8月14日晚间，圣诺生物(688117)正式发布2025年半年报，报告期内，该上市公司实现营业收入3.38亿 元，同比增长69.69%；实现净利润8895.67万元，同比大幅增长308.29%；扣非后净利润表现更为突出， 达8947.63万元，同比增幅高达367.92%。 在此背景下，现象级产品诺和诺德的司美格鲁肽与礼来的替尔泊肽销售纪录屡创新高，推动各大药企加 速相关管线布局与研发投入，直接拉动上游原料药及CDMO需求增长。 圣诺生物指出，公司司美格鲁肽原料药成功获得韩国食品药品安全部(MFDS)认证，为开拓韩国及国际 市场奠定基础；艾塞那肽注射液、醋酸加尼瑞克注射液取得国内药品注册证书，丰富了制剂产品组合； 在美容多肽领域，多个核心原料药获得国际HALAL认证，有助于拓展全球消费市场；在创新药CDMO 服务领域，公司在复杂多肽创新药研发生产方面的综合服务能力突出，客户众生睿创的糖尿病、肥胖适 应症创新药RAY1225注射液项目已进入临床Ⅲ期。 需要指出的是，圣诺生物业绩强劲增长的核心驱动力，源于人胰高糖素样肽-1(GLP-1)原料药司美格鲁 肽、替尔泊肽产品出口销售增加。 再看产能布局方面，圣诺生物多个关 ...

Core Viewpoint - The company has received marketing authorization for injectable bivalirudin from the Therapeutic Goods Administration (TGA) of Australia, indicating its capability to sell the product in Australia, which is expected to positively impact the company's overseas market expansion and performance [1][2]. Group 1: Product Information - Product Name: Injectable Bivalirudin [1] - Dosage Form: Injection [1] - Specification: 250mg [1] - Indication: Used as an anticoagulant for patients with high-risk acute coronary syndrome (ACS) undergoing early invasive treatment and those receiving percutaneous coronary intervention (PCI) [1]. Group 2: Regulatory Approvals and Milestones - In January 2019, the company received a drug registration certificate from the National Medical Products Administration (NMPA) for injectable bivalirudin [2]. - In May 2019, the company obtained a GMP certificate from the Hainan Provincial Drug Administration for the active pharmaceutical ingredient [2]. - In June 2019, the company successfully challenged the patent of the original holder of injectable bivalirudin [2]. - In October 2019, the ANDA for injectable bivalirudin received final approval from the FDA, leading to its market launch in the U.S. in 2020 [2]. - In December 2022, injectable bivalirudin passed the consistency evaluation for generic drug quality and efficacy by the NMPA [2]. - In February 2024, the product received registration approval from the Saudi Food and Drug Authority (SFDA) [2]. Group 3: Company Strategy and Product Portfolio - The company has extensive experience in the research, registration, production, and marketing of chemically synthesized peptide drugs, having developed multiple products including injectable thymosin alpha-1 and various other therapeutic drugs [3]. - The internationalization strategy aims to obtain drug approvals and market sales in developed countries such as the U.S. and EU to increase revenue and profit [3].

Group 1: Development Direction and Progress - The company focuses on high-end complex formulations, particularly in markets with large scale, high technical difficulty, and few competitors, to establish a unique competitive advantage [2][3] - Currently, the company has three peptide injection products (including APIs) approved for market in the U.S., with four more under FDA review [2] - The company aims to accelerate the registration process in Europe and expand into other global markets, leveraging approvals obtained in the U.S. [2] Group 2: Internationalization Efforts - The company has consistently pursued an internationalization strategy, successfully passing GMP inspections from the U.S. FDA, EU EMA, Philippines FDA, and Saudi Arabia SFDA [3] - Products such as thymosin alpha-1 and other injections have received FDA approval and have been exported to the U.S. [3] - The company plans to continue submitting DMF and ANDA applications in the U.S. and EU to further its internationalization efforts [3] Group 3: Raw Material Development - The company's thymosin alpha-1 has passed technical review by the Italian Medicines Agency (AIFA), and its somatostatin API has obtained a CEP certificate [3] - Other raw material businesses are being developed as a key focus for future growth [3] Group 4: Quality Management and CMO Cooperation - The subsidiary Ningbo Shuangcheng has passed the U.S. FDA CGMP inspection, ensuring compliance with quality management standards [3] - The company is actively pursuing CMO collaborations, particularly with major clients, while ensuring the production of its proprietary products [3]