Brexpiprazole

Lundbeck is bracing for the expected U.S. loss of exclusivity for its top-selling drug Rexulti at the end of 2028. Despite falling short in its recent bid to snatch Avadel from Alkermes, Lundbeck is signaling to investors that it’s not desperate for deals and will not lower its standards for future M&A. Even as some analysts question the company’s midterm prospects following a major patent cliff, leadership says it will prioritize strategic fit and financial discipline over a quick fix.“We’re not willing to compromise,” Maria Alfaiate, Lundbeck’s EVP of corporate, portfolio and product strategy, said in an interview with Fierce Pharma on the sidelines of the J.P. Morgan Healthcare Conference 2026 in San Francisco.The biggest threat to Lundbeck’s business is perhaps the expected U.S. loss of exclusivity for Rexulti at the end of 2028. The Otsuka-partnered atypical antipsychotic is currently Lundbeck’s top-selling product, with 4.7 billion Danish kroner ($737 million) in sales for the first nine months of 2025, representing 26% year-over-year growth at constant exchange rates.Lundbeck’s own projection foretells a revenue plateau in 2029 and 2030, followed by accelerated growth if a couple of its pipeline products launch successfully, Thomas Gibbs, EVP and head of Lundbeck U.S., said. That long-term view underpins the company’s unwillingness to rush into subpar deals.“We would rather accept this plateau to then grow than actually compromise,” Alfaiate added.  Gibbs described “programmatic business development” as a key strategy, saying Lundbeck is now in a position where it does not need to pursue a large acquisition.As to the unsolicited bid for Avadel, “we do see that there could be some benefit in terms of either a late-stage or on-the-market asset to help address that 2029-2030 gap,” Gibbs said.After Alkermes increased its offer for Avadel in response to Lundbeck’s unsolicited bid, Lundbeck did not raise its price further.Buying Avadel would have given Lundbeck an immediate revenue stream from the commercial narcolepsy drug Lumryz and an earlier entry into neuro rare disease, “but not at any cost,” Alfaiate said. “Ultimately, walking away, I believe, shows discipline.”But some analysts appear more concerned about Lundbeck’s post-Rexulti life and see a more urgent need for M&A.“Lundbeck has an intriguing pipeline, however potential market entry is 2028+E, and thus will not address the impact of Rexulti LoE in 2029E,” Jefferies analysts wrote in a November note.The Danish pharma is currently banking on growth from Rexulti and its anti-CGRP migraine drug Vyepti, while two late-stage programs—multiple system atrophy candidate amlenetug and bexicaserin for epilepsy disorders—could enter the market around the 2028 timeframe.Rexulti is facing big-name competition from Bristol Myers Squibb’s Cobenfy in schizophrenia and Johnson & Johnson’s Caplyta in major depressive disorder (MDD), and Axsome Therapeutics’ Auvelity is approved in MDD and gunning for an expansion into Alzheimer’s disease agitation.Schizophrenia only makes up about 7.9% of Rexulti’s revenue, while MDD represents 35%. Acknowledging that it’s still early days, Gibbs said Lundbeck has not yet detected an impact from Caplyta’s launch since November. In both MDD and Alzheimer’s disease agitation, Gibbs argued that more products being available could raise awareness, drive diagnosis and overall market growth. Lundbeck and Otsuka recently failed to convince the FDA of Rexulti’s value as a treatment for post-traumatic stress disorder because of mixed data across three clinical trials. According to Gibbs, the pair will not pursue the indication further with another trial as the FDA has suggested.“I think the data package that we submitted was probably, in totality, the best data that have been generated for patients who haven’t responded to [selective serotonin reuptake inhibitors],” Gibbs said. “When you look at the time for payback, it just doesn’t make sense to do anything else.”In 2024, Lundbeck handed responsibilities for its older MDD drug, Trintellix, to partner Takeda. The Danish pharma made the move to “disproportionately allocate resources to our biggest growth drivers,” including Rexulti, Gibbs said, rather than a product that’s slated to lose patent protection in 2026.“As elegant as we tried to be with co-positioning, what our data and analytics suggested is that when our sales force was promoting Rexulti and Trintellix at the same time, we had a 20% less productivity in terms of our impact on Rexulti versus when it was done alone,” Gibbs said.  Following the separation, Rexulti’s year-on-year revenue growth reached 26% in the first nine months of 2025, versus 16% during the same period in 2024, without adding any new indications.As for Vyepti, the infused anti-CGRP therapy has gained traction in a market crowded with subcutaneous injectables and oral options. The drug’s sales rose 57% at constant currencies to nearly 3.3 billion Danish kroner ($518 million) in the first three quarters of 2025. Lundbeck has pegged Vyepti’s peak annual sales at more than $1.4 billion, including $1.1 billion in the U.S.Gibbs attributed Vyepti’s success to an infusion network, which helps patients navigate the entire treatment journey, as well as Lundbeck’s continued effort in building out Vyepti’s data package. The company recently rolled out real-world data suggesting that many patients may enjoy additional benefits from the infused drug following treatment with subcutaneous anti-CGRP therapy.In the pipeline, Lundbeck got bexicaserin through its $2.5 billion acquisition of Longboard Pharmaceuticals. With two phase 3 trials running in parallel in Dravet syndrome and other developmental and epileptic encephalopathy, the 5HT2C agonist is targeting a broad label and a potential market opportunity between $1.5 billion and $2 billion globally. The Longboard buyout fits Lundbeck’s focus on neuropsychiatry, neuro specialty and neuro rare disease; and according to Gibbs, any potential deals will have to fall within that bucket.“We’re not going to buy revenue,” Gibbs added. “It’s got to be a strategic fit that ideally has both revenue and a pipeline associated with it.”That means Lundbeck is not interested in obesity, despite the brain’s involvement in the disorder. Some biotechs have been looking to tackle obesity from a neurological perspective. Neurocrine Biosciences, another major neuroscience drug developer, just unveiled an obesity pipeline.“We’re a mid-size company,” Alfaiate said. “We need to be focused and follow the science in areas where we really understand the biology and where we can have the biggest impact.”“Sometimes in science, you do have some serendipity involved,” the strategy chief continued. “If that were to happen, this is probably something where we would partner with someone who knows what they’re doing, rather than trying to do it ourselves. We remain focused and dedicated to true brain health.”

> 2026年1月14日，成都苑东生物制药股份有限公司（股票代码688513）股价报收于59.18元，单日下跌4.07%，成交额达1.35亿元。更引人注目的是，这已是该股连续第三个交易日下跌，区间累计跌幅达到8.36%，总市值蒸发约9亿元。 此次下跌发生在公司1类新药获批临床、政策面利好频传的背景下，凸显出市场对创新药企业短期增长与长期价值兑现之间的复杂权衡。 1. 股价连续回调：三日累计跌幅8.36% 根据市场数据，苑东生物股价自1月12日起开启下跌通道。截至1月14日收盘，股价从64.6元附近跌至59.18元，**三日累计跌幅为8.36%**。当日成交额1.35亿元，换手率1.26%，总市值缩水至104.47亿元。 资金流向显示，1月14日主力资金净流出**442.55万元**，但值得注意的是，在之前3天的调整中，**主力资金整体净流入703.96万元**，表明资金态度存在显著分歧。 2. 板块拖累与资金分歧：单抗概念跌2%，主力净流出 下跌并非孤立事件。1月14日14点1分，**单抗概念板块指数报1861.854点，跌幅达2%**，板块内迈威生物、信立泰、苑东生物等多只个股同步下跌。这反映出医药板块整体的情绪调整对个股形成了拖累。 尽管有政策利好——国家药监局在2026年将助力创新药“中国首发”，推动药品试验数据保护制度落地——但市场短期风险偏好下降似乎占据了上风。 3. 基本面稳健但增长乏力：营收微降，净利润小幅增长 公司基本面并未出现恶化。2025年前三季度，苑东生物实现营业收入**10.19亿元**，同比微降2.0%；归母净利润**2.20亿元**，同比增长1.45%。第三季度单季表现更为亮眼，归母净利润**8359.06万元**，同比上升18.52%。毛利率保持在**75.69%**的高位。 然而，这份“稳健”的业绩未能提供超出市场预期的增长动力，在板块调整中难以形成支撑。 4. 新药管线进展：EP-0226片获临床批件 就在股价下跌前夕，公司研发管线取得重要进展。1月12日，苑东生物按化药注册分类**1类申报的新药EP-0226片**临床试验申请获默示许可，拟用于治疗神经病理性疼痛。  该新药由苑东生物、中国科学院上海药物研究所和中科中山药物创新研究院联合开发，从申请获承办到获批临床仅用时数月。此外，公司在2025年12月还获得了**布瑞哌唑片**的药品注册证书以及**亚甲蓝注射液**的美国FDA批准。 > “这一突破，标志着苑东生物在创新药研发征程上又迈出了坚实一步。” 然而，从临床试验到最终上市通常需要数年时间，这类长期利好对短期股价的提振作用有限，反而可能加剧部分投资者对研发投入与回报周期的担忧。 5. 机构持仓浮亏：博时、浦银安盛等基金受损 股价连续下跌导致重仓机构出现显著浮亏。数据显示： - **博时基金旗下5只基金**合计持有苑东生物234.36万股，连续3天下跌期间浮亏损失约**1265.52万元**。其中，博时研究优选混合A在三季度新进十大流通股东，持有163.51万股。 - **浦银安盛基金旗下7只基金**合计持有95.36万股，同期浮亏损失约**514.96万元**。 - **长城基金旗下1只基金**持有162.21万股，浮亏损失约875.94万元。 机构的大额持仓及其浮亏，可能影响了市场短期信心，并反映出即使专业投资者也未能规避此次波动。 6. 未来展望：政策红利与研发转化挑战 展望后市，苑东生物的股价走势将取决于多重因素的博弈： - **政策环境**：国家药监局2026年“助力创新药中国首发”的表述，可能为公司的创新药研发与审评提供长期支持。 - **研发转化**：核心在于**EP-0226片**等管线的临床试验推进速度与最终疗效，这决定了长期价值能否兑现。 - **市场情绪**：医药板块整体估值调整是否结束，以及资金对创新药企业盈利确定性的重新定价。 - **经营韧性**：公司能否在营收微降的背景下，通过成本控制与产品结构优化维持利润增长。 苑东生物此次股价连续下跌，本质上是市场在行业调整期对短期增长乏力的反应，叠加了资金面获利了结的压力。尽管新药研发取得里程碑式进展，但创新药的“慢功夫”特性与资本市场的“即时反馈”需求之间存在固有张力。 对于投资者而言，短期波动需警惕板块风险，而长期价值则需聚焦于管线进展与政策落地后的实质性成长。