| Industry | 制造业 | ||||||||||||||||||||||||
| Company Introduction | 联亚药业是一家研发驱动型的高新技术企业,主要从事复杂药物制剂的研发、生产和销售,目前产品主要包括以不同类型的缓控释制剂以及极低剂量药物制剂为代表的两大类高端仿制药;同时公司也凭借领先的药物设计能力和制剂工艺技术为制药企业和研发机构提供研发及其他服务。根据国家发改委印发的《高端医疗器械和药品关键技术产业化实施方案》,高端仿制药指的是“临床需求大、价格高的专利到期药品”的仿制药,以及能够“拓展国际高端市场”的仿制药,具有较强的技术壁垒。公司的产品均能符合“高端仿制药”的定义。 公司致力实现两大目标:一是将自主研发和生产的高端制剂国际化,为处方药物市场和患者提供高性价比的优质药物;二是紧跟医保改革方向,把公司已在美国上市的高端制剂通过中美共线的审批路径快速引入国内市场,持续推动中国高端制剂产业的进步,努力降低药品成本,造福国内患者。 公司是国内领先的具有国际化布局并实现大规模出口美国市场的高端制剂企业,未来公司将依托自身技术优势持续进行产品研发,同时将境外获批产品引进国内,实现境内外双轮驱动发展。截至报告期末,公司依靠自主研发的6大技术平台完成了多款产品研发,已有40个自研产品获FDA批准,适应症包括高血压、冠心病、糖尿病及女性避孕等。根据灼识咨询的统计情况,2010年至报告期末,公司获FDA批准注册的自主研发ANDA产品数量排名国内第一,口服缓控释制剂获FDA批准数量排名国内第一,获得FDA认证的对照标准制剂(RS)数量排名国内第一,多个缓控释制剂在美国市场占有率排名第一。同时,公司加速拓展国内市场,已有琥珀酸美托洛尔缓释片、盐酸二甲双胍缓释片(III)及左炔诺孕酮片三个产品获NMPA批准上市,另有富马酸喹硫平缓释片等5个产品处于CDE审评阶段。此外,公司在研产品管线丰富,截至报告期末,公司有仿制药在研项目34个、改良型新药在研项目3个,其中以结合雌激素缓释片为代表的部分在研项目具有首仿潜力。 | ||||||||||||||||||||||||
| Main Business | 主要从事复杂药物制剂的研发、生产和销售。 | ||||||||||||||||||||||||
| Legal Representative | 张国华 | ||||||||||||||||||||||||
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| Company Secretary | -- | ||||||||||||||||||||||||
| Solicitors | 北京市君合律师事务所 | ||||||||||||||||||||||||
| Auditors | 毕马威华振会计师事务所(特殊普通合伙) | ||||||||||||||||||||||||
| Tel No | 86-0513-85986623 | ||||||||||||||||||||||||
| Fax No | 86-513-85986619 | ||||||||||||||||||||||||
| Website | www.novast.cn | ||||||||||||||||||||||||
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| Listing Date | 15/10/2026 | ||||||||||||||||||||||||
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| EPS(RMB)* | ¥ 0.300 | ||||||||||||||||||||||||
| DPS(RMB)* | -- | ||||||||||||||||||||||||
| NBV Per Share(RMB)* | ¥ 2.650 | ||||||||||||||||||||||||
| Market Capitalization(RMB) | 0.000B |
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| * | Unadjusted Data |
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