Company Information
Industry 制造业
Company Introduction 公司是一家专注于人用疫苗研发、生产、销售的生物制药企业。自成立以来,公司始终坚持以社会公众的健康安全为中心,致力于成长为在人用疫苗领域中具有国际一流水平的中国生物科技公司。 公司已成功开发并商业化的核心产品四价流感病毒裂解疫苗,是传统三价流感疫苗的升级产品,多项关键指标优于国家药典标准,具有免疫效果好、安全性高的优势,为国内唯一以预防用生物制品1类向CDE进行申报的四价流感病毒裂解疫苗。但该产品在获批时,由于国内外均已有同品种疫苗上市,因此取得的药品注册批件中的注册分类为预防用生物制品,未被明确分类。公司是国内最早实现四价流感疫苗批签发及上市销售的两家企业之一,2019年和2020年实现批签发数量分别为134.96万剂和424.03万剂,在国内全部四价流感疫苗生产企业中排名第二和第三。截至2020年12月31日,公司已建立了覆盖全国28个省(直辖市、自治区)1,300余家区县疾控中心的营销网络,为公司未来的品牌化发展和在研产品的市场开拓奠定坚实基础。 公司正发挥技术和品牌优势,深度聚焦开发四价流感疫苗系列产品,进一步巩固并提升在四价流感疫苗细分市场的竞争优势。除已上市的适用于3岁以上人群接种的成人型四价流感疫苗外,公司还正在研发专注于6月至3岁以下儿童接种的儿童型四价流感疫苗和专注于65岁以上老年人接种的高剂量型四价流感疫苗。通过丰富公司四价流感疫苗的产品线,更好为流感高危易感人群(儿童和老年人)提供安全优质的疫苗产品。 目前国内流感疫苗接种率还处于较低水平,同时由四价流感疫苗替代三价流感疫苗的趋势已经形成,未来市场增长空间广阔。根据美国疾病预防控制中心统计,2019-2020年流感季,美国共分发流感疫苗1.75亿剂,成人接种率约48.4%;而根据中国中检院统计,2020年度我国流感疫苗批签发量为0.58亿剂,总体接种率不足4.2%。同时,四价流感疫苗自2013年在美国上市后,逐步替代三价流感疫苗,2019-2020年流感季,美国FDA流感疫苗放行批次中的四价流感疫苗占比约为86.6%;我国四价流感疫苗于2018年才首次上市销售,2020年四价流感疫苗的批签发占比已经达到58.4%。公司现有四价流感疫苗生产车间产能为1,000万剂/年,为充分满足流感疫苗市场的增量需求,公司正新建产能为3,000万剂/年的四价流感疫苗车间,以扩大核心产品的产能。 除深度研发四价流感疫苗系列产品外,公司专注于传统疫苗的升级换代和创新疫苗的研发,积极拓展产品管线,形成符合产业趋势且市场前景广阔的产品梯队。目前,公司主要产品管线已实现了对流行性感冒、狂犬病、水痘、带状疱疹和肺炎疾病等5种重要传染性疾病预防的覆盖,在研主要产品共有9个。其中冻干人用狂犬病疫苗(Vero细胞)已完成临床III期试验,四价流感病毒裂解疫苗(儿童)处于临床I期试验阶段,23价肺炎球菌多糖疫苗、四价流感病毒裂解疫苗(高剂量)、冻干水痘减毒活疫苗、冻干带状疱疹减毒活疫苗、13价肺炎球菌多糖结合疫苗、重组带状疱疹疫苗和冻干人用狂犬病疫苗(MRC-5细胞)等处于临床前研究阶段。 凭借多年的技术积累,公司已经建立了四个核心平台技术,分别为鸡胚基质疫苗制备生产技术、细胞基质病毒培养与疫苗制备技术、多糖纯化与蛋白偶联技术和规模化制剂生产技术,覆盖人用疫苗研发和产业化的全流程。其中,尽管公司已掌握了细胞基质病毒培养与疫苗制备技术、多糖纯化与蛋白偶联技术,但公司目前尚无基于两项核心技术实现产业化产品的情况。公司在疫苗开发过程中所应用的技术路线包括灭活疫苗、减毒疫苗、组分疫苗和重组疫苗等4类主流技术路径,具备持续开发、产业化多种病毒型疫苗及细菌型疫苗的能力。
Main Business 人用疫苗的研发、生产和销售
Legal Representative 余军
Top Executives
董事长:余军
董事:夏建国,张良斌,聂申钱
独立董事:孙红星,管建强,邵蓉
Top 5 Shareholder
Shareholder name Nature Holding Date
张良斌流通A股30.74%30/09/2024
余军流通A股30.74%30/09/2024
张建辉流通A股4.61%30/09/2024
聂申钱流通A股3.84%30/09/2024
夏建国流通A股2.37%30/09/2024
Company Secretary 周进
Solicitors 上海市锦天城律师事务所
Auditors 大华会计师事务所(特殊普通合伙)
Tel No 0523-86205860;0523-86200906
Fax No 0523-86200152
Website www.gdkbio.com
Email gdk001@gdkbio.com
Company Address
Register: 江苏省泰州市郁金路12号
Office: 江苏省泰州市郁金路12号
Listing Date 02/08/2021
Shares Capital
Shares Capital: 123,200,000
Total A Share: 123,200,000
Listed A Share: 123,200,000
Non-tradable A Share: 0
Other Share: 0
Total B Share: 0
Total H Share: 0
EPS(RMB)* ¥ -0.580
DPS(RMB)* --
NBV Per Share(RMB)* ¥ 11.129
Market Capitalization(RMB) 1.928B
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 : Eligible Stock for SH-HK Northbound trade (For all investors/ For institutional professional investors only)
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 : Eligible Stock for SH-HK Ex-Northbound trade (sell only)
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 : Eligible Stock for SZ-HK Northbound trade (For all investors/ For institutional professional investors only)
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 : Eligible Stock for SZ-HK Ex-Northbound trade (sell only)
* Unadjusted Data
Information provided by: etnet
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