本报记者 曹卫新 深耕技术 全球医药创新浪潮奔涌，技术迭代与格局重塑加速演进，中国创新药正打破"跟跑"惯性，在"并跑"中 向"局部领跑"奋力迈进。 今年2月份，前沿生物药业（南京）股份有限公司（以下简称"前沿生物"）与全球生物制药企业葛兰素 史克（GSK）就公司两款处于早期研发阶段的小核酸（siRNA）管线产品达成全球独家授权合作， 以"首付款+里程碑付款+分级特许权使用费"的模式，斩获超10亿美元潜在收益，成为中国小核酸创新 药"出海"的重要突破。 此次合作背后有着怎样的技术底气？又将为中国创新药全球化带来哪些启示？日前，前沿生物董事长、 总经理谢东接受了《证券日报》记者专访，就合作细节、技术布局及行业发展等核心问题展开深入交 流。 战略同频 在小核酸赛道群雄逐鹿的当下，前沿生物能在产品早期阶段就获得GSK的青睐，核心在于产品的差异 化"硬实力"与双方高度契合的战略眼光。这并非偶然的合作，而是双方基于各自优势与发展需求的双向 选择。 谢东在专访中坦言，跨国药企在挑选合作伙伴时，有着清晰的"考量标尺"，核心聚焦于三个维度：一是 战略协同性，即合作资产能否对其现有管线进行有效补充；二是资产本身的竞争力，扎实的研 ...

全球医药创新浪潮奔涌，技术迭代与格局重塑加速演进，中国创新药正打破"跟跑"惯性，在"并跑"中 向"局部领跑"奋力迈进。 今年2月份，前沿生物药业（南京）股份有限公司（以下简称"前沿生物"）与全球生物制药企业葛兰素 史克（GSK）就公司两款处于早期研发阶段的小核酸（siRNA）管线产品达成全球独家授权合作， 以"首付款+里程碑付款+分级特许权使用费"的模式，斩获超10亿美元潜在收益，成为中国小核酸创新 药"出海"的重要突破。 此次合作背后有着怎样的技术底气？又将为中国创新药全球化带来哪些启示？日前，前沿生物董事长、 总经理谢东接受了《证券日报》记者专访，就合作细节、技术布局及行业发展等核心问题展开深入交 流。 战略同频 在小核酸赛道群雄逐鹿的当下，前沿生物能在产品早期阶段就获得GSK的青睐，核心在于产品的差异 化"硬实力"与双方高度契合的战略眼光。这并非偶然的合作，而是双方基于各自优势与发展需求的双向 选择。 谢东在专访中坦言，跨国药企在挑选合作伙伴时，有着清晰的"考量标尺"，核心聚焦于三个维度：一是 战略协同性，即合作资产能否对其现有管线进行有效补充；二是资产本身的竞争力，扎实的研究数据、 鲜明的差异化特色， ...

（文章来源：证券日报） 证券日报网2月25日讯 ，前沿生物在接受调研者提问时表示，2026年及未来两年，公司将围绕现有业务 板块与核心管线，推进多项研发里程碑，同时夯实长期发展基础。一是高端仿制药领域，两款分别面向 美国、中国市场的产品，计划于未来两年内获批上市，为公司带来现金流支撑；二是HIV领域，持续推 进差异化产品研发，力争推出1款新的创新药品种；三是小核酸领域，核心推进已公开的FB7013、 FB7011、FB7023、FB7033四款管线，积极争取推动FB7023/FB7033中的一款完成IND申报，同时计划 推进一款肝外递送相关早期产品达到PCC阶段；2027年计划推动1-2款小核酸产品完成IND申报，更多肝 外递送早期产品达到PCC阶段。此外，公司将同步布局更多未公开的小核酸早期管线，聚焦大适应症领 域，同时持续深化肝外递送技术研发。公司战略分为短期（3-5年）与长期（5-10年）两个维度。短期 来看，将聚焦三大板块：一是深耕HIV主业，依托在该领域积累的研发团队、技术与人才优势，围绕差 异化临床需求布局新产品，争取推进一款新的创新药早研产品进入PCC阶段；二是推进高端仿制药上 市，弥补公司现金 ...

智通财经APP讯，亿腾嘉和(06998)发布公告，旗下小核酸创新药EDP167 II期临床试验成功完成首例受 试者给药。 EDP167 II期临床试验是一项针对纯合子家族性高胆固醇血症(HoFH)成人患者的多中心、剂量探索、开 放标签的试验，旨在评估EDP167在HoFH患者中的疗效和安全性，其主要终点为首次给药24周后低密度 脂蛋白胆固醇(LDL-C)水平相较基线的变化，预计于2026年第四季度完成主要终点的评估。 ...

Core Viewpoint - The clinical trial application for FB7013, a novel siRNA drug targeting the MASP-2 protein for IgA nephropathy treatment, has been accepted by the National Medical Products Administration of China, marking a significant advancement in innovative drug development for this condition [1] Group 1: Drug Mechanism and Innovation - FB7013 is the first-in-class siRNA drug targeting the MASP-2 protein, aiming to block the abnormal activation of the lectin pathway and reduce complement-mediated kidney damage, providing a new targeted treatment option for IgA nephropathy [1] - The drug has potential for expansion into other complement-related diseases such as membranous nephropathy and diabetic nephropathy, potentially benefiting a wider patient population [1] Group 2: Preclinical Data and Efficacy - Preclinical studies demonstrate FB7013's strong, long-lasting, and safe effects, with over 95% reduction in serum MASP-2 protein levels after a single injection, maintaining over 90% reduction for 105 days [2] - In IgA nephropathy models, FB7013 shows significant dose-dependent efficacy, with reductions in urinary protein levels and increases in glomerular filtration rate, indicating substantial improvement in kidney pathology [2] - Safety assessments indicate no significant off-target risks and no adverse effects on cardiovascular, respiratory, or central nervous systems in preclinical studies [2] Group 3: International Recognition and Market Potential - FB7013 has gained international academic recognition, with the company presenting its preclinical efficacy data at the 2025 ASN Kidney Week conference in Houston, Texas, showcasing the strength of Chinese innovative drugs [3] - The global IgA nephropathy patient population is projected to grow from 9.3 million in 2020 to 10.2 million by 2030, with the treatment market expected to increase from $567 million in 2020 to $1.196 billion by 2025, reflecting a compound annual growth rate of 16.1% [4] - The acceptance of FB7013's clinical trial application represents a significant breakthrough for the company in the small nucleic acid innovative drug sector, reinforcing its commitment to advancing innovative drug development [4]

Core Viewpoint - Guoshou Chengda, a major shareholder of Huaxi Biological, plans to reduce its stake by up to 9.63 million shares, representing no more than 2.00% of the total share capital, following a previous reduction of 5,496,782 shares [1][2] Group 1: Shareholder Actions - Guoshou Chengda currently holds 28.94 million shares, accounting for 6.01% of Huaxi Biological, making it the second-largest shareholder [1] - This marks the second reduction by Guoshou Chengda, which previously sold shares between October 31 and November 12, 2024, at prices ranging from 59.28 to 68.10 yuan per share [1] - Huaxi Biological's controlling shareholder, Huaxi Xinyu, recently completed its first share buyback since the company's listing, acquiring approximately 4.52 million shares for about 257 million yuan, increasing its stake to 60.11% [2] Group 2: Financial Performance - Huaxi Biological's revenue has declined from 6.36 billion yuan in 2022 to 5.37 billion yuan in 2024, with a year-on-year decrease of 18.36% to 3.16 billion yuan in the first three quarters of this year [2] - Net profit for the first three quarters was 252 million yuan, down 30.29% year-on-year [2] - Despite a decline in overall performance, net profit showed improvement in the second and third quarters, increasing by 20.89% and 55.63% respectively, primarily due to effective control of sales expenses [2] Group 3: Strategic Adjustments - In response to ongoing challenges, Huaxi Biological's chairman announced a return to operational management and implemented systematic adjustments in business direction and organizational structure [3] - The company plans to invest 138 million Hong Kong dollars to acquire 11.57 million shares of Saint Pharma, aiming to expand into the small nucleic acid innovative drug sector [3]

Core Viewpoint - The investment in Saint Nor Pharmaceutical is a strategic move for the company to enhance its position in the biopharmaceutical sector, particularly in innovative drug development and to leverage synergies in its core business areas [1][2]. Investment Strategy - The investment amount is approximately HKD 138 million, funded entirely from the company's own resources, and will be paid in installments as per the agreement [2]. - The company recognizes the long development cycles and high risks associated with small nucleic acid drug research and has established risk control and exit arrangements through the investment agreement [2]. Business Development - The company reported a steady increase in sales revenue from its innovative hyaluronic acid products and other bioactive substances, accounting for over 23% of total sales in the first half of 2025 [3]. - Six new bioactive raw material products have been launched, including Hyatrue® cross-linked sodium hyaluronate and BloomColla® recombinant type III humanized collagen [3]. Operational Adjustments - The company has undergone systematic adjustments in its operational philosophy and business direction since March 2025, leading to a significant reduction in sales expense ratio by 12.46 percentage points year-on-year in Q2 [4]. - The focus is on transforming consumer products based on long-term technological barriers and scientific assets, particularly in the fields of cell biology and glycoscience [5]. Organizational Changes - The company is shifting away from hiring external "professional operators" and is instead selecting and training entrepreneurial talents who align with the company's values for management positions [6]. - A one-time management expense of approximately CNY 29 million was incurred during this transition, aimed at laying a solid foundation for long-term development [6]. Scientific Communication - The company is committed to reshaping its scientific image and defending scientific values, aiming to establish a rigorous scientific communication system to counter misinformation in the industry [6].

Investment Rating - The report initiates coverage with a "Buy" rating for Shuiyang Co., Ltd. [3][13] Core Insights - The cosmetics and medical beauty sector underperformed the market, with the Shenwan Beauty Care Index increasing by 0.2% from September 5 to September 12, 2025, lagging behind the Shenwan A Index by 2.7 percentage points [3][4] - Domestic cosmetics brands showed strong growth in August, with key brands under Shumei Co. achieving a 70% growth rate on Douyin and Taobao platforms, indicating a robust performance despite high base effects [3][9] - The report highlights the upcoming Double 11 shopping festival, suggesting that brands should prepare for promotional strategies [3][9] Summary by Sections Industry Performance - The cosmetics and medical beauty sector's performance was weaker than the market, with declines in the Shenwan Cosmetics Index by 0.5% and the Shenwan Personal Care Index by 0.8% during the specified period [3][4] Key Company Review - Shuiyang Co., Ltd. is positioned as a leading technology-driven beauty company in China, with stable revenue between 4 to 5 billion yuan from 2021 to 2024 and an expected gross margin of 63.01% in 2024, up by 10.94 percentage points from 2021 [3][10] - The company has a dual business model of proprietary brands and CP agency brands, with a strong focus on high-end and global market transformation [3][10][12] E-commerce Data - In August, key domestic brands on Douyin and Taobao platforms showed significant growth, with Shumei Co. brands achieving a 70% increase, and other brands like Maogeping and Runben also reporting substantial growth rates [3][14] Market Trends - The report notes that the overall retail sales of cosmetics in July 2025 grew by 4.5%, indicating a recovery in consumer spending [3][17] - The domestic skincare market is projected to reach 271.2 billion yuan in 2024, despite a slight decline of 3.7% year-on-year, with domestic brands gaining market share [3][26] Company Announcements - Shumei Co. has appointed Dr. Karl Lintner, a pioneer in peptide beauty, as the chief scientific advisor, aiming to enhance its global competitiveness in research and development [3][21]