注射用ZGGS18

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泽璟制药:注射用ZG005与注射用ZGGS18联用的临床试验申请获得FDA批准
Mei Ri Jing Ji Xin Wen· 2025-08-29 07:45
Core Viewpoint - ZaiJing Pharmaceutical (688266.SH) announced the approval of its clinical trial application for the combination of injectable ZG005 and ZGGS18 by the U.S. Food and Drug Administration for the treatment of advanced solid tumors [1] Group 1 - Injectable ZG005 is expected to be used for the treatment of various solid tumors and is one of the first drugs globally to enter clinical research for the same target [1] - Currently, there are no similar mechanism drugs approved for marketing worldwide [1] - Injectable ZGGS18 is anticipated to become an innovative biological product for the treatment of solid tumors [1] Group 2 - The approval of this clinical trial will not have a significant impact on the company's recent performance [1]
苏州泽璟生物制药股份有限公司关于自愿披露注射用ZG005、注射用ZGGS18与盐酸吉卡昔替尼片联用获得药物临床试验批准通知书的公告
Shang Hai Zheng Quan Bao· 2025-08-21 20:09
Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of injectable ZG005, ZGGS18, and JAK inhibitor Jika Xini tablets in combination for advanced solid tumors [2][3]. Group 1: Drug Information - Injectable ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody, classified as a Class 1 innovative tumor immunotherapy product, with potential applications for various solid tumors. It is one of the first drugs globally to enter clinical research targeting the same mechanism [3][4]. - Injectable ZGGS18 is a recombinant humanized bispecific antibody fusion protein targeting VEGF and TGF-β, also classified as a Class 1 therapeutic biological product, expected to be an innovative treatment for solid tumors [4][5]. - JAK inhibitor Jika Xini tablets, developed by the company, are a new Class 1 drug with independent intellectual property rights. They have received NDA approval for treating high-risk myelofibrosis and are undergoing clinical trials for other indications [5][6]. Group 2: Clinical Trial Approval Impact - The approval for the clinical trial of the combination therapy is not expected to have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development and approval processes [2][7]. - The company will actively promote the research projects in accordance with national regulations and fulfill information disclosure obligations regarding subsequent project developments [7][8].
突发!200亿信创概念股董事兼高级副总经理被立案调查|盘后公告集锦
Xin Lang Cai Jing· 2025-08-21 12:59
Company Announcements - Dameng Data's board member and senior vice president is under investigation by the Hubei Provincial Supervisory Committee, but the company's operations remain normal [1] - Jishi Media reported a net loss of 232 million yuan in the first half of 2025, despite a revenue increase of 8.7% to 999.7 million yuan [2] - Wantai Biological's nine-valent HPV vaccine has received its first batch release certificate, marking its market entry and potential revenue growth [2] - Feilu Co., Ltd. is undergoing a change in control, leading to a suspension of its stock trading starting August 22 [2] Financial Performance - Sany Heavy Industry reported a 46% increase in net profit to 5.216 billion yuan in the first half of 2025, with a revenue of 44.534 billion yuan, up 14.96% [3] - EVE Energy's net profit decreased by 24.9% to 1.605 billion yuan, despite a revenue increase of 30.06% to 28.169 billion yuan [5] - GoerTek achieved a net profit increase of 15.65% to 1.42 billion yuan, with a revenue of 37.55 billion yuan, down 7.02% [6] Approvals and Projects - Changchun High-tech's subsidiary received acceptance for a clinical trial application for GenSci143, a dual-specificity antibody drug targeting B7-H3 and PSMA [7] - Zejing Pharmaceutical received approval for clinical trials of ZG005 and ZGGS18 in combination with a specific cancer drug [7] Financing and Capital Increase - Zhenghe Industrial plans to raise no more than 818 million yuan through a private placement for various projects and working capital [8] Shareholding Changes - Zhongyin Securities announced that Jiangxi Copper plans to reduce its stake by up to 3%, equating to 83.34 million shares [9] - Mengke Pharmaceutical's shareholders plan to transfer 22.946 million shares, representing 3.5% of the total share capital [15] Investments and Strategic Partnerships - Diou Home plans to establish a wholly-owned subsidiary with an investment of 500 million yuan to expand into the generative AI field [11] - Gree Green signed a strategic cooperation agreement with Weilan Lithium to develop ultra-high energy density battery materials and solid-state battery innovations [12]
8月21日晚间公告 | 万泰生物九价疫苗首次获批签发证明;千方科技、赛诺医疗、金麒麟等中报净利润大增
Xuan Gu Bao· 2025-08-21 11:59
Suspension - Feilu Co., Ltd. is planning a change in company control, leading to the suspension of its stock [1] Capital Increase and Mergers - Yunnan Copper Industry has submitted an application to acquire 40% of Liangshan Mining, which has been accepted by the Shenzhen Stock Exchange [2] - Zhenghe Industrial plans to raise no more than 818 million yuan through a private placement for agricultural machinery component expansion, garden tool chain saw system project, micro chain system software and hardware integration R&D, and to supplement working capital [2] - iFlytek intends to raise no more than 4 billion yuan through a private placement for the Spark Education large model and typical products, and to supplement working capital; a shareholder, Yanzhi Technology, plans to subscribe for no less than 250 million yuan and no more than 350 million yuan [2] External Investment and Daily Operations - Wantai Biological Pharmacy's nine-valent human papillomavirus vaccine has received its first batch release certificate [3] - Hanyu Pharmaceutical's acetic acid atoziban injection has obtained marketing approval in Vietnam [4] - Zai Jian Pharmaceutical has received clinical trial approval for injectable ZG005, injectable ZGGS18, and the combination with hydrochloride gikaixin tablets [5] - Changchun High-tech's subsidiary has had its clinical trial application for injectable GenSci143 accepted [6] - Jinbo Co., Ltd. has received a notification from a leading OEM, selecting the company as a designated supplier for developing and supplying carbon-ceramic brake disc products [6] - Greeenmei has signed a strategic cooperation agreement with Weilan Lithium Core to create a high-energy battery materials and solid-state battery innovation consortium [7] - Anyuan Coal Industry plans to change its stock name to "Jiang Tung Equipment" [8] Performance Changes - Qianfang Technology reported a net profit of 170 million yuan in the first half of the year, a year-on-year increase of 1287.12% [9] - Sainuo Medical's net profit in the first half of the year increased by 296.54% year-on-year [10] - Jin Qilin reported a net profit of 108 million yuan in the first half of the year, a year-on-year increase of 226.14% [11] - Qianzhao Optoelectronics reported a net profit of 69.23 million yuan in the first half of the year, a year-on-year increase of 88.04% [12] - Miaokelando reported a net profit of 133 million yuan in the first half of the year, a year-on-year increase of 86.27% [12] - Hudian Co., Ltd. reported a net profit of 1.683 billion yuan in the first half of the year, a year-on-year increase of 48% [12] - GoerTek reported a net profit of 1.417 billion yuan in the first half of the year, a year-on-year increase of 15.65% [12] - Yunnan Ge Industry reported a net profit of 22.15 million yuan in the first half of the year, returning to profitability [12]
泽璟制药(688266.SH):注射用ZG005、注射用ZGGS18与盐酸吉卡昔替尼片联合用于晚期实体瘤的临床试验获得批准
智通财经网· 2025-08-21 11:07
Core Viewpoint - Zai Jian Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of its innovative cancer immunotherapy products, ZG005 and ZGGS18, in combination with JAK and ACVR1 dual inhibitor, JAK inhibitor [1] Group 1 - ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody classified as a Class 1 innovative tumor immunotherapy biological product, expected to treat various solid tumors [1] - ZG005 is one of the first drugs globally to enter clinical research targeting the same mechanism, with no similar mechanism drugs approved for market worldwide [1] - ZGGS18 is a recombinant humanized bispecific antibody fusion protein targeting VEGF/TGF-β, classified as a Class 1 therapeutic biological product, anticipated to be an innovative treatment for solid tumors [1] Group 2 - JAK inhibitor, also known as JAK and ACVR1 dual inhibitor, is a new Class 1 drug independently developed by the company, which holds the intellectual property rights for this product [1]
泽璟制药:注射用ZG005、注射用ZGGS18与盐酸吉卡昔替尼片联合用于晚期实体瘤的临床试验获得批准
Mei Ri Jing Ji Xin Wen· 2025-08-21 10:16
Core Viewpoint - Zai Jing Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of ZG005 and ZGGS18 in combination with Jikaxitinib for advanced solid tumors [2] Group 1: Company Developments - Zai Jing Pharmaceutical announced the approval of clinical trials for ZG005 and ZGGS18, indicating progress in its oncology pipeline [2] - The company's revenue composition for the year 2024 is projected to be 99.73% from pharmaceutical manufacturing and 0.27% from other businesses, highlighting its focus on the pharmaceutical sector [2]
泽璟制药:注射用ZG005、注射用ZGGS18与盐酸吉卡昔替尼片联用获得药物临床试验批准通知书
Mei Ri Jing Ji Xin Wen· 2025-08-21 09:09
Core Viewpoint - ZaiJing Pharmaceutical (688266.SH) has received approval from the National Medical Products Administration for clinical trials of its innovative cancer immunotherapy products, ZG005 and ZGGS18, in combination with a specific drug for advanced solid tumors [1] Company Summary - ZG005 is a recombinant humanized bispecific antibody targeting PD-1/TIGIT, classified as a Class 1 innovative biopharmaceutical, with potential applications in treating various solid tumors [1] - ZG005 is one of the first drugs globally to enter clinical research targeting the same mechanism, with no similar mechanism drugs approved for market worldwide [1]
泽璟制药(688266.SH):注射用ZG005、注射用ZGGS18与盐酸吉卡昔替尼片联用获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-08-21 09:06
Group 1 - The company Zai Lab (688266.SH) has received approval from the National Medical Products Administration for clinical trials of ZG005 and ZGGS18 in combination with JAK inhibitor for advanced solid tumors [1] - ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody, classified as a Class 1 innovative tumor immunotherapy product, and is among the first in the world to enter clinical research for this target [1] - ZGGS18 is a recombinant humanized bispecific antibody fusion protein targeting VEGF/TGF-β, also classified as a Class 1 therapeutic biological product, with potential as an innovative treatment for solid tumors [1] Group 2 - The JAK inhibitor, previously known as JAK inhibitor, is a novel dual inhibitor of JAK and ACVR1 developed by the company, classified as a Class 1 new drug, with the company holding independent intellectual property rights for this product [1]
泽璟制药:注射用ZG005、注射用ZGGS18与盐酸吉卡昔替尼片联合用于晚期实体瘤的临床试验获批
Xin Lang Cai Jing· 2025-08-21 09:06
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its innovative cancer immunotherapy products, ZG005 and ZGGS18, in combination with a specific drug for advanced solid tumors [1] Group 1: Product Information - ZG005 is a recombinant humanized anti-PD-1/TIGIT bispecific antibody classified as a Class 1 innovative tumor immunotherapy biological product [1] - ZG005 is among the first drugs globally to enter clinical research targeting the same mechanism, with no similar mechanism drugs approved for market worldwide [1] Group 2: Clinical Trial Approval - The clinical trial approval includes the use of ZG005 and ZGGS18 in conjunction with hydrochloride gicaxetine tablets for advanced solid tumors [1]