Sosei Heptares Announces That the COPD Treatment Ultibro® Breezhaler® has been Included in the National Reimbursement Drug List in China

治疗慢性阻塞性肺疾病药物Ultibro Breezehaler已被纳入报销范围

2019-11-29 10:34:30 CISION

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Sosei Group Corporation announces that Ultibro® Breezhaler® has been included in the 2019 National Reimbursement Drug List in China for the treatment of chronic obstructive pulmonary disease . The product was launched in China in March 2019, along with related product Seebri® Breezhaler® and both are approved for use in over 100 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia. The NRDL is a list of therapies that are partially, if not fully, reimbursed for eligible patients. The list is approved nationally with the aim of providing basic medical coverage to China's population of 1.4 billion. The list covers well-established medicines as well as newer, innovative medicines. Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei Heptares and Vectura. Sosei Heptares is eligible to receive royalties on global product net sales. Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, said: "We are pleased that COPD patients in China will have improved access to this novel inhaled product through the inclusion in the 2019 NRDL. COPD is the fourth leading cause of death in China1 and a major public-health problem affecting nearly 100 million people2. Ultibro® has shown to be effective in managing COPD symptoms to improve lung function and quality of life and to reduce the incidence of acute exacerbations. Broadened access to new COPD treatments in China could significantly improve the lives of those patients most in need." The event reported today does not generate a milestone payment and therefore has no immediate impact on the consolidated financial results for the accounting period ending December 2019. About Ultibro® Breezhaler®  Ultibro® Breezhaler® is an inhaled once-daily fixed-dose combination of indacaterol (a long-acting beta 2 agonist; LABA) and glycopyrronium bromide (a long-acting muscarinic antagonist; LAMA). Ultibro® Breezhaler® and Seebri® Breezhaler® are being promoted in China by Huizheng (Shanghai) Technology Co., Ltd. ("Huizheng"), a group company of Zheijiang Hisun Pharmaceutical Co., Ltd. (SHG: 600267) under license from Beijing Novartis Pharma Co., Ltd and Sandoz (China) Pharmaceutical Co., Ltd, which are controlled subsidiaries of Novartis. Seebri® Breezhaler® and Ultibro® Breezhaler® are trademarks of Novartis AG. References 1 http://www.nhc.gov.cn. 2 Wang C, Xu J, Yang L, et al. Lancet 2018; 391:1706–17. About Sosei Heptares We are an international biopharmaceutical group focused on the discovery and early development of new medicines originating from our proprietary GPCR-targeted StaR® technology and structure-based drug design platform capabilities. We are advancing a broad and deep pipeline of novel medicines across multiple therapeutic areas, including CNS, immuno-oncology, gastroenterology, inflammation and other rare/specialty indications. We have established partnerships with some of the world's leading pharmaceutical companies, including Allergan, AstraZeneca, Daiichi-Sankyo, Genentech (Roche), Novartis, Pfizer and Takeda; and with innovative biotechnology companies, including Kymab, MorphoSys and PeptiDream. Sosei Heptares is headquartered in Tokyo, Japan with R&D facilities in Cambridge, UK. "Sosei Heptares" is the corporate brand of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR® are Trade Marks of Sosei Group companies. Forward-looking statements This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products. Various risks may cause Sosei Group Corporation's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For more information, please visit https://www.soseiheptares.com LinkedIn: @soseiheptaresco | Twitter: @soseiheptaresco | YouTube: @soseiheptaresco Enquiries: Sosei Heptares  Shinichiro Nishishita – VP Investor Relations+81(0)3-5210-3399IR@SoseiHeptares.com Candelle Chong – VP Corporate Strategy and Communications +44(0)1223-949-392Comms@SoseiHeptares.com Citigate Dewe Rogerson Yas Fukuda – Japanese Media+81(3)4360-9241Yas.Fukuda@citigatedewerogerson.com Mark Swallow, David Dible – International Media+44(0)20-7638-9571SoseiHeptares@citigatedewerogerson.com SOURCE Sosei Heptares
Sosei Group Corporation 宣布, Ultibro ® Breezehaler ®已被列入中国2019年国家报销药品清单,用于治疗慢性阻塞性肺疾病。该产品于2019年3月在中国上市,相关产品 Seebri ® Breezehaler ®也已获准在全球100多个国家使用,包括欧盟和拉丁美洲、日本、加拿大、瑞士和澳大利亚等国家。 NRDL 是一份部分(如果不是全部)偿还合格患者的治疗方案清单。这份名单在全国范围内通过,旨在为中国14亿人口提供基本医疗保险。该清单涵盖了成熟的药物以及新的创新药物。 2005年4月, Sosei Heptares 和 Vectura 向诺华(Novartis)独家许可了溴化甘糖以及某些用途和配方知识产权。Sosei Heptors 有资格获得全球产品净销售额的特许权使用费。 Sosei Heptores 董事长、总裁兼首席执行官 Shinichi Tamura 说:“我们很高兴中国的 COPD 患者能够通过将这种新型吸入产品纳入到2019年的 NRDL 中,从而改善对这种新型吸入产品的获取。是中国第四主要原因,也是影响近1亿人的重大公共卫生问题。Ultibro ®已证明能够有效管理 COPD 症状,以改善肺功能和生活质量,并减少急性加重的发生率。在中国推广新的 COPD 治疗方法可以显著改善最需要的患者的生活。” 今天报告的事件不会产生里程碑付款,因此对截至2019年12月的会计期间的合并财务业绩不会产生直接影响。 关于 Ultibro ® Breezehaler ® Ultibro ® Breezehaler ®是每日吸入一次的吲达卡特罗(长效β2激动剂; LABA )和溴化糖吡咯(长效麝香拮抗剂; LAMA )固定剂量组合。 浙江海正药业股份有限公司( SHG :600267)的集团公司惠正(上海)科技有限公司(以下简称“惠正”)正在中国推广 Ultibro ® Breezehaler ®和 Seebri ® Breezehaler ®。惠正(上海)科技有限公司是诺华(Novartis)的控股子公司。 Seebri ® Breezehaler ®和 Ultibro ® Breezehaler ®是诺华(Novartis) AG 的商标。 参考文献 1 http://www.nhc.gov.cn 。 2王 C ,徐J ,杨L 等。Lancet 2018;391:1706-17。 关于 Sosei Heptres 我们是一家国际生物制药集团,专注于发现和早期开发源于我们专有的 GPCR 靶向 StaR ®技术和基于结构的药物设计平台能力的新药。我们正在推进一条横跨多个治疗领域的广泛而深入的新药管道,包括 CNS 、免疫肿瘤、胃肠病学、炎症和其他罕见/特殊适应症。 我们与一些世界领先的制药公司建立了伙伴关系,包括艾尔建(Allergan)、阿斯利康(AstraZeneca)、 Daiichi-Sankyo 、基因泰克(Genentech)(罗氏(Roche))、诺华(Novartis)、辉瑞(Pfizer)和武田(Takeda),以及与 Kymab 、 MorphoSys 和 PeptionDream 等创新生物技术公司建立了伙伴关系。Sosei Heptares 总部位于日本东京,在英国剑桥设有研发机构。 " Sosei Heptores "是 Sosei Group Corporation 的企业品牌,该公司在东京证券交易所上市(股票代码:4565)。Sosei 、 Heptares 、徽标和 StaR ®是 Sosei 集团公司的商标。 前瞻性陈述 本新闻稿包含前瞻性声明,包括关于产品发现、开发和商业化的声明。各种风险可能导致 Sosei Group Corporation 的实际结果与前瞻性声明中明示或暗示的结果存在重大差异。包括:临床开发计划的不利结果;未能获得发明专利保护;第三方拥有或控制的专利施加的商业限制;依赖战略联盟伙伴开发和商业化产品和服务;由于开发努力而难以或拖延获得市场产品和服务的监管批准;开展研发和扩大商业化活动所需的大量资金;竞争对手的产品举措。由于这些因素,提醒潜在投资者不要依赖任何前瞻性陈述。无论由于新信息、未来事件或其他原因,我们均不承担更新或修改任何前瞻性声明的任何意图或义务。 有关详细信息,请访问 https://www.soseiheptres.com LinkedIn :@ soseiheptresco | Twitter :@ soseiheptresco | YouTube :@ soseiheptresco 查询: Sosei Heptres Shinichiro Nishishita –投资者关系副总裁+81(0)3-5210-33999IR @ SoseiHeptres.com Cantelle Chong –企业战略与沟通副总裁+44(0)1223-949-392Comms @ Sosei Heptres.com 城市大门 Dewe Rogerson Yas Fukuda –日本媒体+81(3)4360-9241Yas 。Fukuda @ citgatedewerogerson.com Mark Swallow , David Dible – International Media +44(0)20-7638-9571Sosei Heptres @ citiggatedewerogerson.com SoURCE Sosei Heptors

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