主营介绍

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 原料药和中间体 11.99亿 26.40% 9.19亿 54.05% 9.87% 23.40%
中药制剂 8.62亿 18.97% 1.98亿 11.66% 23.33% 77.00%
西药制剂-促性激素 7.54亿 16.60% 2.62亿 15.42% 17.30% 65.25%
西药制剂-消化道 6.25亿 13.75% 5247.58万 3.09% 20.12% 91.60%
西药制剂-其他 3.46亿 7.61% 5069.38万 2.98% 10.37% 85.33%
诊断试剂及设备 3.38亿 7.43% 1.33亿 7.85% 7.18% 60.46%
西药制剂-抗微生物药物 2.94亿 6.46% 5790.47万 3.41% 8.29% 80.28%
西药制剂-心脑血管 1.27亿 2.80% 2622.45万 1.54% 3.55% 79.37%
按产品 参芪扶正注射液 5.46亿 100.00% 1.11亿 100.00% 100.00% 79.72%
按地区 境内 39.85亿 87.71% 12.82亿 75.40% 95.07% 67.84%
境外 5.59亿 12.29% 4.18亿 24.60% 4.93% 25.12%

董事会经营评述

  一、概述
  2018年,医改进入深水区,机遇与挑战并存。医保局的成立、一致性评价的不断推进,新版医保的执行落地,药占比的持续管控,都对整个医药行业都带来巨大影响。
  2018年上半年,在新的形势下,本集团积极应对,围绕“创新、规范”的管理方针,稳步推进各项业务发展。本报告期,本集团实现营业收入人民币4,564.70百万元,相比上年同期的人民币4,274.76百万元,同比增长6.78%;实现净利润人民币675.71百万元,相比上年同期的人民币550.39百万元,同比增长22.77%;实现归属于本公司股东的净利润人民币633.35百万元,相比上年同期的人民币504.00百万元,同比增长25... 查看全部▼

  一、概述
  2018年,医改进入深水区,机遇与挑战并存。医保局的成立、一致性评价的不断推进,新版医保的执行落地,药占比的持续管控,都对整个医药行业都带来巨大影响。
  2018年上半年,在新的形势下,本集团积极应对,围绕“创新、规范”的管理方针,稳步推进各项业务发展。本报告期,本集团实现营业收入人民币4,564.70百万元,相比上年同期的人民币4,274.76百万元,同比增长6.78%;实现净利润人民币675.71百万元,相比上年同期的人民币550.39百万元,同比增长22.77%;实现归属于本公司股东的净利润人民币633.35百万元,相比上年同期的人民币504.00百万元,同比增长25.66%;若剔除非经常性损益项目收益,本公司2018年上半年主营业务实现的归属于本公司股东的净利润为人民币571.13百万元,相比上年同期的人民币455.27百万元,同比增长25.45%。
  各业务板块完成情况如下:
  (1)制剂药业务:促低产,抓基层,布局新品上市
  今年是证据营销、服务营销全力推进的一年,也是合作营销的启动元年。在“三个营销”的方针指导下,本集团积极部署,于报告期内,就以下几个方面做了详尽工作:一是梳理低产医院,推进低产医院重点品种的上量;二是开发空白医院,提高重点产品的医院覆盖率;三是拓展基层市场,促进基层终端开发与销售;四是布局部分品种的上市后研究,做深做细学术推广;五是做好精细化服务营销,做到精准收集及精准推送;六是布局注射用艾普拉唑钠的上市工作,推进招标及医保等市场准入进展。
  本报告期内,在制剂药品的研发上,本集团进一步健全研发创新体系,制定研发创新激励办法,引入和发展高端人才,加大技术创新和新产品的研制力度,全力推进重点在研品种的进展。参芪扶正注射液获美国FDA批准Ⅰ期临床,已进入临床研究阶段;注射用高纯度尿促性素已进入临床研究阶段;孤儿药注射用丹曲林钠已进入临床研究阶段。一致性评价工作稳步推进,目前替硝唑片、克拉霉素片已处于临床试验阶段,报告期内,本集团成立注射剂一致性评价工作组,积极推进注射剂的一致性评价工作。
  本报告期内,在制剂药品的生产上,本集团各生产企业生产及质量稳定,未发生重大环保事故、安全事故和职业健康事故。质量内审工作结合企业产品特性和质量管理情况,围绕企业风险控制情况和药政法规实施情况,质量管理总部对4个制剂企业共进行了4次飞行检查,合计进行了9次审计。在产能建设方面,完成参芪袋装输液一车间技术改造,稳步推进注射用重组人绒促性素车间建设及微球生产线的建设。
  制剂药品的海外销售方面,2018年上半年重点开展了促性激素、消化道、精神类、抗感染等产品在巴基斯坦、独联体国家、菲律宾、中美洲、尼日利亚、澳门等国家或地区的注册和销售工作。
  (2)原料药及中间体业务:抓研发、重质量、加强市场推广布局
  本报告期内,原料药事业部持续贯彻“安环”、“质量”、“成本”三架马车齐头并进的管理指导思想,强化人才培养和队伍建设,加大研发力度,以研发为引擎,全面提升研发、销售、生产管理水平。
  本报告期内,原料药研发工作取得明显成效,已立项并开展研发项目11项,其中1项已经申报DMF,数个重点产品菌种及发酵工艺优化工作取得了阶段性进展,多个新产品完成注册前研发工作,并设立了多肽研发中试车间。同时,研发管线中还充实了抗糖尿病、慢性支气管肺阻、新型抗生素及高端兽药等品种。
  2018年上半年,原料药高端抗生素中部分品种在非规范市场销量明显增加,兽药部分重点品种欧美市场继续发力。同时,多个重点品种与客户签订了年度战略合作协议。
  在生产和质量上,管理水平稳步提升,原料药各生产企业未发生重大安全、环保及质量事故或事件。在注册认证方面,截止期末,已通过国际认证现场检查品种11个,取得国际认证证书17个(其中:FDA现场检查品种5个),已有43个品种在83个国家(地区)进行了两百多个项目的注册工作。
  本报告期内,本集团成立原料药事业部产能整合小组,对原料药产能的整体布局、产品的转型升级、新厂搬迁建设、旧厂土地处置和产品异地转移等重大事项进行调研和决策。
  (3)精准医疗:重研发,抓临床,优化业务结构布局
  本报告期内,为更好的实现本集团精准医疗业务中长期发展,精准医疗板块创新了激励模式,优化了业务结构,丽珠圣美进行股权调整,丽珠单抗进行了重组及融资。目前,本集团精准医疗的产业链布局为“丽珠试剂+丽珠单抗+丽珠基因”。本报告期内,各公司主要业务进展如下:
  丽珠试剂:自产品种收入占比持续提高,其中,自产呼吸道金标产品较去年同期增长加速。在研发方面,血筛的核酸产品临床结果可喜,多重免疫设备与试剂顺利完成了性能测试,X光血液辐照仪的注册检测方案得到专家会的认可。同时,新建了免疫POCT研发团队及苏州研发中心,进一步加强诊断试剂领域的研发能力。
  丽珠单抗:聚焦临床和申报,全力推进重点品种的临床进展,各临床试验进展顺利。同时,为确保临床用药生产,加强质量体系建设,准备研发到产业化的战略转型。建立CAR-T平台及研发管理团队,启动研发项目,目前研发管线初步形成差异化布局。为加快推进生物药研发进展与国际化开发拓展,丽珠单抗于本报告期内进行了重组及融资。
  丽珠基因:2018年1月正式启动商业化送检,积极拓展临床及科研合作单位,目前已与多家医院开展业务合作;完成7个新项目的研发验证,丰富了检测项目及可检样本类型。先后满分通过卫生部临检中心“全国肿瘤NGS生信质评”和“全国肿瘤PCR室间质评”;加入“粤港澳液态活检联合研究中心”并成为其临床化落地的检测实验室。
  (4)职能与战略:强服务,促规范,优化内控管理
  本报告期内,本集团在“创新、规范”的核心经营管理方针下,各职能部门积极配合,从本职出发,兼顾全局,主要包括以下方面:一是规范行政管理制度,提高后勤服务水平;二是完善本集团管理干部培训体系,继续加强人力引进;三是合理安排资金管理,提高集团资金收益;四是推进信息化规范建设,本集团管控信息系统上线。
  在战略发展及投资方面,对内,本集团加强了内部股权的整合与管理,新北江制药、丽珠圣美、丽珠单抗等进行了股权结构的调整。对外,本集团不断积极寻找符合公司发展战略的潜在投资购并对象,进一步完善产业架构。
  二、主要的风险和机遇及应对对策
  (1)行业政策变化风险:医药制造业受行业监管程度较高,中国正在进行深化医药卫生体制改革,相关政策法规体系正在逐步制订和完善,政策的出台有可能不同程度地对本集团研发、生产和销售产生影响,比如2017年医保目录的调整、一致性评价的推进和招标降价等因素均可能对本集团造成一定的影响。
  应对措施:公司将密切关注并研究相关行业政策,及时把握行业变化趋势,合规生产经营,加强自身核心竞争力,积极应对行业变革。
  (2)新药研发风险:一般而言,药品的开发要经历临床前研究、申请临床注册、批准临床试验、临床试验、申报生产注册、现场核查、获准生产等过程,环节多、周期长,审批结果具有不确定性,存在研发风险。
  并且产品研制成功后,是否能形成有效的市场销售也具有不确定性。
  应对措施:公司将进一步健全研发创新体系,引入和发展高端人才,不断提升研发水平,优化研发格局,集中力量推进重点在研品种的进展。同时,加强部分重点品种的二次开发,提高工艺水平,降低生产成本。
  (3)产品降价风险:药品获批上市后,还将通过医保、招标等一系列市场准入的工作,将使医药企业面临药品降价的压力。同时,受宏观经济、市场竞争、医保控费等行业政策多方面因素影响,药品价格可能有进一步下降的风险。
  应对措施:公司将密切关注招投标动态,灵活应对及调整招标方案。同时,公司也将开展对部分重点产品的上市后临床研究,强化产品的市场竞争力。另外,公司也将不断创新研发临床急需的、具有一定高附加值的品种,深入挖掘具有市场潜力的在产品种,不断优化产品领域的布局,以确保公司长期可持续发展。
  (4)原材料供应和价格波动风险:中药材、原料药、辅料、包装材料等原材料一直受到诸如宏观经济、货币政策、环保管理、自然灾害等多种因素影响,可能出现供给受限或价格大幅波动,将在一定程度上影响公司的盈利水平。
  应对措施:首先,公司部分重点品种的中药材原材料已自建GAP生产基地;其次,公司将加强市场监控及分析,合理安排库存及采购周期,降低风险;再次,公司在保证质量的前提下,精益生产,实施有效的成本控制措施。

  三、核心竞争力分析
  本报告期内,本集团仍坚持以成为一家高端特色专科制药企业为发展目标,围绕“转型升级、规范发展”的核心经营管理理念,不断提高管控效率与规范治理水平,稳步推进研发进展,优化营销市场布局,实现了业绩稳步增长。本报告期内,本集团的核心竞争力没有发生重大变化。主要体现在以下几个方面:
  (1)多元化的产品结构和业务布局
  本集团产品涵盖制剂产品、原料药和中间体、诊断试剂及设备等多个医药细分领域,并在抗肿瘤用药、辅助生殖用药、消化道用药、精神用药及神经用药等多个特色专科治疗领域方面形成了一定的市场优势。现阶段公司在持续加强单抗药物研发的同时,不断加快推进公司精准医疗业务布局。
  (2)完善的营销体系与专业化的营销团队。
  本集团对营销工作实行精细化管理,不断完善营销体系建设,优化激励考核机制,不断加强学术营销及终端推广,通过优化资源配置,逐步构建了较为完善的营销体系;本集团各个领域营销管理团队及为本集团提供专业销售服务人员共计一万余人,营销网络覆盖全国各地,包括主要的医疗机构、连锁药店、疾控中心和卫生部门等终端。
  (3)成熟的质量管理体系。
  本集团建立了涵盖产品生产质量、科研、销售等业务的立体化质量管理体系。报告期内,本集团持续提升质量管理水平,总体生产、经营质量状况良好,质量管理体系的健康运行,使本集团各领域产品的安全性和稳定性得到了有效保障。
  (4)强大的研发能力与国际化的研发理念。
  本集团在化学药、中药制剂、生物药以及诊断试剂等领域均有较强的研发能力及国际化的研发理念。通过积极引进国内外资深专家和创新型人才、不断加大研发投入、发展海外战略联盟等方式,围绕抗肿瘤、辅助生殖、消化、精神及神经等特色专科药的产品线布局,形成了清晰的产品研发管线,进而增强了本集团的研发竞争力。 收起▲