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        Ruige Pharmaceutical's New Generation of CDK2/4/6 Small-molecule Inhibitor Receives FDA Approval for Clinical Research

        • 分类:最新消息
        • 作者:华讯知识产权
        • 来源:
        • 发布时间:2021-12-30 10:32
        • 访问量:

        【概要描述】Established in 2018, Ruige Pharmaceutical?is committed to the fields of tumors, autoimmunity and metabolism, and develops "first-in-class" and "best-in-class" innovative drugs with independent intellectual property rights. Recently, Ruige Pharmaceutical?announced that its new generation of CDK2/4/6 small- molecule inhibitor RGT-419B has been received FDA approval for clinical research. RGT-419B is a new-generation tumor-targeted inhibitor with an optimized kinase activity spectrum. It is expected to improve the safety of currently approved CDK4/6 inhibitors and overcome resistance to these inhibitors. These inhibitors are used in combination with endocrine therapy to treat patients with premenopausal/postmenopausal hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer. In cell model experiments, RGT-419B showed single-drug activity, which has a greater inhibitory effect on the growth of estrogen receptor positive (ER+) tumor cells. In ER+ breast cancer cells resistant to currently approved CDK4/6 inhibitors, RGT-419B showed complete inhibition of cancer cell proliferation. In these experiments, when RGT-419B is used in combination with a selective estrogen receptor degrader or PI3K signaling pathway inhibitor, its inhibitory effect on tumor cells is further enhanced. As a single agent and used in combination with other approved therapies, RGT-419B will initially be developed for the treatment of human epidermal growth factor receptor 2 negative (HER2-), ER+ breast cancer patients who have primary or acquired resistance to CDK4/6 inhibitors. With the widespread adoption of CDK4/6 inhibitors in clinical practice, patients with refractory and relapsed patients are becoming larger and clinically significant unmet medical needs. The clinical development project of RGT-419B will solve this resistance to CDK4/6 and other hormone receptor modulating therapies, and provide new opportunities for improving the survival and quality of life of patients with advanced breast cancer. RGT-419B is the first of many innovative oncology drugs being developed by Ruige Pharmaceutical. Founder and CEO Dr. Qiu Xiayang said: "This milestone marks the successful entry of Ruige Pharmaceutical into the field of tumor treatment. We have found the best choice for multiple CDKs through our self-developed AI-assisted new drug development CARD platform. Successfully promoted innovative drugs to enter the clinical development stage in the United States. At the same time, we are very excited that this opportunity can bring new and differentiated treatment options to many breast cancer patients around the world.

        Ruige Pharmaceutical's New Generation of CDK2/4/6 Small-molecule Inhibitor Receives FDA Approval for Clinical Research

        【概要描述】Established in 2018, Ruige Pharmaceutical?is committed to the fields of tumors, autoimmunity and metabolism, and develops "first-in-class" and "best-in-class" innovative drugs with independent intellectual property rights.



        Recently, Ruige Pharmaceutical?announced that its new generation of CDK2/4/6 small- molecule inhibitor RGT-419B has been received FDA approval for clinical research. RGT-419B is a new-generation tumor-targeted inhibitor with an optimized kinase activity spectrum. It is expected to improve the safety of currently approved CDK4/6 inhibitors and overcome resistance to these inhibitors. These inhibitors are used in combination with endocrine therapy to treat patients with premenopausal/postmenopausal hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer.

        In cell model experiments, RGT-419B showed single-drug activity, which has a greater inhibitory effect on the growth of estrogen receptor positive (ER+) tumor cells. In ER+ breast cancer cells resistant to currently approved CDK4/6 inhibitors, RGT-419B showed complete inhibition of cancer cell proliferation. In these experiments, when RGT-419B is used in combination with a selective estrogen receptor degrader or PI3K signaling pathway inhibitor, its inhibitory effect on tumor cells is further enhanced.



        As a single agent and used in combination with other approved therapies, RGT-419B will initially be developed for the treatment of human epidermal growth factor receptor 2 negative (HER2-), ER+ breast cancer patients who have primary or acquired resistance to CDK4/6 inhibitors. With the widespread adoption of CDK4/6 inhibitors in clinical practice, patients with refractory and relapsed patients are becoming larger and clinically significant unmet medical needs. The clinical development project of RGT-419B will solve this resistance to CDK4/6 and other hormone receptor modulating therapies, and provide new opportunities for improving the survival and quality of life of patients with advanced breast cancer.


        RGT-419B is the first of many innovative oncology drugs being developed by Ruige Pharmaceutical. Founder and CEO Dr. Qiu Xiayang said: "This milestone marks the successful entry of Ruige Pharmaceutical into the field of tumor treatment. We have found the best choice for multiple CDKs through our self-developed AI-assisted new drug development CARD platform. Successfully promoted innovative drugs to enter the clinical development stage in the United States. At the same time, we are very excited that this opportunity can bring new and differentiated treatment options to many breast cancer patients around the world.

        • 分类:最新消息
        • 作者:华讯知识产权
        • 来源:
        • 发布时间:2021-12-30 10:32
        • 访问量:
        详情

        Established in 2018, Ruige Pharmaceutical is committed to the fields of tumors, autoimmunity and metabolism, and develops "first-in-class" and "best-in-class" innovative drugs with independent intellectual property rights.

        Recently, Ruige Pharmaceutical announced that its new generation of CDK2/4/6 small- molecule inhibitor RGT-419B has been received FDA approval for clinical research. RGT-419B is a new-generation tumor-targeted inhibitor with an optimized kinase activity spectrum. It is expected to improve the safety of currently approved CDK4/6 inhibitors and overcome resistance to these inhibitors. These inhibitors are used in combination with endocrine therapy to treat patients with premenopausal/postmenopausal hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer.

        In cell model experiments, RGT-419B showed single-drug activity, which has a greater inhibitory effect on the growth of estrogen receptor positive (ER+) tumor cells. In ER+ breast cancer cells resistant to currently approved CDK4/6 inhibitors, RGT-419B showed complete inhibition of cancer cell proliferation. In these experiments, when RGT-419B is used in combination with a selective estrogen receptor degrader or PI3K signaling pathway inhibitor, its inhibitory effect on tumor cells is further enhanced.

        As a single agent and used in combination with other approved therapies, RGT-419B will initially be developed for the treatment of human epidermal growth factor receptor 2 negative (HER2-), ER+ breast cancer patients who have primary or acquired resistance to CDK4/6 inhibitors. With the widespread adoption of CDK4/6 inhibitors in clinical practice, patients with refractory and relapsed patients are becoming larger and clinically significant unmet medical needs. The clinical development project of RGT-419B will solve this resistance to CDK4/6 and other hormone receptor modulating therapies, and provide new opportunities for improving the survival and quality of life of patients with advanced breast cancer.

        RGT-419B is the first of many innovative oncology drugs being developed by Ruige Pharmaceutical. Founder and CEO Dr. Qiu Xiayang said: "This milestone marks the successful entry of Ruige Pharmaceutical into the field of tumor treatment. We have found the best choice for multiple CDKs through our self-developed AI-assisted new drug development CARD platform. Successfully promoted innovative drugs to enter the clinical development stage in the United States. At the same time, we are very excited that this opportunity can bring new and differentiated treatment options to many breast cancer patients around the world.

        关键词:

        华讯国际知识产权与涉外法律服务平台携手南京审计大学等六家单位共同成立南京审计大学企业合规研究中心

        华讯国际知识产权与涉外法律服务平台携手南京审计大学等六家单位共同成立南京审计大学企业合规研究中心

        为了促使刑事涉案企业依法合规经营,做实“少捕慎诉慎押”刑事司法政策,同时警示潜在的违法违规企业守法经营,最高人民检察院从2020年3月起稳步推进企业合规改革试点。 2021年12月31日上午,南京审计大学企业合规研究中心成立仪式暨企业合规实务研讨会在南京审计大学成功举行。 这标志着由华讯国际知识产权与涉外法律服务平台作为发起单位之一,参与发起的南京审计大学企业合规研究中心正式成立。 南京审计大学企业合规研究中心 指导单位 江苏省人民检察院 南京市人民检察院 江苏省内部审计协会 江苏法治报社 南京仲裁委员会 南京市江北新区综合治理局 南京市江北新区人民检察院 七家发起单位 南京审计大学 南京扬子国资投资集团有限责任公司 江苏三法(江北新区)律师事务所 厦门美亚亿安信息科技有限公司 南京九洲会计咨询有限公司 华讯国际知识产权与涉外法律服务平台 中审在线(南京)数字科技有限公司 在企业合规实务研讨会上,平台副总经理李悦宁从华讯平台优势出发,结合平台与现有资源,表示要助力南审企业合规研究中心成为企业合规理论和实践融合发展的实践者、企业合规建设发展的有力推动者,积极承担社会责任,为社会经济的健康发展作出更大的贡献。 华讯国际知识产权与涉外法律服务平台是2019年4月26日第19个国际知识产权日,由江北新区管委会牵线,南京华讯知识产权顾问有限公司和江北新区科技创新局揭牌成立,引进国外律所,第一批加入该平台的有台湾庆辰法律事务所、日本山本特许法律事务所、美国艾金?岗波(Akin Gump)国际法律事务所等。这是江苏省第一个真正意义的国际知识产权与涉外法律服务平台,为江北新区建设省级知识产权服务业集聚发展区提供新助力,进而打造国际化高端知识产权服务平合,助力江苏省乃至全国企业创新发展,迈向国际化市场。
        2022-01-07
        在中国发起专利诉讼的外企之地理分布

        在中国发起专利诉讼的外企之地理分布

        上一期推送中我们提到,原告被告都是外企,他们却纷纷选择来到中国提起专利诉讼(点击蓝字回顾原文),从中可以了解到:中国已成为世界上专利诉讼的主战场。那么,这些外企来自哪些国家呢? 从发明专利案件数量来看,过去十年间,以日本企业提起的发明专利案件数量最多,德国位居第二,美国排名第三。其中,戴森(Dyson Technology)的诉讼官司大幅提升了英国的排名,37件发明专利案件中占了28件。 日本公司为原告的数量排名第一其实并不意外。日本的地理位置上很靠近中国,这使日本企业更了解中国市场,且很可能产生利益竞争关系。这些因素大大增加了这些企业在中国提出诉讼的可能。 然而令人惊讶的是,同样是邻居的韩国企业提出的诉讼数量极低,在专利战略上远不及日本积极。一个可能的解释是,日本企业长期以来一直是中国地区专利的积极申请者,这意味着他们已经积累了大量适合提起诉讼的组合。另一方面,韩国企业可能在此年代没有布局中国,因此没有那么多的专利可以出击,故而出现了这样的极其明显的对比。
        2022-01-07
        Ruige

        Ruige Pharmaceutical's New Generation of CDK2/4/6 Small-molecule Inhibitor Receives FDA Approval for Clinical Research

        Established in 2018, Ruige Pharmaceutical?is committed to the fields of tumors, autoimmunity and metabolism, and develops "first-in-class" and "best-in-class" innovative drugs with independent intellectual property rights. Recently, Ruige Pharmaceutical?announced that its new generation of CDK2/4/6 small- molecule inhibitor RGT-419B has been received FDA approval for clinical research. RGT-419B is a new-generation tumor-targeted inhibitor with an optimized kinase activity spectrum. It is expected to improve the safety of currently approved CDK4/6 inhibitors and overcome resistance to these inhibitors. These inhibitors are used in combination with endocrine therapy to treat patients with premenopausal/postmenopausal hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer. In cell model experiments, RGT-419B showed single-drug activity, which has a greater inhibitory effect on the growth of estrogen receptor positive (ER+) tumor cells. In ER+ breast cancer cells resistant to currently approved CDK4/6 inhibitors, RGT-419B showed complete inhibition of cancer cell proliferation. In these experiments, when RGT-419B is used in combination with a selective estrogen receptor degrader or PI3K signaling pathway inhibitor, its inhibitory effect on tumor cells is further enhanced. As a single agent and used in combination with other approved therapies, RGT-419B will initially be developed for the treatment of human epidermal growth factor receptor 2 negative (HER2-), ER+ breast cancer patients who have primary or acquired resistance to CDK4/6 inhibitors. With the widespread adoption of CDK4/6 inhibitors in clinical practice, patients with refractory and relapsed patients are becoming larger and clinically significant unmet medical needs. The clinical development project of RGT-419B will solve this resistance to CDK4/6 and other hormone receptor modulating therapies, and provide new opportunities for improving the survival and quality of life of patients with advanced breast cancer. RGT-419B is the first of many innovative oncology drugs being developed by Ruige Pharmaceutical. Founder and CEO Dr. Qiu Xiayang said: "This milestone marks the successful entry of Ruige Pharmaceutical into the field of tumor treatment. We have found the best choice for multiple CDKs through our self-developed AI-assisted new drug development CARD platform. Successfully promoted innovative drugs to enter the clinical development stage in the United States. At the same time, we are very excited that this opportunity can bring new and differentiated treatment options to many breast cancer patients around the world.
        2021-12-30
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