A RANDOMIZED COMPARATIVE STUDY ASSESSING THEINTERCHANGEABILITY OF PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

开始日期2020-07-30

申办/合作机构

Pfizer Inc.

EUCTR2019-000284-24-CZ

/ Unknown status临床4期

A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.

开始日期2020-02-03

申办/合作机构

Pfizer Inc.

NCT04230213

/ Completed临床3期

A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.

开始日期2020-01-13

申办/合作机构

Pfizer Inc.

100 项与阿达木单抗生物类似药 (辉瑞制药) 相关的临床结果

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100 项与阿达木单抗生物类似药 (辉瑞制药) 相关的专利（医药）

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项与阿达木单抗生物类似药 (辉瑞制药) 相关的文献（医药）

2024-07-02·EXPERT OPINION ON BIOLOGICAL THERAPY

Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications – an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis

Article

作者: Tennyson, Scott D ; Hufnagel, Heather Rae

PURPOSE:

Evaluate the type and quantity of quality information (i.e. Chemistry, Manufacturing, and Control) requested by the US FDA and EMA in queries pertaining to biosimilar applications.

METHODS:

Numbers/types of queries received following regulatory submissions (FDA/EMA, n = 7/n = 5) for seven biosimilars (PF-filgrastim [Nivestym], PF-rituximab [Ruxience®], PF-trastuzumab [Trazimera®], PF-bevacizumab [Zirabev®], PF-pegfilgrastim [Nyvepria®], PF-adalimumab [Abrilada™/Amsparity®], PF-infliximab [Ixifi]) from a single product portfolio were analyzed considering published regulatory authority (RA) guidance and in relation to sections/subsections of Module 3: Quality from the Common Technical Document regulatory dossier and topics based on keyword assignment.

RESULTS:

Queries were most frequently assigned (FDA/EMA %, range) to Drug Substance Manufacture (subsection 3.2.S.2; 21-35%/13-50%), Control of Drug Substance (3.2.S.4; 3-11%/5-17%), Drug Product Pharmaceutical Development (3.2.P.2; 1-12%/1-15%) and Manufacture (3.2.P.3; 17-41%/2-13%), and Analytical Similarity (3.2.R; 4-21%/4-20%). The proportion of Drug Substance and Drug Product queries was significantly different between RAs (n1 = 952, n2 = 468, p-value <0.001; two-sample proportion z-test). Topic assignments included: Control (12-27%/12-28%), Manufacturing (56-72%/34-66%), Stability (1-12%/2-24%), Biosimilarity (5-16%/5-25%), and Container Closure (0-3%/0-9%).

CONCLUSION:

The focus of both RAs on topics related to manufacturing and controls is valuable in understanding expectations for scientific and technical content related to gaining biosimilar approval.

2023-11-01·Journal of comparative effectiveness research

Navigating adalimumab biosimilars: an expert opinion

Review

作者: Habauzit, Caroline ; Abitbol, Vered ; Benkhalifa, Salim ; Marotte, Hubert

The patent expiry of Humira ® in 2018 opened up the current European market to eight adalimumab biosimilars – (in alphabetical order) Amgevita ® , Amsparity ® , Hulio ® , Hukyndra ® , Hyrimoz ® , Idacio ® , Imraldi ® and Yuflyma ® – for the treatment of various immune and inflammatory conditions. Amjevita, Hadlima ® , Hyrimoz and Yuflyma have recently become available in the USA, with others expected to reach this market in 2023 as the US patent protection for Humira ends. Although adalimumab biosimilars demonstrate efficacy, safety and immunogenicity similar to the originator, they may differ in product excipient(s) and preservatives, along with their device type(s). Physicians may find it both difficult and time consuming to navigate their way among the array of available adalimumab biosimilars when they need to make a treatment decision. This article explores the characteristics of various adalimumab biosimilars to help clinicians navigate the various options available across Europe and the USA. In addition to drug selection, effective patient–physician communication is needed to nurture realistic patient expectations and minimise potential nocebo effects when prescribing biosimilars.

2023-09-01·The Lancet. Rheumatology

Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study

Article

作者: Lakhanpal, Sharad ; Alvarez, Daniel F ; Cronenberger, Carol ; Fleischmann, Roy M ; Ianos, Claudia Ana ; Cox, Donna S ; Saikali, Wassim ; Wang, Karen ; Zhang, Wuyan

BACKGROUND:

An adalimumab biosimilar with an interchangeability designation could increase access to effective treatment for more patients. We aimed to assess the interchangeability of adalimumab biosimilar PF-06410293 (adalimumab-afzb) and reference adalimumab using a multi-switch study design.

METHODS:

We did an open-label, randomised, parallel-group study at 61 community (n=29), hospital (n=12), and academic (n=20) sites in ten countries (Bulgaria, Bosnia and Herzegovina, Czech Republic, Lithuania, Poland, Russia, Serbia, South Africa, Ukraine, and USA). Eligible patients were aged 18-70 years and met the 2010 American College of Rheumatology-European League Against Rheumatism classification criteria for rheumatoid arthritis for at least 4 months with moderately to severely active rheumatoid arthritis, based on their physician's evaluation. Eligible patients had been receiving methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks before the first dose of study medication. All patients received subcutaneous reference adalimumab (40 mg/0·4 mL [100 mg/mL] every 2 weeks) for 10 weeks before randomisation. At week 10, patients were randomly assigned (1:1) to either three switches between subcutaneous reference adalimumab (40 mg/0·4 mL [100 mg/mL] every 2 weeks) and adalimumab-afzb (40 mg/0·8 mL [50 mg/mL] every 2 weeks; switching group), or continuous dosing with subcutanous reference adalimumab (40 mg/0·4 mL [100 mg/mL] every 2 weeks; non-switching group) with stratification by bodyweight groups. Patients, investigators, and site personnel were not masked to treatment allocation. Primary endpoints were maximum observed serum concentration (C_max) and area under plasma concentration-time curve (AUC_τ) during weeks 30-32 in the pharmacokinetic population. Interchangeability was based on geometric mean ratios and corresponding 90% CIs within prespecified equivalence margins of 80-125% for both primary endpoints. Safety was analysed in all patients who received at least one dose of adalimumab-afzb or reference adalimumab. This trial is registered with ClinicalTrials.gov, NCT04230213.

FINDINGS:

Of the 569 patients assessed for eligibility between Jan 13, 2020, and June 22, 2021, 445 were enrolled, and 427 completed the first 10 weeks and were randomly assigned (213 to the switching group and 214 to the non-switching group). Participants had a median age of 56 years (IQR 46-63), 354 (83%) of 427 patients were women and 73 (17%) were men, and 422 (99%) were White. In the pharmacokinetic population (n=380), no clinically meaningful differences were observed in mean steady-state pharmacokinetic parameters between the switching and non-switching groups (geometric mean AUC 2237 μg × h/mL in the switching group and 2125 μg × h/mL in the non-switching group; C_max 8·21 μg/mL in the switching group and 8·00 μg/mL in the non-switching group). Geometric mean ratios and 90% CIs for AUC_τ (105·31, 89·16-124·39) and C_max (102·56, 89·78-117·17) were within prespecified equivalence margins. No meaningful differences were observed in the proportion of patients who had serious adverse events (three [1%] of 213 patients in the switching group vs eight [4%] of 214 patients in the non-switching group), grade 3 or higher adverse events of special interest, discontinuations due to adverse events (eight [4%] vs nine [4%]), or immunogenic reactions in antidrug antibody-positive patients. No deaths were reported during the study.

INTERPRETATION:

The risk of multiple switches between reference adalimumab and adalimumab-afzb with respect to diminished efficacy (using pharmacokinetics as a surrogate) or safety is not greater than the risk of using reference adalimumab alone.

FUNDING:

Pfizer. VIDEO ABSTRACT.

项与阿达木单抗生物类似药 (辉瑞制药) 相关的新闻（医药）

2025-03-26

·抗体圈

专利悬崖下的王者黄昏：Humira 生物类似药与新疗法如何重塑免疫治疗格局

导语：曾经年销 220 亿美元的药王 Humira 正经历 “退位潮”。随着专利保护到期，生物类似药的价格战与新疗法的崛起正加速改写免疫治疗版图。当医生开始用 “adalimumab” 通用名处方，当 CVS 将原研药移出报销目录，这场药王退位战已演变为一场关乎行业规则的深度变革。一、专利到期后的市场震荡：从 “药王” 到 “平民药” Humira（阿达木单抗）曾连续多年稳坐全球药王宝座，2021 年销售额突破 220 亿美元。但 2023 年专利到期后，其市场地位迅速崩塌：销售额腰斩：2024 年全球销售额降至 98 亿美元，美国市场份额从 80% 跌至 62%。生物类似药井喷：12 款 Humira 生物类似药涌入市场，Amgen 的 Amjevita、Sandoz 的 Hyrimoz 等通过低价策略抢占份额，其中 Amjevita 2024 年销售额同比激增 22% 至 7.61 亿美元。支付方倒逼转型：CVS Caremark 将 Humira 移出报销目录后，Hyrimoz 处方量暴增，其 2024 年价格仅为原研药的 20%。二、生物类似药的价格战与渠道博弈生物类似药的竞争核心在于价格与渠道：价格屠夫策略：Sandoz 与 CVS 合作推出私有品牌 Hyrimoz，定价仅为原研药的 20%；辉瑞 Abrilada 以 539 美元 / 两剂成为市场最低价。处方权争夺：医生开始使用通用名 “adalimumab” 开具处方，由保险公司决定具体品牌。风湿病学家处方中，生物类似药占比从 2023 年的 3% 升至 2024 年的 10%。渠道分层：诺华 Cosentyx、强生 Stelara 等新疗法通过更高疗效（如银屑病皮肤清除率达 90%）吸引高净值患者，而生物类似药主攻价格敏感型市场。三、专科医生的处方革命：从 “忠诚” 到 “理性” 不同专科医生对生物类似药的接受度差异显著：风湿病学：生物类似药占比已达 38%，Hyrimoz 以 33% 的份额领跑，预计 2025 年原研药份额将降至 12%。皮肤病学：生物类似药占比仅 4%，因患者更倾向选择 J&J 的 Stelara（IL-12/23 抑制剂）等新一代药物，其皮肤清除率比 Humira 高 30%。胃肠病学：生物类似药占比 6%，但新指南推荐优先使用 Takeda 的 Entyvio（α4β7 整合素抑制剂）等靶向疗法。 “医生更关注疗效与患者体验，而非品牌忠诚度。”Spherix Global Insights 专家 Lynn Price 指出，“生物类似药的成功源于支付方压力，而非临床优势。”四、新疗法的逆袭：从 “me-too” 到 “best-in-class” 新疗法的崛起加速了 Humira 的衰落：机制创新：IL-17 抑制剂（Cosentyx）、IL-23 抑制剂（Skyrizi）等精准靶向疗法，将银屑病治疗有效率从 60% 提升至 85%。口服药冲击：辉瑞的 JAK 抑制剂 Xeljanz（2024 年销售额 18 亿美元）以每日一片的便捷性分流轻中度患者。联合疗法趋势：礼来的 Taltz（IL-17A 抑制剂）与甲氨蝶呤联用，使类风湿关节炎患者达标率提升 40%。五、行业启示：药王退位背后的生态重构 Humira 的衰落揭示出三大行业趋势：专利悬崖效应加剧：未来 5 年，全球将有超 2000 亿美元专利药到期，生物类似药市场规模将突破 1500 亿美元。支付方话语权增强：美国医保通过 “参考定价” 等策略，推动生物类似药市场渗透率从 10% 升至 30%。创新药定价逻辑生变：新疗法需通过 “疗效溢价” 而非 “市场独占” 维持高价，如诺华 Kisqali 凭借 OS 延长 4 个月定价 15 万美元 / 年。六、未来展望：生物类似药与创新药的共生时代尽管生物类似药短期内抢占市场，但长期来看：生物类似药面临同质化竞争：12 款阿达木单抗生物类似药将陷入价格战，预计 2026 年平均价格将降至原研药的 15%。创新药聚焦差异化：基因泰克的 Tecentriq（PD-L1 抑制剂）、渤健的 Zeposia（S1P 调节剂）等通过 “多适应症布局 + 精准医疗” 开辟新赛道。行业整合加速：CMO 企业如 Catalent 通过收购扩展生物类似药产能，而 Biogen 等药企则剥离传统管线，聚焦基因治疗等高壁垒领域。七、结语Humira 的退位不是终点，而是免疫治疗新时代的起点。当生物类似药将单抗价格拉入 “千元时代”，当创新疗法重新定义疗效标准，这场药王黄昏战正深刻改变全球医药产业的价值逻辑。而患者，终将成为这场变革最大的受益者 —— 在疗效与价格之间，他们第一次拥有了真正的选择权。参考来源：https://www.biospace.com/business/humira-biosimilars-gain-ground-as-doctors-adjust-and-new-therapies-rise 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

生物类似药专利到期

2025-02-10

·复宏汉霖

产品速递 | 复宏汉霖PD-L1靶向ADC HLX43II期研究完成首例受试者给药

近日，复宏汉霖（2696.HK）宣布，公司基于与宜联生物的合作开发的靶向程序性死亡-配体1（PD-L1）的新型抗体偶联药物（ADC）注射用HLX43在复发/转移性食管鳞癌患者中开展的II期临床研究（HLX43-ESCC201）于中国完成首例受试者给药。目前，全球尚无同类靶向PD-L1的ADC产品获批上市，仅有SGE-PDL1V（来自辉瑞）即将启动临床III期试验，HLX43为全球第二款进入临床阶段的靶向PD-L1的ADC产品。近年来，以抗PD-1/L1抗体为代表的免疫检查点抑制剂（ICI）促进了肿瘤免疫治疗的高速发展，成为肿瘤患者各线治疗的主要手段之一。然而，部分PD-L1阳性患者对该疗法无响应，或者出现耐药[1]。对于免疫治疗耐药或经免疫治疗等标准治疗失败后的患者人群，尚缺少有效的后线治疗方案，亟待探索更前沿的新型治疗方案，进一步提高患者的临床获益。ADC作为当下肿瘤治疗中疗效最突出的新型疗法，已在乳腺癌、肺癌、食管癌、胃癌等多项实体瘤中展现出初步的治疗潜力，成为重要的探索方向[2]。而PD-L1在非小细胞肺癌、结直肠癌、三阴性乳腺癌、鳞状细胞癌等多种癌种中均有表达，且在正常组织中的表达有限，使其成为开发ADC药物的潜力靶点，为肿瘤治疗带来新的途径[3]。 HLX43为复宏汉霖首批进入临床阶段的ADC产品之一，旨在解决PD-1/L1免疫疗法不响应或耐药问题，填补更多晚期/转移性实体瘤患者未满足的临床需求。HLX43兼具抗体分子的高度靶向性和细胞毒素的强大杀伤力，可通过与肿瘤细胞表面PD-L1 抗原特异性结合，经内吞后释放小分子毒素，从而发挥抗肿瘤作用。2023年，HLX43治疗晚期/转移性实体瘤的I期临床试验申请先后获中国国家药品监督管理局（NMPA）和美国食品药品管理局（ FDA）批准，并于2023年11月在中国境内完成首例患者给药。2024年12月，HLX43单药或联合治疗晚期/转移性实体瘤的Ib/II期临床试验申请获NMPA批准。临床前研究及I期临床研究提示，HLX43在PD-1/PD-L1单抗耐药的非小细胞肺癌、宫颈癌、食管鳞癌、肝癌等多个瘤种中显示出显著疗效，且耐受性良好，临床前研究数据于2023欧洲肿瘤内科学会（ESMO）大会以壁报形式进行展示。基于此，复宏汉霖计划于近期启动HLX43在包括食管鳞癌、宫颈癌、肝细胞癌、鼻咽癌、头颈部鳞癌、非小细胞肺癌等实体瘤中的II期临床试验，以进一步评HLX43的疗效和安全性。未来，复宏汉霖将持续立足于未满足的临床需求，充分发挥公司在抗体药物和抗体偶联药物领域的一体化平台优势，加速推动更多前沿治疗方案的研究和开发，为全球患者带来更多高质量、可负担的创新治疗方案。【参考文献】 [1] Attili I, et al. Strategies to overcome resistance to immune checkpoint blockade in lung cancer[J]. Lung cancer: Journal of the International Association for the Study of Lung Cancer, 2021(154-):154. [2] He J, Zeng X, Wang C, Wang E, Li Y. Antibody-drug conjugates in cancer therapy: mechanisms and clinical studies. MedComm (2020). 2024 Jul 28;5(8):e671. [3] Kwan B, et al. 783 SGN-PDL1V, a novel, investigational PD-L1-directed antibody-drug conjugate for the treatment of solid tumors[J]. 2021. 关于HLX43-ESCC201 本研究为评估不同剂量HLX43在经一线标准治疗失败或不可耐受毒性的复发/转移性食管鳞癌患者中的有效性和安全性的II期临床试验。筛选合格的受试者将接受每 3 周一次（Q3W）HLX43治疗。本研究主要目的是评估HLX43 在复发/转移性食管鳞癌中的临床疗效。次要目的是评估安全性和耐受性、药代动力学特征及免疫原性、和潜在预测性生物标志物。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，4个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖50多个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧盟商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就16个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。 First Subject Dosed for a Phase 2 Clinical Trial of Henlius’ PD-L1-Targeting ADC HLX43 Recently, Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first subject has been dosed for a phase 2 clinical trial of HLX43 for Injection (HLX43-ESCC201), the novel Programmed Death-Ligand 1 (PD-L1)-targeting antibody-drug conjugate (ADC) that developed by the company based on the collaboration with MediLink Therapeutics, for the treatment of patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC). At present, no PD-L1 targeting ADC has been approved for marketing globally, and only SGN-PDL1V from Pfizer is about to innitiate a Phase 3 clinical trial. HLX43 is the second PD-L1-targeting ADC to enter clinical trial globally. Immune checkpoint inhibitors represented by PD-1/PD-L1 monoclonal antibodies have emerged in recent years and revolutionised all lines of treatment for tumour patients. However, there are still many patients with positive PD-L1 expression who do not respond to or develop resistance to PD-1/PD-L1-targeted therapy[1]. To date, there has been no subsequent-line treatment for patients who are resistant to PD-1/L1 immunotherapy or failed to benefit from the standard treatments including immunotherapy, indicating a significant unmet medical need to further improve the clinical benefits for these patients. As a novel targeting therapy with the most prominent anti-tumour efficacy, ADCs have shown preliminary therapeutic potential in the treatment of multiple advanced solid tumours, such as breast cancer(BC), lung cancer(LC), esophageal cancer(EC) and gastric cancer(GC) ,making it a promising therapeutic in solid tumours[2]. PD-L1 is expressed in patients across a broad spectrum of tumour types including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), triple negative breast cancer (TNBC), squamous cell carcinoma and displays limited expression on normal tissues, highlighting the potential of PD-L1 as a target for ADCs, which may bring new options for cancer treatment[3]. HLX43 is one of the first ADC candidates of Henlius to enter into clinical development. Combining the selectivity of targeted monoclonal antibodies with the highly potent cytotoxic agent, HLX43 could exert anti-tumour effects through specific binding to the PD-L1 expressed on the surface of tumour cells and release cytotoxic payloads after internalisation by the cancer cells. In 2023, the application for phase 1 clinical trial of HLX43 for the treatment of advanced/metastatic solid tumours was approved by the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA), respectively. And the first patient has been dosed in this trial in November 2023 in the Chinese Mainland. In December 2024, the application for a phase 1b/2 clinical trial of HLX43 for the monotherapy or combination therapy of advanced/metastatic solid tumours has been approved by the NMPA. Several non-clinical studies and the phase 1 clinical trial have shown that, HLX43 has good anti-tumour effects and a favorable tolerability profile in non-small cell lung cancer (NSCLC) , cervical cancer (CC), ESCC, hepatocellular carcinoma (HCC), and other tumour types that were PD-1/L1 mAb-resistant. The results of the pre-clinical studies were published as poster presentation at the 2023 European Society of Medical Oncology (ESMO) Congress. Based on this, Henlius plans to initiate phase 2 clinical trials of HLX43 for potential solid tumour indications including ESCC, CC, HCC, nasopharyngeal carcinoma(NPC), head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC)，to further evaluate the efficacy and safety of HLX43 in patients. With a particular focus on addressing the unmet medical needs, Henlius will further take efforts to accelerate the R&D of more cutting-edge therapeutic options and promote the layout of our innovative portfolio based on the company’s competitive edge of an integrated antibody drug R&D platform, bringing more high-quality and affordable therapeutics for patients worldwide. About HLX43-ESCC201 This study is a phase 2 clinical trial designed to evaluate the efficacy and safety of different doses of HLX43 in patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC) who have failed or are intolerant to first-line standard treatment. Eligible subjects will receive HLX43 every 3 weeks (Q3W). The primary objective of this study is to assess the clinical efficacy of HLX43 in recurrent/metastatic ESCC. Secondary objectives include evaluating safety and tolerability, pharmacokinetic characteristics and immunogenicity, and potential predictive biomarkers. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in the EU), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. 联系方式媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

抗体药物偶联物免疫疗法临床3期临床2期临床1期

2024-08-24

·生物制药小编

神州细胞亏损10余年，今年全年盈利在望

近日，神州细胞发布2024年度中报业绩报告，报告期内，公司实现营业收入13.05亿元，同比增长61.45%。归属于上市公司股东净利润1.26亿元，首次实现半年度盈利。自有财务记录以来，神州细胞连续8年录得亏损，随着过去两年来公司营收飞速增长，亏损大幅缩小，公司也越来越靠近盈利。事实上，2023年神州细胞就离盈利仅差临门一脚了，2023年公司全年总营收约18.87亿元，扣非净利润-6368.05万元，在今年Q1季度也实现了扭亏为盈，归母净利润7419.74万元。照此营收增速，神州细胞今年实现全年度盈利在望。推动营收迅速增长的最大贡献者无疑还是安佳因。安佳因®（重组人凝血因子VIII）是神州细胞首个获批产品，于2021年7月获批上市，用于成人及青少年（≥12岁）血友病A患者出血的控制和预防。在神州细胞的重组八因子上市之前，国内重组八因子市场被拜耳、百特、辉瑞等跨国公司控制，没有一款国产重组八因子药物。安佳因是国内首个获批上市的国产重组人凝血因子Ⅷ，凭借先发和成本优势，上市后迅速放量，在1年内就扭转了国内重组八因子的市场格局。首年，安佳因的销售额达到1.34亿元，2022年销售额破10亿大关，达到10.23亿元。2023年新增了12岁以下儿童适应症，全年销售额约17.8亿元，占据公司总营收的90%以上。目前神州细胞也在布局安佳因的海外市场，公司与印度、俄罗斯等十多个国家的合作伙伴签约，预计到2025年会陆续在海外上市。除安佳因外，神州细胞还有三款上市产品，分别是2022年8月获批上市的瑞帕妥单抗注射液、2023年6月先后获批的阿达木单抗生物类似药--安佳润以及贝伐珠单抗生物类似药--安贝珠，不过三者的营收远不及安佳因，2023年加起来的总收入为1.03亿元。造成亏损多年没能实现盈利的重要原因之一，就是神州细胞一直保持了相对高水平的研发投入，过去5年来，神州细胞研发费用累计超过40亿元。今年上半年研发费用为4.76亿元，较上年同期略有下降，主要用于SCTV01、SCT1000、SCT-I10A 等产品的临床中后期研究，以及众多产品的临床前开发。后续管线方面，PD-1单抗SCT-I10A用于一线治疗头颈部鳞状细胞癌和联合贝伐珠单抗一线治疗肝细胞癌的两个适应症已经递交了上市申请，头颈鳞癌适应症为国产首家申报。另外，公司自主开发的14价HPV疫苗SCT1000已经完成III期临床第三针接种，目前正处在随访阶段。该HPV疫苗涵盖了WHO公布的全部12个高危致癌的HPV病毒型及2个最主要导致尖锐湿疣的HPV病毒型，相比九价HPV疫苗（92%），可将保护率提高到96%。参考出处：神州细胞之年！财务记录亏损八个年头后盈利，重组VIII因子造血

财报生物类似药临床3期疫苗上市批准

100 项与阿达木单抗生物类似药 (辉瑞制药) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	阿达木单抗生物类似药 (辉瑞制药)	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
多关节型幼年特发性关节炎	澳大利亚	Pfizer Australia Pty Ltd.	2021-02-22
中轴性脊柱关节炎	欧盟	Pfizer Europe MA EEIG	2020-02-13
中轴性脊柱关节炎	冰岛	Pfizer Europe MA EEIG	2020-02-13
中轴性脊柱关节炎	列支敦士登	Pfizer Europe MA EEIG	2020-02-13
中轴性脊柱关节炎	挪威	Pfizer Europe MA EEIG	2020-02-13
附着点炎相关关节炎	欧盟	Pfizer Europe MA EEIG	2020-02-13
附着点炎相关关节炎	冰岛	Pfizer Europe MA EEIG	2020-02-13
附着点炎相关关节炎	列支敦士登	Pfizer Europe MA EEIG	2020-02-13
附着点炎相关关节炎	挪威	Pfizer Europe MA EEIG	2020-02-13
化脓性汗腺炎	欧盟	Pfizer Europe MA EEIG	2020-02-13
化脓性汗腺炎	冰岛	Pfizer Europe MA EEIG	2020-02-13
化脓性汗腺炎	列支敦士登	Pfizer Europe MA EEIG	2020-02-13
化脓性汗腺炎	挪威	Pfizer Europe MA EEIG	2020-02-13
非感染性前葡萄膜炎	欧盟	Pfizer Europe MA EEIG	2020-02-13
非感染性前葡萄膜炎	冰岛	Pfizer Europe MA EEIG	2020-02-13
非感染性前葡萄膜炎	列支敦士登	Pfizer Europe MA EEIG	2020-02-13
非感染性前葡萄膜炎	挪威	Pfizer Europe MA EEIG	2020-02-13
小儿克罗恩病	欧盟	Pfizer Europe MA EEIG	2020-02-13
小儿克罗恩病	冰岛	Pfizer Europe MA EEIG	2020-02-13
小儿克罗恩病	列支敦士登	Pfizer Europe MA EEIG	2020-02-13

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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


NCT04230213 (CTgov)	临床3期	类风湿关节炎	455	Adalimumab+Humira (Switching Arm: Humira and PF-06410293 (Adalimumab))	廠齋製繭獵鹽壓衊夢醖(範襯構觸範衊繭顧淵夢) = 齋構鹹醖鬱糧憲構齋範網遞襯蓋遞範鏇夢構鬱 (遞淵獵積鹹觸膚蓋觸製, 97) 更多	-	2022-08-22
				Humira (Adalimumab) (Non-switching Arm: Humira (Adalimumab))	廠齋製繭獵鹽壓衊夢醖(範襯構觸範衊繭顧淵夢) = 憲醖淵築鏇觸選壓糧鑰網遞襯蓋遞範鏇夢構鬱 (遞淵獵積鹹觸膚蓋觸製, 97) 更多
NCT02480153 (not available, EULAR2020)	临床3期	类风湿关节炎	597	ADL-PF	範壓衊選蓋構醖壓艱醖(鑰鹹壓構選顧蓋繭鏇鏇) = 遞齋夢鹹範廠鹹夢餘餘繭鹹憲願艱壓選獵獵願 (憲鹽簾遞築鹹窪願醖構 )	积极	2020-06-03
				ADL-EU	範壓衊選蓋構醖壓艱醖(鑰鹹壓構選顧蓋繭鏇鏇) = 鏇蓋願夢顧鑰遞築衊壓繭鹹憲願艱壓選獵獵願 (憲鹽簾遞築鹹窪願醖構 )
NCT02480153 (Pubmed \| Arthritis Res Ther) 人工标引	临床3期	类风湿关节炎	597	PF-06410293	鏇觸觸製網齋醖夢膚糧(願壓艱鑰窪鹽憲夢築鏇) = 鑰積獵窪製膚鏇鹹衊構範鏇夢繭顧遞鏇膚齋遞 (醖顧願鬱構蓋鏇糧築鏇 )	相似	2018-08-15
				adalimumab	鏇觸觸製網齋醖夢膚糧(願壓艱鑰窪鹽憲夢築鏇) = 艱範鬱構製網夢範襯範範鏇夢繭顧遞鏇膚齋遞 (醖顧願鬱構蓋鏇糧築鏇 )
EULAR2018	N/A	类风湿关节炎	597	PF-06410293	憲築觸餘醖簾醖網築築(餘衊製構製醖繭窪範衊) = 遞築範鏇範糧醖窪繭觸衊廠範構繭範鬱觸築醖 (夢繭製鏇蓋壓鑰膚網鹽 ) 更多	-	2018-06-13
				ADA-EU	憲築觸餘醖簾醖網築築(餘衊製構製醖繭窪範衊) = 觸壓糧鹹製窪簾廠衊廠衊廠範構繭範鬱觸築醖 (夢繭製鏇蓋壓鑰膚網鹽 ) 更多
NCT02480153 (REFLECTIONS B538-02 \| not available, CTgov)	临床3期	类风湿关节炎	597	PF-06410293 (Period 1: PF-06410293)	衊範鹹醖襯糧觸膚網窪 = 壓糧顧選襯鹹膚糧鹽觸遞艱積襯衊獵遞淵壓構 (顧遞醖鬱襯膚廠選築簾, 淵壓衊網壓廠範齋窪遞 ~ 築衊鹹蓋鏇膚積構選製) 更多	-	2017-09-26
				Adalimumab (Period 1: Adalimumab-EU)	衊範鹹醖襯糧觸膚網窪 = 壓夢廠艱膚衊獵繭簾製遞艱積襯衊獵遞淵壓構 (顧遞醖鬱襯膚廠選築簾, 鏇鬱淵選獵壓醖積遞顧 ~ 齋構鹹襯廠鑰構衊蓋窪) 更多