排名前五的靶点	数量

EPO receptor(促红细胞生成素受体)	4
HER2(受体蛋白酪氨酸激酶 erbB-2)	4
NGF(神经生长因子)	2
IL-2R(白细胞介素-2受体)	1
PSGL-1(P选择素糖蛋白配体1)	1

关联

项与三生製藥相关的药物

Clascoterone

克拉司酮

靶点

作用机制

AR拮抗剂

在研机构

Cassiopea SpA [+5]

原研机构

Intrepid Therapeutics, Inc.

在研适应症

寻常痤疮 [+2]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2020-08-26

Qi ming granula

芪明颗粒

靶点-

作用机制-

在研机构

浙江万晟药业有限公司

原研机构

浙江万晟药业有限公司

在研适应症

糖尿病性视网膜病变

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2018-11-12

Apremilast

阿普米司特

靶点

PDE4

作用机制

PDE4抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2014-03-21

167

项与三生製藥相关的临床试验

NCT06639295 / Not yet recruiting临床3期

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of 611 in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

开始日期2024-11-01

申办/合作机构

三生国健药业（上海）股份有限公司

NCT06522828 / Recruiting临床2期

A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 in Advanced Gynecologic Cancer Patients

This is an open, multicenter Phase II clinical study of SSGJ-707 combined with chemotherapy in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer. The objective is to evaluate the safety, tolerability and antitumor activity of SSGJ-707 in the treatment of advanced/recurrent endometrial cancer and platinum-resistant ovarian cancer.

开始日期2024-10-10

申办/合作机构

三生国健药业（上海）股份有限公司

NCT06630494 / Recruiting临床1期

A Single-center, Single-arm, Open-label, Single-dose Phase I Clinical Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of rhTPO in Healthy Caucasian Participants. Approximately 22 Subjects Will be Enrolled.

This is a single-center, single-arm, open-label, single-dose phase I clinical study to evaluate pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of Recombinant Human Thrombopoietin for Injection (rhTPO) in healthy Caucasian participants. Approximately 22 healthy Caucasian participants will be enrolled for this study.
One dose level is planned in this study, and participants will receive a single abdominal subcutaneous injection at a dose of 300 U/kg after entering the study.
Participants will undergo screening, admission (baseline), administration and follow-up observation period. Participants will sign an informed consent form before any study procedures are performed. During screening, all participants will be screened for study eligibility within 28 days prior to administration. Eligible participants will be admitted to the clinical study ward no later than one day prior to dosing (D-1). Participants need to fast for at least 10 hours prior to dosing and 4 hours after dosing. Single abdominal subcutaneous injection of the study drug will be given on D1. The administration and follow-up observation period will be 29 days (D1
D29). Participants may be discharged at D7 at the judgment of the investigator. PK blood samples will be collected from D-1 to D14, tolerance and safety will be observed from D1 to D29, and blood samples for PD and ADA will be collected from screening to D29. After completion of relevant assessments on D29, participants will be considered as having completed this study.

开始日期2024-10-03

申办/合作机构

沈阳三生制药有限责任公司

100 项与三生製藥相关的临床结果

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0 项与三生製藥相关的专利（医药）

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项与三生製藥相关的文献（医药）

2024-06-28·British Journal of Dermatology

P085 Efficacy and safety of 611 for the treatment of moderate-to-severe atopic dermatitis in adults

作者: Xu, Yuyu ; Zhou, Qinghong ; Zhao, Yan ; Zhang, Jianzhong

AbstractAtopic dermatitis (AD) is a chronic, recurring, inflammatory skin disease characterized by extensive rashes on the body, leading to symptoms such as persistent itching and exudation. There is still a need for safe and effective therapies to improve disease management for uncontrolled moderate-to-severe AD, as current treatments may not adequately control the disease. 611 is a novel monoclonal antibody that targets interleukin (IL)-4Rα. It can selectively bind to IL-4Rα, thereby obstructing the signalling pathways of both IL-4 and IL-13. This action aids in modulating immune function, offering potential relief for conditions such as AD and other related diseases. In this phase II study, the safety and efficacy of 611 was investigated in moderate-to-severe AD in adult patients. In total 93 patients were randomly assigned to three groups: group A received a loading dose of 600 mg of 611 followed by 300 mg every 2 weeks (Q2W), group B received a loading dose of 600 mg of 611 followed by 300 mg every 4 weeks (Q4W), and there was also a placebo group. The primary efficacy endpoint was the proportion of patients with Eczema Area and Severity Index (EASI) 75 response (≥ 75% reduction in score from baseline) at week 16. The results showed positive responses in primary and all secondary endpoints in adult patients with moderate-to-severe AD after treatment with 611. There was a significant difference between 611 and placebo in EASI 75 improvement, with a 60.0% response rate for 611 compared with 15.6% for placebo (P < 0.001). The percentage of patients achieving IGA 0/1 (Investigator’s Global Assessment score of 0 or 1, and ≥ 2-point reduction from baseline) also exhibited a significant difference in the groups receiving 611 or placebo, with rates of 35.5% and 9.4%, respectively (P < 0.05). The other endpoints, including EASI 90, EASI 50, and numerical rating scale reduction by ≥ 4 points, improved more in the groups receiving 611 than for placebo. Regarding safety data in the trial, treatment with 611 showed results comparable with placebo. 611 showed a positive effect in treatment of patients with moderate-to-severe AD in terms of efficacy and safety. 611 has potentially become a promising treatment product targeting IL-4Rα, following on from dupilumab.

2023-12-31·Platelets

Recombinant human thrombopoietin (rhTPO) of different dosing regimens for refractory/relapsed primary immune thrombocytopenia: a multicenter, randomized controlled trial and pharmacokinetics study

Article

作者: Cheng, Shuqin ; Qin, Ling ; Song, Yanping ; Zhu, Feiyue ; Liu, Xiaofan ; Lu, Quanyi ; Xia, Ruixiang ; Li, Yan ; Qian, Shenxian ; Wang, Tao ; Chen, Youhua ; Li, Linjie ; Sun, Feng ; Guo, Zhiqiang ; Bai, Yusheng ; Yang, Renchi ; Ma, Jun ; Ye, Xu ; Cao, Sunqiong ; Zhang, Qing ; Zhan, Xinrong ; Guo, Xinhong

Recombinant human TPO (rhTPO) is effective for refractory/relapsed primary immune thrombocytopenia (ITP), but optimal dosing regimen remains elusive. In this multicenter, randomized, controlled trial, a total of 282 adult ITP patients (mean age 47.3 years; 82 men) with a platelet count ≤30 × 10⁹/L or >30 × 10⁹/L with active bleeding randomly received a once daily (QD) subcutaneous injection of 7500 U (n = 64) or 15000 U rhTPO for 14 injections, or 15000 U or 30000 U rhTPO once every other day (QOD) for 7 injections. The primary outcomes included change from baseline in platelet count and total response rate (TRR) on day 14. On day 14, the median increase of platelet count from baseline was the highest in the 15000-U QD group (167.5 × 10⁹/L, interquartile range [IQR] 23.0-295.0 × 10⁹/L), followed by the 30000-U QOD group (57.5 × 10⁹/L, IQR 9.0-190.0 × 10⁹/L) (ANCOVA P < .001; P = .266 with baseline count as a covariate). The TRR on day 14 was also the highest in the 15000-U QD group (63.2%), followed by the 30000-U QOD group (59.7%). The rate of grade 3 and above adverse events did not differ among the four groups. There were no new safety concerns. All 4 regimens are safe and well-tolerated. The 30000-U QOD regimen is practically indistinguishable in efficacy to the 15000-U QD regimen.

2022-11-25·Medicine

Biosimilar erythropoietin in anemia treatment (BEAT)—Efficacy and safety of a 1:1 dose conversion from EPREX® to EPIAO® in patients with end-stage renal disease on hemodialysis: A prospective, randomized, double blind, parallel group study

Article

作者: Li, Man ; Shilo, Valery Yuryevich ; Miao, Bolong ; Isachkina, Alina Nikolaevna ; Zuev, Alexander Vasilievich ; Vareesangthip, Kriengsak ; Perlin, Dmitry Vladislavovich ; Shutov, Evgeny Viktorovich ; Omelchenko, Alexey Mikhailovich ; Davydkin, Igor Leonidovich ; Vetchinnikova, Olga Nikolaevna ; Mironova, Tatyana Pavlovna ; Khadikova, Nadezhda Georgievna ; Selyutin, Alexander Alekseevich ; Solovyova, Olga Mikhailovna ; Li, Xiang ; Tutin, Alexey Pavlovich ; Alexandrov, Ilya Vyacheslavovich ; Kvitkova, Lyudmila Vladimirovna

Background:EPREX®/ERYPO®/PROCRIT® (epoetin alfa, Janssen-Cilag GmbH) was the first available recombinant human erythropoietin (rHuEPO) and was universally reference product as per the recommendation provided by European Medicines Agency. EPIAO® is a biosimilar formulation of EPREX®, and making it a 1:1 dose conversion from EPREX® according to recommendation of European Medicines Agency. This study evaluated the clinical efficacy and safety of EPIAO® in subjects with end-stage renal disease receiving hemodialysis after intravenous administration.Methods:This study was a multicenter, prospective, randomized, double-blind, parallel-group, 2-cohort, maintenance phase, therapeutic equivalence study to evaluate a 1:1 dose conversion from EPREX® to EPIAO® in terms of clinical efficacy and safety that was conducted at 20 sites in 2 countries in patients with end-stage renal disease on hemodialysis. Eligible subjects were treated with EPREX® (reference product of epoetin) for a period of at least 3 months before the treatment period, and then were randomly assigned to the group of EPREX® or EPIAO®. Primary endpoints were mean absolute change in hemoglobin level and mean absolute change in weekly epoetin dosage from baseline to 6 months after treatment with EPIAO®/EPREX® in parallel groups.Results:A total of 200 people received the random intervention and were included in the safety set. After 6, 9, and 12 months of treatment with EPIAO® or EPREX®, there were no significant differences in the hemoglobin levels of the 2 groups compared with baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ±0.5 g/dL. There were no significant differences in the epoetin dosage of the 2 groups compared with the baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ± 45 IU/kg. There were no significant differences in the incidence of adverse events between the EPIAO® and EPREX® groups. Most adverse events were mild to moderate and were reverted/resolved.Conclusion:EPIAO® demonstrated promising effectiveness and manageable safety in patients with end-stage renal disease on hemodialysis.

1,994

项与三生製藥相关的新闻（医药）

2024-10-31

·医药笔记

安进：第2款实体瘤CD3双抗，Xaluritamig将启动前列腺癌三期临床

▎Armstrong 2024年10月30日，安进发布三季度财报，介绍了研发管线的最新进展，肿瘤业务板块中重点提到STEAP1/CD3双抗Xaluritamig将在本季度启动紫杉醇后线的前列腺癌三期临床试验。 Xaluritamig采用Xencor的XmAb 2+1技术设计，目前处于一期临床阶段，意味着安进将直接推进到三期临床。 Xencor还有其他多款实体瘤CD3双抗在推进中，覆盖靶点包括ENPP3、Claudin6、B7H3等，均采用XmAb 2+1技术。今年AACR会议上，安进披露了Xaluritamig的一期临床数据，PSA和RECIST评估疗效数据如下，PSA50为49%，PSA90为28%。以RECIST评估，高剂量组ORR为41%，DCR为79%。总结作为最老牌的biotech，安进研发管线中还有多哥潜在爆款产品，除了前述两款实体瘤CD3双抗，还有自免领域的OX40抗体Rocatinlimab，代谢领域的GIPR抗体融合GLP-1分子MariTide等。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

AACR会议临床3期财报抗体药物偶联物

2024-10-31

·医药笔记

安进：CD3/CD19双抗启动狼疮肾炎二期临床

▎Armstrong 2024年10月30日，安进发布三季度三包，营收81.51亿美元，同比增长23%，扣除收购Horizon的影响，营收增长8%。肿瘤业务板块，CD3/CD19双抗Blincyto三季度销售额3.27亿美元，同比增长49%，小细胞肺癌的DLL3/CD3双抗Imdelltra首季度销售额3600万美元。 Blincyto正在探索皮下剂型，B-ALL的1/2期临床已经完成入组，预计2025年下半年推进到二期注册临床。安进正在积极开拓自免领域，CD3/CD19双抗和CD19单抗已经启动狼疮肾炎的二期临床试验。 2a期临床计划入组50例，其中CD3/CD19双抗采用皮下注射剂型。安全性终点观察52周，疗效终点观察12周和24周。总结 Blincyto为全球首个也是唯一一个获批上市的CD3/CD19双抗，这一波自免浪潮中第一个推进到二期临床。Cullinan刚刚启动1b期临床，计划入组24例狼疮患者。默沙东7亿美元引进了同润生物的CD3/CD19双抗，葛兰素史克8.5亿美元引进恩沐生物的CD3/CD19/CD20双抗。Xencor宣布CD3/CD20双抗、CD3/CD19双抗转战自免领域。Candid收购了嘉和生物的CD3/CD20双抗、岸迈生物的CD3/BCMA双抗。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

临床2期并购临床1期抗体药物偶联物

2024-10-30

·Armstrong生物药资讯

礼来：替尔泊肽前三季度大卖110亿美元

▎Armstrong 2024年10月30日，礼来发布三季度财报，前三季度营业收入315亿美元，同比增长27%，净利润61.8亿美元。前三季度，替尔泊肽降糖版Moujaro销售额80.10亿美元，去年同期为29.58亿美元，替尔泊肽减重版Zepbound销售额30.18亿美元。替尔泊肽合计销售额110亿美元，预计全年超过160亿美元。替尔泊肽去年11月份上市以来放量迅速，累计处方患者超过60万人。降糖版Mounjaro三季度与二季度销售额基本持平，美国处方份额约30%。总结诺和诺德司美格鲁肽今年上半年销售额为130亿美元，替尔泊肽正在快速抢占市场，与司美格鲁肽的差距快速缩小。横向对比，Keytruda今年上半年销售额142亿美元，未来新的药王争夺大概率会在司美格鲁肽、替尔泊肽中间产生。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

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管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

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药物(靶点)	适应症	全球最高研发状态

米诺地尔 ( ABCC9 x Kir6.2 )	斑秃更多	批准上市
干扰素α-2a生物类似药 (沈阳三生制药) ( IFNAR )	肿瘤更多	批准上市
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伊尼妥单抗 ( HER2 )	乳腺癌更多	批准上市
重组人白介素-2 (沈阳三生制药) ( IL-2R )	肾细胞癌更多	批准上市