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扫描二维码即可下载 《数图药讯》2024年第45期 目   录 政策解读 1. 上海阳光医药采购网：关于开展第十批国家组织药品集中采购相关药品信息填报工作的通知 2. 国家药监局：关于批准医用增材制造技术医疗器械标准化技术归口单位换届的公告（2024年第132号） 3. 国家药监局药审中心：关于发布《司美格鲁肽注射液生物类似体重管理适应症临床试验设计指导原则》的通告（2024年第46号） 4. 国家医保局：关于开展医保支付方式改革典型案例征集活动的公告 5. 国家医保局：民政部办公厅关于进一步做好医疗救助对象信息共享工作的通知 6. 上海阳光医药采购网：关于市药市所开展“政府开放日”活动的通知 行业动态 1. 药讯动态：重磅获批 2. 药讯动态：重磅临床 3. 药企动态：市场动态 零售品类数据洞见 1. 心肌炎疾病治疗药品销售品种分析 2. 复方鱼腥草零售放大市场销售分析 3. 复方鱼腥草零售放大市场销售企业分析 政策解读 1、上海阳光医药采购网：关于开展第十批国家组织药品集中采购相关药品信息填报工作的通知 为做好第十批国家组织药品集中采购工作，进一步优化工作流程，建立常态化工作机制，自2024年11月1日起，联合采购办公室开展第十批国家组织药品集中采购相关药品信息填报工作，并将有关事项进行通知。具体信息可登录上海阳光采购网官网查看。 附件：药品填报范围.pdf 相关文件请扫描上方二维码查看 2、国家药监局：关于批准医用增材制造技术医疗器械标准化技术归口单位换届的公告（2024年第132号） 国家药监局批准医用增材制造技术医疗器械标准化技术归口单位换届，现予公布（详见附件）。 附件：第二届医用增材制造技术医疗器械标准化技术归口单位组成方案.doc 相关文件请扫描上方二维码查看 3、国家药监局药审中心：关于发布《司美格鲁肽注射液生物类似体重管理适应症临床试验设计指导原则》的通告（2024年第46号） 为指导司美格鲁肽注射液生物类似药体重管理适应症临床试验设计，在国家药品监督管理局的部署下，药审中心组织制定了《司美格鲁肽注射液生物类似药体重管理适应症临床试验设计指导原则》（见附件）。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》（药监综药管〔2020〕9号）要求，经国家药品监督管理局审查同意，现予发布，自发布之日起施行。 附件：司美格鲁肽注射液生物类似药体重管理适应症临床试验设计指导原则.pdf 相关文件请扫描上方二维码查看 4、国家医保局：关于开展医保支付方式改革典型案例征集活动的公告 为深入贯彻落实党的二十届三中全会精神，持续深化医保支付方式改革，更好发挥医保促进三医协同发展和治理的积极作用，全面总结梳理各地在深入推进医保支付方式改革过程中的典型经验做法，讲好“医保支付改革故事”，分享“医保支付改革经验”，用好“医保支付方式改革方法”，现面向社会开展医保支付改革典型案例征集活动。欢迎各地医疗保障行政部门、医保经办机构和定点医疗机构参加。 附件：医保支付改革方式典型案例征集活动申报表.docx 相关文件请扫描上方二维码查看 5、国家医保局：民政部办公厅关于进一步做好医疗救助对象信息共享工作的通知 党中央高度重视困难群众医疗救助工作，要求按救助对象类别及时精准实施救助保障。但在实际工作中还存在信息尚未有效协同，共享不及时等问题。为全面落实医疗救助制度，切实减轻困难群众和重特大疾病患者家庭医疗费用负担，现就进一步做好医疗救助对象信息共享工作通知。具体信息请登录国家医保局官网查看。 6、上海阳光采购网：关于市药市所开展“政府开放日”活动的通知 为进一步畅通政企沟通渠道，及时回应企业关切，促进信息共享，提高沟通效率，更好助力优化营商环境，构建亲清政商关系，上海市医药集中招标采购事务管理所（以下简称“市药事所”）即日起将开展“政府开放日”活动，并将有关事项进行通知。具体信息可登录上海阳光采购网官网查看。 行业动态 01 药讯动态：重磅获批和重磅临床 最近重磅获批 辉瑞研发的甲苯磺酸他拉唑帕利胶囊的上市申请获得NMPA批准。本次申报上市的适应症为：用于转移性去势抵抗性前列腺癌（mCRPC）成人患者。 百时美施贵宝申报的纳武利尤单抗注射液（商品名：欧狄沃®）获得NMPA批准。联合顺铂及吉西他滨用于不可切除或转移性尿路上皮癌成人患者的一线治疗。  艾伯维（AbbVie）申报的CD3/CD20双抗艾可瑞妥单抗注射用浓溶液新药上市申请获得CDE受理。 杭州中美华东制药有限公司研发的乌司奴单抗注射液获得NMPA上市批准，申报上市的适应症为治疗成年中重度斑块状银屑病。 浙江普利药业有限公司自主研发的新药左亚叶酸钙注射液上市申请获得NMPA批准，主要用于胃癌和结直肠癌的治疗。 最近重磅临床 中山莱博瑞辰生物医药有限公司申报的创新药“注射用RAB001”获得NMPA药品审评中心批准一项新的临床试验默示许可，拟用于治疗骨坏死。 艾赛普生物申报的领先品种注射用iSAP-0909获得FDA的新药临床试验申请（IND）许可，适应症为非肌层浸润性膀胱癌（NMIBC）的辅助诊断和术中定位。 康诺亚申报的CM512注射液获得CDE批准临床，拟用于治疗哮喘、慢性阻塞性肺疾病（COPD）。 汇宇制药及其子公司汇宇海玥申报的1类新药HYP-6589片获得CDE批准临床，拟用于治疗晚期实体瘤。 北京质肽生物医药科技有限公司申报的ZT006片获得CDE临床试验默示许可。该药物拟开发用于成人2型糖尿病患者的血糖控制。  02 药企动态：市场动态 11月3日，苏州珀罗汀生物技术有限公司与上海玄刃科技有限公司举行合作签约仪式，实现蛋白表达自动化高通量合成，加速无细胞蛋白表达技术自动化高通量的产业化进程。 11月4日，Royalty Pharma和Syndax Pharmaceuticals共同宣布，双方达成一项价值 3.5 亿美元的合成专利费融资协议，该协议基于Niktimvo （axatilimab-csfr） 在美国的净销售额。根据协议条款，Syndax收到了3.5亿美元的预付款，以换取Niktimvo美国净销售额的13.8%的特许权使用费。向Royalty Pharma支付的特许权使用费最高将达到2.35倍。 11月6日，GHO Capital Partners LLP和Ampersand Capital Partners宣布他们已就Avid达成最终合并协议，由GHO和Ampersland管理的基金以价值约11亿美元的全现金交易收购。且GHO和Ampersand将以每股12.50美元的现金收购Avid股东持有的所有已发行股份。 零售品类数据洞见 01 心肌炎疾病治疗药品销售品种分析 图1：2019-2024年Q2心肌炎疾病治疗药品零售（放大市场）品种销售额 数据来源： 中国药品零售数据库RPDB药店数据 中国医药工业信息中心 心肌炎疾病主要指心肌的炎性疾病，可呈急性、亚急性或慢性，相对算是比较常见的疾病。根据RPDB数据库，心肌炎治疗药品中，销售额相对较高的药品：有转移因子口服液、甲泼尼龙片、地高辛片、辅酶Q10片等。  02 复方鱼腥草零售放大市场销售分析 图2: 2019-2024年Q2复方鱼腥草零售（放大市场）销售额 数据来源： 中国药品零售数据库RPDB药店数据 中国医药工业信息中心 复方鱼腥草胶囊可用于因外感风热引起的咽喉疼痛，急性咽炎，风热型扁桃体炎等疾病的治疗。根据RPDB数据库，2020年-2024年Q2，复方鱼腥草零售（放大市场）销售额波动幅度较大，2020年总销售额达11.18亿元，同比增长率为50.21％，2023年销售额有所下降。  03 复方鱼腥草零售放大市场销售企业分析 图3: 2019-2024年Q2复方鱼腥草零售（放大市场）销售企业分析 数据来源： 中国药品零售数据库RPDB药店数据 中国医药工业信息中心 根据RPDB数据库，复方鱼腥草零售放大市场销售企业业绩较好的公司：浙江康恩贝中药有限公司、广西百琪药业有限公司、浙江惠松制药有限公司、浙江国镜药业有限公司等。 来源：医药地理、国家药监局、国家药监局审评中心、腾讯、新浪等。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

BOSTON--( BUSINESS WIRE )-- BPGbio, Inc., a leading biology-first, AI-powered clinical-stage biopharma company focused on mitochondrial biology and protein homeostasis, today announced that it will present three scientific posters at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting, taking place November 6-10, 2024, in Houston, Texas. The posters will highlight the latest research on the company’s drug candidates BPM31510 and BRG399 in the immuno-oncology space, providing further validation and paving the way for new potential therapeutic strategies in cancer treatment. In the first study, titled “The Anti-tumor Response of BPM31510 is Associated with Immune Cell Regulation in the Tumor Microenvironment,” researchers showed that BPM31510 significantly increases reactive oxygen species (ROS) levels in cancer cells, leading to cell death across multiple cancer types. They also identified that, BPM31510 can boost the activity of cytotoxic tumor-infiltrating lymphocytes and reduce markers of T cell exhaustion. This dual action gives it the potential to be especially effective in treating "immunologically cold" tumors, such as glioblastoma and pancreatic cancer. The second study, titled “BRG399, a Novel Oral Microtubule Binding Agent, Induces Tumor Regression and Immune Memory in an Orthotopic Glioblastoma Rat Model,” found that BRG399 treatment leads to glioblastoma tumor regression, with 100% survival in treated rats. BRG399 also induces an immune memory response, preventing the recurrence of tumors when surviving rats are re-challenged with glioma cancer cells. The third study, titled, “BRG399, a Novel Oral Microtubule Binding Agent, Exhibits Immune-Modulatory Properties Enhancing Anti-Tumor Responses,” showed that BRG399 alters the immune cell composition within the tumor microenvironment and blood. BRG399 also reduced markers of T cell exhaustion, suggesting that it can reinvigorate immune responses against tumors. These findings suggest that BRG399 should be further investigated as a potential component of cancer therapy, particularly when combined with immunotherapies, as it can both kill cancer cells and enhance immune activity. “These compounds – BPM31510 and BRG399 – push the boundaries of what's possible in cancer therapy, showing that we can not only attack the tumor but also empower the body's immune system to keep fighting long after the treatment ends,” said Stephane Gesta, Ph.D. , VP, Discovery and Translational Biology at BPGbio. “As we advance BRG399 through preclinical trials and approach the completion of BPM31510's Phase 2b study, we will continue leveraging our NAi Interrogative Biology Platform to gain additional insight for exploring new therapeutic opportunities for other diseases.” Poster Presentation Details: The Anti-Tumor Response of BPM31510 Is Associated with Immune Cell Regulation in the Tumor Microenvironment Date and Time: November 8, 2024, 1:00 p.m. CST Location: Exhibit Halls A B, George R. Brown Convention Center, Houston, Texas Presenter: Maria-Dorothea Nastke, Ph.D. Abstract Number: 1312 BRG399, a Novel Oral Microtubule Binding Agent, Induces Tumor Regression and Immune Memory in an Orthotopic Glioblastoma Rat Model Date and Time: November 9, 2024, 2:00 p.m. CST Location: Exhibit Halls A B, George R. Brown Convention Center, Houston, Texas Presenter: Maria-Dorothea Nastke, Ph.D. Abstract Number: 1313 BRG399, a Novel Oral Microtubule-Binding Agent, Exhibits Immune-Modulatory Properties Enhancing Anti-Tumor Responses Date and Time: November 9, 2024, 3:00 p.m. CST Location: Exhibit Halls A B, George R. Brown Convention Center, Houston, Texas Presenter: Kaila Bennett, Ph.D. Abstract Number: 1284 About BPM31510 BPM31510 is BPGbio’s lead candidate in late-stage development for glioblastoma multiforme (GBM) and pancreatic cancer . The compound has demonstrated a tolerable safety profile and shown potential clinical benefit in both populations. The mechanism of action of BPM31510 was first validated by data from BPGbio’s NAi Interrogative Biology platform , which suggested that there is a hallmark shift in the tumor microenvironment (TME) induced by BPM31510 which modulates mitochondrial oxidative phosphorylation in highly aggressive tumors. BPGbio has received FDA's Rare Pediatric Disease Designation for BPM31510IV for primary CoQ10 deficiency and BPM31510T for Epidermolysis Bullosa (EB) . About BRG399 BRG399 is a BPGbio-developed candidate being studied for its therapeutic potential as a treatment for solid and liquid tumor cancers as well as diseases associated with neutrophil-driven inflammation. This experimental drug, a first-in-class, anti-tubulin agent with broad-spectrum anti-cancer activity and favorable pharmacological properties including oral bioavailability for clinical testing. BRG399 is leading the new oncology drug pipeline for BPGbio among other drug candidates which uniquely target the colchicine binding pocket in tubulin. About BPGbio BPGbio is a leading biology-first AI-powered clinical stage biopharma focused on mitochondrial biology and protein homeostasis. The company has a deep pipeline of AI-developed therapeutics spanning oncology, rare disease and neurology, including several in late-stage clinical trials. BPGbio’s novel approach is underpinned by NAi , its proprietary Interrogative Biology Platform, protected by over 400 US and international patents; one of the world’s largest clinically annotated non-governmental biobanks with longitudinal samples; and exclusive access to the most powerful supercomputer in the world. With these tools, BPGbio is redefining how patient biology can be modeled using bespoke causal AI specifically designed for solving large-scale biology challenges. Headquartered in greater Boston, the company is at the forefront of a new era in medicine, combining biology, multi-modal data, and AI to transform the way we understand, diagnose, and treat diseases. For more information, visit www.bpgbio.com .