A Single Arm, Open Label, Single-center Dose-exploratory Clinical Study of Linperlisib in Combination With EZH2 Inhibitor SHR2554 in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma

This is a Phase I, multicenter, non-randomized, open-label, dose-exploratory clinical study to evaluate the safety and tolerability of linperlisib combined with SHR2554 in the treatment of R/R PTCL, and to preliminary observe the antitumor efficacy of the combination of the two drugs.

开始日期2024-12-01

申办/合作机构

中国医学科学院血液病医院

NCT06679673 / Not yet recruiting临床2期IIT

An Explorative Study of SHR-1701 Combined with SHR2554 and BP102(bevacizumab) for Metastatic Colorectal Cancer.

Response to oncologic treatment in mCRC is currently limited.

开始日期2024-12-01

申办/合作机构

复旦大学

NCT06568094 / Recruiting临床1/2期

An Open, Multicenter Phase Ib/II Study on the Safety, Tolerability and Efficacy of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer

The purpose of this study is to evaluate the efficacy, and safety of HRS-5041 tablets combined with antitumor therapy in subjects with advanced prostate cancer.

开始日期2024-09-06

申办/合作机构

江苏恒瑞医药股份有限公司

100 项与 Zeprumetostat 相关的临床结果

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100 项与 Zeprumetostat 相关的转化医学

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100 项与 Zeprumetostat 相关的专利（医药）

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项与 Zeprumetostat 相关的文献（医药）

2024-04-01·Clinical cancer research : an official journal of the American Association for Cancer Research

Enhancer of Zeste Homolog 2 Inhibitor SHR2554 in Relapsed or Refractory Peripheral T-cell Lymphoma: Data from the First-in-Human Phase I Study

Article

作者: Qi, Junyuan ; Cai, Zhen ; Su, Hang ; Huang, Yanhua ; Zuo, Xuelan ; Li, Kunyan ; Li, Yijing ; Wu, Jianyuan ; He, Chuan ; Zhou, Hui ; Hao, Siguo ; Liu, Yanyan ; Li, Lanfang ; Li, Zhi-Ming ; Xiao, Zhenyu ; Zhu, Jun ; Li, Zengjun ; Jin, Zhengming ; Li, Dengju ; Wu, Meng ; Song, Yuqin ; Shen, Jie ; Sun, Xiuhua

Abstract:

Purpose::

Patients with peripheral T-cell lymphomas (PTCL) in the relapsed or refractory (r/r) setting have only a limited number of therapies available, and the prognosis is extremely poor. SHR2554 is an oral inhibitor against EZH2, a rational therapeutic target for lymphomas.

Patients and Methods::

This was a multicenter, two-part, phase I study of SHR2554 in r/r mature lymphoid neoplasms. In part I, 350 mg twice daily was established as the recommended phase II dose (RP2D) based on the findings during dose escalation and expansion; subsequently, selected lymphoma subtypes were recruited in clinical expansion cohorts to receive SHR2554 at RP2D. Here, we provide an in-depth assessment of SHR2554 at RP2D in subpopulation with r/r PTCL.

Results::

Twenty-eight patients were included for analysis (17 angioimmunoblastic T-cell lymphoma and 11 not otherwise specified). Eighteen (64%) patients had received ≥2 lines of previous anticancer therapies. The objective response rate was 61% [95% confidence interval (CI), 41–78]. Responses were still ongoing in 59% (10/17) of the responders; estimated median duration of response was 12.3 months (95% CI, 7.4–not reached). Median progression-free survival was 11.1 months (95% CI, 5.3–22.0), and 12-month overall survival rate was 92% (95% CI, 72–98). The most common grade 3 or 4 treatment-related adverse events were decreased platelet count [nine (32%)] as well as decreased white blood cell count, decreased neutrophil count, and anemia [four (14%) for each]. No treatment-related deaths were reported.

Conclusions::

This extended follow-up analysis further supports SHR2554 as a therapeutic opportunity for patients with r/r PTCL.

2023-01-01·Cancer medicine

Study on pharmacokinetic interactions between SHR2554 and itraconazole in healthy subjects: A single‐center, open‐label phase I trial

Article

作者: Yang, Guoping ; Yang, Xiaoyan ; Huang, Jie ; Xiang, Yuxia ; Zou, Chan ; Wang, Hong ; Yang, Shuang ; Cui, Chang ; Zou, Yi ; Deng, Kunhong

Abstract:

Background:

SHR2554, a novel oral Enhancer of Zeste Homolog 2 inhibitor, shows broad‐spectrum anti‐tumor efficacy in preclinical studies. As SHR2554 is mainly metabolized by CYP3A4, it is helpful to conduct research on the effects of itraconazole, a strong inhibitor of CYP3A4‐metabolizing enzymes, on the pharmacokinetic characteristics and safety of SHR2554.

Methods:

We conducted a single‐center, open‐label pharmacokinetic study of itraconazole on SHR2554 in 18 healthy Chinese subjects. Subjects were orally administrated SHR2554 50 mg on Day 1, itraconazole 200 mg Quaque Die (QD) from Days 4 to 7, SHR2554 50 mg co‐administrated with itraconazole 200 mg on Day 8, and itraconazole 200 mg QD from Days 9 to 12. Then, 4 ml of venous blood was collected at predetermined time points. Plasma SHR2554 concentrations were analyzed using a validated high‐performance liquid chromatography tandem mass spectrometry method. Pharmacokinetic parameters were calculated using Phoenix WinNonlin v8.1.

Results:

The Cmax of SHR2554 alone and in combination was 10.197 ± 7.0262 ng·ml−1 versus 70.538 ± 25.0219 ng·ml−1, AUC0–∞ was 50.99 ± 19.358 h·ng·ml−1 versus 641.53 ± 319.538 h·ng·ml−1, and AUC0–t was 28.70 ± 18.913 h·ng·ml−1 versus 612.13 ± 315.720 h·ng·ml−1. Co‐administration of SHR2554 and itraconazole caused 7.73‐, 12.47‐, and 23.75‐fold adjusted geometric mean ratios increases in SHR2554 Cmax, AUC0−∞ and AUC0−t respectively. The co‐administration regimen was well tolerated and had a good safety profile.

Conclusions:

Compared with a single dose of SHR2554 50 mg, the exposure of SHR2554 in vivo was significantly affected by the combined administration of itraconazole.

2022-07-01·Lancet Haematology

SHR2554, an EZH2 inhibitor, in relapsed or refractory mature lymphoid neoplasms: a first-in-human, dose-escalation, dose-expansion, and clinical expansion phase 1 trial.

Article

作者: He, Chuan ; Cai, Zhen ; Qi, Junyuan ; Su, Hang ; Li, Kunyan ; Zhang, Xiaojing ; Wang, Weiwei ; Zhou, Hui ; Jin, Zhengming ; Li, Zhi-Ming ; Li, Yijing ; Li, Lanfang ; Hao, Siguo ; Wu, Jianyuan ; Zuo, Xuelan ; Song, Yuqin ; Zhu, Jun ; Zou, Jianjun ; Liu, Yanyan ; Zhou, Jianfeng

BACKGROUND:

Dysregulation of EZH2 has a crucial role in lymphomagenesis. We did a first-in-human study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of SHR2554, an oral EZH2 inhibitor, in patients with relapsed or refractory mature lymphoid neoplasms, including B-cell lymphomas, T-cell lymphomas, and classical Hodgkin lymphoma.

METHODS:

This was a multicentre, dose-escalation, dose-expansion, and clinical expansion phase 1 study done at 13 hospitals in China. Eligible patients had histologically or cytologically confirmed mature lymphoid neoplasms that had relapsed or were refractory to standard systemic therapies or had no standard-of-care. The study included a dose-escalation phase, at doses of SHR2554 from 50 mg to 800 mg twice daily; a dose-expansion phase, at two selected doses; and a subsequent clinical expansion phase at the recommended phase 2 dose in selected tumours. Primary endpoints were the safety, maximum tolerated dose, and recommended phase 2 dose. Objective response rate was a secondary endpoint. Safety and activity were assessed in all patients who received at least one dose of SHR2554 and had at least one post-baseline evaluation. This study is registered with ClinicalTrials.gov, NCT03603951, and follow-up is ongoing.

FINDINGS:

Between Aug 14, 2018, and July 13, 2021, 113 patients received SHR2554. At data cutoff (Sept 10, 2021), the median follow-up duration was 7·0 months (IQR 3·7-12·0). 71 (63%) patients were men and 42 (37%) were women, 110 (97%) were of Han ethnicity and 3 (3%) of other ethnicities, and 53 (47%) had received three or more lines of previous anticancer therapies. Dose-limiting toxicities occurred in two (67%) of three patients who received 400 mg SHR2554 twice daily and one (17%) of six patients who received 350 mg SHR2554 twice daily. The maximum tolerated dose and recommended phase 2 dose was determined to be 350 mg twice daily. The most common grade 3 or 4 treatment-related adverse events in all 113 patients were decreased platelet count (20 [18%]), decreased neutrophil count (ten [9%]), decreased white blood cell count (nine [8%]), and anaemia (seven [6%]). 18 (16%) patients had serious treatment-related adverse events. Two patients (2%) died due to treatment-related adverse events: one (1%) due to skin infection and toxic epidermal necrolysis and one (1%) due to respiratory failure. 107 (95%) of the 113 enrolled patients had post-baseline assessments for tumour response and were included in the activity analysis. 46 (43%; 95% CI 33-53) of these 107 patients had an overall response.

INTERPRETATION:

SHR2554 showed an acceptable safety proﬁle and promising antitumour activity in patients with relapsed or refractory lymphomas, providing evidence for future investigations.

FUNDING:

Jiangsu Hengrui Pharmaceuticals.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

107

项与 Zeprumetostat 相关的新闻（医药）

2024-12-03

·Insight数据库

恒瑞医药：我本是高山

恒瑞医药从未忘记自己是一头雄狮。从 2023 年拿下 5 笔 License-out 合作，到今年以 NewCo 形式达成 60 亿美元交易，恒瑞的出海速度明显加快。更重要的是，恒瑞的后续管线中还有不少具备 BD 预期的潜在重磅药物。可以确切地说，「医药一哥」的国际化之路尚未结束。当「医药一哥」剑指海外这几年，国产药企一直在加速全球化的步伐，出海形式也变得多样，涵盖 License-out、兼并收购、NewCo 模式等。比如，近日康诺亚再次以 NewCo 模式成功出海，将 CM336（BCMA/CD3 双抗）在大中华区以外的全球权益授予 Platina Medicines Ltd（PML），总交易额超 6 亿美元。不久前，百济神州宣布将公司英文名更名为「BeOne Medicines」，中文名保持不变。这一品牌焕新的举动，被市场解读为百济又往全球化进程跨了一大步。事实上，百济神州已经在国际化市场结出了丰收的硕果。得益于泽布替尼和替雷利珠单抗实现全球收入快速增长，今年前三季度百济实现总营收同比大幅增长 48.6% 至 191.36 亿元，营收规模已超过去年全年营收。市场预计，今年百济有望突破 200 亿元营收，这几乎相当于恒瑞医药 2023 年的总营收（228.2 亿元）。这几年，百济的海外收入占公司总营收比重一直保持较高比例，从 2020 年不足 6% 迅速飙升至 2022 年的 59.32%，并在 2023 年、2024 年上半年分别达到 55.23%、59.79%。对比来看，恒瑞医药这几年海外收入占比均不足 4%。不过，恒瑞也一直在剑指更广阔的海外市场，近年来频繁达成 BD 合作就是最好证明。恒瑞医药已达成 License-out 的管线数据来源：Insight 数据库例如，恒瑞仅在 2023 年就达成了 5 笔海外授权合作，总交易金额超过 40 亿美元，管线包括 SHR2554、SHR-1905、吡咯替尼、卡瑞利珠单抗、HRS-1167 与 SHR-A1904。值得一提的是，就 HRS-1167 和 SHR-A1904 与德国默克达成交易，是恒瑞首次与大型跨国药企达成合作。而且，今年上半年恒瑞还收到了默克支付的 1.6 亿欧元首付款。若算上这笔对外许可收入和创新药收入，恒瑞的创新收入总和占总营收比重已过半。尤其今年 5 月，恒瑞通过 NewCo 这一创新出海方式，将 3 款 GLP-1 产品组合授予美国 Hercules 公司，不仅达成总价高达 60 亿美元的交易，还获得了 Hercules 公司 19.9% 的股权。这反映出恒瑞的国际化进程不仅提速，而且出海策略更加明智有力。目前，这 3 款 GLP-1 产品都在顺利推进研发：其中，HRS-7535 是口服小分子 GLP-1R 激动剂，相比注射型 GLP-1R 具有差异化优势，治疗糖尿病已处于Ⅲ期临床，针对肥胖、糖尿病肾病均已处于 II 期临床。 GLP-1/GIP 双受体激动剂 HRS9531，正在国内开展用于肥胖和头对头对比司美格鲁肽治疗 2 型糖尿病的Ⅲ期临床，临床研究显示 24 周减重达到 16.8%，而且片剂正在国内开展针对 2 型糖尿病和肥胖的Ⅰ期临床。 HRS-4729 是下一代肠促胰岛素产品，目前尚处于临床前研究阶段。需要注意的是，上述管线只是恒瑞医药众多达成 License-out 管线的缩影。 BD 管线全面开花恒瑞医药已达成 BD 合作的管线，覆盖了肿瘤、心血管与代谢、自免等多个疾病领域。肿瘤管线方面卡瑞利珠单抗已在国内获批 9 个适应症，今年 10 月再次向 FDA 递交了联合阿帕替尼（双艾组合）一线治疗肝癌的上市申请，该项适应症还获得欧盟孤儿药资格认定，而且针对非鳞状非 NSCLC 等实体瘤的海外研究正在进行中。去年 10 月，恒瑞将卡瑞利珠单抗在除大中华区和韩国以外的全球权益和商业化「双艾组合」一线治疗肝癌的独家权利，以总价 6 亿美元授权给美国 Elevar Therapeutics 公司。 HER2 抑制剂吡咯替尼，已经获批一线/二线治疗 HER2 阳性乳腺癌、HER2 阳性乳腺癌新辅助治疗等多个适应症，目前正在美国、欧洲开展治疗 HER2 突变晚期非鳞状 NSCLC 的 III 期试验。在 2020 年和 2023 年，恒瑞已经分将吡咯替尼的海外权益授权给 HLB LifeScience 和 Dr. Reddy's 。新型 PARP1 抑制剂 HRS-1167，正在国内开展联合 SHR-A1921 或贝伐珠单抗或醋酸阿比特龙片（I）及泼尼松/泼尼松龙（AA-P）治疗晚期实体瘤的Ⅱ期试验，同时其合作伙伴默克在美国、欧盟、日本开展针对实体瘤的 I 期临床。首个国产 EZH2 抑制剂 SHR2554，已提交用于治疗既往接受过至少 1 线系统性治疗的复发或难治外周 T 细胞淋巴瘤的上市申请，针对成熟淋巴细胞肿瘤、复发难治滤泡性淋巴瘤等临床研究正在进行中。去年 3 月，恒瑞以超 7 亿美元将 SHR2554 在大中华区以外的全球权益授权给 Treeline 公司。瑞拉芙普-α注射液（SHR-1701）已在国内提交一线治疗胃癌的上市申请，目前国内外尚无 PD-L1/TGF-βRII 双功能融合蛋白获批上市，其他在研适应症还有宫颈癌、围手术期直肠癌、EGFR 突变 NSCLC 等。2020 年 11 月，恒瑞将 SHR-1701 在韩国的权益以总额约 1.4 亿美元授权给韩国东亚公司。 SHR-A1904（CLDN18.2 ADC）针对胃癌已处于 III 期阶段、针对胰腺癌已处于 I/II 期，并在美国、澳洲开展晚期实体瘤的 I/II 期试验，不过这一赛道竞争相当激烈，仅中国就有 20 款左右同类竞品在研发当中，其中已有多款进展到 III 期阶段。恒瑞医药已达成 License-out 管线的海外进展情况数据来源：Insight 数据库自免管线方面除肿瘤管线外，已达成 BD 交易的自免管线同样值得关注。 TSLP 单抗 SHR-1905，正在开展针对哮喘、慢性鼻窦炎伴鼻息肉的Ⅱ期研究，以及慢性阻塞性肺疾病的Ⅰ期研究。去年 8 月，恒瑞将 SHR-1905 在除大中华区以外的全球权益，以超 10 亿美元授权给美国 One Bio 公司。 JAK1 抑制剂艾玛昔替尼（SHR0302）已在国内递交 4 项上市申请：用于治疗成人活动性强直性脊柱炎、青少年中重度特应性皮炎、中重度活动性类风湿关节炎、斑秃，并开展针对银屑病关节炎、溃疡性结肠炎、白癜风等多个适应症的 II 期及以上研究。值得一提的是，早在 2018 年，恒瑞就以约 2.2 亿美元将 SHR0302 授权给美国 Arcutis 公司。目前，SHR0302 正在美国、欧洲开展治疗溃疡性结肠炎的 Ⅲ 期试验，以及在加拿大开展用于中重度特应性皮炎的 Ⅲ 期临床。 ADC 矩阵强势出击除已达成 BD 合作的管线外，恒瑞医药也在大力推进自研管线的海外进展，多个创新药颇具看点，尤其是展现出强劲势头的 ADC 矩阵，其中不乏具备 BD 潜力的管线。截至目前，恒瑞已有 4 个 ADC 产品获得 FDA 授予快速通道资格，有望加速药品临床试验及上市注册的进度，分别为： SHR-A2009（HER3 ADC）用于治疗三代 EGFR-TKI 和含铂化疗耐药的 NSCLC 患者，目前该药正在国内开展该适应症的 Ⅲ 期临床，其他在研适应症还有 ER 阳性乳腺癌等晚期实体瘤，并在日本、韩国开展治疗晚期实体瘤的Ⅰ期临床； SHR-A2102（Nectin-4 ADC）用于治疗晚期尿路上皮癌，目前国内已进入 II 期临床的适应症有食管癌，HR 阳性、HER2 阴性乳腺癌，三阴性乳腺癌等，在美国开展的晚期实体瘤已处于 Ⅱ 期临床； SHR-A1912（CD79b ADC）用于治疗既往接受过至少 2 线治疗的复发/难治性弥漫大 B 细胞淋巴瘤，目前正在美国开展治疗 B 细胞非霍奇金淋巴瘤的Ⅰ期临床； SHR-A1921（TROP-2 ADC）用于治疗铂耐药复发上皮性卵巢癌、输卵管癌及原发性腹膜癌，目前在国内开展的单药、联合或不联合卡铂治疗铂敏感复发上皮性卵巢癌，均已处于 Ⅲ 期临床，同时正在美国、澳洲开展单药治疗晚期实体瘤的 Ⅱ 期临床。值得一提的是，除 CD79b ADC 外，上述药物的同类竞品都达成过重磅交易，例如 BioNTech 以超 10 亿美元引进了宜联生物 HER3 ADC 新药 YL202，石药集团 SYS6002 以总价近 7 亿美元授权给了美国 Corbus，吉利德斥巨资 210 亿美元通过收购 Immunomedics 拿下全球首款 Trop2 ADC 药物 Trodelvy。恒瑞医药的 ADC 管线矩阵数据来源：Insight 数据库在热门的 HER2 ADC 领域，恒瑞布局了 2 款不同定位的药物： SHR-A1811（瑞康曲妥珠单抗）走的是广泛适应症路线，开展了超过 20 项临床试验，2024 半年报显示已有 6 项适应症被 CDE 纳入突破性治疗品种名单，目前已提交治疗 HER2 突变 NSCLC 患者的上市申请，并有多项 III 期试验在进行中，覆盖 HER2 阳性乳腺癌、HER2 低表达乳腺癌、胃癌、结直肠癌，同时在美国、澳洲开展晚期实体瘤的Ⅰ期试验。第 2 款 HER2 ADC 药物 SHR-4602 的定位是针对 DS-8201 或 SHR-A1811 耐药的后线治疗，正在开展治疗 HER2 表达或突变的实体瘤的Ⅱ期试验。其他抗肿瘤管线海外进展：氟唑帕利正在美国、欧洲开展联合阿比特龙用于转移性去势抵抗性前列腺癌的 Ⅲ 期试验。全球首创的 CD112R/TIGIT 双抗 SHR-2002 正在澳洲开展联合阿得贝利单抗用于晚期实体瘤的Ⅰ期试验。自免管线海外进展： IL-4Rα单抗 SHR-1819 正在开展针对特应性皮炎（Ⅲ期）、中重度慢性鼻窦炎伴鼻息肉（Ⅱ 期）的临床试验，同时在澳洲开展评估健康受试者的Ⅰ期试验。但这一赛道竞争十分激烈，目前已有近 10 款国产 IL-4Rα单抗进入 III 期阶段。 HRS-7085（靶点暂未披露）正在国内开展治疗炎症性肠病（包括溃疡性结肠炎和克罗恩病）的Ⅰ期临床，同时在澳洲开展评估健康受试者的Ⅰ期试验。炎症性肠病是 MNC 巨头必争之地，期待 HRS-7085 临床数据读出。结语「我本是高山，而非溪流。」恒瑞医药这头雄狮正在冲向更广阔的海外市场。从频繁达成海外授权合作，到储备了丰富的海外管线，尤其 ADC 矩阵里拥有不少具备 BD 预期的管线，「医药一哥」的国际化之旅可谓越来越有看头。封面来源：站酷海洛 Plus 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：vvy PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

引进/卖出并购临床3期临床1期ASCO会议

2024-11-28

·PRNewswire

Follicular Lymphoma Clinical Trial Pipeline Appears Robust With 50+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

Advances in immunotherapy have ushered in a new era of treatment for follicular lymphoma (FL), particularly for patients who have experienced relapse after conventional chemotherapy regimens. This paradigm shift is characterized by the emergence of innovative therapies like CAR T-cell therapy and bispecific antibodies, which have demonstrated remarkable efficacy in targeting and eradicating lymphoma cells. CAR T-cell therapy represents a groundbreaking approach where a patient's own T-cells are genetically engineered to recognize and attack cancer cells. This personalized treatment has shown significant promise, especially for individuals who have undergone extensive previous therapies. One notable example is Axicabtagene ciloleucel (Yescarta), a CAR T-cell therapy approved for use in patients with relapsed or refractory follicular lymphoma. Clinical trials have highlighted its ability to induce durable remissions, with some patients experiencing long-term remission even after multiple prior therapies. LAS VEGAS, Nov. 28, 2024 /PRNewswire/ -- DelveInsight's ' Follicular Lymphoma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline follicular lymphoma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the follicular lymphoma pipeline domain. Key Takeaways from the Follicular Lymphoma Pipeline Report DelveInsight's follicular lymphoma pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for follicular lymphoma treatment. Key follicular lymphoma companies such as Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others are evaluating new follicular lymphoma drugs to improve the treatment landscape. Promising follicular lymphoma pipeline therapies such as Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others are under different phases of follicular lymphoma clinical trials. In August 2024, the company expects to file a supplemental Biologics License Application for tafasitamab for the treatment of patients with FL who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy by the end of 2024 based on the positive Phase III results. In June 2024, a consortium of Eugene Private Equity and Korea Development Bank Private Equity announced that they would acquire 80% of South Korean vaccine maker Boryung Biopharma Co. for 320 billion won (USD 231 million). In February 2024, Incyte announced that it had entered into an asset purchase agreement with MorphoSys AG, which gives Incyte exclusive global rights for tafasitamab. Incyte will now recognize revenue and cost for all US commercialization and clinical development and MorphoSys will no longer be eligible to receive future milestone, profit split and royalty payments. In September 2023, OncoNano Medicine, Inc. announced a clinical trial supply agreement with Regeneron for the use of Libtayo (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial is a multicenter Phase Ia/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab. In May 2023, Janssen Pharmaceutical Companies of Johnson & Johnson announced that it had entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group Inc. (CBMG) to develop, manufacture, and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies. Under the terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the Chinese territory. Janssen will make an upfront payment of USD 245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon achieving certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China. Request a sample and discover the recent advances in follicular lymphoma treatment drugs @ Follicular Lymphoma Pipeline Report The follicular lymphoma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage follicular lymphoma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the follicular lymphoma clinical trial landscape. Follicular Lymphoma Overview Follicular lymphoma is a common type of non-Hodgkin lymphoma (NHL) that originates from B-cells, a kind of white blood cell responsible for producing antibodies. This cancer is characterized by the growth of abnormal lymphoid follicles, which can disrupt normal lymphatic function. While the exact causes of follicular lymphoma are not fully understood, certain factors may increase the risk, including age (most commonly affecting adults over 60), a family history of lymphoma, and potential environmental factors such as exposure to pesticides or chemicals. Symptoms of follicular lymphoma can vary widely but may include painless swelling of lymph nodes in the neck, armpit, or groin, unexplained weight loss, night sweats, fatigue, and fever. Some patients may remain asymptomatic for extended periods, as this type of lymphoma can progress slowly. Diagnosis typically involves a combination of physical examinations, blood tests, imaging studies (like CT scans), and a biopsy of affected lymph nodes. The biopsy helps determine the subtype and stage of the lymphoma, which is crucial for planning treatment. Treatment for follicular lymphoma depends on the stage of the disease and the patient's overall health. Options may include watchful waiting for asymptomatic cases, chemotherapy, immunotherapy (such as monoclonal antibodies), and targeted therapies. In some cases, stem cell transplants may be considered for patients with more aggressive forms or those who do not respond to initial treatments. Given the indolent nature of follicular lymphoma, ongoing management, and regular monitoring are vital for achieving the best possible outcomes. Find out more about follicular lymphoma treatment drugs @ Drugs for Follicular Lymphoma Treatment A snapshot of the Follicular Lymphoma Pipeline Drugs mentioned in the report: Learn more about the emerging follicular lymphoma pipeline therapies @ Follicular Lymphoma Clinical Trials Follicular Lymphoma Therapeutics Assessment The follicular lymphoma pipeline report proffers an integral view of the follicular lymphoma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Follicular Lymphoma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Phosphatidylinositol 3 kinase delta inhibitors, Phosphatidylinositol 3 kinase gamma inhibitors, Emt protein-tyrosine kinase inhibitors, Interleukin 15 receptor agonists, Histone deacetylase inhibitors, Rad51 recombinase inhibitors, Agammaglobulinaemia tyrosine kinase inhibitors, Apoptosis stimulants, Cell cycle inhibitors, Tubulin inhibitors, Tubulin polymerisation inhibitors, Enhancer of zeste homolog 2 protein inhibitors, Antibody-dependent cell cytotoxicity, Programmed cell death 1 receptor antagonists, T lymphocyte stimulants, Alkylating agents, DNA cross-linking agents Key Follicular Lymphoma Companies: Chia Tai Tianqing Pharmaceutical Group, Incyte Corporation, Mabworks, Johnson & Johnson Innovative Medicine, Nektar Therapeutics, Xynomic Pharmaceuticals, Merck Sharp & Dohme, Jiangsu HengRui Medicine Co., Ltd., ADC Therapeutics, Bristol-Myers Squibb, Swedish Orphan Biovitrum, Zhejiang DTRM Biopharma, Immpact Bio, Galapagos, Immunitas Therapeutics, Enterome, CRISPR Therapeutics, CHO Pharma, Shanghai Blueray Biopharma, BeiGene, AstraZeneca, AVM Biotechnology, Mustang Bio, Merck, Pell Bio-Med Technology, Schrodinger Inc., Sana Biotechnology, Poseida Therapeutics, OncoNano Medicine, Inc., Nurix Therapeutics, Inc., NovalGen, Pfizer, Xencor, Wellington Zhaotai Therapies, MEI Pharma, Sutro Biopharma, Synthekine, Verismo Therapeutics, Vincerx Pharma, Novartis, Century Therapeutics, Newave Pharmaceuticals, Bio-Path Holdings, Affimed GmbH, Iksuda Therapeutics, Allogene Therapeutics, Adicet Bio, Carna Biosciences, Inc., BeiGene, Boryung Pharmaceutical, Accutar Biotechnology, Atara Biotherapeutics, AbbVie, InnoCare Pharma, NeoImmuneTech, and others. Key Follicular Lymphoma Pipeline Therapies: Parsaclisib, TQ-B3525, Tafasitamab, MIL62, Ibrutinib, AZD0486, NKTR-255, Abexinostat, Acalabrutinib, Zilovertamab vedotin, SHR2554, Nivolumab, Loncastuximab tesirine, Golcadomide, Emapalumab, DTRM-555, Capivasertib, IMPT 314, GLPG5101, IMT-009, EO2463, CTX112, CHO-H01, BR1733, BGB-16673, BGB-10188, AZD5492, AVM0703, MB106, MK-1026, PL001, SGR-1505, SC291, SC262, P-CD19CD20-ALLO1, ONM 501, NX-5948, NX 2127, NVG-111, Mevrometostat, Plamotamab, WZTL-002, Voruciclib, STRO001, SYNCAR-001 + STK-009, SynKIR-310, VIP-152, VAY736, CNTY-101, LP-168, BP1002, IOA-244, IKS 03, ALLO-501, ADI-001, AS-1763, BGB-21447, BR101801, AC676, ATA3219, ABBV-319, ABBV-101, ICP-B02, ICP-B05, C-CAR039, Efineptakin Alfa, and others. Dive deep into rich insights for new drugs for follicular lymphoma treatment, visit @ Follicular Lymphoma Drugs Table of Contents For further information on the follicular lymphoma pipeline therapeutics, reach out @ Follicular Lymphoma Treatment Drugs Related Reports Follicular Lymphoma Market Follicular Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key follicular lymphoma companies including Epizyme, Eisai, Bayer Healthcare Pharmaceuticals, Verastem Oncology, Gilead Sciences, TG Therapeutics, Bristol-Myers-Squibb, Roche, Incyte Corporation, Bristol Myers Squibb, ADC Therapeutics, MorphoSys, Nordic Nanovector, AbbVie, Regeneron Pharmaceuticals, Janssen Research & Development, Novartis, MEI Pharma, and BeiGene, among others. Non-Hodgkin Lymphoma Market Non-Hodgkin Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key Non-Hodgkin lymphoma companies, including Roche, Pfizer, Amgen, Novartis, Teva Pharmaceuticals, Genentech, ACD Therapeutics, among others. Non-Hodgkin Lymphoma Pipeline Non-Hodgkin Lymphoma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Non-Hodgkin lymphoma companies, including Novartis, AstraZeneca, Genentech, BioInvent, Genmab, SystImmune, Nordic Nanovector, Pacylex Pharmaceuticals, Artiva Biotherapeutics, Inc., Chipscreen Biosciences, Ltd., Timmune Biotech Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Gilead Sciences, Acerta Pharma BV, Adagene Inc, Conjupro Biotherapeutics, Inc., Rhizen Pharmaceuticals, Juventas Cell Therapy Ltd., Incyte Corporation, HUYA Bioscience International, SecuraBio, Genor Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Antengene Therapeutics Limited, Regeneron Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Xynomic Pharmaceuticals, Inc., BioTheryX, Inc., UWELL Biopharma, Kronos Bio, Bio-Thera Solutions, Spectrum Pharmaceuticals, Inc., Aptose Biosciences Inc., Miltenyi Biomedicine GmbH, Precision BioSciences, Inc., Teneobio, Inc., TCR2 Therapeutics, IGM Biosciences, Inc, among others. Diffuse Large B-cell Lymphoma Market Diffuse Large B-cell Lymphoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key DLBCL companies, including AbbVie, Genmab, Merck, Roche, Xencor, Janssen, Denovo Biopharma, Calithera Biosciences IMV, Biogen, Autolus Therapeutics, Allogene Therapeutics, Novartis, Miltenyi Biomedicine, Regeneron Pharmaceuticals, Debiopharm, Seagen, Takeda, AstraZeneca, Gilead Sciences, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法引进/卖出临床3期疫苗细胞疗法

2024-11-11

·精准药物

创本年度之最：115个品种未被CDE批准！

药智数据显示，10月未被CDE批准的品种高达115个之多，为本年度前10月中最多的一个月，同比增长64%。从ATC分类来看，主要集中于系统用抗感染药，消化道及代谢领域。 >01< 115个品种，未被批准 2024年10月份CDE完成审批960个品种（受理号1278个，包含体外诊断试剂），同比减少7%。其中化药624个品种，中药178个品种，生物制品156个品种。以审评任务类型统计，IND申请完成审批140个品种，NDA申请25个品种，ANDA申请231个品种，一致性评价品种72个品种。按药智数据审评结论统计，批准临床186个品种，批准生产201个品种，批准进口17个品种。未被批准数量来看，为本年度前10月之最，高达115个品种，同比增长64%，从ATC分类来看，主要集中于系统用抗感染药，消化道及代谢。图1 2024年5-10月注册审评结论品种情况以注册分类统计，1类创新型新药完成审批112个品种，同比减少4%，IND申请完成审批107个品种，批准率达100%；NDA申请5个品种，批准率达80%。2类改良型新药完成审批38个品种，IND申请完成审批27个品种，均已批准；NDA申请11个品种，2个品种未被批准。 3类化学仿制药完成审批91个品种，批准临床14个品种，批准生产59个品种，未被批准18个品种。4类化学仿制药ANDA申请完成审批145个品种。生物类似药完成审批10个品种，其中临床试验申请6个品种，批准率达100%；上市申请4个品种，批准率为75%。境外原研5.1类NDA申请完成审批5个品种，批准率达100%。5.2类NDA申请完成审批9个品种，3个品种未被批准。表1 2024年10月创新型、改良型新药上市情况注：数据统计至2024年11月10日 >02< 申报同比减少12% 2024年10月份CDE共受理新的药品注册申请以品种（按药品+企业维度）统计1035个（受理号1366个），同比减少12%。其中化药636个品种，中药237个品种，生物制品162个品种。图2 2024年5-10月注册受理药品类型品种情况以审评任务类型统计，受理新药临床试验申请（以下简称IND）164个品种；新药上市许可申请（以下简称NDA）35个品种；同名同方药、仿制药、生物类似药上市许可申请（以下简称ANDA）299个品种；仿制药质量和疗效一致性评价注册申请（该注册申请类别以下简称一致性评价申请）32个品种。图3 2024年5-10月注册受理任务类型品种情况以注册分类统计，1类创新药受理131个品种，同比减少10%。其中IND申请127个品种，NDA申请仅有4个品种。1类创新药NDA申请分别是江苏恒瑞医药的SHR2554片、Cytokinetics与箕星药业共同开发的Aficamten片、首药控股的康太替尼颗粒，以及四川科伦博泰生物的注射用芦康沙妥珠单抗。 2类改良型新药注册申请受理43个品种，同比减少17%。改良型化药申请32个品种，改良型生物制品申请11个品种，中药品种暂无申请。2类改良型新药IND申报品种最多的企业是江西施美药业，共计申报3个品种；NDA申报品种数最多的企业是荣昌生物，申报2个品种，分别是注射用泰它西普、注射用维迪西妥单抗。 3类化学仿制药注册申请受理134个品种，其中验证性临床申请12个品种，ANDA申请122个品种。4类化学仿制药受理172个品种。中药同名同方药受理1个品种，是神威药业申报上市的3.1类药品——桃红四物颗粒。生物类似药受理18个品种，其中预防用生物制品5个品种，治疗用生物制品13个品种。 5.1类境外原研NDA申请5个品种，5.2类NDA申请4个品种。表2 2024年10月创新药与改良型新药注册申请受理情况 >03< 纳入优先审评品种5个，突破性治疗5个 2024年10月份CDE共将5个品种纳入了优先审评名单，多数为国产品种。以药品类型统计，化药3个品种，生物制品2个品种，中药未有品种纳入优先审评。纳入优先审评理由分别有“纳入突破性治疗药物程序”“附条件批准”“其他优先审评审批情形”。突破性治疗品种名单同样有5个品种，全为生物制品，涉及乳腺癌、小细胞肺癌、乙肝等适应症。表3 2024年10月优先审评与突破性治疗品种名单注：数据按公示日期进行统计数据来源：药智数据企业版——药品注册与受理数据库声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

临床申请生物类似药一致性评价

100 项与 Zeprumetostat 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
外周T细胞淋巴瘤	申请上市	中国	江苏恒瑞医药股份有限公司	2024-10-11
晚期前列腺癌	临床2期	中国	江苏恒瑞医药股份有限公司	2024-09-06
难治性滤泡性淋巴瘤	临床2期	中国	江苏恒瑞医药股份有限公司	2024-04-01
难治性经典霍奇金淋巴瘤	临床2期	中国	中国人民解放军总医院	2023-06-14
去势抵抗性前列腺癌	临床2期	美国	Treeline Biosciences, Inc.初创企业	2023-02-12
晚期恶性实体瘤	临床2期	中国	中国人民解放军总医院	2020-09-01
B细胞淋巴瘤	临床2期	中国	中国人民解放军总医院	2020-09-01
转移性去势抵抗性前列腺癌	临床2期	中国	江苏恒瑞医药股份有限公司	2018-11-20
典型霍奇金淋巴瘤	临床1期	中国	苏州大学附属第一医院	2022-07-01
T细胞淋巴瘤	临床1期	中国	苏州大学附属第一医院	2022-07-01

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临床结果

适应症

分期

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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


NCT04407741 (ASCO2023) 人工标引	临床1期	实体瘤 \| 晚期淋巴瘤	32	SHR-1701 + SHR2554	夢簾觸窪鏇窪憲鏇築鬱(衊鏇餘築廠觸範製製糧) = SHR2554 350mg bid plus SHR-1701 30mg/kg q3w 鏇遞積網衊選艱遞鏇範 (艱廠鏇夢廠網壓淵積繭 ) 更多	积极	2023-05-31