Investment Rating - The industry investment rating is "Positive" (maintained) [1] Core Views - The in vivo CAR-T technology is emerging as a new hotspot in cell therapy, with significant investment opportunities in the domestic market. Major pharmaceutical companies are actively entering this field, with multiple high-value transactions occurring in 2025 [5][14] - Compared to traditional CAR-T, in vivo CAR-T offers advantages such as reduced manufacturing costs, shortened processing times, and improved accessibility for patients, making it applicable in various diseases including B-cell malignancies and autoimmune diseases [6][15] - The report highlights the performance of various sub-sectors within the pharmaceutical industry, noting that the hospital sector showed the highest increase, while the medical R&D outsourcing sector experienced the largest decline [7][24] Summary by Sections Section 1: In Vivo CAR-T Transactions - Numerous significant transactions in the in vivo CAR-T space have occurred in 2025, indicating strong interest and investment potential. Notable deals include AstraZeneca's acquisition of EsoBiotech for $1 billion and BMS's agreement to acquire Orbital Therapeutics for $1.5 billion [5][14] Section 2: Market Performance - In the second week of October 2025, the pharmaceutical sector declined by 1.20%, underperforming the CSI 300 index by 0.69 percentage points, ranking 25th among 31 sub-industries. The hospital sector saw the largest increase at 1.79% [7][18] - The report provides a detailed analysis of sub-sector performance, with the hospital sector leading gains and the medical R&D outsourcing sector facing the most significant losses [24][28] Section 3: Recommended Stocks - The report recommends several stocks for investment, including Shiyao Group, Sunshine Nuohuo, and Yuekang Pharmaceutical, among others [8][16]

Investment Rating - The report rates the industry as "Overweight" [4] Core Insights - The siRNA drug industry is entering a new era with the maturation of technology platforms and the expansion of indications, focusing on the commercial value of siRNA drugs for common diseases [2][3] - siRNA drugs have transitioned from rare diseases to common diseases, showcasing strong target expansion capabilities, robust research and development extensibility, long-lasting effects, and low resistance [4][12] - The industry is witnessing a surge in business development (BD) transactions, particularly among multinational corporations (MNCs), indicating a vibrant market for siRNA technology [4][31] Summary by Sections 1. Dawn of a New Era for Small Nucleic Acid Drugs - Small nucleic acid drugs, including siRNA and ASO, are becoming a significant path for drug development, with a focus on their ability to regulate protein production [7] - The global approval of small nucleic acid drugs has reached 23, with siRNA drugs leading the way in rare disease applications [12][13] - Alnylam and other leading companies have demonstrated significant market capitalization differences due to their innovative drug development technologies [14][16] 2. Platform Characteristics and Focus on Indications - The siRNA drug industry is characterized by high barriers in modification and delivery, with a focus on breakthroughs in extrahepatic delivery systems [6][29] - The commercialization of siRNA drugs is accelerating, with multiple common diseases nearing market readiness [6][29] - The GalNAc delivery system has become the mainstream strategy for liver-targeted siRNA delivery, while breakthroughs in extrahepatic delivery are still needed [6][29] 3. Related Companies - Listed companies in the siRNA space include Yuyuan Pharmaceutical, Hengrui Medicine, and others, while unlisted companies include Bewang Pharmaceutical and others [4][12]

Core Viewpoint - The report from Open Source Securities indicates that small RNA drugs targeting weight loss are focusing on two main targets: INHBE and ALK7, with Arrowhead and Wave making the fastest progress in this area [1][2]. Group 1: Market Potential - The small RNA drug sector is expected to break into the billion-dollar weight loss market, with a focus on INHBE and ALK7 as key targets [1]. - INHBE is expressed in liver cells and plays a role in fat metabolism by encoding and secreting Activin E, which interacts with ALK7 [1]. Group 2: Company Progress - Arrowhead and Wave are leading in the development of INHBE siRNA molecules, with phase 1 trial data expected within the next six months [2]. - Alnylam, while slightly behind, has a comprehensive approach covering INHBE, ALK7, and GeneD for muscle targeting [2]. Group 3: Clinical Insights - Preclinical data shows that Arrowhead's ALK7 siRNA combined with Tirzepatide can enhance weight loss effects and provide longer-lasting efficacy, allowing for less frequent dosing [3]. - Genetic studies suggest that individuals with loss of function in INHBE or ALK7 exhibit healthier metabolic profiles, indicating that targeting these pathways may reduce visceral fat rather than just overall weight [3]. Group 4: Investment Recommendations - Short-term focus is recommended on Arrowhead and Wave's data readouts, particularly regarding safety, pharmacokinetics, dosing intervals, biomarker knockdown levels, early efficacy, and metabolic changes [4]. - Recommended stocks include Yuyuan Pharmaceutical (688658.SH), Sunshine Novo Nordisk (688621.SH), Rejuve Biotech (688068.SH), and Shiyao Group (01093), with beneficiaries including Frontier Biotech-U (688221.SH) and Hengrui Medicine (600276) (01276) [4].

Investment Rating - The report suggests a positive investment outlook for the small nucleic acid drug industry, highlighting its significant growth potential and advantages over traditional therapies [2]. Core Insights - The small nucleic acid drug technology is maturing, offering notable advantages such as shorter development cycles, a rich array of targets, lasting effects, and higher success rates in research and development [2]. - The global market for small nucleic acid drugs has grown from $2.7 billion in 2019 to $4.6 billion in 2023, with a compound annual growth rate (CAGR) of 14.3%. It is projected to reach $46.7 billion by 2033, growing at a CAGR of 26.1% from 2023 [2][41]. - Domestic companies are rapidly entering the market, focusing on chronic diseases rather than the traditional rare disease approach, with several products in clinical trials [2][63]. Summary by Sections 1. Introduction to Small Nucleic Acid Drugs - Small nucleic acid drugs include antisense oligonucleotides (ASO), small interfering RNA (siRNA), and aptamers, which are designed to target mRNA and regulate gene expression [8][12]. 2. Development and Commercialization of Small Nucleic Acid Drugs - The report outlines the historical development of small nucleic acid drugs, noting significant advancements post-2014 due to improved delivery systems [11][34]. - The market is currently dominated by ASO, which holds 62.5% of the market share, while siRNA has rapidly gained traction with a 36.7% share [18]. 3. Overview of Domestic and International Companies - Key domestic companies include Rebio, Shengnuo Pharmaceutical, and others, focusing on chronic diseases like cardiovascular issues and hepatitis B [2][63]. - International leaders such as Alnylam and Ionis are recognized for their pioneering work in the small nucleic acid drug space [2]. 4. Investment Analysis and Recommendations - The report recommends focusing on companies with proprietary technology platforms and advantageous pipelines, such as Rebio and Shengnuo Pharmaceutical [2].

Group 1 - The stock prices of Mengke Pharmaceutical dropped over 10% [1] - Borui Pharmaceutical and Baicheng Pharmaceutical experienced declines of over 7% [1] - Other companies such as Yuekang Pharmaceutical, Kangchen Pharmaceutical, Yuandong Biological, and Fuxiang Pharmaceutical also saw significant drops in their stock prices [1]

Core Viewpoint - Yuyuan Pharmaceutical experienced a 5.01% decline in stock price, closing at 22.58 yuan per share, with a trading volume of 156 million yuan and a turnover rate of 1.50%, resulting in a total market capitalization of 10.161 billion yuan [1] Company Overview - Yuyuan Pharmaceutical Group Co., Ltd. is located in Beijing Economic and Technological Development Zone and was established on August 14, 2001, with its listing date on December 24, 2020 [1] - The company focuses on the research and production of high-end chemical drugs, with major revenue contributions from cardiovascular drugs, digestive system drugs, diabetes medications, and anti-infection drugs [1] - Key products contributing significantly to revenue include Ginkgo biloba extract injection, Tianma injection, Lansoprazole injection, Omeprazole enteric-coated capsules, Metformin sustained-release tablets, Cefuroxime sodium injection, and Ceftriaxone sodium injection [1] - The revenue composition is as follows: cardiovascular drugs 55.67%, anti-infection 20.88%, raw materials 8.73%, digestive system 6.87%, diabetes 4.85%, others 2.62%, and technical services 0.02% [1] Shareholder Information - Southern Fund's Southern Medical Health Flexible Allocation Mixed A Fund (000452) is among the top ten circulating shareholders of Yuyuan Pharmaceutical, holding 7.2677 million shares, unchanged from the previous period, representing 1.62% of circulating shares [2] - The fund has incurred an estimated floating loss of approximately 8.6486 million yuan [2] - The fund was established on January 23, 2014, with a latest scale of 2.405 billion yuan, achieving a year-to-date return of 51.3% and a one-year return of 57.73% [2] Fund Management - The fund manager of Southern Medical Health Flexible Allocation Mixed A is Wang Zhengjiao, who has been in the position for 7 years and 63 days [3] - The total asset scale of the fund is 2.417 billion yuan, with the best return during the tenure being 75.78% and the worst return being -53.83% [3] Fund Holdings - Southern Medical Health Flexible Allocation Mixed A Fund has Yuyuan Pharmaceutical as its third-largest heavy stock, holding 7.2677 million shares, unchanged from the previous period, representing 5.72% of the fund's net value [4] - The fund has also experienced a floating loss of approximately 8.6486 million yuan [4]

Policy Developments - The Central Commission for Discipline Inspection and the National Supervisory Commission are intensifying efforts to rectify issues in the pharmaceutical sector, focusing on eliminating practices such as medical staff accepting "red envelopes" and improper benefits through academic exchanges [1] Drug and Device Approvals - YKYY013 injection from Yuyuan Pharmaceutical has received FDA approval for clinical trials aimed at treating chronic hepatitis B virus infection, which utilizes a dual-stranded siRNA mechanism to silence the virus [2] - *ST Suwu's hydrochloride lincomycin injection has passed the consistency evaluation for generic drugs, receiving approval from the National Medical Products Administration [3] - Tianjin Pharmaceutical's recombinant human urokinase (Puyouke) has been granted approval for a new indication for thrombolytic treatment of acute ischemic stroke, expanding its product line in the neurological field [4] Capital Market - Lepu Medical has entered into a strategic cooperation agreement with Hanhai Information Technology, aiming to enhance its medical aesthetics business through shared resources and a comprehensive sales network [5] Industry Events - The National Medical Insurance Administration has published the first batch of typical cases involving violations by designated medical institutions, highlighting issues such as falsifying medical records and duplicate charges [6] - Starting January 1, 2025, a new management system for medical insurance payment qualifications will be implemented, introducing a point-based system for violations to ensure the safety of medical insurance funds [7] Research and Development - Researchers at Kunming University of Science and Technology have successfully constructed an in vitro model of the stomach, providing a new platform for studying human gastric organ development [8] Public Sentiment Alerts - Zhejiang Pharmaceutical announced that its shareholder, Guotou Gaoke, plans to reduce its stake by up to 1% within three months, which will not affect the company's control [9]

Group 1 - Xinxiang Chemical Fiber will suspend production for approximately 90 days starting October 1, 2025, affecting an annual capacity of 31,200 tons, resulting in a revenue decrease of approximately 185 million yuan and a profit reduction of about 48 million yuan [1] - Bozhong Precision plans to transfer 18.29% of its stake in Suzhou Linghou Robot for 64 million yuan, retaining a 21.61% ownership post-transaction [1] - Haixing Electric is a recommended candidate for a State Grid procurement project, with an expected bid amount of approximately 128 million yuan [2] Group 2 - Samsung Medical is a recommended candidate for multiple State Grid procurement projects, with a total expected bid amount of approximately 193 million yuan [2][3] - Youxunda is a recommended candidate for a State Grid procurement project, with a bid amount of approximately 107 million yuan, representing 10.55% of its 2024 revenue [3] - Tiancheng Self-Control has received a notification for a seat assembly project from a well-known domestic new energy vehicle company, expected to start mass production in June 2026 [4] Group 3 - YKYY013 injection has received FDA approval for clinical trials to treat chronic hepatitis B virus infection [4] - Pulaide has signed a strategic cooperation agreement with an international electric tool brand, with a total procurement amount exceeding 700 million yuan over five years [4] - Sichuan Shuangma's subsidiary has obtained GMP certification from Russia, covering core aspects of drug quality and production systems [6] Group 4 - Boshi Co. has signed an industrial service contract worth approximately 96.99 million yuan with Guoneng Baotou Coal Chemical [7] - Wansheng Intelligent is a recommended candidate for a State Grid project, with an expected bid amount of approximately 67.98 million yuan, representing 7.25% of its 2024 revenue [9][10] - Huazi Industrial plans to sell its dairy farm assets for 38.5 million yuan, expecting a positive impact of approximately 11.7 million yuan on its current profits [10] Group 5 - Jinguang Electric has won a State Grid project with a total bid amount of approximately 28.4 million yuan, accounting for 3.82% of its 2024 revenue [11] - Nanjiao Food reported a net profit of 10,410 yuan for August, a year-on-year decrease of 98.31% [13] - Dongfang Bio's subsidiary has obtained registration certificates for two medical device products [15] Group 6 - Lanhua Kecai has signed a strategic cooperation agreement with Shanghai Pangu Power to promote intelligent and efficient transformation in the coal mining industry [17] - Yabao Pharmaceutical has decided to terminate the SY-009 research project, with a total investment of approximately 87.87 million yuan to be fully impaired [18] - Tian Shili's subsidiary has received approval for a new indication for its recombinant human urokinase injection for acute ischemic stroke treatment [20] Group 7 - Su Yan Jingshen's executives plan to increase their shareholding in the company, with a total investment of between 1.9 million and 2.66 million yuan [22] - Baiyun Electric and its subsidiary have won a State Grid project with a total bid amount of approximately 162 million yuan, covering multiple equipment types [23] - China West Electric's director has resigned due to work reasons, effective September 19, 2025 [25] Group 8 - Jianan Intelligent is a recommended candidate for a State Grid project with a total expected bid amount of approximately 73.12 million yuan [26] - Juhua Technology is a recommended candidate for a State Grid project with a total expected bid amount of approximately 142 million yuan [27] - Tengyuan Cobalt's actual controller has committed not to reduce holdings for the next 12 months, holding 37.89% of the total shares [28] Group 9 - Changfei Optical Fiber announced that Draka Comteq B.V. no longer holds H shares in the company after selling 37.59 million shares [28] - Mongcao Ecological's subsidiary has signed a contract for an ecological restoration project worth 225.2 million yuan [29] - Weiao Co. plans to distribute a cash dividend of 0.1 yuan per share, totaling approximately 39.29 million yuan [30]

悦康药业集团股份有限公司 关于自愿披露子公司 YKYY013 注射液 获得 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"）于近日获得美国食品药品监督管理 局（以下简称"FDA"）关于同意 YKYY013 注射液用于治疗慢性乙型肝炎病毒 感染进行临床试验的函告（Study May Proceed Letter，IND 编号：177486）。现 将相关情况公告如下： 一、函告主要内容： 证券代码：688658 证券简称：悦康药业 公告编号：2025-040 基因组转录的信使 RNA（Messenger RNA，mRNA），进而抑制乙肝病原蛋白的 产生，抑制 HBV 的复制，并为宿主免疫重建创造条件，最终实现乙肝的功能性 治愈。临床拟用于慢性乙型肝炎病毒感染的治疗。 临床前研究结果显示，YKYY013 注射液在体内、外均展现出显著的 HBV 抑制活性，且对 HBV 十种基因型（A–J）均具有广 ...

YKYY013 注射液是悦康科创和公司全资子公司杭州天龙药业有限公司自主研发的一款偶联 N-乙酰半乳 糖胺（N-acetylgalactosamine，GalNAc）配体的化学合成双链 siRNA 药物，通过 RNA 干扰作用有效沉 默乙型肝炎病毒（HBV）基因组转录的信使 RNA（Messenger RNA，mRNA），进而抑制乙肝病原蛋 白的产生，抑制 HBV 的复制，并为宿主免疫重建创造条件，最终实现乙肝的功能性治愈。临床拟用于 慢性乙型肝炎病毒感染的治疗。 格隆汇9月22日丨悦康药业(688658.SH)公布，公司子公司北京悦康科创医药科技股份有限公司（称"悦 康科创"）于近日获得美国食品药品监督管理局（简称"FDA"）关于同意 YKYY013 注射液用于治疗慢 性乙型肝炎病毒感染进行临床试验的函告（Study May Proceed Letter，IND 编号：177486）。 ...