Certolizumab Pegol

New TREMFYA ® (guselkumab) 3-year as-observed data show clinical remission rates of up to 94% (172/183 patients) and endoscopic remission rates of up to 52% (89/172 patients) in adults with moderate to severe Crohn’s disease in the 100 mg q8w dose group 1 FUZION data show combined fistula remission was maintained through Week 48 across both maintenance dose regimens, including an increase from 28% at Week 24 to 35% at Week 48 in the 100 mg q8w dose group 2 Together, these findings expand the evidence for guselkumab across long-term disease management and one of the most difficult-to-treat manifestations of Crohn’s disease 1,2 BEERSE, BELGIUM ( 19 October 2026 ) – Johnson & Johnson today announced new data that further expands the clinical evidence supporting TREMFYA ® (guselkumab) in Crohn's disease (CD) at the 2026 United European Gastroenterology Week (UEG Week). Research from the Phase 3 GALAXI studies shows durable efficacy and a consistent safety pro guselkumab through three years (Week 144) of maintenance treatment in adults with moderately to severely active CD, reinforcing its long-term benefit in this chronic, progressive disease. 1 Additionally, late-breaking one-year results from the Phase 3 FUZION study showed that guselkumab maintained or improved fistula remission through Week 48 in adults with CD with perianal fistula. 2 "The treatment goals in Crohn's disease continue to evolve beyond short-term symptom management towards achieving durable disease control that can be sustained over years," said Mark Graham, Therapeutic Area Head, Immunology, J&J Innovative Medicine EMEA. "These findings reinforce the potential of guselkumab across different stages and manifestations of Crohn's disease, from sustained remission over three years to encouraging outcomes in patients living with perianal fistula, one of the most challenging complications of the disease." Crohn’s disease is one of the two main forms of inflammatory bowel disease (IBD), which affects an estimated two million people across Europe. 3 Guselkumab is an IL-23p19 subunit inhibitor approved in IBD that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. 4,5,6,7 Findings for the unique mechanism of action are limited to in vitro studies, and the clinical significance of this finding is not known. 8 IL-23 is a cytokine secreted by activated monocytes/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases, including Crohn’s disease. 9 Three-year GALAXI results support the known efficacy and safety pro guselkumab Patients in the GALAXI 2 and 3 studies received intravenous induction followed by one of two guselkumab maintenance dosing regimens: 100 mg administered subcutaneously every eight weeks (q8w; n=286) or 200 mg administered subcutaneously every four weeks (q4w; n=296). 1 In total, 432/582 patients continued treatment through Week 144. 1 These were as-observed analyses and do not represent outcomes in the full randomised population. 1 Participants who discontinued, lacked Week 144 data or underwent dose adjustment were not included. 1 Across both regimens, clinical and endoscopic remission were maintained through three years of treatment. 1 At Week 144 in the long-term extension (LTE), the data show: a 94% (172/183) of patients receiving guselkumab 100 mg q8w and 91% (185/204) receiving guselkumab 200 mg q4w achieved clinical remission. b , 1 89% (162/183) of patients receiving guselkumab 100 mg q8w and 88% (179/204) receiving guselkumab 200 mg q4w achieved 90-day corticosteroid-free clinical remission. 1 52% (89/172) of patients receiving guselkumab 100 mg q8w and 61% (119/195) receiving guselkumab 200 mg q4w achieved endoscopic remission. c, 1 74% (432/582) of guselkumab-treated patients remained on treatment through three years. 1 Safety findings through Week 144 were consistent with the known safety pro guselkumab in Crohn’s disease. 1 Common adverse reactions associated with guselkumab include respiratory tract infections, diarrhoea, and injection site reactions. 4 The three-year results demonstrate durable clinical, corticosteroid-free and endoscopic remission across both guselkumab maintenance regimens. 1 "In a chronic condition such as Crohn's disease, maintaining remission is as important as achieving it," said Prof. Silvio Danese, Gastroenterologist and Professor of Gastroenterology at Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital in Milan, Italy. d "The three-year GALAXI results provide valuable longer-term evidence, showing that high levels of clinical remission were accompanied by sustained endoscopic and corticosteroid-free outcomes across both guselkumab maintenance regimens." New FUZION 48-week analysis extends evidence in Crohn’s disease with perianal fistula The 48-week findings showed that combined fistula remission, which incorporates both clinical and radiological assessment, was maintained or improved in both guselkumab maintenance regimens. 2 Among patients initially randomised to the guselkumab 100 mg q8w maintenance regime (n=113), combined fistula remission e further increased from 28% at Week 24 to 35% at Week 48. 2 ,10 Results at Week 48 include patients who underwent blinded dose adjustment to guselkumab 200 mg every four weeks at Week 24 (n=55). 2 Similar findings were observed for rates of clinically assessed fistula remission. f, 2 Results among patients receiving guselkumab 200 mg every 4 weeks (q4w; n=115) remained consistent through Week 48 (27% at Week 24 to 26% at Week 48). 2 ,10 Similar findings were observed for clinically assessed fistula remission. 2 Overall, 90% of all randomised patients, which included both bio-naïve and bio-experienced patients, completed treatment through Week 48. 2 “Perianal fistula remains one of the most debilitating complications of Crohn's disease, where achieving durable disease control beyond symptom improvement is a challenge,” said Ailsa Hart, Ph.D., Director of St Mark's Hospital Inflammatory Bowel Disease Research, Consultant Gastroenterologist, and study investigator. g “The latest findings from the FUZION study show that patients treated with guselkumab maintained or improved upon the clinical benefits observed at Week 24, providing encouraging evidence for its use in this patient population.” Safety findings through Week 48 were consistent with the known safety pro guselkumab in Crohn’s disease. 2 Common adverse reactions associated with guselkumab include respiratory tract infections, diarrhoea, and injection site reactions. 4 These results reinforce the previously shared Week 24 results from FUZION, 2,10 making guselkumab the only IL-23 inhibitor to demonstrate efficacy in a dedicated, randomised, placebo-controlled trial in patients with Crohn’s disease with perianal fistula, one of the most difficult-to-treat manifestations of the disease. 2 Together, the GALAXI and FUZION findings presented at UEG Week 2026 underscore the growing breadth of evidence supporting guselkumab across Crohn's disease, from sustained long-term remission in moderately to severely active disease to efficacy in patients living with complex fistulising complications. 1,2 ,11 Editor’s notes: The Week 144 clinical remission, 90-day corticosteroid-free clinical remission and endoscopic remission results above represent the as observed data for the three-year GALAXI analysis. 1 The observed analysis set included participants who entered the LTE, received ≥1 partial or complete study drug dose during the LTE, remained on treatment, and had data available at Week 144; participants who had a dose adjustment were not included. 1 Clinical remission was defined as a CDAI score 1 on any subcomponent. 1 Silvio Danese is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. Combined fistula remission was defined as 100% closure of all external openings without development of new fistulas or abscesses and without any drainage by external openings, occurring spontaneously or after gentle finger compression and absence of collections >2cm of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the MRI results. 2 Clinically assessed fistula remission was defined as: 100% closure of all treated external openings without development of new fistulas or abscesses and without any drainage by external openings, occurring spontaneously or after gentle finger compression. 2 Ailsa Hart is a paid consultant for Johnson & Johnson. She has not been compensated for any media work. About the GALAXI programme (EudraCT 2017-002195-13) 1 2 GALAXI is a double-blind, placebo-controlled, active-controlled (ustekinumab), parallel group, global, multicentre Phase 2/3 programme designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (immunomodulators, corticosteroids) and/or biologics (infliximab, adalimumab, certolizumab pegol, vedolizumab). 1 2 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3, n=1021). 1 2 Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomised and includes a long-term extension that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years. 4,1 2 ,13 Clinical outcomes include clinical remission (Crohn's Disease Activity Index [CDAI] <150), while endoscopic outcomes include endoscopic response and endoscopic remission as assessed using the Simple Endoscopic Score for Crohn's Disease (SES-CD). 1 2 About the FUZION study (EudraCT 2021-000491-10) 1 4 FUZION is a randomised, placebo-controlled, double-blind, multicentre, Phase 3 study designed to evaluate the efficacy and safety of guselkumab in adults with Crohn’s disease with perianal fistula. 1 4 Patients enrolled in the study had one or more active draining perianal fistulas confirmed by blinded central MRI review, Crohn’s Disease Activity Index [CDAI] <350, and inadequate response to oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or up to 2 advanced therapy classes. 1 0 ,1 4 Patients were randomised 2:2:1 to receive guselkumab 200 mg intravenous (IV) induction at Weeks 0, 4, 8 followed by guselkumab 100 mg subcutaneous (SC) maintenance therapy every 8 weeks (q8w); or guselkumab 200 mg IV infusion at Weeks 0, 4, 8 followed by guselkumab 200 mg SC maintenance therapy every 4 weeks (q4w); or placebo. 1 0 About Crohn’s disease Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated two million people across Europe. 3 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors. 1 5 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss, and fever. 1 6 There is currently no cure for Crohn’s disease. 1 7 About guselkumab Developed by Johnson & Johnson, guselkumab is the first approved fully-human, IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. 4,5,6,7 Findings for the unique mechanism of action are limited to in vitro studies, and the clinical significance of this finding is not known. 8 Guselkumab is approved in the EU for the treatment of moderate to severe plaque psoriasis (Pso) in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug therapy. 4 It is also approved in the EU and U.S. for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a JAK inhibitor and for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 4 ,1 8 Johnson & Johnson maintains exclusive worldwide marketing rights to guselkumab. Guselkumab important safety information In controlled periods of clinical studies with guselkumab, adverse drug reactions (ADRs) that consisted of respiratory tract infections were very common (≥10 percent); increased transaminases, headache, diarrhoea, arthralgia, rash and injection site reactions were common (≥1 to <10 percent); and herpes simplex infections, tinea infections, gastroenteritis, decreased neutrophil count, hypersensitivity, anaphylaxis, and urticaria were rare ADRs (≥0.1 percent to <1 percent). 4 Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab: About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behaviour and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. Media contact: Sophie Daneau SDaneau@ITS.JNJ.com Investor contact: Jessica Margevich investor-relations@its.jnj.com CP-606720 October 2026 References Sands BE, et al. Efficacy and safety of guselkumab maintenance therapy in patients with moderately to severely active Crohn’s disease: results through week 144 from the phase 3 GALAXI 2 & 3 studies. Oral presentation (OP105) at the United European Gastroenterology Week Congress (UEGW). October 2026. Hart A, et al. Efficacy and safety of guselkumab in perianal fistulizing Crohn’s disease: Week 48 results from the Phase 3, randomized, double-blind, placebo-controlled FUZION trial. LB09 at the United European Gastroenterology Week Congress (UEGW). October 2026. Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78. EU SmPC: European Medicines Agency. TREMFYA Summary of Product Characteristics. Available at: . Accessed October 2026. EU SmPC: European Medicines Agency. Ilumetri Summary of Product Characteristics. Available at: . Accessed October 2026. EU SmPC: European Medicines Agency. Skyrizi Summary of Product Characteristics. Available at: . Accessed October 2026. EU SmPC: European Medicines Agency. Omvoh Summary of Product Characteristics. Available at: . Accessed October 2026. Sachen KL, et al. Guselkumab binding to CD64+ IL-23–producing myeloid cells enhances potency for neutralizing IL-23 signaling. J Crohns Colitis. 2025; 12;16:1532852. Available at: . Schinocca C, et al. Role of the IL-23/IL-17 pathway in rheumatic diseases: an overview. Frontiers in Immunology. 2021 Feb 22;12:321. Available at: . Sands BE, et al. Efficacy of guselkumab in perianal fistulizing Crohn’s disease: Week 24 results from the phase 3, randomized, double-blind, placebo-controlled, multicenter FUZION study. P5691 at ACG Annual Scientific Meeting 2026. October 2026. Schubert S, et al. Early symptomatic response to guselkumab in inflammatory bowel disease: first real-world data from the german GORGEOUS study. ePoster (PP1357) at the United European Gastroenterology Week (UEGW). October 2026. EU Clinical Trials Register. Clinicaltrialsregister.eu. A Phase 2/3, randomised, double-blind, placebo- and active-controlled, parallel-group, multicentre protocol to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease (GALAXI). Identifier: 2017-002195-13. Available at: . Accessed October 2026. ClinicalTrials.gov. A Study of the efficacy and safety of guselkumab in participants with moderately to severely active crohn's disease. Identifier: NCT03466411. Available at: . Accessed October 2026. ClinicalTrials.gov. A study of guselkumab in participants with fistulizing, perianal Crohn’s disease (FUZION CD). Identifier: NCT05347095. Available at: Accessed October 2026. Crohn’s & Colitis Foundation. Causes of Crohn’s disease. Available at: . Accessed October 2026. Crohn’s & Colitis Foundation. Signs and symptoms of Crohn’s disease. Available at: . Accessed October 2026. NHS. Crohn’s disease treatment. Available at: . Accessed October 2026. U.S. Food and Drug Administration. TREMFYA Prescribing Information. Available at: . Accessed October 2026.

现在BD>IPO>投融资>M&A。一次成功的BD大概等于3次IPO,6次融资.所以不管是金额还是意愿，都是创新药公司老板的重要时间精力分配。而掌握MNC的精准信息，有的放矢能节省创新药公司老板大量时间。一、核心结论 1、专利悬崖是未来3-5年并购的第一驱动 2028-2030年全球约1,800-3,000亿美元收入面临LOE。 默沙东（Keytruda 2028年到期、占营收48%）五年防御性并购支出已超260亿美元；BMS（Eliquis 2026/Opdivo 2028）、安进（Prolia/Xgeva 2025-26）、Incyte（Jakafi 2028、占收入71%）、诺华（Entresto 2025）、优时比（Cimzia 2029）的并购激进度与LOE压力呈高度正相关。 2、2025-2026年并购范式已切换：CNS超越肿瘤、平台重于单品 2025年CNS并购307亿美元首次超过肿瘤的235亿美元；强生-Intra-Cellular（146亿）为2025年度最大单。迷幻素衍生药物正式进入主流（艾伯维-Gilgamesh、礼来-AtaiBeckley、大塚-Transcend、强生-ICT）。 3、礼来是当前全行业最激进买家 2026年前7个月收购11家公司+4笔大额许可、披露金额超300亿美元，全阶段全模态"买科学"（in vivo CAR-T、环状RNA、迷幻药、嗜睡症、三连疫苗公司）。 4、中国资产license-in已常态化 2025年中国创新药出海BD总额超1,300亿美元（150+笔、约占全球40%）；MNC新增管线30-40%来自中国，预计升至40-50%。PD-1/VEGF双抗、ADC、siRNA是中国资产三大硬通货。阿斯利康对华最活跃（15伙伴16项合作累计超178亿美元），艾伯维2025-26系统重仓中国三特异性TCE（先声SIM0500、信达ISB-2001、泽璟ZG006、荣昌RC148）。 5、RNA与in vivo细胞治疗是2026年最热新平台 诺华-Avidity（120亿AOC）、礼来-Orna/Kelonia（环状RNA/lentiviral in vivo CAR-T）、艾伯维-Capstan、AZ-EsoBiotec、BMS-Orbital——五年内大概率出现该领域首个百亿美元级大单。二、近五年战略调整全景（2020-2026） 1、从"规模"到"聚焦"的业务重组 A、分拆瘦身 辉瑞Upjohn→Viatris（2020）、 GSK→Haleon（2022）、 诺华→Sandoz（2023）、 默沙东→Organon（2021）、 赛诺菲→Opella（2025，回笼104亿欧元）、 强生→Kenvue（2023）、 拜耳（Anderson上任后持续收缩）。 B、日本药企集体转向海外 第一三共（ADC全球化输出）、 小野（Deciphera 24亿美元，首次重大海外并购）、 盐野义（Torii+田边ALS业务，罕见病平台化）、 住友（收缩剥离为主）。 C、韩国双雄差异化 柳韩（license-out标杆：lazertinib授权强生，合同总额125.5亿美元，"后Leclaza"五资产待签约）、 Celltrion（biosimilar现金流→创新药+CDMO+美国产能，3.3亿美元收购礼来新泽西工厂）。 2、治疗领域权重大洗牌 趋势 代表动作 肥胖/代谢成超级赛道 辉瑞-Metsera（100亿）、诺和-Akero（52亿）、罗氏-89bio（35亿）、勃林格survodutide III期成功；口服GLP-1成license新热点（辉瑞-复星药友21亿） CNS/精神迷幻崛起 强生-ICT、艾伯维-Gilgamesh/Cerevel、大塚-Transcend（非致幻PTSD）、灵北-Longboard、Neurocrine 自免持续吸金 艾伯维五年千亿级并购（ImmunoGen/Cerevel/Apogee 109亿）、福泰-Alpine 49亿、UCB-Candid/Neurona/Antengene ADC第二春 辉瑞-Seagen 430亿、吉利德-Tubulis 50亿（新型linker-payload）、艾伯维-ImmunoGen、Genmab-ProfoundBio/Merus 80亿、安斯泰来-信诺维CLDN18.2 罕见病整合 BioMarin-Amicus 48亿+Alesta、赛诺菲-Blueprint、Recordati-Enjaymo；赛诺菲/罗氏/渤健（2025-26罗氏罕见病三连投） RNA平台军备赛 诺华-Avidity AOC、诺华-Argo siRNA（总额52亿）、罗氏-SanegeneBio、Ionis/Alnylam产品兑现（Tryngolza/Wainua/Zanvastro） 3、Biotech→全球玩家的跃迁样本 BioNTech COVID现金（约190亿美元弹药）→肿瘤mRNA+ADC+双抗三支柱；收购CureVac（12.5亿）、普米斯（BNT327）；与BMS的BNT327合作成为"小biotech×大药企50/50"新范本。 argenx/Genmab 从零并购到首次出手（argenx-Forte 22亿、Genmab-Merus 80亿）——Biopharma现金牛到一定规模后必然走向并购，这是未来3-5年交易供给端的重要增量。三、未来3-5年并购与BD方向预测（2027-2030）3.1 谁是买家（弹药榜×动机矩阵） 买家 弹药（BMO 2026） 核心动机 预测动作 诺华 ~530亿美元（第一） Entresto下滑、肾科/核药补强 大概率发起下一个百亿级平台并购（AOC/RNA方向延续Avidity逻辑） 艾伯维 ~336亿美元 免疫+ neuroscience双补 中国TCE资产加码；精神迷幻管线扩容 BMS ~219亿美元 Eliquis/Opdivo/Revlimid三重悬崖（全行业最高敞口之一） 2027-2028年"必须买"；肿瘤之外的血液/自免大单 安进 ~186亿美元 Prolia/Xgeva已到悬崖、Horizon后3年未出手 最值得关注蛰伏买家：肥胖（MariTide）或自免补强大单 礼来 2028年现金或达800亿 巩固肥胖帝国+全模态平台 继续高频中小额"买科学"，in vivo CAR-T/环状RNA加注 赛诺菲 Opella回笼104亿欧元 Dupixent 2031+免疫矩阵 免疫/TCE、疫苗平台（Vicebio/Dynavax逻辑延续） 默沙东 — Keytruda 2028（48%营收） 防御性分散投资（呼吸/感染/血液），不排除肿瘤下一个百亿单3.2 并购方向（适应症/靶点/技术/阶段） 适应症优先级（按确定性排序）： 3.2.1肥胖及并发症 （MASH、OSA、心血管代谢）——最大单一赛道 3.2.2自免/炎症 （TCE为主导技术：UCB/Apogee/艾伯维已抢跑） 3.2.3CNS （阿尔茨海默、嗜睡、PTSD、Dravet/LGS罕见癫痫） 3.2.4肿瘤2.0 （ADC升级换代、双抗TCE、RDC放射性药物——BMS-RayzeBio、AZ-Fusion之后的下一单） 3.2.5罕见病整合 （中间市场继续被BioMarin/Recordati型玩家吃掉） 3.2.6靶点热点： PD-1×VEGF双抗（BNT327/SSGJ-707/LM-299之后仍有标的）、CLDN18.2 ADC、BCMA（CAR-T/TCE）、PSMA×CD3双掩蔽TCE、GLP-1小分子口服、menin（AML）、PI3Kα泛突变、IRAK4/TYK2（自免）、KRAS G12C泛突变、Lp(a)（pelacarsen失败后需重新定价）、FcRn下一代。 3.2.7新技术平台（未来3-5年最可能出百亿大单的赛道）： in vivo CAR-T / 体内细胞治疗 （礼来Kelonia/Orna、AZ-EsoBiotec、Capstan） AOC抗体-寡核苷酸偶联 （诺华-Avidity验证后行业跟风） 环状RNA/下一代mRNA （BioNTech整合CureVac后） AI药物发现平台 （Incyte-Genesis、AZ-石药AI合作、Insilico-施维雅8.88亿） 新型linker-payload ADC （吉利德-Tubulis定义新标准） 非致幻迷幻素/神经塑性 （大冢-Transcend methylone为代表性结构） 3.2.8临床阶段偏好： MNC大额并购（>50亿）偏好已上市/III期临近商业化资产（Metsera、Verona、Blueprint、Nuvalent） BD license-in偏好I-II期（首付低、里程碑空间大） 礼来/BioNTech等平台型买家下沉至临床前/发现期（买平台而非买资产）3.3 BD方向与交易结构偏好 3.3.1中国license-in将持续放量 从单资产license向"平台合作+股权投资+选择权池"演进（GSK-恒瑞12项目打包、AZ-石药三轮合作、礼来-海思科5靶点发现合作）。预测2027-2030年MNC新引进管线中国占比40-50%。 3.3.2结构纪律 CVR/低首付-高里程碑/选择权/股权绑定已成标准配置（2025年Top20并购中9笔含CVR；诺华-Argo首付1.6亿vs总额52亿）。 3.3.3NewCo模式 与中美双向利润分成继续扩散。 3.3.4敌意收购抬头 灵北-Avadel（败于Alkermes 23.7亿）预示中型Biopharma之间的控股权争夺将更常见。 3.3.5PE/非传统买家入局 Bain-三菱田边33亿、CVC+GBL-Recordati 107亿私有化、太阳制药-Organon 126亿——Biotech估值博弈者多元化，MNC面临竞争性竞价。3.4 中国资产的下一波买家画像（对被投项目退出的启示） 买家类型 代表 中国资产偏好 重度活跃 阿斯利康、艾伯维、辉瑞、BMS、诺华、默沙东 双抗TCE、ADC、siRNA 新进入者 赛诺菲（2026首笔：中国生物制药rovadicitinib 15亿）、UCB（Antengene TCE）、罗氏、勃林格（瑞博siRNA） 自免TCE、RNAi 低/零敞口 强生、礼来（仅平台级）、GSK（打包型）、日企多数、灵北/BioMarin/Incyte等 肿瘤以外的差异化资产有机会破冰启示 1、退出窗口 MNC弹药处于历史高位（仅前四家就超1,200亿美元）+ LOE刚性驱动 = 2027-2030年是Biotech被并购的黄金窗口，fast-follow优质资产也能卖出高价（三生SSGJ-707首付12.5亿美元纪录）。 2、资产定价锚 平台型（多资产杠杆）> 单品；III期数据前是估值跳升点；CVR结构下"首付/总额比"是谈判核心指标。 3、赛道选择 in vivo细胞治疗、AOC、非致幻神经塑性、口服小分子GLP-1、CLDN18.2/PSMA×CD3等TCE靶点是中国Biotech当前最顺的出海通道。 4、风险信号 RNA赛道关键读出错配（Ionis pelacarsen III期失败）、mRNA"冷"瘤种受挫（BNT122 CRC终止）——平台叙事需要适应症匹配验证，不能只看技术故事。