| | 问:请问1.公司针对哪些产品进行全球布局?全球布局是委托三方还是公司自己的涉外机构布局?2.也知道新的产品之前签订的和正大天晴合作,不知道还是否继续合作?谢谢!(来自: 上证E互动) | | 答:您好,公司在产品开发的全过程中,会及时评估各个产品管线的潜在商业机会,分析市场竞争环境,制定最佳的商业化方案。基于创新药的患者群体、全球化的产品布局、市场竞争等因素的考量,公司计划采用授权合作与自主销售相结合的方式开展产品的商业化活动。对于产品的境外商业化,公司将优先考虑采用授权合作或授权销售的模式,根据各个国家或地区的情况,与具备雄厚商业化能力的医药企业开展深入合作。公司与正大天晴就D-1553的合作情况具体详见公司公告。感谢您对公司的关注! |
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| | 问:目前有商业化团队吗?商业化有什么打算?(来自: 上证E互动) | | 答:您好,公司在产品开发的全过程中,持续评估各个产品管线的潜在商业机会,分析市场竞争环境,制定最佳的商业化方案,在产品上市前做好充足的前期准备。基于创新药的患者群体、全球化的产品布局、市场竞争等因素的考量,公司采用授权合作与自主销售相结合的方式开展产品的商业化活动。感谢您对公司的关注! |
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| | 问:江总您好!首先祝贺公司KRASG12C抑制剂格索雷塞片获批上市,希望在不久的将来占有一定的市场份额提升公司业绩。江总可否详细的介绍下这款新药的市场前景,目前市场总体规模,与其他竞品相比有何优劣?不知道目前国内用药患者总人数有多少,一年的用药成本大概是多少?谢谢江总祝您身体健康工作顺利!(来自: 上证E互动) | | 答:您好,格索雷塞(D-1553)是公司自主研发的一款KRAS G12C抑制剂,用于治疗带有KRAS G12C突变的非小细胞肺癌、结直肠癌等多种癌症。据有关文献,KRAS G12C突变发生在约14%的非小细胞肺癌、约4%的结直肠癌以及约3%的胰腺癌患者中;根据目前在中国人群中的报告,KRAS G12C突变发生在约4.3%的肺癌、约2.5%的结直肠癌患者以及约2.3%的胆管癌患者中。
基于一项在KRAS G12C突变阳性的局部晚期或转移性NSCLC患者中进行的多中心、单臂、开放标签的关键性II期研究显示,格索雷塞表现出较高的肿瘤缓解率和较长的缓解持续时间以及良好的耐受性。客观缓解率(ORR)为52.0%,疾病控制率(DCR)为88.6%,中位缓解持续时间(DOR)为12.5个月,中位无进展生存期(PFS)为9.1个月,中位总生存时间(OS)为14.1个月,进一步肯定了格索雷塞在该患者人群中的临床价值。感谢您对公司的关注! |
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| | 问:尊敬的江总您好!首先祝贺公司新药通过审批上市。新药获批到目前为止公司股价不知什么原因大跌,请问公司经营出现了问题还是新药不及市场预期或者是其他什么原因?还有正大晴天与公司签定的5.5亿首付款请问是什么时间节点事件触发支付条款?谢谢!(来自: 上证E互动) | | 答:您好,公司目前经营情况正常。股价波动受到宏观政策、经济形势、行业趋势、市场情绪、资金面等多种因素影响。公司将进一步丰富、加强产品管线,同时,对现有临床管线产品采用多元的商业化路径,改善公司的财务状况和经营业绩。
公司已授予正大天晴在协议期限内对益方生物 D-1553 产品在中国大陆地区开发、注册、生产和商业化的独家许可权。正大天晴将向公司支付最高不超过人民币5.5亿元的首付款及里程碑款,并按年净销售额向公司分层支付特许权使用费。具体内容以公司披露的相关公告为准。感谢您对公司的关注! |
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| | 问:请问,微信公众号信息是22年的,公司经营遇到困难了吗?(来自: 上证E互动) | | 答:尊敬的投资者,您好。目前公司经营情况一切正常,公司的产品进展可关注公司披露的公告信息,也可参考官方微信公众号发布的学术动态、研发进展等。感谢您对公司的关注! |
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| | 问:请问益方是否有考虑回购股票?(来自: 上证E互动) | | 答:尊敬的投资者,您好。如有回购计划,公司将按照相关规定及时履行信息披露义务。感谢您对公司的关注! |
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| | 问:请问格舒瑞昔的CDE补充材料评审是否顺利?(来自: 上证E互动) | | 答:尊敬的投资者,您好。Garsorasib在审评流程中,目前公司正积极推进NDA工作,感谢您对公司的关注! |
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| | 问:请问抗癌新药格舒瑞昔的补充材料的CDE评审进展如何?(来自: 上证E互动) | | 答:尊敬的投资者,您好。Garsorasib在审评流程中,目前公司正积极推进NDA工作,感谢您对公司的关注! |
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| | 问:请问公司在开发哪些新药?(来自: 上证E互动) | | 答:尊敬的投资者,您好。目前除对外授权产品贝福替尼已上市外,公司临床阶段产品有D-1553、D-0502、D-0120以及D-2570,此外公司还有多个临床前在研项目。感谢您对公司的关注! |
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| | 问:请问益方的在研发和在申请上市的新药有哪些?(来自: 上证E互动) | | 答:尊敬的投资者,您好。目前除对外授权产品贝福替尼已上市外,公司临床阶段产品有D-1553、D-0502、D-0120以及D-2570,此外公司还有多个临床前在研项目。感谢您对公司的关注! |
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| | 问:贝达药业贝福替尼的销售提成能计入半年报吗?(来自: 上证E互动) | | 答:尊敬的投资者,您好。相关情况请关注公司定期报告。感谢您对公司的关注! |
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| | 问:请问:公司是一家立足中国具有全球视野的创新型药物研发企业,如何推进人工智能技术对创新药的研发的提速效能,Medidata与益方生物科技(上海)股份有限公司于2022年即进行数字化临床试验的合作,这种合作可否促进创新药研发加速。(来自: 上证E互动) | | 答:尊敬的投资者,您好。公司应用有关临床试验平台,赋能试验的高效开展,感谢您对公司的关注! |
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| | 问:请问董秘。根据合作协议,公司授权贝达药业在合作区域(包括中国内地和香港、台湾地区)内进行研发和商业化贝福替尼。益方自己能不能在上述地区售自己合作产品的 益方有没有自己的销售团队。 益方只搞研发。 不搞销量?(来自: 上证E互动) | | 答:尊敬的投资者,您好。根据协议,公司授权贝达药业在合作区域内研发和商业化贝福替尼。随着公司产品的开发,公司会基于创新药的患者群体、全球化的产品布局、市场竞争等因素进行统筹考量,采用授权合作与自主销售相结合的方式开展产品的商业化活动。感谢您对公司的关注! |
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| | 问:请问董秘。根据合作协议,公司授权贝达药业在合作区域(包括中国内地和香港、台湾地区)内进行研发和商业化贝福替尼。益方自己能不能在上述地区售自己合作产品。益方有没有自己的销售团队。还是益方只搞研发。不搞销售。(来自: 上证E互动) | | 答:尊敬的投资者,您好。根据协议,公司授权贝达药业在合作区域内研发和商业化贝福替尼。随着公司产品的开发,公司会基于创新药的患者群体、全球化的产品布局、市场竞争等因素进行统筹考量,采用授权合作与自主销售相结合的方式开展产品的商业化活动。感谢您对公司的关注! |
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