Asciminib Hydrochloride

2025年4月29日，诺华集团公布了2025年第一季度财务业绩，核心财务指标表现亮眼，销售额实现两位数增长，核心运营收入大幅提升，并取得多项重要监管审批进展。财务亮点：净销售额达132.33亿美元（同比增长12%，按固定汇率计算增长15%），主要得益于核心产品Entresto（+22% cc）、Kisqali（+56% cc）、Kesimpta（+43% cc）等的强劲表现。核心运营收入增长27%（按固定汇率计算），利润率提升至42.1%，同比增加400个基点。自由现金流同比飙升66%，达34亿美元。核心每股收益（EPS）为2.28美元，同比增长31%（按固定汇率计算）。创新里程碑：Pluvicto获美国FDA批准用于前列腺癌化疗前治疗，潜在患者群体扩大至三倍。Vanrafia（atrasentan）获FDA加速批准用于IgA肾病，成为该疾病的首个靶向疗法。Fabhalta（iptacopan）在美国、欧盟和中国获批用于C3肾小球病（C3G），覆盖全球主要市场。Remibrutinib完成慢性自发性荨麻疹（CSU）的全球申报，美国进入优先审评。战略进展：诺华CEO Vas Narasimhan表示：“第一季度业绩展现了我们‘纯创新药’战略的成效。核心产品组合的持续放量，以及管线资产的快速推进，为2030年及未来的增长奠定基础。”公司同时上调2025年全年指引，预计销售额将实现高个位数增长，核心运营收入增长低两位数。区域与产品表现：美国、中国、德国和日本等关键市场贡献显著，其中中国区Entresto在高血压适应症的渗透率持续提升。肿瘤学产品线表现突出，Pluvicto、Kisqali（乳腺癌）和Scemblix（白血病）销售额分别增长21%、56%和76%（按固定汇率计算）。资本管理：第一季度诺华斥资26亿美元回购2480万股股票，净债务增至223亿美元，主要因年度股息支付及资产收购。公司维持穆迪Aa3和标普AA-的信用评级。前瞻性声明：诺华提醒，业绩展望受药品定价、研发风险及宏观经济等因素影响，具体参见完整财报免责条款。药事纵横投稿须知：稿费已上调，欢迎投稿

Novartis has raised its full-year guidance even after taking into account potential effects from upcoming U.S. tariffs on pharmaceuticals. Novartis has a lot cooking with new drug launches, and the company is not letting potential U.S. tariffs on pharmaceuticals get in the way of its progress.With recent indication additions, breast cancer drug Kisqali, radioligand therapy Pluvicto and third-generation tyrosine kinase inhibitor Scemblix all delivered double-digit year-over-year sales growth in the first quarter of 2025. Meanwhile, kidney disease drugs Fabhalta and Vanrafia are in the early days of their commercialization.The rollout of Kisqali in early-stage breast cancer has been top on investors’ minds given the $4 billion peak sales potential Novartis has pegged to the indication.In the first quarter, Novartis collected $956 million in global Kisqali sales, a 52% increase compared with the same period last year. The figure beat Wall Street’s estimates by 5%, according to analysts with ODDO BHF.With an FDA approval in the postoperative adjuvant setting in September, Kisqali has grown its new-to-brand share to 60%, Novartis CEO Vas Narasimhan told investors on a call Tuesday. And 56% of those newly added prescriptions are coming from the patient population that’s unique to Kisqali’s label, as opposed to those shared with Eli Lilly’s rival CDK4/6 inhibitor Verzenio, he said.In addition, considering Kisqali's tied-for-the-lead market share in the metastatic setting, the drug is on track to meet its $8 billion total peak sales goal set by Novartis, Narasimhan said. By comparison, Pluvicto appears to need some extra work. For the second quarter in a row, Pluvicto’s sales have missed analysts’ expectations. While the prostate cancer drug saw sales grow 20% year-over-year to $371 million, the number landed 7% below consensus estimates.Pluvicto won a key FDA nod at the end of March to treat PSMA-positive metastatic castration-resistant prostate cancer before taxane-based chemotherapy. This expansion has yet to be reflected in Pluvicto’s quarterly sales, though, as it takes about four to seven weeks for new patients to get treated after necessary scans and lab tests, Narasimhan explained.Initial uptake of Pluvicto for pre-taxane treatment will come from existing treatment centers that have been prescribing the radiopharmaceutical in the post-taxane setting. Novartis expects these accounts will drive Pluvicto’s growth in the second half of the yearBut to realize Pluvicto’s full potential, Novartis needs to expand its reach in the community and urology settings over time, as well as treat more patients at each center, Narasimhan said.Of the 620 treatment sites that Novartis has enlisted, only about half are running at a target number of patients, Narasimhan noted.Pluvicto is already gaining traction in the community setting for the post-taxane indication, with 4,000 total scripts as of the first quarter, which marked an 11% increase versus the prior-year level, according to Narasimhan. But it’ll take a combination of efforts to meet Novartis’ targets, he acknowledged, including making doctors more comfortable with the medicine, building capacity for imaging and easing the referral process.“We’re also continuing to increase—and have increased—our promotional spend,” the chief executive said. “We’ve doubled our field force, and are maintaining a very robust direct-to-consumer advertising campaign.”Thanks to strong growth from eight priority brands, Novartis beat analysts’ expectations with $13.2 billion sales in the first quarter, good for 12% growth year over year.The Swiss pharma raised its full-year 2025 guidance and now expects sales to grow at a high-single-digit percentage compared with 2024. Projecting confidence amid tariff uncertaintyNovartis is “fully comfortable” with this year’s projection, as well as its near-term guidance, because the company has baked in potential effects from the expected U.S. tariffs on pharmaceuticals, Narasimhan said during a separate press call with reporters.“In general, we believe we can manage through the tariffs for this year, and then we’ll have to, step by step, manage for subsequent years,” Narasimhan said.“Our goal, as I mentioned, is [to] have 100% of our products produced in the U.S. for the U.S.,” he continued. “We do have a little bit of a lower mix at the moment, but that, again, is something we believe is manageable.” To achieve that made-in-U.S. target, Novartis earlier this month unveiled a $23 billion plan to build and expand 10 U.S. facilities over the next five years. This includes the build-out of four new manufacturing facilities and two more new radioligand therapy production sites.During Tuesday’s investor call, Narasimhan acknowledged that the company could have made the investment plan sooner.“This is a strategic decision to say that the U.S. is our most important single market from a growth and revenue standpoint, and we want to be in a position to be able to produce all of our key medicines end-to-end in the U.S.,” he said.“I think independent of who’s president, it’s prudent for us to be able to have our supply chain stable inside the United States,” he added.