Ipsen Pharma SA

精彩内容 7月25日，罗欣药业发布公告，其下属子公司山东罗欣乐康制药的蒙脱石散一致性评价补充申请获批过评。米内网数据显示，蒙脱石散在2023年中国三大终端六大市场（统计范围见文末）销售规模超过10亿元。此外，其下属子公司山东罗欣药业集团的注射用头孢哌酮钠舒巴坦钠2.0g规格一致性评价补充申请获批过评。 蒙脱石散由IPSEN PHARMA研发，用于成人急、慢性腹泻，儿童急性腹泻。 近年中国零售药店终端蒙脱石散销售情况（单位：亿元） 来源：米内网格局数据库 蒙脱石散在2023年中国三大终端六大市场销售规模超过10亿元，其中，院外市场（零售药店终端：城市实体药店+网上药店）是主力销售渠道，同比增长超过60%，是止泻药、肠道抗炎/抗感染药TOP2产品，法国益普生的市场份额最大。 米内网数据显示，蒙脱石散有44家企业拥有生产批文，山东罗欣乐康制药、湖南方盛制药、扬子江药业集团等35家企业过评，暂无一致性评价补充申请在审，福建太平洋制药、四川依科制药等5家企业以仿制4类报产在审，获批后视同过评。 罗欣药业消化系统及代谢药过评情况 来源：米内网一致性评价数据库 截至目前，罗欣药业在消化系统及代谢药领域已有11款产品通过/视同通过一致性评价。注射用奥美拉唑钠、奥美拉唑肠溶胶囊、艾司奥美拉唑镁肠溶片等4款产品在2023年中国三大终端六大市场均是10亿级别的大品种。 资料来源：公司公告、米内网数据库注：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。如有疏漏，欢迎指正！ 本文为原创稿件，转载请注明来源和作者，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

Ipsen’s Sohonos has a specific selectivity for the gamma subtype of retinoic acid receptors. Credit: Ipsen Pharma. Ipsen has received approval from the US Food and Drug Administration (FDA) for its Sohonos (palovarotene) capsules to treat people with the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP). It is approved as a retinoid to reduce the volume of new heterotopic ossification in adults and paediatric patients. Female patients must be eight years old and above to receive the treatment, and males must be at least ten. Recommended Reports Reports LOA and PTSR Model - Naratuximab Emtansine in Follicular Lymphoma GlobalData Reports LOA and PTSR Model - Saracatinib Difumarate in Fibrodysplasia Ossificans Progressiva (Myositis Os... GlobalData View all Companies Intelligence Ipsen SA View all The oral medicine Sohonos has a specific selectivity for the gamma subtype of retinoic acid receptors, which are skeletal development and ectopic bone regulators in the retinoid signalling pathway. Sohonos mediates the interactions between the receptors, growth factors and proteins, and lowers the formation of new abnormal bone in FOP sufferers. The FDA approval is based on the pivotal safety and efficacy data from the Phase III multicentre, open-label MOVE study in adult and paediatric patients. This included 107 patients who were administered oral palovarotene and compared with untreated individuals from the Ipsen worldwide FOP natural history study. The study showed that palovarotene successfully decreased the yearly volume of heterotopic ossification compared to no treatment beyond standard care. Ipsen research and development head Howard Mayer stated: ” Developing medicines for rare diseases takes commitment and belief from everyone involved. “We at Ipsen are sincerely grateful to the FOP community of patients and medical experts, as the first-ever treatment in the US for managing FOP would not be possible without their participation in the clinical trials and ongoing support.”

Ipsen’s palovarotene is intended to treat fibrodysplasia ossificans progressiva. Credit: Ipsen Pharma. The European Commission (EC) has refused to grant marketing authorisation for Ipsen’s investigational therapy , palovarotene, intended to treat fibrodysplasia ossificans progressiva (FOP). The EC’s decision comes after the Committee for Medicinal Products for Human Use (CHMP) provided a negative opinion in May 2023. Recommended Reports Reports Nitric Oxide Synthase (NO Synthase or NOS or EC 1.14.13.39) Drugs in Development by Therapy Areas... GlobalData Reports LOA and PTSR Model - Non-Disclosed GlobalData View all Companies Intelligence Ipsen SA C H M P INC View all An oral therapy, palovarotene selectively acts on the retinoic-acid receptor gamma (RARγ). It is the first-of-its-kind medicine to seek approval for FOP treatment. Palovarotene has been analysed in a clinical programme, which included the Phase III MOVE clinical trial for FOP, for more than 15 years. In the US, palovarotene obtained orphan drug and breakthrough therapy designations from the Food and Drug Administration to potentially treat FOP. A decision on the approval by the US FDA is anticipated on 16 August 2023. The company also noted that regulatory approvals will be sought in other nations. Palovarotene obtained authorisation for usage in Canada and received provisional approval in the United Arab Emirates (UAE) as Sohonos (palovarotene capsules). Ipsen research and development executive vice-president and head Howard Mayer stated: “We believe that our clinical data provide evidence supporting the effect of palovarotene on the reduction of new, abnormal bone formation, known as heterotopic ossification, which characterises the disease. “We are therefore disappointed that the European Commission decided not to approve this treatment for patients with FOP in Europe.” A chronic condition, FOP causes flare-ups which can lead to the formation of abnormal bones.