TQB2102是集团自主研发的新一代HER2双表位双特异性抗体偶联药物(ADC)，通过三项核心技术创 新，实现疗效与安全性的优化平衡：1. 双表位靶向设计：抗体端采用非对称型结构设计，同时结合 HER2的ECD II/IV结构域，可显著提升对肿瘤细胞的选择性及药物内吞效率，从而增强抗肿瘤活性。2. 可裂解连接子：采用酶裂解型连接子，能够高效裂解释放毒素，并具备"旁观者效应"，清除周边异质性 肿瘤细胞，扩大杀伤范围。3. 优化的药物抗体比(DAR)：DAR值稳定控制在5.8-6.0，搭配拓扑异构酶I (Topo I)抑制剂毒素，在提升疗效的同时降低毒副作用。以上核心技术的结合，突破了传统HER2单抗及 单靶点ADC的局限，使TQB2102在HER2低表达肿瘤治疗中展现出显著潜力。 格隆汇2月10日丨中国生物制药(01177.HK)发布公告，集团自主研发的国家1类创新药TQB2102"HER2双 抗ADC"正在开展一项"评价注射用TQB2102对比研究者选择的化疗在HER2低表达复发╱转移性乳腺癌 中有效性和安全性的随机、开放、平行对照的III期临床试验(TQB2102-III-01)"，近期已完成全部受试者 入 ...

智通财经APP讯，中国生物制药(01177)发布公告，集团自主研发的国家1类创新药TQB2102"HER2双抗 ADC"正在开展一项"评价注射用TQB2102对比研究者选择的化疗在HER2低表达复发╱转移性乳腺癌中 有效性和安全性的随机、开放、平行对照的III期临床试验(TQB2102-III-01)"，近期已完成全部受试者入 组。 TQB2102是集团自主研发的新一代HER2双表位双特异性抗体偶联药物(ADC)，通过三项核心技术创 新，实现疗效与安全性的优化平衡： 1.双表位靶向设计：抗体端采用非对称型结构设计，同时结合 HER2的ECD II/IV结构域，可显著提升对肿瘤细胞的选择性及药物内吞效率，从而增强抗肿瘤活性。 2. 可裂解连接子：采用酶裂解型连接子，能够高效裂解释放毒素，并具备"旁观者效应"，清除周边异质性 肿瘤细胞，扩大杀伤范围。 3.优化的药物抗体比(DAR)：DAR值稳定控制在5.8-6.0，搭配拓扑异构酶I (Topo I)抑制剂毒素，在提升疗效的同时降低毒副作用。 以上核心技术的结合，突破了传统HER2单抗及单靶点ADC的局限，使TQB2102在HER2低表达肿瘤治 疗中展现出显著潜力 ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has seen a stock increase of over 6%, currently trading at HKD 11.57, with a transaction volume of HKD 12.83 million. The rise is attributed to the FDA granting breakthrough therapy designation for JSKN003, aimed at treating specific types of advanced ovarian cancer in patients previously treated with bevacizumab [1]. Group 1 - Corning Jereh Pharmaceutical announced that its product JSKN003 has received breakthrough therapy designation from the FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer in adults who have previously been treated with bevacizumab [1]. - JSKN003 is a self-developed HER2 dual antibody ADC, with ongoing Phase III clinical trials in China for multiple indications. The efficacy and safety of JSKN003 have shown superior characteristics compared to Enhertu in the platinum-resistant ovarian cancer population [1]. - The company expects to complete data readout for JSKN003 by 2027 and plans to submit a New Drug Application (NDA) to the CDE for 2L HER2-positive breast cancer in 2026. Additionally, a Phase III clinical trial for HER2-positive metastatic colorectal cancer is set to start in October 2025, with projected sales for JSKN003 estimated at 0.05 billion, 0.57 billion, and 1.08 billion for the years 2027, 2028, and 2029 respectively [1].

消息面上，康宁杰瑞制药公布，JSKN003已获美国食品药品监督管理局(FDA)授予突破性疗法认定，用 于治疗既往接受过贝伐珠单抗治疗的晚期或转移性人表皮生长因子受体2有表达(IHC1+、2+和3+)铂耐 药复发性上皮性卵巢癌、原发性腹膜癌或输卵管癌成年患者。 康宁杰瑞制药-B(09966)午前涨超6%，截至发稿，涨6.05%，报11.57港元，成交额1283.17万港元。 国金证券发布研报称，JSKN003为公司自研HER2双抗ADC，该产品针对多适应症的III期临床试验在中 国有序推进：在铂类耐药卵巢癌全人群适应症中，其疗效与安全性已展现出优于Enhertu的特征，预计 2027年完成数据读出并报产；预计2026年向CDE提交2L HER2阳性乳腺癌的NDA；2025年10月启动中 国HER2阳性转移性结直肠癌适应症III期临床，该行预期JSKN003预期27/28/29年销售分成为 0.05/0.57/1.08亿元。 ...

Core Insights - China Biologic Products (01177.HK) announced preliminary data from the first human Phase I clinical study of TQB2102, a HER2 bispecific antibody-drug conjugate (ADC), presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] Efficacy Summary - The trial included 181 patients with advanced solid tumors who had no standard treatment options as of October 1, 2024, including both HER2-positive and HER2 low-expressing patients [1] - In terms of efficacy, the objective response rate (ORR) for HER2-positive breast cancer in the 6mg/kg and above dose group was 51.3%, while for HER2 low-expressing breast cancer, the ORR was 51.5% [1] - The ORR for HER2 high-expressing (HER2 IHC 3+) colorectal cancer was 34.8%, and for HER2-positive gastric or gastroesophageal junction adenocarcinoma, the ORR was 70% [1] - Among the subgroup of HER2-positive breast cancer patients with brain metastases, the ORR was 70%, with one case achieving complete resolution of intracranial lesions [1] - 31% of breast cancer patients who were resistant to T-DM1/DS-8201 still responded to TQB2102 treatment [1] Safety Summary - In terms of safety, the main ≥3 grade adverse events (AE) in the overall population included neutropenia (21.7%), decreased white blood cell count (10.6%), anemia (8.9%), and decreased platelet count (6.1%) [2] - Notably, only one case (0.55%) of grade 2 interstitial lung disease (ILD) was reported, which is significantly lower than the incidence seen with similar drug DS-8201 (greater than 10%) [2] - TQB2102 has shown significant clinical benefits across multiple advanced malignancies while maintaining a low incidence of ILD, achieving a balance between efficacy and safety [2] - Currently, TQB2102 is undergoing Phase III clinical trials and has the potential to reshape the treatment landscape for HER2 ADCs [2]