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。 智通财经获悉，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。 本文源自：智通财经网 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(IHC 1+、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。 ...

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]