智通财经APP讯，复宏汉霖(02696)发布公告，近日，注射用HLX43(靶向PD-L1抗体偶联药物)(HLX43) 获美国食品药品管理局(FDA)批准开展用于治疗胸腺癌(TC)的1期临床试验，可继续推进后续临床相关 工作。公司拟于条件具备后于澳大利亚、日本、美国等国家开展胸腺癌(TC)适应症相关临床试验。 ...

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） 本公司董事會（「董事會」）欣然宣佈，近日，注射用HLX43（靶向PD-L1抗體 偶聯藥物）（「HLX43」）獲美國食品藥品管理局(FDA)批准開展用於治療胸腺 癌(TC)的1期臨床試驗，可繼續推進後續臨床相關工作。本公司擬於條件具 備後於澳大利亞、日本、美國等國家開展胸腺癌(TC)適應症相關臨床試驗。 B. 關於HLX43 HLX43是由本公司利用許可引進的新型DNA拓撲異構酶I抑制劑小分子毒 素－肽鏈連接符與本公司自主研發的靶向PD-L1的抗體進行偶聯開發的靶向 PD-L1的抗體偶聯藥物(ADC)，擬用於晚期/轉移性實體瘤的治療。截至本公 告日，HLX43及相關聯合療法的最新進展情況如下： | 產品/聯合療法 | 適應症 | 最新進展 | | ...

Major Events - Cathay Pacific (00293) has purchased fourteen Boeing 777-9 aircraft [1] - Hengrui Medicine (01276) received FDA orphan drug designation for the combination of injection Rituximab and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma [1] - China National Pharmaceutical Group's self-developed drug TQ05105 (JAK/ROCK inhibitor) has been included in the breakthrough therapy designation program [1] - Junshi Biosciences (02696) completed the first patient dosing in a Phase II clinical study of HLX79 injection combined with Hanli Kang® for active glomerulonephritis in China [1] - YingTai Medical (01501) plans to invest no more than 110 million yuan to establish the Huai Ge Guang Tai Fund [1] - JinJing New Energy (01783) proposed a stock split [1] Financial Data - Cathay Pacific (00293) reported a mid-term profit attributable to shareholders of 3.651 billion HKD, a year-on-year increase of 1.1%, with an interim dividend of 0.20 HKD per share [1] - Uni-President Enterprises China (00220) reported a mid-term profit attributable to shareholders of 1.287 billion CNY, a year-on-year increase of 33.24% [1] - BeiGene (06160) reported a net profit of 94.32 million USD for the second quarter, returning to profitability year-on-year [1] - Sun Hung Kai Properties (00086) issued a profit warning, expecting mid-term profit attributable to shareholders to increase to no less than 800 million HKD year-on-year [1] - Weixin Jinke (02003) issued a profit warning, expecting mid-term comprehensive net profit to be no less than 200 million CNY, a significant year-on-year increase [1] - ZhiZi Cheng Technology (09911) issued a profit warning, expecting mid-term profit attributable to shareholders to increase by approximately 108.9% to 126.7% year-on-year [1] - China Star Optoelectronics (00334) issued a profit warning, expecting a year-on-year increase of no less than 600% in profit attributable to the parent company for the first half of the year [1] - Xinli International (00732) reported a total operating revenue of approximately 1.468 billion HKD in July, a year-on-year decrease of about 3.3% [1]

Major Events - Cathay Pacific (00293) has purchased fourteen Boeing 777-9 aircraft [1] - Hengrui Medicine (01276) received FDA orphan drug designation for the combination of injection Rituximab and chemotherapy for gastric cancer or gastroesophageal junction adenocarcinoma [1] - China National Pharmaceutical Group (01177) has its self-developed drug TQ05105 (JAK/ROCK inhibitor) included in the breakthrough therapy designation program [1] - Junshi Biosciences (02696) completed the first patient dosing in a Phase II clinical study of HLX79 injection combined with Hanli Kang® for active glomerulonephritis in China [1] - YingTai Medical (01501) plans to invest no more than 110 million yuan to establish the Huai Ge Guang Tai Fund [1] - JinJing New Energy (01783) proposed a stock split [1] Financial Data - Cathay Pacific (00293) reported a mid-term profit attributable to shareholders of 3.651 billion HKD, a year-on-year increase of 1.1%, with an interim dividend of 0.2 HKD per share [1] - Uni-President Enterprises China (00220) reported a mid-term profit attributable to shareholders of 1.287 billion CNY, a year-on-year increase of 33.24% [1] - BeiGene (06160) reported a net profit of 94.32 million USD in the second quarter, returning to profitability year-on-year [1] - New World Development Company (00086) issued a profit warning, expecting mid-term profit attributable to shareholders to increase to no less than 800 million HKD year-on-year [1] - Weixin Jinkao (02003) issued a profit warning, expecting mid-term comprehensive net profit to be no less than 200 million CNY, a significant year-on-year increase [1] - ZhiZi Cheng Technology (09911) issued a profit warning, expecting mid-term profit attributable to shareholders to increase by approximately 108.9% to 126.7% year-on-year [1] - Huaxian Optoelectronics (00334) issued a profit warning, expecting a year-on-year increase of no less than 600% in profit attributable to the parent company [1] - Xinli International (00732) reported a total operating revenue of approximately 1.468 billion HKD in July, a year-on-year decrease of about 3.3% [1]

Performance Highlights - BeiGene (06160.HK) reported a revenue of 17.518 billion yuan for the first half of the year, a year-on-year increase of 46%; product revenue was 17.36 billion yuan, up 45.8%; net profit was 450 million yuan, turning from loss to profit [2] - Uni-President China (00220.HK) achieved approximately 17.087 billion yuan in revenue for the first half, a year-on-year increase of 10.6%; net profit was about 1.287 billion yuan, up 33.2% [2] - Zhiyu City Technology (09911.HK) announced a positive profit forecast, expecting mid-term revenue of approximately 3.135 to 3.215 billion yuan, a year-on-year increase of about 38.0% to 41.5%; net profit is expected to be around 470 to 510 million yuan, a year-on-year growth of approximately 108.9% to 126.7% [2] Earnings Forecasts - New World Development Company (00086.HK) expects mid-term net profit to increase to no less than 800 million HKD year-on-year [3] - Weizhi Jinkou (02003.HK) anticipates mid-term net profit exceeding 200 million HKD, a significant increase year-on-year [3] - Wing Chan Industrial (01596.HK) forecasts mid-term net profit of approximately 48.7 million HKD, turning from loss to profit [3] - Huaxian Optoelectronics (00334.HK) expects mid-term net profit to exceed 48.8 million HKD, a year-on-year increase of over 600% [3] - Maifushi (02556.HK) predicts mid-term net profit of approximately 31.8 to 41 million HKD, turning from loss to profit [4] - Xinwei Medical-B (06609.HK) expects mid-term net profit to exceed 40 million HKD, turning from loss to profit [5] - China Nuclear Technology (00611.HK) anticipates mid-term net profit growth of over 15% [6] Earnings Warnings - Hongxing Printing Group (00450.HK) expects mid-term net loss of approximately 49 million HKD, a significant increase year-on-year [7] - Zhongyu Land (01224.HK) forecasts mid-term net loss of approximately 40 million HKD, turning from profit to loss [7] - Beihai Group (00701.HK) anticipates mid-term net loss of 36 to 40 million HKD [8] Real Estate Sales Data - China Overseas Development (00688.HK) reported cumulative contract property sales of approximately 132 billion yuan for the first seven months, a year-on-year decrease of 18.3% [9] - Yuexiu Property (00123.HK) achieved cumulative contract sales of approximately 67.506 billion yuan for the first seven months, a year-on-year increase of about 11.7% [9] - Poly Property Group (00119.HK) reported contract sales of approximately 29.5 billion yuan for the first seven months, a year-on-year decrease of 13.49% [10] - China Overseas Hongyang Group (00081.HK) reported cumulative contract sales of 18.649 billion yuan for the first seven months, a year-on-year decrease of 12.2% [10] - Jindi Commercial Real Estate (00535.HK) reported cumulative contract sales of approximately 6.98 billion yuan for the first seven months, a year-on-year decrease of 37.37% [10] - Agile Group (03383.HK) reported pre-sale amount of approximately 5.69 billion yuan for the first seven months [11] - Hongyang Real Estate (01996.HK) reported cumulative contract sales of 3.208 billion yuan for the first seven months, a year-on-year decrease of 41.6% [12] - Zhengrong Real Estate (06158.HK) reported cumulative contract sales of approximately 2.701 billion yuan for the first seven months, a year-on-year decrease of 30.6% [12] - Jingrui Holdings (01862.HK) reported cumulative contract sales of approximately 571 million yuan for the first seven months, a year-on-year decrease of 52.54% [13] Company News - CITIC Securities (06030.HK) reported that its subsidiary, Huaxia Fund, achieved revenue of 4.258 billion yuan and net profit of 1.123 billion yuan in the first half, with assets under management totaling 285.1237 billion yuan [14] - Xinyi International (00732.HK) reported a cumulative operating revenue of approximately 9.566 billion HKD for the first seven months, a year-on-year decrease of about 5.3% [15] - Heng Rui Pharmaceutical (01276.HK) received orphan drug designation from the US FDA for its injection of Rikan Trastuzumab combined with Adebali for gastric cancer or gastroesophageal junction adenocarcinoma indications [15] - Fuhong Hanlin (02696.HK) completed the first patient dosing in a Phase II clinical study of HLX79 injection combined with Hanlikang® for active renal glomerulonephritis in China [15] - China Biopharmaceutical (01177.HK) announced that its self-developed TQ05105 (JAK/ROCK inhibitor) has been included in the breakthrough therapy designation program for the treatment of chronic graft-versus-host disease [15] Buyback Activities - HSBC Holdings (00005.HK) repurchased approximately 1.65 billion HKD worth of about 1.714 million shares at a price of 95.8 to 96.75 HKD [16] - Hang Seng Bank (00011.HK) spent approximately 22.6347 million HKD to repurchase 200,000 shares at a price of 112.8 to 113.6 HKD [17] - Yum China (09987.HK) repurchased approximately 6.264 million HKD worth of 16,800 shares at a price of 369.8 to 376 HKD [17]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年7月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 上海復宏漢霖生物技術股份有限公司 呈交日期: 2025年8月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02696 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 163,428,541 | RMB | | 1 RMB | | 163,428,541 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 163,428,541 | RMB | | 1 RMB | | 163,428,541 | | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 (請 ...

Core Viewpoint - The company has initiated the first patient dosing in a Phase II clinical study of HLX79 injection combined with Hanlikang for the treatment of active glomerulonephritis in mainland China [1][2]. Group 1: Clinical Study Overview - The study is a double-blind, randomized, controlled, multi-center Phase II trial aimed at evaluating the efficacy, safety, and tolerability of HLX79 combined with Hanlikang compared to a placebo in patients with active glomerulonephritis, including lupus nephritis (LN) and membranous nephropathy (MN) [2]. - The study consists of two phases: the first phase is a dose-escalation period where eligible participants will receive HLX79 (10 mg/kg, 20 mg/kg, or 30 mg/kg) combined with either Hanlikang or a Hanlikang placebo (375 mg/m²) weekly [2]. - The second phase is a preliminary efficacy exploration period, where eligible participants will receive HLX79 (high dose/low dose) combined with Hanlikang (375 mg/m²), HLX79 placebo combined with Hanlikang, or HLX79 placebo combined with Hanlikang placebo weekly, with the primary objective of evaluating clinical efficacy [2]. Group 2: Market Context - As of the date of the announcement, there are no similar combination therapies approved for marketing globally [3].

Group 1 - The company Fuhong Hanlin (02696.HK) announced the completion of the first patient dosing in a Phase II clinical study of HLX79 injection combined with Hanlikang® (Rituximab injection) for the treatment of active glomerulonephritis in mainland China, excluding Hong Kong, Macau, and Taiwan [1]

Core Viewpoint - The company Fuhong Hanlin (02696) has announced the completion of the first patient dosing in a Phase II clinical trial for HLX79 injection combined with Hanlikang (Rituximab injection) for the treatment of active glomerulonephritis in China, excluding Hong Kong, Macau, and Taiwan [1] Group 1 - The study is a double-blind, randomized, controlled, multi-center Phase II clinical trial aimed at evaluating the efficacy, safety, and tolerability of HLX79 combined with Hanlikang compared to placebo in patients with active glomerulonephritis, specifically lupus nephritis (LN) and membranous nephropathy (MN) [2] - The trial consists of two phases: the first phase is a dose-escalation period where eligible participants will receive weekly doses of HLX79 (10 mg/kg, 20 mg/kg, or 30 mg/kg) combined with Hanlikang or Hanlikang placebo (375 mg/m²) [2] - The primary objective of the first phase is to assess the safety and tolerability of HLX79 combined with Hanlikang compared to placebo combined with Hanlikang in treating active glomerulonephritis [2] Group 2 - The second phase is an exploratory efficacy phase where eligible participants will receive weekly doses of HLX79 (high dose/low dose) combined with Hanlikang (375 mg/m²), HLX79 placebo combined with Hanlikang, or HLX79 placebo combined with Hanlikang placebo in a 2:2:1:1 ratio [2] - The primary objective of the second phase is to evaluate the clinical efficacy of HLX79 combined with Hanlikang, placebo combined with Hanlikang, and placebo treatment for active glomerulonephritis on top of standard treatment [2] - Secondary objectives include assessing other clinical efficacy, safety, tolerability, pharmacokinetic characteristics, and immunogenicity, while exploratory objectives aim to evaluate the dynamic changes of potential biomarkers [2] - As of the date of the announcement, there are no similar combination therapies approved for marketing globally [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） 自願公告 HLX79注射液（人唾液酸酶融合蛋白） 聯合漢利康® （利妥昔單抗注射液） 治療活動期腎小球腎炎的 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」）欣然宣布，近日，一項HLX79注射液（人唾液酸酶 融合蛋白）（「HLX79」）聯合漢利康® （利妥昔單抗注射液）（「漢利康®」）治療活 動期腎小球腎炎的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 本研究為一項雙盲、隨機對照、多中心的2期臨床試驗，旨在評估HLX79 聯合漢利康®對比安慰劑在活 ...