Icosapent Ethyl

博瑞生物医药(苏州)股份有限公司 2026 年度“提质增效重回报”行动方案为践行“以投资者为本”的上市公司发展理念,维护博瑞生物医药(苏州) 股份有限公司(以下简称“公司”)全体股东利益,增强投资者信心,基于对公 司未来发展前景的信心和对公司价值的认可,公司于2025 年4 月3 日发布了 《2025 年度“提质增效重回报”行动方案》,并及时发布了2025 年半年度评估 报告。为进一步优化公司经营,提升市场竞争力,树立良好的资本市场形象,公 司制定了《2026 年度“提质增效重回报”行动方案》,并对2025 年度行动方案 进行年度评估。详情如下:一、聚焦经营主业,加快推进新产品开发公司是一家参与国际竞争的创新型制药企业。作为创新药时代的积极参与者 和引领者,成立逾24 年,公司始终以创新驱动为导向,以高技术壁垒构建产品 护城河;从早期的高仿、首仿、难仿制剂和高端原料药开始逐渐形成技术积累, 到现阶段向具备全球竞争力的创新药物管线全面布局,公司持续丰富差异化产品 矩阵。公司现有产品主要覆盖代谢、抗病毒、抗真菌、免疫抑制、呼吸系统及抗 肿瘤等治疗领域,其中代谢领域的核心产品包括创新药BGM0504、BGM1812 等,抗病毒领域的核心产品包括恩替卡韦、奥司他韦等,抗真菌领域的核心产品 包括卡泊芬净、米卡芬净钠、阿尼芬净、泊沙康唑等,免疫抑制领域的核心产品 包括依维莫司、吡美莫司等,呼吸系统领域的核心产品包括布地奈德、沙美特罗 替卡松及噻托溴铵等,抗肿瘤领域的核心产品包括艾立布林、芦比替定等。公司凭借自身在生物化学、微生物、多肽技术、药械组合及递送系统方面深 入的技术优势和研发积累,打造了超长效多肽药物平台、药械组合平台、合成生 物学平台及口服制剂平台等核心药物研发技术平台,形成了具备差异化竞争优势 的创新药及高端制剂产品梯队。公司业务在上述药物研发技术平台上沿着两条主线发展:(1)创新药物研发 领域,公司将强化关键核心技术攻关,孵化独特的、短期内难以仿制的、具有高度差异化和较大临床价值及商业价值的产品。公司将根据战略布局及产品情况, 灵活选择自主申报或寻求合作伙伴的方式将产品最终推进至上市。截至本报告披 露日,公司自主研发的多肽类降糖药BGM0504 注射液目前在国内处于临床Ⅲ期 试验阶段;长效胰淀素类似物产品BGM1812 注射液中国和美国一期临床均在开 展中。(2)高端仿制药领域,公司实现了一系列市场相对稀缺、技术难度较高的 药物的仿制,现已掌握了包括恩替卡韦、卡泊芬净、米卡芬净钠、泊沙康唑、依 维莫司及磺达肝癸钠在内的四十多种高端药物的生产核心技术,公司在国内已获 得多个制剂产品的生产批件,并实现制剂产品的商业化销售。(一)2025 年业绩达成情况2025 年,公司实现营业收入122,364.01 万元,同比减少4.59%;归属于上市 公司股东的净利润5,451.47 万元,同比减少71.18%;归属于上市公司股东的扣 除非经常性损益的净利润2,608.94 万元,同比减少85.55%。公司主营业务收入 分为产品销售收入、技术收入和权益分成收入。报告期内,公司实现产品销售收入107,897.95 万元,较上年同期减少6.10%。 原料药产品收入90,278.88 万元,较上年同期减少8.61%。其中,抗病毒类产品 收入较去年同期减少60.04%,主要为受流感趋势变化及竞争格局变化影响,奥 司他韦原料药需求及价格产生下滑;抗真菌类产品由于去年同期客户临时性需求 较旺盛,同时2025 年客户阶段性商业需求波动及产品价格波动,使得收入较去 年同期减少21.39%;免疫抑制类产品,受商业化需求拉动,收入较去年同期增 长27.79%;其他类产品中由于新产品陆续投入市场,市场开拓工作稳步推进, 收入较去年同期增长25.87%。制剂产品收入17,619.07 万元,较上年同期增长9.33%,主要系磺达肝癸钠 注射液、卡前列素氨丁三醇注射液等产品销售增长所致。公司海外权益分成收入 6,606.62 万元,较上年同期增长10.04%。(二)2025 年研发创新情况在研发创新方面,公司不断加大研发投入,报告期内,公司研发投入为 59,338.37 万元,同比增长90.32%,研发投入占营业收入的48.49%。公司将重点在代谢疾病领域开发具有全球自主知识产权的创新药物,在呼吸吸入为主的药械 组合领域构建具有国际竞争力的产品线。2025 年,公司持续推进BGM0504 注射 液等创新药及吸入制剂的研发,创新药及吸入制剂合计研发投入占公司研发投入 的73.66%,同比增长123.31%;其中创新药投入较去年同期增长204.98%,吸入 剂投入较去年同期减少9.92%。创新药端,公司将强化关键核心技术攻关,孵化独特的、短期内难以仿制的、 具有高度差异化和较大临床价值及商业价值的产品。公司将在代谢领域重点布局 含GLP-1 的多靶点药物,探索除了传统的注射方式之外的新型给药方式,并将 在慢性代谢疾病领域拓展更多临床应用。截至本报告披露日,(1)BGM0504 注 射液2 型糖尿病国内III 期临床试验目前已完成全部入组,处于给药和随访阶段。 减重适应症所有受试者已全部出组,正在按计划顺利推进中。待完成国内III 期 临床研究,并经国家药监局审评、审批通过后方可在国内生产上市。 (2)BGM0504 注射液减重适应症计划根据FDA 的建议完善III 期临床方案并提交。截至目前, BGM0504 注射液减重适应症在美国的后续临床计划具有不确定性。(3) BGM0504 注射液降糖适应症在印尼的三期临床研究工作正式启动,已完成首例 入组给药。(4)口服BGM0504 片剂减重适应症在中国和美国开展的一期临床研 究,均已完成LPLV(最后一位患者的最后一次访视),按计划顺利推进中。(5) BGM1812 注射液减重适应症在中国和美国一期临床均在开展中,正在进行多剂 量爬坡研究;口服BGM1812 片处于临床前研究阶段。(6)BGM2102 注射液、 BGM2101 注射液、BGM1962 处于临床前研究阶段。(7)MSTN 环肽注射液、 ALK7 靶向siRNA 项目处于PCC(临床前候选化合物)阶段。仿制药端,公司将延续仿制市场相对稀缺、技术难度较高的药物,紧盯原研 上市时间短、市场前景广阔的产品,不断丰富产品梯队建设,形成首仿、难仿、 特色原料药叠加复杂制剂两位一体的研发机制。公司将充分发挥微生物发酵等领 域的核心技术优势,在发酵半合成药物方面精耕细作,并逐步向合成生物学延伸。 截至本报告披露日,吸入用布地奈德混悬液已获得生产批件;噻托溴铵奥达特罗 吸入喷雾剂、噻托溴铵吸入喷雾剂已进入发补审评阶段;噻托溴铵吸入粉雾剂已 完成BE 试验(生物等效性试验),目前临床试验进行中;沙美特罗替卡松吸入 粉雾剂(50μg/250μg 规格)和(50μg/500μg 规格)已在国内申报。在研发组织与管理层面,公司近年来持续推进研发体系建设,逐步形成以项 目负责人及跨部门研发团队为核心的创新药研发体系。公司制定了《集团项目立 项实施规范》《研发项目管理制度》《研发质量管理文件》等规范性文件,不断规 范创新药、仿制药的立项程序、项目管理、临床质量和实施流程,把保护受试者 的权益和安全以及临床试验结果的真实、可靠作为临床试验的基本考虑,确保临 床研究的项目进度和数据质量。公司在研发决策、项目推进以及临床开发方面均 通过制度化流程运行,覆盖研发项目管理全生命周期,研发项目的立项评估、临 床规划及资源配置均依托专业化团队协同推进。(三)2026 年行动方案公司将围绕尚未满足的临床需求,瞄准国际先进技术水平,聚焦优势赛道, 不断创新开发新产品,加速推进核心产品商业化。公司将继续秉承高端仿制药和 原创性新药相结合的战略路线,采用精益化研发策略,专注对创新技术含量高、 临床价值突出的管线投入。创新药领域,公司将强化关键核心技术攻关,孵化独 特的、短期内难以仿制的、具有高度差异化和较大临床价值及商业价值的产品。 公司将在代谢领域重点围绕GLP-1 类药物进行差异化布局,包括探索新型给药 方式、开展多靶点联合用药、创新给药频率、拓展更多适应症等。已上市的GLP-1 类药物以注射剂为主,公司将持续探索更多GLP-1 类药物的新剂型,例如口服 制剂、超长效缓释制剂等,突破多肽给药壁垒,以提升患者依从性,给予患者更 多的用药选择,扩大GLP-1 类药物的临床应用,造福广大患者。针对现有已上 市减重药物在应用中存在的肌肉流失等局限性,公司将聚焦于多靶点协同与联合 用药的创新路径,旨在突破“单纯减重”的局限,在实现有效减重的同时维持或 增加瘦体重,从而改善身体成分,推动体重管理向更健康、更可持续的方向发展。 面对当前代谢性疾病治疗中频繁给药带来的依从性挑战,公司致力于开发低频/ 超长效给药技术,为长期体重管理提供创新解决方案。通过脂肪酸修饰、基因治 疗等创新手段,延长药物体内半衰期,实现“周制剂向月制剂升级”乃至“一次 给药、长期维持”的治疗突破,在保障疗效的同时显著提升患者用药便利性。 GLP-1 类药物已被验证可以用于治疗糖尿病、肥胖等疾病,与此同时,其在慢性 代谢疾病领域仍有广阔的临床应用拓展空间,例如高血压伴肥胖适应症或临床应 用的探索,代谢功能障碍相关的脂肪性肝炎(MASH)、心血管保护及阻塞性睡眠呼吸暂停等新的临床应用扩展。未来,公司将尝试应用GLP-1 类药物和其他 靶点联合用药,不断拓展GLP-1 类药物在慢性代谢疾病领域的应用,解决当前 国内外临床痛点。仿制药领域,公司将依托药械组合平台,重点开发经口吸入、 眼科喷雾、经鼻入脑三个方向。根据灼识咨询的资料,按市场规模计,呼吸系统 疾病是全球第五大、中国第七大慢性病领域,临床诊疗对呼吸系统疾病吸入制剂 的需求日益增长。经口吸入方面,公司将重点布局吸入混悬液、吸入喷雾剂、泡 罩型干粉吸入剂和胶囊型干粉吸入剂四个平台。吸入喷雾剂由于雾化机制、精密 装置制造等难度,全球尚无仿制药,原研企业通过装置专利形成技术封锁,仿制 需突破核心专利并验证药械一致性;干粉吸入剂由于其颗粒工程、混合工艺、装 置气流设计等难度,全球仅少数仿制药获批,研发周期和成本较高。公司将充分 发挥微生物发酵等领域的核心技术优势,延续仿制市场相对稀缺、技术难度较高 的药物,紧盯原研上市时间短、市场前景广阔的产品,不断丰富产品梯队建设, 形成首仿、难仿、特色原料药叠加复杂制剂两位一体的研发机制。二、深耕五大区域,持续打造全球化版图公司积极参与全球竞争,不断完善多维度立体化的全球市场布局。公司的药 品生产体系通过了中国、美国、欧盟、日本和韩国的官方GMP 认证,产品覆盖 了中国、欧盟、美国、日韩以及其他“一带一路”国家或地区。公司自主研发和 生产的多个医药中间体和原料药产品已经在美欧日韩等主要的国际规范市场国 家和中国进行了DMF 注册并获得了客户的引用,公司的产品在全球四十多个国 家实现了销售,部分产品帮助客户在特定市场上实现了首仿上市;亦有部分在研 产品通过技术授权实现收入。2025 年,公司积极推进产品商业化进程,国内产品注册方面,依维莫司片、 碘普罗胺注射液、吸入用布地奈德混悬液取得药品注册证书,伏环孢素软胶囊、 噻托溴铵吸入粉雾剂、BGM0504 片、BGM1812 注射液取得药物临床试验批准通 知书,盐酸多巴胺原料药、硫酸艾沙康唑原料药、瑞加诺生原料药、重酒石酸间 羟胺原料药、碘普罗胺原料药、肾上腺素原料药取得化学原料药上市申请批准通 知书,吸入用低密度聚乙烯安瓿瓶通过与制剂关联审评审批;噻托溴铵吸入喷雾 剂、羧基麦芽糖铁注射液、二十碳五烯酸乙酯软胶囊、芦比替定原料药、盐酸曲恩汀原料药在国内申报。国际产品注册方面,BGM0504 注射液降糖适应症由合 作伙伴在印尼递交的临床试验申请获得批准,BGM0504 片减重适应症、 BGM1812 注射液减重适应症在美国的新药临床试验申请(IND)获得批准,泊 沙康唑(晶型Ⅰ)原料药、盐酸达巴万星原料药在美国通过技术审评,阿加曲班 原料药、吡美莫司原料药在韩国获批预注册,舒更葡糖钠原料药在澳大利亚通过 技术审评;BGM0504 注射液减重适应症由合作伙伴在韩国递交IND 申请,泊沙 康唑晶型I 原料药、非达米星原料药在欧洲申报ASMF,醋酸卡泊芬净原料药在 澳大利亚申报DMF,吸入器在美国申报DMF。在知识产权方面,公司高度重视知识产权工作,公司先后获得“国家知识产 权示范企业”(国家知识产权局授予)、“国家知识产权优势企业”(国家知识产权 局授予)、“2017 年度中国专利优秀奖”(国家知识产权局授予)、“第十一届中国 药学会科学技术奖一等奖”等多项荣誉。报告期内,公司新提交国内专利申请 67 件,新获得国内专利授权25 件;新提交国外专利申请25 件,新获得国外专 利授权3 件;截至2025 年12 月末,公司累计申请专利598 件,其中发明专利 523 件;拥有有效专利共297 件,其中发明专利240 件,布局了美国、日本、加 拿大、欧洲、韩国等多个国家和地区。2025 年2 月,公司核心创新药BGM0504 的化合物专利已在中国、美国、欧洲、南非获得了授权,为创新药开拓海外市场 打下了坚实基础。2026 年,公司将以成为真正具有全球竞争力的创新型制药企业为目标,构 建“核心市场深耕+新兴市场突破”的全域布局体系,重点聚焦中国、欧洲、美 国、日韩及“一带一路”沿线国家五大核心区域,形成梯次递进、协同互补的全 球市场矩阵。依靠与国际接轨的质量管理体系和全球化的法规注册能力,持续完 善多维度立体化的产业链全球布局,一方面公司将充分发挥在欧美日韩市场的主 要优势,凭借已建立的渠道资源、合规口碑及产品竞争力,通过精细化运营进一 步提升核心产品的市场渗透率与份额,强化区域领先地位;另一方面公司将“一 带一路”等新兴医药市场作为增量突破口,结合沿线国家医疗保障升级、疾病谱 特点及市场准入规则,以高性价比产品与灵活合作模式快速打开市场局面,填补 区域医药供给缺口。原料药端,公司秉持“存量挖潜、增量拓新、生态绑定”发 展思路:在存量市场中,通过技术升级、成本优化提升客户粘性,挖掘现有合作的增量空间;同时主动开拓全球新兴市场客户,搭建多元化客户矩阵,降低单一 市场依赖风险;商业合作上,采用灵活定制化策略,积极探寻与下游制剂企业的 深度协同机会,从药物早期研发阶段介入,提供定制化原料药解决方案,通过技 术绑定与服务赋能,伴随客户制剂产品从研发到上市的全生命周期,构建长期稳 定的战略合作伙伴关系。制剂方面,公司将结合对应制剂产品自身特点及市场格 局,延续采取多元化的营销策略:一方面,公司将积极应对并参与国家仿制药集 采提升制剂产品的医院覆盖率,另一方面,将持续推进各级代理商的建设与管理, 发展并加强产品的渠道覆盖。对于具有较高技术壁垒的特色制剂和创新制剂产品, 公司将结合产品研发或上市申请的进度加速推进并开展自营团队的搭建,最终形 成以集采直供、招商代理和自营推广为特点的组合营销推广模式。三、加快产能建设,切实推进产业化进度公司以特色原料药及医药中间体为起点,在做大做强特色原料药产业的同时, 不断向下游制剂领域延伸,贯通了从“起始物料?高难度中间体?特色原料药? 制剂”的全产业链,先后取得了注射用米卡芬净钠、磷酸奥司他韦胶囊、阿加曲 班注射液、磷酸奥司他韦干混悬剂、注射用伏立康唑、甲磺酸艾立布林注射液、 碘普罗胺注射液等药品批件,另有一系列制剂产品在审评中。同时,不断推进包 括铁剂和吸入剂在内的复杂制剂产品梯队建设,打造新增长曲线。基于高难度特色原料药及复杂制剂的技术积累及营收基础,公司创新药研发 步入正轨,公司在代谢领域重点布局含GLP-1 的多靶点药物,探索除了传统的 注射方式之外的新型给药方式,并将在慢性代谢疾病领域拓展更多临床应用。为 保障产品安全稳定供应,公司持续推进新产品产能建设。苏州吸入剂及其他化学药品制剂生产基地和生物医药研发中心项目(一期): 公司为推动吸入制剂、抗肿瘤产品的产业化,提升公司的研发和生产能力,发行 了可转换公司债券,合计募集资金人民币46,500 万元用于投资建设。根据产品 临床价值、商业价值及研发进度等,为提高募集资金使用效率,公司对本项目产 品种类进行了变更,将生产资源较为稀缺的高技术壁垒产品置于产业化布局的优 先位置,变更后的项目产品包括沙美特罗替卡松干粉吸入剂、噻托溴铵吸入粉雾 剂、噻托溴铵奥达特罗吸入喷雾剂、伏环孢素软胶囊、生物医药CDMO。截至报告期末,(1)主体厂房结构已封顶,二次结构完成,门窗安装完成;研发楼、 危险品库、污水站结构已封顶,二次结构完成;(2)厂房(一)机电施工已完成, 厂房(二)一层、五层、六层、七层机电施工已完成,设备已完成安装。地下车 库连通车道开挖完成,底板已浇筑。苏州吸入剂及其他化学药品制剂生产基地和生物医药研发中心新建项目(二 期),本项目对应具体产品为噻托溴铵喷雾剂。截至报告期末,软雾车间机电安 装调试完成。创新药制剂和原料生产基地建设项目(一期),本项目主要用于创新药产品 BGM0504 注射液开展Ⅲ期临床试验及早期商业化,公司在苏州建设制剂生产基 地,用于BGM0504 注射液的研发、生产;在泰兴建设原料药生产基地,用于 BGM0504 原料药的研发、生产。截至报告期末,苏州制剂生产基地,机电施工 已完成,验证完成;泰兴原料药生产基地,机电施工已完成、设备已完成安装, 验证完成。2026 年,公司将加快推进各生产基地项目建设,助推公司超长效多肽药物、 药械组合、合成生物等核心技术创新成果尽快实现产业化,以良好的业绩回报广 大投资者。四、强化治理基石,筑实高质量发展之堤公司构建以股东大会、董事会和经营管理层为基础的治理体系,董事会下设 战略发展与ESG 委员会、审计委员会、薪酬与考核委员会、提名委员会4 个专 门委员会,各机构各司其职、分工明确、相互配合、相互监督,合力保障公司规 范运作和高质量发展,切实维护股东及利益相关方合法权益。公司重视公司治理结构的完善和内部控制的健全,不断完善公司法人治理结 构和治理水平。2025 年4 月,公司根据《中华人民共和国公司法》《中华人民共 和国证券法》《上海证券交易所科创板股票上市规则》《上海证券交易所科创板上 市公司自律监管指引第1 号--规范运作》 《上市公司监管指引第10 号--市值 管理》等法律法规及规范性文件的规定,完成了《董事会战略委员会工作制度》 《募集资金使用管理办法》《市值管理制度》《舆情管理制度》《环境、社会与治理(ESG)管理办法》的制定和修订工作。2025 年9-10 月,公司根据《中华人 民共和国公司法》《上市公司章程指引》等相关法律法规的规定,对《博瑞生物 医药(苏州)股份有限公司章程》及《股东大会议事规则》《董事会议事规则》 《可转换公司债券持有人会议规则》进行修订,并废止《监事会议事规则》,完 成监事会、审计委员会职权的调整,监事会的职权由董事会审计委员会行使。2025 年12 月,公司根据《中华人民共和国公司法》《上市公司章程指引》《上海证券 交易所科创板股票上市规则》《上海证券交易所科创板上市公司自律监管指引第 1 号--规范运作》等相关法律法规的规定完成剩余内部管理制度的修订和制定 工作,包括《独立董事工作细则》《募集资金使用管理办法》《重大信息内部报告 制度》《信息披露暂缓与豁免管理制度》等共计21 项制度。2026 年,公司将进一步建立监管法规及动态的持续跟踪和宣贯机制,利用 上市公司协会、交易所、证监局、自行组织等途径积极组织董监高参加证券市场 法律法规及专业知识培训,确保董监高准确理解相关法律法规及业务规则,提升 专业履职能力,不断提升风险意识和自律意识,推动公司持续高质量发展。五、加强投资者交流,增强投资者对公司的认知度和信心公司持续践行以“投资者为本”的上市公司发展理念,始终坚持以信息披露 为中心、以投资者需求为导向,不断优化信息披露内容,增强信息披露的针对性 和有效性;同时积极主动通过策略会、路演、业绩说明会等方式与投资者保持密 切沟通,有效传递公司投资价值,并通过电话、网络等途径搭建友好沟通桥梁, 及时有效回应投资者关切,认真听取投资者对公司发展的意见、建议。公司持续以投资者需求为导向,利用自愿性信息披露制度发布公司研发进展 等,及时向投资者展现公司经营情况,2025 年公司共计发布8 份自愿性披露公 告。对于2024 年年度报告、2025 年半年度报告,公司采用“一图读懂报告”的 形式,简明清晰、通俗易懂地向投资者传递公司经营情况。公司常态化召开业绩说明会,并持续通过“上证e 互动”平台、投资者关系 邮箱、投资者专线、接受现场调研等各种形式加强与投资者的交流与沟通,增强 投资者对公司的认知度和信心。2025 年,公司召开了2024 年度暨2025 年第一 季度业绩暨现金分红说明会、2025 年第三季度业绩说明会、参加2025 年半年度科创板创新药行业集体业绩说明会,对投资者普遍关注的问题进行了解答,同时 年度业绩说明会采用了视频录播形式,由董事长介绍公司主营业务、报告期内经 营情况、未来经营计划等,帮助投资者快速获取关键数据及关键信息,提高了定 期报告的可读性。2026 年,公司将进一步强化信息披露的透明度,保证真实、准确、完整、 及时地披露信息,为股东提供准确的投资决策依据;同时,公司将持续以投资者 需求为导向,利用自愿性信息披露制度发布公司研发进展、销售情况等,及时向 投资者展现公司经营情况,不断提升信息披露有效性,有利于投资者作出价值判 断和投资决策。对于年度报告、半年度报告,公司将继续采用“一图读懂年报” “一图读懂半年报”的形式,简明清晰、通俗易懂地向投资者传递公司经营情况, 不断增强定期报告的可读性、趣味性。2026 年,公司将继续定期举办业绩说明会,并持续通过“上证e 互动”平 台、投资者关系邮箱、投资者专线、接受现场调研等各种形式加强与投资者的交 流与沟通,增强投资者对公司的认知度和信心,促进公司与投资者之间建立长期、 稳定、相互信赖的关系。2026 年公司将计划安排不少于3 次的业绩说明会,围 绕公司主营业务、报告期内研发进展、经营情况等进行沟通交流,帮助投资者快 速获取关键数据及关键信息,提高定期报告的可读性、实用性。六、重视股东回报,提升投资者获得感公司重视对投资者的合理投资回报,上市后,公司分红政策保持连续、稳定, 制定并披露了《未来三年(2025-2027 年)股东分红回报规划》,自上市以来已连 续六年持续分红,2019 年度-2024 年度累计现金分红2.46 亿元,最近三年以现金 方式累计分配的利润不少于最近三年实现的年均可分配利润的30%。未来,公司 将继续按照法律法规以及《公司章程》等关于现金分红的规定,认真执行现金分 红政策,积极维护广大股东的合法权益。基于对公司未来发展前景的信心、对公司价值的认可和切实履行社会责任, 为增强投资者信心,维护公司股价稳定,公司控股股东、实际控制人、董事长袁 建栋先生提议回购公司股份。2025 年9 月26 日,公司召开第四届董事会第十二 次会议,审议通过了《关于以集中竞价交易方式回购股份的议案》。截至2025年12 月15 日,公司已完成本次股份回购,累计回购股份196,871 股,回购金额 10,037,786.34 元(不含印花税、交易佣金等交易费用)。2026 年,公司将继续坚守价值回报,实施持续、稳定的分红。基于2025 年 度经营业绩及财务情况,公司拟定2025 年度利润分配方案:公司拟以实施权益 分派股权登记日登记的总股本为基数,向全体股东每10 股派发现金红利0.16 元 (含税)。截至2025 年2 月28 日,公司总股本423,104,454 股,扣除回购专用证 券账户中股份总数560,332 股,本次实际参与分配的股本数为422,544,122 股, 以此计算合计拟派发现金红利6,760,705.95 元(含税)。如在公告披露之日起至 实施权益分派股权登记日期间,公司总股本发生变动的,公司拟维持每股分配比 例不变,相应调整分配总额。上述议案尚需提交公司股东会审议。七、“关键少数”主动担责,传递公司发展信心基于对公司未来发展的信心和对公司内在价值的认可,同时为增强广大投资 者信心,切实维护投资者权益和资本市场的稳定,公司控股股东、实际控制人袁 建栋先生、实际控制人钟伟芳女士及其一致行动人博瑞鑫稳于2023 年12 月7 日分别自愿承诺自承诺函出具之日起未来6 个月内(即2023 年12 月7 日至2024 年6 月6 日)不以任何方式减持其持有的公司股份。截至2025 年12 月末,本次 承诺已履行完成,未发生违反承诺减持公司股份的情形。八、其他说明公司将持续评估“提质增效重回报”行动方案的执行情况并及时履行信息披 露义务。公司将继续做精做强主营业务,全面提升公司治理水平,努力通过良好 的业绩表现、规范的公司治理、积极的投资者回报,切实履行上市公司的责任和 义务,回馈投资者的信任,维护公司市场形象,共同促进资本市场平稳运行。博瑞生物医药(苏州)股份有限公司董事会2026 年3 月20 日公告原文

DUBLIN and BRIDGEWATER, N.J., March 18, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) (“Amarin”), a company committed to advancing the science of cardiovascular disease (CVD) worldwide, applauded the recommendation that the treatment of CV risk in patients with hypertriglyceridemia be part of a broader dyslipidemia management as discussed in the 2026 American College of Cardiology (ACC) / American Heart Association (AHA)/Multisociety Dyslipidemia Guideline Update. i These newly-issued, evidenced-based recommendations summarize the clinical role of icosapent ethyl (IPE) in reducing cardiovascular (CV) risk in statin-treated patients with elevated triglycerides (TG) and fully align with Amarin’s commitment to addressing the burden of CV disease across the healthcare ecosystem. ii Patients at high CV risk frequently fail to achieve LDL‑C targets, and few receive evidence‑based adjunct therapies. iii , iv This updated dyslipidemia guideline reflects a shift in CV care, toward lifelong, prevention-first management, encouraging earlier screening and a broader approach to risk reduction beyond low-density lipoprotein (LDL-C) alone to address drivers of residual or persistent CV risk. Importantly, the guideline recognizes that achieving LDL-C targets does not eliminate cardiovascular risk, and that many patients continue to experience CV events despite optimized statin therapy. The updated guideline reinforces that patients on statin therapy can experience residual CV risk driven by elevated TG levels - a significant clinical challenge affecting millions of Americans. According to the guideline, elevated TG levels contribute meaningfully to CV disease burden and ongoing cardiovascular events even in patients achieving LDL cholesterol targets, underscoring the need for complementary therapeutic approaches beyond statin monotherapy. Amarin’s VASCEPA ® /VAZKEPA ® (icosapent ethyl) is an effective, safe, oral therapy that has been prescribed more than 30 million times globally. It is the first and only FDA-approved oral therapy proven to reduce the risk of CV events (such as a heart attack or stroke) by 25% when added on top of recommended statin therapy in high-risk patients with elevated and high TG levels. Importantly, the guideline distinguishes therapies aimed at pancreatitis prevention from those proven to reduce atherosclerotic cardiovascular disease (ASCVD) events, reinforcing that CV outcomes - not biomarker changes alone - must guide treatment decisions. For patients who remain at elevated CV risk despite optimized statin therapy, the guideline supports the addition of evidence-based therapies specifically proven to reduce cardiovascular events, such as icosapent ethyl (IPE). This position is consistent with guidance from other cardiovascular societies, including the 2025 ESC/EAS Dyslipidemias guideline focused update which states that “high-dose icosapent ethyl (as in the REDUCE-IT trial) should be considered for high-risk or very high-risk patients with elevated triglyceride levels (fasting triglyceride level 135–499 mg/dL [1.52–5.63 mmol/L]) despite statin therapy to lower CVD events.” Together, these guideline updates reflect growing global consensus around the importance of addressing residual cardiovascular risk beyond LDL-C lowering alone. "This guideline update is a meaningful step forward for patient care," said Michael Miller, MD, MASPC, FACC, FAHA, FNLA, Cardiologist and Professor of Medicine, Hospital of the University of Pennsylvania. "We now have clear evidence-based guidance distinguishing which triglyceride-lowering therapies truly reduce cardiovascular outcomes. Icosapent ethyl stands out as the only TG-lowering medication that reduces ASCVD event risk in combination with statin therapy in individuals at high risk of ASCVD with moderate TG elevations who continue to face cardiovascular events despite achieving sufficient LDL-C lowering. As clinicians, we have an opportunity - and responsibility - to utilize this updated guidance to better protect our high-risk patients from additional cardiovascular events." The 2026 Dyslipidemia Guideline also specifically addresses the limitations of certain triglyceride-lowering agents when added to statin therapy, noting again that fenofibrates do not reduce cardiovascular risk when added to statin therapy. In contrast, icosapent ethyl has consistently demonstrated robust CV event reduction when added to statin treatment in high-risk patients with elevated TGs, as shown in the landmark cardiovascular outcomes trial, REDUCE-IT. “Taken together, these recommendations reinforce the importance of targeting residual cardiovascular risk with therapies proven to improve outcomes,” said Deepak L. Bhatt, MD, MPH, MBA, Director of the Mount Sinai Fuster Heart Hospital at the Icahn School of Medicine at Mount Sinai in New York and Principal Investigator of REDUCE-IT. “For appropriate statin-treated patients with elevated TGs, icosapent ethyl offers a well-established, evidence-based option to meaningfully reduce cardiovascular events.” "The 2026 ACC/AHA/Multisociety guidance marks an important evolution in cardiovascular prevention," said Aaron Berg, President & Chief Executive Officer of Amarin. "The updated recommendations provide further validation that icosapent ethyl addresses an important medical need for the millions of patients with persistent cardiovascular risk. This guideline strengthens our commitment to providing physicians and patients with evidence-based options to reduce cardiovascular events and improve patient outcomes. Beyond clinical outcomes, the emphasis on reducing residual CV risk carries important health economic implications. CV events remain a leading driver of healthcare utilization and cost, and therapies proven to reduce events - not just lipid levels - have the potential to improve long-term outcomes while reducing hospitalizations, procedures, and overall healthcare burden." v , vi About Amarin Amarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering close to 100 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD.  About REDUCE-IT ® REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology. vii The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018. ii The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019. viii These and other publications can be found in the R&D section on the company’s website at . Dr. Bhatt serves as the Chair of the REDUCE-IT Steering Committee with research funding paid to Brigham and Women’s Hospital and the Icahn School of Medicine at Mount Sinai. About Cardiovascular Risk Cardiovascular disease (CVD) is the number one cause of death in the world. In the United States alone, CVD - including heart disease, stroke, hypertension and heart failure - accounts for approximately 915,973 deaths per year, or about one death every 34 seconds. ix Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%. x Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins. xi , xii , xiii About VASCEPA ® /VAZKEPA ® (icosapent ethyl) Capsules VASCEPA capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty-five million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria. United States Indications and Limitation of Use VASCEPA is indicated:  As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter. It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur. VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin. Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%). Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%). Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088. Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA ® in Europe, please visit:  Globally, prescribing information varies; refer to the individual country product label for complete information. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s outlook for achievements in 2026 and beyond; Amarin’s 2026 financial outlook and cash position; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; expectations regarding potential strategic collaboration and licensing agreements with third parties, including our ability to attract additional collaborators, as well as our plans and strategies for entering into potential strategic collaboration and licensing agreements and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin. All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the fiscal year ended 2025. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Investors and others should note that Amarin communicates with its investors and the public using the company website ( ), the investor relations website ( ), including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. Amarin Contact Information Media Inquiries: Tegan Berry Amarin Corporation plc PR@amarincorp.com Investor Inquiries: Devin Sullivan & Conor Rodriguez The Equity Group on Behalf of Amarin devin.sullivan.ext@amarincorp.com or conor.rodriguez.ext@amarincorp.com Investor.relations@amarincorp.com _______________________________ i Blumenthal RS, Morris PB, Gaudino M, et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol . 2026 Mar 13:S0735-1097(25)10254-4. doi: 10.1016/j.jacc.2025.11.016. Epub ahead of print. ii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22. iii Navar AM, Kolkailah AA, Gupta A, et al. Gaps in Guideline-Based Lipid-Lowering Therapy for Secondary Prevention in the United States: A Retrospective Cohort Study of 322,153 Patients. Circ Cardiovasc Qual Outcomes. 2023;16(8):533-543. doi: 10.1161/CIRCOUTCOMES.122.009787. iv Bradley CK, Kolkailah AA, Shah NP, et al. Uptake of non-statin lipid-lowering therapies for secondary prevention in community practice. J Clin Lipidol. 2023;17(3):412-414. doi: 10.1016/j.jacl.2023.03.006. v Weintraub WS, Bhatt DL, Zhang Z, et al. Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT USA: Results From Patients Randomized in the United States. J Am Heart Assoc. 2024;13(1):e032413. doi: 10.1161/JAHA.123.032413 vi Szarek M, Bhatt DL, Miller M, et al. Effects of Icosapent Ethyl on Risk and Duration of Hospitalizations and Death in REDUCE-IT. Eur J Prev Cardiol. 2026 Jan 16:zwag040. doi: 10.1093/eurjpc/zwag040. Epub ahead of print. vii Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148. viii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol . 2019;73:2791-2802. ix Palaniappan LP, Allen NB, Almarzooq ZI, et al. 2026 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2026 Mar 3;153(9):e275-e906. doi: 10.1161/CIR.0000000000001412. Epub 2026 Jan 21. x Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol . 2018;72(3):330-343. xi Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145. xii Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740. xiii Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease: New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.