Macitentan

近日，上海医药全资子公司上海医药集团（本溪）北方药业有限公司的马昔腾坦原料药收到国家药品监督管理局颁发的《化学原料药上市申请批准通知书》（通知书编号：2024YS00196），该药品获得批准生产。 基本情况 名  称 马昔腾坦 注册标准编号 YBY62022024 包装规格 1kg/袋、2kg/袋、3kg/袋 申请事项 境内生产化学原料药上市申请 审批结论 根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求，批准注册。 相关信息 马昔腾坦主要适用于治疗肺动脉高压（PAH，WHO 第1组），由Actelion Pharmaceuticals Ltd.公司研发，最早于2013年在美国上市。2021年12月，上药北方药业向国家药监局递交马昔腾坦原料药技术审评申请并获受理；近日，上药北方药业收到国家药监局下发的《化学原料药上市申请批准通知书》。 本次马昔腾坦获得《化学原料药上市申请批准通知书》，表明该原料药符合国内药品注册的有关规定要求，可以在国内市场进行销售，同时为公司后续产品开展原料药申报积累了宝贵的经验。

MSD’s Winrevair has been approved to treat pulmonary arterial hypertension (PAH), a disorder which is caused by high blood pressure in the lungs. Credits: MMD Creative/Shutterstock.com The European Commission (EC) has granted approval to Merck & Co’s (MSD) Winrevair (sotatercept) to be used as a combination therapy for the treatment of adults with functional class II or III pulmonary arterial hypertension (PAH). The approval was awarded based on data from STELLAR, a Phase III study (NCT04576988) that evaluated 323 adult participants with functional class II or III PAH, as determined by the World Health Organization (WHO), as per the 26 August press announcement, The European approval for the subcutaneously administered therapy follows one from the US Food and Drug Administration (FDA) in March 2024 for the same group of PAH patients. According to GlobalData’s consensus forecasts, Winrevair is expected to generate total sales of $6.3bn in 2030. GlobalData is the parent company of Pharmaceutical Technology . Notably, a day before the approval of Winrevair, the FDA granted approval to Johnson & Johnson ’s (J&J) Opsynvi (macitentan + tadalafil). Opsynvi is approved to treat adult patients with WHO Group 1 and functional classes II and III PAH. According to study results published in the New England Journal of Medicine, Winrevair demonstrated a median change in 6-minute walk distance (6MWD) from baseline of 34.4m, which was superior to the 1.0m with placebo at 24 weeks, the study’s primary efficacy endpoint. While the number of reported adverse events was similar in the treatment and placebo groups (138 vs. 140), participants receiving Winrevair experienced more frequent cases of epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure. See Also: Singapore approves mpox vaccine as it adds border infection checks EC approves Roche’s monoclonal antibody PiaSky to treat PNH Winrevair is a first-in-class activin signaling inhibitor designed to increase exercise capacity by binding to several TGF beta superfamily ligands and blocking their signals that contribute to the progression of PAH. As the first approved PAH therapy targeting the activin signaling pathway, the EC approval of Winrevair is an “important step for patients,” said Dr. Joerg Koglin, MSD senior VP and head of general medicine, global clinical development at Merck Research Laboratories. MSD is committed to further investigation of Winrevair in areas of “unmet needs in the management of PAH,” Koglin added. PAH is a rare, blood vessel disorder characterised by the narrowing of the small blood vessels in an individual’s lungs, which results in high blood pressure (hypertension) in the pulmonary artery. MSD is one of several companies developing treatments for PAH. In 2023, GlobalData tracked 129 drugs in development for PAH, nine of which were under development by institutes and universities.