国内首款CAR-T产品上市在即

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2021-01-27 10:10
Views:

(Summary description)国内首款CAR-T产品上市在即复星凯特的CD19 CAR-T疗法益基利仑赛注射液有望于近期获NMPA批准上市，一旦获批，将会成为国内首款、全球第四款获批上市的CAR-T疗法产品，中国CAR-T疗法也将为国内肿瘤免疫治疗开启新篇章。 CAR-T疗法 CAR-T细胞疗法主要是利用T细胞启动人体自然宿主防御机制。与传统的癌症治疗药物不同，CAR-T通过向患者DNA中导入编码CAR的基因对T细胞进行修饰，T细胞增殖后回输患者体内表达CAR，就可以对靶细胞进行杀伤。CAR-T可以在识别肿瘤抗原时无需主要组织相容性复合体（MHC）的限制，能够识别MHC非依赖型靶标，同时通过共刺激性分子信号增强T细胞免疫的杀伤性，从而克服由于肿瘤细胞下调MHC表达或抑制共刺激分子分泌而造成的免疫逃逸。CAR-T就是一种经过基因修饰的T细胞，比普通T细胞定位攻击肿瘤细胞的能力更强。益基利仑赛注射液益基利仑赛注射液是吉利德/Kite制药开发的CD19CAR-T细胞注射液（商品名Yescarta），该产品将被开发用于治疗两线或以上系统性治疗后复发或难治性大B细胞淋巴瘤，包括：弥漫性大B细胞淋巴瘤（DLBCL）非特指型、原发性纵隔B细胞淋巴瘤（PMBCL）、高级别B细胞淋巴瘤和滤泡淋巴瘤转化的DLBCL。 CAR-T竞争格局目前，全球共有三款获批上市的CAR-T细胞免疫治疗产品，包括Kite制药的Yescarta和Tecartus以及诺华的Kymriah，三者均靶向CD19。CAR-T提供了一种新的治疗手段，并且展现出突破性疗效，自体抗CD19-CAR-T细胞的临床试验在成人和儿童r/r ALL患者中获得了高达93%的缓解率，在r/r CLL患者中使用CAR-T细胞进行的临床试验表明，总有效率（ORR）高达75%，完全缓解（CR）高达66%，同样CAR-T在一些淋巴瘤患者中也展现出前所未有的缓解率。截至目前，全球市场共有366款CAR-T在研，3款CAR-T产品获批上市。国内方面，除了复星凯特外，仅药明巨诺一家的CAR-T产品瑞基仑赛报上市。此外，有多个CAR-T处于临床阶段，其中南京传奇的BCMA靶向CAR-T已于2020年8月被CDE纳入突破性疗法程序。虽然欧美药企在CAR-T领域走在前列，但中国药企也在努力追赶，相信复星凯特Yescarta上市后将在CAR-T市场分一杯羹。

国内首款CAR-T产品上市在即

(Summary description)国内首款CAR-T产品上市在即

复星凯特的CD19 CAR-T疗法益基利仑赛注射液有望于近期获NMPA批准上市，一旦获批，将会成为国内首款、全球第四款获批上市的CAR-T疗法产品，中国CAR-T疗法也将为国内肿瘤免疫治疗开启新篇章。

CAR-T疗法

CAR-T细胞疗法主要是利用T细胞启动人体自然宿主防御机制。与传统的癌症治疗药物不同，CAR-T通过向患者DNA中导入编码CAR的基因对T细胞进行修饰，T细胞增殖后回输患者体内表达CAR，就可以对靶细胞进行杀伤。CAR-T可以在识别肿瘤抗原时无需主要组织相容性复合体（MHC）的限制，能够识别MHC非依赖型靶标，同时通过共刺激性分子信号增强T细胞免疫的杀伤性，从而克服由于肿瘤细胞下调MHC表达或抑制共刺激分子分泌而造成的免疫逃逸。CAR-T就是一种经过基因修饰的T细胞，比普通T细胞定位攻击肿瘤细胞的能力更强。

益基利仑赛注射液

益基利仑赛注射液是吉利德/Kite制药开发的CD19CAR-T细胞注射液（商品名Yescarta），该产品将被开发用于治疗两线或以上系统性治疗后复发或难治性大B细胞淋巴瘤，包括：弥漫性大B细胞淋巴瘤（DLBCL）非特指型、原发性纵隔B细胞淋巴瘤（PMBCL）、高级别B细胞淋巴瘤和滤泡淋巴瘤转化的DLBCL。

CAR-T竞争格局

目前，全球共有三款获批上市的CAR-T细胞免疫治疗产品，包括Kite制药的Yescarta和Tecartus以及诺华的Kymriah，三者均靶向CD19。CAR-T提供了一种新的治疗手段，并且展现出突破性疗效，自体抗CD19-CAR-T细胞的临床试验在成人和儿童r/r ALL患者中获得了高达93%的缓解率，在r/r CLL患者中使用CAR-T细胞进行的临床试验表明，总有效率（ORR）高达75%，完全缓解（CR）高达66%，同样CAR-T在一些淋巴瘤患者中也展现出前所未有的缓解率。

截至目前，全球市场共有366款CAR-T在研，3款CAR-T产品获批上市。国内方面，除了复星凯特外，仅药明巨诺一家的CAR-T产品瑞基仑赛报上市。此外，有多个CAR-T处于临床阶段，其中南京传奇的BCMA靶向CAR-T已于2020年8月被CDE纳入突破性疗法程序。

虽然欧美药企在CAR-T领域走在前列，但中国药企也在努力追赶，相信复星凯特Yescarta上市后将在CAR-T市场分一杯羹。

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2021-01-27 10:10
Views:

Information

国内首款CAR-T产品上市在即

复星凯特的CD19 CAR-T疗法益基利仑赛注射液有望于近期获NMPA批准上市，一旦获批，将会成为国内首款、全球第四款获批上市的CAR-T疗法产品，中国CAR-T疗法也将为国内肿瘤免疫治疗开启新篇章。

CAR-T疗法

CAR-T细胞疗法主要是利用T细胞启动人体自然宿主防御机制。与传统的癌症治疗药物不同，CAR-T通过向患者DNA中导入编码CAR的基因对T细胞进行修饰，T细胞增殖后回输患者体内表达CAR，就可以对靶细胞进行杀伤。CAR-T可以在识别肿瘤抗原时无需主要组织相容性复合体（MHC）的限制，能够识别MHC非依赖型靶标，同时通过共刺激性分子信号增强T细胞免疫的杀伤性，从而克服由于肿瘤细胞下调MHC表达或抑制共刺激分子分泌而造成的免疫逃逸。CAR-T就是一种经过基因修饰的T细胞，比普通T细胞定位攻击肿瘤细胞的能力更强。

益基利仑赛注射液

益基利仑赛注射液是吉利德/Kite制药开发的CD19CAR-T细胞注射液（商品名Yescarta），该产品将被开发用于治疗两线或以上系统性治疗后复发或难治性大B细胞淋巴瘤，包括：弥漫性大B细胞淋巴瘤（DLBCL）非特指型、原发性纵隔B细胞淋巴瘤（PMBCL）、高级别B细胞淋巴瘤和滤泡淋巴瘤转化的DLBCL。

CAR-T竞争格局

目前，全球共有三款获批上市的CAR-T细胞免疫治疗产品，包括Kite制药的Yescarta和Tecartus以及诺华的Kymriah，三者均靶向CD19。CAR-T提供了一种新的治疗手段，并且展现出突破性疗效，自体抗CD19-CAR-T细胞的临床试验在成人和儿童r/r ALL患者中获得了高达93%的缓解率，在r/r CLL患者中使用CAR-T细胞进行的临床试验表明，总有效率（ORR）高达75%，完全缓解（CR）高达66%，同样CAR-T在一些淋巴瘤患者中也展现出前所未有的缓解率。

截至目前，全球市场共有366款CAR-T在研，3款CAR-T产品获批上市。国内方面，除了复星凯特外，仅药明巨诺一家的CAR-T产品瑞基仑赛报上市。此外，有多个CAR-T处于临床阶段，其中南京传奇的BCMA靶向CAR-T已于2020年8月被CDE纳入突破性疗法程序。

虽然欧美药企在CAR-T领域走在前列，但中国药企也在努力追赶，相信复星凯特Yescarta上市后将在CAR-T市场分一杯羹。

Keyword:

Previous: 看春晚“拓荒牛”浅谈专利为企业的保驾护航

Next: 辞旧迎新，关怀送暖省市台办领导走访慰问莅临华讯平台

Previous: 看春晚“拓荒牛”浅谈专利为企业的保驾护航

Next: 辞旧迎新，关怀送暖省市台办领导走访慰问莅临华讯平台

Electronic Arts pledges free use for five accessibility patents

Electronic Arts pledges free use for five accessibility patents Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The code of the mentioned technology is published on EA’s GitHub, and it is open to all developers. Thus, the developers can use it or adapt it for their games without spending the costs to research. It is good that EA shares the patents for free use and aims to create an accessibility-increased gaming environment for players. However, it is not “unconditional” to use the listed patents. In the pledge, EA mentioned that it may terminate the promise for a specific party which files a patent infringement lawsuit or other patent proceedings against EA. We can see parts of EV’s ambition behind the announcement—to build a large game developer league and a community of shared interests. Reference: https://www.ea.com/commitments/positive-play/accessibility-patent-pledge https://iknow.stpi.narl.org.tw/Post/Read.aspx?PostID=14562 https://www.polygon.com/22639469/apex-legends-electronic-arts-patent-pledge-accessibility-developers https://www.theverge.com/2021/8/24/22638535/ea-accessibility-patent-pledge-apex-legends-ping-system https://www.gamesradar.com/ea-secures-a-patent-for-the-apex-legends-ping-system-and-its-giving-it-away-for-free/ https://dotesports.com/apex-legends/news/apex-legends-ping-system-is-now-patent-free-for-accessibility https://www.nintendolife.com/news/2021/08/apex_legends_ping_system_now_patent-free_as_ea_announces_accessibility_pledge Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The

2021-10-22

The forum on "China's Intellectual Property-related Reform Measures and New Trends in Patent Litigation" will be held successfully!

The forum on "China's Intellectual Property-related Reform Measures and New Trends in Patent Litigation" will be held successfully! In response to the call for building a strong country with intellectual property rights, at 2 o'clock in the afternoon of October 21, the forum on "China's reform measures related to intellectual property rights and new trends in patent litigation" will be successfully held in Nanjing Jiangbei New District Industrial Technology Research and Innovation Park. The event was hosted by the Science and Technology Innovation Bureau of Nanjing Jiangbei New Area Management Committee, Nanjing Jiangbei New Area Industrial Technology Research and Innovation Park, Nanjing Intellectual Property Rights Protection Assistance Center Jiangbei New District Center, Nanjing Huaxun Intellectual Property Consultant Co., Ltd., Nanjing Intellectual Property Co-organized by the Protection Center (Nanjing Intellectual Property Rights Protection Assistance Center), Taiwan Pharmaceutical Development Association, and Gene Online. The director of Nanjing Intellectual Property Protection Center, Mou Xiaojian, delivered a speech. Director Mu expressed his warm congratulations on the holding of this event and introduced in detail the new pattern of intellectual property protection in Nanjing. He said: At present, Nanjing has implemented a rights protection assistance network in the municipal area. With full coverage, Nanjing Intellectual Property Protection Center is willing to closely communicate and interact with Nanjing's innovation entities, and provide relevant public welfare services such as rapid pre-review, rapid rights protection, and comprehensive utilization for enterprises in need. In addition, Huang Funan, CEO of Gene Online, was unable to come to congratulate due to the epidemic, and recorded a congratulatory video. In the video, he said: China Innovative Pharmaceuticals has already made many outstanding achievements on the international stage, and these are inseparable from intellectual property rights. The support of the company can also show the importance of intellectual property rights to biotechnology and pharmaceutical companies. This event invites four industry experts to focus on China's reform measures related to intellectual property rights and new trends in patent litigation, discuss with companies and universities, and make arrangements in advance. Dr. Qingchen Hou, general manager of Nanjing Huaxun Intellectual Property Consulting Co., Ltd., introduced the "Guidelines for Building a Powerful Country with Intellectual Property Rights (2021-2035)" and explained his views from four aspects: background, strategic layout, overall requirements, and organizational guarantees. . Subsequently, a detailed analysis of China's patent linkage system was carried out, and compared with the same types of cases at home and abroad, questions were raised: Why should we reward the first person who successfully challenged patents? Not the first person to file a P4 application? And have a series of discussions with you. Director Jiang Haijun of the Intellectual Property Protection Legal Committee of the Nanjing Lawyers Association gave a speech on three points: the problems after the amendment of the patent law, the enforceability of the amount of compensation, and the legal conflicts related to service inventions. Regarding the patent right evaluation report, he emphasized that the patentee, interested party or accused infringer can also proactively issue a patent right evaluation report. "Patent is a work of art that combines technology and law" is a message shared by Mr. Feng Tao from Jiangsu Junbo Law Firm at this event. Mr. Feng analyzes the big data of Chinese patent litigation cases through graphs and examples. Explore. The last topic of the event was shared by Guo Huangying, Intellectual Property Manager of Nanjing Huaxun Intellectual Property Agency (General Partnership)-China's Patent Infringement Judgment Principles and New Developments. Manager Guo explained to everyone the principles of patent infringement judgment and the necessity of patent infringement search and analysis before producing and selling products. In the intellectual property industry, ECCOM has been providing high-quality and professional comprehensive intellectual property services to enterprises and universities one step at a time. It also hopes that under the leadership of the state and the government, it will contribute to the building of a strong intellectual property nation in China. Make a contribution.

2021-10-22

Types of patents that are easily overlooked- Design Patent

Types of patents that are easily overlooked- Design Patent In recent years, as the public’s awareness of intellectual property has increased, people have begun to consciously use the patent law to protect their intellectual property rights. However, in the process of implementation, they often only focus on invention patent and utility model patent, and tend to ignore the protection of design patent. Recently, Midea sued Haotaitai for two models of CXW-300-D998 and CXW-300-D908 Haotaitai brand range hoods In the case of suspected infringement of its design patent (patent number: ZL201930621598.X), the Guangzhou Intellectual Property Court made a first-instance judgment after hearing that it determined that the two products of Haotaitai constituted infringement, and ordered it to immediately stop the infringement and compensate Midea, The company's economic losses and reasonable expenses totaled 360,000 yuan. In fact, appearance infringement cases have occurred from time to time before, such as: "Molly" blind box design patent case, "Siemens" switch design patent infringement dispute case received a compensation of 6 million yuan, three Casio watch design patents were infringed Received a compensation of 8.8 million yuan and so on. The reason why people ignore the protection of design patents, in the final analysis, is that they have insufficient knowledge of design patents. Today, let's take a look at what is protected by design patents and what rights protections can we apply for? Design patent definition: Article 2 of the "Patent Law", design patent, refers to a new design that is aesthetically pleasing and suitable for industrial applications based on the shape, pattern, or combination of products, and the combination of color, shape, and pattern. Protected range: The shape of the product; the pattern of the product; the shape and pattern of the product; the shape and color of the product; the pattern and color of the product; the shape, pattern and color of the product. Protection period: The term of protection for design patent rights is 15 years, calculated from the date of filing. What are the conditions for applying for a design patent? The design should be aesthetically pleasing Appearance patents should be suitable for industrial applications The design patent application should be novel The design patent application should be inventiveness What are the advantages and functions of design patents? Protect the rights and interests of enterprises in product designs and fight against infringements in market competition. To enhance brand value, the quality and quantity of patents are the embodiment of the company's innovation ability and core competitiveness. Receive consumer recognition. If a company's new product appearance is filed for a patent in a timely manner, its appearance design will enjoy the exclusive right. Nowadays, consumers often choose products with trendy and beautiful appearance when buying their products. Applying for a design patent is a necessary condition for applying for a high-tech enterprise.

2021-09-26

Colopl Settles Patent Infringement Lawsuit with Nintendo by Paying $30 Million

Colopl Settles Patent Infringement Lawsuit with Nintendo by Paying $30 Million This August, Nintendo and a game developer Colopl announced that they have settled for patent infringement regarding White Cat Project (Shironeko Project in Japanese), a smartphone game developed by Colopl. Although both companies did not publicly share exact details of the settlement, at least it is sure that Colopl agreed to pay 3.3 billion yen (about US$30.2 million) as the settlement fee for the proceedings, including the future license of Nintendo's patents. How did the battle begin? Being developed and published by a Japanese game developer, Colopl, White Cat Project is a free-to-play action role-playing game for Android and iOS systems. The mobile game was launched in July 2014 as well as got a television anime adaptation in 2020. It is incredibly popular to have more than 50 million downloads. Furthermore, the game is set to receive a Switch version titled "Shironeko New Project". In September 2016, Nintendo noted the Colopl's game and considered that the game had infringed on several of Nintendo's technology patents. The two companies communicated with each other for over a year; however, Nintendo did not accept the explanations from Colopl, and Nintendo filed a lawsuit against Colopl at the beginning of 2018. Nintendo claimed that Colopl infringed 6 of its patents. These patents protect touch-screen joystick functionality (patent no. JP3734820), multiplayer connectivity (patent no. JP5595991, JP6271692), confirmation screens in sleep mode (patent no. JP4010533), character attacks based on touch input locations (patent no. JP4262217), and a shadow effect placed on characters hidden behind the game geometry (patent no. JP3637031). These patents almost cover various ways of game technology, especially the patent JP5595991 and JP6271692. Their patent family is wide-reaching, and many divisional applications of the family are pending in Japan. They protect a communication game system and its related devices. It is not easy to detect the patent's existence and boundary since this kind of hardcore technique is so common in the gaming field and our daily lives. The five-year patent war has been settled. After a five-year dispute, the situation appeared to turn in Nintendo's favor as the Switch maker increased its monetary demands, which convinced Colopl to strike a deal that lets it use the disputed patents. Furthermore, a Switch version of White Cat Project remains in the works at Colopl. With the extraordinary losses of Colopl, the legal battle between the two companies came to an end.

2021-09-09