注射用GenSci136
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长春高新技术产业(集团)股份有限公司关于子公司注射用GenSci136境内生产药品注册临床试验申请获得批准的公告
Shang Hai Zheng Quan Bao· 2026-02-09 19:00
Core Viewpoint - The company, Changchun High-tech Industry (Group) Co., Ltd., announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial application of the injectable GenSci136 drug, which is intended for the treatment of Immunoglobulin A Nephropathy (IgAN) [1][2]. Group 1: Drug Information - The product name is injectable GenSci136, and it is a Class 1 biological product developed by Jinsai Pharmaceutical for the treatment of IgAN [1]. - The clinical trial application was approved under acceptance number CXSL2600033, allowing the drug to proceed with clinical trials [1]. Group 2: Disease Context - IgAN is the most common primary glomerulonephritis globally and accounts for 39.73% of primary glomerulonephritis cases in China, primarily affecting individuals aged 30 to 40 [2]. - The disease progresses slowly but has a poor prognosis, with 20%-50% of patients eventually progressing to renal failure, posing a significant burden on families and the healthcare system [2]. - There is a substantial unmet clinical need for effective treatments for IgAN, as existing therapies have limitations in efficacy and safety [2]. Group 3: Drug Mechanism and Potential - Injectable GenSci136 is designed as a B-cell maturation antigen (BCMA) trimeric fusion protein, which enhances the blocking activity against endogenous ligands, potentially impacting the survival and differentiation of B lymphocytes and plasma cells [3]. - The drug aims to provide a new, safe, and effective first-line targeted treatment option for IgAN patients, with the potential for long-term application without the need for preventive anti-infection treatment [3].
长春高新(000661.SZ):金赛药业注射用GenSci136境内生产药品注册临床试验申请获得批准
智通财经网· 2026-02-09 14:08
Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of its self-developed drug, GenSci136, aimed at treating Immunoglobulin A Nephropathy (IgAN) [1] Group 1 - GenSci136 is a class 1 therapeutic biological product designed to treat IgAN, showcasing the company's commitment to innovative drug development [1] - The drug is a B-cell maturation antigen (BCMA) trimeric fusion protein, which utilizes novel molecular design to enhance the blocking activity against endogenous ligands, potentially impacting the survival and differentiation of B lymphocytes and plasma cells [1] - GenSci136 is expected to provide a new, safe, and effective first-line targeted treatment option for IgAN patients, significantly improving their long-term prognosis [1] Group 2 - The design of GenSci136 includes an anti-human serum albumin heavy chain single-domain antibody to extend its half-life in the body, suggesting a potential for efficient and sustained therapeutic effects [1] - The drug aims to address various autoimmune diseases caused by pathogenic antibodies, indicating its broader therapeutic potential beyond IgAN [1] - The approval of the clinical trial marks a significant milestone for the company, reflecting its ongoing efforts in advancing biopharmaceutical innovations [1]
长春高新:金赛药业注射用GenSci136境内生产药品注册临床试验申请获得批准
Zhi Tong Cai Jing· 2026-02-09 14:04
Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of its self-developed drug, GenSci136, aimed at treating Immunoglobulin A Nephropathy (IgAN) [1] Group 1 - GenSci136 is a class 1 therapeutic biological product designed to treat IgAN, showcasing innovative molecular design that mimics the natural extracellular domain of B-cell maturation antigen (BCMA) [1] - The drug enhances the blocking activity against various endogenous ligands, potentially impacting the survival and differentiation of B lymphocytes and plasma cells, thus addressing multiple autoimmune diseases caused by pathogenic antibodies [1] - GenSci136 is engineered with an anti-human serum albumin heavy chain single-domain antibody to extend its half-life in the body, suggesting a potential for effective and long-lasting treatment with improved convenience for patients [1] Group 2 - The drug is expected to provide a new, safe, and long-term targeted treatment option for IgAN patients without the need for prophylactic anti-infection therapy, aiming to significantly improve the long-term prognosis of these patients [1]
长春高新注射用GenSci136临床试验申请获批
Bei Jing Shang Bao· 2026-02-09 12:12
Core Viewpoint - Changchun High-tech (000661) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), received approval from the National Medical Products Administration for the clinical trial application of its injectable drug GenSci136, which is intended for the treatment of Immunoglobulin A Nephropathy (IgAN) [1] Group 1 - Jinsai Pharmaceutical's injectable GenSci136 is a self-developed Class 1 biological product [1] - The clinical trial application for GenSci136 has been approved for use in treating IgAN and generalized myasthenia gravis [1]
长春高新:子公司金赛药业生产注射用GenSci136注册临床试验申请获受理
Cai Jing Wang· 2026-02-04 08:32
Group 1 - The core announcement is that Changchun High-tech has received acceptance for the clinical trial application of its subsidiary Changchun Jinsai Pharmaceutical's injectable GenSci136 for domestic drug registration [1] - GenSci136 is a Class 1 therapeutic biological product independently developed by Jinsai Pharmaceutical, intended for the treatment of generalized myasthenia gravis (gMG) [2] - If the clinical trial application progresses smoothly, it will help the company expand its business structure, optimize its product structure, and enhance its core competitiveness [2]
长春高新技术产业(集团)股份有限公司关于子公司注射用GenSci136 境内生产药品注册临床试验申请获得受理的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-02-03 22:38
Core Viewpoint - The company, Changchun High-tech Industry (Group) Co., Ltd., announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received a clinical trial application acceptance notice from the National Medical Products Administration for the domestically produced drug, GenSci136, intended for the treatment of generalized myasthenia gravis (gMG) [1][4]. Group 1: Drug Information - Product Name: GenSci136, an injectable drug developed by Jinsai Pharmaceutical [1] - Application: Acceptance of clinical trial application for domestic production [1] - Indication: Treatment of generalized myasthenia gravis [1][2] Group 2: Disease Background - gMG is an autoimmune disease characterized by neuromuscular transmission disorders, with a global prevalence of approximately 12.4 per 100,000 people and an incidence rate in China of about 0.68 per 100,000 [2] - Traditional treatments include cholinesterase inhibitors, corticosteroids, and immunosuppressants, but about 20% of patients do not respond well to these therapies [2] Group 3: Drug Mechanism and Research - GenSci136 features a novel drug structure and dual-target mechanism, designed to enhance its blocking activity and prolong its half-life in the body [3] - Non-clinical pharmacology, pharmacokinetics, and toxicology studies indicate that GenSci136 has good efficacy and safety, potentially offering a better treatment option for patients with gMG in China [3] Group 4: Company Impact - Successful progress of the clinical trial application could help the company expand its business structure, optimize product offerings, and enhance its core competitiveness [4]
长春高新:关于子公司注射用GenSci136境内生产药品注册临床试验申请获得受理的公告
Zheng Quan Ri Bao· 2026-02-03 13:14
Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun JinSai Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the clinical trial application of GenSci136 injection, marking a significant step in the drug registration process [2] Group 1 - The acceptance notice indicates that the clinical trial application for GenSci136 has been officially recognized by regulatory authorities [2] - This development may enhance the company's product pipeline and potential market offerings in the pharmaceutical sector [2] - The approval process reflects the company's commitment to advancing its research and development initiatives [2]
2月3日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-03 10:11
Group 1 - Fulin Precision's subsidiary Jiangxi Shenghua invested 270 million yuan to establish a joint venture for a 500,000-ton ferrous oxalate project, with a total investment of 1.5 billion yuan expected to be completed by September 30, 2026 [1] - Xuguang Electronics plans to raise up to 1 billion yuan through a private placement to fund high-voltage vacuum arc extinguishing chamber expansion and other projects [2] - Minexplosion Optoelectronics intends to acquire 100% equity of Xiazhi Precision, with the transaction subject to shareholder and regulatory approvals [3] Group 2 - Shangluo Electronics' controlling shareholder plans to reduce his stake by up to 3% due to personal financial needs [4] - Babi Food reported a 1.3% decline in net profit for 2025, despite an 11.22% increase in revenue [5] - Pengding Holdings' subsidiary acquired industrial land in Huai'an for 66.14 million yuan [6] Group 3 - Zhuoyue New Energy's net profit for 2025 increased by 14.16%, despite a 17.43% decline in revenue [7] - Zhongyuan Media's net profit grew by 30.99% in 2025, with revenue decreasing by 5.13% [8] - Huangshan Tourism plans to invest approximately 530 million yuan in a hotel project with a 24-month construction period [9] Group 4 - *ST Jinling's restructuring plan was approved by the court, which may improve the company's financial situation [11] - Jichuan Pharmaceutical's subsidiary paid 80 million yuan for exclusive commercialization rights of a drug [12] - Pilin Bio's subsidiary received a notice for the acceptance of a drug supplement application [13] Group 5 - Nepe Mining terminated its investment in Swiss Veritas Resources AG due to changes in conditions [14] - Jinhui Wine announced a cash dividend of 0.20 yuan per share for the first three quarters of 2025 [15] - Hualan Biological's clinical trial for a new drug received approval for an additional indication [16] Group 6 - Industrial Fulian reported a total of 247 million yuan spent on share buybacks as of January 31, 2026 [17] - Yitong Century was pre-selected for a 107 million yuan project with China Tower [18] - Wanfeng Co. noted uncertainty in future price changes for disperse dyes [19] Group 7 - Bibet's clinical trial application for a new drug was approved by the National Medical Products Administration [21] - Chengbang Co. signed new project contracts worth 40.03 million yuan in Q4 2025 [22] - *ST Hengji received a court ruling for a performance compensation of 175 million yuan [23] Group 8 - Jihua Group is planning a change in control, leading to continued stock suspension [24] - Ningbo Port expects a container throughput of 5.03 million TEUs in January 2026, a 9.5% increase [25] - Hengli Petrochemical's actual controller increased his stake by 3.3 million shares [26] Group 9 - Hongfuhan signed a sales contract worth 480 million yuan with Guangdong Quanxiang [27] - All New Good's shareholder lifted a judicial freeze on 4.36% of the company's shares [28] - Changchun High-tech's subsidiary's clinical trial application for a new drug was accepted [29] Group 10 - Xingqi Eye Medicine's clinical trial for a new drug entered the first/second phase [31] - Hanma Technology reported a 140.04% increase in new energy heavy truck production in January 2026 [32] - Hengfeng Paper plans to invest 349 million yuan in a new green printing project [33] Group 11 - Zhifei Biological's mRNA vaccine for shingles received clinical trial approval [34] - Yutong Bus reported a 15.35% decrease in production in January 2026 [35] - StarNet Ruijie plans to sign a lease contract with an affiliate for a total rent of up to 110 million yuan [36] Group 12 - Hacheng Bonda's director completed a 0.97% share reduction [37] - Hendi Pharmaceutical's application for a new drug was approved [38] - Xinhua Medical's subsidiary received a medical device registration certificate [40] Group 13 - Yaokang Bio reported a 31.49% increase in net profit for 2025 [41] - Gaotie Electric reported a 14.02% increase in net profit for 2025 [42]
长春高新:子公司注射用GenSci136临床试验申请获受理
Xin Lang Cai Jing· 2026-02-03 08:08
Core Viewpoint - Changchun High-tech announced that its subsidiary, Jinsai Pharmaceutical, has had its clinical trial application for the domestically produced injectable GenSci136 accepted by the National Medical Products Administration, marking a significant step in the development of a new treatment for myasthenia gravis [1] Group 1: Product Development - GenSci136 is a Class 1 biological product designed to treat generalized myasthenia gravis, featuring a novel drug structure and a dual-target mechanism of action [1] - The drug aims to provide better treatment options for patients with myasthenia gravis in China [1] Group 2: Business Impact - The progress of this application is expected to broaden the company's business structure and enhance its core competitiveness [1] - The clinical trial process, however, still carries uncertainties that could affect the timeline and outcomes [1]
长春高新(000661.SZ):子公司注射用GenSci136境内生产药品注册临床试验申请获得受理
Ge Long Hui A P P· 2026-01-08 08:50
Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received the Acceptance Notice from the National Medical Products Administration for the clinical trial application of its injectable GenSci136, a first-class therapeutic biological product developed in-house, aimed at treating Immunoglobulin A Nephropathy (IgAN) [1] Group 1 - Jinsai Pharmaceutical's injectable GenSci136 is a first-class therapeutic biological product developed for the treatment of IgAN [1] - GenSci136 is a B-cell maturation antigen (BCMA) trimeric fusion protein that can bind to B lymphocyte stimulator (BlyS) and a proliferation-inducing ligand (APRIL) [1] - The drug has the potential to treat various autoimmune diseases characterized by tissue damage caused by pathogenic antibodies, by affecting the survival and differentiation of B lymphocytes and plasma cells [1]