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- Transaction Includes JNT-517, a Potential First-In-Class Oral Treatment for Phenylketonuria (PKU) - - Expands Specialty and Autoimmune Portfolios and Drug Discovery Technologies - TOKYO and BOSTON, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Jnana Therapeutics Inc. (Jnana) today announced that they have entered into a definitive merger agreement pursuant to which Otsuka will acquire Jnana, making it a wholly owned subsidiary through Otsuka’s 100-percent owned subsidiary, Otsuka America, Inc. (OAI). The acquisition is expected to be completed in the third quarter of fiscal 2024, subject to customary closing conditions. Based on the terms of the agreement, Otsuka will pay USD $800 million to the shareholders of Jnana upon completion of the acquisition, as well as up to an additional USD $325 million in development and regulatory milestones. 1．Reasons for the acquisition Jnana’s novel approach to drug discovery is enabled by RAPID – the company’s next-generation chemoproteomics platform designed to discover medicines for highly validated but challenging-to-drug targets. The platform leverages a high-throughput, binding-based screening approach that is inherently flexible, enabling the discovery of binding sites across the surface of a target protein and the identification of small molecules that elicit diverse pharmacologies. Jnana has used RAPID to successfully identify first-in-class compounds and address a range of historically challenging-to-drug target classes, including solute carriers, transcription factors, and signaling scaffold proteins. Jnana pursues drug discovery based on concepts that are complementary to those of Astex Pharmaceuticals, a subsidiary of Otsuka based in Cambridge, UK. While Jnana's RAPID platform is not limited to any specific therapeutic area, the company has built a unique competitive position by concentrating on PKU, a rare inherited metabolic disorder in which phenylalanine accumulates to abnormally high levels in the blood, and autoimmune diseases, where small molecule drug discovery has been challenging. Jnana’s technology successfully generated JNT-517, an allosteric small molecule inhibitor of SLC6A19, an SLC (solute carrier) that regulates amino acid reabsorption in the kidney. JNT-517 has the potential to become a first-in-class oral treatment for PKU, as it has been shown to be effective, well-tolerated, and safe in a Phase 1b/2 study. A majority of the PKU population is not effectively treated with existing therapies, and JNT-517 is an approach that could address individuals of all ages across the spectrum of mild to severe disease. In the autoimmune disease field, the company is pursuing small molecule drug discovery for highly validated, but challenging-to-drug, targets such as interferon regulatory factor 3 (IRF3), a master transcription factor for the production of interferon. Otsuka has advanced contributions to patients with a wide range of rare diseases, not only in the renal area with JINARC (approved for autosomal dominant polycystic kidney disease), sibeprenlimab (IgA nephropathy), and voclosporin (lupus nephritis), but also by adding new specialty drugs such as donidalorsen (hereditary angioedema). Additionally, through Visterra, a Boston-based company that Otsuka acquired in 2018, Otsuka is advancing research and development in the autoimmune field using antibody drug technology, while also expanding its drug discovery platform. Makoto Inoue, president and representative director of Otsuka Pharmaceutical commented, "I am gratified that Otsuka has entered into an agreement with Jnana. The addition of Jnana's drug discovery technology and small molecule pipeline in PKU and autoimmune diseases will strengthen our R&D in the Boston area of the U.S., one of the most important bioclusters in the world, and in a combined form will have a synergistic effect on Otsuka Pharmaceutical's global expansion.” Joanne Kotz, Ph.D., CEO and co-founder of Jnana, commented, "This transaction recognizes the Jnana team’s accomplishments since the founding of the company, which include creating RAPID – a world-class small molecule drug discovery platform. Leveraging our platform, the team discovered JNT-517, a potential first-in-class oral medicine for the treatment of PKU, and has demonstrated positive clinical proof of concept for JNT-517 in individuals with PKU. We are excited to join Otsuka with our shared goal of developing transformative therapies for patients and look forward to advancing JNT-517 into a registrational study in 2025 and continuing to progress our pipeline of innovative oral medicines for autoimmune diseases." 2．Outline of the acquisition Upon completion of the acquisition, Jnana will operate as a wholly owned subsidiary of Otsuka in Boston and will continue its research and development. The acquisition will be implemented by merging a special purpose company, established under OAI for this acquisition, into Jnana Therapeutics, with Jnana remaining as the surviving company. Existing shareholders of Jnana will be paid cash as consideration for this merger. Although the Boards of Directors of both Otsuka and Jnana have approved this acquisition, the execution of this acquisition may require the approval of Jnana's shareholders and the fulfillment of conditions under U.S. antitrust laws. After completion of necessary procedures, we aim to complete the acquisition during the third quarter of 2024. 3．Additional information about Otsuka (https://www.otsuka.co.jp/en/) Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. 4．Additional information about Jnana (https://www.jnanatx.com/) Jnana Therapeutics is a clinical-stage biotechnology company leveraging its next-generation RAPID chemoproteomics platform to discover medicines for highly validated, challenging-to-drug targets to treat diseases with high unmet needs. Jnana is focused on developing first- and best-in-class therapies to treat a wide range of diseases, including rare diseases and immune-mediated diseases. Jnana’s lead program, JNT-517, which targets an allosteric site on the phenylalanine transporter SLC6A19, is a potential first-in-class oral approach for the treatment of PKU, a rare genetic metabolic disease. Located in Boston, Jnana brings together scientific leaders in small molecule drug discovery and development, a highly experienced management team, and the backing of leading life science investors Bain Capital Life Sciences, RA Capital Management, Polaris Partners, Versant Ventures, Avalon Ventures, Pfizer Ventures, and AbbVie Ventures. 5．Advisors Centerview Partners LLC acted as financial advisor to Jnana and Latham & Watkins LLP acted as its legal advisor.

近期，一品红发布公告，公司全资子公司广州一品红制药有限公司于近日收到国家药品监督管理局核准签发的关于奥美沙坦酯口崩片的《药品注册证书》。 奥美沙坦酯口崩片适用于高血压的治疗。公司获批的奥美沙坦酯口崩片是以化学药品3类申报注册，是国内首家获批的视同通过一致性评价产品，目前原研尚未进入国内销售。 2023年抗高血压药销售242亿元 奥美沙坦酯属于非肽类血管紧张素Ⅱ受体拮抗剂，降压效果强大且持久，一天一次给药可以维持降压24小时。同时，可以保护心血管和肾脏，不经过细胞色素P450酶代谢，与心血管系统常用药物联用顾虑少。 与普通片剂相比，口崩片剂型拥有服用方便；能够避免肝脏首过效应，起效迅速；口感良好，容易吞咽，降低胃肠道刺激等特点。但此前国内获批上市的仅普通片剂、胶囊等剂型。 据国家药审中心官网显示，包括一品红在内，共有3家企业的奥美沙坦酯口崩片被受理，但目前处于审批阶段的仅吉林省德商药业一家。共有2家药企的奥美沙坦酯片在审批中，包括深圳信立泰药业、浙江华海药业，其中浙江华海药业以报产申请形式受理。 奥美沙坦酯口崩片国家药审中心审批情况 来源：国家药审中心 2020年1月，作为降血压常用药，奥美沙坦酯片被入选第二批国家组织的药品带量采购的32个品种之一，由东阳光（0.61元/片）、信立泰（0.69元/片）、南京正大天晴（1.268元/片）、北京福元医药（1.7471元/片）共计4家企业低价中标。 据中康开思系统显示，奥美沙坦酯片在2019年达到销售峰值，为6.33亿元；或受第二批集采影响，2020年销售额同比下滑43.4%，仅3.58亿元；2021年开始，“以价换量”效应显现，销售额逐年平稳上涨，2023年达2.77亿元，同比上涨1.7%；2024年一季度销售7千万元。 奥美沙坦酯片全国等级医院销售情况 来源：中康开思系统 作为有着强劲用药需求，且此前主要由原研主导的品类，高血压药是历次国家带量采购的重点对象。随着集采落地执行，相继有三十多个品种被纳入集采。但大部分高血压品种在集采后销售额明显“缩水”。 据中康开思系统显示，2023年高血压药在等级医院销售额约达242亿元。在2023高血压化药TOP10产品中，昔日“药王”硝苯地平跌落，销售额大幅下滑为13.96亿元，从第一的宝座退居第四，同比下降60.1%。 2023全国等级医院高血压药化药销售额TOP10 来源：中康开思系统，新康界整理 排名第二的美托洛尔较去年相比，销售额也下滑明显，仅17.75亿元，同比下降39.7%；此外还有非洛地平、缬沙坦氨氯地平也分别下滑17.7%、25.8%。 不过销售额实现正向增长的品种仍占大多数，如沙库巴曲缬沙坦钠、艾司洛尔、阿利沙坦酯、贝尼地平等，分别增长70.6%、18.3%、15.5%和31.5%。 超8大品种满足第十批集采门槛 高血压作为患病率最高的慢性药，在历届集采中向来是“重头戏”，集采所涉及的品种范围不断扩大，剂型更加丰富，在2023年7月执行的第八批集采中有5个品种入选，在第九批集采中也有4个品种被纳入目录。 据新康界统计，除去已纳入国家集采的品种，目前高血压化药已有超8个品种满足集采门槛，符合申报资格企业数达5家以上，包括沙库巴曲缬沙坦钠、艾司洛尔、多沙唑嗪、螺内酯、托伐普坦、替米沙坦氢氯噻嗪和马昔腾坦等。 部分满足集采门槛的抗高血压药品种 来源：公开资料，中康开思系统，新康界整理 其中，沙库巴曲缬沙坦钠片原研来自诺华，是由沙库巴曲和缬沙坦两种成分以1:1摩尔比例结合而成的盐复合物晶体，为驱动诺华业绩增长的核心药物之一。该品种最早于2015年获FDA批准上市，是全球首款心衰治疗领域的突破性创新药物。 据中康开思系统显示，作用于肾素-血管紧张素系统的药物销售额在2023年等级医院约109亿元，而沙库巴曲缬沙坦钠片突破30亿元，稳坐该细分赛道第一的宝座。其在2024年一季度持续放量，销售额达9.96亿元，同比增长率达22.8%。 现阶段，我国的抗高血压用药市场规模还在扩大。据《中国心血管健康与疾病报告2022概要》，我国高血压患者的控制率仅为16.8%。因此未来我国高血压药物市场规模仍将扩大，随着国内人口老龄化趋势不断加剧，预计到2025年，我国高血压药物市场或将达到1420亿元以上。 国家心血管病中心的数据显示，目前高血压是我国乃至全球第一大慢性疾病，我国18岁及以上居民高血压患病率达27.5%，也就是大约每4个成年人中就有1人是高血压患者，患病人数约为2.45亿。高血压引起的心脑血管并发症是导致我国居民死亡的首要原因。 由于长期服药控制是高血压等慢性病最具挑战性的问题，保持药物依从性和规律用药对于有效管理这些慢性病的重要性不可忽视。可以预见，抗高血压用药市场还将占据重要位置。 封面图来源：123rf 版权声明/免责声明 本文为授权转载文章。 本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。 文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。 如有任何问题，请与我们联系。 衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 一个靶点，60年的“误解” 「肝炎」新药，下一个赛点在哪儿？ 拜登退出大选，对制药界有何影响？ 点击这里，发现价值信息！