2025年，中国创新药BD交易总额历史性突破千亿美元，并出现百亿美元级订单，跨国药企支付的首付 款站在12.5亿美元的新台阶。 如果要挑选2025年的股市关键词，创新药一定是其中之一。2025年1月至9月，多只创新药企股票实现翻 倍上涨，而支撑行业在二级市场受热捧的，并非传统意义上的已上市药品带来的业绩增长，而是在研创 新药通过BD交易出海带来的想象空间。 年度标志性交易刷新多项纪录： 1月，启光德健与美国Biohaven、韩国AimedBio达成的超130亿美元合作，涵盖同类首创FGFR3靶点 ADC药物GQ1011的全球权益授权，同时涉及21个ADC靶点的联合开发平台，是中国ADC底层技术能力 获得国际背书的里程碑。 2025年初，迪哲医药（688192.SH）研发的肺癌靶向药向美国FDA递交新药上市申请并获得优先审评资 格，7月该药正式获批，成为中国首款独立研发在美获批的全球首创新药。7月，凯思凯迪研发的1类新 药CS0159口服片剂获FDA突破性疗法认定。8月，禾元生物（688765.SH）研发的重组人白蛋白注射液 获FDA批准开展三期临床试验。12月，康宁杰瑞（09966.HK）研发的HER2双抗A ...

整理 | GLP1减重宝典内容团队 联邦制药此前披露过UBT251的一期数据要点，主要卖点集中在长半衰期与每周一次给药的便利性。公开口径显示，其半衰期约136至170小 时，支持周制剂给药节奏。在早期剂量探索中，体重下降在一定剂量范围内优于安慰剂对照。对诺和诺德来说，这类早期信号足以支撑把项目 推向更大样本、更长周期的二期试验，但真正关键的看点会从单纯的体重变化，升级为更系统的综合评价：不同剂量梯度下的减重幅度和速度 曲线是否稳定，停药或减量后的反弹如何，胃肠道不良反应与依从性如何，代谢指标和心血管风险因子改善是否同步，以及是否出现与胰高糖 素通路相关的潜在风险需要长期盯防。 这也是诺和诺德当初为什么愿意用大额交易把全球权益拿在手里的原因。2025年3月，诺和诺德与联邦制药相关主体达成授权合作，交易结构 包括2亿美元预付款、最高18亿美元里程碑付款，以及中国大陆、港澳台以外市场的分级销售分成。对诺和诺德而言，这类结构有一个非常现实 的算盘：用相对可控的前期现金换取一个可能抬高疗效上限的候选药物，同时把真正昂贵的支付环节押注在后续里程碑上，用临床结果来决定 资金继续加码的力度。对联邦制药而言，保留大中华区权益、 ...

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]

整理 | GLP1减重宝典内容团队 在全球减重药物竞争逐步从"体重数字"走向"并发症获益"的背景下，中国创新药正在加速进入更具医学价值的细分战场。 2月2日，联邦制药 全资附属公司联邦生物科技（珠海横琴）有限公司宣布，其自主研发的1类新药UBT251注射液，针对合并肥胖的中重度阻塞 性睡眠呼吸暂停（OSA）新适应症，已正式获得 国家药品监督管理局 批准开展临床试验。这一进展不仅意味着UBT251的适应症版图进一步扩 大，也标志着国内三靶点减重药开始正面切入高风险慢性疾病领域。 UBT251是联邦制药围绕代谢相关疾病重点打造的核心创新资产，拥有完整、清晰的自主知识产权体系。与当前主流GLP-1单靶点或双靶点产品 不同，UBT251同时作用于GLP-1、GIP及GCG三大代谢关键靶点，形成协同调节能量摄入、体重和代谢状态的机制组合。这一多靶点策略，使 其在体重控制之外，具备更强的代谢重塑潜力，而肥胖正是中重度OSA最重要、且可干预的危险因素之一。 此前披露的1b期临床数据显示，在12周治疗周期内，UBT251最高剂量组患者平均减重幅度达到15.1%，同时安全性与耐受性表现良好。正是基 于这一具有竞争力的早期数据， ...

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].

智通财经APP讯，联邦制药(03933)公布，公司全资附属公司珠海联邦制药股份有限公司中山分公司申报 的罗红霉素胶囊(规格：150mg)通过中国国家药品监督管理局仿制药质量和疗效一致性评价。 罗红霉素胶囊是第二代大环内酯类抗生素，具有耐酸性好、抗菌谱广、组织穿透性强、不良反应发生率 较低等显著抗感染优势。临床适用于治疗由罗红霉素敏感病原体导致的耳鼻喉、呼吸道、皮肤及软组 织、泌尿生殖道等感染。现时该产品为国家医保目录(2025年版)乙类药品。公司为首家通过罗红霉素胶 囊剂型一致性评价的企业。 本次获批将进一步有助于公司巩固于抗感染领域的优势地位。公司将持续致力于新产品研发，预期将为 公司及其股东创造更大收益。 ...

本次获批将进一步有助于公司巩固于抗感染领域的优势地位。公司将持续致力于新产品研发，预期将为 公司及其股东创造更大收益。 联邦制药(03933)公布，公司全资附属公司珠海联邦制药股份有限公司中山分公司申报的罗红霉素胶囊 (规格：150mg)通过中国国家药品监督管理局仿制药质量和疗效一致性评价。 罗红霉素胶囊是第二代大环内酯类抗生素，具有耐酸性好、抗菌谱广、组织穿透性强、不良反应发生率 较低等显著抗感染优势。临床适用于治疗由罗红霉素敏感病原体导致的耳鼻喉、呼吸道、皮肤及软组 织、泌尿生殖道等感染。现时该产品为国家医保目录(2025年版)乙类药品。公司为首家通过罗红霉素胶 囊剂型一致性评价的企业。 ...

罗红霉素胶囊是第二代大环内酯类抗生素，具有耐酸性好、抗菌谱广、组织穿透性强、不良反应发生率 较低等显着抗感染优势。临床适用于治疗由罗红霉素敏感病原体导致的耳鼻喉、呼吸道、皮肤及软组 织、泌尿生殖道等感染。现时该产品为国家医保目录(二零二五年版)乙类药品。公司为首家通过罗红霉 素胶囊剂型一致性评价的企业。 格隆汇2月9日丨联邦制药(03933.HK)公布，公司全资附属公司珠海联邦制药股份有限公司中山分公司申 报的罗红霉素胶囊(规格：150mg)通过中国国家药品监督管理局仿制药质量和疗效一致性评价。 本次获批将进一步有助于公司巩固于抗感染领域的优势地位。公司将持续致力于新产品研发，预期将为 公司及其股东创造更大收益。 ...

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。 本次獲批將進一步有助於本公司鞏固於抗感染領域的優勢地位。本公司將持續致力於 新產品研發，預期將為本公司及其股東創造更大收益。 承董事會命 聯邦制藥國際控股有限公司 主席 蔡海山 The United Laboratories International Holdings Limited 聯邦制藥國際控股有限公司 ( 於開曼群島成立之有限公司 ) (股份代號: 3933) 本集團產品羅紅霉素膠囊通過一致性評價 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珠海聯邦制藥股份有限公 司中山分公司申報的羅紅霉素膠囊（規格：150mg）通過中國國家藥品監督管理局仿 製藥質量和療效一致性評價（「一致性評價」）。 羅紅霉素膠囊是第二代大環內酯類抗生素，具有耐酸性好、抗菌譜廣、組織穿透性強、 不良反應發生率較低等顯著抗感染優勢。臨床適用於治療由羅紅霉素 ...

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry [3] Core Insights - The commercialization of ADC (Antibody-Drug Conjugates) is accelerating, with 20 ADC drugs approved globally, and 6 of them have been in the "billion-dollar club" for two consecutive years [30][31] - The report highlights the increasing competition in the ADC sector, with approximately 60 ADC drugs currently in clinical phase 3 and application stages [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 [31][32] Summary by Sections Market Review - 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] - Year-to-date, the pharmaceutical index has increased by 3.28%, also outperforming the CSI 300 index by 2.99 percentage points, ranking 23rd [10] Individual Stock Performance - In the A-share market, 255 out of 479 pharmaceutical stocks rose, with the top five performers being Guangshengtang (+29.83%), Haixiang Pharmaceutical (+18.64%), and Meidixi (+18.04%) [20] - In the Hong Kong market, 38 out of 116 pharmaceutical stocks rose, with the top performers including Yiteng Jiahe (+14%) and Kedi-B (+9.96%) [24] Industry News and Policies - The newly revised "Regulations on the Implementation of the Drug Administration Law" supports segmented contract manufacturing and commercial-scale drug sales, providing a foundation for ADC commercialization cooperation [32] - Notable industry developments include Novartis's application for Ianalumab in China and Johnson & Johnson's approval of Daratumumab injection for multiple myeloma treatment [27][28] Weekly Insights - The ADC commercialization battle has begun, with a significant increase in demand for ADC production capacity, leading to a supply-demand imbalance [30] - Major CXO companies are expanding ADC production capacity, with companies like WuXi AppTec acquiring East Yao Pharmaceutical to meet rising orders [31]