2018年即将在中国上市的药物（上）

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Time of issue:2017-12-27 01:47
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(Summary description)2017年，一大波进口和国产新药借助优先审评快速获批上市，一些幸运者还赶上了部分省市医保谈判的班车。那么在2018年中国市场还有哪些重磅新药值得期待呢?小编将分上下两期介绍即将上市的药物。　　1.注射用艾博卫泰-前沿生物　　艾博卫泰是前沿生物自主研发的1类新药，属于gp41抑制剂，是全球第一个长效艾滋病药物，其优势一方面是给药便捷，可每周注射给药1次，另一方面是对发生耐药的患者有效。艾博卫泰获得了

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2018年即将在中国上市的药物（上）

Categories:最新消息
Author:
Origin:
Time of issue:2017-12-27 01:47
Views:

Information

　　2017年，一大波进口和国产新药借助优先审评快速获批上市，一些幸运者还赶上了部分省市医保谈判的班车。那么在2018年中国市场还有哪些重磅新药值得期待呢?小编将分上下两期介绍即将上市的药物。

　　1.注射用艾博卫泰-前沿生物

　　艾博卫泰是前沿生物自主研发的1类新药，属于gp41抑制剂，是全球第一个长效艾滋病药物，其优势一方面是给药便捷，可每周注射给药1次，另一方面是对发生耐药的患者有效。艾博卫泰获得了国家重大新药创制专项资助。

　　注射用艾博卫泰的上市申请在2016/7/18获得CDE承办受理，走特殊审批通道，2016/11/3被CDE以“抗艾滋病，创新药”的理由纳入优先审评，目前技术审评(药学、药理毒理、临床)已完成，正在等待认证中心的现场检查，三合一报告(技术审评报告、现场核查报告、抽检报告)即将出具，预计会在2018Q1获批上市。

　　2. Nivolumab注射液-百时美施贵宝

　　Nivolumab是全球首个上市的PD-1单抗，最早在日本批准。自从2014/12/22首次在美国拿到黑色素瘤适应症以来，已经陆续被FDA批准了9大适应症。2016年，BMS的Opdivo全球销售额为37.74亿美元，2017年1-9月销售额为35.87亿美元(+46%)。

　　Nivolumab在中国二线治疗NSCLC的上市申请于2017/11/2获得CDE承办受理，在2017/12/18被CDE以"与现有治疗手段相比具有明显治疗优势"的理由纳入优先审评。Nivolumab虽然目前尚未进入审评排队序列，但是鉴于其临床疗效确切、受关注程度极高，而且生物药的审评任务相对较少，几乎没有积压，因此非常看好Nivolumab神速获批。

　　以同样热门的奥希替尼为参照(2017/2/3提交上市申请，2017/3/3纳入优先审评，2017/3/24获CFDA批准)，乐观预计Nivolumab将在2018Q1在中国获批上市，成为中国上市的第一个PD-1/PD-L1类药物。

　　3. 硫培非格司亭注射液-恒瑞

　　硫培非格司亭注射液即19K(HHPG-19K，聚乙二醇重组人粒细胞刺激因子注射液)，临床上可以用于肿瘤患者化疗相关的中性粒细胞减少症，因为获得了WHO通用名，属于长效粒细胞集落刺激因子(G-CSF)家族的新药，而非安进重磅炸弹Neulasta(聚乙二醇非格司亭)的仿制药。券商预测其销售峰值可超过20亿元。

　　硫培非格司亭注射液的上市历程颇为波折，恒瑞最早在2013/3/4提交19K的上市申请(CXSS1300007)，经历了2年多的辛苦排队，但赶上了2015/7/22的临床数据自查，2016/5/18恒瑞公告撤回该上市申请，表示将尽快完善相关研发数据并补充申报。

　　2017/3/24恒瑞以硫培非格司亭注射液的药品名重新申请19K上市，一度以“与现有治疗手段相比具有明显治疗优势，重大专项”的理由出现在CDE的拟纳入优先审评名单中，虽然最终未被纳入，但技术审评(药学、药理毒理、临床)已于2017/10/13完成，正在等待现场核查，顺利的话有望在2017Q2获得CFDA批准。

　　4. 盐酸安罗替尼胶囊-正大天晴

　　安罗替尼是一种多靶点的酪氨酸激酶抑制剂，能有效抑制VEGFR、PDGFR、FGFR、c-Kit等激酶，具有抗肿瘤血管生成和抑制肿瘤生长的作用，获得了国家重大新药创制专项资助。

　　根据ASCO2017公布的安罗替尼三线治疗晚期NSCLC的ALTER 0303研究的结果，安罗替尼相比安慰剂对照组可以显著延长OS(9.63 vs 6.30 个月)和PFS(5.37 vs1.40个月)，显著提高ORR(9.18% vs0.7%)。

　　安罗替尼治疗非小细胞肺癌的上市申请在2017/3/16获得CDE承办受理，走特殊审批通道，2017/4/27以“与现有治疗手段相比具有明显治疗优势;重大专项”的理由被CDE纳入优先审评。目前药理毒理、临床部分的技术审评已完成，药学部分排队待审评，之后将会陆续进入现场核查，出具三合一报告，预计在2017Q2可以获得CFDA批准。

　　5. 马来酸吡咯替尼片-恒瑞

　　吡咯替尼是一种EGFR/HER2 小分子抑制剂，开发用于治疗HER2+乳腺癌、胃癌和NSCLC，获得国家重大新药创制专项资助，是恒瑞寄予厚望的一个新药项目。截至目前，恒瑞已在吡咯替尼项目上投入研发费用5.2亿元。

　　在针对治疗经蒽环类和紫杉类药物治疗失败，且复发/转移后化疗不超过 2 线的乳腺癌患者的 II 期临床试验中，吡咯替尼+卡培他滨( 简称“吡咯替尼组”)的客观缓解率为 78.5%，拉帕替尼+卡培他滨(以下简称“拉帕替尼组”)的客观缓解率为 57.1%。吡咯替尼组与拉帕替尼组相比，客观缓解率提升了约 21%。吡咯替尼组的中位PFS为 18.1 个月，拉帕替尼组的中位PFS为 7.0 个月，吡咯替尼组的疾病进展和死亡风险降低了63.7%。

　　鉴于出色的II期临床数据，恒瑞向CDE提交了吡咯替尼治疗乳腺癌的有条件上市申请，该申请在2017/8/24获得CDE承办受理，走特殊审批通道，2017/9/26以“具有明显临床价值，重大专项”的理由被CDE纳入优先审评。目前临床部分的技术审评已完成，药学和药理毒理部分排队待审评，预计会在2018Q2获得CFDA批准。

　　6.呋喹替尼胶囊-礼来/和黄

　　呋喹替尼是和黄医药自主研发的小分子VEGFR抑制剂，拟开发用于治疗结直肠癌、胃癌、NSCLC，获得国家重大新药创制专项资助。

　　结直肠癌是中国第二大常见癌症类型，每年的新发病例数约为38万。根据ASCO2017大会公布的III期FRESCO研究的结果，416例既往接受过2轮以上系统性化疗的中国转移性结直肠癌患者按2:1分组，分别给予呋喹替尼和安慰剂治疗，中位总生存期为9.30 vs 6.57个月，其他次要临床终点如PFS、ORR、DCR也达到了统计学显著差异。3级以上不良反应主要是高血压(21.6%)、手足皮肤反应(10.8%)、蛋白尿(3.2%)、腹泻(3.2%)。

　　呋喹替尼治疗晚期结直肠癌的上市申请2017/6/30获得CDE承办受理，2017/9/4以“具有明显临床价值;重大专项”的理由被CDE纳入优先审评。目前药理毒理部分的技术审评已完成，药学和临床排队待审评，预计会在2017Q3获得CFDA批准上市。呋喹替尼在中国上市后的商业化推广主要由礼来负责。

　　下一期小编将介绍其余几种2018年即将在中国上市的新药，还请大家多多关注。

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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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