TQ-B3234用于治疗成人PN的Ⅲ期註册临床研究已获CDE批准。该研究旨在更大规模的患者群体中确证 其疗效与安全性，以填补国内治疗空白。此次TQ-B3234纳入BTD，将加速药物上市进程，有望早日惠 及更多患者。 TQ-B3234是一款选择性MEK1/2抑制剂。MEK是细胞外信号相关激酶(ERK)通路的上游调节因子，MEK 抑制剂能够通过抑制RAS调节的RAF/MEK/ERK通路活性抑制肿瘤生长。 中国生物制药(01177)公布，该集团主导开发的国家1类新药TQ-B3234胶囊"选择性MEK1/2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)，用于伴有症状、不能手 术的神经纤维瘤病I型(NF1)相关的成人丛状神经纤维瘤的治疗。 ...

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]

Core Insights - China National Pharmaceutical Group's self-developed drug TQ05105 (Ruxolitinib) has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for the treatment of chronic graft-versus-host disease (cGVHD) [1][2] - Ruxolitinib is the fastest progressing JAK/ROCK dual small molecule inhibitor globally, with a marketing application submitted to CDE for myelofibrosis (MF) treatment [1] - The drug is currently undergoing Phase III clinical trials for cGVHD in China and has received approval for Phase II trials in the United States [1] Clinical Trial Results - Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment for malignant hematological diseases, with cGVHD being a major complication occurring in 30%-70% of cases [2] - Phase Ib/IIa clinical trial results published in the journal "Blood" included 44 patients with moderate to severe steroid-refractory or dependent cGVHD, showing no dose-limiting toxicities and no drug-related adverse events leading to discontinuation [2] - The best overall response rate (BOR) was 86.4%, with a 12-month failure-free survival rate (FFS) of 85.2%, and 88.6% of participants reduced their steroid dosage requirements, while 59.1% experienced improvement in cGVHD-related symptoms [2] - The company is accelerating the global clinical development of Ruxolitinib to provide better treatment options for patients worldwide [2]