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博瑞医药: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
2024-12-03 08:10
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 ...
博瑞医药:双靶点GLP-1/GIP乘势而上,高端复杂制剂兑现在即
东吴证券· 2024-12-03 02:23
证券研究报告·公司深度研究·化学制药 博瑞医药(688166) 双靶点 GLP-1/GIP 乘势而上,高端复杂制剂 兑现在即 2024 年 12 月 02 日 增持(维持) | --- | --- | --- | --- | --- | --- | |------------------------------|--------|---------|--------|--------|--------| | 盈利预测与估值 [Table_EPS] | 2022A | 2023A | 2024E | 2025E | 2026E | | 营业总收入(百万元) | 1017 | 1180 | 1309 | 1515 | 1749 | | 同比( % ) | (3.33) | 15.94 | 11.02 | 15.72 | 15.41 | | 归母净利润(百万元) | 239.62 | 202.47 | 208.11 | 257.62 | 294.91 | | 同比( % ) | (1.77) | (15.51) | 2.79 | 23.79 | 14.48 | | EPS- 最新摊薄(元 / 股) | 0.57 | ...
博瑞医药:双靶点GLP1/GIP创新药未来可期;首予买入
招银国际· 2024-11-12 05:35
2024 年 11 月 6 日 招银国际环球市场 | 睿智投资 | 首次覆盖 博瑞医药 (688166 CH) 双靶点 GLP1/GIP 创新药未来可期;首予买入 原料药和制剂业务稳定增长。公司贯彻执行原料药与制剂一体,仿制药与创新 药结合的策略,聚焦于首仿、难仿、特色原料药、复杂制剂和原创性新药。公 司以特色原料药及医药中间体为起点,并不断向下游制剂领域延伸。随着原料 药和制剂产品数量的增加,公司的收入体量呈现快速增长趋势。2023 年,公司 实现营业收入 11.80 亿元,同比增长 15.9%。2024 年前三季度,收入同比增长 6.8%至 9.77亿元。公司的制剂产品持续丰富。截至 2024 年 9 月公司累计有 16 款制剂获批上市。2024 年上半年,公司实现制剂产品收入 1.10 亿元,同比增 长 30.4%;制剂产品收入占产品销售收入的比例进一步提升至 17.9%。 未来公司重点布局复杂制剂和创新药。公司重视产品研发,随着业务的增长, 公司持续加大研发投入。2023 年公司的研发费用为 2.49 亿元,同比增长 20.1%,研发费用占营业收入的 21.1%。公司未来业务的重点将投向吸入剂、 GL ...
睿智投资|博瑞医药 (688166 CH) - 双靶点GLP1/GIP 创新药未来可期;首予买入
招银国际· 2024-11-07 08:08
点击蓝字 关注我们 招商银行全资附属机构 原料药和制剂业务稳定增长。公司贯彻执行原料药与制剂一体,仿制药与创新药结合的策略,聚焦于首仿、难 仿、特色原料药、复杂制剂和原创性新药。公司以特色原料药及医药中间体为起点,并不断向下游制剂领域延 伸。随着原料药和制剂产品数量的增加,公司的收入体量呈现快速增长趋势。2023年,公司实现营业收入 11.80亿元,同比增长15.9%。2024年前三季度,收入同比增长6.8%至9.77亿元。公司的制剂产品持续丰 富。截至2024年9月公司累计有16款制剂获批上市。2024年上半年,公司实现制剂产品收入1.10亿元,同比 增长30.4%;制剂产品收入占产品销售收入的比例进一步提升至17.9%。 未来公司重点布局复杂制剂和创新药。公司重视产品研发,随着业务的增长,公司持续加大研发投入。2023 年公司的研发费用为 2.49亿元,同比增长 20.1%,研发费用占营业收入的 21.1%。公司未来业务的重点将投 向吸入剂、GLP-1类药物等复杂制剂及原创性新药。2024年上半年,创新药及吸入制剂合计研发投入占公司研 发费用的53.0%,同比增长105.3%。公司自主研发的多肽类降糖和减 ...
博瑞医药:关于召开2024年第三季度业绩说明会的公告
2024-11-05 08:36
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 ...
博瑞医药:临床数据表现优异,海外全面布局
国盛证券· 2024-11-04 11:12
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].
博瑞医药:公司信息更新报告:BGM0504临床进展较快,吸入制剂进展顺利
开源证券· 2024-11-02 13:12
f憶证券 医药生物/化学制药 公 司 研 究 BGM0504 临床进展较快,吸入制剂进展顺利 博瑞医药(688166.SH) 2024 年 11 月 02 日 投资评级:买入(维持) | --- | --- | |-------------------------|-------------| | 日期 | 2024/11/1 | | 当前股价 ( 元 ) | 28.79 | | 一年最高最低 ( 元 ) | 41.39/19.63 | | 总市值 ( 亿元 ) | 121.63 | | 流通市值 ( 亿元 ) | 121.63 | | 总股本 ( 亿股 ) | 4.22 | | 流通股本 ( 亿股 ) | 4.22 | | 近 3 个月换手率 (%) | 161.34 | 股价走势图 -60% -40% -20% 0% 20% 40% 2023-11 2024-03 2024-07 博瑞医药 沪深300 数据来源:聚源 相关研究报告 《2024 年上半年业绩稳健增长, BGM0504 及吸入制剂进展顺利—公 司信息更新报告》-2024.8.25 《减重降糖产品进展顺利,吸入制剂 新赛道曙光初现—公司首次覆盖 ...
博瑞医药:2024年三季报点评:0504降糖减重数据优秀,原料药制剂业务稳健
民生证券· 2024-10-30 22:31
博瑞医药(688166.SH)2024 年三季报点评 [盈利预测与财务指标 Table_Forcast] 0504 降糖减重数据优秀,原料药制剂业务稳健 2024 年 10 月 31 日 ➢ 事件:2024 年 10 月 30 日,博瑞医药发布 2024 年三季报业绩。公司前三 季度实现收入 9.77 亿元,同比增长 6.77%,归母净利润 1.77 亿元,同比减少 7.50%,扣非净利润 1.74 亿元,同比下降 7.50%。单季度看,Q3 实现收入 3.19 亿元,同比减少 2.52%,归母净利润 0.71 亿元,同比减少 13.73%,扣非净利润 0.68 亿元,同比减少 17.34%。 ➢ BGM0504 二期临床数据优异,后续临床正常推进中。BGM0504 注射液减 重和 2 型糖尿病治疗两项适应症在国内的 II 期临床试验达成预期目标,减重适应 症中第 24 周时 5mg 组、10mg 组和 15mg 组体重较基线平均降幅百分比(扣 除安慰剂)分别为 10.8%、16.2%和 18.5%,腰围较基线平均降幅(扣除安慰剂) 分别为 6.4cm、8.8cm 和 10.2cm,次要指标提升显著降低多项心 ...
博瑞医药:2024年三季报点评:业绩符合预期,创新管线稳步推进,研发费用影响当期利润
东吴证券· 2024-10-30 03:30
证券研究报告·公司点评报告·化学制药 博瑞医药(688166) 2024 年三季报点评:业绩符合预期,创新管 线稳步推进,研发费用影响当期利润 2024 年 10 月 29 日 增持(维持) | --- | --- | --- | --- | --- | --- | |------------------------------|--------|---------|--------|--------|--------| | 盈利预测与估值 [Table_EPS] | 2022A | 2023A | 2024E | 2025E | 2026E | | 营业总收入(百万元) | 1017 | 1180 | 1310 | 1515 | 1749 | | 同比( % ) | (3.33) | 15.94 | 11.02 | 15.72 | 15.41 | | 归母净利润(百万元) | 239.62 | 202.47 | 208.11 | 257.62 | 294.91 | | 同比( % ) | (1.77) | (15.51) | 2.79 | 23.79 | 14.48 | | EPS- 最新摊薄(元 / 股) ...
博瑞医药(688166) - 2024 Q3 - 季度财报
2024-10-29 09:01
Financial Performance - The company's operating revenue for Q3 2024 was ¥319,137,248.68, a decrease of 2.52% compared to the same period last year[2]. - The net profit attributable to shareholders for Q3 2024 was ¥71,044,018.70, down 13.73% year-on-year[2]. - The basic earnings per share for Q3 2024 was ¥0.17, a decrease of 10.53% compared to the same period last year[2]. - Total operating revenue for the first three quarters of 2024 reached RMB 976,825,695.67, an increase of 6.8% compared to RMB 914,877,843.44 in the same period of 2023[22]. - Net profit for the first three quarters of 2024 was RMB 146,757,526.84, down 17.0% from RMB 176,740,694.87 in the same period of 2023[23]. - The total profit for the first three quarters of 2024 was RMB 168,076,343.14, a decrease from RMB 197,688,288.52 in the previous year[23]. - Earnings per share for the first three quarters of 2024 were RMB 0.42, compared to RMB 0.45 in the same period of 2023[23]. Research and Development - R&D investment totaled ¥78,874,621.38 in Q3 2024, an increase of 30.53% compared to the same period last year, representing 24.71% of operating revenue[2][7]. - The company reported a net profit growth of 16.11% when excluding the impact of R&D expenses for innovative drugs[4]. - The company has maintained a "R&D-driven" strategy, increasing investment in products like BGM0504 injection[4]. - The company achieved significant progress in the clinical trials for its innovative drug BGM0504, with the weight loss indication entering Phase III trials in China and receiving ethical approval for the first subject enrollment[13]. - The company has submitted 10 new domestic patent applications and received 9 new domestic patent authorizations in Q3 2024, bringing the total patent applications to 490, including 434 invention patents[15]. - The company has completed the Phase I clinical trial for the injectable BGC0228[13]. - The company has received IND approval for BGM0504 in the United States for weight loss indication, with the first subject already enrolled[15]. - The company has received clinical trial approval for the inhalation powder of Salmeterol and Fluticasone, with the first subject already enrolled[14]. Assets and Liabilities - Total assets at the end of Q3 2024 were ¥4,878,532,811.80, a decrease of 3.05% from the end of the previous year[3]. - Total equity attributable to shareholders at the end of Q3 2024 was ¥2,352,381,122.67, a decrease of 0.69% from the previous year[3]. - Current assets decreased from CNY 1,839,738,327.73 to CNY 1,382,517,329.28, representing a decrease of about 24.87%[19]. - Cash and cash equivalents dropped significantly from CNY 998,045,685.92 to CNY 505,357,865.57, a reduction of approximately 49.3%[19]. - Accounts receivable increased from CNY 282,978,228.31 to CNY 369,536,455.40, reflecting an increase of about 30.54%[19]. - Total liabilities decreased from CNY 2,614,247,828.99 to CNY 2,536,193,149.01, a decrease of approximately 2.93%[20]. - Long-term borrowings decreased from CNY 1,184,658,415.12 to CNY 1,104,249,061.43, a decline of about 6.77%[20]. - Total equity decreased from CNY 2,417,583,546.93 to CNY 2,342,339,662.79, a decrease of approximately 3.11%[20]. - The company reported a significant reduction in short-term borrowings from CNY 156,873,727.68 to CNY 122,138,205.34, a decrease of about 22.2%[20]. - The company’s inventory slightly decreased from CNY 344,627,860.71 to CNY 339,742,470.71, a reduction of approximately 1.14%[19]. - The company’s long-term equity investments decreased from CNY 43,490,102.12 to CNY 39,325,778.89, a decline of about 9.93%[19]. Cash Flow and Investments - The net cash flow from operating activities for the year-to-date period was ¥119,589,702.03, an increase of 21.01% year-on-year[2]. - Cash outflow from investment activities totaled $523.15 million, an increase from $419.79 million in the previous period, resulting in a net cash flow from investment activities of -$424.87 million, compared to -$367.59 million previously[25]. - Cash inflow from financing activities was $595.96 million, slightly down from $619.28 million in the previous period, with net cash flow from financing activities at -$173.77 million, a decrease from $66.68 million[25]. - The net increase in cash and cash equivalents was -$477.72 million, compared to -$205.88 million in the previous period, leading to an ending cash balance of $493.32 million[25]. - The company reported a significant increase in cash paid for fixed assets, intangible assets, and other long-term assets, totaling $251.05 million, compared to $300.32 million previously[25]. - Cash paid for investments rose to $272.10 million from $115.60 million, indicating a strategic focus on expanding investment activities[25]. - Cash paid for debt repayment increased to $627.88 million from $447.12 million, reflecting a higher commitment to managing debt obligations[25]. - Cash dividends and interest payments totaled $118.86 million, up from $100.51 million, indicating a stable return to shareholders[25]. - The impact of exchange rate changes on cash and cash equivalents was positive at $1.33 million, contrasting with a negative impact of -$3.81 million in the previous period[25]. - The company did not receive any cash from minority shareholders' investments during the current period, compared to $60 million previously[25]. Accounting and Reporting - The company has adopted new accounting standards starting in 2024, which may affect future financial reporting[26].