Core Viewpoint - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology, has developed the innovative drug LM-302, which has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for treating CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in combination with PD-1 monoclonal antibody [1][2] Group 1: Drug Development and Clinical Trials - LM-302 is a first-in-class antibody-drug conjugate (ADC) targeting CLDN18.2, showing clinical efficacy in patients with gastric cancer, pancreatic cancer, and biliary tract cancer [1] - The latest research data presented at the 2025 ASCO annual meeting indicates an overall response rate (ORR) of 65.9% and a disease control rate (DCR) of 85.4% in 41 evaluable patients [1] - In patients with CLDN18.2 expression ≥25%, the ORR was 71.9% and the DCR was 96.9%, demonstrating good anti-tumor activity and controllable safety in CLDN18.2 positive patients [1] Group 2: Regulatory and Market Implications - LM-302 is currently undergoing Phase III clinical trials in China for treating CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma after progression on second-line or higher systemic therapy [2] - The inclusion in the Breakthrough Therapy Designation program is expected to accelerate the market entry of LM-302, providing innovative treatment options for more CLDN18.2 positive gastric cancer patients [2]

智通财经APP讯，中国生物制药(01177)公布，该集团自主研发的罗伐昔替尼片"TQ05105 (JAK/ROCK抑 制剂)"已被中国国家药品监督管理局药品审评中心 (CDE)纳入突破性治疗药物程序(BTD)，用于慢性移 植物抗宿主病(cGVHD)的治疗。 异基因造血干细胞移植(allo-HSCT)是治疗恶性血液系统疾病的一种有效方式，而慢性移植物抗宿主病 (cGVHD)是allo-HSCT的主要并发症之一，发生率可达30%-70%。罗伐昔替尼的Ib/IIa期临床结果已发表 于国际血液学领域顶级期刊《Blood》：该研究共纳入44例中度或重度糖皮质激素难治性或依赖性 cGVHD患者，未出现剂量限制性毒性，且未发生与罗伐昔替尼相关导致停药的不良事件。最佳总体缓 解率(BOR)为86.4%，12个月无失败生存率(FFS)为85.2%，88.6%的受试者降低了对糖皮质激素剂量的需 求，59.1%的受试者cGVHD相关症状得到改善。 罗伐昔替尼是全球研发进度最快的JAK/ROCK双重小分子抑制剂。该集团已于2024年7月向CDE递交罗 伐昔替尼的上市申请并获受理，用于治疗中高危骨髓纤维化(MF)。目前，罗伐昔替尼正在 ...