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制药/生物工程 民营企业

先声药业,成立于1995328日。创业以来,我们从278万注册资本到超过30亿总资产、从几十人到3000多人的研发驱动型制药企业、从纳税几十万到年纳税近5亿元、连续多年位列“中国制药工业百强榜”……这些仅仅是数字上的体现,最大的改变,是自我的成熟、成长。

 

为了心中的梦想,我们先后作出了开发首仿药、聚焦于产品的并购、成立研究院自主研发、与国际巨头联合研发、创新研发机制等一系列循序渐进的战略选择。未来,我们将基于真正帮助患者,聚焦创新药和首上市药,建立领先的开放合作与研发创新能力,国际标准的制药能力,专业的品牌塑造与推广能力。

 

2009年,我们的蒙脱石散原料和制剂先后顺利通过欧盟GMP认证并出口欧洲,大大提升了“先声制造”的品质水平。我们正在按CGMPEUGMP改造三个生产厂,全面对接国际标准。

 

多年来,先声药业持续开展多种模式的国际合作,与美国安进达成生物类似物战略联盟,双方达成多个产品组合的合作,先声一次性将安进公司多款生物类似药引进中国;与国际著名生物制药企业百时美施贵宝公司共同研发抗肿瘤药物,双方携手开发用于治疗类风湿性关节炎的皮下注射生物药品阿巴西普针剂;与欧洲生物技术公司Merus就双特异抗体达成战略合作,先声诊断与美国分子基因分析平台Agena达成战略合作,共同拓展核酸质谱平台MassARRAY系统在中国伴随诊断和药物基因组学检测领域的产业化应用……这些具有里程碑意义的事件,证明了中国医药企业可以与国际性大公司合作,大幅降低研发成本,加快创新药研发进程。

 

现在,我们已经拥有50多种产品组合,重点覆盖抗肿瘤、心脑血管、抗感染、风湿免疫等疾病治疗领域。其中全球第一家上市产品3个(恩度、中人氟安、艾得辛)、国内第一家上市产品6个(必存、再林、英太青、也青、捷佰舒、安信)。

 

我们时刻牢记“让患者早日用上更好药物”的企业使命。2007年以来,我们共提交了200多项囯内和PCT专利申请。目前已有超过10个创新药进入临床研究阶段,将极大的丰富和补充现有产品线。2015年,定位于聚焦转化医学关键技术, 助力创新药物研发的“转化医学与创新药物国家重点实验室”获国家科技部批准。2018年,先声药业成立23周年纪念日上,我们宣布先声上海(波士顿)创新中心正式启航。因此,我们连续多年被行业权威媒体评为“中国医药创新力十强企业”。

 

Simcere Pharmaceutical Group was founded on March 28, 1995 with an enterprise mission to “discover and develop high-quality medicines for patients.” Since its inception, we have grown from a registered capital of 2.78 million to total assets of over 3 billion yuan, from a few dozen people to a R&D-driven pharmaceutical enterprise with more than 3,000 talents, and from an annual tax of less than a million to about 500 million yuan. We have ranked among “the top 100 Chinese Pharmaceutical Companies” for consecutive years, and our growth goes beyond the numbers.

 

To fulfill our dream, we have progressed through a string of strategic options, including but not limited to the development of first generic products, merger and acquisition, the build-up of research institute, an alliance with multinational corporations, and innovative research mechanisms.

 

At present, these efforts are bearing fruits:

In 2009, our montmorillonite powder product successfully passed EU GMP certification and started exporting to Europe, a milestone for 'Made in Simcere' for global markets. Currently, we are actively implementing cGMP and EUGMP to transform all of our small molecule manufacture sites to comply with international standards.

 

In recent years, Simcere has established high-quality international cooperation through various partnership models. In March 2018the companys newly found precision medicine sector, Simcere Diagnotics, has formed strategic partnership agreement with a Agena Biosciencefocusing on expanding the use of Agenas MassARRAY® System for companion diagnostics and pharmacogenetic testing in China. In January 2018, Simcere obtained an exclusive license from European biotech Merus to develop and commercialize in China 3 bispecific antibodies utilizing Meruss proprietary Biclonics® technology platform in the area of immuno-oncology. In September 2017Simcere entered into Collaboration with Amgen to co-develop and commercialize a series of biosimilars In China. Together with Bristol-Myers Squibb, we are conducting Phase III trial for abatacept, a monoclonal antibody for treatment of rheumatoid arthritis. These partnerships are a powerful testament to the fact that Chinese pharmaceutical companies can collaborate with multinational corporations to scale down R&D cost and accelerate R&D innovation in China.

We now own over 50 products that cover Oncology, Cardiovascular and Cerebrovascular, Anti-infection, Rheumatology and other therapeutic areas. We have three products (Endostar®, Sinofuan®, Iremod®) that were the first-to-launch in the world, and six products (BICUN®ZAILIN®ANTINE®YEQING®JIEBAISHU®Newanti®) that were the first-in-class in China. Since 2007, we have submitted over 200 domestic and PCT patent applications. Over 10 innovative drugs are being studied in clinical trials, which will broaden our current marketed product portfolio.

 

In 2015, the Ministry of Science and Technology designated one of our laboratories as the 'national key laboratory for translational medicine and innovative drugs'. Simcere ranks among the 'Top 10 Chinese Companies in Pharmaceutical Innovation' in recent years. On March 28, 2018, Simcere announced the official establishment of Simcere Innovation Center on the company's 23rd anniversary.

 

SIMCERE, we race with time to provide you the better treatment.