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]

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]

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 ...

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]

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]

Core Viewpoint - Yuekang Pharmaceutical is facing a significant decline in performance, prompting the company to initiate an H-share listing to diversify its financing channels and enhance its international brand image amidst ongoing financial difficulties [1][4]. Company Operations - Yuekang Pharmaceutical, established in 2001 and headquartered in Beijing, operates as a pharmaceutical group involved in new drug research and development, production, distribution, and international trade, with nine core R&D platforms [2][9]. - The company went public on the Shanghai Stock Exchange's Sci-Tech Innovation Board on December 24, 2020, raising 2.192 billion yuan for various projects, but has struggled with project progress and has had to adjust its plans multiple times [3][10]. Financial Performance - The company has experienced a continuous decline in net profit over the past three years, with decreases of 38.53% in 2022, 44.87% in 2023, and 33.05% in 2024 [5][12]. - In the first three quarters of 2025, Yuekang reported total revenue of 1.759 billion yuan, a year-on-year decrease of 41.20%, and a net loss of 148 million yuan compared to a profit of 210 million yuan in the same period the previous year [7][14]. Recent Developments - The company announced plans to issue H-shares and list on the Hong Kong Stock Exchange, which requires approval from shareholders and regulatory bodies [2][9]. - Yuekang's cash flow situation has worsened, with a net cash flow from operating activities of 168 million yuan, down 60.9% year-on-year, and a net increase in cash and cash equivalents of -256 million yuan, a drop of 338.24% [10]. Market Challenges - Yuekang's core product, Ginkgo biloba extract injection, faced controversy over pricing practices, leading to a significant revenue drop of 36% in Q4 2024 and a net loss of 86.01 million yuan [4][11]. - The company has incurred high marketing expenses, totaling 7.373 billion yuan from 2021 to 2024, with 97% of this amount attributed to market promotion [14]. Shareholder Issues - The controlling shareholder, the Yu family, has faced difficulties, including the judicial auction of 26.5 million shares, which sold for 486 million yuan [8][15].

Group 1 - Haichuang Pharmaceutical increased by over 10% [1] - Frontier Biotech rose by over 8% [1] - Yuekang Pharmaceutical, Rejing Biotech, Huisheng Biotech, and Zhongsheng Pharmaceutical also experienced gains [1]

Core Insights - The weight loss sector is entering a market explosion phase, driven by increasing public health awareness and significant clinical demand for weight loss solutions [2][5] - Current leading drugs, Semaglutide and Tirzepatide, are dominating the market due to their remarkable weight loss effects, with expectations that they will claim the title of "king of drugs" in the pharmaceutical field by 2025 [2][5] - However, mainstream weight loss drugs exhibit notable shortcomings, particularly GLP-1 single-target and dual-target peptide drugs, which primarily suppress appetite to reduce food intake, potentially leading to mental health side effects such as depression and emotional distress [2][5] Industry Challenges - The core issue in healthy weight loss is the need to reduce fat without losing muscle mass, yet GLP-1 drugs often result in muscle loss during fat reduction, which can impair bodily functions and lead to weight regain, contradicting the goal of healthy weight loss [2][5] - Despite some exploration in the development of multi-target GLP-1 drugs, these fundamental issues have not been adequately addressed [2][5] Innovative Solutions - An innovative solution proposed is the development of small nucleic acid drugs, which show unique advantages over traditional peptide drugs by potentially allowing for "weight loss without muscle loss" [2][5] - Some small nucleic acid drugs may even promote muscle growth while facilitating weight loss, effectively circumventing the core shortcomings of traditional weight loss medications [2][5]

Group 1 - TaiLong Pharmaceutical's controlling shareholder has made significant progress in planning the transfer of company shares, with an agreement reached to transfer 8.73% of the company's total shares to Jiangyao Holdings at a price of 11.043 yuan per share, totaling 553 million yuan [1] - The transfer of control to Jiangyao Holdings is expected to inject resources into TaiLong Pharmaceutical's core business, although it is subject to government approval and subsequent integration actions [1] Group 2 - Minsheng Health announced its first share buyback of 82,900 shares at a maximum price of 15.67 yuan per share, totaling 1.29 million yuan, signaling recognition of the company's value and stability in stock price [2] - If Minsheng Health increases the buyback scale, it may further boost market confidence and solidify its long-term development foundation [2] Group 3 - Gaoguang Pharmaceutical has submitted its listing application to the Hong Kong Stock Exchange, with a post-C round financing valuation exceeding 2.462 billion yuan after raising 162 million yuan [3] - The company aims to accelerate research and development with capital support, although details on its core pipeline remain undisclosed [3] Group 4 - Yuekang Pharmaceutical plans to issue shares overseas (H shares) and list on the Hong Kong Stock Exchange to enhance its comprehensive competitiveness and international brand image [4] - This move aligns with the trend of globalization for pharmaceutical companies, and attention should be paid to the timing of the issuance and market feedback [4]

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]