A Phase 3, Randomised, Double-blind Study to Compare the Efficacy, Safety, PK and Immunogenicity Between SB8 (Proposed Bevacizumab Biosimilar) and Avastin® in Subjects With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer

This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

开始日期2016-07-05

申办/合作机构

Samsung Bioepis Co., Ltd.

NCT02453672

/ Completed临床1期

A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) in Healthy Male Subjects

Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab

开始日期2015-04-01

申办/合作机构

Samsung Bioepis Co., Ltd.

100 项与贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的临床结果

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100 项与贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的转化医学

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项与贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的文献（医药）

2026-08-01·AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

Critical illness outcomes of hospitalized pregnant women following a Texas abortion ban

Article

作者: Cao, Jing ; Callison, Kevin ; Chen, Catherine ; Ashana, Deepshikha C ; Yuan, Li ; Baker, Courtney ; Gershengorn, Hayley B ; Burns, Ralph Nicholas

Abstract:

Importance:

In September 2021, Texas Senate Bill 8 (SB8) banned abortion after embryonic cardiac activity.

Objective:

To estimate the association of SB8 with critical illness rates.

Design:

Interrupted time series (ITS).

Setting:

Hospitals in Texas.

Participants:

Retrospective cohort of pregnant women between 10 and 54 years of age hospitalized between January 2018 and March 2024. A subgroup of patients with high-risk features, defined as age <18 or >34 years or ≥ 1 chronic illness.

Measurements:

The primary outcome was critical illness, defined as sepsis or mechanical ventilation (MV). Secondary outcomes included sepsis, MV, and infection without organ dysfunction. ITS results are reported as the immediate step change and the sustained slope change (ie, difference in trend line slopes following vs without SB8).

Results:

In the full cohort (n = 2 344 135), SB8 was not associated with rates of critical illness, sepsis, MV, or infection in adjusted analyses. Following SB8, significantly more hospitalized pregnant patients had high-risk features (slope change per quarter per 1000 hospitalizations: 0.92 [0.08, 1.77]). In the high-risk subgroup (n = 497 144), SB8 was significantly associated with sustained increases in critical illness, sepsis, and infection (slope changes per quarter per 1000 hospitalizations: 0.17 [0.02, 0.33], 0.15 [0.02, 0.28], 1.60 [1.02, 2.17], respectively), but not MV (slope change per quarter per 1000 hospitalizations: 0.05 [−0.03, 0.13]). No significant step changes were observed.

Conclusion:

Following SB8, hospitalized pregnant women with high-risk features experienced significant increases in rates of critical illness, sepsis, and infection. These results may inform infection prevention programs and critical illness training in abortion-restrictive states.

2026-05-01·AMERICAN JOURNAL OF PERINATOLOGY

Maternal Morbidity following Periviable Prelabor Rupture of Membranes after Texas Senate Bill 8

Article

作者: Ukoh, Nancy ; Ghafir, Danna ; Blackwell, Sean C. ; Fahl, Emily ; Chen, Han-Yang ; Stafford, Irene A. ; Gutierrez, Julie

Abstract:

Standard practice prior to Texas Senate Bill 8 (SB 8) for those with periviable prelabor rupture of membranes (PROM) without contraindications to expectant management was to offer termination of pregnancy or expectant management. After SB 8 went into effect, pregnancy termination was only offered for these patients after the development of chorioamnionitis or clinically significant maternal hemorrhage. The aim of this study was to compare maternal outcomes of periviable PROM before and after SB 8 in Houston, TX.This retrospective cohort study compared outcomes of periviable PROM less than 22 weeks of gestational age before and after SB 8 at three tertiary care hospitals from January 1, 2018, to March 31, 2023. Our primary outcome was a composite of adverse maternal outcomes: Sepsis, transfusion, and intensive care unit (ICU) admission. Secondary outcomes included intraamniotic infection, postpartum hemorrhage, abruption, septic shock, hospital length of stay, time from rupture of membranes to delivery, and neonatal survival.Over the 5-year study period, 161 women met the inclusion criteria (96 pre-SB 8 vs. 65 post-SB8). Approximately half (54%) of those with periviable PROM opted for termination prior to SB8. Post-SB8, women were more likely to develop an adverse outcome (22.9 vs. 35.4%; aRR = 1.69, 95% confidence interval [CI]: 1.03–2.78), and were more likely to develop sepsis (9.4 vs. 29.2%; adjusted relative risk [aRR] = 2.97, 95% CI: 1.43–6.17). Five neonates survived to hospital discharge post-SB8, and one survived prior to SB8. Additionally, those expectantly managed post-SB8, compared with those expectantly managed pre-SB8, experienced a longer time from rupture of membranes to delivery (6.5 days post [2–14] vs. 3 days pre [1–7.5]), and a higher rate of sepsis (18 post [30.0%] vs. 6 pre [15.0%]).These results provide evidence that periviable PROM alone is a life-threatening condition with a serious risk of maternal harm. Waiting for maternal infection or hemorrhage to develop before offering pregnancy termination increases the risks of serious maternal morbidity.

2026-01-01·JOURNAL OF PEDIATRICS

Increase in Health Care Utilization of Texas Infants with Congenital Anomalies Following Senate Bill 8

Article

作者: Lee, Timothy C ; King, Alice ; Larabee, Shannon M ; Keswani, Sundeep G ; Hosek, Kathleen E ; Guerra, Mary Elizabeth ; Peiffer, Sarah E ; Cheng, Lily S

OBJECTIVE:

To evaluate the impact of Texas Senate Bill 8 (SB8), which bans early abortion, on health care utilization of infants with congenital anomalies.

STUDY DESIGN:

The Texas Inpatient Public Use Data File was queried for inpatient encounters of Texas patients <1 year old between July 1, 2020, and June 30, 2023. Encounters were grouped as pre-SB8 (July 1, 2020-June 30, 2021) and post-SB8 (July 1, 2022-June 30, 2023). Descriptive statistics and bivariate analyses were used to compare rates of congenital anomaly admissions, mortality, length of stay, and hospital charges.

RESULTS:

Among 1 149 242 infant inpatient admissions, 204 580 were for patients with congenital anomalies. Post-SB8, the proportions of anomaly admissions increased from 17.1% to 19.0% (P < .0001). Mortality and length of stay of these admissions remained similar. However, total charges for congenital anomaly admissions increased by $1.89 billion to over $8.7 billion post-SB8 (P < .0001), accounting for 56.5% of all inpatient charges despite comprising a minority of admissions.

CONCLUSIONS:

Following SB8, inpatient admissions and charges for infants with congenital anomalies increased significantly. Although these patients represent a small proportion of admissions, their care accounts for a disproportionate share of hospital costs and increased by $1.89 billion following SB8. Future studies should explore outpatient costs and long-term outcomes following abortion restrictions.

项与贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的新闻（医药）

2026-10-20

·SeekingAb

K-Bio日报 | 韩国药企每日动态 20261020

一、BD与投融资Samsung Bioepis签订巴西生物类似药长期供应合作二、临床与研发进展Voronoi授权药enozertinib披露一线肺癌早期数据ABL Bio披露givastomig联合治疗胃癌的1b期结果Hanmi披露EZH1/2抑制剂HM97662早期抗肿瘤信号Huons展示HUC1A-626抗肠纤维化临床前研究Y-Biologics拟更新两项多特异性抗体临床前结果三、业绩与商业动态Curocell的CD19 CAR-T推进医院准入与医保谈判Celltrion披露日本及其他市场生物类似药份额四、会议动态与预告BIX 2026将于10月28日至30日在首尔举行Promega Discover Glo 2026今日举行创药方法学研讨会一、BD与投融资1. Samsung Bioepis签订巴西生物类似药长期供应合作事件：Samsung Bioepis与巴西合作方达成面向公共医疗系统的长期供应安排，涉及SB12（依库珠单抗生物类似药；结合补体C5，用于阵发性睡眠性血红蛋白尿症等补体相关疾病），并计划配套本地技术转移。报道提及合作期限约十年，未披露交易金额。值得关注：巴西公共采购渠道和本地化生产安排，可拓宽韩国生物类似药在拉美的长期市场进入路径；供应与转移落地进度仍待跟踪。二、临床与研发进展2. Voronoi授权药enozertinib披露一线肺癌早期数据事件：Voronoi授权给美国Oric的enozertinib（ORIC-114，靶向EGFR非典型突变；用于EGFR突变非小细胞肺癌）披露1b期一线队列数据：20名可评估患者中16人缓解，客观缓解率80%；脑转移亚组9人中6人缓解。数据来自早期小样本研究。值得关注：观察到颅内活性信号，为后续注册设计及原授权资产价值提供依据；样本量有限，不能据此与其他药物直接比较。 Voronoi是韩国开发靶向抗癌药的生物技术公司，官网：https://www.voronoi.io/ 。3. ABL Bio披露givastomig联合治疗胃癌的1b期结果事件：ABL Bio与NovaBridge披露givastomig（ABL111，CLDN18.2×4-1BB双特异性抗体；用于晚期胃癌或胃食管结合部癌）联合化疗和PD-1抑制剂的1b期数据。12 mg/kg组入组37人，其中32人可评估，24人缓解（客观缓解率75%），报告中位无进展生存期14.5个月；8 mg/kg组26名可评估患者中20人缓解（77%）。值得关注：较前一日报的“即将披露”新增了具体结果；仍是非随机早期队列，疗效和安全性需在更大研究中验证。4. Hanmi披露EZH1/2抑制剂HM97662早期抗肿瘤信号事件：Hanmi介绍HM97662（EZH1/EZH2双重抑制剂；研究用于部分晚期实体瘤）的1期剂量探索数据，报告出现部分缓解病例。研究仍处于早期，适宜进一步核对不同剂量及扩展队列的有效样本数。值得关注：双靶点表观遗传调节药有望覆盖既有EZH2药物未满足的亚群，但现阶段不能据少数缓解病例推断整体疗效。5. Huons展示HUC1A-626抗肠纤维化临床前研究事件：Huons披露HUC1A-626（口服TG2抑制剂；拟用于纤维狭窄型克罗恩病）在人源成纤维细胞及动物模型中的抗纤维化研究结果，相关内容在欧洲消化病学会议期间展示。尚无人体疗效结果。值得关注：克罗恩病纤维化缺少直接针对狭窄进展的药物，临床前机制与转化可行性值得跟踪。 Huons是韩国处方药及创新药开发企业，官网：https://www.huons.com/ 。6. Y-Biologics拟更新两项多特异性抗体临床前结果事件：Y-Biologics预告在11月SITC展示AR170（PD-1×VEGF×IL-2变体）和AR166（PD-1×LAG-3×IL-2变体）两项免疫肿瘤临床前研究，包括患者来源组织的离体数据，并拟参加BIO-Europe开展BD会谈。两项资产的潜在适应症均为实体瘤，具体病种尚未披露。值得关注：患者来源样本数据可增强早期管线的转化论证；目前是计划披露及会谈，不能写成已达成授权或已取得人体结果。 Y-Biologics是韩国多特异性抗体开发公司，官网：https://ybiologics.com/en/ 。三、业绩与商业动态7. Curocell的CD19 CAR-T推进医院准入与医保谈判事件：Curocell的Rimcato（自体CD19 CAR-T；用于复发或难治性大B细胞淋巴瘤）已通过三星首尔、首尔大学及首尔峨山三家医院的院内药事审批，正在与韩国医保机构进行药价谈判。其他医院准入与报销决定尚未完成。值得关注：医院准入和医保谈判是CAR-T从获批走向实际用药的重要环节；不得将谈判中表述为已纳入医保。 Curocell是韩国细胞治疗公司，官网：https://curocellbtx.com/ 。8. Celltrion披露日本及其他市场生物类似药份额事件：Celltrion汇总亚洲及拉美的生物类似药销售进展。按公司口径，截至7月，Remsima（英夫利西单抗生物类似药；抗TNF-α，用于炎症性疾病）在日本的份额为48%，Herjuma（曲妥珠单抗生物类似药；抗HER2，用于HER2阳性肿瘤）及Vegzelma（贝伐珠单抗生物类似药；抗VEGF，用于多种实体瘤）分别为78%和64%；公司亦披露新加坡、香港、泰国及马来西亚等市场份额。值得关注：体现韩国生物类似药在成熟市场的商业化能力；具体份额仍需结合统计口径和期间核对。四、会议动态与预告9. BIX 2026将于10月28日至30日在首尔举行事件：BIOPLUS-INTERPHEX KOREA（BIX）2026由KoreaBIO主办、RX组织，10月28—30日10:00—17:00 KST（北京时间9:00—16:00）在首尔COEX举行，地址：韩国首尔江南区永东大路513号。会议设置医药研发、生产和市场专题及一对一合作洽谈；合作洽谈须先完成预登记。费用与截止时间以官方报名页为准。值得关注：可提前预约药物开发与商业合作对象；这是一项此前未列的会议预告，不代表交易已经产生。会议详情 https://www.bioplusinterphex.co.kr/10. Promega Discover Glo 2026今日举行创药方法学研讨会事件：Promega Korea主办的Discover Glo 2026于10月20日12:30—18:00 KST（北京时间11:30—17:00）在首尔COEX三层327号会议室举行，地址：首尔江南区永东大路513号。官方议程聚焦小分子药物发现、AI设计、靶点结合验证、靶向蛋白降解和临床转化。官方介绍为免费预登记活动，报名期已结束。值得关注：涉及从筛选到药效机制确认的实用方法，适合关注早期创新药项目的研发团队；这里只概述议程，不推断会后研究结果或交易。会议详情 https://www.promega.kr/c/promo/discover-glo-2026/

生物类似药临床结果临床1期

2026-10-18

·类器官分晓

胶质瘤：取材窗口只有 3 小时（下）

上期回顾｜一、疾病与市场背景：一个「手术采样即终点」的瘤种 / 二、亚型与分子分型全景：逐亚型点出建立难点 / 三、样本来源与取材策略：真正卡住产能的 3 小时 / 四、分亚型建立配方：五条路线，各配一套认证话术 / 五、建立成功认证标准：通用五件套 + 胶质瘤专属加项本篇承接上期。未读上期可在公众号历史消息中查看。六、药敏检测与 Panel 设计 6.1 三层 Panel 层级药物判读指标依据层 1 一线锚点替莫唑胺（TMZ）、洛莫司汀、贝伐珠单抗（复发）IC50 + AUC 双指标；TMZ 的 AUC 参考区间 200–600，MGMT 甲基化者 AUC 更低（更敏感） Golebwska 团队口径；与临床试验高度一致层 2 分型靶向 vorasidenib / IDH 双靶点抑制剂（IDH 突变）；vebreltinib 等 MET 抑制剂（MET 扩增）；lazertinib（第三代 EGFR-TKI）；regorafenib；pexidartinib（CSF1R） IC50；与分子靶点状态的相关性 IDH1 突变类器官对 vorasidenib 敏感性显著高于野生型（Current Medicinal Chemistry 2026）；lazertinib 在 TMZ 耐药 GBO 中有效（Cell Rep Med 2026）层 3 机制发现蛋白酶体抑制剂（carfilzomib/bortezomib/ixazomib）、HDAC 抑制剂（panobinostat/romidepsin）；FDA 药物库 166 药初筛 2.5 μM 单浓度 72 h；仅上述 4 药达到 Cmax/IC50 > 1 npj Precision Oncology 2026（HTS + RNAi 验证 PSMB5、HDAC1/2）放疗响应（加项） 8 Gy γ 照射（第 0 天与第 4 天各一次）相对活力 IDH1 突变类器官活力显著下降，野生型无显著变化 6.2 一致性数据（样本量必须随数字一起引用）研究样本量一致性结论 KAIST / 忠南大学（Cell Rep Med 2026-06-12）55 例/59 样本 → 36 株；18 株进入临床相关性分析（含 PFS/OS 终点）GBO-DST 与 TMZ 临床响应 100% 一致；同期 MGMT 甲基化仅 77.8%；IC50 低者 PFS/OS 显著更长（p<0.05）；新诊断与复发两组均成立 SNO 2025 TMOD-07（同一体系）19 株中 10 株进入 TMZ 评估 3 株在 50 μM TMZ 下存活率 <50%；PFS 按 GBO-DST 分层 p=0.011 IPTO 前瞻队列（Cell Stem Cell 2025）35 例 GBM 准确预测 TMZ 响应，优于 MGMT 状态；3 周出结果 AI4Med（ASCO 2026，JCO 2026;44(16_suppl):e14086） 1,406 细胞系 / 481 化合物（模型层）+ 类器官实体验证 top-5 药敏预测准确率 97%、top-10 85% GlioME（Bioactive Materials 2025）n=1 个案 IDH 突变复发 4 级星形细胞瘤、MET 扩增患者，vebreltinib 用药 2 个月 MRI 明显缩小，达 RANO 2.0 CR。单例，不得作为一致性率引用判断判读流程与窗口：2.5 μM 单浓度 72 h 初筛 → 剂量-反应 8 点复筛 → IC50/AUC 双指标报告。脑肿瘤类器官药测的报告周期全行业口径为 2–4 周——这个窗口是临床药敏能不能落地的硬约束，也是自动化建库设备（5–7 天出微球、7–9 天出报告）的卖点所在。判断一个必须承认的局限：复发胶质母细胞瘤（rGBM）综述明确指出，GBO 路线存在 20%–30% 培养失败率，且 AI 模型泛化性不足。对临床客户的承诺必须写成「建库成功后 X 天出报告」，而不是「送样后 X 天出报告」。七、产业化与商业化：谁在买，按什么价买 7.1 监管路线图（2021–2026）中国：2021-11 CDE 在《基因治疗产品非临床研究与评价技术指导原则（试行）》中首次将类器官列入替代方法；2024-10《模型引导的罕见病药物研发技术指导原则》征求意见，2025-07 配套正式文件明确纳入类器官与器官芯片；2026-07-07 CDE 发布《推进新方法（NAMs）研究和应用试点计划（「先锋计划」）》申报通知，2026-09-28 正式发布（通告 2026 年第 46 号），设两类申请情形（围绕具体药物的应用 / 围绕新方法的方法学验证），每次申请只能包含一个应用场景（COU）；2026-08-31 CDE《单克隆抗体动物试验减少或替代指导原则（征求意见稿）》明确将类器官/器官芯片纳入**证据权重（WoE）**框架。行政法规层面，2025-10 国务院令第 818 号《生物医学新技术临床研究和临床转化应用管理条例》2026-05 施行；2025-05《人源类器官研究伦理指引》首次构建全过程伦理治理框架。收费端，2026-08-14 国家医保局《检验类医疗服务价格项目立项指南（试行）》设「肿瘤组织类器官培养费」（计价单位「次」）与「肿瘤类器官药物敏感性检测费」（定性/定量两子项，按「每例标本·每种药物」计费），价格构成明确纳入人工智能辅助操作与数据上传成本，并延续「缺数减收」（未上传数据每项减收 ≥10%，上限 5 元）。海外：FDA 2026-03-18 发布《General Considerations for the Use of New Approach Methodologies in Drug Development》指南草案，确立 COU / 人类生物学相关性 / 技术表征 / fit-for-purpose 四原则；欧盟委员会 2026-06-01 发布化学品安全评估动物试验淘汰路线图（C(2026)3497）；EMA 2026-03 就虚拟对照组资格认定征求意见。ICH 层面尚无类器官专门指南——这是行业最大的制度性不确定性。 7.2 玩家格局：胶质瘤专属商业化仍然稀缺主体类型胶质瘤相关度可核验动态HUB Organoid Technology （荷兰） PDO 模型库 / CRO 泛瘤种（含脑癌） 1,500+ 模型库；2024/2025-01 被 Merck KGaA 完成收购；分层收费（基础药敏 vs 高端 PDXO 建模）冠科生物 Crown Bioscience （JSR 生命科学集团） CRO 泛瘤种取得 HUB 全套技术商用授权，共建荷兰乌得勒支联合实验室，搭建 OrganoidXplore 平台；约 1,000 个 HUB 赋能类器官模型，覆盖 35 种适应症；苏州实验室 2025 年 10 月获 CLIA 认证；2026-04 与 Turbine 合作（AI 靶点预测 + 类器官实体验证）Cellesce （英国） PDO 规模化生产泛瘤种 2022-12 被丹纳赫 Molecular Devices 收购；周产能 10,000 类器官Samsung Biologics （韩国）类器官 CRO 泛瘤种已推出类器官平台，活检→药敏报告周期压缩至 21 天DKFZ / 上海科技大学 IPTO 项目学术 → spin-off胶质瘤强相关已成立 DKFZ spin-off 推进药物测试；目标为「多组学 + AI 个体化推荐」首都医科大学天坛医院 GlioME （江涛院士 / 保肇实教授）医院主导胶质瘤强相关保留原生免疫微环境；个案实现类器官指导用药并达 RANO 2.0 CR首都医科大学张力伟团队 BSGO 医院主导胶质瘤强相关 54/59 = 91.5%，含鞘内三联治疗（TIT）方案发现国内泛瘤种平台（科途医学、创芯国际、丹望医疗、大橡科技、艾名医学、基石生命、耀速科技等）试剂/CRO/设备泛瘤种，胶质瘤非主攻各类公开动态均集中在泛瘤种药敏、器官芯片、自动化设备与 AI 方向一句必须写进尽调纪要的话：胶质瘤类器官目前最接近转化的成果全部来自「学术/医院 → spin-off 或院内平台」，尚未检索到公开的、胶质瘤专属的规模化商业报价与批量交付案例。任何声称已有「胶质瘤类器官标准化商业产品线」的说法，都应要求对方提供株数、取材通道构成、成功定义三项证据——这正是本系列第 03、04 期确立的「建立率四要素」引用纪律。 7.3 场景优先级与客户药企 HTS（最优先） 8 天内完成 166 药筛选的流水线已跑通，买方是神经肿瘤管线药企与 CRO；临床药敏（政策刚落地）医保立项已通，买方是三级医院神经外科/检验科，报告周期 2–4 周是竞争焦点；模型授权（中长期） GBO 株库按亚型分组授权，须先解决第 4 节的亚型认证问题； IO 共培养 / 电场治疗评价（前沿） TTFields 的体外敏感性尚无明确预测标志物，200 kHz 电场下肿瘤球形成抑制率 >50% 是当前唯一的体外判读线索（行业口径，须自建验证，不可直接引用为客户承诺）。八、风险与红线清单类别风险规避动作技术取材超窗（>3 h 或解剖 >2 h）导致活力断崖术前获取排台信息、派员进手术室；建库份与病理份同时分装技术坏死区混入拉低成球率按 npj 2026 纪律只取增强区、避坏死；导航取样 SOP 写死，不接受技术员裁量技术亚型漂移（少突→星形、GBM 转录态漂移）建库时即做 1p/19q + IDH 双锚定；每 10–15 代复测分子锚与转录态技术建立率口径混淆（GSC 培养 96% ≠ 类器官）对外材料严格区分「GSC 培养 / organoid」两类资产；报数必须附「取材通道 × 培养基版本 × 成功定义 × 样本量」四要素技术未建成亚型被误排入产品线毛细胞型星形细胞瘤、SEGA、ATRT、间变性脑膜瘤、前庭神经鞘瘤一律标注「研究性建模」技术复发样本 20%–30% 培养失败率临床承诺写「建库成功后 X 天出报告」，不写「送样后 X 天」合规人遗：胶质瘤基因数据（WES / scRNA-seq / 甲基化）属人类遗传资源信息对齐《人类遗传资源管理条例》（2024-03-10 修订，主管部门已由科技部调整为国家卫生健康委）与《实施细则》（科技部令第 21 号）；采集/保藏/对外提供均须审批或报告合规外方合作（如中德 IPTO 模式）境外主体及其实际控制的境内主体均可能构成外方单位；外方单位不得在境内采集、保藏我国人类遗传资源，不得向境外提供；须走国际科学研究合作行政许可或国际合作临床试验备案合规人遗信息出境对外提供/开放使用须事先向国家卫健委报告并提交信息备份；人数 >500 例的外显子组/基因组测序资源须经安全审查合规脑类器官伦理 2025-05《人源类器官研究伦理指引》对复杂脑类器官的意识属性风险提出检测要求；iPSC 脑类器官 + 人肿瘤体系属高敏感类别，须单独说明意识/痛觉风险的检测与限制合规知情同意术中冗余组织采集须在手术知情同意中设单独条款；复发患者二次取材须重新取得同意；脑组织样本的用途边界（是否可用于基因数据、是否可用于外方合作）须逐项勾选质控无抗生素悬浮培养的污染风险两性霉素 B 常规加入；支原体每 4–8 周复检；建立批次污染归档追溯质控代次过深 >P10 须复测 TMZ IC50 与亚型锚；冻存-复苏株须重做 SNV 重叠（实测 88.4%）质控「重聚球」冒充「原位类器官」单细胞重聚球直径缩小 ≥60%（npj 2026），仍可作为药敏资产，但不得声称保留了原位组织结构与微环境；微环境声明只能由 GlioME/ALI 类路线发出本篇判断该不该投产：该，但只投两条线，且必须与神外手术室绑定。纯悬浮 GBO 线（产量 + 药企 HTS）按 61%–63% 的稳定建立率立项，预设 66.7% 门槛。核心资产是「可传代 GBO 株库 + 8 天 166 药筛选流水线」，卖方是神经肿瘤管线药企与 CRO。建议投产。 GlioME / ALI 线（临床药敏 + 免疫场景） 88.2% 建立率 + 原生免疫保留是胶质瘤唯一可与上皮瘤种拉开差距的差异化资产，且直接对接已打通的医保立项与电场治疗评价需求。建议以合作研发方式优先投产（与有天坛/华山级别神外中心的医院共建），不要自建。不建议投产：IDH 突变低级别（生长过慢，回收周期长）、儿童低级别（毛细胞型/SEGA 无模型）、ATRT、脑转移（属独立产品线）。投资优先级亚型认证能力 > 建立率 > 通量。胶质瘤的建立率天花板已经清楚（61%–63% 悬浮 / 88.2% ALI），任何团队再往上挤 10 个百分点的边际价值，都低于「把 1p/19q + IDH + MGMT + H3K27M 四个锚打进每一株的放行标准」。一句话风险定价胶质瘤类器官的护城河不在实验室，在手术室的 3 小时。能拿到导航定点取材的人，才有产能；拿不到的人，只能在病理科门口等剩下的标本。来源与数据说明建立率数据（第 4 节）：GBO 悬浮 61.0%（55 例/59 样本 → 36 株，成功定义=建成可传代株）来自 Cell Reports Medicine 2026-06-12（KAIST / 忠南大学医院，DOI 见文献库）；63.3% 来自 Neuro-Oncology 2025 Vol.27 Suppl.5 TMOD-07（28 例/30 样本 → 19 株，DOI 10.1093/neuonc/noaf201）；前瞻注册预设 66.7% 来自 ClinicalTrials.gov NCT06782984（研究期 2021-08-18 起，预计 2028-12 完成，目标 100 株/150 例）。73%→83%（15/18）来自 FASEB 期刊系 DOI 10.1002/cns.71024（改良法，成功定义=可传代/冻存/复苏）。88.2% 来自 Bioactive Materials 2025;53:205-217（GlioME，DOI 10.1016/j.bioactmat.2025.07.015）。91.5%（54/59）来自 Cell Stem Cell 2026-09-16（首都医科大学张力伟团队 BSGO；同期摘要亦见 Neuro-Oncology Pediatrics 2026 Suppl）。96% 为 PMC12116786 报告的 GSC 培养建立率（114 例连续 HGG 标本，手术切除 + 超声吸引，SCD + 3DD 双路），非类器官建立率，本文明示区分。血清-free 患者来源培养报道成功率 30%–70% 为 PMC12116786 引言汇总口径。分子分型依据：WHO CNS5（2021）中枢神经系统肿瘤分类；GBM 转录亚型沿用 Verhaak 2010 三分类与 Neftel 2019 四态框架。药敏一致性数据：100% / 77.8% / p<0.05 来自 Cell Reports Medicine 2026-06-12；p=0.011 来自 SNO 2025 TMOD-07；IPTO 35 例前瞻队列来自 Cell Stem Cell 2025（Peng 等）；AI4Med 97%/85% 来自 ASCO 2026，JCO 2026;44(16_suppl):e14086；TMZ AUC 200–600 区间为 Golebwska 团队口径（经《协和医学杂志》综述转述，建议回溯原文）；8 Gy γ 照射数据来自 Current Medicinal Chemistry 2026；蛋白酶体/HDAC 抑制剂与 166 药 HTS 来自 npj Precision Oncology 2026;10(1):228（DOI 10.1038/s41698-026-01552-5）。GlioME 的 vebreltinib 案例为 n=1 个案，本文已显式标注，不得作为一致性率引用。流行病学口径：年发病率 5–8/10 万来自新华网 2025-09-29（华山医院口径）；5.8/10 万（95% CI 5.2–6.4）为中国脑肿瘤登记中心口径。GBM 占颅内原发恶性肿瘤 45.2% 为 2025 年行业口径（再鼎医药支持的医患分享会/环球网 2025-07-15），另一「>50%」表述分母不同，本文并列标注。5 年生存率三口径（<5% / <7% / <10%）来源不同，本文不取单一数字。IDH1/2 突变率 47%–53% 来自新华网 2025-09-29。儿童胶质瘤年新增 8,000–10,000 例为 2025 年国家癌症中心口径（经第三方转述，建议回溯年报原文）。DMG 0.06/10 万来自 CBTRUS，占中国 CNS 肿瘤 1.01% 来自 NBTRC。治疗端动态：EF-14 长期随访（中位 OS 20.9 vs 16.0 个月，5 年 13% vs 5%）为已发表数据；国产电场治疗 ASVir-G3（天坛医院牵头 11 家医院，mOS 31.11 个月、mPFS 12.91 个月）及 2025-12 NMPA 获批来自央广网 2025-12-29 报道；IDH 双靶点抑制剂经《临床急需药品临时进口工作方案》在华山医院落地来自新华网 2025-09-29。上述为企业与媒体披露口径，正式临床数据以官方公告与期刊原文为准。监管进展：CDE 类器官监管时间线（2021-11 起）、2026-07-07「先锋计划」申报通知与 2026-09-28 正式发布（通告 2026 年第 46 号）、2026-08-31 单抗减替指导原则征求意见稿，均引自 CDE 官网及行业解读（丹望医疗 2026-09-30、傲睿科技行业梳理）。2026-08-14 国家医保局《检验类医疗服务价格项目立项指南（试行）》纳入「肿瘤组织类器官培养费」与「肿瘤类器官药物敏感性检测费」及其计价规则（每例标本·每种药物；缺数减收 ≥10%、上限 5 元），引自国家医保局发布及行业解读。FDA 2026-03-18 NAMs 指南草案四原则、EU C(2026)3497、EMA 2026-03 虚拟对照组征求意见为公开文件。「先锋计划」实施细则与各省价格基准以官方发布为准。企业与市场数据：HUB 被 Merck KGaA 收购（2025-01 完成，官方公告）、冠科生物 HUB 授权与约 1,000 个类器官模型/35 种适应症/苏州实验室 2025-10 CLIA 认证（企业官方新闻稿与腾讯新闻转载）、Cellesce 被 Molecular Devices 收购、QGel 与 Samsung Biologics 定价（第三方市场研究报告口径，未经审计，引用时须标注「以官方公告为准」）。国内企业动态引自公开行业梳理（2026-09 类器官企业盘点、艾名医学访谈、基石生命资料）。本文未编造任何公司名或数据。合规依据：《中华人民共和国人类遗传资源管理条例》（2019 国务院令第 717 号，2024-03-10《国务院关于修改和废止部分行政法规的决定》修订，主管部门由国务院科学技术行政部门调整为国家卫生健康委）；《人类遗传资源管理条例实施细则》（科技部令第 21 号，2023-05-26）；国家卫健委科教司《人类遗传资源管理常见问题解答》（2025-03-27）；2026-05-08《实施细则》征求意见稿（采集行政许可门槛由 3,000 例提高至 10,000 例）；安全审查情形含人数 >500 例的外显子组/基因组测序资源。伦理依据：《人源类器官研究伦理指引》（2025-05）；《生物医学新技术临床研究和临床转化应用管理条例》（国务院令第 818 号，2026-05 施行）。区域表述：中国香港 / 中国澳门 / 中国台湾。本文所有建立率均写成「瘤种 × 取材方式 × 培养基版本 × 成功定义 × 样本量」的条件组合，未给出任何无条件的单一数字。本文完｜上下两期合为一篇完整的瘤种分析，未做删减。

ASCO会议临床1期临床结果申请上市

2026-06-18

·BioSpace

Organon and Samsung Bioepis Expand Agreement to Commercialize PYZCHIVA® (ustekinumab), a Biosimilar Referencing STELARA® (ustekinumab) in Canada

The amended agreement deepens Organon and Samsung Bioepis’s collaboration to six biosimilars in Canada across multiple therapeutic areas, including immunology, oncology and dermatology. To be launched in Canada in 2026 INCHEON, South Korea & KIRKLAND, Quebec--(BUSINESS WIRE)--Samsung Bioepis and Organon, a global healthcare company with a deep expertise in biosimilars, announced the expansion of their development and commercialization agreement, whereby Organon will obtain commercialization rights in Canada to PYZCHIVA ® , Samsung Bioepis’s biosimilar referencing STELARA ® (ustekinumab). PYZCHIVA ® is indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFα) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids, moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. Under the terms of the agreement, Organon will obtain exclusive commercial rights to the product in Canada while Samsung Bioepis will maintain full development, manufacturing, and regulatory responsibilities. This agreement expands the biosimilar portfolio under Organon and Samsung Bioepis’s collaboration in Canada from five to six complementary products. The five other products in the collaboration in Canada are HADLIMA ® (adalimumab), BRENZYS ® (etanercept), RENFLEXIS ® (infliximab), AYBINTIO ® (bevacizumab), and ONTRUZANT ® (trastuzumab). PYZCHIVA ® is expected to be launched in the market in 2026. "In Canada, biosimilars have played a significant role in strengthening the financial stability of the healthcare systems by reducing medical expenditure for the governments, hospitals, and patients. Samsung Bioepis is proud to have contributed to making biologic medicines more affordable for all stakeholders. By expanding our commercial partnership with Organon, we hope to create greater synergy in accelerating access to our biologic medicines,” said Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets, Samsung Bioepis. “We will work relentlessly to ensure continued supply of our ustekinumab biosimilar to patients in the Canadian market.” “We’re proud to strengthen our longstanding relationship with Samsung Bioepis one of Organon’s key global collaborators as we continue to work to help expand access to medicines and advance a more sustainable healthcare system,” said Dominic Bégin, President and Managing Director, Organon Canada. “In Canada, we have built a strong foundation in delivering accessible biosimilars for patients, as demonstrated over the past ten years. By leveraging our capabilities and expertise, we see opportunity to expand access to this treatment, helping more patients receive the care they need while providing an important alternative option that supports both healthcare providers and the broader system.” With the addition of PYZCHIVA ® to the Samsung Bioepis and Organon portfolio, the companies reinforce their commitment to delivering more treatment options that can help reduce spending pressures on healthcare systems and expand access to medicines for patients. An estimated 1 in 140 Canadians lives with Crohn’s or colitis, the two main forms of inflammatory bowel disease (IBD), which cause inflammation of the intestines. i Also, it is estimated that one million Canadians are currently living with psoriasis, a chronic inflammatory skin condition that causes red to violet elevated areas of skin (plaques), usually covered with silvery-white scales that can be itchy and painful. Up to 30% of patients with psoriasis have associated psoriatic arthritis. ii For more information about PYZCHIVA ® (ustekinumab) in Canada, including important safety information, visit . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit and follow us on LinkedIn and X . About Organon Organon is an independent global healthcare company dedicated to improving the health of women throughout their lives. With a diverse portfolio of over 70 medicines and products in women’s health, biosimilars, and general medicines across a range of therapeutic areas, Organon is committed to innovation and collaboration. Headquartered in Jersey City, New Jersey, with a Canadian office in Kirkland, Quebec, Organon has approximately 10,000 employees worldwide. For more information, visit and connect with us on LinkedIn . Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States’ Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about PYZCHIVA ® for the treatment of adult patients with chronic moderate to severe plaque psoriasis and other conditions, as well as statements regarding the expanded commercial launch of that product and other biosimilars in Canada pursuant to the development and commercialization agreement. Forward-looking statements may be identified by words such as “will,” “expected,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the U.S. Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and other SEC filings, available at the SEC’s Internet site ( ). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. STELARA ® is a trademark registered in Canada in the name of Johnson & Johnson. Organon is not associated with this trademark owner. i Crohn’s and Colitis Canada. Resources and Publications. Available at: . Accessed on June 12, 2026. ii Canadian Dermatology Association. Psoriasis. Available at: . Accessed on June 12, 2026. Contacts Organon Canada Media Contact: media_canada@organon.com Organon Investor Relations: Jennifer Halchak (201) 275-2711 Samsung Bioepis Media Contacts: Yoon Kim, yoon1.kim@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com

引进/卖出上市批准

100 项与贝伐珠单抗生物类似药(Samsung Bioepis Co., Ltd.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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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
晚期肾细胞癌	澳大利亚	Samsung Bioepis AU Pty Ltd	2024-01-24
高级别胶质瘤	澳大利亚	Samsung Bioepis AU Pty Ltd	2024-01-24
局部晚期乳腺癌	澳大利亚	Samsung Bioepis AU Pty Ltd	2024-01-24
转移性结直肠癌	澳大利亚	Samsung Bioepis AU Pty Ltd	2024-01-24
转移性肾细胞癌	澳大利亚	Samsung Bioepis AU Pty Ltd	2024-01-24
非鳞状非小细胞肺癌	澳大利亚	Samsung Bioepis AU Pty Ltd	2024-01-24
胶质母细胞瘤	韩国	Samsung Bioepis Co., Ltd.	2021-03-10
复发性原发性腹膜癌	欧盟	Samsung Bioepis Co., Ltd.	2021-01-11
复发性原发性腹膜癌	冰岛	Samsung Bioepis Co., Ltd.	2021-01-11
复发性原发性腹膜癌	列支敦士登	Samsung Bioepis Co., Ltd.	2021-01-11
复发性原发性腹膜癌	挪威	Samsung Bioepis Co., Ltd.	2021-01-11
乳腺癌	英国	Samsung Bioepis Co., Ltd.	2020-08-19
结肠癌	欧盟	Samsung Bioepis Co., Ltd.	2020-08-19
结肠癌	冰岛	Samsung Bioepis Co., Ltd.	2020-08-19
结肠癌	列支敦士登	Samsung Bioepis Co., Ltd.	2020-08-19
结肠癌	挪威	Samsung Bioepis Co., Ltd.	2020-08-19
结直肠癌	英国	Samsung Bioepis Co., Ltd.	2020-08-19
EGFR阳性非鳞状非小细胞肺癌	欧盟	Samsung Bioepis Co., Ltd.	2020-08-19
EGFR阳性非鳞状非小细胞肺癌	冰岛	Samsung Bioepis Co., Ltd.	2020-08-19
EGFR阳性非鳞状非小细胞肺癌	列支敦士登	Samsung Bioepis Co., Ltd.	2020-08-19

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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


NCT02754882 (CTgov)	临床3期	非鳞状非小细胞肺癌	763	Carboplatin+Paclitaxel+Bevacizumab (Bevacizumab (Avastin))	鹽壓選憲窪醖製選衊築 = 觸願醖糧鹹衊鹹築鹽選夢淵選鑰遞醖壓襯齋鑰 (鏇構觸觸鏇蓋範遞構淵, 觸襯淵糧範醖淵膚齋淵 ~ 餘願鹹築鏇選壓鏇艱憲) 更多	-	2024-12-16
				Carboplatin+Paclitaxel+SB8 (SB8 (A Proposed Bevacizumab Biosimilar))	鹽壓選憲窪醖製選衊築 = 範遞襯淵繭觸顧鏇糧齋夢淵選鑰遞醖壓襯齋鑰 (鏇構觸觸鏇蓋範遞構淵, 築鑰觸築醖憲構衊窪蓋 ~ 觸製積糧構膚顧獵艱積) 更多
NCT02754882 (ESMO2020)	临床3期	复发性非鳞状非小细胞肺癌维持	665	SB8	範壓遞網憲觸築衊繭遞(壓積觸衊鏇網製衊憲鹹) = 遞襯鹽夢膚淵糧餘鹹範膚廠觸衊獵範餘艱憲夢 (鬱顧範鹹網鹹鏇顧蓋糧 )	积极	2020-09-17
				Reference bevacizumab	範壓遞網憲觸築衊繭遞(壓積觸衊鏇網製衊憲鹹) = 獵憲壓艱淵獵淵鹽窪憲膚廠觸衊獵範餘艱憲夢 (鬱顧範鹹網鹹鏇顧蓋糧 )
NCT02754882 (Pubmed) 人工标引	临床3期	非鳞状非小细胞肺癌	763	Paclitaxel+Carboplatin+Bevacizumab-SB8	鹹選鏇網獵鹹齋觸廠願(繭齋鑰構顧簾鑰製蓋構): RR = 1.11 (90% CI, 0.975 ~ 1.269) 更多	相似	2020-08-01
				Paclitaxel+Carboplatin+Bevacizumab
NCT02754882 (ESMO2019)	临床3期	复发性非鳞状非小细胞肺癌	763	SB8	獵壓蓋憲齋築築願鑰網(構顧繭齋鏇鑰鹹憲網遞) = 選鬱壓鹽遞繭餘膚糧範簾壓廠餘壓壓顧鹹築網 (繭蓋壓艱壓壓網廠壓壓, [0.975 ~ 1.269]) 更多	积极	2019-09-28
				Reference bevacizumab	獵壓蓋憲齋築築願鑰網(構顧繭齋鏇鑰鹹憲網遞) = 淵積積製選鬱膚鏇餘襯簾壓廠餘壓壓顧鹹築網 (繭蓋壓艱壓壓網廠壓壓 ) 更多
NCT02453672 (CTgov)	临床1期	-	119	EU sourced Avastin® (EU Sourced Avastin®)	範壓製齋繭獵繭廠蓋鹽(選鑰觸餘製顧鬱觸夢範) = 網構膚獵壓醖繭顧醖遞餘蓋齋積窪築鬱鹹獵淵 (願餘蓋艱獵獵廠廠鑰選, 6221.62) 更多	-	2019-06-03
				US Sourced Avastin® (US Sourced Avastin®)	範壓製齋繭獵繭廠蓋鹽(選鑰觸餘製顧鬱觸夢範) = 鏇顧襯淵鹽願鑰衊醖選餘蓋齋積窪築鬱鹹獵淵 (願餘蓋艱獵獵廠廠鑰選, 5425.14) 更多