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FiercePharma发布2020年最受期待的十大新药上市

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2020-02-14 15:16
Views:

(Summary description)2020年已经来到2月份，意味着新一轮新药上市即将到来。今年，从抗击肿瘤的抗体药物偶联物到试图改变食品过敏市场的有争议的顺势疗法，依旧有各种新药等待上市。FiercePharma根据EvaluatePharma团队对2024年的预估全球销售额汇总了2020年最受期待的十大新药上市清单。1.药物：Enhertu（fam-trastuzumabderuxtecan-nxki）公司：阿斯利康，第一三共适

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FiercePharma发布2020年最受期待的十大新药上市

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2020-02-14 15:16
Views:

Information

2020年已经来到2月份，意味着新一轮新药上市即将到来。今年，从抗击肿瘤的抗体药物偶联物到试图改变食品过敏市场的有争议的顺势疗法，依旧有各种新药等待上市。FiercePharma根据EvaluatePharma团队对2024年的预估全球销售额汇总了2020年最受期待的十大新药上市清单。

1. 药物：Enhertu（fam-trastuzumab deruxtecan-nxki）

公司：阿斯利康，第一三共

适应症：HER2阳性乳腺癌

预估2024年销售额：24亿美元

FDA在2019年末批准了抗体药物偶联物Enhertu的治疗方法，用于无法手术或转移性HER2阳性乳腺癌患者，这些患者在转移性情况下至少有其他两种治疗方法失败。Enhertu将带有黑框警告标签，警告间质性肺病和胚胎-胎儿毒性。阿斯利康和第一三共将在日本以外的地方共同开发和销售该药物，第一三共在日本拥有专有权。

Enhertu由罗氏赫赛汀（靶向HER2的抗体）和拓扑异构酶I抑制剂有效载荷组成，目前正在胃癌以及非小细胞肺癌和结肠直肠癌中进行测试。

第一三共表示，FDA的批准基于2期Destiny研究，其中Enhertu缩小了61%的患者的肿瘤，并在6%的患者中彻底消除肿瘤。97%的疾病控制率包括了看到肿瘤缩小但还不足以被视为反应者的患者。几乎所有的Destiny患者（99%）都有副作用，包括恶心、呕吐和白细胞计数低。该公司表示，有15％的人由于副作用而停止了治疗。

2. 药物：ozanimod

公司：百时美施贵宝

适应症：多发性硬化症

预估2024年销售额：15.98亿美元

Ozanimod是百时美施贵宝以740亿美元收购Celgene的关键组成部分。它是一种S1P受体调节剂，旨在通过阻止免疫细胞从淋巴结进入中枢神经系统来抑制炎症活性。现有和未来的多种强力对手都针对同一机制。

要想彻底冲破障碍，它必须与几种FDA批准的药物以及有前途的实验药物竞争。其中包括诺华的年销售额33亿美元的Gilenya，该药陷入了专利争夺战，而且可能比原计划更快地面临仿制药的挑战。Celgene标榜ozanimod的安全性优于旧的诺华药物，特别是在肝毒性和心脏副作用方面。然而，还有其他一些较新的MS疗法值得担心。

除MS之外，百时美施贵宝还呼吁将ozanimod用于炎症性肠病，已进入3期测试。

3. 药物：inclisiran

公司：诺华

适应症：高LDL胆固醇

预估2024年销售额：15.29亿美元

现有PCSK9药物，安进的Repatha以及赛诺菲和再生元的Praluent年销售总额仅为10亿美元。诺华认为它的新药inclisiran会表现得不一样，inclisiran是广受讨论的以97亿美元收购The Medicines Company的核心。

Inclisiran已就其降低不良胆固醇的能力提供了可比的数据。该新药与两种抗体的不同之处在于，它使用小干扰RNA靶向PCSK9。Inclisiran在两次导入剂量后每年给予两次即可，而两种FDA批准的药物每两周一次或每月一次。

在美国，MedCo（现为诺华）于2019年12月向FDA提交了inclisiran的新药申请。

4. 药物：Evrenzo（罗沙司他）

公司：珐博进，阿斯利康，安斯泰来

适应症：肾病相关的贫血

预估2024年销售额：14.88亿美元

阿斯利康与珐博进在美国和中国共同拥有贫血药Evrenzo（罗沙司他）的权利，中国已批准并涵盖非透析依赖型和透析依赖型慢性肾病贫血患者，珐博进在美国于2019年12月申请该药用于两种适应症。在日本，其合作伙伴安斯泰来为透析患者赢得了绿灯。

罗沙司他是缺氧诱导因子脯氨酰羟化酶抑制剂类别中第一个在任何地方都被批准的药物。与安进和强生的标准护理注射剂Epogen/Procrit不同，口服罗沙司他通过模拟对氧含量降低的反应来弥补贫血。

罗沙司他很快会面临一些强力竞争。其中包括葛兰素史克的daprodustat，它与Kyowa Kirin合作在日本申请批准。Akebia Therapeutics和当地合作伙伴三菱于2019年7月在日本申请了他们的竞争对手vadadustat。在美国，Akebia与日本制药公司Otsuka合作进行贫血治疗。

5. 药物：sacituzumab govitecan

公司：Immunomedics

适应症：三阴性乳腺癌

预估2024年销售额：14.4亿美元

三阴性乳腺癌（TNBC）疗法sacituzumab govitecan作为晚期转移性TNBC的三线治疗，并未顺利通过FDA：2019年初的完整回复信（CRL）几乎打消了批准希望。但Immunomedics公司已于12月初重新提交了该药的申请，而FDA已将决定日期定为6月。

Sacituzumab govitecan是一种抗体药物偶联物，包括化疗Onivyde中的活性成分。化疗的任务是对抗罗氏I-O疗法Tecentriq，该疗法已于3月获批用于治疗TNBC。

Cantor分析师Varun Kumar博士假设sacituzumab如果获得FDA批准为三线或更晚的治疗，则可能成为并购的强力候选者。Kumar估计该药的潜在收购价值为71亿美元。

6. 药物：非戈替尼（filgotinib）

公司：吉利德科学

适应症：类风湿关节炎

预估2024年销售额：12.8亿美元

在FDA申请文件的快速审查下，类风湿关节炎候选药非戈替尼可能会大大帮助吉利德科学公司进入抗炎药市场。

非戈替尼已经在欧洲和日本申请批准，但美国市场是大笔资金的来源，这对于吉利德来说是一个重要的里程碑。最近的数据显示该药优于单独甲氨蝶呤，同时表明它比艾伯维的老牌类风湿关节炎药修美乐（Humira）更有优势。

非戈替尼的安全性是持续不确定性的一个特殊来源。吉利德和Galapagos认为，非戈替尼不会受到影响辉瑞公司Xeljanz和礼来公司Olumiant以及JAK家族其他成员的安全问题的困扰。然而，艾伯维的Rinvoq，像非戈替尼一样对JAK1具特异性，在今年初获得FDA批准时收到了黑框警告。

7. 药物：Palforzia（AR101）

公司：Aimmune

适应症：花生过敏

预估2024年销售额：12.8亿美元

1月31日，FDA批准了Aimmune的Palforzia用于治疗花生过敏反应。Palforzia将在以避免为准则的食品过敏领域树立主要先例。尽管一些市场观察者对此表示怀疑，但FDA的批准可能会使Palforzia在未来几年内造成轰动。

Palforzia，作为一种花生过敏免疫疗法，通过给予渐增剂量的花生蛋白使患者脱敏而起作用。

“鉴于需要频繁门诊和加药期间的胃肠道副作用，我们认为很多投资者会对该产品的商业机会有疑问。”瑞士信贷分析师Vamil Divan写道，“但我们发现医师和患者/父母对产品有极大兴趣，副作用似乎易于管理，并且商业机会可以通过目标销售人员解决。”

8. 药物：valoctocogene roxaparvovec

公司：BioMarin制药公司

适应症：A型血友病

预估2024年销售额：12.12亿美元

BioMarin于2019年底向FDA提交了其A型血友病基因疗法valoctocogene roxaparvovec（valrox）的申请，此前其已向EMA提交了申请。而其竞争对手罗氏/Spark仍处于一项引入研究中，该研究测试了SPK-8011未来3期的传统VIII因子替代疗法。

BioMarin已将其基因疗法的生产能力提升至每年10,000剂以使valrox能在2020年投放市场，这意味着该公司可以在可能的SPK-8011批准之前，在两年内治疗美国所有现有的严重A型血友病患者。

一旦获批，valrox将首先与罗氏的抗体药物Hemlibra竞争非抑制剂患者，后者已迅速从VIII因子治疗中抢夺份额，并在2019年前9个月为罗氏的收入贡献了9.5亿美元，因为最近花旗对60位美国血液学家的调查显示，他们预计一年内会有29%的Hemlibra患者和34%的VIII因子患者转向基因治法。

9. 药物：rimegepant

公司：Biohaven制药公司

适应症：偏头痛

预估2024年销售额：8.97亿美元

尽管Biohaven在首个上市口服CGRP竞争中输给了Allergan，后者的Ubrelvy（ubrogepant）在2019年底在FDA获批；但行业观察家认为，rimegepant的销售会更成功，这可能是基于如下事实：尽管急性治疗可能是rimegepant的第一个适应症，但Biohaven还在寻求扩大到更大的预防市场。

三种市售CGRP药，安进和诺华的Aimovig、梯瓦制药的Ajovy以及礼来公司的Emgality，是获批用于预防偏头痛的注射剂；Biohaven令人惊喜地带来口服选择。礼来公司还新推出了口服药Reyvow，这是血清素(5-HT)1F受体激动剂类别中的第一个。但这种疗法的副作用，包括头昏眼花和嗜睡，可能使其峰值销售额限制在5亿美元以下。

因为有口服CGRP偏头痛药rimegepant作为其首个商业产品，Biohaven有信心挑战所有这些大型制药公司。

10. 药物：risdiplam

公司：罗氏

适应症：脊髓性肌萎缩症

预估2024年销售额：8.03亿美元

罗氏的risdiplam将在诺华的Zolgensma和渤健的Spinraza之后进入脊髓性肌萎缩症市场，前提是FDA在5月的决定截止日期前批准它。

Risdiplam为一种运动神经元存活基因2剪接修饰剂，是患者可在家中服用的口服液体。百健的Spinraza注射剂在头两个半月内进行多个负荷给药，此后每四个月维持一次剂量。诺华的基因疗法Zolgensma是2岁以下患者的一次性疗法。

Cantor的分析师Alethia Young在最近的一份报告中指出，如果该口服药物获批，它可能改变SMA的“游戏规则”。

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Next: 武汉病毒所抢注专利，疫情当前引起巨大争议！

Previous: 10 most-anticipated drug launches of 2020 by FiercePharma

Next: 武汉病毒所抢注专利，疫情当前引起巨大争议！

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