丙肝新药进展！艾伯维向美国FDA提交泛基因型丙肝鸡尾酒G/P上市申请

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Time of issue:2016-12-26 10:55
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(Summary description)美国生物技术巨头艾伯维(AbbVie)近日宣布已向美国食品和药物管理局(FDA)提交了泛基因型丙肝鸡尾酒glecaprevir/pibrentasvir(G/P)的新药申请(NDA)。G/P(300mg/120mg)是一种泛基因型丙肝鸡尾酒，开发用于全部6种基因型丙肝的治疗;其中，glecaprevir(G)是一种NS3/4A蛋白酶抑制剂，pibrentasvir(P)则是一种NS5A抑制剂。如果

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丙肝新药进展！艾伯维向美国FDA提交泛基因型丙肝鸡尾酒G/P上市申请

Categories:最新消息
Author:
Origin:
Time of issue:2016-12-26 10:55
Views:

Information

　　美国生物技术巨头艾伯维(AbbVie)近日宣布已向美国食品和药物管理局(FDA)提交了泛基因型丙肝鸡尾酒glecaprevir/pibrentasvir(G/P)的新药申请(NDA)。G/P(300mg/120mg)是一种泛基因型丙肝鸡尾酒，开发用于全部6种基因型丙肝的治疗;其中，glecaprevir(G)是一种NS3/4A蛋白酶抑制剂，pibrentasvir(P)则是一种NS5A抑制剂。如果获批，G/P将为无肝硬化的全部基因型丙肝患者群体提供一种8周、全口服、每日一次、无利巴韦林(RBV)的治疗方案。今年10月，FDA已授予G/P治疗既往接受直接作用抗病毒药物(DAAs，包括NS5A抑制剂和/或蛋白酶抑制剂)未治愈的基因型1丙肝的突破性药物资格。在欧盟监管方面，艾伯维已计划在2017年初提交G/P的上市许可申请(MAA)。

　　在III期临床研究中，G/P 8周治疗方案在横跨全部6种基因型(GT 1-6)无肝硬化丙肝患者群体中实现了非常高的病毒学治愈率(SVR12，完成治疗后12周的持续病毒学应答);在伴有代偿性肝硬化的患者中，G/P 12周治疗方案也取得了非常高的病毒学治愈率。另外，G/P在治疗性选择有限的患者群体中也取得了非常高的治愈率，包括伴有严重慢性肾脏病(CKD)的患者。在历史上难以治疗的患者群体中，包括以前接受直接抗病毒药物(DAAs)未治愈的丙肝患者，G/P 12周治疗方案也取得了非常高的持续病毒学应答。

　　G/P NDA的提交，是基于艾伯维G/P临床开发项目中8个注册研究的数据，该项目在27个国家超过2300例丙肝患者中开展，评估了G/P治疗全部6种基因型丙肝的疗效和安全性，包括既往未接受治疗(初治)和既往接受治疗(经治)患者群体，伴有代偿性肝硬化和无肝硬化的患者群体，临床上极具挑战性的难治性患者群体，如伴有严重慢性肾脏病的患者及既往接受过直接作用抗病毒药物(DAAs)未治愈的患者。

　　之前公布的数据显示，G/P 8周治疗方案在无肝硬化和初治基因型1-6丙肝患者群体中的病毒学治愈率(SVR12)达到了97.5%(n=693/711)。上月中旬在美国波士顿举行的美国肝病研究协会年会(AASLD 2016)上公布的数据显示，在伴有严重慢性肾脏病(CKD)的基因型1-6(GT 1-6)丙肝患者中，意向治疗(ITT)分析显示G/P 12周方案的病毒学治愈率达到了98%(n=102/104);修正后的意向治疗(mITT)分析显示G/P 12周方案的病毒学治愈率达到了100%(n=102/102)。mITT排除了因各种原因(病毒学失败除外)未能达到SVR的患者。安全性方面，大多数治疗相关不良事件为轻度或中度，最常报道的不良事件包括瘙痒、疲劳、恶心。经历严重不良事件的24%患者中，无一例被认为与G/P相关。4例(4%)严重不良事件导致G/P停药，1例在达到SVR4后因一次严重不良事件(脑内出血)死亡，均被认为与G/P无关。

　　此次公布的数据也是艾伯维G/P临床开发项目的最新数据，该数据显示，泛基因型丙肝鸡尾酒G/P针对全部6种基因型丙肝治疗疗效均很高，包括伴有严重慢性肾脏疾病(CKD)的患者群体，同时该疗效与患者之前接受的治疗方案或是否伴有代偿性肝硬化均无关。

　　丙型肝炎成世界性流行现状，是欧美及日本等国家终末期肝病的最主要原因。在我国，丙肝患者人数已达1000万，并且以15%的速度持续增长。如此庞大的市场，却因为专利技术垄断，目前国内最常用的丙肝治疗药物仍是干扰素，不仅治愈率低，还存在副作用大的问题。目前国外市场上的最常见的Harvoni、Sovaldi、Viekira、Zepatier等都尚未进入中国市场，目前对这类药物的获取都依赖于代购，但相比于从美国代购，患者们更愿意从印度代购，因为同样的产品，从印度代购的疗效相差无几，价格却只有美国的10%。由此可见，这些药物的生产成品并不很高，期待中国企业早日完成仿制药的申请，在给企业带来效益的同时，挽救万千患者的生命。

　　新闻来源：http://news.bioon.com/article/6695845.html

　　本新闻经华讯团队重新编辑整理并添加分析意见。

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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

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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.

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

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