Junshi Biosciences(688180)
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君实生物再涨超5% 特瑞普利单抗皮下注射III期临床达主要终点 后续拟申报上市
Zhi Tong Cai Jing· 2025-11-26 03:14
消息面上,君实生物宣布,由公司自主研发的特瑞普利单抗注射液(皮下注射)(产品代号:JS001sc)对比 特瑞普利单抗注射液(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(NSCLC)的 多中心、开放、随机对照Ⅲ期临床研究达到主要研究终点。君实生物计划将于近期向监管部门递交该产 品的上市许可申请。 公开资料显示,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。 君实生物(01877)再涨超5%,截至发稿,涨4.43%,报25.48港元,成交额4614.77万港元。 ...
君实生物涨2.03%,成交额6630.93万元,主力资金净流入33.84万元
Xin Lang Cai Jing· 2025-11-26 01:49
Core Viewpoint - Junshi Biosciences has shown a significant stock price increase of 37.80% year-to-date, despite recent fluctuations in the short term [2] Group 1: Stock Performance - As of November 26, Junshi Biosciences' stock price rose by 2.03% to 37.66 CNY per share, with a market capitalization of 38.665 billion CNY [1] - The stock has experienced a 1.76% increase over the last five trading days, a 3.34% decrease over the last 20 days, and a 16.63% decrease over the last 60 days [2] Group 2: Financial Performance - For the period from January to September 2025, Junshi Biosciences reported a revenue of 1.806 billion CNY, representing a year-on-year growth of 42.06% [2] - The company recorded a net loss attributable to shareholders of 596 million CNY, which is a 35.72% increase compared to the previous year [2] Group 3: Shareholder Information - As of September 30, 2025, the number of shareholders for Junshi Biosciences increased by 15.17% to 35,900, while the average circulating shares per person decreased by 12.96% to 21,361 shares [2] - The top ten circulating shareholders include notable ETFs, with E Fund's ETF holding 19.3929 million shares, down by 2.8203 million shares from the previous period [3]
11月25日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-25 10:16
分组1 - Weili Medical plans to distribute a cash dividend of 2 yuan per 10 shares to all shareholders, based on an undistributed profit of 704 million yuan as of September 30, 2025 [1] - Tongding Interconnect's shareholder plans to reduce their stake by up to 0.49%, equating to a maximum of 605,800 shares [1] - Caitong Securities has received approval from the China Securities Regulatory Commission to issue short-term corporate bonds with a total face value of up to 5 billion yuan [1] 分组2 - Youfu Food intends to use 70 million yuan of its own funds to invest in wealth management products with expected annual returns of up to 4.2% [3] - Keres received an administrative regulatory decision from the Guangdong Securities Regulatory Bureau for violations related to accounts receivable aging calculations and related party transactions [5] - Ouma Software's controlling shareholder has completed the transfer of state-owned equity, changing the controlling shareholder to Shandong Guotou [7] 分组3 - ST Huapeng's wholly-owned subsidiary has completed a major overhaul project and is now in production [8] - Beiqi Blue Valley has received approval from the China Securities Regulatory Commission for a stock issuance to specific investors [8] - Weijie Chuangxin received a government subsidy of 5 million yuan, accounting for 21.07% of its projected net profit for 2024 [9] 分组4 - China Resources Double Crane's subsidiary has received a drug registration certificate for a hypertension treatment drug [11] - Huafeng shares are continuing to suspend trading due to a planned change in control [13] - Kaifa Electric's shareholder plans to transfer 36.6869 million shares, representing 11.63% of the total share capital [14] 分组5 - Heng Rui Medicine has received approval for two clinical trials for innovative anti-tumor drugs [15] - Kosen Technology plans to invest 30 million USD to establish a new production base in Malaysia [17] - Sanxing Medical's subsidiary is expected to win a procurement project from the State Grid worth approximately 107 million yuan [18] 分组6 - Sitai Li's subsidiary has received a drug registration certificate for a contrast agent used in MRI [21] - Daren Tang's subsidiary has received a drug registration certificate for a pain relief gel [22] - Saike Xide has received approval for three medical device products, expanding its product range in the in vitro diagnostic field [23] 分组7 - Hasa Lian has elected a new chairman and vice chairman for its board of directors [24] - Two-sided Needle's subsidiary plans to invest 68.8522 million yuan in a production base expansion project [25] - Sunshine Nuohe plans to transfer 70% of its controlling subsidiary's equity for 2 million yuan [26] 分组8 - Hengbang shares received an administrative regulatory decision from the Shandong Securities Regulatory Bureau for failing to complete the election of independent directors [27] - Huali shares plan to sign a related transaction contract worth approximately 59.2847 million yuan [28] - Shangwei shares plan to invest 520.4 million yuan to gain a controlling stake in Sichuan Zhongfu Taihua [30] 分组9 - Zejing Pharmaceutical's ZG006 has been included in the list of breakthrough therapeutic varieties for treating advanced neuroendocrine cancer [32] - Yaopi Glass's shareholder plans to reduce their stake by up to 2.26%, equating to a maximum of 21.1469 million shares [34] - Huate Gas has initiated a major lawsuit involving a claim of 180 million yuan [36] 分组10 - Zhongchumei's controlling shareholder plans to increase their stake by between 42 million and 80 million yuan [37] - Huitong shares' shareholder plans to reduce their stake by up to 1% [38] - Miaowei Exhibition plans to apply for an initial public offering of H shares on the Hong Kong Stock Exchange [40] 分组11 - Tianqi Lithium's subsidiary has appealed to the Chilean Supreme Court regarding a partnership agreement with SQM and Codelco [42] - Naxin Micro plans to repurchase shares worth between 200 million and 400 million yuan [44] - Pingao shares have reported significant uncertainty regarding future business development and profitability [46] 分组12 - Shunyu shares have been pre-selected for a project worth 1.023 billion yuan [48] - Zhongyuan Neipei plans to acquire a 2.5% share in an aerospace industry fund for 50 million yuan [50] - Huifa Food's shareholder plans to reduce their stake by up to 3%, equating to a maximum of 727.14 million shares [53] 分组13 - Junshi Biosciences' subcutaneous PD-1 new formulation has reached its primary endpoint in a Phase III clinical trial [54] - Industrial Fulian clarified that it has not lowered its fourth-quarter profit target amid market rumors [55] - Longpan Technology's subsidiary has signed a major supply agreement for lithium iron phosphate materials, significantly increasing the supply volume [56]
生物制品板块11月25日涨0.83%,金迪克领涨,主力资金净流入4087.68万元
Zheng Xing Xing Ye Ri Bao· 2025-11-25 09:10
Market Overview - The biopharmaceutical sector increased by 0.83% on November 25, with Jindike leading the gains [1] - The Shanghai Composite Index closed at 3870.02, up 0.87%, while the Shenzhen Component Index closed at 12777.31, up 1.53% [1] Top Gainers in Biopharmaceutical Sector - Jinke (688670) closed at 25.75, up 19.99% with a trading volume of 92,200 shares [1] - Hualan Biological (301207) closed at 23.33, up 11.25% with a trading volume of 250,500 shares [1] - Saiseng Pharmaceutical (300485) closed at 11.95, up 5.19% with a trading volume of 168,000 shares [1] - Other notable gainers include Bohui Innovation (300318) at 6.84 (+3.32%) and Dongbao Biological (300239) at 5.72 (+3.25%) [1] Market Capital Flow - The biopharmaceutical sector saw a net inflow of 40.88 million yuan from institutional investors, while retail investors experienced a net outflow of 147 million yuan [2] - The sector's overall capital flow indicates a strong interest from institutional investors despite retail selling pressure [2] Individual Stock Capital Flow - Jinke (688670) had a net inflow of 39.66 million yuan from institutional investors, while retail investors showed a net outflow of 13.72 million yuan [3] - Other stocks like Watson Bio (300142) and Hualan Bio (002007) also experienced significant net inflows from institutional investors, indicating positive sentiment [3] - Conversely, stocks like Dongbao Biological (300239) and Bohui Innovation (300318) faced net outflows from retail investors, suggesting mixed investor sentiment [3]
君实生物现涨近5% JS001sc肺癌III期临床达主要终点 公司近期将递交上市许可申请
Zhi Tong Cai Jing· 2025-11-25 02:52
君实生物(01877)现涨近5%,截至发稿,涨4.71%,报24.92港元,成交额3254.28万港元。 消息面上,君实生物宣布,由公司自主研发的特瑞普利单抗注射液(皮下注射)(产品代号:JS001sc)对比 特瑞普利单抗注射液(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(NSCLC)的 多中心、开放、随机对照Ⅲ期临床研究达到主要研究终点。君实生物计划将于近期向监管部门递交该产 品的上市许可申请。 公告显示,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。 ...
港股君实生物涨近5%

Mei Ri Jing Ji Xin Wen· 2025-11-25 02:41
每经AI快讯,君实生物(01877.HK)涨近5%,截至发稿,涨4.71%,报24.92港元,成交额3254.28万港 元。 ...
港股异动 | 君实生物(01877)现涨近5% JS001sc肺癌III期临床达主要终点 公司近期将递交上市许可申请
智通财经网· 2025-11-25 02:25
消息面上,君实生物宣布,由公司自主研发的特瑞普利单抗注射液(皮下注射)(产品代号:JS001sc)对比 特瑞普利单抗注射液(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(NSCLC)的 多中心、开放、随机对照Ⅲ期临床研究达到主要研究终点。君实生物计划将于近期向监管部门递交该产 品的上市许可申请。 智通财经APP获悉,君实生物(01877)现涨近5%,截至发稿,涨4.71%,报24.92港元,成交额3254.28万 港元。 公告显示,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。 ...
Junshi Biosciences Announces Primary Endpoints Met in JS001sc's Phase 3 Study for the 1ST-line Treatment of NSQ-NSCLC
Globenewswire· 2025-11-25 01:24
Core Insights - Junshi Biosciences announced that its JS001sc-002-III-NSCLC study has met its primary endpoints, indicating a successful Phase 3 clinical trial for its subcutaneous formulation of toripalimab in treating recurrent or metastatic non-squamous non-small-cell lung cancer [1][5] - The company plans to submit a new drug application (NDA) to regulatory authorities soon, aiming to enhance treatment accessibility and convenience for patients [1][6] Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of novel therapies [8] - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas, including cancer, autoimmune, metabolic, neurological, and infectious diseases [8] - It has received approvals for five products in China and international markets, including toripalimab, which is China's first domestically produced anti-PD-1 monoclonal antibody [9] Industry Context - In 2022, China reported 1.06 million new lung cancer cases, with non-small-cell lung cancer (NSCLC) being the predominant subtype, accounting for approximately 85% of cases [2] - Immunotherapy, particularly anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various cancers, including lung cancer, addressing a significant clinical need for more convenient administration methods [3][4]
Junshi Biosciences Announces Primary Endpoints Met in JS001sc’s Phase 3 Study for the 1ST-line Treatment of NSQ-NSCLC
Globenewswire· 2025-11-25 01:24
Core Insights - Junshi Biosciences announced that its JS001sc-002-III-NSCLC study has met its primary endpoints, indicating a successful Phase 3 clinical trial for its subcutaneous formulation of toripalimab in treating recurrent or metastatic non-squamous non-small-cell lung cancer (NSQ-NSCLC) [1][5] - The company plans to submit a new drug application (NDA) to regulatory authorities soon, aiming to enhance treatment accessibility and convenience for patients [1][6] Company Overview - Junshi Biosciences, founded in December 2012, is an innovation-driven biopharmaceutical company focused on discovering, developing, and commercializing novel therapies, with a diverse R&D pipeline of over 50 drug candidates [8][10] - The company has five therapeutic focus areas: cancer, autoimmune, metabolic, neurological, and infectious diseases, and has received approvals for five products in China and international markets [9][8] Clinical Study Details - The JS001sc-002-III-NSCLC study is a multi-center, open-label, randomized Phase 3 clinical trial led by Professor Lin WU from Hunan Cancer Hospital, marking the first Phase 3 study of a domestic anti-PD-1 monoclonal antibody subcutaneous formulation [4][7] - The study results showed that the drug exposure of JS001sc was non-inferior to that of the intravenous formulation, with comparable efficacy and safety profiles [5][6] Market Context - In 2022, China reported 1.06 million new lung cancer cases, with non-small-cell lung cancer (NSCLC) being the predominant subtype, accounting for approximately 85% of cases [2] - Immunotherapy, particularly anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various cancers, highlighting the urgent need for more convenient administration methods [3][6]
君实生物(688180.SH):关于 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 20:16
Core Viewpoint - Junshi Biosciences (688180.SH) announced that its product Toripalimab injection (subcutaneous) has achieved the primary endpoint in a Phase III clinical study for the treatment of recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy [1][2] Group 1: Clinical Research - The JS001sc-002-III-NSCLC study is a multicenter, open-label, randomized controlled Phase III clinical trial, marking the first Phase III clinical study for a domestic PD-1 subcutaneous formulation [2] - The study aims to compare the drug exposure, efficacy, and safety of JS001sc and Toripalimab injection in patients with recurrent or metastatic non-squamous NSCLC [2] - Results indicate that the drug exposure of JS001sc is non-inferior to that of Toripalimab injection, with similar efficacy and safety profiles for both treatments [2] Group 2: Market Context - According to GLOBOCAN 2022, there were 1.06 million new lung cancer cases in China in 2022, accounting for 22.0% of all new cancer cases, with lung cancer deaths reaching 730,000, representing 28.5% of cancer deaths [1] - Non-small cell lung cancer (NSCLC) constitutes approximately 85% of all lung cancer cases, with non-squamous NSCLC patients making up about 65% of NSCLC cases [1] - There is a pressing clinical need to enhance the convenience of immunotherapy, as current domestic immunotherapy drugs are primarily intravenous formulations, which are time-consuming and inconvenient for patients [2]