亚盛医药连获六项FDA孤儿药资格

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2020-10-15 14:18
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(Summary description)“孤儿药”又称为罕见病药，指用于预防、治疗、诊断罕见病的药品。在美国，罕见疾病是指患病人数少于20万人的疾病。自1983年以来，美国通过《孤儿药法案》的实施，给予企业相关政策扶持，以鼓励罕见病药品的研发。亚盛医药，作为一家旨在瞄准中国乃至全球患者“无药可医、尚未满足”的临床需求，研发具有“First-in-Class”和“Best-in-Class”潜力的国际新型原创小分子药物，以填补国内空白，并进军国际高端医药市场的原创新药研发企业，截至目前为止，亚盛医药共有4个在研新药获得6项FDA孤儿药资格。今年五月份，亚盛医药第三代BCR-ABL抑制剂HQP1351获得FDA孤儿药资格认定，适应症为慢性髓性白血病（CML）；7月份和9月份，FDA授予APG-2575两个孤儿药资格认定，适应症分别为华氏巨球蛋白血症(WM)和慢性淋巴细胞白血病(CLL)；9月份，FDA授予MDM2-p53抑制剂APG-115孤儿药资格认定，用于治疗胃癌；10月9日，亚盛医药宣布再获两项FDA孤儿药认证：FDA授予其细胞凋亡管线在研原创新药MDM2-p53抑制剂APG-115、Bcl-2/Bcl-xL抑制剂APG-1252两项孤儿药资格认证，分别用于治疗急性髓系白血病（AML）和小细胞肺癌（SCLC）。 HQP1351是亚盛医药在研原创1类新药，为口服第三代BCR-ABL抑制剂，对BCR-ABL以及包括T315I突变在内的多种BCR-ABL突变体有突出效果，用于治疗一代、二代TKI耐药的CML患者。去年7月，该品种获美国FDA临床试验许可，直接进入Ib期临床研究。HQP1351为中国首个三代BCR-ABL靶向耐药CML治疗药物，目前已处于关键II期临床试验阶段，计划今年提交新药上市申请（NDA）。 APG-2575是亚盛医药在研的新型口服Bcl-2选择性小分子抑制剂，现已获得美国、中国、澳大利亚多项Ib/II期临床试验许可，正在全球同步推进多个血液肿瘤适应症的临床开发。其中作为单药或联合治疗复发╱难治CLL/SLL (小淋巴细胞淋巴瘤)的一项全球Ib/II期临床研究在进行中，正在美国和澳大利亚进行患者招募。 APG-115是一种口服的、高选择性的小分子MDM2抑制剂，对MDM2具有高度结合亲和力，通过阻断MDM2-p53相互作用从而恢复p53的肿瘤抑制活性。APG-115也是首个在中国进入临床阶段的MDM2-p53抑制剂，已在中国和美国展开多项治疗实体瘤及血液肿瘤的临床研究。 APG-1252为亚盛医药自主研发的新型高效小分子药物，可通过选择性抑制Bcl-2及Bcl-xL蛋白修复细胞凋亡。正在美国和澳大利亚进行针对晚期癌症患者的临床I期剂量爬坡试验，在美国进行针对联合紫杉醇治疗复发难治SCLC患者的Ib/II期试验，并在中国进行针对SCLC患者的单药临床I期剂量爬坡试验。临床数据表明，APG-1252在SCLC及其他晚期实体瘤患者中具有良好的安全性，并初步显示疗效。慢性髓性白血病（CML），华氏巨球蛋白血症(WM)和慢性淋巴细胞白血病(CLL)，胃癌，急性髓系白血病（AML）和小细胞肺癌（SCLC）等疾病的治疗都是全球层面目前尚未完全满足的临床需求。获得FDA孤儿药资格认定是HQP1351、APG-2575、APG-115和APG-1252产品开发和商业化的重要里程碑，充分说明了美国FDA对亚盛医药产品质量以及临床效果的认可，相关政策的扶持也将有助于亚盛医药公司加快这几种药物的全球临床开发与产品上市，从而能够早日惠及更多的罕见病患者。

亚盛医药连获六项FDA孤儿药资格

(Summary description)“孤儿药”又称为罕见病药，指用于预防、治疗、诊断罕见病的药品。在美国，罕见疾病是指患病人数少于20万人的疾病。自1983年以来，美国通过《孤儿药法案》的实施，给予企业相关政策扶持，以鼓励罕见病药品的研发。

亚盛医药，作为一家旨在瞄准中国乃至全球患者“无药可医、尚未满足”的临床需求，研发具有“First-in-Class”和“Best-in-Class”潜力的国际新型原创小分子药物，以填补国内空白，并进军国际高端医药市场的原创新药研发企业，截至目前为止，亚盛医药共有4个在研新药获得6项FDA孤儿药资格。

今年五月份，亚盛医药第三代BCR-ABL抑制剂HQP1351获得FDA孤儿药资格认定，适应症为慢性髓性白血病（CML）；7月份和9月份，FDA授予APG-2575两个孤儿药资格认定，适应症分别为华氏巨球蛋白血症(WM)和慢性淋巴细胞白血病(CLL)；9月份，FDA授予MDM2-p53抑制剂APG-115孤儿药资格认定，用于治疗胃癌；10月9日，亚盛医药宣布再获两项FDA孤儿药认证：FDA授予其细胞凋亡管线在研原创新药MDM2-p53抑制剂APG-115、Bcl-2/Bcl-xL抑制剂APG-1252两项孤儿药资格认证，分别用于治疗急性髓系白血病（AML）和小细胞肺癌（SCLC）。

HQP1351是亚盛医药在研原创1类新药，为口服第三代BCR-ABL抑制剂，对BCR-ABL以及包括T315I突变在内的多种BCR-ABL突变体有突出效果，用于治疗一代、二代TKI耐药的CML患者。去年7月，该品种获美国FDA临床试验许可，直接进入Ib期临床研究。HQP1351为中国首个三代BCR-ABL靶向耐药CML治疗药物，目前已处于关键II期临床试验阶段，计划今年提交新药上市申请（NDA）。

APG-2575是亚盛医药在研的新型口服Bcl-2选择性小分子抑制剂，现已获得美国、中国、澳大利亚多项Ib/II期临床试验许可，正在全球同步推进多个血液肿瘤适应症的临床开发。其中作为单药或联合治疗复发╱难治CLL/SLL (小淋巴细胞淋巴瘤)的一项全球Ib/II期临床研究在进行中，正在美国和澳大利亚进行患者招募。

APG-115是一种口服的、高选择性的小分子MDM2抑制剂，对MDM2具有高度结合亲和力，通过阻断MDM2-p53相互作用从而恢复p53的肿瘤抑制活性。APG-115也是首个在中国进入临床阶段的MDM2-p53抑制剂，已在中国和美国展开多项治疗实体瘤及血液肿瘤的临床研究。

APG-1252为亚盛医药自主研发的新型高效小分子药物，可通过选择性抑制Bcl-2及Bcl-xL蛋白修复细胞凋亡。正在美国和澳大利亚进行针对晚期癌症患者的临床I期剂量爬坡试验，在美国进行针对联合紫杉醇治疗复发难治SCLC患者的Ib/II期试验，并在中国进行针对SCLC患者的单药临床I期剂量爬坡试验。临床数据表明，APG-1252在SCLC及其他晚期实体瘤患者中具有良好的安全性，并初步显示疗效。

慢性髓性白血病（CML），华氏巨球蛋白血症(WM)和慢性淋巴细胞白血病(CLL)，胃癌，急性髓系白血病（AML）和小细胞肺癌（SCLC）等疾病的治疗都是全球层面目前尚未完全满足的临床需求。获得FDA孤儿药资格认定是HQP1351、APG-2575、APG-115和APG-1252产品开发和商业化的重要里程碑，充分说明了美国FDA对亚盛医药产品质量以及临床效果的认可，相关政策的扶持也将有助于亚盛医药公司加快这几种药物的全球临床开发与产品上市，从而能够早日惠及更多的罕见病患者。

Categories:最新消息
Author:华讯知识产权
Origin:
Time of issue:2020-10-15 14:18
Views:

Information

“孤儿药”又称为罕见病药，指用于预防、治疗、诊断罕见病的药品。在美国，罕见疾病是指患病人数少于20万人的疾病。自1983年以来，美国通过《孤儿药法案》的实施，给予企业相关政策扶持，以鼓励罕见病药品的研发。

亚盛医药，作为一家旨在瞄准中国乃至全球患者“无药可医、尚未满足”的临床需求，研发具有“First-in-Class”和“Best-in-Class”潜力的国际新型原创小分子药物，以填补国内空白，并进军国际高端医药市场的原创新药研发企业，截至目前为止，亚盛医药共有4个在研新药获得6项FDA孤儿药资格。

今年五月份，亚盛医药第三代BCR-ABL抑制剂HQP1351获得FDA孤儿药资格认定，适应症为慢性髓性白血病（CML）；7月份和9月份，FDA授予APG-2575两个孤儿药资格认定，适应症分别为华氏巨球蛋白血症(WM)和慢性淋巴细胞白血病(CLL)；9月份，FDA授予MDM2-p53抑制剂APG-115孤儿药资格认定，用于治疗胃癌；10月9日，亚盛医药宣布再获两项FDA孤儿药认证：FDA授予其细胞凋亡管线在研原创新药MDM2-p53抑制剂APG-115、Bcl-2/Bcl-xL抑制剂APG-1252两项孤儿药资格认证，分别用于治疗急性髓系白血病（AML）和小细胞肺癌（SCLC）。

HQP1351是亚盛医药在研原创1类新药，为口服第三代BCR-ABL抑制剂，对BCR-ABL以及包括T315I突变在内的多种BCR-ABL突变体有突出效果，用于治疗一代、二代TKI耐药的CML患者。去年7月，该品种获美国FDA临床试验许可，直接进入Ib期临床研究。HQP1351为中国首个三代BCR-ABL靶向耐药CML治疗药物，目前已处于关键II期临床试验阶段，计划今年提交新药上市申请（NDA）。

APG-2575是亚盛医药在研的新型口服Bcl-2选择性小分子抑制剂，现已获得美国、中国、澳大利亚多项Ib/II期临床试验许可，正在全球同步推进多个血液肿瘤适应症的临床开发。其中作为单药或联合治疗复发╱难治CLL/SLL (小淋巴细胞淋巴瘤)的一项全球Ib/II期临床研究在进行中，正在美国和澳大利亚进行患者招募。

APG-115是一种口服的、高选择性的小分子MDM2抑制剂，对MDM2具有高度结合亲和力，通过阻断MDM2-p53相互作用从而恢复p53的肿瘤抑制活性。APG-115也是首个在中国进入临床阶段的MDM2-p53抑制剂，已在中国和美国展开多项治疗实体瘤及血液肿瘤的临床研究。

APG-1252为亚盛医药自主研发的新型高效小分子药物，可通过选择性抑制Bcl-2及Bcl-xL蛋白修复细胞凋亡。正在美国和澳大利亚进行针对晚期癌症患者的临床I期剂量爬坡试验，在美国进行针对联合紫杉醇治疗复发难治SCLC患者的Ib/II期试验，并在中国进行针对SCLC患者的单药临床I期剂量爬坡试验。临床数据表明，APG-1252在SCLC及其他晚期实体瘤患者中具有良好的安全性，并初步显示疗效。

慢性髓性白血病（CML），华氏巨球蛋白血症(WM)和慢性淋巴细胞白血病(CLL)，胃癌，急性髓系白血病（AML）和小细胞肺癌（SCLC）等疾病的治疗都是全球层面目前尚未完全满足的临床需求。获得FDA孤儿药资格认定是HQP1351、APG-2575、APG-115和APG-1252产品开发和商业化的重要里程碑，充分说明了美国FDA对亚盛医药产品质量以及临床效果的认可，相关政策的扶持也将有助于亚盛医药公司加快这几种药物的全球临床开发与产品上市，从而能够早日惠及更多的罕见病患者。

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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