CMK-389

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 10月29日，诺华公布2024年第三季度业绩并披露其29亿美元收购MorphoSys的赌注遇到危机。 财报概述 诺华财报显示：前三季度总收入371.64亿美元，同比增长11%；净收入91.19亿美元，同比增长62%；核心业务收入146.35亿美元，同比增长20%；研发投入为71.80亿美元，同比下降19%。 其中第三季度收入128.23亿美元，同比增长10%；净收入为31.85亿美元，同比增长121%；研发投入为23.92亿美元，同比下降40%。 在核药领域，诺华同时拥有Lutathera和Pluvicto两款畅销产品并在持续拓展适应症。2024Q3 Lutathera收入1.9亿美元，同比增长19%；前三季度Pluvicto总收入5.34亿美元，同比增长17%。 2024Q3 Pluvicto收入3.86亿美元，同比增长50%；前三季度Pluvicto总收入10.41亿美元，同比增长47%。目前诺华已提交Pluvicto用于二线治疗PSMA阳性mCRPC的上市申请。该适应症获批后，Pluvicto的全年销售额有望突破新高。 收购减值 此外，诺华公司在其第三季度财报中表示，在完成对MorphoSys公司29亿美元的收购交易仅五个月后，公司记录了一笔8亿美元的收购减值。 这项收购的重点是MorphoSys公司的骨髓纤维化药物候选物Pelabresib，收购基于MorphoSys公司的骨髓纤维化药物候选物pelabresib 3期临床试验MANIFEST-2的顶线结果达到了主要终点。 但今年7月，Pelabresib在III期MANIFEST-2研究中的结果好坏参半，而且有未经证实的报道显示其存在潜在安全风险。早在今年4月，STAT news引用参与Pelabresib 3期研究的匿名人员信息，有“多例”患者在接受Pelabresib治疗后，从骨髓纤维化“迅速进展”为更具侵袭性的急性髓性白血病（AML）。3期研究中的212名患者中6名患者进展为AML，而对照组只有2名。MorphoSys已经向FDA通报了这些安全信号，监管机构正在监控情况，并已向参与该研究的医生发出警告。 这使该公司为收购的pelabresib申请批准的计划推迟数年，因为它需要更长时间地跟踪患者以应对对于突发恶性肿瘤的担忧。该公司最初希望今年获得批准用于骨髓纤维化治疗。 诺华周二还披露了三项二期研究计划：一种用于多发性骨髓瘤的BCMA细胞疗法，名为durcabtagene autoleucel；一种用于高血压和心力衰竭的候选药物 XXB750；一种用于肺肉瘤病的IL-17抑制剂，名为CMK389。 目前公司共有105条研发管线。 参考资料： [1]公司公告 [2]https://endpts.com -END- 2025CMC-CHINA药博会 • 展位火热预定中！

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.