QC（微生物）(J10341)

北京康蒂尼药业股份有限公司创立于2002年，是一家以器官纤维化疾病为核心，集研发、生产、销售于一体的创新药物开发企业。北京康蒂尼为美国纳斯达克上市公司Gyre Therapeutics, Inc.(股票简称：GYRE)的控股子公司。作为器官纤维化领域的先行者，公司的旗舰产品1.1类新药艾思瑞®（吡非尼酮胶囊）是全球唯二已获批且受指南推荐的特发性肺纤维化（IPF）治疗药物，也是国内首款用于治疗IPF的创新药物，2014年成功上市后填补了该领域的空白。公司下一阶段关键性产品—治疗肝纤维化的F351（羟尼酮）被药审中心认定为“突破性治疗药物”，有望成为全球首款获批治疗慢性乙肝（CHB）相关纤维化的药物。公司将通过艾思瑞®积累的从自主开发到商业化成功的完整经验丰富并推进产品管线，将治疗领域逐渐拓宽至其他器官纤维化，研究和开发治疗肺纤维化、肝纤维化及肾纤维化的创新药品，为更多器官纤维化患者带来新希望。Beijing Continent Co., Ltd was founded in 2002, which is a innovate drug development enterprise committed to organ fibrosis diseases, and integrated R&D, production and commercialization. Beijing Continent is the holding subsidiary of the NASDAQ-listed company Gyre Therapeutics, Inc.(Stock Ticker: GYRE).s a pioneer in the field of anti-organ fibrosis, company’s flagship product Class 1.1 new drug ETUARY®(Pirfenidone Capsule) is one of the only two types approved drugs for IPF treatment worldwide. As the first innovate drug approved to be used for IPF in China, it filled the gap in the IPF treatment field after its successful launch in 2014. F351(Hydronidone) the company’s key production for next stage, was granted a Breakthrough Therapy designation as the liver fibrosis treatment drug by the CDE. It is expected to be the first approved drug for the treatment of liver fibrosis associated with CHB.The company will enrich and boost the product pipeline by utilizing our successful and complete experience accumulated from in-house development to commercialization of ETUARY®. We are expanding our therapeutic field to other organs fibrosis by researching and developing the treatment of pulmonary fibrosis, liver fibrosis and renal fibrosis to bring new hope to the patients with organs fibrosis.