Core Viewpoint - The company has received approval from the National Medical Products Administration for its innovative antiviral drug, Mapasavir Capsules, which is indicated for the treatment of uncomplicated influenza in healthy adolescents and adults aged 12 and above [1][2]. Group 1: Drug Approval and Indications - Mapasavir Capsules (brand name: Yilikang®) is classified as a Class 1 chemical drug and has been granted the registration number H20250070 [1]. - The drug is specifically indicated for the treatment of uncomplicated influenza caused by both influenza A and B viruses, excluding patients at high risk for flu-related complications [1]. Group 2: Clinical Study Results - The approval is based on a Phase III, multi-center, randomized, double-blind study that demonstrated the efficacy and safety of a single oral dose of Mapasavir compared to a placebo in healthy adolescents and adults with uncomplicated influenza [1]. - The study achieved both primary and secondary endpoints, confirming clear clinical benefits [1]. Group 3: Clinical Advantages - Mapasavir Capsules require only a single dose for the entire treatment course, significantly improving patient compliance [2]. - The drug shows good efficacy against both influenza A and B viruses, with a median time to symptom relief reduced by 27 hours compared to the placebo group, which is statistically significant (P < 0.001) [2]. - In adolescents, the median time to symptom relief was shortened by 61 hours compared to the placebo group (P < 0.001) [2]. Group 4: Resistance and Safety Profile - The risk of resistance to Mapasavir is lower, with a total incidence of amino acid substitutions related to decreased sensitivity being 0% for H1N1, 1.2% for H3N2, and 0% for influenza B in the clinical studies [2]. - The safety profile of Mapasavir is favorable, with a low incidence of adverse reactions in the Phase III study, showing comparable or lower rates of overall adverse reactions and those classified by system organ compared to the placebo group [2].

近日，健康元药业集团股份有限公司（以下简称：本公司）收到国家药品监 督管理局核准签发的《药品注册证书》，现将有关详情公告如下： 健康元药业集团 获得药品注册证书的公告 证券代码：600380 证券简称：健康元 公告编号：临 2025-081 健康元药业集团股份有限公司 关于玛帕西沙韦胶囊（壹立康®）获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 一、药品注册证书主要内容 药品名称：玛帕西沙韦胶囊 英文名/拉丁名：Pixavir Marboxil Capsules 剂型：胶囊剂 规格：20mg 申请事项：药品注册（境内生产） 注册分类：化学药品 1 类 上市许可持有人：健康元药业集团股份有限公司 生产企业：凯莱英生命科学技术(天津)有限公司 药品批准文号：国药准字 H20250070 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 符合药品注册的有关要求，批准注册，发给药品注册证书。 二、药品研发及相关情况 玛帕西沙韦胶囊（壹立康®）（以下简称：本品）为公司创新抗流感 1 类新 药，适 ...

Core Viewpoint - The announcement by the company regarding the approval of a new innovative anti-influenza drug, Marpasi Savir Capsules, highlights significant advancements in treatment options for influenza patients aged 12 and above, showcasing its efficacy and safety profile [2]. Group 1: Product Approval - The company received the drug registration certificate from the National Medical Products Administration for Marpasi Savir Capsules (Yilikan®) [2]. - This drug is classified as a first-class innovative anti-influenza medication [2]. Group 2: Target Patient Population - The drug is intended for the treatment of uncomplicated influenza A and B in previously healthy adolescents aged 12 and older, as well as adults [2]. Group 3: Drug Efficacy and Safety - The medication requires only a single dose for the entire treatment course [2]. - It demonstrates good efficacy against both influenza A and B virus infections, with superior effectiveness against influenza B compared to similar drugs [2]. - The drug shows particularly notable efficacy in treating influenza in adolescents, with a lower risk of resistance and significant safety advantages [2].

健康元（600380）(600380.SH)公告，公司收到国家药品监督管理局核准签发的《药品注册证书》，药 品名称为：玛帕西沙韦胶囊。玛帕西沙韦胶囊(壹立康)为公司创新抗流感1类新药，适用于既往健康的 12岁及以上青少年和成人单纯性甲型和乙型流感患者的治疗，不包括存在流感相关并发症高风险的患 者。 ...

Core Viewpoint - The company, Health元, has received approval from the National Medical Products Administration for its innovative anti-influenza drug, Marpacisavir Capsules (Yilikan), which is designed for the treatment of uncomplicated influenza A and B in adolescents and adults aged 12 and above [1] Group 1 - The drug requires only a single dose for the entire treatment course [1] - It demonstrates good efficacy against both influenza A and B virus infections, with superior efficacy against influenza B compared to similar drugs [1] - The drug shows particularly strong efficacy in treating influenza in adolescents, with a lower risk of resistance and significant safety advantages [1]

Group 1 - The company and its subsidiaries have a total of 218 products included in the new National Medical Insurance Drug List, with 94 classified as Category A and 124 as Category B [1] - Notable products include injectable Aripiprazole microspheres, which were included through negotiation, and injectable Triptorelin microspheres, which have a new indication [1] - The inclusion of these products is expected to enhance market expansion and improve drug accessibility, positively impacting the company's future operating performance [1] Group 2 - The new Medical Insurance Drug List will officially take effect on January 1, 2026, and is not expected to have a significant impact on the company's current operating performance [1]

证券日报网讯 12月8日，健康元在互动平台回答投资者提问时表示，公司在抗流感领域的核心产品推进 成效显著：抗流感1类创新药玛帕西沙韦胶囊正处于审评后期，即将上市；针对儿童群体的玛帕西沙韦 干混悬剂，已顺利进入III期临床。这款药物具备突出优势，能从源头精准阻断甲、乙型流感病毒复制， 单次口服即可完成整个疗程，儿童剂型适配性强，且整体耐药风险低、安全性良好。公司将加速推进两 款产品的后续落地进程，力争为全年龄段人群提供优质、便捷的流感治疗方案。 （编辑 姚尧） ...

（文章来源：证券日报） 证券日报网讯 12月8日，健康元在互动平台回答投资者提问时表示，公司间接持有新元素药业的股权比 例较小，对公司整体财务状况不构成重大影响。丽珠集团对其投资详情及新元素药业上市进展、具体时 间表，请分别以丽珠集团及新元素药业的官方披露信息为准。 ...

Core Viewpoint - Health元药业集团股份有限公司 has successfully had 218 products included in the new National Medical Insurance Directory, which is expected to positively impact the company's future operating performance, although it will not have a significant effect in the current period [1]. Group 1: Stock Performance - As of December 8, 2025, Health元's stock closed at 12.54 yuan, down 0.79% from the previous trading day, with a total market capitalization of 22.941 billion yuan [1]. - The stock opened at 12.63 yuan, reached a high of 12.76 yuan, and a low of 12.48 yuan, with a trading volume of 2.51 billion yuan and a turnover rate of 1.09% [1]. Group 2: Product Inclusion in National Medical Insurance Directory - On December 7, 2025, the National Medical Insurance Bureau released the updated National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Directory, which includes 218 products from Health元 and its subsidiaries [1]. - Among the included products, 94 are classified as Category A and 124 as Category B [1]. - Notable inclusions are the injectable Aripiprazole microspheres and the injectable Triptorelin acetate microspheres, which now have an added indication for endometriosis [1]. - The renewal of the Tobramycin inhalation solution and injectable Esomeprazole sodium was also successful, with no products being removed from the directory [1]. - The new directory will take effect on January 1, 2026, and while it is expected to have a positive impact on future sales, the sales performance remains subject to policy and market uncertainties [1].

（原标题：健康元(600380.SH)：创新药研发方面已在呼吸、抗感染等核心领域布局超20款1类创新药） 格隆汇12月8日丨健康元(600380.SH)在投资者互动平台表示，在创新药研发方面，公司已在呼吸、抗感 染等核心领域布局超20款1类创新药。例如抗流感1类创新药玛帕西沙韦胶囊处于审评后期，即将上市， 儿童剂型进入III期临床；针对慢阻肺的TSLP单抗、PREP抑制剂等多款创新药也在稳步推进临床，致力 于突破现有治疗瓶颈。未来，公司将持续聚焦创新药研发核心，以全球视野推进产品布局与技术突破。 ...