Core Insights - The innovative PD-1 inhibitor H drug (Hanshuo, known as Hetronifly in Europe) has been officially included in the breakthrough therapy list by the National Medical Products Administration (NMPA) for use in neoadjuvant/adjuvant treatment of gastric cancer, marking it as the first drug recognized for perioperative treatment of gastric cancer in this category [1] - The Phase III clinical study (ASTRUM-006) demonstrated significant efficacy, showing that H drug combined with chemotherapy can significantly extend event-free survival (EFS) and achieve a pathological complete response (pCR) rate over three times that of the control group, indicating a substantial reduction in recurrence risk [1] - The recognition of H drug as a breakthrough therapy highlights its potential and clinical value in gastric cancer treatment, which may accelerate its review and market entry, filling a gap in immunotherapy for this field [1] Company Developments - On February 5, 2025, the company announced that H drug received approval from the European Commission for use in first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in adults, making it the first and only PD-1 monoclonal antibody approved for this indication in the EU [2] - The company has established partnerships with global commercial partners such as Accord, KGbio, and Fosun Pharma, covering over 70 countries and regions, indicating a strong international market presence [2] - The company's stock has surged by 185.23% this year, reflecting positive market feedback and the potential of Chinese innovative pharmaceutical companies in the global market [2] Industry Trends - The trend of Chinese innovative pharmaceutical companies expanding internationally is becoming evident, with a shift from "importing and imitating" to "innovative output" in the industry [2] - The ongoing reforms in drug approval processes are providing significant benefits, supported by a rich clinical resource base and favorable policies, marking the transition of the Chinese innovative drug industry into its 2.0 era [2] - The breakthrough recognition of H drug in perioperative therapy for gastric cancer serves as a strong example of the capabilities of Chinese innovative pharmaceutical companies on the global stage [2]
重磅突破！复宏汉霖H药汉斯状 获CDE突破性疗法认定 成胃癌围手术期首个免疫创新药