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贝达药业首份中报出炉 三驾马车齐头并进
2017-08-30 21:10:42 中国经济网
近日,刚刚登陆创业板的贝达药业(SZ.300558)公布上市后首份半年报。公告显示:2017年上半年,公司上半年实现营业收入4.98亿元,同比下降近3.94%;净利润1.37亿元,较上年同期下滑35.45%。公司市场销售、自主研发、战略合作三驾马车齐头并进。 对于公司业绩出现下滑,贝达药业并不避讳。公告指出,营收和净利润下降主要由于产品大幅降价;报告期内多个新药进入临床试验阶段,研发投入增加较多;公司募集资金投资项目新生产基地大部分已于2016年末结转至固定资产等原因。 东兴证券研报指出,贝达药业核心品种凯美纳销售价格进入医保谈判后降价幅度较大。由于全国部分省市医保目录的落地仍在逐步推进中,市场反应存在滞后性,销售量的增量还在逐步体现,销售收入同比有所下降。下半年凯美纳将销量增速将迎来爆发,弥补降价带来的影响。 国内首个小分子靶向抗癌药望迎市场拐点 贝达药业是一家由海归博士团队创办的,以自主知识产权创新药物研究和开发为核心,集医药研发、生产、营销于一体的国家级高新技术企业,拥有独立完整的研发、采购、生产和销售体系。公司自主研发的产品埃克替尼属于国家1类新药,也是我国第一个拥有自主知识产权的小分子靶向抗癌药。 上半年公司继续精耕细作现有肺癌靶向药市场,加大产品宣传和学术推广力度,在潜力地区针对市场情况出台相应的市场策略,加快对新市场的布局和拓展。在2月份国家医保目录发布后,凯美纳在绝大部分地区陆续执行国家医保谈判价格,产品降价幅度较大,而全国各省市医保目录的落地仍在逐步推进中。 由于市场反应存在滞后性,销售量的增量还在逐步体现,从各月销售增速来看,初步显现量价转换成效。针对各省市医保陆续落地,贝达市场、销售团队重点做好各地医保的衔接落实,为下半年各地凯美纳的销售打下基础,下半年销售有望迎来市场拐点。 自主研发推进多个新药进入临床阶段 报告期内贝达药业自主研发新药计划稳步推进,研发费用投入总额9039.02万元,比去年同期增长22.6%,占营业收入比重18.15%。研发投入力度大,巨额的研发投入,让新药研制速度大大加快,多个新药研发已进入临床试验阶段。 按照贝达药业年初制定的新药研发目标,2017年将力争实现1个新药项目IND(临床研究申请),确定2个候选化合物,新立项3-5个项目。其中,BPI-16000项目候选化合物的体内外活性良好;17000项目备选化合物有较好体内药效,下一步准备进行代谢特性鉴定以及安全性初步评价;18000项目经分子优化后已获有潜力的先导化合物,下一步继续进行体内活性和安全性的筛选;21000项目候选化合物体内外药效已得到验证,目前正在开展其他临床前研究。 在新药临床前研究不断突破的同时,公司主要临床研究项目快速开展。目前,Ensartinib(X-396)与克唑替尼头对头的全球III期临床试验已在全球80多家中心启动;中国部分6月初获得国家食品药品监督管理总局(CFDA)全球多中心临床批件,III期临床研究于7月7日召开启动会,29家中心启动工作也在顺利推进之中。X-082化合物眼科适应症研究在美国已经完成II期试验入组,后续将讨论和确定III期试验方案;X-082化合物肾癌Ⅲ期研究已于3月启动。 东兴证券研报指出,贝达药业研发实力强劲,后续产品多个产品处于临床阶段,公司研发的战略定位还是聚焦分子靶向药,积极开展免疫疗法的研究,利用自己优势,同时开展对外合作。 对外合作呈现加速态势 报告期内,作为公司快速发展三架马车之一的对外合作,得到加速发展。 2017年3月公司以现金3.72亿受让卡南吉77.4%股权。随后在6月16日以自有资金1.08亿公开摘牌收购张江生物和张江科投分别持有的卡南吉13.5%和9.0909%的股权。实现100%控股。卡南吉公司主要从事靶向新药X-082(抗血管生成药)的研究开发,其最大特点是安全性高,疗效好。 2017年4月,公司以2000万美金参与XcoveryD轮融资,融资完成后,持有Xcovery86.24%股权。主要合作项目为X396,是2014年引进的第二代ALK抑制剂。目前进度如下。 同时公司与北京天广实生物技术股份有限公司就MIL60抗体(贝伐单抗的仿制药)达成战略合作,投资5000万元取得MIL60产品权益,开始拓展大分子药物产品线;目前I期结果很好,开始后续研究。全国30家医院已经逐渐开启试验。 贝达药业将所占股份的15%无偿转让给华昊中天技术及管理团队控股的公司,作为技术和高管团队的激励股权,转让完成后,贝达药业将持有华昊中天4.4737%股权,此举进一步扩大肿瘤靶向药领域产品线布局。 自上市以来,公司的对外战略合作工作有序开展,在引进项目时公司始终考虑与企业发展方向匹配,优先引进与公司现有产品线形成互补的项目,争取尽快实现新产品的上市。 公司表示,将继续执行以市场销售、自主研发、战略合作三驾马车驱动公司发展的企业战略,三驾马车齐头并进,显示出良好的引领和协同作用,推动经营全面顺利展开。(白宝玉)
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