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悦康药业:关于自愿披露子公司注射用YKYY031获得国家药品监督管理局临床试验批准的公告
Zheng Quan Ri Bao· 2025-12-12 12:11
Core Viewpoint - Yuyuan Pharmaceutical announced that its wholly-owned subsidiary, Beijing Yuyuan Ketech Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. have received approval from the National Medical Products Administration for the clinical trial of YKYY031 for advanced solid tumors [2] Group 1 - The approval pertains to the clinical trial of an injectable drug, YKYY031, specifically targeting advanced solid tumors [2] - The announcement was made on the evening of December 12 [2] - This development indicates progress in the company's research and development efforts in oncology [2]
12月12日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-12 10:41
Group 1 - Shouyao Holdings is planning to issue H-shares and list on the Hong Kong Stock Exchange, with discussions ongoing with intermediaries regarding the specifics of the listing [1] - Jiangsu Guoxin's subsidiary, Guoxin Mazhou, has completed the trial operation of a 1000MW coal-fired power unit, which is set to officially commence operations on December 12, 2025 [2] - Yuekang Pharmaceutical's mRNA tumor vaccine has received clinical trial approval from the National Medical Products Administration for treating advanced solid tumors [3] Group 2 - Dongli New Science plans to invest 666 million yuan in the restructuring of SAIC Hongyan, acquiring approximately 14.66% equity post-restructuring [4] - Longsheng Technology is set to invest approximately 350 million yuan in the establishment of an intelligent robot innovation center in Wuxi [5] - Shangwei Co. has received a government subsidy of 2.212 million yuan, which accounts for 13.53% of its audited net profit for 2024 [6] Group 3 - Anglikang has received drug registration certificates for Diclofenac Sodium Enteric-Coated Tablets and approval for a supplemental application for Sacubitril/Valsartan Sodium Tablets [7] - Guangzhou Development has received acceptance notices for the registration of 8 billion yuan in medium-term notes and 6 billion yuan in short-term financing bonds [8] - Kebo Da plans to increase capital by 21.2 million euros (approximately 174 million yuan) in its wholly-owned subsidiary in Germany [9][10] Group 4 - Changguang Huaxin has received a total of 11.6672 million yuan in government subsidies, including 8.0552 million yuan related to income [11] - Haizheng Pharmaceutical's subsidiary has received a European Pharmacopoeia suitability certificate for its raw material [12] - Qianjin Pharmaceutical's subsidiary has received a drug registration certificate for Lurasidone Hydrochloride Tablets, used for treating schizophrenia [13] Group 5 - Daimai Co. has received a warning letter from the Shanghai Securities Regulatory Bureau due to failure to timely disclose a significant event related to a fire incident [14] - ST Changyao's subsidiary has recently ceased production due to financial difficulties and competitive pressures in the photovoltaic industry [15] - Guodian Power is investing in the construction of a 2×1000MW expansion project at the Ganbi Power Plant, with a total dynamic investment of 7.218 billion yuan [16] Group 6 - Kaichuang International's subsidiary has completed the handover of a tuna purse seine vessel, expected to be operational by 2026 [16] - Tieke Rail plans to sign an energy management agreement for a distributed photovoltaic project, which is expected to save approximately 1.441 million yuan in electricity costs over 25 years [18] - Bailian Co. plans to sign a land compensation agreement with Friendship Logistics, with a total compensation of 103 million yuan [19] Group 7 - Dayu Water-saving's subsidiary has been pre-awarded two high-standard farmland construction projects, with total expected amounts of 137 million yuan and 135 million yuan respectively [20] - Tianma Technology reported a total eel output of approximately 1197.15 tons in November, with sales prices ranging from 53,000 yuan/ton to 89,000 yuan/ton [21] - Guorui Technology's subsidiary has been shortlisted for the GXLF project with a bid of 76 million yuan [22] Group 8 - Qingdao Food's deputy general manager has resigned for personal reasons [23] - Guosheng Zhike plans to use up to 900 million yuan of idle funds for cash management [24] - Guodian Nanrui plans to use up to 23 billion yuan of idle funds for entrusted wealth management [25] Group 9 - Jiahuan Energy plans to merge its wholly-owned subsidiary, Zhejiang Jiahuan Hydrogen Peroxide Co., Ltd., through an overall absorption merger [26] - Ganyue Expressway reported vehicle toll service revenue of 309 million yuan for November [27] - Jinling Hotel's chairman has resigned due to work changes [28] Group 10 - Lisheng Pharmaceutical's subsidiary has received drug registration certificates for Apremilast Tablets [29] - Baotai has received a positive opinion from the European Medicines Agency for Gotenfia® for various inflammatory conditions [30] - ST Zhisheng has been awarded a smart city governance project with a bid amount of 104 million yuan [31] Group 11 - Chenxi Aviation and its related personnel have received administrative regulatory measures from the Shaanxi Securities Regulatory Bureau due to financial reporting issues [32] - Portong Medical has appointed Xia Canglan as the new deputy general manager [33] - Maide Medical plans to repurchase shares with a total amount between 20 million and 40 million yuan [34] Group 12 - Jimin Health plans to establish a joint venture with a total investment of 600 million yuan, focusing on AI and software development [35] - Beilu Pharmaceutical has received a drug registration certificate for Pioglitazone Metformin Tablets [36] - Hainan Mining plans to entrust the overall management of the Shiluo Iron Mine to a construction company for three years, with a total contract amount of approximately 818 million yuan [38] Group 13 - Huiyu Pharmaceutical has received a drug registration certificate for Nicardipine Hydrochloride Injection [39] - Baoland has received a government subsidy of 10 million yuan related to income [40] - Qingdao Port has terminated the acquisition of 100% equity in an oil company and 50% equity in Rizhao Shihua due to regulatory concerns [41]
悦康药业:子公司注射用YKYY031获药物临床试验批准通知书
Mei Ri Jing Ji Xin Wen· 2025-12-12 09:45
Core Viewpoint - Yuyuan Pharmaceutical (688658.SH) announced that its wholly-owned subsidiary, Beijing Yuyuan Ketech Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. have received approval from the National Medical Products Administration for the clinical trial of injectable YKYY031, a universal mRNA tumor vaccine intended for the treatment of advanced solid tumors [2]. Group 1 - Yuyuan Pharmaceutical's subsidiary has obtained a clinical trial approval for YKYY031 [2] - YKYY031 is designed as a universal mRNA vaccine targeting advanced solid tumors [2]
悦康药业:注射用YKYY031用于开展晚期实体瘤临床试验获得批准
智通财经网· 2025-12-12 09:40
Core Viewpoint - YKYY031, a novel mRNA tumor vaccine developed by the company, has received approval from the National Medical Products Administration (NMPA) for clinical trials targeting advanced solid tumors [2][3] Group 1: Product Development - YKYY031 is designed as a general mRNA tumor vaccine for the treatment of advanced solid tumors, utilizing a proprietary cationic lipid-based lipid nanoparticle (LNP) delivery system that offers high delivery efficiency and good safety [2] - The vaccine contains mRNA sequences encoding multiple tumor-associated antigens (TAA) and tumor-specific antigens (TSA), which can induce specific cytotoxic T cell responses to inhibit tumor cell growth [2] Group 2: Intellectual Property - The core sequence and delivery system of YKYY031 have been granted invention patent authorization by the National Intellectual Property Administration, and international patent applications have been completed, granting the company global exclusive rights [2] Group 3: Preclinical Research - Preclinical studies have demonstrated significant efficacy and good safety for YKYY031, showing the ability to induce strong and lasting tumor antigen-specific T cell immune responses and clear anti-tumor activity under various dosing regimens [3] - The combination of YKYY031 with anti-PD-1 antibodies has been shown to further enhance therapeutic efficacy [3] Group 4: Stability and Logistics - The product employs advanced LNP freeze-drying technology, which eliminates the dependence on ultra-low temperature cold chain logistics, significantly reducing transportation and storage costs while improving accessibility [3]
悦康药业:注射用YKYY031获药物临床试验批准通知书
Core Viewpoint - Yuyuan Pharmaceutical (688658) announced that its wholly-owned subsidiary, Beijing Yuyuan Kete Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. have recently received approval from the National Medical Products Administration for the clinical trial of injectable YKYY031 for advanced solid tumors [1] Group 1 - Yuyuan Pharmaceutical's subsidiary has obtained a clinical trial approval for YKYY031 [1] - The approval is specifically for the treatment of advanced solid tumors [1]
悦康药业(688658.SH):子公司注射用YKYY031获得国家药品监督管理局临床试验批准
Ge Long Hui A P P· 2025-12-12 09:34
Core Viewpoint - Yuyuan Pharmaceutical (688658.SH) has received approval from the National Medical Products Administration (NMPA) for its clinical trial of the injectable YKYY031, a generic mRNA tumor vaccine intended for the treatment of advanced solid tumors [1] Group 1 - The clinical trial approval is granted to Yuyuan Pharmaceutical's wholly-owned subsidiary, Beijing Yuyuan Kete Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. [1] - YKYY031 is designed to treat advanced solid tumors and utilizes a novel cationic lipid YK-009-based lipid nanoparticle (LNP) delivery system, which is characterized by high delivery efficiency and good safety [1]
悦康药业(688658.SH):注射用YKYY031用于开展晚期实体瘤临床试验获得批准
智通财经网· 2025-12-12 09:29
Core Viewpoint - YKYY031, a novel mRNA tumor vaccine developed by the company, has received approval from the National Medical Products Administration (NMPA) for clinical trials targeting advanced solid tumors [1][2] Group 1: Product Development - YKYY031 is designed to treat advanced solid tumors using a lipid nanoparticle (LNP) delivery system based on the company's proprietary cationic lipid YK-009, which offers high delivery efficiency and good safety [1] - The vaccine contains mRNA sequences that encode multiple tumor-associated antigens (TAA) and tumor-specific antigens (TSA), aiming to induce specific cytotoxic T cell responses to inhibit tumor growth [1] Group 2: Clinical Research and Efficacy - Preclinical studies have demonstrated significant efficacy and good safety for YKYY031, showing the ability to induce durable tumor antigen-specific T cell immune responses and clear anti-tumor activity under various dosing regimens [2] - The combination of YKYY031 with anti-PD-1 antibodies has been shown to further enhance therapeutic efficacy [2] Group 3: Safety and Stability - Toxicological studies indicate that YKYY031 has a good safety profile and a broad therapeutic window, providing a solid foundation for clinical application [2] - The advanced LNP lyophilization process used for YKYY031 overcomes the dependency on ultra-low temperature cold chain logistics, significantly reducing transportation and storage costs while improving accessibility [2]
悦康药业:子公司注射用YKYY031获得国家药品监督管理局临床试验批准
Xin Lang Cai Jing· 2025-12-12 09:16
Core Viewpoint - The announcement indicates that Yuyuan Pharmaceutical's wholly-owned subsidiary, Beijing Yuyuan Ketech Pharmaceutical Technology Co., Ltd., and Hangzhou Tianlong Pharmaceutical Co., Ltd. have received approval from the National Medical Products Administration for the clinical trial of injectable YKYY031, a generic mRNA tumor vaccine intended for the treatment of advanced solid tumors [1] Group 1 - Yuyuan Pharmaceutical's subsidiary has obtained a clinical trial approval notice for YKYY031 [1] - YKYY031 is designed as a generic mRNA tumor vaccine [1] - The vaccine is aimed at treating advanced solid tumors [1]