Core Viewpoint - Health元 announced the approval of its innovative drug, Marpasisavir Capsules (Yilikan®), for domestic market, offering a new experience in flu treatment with a single oral dose for complete therapy [2] Group 1: Drug Development and Approval - The drug was developed in just two years, significantly shorter than the typical 6-8 years for global flu drug development [2] - The rapid development was facilitated by the company's AI-assisted drug design platform, which optimized structure, predicted enzyme activity, and ensured cross-strain coverage [2] - Health元 has built a strong CMC (Chemistry, Manufacturing, and Control) capability over ten years, enabling a streamlined process from small-scale trials to large-scale production in less than half the industry average time [2] Group 2: Clinical Efficacy and Safety - In phase III clinical trials, the median time for symptom relief in the Yilikan® group was significantly shorter than that of the placebo group, with a difference of -27.0 hours (P<0.0001) [3] - Particularly in patients with type B influenza, the Yilikan® group showed a statistically significant improvement with a symptom relief time difference of -31.0 hours (p<0.05) [3] - The drug demonstrated good efficacy in adolescents, with no serious adverse events reported, indicating stable safety performance [3] - Yilikan® maintains clear efficacy against both type A and type B influenza, requiring only a single oral dose and unaffected by food intake, enhancing treatment convenience and compliance [3]

Group 1 - The core point of the article is that Health元 (600380) has received domestic approval for its innovative drug, Marpacisavir Capsules (壹立康®), which offers a new treatment experience for influenza, allowing for "one-time oral administration to complete treatment" [1] - The drug's development cycle was significantly shorter than the global average for new influenza treatments, taking only two years to reach Phase III clinical trials, compared to the typical 6-8 years [1] - The company attributes this rapid development to its early investment in an AI-assisted drug design platform, which enabled quick results in key areas such as structural optimization and enzyme activity prediction [1] Group 2 - In Phase III clinical trials, the Marpacisavir group showed a statistically significant reduction in median time to symptom relief compared to the placebo group, with a difference of -27.0 hours (P<0.0001) [2] - The drug demonstrated particularly effective results in patients with type B influenza, with a symptom relief time difference of -31.0 hours (P<0.05) [2] - Marpacisavir also exhibited good efficacy in the adolescent population, with no serious adverse events reported, indicating stable safety performance [2]

Group 1 - The core point of the article is that Health元 has successfully launched its innovative drug, Marpasisavir capsules (Yilikan), for flu treatment in China, which allows for "one-time oral treatment" [1] - The drug's development cycle was significantly shortened to two years, compared to the typical 6-8 years for flu drugs, due to the company's early investment in an AI-assisted drug design platform [1] - Health元 has built a strong CMC (Chemistry, Manufacturing, and Control) capability over ten years, enabling a rapid internal process for drug development and production, achieving scale in less than half the industry average time [1] Group 2 - In Phase III clinical trials, the median time for symptom relief in the Yilikan group was significantly shorter by 27.0 hours compared to the placebo group (P<0.0001) [2] - The drug showed particularly strong efficacy in patients with type B influenza, with a symptom relief time reduced by 31.0 hours compared to the placebo (P<0.05) [2] - Yilikan demonstrated good efficacy in adolescents with no serious adverse events reported, maintaining clear effectiveness against both type A and type B influenza, and enhancing treatment convenience and compliance with a single oral dose [2]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Marbocil Capsules, an innovative antiviral drug for treating influenza in healthy adolescents and adults [1][2]. Drug Registration Details - Drug Name: Marbocil Capsules - English/Latin Name: Pixavir Marboxil Capsules - Dosage Form: Capsule - Specification: 20mg - Registration Classification: Class 1 Chemical Drug - License Holder: Health元药业集团股份有限公司 - Manufacturing Company: 凯莱英生命科学技术(天津)有限公司 - Approval Number: 国药准字H20250070 - Approval Conclusion: The drug meets the registration requirements and has been granted a registration certificate [1]. Drug Development and Clinical Data - Marbocil Capsules are indicated for the treatment of uncomplicated influenza A and B in healthy individuals aged 12 and above, excluding those at high risk for complications [2]. - The approval is based on a Phase III, multi-center, randomized, double-blind study demonstrating the drug's efficacy and safety compared to a placebo [2]. - The drug requires only a single dose for the entire treatment course, significantly improving patient compliance [3]. - In clinical trials, the median time to symptom relief for the treatment group was reduced by 27 hours compared to the placebo group (P<0.0001) [3]. - For patients with influenza B, the median time to symptom relief was shortened by 31 hours (P<0.05) [3]. - In adolescents, the median time to symptom relief was reduced by 61 hours compared to the placebo group (P<0.05) [3]. - The drug shows a lower risk of resistance, with a total incidence of amino acid substitutions related to sensitivity decline being 0% for H1N1, 1.2% for H3N2, and 0% for influenza B [3]. - The safety profile is favorable, with a low incidence of adverse reactions compared to the placebo group [3]. Market Situation - Influenza poses a global public health issue, with seasonal outbreaks causing significant health impacts [5]. - The estimated domestic sales of antiviral drugs for influenza are projected to reach approximately RMB 4.7 billion in 2024 [5]. R&D Investment - The cumulative direct investment in the research and development of Marbocil Capsules is approximately RMB 203.0361 million [4].

Group 1: Company Announcements - 蓝盾光电 announced the termination of the equity transfer agreement with Shanghai Xingsi Semiconductor, with no payment made for the equity transfer [1] - 兆新股份 plans to acquire 70% of Youde New Energy for a maximum price of 220 million yuan, enhancing its capabilities in the renewable energy operation sector [2] - 南都电源 is in the process of planning a change in control and has suspended its stock trading, with the suspension expected to last no more than two trading days [3] - 万科A reported a guarantee balance of 84.476 billion yuan as of October 31, with no overdue guarantee matters [4] - 国晟科技's stock price has increased significantly, with a cumulative rise of 206.62%, indicating potential irrational speculation and risks of a rapid price drop [5] - 中威电子 announced a change in its actual controller to Fu Yingbo, with stock trading set to resume [6] Group 2: Mergers and Acquisitions - 新兴铸管's subsidiary plans to acquire 100% of China Resources Steel for 1.244 billion yuan [7] Group 3: Share Transfers and Investments - 太龙药业's shareholder plans to transfer 50.1 million shares to Jiangyao Holdings [8] - 医药 approvals include 常山药业 receiving a drug registration certificate for heparin sodium injection in Turkmenistan [9] - 真兰仪表's shareholder intends to increase holdings by 10 to 20 million yuan [9] - 海南瑞泽's vice president plans to reduce holdings by 231,000 shares [9] - 金陵体育's director has reduced holdings by 0.0276% [9] - 佰仁医疗's subsidiary has received approval for a collagen implant product [9]

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]