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]

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]

Core Insights - The company, Fuhong Hanlin (2696.HK), announced a significant breakthrough in gastric cancer treatment with its self-developed PD-1 inhibitor, H drug (sulfuril monoclonal antibody), achieving the primary endpoint of event-free survival in the phase III clinical study (ASTRUM-006) [1] Group 1 - The ASTRUM-006 study represents the first global instance of using an immune monotherapy to replace postoperative adjuvant chemotherapy in perioperative gastric cancer treatment [1] - The mid-term analysis of the clinical study was reported on October 9, indicating a successful outcome [1] - This development marks a major advancement in the field of gastric cancer therapy [1]