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]

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。 重要内容提示： 会议召开时间：2024 年 11 月 14 日（星期四）下午 13:00-14:00 会议召开地点 ： 上 海 证 券 交 易 所 上 证 路 演 中 心 （ 网 址 ： https://roadshow.sseinfo.com/） 证券代码：688166 证券简称：博瑞医药 公告编号：2024-083 博瑞生物医药（苏州）股份有限公司 关于召开 2024 年第三季度业绩说明会的公告 本次投资者说明会以网络互动形式召开，公司将针对 2024 年第三季度的经 营成果及财务指标的具体情况与投资者进行互动交流和沟通，在信息披露允许的 范围内就投资者普遍关注的问题进行回答。 二、 说明会召开的时间、地点 （一）会议召开时间：2024 年 11 月 14 日下午 13:00-14:00 （二）会议召开地点： 上 海 证 券 交 易 所 上 证 路 演 中 心 （ 网 址 ： https://roadshow.sseinfo.com/） （三）会议召开方式：上证路演中心网络互 ...

Investment Rating - The report maintains a "Buy" rating for the company [4]. Core Views - The company has shown excellent clinical data performance, with significant weight loss results from the BGM0504 injection in phase II clinical trials for obesity and type 2 diabetes [1][2]. - The company is actively expanding its international presence, with approvals for BGM0504 injection in the US and IND applications submitted in Indonesia [2]. - The financial outlook is positive, with projected revenue growth from 1.34 billion in 2024 to 1.91 billion in 2026, representing a CAGR of 14.0% to 23.8% [2][3]. Financial Summary - Q3 2024 revenue was 319 million, a decrease of 2.52% year-on-year, while net profit attributable to the parent company was 68.39 million, down 17.34% [1]. - For the first three quarters of 2024, revenue reached 977 million, an increase of 6.77% year-on-year, with a net profit of 174 million, down 7.50% [1]. - The company’s revenue is expected to grow to 1.34 billion in 2024, 1.55 billion in 2025, and 1.91 billion in 2026, with net profits projected at 210 million, 231 million, and 296 million respectively [2][3]. Clinical and R&D Progress - The company has made significant investments in R&D, with Q3 2024 R&D expenses amounting to 69.62 million, an increase of 15.21% year-on-year [1]. - The BGM0504 injection has shown promising results in clinical trials, with weight loss percentages of 8.4%, 12.0%, and 13.8% across different dosage groups [1]. Market Position and Strategy - The company is focusing on both innovative drugs and raw materials, with multiple approvals and submissions for its products in various international markets [2]. - The total market capitalization of the company is approximately 12.16 billion [4].

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has shown steady revenue growth in the first three quarters of 2024, with revenue reaching 977 million yuan, a year-on-year increase of 6.77%. However, the net profit attributable to shareholders decreased by 7.5% to 177 million yuan [4] - The clinical progress of BGM0504 is rapid, with significant advancements in inhalation formulations. The company is optimistic about its long-term development and maintains its profit forecast for the years 2024-2026 [4][6] - The company’s R&D investment has increased by 35.3% year-on-year, accounting for 22.69% of its operating revenue, indicating a strong commitment to innovation [6] Financial Performance Summary - In Q3 2024, the company achieved revenue of 319 million yuan, a decrease of 2.52% year-on-year, while the net profit attributable to shareholders was 71 million yuan, down 13.73% year-on-year. Excluding the impact of R&D expenses, the net profit grew by 16.11% [4] - The gross margin for Q3 2024 was 63.58%, an increase of 0.42 percentage points year-on-year, while the net margin was 20.22%, a decrease of 3.71 percentage points [4] - The company’s projected net profit for 2024-2026 is estimated at 217 million yuan, 227 million yuan, and 250 million yuan respectively, with corresponding P/E ratios of 56.1, 53.6, and 48.6 [4][7] R&D and Product Development - BGM0504 has received ethical approval for its Phase III clinical trial for weight loss indications, with the first subject already enrolled. The diabetes indication has also received communication approval from CDE to proceed with Phase III clinical trials [6] - The company has made significant progress in its inhalation formulations, with several products either approved or in various stages of clinical trials [6] Expense Ratios - The company’s R&D expense ratio has increased to 21.74% in the first three quarters of 2024, reflecting a focus on innovation and product development [5]

Investment Rating - The report maintains a "Recommended" rating for the company [2][4]. Core Insights - The company achieved a revenue of 977 million yuan in the first three quarters of 2024, representing a year-on-year growth of 6.77%. However, the net profit attributable to shareholders decreased by 7.50% to 177 million yuan [2]. - The BGM0504 clinical trial data showed promising results, with significant weight loss and improved glycemic control in participants. The drug is progressing to Phase III clinical trials [2]. - The company is expanding its raw material and formulation production capacity to meet the demand for innovative drugs and difficult-to-generate formulations [2]. Financial Forecasts - The projected revenues for 2024, 2025, and 2026 are 1.339 billion yuan, 1.529 billion yuan, and 1.762 billion yuan, respectively, with growth rates of 13.6%, 14.2%, and 15.2% [3][5]. - The net profit attributable to shareholders is expected to be 211 million yuan in 2024, 237 million yuan in 2025, and 268 million yuan in 2026, with growth rates of 4.0%, 12.4%, and 13.0% [3][5]. - The company’s PE ratios are projected to be 61, 54, and 48 for the years 2024, 2025, and 2026, respectively [3][5]. Clinical Development - The BGM0504 injection for weight loss and type 2 diabetes treatment has met its expected goals in Phase II clinical trials, with significant reductions in body weight and waist circumference observed [2]. - The company has received ethical approval for the Phase III clinical trial for the weight loss indication, and the first participant has been enrolled [2]. Production Capacity Expansion - The company is expanding its production facilities, including the completion of various construction phases for raw material and formulation production bases [2].

Investment Rating - The investment rating for the company is "Accumulate" (maintained) [1] Core Views - The company's Q3 2024 performance met expectations, with revenue of 977 million yuan (+6.77% year-on-year) and a net profit attributable to shareholders of 177 million yuan (-7.5% year-on-year) [2] - R&D expenses significantly impacted profits, with a Q3 R&D investment of 79 million yuan (+30.53% year-on-year), leading to a 16.11% year-on-year increase in net profit when excluding R&D costs [3] - The innovation pipeline is progressing smoothly, with promising clinical data for BGM0504 in diabetes and weight loss indications [4] Summary by Sections Financial Performance - Q3 2024 revenue was 319 million yuan (-2.52% year-on-year), with a net profit of 71 million yuan (-13.73% year-on-year) [2][3] - The gross margin for Q3 was 63.58% (+0.42 percentage points), while the net margin was 20.22% (-3.71 percentage points) [3] R&D and Innovation - The company is focusing on high-difficulty generics and has made significant progress in its innovation pipeline, including the completion of Phase II clinical trials for BGM0504 [4] - The clinical data for weight loss showed significant average weight reduction percentages of 10.8%, 16.2%, and 18.5% for different dosage groups [4] Earnings Forecast and Valuation - The forecast for net profit attributable to shareholders for 2024-2026 has been adjusted to 2.08 billion yuan, 2.58 billion yuan, and 2.95 billion yuan respectively, with corresponding P/E ratios of 61, 50, and 43 [5] - The company maintains a positive outlook based on the continuous improvement of its product matrix and the successful advancement of its innovation pipeline [5]