智通财经APP讯，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类创新药维特柯妥拜单抗(研发代号：LM-302)"CLDN18.2 ADC"正在开展用于治 疗三线及以上CLDN18.2阳性的局部晚期或转移性胃及胃食管交界部腺癌的III期注册临床试验(LM302- 03-101)，已顺利完成患者入组。其中，LM302是全球首款完成注册III期临床试验入组的CLDN18.2 ADC 药物。 LM-302是一款靶向CLDN18.2的抗体偶联药物(ADC)，通过与CLDN18.2阳性肿瘤细胞特异性结合，并 经内吞作用进入细胞后释放小分子毒素，从而实现对肿瘤细胞的精准杀伤。作为潜在同类首创 (FIC)药 物，LM-302在胃癌、胰腺癌及胆道癌等多个消化道肿瘤中展现出良好的临床开发潜力，并有望为 CLDN18.2低表达和PD-L1低表达患者提供新的治疗选择。 在2025年美国临床肿瘤学会(ASCO)年会上，礼新医药公布了LM-302联合特瑞普利单抗治疗胃癌的最新 研究数据：在41例疗效可评估的患者中，客观缓解率(ORR)为65.9%，疾病控制率(DCR)为 ...

Core Viewpoint - The company has presented additional follow-up data for IBI363 and IBI343 at the ASCO conference, showing promising results that enhance confidence in their development, leading to an upward revision of the target price to HKD 95 and a reaffirmation of the "buy" recommendation [1][5]. Group 1: IBI363 Data Insights - The mPFS for the IBI363 3mg/kg dose group in IO-treated sq-NSCLC has been extended to 9.3 months, an improvement from the previously reported 7.3 months, indicating strong efficacy [2][3]. - In the EGFR wild-type adenocarcinoma (EGFRwt Ad-NSCLC), the mPFS remains consistent at 4.2 months, outperforming docetaxel's mPFS of 2.5-4 months [2]. - The company plans to initiate a Phase III registration clinical trial for IBI363 in 3L+ sq-NSCLC, with the 3mg/kg dose expected to be used [2]. Group 2: IBI343 and Other Data - IBI363 combined with bevacizumab shows a 15.1% cORR and a 4.7-month mPFS, with a notable 31.3% cORR and 7.4-month mPFS in the population without liver metastasis [3]. - The overall mOS for IBI363 monotherapy is reported at 16.1 months, with subgroup analysis showing mOS of 14.4 months for liver metastasis patients and 17.0 months for those without, both significantly higher than the 9.3 months for fruquintinib in 3L CRC [3]. - In melanoma, the IBI363 1mg/kg Q2W dose group shows mPFS of 5.7 months and mOS of 14.8 months, significantly better than real-world data [4]. Group 3: Financial Projections - The company forecasts peak sales of approximately HKD 2.5 billion for IBI363 and HKD 1.5 billion for IBI343 in China, adjusted for risk [5]. - Projected net profits for the company are estimated at HKD 430 million, HKD 850 million, and HKD 1.89 billion for the years 2025, 2026, and 2027, respectively [5].