Beijing Kangdini Pharmaceutical Co., Ltd.

SAN DIEGO, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced that the last patient in Gyre Pharmaceuticals’ pivotal Phase 3 trial in the People’s Republic of China (“PRC”) evaluating F351 (hydronidone) for Chronic Hepatitis B (“CHB”)-associated liver fibrosis has completed the 52-week study. Gyre Pharmaceuticals expects to report topline data from this trial by the first quarter of 2025. “The final patient completing our pivotal F351 Phase 3 trial marks an important milestone for Gyre and our development pipeline. We are grateful to the patients, researchers, trial investigators, and various teams who supported this trial and look forward to sharing data in the first quarter of 2025,” said Han Ying, Ph.D., CEO of Gyre Therapeutics. “Furthermore, we are excited to potentially use these results to spur initiation of our Phase 2 clinical trial in the United States evaluating F351 for Metabolic Dysfunction-Associated Steatohepatitis (“MASH”)-associated fibrosis in 2025.” The randomized, double-blind, placebo-controlled, multicenter Phase 3 trial (NCT05115942) enrolled 248 patients across 39 clinical research hospitals in the PRC. Patients were randomized 1:1 to receive either F351 or placebo in addition to entecavir antiviral basic therapy for CHB. The primary endpoint is a decrease in liver fibrosis (as measured by the Ishak Scoring System) by at least one stage after 52 weeks of treatment relative to baseline. China’s National Medical Products Administration (“NMPA”) designated F351 as a “Breakthrough Therapy” in 2021. About Hydronidone (F351) F351 is a structural analogue of the approved anti-fibrotic drug Pirfenidone (approved in the PRC for the treatment of idiopathic pulmonary fibrosis) and has been shown to inhibit in vitro both p38γ kinase activity and TGF-β1-induced excessive collagen synthesis in hepatic stellate cells (“HSCs”), which are recognized as critical event in the development and progression of fibrosis in the liver. This is further supported by its anti-proliferative effects on the HSCs in the liver. In vitro anti-fibrotic effects of F351 were also confirmed in several established in vivo models of liver fibrosis, such as CCI4-induced liver fibrosis mouse model, DMN-induced liver fibrosis rat model, and HSA-induced liver rat model, as well as mouse model of MASH fibrosis (CCI4+Western High Fat Diet). About Gyre Therapeutics Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the Company’s experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230. About Gyre Pharmaceuticals Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2023 net sales of $112.1 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to readout topline data by the first quarter of 2025. F351 received Breakthrough Therapy designation by the National Medical Products Administration’s Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.). Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts, timing of expected clinical readouts, including timing of topline data from Gyre Pharmaceuticals’ Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC, and the initiation of Gyre’s Phase 2 trial in the U.S. for F351. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2023 filed on March 27, 2024 and in other filings with the Securities and Exchange Commission. Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. For Investors:Stephen Jasperstephen@gilmartinir.com

精彩内容 高血压作为常见的慢性病之一，相关用药市场备受关注。米内网数据显示，内服高血压化药在2024年一季度中国零售药店终端销售规模同比有所下滑。TOP20中，苯磺酸氨氯地平片、硝苯地平控释片、苯磺酸左氨氯地平片位居前三，施慧达、石药、华润双鹤等7大国产品牌突围。今年以来，口服高血压化药已有55个品种（225个受理号）报产在审，11款新药（22个受理号）获批临床。 口服高血压化药三大品类销售火热，诺华领跑 近年中国零售药店终端内服高血压化药销售情况（单位：亿元） 来源：米内网格局数据库 米内网数据显示，内服高血压化药在近年中国零售药店终端（城市实体药店+网上药店）市场规模均超过170亿元，2024年一季度同比有所下滑。其中，城市实体药店是主要销售渠道，网上药店则持续增长。2024年一季度中国零售药店终端内服高血压化药TOP3小类 来源：米内网格局数据库 从治疗小类来看，钙通道阻滞剂、高血压复方制剂、作用于肾素-血管紧张素系统的药物位居前三，合计市场份额占比超过80%。其中，高血压复方制剂保持快速增长，已成为第二畅销小类。 2024年一季度中国零售药店终端内服高血压化药TOP5集团来源：米内网格局数据库 从集团TOP20来看，诺华集团、拜耳、晖致、施慧达药业集团、阿斯利康位居前五。从增速来看，诺华集团、石药集团、信立泰、华海药业、正大制药5家均有双位数增速。 TOP20出炉！10个产品销售过亿，施慧达、华润双鹤7大国产品牌突围 2024年一季度中国零售药店终端内服高血压化药产品TOP20（单位：亿元）来源：米内网格局数据库注：销售额低于1亿元用*表示 产品TOP20中，有10个销售额均超过1亿元，苯磺酸氨氯地平片继续位居“销冠”宝座，是唯一一个超5亿元的产品。高血压复方制剂沙库巴曲缬沙坦钠片凭借58.63%的增速跻身前五，也是TOP20中增速最快的产品。 2个独家产品，分别是复方利血平氨苯蝶啶片（华润双鹤药业）、马来酸左氨氯地平片（石药欧意药业）。 2024年一季度中国零售药店终端内服高血压化药品牌TOP20（单位：亿元）来源：米内网格局数据库注：销售额低于1亿元用*表示 品牌TOP20中，外资品牌占据头部位置；7个国产品牌上榜，数量与2023年相比增加1个，施慧达药业集团(吉林)的苯磺酸左氨氯地平片在前三之列，深圳信立泰药业的阿利沙坦酯片是增速最快的国产品牌，江西制药的苯磺酸氨氯地平片则是新上榜。 从数量来看，诺华最多，有4个；阿斯利康有3个上榜。 近年中国零售药店终端苯磺酸氨氯地平片季度销售情况（单位：万元）来源：米内网格局数据库 苯磺酸氨氯地平片是一种二氢吡啶类钙拮抗剂，可用于治疗高血压，缓解心绞痛症状，可治疗血管痉挛型心绞痛。米内网数据显示，苯磺酸氨氯地平片在近年中国零售药店终端是20亿元级别的重磅产品，2024年一季度销售额超过5亿元，是产品TOP20中竞争最激烈的品种，在销企业数超过60家，辉瑞的市场份额最大，其次是江西制药和华润赛科药业，分别位居第二、三位。 近年中国零售药店终端阿利沙坦酯片季度销售情况（单位：万元）来源：米内网格局数据库 阿利沙坦酯片是唯一由国内自主研发、拥有自主知识产权（1.1类新药）的血管紧张素Ⅱ受体拮抗剂类降压药物，用于轻、中度原发性高血压的治疗。米内网数据显示，阿利沙坦酯片在近年中国零售药店终端销售规模快速扩容，2024年一季度同比增长超过20%。信立泰在年报中指出，阿利沙坦酯片在上市以来开展多项高血压领域的临床研究，为市场推广提供更多循证医学证据。此外，还以阿利沙坦酯为基础，布局1类新药S086（高血压、慢性心衰适应症）、首个国产ARB/CCB类2类复方制剂SAL0107等，这些产品上市后将有针对性地覆盖不同细分市场领域，满足更多未被满足的临床需求。 新品大爆发，京新、康恩贝……同日报产，石药、信立泰超10款新药亮眼 9月25日，CDE官网显示，桂林华信制药的培哚普利氨氯地平片（Ⅲ）、浙江京新药业的苯磺酸氨氯地平口崩片、杭州康恩贝制药的替米沙坦氨氯地平片（Ⅱ）、石家庄四药的甲磺酸多沙唑嗪缓释片等多款口服高血压化药同日报产在审。在此之前，石药集团发布公告，集团开发的缬沙坦马来酸左氨氯地平片获批临床，该产品是全球首款获批临床的由缬沙坦和马来酸左氨氯地平组成的新复方制剂。 今年以来口服高血压化药新药临床获批情况来源：米内网中国申报进度（MED）数据库 今年以来，口服高血压化药已有55个品种（225个受理号）报产在审，包括2款新药，分别是上药信谊药厂的1类新药苹果酸司妥吉仑片和四川奥邦古得药业的2.2类新药盐酸普萘洛尔滴剂。此外，有11款新药（22个受理号）获批临床，其中，深圳信立泰药业的SAL0120片、北京康蒂尼药业的F230片、原研药港生命科学研究(辽宁)的MT-1207片、石家庄四药的SYN045片均为1类新药。 资料来源：米内网数据库、公司公告注：米内网《中国城市实体药店药品终端竞争格局》，统计范围是：全国地级及以上城市实体药店，不含县乡村药店；《中国网上药店药品终端竞争格局》，统计范围是：全国网上药店所有药品数据，包括天猫、京东等第三方平台及私域平台上所有网上药店药品数据；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！ 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

2024年7月30日，中国深圳、美国加州红木城——泽安生物医药（LTZ Therapeutics，以下简称“LTZ”或“公司”）宣布完成A轮融资，募集金额超过2000万美元。本轮融资由龙磐投资领投，高瓴创投参与投资，并且获得启明创投、险峰旗云、顺为资本等老股东的追加投资。自2022年成立以来，公司已累计募资约5000万美元。 LTZ致力于研发以“髓系细胞衔接器”技术平台（Myeloid Engager Platform）为基础的新型免疫疗法，以更好应对癌症和自身免疫性疾病等领域的未满足临床需求。本轮新募资金将主要用于加速 LTZ 管线的开发，包括申报临床批件（IND）、启动首个品种LTZ-301的Ⅰ期临床研究和第二个品种LTZ-232的 IND-enabling 工作、快速推进其他在研项目等；此外，还将用于进一步扩充全球团队。 LTZ 创始人兼首席执行官李金泽博士（Dr. Robert Li）表示：“衷心感谢新投资人的高度认可和老股东的持续增资。在开发新型‘髓系细胞衔接器’技术平台的征途中，本轮融资代表至关重要的一步。LTZ的方法论核心是有机融合‘反向转化科学’与我们对‘肿瘤微环境’（TME）生物学（特别是‘髓系细胞生物学’）的深刻理解。得益于投资人股东、科学顾问委员会和团队成员的鼎力支持与精诚合作，公司在过去一年迎来重大进展，不仅在各种临床前测试系统（包括癌症患者衍生的类器官模型）中验证了自研技术平台，而且将首个品种 LTZ-301 从早期发现阶段推到IND-enabling阶段。我们将再接再厉，借助本轮募集资金，将LTZ全力推进到下一个里程碑。” 龙磐投资创始合伙人余治华先生表示：“泽安生物医药是一家专注于开发全球领先的髓系细胞多功能衔接抗体的平台型公司。公司构建的技术平台能有效利用并激活肿瘤微环境中富集的巨噬细胞作为效应细胞，实现对肿瘤细胞直接、有效、安全的杀伤作用，并已得到多种临床相关性模型的验证，有望在肿瘤和其他疾病领域（例如自身免疫性疾病）带来突破性治疗效果。凭借精耕行业多年的深厚积累和广博的国际化视野，泽安团队在管线立项战略布局和全球临床开发策略等方面都展现出卓越的专业能力。龙磐投资很高兴成为本轮融资的领投方。我们热切期待泽安持续创新，早日为广大患者带来全新治疗方案。” 关于科学原理 在各种血液瘤和实体瘤的肿瘤微环境（TME）中，巨噬细胞都显示为最常见的免疫细胞群之一。因此，对患者而言，有效调动和激活巨噬细胞，从而杀伤癌细胞，具有重大的治疗潜力和临床价值。针对泛癌种的疾病谱，基于启迪药物发现的“反向转化研究”和新兴的TME髓系细胞生物学，LTZ 正在开发全新的“髓系细胞衔接器”技术平台（Myeloid Engager Platform），重点增强巨噬细胞与单核细胞的吞噬功能，铸就广谱抗肿瘤的免疫屏障。 关于泽安生物医药（LTZ Therapeutics） LTZ是一家聚焦新型免疫疗法的全球一体化生物技术公司。针对癌症、自身免疫性疾病等领域的重大未满足临床需求，公司自主研发“髓系细胞衔接器”技术平台（Myeloid Engager Platform）和相关原创新药，旨在提升广大患者的综合临床获益。公司的国际化团队分布于中国深圳、美国加州红木城和德国海德堡。基于反向转化科学与新兴的肿瘤微环境生物学，LTZ致力于开发既能克服耐药、又能增强抗肿瘤免疫力的新一代免疫疗法。 关于龙磐投资（Lapam Capital） 龙磐投资是中国领先的生物医药风险投资机构，目前在管5支人民币基金和1支美元基金，总规模超过100亿元人民币，是中国最顶尖的两家人民币LP出资人——全国社保基金和国家中小企业发展基金迄今为止均出资支持过的唯一一家生物医药投资机构。龙磐投资以初创期、早中期投资为主，已累计投资企业超120家，包括贝达药业（SZ.300558）、荣昌生物（SH.688331）、亚虹医药（SH.688176）、凯因科技（SH.688687）、宜明昂科（HK.01541）、爱博诺德（SH.688050）、康蒂尼药业（GYRE）等众多明星项目。龙磐投资管理团队多名合伙人拥有20年以上的国际/国内生物医药产业研发及管理经验，可为被投资企业提供全面的增值服务。 关于高瓴创投（GL Ventures） 高瓴创投是中国最活跃的创业投资平台之一，专注于创新型公司的价值发掘与价值创造，尤其关注新技术、新能源、新材料、新消费等重点领域。自2020年独立推出以来，我们致力于以系统化的DVC（Deep Value Creation，深度价值创造）服务，助力早期创新企业的长期发展。 如果您想对接文章中提到的项目，或您的项目想被动脉网报道，或者发布融资新闻，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。 近 期 推 荐 声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。 动脉网，未来医疗服务平台