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 ...

Core Viewpoint - YKYY013 injection, developed by the company and its subsidiary, has received FDA approval for clinical trials to treat chronic hepatitis B virus infection [1] Group 1: Product Development - YKYY013 is a chemically synthesized double-stranded siRNA drug that utilizes an N-acetylgalactosamine (GalNAc) ligand [1] - The drug works through RNA interference to effectively silence the HBV genome's messenger RNA, inhibiting the production of hepatitis B pathogen proteins and HBV replication [1] - The ultimate goal of YKYY013 is to achieve functional cure for hepatitis B by creating conditions for host immune reconstitution [1] Group 2: Regulatory Approval - The FDA has issued a Study May Proceed Letter (IND number: 177486) allowing the company to initiate clinical trials for YKYY013 [1] - This regulatory milestone is significant for the company's pipeline and potential market entry in the hepatitis B treatment sector [1]

Core Viewpoint - YKYY013 injection, developed by Yuyuan Pharmaceutical's subsidiary, has received FDA approval for clinical trials targeting chronic hepatitis B virus infection [1] Company Summary - Yuyuan Pharmaceutical's subsidiary, Beijing Yuyuan Kete Pharmaceutical Technology Co., Ltd., is responsible for the development of YKYY013 injection [1] - The injection is a chemically synthesized double-stranded siRNA drug that utilizes N-acetylgalactosamine (GalNAc) as a ligand [1] - The drug aims to silence the HBV genome transcription messenger RNA through RNA interference, thereby inhibiting the production of hepatitis B pathogen proteins and HBV replication [1] Industry Summary - The clinical application of YKYY013 injection is focused on treating chronic hepatitis B virus infections [1] - The drug is designed to create conditions for host immune reconstitution, ultimately aiming for functional cure of hepatitis B [1]

Core Viewpoint - YKYY013 injection, developed by the company and its subsidiary, has received FDA approval to proceed with clinical trials for the treatment of chronic hepatitis B virus infection [1] Group 1: Company Developments - The company’s subsidiary, Beijing YKang Kechuang Pharmaceutical Technology Co., Ltd., has obtained a Study May Proceed Letter from the FDA for YKYY013 injection [1] - YKYY013 is a chemically synthesized double-stranded siRNA drug that utilizes an N-acetylgalactosamine ligand for RNA interference to silence HBV mRNA [1] Group 2: Product Details - The drug aims to inhibit the production of HBV proteins, suppress HBV replication, and create conditions for host immune reconstruction, ultimately targeting functional cure for hepatitis B [1] - The clinical application is specifically focused on treating chronic hepatitis B virus infections [1]

Core Viewpoint - Yuyuan Pharmaceutical (688658) announced that its subsidiary, Beijing Yuyuan Ketech Pharmaceutical Technology Co., Ltd., has received approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials for YKYY013 injection for the treatment of chronic hepatitis B virus infection [1] Company Summary - Yuyuan Pharmaceutical's subsidiary has obtained FDA approval for clinical trials [1] - The drug YKYY013 is aimed at treating chronic hepatitis B virus infection [1] Industry Summary - The approval from the FDA highlights the ongoing developments in the pharmaceutical industry, particularly in the area of hepatitis B treatments [1]

Core Viewpoint - YKYY013 injection, developed by the company and its subsidiary, has received FDA approval to proceed with clinical trials for the treatment of chronic hepatitis B virus infection [1] Group 1: Company Developments - The company’s subsidiary, Beijing YK Innovation Pharmaceutical Technology Co., Ltd., has obtained a Study May Proceed Letter from the FDA for YKYY013 injection [1] - YKYY013 is a chemically synthesized double-stranded siRNA drug that utilizes an N-acetylgalactosamine ligand [1] Group 2: Product Details - YKYY013 works through RNA interference to effectively silence the HBV genome's messenger RNA, thereby inhibiting the production of hepatitis B viral proteins and replication [1] - The drug aims to create conditions for host immune reconstitution, ultimately achieving functional cure for hepatitis B [1]

Core Viewpoint - YKYY13 injection, developed by YKYY13 and Hangzhou Tianlong Pharmaceutical, has received FDA approval for clinical trials to treat chronic hepatitis B virus infection, marking a significant milestone in its development [1] Company Summary - YKYY13 injection is a double-stranded siRNA drug aimed at achieving functional cure for hepatitis B by inhibiting HBV replication and pathogen protein production through RNA interference [1] - Preclinical studies have demonstrated significant HBV suppression activity in vitro and in vivo, along with good safety and tolerability in animal trials [1] Industry Summary - The FDA's approval signifies a phase of success in the drug's development, although the company cautions investors about the inherent uncertainties in drug development [1]