Eltrombopag Diolamine

精彩内容 第十批集采报量目录官宣，科伦药业21个过评品种在列。今年以来，科伦药业研发管线快速推进，21个品种（3个首仿）获批上市、9个存量品种过评。前三季度公司研发费用15.84亿元，39款新药处于申报临床及以上阶段，5款上市可期。公司累计有162个品种过评（49个首家），21个品种拟纳入第十批集采。 Q3净利润增长19.88%，1类新药上市在即 10月28日，科伦药业发布2024年三季度报告，公司第三季度的营业收入49.62亿元，同比增长0.35%；归母净利润6.71亿元，同比增长19.88%；扣非净利润6.93亿元，同比增长21.49%。 得益于销售收入的增加及成本控制的有效性，今年前三季度科伦药业的营业收入达到了167.89亿元，同比增长6.64%；归母净利润24.71亿元，增幅为25.85%；扣非净利润24.47亿元，同比增长27.32%。 科伦药业三季报主要财务数据 科伦药业坚持研发投入，2024年前三季度研发费用15.84亿元。2024年至今，公司已有7款1类新药的IND申请获CDE承办，其中3款1类新药注射用SKB571、注射用SKB500、注射用MK-6204为首次申报IND。此外，1类新药塔戈利单抗注射液、2类改良型新药布瑞哌唑口溶膜提交上市申请。 10月31日，科伦药业公告称，控股子公司科伦博泰的核心产品芦康沙妥珠单抗（sac-TMT）新药申请已获国家药监局（NMPA）受理。该药物用于治疗经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗后进展的EGFR突变局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。这是芦康沙妥珠单抗获NMPA受理的第三个上市申请。 目前，科伦药业主要有39款新药处于申报临床及以上研究阶段，涉及24款1类新药、13款2类改良型新药、2款生物类似药。其中，3款1类新药芦康沙妥珠单抗（TROP2 ADC）、A166（HER2 ADC）、A167（PD-L1），生物类似药西妥昔单抗，改良型新药布瑞哌唑口溶膜预计2024-2025年陆续获批上市，公司的创新板块即将商业化兑现。 拿下21个品种，162个过评品种亮眼 今年以来，科伦药业仿制药管线持续推进，新注册分类品种获批上市、存量品种通过一致性评价消息不断。 2024年至今科伦药业获批产品 新注册分类品种审评方面，科伦药业有21个品种获批上市并视同过评，包括吡拉西坦注射液、奥拉帕利片、艾曲泊帕乙醇胺片、瑞戈非尼片、艾地骨化醇软胶囊、盐酸乌拉地尔注射液、间苯三酚注射液等，进一步丰富了公司的产品布局。 21个品种中，多个品种为国内首批上市，注射用美罗培南/氯化钠注射液、ω-3甘油三酯（2%）中/长链脂肪乳/氨基酸（16）/葡萄糖（16%）注射液、艾曲泊帕乙醇胺片为国内首仿+首家过评，布比卡因脂质体注射液、奥拉帕利片为国产第2家，地屈孕酮片、麦考酚钠肠溶片为国产第3家。 存量品种一致性评价方面，科伦药业的注射用头孢唑林钠、注射用哌拉西林钠、甘油果糖氯化钠注射液、乳酸钠林格注射液、复方醋酸钠林格注射液、注射用头孢噻肟钠、腹膜透析液(乳酸盐-G1.5%)、腹膜透析液(乳酸盐-G2.5%)、腹膜透析液(乳酸盐-G4.25%)相继过评。 截至目前，科伦药业已有162个品种通过/视同通过一致性评价。其中，49个品种为国内首家过评，氢溴酸西酞普兰胶囊、琥珀酸曲格列汀片、阿奇霉素分散片、氢溴酸替格列汀片、泊沙康唑口服混悬液、注射用美罗培南/氯化钠注射液等17个品种为独家过评。 科伦药业年度过评品种情况 从治疗领域上看，162个品种主要集中在全身用抗感染药物（51个）、血液和造血系统药物（38个）、抗肿瘤和免疫调节剂（16个）、消化系统及代谢药（16个）。米内网数据显示，这四大治疗领域2023年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额均超过1000亿元。 抢攻168亿市场，21个品种备战第十批集采 已落地执行的八批化药集采中，科伦药业分别有1个、5个、4个、4个、11个、11个、7个、4个品种成功中选，合计47个品种。集采常态化推进背景下，科伦药业恰逢产品线密集收获期，并积极参与集采，已跻身集采头部供应商之列。 11月1日，国家组织药品联合采购办公室发布通知，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，62个品种（263个品规）被纳入填报范围。科伦药业有21个过评品种在列，是本次集采的主力军。 科伦药业第十批拟集采品种竞争格局 21个通用名药品2023年在中国公立医疗机构终端合计销售额超过168亿元，其中哌拉西林注射剂、西格列汀口服常释剂型、间苯三酚注射剂、氨苄西林注射剂、利格列汀口服常释剂型、复方聚乙二醇电解质散、己酮可可碱注射剂等7个药品销售额均超过10亿元。 从竞争格局上看，15个药品过评企业达10家及以上，其中间苯三酚注射剂、西格列汀口服常释剂型过评企业均有34家，己酮可可碱注射剂、舒更葡糖钠注射液分别有22家、21家企业过评，竞争十分激烈。而枸橼酸托法替布缓释片、泊沙康唑肠溶片分别有6家、7家企业过评，竞争相对较小。 从市场份额上看，科伦药业具备参标资格的21个品种的市场份额普通较低，若中标可进一步为公司仿制药业务贡献增量。11个品种市场份额为零，其中7个为2023年或2024年新获批上市的品种，包括间苯三酚注射液、己酮可可碱注射液、艾地骨化醇软胶囊、瑞戈非尼片、泊沙康唑注射液、枸橼酸托法替布缓释片等，可借助集采中标快速抢占市场。 资料来源：米内网数据库、公司公告注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

Just five months after closing its $2.9 billion deal for MorphoSys, Novartis has recorded an $800 million impairment on the acquisition after a review of “certain clinical trial data,” the company said in its third-quarter earnings report . A company spokesperson confirmed that the review was triggered by pelabresib, an oncology candidate at the center of the MorphoSys buyout. Novartis shared Tuesday that it’s expecting a delayed regulatory submission for pelabresib, as it needs to follow patients longer to assess concerns about emergent malignancies. The company had initially hoped to file for approval in myelofibrosis this year. Emergent malignancies in patients treated with pelabresib were first reported by STAT earlier this year. Novartis will “look at the data over the course of next year,” and assess the potential need for additional studies, CEO Vas Narasimhan said during its Q3 earnings call with the media. Novartis also disclosed three Phase 2 pipeline cuts Tuesday: a BCMA cell therapy called durcabtagene autoleucel or PHE885 in multiple myeloma; XXB750 in hypertension and heart failure; and an IL-17 inhibitor subbed CMK389 in pulmonary sarcoidosis. Overall, Barclays analysts said Novartis had a “strong” quarter. The company raised its end-of-year guidance, with Narasimhan saying its “pure-play” strategy is starting to pay off. While executives previously expected net sales growth in the high single digits to low double digits, Novartis now says the low end of that range will be in the double digits. “The changes we’ve made to become a focused, pure-play company focused on key therapeutic areas, focused on key geographies, is really working,” Narasimhan told reporters. Elsewhere, Narasimhan also fielded a variety of questions about Novartis’ new structure, legal strategy and manufacturing capacity: On the company’s reorganization: It’s been roughly two years since Novartis announced a global restructuring that impacted thousands of positions and involved the spinout of generics unit Sandoz. The company said it completed its transformation in November 2023, though “additional streamlining” this year brought some cuts on the development side. Narasimhan said Novartis is “always going to be fine-tuning at a low level, but we don’t foresee any other large changes at this time.” On radioligand supply: Novartis applied for a label expansion last quarter to bring Pluvicto into the pre-taxane setting for patients with metastatic castration-resistant prostate cancer. But despite recent shortage concerns across the radiopharma space, Narasimhan said Novartis’ manufacturing plans will enable not only the supply of Pluvicto, but also “a very large pipeline of radioligand therapies moving forward.” He added that Novartis’ supply has been “unconstrained for most of this year,” with the ability to produce volumes that support $7 billion to $8 billion-plus in sales. The company has plans to expand its Indianapolis site, and is putting up new sites in California, China and Japan. On the Inflation Reduction Act and a recent court loss: A New Jersey federal court recently rejected Novartis’ legal challenge to the IRA. The company has appealed, though Narasimhan said it’s “difficult to say” whether Novartis’ case or cases brought by other drugmakers will conclude before negotiated prices take effect in 2026. For now, the CEO said Novartis is pushing for legislative changes, including around a provision that calls for negotiations to occur sooner for small molecule drugs than for biologics. “We are operating under the assumption that we need to work under the rules of the law and rather focus on trying to educate policymakers,” he said. On generic entry: Novartis said it expects generic rivals to Tasigna, Promacta and Entresto to hit the US market in mid-2025. “That will certainly be a headwind we’ll face in the second half of 2025,” Narasimhan said. “We still expect good growth next year, both on the top and bottom line.” Editor’s note: This story has been updated to include comment from Novartis on the MorphoSys impairment.