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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.


Can artificial intelligence (AI) be registered as an inventor? As Stephen Thaler, the owner of Dabus, succeeded in letting AI be recognized as an inventor in South Africa and Australia, the challenge has transferred to Europe. In September, the UK court rejected the notion that the AI system Dabus is an inventor in its own right. However, after Thaler failed the appeal in the UK, the situation became a little different in Germany. The German Federal Patent Court gave a solution. The decision pointed a way forward in the debate surrounding how inventions created by AI can be correctly registered. The person behind the process must be named as the inventor on the inventor form, and this may be supplemented by the AI system. Patent authorities and courts around the globe have dealt with the inventions of Dabus. The German Federal Patent Court has now come to a pragmatic decision over DE1020191281202. According to the court, the listed inventor must be a natural person, even if the AI has identified both the problem and the solution. At the same time, however, the AI system itself can be additionally named. There is also a great deal of academic interest in the proceedings because of the fundamental role of AI in the invention protection. Following the decisions in Germany and the UK, the patent scene awaits the hearing at the European Patent Office on 21 December 2021. Reference:

Zhongsheng Pharma: Holding subsidiary obtains international patent certificate

Zhongsheng Pharma: Holding subsidiary obtains international patent certificate Recently, Zhongsheng Pharmaceutical (002317.SZ) issued an announcement that Guangdong Zhongsheng Ruichuang Biotechnology Co., Ltd. (referred to as "Zhongsheng Ruichuang"), a subsidiary of the company, has received patent certificates issued by the US Patent and Trademark Office and the Japan Patent Office. Among them, the certified patent ANTI-INFLUENZA VIRUS PYRIMIDINE DERIVATIVE is a compound patent of the ZSP1273 project, an innovative drug developed by Zhongsheng Ruichuang for the prevention and treatment of influenza A and human avian influenza, and belongs to the core patent of the project. The ZSP1273 project is the first small-molecule RNA polymerase inhibitor approved for clinical trials in China for the treatment of influenza A. A phase III clinical trial for the treatment of adult simple influenza A is currently underway to further confirm its efficacy and safety. ZSP1273 granules have obtained the "Notice of Drug Clinical Trial Approval" issued by the National Medical Products Administration (NMPA), and are actively preparing to carry out phase II clinical studies of simple influenza for children. Another certified patent for the amorphous form of a pyrrolidine derivative as a PPAR agonist and its preparation method is the crystal form patent of the ZSP0678 project, a class of innovative drugs deployed in the field of liver diseases by Zhongsheng Ruichuang, which belongs to the core patent of the project. ZSP0678 is an innovative drug developed by Zhongsheng Ruichuang for the treatment of non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC) with a clear mechanism of action and independent intellectual property rights. At present, the clinical trial of ZSP0678 tablets for the treatment of NASH has been approved by the NMPA, and it is in the stage of writing the summary report of the phase I clinical study. The clinical trial of ZSP0678 tablets for the treatment of  PBC for new indications has obtained the "Clinical Trial Notice" issued by the NMPA, and the clinical trial work will be organized and implemented as planned. Up to now, the compound patent of the ZSP1273 project has been granted patents in China, the United States, Japan, South Korea, Australia, New Zealand, Russia, Singapore, South Africa, Hong Kong Special Administrative Region, Macau Special Administrative Region and other countries/regions; The crystal form patent of the ZSP0678 project has obtained patent authorization from Australia, Russia, Japan and other countries/regions, and the global intellectual property protection system of the company's innovative drug project is gradually improving.


近日,太平鸟因屡陷抄袭风波而被冲上热搜,曾一度被评为国货之光并转型成功的太平鸟再次被推向公众审判台。太平鸟企业因抄袭而产生的一次次纠纷属于服装行业的知识产权纠纷,具体涉及的是服装著作权的问题。 在著作权意义上,服装可以分为两类,第一类是指目前服装市场上一些定型化的大类服装;第二类是指具有欣赏性的时装艺术服装。对于第二类,它一般是由专门的服装设计者设计,表达着特定的思想与情感,体现了设计者的独特构思,属于我国著作权法所规定的作品,应受著作权法保护。第二类服装设计中的设计图纸包含服装设计效果图和服装框架图。服装设计效果图能够归于绘画作品类开展保护。而具备独创性的服装框架图可归于图型作品和实体模型作品开展保护。但著作权作为一种内在的权利,它随着作品的创作而产生,而不是产生于行政机关的承认,作品一经完成则自动受保护,无需登记注册,但同时也很难确定服装设计的创作日期,导致原创设计者怠于维权。 为了后期更有效地积极维权,原创设计者可及时将作品进行著作权登记,虽然著作权登记不是著作权保护的必要条件,但是在侵权发生时,著作权登记能够更容易地证明著作权的归属,可提高维权效率。但在维权过程中,还有一关键问题困扰于设计者,即如何界定是否构成侵权,有些人认为只要存在几处设计上的不同就可以规避侵权,该认知会一定程度的助长抄袭现象,也会极大损害原创设计者的合法权益。对著作权侵权的判断标准是“接触+实质相似”,即后一作品的作者有机会接触到前一作品,且后一作品与前一作品应受著作权保护的部分构成实质相似。其中,著作权中是否构成实质相似的判断与外观设计专利的判断类似,也需要从普通公众的视角出发进行判断。若有需要,可依托专业人士的专业知识及其专业运用,寻求最优的维权方式。 为了整个服装行业的健康有序发展,不仅需要原创设计者的积极维权,还需要提高行业内对版权的保护意识,创造良好的版权保护氛围。服装企业在发展中,应增强研发力度,回归设计本身,注重独创性设计,才能在激烈的竞争中立足。



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