Tranexamic Acid

多个品种被集采，缺乏后继产品，这家药企或面临退市。 业绩"变脸" 两个月内由盈转亏 3月15日，赛隆药业发布《关于公司股票交易可能被实施退市风险警示的提示性公告》 。 经赛隆药业财务部门初步测算，预计其2024年度扣除非经常性损益后的净利润为亏损2200万元-4200万元，扣除后营业收入为2.3亿元–2.5亿元。 赛隆药业是一家集医药中间体、原料药、制剂的研发、生产、营销和技术服务为一体的医药全产业链的现代化制药企业，注射剂和原料药是其主要产品，拥有包括注射用艾司奥美拉唑钠、门冬氨酸鸟氨酸注射液、注射用帕瑞昔布钠、注射用胸腺法新、阿加曲班注射液等。 1月22日，赛隆药业发布2024年业绩预告称，预计2024年归母净利润盈利450万元-650万元；扣非净利润盈利420万元-620万元。 不到两个月的时间，赛隆药业的业绩“由预盈转为预亏”。 根据《深圳证券交易所股票上市规则》第9.3.1条第（一）项规定，在披露2024年年度报告后，赛隆药业股票交易可能被深圳证券交易所实施退市风险警示（股票简称前冠以“*ST”字样）。 赛隆药业称，业绩修正主要有两个原因，一是其与年审会计师深入沟通后，结合业务实际情况，对部分销售收入确认进行再次分析，基于谨慎性原则，部分收入2024年度不予确认。预计减少收入约3963.25万元，减少毛利约3395.71万元；二是在资产减值方面，其针对部分闲置的固定资产进行减值测试，预计将补充计提资产减值准备200-450万元。 赛隆药业在1月份的业绩预告中称，扣非净利润的增长主要是其报告期内合理控制各项费用支出。值得注意的是，控费带来的盈利可持续性具有较大的不确定性。 多次修正业绩预告 此前曾收监管函 这已经不是赛隆药业第一次修正业绩预报，此前，赛隆药业对2022年业绩预告进行修正，归母净利润由亏损1500万元-2500万元，修正为亏损3500万元-4600万元。 修正的原因是，增加信用减值损失计提约600万元；调增当期收入对应的成本费用约200万元；补提资产减值损失约400万元。 深交所还曾发布监管函指出，赛隆药业预告披露的预计净利润与年度报告披露的经审计净利润相比，差异幅度较大且未及时修正。 从赛隆药业的发展来看，2020年-2022年连连亏损，净利润分别是-6722.19万元、-2334.14万元、-3731.23万元。2023年赛隆药业的业绩有所回暖，净利润达到953.37万元，同比增长125.55%。不过，如果2024年业绩发布，赛隆药业净利润为亏本，仍有被*ST的风险。 仿制药集采承压 缺乏原研产品成硬伤 截至2024年上半年，赛隆药业主要生产、销售及拥有生产批文的原料药品种13个，制剂品种17个，其中11个品种通过仿制药一致性评价，16个品种被列入《国家基本医疗保险、工伤保险和生育保险药品目录（2023版）》。 赛隆药业的产品均为仿制药，且处方药居多，院内市场是发展主力“战场”。随着集采的深入推进，其已经有多个产品被纳入，业绩承压。 照片来源：同花顺 如阿加曲班注射液、氨甲环酸注射液两个品种三个规格中标第八批国采；注射用奥美拉唑钠、米力农注射液和注射用替加环素等三个品种四个规格中标第七批国采；门冬氨酸鸟氨酸中标云南、北京地方集采；赖氨匹林中标江苏地方集采等。 赛隆药业称，要继续积极参与国家、省级联盟等各类集采，进一步优化营销中心组织架构，突出重点品种的销售占比及毛利贡献，促进销售指标达成。 在第十批国采中，湖南赛隆药业(长沙)的盐酸艾司洛尔注射液、氟尿嘧啶注射液中标，4月第十批国采就将执行，以价换量之下，最终对业绩的影响仍不确定。 严格强制退市标准 业绩差公司首当其冲 梳理发现，目前已经有不少药企股票触及终止上市的情形，包括*ST吉药、*ST大药等。 中国证监会发布《关于严格执行退市制度的意见》提出，进一步严格强制退市标准。加大绩差公司退市力度，提高亏损公司的营业收入退市指标，淘汰缺乏持续经营能力的公司；完善市值标准等交易类退市指标。 一般来看，药企股票触及终止上市的情形可能有：财务指标不达标：连续亏损或净资产持续为负；股价长期低于面值或交易所规定的最低标准；涉及财务造假、信息披露违规等行为；药企进入破产或清算程序；药企可能因私有化、并购等原因主动申请退市。 财务状况不佳是很多药企触发退市风险的主要问题，回到赛隆药业，后续如何扭亏并改善经营是关键。 来源：赛柏蓝 作者：颜色 点击 阅读原文 了解更多

Endometriosis can cause severe pain, heavy periods, fatigue, and fertility issues. Credit: LaylaBird via Getty Images. The UK’s National Institute for Health and Care (NICE) has approved Gedeon Richter’s Ryeqo (relugolix–estradiol–norethisterone), a once-daily oral treatment for endometriosis, for use on the National Health Service (NHS). The drug works by blocking gonadotrophin releasing hormone (GnRH) that contributes to endometriosis while simultaneously providing necessary hormone replacement. Unlike traditional GnRH agonists – such as Takeda’s Prostap (leuprorelin) and AstraZeneca’s Zoladex (goserelin) – which are limited to six months of use, Ryeqo can be taken until menopause. NICE estimates that around 1,000 women per year could benefit from the treatment, which has a list price of £72 per 28-day pack. Helen Knight, director of medicines evaluation at NICE, highlighted the benefits of a pill-based treatment: “Instead of travelling to clinics for injections, there is now a daily tablet that can be taken at home. The treatment can also be stopped and started more easily, which is particularly important for those planning to have children and for managing side effects.” Endometriosis, a condition where tissue similar to the womb lining grows outside the uterus, causes severe pain, heavy periods, fatigue and fertility issues. Current treatment options include pain relief, hormonal therapy, and surgery. Ryeqo is now an option for those who have previously undergone medical or surgical treatments but found alternatives like tranexamic acid, hormonal contraceptives, and intrauterine delivery systems ineffective or unsuitable. NICE’s final draft guidance emphasised the need for non-invasive, long-term treatment options for endometriosis symptoms, as there is no cure. Charities, including Endometriosis UK, welcomed the news, but noted that Ryeqo induces a state of “medical menopause” alongside hormone replacement therapy (HRT), meaning it may only be suitable for “a small proportion of the 1.5 million with the disease”. NICE reversed its previous negative stance on the drug after Gedeon Richter provided additional evidence on the drug’s effectiveness and cost-effectiveness. Ryeqo improved endometriosis-associated pain and was well tolerated compared to placebo in the Phase III SPIRIT 1 (NCT03204318) and SPIRIT 2 (NCT03204331) clinical studies, which enrolled over 1,200 women. Beyond the approval of new treatments, Endometriosis UK has called for greater investment in research to find the root cause of the disease, improve management strategies, and to develop a cure. At the Royal Society of Medicine’s Innovation in Women’s Health and Femtech meeting on 3 March 2025, McKinsey partner Anouk Petersen pointed out that despite affecting a similar proportion of the population as diabetes (about 10%), endometriosis receives eight to ten times less funding. A report from McKinsey & Company and the World Economic Forum underscored the economic impact of conditions like endometriosis, finding that while women live longer than men, they spend 25% more of their lives in debilitating health conditions. This has direct productivity consequences, with 60% of the gender health gap occurring during prime working years, contributing to 80% of the economic burden on gross domestic product (GDP). According to GlobalData’s Pharma Intelligence Center, Ryeqo is forecast to generate up to $775m in sales in 2030. GlobalData is the parent company of Pharmaceutical Technology.