A Multicenter, International, Prospective, Non-interventional, Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting

An international, multicenter, non-interventional, prospective, post-authorization, descriptive, non-PASS, study.

开始日期2023-02-16

申办/合作机构

Sandoz Group AG

JPRN-jRCT1031210582

/ Not yet recruitingN/A

Effectiveness and Safety of Adalimumab Biosimilar FKB327 with Ulcerative Colitis, Crohn's Disease, and Psoriatic Arthritis (FKB327 Registry Study)

开始日期2021-11-01

申办/合作机构

Sandoz KK

[+1]

NCT03906136

/ Completed临床3期

A Randomized, Open Label Multicenter Trial to Investigate the Efficacy of a Treat-to-target (T2T) Treatment Strategy With Secukinumab (AIN457) as a First-line Biologic Compared to a Standard-of-care (SOC) Treatment Over 36 Weeks in Patients With Active Axial Spondyloarthritis (axSpA)

This was a randomized, parallel-group, open-label, multicenter study in patients with active axSpA. The aim of the study was to demonstrate that the efficacy of a T2T approach (with secukinumab as a first-line biologic) was superior to a SOC approach in terms of achieving strong clinical efficacy in patients with active axSpA who were naïve to biological therapy and who had an inadequate response to prior non-steroidal anti-inflammatory drug (NSAID) treatment.

开始日期2019-06-04

申办/合作机构

Novartis Pharmaceuticals Corp.

100 项与阿达木单抗生物类似药(Sandoz) 相关的临床结果

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100 项与阿达木单抗生物类似药(Sandoz) 相关的转化医学

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100 项与阿达木单抗生物类似药(Sandoz) 相关的专利（医药）

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项与阿达木单抗生物类似药(Sandoz) 相关的文献（医药）

2026-09-02·EXPERT OPINION ON BIOLOGICAL THERAPY

Comparable long-term outcomes with biosimilar and originator adalimumab in juvenile idiopathic arthritis: a multicenter cohort study

Article

作者: Doğru Kılınç, Ayşenur ; Başer Taşkın, Büşra ; Çinpolat, Büşra ; Aktay Ayaz, Nuray ; Çakmak, Figen ; Akgün, Özlem ; Demirkan, Fatma Gül ; Çakan, Mustafa ; Tanatar, Ayşe

BACKGROUND:

Real-world evidence on biosimilar adalimumab in juvenile idiopathic arthritis (JIA) remains limited. We compared the effectiveness, treatment persistence, and safety of biosimilar and originator adalimumab.

METHODS:

This multicenter retrospective cohort study included children with JIA treated with biosimilar or originator adalimumab for ≥24 weeks. Disease activity was assessed using the Juvenile Arthritis Disease Activity Score-27 (JADAS-27) and, in enthesitis-related arthritis (ERA), the Juvenile Spondyloarthritis Disease Activity Index (JSpADA). Treatment persistence and adverse events were compared.

RESULTS:

129 patients were analyzed (originator product [OP], n = 86; biosimilar product [BP], n = 43; ABP 501, n = 39; GP2017, n = 4). Prior biologic exposure was higher in OP (p = 0.007), and time to adalimumab initiation was longer in OP (p = 0.015). JADAS-27 scores were higher in BP at treatment initiation (T0) and month 3 (T3) (p = 0.029 and p = 0.027) but not thereafter. JSpADA scores were similar overall. Treatment persistence was similar between groups (p = 0.080). Remission ≥6 months was more frequent in OP (p = 0.039), whereas drug-free remission and adverse event rates were similar.

CONCLUSIONS:

Biosimilar adalimumab demonstrated comparable long-term outcomes to the originator, although baseline differences between groups should be considered.

2026-08-28·MEDICINE

Early real-world utilization of ADA-adaz (Hyrimoz) in the United States

Article

作者: Li, Edward ; Bungay, Rebecca ; Gagnon-Sanschagrin, Patrick ; Chen, Anna ; Gobeil, Nathan ; Guerin, Annie ; Bedard, Jerome

Adalimumab (ADA)-adaz (Hyrimoz®; Sandoz, Inc.) became available in the United States (US) in July 2023. This study assessed real-world ADA-adaz adoption experience by describing characteristics and treatment history of patients initiating ADA-adaz in the months following its US availability and preliminarily assessing persistence and adherence to ADA-adaz. A retrospective cohort study using open and closed claims from Komodo Research Data (01/2016-05/2024) was conducted. The index date was the first ADA-adaz prescription after July 2023. For the demographics and clinical assessment subgroup, ≥12 months of continuous data availability pre-index (baseline period) was required. For the persistence and adherence assessment subgroup, ≥3 months of continuous health plan enrollment post-index (study period) was required. Persistence was measured as time from index to the earlier of switch or discontinuation (45-day gap). Adherence was measured as the proportion of days covered (PDC) while on ADA-adaz. A total of 23,737 patients with an ADA-adaz prescription after July 2023 were included. For patients in the demographics and clinical assessment subgroup, the median age was 49.0 years, 59.4% were female, and 91.0% had commercial insurance. Patients received ADA-adaz mostly for rheumatoid arthritis (33.0%) and Crohn disease (23.2%). Common baseline comorbidities included hyperlipidemia (29.2%), hypertension (29.0%), anxiety (22.8%), and osteoarthritis (21.4%). During baseline, 93.2% of patients received a biologic; 98.2% received the reference ADA, and 83.0% were treated with biologics for at least 6 to 12 months. Other baseline treatments included systemic corticosteroids (52.3%), non-steroidal anti-inflammatory drugs (35.4%), and disease-modifying antirheumatic drugs (34.6%). Of the 1108 (4.7%) patients in the persistence and adherence assessment subgroup, persistence at 3 months was 65.7%, and average PDC was 93.9% while on ADA-adaz. These findings should be interpreted with caution due to limited follow-up availability. In summary, patients who initiated ADA-adaz in the months following its US availability were predominantly commercially insured. The high rate of prior ADA use highlighted a transition to biosimilars in biologic-experienced patients. The end of ADA-adaz persistence was largely driven by switching to other ADA treatments. Among patients with available short-term follow-up, adherence while on ADA-adaz was high. Further studies with longer follow-up can assess ADA-adaz utilization patterns and long-term outcomes.

2026-04-01·SAUDI PHARMACEUTICAL JOURNAL

Comparing the pharmacokinetics of adalimumab originator and biosimilar product in patients with Inflammatory bowel disease or autoimmune disease

Article

作者: Alkofide, Hadeel ; Emsaad, Shaimaa Abdulhadi ; Alruthia, Yazeed ; Albassam, Ahmed ; Assiri, Abdulmohsen ; Alqassim, Hussain Abdalghani ; Alsultan, Abdullah ; Alotaibi, Amal ; Almutairi, Fares ; Drweesh, Hadeel ; Higazy, Alya Salah ; Alturaiki, Abdulrahman ; Alhussain, Abdulsattar ; Saad, Mohamed Omar ; Eid, Mohammed Mustafa

Adalimumab is a monoclonal antibody approved for managing inflammatory bowel disease (IBD) and other autoimmune conditions. Biosimilars can offer a more affordable alternative to reference biologics and improve access to treatments. Despite their advantages, there are still concerns regarding physicians' adoption of biosimilar products. This study aimed to compare the clearance of originator adalimumab with its biosimilar products in patients with inflammatory bowel disease and other autoimmune diseases. This multicenter retrospective study was conducted across seven hospitals in Saudi Arabia and Qatar. The study population included adult patients who received adalimumab and underwent routine therapeutic drug monitoring. Population pharmacokinetic analysis was performed using Monolix software, and the empirical Bayesian estimate of clearance was determined for individual patients. Stepwise linear regression was then conducted to assess the effects of product type and other covariates on adalimumab clearance. This study included a total of 99 patients. Patients received various adalimumab products, including the reference biologic (Humira, 70.7%) and biosimilars (Amgevita, 16.2%; Hyrimoz, 13.1%). The average estimated clearance was 0.018 ± 0.012 L/hr. The only significant covariates in the multivariable regression were age and the presence/absence of antibodies. There was no significant difference in clearance between the originator and biosimilar products. Our study compared the clearance of adalimumab originator and its biosimilars in patients with inflammatory bowel disease and other autoimmune disorders. No significant differences in clearance were observed, suggesting comparable clearance. The adoption of biosimilars in clinical practice could improve patient access to biologic therapies while substantially reducing healthcare costs.

133

项与阿达木单抗生物类似药(Sandoz) 相关的新闻（医药）

2026-09-10

·微信

褪去诺华标签：Sandoz改写生物类似药竞争格局，交出成绩单

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。作为全球可负担药物领域的龙头企业，独立运营后的Sandoz（山德士）确立以生物类似药biosimilar为核心增长引擎、仿制药作为基本盘的发展战略。伴随大批重磅原研生物药陆续专利到期，公司迎来生物类似药“黄金十年”机遇期。 2026年9月8日，Sandoz 在伦敦资本市场日推出 Bio100 战略，计划到 2040 年将生物类似药组合从目前的 13 个扩展至 100+ 个，并宣布在斯洛文尼亚投资 3 亿美元建设新制造设施。生物类似药成为核心增长动力 2026上半年，Sandoz全球净销售额达58亿美元，同比增长5%。其中生物类似药板块实现20%的高速增长，营收占比创下33%的历史新高，第二季度生物类似药增速进一步提升至22%；仿制药业务占总销售额67%，上半年同比下降1%，但第二季度重回1%正增长，展现韧性。分区域看，北美市场表现最为亮眼，整体增长15%，生物类似药板块暴涨47%，主要来自地舒单抗类似药两款新品Wyost、Jubbonti的上市拉动，Sandoz也借此跃居北美仿制药与生物类似药综合市场第二位。欧洲市场营收同比增长3%，国际市场增长1%，各区域生物类似药全部实现双位数增长。盈利层面，公司核心EBITDA达到12.06亿美元，核心EBITDA利润率提升至20.9%，同比提升90个基点，受益于生物类似药占比提升带来的产品结构优化、成本管控以及运营效率改善。管理自由现金流维持5.03亿美元，保持稳健现金生成能力。公司确认2026全年指引，净销售额实现中高个位数增长，核心EBITDA利润率继续扩大约100个基点。依托强大的商业化落地能力，Sandoz多款新上市生物类似药快速抢占市场，成为业绩增长支柱。Wyost与Jubbonti（denosumab-bbdz）两款产品2025年6月在美国上市，2026年第一季度，Jubbonti在同品类生物类似药市场份额达64%，Wyost达54%；上市首日覆盖欧洲27国，同时在巴西、澳大利亚快速铺开，是北美市场增长的最大驱动力。 Afqlir（aflibercept）眼科生物类似药已进入19个欧洲国家，当前市场竞争较少，计划2026年第四季度登陆美国市场，打开眼科生物药增量空间。阿达木单抗生物类似药Hyrimoz在美国实现广泛支付方覆盖；乌司奴单抗生物类似药Pyzchiva成为欧洲市场头部品种，在欧洲主要国家市场份额达35%；那他珠单抗生物类似药Tyruko在欧洲市场份额稳定17%；诞生20周年的全球首款生物类似药Omnitrope（somatropin）依旧保持37%全球市场占有率，持续稳固赛道龙头地位；仿制药业务同样持续输出新品，近期在欧美推出尼达尼布、达格列净、西格列汀及复方制剂，整体仿制药管线储备超300个项目，对标原研销售规模约2500亿美元，按销售额覆盖率66%，筑牢基本业务底盘。 36个生物类似药覆盖全治疗周期 2026上半年，Sandoz新增4个自研生物类似药管线sotatercept、polatuzumab vedotin、burosumab、anifrolumab，叠加与三星生物合作最多5个项目，生物类似药管线扩充至36个，覆盖肿瘤、自身免疫、眼科、内分泌、呼吸、血液等多个高价值赛道，覆盖待上市申报、临床开发、技术开发、早期研发完整周期。待上市/审评阶段有曲妥珠单抗生物类似药Herwenda、贝伐珠单抗生物类似药Avzivi，以及甘精、门冬、赖脯三款胰岛素生物类似药。多款胰岛素已经获得欧盟批准，部分品种向美国提交上市申请，夯实糖尿病内分泌板块实力；临床开发阶段包含帕博利珠单抗、纳武利尤单抗、阿替利珠单抗生物类似药等多款肿瘤免疫重磅靶点，布局肿瘤免疫药物专利到期窗口；技术与早期开发阶段布局度伐利尤单抗、dupi单抗、risankizumab、faricimab生物类似药等下一代明星生物制剂，提前锁定未来数年专利到期机会。管线快速推进的背后是制造与研发体系的重投入。2026年6月，Sandoz投资9900万美元的卢布尔雅那生物类似药研发中心在斯洛文尼亚正式启用。该基地面积约10000平方米，拥有200余名科研人员，实现全数字化集成，打通从早期分子开发、工艺开发到技术转移的全链条。该中心与当地原料药生产基地、灌装基地，以及德国、英国实验室联动，构建欧洲完整生物类似药产业集群，加快候选药物从研发走向商业化的转化效率，支撑36条生物类似药管线向前推进。此外，今年还与中国药企复星医药旗下的复宏汉霖达成多项新药研发BD和委托开发合作服务。战略新赛道突破：GLP‑1实现从0到1的重要卡位 GLP‑1是全球医药市场高景气赛道，Sandoz完成该赛道关键监管里程碑，正式切入代谢减重降糖领域。 2026年7月底，Owozy（司美格鲁肽）在巴西获批，这是Sandoz第一款获批的GLP‑1产品，计划2026下半年在巴西商业化，与Adalvo合作负责当地市场运营，切入巴西庞大的糖尿病与肥胖市场；2026年6月，FDA受理Sandoz两款替尔泊肽自动注射器仿制药ANDA申请，覆盖2型糖尿病、肥胖等核心适应症，为美国市场申报铺路。未来，Sandoz一方面将推动Afqlir美国上市、多款胰岛素生物类似药在欧美落地、GLP‑1品种逐步在多国推进；另一方面，大量处于临床、技术开发阶段的肿瘤免疫、自身免疫类生物类似药，将陆续进入申报周期。依托丰富多层次管线、垂直整合的研发制造体系以及全球化商业化网络，Sandoz持续面向全球患者提供高可负担的生物药，把握全球生物药专利到期浪潮带来的重大发展机遇。参考：NMPA/CDE； FDA/EMA/PMDA；相关公司公开披露（除标注外，正文图片均来自企业官网）； https://www.sandoz.com/investors/； https://www.sandoz.com/media/news/； https://mp.weixin.qq.com/s/lXvN28O-eh0o8BtyLA3TlA；等。

2026-09-09

·Pharmaceutical Technology

“Unparalleled opportunity”: Sandoz embarks on ambitious biosimilar growth strategy

While drugmakers are scrambling to renew pipelines amid a vast patent cliff, Sandoz is strategically gearing up for a period of intense growth. Credit: RobertBarrie/GlobalData.com. This year, Sandoz celebrated the 20th anniversary of its – and the world’s – first marketed biosimilar. But instead of focusing on the past, the company has its eye on the future where it plans to extend its dominant position in the off-patent landscape. Harnessing what it calls a ‘golden decade’ for biosimilars, Sandoz has outlined an ambitious growth strategy that could see the manufacturer harbour more than 100 of the compounds in its portfolio by 2040. Announcing the news at its Capital Markets Day on 8 September, Sandoz said the targets – part of a roadmap dubbed Bio100 – would help it become the undisputed leader in the biosimilar industry within the decade. In a media briefing ahead of the event, CEO Richard Saynor said: “We’re launching Bio100 now because the window of opportunity is wide open. We believe it is our responsibility to capitalise on that opportunity.” Currently, Sandoz relies primarily on generics for its revenue, with the 13 biosimilars in its portfolio dwarfed by the number of generics. That could soon change. By 2040, the company wants to have more than 100 biosimilars in its portfolio – a number that would firmly place it as market leader with room to spare. Alongside this, Sandoz plans to more than double net sales over the next 10 years. Speaking to Pharmaceutical Technology , chief commercial officer Rebecca Guntern said: “There’s an unparalleled opportunity in terms of loss of exclusivity (LOE) value and number of assets. Compared to the last 10 years, it’s now triple the value, and if you look at 15 years ahead, it’s an even bigger LOE opportunity, and that’s why we believe we now have a huge opportunity for Sandoz to make a play in this market.” Rebecca Guntern has served as chief commercial officer for Sandoz since late 2024. Credit: Sandoz. The size of opportunity arises from pharma’s ongoing patent cliff , one of the largest ever to hit the industry. While drugmakers are scrambling to renew pipelines with fresh assets, Sandoz is strategically gearing up in the wings with a steady stream of generics and biosimilars referencing originator drugs going off patent – many of which have blockbuster status. For example, Sandoz already markets Hyrimoz, a biosimilar referencing AbbVie’s Humira (adalimumab) that at its peak brought in over $21bn in sales. The LOE window is only going to grow bigger courtesy of the patent cliff, and Sandoz wants prime position – from 2035 onwards, the company wants to cover 80% of LOE value. That would mark a sizeable chunk, given there is over $300bn in originator sales not currently targeted by the company, according to its analysis. A major growth driver for Sandoz will be glucagon-like peptide-1 receptor agonists (GLP-1RAs), a modality that has burgeoned in market value. Eli Lilly, which leads the branded market, netted $23bn in Q2 revenue this year, up 48% from the same period in 2025. Semaglutide, known under Novo Nordisk’s brand name Wegovy, is one of the assets that Sandoz has already begun launching in certain territories. There are, however, plenty of other modalities that Sandoz is harnessing. “We’re not stopping just with the standard biosimilars. Monoclonal antibodies (mABs) will obviously be a big part in our Bio100 strategy simply because the LOE landscape is driven by them. Antibody drug conjugates (ADCs) are an attractive opportunity because of LOE value and their impressive growth trajectory. Despite their complexity, we believe we have the capabilities to develop ADCs, bispecifics, and other proteins. We see the opportunity in these adjacent technologies, and we’re going to also bring those to the market,” Guntern commented. Sandoz is ensuring it is ready to meet those demands. While most will be developed in-house, some will be borne from partnerships. For example, last month the company signed a $322m deal with China-based Henlius that will see the two collaborate on up to 10 biosimilars. Also announced at its Capital Markets Day was a $300m investment into a new drug substance facility in Ljubljana, Slovenia. The new facility, expected to become operational in 2029, will add disposable fed-batch technology to the company’s capabilities, and be tasked with strengthening in-house biosimilar manufacturing and supply across Europe. The investment adds to Sandoz’s already global presence, with development and manufacturing facilities in Germany, France, and the UK, along with an existing network in Slovenia. At the media event, Saynor concluded by saying: “This is not just a network of individual sites and technologies; it is a fully coordinated end-to-end ecosystem that, for us, is the ideal platform to deliver Bio100. In case I wasn’t already very clear, Bio100 is not just an ambition; it is a clear strategic grower.”

2026-08-19

·星际微光

Sandoz与复宏汉霖达成最高3.22亿美元合作，复宏汉霖把8.4万升产能做成“全球货架”

Sandoz与复宏汉霖达成最高3.22亿美元战略合作，最多覆盖10款生物类似药。首批包括西妥昔单抗、依洛尤单抗和贝利尤单抗生物类似药，并附带重组人透明质酸酶项目选择权；复宏汉霖负责研发、生产和供应，Sandoz主要负责中国以外市场的注册与商业化。 2026年复宏汉霖预计相关开票金额最高1.005亿美元。首批三款原研药均拥有较大市场，其中Repatha仍高速增长。交易使Sandoz生物类似药管线增至39项，也体现复宏汉霖研发、生产平台进一步获得国际头部仿制药企业认可。不过多数项目仍处早期阶段，专利期限、研发成功率及未来生物类似药价格竞争仍是主要风险。有问题，问星光智能体！人类基地：数据中心爆火之后：谁在为AI的算力狂飙买单？投资亮点这笔交易对复宏汉霖的直接财务与估值意义更大，而对Sandoz更多属于中长期战略补强。核心亮点是它验证了复宏汉霖正在从单个产品License-out，升级为向跨国药企输出一整套“研发+生产+供应”的生物类似药平台。 1．交易金额具有一定财务实质性，但不能把3.22亿美元全部计入价值。 3.22亿美元由首付款、选择权费用和里程碑款构成，很多付款取决于后续资产进入合作及研发进展；真正近期确定性较高的是2026年最高1.005亿美元开票额。复宏汉霖2025年收入66.67亿元、净利润8.27亿元。若仅为量级比较，假设美元兑人民币7.1，则1.005亿美元约7.1亿元，相当于2025年收入约11%。因此即便不考虑远期里程碑，这笔合作对当期收入结构也可能具有可见影响。但“开票”不等同于全部当期利润确认，最终会计确认仍要看合同履约节点。 2．真正大的价值在于标的药物池非常优质。根据复宏汉霖引用的数据，2025年全球西妥昔单抗、依洛尤单抗和贝利尤单抗市场规模分别约16.96亿、66.02亿和24.75亿美元，合计约107.7亿美元。这里不能简单理解为Sandoz未来可以分享107亿美元，因为中国市场被排除、原研专利尚未全部到期，而且生物类似药上市后通常会引起显著降价。但它至少说明首批三个项目不是“小品种”，而是建立在成熟且规模巨大的治疗市场之上。其中Repatha可能是最值得关注的资产。安进2026年第二季度Repatha销售同比增长37%至9.53亿美元，说明PCSK9降脂市场仍在扩容。对生物类似药而言，一个非常好的进入对象通常不是已经快速萎缩的老药，而是专利到期时仍拥有巨大且增长中的患者市场，因此Repatha的长期商业潜力尤其突出。 3．西妥昔单抗可能构成一个“竞争结构异常”的机会。 Erbitux专利到期已久，却没有形成类似阿达木单抗、曲妥珠单抗那样的大量生物类似药竞争。其复杂结构一方面提高技术开发难度，另一方面也形成进入壁垒。复宏汉霖HLX05-N已经在2026年7月进入Ⅰ期临床。如果公司能够率先解决可比性和监管问题，竞争格局可能比普通成熟生物类似药更好。当然，这也是“双刃剑”：没有竞争者可能意味着机会，也可能意味着产品开发本身确实困难。 4．Sandoz的加入显著降低了商业化风险。复宏汉霖擅长抗体开发、工艺和大规模生产，但在美国、欧洲、日本等市场自行搭建完整销售网络成本巨大。Sandoz拥有约1,300种药物、覆盖100多个国家，并已拥有成熟的全球市场准入体系。因此这一合作本质上是“复宏汉霖做自己擅长的研发制造，Sandoz解决国际注册、准入和销售”。与复宏汉霖自己重资产出海相比，这种模式资本效率明显更高。 5．这不是一次偶然交易，而是Sandoz对复宏汉霖平台能力的二次投票。双方2025年已经合作HLX13伊匹木单抗生物类似药，覆盖欧美等46个国家和地区；一年后进一步扩展到最多10款产品，说明合作关系从单品种升级为平台级合作。对复宏汉霖估值而言，这一点可能比单笔首付款更加重要：如果未来BD模式可以重复，公司就不再只是依赖国内药品销售，而可能形成“产品销售+国际License-out+全球CDMO式供应”的多元现金流。 6．rHuPH20是一个容易被低估的期权。透明质酸酶能够帮助大分子药物由静脉输注转向快速皮下注射。如果复宏汉霖这一平台最终证明具有良好的技术、知识产权和监管可行性，其价值可能并不局限于一个产品，而可能与多款抗体进行组合。不过目前项目仍很早期，不能直接给予类似成熟皮下给药平台的估值，这是明显的长期期权，而非当前核心价值。 7．最大的风险是时间和竞争。 HLX16和贝利尤单抗类似药目前都还处于临床前/早期阶段，距离全球上市很远。生物类似药竞争最终比拼的并不仅是“能不能做出来”，还包括能否赶上第一梯队、生产成本、专利挑战、FDA/EMA可比性要求，以及上市后的价格折扣。如果多个竞争者同时进入，即使原研药销售几十亿美元，最终单个类似药的销售额也可能明显低于市场直觉。 ~ 投资结论 ~ Bull case：复宏汉霖通过Sandoz把自身成熟的抗体研发和8.4万升生产平台变成全球化资产，未来持续复制多产品License-out；Repatha等大型品种成功进入首批梯队，使国际收入和利润快速提升。Sandoz则提前锁定下一轮生物药专利悬崖的优质资产。 Bear case：3.22亿美元大量属于远期或有付款，多数项目仍处早期；专利窗口较远、竞争对手可能增加，最终市场价格下降幅度超过预期，导致Headline TAM无法转化为实际利润。最值得跟踪的三个指标：未来12—24个月新增哪些资产进入这10个项目框架；HLX05-N临床和欧美注册路径能否顺利推进；以及复宏汉霖来自海外授权和商业供应的收入占比能否持续提升。若这三项同时兑现，这笔交易的意义就可能从“一笔不错的BD”升级为复宏汉霖全球化平台价值被持续验证的重要拐点。以上内容属于事件研究与风险分析，不构成针对任何证券的个人投资建议。复宏汉霖的价值分析公司的核心竞争力已经从早期“生物类似药研发能力”升级为“生物类似药现金流+创新药研发+全球注册生产+海外授权”的一体化生物药平台。 1.产品优势成熟产品提供现金流，创新管线提供弹性。公司目前已有10款产品在全球获批，覆盖肿瘤、自身免疫、骨健康等领域。核心产品汉曲优（曲妥珠单抗）已进入50多个市场，2025年销售约29.6亿元；PD-1斯鲁利单抗销售约14.9亿元，并成为全球首个获批一线治疗小细胞肺癌的PD-1抗体。产品组合兼具成熟生物类似药和创新药，降低单一产品风险。 2.技术优势从单抗向ADC、双抗/TCE及小分子扩展。公司拥有50多个早期创新项目，并建立免疫检查点、多特异性T细胞连接器、ADC及AI辅助早期发现等平台。其自研Hanjugator™ ADC平台采用高亲水性喜树碱类linker-payload，可调节毒素强度、兼容不同抗体，并布局PD-L1 ADC HLX43、c-MET×EGFR双抗ADC等产品。技术路线具有差异化潜力，但目前不少数据仍停留在临床早期或临床前，真正的BIC价值仍需人体数据验证。 3.平台与生产优势具备完整“研发—临床—注册—生产—销售”闭环。公司拥有3个生产基地、总产能8.4万升，质量体系接受过中国、欧盟和美国监管机构检查并取得相关GMP认证；同时拥有全球临床和注册能力。这意味着复宏汉霖不仅能够发现药物，也能够把资产推进到全球商业化阶段。 4.服务及商业模式优势国内直营、海外合作，资本效率较高。国内拥有超过1500人的商业化团队，覆盖市场准入、渠道、定价和销售；海外则通过Organon、Sandoz等合作伙伴进行授权、注册和销售，同时由复宏汉霖承担部分研发和生产供应。因此收入来源可形成“产品销售+License-out首付款/里程碑+销售分成/特许权使用费+长期供货”的组合。 5.医疗价值核心逻辑是“降低成熟生物药成本，同时解决尚未满足的临床需求”。生物类似药提高曲妥珠单抗、利妥昔单抗、地舒单抗等成熟疗法的可及性，而斯鲁利单抗、HLX22、HLX43等创新项目则尝试改善肺癌、胃癌、乳腺癌等疾病治疗效果。目前公司产品已惠及全球超过100万患者。 6.未来前景最大的重估机会来自“全球化+创新兑现”。公司提出2030年前全球上市20款以上产品的目标，并计划利用生物类似药稳定现金流反哺ADC、双抗和TCE创新。对投资者而言，真正需要观察的不是管线数量，而是海外收入占比能否持续提升、HLX22/HLX43等创新药能否形成强临床数据、License-out能否持续复制，以及创新研发投入能否最终转化为高利润产品。如果这几项兑现，复宏汉霖有机会从“中国生物类似药龙头”逐步转向具有全球竞争力的综合性Biopharma；反之，若创新药临床失败或海外商业化低于预期，其估值仍可能主要由成熟生物类似药业务决定。欲深入了解更多行业洞察，请扫以下二维码加入社群：公司已完成项目星际微光已完成的项目（截至2023.9，仍在继续......）圆满中秋 | 星际微光七年完成100个咨询项目咨询、调研、PR、投资、融资、营销、技术转化项目需求请扫码联系我们：点击“阅读原文”，看看：AI巨头为什么急招哲学家？

生物类似药专利到期财报

100 项与阿达木单抗生物类似药(Sandoz) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB04	DB00051

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
中间葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2022-02-16
后葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2022-02-16
白塞氏葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
全葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
脓疱型银屑病	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
关节炎	澳大利亚	Sandoz Pty Ltd.	2019-03-01
多关节型幼年特发性关节炎	澳大利亚	Sandoz Pty Ltd.	2019-03-01
强直性脊柱炎	欧盟	Sandoz GmbH	2018-07-26
强直性脊柱炎	冰岛	Sandoz GmbH	2018-07-26
强直性脊柱炎	列支敦士登	Sandoz GmbH	2018-07-26
强直性脊柱炎	挪威	Sandoz GmbH	2018-07-26
银屑病关节炎	欧盟	Sandoz GmbH	2018-07-26
银屑病关节炎	冰岛	Sandoz GmbH	2018-07-26
银屑病关节炎	列支敦士登	Sandoz GmbH	2018-07-26
银屑病关节炎	挪威	Sandoz GmbH	2018-07-26
中轴性脊柱关节炎	欧盟	Sandoz GmbH	2018-07-26
中轴性脊柱关节炎	冰岛	Sandoz GmbH	2018-07-26
中轴性脊柱关节炎	列支敦士登	Sandoz GmbH	2018-07-26
中轴性脊柱关节炎	挪威	Sandoz GmbH	2018-07-26
溃疡性结肠炎	欧盟	Sandoz GmbH	2018-07-26

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ARVO2026	N/A	非感染性前葡萄膜炎	24	Infliximab-dyyb	憲壓製鑰艱憲鏇齋鏇鏇(醖範憲艱簾淵顧齋鏇襯) = 觸糧製夢襯蓋齋衊壓鑰蓋鹹獵糧衊鬱夢鹹壓憲 (簾願築構築繭醖壓積獵 )	积极	2026-05-03
				Infliximab-dyyb	憲壓製鑰艱憲鏇齋鏇鏇(醖範憲艱簾淵顧齋鏇襯) = 壓網齋衊膚鏇糧淵製繭蓋鹹獵糧衊鬱夢鹹壓憲 (簾願築構築繭醖壓積獵 )
FLYWAY STUDY (EULAR2024)	N/A	银屑病关节炎	-	Secukinumab	鑰憲遞鑰餘淵襯衊膚鏇(廠齋醖鏇糧顧願鑰積醖) = 憲憲齋艱齋製醖獵鹹廠糧鹹構糧襯蓋鏇鹽願獵 (積蓋蓋鏇顧製鑰鹹觸鏇 ) 更多	积极	2024-06-05
				Adalimumab	鹹夢鬱鬱艱糧簾齋製製(憲願網構憲網齋醖獵製) = 構鬱積糧夢獵衊獵餘觸構襯積膚窪衊膚衊衊襯 (夢淵糧築願選積簾夢廠 ) 更多
NCT03259074 (SURPASS, EULAR2024)	临床3期	中轴性脊柱关节炎	288	Secukinumab 150 mg	鹽壓膚夢鑰鏇淵艱窪膚(鏇膚選壓糧膚憲鹹繭壓) = 鑰衊製廠鑰蓋憲夢窪願觸壓膚衊餘醖遞鹽簾鬱 (鑰遞鹽繭艱繭夢繭鬱襯 )	积极	2024-06-05
				Secukinumab 300 mg	鹽壓膚夢鑰鏇淵艱窪膚(鏇膚選壓糧膚憲鹹繭壓) = 艱膚憲襯窪壓膚廠襯願觸壓膚衊餘醖遞鹽簾鬱 (鑰遞鹽繭艱繭夢繭鬱襯 )
ACR2021	N/A	银屑病 \| 银屑病关节炎 \| 类风湿关节炎	-	SDZ-ADL (GP2017)	廠鹹夢獵艱膚簾衊蓋選(築築衊繭淵餘膚廠鏇壓) = At 1-hour post-dose, 96.6% of HV experienced no pain (VAS score, 0-4 mm) 鏇鏇艱鑰蓋鬱積醖製夢 (艱憲選範簾醖遞鬱鹽醖 )	积极	2021-11-07
NCT02744755 (ADMYRA, Pubmed \| BioDrugs) 人工标引	临床3期	类风湿关节炎	353	Adalimumab-ADAZ	壓鏇壓觸窪製醖積鹽構(衊窪鹽簾壓艱鬱窪選蓋) = 觸網製醖膚構淵憲窪觸襯壓繭蓋壓製觸壓鹹餘 (壓製鏇願餘餘鹽壓製網 ) 更多	相似	2020-12-01
				adalimumab	壓鏇壓觸窪製醖積鹽構(衊窪鹽簾壓艱鬱窪選蓋) = 鏇醖選憲糧窪鏇鬱餘鹹襯壓繭蓋壓製觸壓鹹餘 (壓製鏇願餘餘鹽壓製網 ) 更多
NCT02016105 (Pubmed \| Br J Dermatol) 人工标引	临床3期	银屑病	465	GP2017	糧築鏇積齋窪廠鹽觸齋(壓衊鏇衊膚製遞構窪鑰) = 鏇淵膚網觸構遞窪廠衊膚鏇窪網壓願窪艱選蓋 (壓製鑰膚網艱鑰觸壓鑰 ) 更多	相似	2018-09-01
				ref-ADMB	糧築鏇積齋窪廠鹽觸齋(壓衊鏇衊膚製遞構窪鑰) = 鏇鏇齋構醖顧鬱糧願衊膚鏇窪網壓願窪艱選蓋 (壓製鑰膚網艱鑰觸壓鑰 ) 更多
UEGW2017	N/A	-	-	GP2017	餘簾蓋製壓簾淵積鬱鹹(餘獵醖鹽窪鹹網鏇願廠) = There were no clinically relevant differences between the continual GP2017/reference adalimumab groups in the frequency of adverse events (AEs) (61.3%/64.9%), treatment-related AEs (17.9%/18.7%), serious AEs (3.0%/8.8%), or AEs leading to discontinuation of study drug (4.8%/7.0%). Infections/infestations were the most commonly reported AEs, with nasopharyngitis most frequently reported by 8.9%/10.5% of patients treated with continual GP2017/reference adalimumab. 鹹鏇鏇憲壓壓鹹網鑰餘 (遞鹹齋蓋繭鹽製壓鬱顧 )	-	2017-10-01
				Reference Adalimumab
EULAR2017	临床3期	银屑病 \| 银屑病关节炎	545	CHS-1420	餘夢網膚蓋獵夢壓構餘(壓糧糧壓繭鑰願糧鹹夢) = 觸顧選壓簾膚遞鹹蓋範膚鹹鏇淵築憲網蓋繭糧 (構淵遞鬱積範壓選鏇積 ) 更多	积极	2017-06-14
				Adalimumab	餘夢網膚蓋獵夢壓構餘(壓糧糧壓繭鑰願糧鹹夢) = 蓋選糧夢鹽膚糧獵鹽遞膚鹹鏇淵築憲網蓋繭糧 (構淵遞鬱積範壓選鏇積 ) 更多
NCT02016105 (ADACCESS, CTgov)	临床3期	斑块状银屑病	465	GP2017 Adalimumab (GP2017 Adalimumab)	觸蓋鹹範繭壓鬱壓製窪 = 糧構顧壓繭獵築齋齋繭鹹構顧構製蓋鑰簾窪繭 (鬱齋獵膚鬱艱鏇衊鏇憲, 繭簾夢製鹽膚遞鬱壓膚 ~ 淵衊構繭壓醖廠構蓋餘) 更多	-	2017-04-07
				Humira ® Adalimumab (Humira ® Adalimumab)	觸蓋鹹範繭壓鬱壓製窪 = 範鹽餘遞願鑰夢艱壓築鹹構顧構製蓋鑰簾窪繭 (鬱齋獵膚鬱艱鏇衊鏇憲, 蓋鹽積襯齋蓋願膚願遞 ~ 鑰蓋壓顧膚遞糧衊簾壓) 更多