证券代码：688658 证券简称：悦康药业 公告编号：2025-058 6、审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查， 2025 年 11 月 17 日受理的 YKYY032 注射液临床试验申请符合药品注册的有关 （一）国家药品监督管理局临床批件主要内容 1、药品名称：YKYY032 注射液 2、受理号：CXHL2501263 3、通知书编号：2025LP03415 4、申请适应症：高脂蛋白(a)血症 4、申请人：北京悦康科创医药科技股份有限公司、杭州天龙药业有限公司 5、申报阶段：临床试验 要求，同意本品开展临床试验。 （二）美国食品药品监督管理局函告主要内容 悦康药业集团股份有限公司 关于自愿披露子公司 YKYY032 注射液获得国家药品 监督管理局和 FDA 临床试验批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 悦康药业集团股份有限公司（以下简称"公司"）子公司北京悦康科创医药 科技股份有限公司（以下简称"悦康科创"）、杭州天龙药业有限公司（以下简 称"杭州天龙"）于近日获得国家药品 ...

Core Viewpoint - Yuyuan Pharmaceutical announced that its subsidiaries, Beijing Yuyuan Kechuang Pharmaceutical Technology Co., Ltd. and Hangzhou Tianlong Pharmaceutical Co., Ltd., have received approval from the National Medical Products Administration for the clinical trial of YKYY032 injection for the treatment of hyperlipoproteinemia(a) [1] Group 1 - The approval from the National Medical Products Administration includes the issuance of a "Drug Clinical Trial Approval Notice" for YKYY032 injection [1] - Yuyuan Kechuang has also received a letter of consent from the U.S. Food and Drug Administration to conduct clinical trials for YKYY032 injection for the same indication [1]

每经AI快讯，12月19日，悦康药业(688658.SH)公告称，公司子公司北京悦康科创医药科技股份有限公 司、杭州天龙药业有限公司近日获得NMPA核准签发的关于YKYY032注射液用于治疗高脂蛋白(a)血症 的《药物临床试验批准通知书》。同时，悦康科创获得FDA关于同意YKYY032注射液用于治疗高脂蛋 白(a)血症进行临床试验的函告。YKYY032注射液是一款偶联N-乙酰半乳糖胺(GalNAc)配体的化学合成 双链siRNA药物，通过RNA干扰机制特异性沉默LPA基因转录的mRNA，从源头阻断脂蛋白(a)[Lp(a)]生 成，拟用于高脂蛋白(a)血症治疗。该新药临床试验申请获NMPA及FDA批准是公司新药研发的阶段性成 果，但药品从研制到投产的周期长、环节多、风险高，对公司近期业绩不会产生重大影响。 ...

Group 1 - The core viewpoint of the news highlights a significant increase in the Shanghai Stock Exchange's Sci-Tech Innovation Board Innovative Drug Index, with a rise of 3.26% as of December 19, 2025, driven by strong performances from constituent stocks such as Chengdu Xian Dao (up 10.44%) and Yifang Bio (up 9.82%) [1] - The recent announcement by the National Healthcare Security Administration and the Ministry of Human Resources and Social Security regarding the 2025 National Basic Medical Insurance Drug List includes 114 new drugs, of which 50 are innovative drugs, marking an 88% success rate, a 12 percentage point increase from 2024 [3] - The total R&D investment by innovative drug companies on the Sci-Tech Innovation Board reached a new high in the first three quarters of 2025, with a year-on-year increase of over 10% and an R&D intensity of 42%, significantly surpassing the overall level of A-shares [4] Group 2 - The collaboration between Innovent Biologics and Takeda Pharmaceutical regarding three innovative cancer drugs has been completed, with Innovent receiving a total upfront payment of $1.2 billion, including a strategic investment of $100 million, and potential milestone payments of up to $10.2 billion [5] - The CXO industry is entering a new high prosperity cycle, driven by external improvements, including overseas interest rate cuts and domestic recovery, with a focus on innovative drug companies benefiting from policy support and innovation upgrades [6] - The implementation of the "Medicare + Commercial Insurance" multi-layered medical security system is seen as a substantial breakthrough, with nearly 90% of new drugs approved by Sci-Tech Board biopharmaceutical companies included in the insurance list [3][4]

Core Viewpoint - Yuyuan Pharmaceutical experienced a stock price decline of 2.08% on December 18, with a current price of 21.68 CNY per share and a market capitalization of 9.756 billion CNY [1] Financial Performance - For the period from January to September 2025, Yuyuan Pharmaceutical reported a revenue of 1.759 billion CNY, a year-on-year decrease of 41.20%, and a net profit attributable to shareholders of -148 million CNY, a year-on-year decrease of 170.56% [3] - The company has distributed a total of 1.092 billion CNY in dividends since its A-share listing, with 584 million CNY distributed over the past three years [4] Stock Market Activity - Yuyuan Pharmaceutical's stock has increased by 50.45% year-to-date, but has seen a decline of 19.23% over the last five trading days, 3.08% over the last 20 days, and 11.98% over the last 60 days [1] - The company has appeared on the "Dragon and Tiger List" four times this year, with the most recent appearance on August 27, where it recorded a net buy of -105 million CNY [1] Shareholder Information - As of September 30, 2025, Yuyuan Pharmaceutical had 10,700 shareholders, a decrease of 8.39% from the previous period, with an average of 42,095 circulating shares per shareholder, an increase of 9.16% [3] - The top ten circulating shareholders include notable funds such as the Fortune Precision Medical Flexible Allocation Mixed A and the E Fund Healthcare Industry Mixed A, with changes in their holdings noted [4] Business Overview - Yuyuan Pharmaceutical, established on August 14, 2001, and listed on December 24, 2020, focuses on the research and production of high-end chemical drugs, with significant revenue contributions from cardiovascular, digestive, diabetes, and anti-infection medications [2] - The revenue composition includes 55.67% from cardiovascular drugs, 20.88% from anti-infection drugs, and smaller percentages from other categories [2]

悦康药业集团股份有限公司 2025 年第三次临时股东会会议资料 悦康药业集团股份有限公司 2025 年第三次临时股东会会议资料 悦康药业集团股份有限公司 2025 年第三次临时股东会 会议资料 2025 年 12 月 | | | 悦康药业集团股份有限公司 2025 年第三次临时股东会会议须知 为了维护全体股东的合法权益，确保股东会的正常秩序和议事效率，保证大 会的顺利进行，根据《公司法》、《证券法》、《上市公司股东会规则》以及《悦 康药业集团股份有限公司章程》（以下简称"《公司章程》"）的相关规定，认真 做好召开股东会的各项工作，特制定本须知： 一、为保证股东会的严肃性和正常秩序，切实维护股东的合法权益，除出席 会议的股东及股东代表、董事、公司高级管理人员、公司聘任律师及中介机构外， 公司有权依法拒绝其他人员入场。 二、请出席会议的股东及股东代表在会议召开前 20 分钟到达会议现场办理 签到手续。大会工作人员将对出席会议者的身份进行必要的核对工作，请被核对 者给予配合。 三、股东及股东代表参加股东会依法享有发言权、质询权、表决权等权利。 如股东及股东代表欲在本次股东会上发言，可在签到时先向大会工作人员进行登 ...

Group 1 - The report highlights the recent performance of various industries, with notable gains in sectors such as non-ferrous metals, electronics, and power equipment, while retail and real estate sectors faced declines [1][1][1] - The central economic work conference emphasized the importance of technological breakthroughs and supply-demand optimization, indicating a shift towards quality improvement in economic growth [11][12][19] - The commercial aerospace sector is experiencing significant growth, with the establishment of a dedicated regulatory body and a notable increase in the commercial aerospace index, which has risen by 46.52% since April 7 [47][48] Group 2 - The report indicates a seasonal recovery in social financing, with November seeing an increase of 24,885 billion yuan, driven primarily by government bond issuance [4][7] - The credit environment is showing signs of marginal improvement, particularly in corporate loans, which increased by 6,100 billion yuan in November, reflecting a recovery in demand [5][6] - The report notes that the retail sector is undergoing a transformation, with a focus on quality, as highlighted by the Ministry of Commerce's emphasis on retail quality upgrades [1][1][1] Group 3 - The report discusses the rising interest in inquiry transfers, which have seen a significant increase in both project numbers and transfer scale, indicating a growing trend in the market [51][52] - The technology sector is expected to remain a key focus, with upcoming events such as the Volcano Engine FORCE conference anticipated to showcase advancements in AI and cloud services [56]

Core Insights - The pharmaceutical industry is experiencing a surge in innovative products, with clear domestic demand and significant potential for international expansion [4][14][25] - Investment opportunities are concentrated in innovative drugs and their supply chains, with a notable performance from CRO/CMO and chemical pharmaceuticals [9][15][17] - The report emphasizes the importance of innovation as the primary solution to industry challenges, driven by stable demand and supportive policies [26][32][41] Industry Overview - The pharmaceutical sector has faced revenue declines, with a 0.9% year-on-year decrease in revenue for the first three quarters of 2025, and net profit down by 2.2% [15][16] - The innovative drug sector has outperformed, with CRO/CMO and chemical pharmaceuticals showing net profit growth of 31.0% and 16.6% respectively [17][18] - The overall market is characterized by low fund holdings and historical valuation bottoms, indicating high investment value [20][25] Demand and Payment Dynamics - The demand for healthcare services is steadily increasing, with a projected 5% growth in total medical visits and hospital admissions in 2024 [26][28] - The aging population is expected to drive long-term demand, with 220 million people aged 65 and above by 2050 [28][30] - The medical insurance fund's income growth has outpaced expenditure growth, leading to a significant increase in fund reserves [32][36] Financing and Market Trends - The IPO market for healthcare has rebounded, with 28 IPOs in the first three quarters of 2025, a 100% increase from the previous year [42][43] - License-out transactions have surged, with transaction numbers increasing by 41% and total amounts reaching $92 billion, indicating a robust market for innovative drug licensing [48][50] - The number of IND applications and new clinical trials for innovative drugs has been steadily increasing, with a notable rise in NDA approvals [53][57] Technological Advancements - The report highlights the emergence of new technologies such as ADC and small nucleic acids, with domestic companies leading in these areas [60] - The focus on dual antibodies and GLP-1 drugs is expected to drive significant growth, with multiple development directions emerging [9][60] - The report notes that domestic companies are increasingly recognized for their innovative capabilities, particularly in the ADC space [60]

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]

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]