君实生物(01877)涨超4%，截至发稿，涨4.33%，报25港元，成交额3483.03万港元。 消息面上，12月14日，君实生物发布公告，本公司收到美国食品药品监督管理局(FDA)的通知， EGFR/HER3双特异性抗体偶联药物(代号：JS212)用于治疗晚期实体瘤的临床试验申请获得FDA批准。 2025年1月，JS212的临床试验申请获得国家药品监督管理局(国家药监局)受理，并于2025年3月获得国 家药监局批准。截至本公告日期，JS212正在中国内地开展一项开放标签、剂量递增和剂量扩展的I/II期 临床试验，旨在晚期实体瘤患者中评估JS212的安全性、耐受性、药代动力学和初步疗效。此外，JS212 多队列联合用药的临床试验申请已于2025年11月获得国家药监局批准，计划于近期开展相关临床研究。 ...

君实生物(688180.SH)公告，公司收到美国食品药品监督管理局("FDA")的通知，EGFR/HER3双特异性 抗体偶联药物(代号：JS212)用于治疗晚期实体瘤的临床试验申请获得FDA批准。 ...

HLX87是靶向HER2的创新抗体偶联药物(ADC)，通过稳定可裂解的开环连接子将拓扑异构酶I抑制剂与 抗HER2单抗偶联而成，目前正处于3期临床研究阶段，拟用于HER2阳性乳腺癌治疗等。该药物采用高 透膜性拓扑异构酶抑制剂作为有效载荷，具有强效旁观者杀伤作用，同时结合独特、稳定的连接子设计 降低全身毒性，实现疗效与安全性的平衡。临床前研究显示，HLX87在多个肿瘤细胞系异种移植模型 中展现出与德曲妥珠单抗相当的抗肿瘤活性，且安全性优势明显。根据2024年美国癌症研究协会年会 (AACR2024)公布的HLX87治疗HER2表达或突变晚期实体瘤的1期临床数据，结果显示，HLX87在 2.0mg/kg~8.4mg/kg剂量范围内均表现出良好的耐受性和安全性，同时在乳腺癌、胃癌、肺癌等多种实 体肿瘤患者中表现出优异的治疗效果。目前，一项HLX87用于HER2阳性乳腺癌二线治疗的3期临床试 验正于中国境内开展。此前，本公司与外部合作伙伴就本公司引进HLX87达成战略合作，具体合作安 排及执行将以双方后续拟签订的正式许可协议中的交易安排为准。 HLX22为本公司许可引进并后续自主研发的新型靶向HER2的单克隆抗体，潜 ...

智通财经APP讯，复宏汉霖(02696)发布公告，近日，HLX22(重组人源化抗HER2单克隆抗体注射液) (HLX22)联合注射用HLX87(靶向HER2抗体偶联药物)(HLX87)用于HER2阳性乳腺癌(BC)一线治疗，以 及用于HER2阳性乳腺癌新辅助治疗(BC neo)的2/3期临床试验申请，分别获国家药品监督管理局批准。 本公司拟于条件具备后于中国境内开展相关临床研究。 HLX22为本公司许可引进并后续自主研发的新型靶向HER2的单克隆抗体，潜在适应症包括胃癌和乳腺 癌等实体瘤。HLX22用于治疗胃癌已分别于2025 年3月及2025年5月获美国食品药品监督管理局(FDA)及 欧盟委员会(EC)授予孤儿药资格认定(Orphan-drug Designation)。 HLX87是靶向HER2的创新抗体偶联药物(ADC)，通过稳定可裂解的开环连接子将拓扑异构酶I抑制剂与 抗HER2单抗偶联而成，目前正处于3期临床研究阶段，拟用于HER2阳性乳腺癌治疗等。该药物采用高 透膜性拓扑异构酶抑制剂作为有效载荷，具有强效旁观者杀伤作用，同时结合独特、稳定的连接子设计 降低全身毒性，实现疗效与安全性的平衡。临床前研 ...

Core Viewpoint - Minghui Pharmaceutical has submitted its IPO application, focusing on its pipeline of nearly 10 antibody-drug conjugates (ADCs) in early development stages, including targets like TROP-2, B7-H3, B7-H4, c-Met, and PSMA, as well as a PD-1/VEGF bispecific antibody [1][4]. Group 1: Company Overview - Minghui Pharmaceutical was established in 2018 and is currently developing a range of ADCs, with a notable focus on innovative drug development [1]. - The company has no marketed products yet and is facing significant competition in the ADC space, particularly from companies like Hansoh Pharmaceutical [5][9]. - The founder and chairman, Cao Guoqing, previously held a senior position at Heng Rui Pharmaceutical, which adds credibility to the company [8]. Group 2: Financial Performance - The company reported losses of 137 million yuan in 2023 and 283 million yuan in 2024, with no revenue expected in these years [5][7]. - In the first half of 2025, the company generated revenue of 264 million yuan but incurred a loss of 167 million yuan [7]. - The company’s cash and cash equivalents were reported at 1.3 billion yuan in 2023 and 290 million yuan in 2024, indicating a potential liquidity issue [7]. Group 3: Product Pipeline and Market Potential - The ADC market is experiencing significant growth, with products like Enhertu generating sales of 1.976 billion USD in the first three quarters of the year, reflecting a 37% year-on-year increase [1]. - Minghui's B7-H3 ADC (MHB088C) has been licensed to Qilu Pharmaceutical for development in Greater China, with an initial payment of 280 million yuan and potential milestone payments exceeding 1 billion yuan [4]. - The company is also developing a topical JAK inhibitor for atopic dermatitis, which is closest to commercialization, with its application already accepted [5]. Group 4: Industry Trends - The ADC sector is evolving, with innovations in antibody, payload, linker, and conjugation technologies expected to enhance clinical differentiation and market potential [8]. - Chinese companies are moving from a fast-follow approach to becoming global leaders in ADC development, with a focus on innovative targets and combination therapies [8].

Core Viewpoint - China Biopharmaceutical (01177) shares rose over 4%, currently up 2.87% at HKD 7.16, with a trading volume of HKD 174 million, following the publication of positive Phase II clinical trial results for TQB2102 in the treatment of HER2-positive breast cancer [1] Group 1 - TQB2102 is a targeted antibody-drug conjugate (ADC) developed by China Biopharmaceutical's subsidiary, Zhengda Tianqing, targeting two non-overlapping epitopes ECD2 and ECD4 of HER2 [1] - The Phase II clinical study, led by Professor Shao Zhimin's team from Fudan University Shanghai Cancer Center, is the first to demonstrate the efficacy and safety of dual-epitope HER2 ADC TQB2102 in the neoadjuvant treatment of breast cancer [1] - The results were published online in the prestigious Journal of Clinical Oncology, which has an impact factor of 43.4 [1] Group 2 - A Phase III registration clinical study for TQB2102 is currently underway [1]

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]