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：PixavirMarboxil Capsules 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。 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： 规格：20mg 申请事项：药品注册（境内生产） 剂型：胶囊剂 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。 该适应症获批是基于一项III期、多中心、随机、双盲研究，旨在评价单次口服本品对比安慰剂在既往健 康 ...

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） ...

Core Viewpoint - The recent monitoring data from the Chinese Center for Disease Control and Prevention indicates a significant rise in influenza cases, with the percentage of influenza-like cases reaching 6.5%, signaling a rapid increase in flu activity across the country. This surge has led to a dramatic increase in sales of antiviral medications, particularly oseltamivir and baloxavir marboxil, with sales of oseltamivir increasing by 237% in one week and baloxavir marboxil rising by 180% [1][4][8]. Group 1: Market Dynamics - The sales of oseltamivir capsules in the domestic hospital market are projected to reach nearly 1.9 billion yuan in 2024, with Dongyang Sunshine Pharmaceutical holding a market share of 56.66%, dominating the domestic hospital market [4]. - Following the expiration of Roche's patent in 2016, numerous domestic generic versions of oseltamivir have emerged, with 138 related drug approvals currently available, indicating increased competition for Dongyang Sunshine Pharmaceutical [7]. - Baloxavir marboxil, developed by Roche, has seen its sales in the domestic market exceed 400 million yuan in 2023, with a projected sales figure of nearly 1.4 billion yuan in 2024, reflecting a year-on-year growth of 216.54% [8]. Group 2: Innovation and New Entrants - New domestic antiviral drugs are emerging, with Qingfeng Pharmaceutical's GP681, a first-class new drug for influenza, approved for the market in March 2025, providing a new treatment option for influenza patients aged 12 and older [13]. - The launch of innovative drugs such as Amlodipine tablets by Zhongsheng Pharmaceutical in May 2025 marks a significant breakthrough in the antiviral drug development field in China, potentially allowing the country to secure a position in the global influenza market [15]. - The inclusion of Jichuan Pharmaceutical's Jin Tong Bei and Ji Ke Shu in the first batch of the Jiangsu Province Innovation Drug and Device Product Directory highlights the recognition of their advanced technology and clinical value, enhancing their competitive edge in the antiviral market [21]. Group 3: Overall Market Trends - The current landscape of China's antiviral drug market is characterized by a combination of steady growth in traditional products and explosive growth in innovative products, with Dongyang Sunshine Pharmaceutical leading the market with oseltamivir, while Roche's baloxavir marboxil rapidly gains traction due to its unique advantages [22].

Core Insights - The flu medication market is undergoing a significant transformation, with Oseltamivir losing popularity and Marboxilavir rapidly gaining traction as a preferred treatment option [2][14]. Group 1: Market Dynamics - Oseltamivir, once the dominant flu treatment since its introduction in 1999, is experiencing a decline in market interest, with sales dropping significantly from over 6.5 billion yuan in 2019 to approximately 206.8 million yuan in 2020, a decrease of 65.1% [5][7]. - In contrast, Marboxilavir, which was approved in Japan in 2018 and in China in 2021, is witnessing a surge in demand, with sales reaching 510 million yuan in 2024 and capturing 10.8% of the market share [9][11]. Group 2: Competitive Landscape - The competition in the flu medication market is intensifying, with over 120 companies producing flu medications in China, including more than 70 competitors for Oseltamivir alone [8][16]. - New entrants like Marboxilavir are disrupting the market dynamics, leading to a potential dual dominance scenario alongside Oseltamivir, while other new drugs like Baloxavir and Mavrilavir are also emerging [16][17]. Group 3: Consumer Preferences - Marboxilavir's unique advantage of requiring only a single dose for treatment enhances patient compliance, making it particularly appealing for busy individuals and parents managing children's medication [11][12]. - Clinical studies indicate that Marboxilavir offers faster symptom relief compared to Oseltamivir, with an average symptom alleviation time of 53.7 hours versus longer durations for Oseltamivir [11][12]. Group 4: Future Outlook - The shift in market preference from Oseltamivir to Marboxilavir is expected to drive further research and development in the flu medication sector, fostering innovation and the introduction of more effective and safer treatments [18]. - Companies are encouraged to enhance their core competencies, optimize production processes, and leverage technologies like AI and big data to improve drug development and market strategies [17][18].

Overview - The demand for antiviral drugs in China is significantly influenced by the number of influenza cases, with the market size reaching 11 billion yuan in 2023, a year-on-year increase of 150% [1][7] - In 2024, the market size is expected to decrease to 8 billion yuan due to a reduction in influenza cases, with oseltamivir accounting for approximately 78% of the market [1][7] Industry Chain - The upstream of the antiviral drug industry includes suppliers of raw materials such as chemical APIs, traditional Chinese medicine materials, and packaging materials, while the midstream consists of antiviral drug manufacturers, and the downstream includes medical institutions, pharmacies, and e-commerce platforms [4] Development Background - The large population base in China leads to a high susceptibility to influenza, with an estimated 8.59 million cases and 19 deaths in 2024, driving demand for antiviral drugs, especially among the elderly [6][7] - Increased health awareness among the public has led to a greater willingness to purchase antiviral medications during flu season [6] Current Market Situation - The antiviral drug market in China is heavily influenced by influenza case numbers, with a significant expansion in 2023 due to a broader and longer-lasting influenza outbreak compared to pre-COVID-19 times [1][7] - The market is projected to contract in 2024 as influenza cases decline [1][7] Competitive Landscape - The antiviral drug market is currently dominated by neuraminidase inhibitors, with oseltamivir being the primary product, facing increasing competition from generic versions after its patent expired [8][9] - As of August 2025, there are 118 approved oseltamivir products from 69 companies, indicating a highly competitive environment [9] Key Companies - **East Sunshine Pharmaceutical**: Holds a 64.8% market share in the oseltamivir market and a 50.5% share in the overall antiviral market, with a revenue of 4.019 billion yuan in 2024 [10] - **Shijiazhuang Pharmaceutical Group**: Focuses on innovative drugs and reported a revenue of 29.01 billion yuan in 2024, with a gross profit margin of 69.97% [11] Development Trends - The rapid mutation of influenza viruses is driving research towards more effective antiviral drugs with lower resistance rates, particularly RNA polymerase inhibitors [11] - The emergence of innovative domestic drugs is expected to enhance China's position in the global antiviral market, with potential for international expansion of products with independent intellectual property rights [11]

Core Viewpoint - The market for antiviral drugs, particularly oseltamivir, is undergoing significant changes due to price adjustments, increased competition from generics, and the emergence of new drugs, leading to a potential reshaping of the industry landscape [1][3][12]. Price Adjustments and Market Dynamics - Zhejiang Province's medical insurance bureau has announced price adjustments for oseltamivir capsules, affecting several manufacturers, including East Sunshine Pharmaceutical [1][4]. - Prior to the collective procurement, oseltamivir capsules were priced over 100 yuan, but the minimum winning price in the seventh national procurement was less than 1 yuan per capsule, representing a 92% reduction from the highest bid [1][5]. - The domestic flu drug market exceeded 10 billion yuan in 2023, with oseltamivir holding over 80% market share, but this is threatened by the rapid growth of Roche's baloxavir marboxil, which saw sales increase from 70 million yuan in 2022 to 630 million yuan in 2023 [2][5]. Competitive Landscape - East Sunshine Pharmaceutical's market share for oseltamivir has dropped to 54.8% as of 2024, facing competition from over 70 other pharmaceutical companies producing generic versions [2][6]. - The company’s sales from oseltamivir products accounted for 81.2%, 86.9%, and 64.2% of total revenue from 2022 to 2024, indicating a significant reliance on this product line [7]. - The expiration of key patents for oseltamivir will intensify competition, with the last synthesis process patent expiring in March 2024 [5][6]. New Drug Developments - The introduction of new antiviral drugs, such as baloxavir marboxil and PB2-targeting drug, has the potential to disrupt the existing market, particularly with baloxavir's pediatric formulation targeting children aged 5 to 12 [8][10]. - The increasing resistance rates of flu viruses to existing treatments, including oseltamivir, highlight the urgent need for new drug development [10][11]. - The approval of multiple new antiviral drugs in China and the U.S. indicates a growing focus on innovative treatments to address flu virus mutations and resistance issues [9][10]. Future Outlook - The ongoing shifts in the antiviral drug market, driven by pricing pressures, patent expirations, and the introduction of new therapies, suggest that companies like East Sunshine Pharmaceutical may need to diversify their product offerings to sustain growth [7][12]. - The competitive landscape is expected to evolve rapidly, with both domestic and international players vying for market share in the antiviral segment [12].

Core Viewpoint - The approval of ZHONGSHENG Pharmaceutical's Angladiwe Tablets by the National Medical Products Administration marks a significant advancement in the treatment of influenza, being the first RNA polymerase PB2 protein inhibitor globally [1] Company Summary - ZHONGSHENG Pharmaceutical (002317) announced the approval of Angladiwe Tablets on May 22, 2025, for the treatment of adult uncomplicated influenza A patients [1] - Angladiwe Tablets are the only antiviral drug in China that has undergone head-to-head Phase III clinical trials against Oseltamivir and received market approval [1] Clinical Trial Results - Phase III clinical trial results indicated that Angladiwe Tablets significantly outperformed the placebo group in seven primary endpoints related to the relief of influenza symptoms, achieving statistical significance [1] - The Angladiwe group demonstrated a nearly 10% reduction in median time to alleviation of total symptoms (TTAS) and fever relief compared to the Oseltamivir group [1]