民生证券股份有限公司 关于博瑞生物医药（苏州）股份有限公司 2024年度持续督导工作现场检查报告 上海证券交易所： 根据中国证券监督管理委员会下发的《关于同意博瑞生物医药（苏州）股份 有限公司向不特定对象发行可转换公司债券注册的批复》（证监许可[2021]3551 号），2022 年 1 月 4 日，公司按面值发行 46,500.00 万元可转债，每张面值为人 民币 100 元，共计 465 万张。 民生证券股份有限公司（以下简称"民生证券"、"保荐机构"）作为博瑞医药 的保荐机构，根据《证券发行上市保荐业务管理办法》（以下简称"《保荐办法》"） 等有关法律法规和规范性文件的要求对公司开展了现场检查工作，现将本次现场 检查工作报告如下： 一、本次现场检查的基本情况 （一）保荐机构 民生证券股份有限公司 （二）保荐代表人 黄丹青、邵航 （三）现场检查时间 2024 年 12 月 17 日-2024 年 12 月 18 日 （四）现场检查人员 邵航、黄丹青 （五）现场检查内容 公司治理和内部控制情况；信息披露情况；公司的独立性以及与控股股东、 实际控制人及其他关联方资金往来情况；募集资金使用情况；关联交易、对外担 ...

博瑞生物医药（苏州）股份有限公司自愿披露 关于磺达肝癸钠注射液获得美国 FDA 批准的公告 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、准确性和完整性依法承担法律责任。 近日，博瑞生物医药（苏州）股份有限公司（以下简称"公司"）收到了美 国食品药品监督管理局（以下简称"FDA"）的通知，公司向 FDA 申报的磺达肝 癸钠注射液的简略新药申请（ANDA，即美国仿制药申请）获得正式批准。 现就相关信息公告如下： 一、 药品基本信息 药品名称：磺达肝癸钠注射液 证券代码：688166 证券简称：博瑞医药 公告编号：2024-087 磺达肝癸钠为全合成抗凝血药物，适用于进行下肢重大骨科手术如髋关节骨 折、重大膝关节手术或者髋关节置换术等患者，预防静脉血栓栓塞事件的发生。 用于无指征进行紧急（< 120 分钟）侵入性治疗（PCI）的不稳定性心绞痛或 非 ST 段抬高心肌梗死（UA/NSTEMI）患者的治疗。 用于使用溶栓或初始不接受其它形式再灌注治疗的 ST 段抬高心肌梗死患者 的治疗。 磺达肝癸钠注射液于 2001 年 12 月获美国 FDA 批准上市。据统计 ...

博瑞生物医药（苏州）股份有限公司（以下简称"公司"）全资子公司博瑞 制药（苏州）有限公司（以下简称"博瑞制药"）参加了联合采购办公室组织的 第十批全国药品集中采购的投标工作。经联合采购办公室开标、评标后，博瑞制 药产品卡前列素氨丁三醇注射液拟中标本次集中采购。现将相关情况公告如下： 一、拟中标产品基本情况 证券代码：688166 证券简称：博瑞医药 公告编号：2024-086 博瑞生物医药（苏州）股份有限公司 自愿披露关于参与全国药品集中采购拟中标的公告 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、准确性和完整性依法承担法律责任。 二、此次拟中标对公司的影响 博瑞制药此次拟中标产品卡前列素氨丁三醇注射液于 2024 年 3 月获得国家 药品监督管理局核准签发的药品注册证书，为公司新上市产品，2024 年 1-9 月尚 未产生销售收入。 本次药品集中采购是国家组织的第十批国家药品集中采购，在执行上要求全 国医疗机构优先使用集中采购中选品种，并确保完成约定采购量。本次拟中选的 品种若确定中选、签订购销合同并实施后，将有利于上述产品快速打开国内销售 市场，提 ...

博瑞医药：子公司产品卡前列素氨丁三醇注射液拟中标全国药品集中采购 财联社12月13日电，博瑞医 药公告，全资子公司博瑞制药参加了联合采购办公室组织的第十批全国药品集中采购的投标工作，其产 品卡前列素氨丁三醇注射液拟中标本次集中采购。 该产品主要适用于妊娠期为13周至20周的流产及常规处理方法无效的子宫收缩弛缓引起的产后出血现 象，拟中标价格为16.96元/支，首年约定采购量基数为22.0395万支，主供省份为河南、湖北、广西、陕 西、甘肃、宁夏，采购周期自中选结果执行之日起至2027年12月31日。 查看公告原文 ...

近日，博瑞生物医药（苏州）股份有限公司（以下简称"公司"）全资子公司 博瑞新创生物医药科技（无锡）有限公司（以下简称"博瑞新创"）自主研发的 BGM0504 注射液降糖适应症的Ⅲ期临床研究方案通过了牵头医院北京大学人民 医院伦理审查委员会的审批，获得了《北京大学人民医院伦理审查委员会伦理审 查批件》。现将相关情况公告如下： 一、药品基本情况 BGM0504 注射液是公司自主研发的 GLP-1（胰高血糖素样肽 1）和 GIP（葡 萄糖依赖性促胰岛素多肽）受体双重激动剂，属于境内外均未上市化学药品 1 类 创新药。BGM0504 注射液可激动 GIP 和 GLP-1 下游通路，产生控制血糖、减重 和治疗非酒精性脂肪性肝炎（NASH）等生物学效应，展现多种代谢疾病治疗潜 力。 证券代码：688166 证券简称：博瑞医药 公告编号：2024-085 博瑞生物医药（苏州）股份有限公司 自愿披露关于 BGM0504 注射液降糖适应症 获得Ⅲ期临床试验伦理批件的公告 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、准确性和完整性依法承担法律责任。 2、BGM0504 注 ...

证券代码：688166 证券简称：博瑞医药 公告编号：2024-084 博瑞生物医药（苏州）股份有限公司 自愿披露关于子公司获得药品注册证书及化学原料 药上市申请批准通知书的公告 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、准确性和完整性依法承担法律责任。 近日，博瑞生物医药（苏州）股份有限公司（以下简称"公司"）全资子公司 博瑞制药（苏州）有限公司收到国家药品监督管理局签发的"地诺孕素片"《药品 注册证书》、"地诺孕素"及"重酒石酸去甲肾上腺素"《化学原料药上市申请批准 通知书》。现就相关信息公告如下： 一、产品基本信息 （一）地诺孕素片 药品名称：地诺孕素片 剂型：片剂 申请事项：药品注册（境内生产） 注册分类：化学药品 4 类 上市许可持有人：博瑞制药（苏州）有限公司 生产企业：浙江仙琚制药股份有限公司 药品批准文号：国药准字 H20249468 药品批准文号有效期：至 2029 年 11 月 30 日 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）地诺孕素原料药 ...

财联社12月3日电，博瑞医药公告，全资子公司博瑞制药（苏州）有限公司收到国家药品监督管理局签 发的"地诺孕素片"《药品注册证书》、"地诺孕素"及"重酒石酸去甲肾上腺素"《化学原料药上市申请批 准通知书》。 ...

Investment Rating - The report maintains an "Accumulate" rating for the company [1]. Core Viewpoints - The GLP-1 drug market is expanding rapidly, with significant potential for dual-target weight loss drugs. The mainstream GLP-1 drug, Semaglutide, achieved over $20 billion in global sales in 2023, a year-on-year increase of over 70%. The newly approved Zepbound is expected to capture a substantial market share due to its superior weight loss effects [2]. - The company's dual-target weight loss drug BGM0504 has advanced clinical data, showing promising results in its Phase II trials, positioning it as a strong competitor in the market [3]. - The company is building high-end complex formulations with five major technology platforms, which create high barriers to entry. The domestic inhalation formulation market is largely dominated by foreign companies, indicating significant room for domestic alternatives [4]. Summary by Sections Revenue and Profit Forecast - The company is expected to achieve revenues of 13.1 billion, 15.2 billion, and 17.5 billion yuan from 2024 to 2026, with year-on-year growth rates of 11%, 16%, and 15% respectively. The net profit attributable to shareholders is projected to be 2.1 billion, 2.6 billion, and 2.9 billion yuan for the same period, with growth rates of 3%, 24%, and 14% respectively. The P/E ratios for 2024-2026 are estimated at 68, 55, and 48 times [5].

Investment Rating - The report initiates coverage with a "Buy" rating for the company, setting a target price of 44.21 RMB, indicating a potential upside of 47.2% from the current price of 30.03 RMB [3]. Core Insights - The company focuses on a dual strategy of integrating raw materials and formulations, combining generic and innovative drugs, with a strong emphasis on complex formulations and original new drugs. The company has seen rapid revenue growth, achieving 1.18 billion RMB in revenue for 2023, a year-on-year increase of 15.9% [1][12]. - The innovative drug BGM0504, a dual GLP-1/GIP receptor agonist, is positioned as a leading product in the domestic market, with promising clinical data for weight loss and diabetes treatment. The company has initiated Phase III clinical trials for weight loss and is expected to start Phase III trials for diabetes soon [1][26][31]. Company Overview and Development Strategy - The company was founded in 2001 and listed on the STAR Market in November 2019. It operates a business model that balances international and domestic markets, focusing on first-generic, difficult-to-generate, and specialty raw materials, as well as complex formulations and original new drugs [9][10]. - The company has a comprehensive product range covering antiviral, antifungal, immunosuppressive, respiratory, and oncology treatments, with a focus on high-tech and clinically valuable pipelines [10][11]. Financial Performance - In 2023, the company reported a revenue of 1.18 billion RMB, with raw material product revenue of 885 million RMB, and a significant increase in antiviral product revenue due to heightened demand [12][13]. - The company’s net profit for 2023 was 173 million RMB, a decrease of 18.0% from the previous year, primarily due to lower gross margins and increased R&D expenses [16][22]. R&D Investment - The company emphasizes R&D, with R&D expenses reaching 249 million RMB in 2023, accounting for 21.1% of revenue. The focus is on innovative drugs and inhalation formulations, with a significant increase in R&D investment for BGM0504 [22][23]. - BGM0504 has shown promising results in clinical trials, demonstrating significant weight loss and blood sugar control compared to competitors [26][32]. Product Pipeline - The company has multiple products in various stages of clinical trials, including BGM0504 for diabetes and weight loss, and BGC0228 for oncology, indicating a robust pipeline for future growth [24][25][30]. - The company is also advancing its inhalation and iron supplement products, which are expected to contribute to future revenue streams [24][25].

Investment Rating - The report initiates coverage with a "Buy" rating and sets a target price of 44.21 CNY [4] Core Insights - The company has experienced stable growth in its raw materials and formulations business, achieving a revenue of 1.18 billion CNY in 2023, a year-on-year increase of 15.9% [1] - The company is focusing on complex formulations and innovative drugs, with R&D expenses reaching 249 million CNY in 2023, a 20.1% increase, accounting for 21.1% of revenue [2] - The innovative drug BGM0504 has shown promising results in clinical trials, with a significant weight loss of 18.5% in the 15mg dosage group during the second phase of clinical trials [3] Summary by Sections Revenue Growth - The company reported a revenue of 1.18 billion CNY in 2023, with a 15.9% year-on-year growth, and a revenue of 977 million CNY in the first three quarters of 2024, reflecting a 6.8% increase [1] - The revenue from formulation products reached 110 million CNY in the first half of 2024, marking a 30.4% increase, with formulation products accounting for 17.9% of total sales [1] R&D Focus - The company is prioritizing R&D in inhalation agents and GLP-1 class drugs, with 53.0% of R&D expenses directed towards innovative drugs and inhalation formulations in the first half of 2024, a 105.3% increase year-on-year [2] Clinical Development - BGM0504, a dual agonist for GLP-1/GIP, is in the first tier of domestic formulations, with a 2.76% reduction in HbA1c levels observed in diabetes patients during the second phase of clinical trials [3] - The company has initiated the third phase of clinical trials for BGM0504 for weight loss, with IND approval obtained in the U.S. [3] Financial Projections - Revenue is projected to grow steadily, with expected increases of 9.6%, 11.5%, and 14.5% from 2024 to 2026, reaching 1.29 billion CNY, 1.44 billion CNY, and 1.65 billion CNY respectively [4] - Net profit is forecasted to be 200 million CNY, 230 million CNY, and 290 million CNY for the same period, with growth rates of 13.7%, 16.3%, and 27.9% respectively [4]