特瑞普利单抗注射液
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异动盘点1126 | 高雅光学涨超49%,阿里巴巴-W盘中跌近2%;柯尔百货暴涨42.53%,美股加密货币概念股普跌
贝塔投资智库· 2025-11-26 04:03
点击蓝字,关注我们 今日上午港股 1 . 维他奶国际(00345)微涨0.15% 。消息面上,维他奶国际昨日公布截至2025年9月30日止6个月中期 业绩,收入同比减少6%;毛利同比减少7%。收入减少6%主要由于中国内地业务受市况疲弱影响,表 现面临挑战。 6. 绿叶制药(02186)涨近2% 。消息面上,11月24日,绿叶制药发布公告,该集团自主研发的新一代5- 羟色胺2A型受体(5-HT2AR)反向激动剂和5-羟色胺2C型受体(5-HT2CR)拮抗剂LY03017已获得美国食 品药品监督管理局(FDA)许可开展临床试验。 7 . 恒瑞医药(01276)涨超5% 。消息面上,11月25日晚,恒瑞医药公告收到国家药品监督管理局核准签 发关于两项药物临床试验批准通知书。公告指出,HRS-8364片将于近期开展在晚期实体瘤中开展临 床试验。 8 . 美团-W(03690)早盘涨6% 。消息面上,阿里巴巴集团CFO徐宏在三季度财报会上透露,公司对淘 宝闪购的投入将在9月季度达到高点。 9 . 阿里巴巴-W(09988)盘中跌近2% 。消息面上,11月25日,阿里巴巴发布了截至2025年9月30日止季 度及六个月业绩 ...
异动盘点1125 | 航空股跌幅居前,小米集团-W涨超5%;美股存储概念股集体上涨,热门中概股多数上涨
贝塔投资智库· 2025-11-25 04:00
Group 1 - Fubo Group (03738) increased by over 9% after launching AI music detection services on November 21 [1] - Hard Egg Innovation (00400) rose nearly 8% as it reported a revenue of approximately RMB 3.332 billion for Q3 2025, a year-on-year increase of about 22.1% [1] - ZTO Express (02057) saw a rise of over 4% following a report indicating a Q3 revenue and adjusted net profit growth of 11% and 7% year-on-year, respectively [1] - Qiniu Intelligent (02567) increased by 5% due to its core advantage in integrated MPaaS technology, supporting one-stop audio and video solutions [1] Group 2 - HAPO Pharmaceuticals-B (02142) rose nearly 5% after announcing an expanded collaboration with AstraZeneca for new generation biotherapies [2] - Junshi Biosciences (01877) increased by over 5% after achieving primary research endpoints in a clinical study for its drug JS001sc [2] - Dazhong Public Utilities (01635) rose over 8% following the announcement of the successful IPO of Moer Thread, marking a record high issuance price in the A-share market [2] Group 3 - Airline stocks faced declines, with China Eastern Airlines (00670) dropping nearly 6% and China Southern Airlines (01055) down nearly 3% due to a significant increase in flight cancellations to Japan [3] Group 4 - Alibaba-W (09988) increased by over 3% after its app surpassed 10 million downloads within a week of public testing [4] - Xiaomi Group-W (01810) rose over 5% as its founder invested over HKD 100 million to increase his stake to 23.26%, reflecting confidence in the company's growth potential [4] Group 5 - U.S. storage stocks saw collective gains, with SanDisk (SNDK.US) up 13.33% and Western Digital (WDC.US) up 8.43%, following a bullish outlook from Bank of America [5] - Qudian (QD.US) rose 10.3% after reporting a Q3 diluted earnings per ADS of RMB 2.47, exceeding last year's figure [5] - WeRide (WRD.US) surged 14.72% with a 144% year-on-year revenue growth to RMB 171 million for Q3, attributed to fleet expansion [5] Group 6 - Lotus (LOT.US) fell 1.57% after reporting a narrower loss of USD 0.10 per share for Q3, with sales declining to USD 137 million [6] - Chinese concept stocks mostly rose, with HSAI (HSAI.US) up 18.08% and Alibaba (BABA.US) up 5.1%, driven by significant partnerships in the ADAS sector [6] Group 7 - Major tech stocks in the U.S. saw gains, with Google A (GOOGL.US) up 6.31% and Tesla (TSLA.US) up 6.82%, following advancements in AI technology [7]
君实生物(01877.HK):“JS001sc” 一线治疗非鳞状非小细胞肺癌的Ⅲ期临床研究达到主要研究终点
Ge Long Hui· 2025-11-24 11:57
JS001sc是公司在已上市产品特瑞普利单抗注射液的基础上开发的皮下注射制剂,为首款进入III期临床 研究阶段的国产抗PD-1单抗皮下制剂,有望给患者带来用药的便捷性。截至本公告披露日,一项对比 JS001sc和特瑞普利单抗注射液联合化疗一线治疗复发或转移性非鳞状非小细胞肺癌的多中心、开放、 随机对照III期临床研究(JS001sc-002-III-NSCLC研究)已达到主要研究终点。 格隆汇11月24日丨君实生物(01877.HK)公告,近日,上海君实生物医药科技股份有限公司(以下简称"公 司")产品特瑞普利单抗注射液(皮下注射)(代号:JS001sc)对比特瑞普利单抗注射液(商品名:拓益®,产 品代号:JS001)联合化疗一线治疗复发或转移性非鳞状非小细胞肺癌的多中心、开放、随机对照III期临 床研究(JS001sc-002-III-NSCLC研究,NCT06505837)达到主要研究终点。公司计划将于近期向监管部门 递交该产品的上市许可申请。由于药品的研发周期长、审批环节多,容易受到一些不确定性因素的影 响,敬请广大投资者谨慎决策,注意防范投资风险。 ...
中新健康丨创新药企业三季报亮眼 行业步入商业化收获期
Zhong Guo Xin Wen Wang· 2025-11-10 14:18
Group 1 - The core viewpoint of the article highlights that innovative pharmaceutical companies are transitioning from a "research and development investment phase" to a "commercialization harvest phase," driven by policy benefits, capital support, and clinical demand [1][4][5] Group 2 - Innovative pharmaceutical companies have reported impressive third-quarter results, with BeiGene achieving over 10 billion yuan in revenue, a year-on-year increase of 41.1%, and total revenue for the first three quarters reaching 27.595 billion yuan, up 44.2% [2] - Other leading innovative pharmaceutical companies also showed strong performance, with Hengrui Medicine reporting a revenue of 23.188 billion yuan for the first three quarters, a year-on-year growth of 14.85%, and WuXi AppTec achieving 32.857 billion yuan in revenue, up 18.61% [3] - The sales growth of core products, such as BeiGene's Zebrutinib and Junshi Biosciences' Toripalimab, is driving the performance of these companies, indicating a significant return on investment in research and development [5][6] Group 3 - The innovative drug sector is experiencing rapid growth, with a notable increase in business development (BD) transactions, totaling 92.03 billion USD in the first three quarters of 2025, reflecting a surge in licensing deals for domestic innovative drugs [6] - Analysts from Dongwu Securities express optimism about the innovative drug sector, predicting it will remain a key investment theme in the pharmaceutical industry through 2026, driven by the rising international status of Chinese innovative drug companies and a boom in BD transactions [7]
君实生物的前世今生:2025年三季度营收18.06亿元行业排第8,净利润亏损行业垫底
Xin Lang Cai Jing· 2025-10-31 13:15
Core Insights - Junshi Biosciences, founded in December 2012 and listed on the Shanghai Stock Exchange in July 2020, is a leading domestic innovative drug company focused on monoclonal antibody drug development with strong R&D capabilities and international presence [1] Group 1: Financial Performance - In Q3 2025, Junshi Biosciences achieved revenue of 1.806 billion yuan, ranking 8th among 34 companies in the industry, while the industry leader, Changchun High-tech, reported revenue of 9.807 billion yuan [2] - The company reported a net loss of 674 million yuan, ranking last in net profit among the industry peers, with the industry leader, Tonghua Dongbao, posting a net profit of 1.188 billion yuan [2] - The asset-liability ratio for Q3 2025 was 46.14%, higher than the industry average of 26.88%, while the gross profit margin was 80.65%, exceeding the industry average of 70.17% [3] Group 2: Management and Shareholder Information - Chairman Xiong Jun's salary for 2024 was 3.8333 million yuan, a decrease of 3.2876 million yuan from 2023, while CEO Zou Jianjun's salary increased to 8.9874 million yuan, up by 3.1257 million yuan [4] - As of September 30, 2025, the number of A-share shareholders increased by 15.17% to 35,900, with an average holding of 21,400 circulating A-shares, a decrease of 12.96% [5] Group 3: Product and Market Developments - The core product, Toripalimab injection, generated approximately 1.495 billion yuan in domestic sales in the first three quarters of 2025, reflecting a year-on-year growth of about 40% [5] - The company is advancing its internationalization process and has submitted applications for new indications, with ongoing clinical trials for key products [6]
君实生物(688180):产品销售维持高增,JS107开展美国2、3期临床
Huaan Securities· 2025-10-31 06:29
Investment Rating - Investment rating: Buy (maintained) [2] Core Views - The company reported a revenue of 1.806 billion yuan for the first three quarters of 2025, representing a year-on-year increase of 42.06%. The net profit attributable to the parent company was -596 million yuan, a reduction in losses by 35.72% year-on-year [6] - The overall gross margin for the first three quarters was 80.65%, an increase of 6.24 percentage points year-on-year, while the expense ratio decreased significantly [7] - The core product, Toripalimab injection, achieved sales revenue of approximately 1.495 billion yuan in the domestic market, a year-on-year growth of about 40% [8] - The company is advancing its research pipeline, with JS207 (a PD-1/VEGF bispecific antibody) receiving FDA approval for a Phase II/III clinical trial [9] - Revenue projections for 2025-2027 are 2.552 billion, 3.253 billion, and 3.836 billion yuan, with expected year-on-year growth rates of 31.0%, 27.5%, and 17.9% respectively [10] Financial Summary - For the first three quarters of 2025, the company reported a net cash flow from operating activities of -343 million yuan, a decrease of 69.16% year-on-year [7] - The company’s total market capitalization is 39.19 billion yuan, with a circulating market value of 29.25 billion yuan [2] - The projected net profit for 2025 is -730 million yuan, with a forecasted return on equity (ROE) of -14.2% [13]
上海君实生物医药科技股份有限公司 自愿披露关于全资子公司通过FDA现场检查的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-10-23 00:58
Group 1 - The company’s subsidiary, Suzhou Zhonghe Biopharmaceutical Technology Co., Ltd., successfully passed an unannounced FDA CGMP inspection from June 16 to June 24, 2025, indicating ongoing international recognition of its high-quality manufacturing system [1][2] - The inspection report confirms that Suzhou Zhonghe has met the necessary standards for the production of its product, Toripalimab injection, which is crucial for its overseas commercialization efforts [1][2] - The Suzhou Wujiang production base has a fermentation capacity of 4,500 liters and has obtained GMP certifications from multiple countries and regions, including the US, EU, and Australia, enhancing its ability to supply the overseas market [1] Group 2 - The successful FDA inspection is a significant step for the company’s strategy to expand in the US market, providing a solid foundation for future growth and positively impacting its operations [2]
上海君实生物医药科技股份有限公司自愿披露关于特瑞普利单抗一线治疗HER2表达的尿路上皮癌的新适应症上市申请获得受理的公告
Shang Hai Zheng Quan Bao· 2025-08-08 20:19
Core Viewpoint - Shanghai Junshi Biosciences has received acceptance for a new indication application for Toripalimab in treating HER2-expressing urothelial carcinoma, highlighting the company's ongoing innovation in cancer treatment [1][2]. Group 1: Drug Information - Toripalimab (brand name: Tuoyi) is a PD-1 monoclonal antibody that has been approved for multiple indications in China, including advanced urothelial carcinoma [4]. - The new indication application is based on the RC48-C016 study, a Phase III clinical trial comparing Toripalimab combined with the antibody-drug conjugate Vadimezumab against traditional chemotherapy in patients with HER2-expressing locally advanced or metastatic urothelial carcinoma [2][3]. - The study's primary endpoints, progression-free survival (PFS) and overall survival (OS), met the pre-defined efficacy boundaries, indicating significant benefits over traditional chemotherapy [3]. Group 2: Market Context - Urothelial carcinoma is one of the top ten most common malignant tumors globally, with increasing incidence and mortality rates in China, posing a significant unmet clinical need [2]. - The introduction of new therapies, including PD-(L)1 inhibitors and novel antibody-drug conjugates, is reshaping the treatment landscape for advanced urothelial carcinoma, offering more diverse and precise treatment options compared to traditional chemotherapy [2]. Group 3: Regulatory and Approval Status - The application for the new indication has been officially accepted by the National Medical Products Administration, with the registration numbers CXSS2500079 and CXSS2500080 [1]. - Toripalimab has been involved in over 40 clinical studies across more than 15 indications globally, demonstrating its extensive research and development efforts [4].
君实生物: 君实生物自愿披露关于特瑞普利单抗一线治疗HER2表达的尿路上皮癌的新适应症上市申请获得受理的公告
Zheng Quan Zhi Xing· 2025-08-08 16:11
Core Viewpoint - Shanghai Junshi Biosciences has received acceptance for a new indication application for Toripalimab in treating HER2-expressing locally advanced or metastatic urothelial carcinoma, marking a significant step in expanding treatment options for this cancer type [1][2][3] Group 1: Drug Information - The drug Toripalimab (brand name: Tuoyi) is a PD-1 monoclonal antibody and is the first domestically approved PD-1 targeted monoclonal antibody in China [4] - The application for the new indication is based on the RC48-C016 study, a Phase III clinical trial comparing the efficacy and safety of Toripalimab combined with Vadimezumab against Gemcitabine combined with Cisplatin/Carboplatin in patients with HER2-expressing locally advanced or metastatic urothelial carcinoma [3] - The study demonstrated that Toripalimab combined with Vadimezumab significantly prolonged progression-free survival (PFS) and overall survival (OS) compared to traditional chemotherapy [3] Group 2: Market Context - Urothelial carcinoma is one of the top ten most common malignant tumors globally, with a rising incidence and mortality rate in China, highlighting a significant unmet clinical need [2] - The emergence of PD-(L)1 monoclonal antibodies and novel antibody-drug conjugates over the past five years is reshaping the treatment landscape for advanced urothelial carcinoma, offering improved survival benefits and tolerability compared to traditional chemotherapy [2]
君实生物-U股价上涨4.78% 创新药国际化布局持续推进
Jin Rong Jie· 2025-08-05 11:48
Core Viewpoint - Junshi Biosciences-U's stock price has shown an upward trend, reflecting positive market sentiment towards its innovative drug development and commercialization efforts [1] Company Overview - Junshi Biosciences-U's latest stock price is 39.46 yuan, up by 1.80 yuan from the previous trading day, with a trading volume of 196,000 hands and a transaction amount of 755 million yuan [1] - The company specializes in the research and commercialization of innovative drugs, with its core product being the first domestically approved PD-1 monoclonal antibody, Toripalimab injection, which has received approval for 12 indications, 10 of which are included in the national medical insurance catalog [1] - The company has established a diverse research and development system covering monoclonal antibodies, bispecific antibodies, and ADCs, with R&D centers located in the US, Shanghai, and Suzhou [1] Financial Activities - Recently, the company raised over 1 billion Hong Kong dollars through a rights issue, with 70% of the funds allocated for innovative drug research and development, including PD-1/VEGF bispecific antibodies and EGFR/HER3 bispecific ADCs [1] - In the first quarter of 2025, the total number of license-out transactions for innovative drugs in China reached 41, with a total value of 36.929 billion US dollars [1] Market Position - Junshi Biosciences-U has established a global commercialization network covering over 80 countries and regions, utilizing various models such as licensing and joint ventures to advance its international strategy [1] - As of August 5, 2025, the net inflow of main funds into Junshi Biosciences-U was 45.8254 million yuan, accounting for 0.15% of its circulating market value, while the cumulative net outflow over the past five trading days was 126 million yuan, representing 0.42% of its circulating market value [1]