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恩那度司他获批上市,肾性缺血国内首仿独家
事件:
2023年6月9日国家药品监督管理局批准信立泰药业股份有限公司申报的口服小分子创新制剂恩那度司他(商品名:恩那罗)。本品为新一代缺氧诱导因子脯氨酰羟化酶抑制剂(HIF-PHI)口服药,用于非透析的成人慢性肾脏病(CKD)患者的贫血治疗。
点评:
肾性缺血国内可用药物稀缺,国内第二款HIF-PHI药物
《中国心血管健康与疾病报告2020》表明我国CKD患者目前约有1.2亿人且呈逐年增多的趋势,给国家医疗卫生资源带来沉重负担。罗沙司他作为国内首款获批上市的口服小分子低氧诱导因子脯氨酰羟化酶(HIF-PH)抑制剂,由FibroGen和阿斯利康共同开发。据阿斯利康财报,2021年罗沙司他销售额达到1.8亿美元,主要来源于中国市场。国产HIF-PHI药物恩那度司他的上市,将更好的满足国家肾性贫血患者用药需求,并在2025年之前与罗沙司他形成双寡头竞争格局。
安全性及依从性等优势,为中国CKD患者提供新选择
恩那度司他片是信立泰于2019年从日本JapanTobacco公司引进的一款口服活性低氧诱导因子脯氨酰羟化酶抑制剂(HIF-PHI)。恩那罗对HIF靶点的调控更加合理适度,刺激生成的内源性EPO(促红细胞生成素)更贴近生理浓度,具有用药依从性好、药物相互作用风险低、给药方便等优势。CKD患者无需按体重调整药物剂量,每天只需服用一次口服药便能达到治疗效果。上市后,将为中国广大成人慢性肾脏病患者带来全新的用药选择,更好地满足该领域未被满足的临床需求。
公司团队构成及产品布局均为国内领先,多管线即将进入收获期
信立泰专注以心脑血管为主的慢病领域,以心脑血管领域为核心,向肾科、代谢、骨科、自身免疫等领域拓展延伸,建立起了系列产品梯队,既有上市多年的仿制药产品,也布局多项拥有自主知识产权的创新药在研管线,行业专科地位巩固。除恩那度司他已在中国上市外,公司阿利沙坦复方制剂SAL0107、DPP-4i降糖药物SAL067已申报上市申请,SAL0108、S086(高血压)、长效特立帕肽等多个产品处于Ⅲ期临床,公司创新转型成果初显。
投资建议:维持“买入”评级
我们预计2023-2025年信立泰营业收入分别为40.32亿元、50.71亿元、60.88亿元,同比增长分别为15.8%、25.8%、20.1%。归母净利润分别为7.35亿元、9.25亿元、11.48亿元,同比增长分别为15.4%、25.9%、24.1%。对应PE分别为57X、46X、37X。未来公司创新产品持续发力,我们看好公司走出低谷之后创新药不断兑现带来的持续增长,看好公司多板块陆续放量的良好势头。维持“买入”评级。
风险提示
新药研发失败风险:医药行业创新研发投入高、周期性长,风险大。创新之路充满不确定因素;公司虽制定相应的风险防范措施,提升产品成药率,但研发仍需承担相应的失败风险;
审批准入不及预期风险:公司药品及器械申报临床及注册等环节可能面临审批进度不及预期的风险;公司产品进入医保获集采可能会面临丢标等风险;
行业政策风险:随着医保控费逐渐深化,国家带量采购政策的全面实施,一系列政策趋势或将影响药品招标价格。市场竞争较大的创新药品种或面临医保谈判降价幅度超预期的风险,生物类似药或面临集中采购降价幅度超预期的风险;
成本上升风险:原材料成本、人力资源成本以及环保成本均呈现刚性上涨趋势,给公司的成本控制带来持续压力;
销售浮动风险:市场竞品及未来上市新药可能对产品销售造成一定影响,导致销售不及预期。