主营介绍

  • 产品类型:

    自主疫苗、疫苗代理、药品代理

  • 产品名称:

    b型流感嗜血杆菌结合疫苗(预充)

  • 经营范围:

    生物制剂的研究与开发(不含管理商品);生物项目的引进、合作与开发;生物技术相关项目的技术服务研究与开发;生物制品、生物类药品及相关材料的进出口;技术进出口。(依法须经批准的项目,经相关部门批准后方可开展经营活动)。

运营业务数据

最新公告日期:2018-04-24 
业务名称 2017-12-31 2017-06-30 2016-12-31 2016-06-30 2015-12-31
自主疫苗销量(剂) 1665.41万 - 1030.32万 - 1112.59万
自主疫苗产量(剂) 1774.64万 - 1073.99万 - 937.12万
Hib(预灌封)批签发量(剂) - 21.75万 - 102.49万 -
Hib(西林瓶)批签发量(剂) - 34.51万 - 66.13万 -
AC(结合疫苗)批签发量(剂) - 46.02万 - 63.27万 -
AC(多糖疫苗)批签发量(剂) - 457.85万 - 293.21万 -
ACYW135多糖疫苗批签发量(剂) - 22.64万 - 17.65万 -
百白破疫苗签发量(剂) - 9.87万 - - -
代理疫苗销量(剂) - - 137.27万 - 753.51万
代理疫苗产量(剂) - - 104.67万 - 771.12万

主营构成分析

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营业收入 X

单位(%) 单位(万元)
注:通常在中报、年报时披露 
业务名称 营业收入(元) 收入比例 营业成本(元) 成本比例 利润比例 毛利率
按行业 自主疫苗 5.15亿 78.25% 9899.08万 53.72% 97.75% 80.77%
药品代理 9486.49万 14.42% 8528.03万 46.28% 2.25% 10.10%
服务收入 3847.34万 5.85% - - - -
技术转让收入 975.00万 1.48% - - - -
疫苗代理 - - - - - -
按产品 b型流感嗜血杆菌结合疫苗(预充) 1.33亿 20.25% 1569.65万 7.53% 26.73% 88.22%
b型流感嗜血杆菌结合疫苗(西林) 1.16亿 17.68% 1262.49万 6.06% 23.59% 89.15%
23价肺炎球菌多糖疫苗 1.02亿 15.54% 494.88万 2.37% 22.13% 95.16%
代理药品 9486.49万 14.42% 8528.03万 40.92% 2.18% 10.10%
冻干A+C疫苗群脑膜炎球菌多糖结合疫苗 8053.93万 12.24% 1495.72万 7.18% 14.92% 81.43%
ACYW135群脑膜炎球菌多糖疫苗 4370.69万 6.64% 1462.35万 7.02% 6.62% 66.54%
服务收入 3847.34万 5.85% 2413.57万 11.58% 3.26% 37.27%
A群C群脑膜炎球菌多糖疫苗 3771.46万 5.73% 3345.88万 16.05% 0.97% 11.28%
技术转入收入 975.00万 1.48% - - - -
吸附无细胞百白破联合疫苗 96.76万 0.15% 268.12万 1.29% -0.39% -177.09%
代理疫苗产品 - - - - - -
按地区 西南西北大区 2.35亿 35.19% 1.25亿 57.98% 24.35% 46.91%
华东大区 1.97亿 29.46% 5640.12万 26.19% 31.02% 71.35%
华中大区 1.35亿 20.23% 2491.15万 11.57% 24.35% 81.58%
华南大区 8048.61万 12.04% 1290.50万 5.99% 14.92% 83.97%
东北华北大区 2930.22万 4.38% 383.70万 1.78% 5.62% 86.91%
海外地区 962.69万 1.44% 527.77万 2.45% 0.96% 45.18%
分部间抵销 -1841.58万 -2.76% -1283.45万 -5.96% -1.23% -

董事会经营评述

  一、业务回顾和展望
  1、业务回顾
  报告期内,公司顺应新的流通管理政策,优化营销策略和模式,充分发挥产品品牌和产品质量优势,积极拓展疫苗销售业务,原有自主生产疫苗产品销量持续稳定增长,同时新产品23价肺炎球菌多糖疫苗取得较好的销售业绩。伴随着国内疫苗行业的良好发展态势,公司自主疫苗产品销售收入及净利润实现同步增长,与上年同期相比,本报告期公司归属于上市公司股东的净利润实现扭亏为盈。
  报告期内,子公司玉溪沃森获批签发产品数量合计7,131,790剂(瓶),较上年同期增长182.27%。
  报告期内,公司集中优势资源,全力推进已处于临床研究和产业化关键阶段的各重磅产品的研究和产业化... 查看全部▼

  一、业务回顾和展望
  1、业务回顾
  报告期内,公司顺应新的流通管理政策,优化营销策略和模式,充分发挥产品品牌和产品质量优势,积极拓展疫苗销售业务,原有自主生产疫苗产品销量持续稳定增长,同时新产品23价肺炎球菌多糖疫苗取得较好的销售业绩。伴随着国内疫苗行业的良好发展态势,公司自主疫苗产品销售收入及净利润实现同步增长,与上年同期相比,本报告期公司归属于上市公司股东的净利润实现扭亏为盈。
  报告期内,子公司玉溪沃森获批签发产品数量合计7,131,790剂(瓶),较上年同期增长182.27%。
  报告期内,公司集中优势资源,全力推进已处于临床研究和产业化关键阶段的各重磅产品的研究和产业化进度。公司13价肺炎结合疫苗Ⅲ期临床试验成功揭盲并于2018年1月21日获得了临床试验报告。2018年2月1日,公司收到了国家药监总局出具的13价肺炎结合疫苗申报生产的《受理通知书》,4月9日,公司13价肺炎结合疫苗正式纳入优先审评品种。目前,该疫苗申报生产的相关审评工作正在进行中。子公司上海泽润生物科技有限公司(以下简称“上海泽润”)二价HPV疫苗已进入了Ⅲ期临床研究的关键时期,正处于收集分析临床结果判定终点病例样本的最后阶段;九价HPV疫苗已于2018年1月获得临床试验批件,目前,临床试验现场准备的各项工作正在持续推进。子公司嘉和生物注射用重组抗HER-2人源化单克隆抗体和注射用重组抗TNF-alpha人鼠嵌合单克隆抗体Ⅲ期临床研究持续推进病例入组工作,并同时开展工艺转移和优化的相关研究工作,各项工作正在按计划有序开展。
  报告期内,公司其他处于临床研究和临床申报阶段的在研产品按计划持续推进各项工作。
  重组抗血管内皮生长因子人源化单克隆抗体注射液进入Ⅲ期临床研究阶段,重组抗PD-1单抗和重组抗IL-6单抗均已启动临床研究,各项工作正在按计划有序推进。另外,公司的新型重组抗HER-2全人源单克隆抗体(注射用GB235单抗)和抗人RANKL单克隆抗体(GB223单抗注射液)也已获得了临床试验批件。公司已形成了丰富的后续产品梯队储备,构建了成熟稳定的疫苗和单抗药物的研发平台,公司将根据公司的产品研发战略和计划持续推进各个产品的研发、临床和产业化进度,为公司的长远发展不断添砖加瓦,提供更新更好的产品和服务。
  公司在云南省玉溪国家高新技术产业开发区建有现代化的生物技术药生产基地。报告期内,在已有疫苗生产基地的基础上,公司持续推进在玉溪产业化基地实施的HPV疫苗的产业化建设项目。公司HPV疫苗产业化项目按WHO预认证标准和其他通行的国际标准设计建设,目前,产业化生产车间已建成并进入试生产阶段,为公司HPV疫苗的产业化和国际化进程奠定了坚实的硬件基础。
  2、工作展望
  2018年,公司将重点推进自主生产疫苗产品的生产和销售工作,继续保持自主疫苗产品收入持续增长的势头,确保公司业绩显现产品叠加效应。继续推进新产品的研发和产业化工作,同时,严格控制各项成本费用支出,使公司年度计划预算得到有效落实,确保全年业绩目标的实现。另外,公司还将通过提供外包服务(CRO)、落实政府大宗采购、争取政府补贴等举措,进一步提升公司业绩。
  在销售上,公司将积极调动内外部资源,全面推进以23价肺炎疫苗、Hib疫苗为代表的公司自主生产疫苗产品的市场推广和销售业务,同时,采用专业学术推广、品牌营销等方式深挖产品的销售潜力。继续强化国际合作,加强与盖茨基金会等国际组织的合作与交流,努力开拓国际市场,积极推进产品在海外市场的注册和出口。
  在生产上,狠抓产品生产和质量管理,通过精细化管理,提高生产效益,确保产品稳定供应市场,同时,加快实施公司产品WHO预认证工作,为产品大宗出口奠定坚实基础。
  在产品研发和新产品产业化方面,集中优势资源,全力推进13价肺炎结合疫苗申报生产和上市工作,同时,进一步加快二价HPV疫苗的产业化进度以及单抗药物等产品的临床研究进度,确保产品临床研究和申报生产的无缝衔接,早日实现产品上市。
  在管理上,公司将持续进行内部发展要素调整和资源优化,提高资源利用率。加强团队建设与人才培养,提升职能专业度,持续完善有效的激励及考核机制。同时,继续以预算管理为核心抓手,规范费用支出,开源节流,加强内部控制和制度流程建设,提升公司的管理水平。

  二、重大风险提示
  1、在研产品的研发风险
  药品研发均具有一定的研发风险,随着药品注册审批标准和要求的提高,药品研发的风险也会进一步加大。创新度越高的产品,其研发风险也越大,平衡好创新和风险防范的关系对公司未来的发展非常重要。为有效降低研发风险,公司将持续在药物研发的各阶段严格遵照药物研发的规律和要求开展研发工作,充分平衡好创新与风险的关系,科学评估,及早识别、控制和降低风险。
  2、政策风险
  近年来,医药行业的发展突飞猛进,国家对制药行业的监管力度也在不断加强。药品从研发到临床、从生产到流通直至产品上市后的监管要求均在大幅提升,整个行业也在不断进步,企业需要快速达到并适应新的要求,客观上使得政策风险增加。面对不断提高的政策要求和行业需要,公司也在不断提高自身的标准,主动变革,站在行业前沿,顺应市场的需求,在全产业链上均以更高的标准对自身严格要求,确保公司始终保持主动,充分降低因政策变化引起的风险。
  3、市场竞争加剧的挑战
  公司目前上市的产品均非独家品种,每一个品种都有竞争厂家,后续还陆续有新厂家加入,传统疫苗市场的竞争日益激烈,这些都将对公司产品的市场占有率和销售价格造成不利影响。
  为应对这一挑战,公司将不断加快产品研发进度,主动实现产品升级,强化质量意识,加快13价肺炎结合疫苗、二价HPV疫苗的产业化进度以及曲妥珠单抗、英夫利昔单抗等新产品的临床研究进度,加大力量打造沃森产品高品质的品牌形象,维护和增强公司产品在市场竞争中的优势。
  4、药品不良反应风险
  药品客观上存在不良反应风险。根据国家食品药品监督管理总局的定义:药品不良反应,是指合格药品在正常用法用量下出现的与用药目的无关的有害反应。根据WHO国际药品监测合作中心的定义:药品不良反应是为了预防、诊断、治疗疾病或改变人体的生理功能,人在正常用法用量下使用药品所出现的非预期的有害效应。药品使用后导致严重不良反应(包括偶合反应)发生后,如果不能依法及时处置,可能导致媒体和消费者对公司产品的不信任,轻则影响产品销售,重则危害行业声誉。
  为应对和控制药品不良反应风险,公司一方面在产品研发、生产、营销的全过程严格按照《药品注册管理办法》、GMP、GSP的要求建立完善的质量管理体系,保证质量合格、安全有效的药品传递到最终用户手中;另一方面公司根据国家新的《疫苗流通和预防接种管理条例》、《药品不良反应报告和监测管理办法》要求,制定了药品不良反应应急处理制度和预案,并完善了组织机制,以降低药品不良反应的风险。
  5、药品质量风险
  一方面,药品生产工艺复杂,涉及面较广,特别对于疫苗、单抗药物等生物制品而言更是如此,另一方面,生物制品在流通环节也比普通药品的要求更高,即使各环节严格遵循现有的各类标准化指导文件进行生产和流通,客观上也依然存在发生产品不合格的概率,最终将导致该批产品报废,造成损失。为防范这一风险,公司在新产品临床研究阶段即同步开展产业化研究,以便解决大规模生产的工艺稳定性问题,最大限度的降低药品质量风险。同时,子公司专门设置了风险管理部,采用科学的风险管理技术和方法进行生产管理和质量管理过程中的风险识别和防范,根据新版GMP的要求对生产全过程实施基于风险的管理。
  6、应收账款风险
  疫苗行业最终客户均为各地的区县疾控中心,存在费用审批环节较多、付款周期较长的特点,由于应收账款占用了公司较多的资金,若不能及时收回,可能影响公司的现金流量,如形成坏账将给公司造成损失。但疾控中心疫苗产品采购经费属政府预算,应收账款回收的风险较小。公司将采取积极措施严格控制应收账款的额度和回收周期,降低应收账款风险。 收起▲