TERN-701

从2025年4月的冰点到2026年4月的沸点，标普生物科技指数XBI在短短12个月内暴涨110%，一举突破2022-2025年的长期震荡平台，刷新三年新高，距离2021年历史高位仅一步之遥。 这不是一次短暂的情绪反弹，而是一场由MNC并购刚需爆发与PE资本疯狂进场共同驱动的产业级行情。3月31日XBI单日暴涨7.53%，创下近年纪录，背后正是渤健、礼来两大巨头同日官宣百亿级并购，彻底点燃了市场情绪。 这轮行情到底是怎么来的？它的核心逻辑是什么？又能持续多久？一、核心导火索：百亿并购密集落地，MNC集体"扫货" 本轮行情最直接的驱动力，是席卷全行业的并购浪潮。 据Evaluate统计，2026年第一季度全球生物制药行业并购交易达41笔，较2025年第四季度增长32%。仅3月底短短一周，多家MNC密集达成6笔并购交易，超200亿美元资金疯狂涌入生物科技赛道。1.两笔标志性交易，折射MNC两种生存逻辑 3月31日同日官宣的两笔百亿级并购，精准代表了当前巨头们的两种核心战略： 渤健56亿美元收购Apellis：140%溢价换"即期现金流" 作为神经科学老牌巨头，渤健正面临多发性硬化症（MS）业务持续萎缩的危机。此次收购Apellis，是典型的"救急式"布局：Apellis拥有全球首个年龄相关性黄斑变性（AMD）地图样萎缩药物Syfovre（2025年销售额5.87亿美元，市占率60%）和补体C3抑制剂Empaveli，两款产品合计贡献6.89亿美元年收入，且未来三年将保持中高双位数增速。 140%的天价溢价刷新了近年并购纪录，背后是MNC对成熟现金流资产的极端渴求——用确定性收入对冲主业下滑。 礼来78亿美元收购Centessa：跳出减肥药依赖，打造第二增长曲线 凭借GLP-1爆款Mounjaro和Zepbound，礼来2025年营收达652亿美元，跻身全球前三药企。但单一赛道的天花板日益临近，此次收购Centessa正是为了开辟神经科学新战场。 Centessa的核心资产OX2R激动剂ORX750，针对发作性睡病的Ⅱa期数据惊艳：使患者嗜睡量表评分从19.6降至5.1，每周猝倒发生率减少87%，且无传统睡眠药的成瘾和宿醉效应，有望成为该领域的BIC（最佳同类）品种。2.全行业并购潮：巨头们的"管线大补丸" 不止渤健和礼来，2026年一季度全球药企掀起了集体并购潮，每一笔交易都精准对应着巨头们的战略短板： 默沙东67亿美元收购Terns Pharmaceuticals，获得白血病候选药物TERN-701，补充血液肿瘤管线 诺华20亿美元收购Excellergy，布局下一代抗IgE过敏疗法 吉利德17亿美元收购Ouro Medicines，加码T细胞衔接器自免赛道 辉瑞完成430亿美元收购Seagen，全面整合ADC平台，Padcev已成为其肿瘤业务核心增长极二、并购潮的底层逻辑：专利悬崖+估值修复+资本竞逐 MNC的并购刚需并非新鲜事，但为何偏偏在2026年集中爆发？这背后是三大因素的完美共振。1.专利悬崖迫近，增长焦虑达到顶峰 2025年全球药企排名显示，前20大药企中超过半数面临核心产品专利到期的压力： 默沙东的PD-1明星药Keytruda将于2028年专利到期，2025年贡献超200亿美元营收 艾伯维的修美乐已过专利期，Skyrizi和Rinvoq正全力接棒 罗氏的Tecentriq、诺华的Cosentyx等重磅产品也将在未来3-5年迎来专利悬崖 为了填补产品断层，MNC不得不通过并购快速获取后期管线，这是一场关乎生存的"军备竞赛"。2.估值修复完成，买卖双方预期趋同 过去三年的熊市让Biotech估值跌到了历史谷底。2025年4月XBI指数最低跌至66.42美元，大量优质公司股价甚至低于现金价值。 随着2025年下半年XBI反弹超86%，Biotech估值逐步回归合理区间，买卖双方对价格的预期终于达成一致。此前因估值过低不愿出售的创始人，现在愿意接受并购；而MNC也认为此时收购性价比依然很高。3.PE资本进场，掀起"双轨竞赛" 除了MNC，PE资本也在疯狂抢筹优质生物科技资产。2026年开年以来，黑石等头部私募在生物技术领域累计投资超150亿美元，创下历史同期新高。3月30日，黑石官宣第六期生命科学基金完成63亿美元募集，成为全球规模最大的生命科学专项基金之一。 PE资金决策更快、出价更灵活，直接倒逼MNC提高报价、加快决策节奏。这场MNC与PE之间的"抢货大战"，持续推高了行业的估值中枢。三、基本面支撑：临床数据井喷与FDA审批大提速 如果说并购是点火器，那么实打实的临床突破和政策利好就是这轮行情的燃料。2025年第四季度到2026年第一季度，生物科技行业迎来了历史罕见的临床数据集中爆发期。1.多个"绝症"领域取得历史性突破 阿尔茨海默病：礼来的Donanemab三期临床显示，能将早期患者认知衰退速度降低47%，2026年3月获批后预计年销售额将突破150亿美元 ADC药物：第一三共和阿斯利康的Enhertu持续扩大适应症，Seagen的新一代TROP2ADC在三阴性乳腺癌中客观缓解率达58% 罕见病：2026年第一季度共有8款罕见病药物获批，包括首款口服SMA基因治疗药物和血友病A一次性治愈疗法 HIV预防：吉利德推出每年两次给药的长效注射PrEP疗法Yeztugo，彻底改变了HIV预防的格局2.FDA进入历史最宽松审批周期 政策东风进一步放大了基本面的利好。2025年FDA全年共批准了65款新药，创下近十年新高，平均审批时间缩短至6.2个月，比2024年快了近30%。 尤其是在基因治疗、ADC和罕见病领域，FDA不仅加快了审批速度，还放宽了临床终点要求，允许使用替代终点加速获批。2025年底发布的《基因治疗监管框架修订版》，更是消除了行业最大的政策不确定性。四、资金面共振：降息预期与IPO回暖，资金全面回流 生物科技是典型的利率敏感型行业。2025年12月美联储首次降息25个基点，并暗示2026年将降息3-4次，彻底扭转了过去三年的资金环境。 美国10年期国债收益率从4.5%降至3.2%，大量资金从债券市场流向高成长的权益市场。根据高盛报告，对冲基金对生物科技板块的配置比例从2025年第三季度的5%飙升至2026年第一季度的18%，达到超配状态。 与此同时，IPO市场也迎来了久违的回暖： 2026年第一季度，生物制药公司通过IPO共募资17亿美元，创下2021年以来最高季度纪录 平均募资金额达2.87亿美元，是去年同期的两倍多 减肥药企业Kailera Therapeutics以6.25亿美元募资额，成为纳斯达克生物科技史上最大IPO AI制药企业Generate Biomedicines完成4亿美元IPO，领跑AI制药赛道。 当然，生物科技行业永远不缺风险。临床失败、政策反复、利率反弹，任何一个黑天鹅事件都可能导致股价波动。但不可否认的是，经过三年的深度出清，美国生物科技行业已经迎来了新的上升周期。 对于中国市场而言，这轮行情也有着重要的启示。海外巨头的并购潮正在与中国创新药的BD热潮形成全球共振：越来越多的MNC开始瞄准中国的优质创新资产，本土药企也通过出海授权实现管线价值兑现。 当产业周期与资本周期同向向上，当技术突破与政策利好相互叠加，美国生物科技的春天已经到来。而中国的创新药行业，也终将迎来属于自己的高光时刻。

Terns Pharmaceuticals (Nasdaq: TERN), headquartered in Foster City, California, announced that the US FDA granted Breakthrough Therapy Designation (BTD) to TERN-701, an oral allosteric BCR::ABL1 inhibitor, for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase without the T315I mutation who have received two or more prior tyrosine kinase inhibitors (TKIs). BTD provides intensive FDA guidance, rolling review of application sections, and senior agency involvement throughout development — benefits the company expects to apply toward advancing TERN-701 into a pivotal trial. No prior expedited designations for TERN-701 appear in the public record. The designation was supported by data from the ongoing Phase I/II CARDINAL trial (NCT06163430). At a December 2025 presentation at the 67th American Society of Hematology Annual Meeting, Terns reported results from 38 efficacy-evaluable patients at a September 13, 2025 data cutoff. Among patients without MMR at baseline, TERN-701 produced a major molecular response (MMR) rate of 64% by week 24, rising to 75% at doses of 320 mg once daily or higher. The cumulative MMR rate — combining patients who achieved or maintained MMR — was 74% (28 of 38 patients). A deep molecular response (DMR, defined as BCR::ABL1^IS ≤0.01%) was observed in 36% of efficacy-evaluable patients. No dose-limiting toxicities, treatment discontinuations due to adverse events, or dose reductions were recorded across any dose level up to 500 mg once daily. No clinically meaningful blood pressure changes were observed. The patient population in CARDINAL is heavily pretreated, with a median of four prior therapies, and includes patients who had previously received an allosteric TKI. In the subgroup defined by lack of efficacy to the last TKI, the MMR achievement rate was 63% (12 of 19 patients). In five patients with the T315I mutation — a population excluded from the BTD indication but enrolled in the broader trial — the MMR rate was 80%, though this subgroup is small and the finding should be interpreted with caution. CML is driven by the BCR::ABL1 fusion oncoprotein, and TKIs targeting its ATP-binding site have transformed the disease from a condition with limited treatment options into one where many patients achieve durable molecular remissions. However, a subset of patients develop resistance or intolerance after multiple lines of therapy, leaving a population where further treatment options narrow considerably. The competitive context for TERN-701 is shaped primarily by asciminib (Scemblix, Novartis), the first approved allosteric BCR::ABL1 inhibitor, which binds the myristoyl pocket rather than the ATP site. Asciminib received US FDA approval in 2021 for CML resistant to or intolerant of at least two prior TKIs and, separately, for T315I-mutant disease. Its Phase III ASCEMBL trial demonstrated a 25.5% MMR rate at 24 weeks versus 13.2% for bosutinib in the third-line setting. The CARDINAL data for TERN-701, while from a Phase I/II study without a comparator arm, show a 64% MMR-achievement rate in a similarly defined population, though cross-trial comparisons carry substantial methodological limitations. TERN-701 differs from asciminib in its binding characteristics within the allosteric pocket. Terns has described TERN-701 as retaining activity in patients who previously received asciminib, which, if confirmed in larger cohorts, would be a meaningful differentiator given that asciminib use is expanding in earlier lines of therapy. The CARDINAL data include patients with prior allosteric TKI exposure, and responses were observed in that subgroup, though precise rates for that specific cohort were not separately disclosed in the December 2025 presentation materials reviewed here. The broader later-line CML landscape includes ponatinib (Iclusig, Takeda), a third-generation ATP-site inhibitor with activity against T315I, and the combination of asciminib with ATP-site TKIs, which is under investigation. The cardiovascular risk associated with ponatinib has historically constrained its use, and the clean vascular safety profile reported for TERN-701 to date — absent blood pressure changes and without dose-related toxicity signals — may prove relevant to positioning, pending longer follow-up. Terns also disclosed in April 2026 that Merck has agreed to acquire the company, a transaction that, if completed, would transfer TERN-701’s development to a larger organization with resources to execute a registrational program. The BTD, combined with the pending acquisition, sets a context in which the path to a pivotal trial design and FDA interactions would benefit from the designation’s collaborative framework. CARDINAL continues to enroll, with dose expansion initiated in April 2025 and an additional mutation cohort added in January 2026. Exact response rates by individual dose cohort and longer-term durability data have not yet been disclosed publicly, and the absence of a control arm means that the observed MMR rates cannot yet be interpreted as definitive evidence of comparative benefit over available therapies. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website