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。 证券代码：688658 证券简称：悦康药业 公告编号：2025-057 悦康药业集团股份有限公司 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 注射用 YKYY031 是一种通用型 mRNA 肿瘤疫苗，拟用于晚期实体瘤的治 疗。本项目采用基于公司自主知识产权的新型阳离子脂质 YK-009 组成的脂质 纳米颗粒（LNP）递送系统，该系统具备递送效率高、安全性良好的特点。注 射用 YKYY031 所含的 mRNA 序列编码由多个在实体瘤组织中高表达的肿瘤相 关抗原（TAA）及特异性表达的肿瘤特异性抗原（TSA）表位肽串联组成的多 肽抗原序列。该疫苗递送至体内后，可诱导机体产生针对这些抗原的特异性杀 伤 T 细胞，抑制肿瘤细胞生长。本项目核心序列专利及递送系统专利已获得国 家知识产权局发明专利授权，并同步完成了国际专利申请，公司享有全球独占 权益。 注射用 YKYY031 临床前研究充分证实其具备显著的有效性与良好的安全 性，优势突出。有效性 ...

注射用YKYY031临床前研究充分证实其具备显著的有效性与良好的安全性，优势突出。有效性方面， 注射用YKYY031可诱导显著且持久的肿瘤抗原特异性T细胞免疫反应，并在多种给药方案下表现出明确 的抗肿瘤活性，且与抗PD-1抗体联合使用可进一步增强疗效。安全性方面，毒理学研究显示安全性良 好，存在宽泛治疗窗口，为临床应用奠定坚实基础。稳定性方面，本品采用先进的LNP冻干工艺，能够 彻底突破mRNA产品对超低温冷链的依赖，大幅降低运输和储存成本，提高本品可及性。 智通财经APP讯，悦康药业(688658.SH)发布公告，公司全资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于近日获得国家药品监督管理局(以下简称"NMPA")核准签发的关于同意注 射用YKYY031用于开展晚期实体瘤的《药物临床试验批准通知书》。 注射用YKYY031是一种通用型mRNA肿瘤疫苗，拟用于晚期实体瘤的治疗。项目采用基于公司自主知 识产权的新型阳离子脂质YK-009组成的脂质纳米颗粒(LNP)递送系统，该系统具备递送效率高、安全性 良好的特点。注射用YKYY031所含的mRNA序列编码由多个在实体瘤组织中高表达的肿瘤相关 ...

悦康药业公告，全资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于近日获得国 家药品监督管理局核准签发的关于同意注射用YKYY031用于开展晚期实体瘤的《药物临床试验批准通 知书》。注射用YKYY031是一种通用型mRNA肿瘤疫苗，拟用于晚期实体瘤的治疗。 ...

（来源：深圳商报） "一边是创始人股权被司法拍卖，一边是紧急启动H股上市募资"，正陷入业绩滑坡困境的科创板上市公司悦康药业近期的一系列操作，让市场充满疑虑。 近日，悦康药业发布公告称，为进一步提高公司综合竞争力，提升公司国际品牌形象，同时更好地利用国际资本市场，多元化融资渠道，公司拟在境外发 行股份（H股）并在港交所主板上市。 根据公告，本次发行上市方案尚需提交公司股东大会审议，并需获得中国证监会、香港联交所等相关监管机构的备案、批准或核准。公司表示将在股东会 决议有效期内（即自公司股东会审议通过之日起24个月或同意延长的其他期限）选择适当的时机和发行窗口完成本次发行H股并上市。 资料显示，悦康药业集团股份有限公司成立于2001年，总部位于北京，是一家集新药研发、药品生产、流通销售及国际贸易于一体的医药集团企业。目前 已形成核酸药物靶点发现平台、多肽药物开发平台、缓控释制剂技术平台等九大核心研发平台，涵盖核酸药、多肽药、中药创新药以及高端化药等领域。 2020年12月24日，悦康药业在上海证券交易所科创板上市。然而，公司募投项目进展并不顺利。 2024年12月19日，悦康药业公告将研发中心建设、固体制剂生产线 ...

海创药业涨超10%，前沿生物涨超8%，悦康药业、热景生物、回盛生物、众生药业跟涨。 (本文来自第一财经) 海创药业涨超10%，前沿生物涨超8%，悦康药业、热景生物、回盛生物、众生药业跟涨。 (本文来自第一财经) ...

专题：2025中国企业竞争力年会 肌肉流失则是另一大亟待解决的痛点。宋更申强调，健康减重的核心是减少脂肪而非肌肉，但GLP-1类 药物在减脂过程中往往伴随肌肉量下降，这不仅影响身体机能，还可能导致减重后易反弹，与健康减重 的目标相悖。"尽管行业在GLP-1多靶点药物研发上已有探索，但尚未从根本上解决这些问题。" 新浪声明：所有会议实录均为现场速记整理，未经演讲者审阅，新浪网登载此文出于传递更多信息之目 的，并不意味着赞同其观点或证实其描述。 责任编辑：李思阳 专题：2025中国企业竞争力年会 "2025中国企业竞争力年会"于12月9日至10日在北京举行，悦康药业集团股份有限公司董事、药物研究 院院长宋更申在演讲中表示，减重领域正迎来市场爆发期。随着大众健康意识的提升，减重已成为巨大 的临床需求，这一趋势也推动相关药物快速崛起。"当前索马鲁肽、替尔泊肽两款药物出道即巅峰，凭 借显著的减重效果占据市场核心地位，不出意外2025年医药领域的药王头衔将由二者包揽。" 然而，在市场繁荣背后，主流减重药物的短板日益凸显。宋更申重点分析了GLP-1单靶点、双靶点多肽 药物的局限性：其核心减重原理是通过抑制食欲减少进食，这种 ...

丨2025年12月9日星期二丨 NO.1 太龙药业：控股股东筹划公司股份转让事宜已取得重大进展 NO.3 高光制药递表港交所，C轮投后估值超24亿元 港交所官网显示，高光制药递交港交所上市申请，中金公司和招银国际为联席保荐人。高光制药成立于 2017年，2025年11月完成1.62亿元C轮融资，投后估值24.62亿元。 点评：高光制药递表港交所，C轮投后估值超24亿元。虽暂未披露核心管线细节，但资本加持下冲刺上 市，有望加速研发，需关注其后续管线竞争力与商业化路径。 NO.4 悦康药业宣布赴港IPO，冲刺A+H 太龙药业公告称，12月8日，公司接到控股股东泰容产投通知，泰容产投、太龙药业持股5%以上的股东 郑州众生实业集团有限公司与江药控股就部分股份转让、一致行动安排、公司治理等一揽子事项达成一 致，并签署了《股份转让协议》，约定泰容产投将持有的上市公司股份（占公司当前总股本的8.73%） 以11.043元/股的价格分两次转让给江药控股，总价款为5.53亿元。 点评：太龙药业控制权落定江药控股，国资入主有望注入资源，助力其医药主业发展，但需待国资审批 等程序落地，复牌后可关注后续整合动作。 NO.2 民生健康 ...

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Insights - The 2025 National Medical Insurance and Commercial Health Insurance Innovation Drug Catalogs were released, adding 114 new drugs to the national insurance list, with a success rate of 88%, significantly higher than the previous year's 76% [2] - The first three quarters of 2025 saw a notable recovery in domestic innovative drug financing, with 324 financing events totaling $5.51 billion, a 67.6% increase year-on-year [3] - The flu positivity rate has not peaked yet, with a significant increase in flu cases, indicating a growing market for flu medications [4] - The report highlights breakthroughs in dual-target and new-target opportunities in the autoimmune field, with several companies making significant advancements [5] - There is a focus on inhalation formulations in respiratory diseases, with new drugs showing promising results [6] - Progress in liver-targeted small nucleic acids is noted, with companies like Arrowhead Pharmaceuticals making strides in this area [7] Summary by Sections 1. National Medical Insurance and Commercial Insurance Innovation Drug Catalogs - The 2025 catalog added 114 new drugs, including 50 innovative drugs, with a success rate of 88% [2] 2. Financing Trends and CXO Order Changes - Innovative drug financing events increased by 5.2% year-on-year, with total financing amounting to $5.51 billion [3] 3. Flu Positivity Rates - The flu positivity rate reached 51.1%, indicating a rising demand for flu medications [4] 4. Autoimmune Field Developments - Significant partnerships and advancements in dual-target drugs for autoimmune diseases were reported [5] 5. Inhalation Formulations in Respiratory Diseases - New inhalation drugs are showing positive clinical results, indicating a shift in treatment approaches [6] 6. Progress in Liver-Targeted Small Nucleic Acids - Arrowhead Pharmaceuticals achieved a milestone payment for its innovative RNA therapy, expanding its research pipeline [7] 7. Stock Recommendations - The report recommends stocks in various sectors, including inhalation formulations, small nucleic acids, and innovative drugs, highlighting specific companies for investment [8]

Group 1: Market Overview - The Hong Kong stock market showed a collective rebound with the Hang Seng Index rising approximately 0.6%, the Hang Seng China Enterprises Index increasing about 1%, and the Hang Seng Tech Index up around 0.8% [2][3] - Market sentiment improved significantly compared to previous days, with total market turnover rising to approximately 210.4 billion HKD and the short-selling amount on the main board decreasing to about 15.74% of total turnover [2] - Southbound capital flows remained weak, with net inflows from northbound trading at around 1.3 billion HKD on Friday [2] Group 2: Sector Performance - Resource and cyclical stocks led the market rally, with rare earth, non-ferrous metals, and gold stocks performing well due to the implementation of export licenses and increased copper stockpiling by global commodity traders [3] - The financial sector also played a crucial role in driving the market upward, with insurance stocks, Chinese brokerage firms, and domestic banks generally showing strong performance [3] - Energy-related sectors, including electric power equipment, wind power, and nuclear power, were active, reflecting ongoing interest in energy transition and equipment investment opportunities [3] Group 3: Economic Indicators - The U.S. core PCE year-on-year growth rate fell to 2.8%, providing strong support for the Federal Reserve's potential interest rate cut [4] - Personal consumption expenditures in the U.S. showed almost no growth in September, indicating a cooling consumer market, with significant declines in spending on durable and non-durable goods [5] - The income distribution in the U.S. is becoming polarized, with lower-income households reducing spending while high-income groups maintain purchasing power due to asset appreciation [5] Group 4: Industry Insights - The small nucleic acid drug sector is emerging as a significant investment theme for 2026, characterized by rapid global market growth and advantages such as broad target coverage and high clinical trial success rates [7] - The global small nucleic acid drug market is projected to grow from 2.7 billion USD in 2019 to 5.7 billion USD in 2024, with a compound annual growth rate of 16.2% [7] - The market for siRNA drugs is expected to increase its share from 6.2% in 2019 to 44.5% in 2024, driven by advancements in delivery technologies and expanding indications [7] Group 5: Collaboration and Market Dynamics - The small nucleic acid field is becoming a hub for business development collaborations, with nearly 100 deals in the past three years and increasing transaction values [8] - Leading companies in the small nucleic acid market, such as Alnylam and Ionis, are setting the pace for global technological development, with Alnylam reporting a 149% year-on-year revenue increase in Q3 2025 [9] - Domestic pharmaceutical companies are also focusing on small nucleic acid drugs, with several candidates in clinical trials targeting conditions like high cholesterol [9] Group 6: Investment Recommendations - The report suggests that small nucleic acid drugs may become a major investment theme next year, with opportunities in both domestic and international markets [10] - Key companies to watch include overseas leaders like Alnylam, Arrowhead, and Ionis, as well as domestic firms like CSPC Pharmaceutical Group and Hengrui Medicine [10]

悦康药业，成立于2001年，是一家集新药研发、药品生产、流通销售及国际贸易于一体的医药集团企 业，目前已形成核酸药物靶点发现平台、多肽药物开发平台、缓控释制剂技术平台等九大核心研发平 台，涵盖核酸药、多肽药、中药创新药以及高端化药等领域，并相继组建了头孢药物晶型研究国家地方 联合工程实验室、心脑血管北京市工程研究中心等，建立了悦康集团院士专家工作站、博士后科研工作 站、博导工作站等完善的研发体系。2023年7月，完成国内首家自主知识产权LNP阳离子脂质辅料 （YK-009）的备案登记，是国内外少数可规模化生产自主知识产权阳离子脂质辅料的药企。 (截图来自雪球) 悦康药业表示，公司将充分考虑现有股东的利益和境内外资本市场的情况，在股东会决议有效期内选择 适当的时机和发行窗口完成本次发行H股并上市。 悦康药业指，截至本公告披露日，公司正积极与相关中介机构就本次发行H股并上市的相关工作进行商 讨，除本次董事会审议通过的相关议案外，其他关于本次发行H股并上市的具体细节尚未确定。 ...