Core Viewpoint - 招银国际 has raised the target price for复宏汉霖 from HKD 20.33 to HKD 61.98, indicating strong potential for growth in the innovative drug development sector [1] Company Summary - 复宏汉霖 is transitioning from a profitable biosimilar company to a leading player in the biopharmaceutical field, with several innovative drugs such as HLX43, HLX22, and Serplulimab showing promising clinical data [1] - The company is actively expanding its global biosimilar business through partnerships with pharmaceutical companies, with strong commercialization performance from 汉曲优 (Trastuzumab) and Serplulimab [1] - The FDA is currently reviewing the market approval applications for HLX14 and HLX11, which are expected to contribute to overseas revenue sources [1]

Core Viewpoint - The company has initiated a bridging trial in Japan for its drug Hanshuo® (sulunatuzumab injection) in combination with chemotherapy for the treatment of extensive-stage small cell lung cancer (ES-SCLC) patients, aiming to support future market approval in Japan [1][2] Group 1 - The bridging trial is a single-arm, open-label, phase 2 study conducted in Japan, where eligible patients will receive Hanshuo® combined with chemotherapy (carboplatin - etoposide) every three weeks [2] - The primary objective of the study is to evaluate the efficacy of Hanshuo® in combination with chemotherapy in first-line treatment of ES-SCLC patients, while secondary objectives include assessing safety, pharmacokinetics, and immunogenicity [2] - The main endpoint of the study is the response rate at 24 weeks, which includes complete response (CR) or partial response (PR), with secondary endpoints including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), quality of life, safety, pharmacokinetics, and immunogenicity metrics [2]

Core Viewpoint - The company has completed the first patient dosing in a bridging trial in Japan for its self-developed drug Hanshu (Sruvelizumab injection) in combination with chemotherapy (carboplatin-etoposide) for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) [1] Group 1 - The trial aims to support the market application of Hanshu in Japan [1] - An international multicenter phase 3 clinical trial comparing Hanshu or placebo in combination with chemotherapy for first-line treatment of ES-SCLC reached its primary endpoint of overall survival (OS) in December 2021 [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 漢斯狀® （斯魯利單抗注射液）聯合化療一線治療廣泛期 小細胞肺癌(ES-SCLC)的日本橋接試驗完成首例患者給藥 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，一項在日本一線治療廣泛期小 細胞肺癌(ES-SCLC)患者中開展的漢斯狀® （斯魯利單抗注射液）（「漢斯狀®」） 聯合化療（卡鉑 － 依託泊苷）的橋接試驗已完成首例患者給藥。本次試驗系 本公司依據日本藥品醫療器械綜合機構(PMDA)的2期臨床試驗默示許可開 展的橋接試驗，用於支持未來漢斯狀®於日本的上市申報。此前，一項比較 漢斯狀®或安慰劑聯合化療（卡鉑 ...

Investment Rating - The report maintains a "Buy" rating for multiple companies in the pharmaceutical and biotech industry, indicating a positive outlook on their growth potential and market performance [6]. Core Insights - The ASCO conference showcased significant advancements in domestic innovative drugs, highlighting the competitive edge of Chinese pharmaceutical companies in the global market [4][12]. - The report emphasizes the clinical value and market potential of several key drugs presented at ASCO, including promising results from various companies [4][12]. Summary by Relevant Sections Domestic Key Research Overview - BaiLi Tianheng's BL-B01D1 demonstrated a 35.3% confirmed overall response rate (cORR) in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [18]. - DiZhe Pharmaceutical's DZD6008 achieved over 80% overall response rate (ORR) in heavily treated chronic lymphocytic leukemia (CLL) patients, indicating its potential as a new treatment option [4][12]. - FuHong HanLin's PD-L1 ADC showed excellent performance in immune-resistant squamous NSCLC patients, while HLX22 is expected to redefine first-line treatment for advanced gastric cancer [4][12]. - KeLun BoTai's sac-TMT data confirmed long-term survival benefits in third-line EGFR-mutant NSCLC and first-line triple-negative breast cancer (TNBC) [4][12]. - KangNing JieRui's HER2 bispecific ADC demonstrated comparable efficacy and better safety than existing treatments [4][12]. - MaiWei Biotech's 9MW2821 combined with toripalimab is anticipated to be a strong contender in first-line urothelial carcinoma treatment [4][12]. - SanSheng Pharmaceutical updated data on SSGJ-707 for first-line treatment of wild-type NSCLC, with a significant partnership with Pfizer [4][12]. - XinDa Biotech's IBI363 showed potential in activating "cold" tumors, aiming to become a cornerstone drug in immunotherapy [4][12]. - YaSheng Pharmaceutical's Lisaftoclax achieved positive results in patients resistant to venetoclax, filling a treatment gap in myeloid malignancies [4][12]. - ZhengDa TianQing's "DeFu combination" was selected for LBA, potentially offering a new first-line treatment for PD-L1 positive NSCLC [4][12]. - ZeJing Pharmaceutical and ZaiDing Pharmaceutical presented excellent data on ZG006 and ZL-1310 for late-line SCLC treatment, showcasing the global competitiveness of domestic drugs [4][12].

Core Viewpoint - The company has received acceptance for its H-share full circulation filing by the China Securities Regulatory Commission, which is expected to enhance liquidity, governance, and market competitiveness, driving business growth and shareholder value [1] Group 1: Company Developments - The company's stock price increased by 2.17% to HKD 49.40 on June 10, following the announcement of the H-share full circulation application [1] - The company has six products approved in China and four internationally, reaching over 50 countries and benefiting more than 800,000 patients globally [2] - The company has been included in the MSCI Global Small Cap Index, which is likely to attract more international capital [2] Group 2: Research and Clinical Trials - The company showcased its research results at the American Society of Clinical Oncology (ASCO) annual meeting, including the innovative anti-HER2 monoclonal antibody HLX22 and the anti-PD-1 monoclonal antibody H药 汉斯状® [1] - The company presented Phase I clinical trial data for HLX43 (PD-L1 ADC) for treating advanced/metastatic solid tumor patients, addressing issues of non-response or resistance to PD-1/L1 immunotherapy [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 注射用HLX43（靶向PD-L1抗體偶聯藥物）用於治療晚期非小細胞肺癌 (NSCLC)的國際多中心2期臨床研究於中國境內完成首例患者給藥 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，一項注射用HLX43（靶向PD-L1 抗體偶聯藥物）（「HLX43」）在晚期非小細胞肺癌(NSCLC)患者中開展的國際 多中心2期臨床研究於中國境內（不包括中國港澳台地區，下同）完成首例患 者給藥。 B. 臨床試驗設計及目的 HLX43是由本公司利用自蘇州宜聯生物醫藥有限公司許可引進的新型DNA拓 撲異構酶I抑制劑小分子毒素－肽鏈連 ...

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。 茲提述本公司日期為2025年3月24日的公告（「該公告」），內容有關董事會審議並 批准關於建議實施H股全流通的議案。除另有界定者外，本公告所用詞彙與該公 告所界定者具有相同涵義。 本公司董事會欣然宣佈，中國證監會已於近日受理本公司代表本公司若干股東向 中國證監會遞交的關於建議實施H股全流通的備案申請，待取得所有相關批准（包 括中國證監會備案及聯交所批准等）及符合所有適用法例、規則及條例後，本公 司若干非上市股份將轉換為本公司H股，並在聯交所主板上市及買賣。本公司將 適時遵照內幕消息條文及/或上市規則要求就H股全流通及轉換及上市的進度作出 進一步公告。 H股全流通和轉換及上市須待滿足中國證監會、聯交所及其他監管機構所的相關 程序規定後方可完成。本公司股東及潛在投資者於買賣本公司股份及其他證券時 務須審慎行事。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （ ...

本文源自：金融界 上海复宏汉霖生物技术股份有限公司(2696.HK)是一家国际化的创新生物制药公司,致力于为全球患者提 供可负担的高品质生物药,产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域,已在中国上市5款产品,在国 际上市2款产品,19项适应症获批,7个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年 成立以来,复宏汉霖已建成一体化生物制药平台,高效及创新的自主核心能力贯穿研发、生产及商业运营 全产业链。公司已建立完善高效的全球创新中心,按照国际药品生产质量管理规范(GMP)标准进行生产 和质量管控,不断夯实一体化综合生产平台,其中,上海徐汇基地和松江基地(一)均已获得中国和欧盟GMP 认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线,涵盖50多个分子,并全面推进基于自有抗 PD-1单抗H药汉斯状的肿瘤免疫联合疗法。继国内首个生物类似药汉利康(利妥昔单抗)、中国首个自主 研发的中欧双批单抗药物汉曲优(曲妥珠单抗,欧洲商品名:Zercepac)、汉达远(阿达木单抗)和汉贝泰(贝伐 珠单抗)相继获批上市,创新产品汉斯状(斯鲁利单抗)已获批用于治疗微卫星高度不稳定(MSI-H)实体瘤、 鳞状 ...

（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 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 HLX22（重組人源化抗HER2單克隆抗體注射液）用於胃癌(GC)治療 獲歐盟委員會(EC)孤兒藥資格認定 A. 緒言 HLX22為本公司許可引進並後續自主研發的新型靶向HER2的單克隆抗體， 潛在適應症包括胃癌和乳腺癌等實體瘤。HLX22用於治療胃癌(GC)已分別於 2025年3月及2025年5月獲美國食品藥品監督管理局(FDA)及歐盟委員會(EC) 授予孤兒藥資格認定(Orphan-drug Designation)。截至本公告日，HLX22相關 研發進展情況如下： 1 | 產品/聯合療法 | 適應症 | 最新進展 | | --- | --- | --- | | HLX22 | HER2 過表達的晚期 | 已於中國境內完成1期臨床 ...