主营介绍

运营业务数据

最新公告日期:2018-04-26 
业务名称 2017-12-31
工业销量(元) 2.17亿
工业产量(元) 5789.62万
商业(药品销售)销量(元) 2567.37万

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 工业 1.25亿 76.42% 2496.17万 43.45% 94.21% 80.07%
商业 3865.72万 23.58% 3249.36万 56.55% 5.79% 15.94%
按产品 其他产品 8377.50万 51.11% 4769.11万 83.01% 33.90% 43.07%
多肽类产品 8013.26万 48.89% 976.41万 16.99% 66.10% 87.82%
按地区 华东地区 5642.74万 31.93% 1637.27万 27.05% 34.46% 70.98%
华南地区 5017.45万 28.39% 1582.13万 26.14% 29.56% 68.47%
西南地区 2210.10万 12.50% 1170.69万 19.34% 8.94% 47.03%
华中地区 2104.39万 11.91% 950.86万 15.71% 9.92% 54.82%
华北地区 1050.88万 5.95% 326.57万 5.40% 6.23% 68.92%
西北地区 973.56万 5.51% 133.58万 2.21% 7.23% 86.28%
出口 378.40万 2.14% 157.03万 2.59% 1.90% 58.50%
东北地区 297.27万 1.68% 93.60万 1.55% 1.75% 68.51%

董事会经营评述

  一、概述
  在国家深化医药卫生体制改革的政策背景下,整个医药产业链优胜劣汰的竞争格局加大,产业规模集中加快。在这一大背景下,对公司来说既是大力发展的机会,同时也是对公司经营的极大挑战。为应对这种紧迫局面,公司重点加强员工的国际法规专业知识,不断提升经营班子的管理能力。
  1、研发方面及技术平台
  经过研发团队的不懈努力和生产质量等各部门的紧密配合,报告期内公司的研发工作取得了较大进展并收获了不少成果,主要工作如下:
  1)胸腺法新原料药在完成了工艺变更和质量标准提高的相关研究后,向CFDA申报的补充申请已获得批件。胸腺法新原料药和注射用胸腺法新制剂ANDA申请在意大利获批。制剂一致... 查看全部▼

  一、概述
  在国家深化医药卫生体制改革的政策背景下,整个医药产业链优胜劣汰的竞争格局加大,产业规模集中加快。在这一大背景下,对公司来说既是大力发展的机会,同时也是对公司经营的极大挑战。为应对这种紧迫局面,公司重点加强员工的国际法规专业知识,不断提升经营班子的管理能力。
  1、研发方面及技术平台
  经过研发团队的不懈努力和生产质量等各部门的紧密配合,报告期内公司的研发工作取得了较大进展并收获了不少成果,主要工作如下:
  1)胸腺法新原料药在完成了工艺变更和质量标准提高的相关研究后,向CFDA申报的补充申请已获得批件。胸腺法新原料药和注射用胸腺法新制剂ANDA申请在意大利获批。制剂一致性评价的相关研究已经完成,并向CFDA提交了申报资料,现已在技术审评中;
  2)比伐芦定原料药和注射用比伐芦定的研发工作已顺利完成,向美国FDA递交的DMF已审评完毕处于可用状态,注射用比伐芦定ANDA申请在美国获得暂定批准,在中国CFDA的申请已进入尾声;
  3)生长抑素原料药已按欧盟技术要求基本完成了相关质量研究、杂质谱分析和方法学开发与验证。三批注册申报批生产已经完成,正在进行稳定性研究中;
  4)注射用泮托拉唑钠和依替巴肽注射液仿制药研发正在进行中。
  2、工程建设方面
  报告期内,公司主要实施的工程项目有:溶剂回收设备基础及回收车间设备和管道安装项目;污水处理站设备基础及设备安装项目。
  宁波双成的建设情况:2018年3月,宁波双成抗肿瘤车间已经取得药品生产许可证。
  3、生产方面
  报告期内,公司继续保持无安全事故、无生产事故。公司不断完善并严格执行环境保护制度,设有专职环境保护管理部门,维护环保设施的正常运行。公司与专业水处理单位合作,进行污水处理工艺的技术改造,采用较为先进的处理工艺和设备,增加污水排放水质在线监测,并与海口市环境保护监察平台联网,确保公司环保达标排放。

  二、公司面临的风险和应对措施
  1、行业政策变化风险
  国家对医药行业的监管力度不断加强,包括国家及各级地方药品监管部门制订的相关政策法规。我国医疗卫生行业正处于深度改革阶段,相关政策法规体系正在逐步制订和完善,相关政策的出台有可能不同程度地对公司生产、销售和研发、流通环节产生影响。
  公司将密切关注、研究国家政策的变化,不断修正生产、销售、研发策略,在经营策略上及时调整应对,顺应国家有关医药政策和行业标准的变化,以保持公司的综合竞争优势。
  2、原材料和辅料价格上涨风险
  随着医药行业进一步的规范发展,以及环保方面的法律法规调控措施的加强,近年来公司采购的原辅料价格都有不同程度的上涨,也导致生产成本不同程度的增加。为了应对原辅料价格上涨的情况,公司将在规定的范围内提前制定采购计划,同时与多年有合作的原辅料生产厂商进行及时有效的沟通,确保做到最大程度降低采购成本,尽量避免原辅料价格上涨带来的成本增加。
  3、主导产品较为集中的风险
  公司主要从事多肽原料药及制剂的研发、生产和销售,主导产品为胸腺法新原料药及制剂。通过近年广泛的临床使用和市场推广,胸腺法新制剂的疗效和安全性得到有效验证,从而推动其市场需求快速增长。
  如受医药行业政策,市场波动及公司产品销售、质量等因素的影响大,风险集中度高。
  为了避免产品单一、集中给公司带来的风险,公司将一方面通过市场营销策略增加市场占有率,另一方面,通过研发和并购不断丰富产品线,以获取更多的新产品,调整优化产品结构,分散产品单一、集中可能带来的风险,同时加快公司产业链的延伸。
  4、固定资产折旧增加导致利润下降的风险
  公司控股子公司宁波双成投资项目建设完成后,由于新建项目需要逐步达产,其经济效益在达到设计产能后方可完全体现。因此,宁波双成项目在建设完成后尚未达到满产状态前期新增固定资产折旧会影响公司当期的利润水平。为了避免新建项目折旧对公司利润的影响,公司在加快新品种落户宁波双成的同时,也积极寻找新的合作机会增加宁波双成的销售收入,以抵减新增固定资产折旧对公司利润水平的影响。
  5、环保风险
  第十二届全国人大常委会第八次会议审议通过了修订后的《环境保护法》,新《环保法》于2015年1月1日起正式施行。新《环保法》一方面通过加强执法监督、提高企业的环境违法成本、加强信息公开和公众参与来督促企业的环保履职,另一方面通过市场化手段促使企业主动实施污染防治。
  公司产品的生产过程中会产生废水、废气、固体废弃物等污染性排放物,为实现公司长期稳定健康发展,公司建立了系统的污染物处理管理制度,拥有完备的污染物处理设施设备,严格按照有关环保法规及相应标准对上述污染性排放物进行了有效治理,使其排放达到了环保规定的标准,公司建立了废料回收处理装置、污水处理装置等,深入推行清洁生产,提高公司环保水平,降低了因环保问题给公司带来的风险。
  6、产品价格风险
  近年来,国家针对药品价格进行了多次政策性下调,药价呈下降态势。随着国家医疗改革的深入,在医保控费的大背景下,受宏观经济、医药环境、行业政策等多方面因素影响,药品价格可能继续下调,进而影响公司产品销售价格。面对价格下调风险,公司在产品质量、招标价格等方面加大力度,在不同政策的范围内,抓住市场机遇,以确保公司长期可持续发展。
  7、药品质量风险
  公司以生产冻干粉针制剂为主,药品作为一种特殊商品,直接关系到人民生命健康,药品质量安全尤其重要,相关政策法规在药品生产、运输、储存及使用过程中都有严格要求,以避免有可能发生的质量风险。针对药品质量,公司多年来一直坚持严格要求,完善质量管理体系,完善质量控制的标准及程序,提高工作人员素质,加强监督管理,严格按照《药品管理法》、《药品生产质量规范》及CGMP的规定,加大对生产过程中的日常监督及检查力度,督促和监督严格按照CGMP要求组织生产,加强对采购、生产、检验等各环节的质量控制,把质量监管责任落实到人。
  8、人才流失风险
  公司根据自身发展战略,一直以来对于新药研发方面的高级技术人才需求强烈,尤其是化学合成、药理药效、制剂研究、质量控制等方面的专业人才。公司注重高级专业人才的引进,同时加强公司内部的人才培养力度,从外部招聘和内部培养双重渠道来保证公司发展的用人需求。公司也会利用上市公司平台采取有效的薪酬体系、激励政策等多层次多元化的激励机制,吸引和留住优秀人才,调动和发挥员工的积极性和创造力。

  三、核心竞争力分析
  1、近年来公司坚持国际化路线,建立了包括有多位具有多年国际经验的专业技术人员的研发团队和体制,同时也大大提高和完善了公司GMP的体系,其研发和GMP均能满足国际要求。公司的研发项目形成了丰富的产品管线,公司拟定在今后的多年内将不断地向美国和欧盟国家申报原料药DMF和ANDA,加快公司国际化进程。
  2、报告期内,公司收到美国食品和药品监督管理局的通知,公司2016年12月27日向美国FDA申报的注射用比伐芦定的简化新药申请已获得暂定批准。该批准标志着公司生产的比伐芦定原料药和注射用比伐芦定制剂与原研药一致,在安全性和有效性上达到了国际水平。 收起▲