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Innovative Anti-tumor Drug Lurbinectedin Received Clinical Approval in China

  • 分类:最新消息
  • 作者:华讯知识产权
  • 来源:
  • 发布时间:2020-08-28 14:18
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【概要描述】Following the approval of the innovative anti-tumor drug Lurbinectedin in the United States in June this year, it is used to treat adult patients with metastatic Small Cell Lung Caner (SCLC) who have progressed during or after platinum drug chemotherapy. According to the latest announcement by the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration on August 27,the innovative anti-tumor drug Lurbinectedin introduced by Luye Pharma has been approved for clinical use in China and is intended to be used for the treatment of SCLC patients after the failure of first-line platinum-containing chemotherapy. SCLC is one of the more common types of lung cancer, accounting for about 15%-20% of bronchogenic lung cancer. Although compared with other types of lung cancer, SCLC accounts for a small proportion of all lung cancers and has better curative effect of chemotherapy and radiotherapy, unfortunately, most SCLC patients will have relapse and drug resistance after initial treatment. which is often difficult to cure. Lurbinectedin is an Ecteinascidins derivative, an inhibitor of RNA polymerase II, and can covalently bind to the minor groove on the DNA double helix structure. RNA polymerase II is often over-activated during the transcription process of tumor cells, which can make tumor cells aberrate and apoptosis during mitosis, thereby reducing cell proliferation. This approval is mainly based on the clinical data of an open-label, multi-center, single-arm study of 105 patients with SCLC (including platinum-sensitive and resistant patients) who have progressed after platinum-based chemotherapy with Lurbinectedin monotherapy. The results of the study showed that the Overall Response Rate (ORR) assessed by the investigator reached 35%, and the median Duration of Response (DoR) was 5.3 months; the Independent Review Committee (IRC) assessed ORR reached 30%, and the median DoR was 5.1 months. In addition to the approval of Lurbinectedin in the United States, lurbinectedin has recently passed a special access mechanism to give priority to SCLC patients in Australia and Singapore. In addition, lurbinectedin has successively obtained orphan drug qualifications for the treatment of SCLC in the United States, the European Union, Switzerland and Australia. The approval of Lurbinectedin in China this time means that this product is about to enter the clinical development stage in China. Lurbinectedin is expected to provide new treatment options for SCLC patients and to bring more hope to SCLC patients.

Innovative Anti-tumor Drug Lurbinectedin Received Clinical Approval in China

【概要描述】Following the approval of the innovative anti-tumor drug Lurbinectedin in the United States in June this year, it is used to treat adult patients with metastatic Small Cell Lung Caner (SCLC) who have progressed during or after platinum drug chemotherapy. According to the latest announcement by the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration on August 27,the innovative anti-tumor drug Lurbinectedin introduced by Luye Pharma has been approved for clinical use in China and is intended to be used for the treatment of SCLC patients after the failure of first-line platinum-containing chemotherapy.



SCLC is one of the more common types of lung cancer, accounting for about 15%-20% of bronchogenic lung cancer. Although compared with other types of lung cancer, SCLC accounts for a small proportion of all lung cancers and has better curative effect of chemotherapy and radiotherapy, unfortunately, most SCLC patients will have relapse and drug resistance after initial treatment. which is often difficult to cure.

Lurbinectedin is an Ecteinascidins derivative, an inhibitor of RNA polymerase II, and can covalently bind to the minor groove on the DNA double helix structure. RNA polymerase II is often over-activated during the transcription process of tumor cells, which can make tumor cells aberrate and apoptosis during mitosis, thereby reducing cell proliferation.



This approval is mainly based on the clinical data of an open-label, multi-center, single-arm study of 105 patients with SCLC (including platinum-sensitive and resistant patients) who have progressed after platinum-based chemotherapy with Lurbinectedin monotherapy. The results of the study showed that the Overall Response Rate (ORR) assessed by the investigator reached 35%, and the median Duration of Response (DoR) was 5.3 months; the Independent Review Committee (IRC) assessed ORR reached 30%, and the median DoR was 5.1 months.



In addition to the approval of Lurbinectedin in the United States, lurbinectedin has recently passed a special access mechanism to give priority to SCLC patients in Australia and Singapore. In addition, lurbinectedin has successively obtained orphan drug qualifications for the treatment of SCLC in the United States, the European Union, Switzerland and Australia.

The approval of Lurbinectedin in China this time means that this product is about to enter the clinical development stage in China. Lurbinectedin is expected to provide new treatment options for SCLC patients and to bring more hope to SCLC patients.

  • 分类:最新消息
  • 作者:华讯知识产权
  • 来源:
  • 发布时间:2020-08-28 14:18
  • 访问量:
详情

Following the approval of the innovative anti-tumor drug Lurbinectedin in the United States in June this year, it is used to treat adult patients with metastatic Small Cell Lung Caner (SCLC) who have progressed during or after platinum drug chemotherapy. According to the latest announcement by the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration on August 27,the innovative anti-tumor drug Lurbinectedin introduced by Luye Pharma has been approved for clinical use in China and is intended to be used for the treatment of SCLC patients after the failure of first-line platinum-containing chemotherapy.

SCLC is one of the more common types of lung cancer, accounting for about 15%-20% of bronchogenic lung cancer. Although compared with other types of lung cancer, SCLC accounts for a small proportion of all lung cancers and has better curative effect of chemotherapy and radiotherapy, unfortunately, most SCLC patients will have relapse and drug resistance after initial treatment. which is often difficult to cure.

Lurbinectedin is an Ecteinascidins derivative, an inhibitor of RNA polymerase II, and can covalently bind to the minor groove on the DNA double helix structure. RNA polymerase II is often over-activated during the transcription process of tumor cells, which can make tumor cells aberrate and apoptosis during mitosis, thereby reducing cell proliferation.

This approval is mainly based on the clinical data of an open-label, multi-center, single-arm study of 105 patients with SCLC (including platinum-sensitive and resistant patients) who have progressed after platinum-based chemotherapy with Lurbinectedin monotherapy. The results of the study showed that the Overall Response Rate (ORR) assessed by the investigator reached 35%, and the median Duration of Response (DoR) was 5.3 months; the Independent Review Committee (IRC) assessed ORR reached 30%, and the median DoR was 5.1 months.

In addition to the approval of Lurbinectedin in the United States, lurbinectedin has recently passed a special access mechanism to give priority to SCLC patients in Australia and Singapore. In addition, lurbinectedin has successively obtained orphan drug qualifications for the treatment of SCLC in the United States, the European Union, Switzerland and Australia.

The approval of Lurbinectedin in China this time means that this product is about to enter the clinical development stage in China. Lurbinectedin is expected to provide new treatment options for SCLC patients and to bring more hope to SCLC patients.

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“医药产业的强国战略”线上论坛成功举行!

“医药产业的强国战略”线上论坛成功举行!

生物医药是攸关人民健康、维护国家安全的重要战略性产业,生物技术创新成为医药大国竞争的主战场。2021年12月发布的《“十四五”医药工业发展规划》明确提出了创新驱动转型的发展目标。为了响应国家生物医药创新,7月20日下午两点,“医药产业的强国战略--技术,资本与知识产权”线上论坛成功举行。                 本次活动由南京江北新区产业技术研创园和北京培优创新医药生物科技有限公司主办,华讯.国际知识产权与涉外法律服务平台、南京华讯知识产权顾问有限公司、华讯(上海)知识产权顾问有限公司、台湾庆辰法律事务所、健策知识产权顾问南京有限公司承办。   本次活动力邀四位行业专家,共同探讨、交流学习医药产业的强国战略--技术,资本与知识产权,目前我国生物医药创新水平与欧美发达国家和地区相比还有较大差距,从医药大国向强国迈进仍面临制度、技术、人才等方面的制约。但知识产权作为国家发展战略性资源和国际竞争力核心要素的作用更加凸显,实施知识产权强国战略,全面提升我国知识产权综合实力,大力激发全社会技术、资本与知识产权的创新活力,提升国家核心竞争力。     南京华讯知识产权顾问有限公司董事长侯庆辰博士分析了药品专利问题的三个利益族群:专利药商、仿制药商、用药大众,并强调任何涉及医药专利的议题,特别是产业化问题,都跟在政策上如何协调以上三者的利益息息相关。从医药专利强制许可的各个方面来解析,给大家提供了一系列建议。   庆辰法律事务所知识产权律师(澳大利亚)简志洋律师从海外的角度,首先分析了澳洲的医药市场的现状以及“旧药新用”的概念。同时为我们讲述了国际大药厂在走专利布局的时候,很多的第一布会从澳洲切入,那药企选择澳洲作为投资的考量优势又有哪些呢:1.效率高、2.投资回报率、3.专利纠纷。简律师给出“可以好好的使用,变成法律工具”的建议。   第三个讲题,由南京知和医药科技有限公司副总经理/多肽首席科学家丁伟博士为大家分享--疫情下国内医药企业的变革。丁博士为我们分析疫情下医药行业发展趋势,从政策层面来看医药企业面临的市场环境,以及对医药企业未来变革的思考。并讲述中医药的破局曙光。   活动的最后,恩然创投合伙人施凯凯博士向我们展示了中国创新药研发的发展历程与2022年上半年-IPO市场回顾,从中美错位对比的角度分析创新药市场发展路径,带来当前生物医药行业的基本判断--“历经风雨,回归常态” 。              华讯在知识产权行业中,一直是一步一个脚印的为企业和高校提供优质且专业的知识产权综合服务,希望在国家和政府的带领下,为中国知识产权强国建设出一份力量、作一份贡献。
2022-08-10
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