Core Insights - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech, has received inclusion in the Breakthrough Therapy designation for its independently developed drug, Surulitinib Injection, for use in combination chemotherapy for gastric cancer [1] Group 1: Drug Development and Approvals - Surulitinib Injection, marketed as Hanshuan® in China, is an innovative anti-PD-1 monoclonal antibody developed by the company [1] - The drug has been approved for marketing in multiple countries, including China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [1] - In China, the approved indications include first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] Group 2: Regulatory Designations and Clinical Trials - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [1] - Multiple combination therapy clinical trials involving Surulitinib are ongoing globally, targeting indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [1] - Inclusion in the Breakthrough Therapy program is expected to expedite the review and market launch process for the drug's related indications in China [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech, has received inclusion in the breakthrough therapy designation for its independently developed drug, Surulitinib injection, for the treatment of gastric cancer, which is a significant milestone as no PD-1 targeted monoclonal antibody has been approved for this indication globally [1] Group 1 - The drug Surulitinib (marketed as Hanshuang in China) is intended for use in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer [1] - The inclusion in the breakthrough therapy program is expected to expedite the review and market launch process for this indication in China [1] - As of the announcement date, there are no approved PD-1 targeted monoclonal antibodies for neoadjuvant/adjuvant treatment of gastric cancer worldwide [1]

（於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 | 產品/聯合療法 | 適應症 | 最新進展 | | --- | --- | --- | | 漢斯狀®+化療 | 廣泛期小細胞肺癌 | 於美國處於橋接試驗中 | | | | 於日本處於橋接試驗中 | | | 胃癌新輔助/輔助 | 於中國境內處於3期臨 | | | | 床試驗中，已達到主要 | | | | 研究終點 | | | 局限期小細胞肺癌（漢 | 於中國境內、美國、澳 | | | 斯狀®聯合化療同步放 | 大利亞及歐盟國家處於 | | | 療） | 3期臨床試驗中（國際 | | | | 多中心試驗） | | 漢斯狀®+貝伐珠單抗+化 | 轉移性結直腸癌 | 於中國境內、日本、印 | | 療 | | 度尼西亞處於2/3期臨 | | ...

Core Viewpoint - China Biopharmaceutical (01177) has announced that its self-developed national class 1 new drug TQ-B3234 capsule, a selective MEK1/2 inhibitor, has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of symptomatic, unresectable neurofibromatosis type I (NF1) related adult plexiform neurofibromas [1] Group 1 - TQ-B3234 is a selective MEK1/2 inhibitor that targets the upstream regulatory factor of the extracellular signal-regulated kinase (ERK) pathway, which can inhibit tumor growth by suppressing the activity of the RAS-regulated RAF/MEK/ERK pathway [1] - The phase III registration clinical study for TQ-B3234 in treating adult plexiform neurofibromas has been approved by the CDE, aiming to confirm its efficacy and safety in a larger patient population to fill the domestic treatment gap [1] - The inclusion of TQ-B3234 in the BTD program will accelerate the drug's market launch process, potentially benefiting more patients sooner [1]

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]