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中国生物制药(01177.HK):LM-24C5"CEACAM5/4-1BB双抗"II期临床试验申请获NMPA批准
Ge Long Hui· 2025-08-07 13:51
临床前研究表明,LM-24C5可诱导持久的抗肿瘤免疫记忆,并与其他免疫治疗药物具有协同效应,具有 成为同类首创(First-in-Class)免疫疗法的潜力。目前,LM-24C5正在美国开展I/II期临床试验。 格隆汇8月7日丨中国生物制药(01177.HK)公告,集团全资附属公司礼新医药科技(上海)有限公司("礼新 医药")自主研发的创新药LM-24C5"CEACAM5/4-1BB双抗"已获得中国国家药品监督管理局(NMPA)的临 床试验批准,同意其在CEACAM5阳性的晚期实体瘤患者中开展一项联合其他抗肿瘤药物的II期临床试 验。 CEACAM5(癌胚抗原相关细胞黏附分子5)在多种实体瘤中高表达,包括非小细胞肺癌、结直肠癌和胃癌 等,使其成为一个极具前景的肿瘤治疗靶点。LM-24C5是礼新医药基于条件激活型4-1BB平台开发的双 特异性抗体,通过特异性结合肿瘤细胞表面的CEACAM5和免疫细胞表面的4-1BB,将免疫细胞特异性 定向至肿瘤微环境,激活并增强其抗肿瘤活性。LM-24C5的独特结构可以CEACAM5依赖性方式选择性 激活4-1BB信号通路,避免非特异性外周免疫系统激活带来的毒性风险。 ...
中国生物制药(01177) - 自愿公告 - LM-24C5「CEACAM5/4-1BB 双抗」II...
2025-08-07 13:43
(於開曼群島註冊成立之有限公司) 網站:www.sinobiopharm.com (股份編號:1177) 自願公告 LM-24C5「CEACAM5/4-1BB 雙抗」II期臨床試驗申請獲NMPA批准 中國生物製藥有限公司(「本公司」,連同其附屬公司統稱「本集團」)董事會(「董事會」)宣佈, 本集團全資附屬公司禮新醫藥科技(上海)有限公司(「禮新醫藥」)自主研發的創新藥LM-24C5 「CEACAM5/4-1BB雙抗」已獲得中國國家藥品監督管理局(NMPA)的臨床試驗批准,同意其在 CEACAM5陽性的晚期實體瘤患者中開展一項聯合其他抗腫瘤藥物的II期臨床試驗。 CEACAM5(癌胚抗原相關細胞黏附分子5)在多種實體瘤中高表達,包括非小細胞肺癌、結直腸癌和 胃癌等,使其成為一個極具前景的腫瘤治療靶點[1]。LM-24C5是禮新醫藥基於條件激活型4-1BB平台 開發的雙特異性抗體,通過特異性結合腫瘤細胞表面的CEACAM5和免疫細胞表面的4-1BB,將免疫 細胞特異性定向至腫瘤微環境,激活並增強其抗腫瘤活性。LM-24C5的獨特結構可以CEACAM5依 賴性方式選擇性激活4-1BB信號通路,避免非特異性外周免疫系 ...
智通港股早知道 新一轮农村公路提升行动方案印发 到2027年新改建农村公路30万公里
Jin Rong Jie· 2025-08-06 23:57
Group 1 - The Ministry of Transport, Ministry of Finance, and Ministry of Natural Resources have issued a plan to complete the construction and renovation of 300,000 kilometers of rural roads by 2027, aiming to establish a convenient and efficient rural road network [1] - The plan includes implementing 300,000 kilometers of repair and maintenance projects, maintaining a good road condition rate of over 70%, and carrying out safety protection projects on 150,000 kilometers of roads [1] - The initiative aims to enhance rural transportation services and support the vision of a well-structured, high-quality rural transportation system by 2035 [1] Group 2 - U.S. stock markets saw an overall increase, with the Dow Jones rising by 81.38 points (0.19%) and the Nasdaq increasing by 252.87 points (1.21%) [2] - Notable stock movements included Apple rising by 5% due to anticipated investments in U.S. manufacturing, and McDonald's gaining over 3% following better-than-expected earnings [2] - Many popular Chinese concept stocks also saw gains, with Alibaba up over 3% and NIO increasing by over 2% [2] Group 3 - The State Grid reported a record high electricity load for three consecutive days, reaching a maximum load of 1.233 billion kilowatts, an increase of 53 million kilowatts compared to last year's peak [3] - The electricity load is expected to remain above 1.2 billion kilowatts, with a potential decrease anticipated due to upcoming rainfall and cooler temperatures [3] Group 4 - The Hong Kong Monetary Authority intervened in the currency market, buying HKD 8.439 billion after the Hong Kong dollar hit the weak end of its trading band [4] - This action is part of the linked exchange rate system, where the HKMA sells USD and buys HKD to stabilize the currency [4] Group 5 - The China Photovoltaic Industry Association is soliciting opinions on the draft amendment to the Price Law, focusing on price behavior norms and regulatory mechanisms [5] - This initiative aims to reflect the demands of the photovoltaic industry and gather feedback for potential modifications [5] Group 6 - Guangnan Group's subsidiary successfully acquired land use rights in Foshan for RMB 56.16 million, expanding its meat industry chain [6] Group 7 - Caocao Travel is exploring the tokenization of real-world assets and stablecoin payments through a strategic partnership with a licensed financial institution in Hong Kong [7][8] Group 8 - Lianzhong is integrating AI technology into traditional board games, collaborating with tech companies to enhance gaming experiences [9] Group 9 - China National Pharmaceutical Group's self-developed drug TQ05105 has been included in the breakthrough therapy designation program for chronic graft-versus-host disease treatment [10] Group 10 - China Nuclear Technology expects a mid-year profit increase of no less than 15% compared to the previous year [11] Group 11 - Hengrui Medicine's product received orphan drug designation from the FDA, which may provide regulatory advantages in the U.S. market [12] Group 12 - Huaxian Optoelectronics anticipates a significant profit increase of at least 600% for the first half of 2025 [13] Group 13 - New World Development expects a mid-year profit of no less than HKD 800 million, a substantial increase from the previous year's HKD 75.4 million [14] Group 14 - Xinwei Medical expects to achieve a net profit of at least RMB 40 million in the first half of 2025, marking a turnaround from losses [15] Group 15 - Zhiyu Technology anticipates a mid-year profit increase of approximately 108.9% to 126.7% [16] Group 16 - Ningmeng Media expects to achieve a net profit of approximately RMB 10 million to 12 million in the first half of 2025, reversing previous losses [17] Group 17 - Weixin Jinke anticipates a significant profit increase of no less than RMB 200 million for the first half of 2025, reflecting a growth of at least 65% [18] Group 18 - Uni-President China reported a 33.24% increase in shareholder profit to RMB 1.287 billion for the mid-year period [19] Group 19 - BeiGene reported a net profit of USD 94.32 million for the second quarter, marking a turnaround from a loss of USD 120 million in the previous year [20] Group 20 - Maifushi expects to achieve a net profit of approximately RMB 31.8 million to 41 million in the first half of 2025, reversing a significant loss from the previous year [21]
港股公告掘金|国泰航空上半年股东应占溢利36.51亿港元 百济神州上半年业绩扭亏为盈至9559万美元
Jin Rong Jie· 2025-08-06 16:52
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]
港股公告掘金 国泰航空上半年股东应占溢利36.51亿港元 百济神州上半年业绩扭亏为盈至9559万美元
Jin Rong Jie· 2025-08-06 16:03
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]
港股公告精选|百济神州上半年营收同比增超4成 中国海外发展前7月销售额超1300亿元
Xin Lang Cai Jing· 2025-08-06 12:09
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]
中国生物制药 自主研发的罗伐昔替尼片“TQ05105 (JAK/ROCK抑制剂)”被纳入突破性治疗药物程序
Zhi Tong Cai Jing· 2025-08-06 10:29
Core Viewpoint - China National Pharmaceutical Group's self-developed drug TQ05105 (Ruxolitinib) has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for the treatment of chronic graft-versus-host disease (cGVHD) [1][2] Group 1: Drug Development and Approval - Ruxolitinib is the fastest progressing JAK/ROCK dual small molecule inhibitor globally [1] - The company submitted a marketing application for Ruxolitinib to the CDE in July 2024, which has been accepted for the treatment of intermediate to high-risk myelofibrosis (MF) [1] - Currently, Ruxolitinib is undergoing a Phase III clinical trial for cGVHD in China and has been approved for a Phase II clinical trial in the United States [1] Group 2: Clinical Trial Results - The Phase Ib/IIa clinical results for Ruxolitinib were published in the top journal "Blood," involving 44 patients with moderate to severe steroid-refractory or dependent cGVHD [2] - No dose-limiting toxicities were observed, and there were no adverse events leading to discontinuation related to Ruxolitinib [2] - The best overall response rate (BOR) was 86.4%, with a 12-month failure-free survival rate (FFS) of 85.2% [2] - 88.6% of participants reduced their steroid dosage requirements, and 59.1% experienced improvement in cGVHD-related symptoms [2] - The company is accelerating the global clinical development of Ruxolitinib to provide better treatment options for patients worldwide [2]
中国生物制药(01177) 自主研发的罗伐昔替尼片“TQ05105 (JAK/ROCK抑制剂)”被纳入突破性治疗药物程序
智通财经网· 2025-08-06 10:29
Core Insights - China National Pharmaceutical Group's self-developed drug TQ05105 (Ruxolitinib) has been included in the Breakthrough Therapy Designation (BTD) program by the CDE for the treatment of chronic graft-versus-host disease (cGVHD) [1][2] - Ruxolitinib is the fastest progressing JAK/ROCK dual small molecule inhibitor globally, with a marketing application submitted to CDE for myelofibrosis (MF) treatment [1] - The drug is currently undergoing Phase III clinical trials for cGVHD in China and has received approval for Phase II trials in the United States [1] Clinical Trial Results - Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment for malignant hematological diseases, with cGVHD being a major complication occurring in 30%-70% of cases [2] - Phase Ib/IIa clinical trial results published in the journal "Blood" included 44 patients with moderate to severe steroid-refractory or dependent cGVHD, showing no dose-limiting toxicities and no drug-related adverse events leading to discontinuation [2] - The best overall response rate (BOR) was 86.4%, with a 12-month failure-free survival rate (FFS) of 85.2%, and 88.6% of participants reduced their steroid dosage requirements, while 59.1% experienced improvement in cGVHD-related symptoms [2] - The company is accelerating the global clinical development of Ruxolitinib to provide better treatment options for patients worldwide [2]
中国生物制药(01177.HK):罗伐昔替尼片“JAK/ROCK抑制剂”纳入突破性治疗药物程序
Ge Long Hui· 2025-08-06 10:27
Core Viewpoint - China Biologic Products (01177.HK) announced that its self-developed drug TQ05105 (a JAK/ROCK inhibitor) has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China for the treatment of chronic graft-versus-host disease (cGVHD) [1] Group 1 - TQ05105 is the fastest developing dual small molecule inhibitor of JAK/ROCK globally [1] - The company submitted a marketing application for TQ05105 to the CDE in July 2024, which has been accepted for the treatment of intermediate to high-risk myelofibrosis (MF) [1] - Currently, TQ05105 is undergoing a Phase III clinical trial for cGVHD in China, and has been approved to conduct a Phase II clinical trial in the United States [1] Group 2 - The Phase III clinical trial for TQ05105 in treating moderate to severe cGVHD is currently in the subject recruitment phase [1] - The company aims to accelerate the global clinical development of TQ05105 to provide better treatment options for patients worldwide as soon as possible [1]
中国生物制药(01177) - 自愿公告 - 罗伐昔替尼片「JAK/ROCK抑制剂」纳入突破性治疗药...
2025-08-06 10:20
(於開曼群島註冊成立之有限公司) 網站:www.sinobiopharm.com (股份編號:1177) 自願公告 羅伐昔替尼片「JAK/ROCK抑制劑」 納入突破性治療藥物程序 中國生物製藥有限公司(「本公司」,連同其附屬公司統稱「本集團」)董事會(「董事會」)宣佈,本集團自 主研發的羅伐昔替尼片「TQ05105 (JAK/ROCK抑制劑)」已被中國國家藥品監督管理局藥品審評中心 (CDE)納入突破性治療藥物程序(BTD),用於慢性移植物抗宿主病(cGVHD)的治療。 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,概不對因本公告全部或任何部份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。 異基因造血干細胞移植(allo-HSCT)是治療惡性血液系統疾病的一種有效方式,而慢性移植物抗宿主 病(cGVHD)是allo-HSCT的主要併發症之一,發生率可達30%-70%[1]。羅伐昔替尼的Ib/IIa期臨床結果 已發表於國際血液學領域頂級期刊《Blood》:該研究共納入44例中度或重度糖皮質激素難治性或依賴 性cGVHD患者, ...