经济观察网9月15日博瑞医药发布公告，全资子公司博瑞制药近日收到国家药监局关于BGM0504片的 《药物临床试验批准通知书》，允许其在成人超重/肥胖患者中进行临床试验。BGM0504是博瑞医药自 主研发的GLP-1和GIP受体双重激动剂，具有控制血糖、减重和治疗NASH等多重生物效应。BGM0504 注射液的2型糖尿病和减重适应症已进入III期临床试验，而BGM0504片作为其口服剂型，目前全球尚无 同类靶点口服剂型获批上市。公司提醒投资者注意药品研发的长期性和不确定性，短期内对公司的经营 业绩不会产生重大影响。 ...

博瑞医药(688166.SH)发布公告，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")近日收 到国家药品监督管理局(以下简称"国家药监局")签发的《药物临床试验批准通知书》，同意博瑞制药 BGM0504片在成人超重/肥胖患者中开展临床试验。 BGM0504注射液2型糖尿病和减重两项适应症目前在国内处于III期临床试验阶段，BGM0504片是 BGM0504的口服剂型。截至本公告披露日，全球尚无同类靶点口服剂型获批上市。 BGM0504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，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。 ...

BGM0504注射液2型糖尿病和减重两项适应症目前在国内处于III期临床试验阶段，BGM0504片是 BGM0504的口服剂型。截至本公告披露日，全球尚无同类靶点口服剂型获批上市。 BGM0504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，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。 智通财经APP讯，博瑞医药(688166.SH)发布公告，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")近日收到国家药品监督管理局(以下简称"国家药监局")签发的《药物临床试验批准通知 书》，同意博瑞制药BGM0504片在成人超重/肥胖患者中开展临床试验。 ...

【博瑞医药（维权）：全资子公司BGM0504片获得药物临床试验批准通知书】《科创板日报》15日 讯，博瑞医药(688166.SH)公告称，公司全资子公司博瑞制药近日收到国家药品监督管理局签发的《药 物临床试验批准通知书》，同意BGM0504片在成人超重/肥胖患者中开展临床试验。BGM0504是公司自 主研发的GLP-1和GIP受体双重激动剂，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。BGM0504注射液2型糖尿病和减重两项适应症目前在国内处 于III期临床试验阶段，BGM0504片是BGM0504的口服剂型。截至本公告披露日，全球尚无同类靶点口 服剂型获批上市。 转自：智通财经 ...

BGM0504注射液2型糖尿病和减重两项适应症目前在国内处于III期临床试验阶段，BGM0504片是 BGM0504的口服剂型。截至本公告披露日，全球尚无同类靶点口服剂型获批上市。 格隆汇9月15日丨博瑞医药（维权）(688166.SH)公布，公司全资子公司博瑞制药(苏州)有限公司(称"博 瑞制药")近日收到国家药品监督管理局签发的《药物临床试验批准通知书》，同意博瑞制药BGM0504 片在成人超重/肥胖患者中开展临床试验。 BGM0504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，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。 ...

Core Viewpoint - China Resources Sanjiu and Borui Pharmaceutical have entered into a significant collaboration for the development and commercialization of BGM0504 injection, a dual agonist of GLP-1 and GIP, in mainland China [1][3]. Group 1: Collaboration Details - The collaboration includes a research and development agreement for BGM0504 injection, granting China Resources Sanjiu exclusive rights for development and commercialization in mainland China [1][3]. - Borui Pharmaceutical will receive milestone payments from China Resources Sanjiu, totaling up to 282 million yuan, based on the progress of clinical trials and regulatory approvals [3][4]. - The agreement allows for priority cooperation on new product licenses and transfers within the defined collaboration area [3]. Group 2: Market Potential and Strategic Importance - BGM0504 injection is considered a highly anticipated product in the domestic weight loss drug market, currently undergoing Phase III clinical trials [4]. - The collaboration is seen as a strategic move for China Resources Sanjiu to enter a high-growth market with a controlled cost structure, leveraging its extensive distribution network and marketing experience [5]. - The partnership aims to ensure rapid market access for BGM0504 upon approval, allowing for immediate sales growth and market capture [5].

Core Viewpoint - The collaboration between Borui Pharmaceutical and China Resources Sanjiu aims to expedite the development and commercialization of BGM0504 injection in mainland China, leveraging each other's strengths in clinical trials and market access [1][6]. Group 1: Collaboration Details - Borui Pharmaceutical and its subsidiaries have signed a cooperation and research agreement with China Resources Sanjiu for the development, registration, production, and commercialization of BGM0504 injection in mainland China, excluding Hong Kong, Macau, and Taiwan [1][4]. - The agreement grants China Resources Sanjiu exclusive rights for cooperative development and commercialization of BGM0504 injection, which is a dual agonist of GLP-1 and GIP, classified as a first-class innovative drug not yet marketed [4][6]. - Borui Pharmaceutical will receive a maximum milestone payment of 282 million yuan from China Resources Sanjiu based on the clinical progress and approval of the product [4][5]. Group 2: Financial Aspects - The agreement includes provisions for milestone payments based on the results of two new clinical trials, with each payment capped at the lower of 50% of the actual trial costs or 28.5 million yuan [5]. - Following the first commercial sale of the product, Borui Pharmaceutical will pay a service fee to China Resources Sanjiu based on a percentage of net sales, with different settlement methods depending on the sales model [4]. Group 3: Market Potential and Strategic Importance - BGM0504 injection is highly anticipated in the domestic weight loss drug market, with ongoing Phase III clinical trials progressing as planned [6]. - The partnership is seen as a strategic move for both companies, allowing China Resources Sanjiu to enter a high-growth market while providing Borui Pharmaceutical with access to established sales channels and marketing expertise [6][7]. - The collaboration is characterized as a deep binding of resources and risk-sharing rather than a simple transaction, which is crucial for both companies to capitalize on the potential of the product [7].

Core Viewpoint - The company has signed a cooperation and research agreement with China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. for the development, registration, production, and commercialization of BGM0504 injection in mainland China, excluding Hong Kong, Macau, and Taiwan [1][2]. Group 1: Agreement Details - The agreement grants China Resources Sanjiu exclusive rights for cooperative development and commercialization of BGM0504 injection, which is a dual agonist of GLP-1 and GIP, currently in the research phase [1][3]. - The agreement has passed internal approval processes and does not require further board or shareholder review [1]. - The milestone payments outlined in the agreement are contingent upon certain conditions, and the total amount remains uncertain [2][10]. Group 2: Product Information - BGM0504 injection is an innovative drug that has shown potential for treating metabolic diseases, including type 2 diabetes and non-alcoholic fatty liver disease (NASH) [3]. - The product has achieved expected goals in phase II clinical trials for weight loss and type 2 diabetes treatment, with phase III trials currently ongoing [3]. Group 3: Financial Terms - The total maximum milestone payment for research and development from China Resources Sanjiu is set at 282 million RMB [10]. - The company will receive service fees based on net sales from the commercialization of the product, with different settlement methods depending on the sales model [11]. - Additional sales milestone payments will be based on the results of new clinical trials, with a cap of 28.5 million RMB for each trial [12]. Group 4: Impact on the Company - The agreement is expected to accelerate the commercialization process of BGM0504 injection in China, leveraging China Resources Sanjiu's established sales channels and market experience [16]. - The cooperation is anticipated to positively impact the company's future operating performance once the product is launched, although it will not affect current performance [2][16].

Group 1 - The core point of the article is that Borui Pharmaceutical has signed a cooperation research and development agreement with China Resources Sanjiu to jointly develop and commercialize the BGM0504 injection in mainland China [1][2] - BGM0504 injection is a dual agonist of GLP-1 and GIP, classified as a first-class innovative drug that has not yet been launched in domestic and international markets [1] - The agreement allows Borui Pharmaceutical to receive milestone payments from China Resources Sanjiu, with a total potential payment of up to 282 million yuan based on the clinical progress and approval of the product [1] Group 2 - The signing of the agreement is expected to accelerate the commercialization process of BGM0504 injection in China, as China Resources Sanjiu will share the clinical trial costs and leverage its established sales channels and marketing experience [2] - This collaboration aligns with the strategic development needs of Borui Pharmaceutical, aiming to expand the patient coverage for BGM0504 injection [2]

Group 1 - The core viewpoint of the news is the collaboration between China Resources Sanjiu (华润三九) and Borui Pharmaceutical (博瑞医药) to develop the BGM0504 injection, aimed at addressing the rising public health challenges of Type 2 Diabetes Mellitus (T2DM) and obesity in China [1][2] - The BGM0504 injection is a dual agonist of GLP-1 and GIP receptors, classified as an innovative peptide drug, and is currently in the critical phase of Phase III clinical trials [2] - The partnership aims to leverage the strengths of both companies, combining China Resources Sanjiu's commercial capabilities with Borui Pharmaceutical's research advantages to accelerate the development and commercialization of BGM0504 in the Chinese market [2] Group 2 - The collaboration is expected to enhance the brand's competitive edge by focusing on weight loss and blood sugar reduction, while also exploring other potential indications for the drug [2] - Both companies emphasize the importance of addressing unmet clinical needs and aim to efficiently translate innovative results into clinical value for patients [2] - The cooperative model of resource sharing and complementary advantages is anticipated to lead to mutual benefits for both companies and ultimately benefit patients [2]