Workflow
BOAN BIOTECH(06955)
icon
Search documents
博安生物自主开发药物度拉糖肽注射液获批上市
Zhong Zheng Wang· 2025-08-09 09:04
Core Insights - The company Boan Biotech has received approval from the National Medical Products Administration for its self-developed drug, Boyouping (Dulaglutide Injection), aimed at blood sugar control in adult patients with type 2 diabetes [1] - Boyouping is a long-acting GLP-1 receptor agonist, and its commercialization in mainland China will be conducted in collaboration with Shanghai Pharmaceuticals [1] Distribution and Marketing - Shanghai Pharmaceuticals has a comprehensive distribution network covering 25 provinces and over 70,000 medical institutions, supported by nearly 1,000 professional marketing personnel [1] - The company will leverage its integrated marketing services and extensive market coverage to accelerate the distribution of Boyouping across hospitals, retail pharmacies, and DTP specialty pharmacies nationwide [1] Company Overview - Boan Biotech operates with an integrated "R&D-production-sales" model and is a local biopharmaceutical company [1] - The company has developed innovative antibody drugs based on three technology platforms: antibody-drug conjugate technology, bispecific T-cell engager technology, and fully human antibody transgenic mice and phage display technology [1] - In the biosimilar drug sector, the company has successfully launched four products [1] Financial Performance - For the year 2024, the company is projected to achieve a revenue of 730 million yuan, representing a year-on-year growth of 17.5% [1] - The net profit is expected to be 73.19 million yuan, marking a turnaround from previous losses [1]
博安生物(06955.HK):度拉糖肽注射液博优平®在中国获批上市
Jin Rong Jie· 2025-08-08 09:33
Core Viewpoint - The company Boan Biotech (06955.HK) has received approval from the National Medical Products Administration for its self-developed product, Boyouping® (Dulaglutide Injection), aimed at blood sugar control in adult patients with type 2 diabetes. This product is the world's first and currently the only approved biosimilar to Trulicity® and is the only domestic dulaglutide injection that has not entered the Biologics License Application (BLA) stage in China [1]. Group 1 - Boan Biotech's Boyouping® is the first and only approved biosimilar to Trulicity® globally [1] - The product is specifically designed for blood sugar control in adult type 2 diabetes patients [1] - The commercialization of Boyouping® in mainland China will be conducted in collaboration with Shanghai Pharmaceuticals Holding Co., Ltd [1]
博安生物(06955):度拉糖肽注射液博优平在中国获批上市
智通财经网· 2025-08-08 09:17
Core Viewpoint - The company has received approval from the National Medical Products Administration for its self-developed product, Boyouping® (Dulaglutide Injection), which is the first and only biosimilar to Trulicity® approved for the treatment of type 2 diabetes in adults in China [1][3] Group 1: Product Development and Approval - Boyouping® is a long-acting GLP-1 receptor agonist that can improve pancreatic beta-cell function and effectively lower blood glucose and HbA1c levels [1] - The product's development process adhered to biosimilar guidelines from China, the US, and the EU, confirming its overall similarity to Trulicity® in quality, efficacy, safety, and immunogenicity [3] - The company has overcome complex CMC challenges in developing the biosimilar, leveraging its advanced technical expertise and analysis platforms [2] Group 2: Market Potential and Commercialization - China has the highest number of diabetes patients globally, with projections of approximately 148 million adults with diabetes in 2024, expected to rise to 168 million by 2050 [4] - The GLP-1 drug market in China is projected to reach approximately 6.376 billion RMB in 2024, driven by the increasing patient demand [4] - The company has granted exclusive commercialization rights of Boyouping® in mainland China to Shanghai Pharmaceuticals, which has a vast distribution network covering over 70,000 medical institutions [4]
博安生物(06955):度拉糖肽注射液博优平®在中国获批上市
智通财经网· 2025-08-08 09:14
度拉糖肽是一种长效胰高血糖素样肽-1(GLP-1)受体激动剂,每周给药一次。度拉糖肽可改善胰岛β细胞 的功能,稳定、有效地降低血糖及糖化血红蛋白(HbA1c)水平。除了实现良好的血糖控制,度拉糖肽亦 具备多重临床获益,包括可减少主要心血管不良事件,减轻体重,对肾脏具有保护作用,且低血糖发生 率低,胃肠道不良反应低。此外,其每周一次的给药频率可减少患者用药不便,有助于提升治疗依从 性。 作为一种多肽-Fc融合蛋白,度拉糖肽的工艺复杂程度高,其生物类似药的药学(CMC)开发难度大。公 司在CMC领域具有丰富的技术专长和经验积累,其先进的工艺开发平台在控制融合蛋白分子GLP-1端的 截短、羟基化与氧化、甲醯化、丙酮酸醯化等方面发挥了很强的技术优势;同时,其高效的分析平台独 创开发了上述关键质量属性的控制方法,通过全面的质控策略赋能工艺开发及可比性分析,成功攻克了 CMC技术难题,推动博优平率先获批上市。在中国市场之外,博优平也已在美国获准开展临床试验。 博优平的研发过程严格遵循中国、美国、欧盟的生物类似药相关指导原则,通过药学、非临床、人体药 代动力学、临床有效性、安全性和免疫原性一系列逐步递进的研究,科学、完整的 ...
博安生物(06955.HK):度拉糖肽注射液博优平®在中国获批上市 用于成人2型糖尿病患者的血糖控制
Ge Long Hui· 2025-08-08 09:11
Core Viewpoint - The company announced that its self-developed product, BoYouPing® (Dulaglutide Injection), has received approval from the National Medical Products Administration for use in blood sugar control in adult patients with type 2 diabetes, marking it as the first and only approved biosimilar of Trulicity® globally [1][2]. Group 1: Product Approval and Market Position - BoYouPing® is the first and currently the only approved biosimilar of Trulicity® in the market, with no other domestic dulaglutide injections having entered the BLA stage in China [1]. - The commercialization of BoYouPing® in mainland China will be conducted in collaboration with Shanghai Pharmaceuticals Holding Co., Ltd [1]. Group 2: Product Characteristics and Benefits - Dulaglutide is a long-acting GLP-1 receptor agonist administered once a week, which improves pancreatic beta-cell function and effectively lowers blood sugar and HbA1c levels [1]. - In addition to good blood sugar control, dulaglutide offers multiple clinical benefits, including reducing major cardiovascular adverse events, weight loss, renal protection, and a low incidence of hypoglycemia and gastrointestinal adverse reactions [1]. - The weekly administration frequency enhances patient compliance by reducing medication inconvenience [1]. Group 3: Development and Clinical Research - The development of BoYouPing® adhered strictly to biosimilar guidelines from China, the US, and the EU, confirming its overall similarity to Trulicity® through a series of studies [3]. - Key clinical studies in China demonstrated that BoYouPing® can rapidly, stably, and persistently lower blood sugar while also reducing weight, showing consistent efficacy with Trulicity® in treating adult patients with type 2 diabetes [3]. - The results of the Phase I and Phase III clinical studies have been published in international academic journals, confirming the high similarity in quality, efficacy, safety, and immunogenicity between BoYouPing® and Trulicity® [3].
博安生物(06955) - 自愿性公告度拉糖肽注射液博优平在中国获批上市
2025-08-08 09:00
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不 負 責,對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明,並 明 確 表 示,概 不 就 因 本 公 告 的全部或任何部份內容而產生或因倚賴該等內容而引致的任何損失承擔任何 責 任。 Shandong Boan Biotechnology Co., Ltd. 山東博安生物技術股份有限公司 (於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司) (股 份 代 號:6955) 自願性公告 度拉糖肽注射液 博優平®在中國獲批上市 山東博安生物技術 股份有限公司(「本公司」)董事會(「董事會」)宣 佈,本 公 司 自 主開發的 博優平® (度 拉 糖 肽 注 射 液)已 獲 得 國 家 藥 品 監 督 管 理 局 的 上 市 批 准, 用於成人2型 糖 尿 病 患 者 的 血 糖 控 制。該 產 品 是 全 球 首 個 且 當 前 唯 一 獲 批 上 市 的度易 達(英 文 商 品 名: ® Trulicity®)的 生 物 類 似 藥,國 內 尚 無 其 他 國 產 度 拉 糖 肽 注射液進入上市許可申請( ...
博安生物(06955)上涨8.2%,报18.48元/股
Jin Rong Jie· 2025-08-08 08:27
8月8日,博安生物(06955)盘中上涨8.2%,截至15:53,报18.48元/股,成交7.39亿元。 山东博安生物技术股份有限公司是一家生物制药公司,主要业务包括生物药开发、生产和商业化,特别 专注于肿瘤、自身免疫、眼科和代谢疾病领域。目前,公司拥有三款商业化产品,已在中国及包括欧美 在内的海外市场进行生物药产品开发,并有几个在研的创新生物药和生物类似药产品组合,已构建起全 覆盖"研发-生产-商业化"的产业价值链运营体系。 截至2024年年报,博安生物营业总收入7.26亿元、净利润7318.9万元。 8月7日,拟配售4800万新股份,占扩大后股本7.71%,每股配售价16.42港元,较前一收市日折价8.78% (预案)。 本文源自:金融界 作者:行情君 ...
博安生物尾盘飙升逾16% 旗下度拉糖肽生物类似药BA5101获批上市
Zhi Tong Cai Jing· 2025-08-08 07:55
此外,博安生物近日宣布,拟配售总计4800万股股份,预计募集资金净额约7.80亿港元,公司拟将50% 主要用于研发、临床试验及产品制造;20%用于产品商业化以及30%用于补充营运资金和一般企业用 途。值得注意的是,博安生物6月初宣布配售3840万股,净筹约3.96亿元。 消息面上,8月8日,国家药监局官网显示,博安生物申报的度拉糖肽注射液(BA5101)获批上市,用于 成人2型糖尿病患者的血糖控制。这是首款获批上市的国产度拉糖肽生物类似药。据礼来财报,2024年 度拉糖肽全球销售额为52.535亿美元。 博安生物(06955)尾盘飙升逾16%,截至发稿,涨10.89%,报18.94港元,成交额6.45亿港元。 ...
港股公告掘金|中国移动上半年股东应占利润同比增加5.03%至842.35亿元 中芯国际二季度股东应占溢利同比减少19.5%
Jin Rong Jie· 2025-08-07 17:39
Major Events - Silver诺医药-B (02591) is set to conduct an IPO from August 7 to August 12, with an expected listing date of August 15 [1] - Boan Biotech (06955) plans to place 48 million shares at a discount of approximately 8.78%, aiming to raise about HKD 780 million [1] - Derin Holdings (01709) intends to raise HKD 653.3 million, focusing on the development of blockchain, RWA, and virtual asset businesses [1] - Fuhong Hanlin (02696) received FDA approval to initiate a Phase 1 clinical trial for HLX43, a PD-L1 targeted antibody-drug conjugate for thymic cancer treatment [1] - China Biopharmaceutical (01177) obtained NMPA approval for the Phase II clinical trial application of LM-24C5, a dual antibody targeting CEACAM5/4-1BB [1] Financial Reports - China Mobile (00941) reported a shareholder profit of HKD 84.235 billion, a year-on-year increase of 5.03% [1] - Manulife Financial-S (00945) announced a core profit of CAD 1.7 billion for the second quarter [1] - Swire Properties (01972) reported a basic profit attributable to shareholders of HKD 4.42 billion, a year-on-year growth of 15% [1] - Hutchison Whampoa (00013) posted a net profit of USD 455 million, a significant year-on-year increase of 1663.32% [1] - MGM China (02282) disclosed a net profit of HKD 2.383 billion, a year-on-year decrease of 11.25% [1] - SMIC (00981) reported a shareholder profit of USD 132 million for the second quarter, with a revenue guidance for the third quarter indicating a sequential growth of 5% to 7% [1] - Zai Lab (09688) achieved a total revenue of approximately USD 216 million for the first half of the year, reflecting a year-on-year growth of 15.35% [1] - Innovent Biologics (01801) reported total product revenue exceeding RMB 5.2 billion for the first half of the year, maintaining a strong growth rate of over 35% [1] - Pacific Basin Shipping (02343) announced a profit attributable to shareholders of USD 25.6 million, a year-on-year decrease of 56% [1] - Lee & Man Paper Manufacturing (02314) reported a net profit of HKD 811 million, a year-on-year increase of 0.7%, with an interim dividend of HKD 0.066 per share [1] - Swire Group reported a profit attributable to shareholders of HKD 815 million for the first half of the year, a year-on-year decrease of 79% [1] - Lee & Man Chemical Company (00746) reported a profit increase of 36.0% to HKD 327 million, with an interim dividend of HKD 0.195 per share [1] - Hua Hong Semiconductor (01347) reported a profit attributable to parent company owners of USD 7.952 million for the second quarter, a year-on-year increase of 19.2% [1] - Wharf Real Estate Investment (01997) reported a loss attributable to shareholders of HKD 2.406 billion, a year-on-year increase of 128.71%, with the first interim dividend of HKD 0.066 per share [1] - Dekang Agriculture (02419) issued a profit warning, expecting a year-on-year increase in fair value adjustments of biological assets to approximately RMB 1.1 billion to 1.4 billion [1] - Mongol Mining (00975) issued a profit warning, anticipating a net loss of approximately USD 15 million to 25 million for the first half of the year, marking a shift from profit to loss [1] - Dongfeng Motor Group (00489) issued a profit warning, expecting a decline in net profit attributable to the parent company of 90% to 95% for the first half of the year [1]
异动盘点0807|宜搜科技涨超12%,曹操出行早盘涨超15%;美股Shopify大涨21.97%
贝塔投资智库· 2025-08-07 04:00
Group 1 - Yisou Technology (02550) rose nearly 12.63% after announcing a share subscription agreement with Lightnet Pte. Ltd., acquiring approximately 1.23% equity for $5 million [1] - Maifushi (02556) fell nearly 2.28% despite a profit forecast of RMB 31.8 million to RMB 41 million for the six months ending June 30, 2025, a significant turnaround from a loss of RMB 820 million in the same period last year [1] - New World Development (00086) increased nearly 4.19% after announcing a profit forecast of no less than HKD 800 million for the six months ending June 30, 2025, compared to HKD 75.4 million in the same period last year [2] Group 2 - Cao Cao Travel (02643) surged nearly 15.68% after signing a strategic cooperation memorandum with Victory Securities to explore virtual asset tokenization and stablecoin applications [2] - Boan Bio (06955) dropped nearly 5.06% after announcing a placement of 48 million shares at HKD 16.42 each, aiming to raise approximately HKD 780 million for R&D and operational purposes [2] - Huaxing Capital Holdings (01911) rose nearly 6%, with a year-to-date stock price increase of 1.1 times, as it plans to invest $100 million in Web 3.0 and cryptocurrency assets [3] Group 3 - Cathay Pacific Airways (00293) continued to decline nearly 3% after a report indicated an 8.3% year-on-year increase in net profit for the first half of the year, but operating profit fell short of market expectations [3] - Keep (03650) rose over 10%, with a cumulative increase of over 22% this week, reporting an adjusted net profit of approximately RMB 10 million for the first half of the year [4] - Smoore International (06969) increased nearly 5%, with BAT's new tobacco product revenue growing 2.4% year-on-year, and Smoore is expected to benefit from this growth [4] Group 4 - Xiaomi Group-W (01810) fell over 4% after Nomura raised its target price by 79% to HKD 61 but downgraded its rating to "Neutral" due to limited upside potential [5] - Apple (AAPL.US) rose 5.09% after announcing a commitment to invest an additional $100 billion in U.S. manufacturing, bringing its total investment commitment to $600 billion [6] - McDonald's (MCD.US) increased 2.98% with second-quarter revenue growing 5.4% year-on-year to $6.84 billion, exceeding analyst expectations [6]