齐鲁制药安可达获批，国产生物类似药家族迎第三位成员

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Author:华讯知识产权
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Time of issue:2020-01-21 19:50
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(Summary description)12月9日，齐鲁制药有限公司研制的贝伐珠单抗注射液（商品名：安可达）上市注册申请获得国家药品监督管理局批准。该药是国内首家以原研贝伐珠单抗为参照药、按照生物类似药途径研发和申报生产的产品，是国内获批的首个贝伐珠单抗生物类似药，主要用于晚期、转移性或复发性非小细胞肺癌、转移性结直肠癌患者的治疗。这意味着齐鲁制药历时近10年科研攻关的重磅产品——重组抗VEGF人源化单克隆抗体注射液（商品名：安可达

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齐鲁制药安可达获批，国产生物类似药家族迎第三位成员

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2020-01-21 19:50
Views:

Information

12月9日，齐鲁制药有限公司研制的贝伐珠单抗注射液（商品名：安可达）上市注册申请获得国家药品监督管理局批准。该药是国内首家以原研贝伐珠单抗为参照药、按照生物类似药途径研发和申报生产的产品，是国内获批的首个贝伐珠单抗生物类似药，主要用于晚期、转移性或复发性非小细胞肺癌、转移性结直肠癌患者的治疗。

这意味着齐鲁制药历时近10年科研攻关的重磅产品——重组抗VEGF人源化单克隆抗体注射液（商品名：安可达）即将进入临床使用，将提高该类药品的可及性，为国内患者治疗提供了新的选择。

原研贝伐珠单抗（安维汀，Avastin）是一种人源化抗VEGF单克隆抗体，是罗氏旗下的全球首个可广泛用于多种瘤的抗血管生成药物，通过阻断VEGF而抑制肿瘤的血管新生，切断肿瘤区域的供血，抑制肿瘤的生长和转移，从而产生抗肿瘤作用。

该药于2004年首次获FDA批准，2005年在欧洲获批，2010年在中国上市用于治疗转移性结直肠癌，2015年又被NMPA批准用于治疗非小细胞肺癌。截止今日，获批包括结直肠癌、非小细胞肺癌、胶质母细胞瘤、肾细胞癌、宫颈癌、卵巢癌、输卵管癌、腹膜癌等多个实体瘤适应症。贝伐珠单抗的疗效和安全性已得到大量临床研究的证实，在多个瘤种中的应用，被国内外众多指南、诊疗规范纳入，并依据临床研究证据级别进行相应等级的推荐。

作为罗氏单抗三巨头之一，该药称霸销售榜多年，2018年全球市场销售额约为68.49亿瑞士法郎。Insight销售数据库显示，国内贝伐珠单抗2017年销售额约为15亿元。

贝伐珠单抗在中国的专利保护2018年到期，参与开发这样一个超级重磅品种的厂家日益增多，除首个获批的齐鲁制药是在2018年8月获得国家药品监督管理局药品审评中心受理承办之外，信达生物紧随其后于2019年1月提出上市申请获受理，目前共有12家企业处在临床III期，视为第二梯队；5家处于I期，视为第三梯队。

2017年国家医保谈判使得贝伐珠单抗的价格明显下调，从每瓶（100 mg/4 ml）5210元降为1998元，大大提高了可及性。未来随着国产生物类似物的陆续上市，中国肿瘤患者在贝伐珠单抗这一药物上的支付压力将会进一步减轻。

首款国产贝伐珠单抗生物类似药安可达成为了国产生物类似药家族的第三位成员。在其获批之后，2019年已有3款中国国产生物类似药获批，且均为重磅产品。它们分别是来自复宏汉霖的首款国产利妥昔单抗生物类似药；来自百奥泰生物的首款国产阿达木单抗生物类似药；以及来自齐鲁制药的首款国产贝伐珠单抗生物类似药。这是即将过去的这一年，中国生物医药产业在生物类似药研发领域取得的重大进展和突破。

生物类似药，是指在质量、安全性和有效性方面与已获准注册的参照药具有相似性的治疗用生物制品。通常，生物类似药上市被认为有助于提高生物药的可及性和降低价格，能够更好地满足公众对生物治疗产品的需求。

然而，由于生物药的研发和生产壁垒较高，在2019年之前中国尚未有国产生物类药获批上市。2015年2月，中国药品监管部门制订发布了《生物类似药研发与评价技术指导原则（试行）》。这为研发企业提供了方向，一部分中国医药研发企业快速布局生物类似药开发。

直至今年2月，中国首款生物类似药——由复宏汉霖研制的利妥昔单抗生物类似药的获批，使得该领域成功破冰。之后，百奥泰生物和齐鲁制药也各自拿下了重磅生物类似药的“首款”称号。值得一提的是，根据中国国家药监局早前公开数据，目前中国已成为生物类似药在研药物数量最多的国家，先后有近200余个生物类似药临床申请获得批准，且部分在研产品已完成3期临床，并提交了上市申请。

中国在2019年在生物类似药研发领域取得重大进展，这离不开中国一批生物医药企业和研发科学家们的努力，也离不开国家鼓励药械创新、鼓励生物类似物研发等政策的支持，以及近年来中国国家药监局在加快药品审评审批、解决药品可及性问题方面做出的努力。这些药物必将为患者带来新的治疗选择，也希望未来有更多新药好药为疾病治疗和人类健康发挥更大的能量。

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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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Types of patents that are easily overlooked- Design Patent

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

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