Industry | 制造业 | ||||||||||||||||||||||||
Company Introduction | 公司现为国家高新技术企业,在多肽药物领域长期耕耘,具备产品管线丰富、具有国际研发注册能力、集原料药与制剂仿制药开发为一体、研发技术梯队较为完整的整体优势。 公司聚焦于多肽产品的研发、生产和销售,已有多个多肽品种(包括原料药和制剂)在发达国家获批,并上市销售,是中国多肽行业中具有国际水平的企业,生产场地也多次通过美国FDA和欧盟的GMP检查。主导产品注射用胸腺法新,商品名“基泰”药品质量和适应症与原研参比制剂一致,已通过国家药品监督管理局注射剂仿制药质量和疗效一致性评价,已获得原研药注册地意大利药品管理局颁发的注射用胸腺法新(基泰)上市许可证,质量层次已达到和原研药同等的标准;公司产品注射用比伐芦定和依替巴肽注射液出口美国。 1、公司所从事的主要业务 公司所属行业为医药制造业,公司主营业务涵盖药品注射剂、原料药的研发、生产、销售等。 2、主要产品及其功能或用途 公司主要业务是专业从事化学合成多肽药品的生产、销售和研发,公司在化学合成多肽药物合成、纯化、分析、质量保证、活性测定、制剂工艺等方面形成了一整套成熟的技术工艺体系。 公司拥有丰富的化学合成多肽药物研发、注册申报、生产和市场营销经验,已成功开发了多个化学合成多肽药物和20个其他各种治疗类药物,其中多肽类药物主要有:注射用胸腺法新(“基泰”)系增强免疫药物,主要用于慢性乙型肝炎、肿瘤、老年科及感染类疾病等的治疗及肌体免疫力提高,同时,该产品已通过国家药品监督管理局注射剂仿制药质量和疗效一致性评价以及获得意大利药品管理局颁发的上市许可证;注射用生长抑素,用于严重急性食道静脉曲张出血、严重急性胃或十二指肠溃疡出血、糖尿病酮症酸中毒等的治疗,该产品同样通过国家药品监督管理局注射剂仿制药质量和疗效一致性评价,同时,生长抑素原料药获得CEP(欧洲药典适用性)证书,标志着公司生长抑素原料药在安全性和有效性上达到了国际水平;注射用比伐芦定,获得美国FDA和国家药品监督管理局的上市许可,主要应用于预防血管成型介入治疗不稳定性心绞痛,前后的缺血性并发症,是直接凝血酶抑制剂的一线用药;依替巴肽注射液,用于急性冠状动脉综合征(不稳定型心绞痛/非ST段抬高性心肌梗死)患者。依替巴肽注射液小规格(20mg/10mL)ANDA和大规格(75mg/100mL)sANDA均通过美国FDA上市许可批准。 | ||||||||||||||||||||||||
Main Business | 涵盖药品注射剂、原料药的研发、生产、销售等。 | ||||||||||||||||||||||||
Legal Representative | 王成栋 | ||||||||||||||||||||||||
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Company Secretary | 于晓风 | ||||||||||||||||||||||||
Solicitors | 北京市中伦律师事务所 | ||||||||||||||||||||||||
Auditors | 立信会计师事务所(特殊普通合伙) | ||||||||||||||||||||||||
Tel No | 0898-68592978 | ||||||||||||||||||||||||
Fax No | 0898-68592978 | ||||||||||||||||||||||||
Website | www.shuangchengmed.com | ||||||||||||||||||||||||
yuxiaofeng@shuangchengmed.com;lifen@shuangchengmed.com | |||||||||||||||||||||||||
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Listing Date | 08/08/2012 | ||||||||||||||||||||||||
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EPS(RMB)* | ¥ -0.120 | ||||||||||||||||||||||||
DPS(RMB)* | -- | ||||||||||||||||||||||||
NBV Per Share(RMB)* | ¥ 1.133 | ||||||||||||||||||||||||
Market Capitalization(RMB) | 12.662B |
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* | Unadjusted Data |
Information provided by: etnet | ||
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