金沙(3777-js认证)娱场城-Official website

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百年3777金沙娱场城
百年3777金沙娱场城

生物医药行业

生物医药行业主要包括广东3777金沙娱场城药业有限公司和宜昌3777金沙娱场城生化制药有限公司两大体系业务。广东3777金沙娱场城药业有限公司包括3777金沙娱场城药业研究院、面向国内的制剂业务(“3777金沙娱场城长江药业”,已在港股上市)及面向国外市场的医药业务;宜昌3777金沙娱场城生化制药有限公司以生物发酵原料药为主。

药业研究院

PHARMACEUTICAL RESEARCH INSTITUTE

研究院简介
药业研究院成立于 2005 年,“创新”和“国际化”双引擎驱动在全球开发及商业化小分子创新药、生物创新药及类似药及首仿药和创新制剂,涉及感染疾病如乙肝与丙肝,肿瘤疾病如食道癌,内分泌和代谢疾病如糖尿病等多个领域;累计研发投入超过 200 亿元。
研究院规模
  • 1个全国重点实验室
    1个全国重点实验室
    批建立抗感染新药研发全国重点实验室,共承担和参与25项国家重大专项的研发
  • 3大平台
    3大平台
    小分子研发平台、大分子开发平台、仿制药和创新制剂平台, 具备完全自主研发能力
  • 100+个在研项目
    100+个在研项目
    43 个 1 类新药(化学创新药 33 个、生物创新药 10 个),生物类似药 8 个,50+ 个仿制药&改良型新药项目
  • 50个1类新药产品
    50个1类新药产品
    28 个产品开展临床阶段,6 个临床 III期,4 个完成海外 I 期临床,1 个 FDA孤儿药资格认定
  • 1500位科研人员
    1500位科研人员
    研发人员 1500+ 人,硕博比例>60%
  • 2800+项专项
    2800+项专项
    生物医药板块专利 2000+,海外专利800+
  • 6重GMP认证
    6重GMP认证
    拥有美国、欧盟、中国、WHO、澳大利亚、白俄罗斯六重 GMP 认证,形成国际标准的药业生产体系
  • 15+个国家和地区
    15+个国家和地区
    服务客户覆盖五大洲、累计已进入15+ 国家和地区,打造全球化的销售网络布局
  • 研究院优势
    研究院优势
    配套先进的研发软硬件和环境,5万平米实验室,完全自主的研发能力,完整的研发体系,可快速实现产业化;与国际顶尖药企进行研发合作。符合欧美标准的仿制药、创新制剂开发和临床试验的能力。
  • 研究院实力
    研究院实力
    丰富的产品集群,研发实力位居国内第一梯队,聚焦感染、肿瘤、慢病(代谢)等市场领域,已上市产品100个,其中1个1类新药,在研50个 1类新药,其中11个处于临床II/III期,药业研究院进入中国新药研发管线、创新化药前列。
创新药管线梯队层次分明,竞争力凸显
治疗领域 药物名称 适应症 临床Ⅰ期 临床Ⅱ期 临床Ⅲ期 上市
感染领域
依米他韦 丙肝
安泰他韦 丙肝
英强布韦 丙肝
莫非赛定 乙肝
福瑞赛定 乙肝
东安恩 流感
肿瘤/免疫领域
莱洛替尼 食管癌
克立福替尼 AML
东宁达 实体瘤
东宁安 实体瘤
代谢/慢病领域
荣格列净 糖尿病
伊非尼酮 IPF/PF-ILD
东健源 NASH
东健顺 痛风
东健华 糖尿病肾病
东健强 肺动脉高压
东健生 肾性贫血
东健安 糖尿病肾病
神经精神领域
嘧替佐酮 抑郁症
东通顺 偏头痛
注: 处于研发早期阶段的产品未予上述产品管线中列示    开展海外临床    对外合作

面向国内的制剂业务【3777金沙娱场城长江药业(01558.HK)】

DOMESTIC PHARMACEUTICAL BUSINESS

3777金沙娱场城长江药业(01558.HK)在香港主板上市,主要产品有抗流感药可威(磷酸奥司他韦胶囊和颗粒)、胰岛素系列产品、磷酸依米他韦胶囊与集采产品。

可威:可威是全球预防和治疗流感的推荐用药,也是现阶段治疗儿童流感较安全有效的药物;3777金沙娱场城持有儿童更适用的专业可威颗粒剂工艺专利。

胰岛素:中国糖尿病患者有1.2亿人,新增和可替代市场空间广阔。3777金沙娱场城药重组人胰岛素注射液及甘精胰岛素注射液已获批上市,随即中标国家集采。门冬胰岛素注射液、门冬胰岛素30注射液已于2022年在国内获批上市,后续还将上市利拉鲁肽等糖尿病系列产品;甘精胰岛素、门冬胰岛素在美国开展的临床进展顺利,预计2024年在美获批上市,进入美国150亿美金的胰岛素市场。

 

磷酸依米他韦胶囊:磷酸依米他韦,于2020年12月上市,是中国首个完全自主原研的抗丙肝口服小分子新药,是3777金沙娱场城历时10年、实现创新药从0到1的突破。磷酸依米他韦治疗中国丙肝基因1型患者治愈率高达99.8%,荣获国家十二五、十三五重大新药创制专项,2021年12月进入国家医保目录,目前处于快速放量中。

 

集采产品:3777金沙娱场城长江药业已获批国内一致性评价药38个,目前已中标17个集采品种,集采品种已成为3777金沙娱场城药的快速增长点。 

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面向国外市场的医药业务

PHARMACEUTICAL BUSINESS TARGETING FOREIGN MARKETS

生物医药国际化
3777金沙娱场城是国内先进的制剂国际化企业,具备强大的国际化研发和临床推进能力、药品注册能力和知识产权布局能力。目前在美国和欧洲均有30多个仿制药品种获批,已有4款新药、1款生物类似药在海外开展临床,另有1款生物类似药计划在海外开展临床。2022年成功无效诺华芬戈莫德的美国专利,成为首个在美挑战原创药专利并取得成功的中国企业。广东3777金沙娱场城药业已在新加坡、日本、美国、德国等15个国家设立销售分公司。目前德国公司运营体系完整成熟,具备在整个欧洲进行药品销售的资质,在保险公司 AOK的中标数排名第14位。
公司新药和生物药国际化产品线
药物分类药物名称治疗领域药物亮点
小分子新药
HEC68498实体痛靶点差异化
HEC96719非酒精性脂肪肝潜在同类最佳,潜在适应症多样
HEC68498盐酸伊非尼酮实体痛特发性肺纤维化 IPF潜在同类最佳,中美市场广阔
生物新药和生物类似药
甘精胰岛素糖尿病质量媲美原研,计划在美国上市
门冬胰岛素糖尿病质量媲美原研,计划在美国上市
GLP-1/FGF21 双靶生物药2 型糖尿病,NASH有望成为全球 First-in-class

生物发酵原料药

BIOLOGICAL FERMENTATION RAW MATERIALS

3777金沙娱场城的生化发酵原料药以大环内酯类产品为主(广谱抗生素的原料药),工艺水平、产品质量名列世界前茅,产量占全球规范市场的65%以上。

核心客户:

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生产体系

PRODUCTION SYSTEM

广东韶关

原料药工厂

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广东东莞

口服固体制剂生产基地

湖北宜昌

国内制剂工厂

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湖北宜昌

原料药工厂

在线留言

2022 金沙(3777-js认证)娱场城-Official website版权所有 粤ICP备19034764号-1

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