer to clinicaltrials.gov: NCT06979544. About LPCN 1154 LPCN 1154 is an oral formulation of brexanolone being developed to provide rapid relief of postpartum depression in a convenient, at-home treatment. It has potential as first line treatment choice for women with PPD. It also has characteristics that could be particularly beneficial to patients with severe PPD (including those with elevated suicide risk) for whom rapid improvement is a priority. LPCN 1154 is expected to offer a compelling safety profile for breastfeeding mothers. Data from a qEEG study in healthy volunteers demonstrated target engagement consistent with robust central nervous system (CNS) activity, with concentration- and time-dependent post-dose changes in qEEG. About Postpartum Depression and Unmet Needs PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting up to 12 months after childbirth. Hormonal changes leading to GABA dysfunction are common in depression and pregnancy. Symptoms of PPD include hallmarks of major depression, including, but not limited to, sadness, depressed mood, loss of interest, change in appetite, insomnia, sleeping too much, fatigue, difficulty thinking/concentrating, excessive crying, fear of harming the baby/oneself, and/or thoughts of death or suicide. Further, obstetricians are comfortable making a diagnosis and prescribing antidepressants for PPD. Traditional antidepressants, not approved for PPD, have slow onset of action, side effects such as weight gain, and do not demonstrate adequate remission. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. As of January 30, 2026, the Company had cash and cash equivalents of approximately $19 million. Lipocine's development pipeline includes: LPCN 1154 for the treatment of postpartum depression, LPCN 2201 for treatment of major depressive disorder, LPCN 2101 for the treatment of epilepsy, LPCN 2203 targeted for the management of essential tremor, LPCN 2401 as an aid for improved body composition in obesity management, LPCN 1148 targeted for the management of symptoms associated with liver cirrhosis, and LPCN 1107 our candidate for prevention of preterm birth. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit . Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our Phase 3 safety and efficacy study relating to LPCN 1154, including the timing and potential results of the study, and the potential uses and benefits of our product candidates, including the impact of LPCN 1154 on the treatment of PPD. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete the development processes for our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our assets, safety and efficacy studies, including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. 21% more press release views with Request a Demo