Core Viewpoint - 博瑞医药's subsidiary, 博瑞制药, has received approval from the National Medical Products Administration for clinical trials of BGM1812 injection for overweight or obesity treatment, marking a significant step in the company's development pipeline [1] Group 1 - 博瑞医药's BGM1812 injection has already received FDA approval for clinical trials in the United States, with the first patient enrolled [1] - As of the announcement date, there are no similar targeted therapies for weight loss approved for market globally [1]

Core Viewpoint - 博瑞医药's subsidiary received approval for clinical trials of BGM1812, a new long-acting Amylin analog for weight management, marking a significant step in its drug development pipeline [1] Group 1: Drug Development and Clinical Trials - BGM1812 injection is designed to activate satiety pathways in the brain, suppress appetite, delay gastric emptying, and inhibit glucagon secretion, contributing to weight loss [1] - The drug has already received FDA approval for clinical trials in the U.S., with the first patient enrolled [1] - No similar targeted weight loss drugs have been approved globally as of the announcement date [1] Group 2: Financial and Market Strategy - 博瑞医药 plans to list on the Hong Kong Stock Exchange, aiming to enhance its global strategy and expand overseas markets [2] - The funds raised from the H-share issuance will support drug development, upgrade production and R&D facilities, and supplement working capital [2] - The company reported projected revenues of 1.017 billion, 1.164 billion, and 1.255 billion RMB for 2022, 2023, and 2024, respectively, with net profits of 211 million, 173 million, and 141 million RMB [3] Group 3: Product Portfolio and Market Presence - 博瑞医药 has a diverse product portfolio, including over 40 formulations and active pharmaceutical ingredients, focusing on unmet medical needs in metabolic and respiratory diseases [2] - The company has established a commercial network covering over 40 countries and regions globally [2] - BGM0504, another core candidate drug, is a GLP-1/GIP dual-target agonist showing promising results in Phase II trials for type 2 diabetes and obesity [3]

Group 1 - The core point of the article is that Borui Pharmaceutical (688166) has received approval from the National Medical Products Administration for clinical trials of its BGM1812 injection aimed at treating overweight or obesity [1] Group 2 - Borui Pharmaceutical's wholly-owned subsidiary, Borui Medicine, is responsible for the clinical trial of BGM1812 injection [1] - The approval signifies a step forward in the company's efforts to develop treatments for obesity, which is a growing health concern [1]

Group 1 - The core point of the article is that Borui Pharmaceutical announced the receipt of a clinical trial approval notice from the National Medical Products Administration for its subsidiary Borui Pharmaceutical (Suzhou) Co., Ltd. to conduct clinical trials for the BGM1812 injection aimed at overweight or obesity [1] Group 2 - The approval signifies a step forward in the development of BGM1812, which targets a significant health issue, potentially expanding the company's product pipeline [1] - This clinical trial could enhance Borui Pharmaceutical's market position in the obesity treatment sector, which is increasingly gaining attention due to rising obesity rates globally [1] - The announcement reflects the company's commitment to advancing its research and development efforts in the pharmaceutical industry [1]

Group 1 - China Pacific Insurance's subsidiary, China Pacific Life, reported a cumulative premium income of 241.32 billion yuan for the first ten months, a year-on-year increase of 9.9% [1] - China Pacific Property Insurance, another subsidiary, achieved a cumulative premium income of 173.57 billion yuan, with a year-on-year growth of 0.4% [1] - Nocera Biopharma reported a net loss of 64.41 million yuan for the first three quarters, despite a revenue increase of 59.85% to 1.115 billion yuan [1] Group 2 - Founder Securities received approval from the China Securities Regulatory Commission to issue short-term corporate bonds not exceeding 5 billion yuan [1] - Haicheng Bonda's director plans to reduce his stake by up to 0.97%, equating to 198,400 shares [1] - Yuyuan Group intends to repurchase shares worth between 200 million and 300 million yuan, with a maximum price of 8.60 yuan per share [1] Group 3 - Huaren Shuanghe's subsidiary passed the GMP compliance inspection for a specific diabetes medication [4] - Lichong Group received project notifications from three international automotive manufacturers, with expected sales amounting to approximately 1.135 billion yuan [6] - Deyang Co. is planning to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy [7] Group 4 - Longxin General announced the transfer of its entire stake in a subsidiary for 105.6 million yuan, and also plans to divest another stake for 1 yuan due to poor performance [16] - Kangda New Materials decided to terminate the acquisition of a semiconductor company due to unsatisfactory due diligence progress [17] - Lu'an Environmental reported a 3.28% year-on-year increase in coal sales for October, totaling 3.78 million tons [18] Group 5 - Shanghai Port Group plans to invest 2 billion yuan to establish a new holding company with several state-owned enterprises [20] - Borui Pharmaceutical's new drug for obesity treatment has received clinical trial approval [23] - Silver Dragon Co. has completed the registration of a new energy industry fund focusing on high-growth potential projects [24] Group 6 - Hengrui Medicine received approval for a clinical trial of a prostate cancer drug [11] - Baiji Shenzhou reported a net profit of 1.139 billion yuan for the first three quarters, marking a turnaround from losses [36] - Huasheng Pharmaceutical's special medical food product has received registration certification [60]

Core Viewpoint - 博瑞医药's subsidiary, 博瑞制药, has received approval from the National Medical Products Administration for clinical trials of BGM1812 injection for overweight or obesity, marking a significant step in its development pipeline [1] Group 1: Company Developments - 博瑞制药 has been granted a Clinical Trial Approval Notice for BGM1812 injection, allowing it to conduct clinical trials for weight loss indications [1] - The FDA has already approved the clinical trial for BGM1812 injection in the United States, with the first patient enrolled [1] - There are currently no similar targeted therapies for weight loss approved for market globally, indicating a unique position for 博瑞医药 in this therapeutic area [1]

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。 证券代码：688166 证券简称：博瑞医药 公告编号：2025-096 重要内容提示： 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"）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 BGM1812 注射液开展超重或肥胖的临床试验。 博瑞生物医药（苏州）股份有限公司 自愿披露关于 BGM1812 注射液获得药物临床试验 批准通知书的公告 相关风险提示： 1、根据国家药品注册相关法律法规要求，药品在获得《药物临床试验批准 通知书》后，尚需开展一系列临床试验，并经国家药监局批准后方可生产，短期 内对公司经营业务不会产生较大影响。 2、药品的研发周期长、审批环节多、研发投入大，各环节均受多维度因素 影响，不可预测因素较多。根据研发经验，新药研发存在一定风险，例如临床试 验可能会因安全性和/或有效性等问题而终止。敬请广大投资者谨慎决策，注意 防范投资风险。公司将积极 ...

Core Viewpoint - 博瑞医药's subsidiary, 博瑞制药, has received approval from the National Medical Products Administration for clinical trials of BGM1812 injection in overweight or obese patients, marking a significant step in the development of a new obesity treatment [1] Group 1: Company Developments - 博瑞制药 has been granted a clinical trial approval for BGM1812 injection, a novel long-acting Amylin analog designed for weight loss [1] - The BGM1812 injection is characterized by good molecular activity and pharmaceutical stability, indicating its potential effectiveness in clinical applications [1] Group 2: Product Details - BGM1812 injection functions as an Amylin analog, which is a 37-amino acid peptide hormone that works in conjunction with insulin to suppress appetite and delay gastric emptying [1] - The mechanism of action includes activating brain pathways that promote satiety, inhibiting glucagon secretion, and providing multiple weight loss mechanisms [1] Group 3: Market Context - As of the announcement date, BGM1812 injection has received FDA approval for clinical trials in the United States, with the first patient enrolled [1] - There are currently no approved weight loss treatments targeting the same mechanism globally, positioning BGM1812 as a potentially unique product in the market [1]

Core Viewpoint - 博瑞医药's subsidiary, 博瑞制药, has received approval from the National Medical Products Administration for clinical trials of BGM1812 injection for overweight or obesity treatment [1] Group 1: Company Developments - 博瑞制药 has been granted a clinical trial approval for BGM1812 injection, a new long-acting Amylin analog designed to aid in weight management [1] - BGM1812 injection is noted for its good molecular activity and pharmaceutical stability, indicating potential effectiveness in clinical applications [1] Group 2: Product Mechanism - Amylin, a hormone composed of 37 amino acids, is released by pancreatic β-cells alongside insulin and plays a role in appetite regulation [1] - The mechanism of Amylin includes activating brain pathways that suppress appetite, delaying gastric emptying, and inhibiting glucagon secretion, contributing to weight loss [1]

Core Viewpoint - The announcement highlights that Borui Pharmaceutical's subsidiary, Borui Medicine, has received approval from the National Medical Products Administration for clinical trials of BGM1812 injection, aimed at treating overweight or obesity [1] Group 1: Clinical Trial Approval - Borui Medicine has been granted a Clinical Trial Approval Notice for BGM1812 injection, a new long-acting Amylin analog designed for weight loss [1] - The drug has shown good molecular activity and pharmaceutical stability [1] - The FDA has already approved the clinical trial for BGM1812 injection in the United States, with the first patient enrolled [1] Group 2: Market Position - There are currently no similar targeted formulations approved for weight loss on the global market [1]