12月12日，复宏汉霖（2696.HK）宣布公司自研创新型抗PD-1单抗H药汉斯状®（斯鲁利单抗，欧洲商 品名：Hetronifly®）联合含铂化疗新辅助治疗，在手术后辅助治疗，用于PD-L1阳性的、可手术切除的 胃癌患者的上市注册申请（NDA）获国家药品监督管理局（NMPA）受理，并被纳入优先审评审批程 序。此次被纳入优先审评意味着审评时限将大幅缩短至130个工作日，标志着H药胃癌围手术期治疗适 应症的上市进程全面提速，H药有望成为全球首个获批用于该领域的抗PD-1单抗。 ...

Core Viewpoint - The company Fuhong Hanlin (2696.HK) announced that its innovative PD-1 inhibitor, H drug (Han's Zhuang®), has been officially included in the National Medical Products Administration (NMPA) breakthrough therapy list for use in combination with chemotherapy for new adjuvant/adjuvant treatment of gastric cancer, marking it as the first drug recognized by the NMPA for perioperative treatment of gastric cancer [1] Group 1 - The H drug has achieved significant clinical milestones, including reaching the primary endpoint in its Phase III clinical study, which demonstrated a significant reduction in recurrence risk and an increase in cure opportunities for gastric cancer patients [1] - This therapy is the first in the world to replace postoperative adjuvant chemotherapy with a single-agent immunotherapy for perioperative treatment of gastric cancer, potentially offering dual benefits of survival improvement and enhanced quality of life for patients [1] - The inclusion in the breakthrough therapy program allows the company to apply for conditional approval and priority review during the drug listing application process, which could accelerate the review and market launch of the H drug [1] Group 2 - Currently, there are no approved immunotherapies for perioperative treatment of gastric cancer globally, highlighting the potential market opportunity for the H drug [1] - The recognition of the H drug as a breakthrough therapy underscores its clinical value and potential in the field of gastric cancer treatment, filling a significant gap in immunotherapy options [1] - Following the announcement, the company's stock rose by 4.89% to HKD 67.6, marking a 185% increase year-to-date and a rebound of over 3.4 times from its year-to-date low on January 23 [1]

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 company announced that its self-developed innovative PD-1 inhibitor, Hanshuo® (Slulizumab), achieved the primary endpoint of event-free survival (EFS) in a Phase III clinical study for gastric cancer, marking a significant breakthrough in the field [1] Group 1: Clinical Study Results - The interim analysis by the independent data monitoring committee showed that the study met the predefined efficacy standards [1] - Hanshuo® combined with chemotherapy significantly improved EFS compared to placebo combined with chemotherapy, with a pathological complete response (pCR) rate more than three times that of the control group [1] - The treatment regimen demonstrated good safety, with no new safety signals identified [1] Group 2: Company Strategy and Future Plans - The CEO of the company emphasized that gastrointestinal tumors are a core area of focus for the company, and the achievement in the Phase III study represents a key breakthrough [1] - The company plans to actively promote the translation of these results to benefit patients and will continue to accelerate the exploration and application of more innovative therapies [1]