Dexamethasone

地塞米松原料药垄断案终于尘埃落定。6月11日，江苏联环药业股份有限公司（简称“联环药业”）收到天津市市场监督管理委员会下发的《行政处罚决定书》，责令其停止违法行为，并处罚款合计6103.82万元。而此次被罚没的金额，占据联环药业去年超七成的净利润。三家药企累计被罚3.26亿元根据《行政处罚决定书》，天津市市场监督管理委员会认为，联环药业与具有竞争关系的经营者，以垄断协议形式变更、固定地塞米松磷酸钠原料药价格，排除、限制了地塞米松磷酸钠原料药销售领域的竞争，违反了《中华人民共和国反垄断法》相关规定，属于达成并实施“固定或者变更商品价格”垄断协议的行为，应当依据《反垄断法》第五十六条的规定依法追究法律责任。监管部门决定责令联环药业停止违法行为，没收违法所得1789.92万元，并处2023年度销售额8%的罚款6162.72万元，结合宽大情形，减免罚款额的30%，减免后实际罚款4313.9万元，以上罚没款合计6103.82万元。联环药业表示，本次罚没金额占公司合并报表范围最近一个会计年度经审计的营业收入和归属净利润的比例分别为2.83%和72.53%。上述罚没款金额将相应减少公司2025年度归属净利润6103.82万元。地塞米松磷酸钠是一种肾上腺皮质激素类药物，具有抗炎、抗过敏、抗风湿、免疫抑制作用，因被证明对新冠肺炎重症患者有疗效，被编入国内《新型冠状病毒肺炎诊疗方案》（第九版、第十版）推荐用药，用于重症新冠肺炎临床治疗。资料显示，三家药企属于国内拥有地塞米松磷酸钠注射液批文和一致性评价的企业。2021年11月20日，自然人郭相国和包括联环药业在内的四家企业代表在天津聚会，商议地塞米松磷酸钠原料药共同涨价事宜。各方达成停止价格竞争、共同涨价的口头协议，并约定于会后向市场释放涨价信息，春节后正式涨价。2022年1月，四家药企开始一致断供地塞米松磷酸钠原料药，随后将价格大幅提升。因达成并实施关于地塞米松磷酸钠原料药的垄断协议，另外两家早于联环药业收到天津市市场监督管理委员会下发的《行政处罚决定书》。三家药业因地塞米松磷酸钠原料药违反《反垄断法》合计被罚3.26亿元。研发投入增加，净利润下滑明显财务数据显示，2024年，联环药业实现营业收入21.60亿元，同比微降0.63%；实现归母净利润8416万元，同比减少37.66%；实现扣非归母净利润4986.80万元，同比下滑56.89%。今年一季度，公司增收不增利，营业收入同比增长18.78%，但归母净利润同比减少近30%。在2024年度业绩说明会上，联环药业表示，2024年净利润下滑，主要因为研发投入大幅增长，同时受医保政策、市场需求变化和市场结构调整等综合因素影响，期间费用上涨。近年来，联环药业开始逐步向高端制剂和创新药领域倾斜，布局抗肿瘤、抗老年痴呆等药物研发。研发投入也随之逐年增加，2021-2024年研发费用保持双位数增长，分别为0.66亿元、0.92亿元、1.32亿元、1.55亿元，增幅分别为51.01%、39.06%、42.95%、16.99%。研发投入的增长挤压了利润空间，联环药业多次寻求对外融资用于其创新药LH-1801均以失败告终，转而选择申请贷款推进创新药研发，这也引发了市场对其财务状况的担忧。2022年底，联环药业提出可转债募资计划，拟募集4.5亿元，其中3.13亿元用于LH-1801，1.35亿元用于补充流动资金。不过该方案于2024年宣告终止。2024年，联环药业又推出定增计划，拟募资2.85亿元，其中，2亿元用于LH-1801，8500万元用于补充流动资金，该计划亦于今年2月宣布终止。两次募资计划终止的理由均为“市场环境变化及公司实际经营情况”。今年2月，联环药业宣布，拟向国家开发银行江苏省分行申请研发贷款，授信金额为2.4亿元，用于公司创新药LH-1801研发项目。融资渠道从股权转向债务，无疑会加重财务负担。创新药也面临激烈的行业竞争。以创新药LH-1801研发项目为例，目前进入Ⅲ期临床试验的LH-1801是SGLT2（钠-葡萄糖协同转运蛋白2）抑制剂，可联合二甲双胍治疗2型糖尿病。但国内已有多个同类药物上市销售，2017年恩格列净首次在中国获批上市；恒瑞医药的恒格列净于2021年12月获批上市；2023年6月，阿斯利康的达格列净也在国内获批上市，成为中国唯一一个每日一次、固定剂量的SGLT2抑制剂和盐酸二甲双胍缓释剂的复方制剂。超6000万元罚款占2024年归母净利润的72.53%，是否已对公司现金流、日常运营（如原材料采购、生产投入）造成压力？如何缓解短期资金紧张？公司近年向抗肿瘤、抗老年痴呆药物领域倾斜，除LH-1801外，其他在研项目的进展及商业化预期如何？研发投入持续增长但净利润下滑，是否考虑优化研发管线，聚焦高回报项目？是否有专利布局或技术壁垒以应对行业竞争？是否愿意就此次事件向行业及公众说明整改决心？针对上述问题，6月12日，新京报记者向联环药业发送采访提纲，截至发稿，未收到回复。来源：新京报作者：张兆慧点击 阅读原文了解更多

The NHS in England will be the first health system in the world to roll-out a ‘trojan horse’ targeted therapy for blood cancer patients which could halt the disease’s progression by nearly three times as long as existing treatments. Around 1,500 patients a year with multiple myeloma – an incurable cancer of the bone marrow – could now be offered belantamab mafodotin on the NHS in England, after it was approved by the National Institute for Health and Care Excellence (NICE) yesterday [12 June]. The drug will be offered to eligible patients whose cancer has progressed or not responded to first-line treatment with another drug, lenalidomide. Belantamab mafadotin – which was research and developed in the UK – is an antibody-drug conjugate, a type of treatment which targets and attaches to cancer cells. The drugs have been described by researchers as ‘trojan horses’ as they are designed to be taken up by the cancer cell, before releasing a high concentration of a lethal molecule to destroy the cell from within. Trials showed that in a broader group of patients with relapsed or refractory multiple myeloma, belantamab mafodotin (in combination with bortezomib and dexamethasone) delayed progression of the disease by an average of three years, compared to just over a year for patients taking commonly-used drug daratumumab (with bortezomib and dexamethasone). Progression-free survival data for the narrower group of patients for whom the drug is being recommended by NICE is not publicly available. NHS England is fast-tracking access to the treatment for patients from today, through immediate funding via the Cancer Drugs Fund. Eligible patients will be treated via an infusion every three weeks in combination with other cancer drugs, bortezomib (injection) and dexamethasone (orally). Paul Silvester, 60, from Sheffield, was diagnosed with myeloma in July 2023 after his cancer caused broken bones in his back and a tumour in his spine. After initial treatment failed to stop his cancer’s progression, he received belantamab mafadotin via an early access programme and was in remission within weeks. Paul was treated at the Royal Hallamshire Hospital. He said: “I feel like this treatment has brought the party balloons back in the house. It has been amazing – within the first two or three weeks, after the first dose, I was in remission. “It gives me quite a lot of confidence in the drugs and it makes me more optimistic about the future. I’ve been feeling well and I’m still quite active – that’s what’s important in terms of your quality of life. One of my daughters is graduating from university in October and it’s a goal for me to be there.” Multiple myeloma is a type of bone marrow cancer than often affects multiple parts of the body, including the spine, skull, pelvis and ribs. It is more common in men than women, adults over 60, those with a family history of the condition and is twice as common in black populations than white and Asian populations. Myeloma cannot be cured, and patients often experience multiple relapses – treatment is usually about halting the cancer for as long as possible with the least side-effects from treatment. The disease can have a significant impact on quality of life, with the possibility of relapse having a major psychological effect on patients. Each year, more than 6,000 people are diagnosed with multiple myeloma in the UK, and it is estimated there are around 33,000 people living with the cancer. Professor Peter Johnson, NHS England’s National Clinical Director for Cancer, said: “Myeloma is an aggressive type of blood cancer, but we have seen a steady improvement in the outlook for patients over recent years as we have introduced new targeted therapies. “I am delighted that patients in England will be the first to benefit from this new treatment, which has the potential to keep cancer at bay for years longer, giving people the chance of more precious time with friends and family. “This treatment could be life-changing for many patients and their families, and that’s why it is so important that the NHS continues to secure quick access to the latest, innovative treatments like this, at affordable prices to the taxpayer.” Health Minister, Karin Smyth, said: “This groundbreaking therapy puts the NHS at the forefront of cancer innovation. By harnessing cutting-edge ‘trojan horse’ technology, we’re offering new hope to blood cancer patients across the country. “We’re determined to back scientific breakthroughs that deliver real results for patients – bringing the latest treatments from the lab to those who need them most. It’s another example of how we’re building an NHS fit for the future, one that embraces medical innovation to transform patient care.” Shelagh McKinlay, Director of Research and Advocacy at blood cancer charity Myeloma UK, said: “It’s fantastic to see the UK at the forefront of myeloma treatment. NHS England has demonstrated that it is possible for myeloma patients to have world-first access to innovative drugs. “We have been working very hard for the last year to get this treatment approved and we know it will transform the lives of thousands of people with myeloma.” Antoine Herbaux, Vice President, Head of Oncology UK, GSK, said: “We are delighted to have worked with NHS England and NICE on this significant recommendation in helping support unmet need in multiple myeloma. “Today’s announcement highlights an example of local innovation – Belantamab mafodotin was partly discovered in Stevenage, the first patient to receive it in clinical trials was in London, and now the UK is the first country to grant patient access. This milestone is a great example of the power of scientific innovation and open collaboration to achieve positive outcomes for patients in the UK.” Patients must have routine ophthalmological assessments before starting treatment and after each of the first three treatments. Side effects can include ocular toxicity, difficulty seeing clearly, blurred vision, dry eyes and photophobia. Cutting-edge treatments like belantamab mafodotin have been enabled by the country’s thriving life sciences sector and the largest cluster of cell and gene therapy companies outside the US, centred around Stevenage and extending to Oxford, London, and Cambridge. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. 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