Xanomeline Tartrate/Trospium Chloride

11月5日，再鼎医药公布2026年第三季度业绩。产品收入净额1.076亿美元，环比增长2%，中国商业化业务保持盈利；净亏损4610万美元，研发费用4980万美元，SG&A费用7010万美元，两项开支同比基本持平。截至9月底，现金及短期投资6.597亿美元；10月完成一笔约2.5亿美元、相对市价零折价的股权融资。 截图来源：企业公告 如果只看中国商业化，这是一份“企稳”的财报。但这一季真正的信息量不在1.076亿美元里。ESMO大会上公布的zoci一线联合阿替利珠单抗治疗广泛期小细胞肺癌的1b期数据中，确认ORR达到81.8%（27/33），6个月PFS率81.9%，3级及以上zoci相关不良事件发生率仅9.1%。在至少随访6个月的15例患者中，中位PFS和中位DOR均未达到，66.7%的患者在中位10个月随访时仍未发生进展或死亡。公司明确表示，2027年有望在美国递交zoci的首个BLA，上半年epNEC扩展队列数据、下半年DLLEVATE中期分析，均指向加速批准路径。 当中国商业化业务的同比增速暂时转负，再鼎正在把“这家公司值多少钱”的锚点，从产品收入曲线，转移到一条DLL3 ADC的全球注册路径上。这个切换是否成立，2027年会给出一部分答案。 中国商业化：盈利是真的，压力也是真的，但“过渡期”是主动选择 先把“企稳”拆开。产品收入1.076亿美元，环比+2%，但同比2025年同期的1.154亿美元下滑了约6.8%。增长驱动来自纽再乐和6月上市的凯捷乐；拖累项是肿瘤电场治疗，因胶质母细胞瘤竞争格局变化而下滑。则乐的收缩在半年报中已被明确归因于奥拉帕利仿制药集采后医院用药模式的变化，不是Q3才出现的新变量。 但“中国商业化业务保持盈利”这句话是真实的，而且它的含金量恰恰体现在费用端。在一个产品收入同比收缩的季度里，研发费用和SG&A同比基本持平，没有跟着收入一起收缩，利润仍然为正。这不是“收缩换盈利”，而是商业化团队在收入承压时守住了费用底线。 公司自己的定位也很清楚：2026年下半年是“稳定产品销量、为2027年恢复显著增长奠定基础”的过渡期。2027年的增长驱动指向纽再乐和凯捷乐的可及性提升与潜在NRDL纳入，而不是依赖任何一个单一产品的爆发。 对于一个需要为全球III期和BLA准备资金的药企，一个“盈利但微增”的中国业务是必要的基础。但它的角色正在发生变化——从“增长引擎”变成“现金流底盘”。底盘的价值在于稳，不在于快。 81.8%的ORR，以及一个比ORR更值得看的信号 再鼎全球管线中，zoci是进展最快、也最接近注册的核心资产。ESMO的一线ES-SCLC数据把它的定位从“有潜力的早期ADC”推到了一个更具体的位置。 81.8%的确认ORR和9.1%的3级以上zoci相关AE，指向的是一个不含化疗的一线联合方案。但比ORR更值得看的是持久性：在至少6个月随访的15例患者中，中位随访10个月时，中位PFS和中位DOR均未达到，66.7%仍未进展。对于一个标准一线治疗后中位进展时间约5个月的癌种，“中位PFS尚未达到”本身就是一个有临床分量的信号——它意味着在这个小样本中，相当比例的患者在10个月时仍在获益。当然，n=15的样本量决定了这只能被读作“信号”，而不是“结论”。 注册节奏已经具体化。二线及以上SCLC的全球III期DLLEVATE正在进行，2027年上半年完成入组，下半年中期分析，随后可能在美国递交加速批准申请；二线epNEC的注册性扩展队列数据预计2027年上半年读出，同样指向加速批准BLA。一线ES-SCLC的全球随机III期预计2026年底前启动。如果一切按计划推进，2027年将成为再鼎在美国递交首个BLA的年份。 对于一家长期被归类为“中国商业化平台”的公司，这是一次身份层面的变化。中国商业化贡献的是现金流和盈利底线；zoci贡献的是一个美国注册性肿瘤资产的估值期权。前者的上限是清晰的，后者的上限，取决于81.8%和“中位PFS未达到”这两个信号能否在更大样本和III期中被复制。 2027年不是“催化剂之年”，是“验证之年” 再鼎将2027年定义为“催化剂丰富的一年”。但更准确的描述是：2027年同时验证两件性质完全不同的事。 第一，zoci的注册性数据能否把“信号”变成“证据”。2027年上半年epNEC扩展队列和下半年DLLEVATE中期分析，是两条独立的加速批准路径。如果其中至少一条读出支持性数据，zoci在美国的BLA递交就有了实质基础；如果两条路径都延迟或数据不及预期，全球管线的估值锚点将被推迟到一线ES-SCLC的III期读出，时间窗口至少后移一年以上。 第二，中国商业化能否在不重新推高费用率的前提下恢复同比正增长。 公司指引2027年恢复增长，驱动力是纽再乐和凯捷乐的可及性提升与NRDL潜力。但这需要被拆成两个可检验的问题：凯捷乐作为6月才上市的新产品，NRDL纳入的时间和放量斜率是否足以在2027年形成有意义的增量；纽再乐的覆盖率和渗透率提升能否在集采和医保降价的大环境下维持足够的净价格弹性。费用持平、收入恢复增长，两个条件同时成立，中国业务才能从“现金流底盘”回到“增长贡献者”的位置。 10月那笔2.5亿美元的零折价融资，加上Q3末的6.597亿美元现金，把跑道铺到了2027年。但资金充裕本身不构成估值支撑。真正的分水岭是：当2027年zoci的注册性数据读出时，再鼎的故事能否从“中国业务盈利、全球管线有潜力”，变成“中国业务提供现金流、全球管线提供增长”。 如果能，81.8%就是一个新估值框架的起点；如果不能，中国商业化的“企稳”将被迫承担更大的独撑压力。 结束语 再鼎的三季报里，1.076亿美元的产品收入和81.8%的ORR，属于两种不同的时间尺度。前者回答的是“现在靠什么活着”，后者回答的是“未来靠什么值钱”。2027年要做的，是把这两个答案焊在一起。而“焊”得住的前提，是zoci的持久性信号能在III期中被复制，同时中国业务不再需要靠收缩来维持盈利。 81.8%不是答案。2027年的III期数据才是。 联系我们 AntibodyChina 展位火热预定中！ 扫码立即咨询 电话：13816031174 （同微信） 赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。 点击此处“阅读全文”咨询更多精彩！

iStock, Thawatchai Chawong After emraclidine’s schizophrenia fail and Cobenfy’s laggard launch, it’s too early to know who made the better buy: AbbVie, in its $8.7 billion Cerevel takeover in late 2023, or Bristol Myers Squibb, which spent $14 billion for Karuna just two weeks later. Earlier this fall, the FDA approved AbbVie’s Parkinson’s disease drug Juvmo—formerly tavapadon — prompting analysts and observers to revisit the pharma’s $8.7 billion takeover of Cerevel Therapeutics, along with a parallel transaction: Bristol Myers Squibb’s $14 billion buyout of Karuna Therapeutics. But at least one analyst says it’s too early for a reckoning on either transaction. “It’s still early days, but as of today, I don’t think there’s a clear winner,” Graig Suvannavejh, managing director and senior biotech and biopharma analyst at Mizuho Securities, told BioSpace . Less than a year after AbbVie bought Cerevel in December 2023, the centerpiece of the buyout, schizophrenia drug emraclidine, failed two Phase 2 studies . The news sent the pharma’s shares crashing 12% and led analysts to question its decision to move on Cerevel. The failure looked even worse given that competing schizophrenia candidate KarXT, which BMS picked up in its acquisition of Karuna Therapeutics just two weeks after AbbVie’s Cerevel play, had just won the FDA’s blessing and entered the market as Cobenfy, the first novel schizophrenia drug in more than three decades. But with Juvmo’s approval, and Cobenfy struggling to meet sales expectations, the ultimate value of both deals is looking less clear cut. Matt Phipps, group head of biotechnology equity research at William Blair, agreed that AbbVie’s buy is not down for the count yet. “At the time of the Cerevel acquisition no one was really thinking about tavapadon,” he told BioSpace in an email. Its September approval “clearly should offer some support” for the deal, he added. Meanwhile, Cobenfy has long disappointed. After exceeding expectations in the fourth quarter of 2024, its first full quarter on the market, the drug began to slip. In 2025, Cobenfy brought in $155 million in sales , less than half of some analysts’ initial predictions, Suvannavejh previously told BioSpace , and sales continued to miss expectations in 2026. “I’m not sure anyone would declare victory there,” Suvannavejh said of Cobenfy’s sales to date. “You certainly don’t want to pay $14 billion to get that kind of sales trajectory.” As for AbbVie’s Cerevel buy, he added, the pharma gained a pipeline beyond emraclidine—and it is still working on that asset as well. Schizophrenia FDA Approves First Novel Schizophrenia Drug in 35 Years BMS’ KarXT targets muscarinic receptors and “is at least 2-3 years ahead of the competition” including AbbVie and Neurocrine Biosciences, Truist Securities wrote in a note to investors. September 27, 2024 · 8 min read · Heather McKenzie Read more Cobenfy’s tolerability troubles In addition to the timing, the size of the deals and the neuro focus of both, the AbbVie and BMS deals are often put in the same bucket because the schizophrenia assets that starred in those transactions both act on the muscarinic receptors. It’s difficult to pinpoint where Cobenfy went wrong, but Suvannavejh flagged its safety pro one issue. “I think that is part of the reason why Cobenfy commercially has not done that well because . . . the side effects, the GI adverse events, are likely to be in the real world much worse than what was reported in the Phase 3 studies.” MapLight CEO Christopher Kroeger agreed . “The challenge with Cobenfy has been that it is not proven to be particularly tolerable,” Kroeger told BioSpace in August. Because Cobenfy’s components—the muscarinic agonist xanomeline and the muscarinic antagonist trospium chloride—have to be in exquisite balance, there can be high interpatient variability, he added. Even as Cobenfy’s market uptake continues to be a challenge, BMS is pushing the drug forward in Alzheimer’s disease psychosis, positioning it as a safer option versus current antipsychotics on the market, most of which have boxed warnings for an elevated risk of death in older patients with dementia. But readouts from the ADEPT program studying Cobenfy in this indication keep being pushed back, impeded by enrollment problems and the slow accrual of outcome events. BMS had originally expected data from the ADEPT-2 trial by the end of last year, but announced in December 2025 that the results would instead come by the end of this year. In July, BMS disclosed another delay for the program, with CEO Chris Boerner saying on the company’s second quarter earnings call that topline data readouts from ADEPT are now anticipated in early 2027, with a potential interim analysis for ADEPT-1 later this year. Earnings BMS positions Cobenfy as safer alternative ahead of pivotal Alzheimer’s psychosis readout After delaying a late-stage readout last year due to “irregularities” at certain study sites, pivotal data for Bristol Myers Squibb’s Cobenfy appear set to arrive later this year. April 30, 2026 · 2 min read · Tristan Manalac Read more While delays to readouts don’t necessarily mean that those studies failed, Suvannavejh indicated it’s not something analysts regard positively. BMS is also studying Cobenfy in bipolar mania, Alzheimer’s disease agitation, Alzheimer’s disease cognition and pediatric autism irritability. Cerevel: A riskier bet Cobenfy may be struggling on the market, but for Suvannavejh, AbbVie’s Cerevel acquisition was always the riskier of the two bets. In December 2023, when both deals went down, Karuna was farther along in the drug development journey. Cobenfy, still known as KarXT at the time, already had two Phase 3 studies under its belt, both of which had demonstrated the drug’s benefits. Meanwhile, Cerevel’s emraclidine had only cleared Phase 1b testing and was still wrapping up two registration-enabling Phase 2 studies. This is possibly what enabled Karuna to be sold at a higher valuation, Suvannavejh explained. “AbbVie, I guess, jumped the gun and said, ‘Well, we have a lot of confidence that the Phase 2/3 data will be positive,’” he continued. While the earlier-stage asset may have saved AbbVie a few billion dollars, the pharma gambled by “buying something that’s less derisked.” But the book isn’t closed on emraclidine just yet. AbbVie is studying the molecule in a Phase 2 trial in adults with schizophrenia. The asset is also in early-stage development for psychosis, with data for both indications slated for this year . Of the Juvmo approval, Suvannavejh said it’s difficult to predict peak sales, and noted that a lot of Parkinson’s drugs, which are mostly symptomatic treatments, “don’t tend to be blockbuster products.” William Blair projects Juvmo to make $1.4 billion in 2040. Even assuming the drug’s peak sales were to reach four to five times the firm’s estimate, Phipps is unconvinced it will justify AbbVie’s Cerevel buy. “You probably aren’t fully justifying the take out price of Cerevel,” he told BioSpace . “So I think many people would say they overpaid, but at least were fortunate to have it not be a complete zero.” Editor’s note: Heather McKenzie contributed reporting to this piece.