Core Insights - The innovative PD-1 inhibitor H drug, Hanshuozhuang® (Slulizumab), 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 China [1][2] - 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][2] Company Developments - The breakthrough therapy designation is expected to accelerate the review and market entry of H drug, filling a gap in immune therapy for gastric cancer [2] - On February 5, 2025, the company announced that Hanshuozhuang® received approval from the European Commission for use in first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), making it 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 strategy [2] Market Performance - The market response has been positive, with the company's stock price increasing by 185.23% this year, reflecting investor confidence in its growth potential [2] - The trend of Chinese innovative pharmaceutical companies expanding internationally is evident, with ongoing reforms in drug approval processes and supportive policies driving the industry towards a new phase of innovation and output [2][3]
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