Group 1 - China National Pharmaceutical Group announced that the selective HER2 tyrosine kinase inhibitor "Zongaitini" has received breakthrough therapy designation from the Center for Drug Evaluation (CDE) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) carrying HER2 tyrosine kinase domain (TKD) activating mutations [1] - The breakthrough therapy designation is based on data from the Beamion LUNG-1 clinical trial, which is a Phase Ia/Ib open-label trial assessing the safety, maximum tolerated dose (MTD), pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of Zongaitini in patients with HER2-mutant solid tumors [1] - The five-year survival rate for advanced non-small cell lung cancer patients is less than 30%, with approximately 2-4% of NSCLC driven by HER2 gene mutations, indicating a significant unmet medical need for targeted therapies in this patient population [1] Group 2 - Zongaitini is a covalent, orally administered selective HER2 small molecule inhibitor developed by Boehringer Ingelheim, which covalently binds to both wild-type and mutant HER2 receptors while preserving wild-type EGFR signaling, ensuring efficacy along with good tolerability and safety [2] - Zongaitini has previously received priority review and breakthrough therapy designation from CDE for the indication of previously treated patients with advanced HER2-mutant NSCLC, and it received accelerated approval from the U.S. Food and Drug Administration (FDA) in August [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） （股份代號：2696） A. 緒言 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」）欣然宣佈，近日，一項HLX22（重組人源化抗 HER2單克隆抗體注射液）（「HLX22」）聯合德曲妥珠單抗治療HER2低表達 HR陽性的局部晚期或轉移性乳腺癌的2期臨床研究於中國境內（不包括港澳 台地區，下同）完成首例患者給藥。 B. 臨床試驗設計及目的 本研究是一項多中心的2期臨床研究，旨在評估HLX22聯合德曲妥珠單抗治 療經標準治療後疾病進展或不可耐受毒性反應的，HER2低表達HR陽性的 局部晚期或轉移性乳腺癌患者的療效和安全性。符合條件的受試者將接受 HLX22（15mg/kg，靜脈注 ...