Core Viewpoint - The company Fuhong Hanlin (02696) has announced the completion of the first patient dosing in a Phase 2/3 clinical study of HLX22 combined with HLX87 for the first-line treatment of HER2-positive recurrent or metastatic breast cancer in mainland China [1][2] Group 1 - The clinical study is an open-label, randomized, multi-center Phase 2/3 trial evaluating the efficacy of HLX22 combined with HLX87 in patients with HER2-positive recurrent or metastatic breast cancer [2] - The study consists of two phases: the first phase is a Phase 2 trial with a 2:2:1:1 randomization ratio for treatment groups, including HLX22 combined with HLX87, and various combinations of other therapies [2] - The primary endpoint of the first phase is the objective response rate (ORR) and progression-free survival (PFS) assessed by an independent imaging review committee (BICR) [2] Group 2 - The second phase is a Phase 3 trial with a 1:1 randomization ratio comparing HLX22 combined with HLX87 to other treatment combinations [2] - The primary endpoint of the second phase is PFS evaluated by BICR [2] - The main objective of the study is to assess the clinical efficacy of HLX22 combined with HLX87, with secondary objectives including safety, tolerability, pharmacokinetics (PK), immunogenicity, and exploration of potential predictive or resistance biomarkers [2]

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has announced the completion of the first patient dosing in a Phase 2/3 clinical study of HLX22 in combination with HLX87 for the treatment of HER2-positive recurrent or metastatic breast cancer in mainland China [1][2]. Group 1: Clinical Study Overview - The study is an open-label, randomized, multi-center Phase 2/3 clinical trial evaluating the efficacy of HLX22 combined with HLX87 in treating HER2-positive recurrent or metastatic breast cancer patients [2]. - The first phase involves a randomized, parallel-controlled design with a 2:2:1:1 allocation ratio for participants receiving HLX22 combined with HLX87, or other combinations including pertuzumab and trastuzumab [2]. - The primary endpoints for the first phase include objective response rate (ORR) and progression-free survival (PFS) assessed by an independent imaging review committee (BICR) [2]. Group 2: Study Objectives and Design - The second phase of the study is also an open-label, randomized, multi-center trial, with participants allocated in a 1:1 ratio to receive either HLX22 combined with HLX87 or pertuzumab combined with trastuzumab and docetaxel [2]. - The main objective of the study is to evaluate the clinical efficacy of HLX22 combined with HLX87 in treating HER2-positive recurrent or metastatic breast cancer, while secondary objectives include assessing safety, tolerability, pharmacokinetics (PK), immunogenicity, and exploring potential predictive or resistance biomarkers [2].

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has announced the completion of the first patient dosing in a Phase 2/3 clinical study for HLX22, a humanized anti-HER2 monoclonal antibody injection, in combination with HLX87, a targeted HER2 antibody-drug conjugate, for the treatment of HER2-positive recurrent or metastatic breast cancer patients in mainland China [1] Group 1 - The clinical study is focused on HER2-positive recurrent or metastatic breast cancer patients [1] - HLX22 is a restructured humanized anti-HER2 monoclonal antibody injection [1] - HLX87 is a targeted HER2 antibody-drug conjugate [1]

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） （股份代號：2696） 自願公告 HLX22（重組人源化抗HER2單克隆抗體注射液）聯合注射用HLX87 （靶向HER2抗體偶聯藥物）一線治療HER2陽性復發或轉移性 乳腺癌(BC)患者的2/3期臨床研究於中國境內完成首例患者給藥 A. 緒言 B. 臨床試驗設計及目的 本研究是一項評估HLX22聯合HLX87一線治療HER2陽性復發或轉移性乳腺 癌患者的開放、隨機、多中心的2/3期臨床研究。研究包括兩個階段，第一階 段是一項開放、多中心、隨機、平行對照的2期臨床研究，合格受試者將按照 2:2:1:1的比例隨機分配接受HLX22聯合HLX87、帕妥珠單抗聯合HLX87、帕 妥珠單抗聯合德曲妥珠單抗或帕妥珠單抗聯合曲妥珠單抗及多西他賽治療。 第一階段的主要終點是獨立影像評 ...

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct clinical trials for HLX22 and HLX87 in China, targeting HER2-positive breast cancer [1] Group 1 - The approved clinical trials include a Phase II/III trial for HLX22 as a first-line treatment for HER2-positive breast cancer [1] - A second Phase II/III trial is approved for HLX22 in neoadjuvant therapy for HER2-positive breast cancer [1] - Fuhong Hanlin plans to initiate these clinical studies in China once conditions are met [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech Co., Ltd., has received approval from the National Medical Products Administration to conduct clinical trials for HLX22 and HLX87 in China, targeting HER2-positive breast cancer [1] Group 1 - The approved clinical trials include a Phase II/III trial for HLX22 as a first-line treatment for HER2-positive breast cancer [1] - A second Phase II/III trial is approved for HLX87 as neoadjuvant therapy for HER2-positive breast cancer [1] - Fuhong Hanlin plans to initiate these clinical studies in China once conditions are met [1]

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has received approval from the National Medical Products Administration for clinical trial applications of HLX22 and HLX87 for the treatment of HER2-positive breast cancer [1] Group 1 - HLX22, a humanized anti-HER2 monoclonal antibody injection, is approved for first-line treatment of HER2-positive breast cancer [1] - HLX87, a HER2-targeted antibody-drug conjugate, is approved for neoadjuvant treatment of HER2-positive breast cancer [1] - The company plans to conduct related clinical research in China once conditions are met [1]

自願公告 HLX22（重組人源化抗HER2單克隆抗體注射液）聯合 注射用HLX87（靶向HER2抗體偶聯藥物）分別用於 HER2陽性乳腺癌(BC)一線治療與HER2陽性乳腺癌新輔助治療 (BC neo)的2/3期臨床試驗申請獲國家藥品監督管理局批准 A. 緒言 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） （股份代號：2696） 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣布，近日，HLX22（重組人源化抗HER2單 克隆抗體注射液）（「HLX22」）聯合注射用HLX87（靶向HER2抗體偶聯藥物） （「HLX87」）(1)用於HER2陽性乳腺癌(BC)一線治療，以及(2)用於HER2陽性 乳腺癌新輔助治療(B ...

Summary of Weekly Review on Pharmaceutical Sector Industry Overview - The pharmaceutical sector in A-shares showed a positive performance with the index (CITIC) increasing by 2.21% while the CSI 300 index decreased by 1.08% and the ChiNext index fell by 1.40% [1][2] - In H-shares, the Hang Seng Index for healthcare increased by 3.43%, contrasting with a decline of 1.32% in the Hang Seng Index and a drop of 1.46% in the Hang Seng Technology Index [1][2] Market Performance - The CSI 300 pharmaceutical index rose by 0.61% and the CSI 500 pharmaceutical index increased by 1.83% [3] - The overall daily trading volume for the market remained between 9,900 million and 12,000 million, with the pharmaceutical sector's market trading share fluctuating between 7.3% and 10.1% [3] - The pharmaceutical sector outperformed both the CSI 300 index and the ChiNext index during the week [3] Key Announcements and News - **WuXi AppTec**: The NMPA has accepted the application for the new indication of its cell immunotherapy product, Beiduo® (Regorafenib Injection), for second-line treatment of relapsed or refractory adult B-cell lymphoma patients [4] - **Hengrui Medicine**: The company received approval from the National Medical Products Administration for the clinical trial of SHR-4712 injection, which targets tumor-associated antigens and activates immune cells in the tumor microenvironment [4] - **Junshi Biosciences**: The company's HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) has been granted orphan drug designation for gastric cancer treatment by the European Commission [4] - **Kejia Pharmaceutical**: The candidate product targeting Claudin18.2 protein, "Shu Rui Ji Ao Lun Sai Injection," has been included in priority review by the NMPA for treating Claudin18.2 positive patients with advanced gastric and gastroesophageal junction adenocarcinoma who have failed at least second-line treatment [4] - **Rongchang Biologics**: The company announced that its dual-target fusion protein, Tai Ta Xi Pu, has been approved for listing in China for the treatment of acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG), showing significant improvement in patient symptoms after 24 weeks of treatment [5]

Core Viewpoint - Fosun Pharma's subsidiary Henlius Europe GmbH has received orphan drug designation from the European Commission for HLX22, a humanized anti-HER2 monoclonal antibody injection for gastric cancer treatment [1] Group 1: Product Development - HLX22 is developed by the company under a license from AbClon, Inc. and is intended for the treatment of solid tumors such as gastric and breast cancer [1] - As of April 2025, the company has invested approximately 310 million yuan in the research and development of HLX22 [1] Group 2: Market Potential - According to IQVIA MIDAS data, the global sales of targeted HER2 monoclonal antibody products are projected to be approximately 9.029 billion USD in 2024 [1] - The orphan drug designation will facilitate HLX22's subsequent research, registration, and commercialization in the European Union by providing policy support [1]