Core Insights - The innovative PD-1 inhibitor H药 (Hanshuan®) has been officially included in the National Medical Products Administration (NMPA) breakthrough therapy list for the neoadjuvant/adjuvant treatment of gastric cancer, marking it as the first drug recognized for this indication in perioperative treatment of gastric cancer [1] - The Phase III clinical trial (ASTRUM-006) demonstrated significant clinical efficacy, showing a more than threefold increase in the pathological complete response (pCR) rate compared to the control group, and a notable reduction in recurrence risk [1][2] - The recognition of H药 as a breakthrough therapy highlights its potential and clinical value in gastric cancer treatment, which may accelerate its review and market launch, filling a gap in immunotherapy for this field [1] Company Developments - On February 5, 2025, H药 received approval from the European Commission for use in first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), becoming the first and only PD-1 monoclonal antibody approved in the EU for this indication [2] - The company has established partnerships with global commercial partners, covering over 70 countries and regions, indicating a strong international market presence [2] - The stock price of the company 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" [2] - The ongoing reforms in drug approval processes are releasing dividends, supported by a rich clinical resource environment and favorable policies, indicating that the Chinese innovative drug industry has entered a 2.0 era [2] - The breakthrough recognition of H药 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(02696)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