黑马！国内第一家拿到细胞免疫疗法药品临床批件的公司

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Time of issue:2018-03-26 13:42
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(Summary description)随着诺华、Kite制药的CAR-T产品获批上市以及国内细胞疗法监管路径清晰，CAR-T成为了产业界和投资界的热门领域，国内CAR-T公司的估值快速飙升，不仅有数家公司先后拿到巨额融资，也吸引了国际制药巨头的合作。　　不过放大到整个细胞治疗领域来看，国内率先按照药品形式申报并获得临床批件的细胞治疗产品并不在CAR-T领域，而是两款分别叫做「自体卵巢癌细胞毒T淋巴细胞注射液」和「扩增活化的淋巴细胞」的

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黑马！国内第一家拿到细胞免疫疗法药品临床批件的公司

Categories:最新消息
Author:
Origin:
Time of issue:2018-03-26 13:42
Views:

Information

　　随着诺华、Kite制药的CAR-T产品获批上市以及国内细胞疗法监管路径清晰，CAR-T成为了产业界和投资界的热门领域，国内CAR-T公司的估值快速飙升，不仅有数家公司先后拿到巨额融资，也吸引了国际制药巨头的合作。

　　不过放大到整个细胞治疗领域来看，国内率先按照药品形式申报并获得临床批件的细胞治疗产品并不在CAR-T领域，而是两款分别叫做「自体卵巢癌细胞毒T淋巴细胞注射液」和「扩增活化的淋巴细胞」的产品，分别于2015/3/11和2017/10/26获批临床，研发上述产品的公司则是一家被投资界忽略的黑马公司——永泰生物。

　　截至目前，国内已有16款细胞治疗产品按药品申报临床。永泰生物是国内第一家拿到细胞免疫疗法药品临床批件的公司，也是国内唯一一家同时拥有两个过继细胞免疫疗法临床批件的公司，具有明显先发优势。

　　以永泰生物新近获批的扩增活化的淋巴细胞(Expanded Activated Lymphocytes，EAL)产品为例介绍。EAL技术是由患者自身外周血液中的单个核细胞制备而成，主要成分为扩增活化的淋巴细胞，以CD8+杀伤性T淋巴细胞(表面标志为CD3分子)为主要活性成分。经过一次或多次回输，用于辅助治疗恶性肿瘤和慢性传染性病毒感染。自2006年成立以来，永泰生物一直致力于应用先进的免疫学、细胞生物学、遗传学等理论，结合国际先进过继免疫治疗方式，对肿瘤等重大疾病的免疫治疗及临床应用进行研究和开发，所掌握的自主专利技术——扩增活化的淋巴细胞(EAL，Expanded Activated Lymphocytes)，已经成功地应用于临床并取得了非常明确的疗效，获得了专家和患者的认可，逐渐成为继外科手术、放射疗法和化学药物疗法之后，肿瘤治疗的第四种疗法。该技术与国内同类技术相比，安全性更高，疗效更为明显，治疗痛苦小。优质的细胞产品和服务，使得永泰生物成为行业的翘楚。此外，永泰生物所研发的具有国际先进水平的抗原特异性淋巴细胞和树突状细胞免疫治疗临床应用技术，在部分患者中观察到治愈和(或)肿瘤长期不复发的结果。

　　EAL技术自2000年开始崭露头角，经过近20年的发展逐渐趋于成熟。日本开展的临床试验研究表明，肝癌患者术后进行了EAL治疗可明显推迟首次复发的时间，复发风险降低41%;韩国针对早期、晚期肝癌患者的EAL单独用药与联合用药试验结果显示，细胞免疫治疗组可显著延长中位无复发生存期，且死亡风险降低37%。

　　在向CDE申报临床前，永泰生物的EAL作为第三类医疗技术进行管理，与常规治疗方案联用已经在约5000名患者身上展开临床治疗，结果显示可显著延长包括非小细胞肺癌、胃癌、结直肠癌等恶性肿瘤患者的总生存期，其中有部分患者单独使用EAL细胞实现了超过5年的长期生存。比如，在北京大学人民医院儿科收治的65例AML患儿试验中，发现EAL联合化疗治疗儿童AML的疗效优于单纯化疗，可明显延长MRD阴性持续时间及无事件生存时间。在联合治疗试验中，在化疗10个月内加入细胞治疗可使更多的病人更好地清除MRD。

　　除了EAL之外，永泰生物在CAR-T领域也有深厚的管线储备。

　　永泰生物与解放军总医院肿瘤中心联合开展了CAR-T-19治疗难治复发型急性淋巴细胞白血病与淋巴瘤的科研型临床试验，并取得了良好的治疗效果。2017年6月-2018年2月期间，针对14例B-ALL儿童患者的实验中有93%缓解

　　永泰生物计划在今年年中提交CAR-T-19产品的IND申请。此外，永泰生物研发的其他CAR-T产品还包括HBV、CD22、BCMA等，均取得了有效的临床前数据。

　　https://www.sogou.com/link?url=DSOYnZeCC_ruHV9NZ_wnsNuKkj_Z381qycteo2GwoW1ujAyYY-bWhdFJy-VpKNtK3Jy14NR_TTk.

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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