（原标题：港股异动 | 中国生物制药(01177)涨超4% 旗下正大晴天自研HER2双抗ADC新辅助治疗乳腺癌取得重要突破） 消息面上，11月25日，注射用TQB2102单药用于HER2阳性乳腺癌新辅助治疗的Ⅱ期临床研究结果，获国际著名期刊《临床肿瘤学杂志》(Journal of Clinical Oncology，IF 43.4) 在线发表。TQB2102是中国生物制药旗下正大天晴自主研发的一种靶向HER2两个非重叠表位ECD2及ECD4的抗体偶 联药物(ADC)。该项研究由复旦大学附属肿瘤医院邵志敏教授团队领衔，为首个证实双表位HER2 ADC TQB2102在乳腺癌新辅助治疗阶段具有良 好疗效和安全性的研究，Ⅲ期注册临床研究正在开展中。 智通财经APP获悉，中国生物制药(01177)涨超4%，截至发稿，涨2.87%，报7.16港元，成交额1.74亿港元。 ...

中国生物制药(01177)发布公告，集团全资附属公司礼新医药科技(上海)有限公司(礼新医药)自主研发的 国家1类创新药LM-350"CDH17抗体偶联药物(ADC)"已获得中国国家药品监督管理局(NMPA)的临床试 验批准。 CDH17在多种肿瘤侵袭转移中发挥重要作用，并在约99%的结肠癌、86%的胃腺癌、79%的食管腺癌、 50%的胰腺导管腺癌中高表达。消化道肿瘤(包括结直肠癌、胃癌、胰腺癌、食管癌等)是全球发病率和 死亡率最高的癌症种类之一，2022年全球新发患者数量超过400万人，存在巨大的尚未被满足的临床需 求。 此前，LM-350已获得美国食品药品监督管理局(FDA)的IND批件，并于2025年9月在澳大利亚完成首例 患者入组。随着此次中国临床试验申请的获批，礼新医药将加速推进中国临床研究，致力于尽早为患者 提供全新的治疗选择。 LM-350是基于礼新医药新一代LM-ADC平台开发的一款靶向CDH17的ADC，能够高度选择性地结合 CDH17，具有很强的内化能力。LM-350采用IgG1野生型构型，同时具备抗体依赖细胞介导的细胞毒性 作用(ADCC)活性。临床前研究显示，LM-350在多个异种移植模 ...

Core Viewpoint - Yuan Dong Biotech (688513.SH) announced that its wholly-owned subsidiary, Shanghai Youluo, has initiated Phase I/II clinical trials for its self-developed antibody-drug conjugate, YLSH003, targeting advanced solid tumors, with the first patient successfully enrolled for treatment [1] Group 1: Product Development - YLSH003 is a novel antibody-drug conjugate designed to target Tissue Factor (TF), which plays a crucial role in the coagulation process and is highly expressed in advanced solid tumors [1] - The development of YLSH003 aims to address the recurrence and metastasis issues associated with high TF expression in late-stage solid tumors [1]

Core Viewpoint - Yuan Dong Biotech (688513.SH) announced that its wholly-owned subsidiary, You Luo Biotech (Shanghai) Co., Ltd., has initiated I/II clinical trials for its self-developed antibody-drug conjugate, YLSH003, targeting advanced solid tumors, with the first patient successfully enrolled for treatment [1] Group 1: Product Development - YLSH003 is a novel antibody-drug conjugate designed to target Tissue Factor (TF), which plays a crucial role in the coagulation process and is highly expressed in advanced solid tumors [1] - The development of YLSH003 aims to address the recurrence and metastasis issues associated with high TF expression in late-stage solid tumors [1] Group 2: Clinical Trials - The I/II phase clinical trials for YLSH003 are currently underway, marking a significant step in the company's research and development efforts in oncology [1] - The successful enrollment of the first patient indicates progress in the clinical trial process and potential future advancements in treatment options for patients with advanced solid tumors [1]

Financial Performance - In the first nine months of 2025, the company achieved revenue of CNY 3.624 billion, a year-on-year increase of 6.23% [1] - Net profit attributable to the parent company was CNY 1.033 billion, up 6.08% year-on-year [1] - Revenue breakdown: - Traditional Chinese medicine: CNY 1.138 billion, up 8.72% [1] - Chemical drugs: CNY 441 million, down 14.21% [1] - Biological drugs: CNY 2.040 billion, up 11.36% [1] R&D Progress - KH902-R10 (high-dose Conbercept for diabetic macular edema) is in Phase II clinical trials [2] - Gene therapy products KH631 and KH658 (for neovascular age-related macular degeneration) are in Phase II in China and Phase I in the U.S. [2] - KH617 (for advanced solid tumors) is in Phase II [2] - Antibody-drug conjugate KH815 (for various advanced solid tumors) is in Phase I in China and Australia [2] - Traditional Chinese medicine KH110 (for Alzheimer's disease) is in Phase III [2] - Small molecule innovation drug KH607 (for depression) is in Phase II [2] Market Insights - The global market for nAMD drugs is expected to become more competitive, with anti-VEGF drugs remaining mainstream [3] - The U.S. market holds a significant share, with China ranking second in terms of market size [3] - The company aims to leverage its product lineup to meet diverse clinical needs in the ophthalmology sector [3] Future Plans - The company will focus on chronic diseases, including cardiovascular, central nervous system, metabolic, and oncology areas for innovative R&D [4] - Plans to expand the pipeline in oncology with antibody conjugates and small molecule drugs [5] - The company anticipates a revenue and net profit growth of 5%-15% for 2025 compared to 2024 [4] Competitive Landscape - Conbercept is currently a leader in the domestic anti-VEGF market [4] - The company plans to enhance its product line with high-concentration Conbercept expected to be approved by 2028 [7] - The company is committed to optimizing drug delivery methods and addressing unmet clinical needs through innovative research [4]

Core Insights - The collaboration between Innovent Biologics and Takeda Pharmaceutical aims to develop cancer treatment drugs, with a total deal value of $11.4 billion, marking the highest record for a biopharmaceutical licensing deal from China [2][4] - The partnership focuses on two late-stage therapies and one early-stage project, leveraging Innovent's innovative immune-oncology and antibody-drug conjugate (ADC) therapies [2][5] Group 1: Deal Structure and Strategic Importance - The deal involves a co-development model where both companies will share development costs and commercial rights, with a 40/60 cost-sharing ratio for IBI363 [9] - Takeda's leadership sees this collaboration as a way to enhance its oncology pipeline, balancing developments in hematologic and solid tumors [4][22] - Takeda has made significant investments in China over the past three years, with disclosed transaction amounts exceeding 100 billion RMB [4][23] Group 2: Product Details and Clinical Status - IBI363 is a dual-antibody product that targets PD-1/PD-L1 pathways and activates IL-2 pathways, showing promise in treating lung and colorectal cancers [5][8] - IBI343, an ADC, has demonstrated significant efficacy against advanced gastric cancer and pancreatic ductal adenocarcinoma [5][8] - Both products have entered Phase III clinical trials, indicating advanced stages of development [8] Group 3: Takeda's Global Strategy and Market Focus - Takeda's CEO, Christophe Weber, emphasizes the importance of bringing Chinese innovations to the global market, aligning with the company's "Takuvi China" strategy to make China its second-largest market by 2030 [15][22] - The company has shifted focus to oncology, neuroscience, and gastrointestinal diseases, prioritizing innovative biotherapeutics and ADCs [14][22] - Takeda's global presence spans over 80 countries, with a strong emphasis on research and development, investing over $5 billion annually [27][28] Group 4: Leadership and Future Outlook - Christophe Weber, the first non-Japanese CEO of Takeda, has been pivotal in the company's global expansion and innovation strategy [29][30] - The upcoming leadership transition to Julie Kim is expected to continue the momentum in commercializing rare disease and oncology products [32][33] - The collaboration with Innovent is viewed as a significant asset for Takeda's future growth, particularly in the context of increasing competition and innovation in the biopharmaceutical sector [11][22]

Core Viewpoint - The article discusses a significant clinical study on bladder cancer treatment conducted by Chinese researchers, highlighting the promising results of combining two novel drugs, a PD-1 immune drug and an HER2-targeted antibody-drug conjugate, which may redefine first-line treatment standards for advanced bladder cancer [1][6][9]. Group 1: Bladder Cancer Overview - Bladder cancer is the most common type of urinary system tumor, with nearly 100,000 new cases reported annually in China, primarily affecting middle-aged and older men, largely due to smoking [1][2]. - Early detection of bladder cancer leads to high survival rates, but advanced stages are challenging due to drug resistance and recurrence [2]. Group 2: Treatment Landscape - Traditional chemotherapy has been the main treatment for bladder cancer for decades, but it has limited effectiveness, with a median survival of just over one year and significant side effects [3]. - New drug classes, including immune therapies and antibody-drug conjugates (ADCs), have emerged as hopeful alternatives, with several PD-1/PD-L1 immune drugs already approved for bladder cancer [4][5]. Group 3: Clinical Study Insights - The recent study involved 484 patients with HER2-positive advanced urothelial carcinoma, randomly assigned to receive either the new drug combination or traditional chemotherapy [9]. - Results showed that the new drug combination significantly outperformed chemotherapy across various metrics, indicating a potential shift in treatment standards [10][14]. Group 4: Drug Development and Approval - The combination of the PD-1 immune drug Toripalimab and the HER2-targeted ADC Disitamab Vedotin has shown promising results, with the potential for approval in first-line treatment for advanced bladder cancer [17][18]. - The success of this study reflects the rapid advancement of China's domestic drug development capabilities, with increasing recognition in top-tier clinical journals [19][20]. Group 5: Future Directions - The emergence of multiple treatment options for bladder cancer, including various drug combinations, suggests a move away from traditional chemotherapy as the sole first-line treatment [21]. - Future treatment decisions may rely on biomarker expressions, such as HER2 and PD-L1, to optimize patient outcomes [22]. - Ongoing research is expected to explore the durability of treatment responses and the potential for earlier intervention in the treatment process [24].

Core Viewpoint - The announcement of the latest research results for the CLDN18.2 antibody-drug conjugate ATG-022 at the ESMO 2025 conference has positively impacted the stock price of DQ Pharma-B, reflecting investor confidence in the drug's potential [1][2]. Group 1: Clinical Research Results - ATG-022 demonstrated good safety and significant anti-tumor activity in patients with varying levels of CLDN18.2 expression in gastric cancer (GC) and gastroesophageal junction cancer (GEJC) [1]. - Preliminary efficacy was also observed in other non-gastrointestinal tumors, with further data expected to be presented at upcoming academic conferences [1]. Group 2: Dosage and Safety Data - The safety data for the 2.4 mg/kg dosage group was favorable, while the 1.8 mg/kg dosage group showed even better safety and tolerability [2]. - This data supports the potential for ATG-022 to be combined with immune checkpoint inhibitors and chemotherapy in frontline treatment, which could significantly expand its clinical applications and commercialization potential [2]. Group 3: Ongoing Development - The I phase dose expansion study of ATG-022 is progressing smoothly in mainland China and Australia [2]. - The company is actively preparing for clinical research on combination therapies involving ATG-022 to further advance its clinical development [2].

Core Insights - The company, Shiyao Group, announced that its subsidiary, Shanghai Jinmant Biotech Co., Ltd., has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for JSKN003, a targeted HER2 bispecific antibody-drug conjugate, for the treatment of HER2-positive advanced colorectal cancer patients who have failed previous treatments with oxaliplatin, fluorouracil, and irinotecan [1][4] Industry Context - Colorectal cancer is one of the most common malignancies globally, with 1.9262 million new cases and 903,900 deaths reported in 2022, ranking third in incidence and second in mortality among all cancers [2] - In China, colorectal cancer has a high incidence rate, second only to lung cancer, with over 500,000 new cases annually, and the number is rising [2] - Current approved treatments for HER2-positive advanced colorectal cancer patients who have failed previous therapies include regorafenib, fruquintinib, and trifluridine/tipiracil, but these have limited efficacy, with median progression-free survival (mPFS) of only 2-3.7 months and median overall survival (mOS) of 7-10 months [2] Clinical Research Findings - Preliminary clinical research results for JSKN003 show significant efficacy and good safety in the target patient population, with an objective response rate (ORR) of 61.9% and a disease control rate (DCR) of 95.2% among patients who had at least one tumor efficacy assessment [3] - The median progression-free survival (mPFS) for colorectal cancer patients treated with JSKN003 was reported at 13.77 months, with a median duration of response (mDoR) of 12.06 months [3] - Safety data indicated that only 14.0% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs), and no TRAEs led to treatment discontinuation or death [3] Regulatory Developments - JSKN003 has received its second breakthrough therapy designation, previously granted for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [4] - The ongoing clinical studies for JSKN003 in China include multiple Phase II and III trials for various solid tumors, including breast cancer, ovarian cancer, and gastric cancer, which will expedite the product's development and review process [4]

Core Viewpoint - The announcement highlights the breakthrough therapy designation granted to JSKN003, a targeted HER2 bispecific antibody-drug conjugate, for treating HER2-positive metastatic colorectal cancer patients who have failed previous treatments [1][4]. Group 1: Company Developments - Shanghai Jinmant Biotech, a subsidiary of the company, collaborates with Jiangsu Hengrui Medicine Co., Ltd. to develop JSKN003 [1]. - JSKN003 has received its second breakthrough therapy designation, previously granted for treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [4]. - The ongoing clinical studies for JSKN003 include multiple Phase II and III trials for treating breast cancer, ovarian cancer, and gastric cancer in China [4]. Group 2: Industry Context - Colorectal cancer is one of the most common malignancies globally, with 1.9262 million new cases and 903,900 deaths reported in 2022, ranking third in incidence and second in mortality among all cancers [2]. - In China, colorectal cancer has a high incidence rate, with over 500,000 new cases annually, making it the second most common cancer after lung cancer [2]. - Current approved treatments for HER2-positive metastatic colorectal cancer in China show limited efficacy, with median progression-free survival (mPFS) of only 2-3.7 months and median overall survival (mOS) of 7-10 months [2]. Group 3: Clinical Research Findings - Preliminary clinical research results for JSKN003 indicate significant efficacy and safety in treating HER2-positive metastatic colorectal cancer, with an objective response rate (ORR) of 61.9% and disease control rate (DCR) of 95.2% among patients who had at least one tumor efficacy assessment [3]. - The median progression-free survival (mPFS) for colorectal cancer patients treated with JSKN003 was reported at 13.77 months, with a median duration of response (mDoR) of 12.06 months [3]. - Safety data from the Phase II recommended dose cohort showed that only 14.0% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs), with no treatment-related deaths reported [3].