本研究采用随机、双盲、平行、安慰剂对照的试验设计，共纳入205例肥胖(BMI≥28.0kg/m2)或伴有至少 一种体重相关合并症的超重患者(24.0kg/m2≤BMI<28.0kg/m2)，受试者基线平均体重为92.2kg，基线平 均BMI为33.1kg/m2。受试者按1:1:1:1的比例随机分配至UBT251注射液2mg、4mg、6mg组或安慰剂组， 每周皮下注射给药1次，连续给药24周，本研究的主要评价终点为治疗24周后体重较基线变化百分比 (%)。 联邦制药(03933)公布，公司全资附属公司联邦生物科技(珠海横琴)有限公司(联邦生物科技)自主研发的1 类创新药UBT251注射液已完成在中国超重/肥胖患者中的II期临床研究。 本研究结果显示，UBT251各剂量组减重效果显著。给药24周后，试验药组平均体重较基线变化最高 达-19.7%(-17.5kg)，安慰剂组为-2.0%(-1.6kg)。此外，UBT251各剂量组在腰围、血糖、血压、血脂等关 键次要终点指标的改善均显著优于安慰剂。UBT251各剂量组整体安全性和耐受性良好，未发生因任何 不良事件导致的退出。不良事件与同类药物类似，主要为胃肠道反应，且 ...

本研究结果显示，UBT251各剂量组减重效果显著。给药24周后，试验药组平均体重较基线变化最高 达-19.7%(-17.5kg)，安慰剂组为-2.0%(-1.6kg)。此外，UBT251各剂量组在腰围、血糖、血压、血脂等关 键次要终点指标的改善均显著优于安慰剂。UBT251各剂量组整体安全性和耐受性良好，未发生因任何 不良事件导致的退出。不良事件与同类药物类似，主要为胃肠道反应，且绝大多数为轻度至中度，未见 预期外的安全性问题。 UBT251注射液在超重/肥胖患者中的II期临床研究达到预期目标，支持其进入下一阶段临床研究。 格隆汇2月24日丨联邦制药(03933.HK)发布公告，公司全资附属公司联邦生物科技(珠海横琴)有限公司 ("联邦生物科技")自主研发的1类创新药UBT251注射液已完成在中国超重/肥胖患者中的II期临床研究 ("本研究")。 本研究采用随机、双盲、平行、安慰剂对照的试验设计，共纳入205例肥胖(BMI≥28.0kg/m2)或伴有至少 一种体重相关合并症的超重患者(24.0kg/m2≤BMI＜28.0kg/m2)，受试者基线平均体重为92.2kg，基线平 均BMI为33.1kg/m2。受试 ...

UBT251 注射液在超重/肥胖患者中的 II 期临床研究达到预期目标，支持其进入下一阶段临床研究。后 续公司将尽快启动中国超重/肥胖患者的 III 期临床研究。 智通财经APP讯，联邦制药(03933)公布，公司全资附属公司联邦生物科技(珠海横琴)有限公司(联邦生物 科技)自主研发的 1 类创新药 UBT251 注射液已完成在中国超重/肥胖患者中的 II 期临床研究。 本研究采用随机、双盲、平行、安慰剂对照的试验设计，共纳入 205 例肥胖(BMI≥28.0 kg/m2)或伴有至 少一种体重相关合并症的超重患者(24.0 kg/m ≤BMI<28.0 kg/m)，受试者基线平均体重为 92.2 kg，基线 平均 BMI 为 33.1 kg/m。受试者按 1:1:1:1 的比例随机分配至 UBT251 注射液 2 mg、4 mg、6 mg 组或安 慰剂组，每周皮下注射给药 1 次，连续给药 24 周，本研究的主要评价终点为治疗 24 周后体重较基线变 化百分比(%)。 本研究结果显示，UBT251 各剂量组减重效果显著。给药 24 周后，试验药组平均体重较基线变化最高 达-19.7%(-17.5 kg)，安慰 ...

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，概不對因本公告全部或任何部份內容 而產生或因依賴該等內容而引致的任何損失承擔任何責任。 本集團產品 UBT251 注射液臨床研究進展 本公告乃由聯邦制藥國際控股有限公司（「本公司」）自願發出。 本公司董事會（「董事會」）欣然公佈，本公司全資附屬公司聯邦生物科技（珠海橫琴） 有限公司（「聯邦生物科技」）自主研發的 1 類創新藥 UBT251 注射液已完成在中國超 重/肥胖患者中的 II 期臨床研究（「本研究」）。 UBT251 是一款長效 GLP-1（胰高血糖素樣肽-1）/GIP（葡萄糖依賴性促胰島素多肽）/GCG （胰高血糖素）三靶點受體激動劑。截至目前，已獲准在中國及/或美國開展成人 2 型糖 尿病、超重/肥胖、慢性腎臟病、代謝相關脂肪性肝炎多個適應症的臨床試驗。本公司是 中國首家、全球第二家以化學合成多肽法製備的長效 GLP-1R/GIPR/GCGR 三靶點激動 劑獲批臨床的企業。 於二零二五年三月，聯邦生物科技及本公司與諾和諾德股份有限公司已訂立關於 UBT251 的獨家許可協議。 ...

Core Viewpoint - The keyword for the stock market in 2025 is expected to be "innovative drugs," with significant stock price increases driven by the potential of in-development innovative drugs and BD (business development) transactions rather than traditional revenue from already marketed drugs [1] Group 1: BD Transactions - In 2025, China's innovative drug BD transaction total exceeded $100 billion, with notable orders reaching $10 billion, and upfront payments from multinational pharmaceutical companies reaching a new high of $1.25 billion [1] - Landmark transactions include a $13 billion collaboration between Qihuang Dejian and Biohaven/AimedBio in January, marking a milestone for China's ADC technology [2] - In May, 3SBio's deal with Pfizer exceeded $6 billion, setting a record for upfront payments in China at $1.25 billion, highlighting the value of both first-in-class and fast-follow drugs [2] - In July, a $12 billion strategic partnership between Hengrui Medicine and GlaxoSmithKline showcased the depth of early-stage pipelines in leading Chinese pharmaceutical companies [2] - In October, Innovent Biologics and Takeda's collaboration worth $11.4 billion included a cost-sharing model for global R&D, enhancing operational capabilities for future international ventures [2] Group 2: Milestone Payments and Emerging Fields - Several past BD transactions reached milestone payments in 2025, including a $300 million payment to China National Pharmaceutical's subsidiary from Merck and a $250 million payment to Bairui Tianheng from Bristol-Myers Squibb [3] - The focus of BD transactions is shifting from oncology to other therapeutic areas, with autoimmune diseases, metabolism, and central nervous system disorders emerging as new hot fields [3] - Notable deals include the global rights licensing of BTK inhibitor Orelabrutinib for multiple sclerosis by Nocera Biopharma, with a potential total transaction value exceeding $2 billion [3] - The metabolic field is gaining traction, driven by global weight loss trends, with several companies entering into licensing agreements for GLP-1 targeted drugs [3] Group 3: Independent Clinical Trials and Regulatory Approvals - Numerous innovative drug companies in China are advancing their own overseas clinical trials, achieving significant progress [4] - In early 2025, Dize Pharmaceutical's lung cancer targeted drug received priority review from the FDA and was approved in July, becoming the first globally innovative drug independently developed in China to gain approval in the U.S. [4] - Other advancements include breakthrough therapy designations for CS0159 by Kexi Kedi and a Phase III trial approval for a recombinant human albumin injection by Heyuan Biopharma [4] - These developments indicate that the Chinese innovative drug industry is becoming a significant force in global innovation, transitioning from fast-following to original innovation and integrating deeply into the global value chain [4]

Core Viewpoint - Novo Nordisk is advancing its weight loss pipeline with the addition of UBT251, a GLP-1/GIP/GCG tri-receptor agonist, which aims to enhance weight loss efficacy and metabolic improvements while addressing safety and tolerability concerns [6][8][11] Group 1: UBT251 Development - A global Phase II study for UBT251 has been registered, targeting 333 participants, with completion expected by January 2027 [6] - UBT251's long half-life of approximately 136 to 170 hours supports a once-weekly dosing regimen, showing superior weight loss compared to placebo in early trials [8] - The drug's tri-receptor approach aims to suppress appetite, improve glucose metabolism, and enhance energy expenditure for greater weight loss [6][8] Group 2: Competitive Landscape - The initiation of UBT251's Phase II trial coincides with heightened industry interest following Eli Lilly's Retatrutide Phase III results, which demonstrated significant weight loss and functional benefits [11] - Novo Nordisk's strategy includes leveraging its established GLP-1 system and commercial capabilities while responding to new competitive benchmarks set by emerging therapies [11] - The key focus for UBT251 in Phase II will be to achieve substantial weight loss while maintaining acceptable safety and tolerability profiles [11] Group 3: Financial and Strategic Considerations - In March 2025, Novo Nordisk entered a licensing agreement with a $200 million upfront payment and potential milestone payments up to $1.8 billion, reflecting a strategic investment in UBT251's potential [9] - This deal structure allows Novo Nordisk to manage initial cash outflows while betting on the drug's future clinical success to justify further investments [9]

Summary of Industry Reports Industry: Pharmaceutical and Biotechnology Key Points from Document 1 1. **Raw Material Supply Changes**: The supply of raw materials is accelerating, with a focus on subsequent volume and price changes [1] 2. **Global GLP-1 Landscape**: The global GLP-1 landscape is continuously evolving, and Chinese companies are still pursuing international expansion [1] 3. **Small Nucleic Acid Sector**: Leading companies are gradually entering the small nucleic acid field, with market progress expected to drive the development of supporting industrial chains [1] 4. **Retail Pharmaceutical Market Outlook**: The retail pharmaceutical market is expected to improve by Q4 2025, with an enhanced positioning of chain pharmacies [1] 5. **Value of Oral Immunomodulatory Drugs**: Emphasis on the market value of oral immunomodulatory drugs [1] 6. **Investment Recommendations**: Recommended companies include Chuaning Biological, with attention to Lianbang Pharmaceutical, Guobang Pharmaceutical, and Puluo Pharmaceutical, as well as synthetic biology companies [1] 7. **CXO Order Trends**: Positive trends in CXO orders and rising prices for safety evaluation orders, with recommendations for Yinos and Zhaoyan New Drug, and recommendations for Weiya Biological and Puris [1] Key Points from Document 2 1. **Small Nucleic Acids Breakthrough**: Continuous breakthroughs in small nucleic acids, with ongoing progress in external authorizations by Chinese companies, recommending Yuekang Pharmaceutical and Sunshine Novo [2] 2. **Self-Immunity Field**: Focus on breakthroughs in oral directions and difficult-to-treat areas like UC/IBD, recommending Yahong Pharmaceutical and Yifang Biological [2] 3. **GLP-1 Weight Loss Authorizations**: Recommendations for Zhongsheng Pharmaceutical in the GLP-1 weight loss field, with attention to Lianbang Pharmaceutical and Shiyao Group [2] 4. **ZAP-X Radiation Therapy Equipment**: Initiation of domestic clinical research for ZAP-X radiation therapy equipment, recommending Baiyang Pharmaceutical [2] 5. **Policy Support for Brain-Computer Interface Technology**: Support for the development of invasive brain-computer interfaces, recommending Meihao Medical and Botuo Biological, with accelerated approvals for non-invasive devices, focusing on Xiangyu Medical and Kefu Medical [2] 6. **High-Value Medical Device Exports**: Breakthroughs in exports of high-value medical consumables, with attention to Chunli Medical, Aikang Medical, Nanwei Medical, and Baixin An [2] 7. **AI in Healthcare**: Accelerated applications of AI in healthcare, reshaping application scenarios and bringing changes in industrial chain value, recommending Anbiping and focusing on Yuyue Medical and Meinian Health [2] 8. **Chain Pharmacy Industry**: Industry consolidation in chain pharmacies, with policy support for enhanced positioning, recommending Yifeng Pharmacy and Laobaiqing, with attention to Yixintang [2]

Core Viewpoint - The article discusses the acceleration of Chinese innovative drugs entering the high-value medical segment of obesity treatment, particularly focusing on the approval of UBT251 for the treatment of moderate to severe obstructive sleep apnea (OSA) [4][5]. Group 1: UBT251 Development - UBT251, developed by Federated Pharmaceuticals, has received approval from the National Medical Products Administration to conduct clinical trials for OSA, expanding its indication [4]. - UBT251 targets three metabolic pathways: GLP-1, GIP, and GCG, which allows for a synergistic effect on energy intake, weight, and metabolic status, differentiating it from current single or dual-target GLP-1 products [5]. - In a 12-week Phase 1b clinical trial, patients in the highest dose group experienced an average weight loss of 15.1%, with good safety and tolerability [5]. Group 2: OSA as a Target Condition - OSA is a chronic disease that has been underestimated, characterized by repeated airway collapse during sleep, leading to significant health risks such as hypertension, arrhythmias, and metabolic diseases [7]. - Traditional treatments relying solely on CPAP machines are insufficient to address the systemic metabolic issues associated with OSA [7]. - The approval of UBT251 for OSA clinical research aligns with the growing evidence that metabolic interventions can improve outcomes for OSA patients [7].

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry, indicating a positive outlook for investment opportunities in this sector [3]. Core Insights - The commercialization of Antibody-Drug Conjugates (ADC) is accelerating, with 20 ADC drugs approved globally, and 6 of them consistently generating over $1 billion in revenue for two consecutive years. The competition in the ADC market is entering a new phase, with approximately 60 ADC drugs currently in clinical phase 3 or awaiting market approval [6][30]. - Domestic innovative pharmaceutical companies are adopting various strategies for ADC capacity layout, with companies like Rongchang Biopharma transitioning from outsourcing to in-house production, while others like Kelong Biotechnology are building their own production bases [6][31]. - The recent revision of the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" supports segmented contract manufacturing and commercial-scale drug sales, providing a foundation for ADC commercialization partnerships [6][32]. Market Performance - The pharmaceutical index rose by 0.14% this week, outperforming the CSI 300 index by 1.47 percentage points, ranking 15th in industry performance [10]. - Since the beginning of 2026, the pharmaceutical index has increased by 3.28%, again outperforming the CSI 300 index by 2.99 percentage points, ranking 23rd [10]. - The best-performing sub-sector this week was Traditional Chinese Medicine, which increased by 2.56%, while Chemical Pharmaceuticals and Biological Products saw declines of 0.62% and 1.82%, respectively [15][17]. Stock Performance - Among A-share pharmaceutical stocks, the top five performers this week were Guangshengtang (+29.83%), Haixiang Pharmaceutical (+18.64%), and Meidixi (+18.04%) [20]. - In the Hong Kong market, the top performers included Yiteng Jiahe (+14%) and Kedi-B (+9.96%), with 38 out of 116 pharmaceutical stocks rising, representing 32.76% [24][25]. Industry News and Policies - The inclusion of implantable brain-machine interfaces in the category of Class III medical devices marks a significant regulatory development, indicating a focus on innovative medical technologies [27]. - Novartis has submitted an application for the marketing of Ianalumab in China, a drug targeting various autoimmune diseases, which has shown promising results in clinical trials [27]. - Johnson & Johnson announced the approval of Daratumumab injection for a new combination therapy in China, providing a new treatment option for multiple myeloma patients [28].

Core Viewpoint - The company has successfully passed the consistency evaluation for the generic drug Roxithromycin capsules (150mg) by the National Medical Products Administration of China, which will strengthen its position in the anti-infection sector [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., has received approval for Roxithromycin capsules, marking it as the first company to pass this evaluation for this dosage form [1] - Roxithromycin is a second-generation macrolide antibiotic known for its good acid resistance, broad antibacterial spectrum, strong tissue penetration, and low incidence of adverse reactions [1] Group 2: Clinical Applications - The drug is clinically applicable for treating infections caused by Roxithromycin-sensitive pathogens in areas such as otolaryngology, respiratory tract, skin and soft tissue, and urogenital infections [1] Group 3: Market Position and Future Prospects - The product is listed as a Class B drug in the National Medical Insurance Directory (2025 version), which may enhance its market accessibility [1] - The approval is expected to help the company consolidate its competitive advantage in the anti-infection field and drive further product development, potentially leading to greater returns for the company and its shareholders [1]