Group 1 - Ruikang Pharmaceutical's executive Li Zhe has had his detention changed to a notice of investigation, indicating a shift in the investigation phase [1] - The change from detention to a notice of investigation suggests a reduced level of coercion, highlighting the importance of internal control and compliance systems in listed companies [1] Group 2 - Zhixiang Jintai has initiated a Phase III clinical trial for GR1802 injection for allergic rhinitis, following communication with the National Medical Products Administration [2] - GR1802 is slightly behind in clinical progress compared to two other approved drugs targeting the same indication, but successful commercialization could lead to competition with Dupilumab [2] Group 3 - Rongchang Biopharmaceutical's innovative drug RC18 (Taitaxip) for primary Sjögren's syndrome has met its primary endpoint in Phase III clinical trials, marking a potential first in the global market for this indication [3] - If approved, this drug could provide a breakthrough treatment for millions of patients in China and strengthen Rongchang's position in the autoimmune field [3] Group 4 - Hengrui Medicine's SHR-A2102, a targeted antibody-drug conjugate (ADC) for Nectin-4, has received approval for clinical trials in combination with Atezolizumab for recurrent/metastatic head and neck squamous cell carcinoma [4] - There is currently only one similar product on the market, Padcev, which is projected to generate $1.949 billion in sales in 2024, indicating significant market potential for this target [4] Group 5 - BeiGene has launched the first domestic Phase III clinical trial for subcutaneous Tislelizumab, a PD-1 inhibitor, for use in combination with chemotherapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma [5] - The subcutaneous formulation is becoming a competitive area for PD-1/PD-L1 inhibitors, with three other subcutaneous PD-1/L1 products already approved globally [5]

Core Viewpoint - The study presented at the 2025 ASCO annual meeting indicates that the combination of Adebali monoclonal antibody, Bevacizumab, and Cisplatin/Carboplatin may provide a new treatment option for patients with advanced triple-negative breast cancer (TNBC) with brain metastases [1][2]. Group 1: Study Overview - The study is a single-center, single-arm Phase II clinical trial involving 35 patients with recurrent metastatic TNBC and brain metastases who had not previously received Bevacizumab or PD-1/PD-L1 inhibitors [2]. - Patients received Adebali monoclonal antibody (20 mg/kg) combined with Bevacizumab (7.5 mg/kg) and either Cisplatin (75 mg/m²) or Carboplatin (AUC=5) until disease progression or intolerable side effects occurred [2]. Group 2: Efficacy and Safety Results - The primary endpoint was the central nervous system objective response rate (CNS-ORR) assessed by RANO-BM criteria, with secondary endpoints including CNS clinical benefit rate (CNS-CBR), progression-free survival (PFS), overall survival (OS), and safety [2]. - As of April 10, 2025, the confirmed CNS-ORR was 77.1% (27 out of 35 patients), and the CNS-CBR was 80% (28 out of 35 patients) [2]. - The median CNS-PFS was 11.5 months (range 6.2-NR), and the overall median PFS was 8.3 months (range 5.8-11.5) [2]. Group 3: Subgroup Analysis - Subgroup analysis revealed that in the PD-L1 negative population (CPS<1), the CNS-PFS was 11.5 months, while in the PD-L1 positive population (CPS≥1), the CNS-PFS had not yet been reached due to insufficient events [3]. - The study introduced the "Fudan classification" for TNBC, showing that in the immune regulatory type (IM type), the CNS-PFS had not been reached, while in the non-immune regulatory type (Non-IM type), the CNS-PFS was 10 months [3]. - Overall PFS demonstrated significant differences between the IM type (19 months) and Non-IM type (6.1 months) [3]. Group 4: Conclusion and Future Directions - The combination treatment of Adebali monoclonal antibody, Bevacizumab, and Cisplatin/Carboplatin is the first to show high intracranial anti-tumor activity and prolonged CNS-PFS and PFS in TNBC with brain metastases, with good safety profile [3]. - The study suggests that PD-L1 status and TNBC "Fudan classification" may predict the efficacy of this combination therapy, warranting further research to validate these findings [3].