Fexolazan hydrochloride

精彩内容步入2024年，扬子江药业的泊沙康唑肠溶片、替吉奥胶囊相继获批上市、1类新药YZJ-5799磷酸盐胶囊获批临床。2023年至今，公司已有29个品种（2个首仿）获批上市，累计157个品种过评（34个首家），51个品种中标国采，23个品种备战第十批集采。目前公司有20款1类新药处于获批临床及以上阶段，4款上市可期。仿制药大爆发！拿下29个重磅品种日前，NMPA官网显示，扬子江药业的替吉奥胶囊获批上市并视同过评。替吉奥胶囊是第三代口服氟尿嘧啶类抗肿瘤药物，2022年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额超过12亿元。今年以来公司已有2个品种获批上市，其中泊沙康唑肠溶片为国产第5家、替吉奥胶囊为国产第4家。2023年至今扬子江药业获批产品在过去的2023年，扬子江药业仿制药产品线再次交出一份亮眼的成绩单，累计有27个品种（仿制3/4类，不含补充申请）获批生产并视同过评，进一步丰富了公司的产品线。从治疗领域上看，全身用抗感染药物、消化系统及代谢药皆有7个，抗肿瘤和免疫调节剂、心脑血管系统药物各有4个。27个品种中多个为国内首批上市，盐酸奈康唑乳膏、氨氯地平贝那普利胶囊为国内首仿+首家过评；富马酸伏诺拉生片、帕拉米韦注射液、盐酸艾司洛尔氯化钠注射液为国产第2家；盐酸伐地那非片、左西孟旦注射液为国产第3家；钆布醇注射液、注射用右雷佐生、比卡鲁胺片为国产第4家。近年来扬子江药业仿制药产品线保持“高产稳产”的状态，2021-2023年公司分别有31个、29个、27个品种（仿制3/4/6类，不含补充申请）获批上市，在年度仿制药获批TOP10企业榜单中持续名列前茅，分别位列第一、第一、第二。157个过评品种霸屏！23个备战第十批集采截至目前，扬子江药业已有157个品种通过/视同通过一致性评价，在仿制药过评榜中稳居首位。其中，34个品种为国内首家过评，兰索拉唑肠溶胶囊、氨氯地平贝那普利胶囊、头孢克洛缓释片（Ⅱ）、盐酸奈康唑乳膏、伏立康唑分散片、枸橼酸他莫昔芬片等品种为独家过评。扬子江药业通过/视同过评品种（带*为首家过评）从治疗领域上看，157个过评品种涵盖12个治疗大类，主要集中在全身用抗感染药物（32个）、消化系统及代谢药（20个）、抗肿瘤和免疫调节剂（20个）、神经系统药物（19个）、心脑血管系统药物（17个）。可见，公司过评产品集群立足于抗感染核心治疗领域，并向肿瘤免疫、消化代谢、精神神经、心脑血管等疾病领域协同发展。米内网数据显示，2022年中国公立医疗机构终端消化系统及代谢药、抗肿瘤和免疫调节剂、全身用抗感染药物的销售额都超过1500亿元，心脑血管系统药物销售额超过1000亿元，神经系统药物销售额接近1000亿元。凭借庞大的过评产品集群，扬子江药业在国家开展的八批化药集采中收获满满，分别有2个、4个、7个、8个、10个、12个、2个、6个品种成功中选，合计51个品种。集采常态化推进背景下，扬子江药业恰逢仿制药密集收获期，并积极参与集采，已跻身集采头部供应商之列。扬子江药业八批化药集采中选情况第十批集采已提上日程，扬子江药业已有23个过评品种满足集采门槛，符合申报资格企业数达5家及以上。23个品种包括11个注射剂、8个口服常释剂型、4个口服液体剂，其中帕拉米韦注射液、钆布醇注射液、泊沙康唑注射液、氢溴酸伏硫西汀片、氨溴特罗口服溶液等皆为新获批品种，若被纳入第十批集采，可通过集采中标快速打开市场。步入2024年，扬子江药业已相继提交了4款仿制药的注册申请，具体为硫酸氨基葡萄糖胶囊、西甲硅油乳剂、注射用醋酸西曲瑞克、琥珀酸地文拉法辛缓释片。目前扬子江药业还有28个新注册分类品种上市申请在审，获批生产后将视同通过一致性评价。20款1类新药曝光！4款上市可期近期，扬子江药业的1类新药YZJ-5799磷酸盐胶囊获批临床，用于治疗晚期恶性肿瘤。米内网数据显示，2022年中国公立医疗机构终端抗肿瘤药销售额超过1100亿元。YZJ-5799磷酸盐胶囊是公司2024年首款获批临床的1类新药。近年来扬子江药业创新研发的步伐持续加快，2020-2022年公司皆有3款1类新药申报IND，2023年则有2款1类新药申报IND、一款1类新药申报NDA。随着行业掀起创新浪潮，公司审时度势，及时调整研发管线，于2024年2月将早前从迈威生物引进的PD-1和G-CSF类药物“退货”。扬子江药业主要在研1类新药除了已上市的注射用磷酸左奥硝唑酯二钠，目前扬子江药业还有20款1类新药处于获批临床及以上阶段，其中小分子化学创新药有14个、中药创新药有6个，涵盖抗肿瘤、神经系统、内分泌、心血管、呼吸系统等疾病领域。中药创新药方面，感冒双解颗粒（治疗流行性感冒）已处于Ⅲ期临床阶段，银曲胶囊（治疗血脂异常）、清肠温中片（治疗溃疡性结肠炎）、复方蓉术颗粒（治疗老年功能性便秘）皆处于Ⅱ期临床阶段。小分子化学创新药方面，盐酸妥诺达非片（治疗男性勃起功能障碍）已于2023年2月25日申报NDA，最快有望于今年获批上市；盐酸非苏拉赞片（治疗反流性食管炎）、YZJ-1139片（治疗失眠症）皆处于Ⅲ期临床阶段，上市可期。数据来源：米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。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

Recorded FY'23 unconsolidated revenue of KRW 1.22 trillion and FY'23 operating profit of KRW 133.4 billion SEOUL, South Korea, Feb. 6, 2024 /PRNewswire/ -- Daewoong Pharmaceutical (KRX: 069620.KS), a global pharmaceutical company located in Seoul, announced its marvelous financial results for 2023. Demonstrating a consistent growth trajectory, the company reported stand-alone sales of KRW 1.22 trillion and a commendable operating profit of KRW 133.4 billion. Chang-jae Lee, CEO of Daewoong Pharmaceutical, emphasized the company's global reach and innovative edge, stating, "Our role as a global healthcare solutions provider is mirrored in the impressive global performance of our novel drugs and our strategic expansion initiatives. Our strong financial results, characterized by record revenues and profits, affirm our unwavering commitment to innovation and to expanding our global market presence." Key Highlights (Unconsolidated) (unit: KRW billion) Revenues reached KRW 1,222 billion in 2023, marking a 60.7% increase from the previous year. Operating profit was KRW 134 billion in 2023, reflecting a 25.9% increase from the previous year. The annual net income was KRW 111.5 billion, an increase of 129.6% compared to the previous year. Product Developments: Fexuclue (Fexuprazan): A P-CAB drug for GERD, Fexuclue, has shown strong sales since its launch, amassing KRW 55 billion. It quickly became a blockbuster, accumulating a cumulative revenue of KRW 71.7 billion, attributable to its fast positioning in both local and global markets. Within just 17 months of its release, Fexuclue climbed to the 2nd rank in the domestic GERD treatment market. Additionally, it is gaining international traction, with NDA submissions in 18 countries and approvals from 5, including key Latin American markets such as Ecuador, Chile, and Mexico. Envlo (Enavogliflozin): An SGLT-2 inhibitor, Envlo, has rapidly expanded globally, submitting NDAs in 11 countries, including Indonesia and the Philippines, within just six months of its domestic launch. The global expansion of Envlo is regarded as a meaningful step, considering it is the only SGLT-2 inhibitor originally made by South Korea. NABOTA (Botulinumtoxin Type A): Recognized as Asia's first FDA-approved botulinum toxin, NABOTA has recorded sales of KRW 147 billion. It is expanding its international footprint through Evolus, launching as Nuceiva in several European countries and strengthening its position in North America and Europe. Additionally, Daewoong's US clinical trial partner, AEON Biopharma, secured a U.S. patent for migraine treatment last September. Pipeline Developments: DWP213388, targeting both BTK and ITK for immune cell activation, has received approval for U.S. Phase 1 Clinical Trials. The FDA endorsed its IND application in August 2023, highlighting its potential in treating autoimmune diseases such as RA. Bersiporocin, focusing on the PARS1 enzyme essential for collagen synthesis, is progressing through Phase 2 trials in the US and Korea. With its potential anti-fibrotic benefits, Daewoong remains dedicated to ensuring its safe use. The drug has achieved the FDA's Orphan Drug and Fast Track Designations for IPF. Additionally, it has received Orphan Drug and Fast Track Designations for IPF in Europe. DWRX2008, a novel drug candidate from Daewoong Therapeutics, a subsidiary of Daewoong Pharmaceutical Group, aims to revolutionize the treatment of diabetic retinopathy by transitioning Envlo from oral administration to an innovative ocular pathway. As a first-in-class development, DWRX2008 has secured approval from South Korean's Ministry of Food and Drug Safety (MFDS) to commence Phase 1 clinical trials for its innovative candidate targeting diabetic eye diseases. DWP306001, which incorporates Envlo, is in development as a potential treatment for obesity. The combination of Envlo with an appetite suppressant is set to enter Phase 2 clinical trials later this year. Forward-Looking Statements: This press release contains forward-looking statements that are based on the current beliefs and expectations of Daewoong Pharmaceutical's management. Factors that could cause or contribute to such differences include, but are not limited to: (1) Regulatory and governmental approvals: The approval process for pharmaceutical products is subject to extensive regulations and may involve uncertainties and delays. Any failure to obtain necessary approvals or the occurrence of delays in the approval process could adversely affect Daewoong Pharmaceutical's business and results of operations; and (2) Clinical trials: The success of Daewoong Pharmaceutical's products depends on the results of clinical trials. The results of early clinical trials may not be indicative of the results of later-stage or larger-scale clinical trials. About Daewoong Pharmaceutical: Daewoong Pharmaceutical (KRX: 069620.KS), established in 1945, is a global pharmaceutical company based in South Korea. The company is committed to the development, manufacturing, and commercialization of pharmaceutical products, with a mission to provide the most beneficial total solutions, including pharmaceuticals and services, which contribute to improving the quality of life of valued consumers. Operating with a keen focus on both domestic and international markets, Daewoong Pharmaceutical specializes in developing treatments for intractable and rare diseases. The company's diverse portfolio encompasses novel drugs, biologics, new products, and C&D, all supported by in-house research and development, open collaboration, and advanced manufacturing facilities. Marking significant achievements in drug development, Daewoong Pharmaceutical has successfully developed novel drugs for GERD, featuring the active ingredient Fexuprazan, and for Type 2 diabetes, with the active ingredient Enavogliflozin, in two consecutive years. The company is currently advancing in the development of First-in-Class Oral Anti-Fibrotic Agent for Idiopathic Pulmonary Fibrosis, utilizing Bersiporocin as a PRS Inhibitor. Notably, Bersiporocin has been designated by the U.S. FDA as an orphan drug and a Fast Track development product. Daewoong is dedicated to completing the Phase 2 clinical study of this drug by 2025. For more information, visit Daewoong Pharmaceutical's website and LinkedIn page. SOURCE Daewoong Pharmaceutical Co., Ltd.