Core Viewpoint - The clinical update of PD-L1 ADC HLX43 presented at the World Conference on Lung Cancer demonstrates its superior efficacy in advanced non-small cell lung cancer (NSCLC) compared to standard treatments, indicating strong potential for broader application in various cancer types [1][2]. Investment Highlights - Expanded sample size continues to show excellent efficacy: The updated data from NSCLC patients in the Ia and Ib phase with doses of 2.0 mg/kg and 2.5 mg/kg show an overall response rate (ORR) of 28.6% and a disease control rate (DCR) of 82.1% in fourth-line and later squamous NSCLC patients (n=28), significantly outperforming docetaxel (ORR=12.8%) [1]. In third-line and later non-squamous NSCLC patients (n=26), the ORR reached 46.2% and DCR was 96.2% [1]. - Significant benefits across multiple subgroups highlight broad potential: In previously treated third-line and later NSCLC patients (n=10), the ORR was 30.0% and DCR was 80% [1]. In EGFR wild-type non-squamous NSCLC patients (n=15), confirmed objective response rate (cORR) was 46.7% and DCR was 93.3% [2]. Patients receiving 2.5 mg/kg HLX43 (n=5) had a cORR of 60.0% and DCR of 80% [2]. In advanced brain metastasis NSCLC patients (n=11), cORR was 36.4% and DCR was 100.0% [2]. In PD-L1 negative patients (TPS<1%, n=21), ORR and DCR were 38.1% and 85.7%, respectively, indicating efficacy independent of PD-L1 expression [2]. - Safety profile remains favorable, supporting expansion into first-line therapy and combination treatments: The most common grade ≥3 treatment-related adverse events (TRAEs) included anemia (19.6%), leukopenia (19.6%), neutropenia (16.1%), and lymphopenia (12.5%), with thrombocytopenia at only 3.6%. This aligns with previously reported safety data, indicating low hematological toxicity and supporting future expansion into first-line and combination therapy [2]. Investment Recommendation - The company's biosimilar business is driven by both domestic and overseas markets, providing robust cash flow for innovative R&D. The innovative pipeline, including HLX43, shows potential for competitive advantage and opportunities for global market expansion. The projected net profit for 2025-2027 is estimated at 840 million, 790 million, and 1.06 billion yuan, with year-on-year growth rates of 2%, -6%, and 34%, respectively, corresponding to P/E ratios of 44, 47, and 35 [2]. - Initiating coverage with a "Buy" rating [3].

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]

Core Insights - Fuhong Hanlin's self-developed PD-1 inhibitor, Hanshuai (Slulizumab), achieved the primary endpoint of event-free survival (EFS) in the Phase III clinical study (ASTRUM-006) for gastric cancer, marking a significant breakthrough in perioperative treatment options [1] - The study demonstrated that Hanshuai combined with chemotherapy significantly improved EFS and achieved a pathological complete response (pCR) rate over three times higher than the control group, with no new safety signals reported [1] Company Focus - Fuhong Hanlin is strategically focused on gastrointestinal tumors, including esophageal, gastric, and colorectal cancers, developing a diversified product portfolio that spans from immunotherapy to targeted drugs [2] - The company aims to leverage its multi-layered innovative therapy matrix and extensive global multi-center clinical trial data to maintain its leading position in the gastrointestinal tumor field [2]

Group 1 - The company announced that its self-developed innovative PD-1 inhibitor, Hanshuozhuang (Slulizumab), achieved the primary endpoint of event-free survival (EFS) in the interim analysis of the Phase III clinical study (ASTRUM-006) for gastric cancer, marking a significant breakthrough in the field [1] - The ASTRUM-006 study is a randomized, double-blind, multi-center Phase III clinical trial aimed at evaluating the clinical efficacy and safety of Hanshuozhuang combined with chemotherapy compared to placebo combined with chemotherapy in early gastric cancer patients [1] - The independent data monitoring committee reported that the study met the pre-set superiority criteria, with Hanshuozhuang combined with chemotherapy significantly improving EFS and achieving a pathological complete response (pCR) rate more than three times that of the control group, while showing good safety without new safety signals [1] Group 2 - The company focuses on gastrointestinal tumors, including esophageal, gastric, and colorectal cancers, and has developed a diversified product portfolio that includes immunotherapy and targeted drugs, covering different molecular types and disease stages [2] - The company aims to leverage its multi-layered innovative therapy matrix and extensive global multi-center clinical trial data to maintain its leading advantage in the gastrointestinal tumor field [2]

Group 1 - The core point of the news is that the clinical trial for the company's self-developed drug, Hanshuai (Sru Li Antibody Injection), has met the primary endpoint of event-free survival (EFS) in a mid-term analysis, supporting an early application for market approval [1] - The study is a randomized, double-blind, multi-center Phase 3 clinical trial comparing the efficacy and safety of Hanshuai combined with chemotherapy against placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) found that Hanshuai combined with chemotherapy showed a significant improvement in EFS compared to the control group, with a pathological complete response (pCR) rate more than three times that of the control group, and a significant reduction in recurrence risk, while safety was good with no new safety signals identified [1] Group 2 - Hanshuai is an innovative anti-PD-1 monoclonal antibody developed by the company, which has been approved for several indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [2] - The drug has also been approved in various countries/regions including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [2] Group 3 - The company is actively advancing multiple clinical trials for Hanshuai and related combination therapies globally, covering a wide range of indications including lung cancer, esophageal cancer, head and neck squamous cancer, colorectal cancer, and gastric cancer [3]

Core Insights - The company, Fuhong Hanlin (02696), announced that its self-developed Hanshuo® (sulunatuzumab injection) has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for the treatment of gastric cancer, supporting early market application [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshuo® combined with chemotherapy to placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) conducted a pre-specified interim analysis, showing significant improvement in EFS for the Hanshuo® group compared to the placebo group, achieving the predefined superiority criteria [1] Group 2: Efficacy and Safety - The pathological complete response (pCR) rate for the Hanshuo® group was over three times that of the control group, indicating a substantial reduction in the risk of recurrence for patients [1] - The safety profile of Hanshuo® was reported to be good, with no new safety signals identified during the trial [1]

Core Insights - The company, Junshi Biosciences (复宏汉霖), has announced that its self-developed drug, Hanshu (Sruilumab injection), has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for gastric cancer, allowing for early submission for market approval [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshu combined with chemotherapy against a placebo combined with chemotherapy for early gastric cancer patients [1] - The interim analysis conducted by the Independent Data Monitoring Committee (IDMC) showed significant improvement in EFS for the Hanshu group compared to the placebo group, meeting the predefined superiority criteria [1] Group 2: Efficacy and Safety - The pathological complete response (pCR) rate for the Hanshu group was over three times that of the control group, indicating a substantial reduction in the risk of recurrence for patients [1] - The safety profile of Hanshu was reported to be good, with no new safety signals identified during the trial [1]

Core Viewpoint - The company, Fuhong Hanlin (02696), has announced that its self-developed drug, Hanshu (Sru Li Antibody Injection), has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for the treatment of early gastric cancer, supporting an early application for market approval [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshu combined with chemotherapy against a placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) conducted a pre-specified interim analysis, which showed significant improvement in EFS for the Hanshu combination therapy compared to the placebo group [1] Group 2: Efficacy and Safety Results - The pathological complete response (pCR) rate for the Hanshu group was more than three times that of the control group, indicating a substantial efficacy advantage [1] - The risk of recurrence for patients receiving Hanshu was significantly reduced, and no new safety signals were identified, demonstrating good safety [1]

Core Insights - The company announced that its self-developed drug Hansizhuang® (sulizumab injection) has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for gastric cancer, allowing for early submission for market approval [1][2] Group 1: Clinical Trial Results - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hansizhuang® combined with chemotherapy to placebo combined with chemotherapy for early gastric cancer patients [1] - The interim analysis conducted by the Independent Data Monitoring Committee (IDMC) showed significant improvement in EFS for the Hansizhuang® group, achieving pre-set superiority standards [1] - The pathological complete response (pCR) rate for Hansizhuang® was over three times that of the control group, with a significant reduction in recurrence risk and no new safety signals reported [1] Group 2: Product Information and Approvals - Hansizhuang® is an innovative anti-PD-1 monoclonal antibody that has been approved for various indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [2] - The drug has also received approvals in several countries/regions, including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation in the US, EU, Switzerland, and South Korea [2] - The company is actively advancing multiple clinical trials for Hansizhuang® and related combination therapies across various indications, including lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） C. 關於漢斯狀® 漢斯狀®為本公司自主開發的創新型抗PD-1單抗，其於中國境內（不包括中國 港澳台地區，下同）已獲批上市的適應症包括聯合化療一線治療鱗狀非小細 胞肺癌(sq-NSCLC)，廣泛期小細胞肺癌(ES-SCLC)、食管鱗狀細胞癌(ESCC) 及非鱗狀非小細胞肺癌(nsq-NSCLC)。同時，漢斯狀®亦已分別於歐盟、英 國、印度尼西亞、柬埔寨、泰國、馬來西亞、新加坡、及印度等國家/地區獲 批上市，並分別獲美國、歐盟、瑞士及韓國等國家/地區的藥品監督管理部門 授予孤兒藥資格認定(Orphan-drug Designation)。 （股份代號：2696） 自願公告 漢斯狀® （斯魯利單抗注射液）聯合化療用於 胃癌新輔助/輔助治療的3期臨床研究達到主要研究終點 A ...