这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 天士力的普佑克新增适应症获批 9月22日，天士力(600535.SH)公告称，公司全资子公司天士力生物收到国家药品监督管理局核准签发的 《药品注册证书》，批准注射用重组人尿激酶原（普佑克）新增急性缺血性脑卒中的溶栓治疗适应症。 普佑克作为国内目前唯一获批上市的重组人尿激酶原产品，也是首个获批"十一五"规划期间国家"重大 新药创制"科技重大专项支持下的1类生物创新药。该药已上市适应症为急性ST段抬高型心肌梗死，本 次新增急性缺血性脑卒中溶栓治疗适应症的获批丰富了公司神经/精神领域产品线。 资本市场 政策动向 驻国家卫生健康委纪检监察组聚焦整治重点 加力推进医药领域纠风治乱 9月22日，中央纪委国家监委网站发布《驻国家卫生健康委纪检监察组聚焦整治重点 加力推进医药领域 纠风治乱》一文，指出持续净化医药领域政治生态和行业生态，是维护人民群众切身利益的必然要求。 记者近日从中央纪委国家监委驻国家卫生健康委纪检监察组了解到，该纪检监察组今年以来加力推进医 药领域纠风治乱，督促综合监督单位重点纠治医务人员收受"红包"、假借学术交 ...

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]

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）。 ...

北京商报讯（记者 丁宁）9月22日晚间，悦康药业（688658）发布公告称，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。 公告显示，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。 ...

人民财讯9月22日电，悦康药业(688658)9月22日公告，子公司北京悦康科创医药科技股份有限公司近日 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。 ...

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。 悦康药业(688658.SH)发布公告，公司子公司北京悦康科创医药科技股份有限公司(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)。 ...

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。 智通财经APP讯，悦康药业(688658.SH)发布公告，公司子公司北京悦康科创医药科技股份有限公司(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)。 ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 25.35 CNY, based on a 65x PE valuation for 2026 [4][9]. Core Views - The company's performance is under pressure due to the price adjustment of its core product, Ginkgo biloba extract injection, which has significantly impacted revenue and profit margins [12]. - The company is accelerating its small nucleic acid drug pipeline, which shows potential for international expansion, with several products already in clinical trials in both China and the United States [12]. - Increased investment in R&D is evident, with R&D expenses rising to 2.1 billion CNY, accounting for 17.9% of revenue, indicating a commitment to innovation [12]. Financial Performance Summary - Revenue is projected to decline from 4,196 million CNY in 2023 to 3,107 million CNY in 2025, reflecting a year-on-year decrease of 17.8% [6]. - Operating profit is expected to drop significantly to 76 million CNY in 2025, down from 232 million CNY in 2023, with a projected recovery in subsequent years [6]. - The net profit attributable to the parent company is forecasted to decrease to 57 million CNY in 2025, a decline of 53.7% compared to 2023 [6]. - The gross margin is expected to decline to 49.3% in 2025, with a gradual recovery projected thereafter [6].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 25.35 CNY, based on a 65 times PE valuation for 2026 [4][9]. Core Views - The company's performance is under pressure due to the price adjustment of its core product, Ginkgo biloba extract injection, which has significantly impacted revenue and profit margins [12]. - The company is accelerating its small nucleic acid drug pipeline, which shows potential for international market expansion [12]. - Increased investment in R&D is noted, with R&D expenses projected to rise, indicating a commitment to innovation [12]. Financial Performance Summary - Revenue for 2025 is expected to decline to 3,107 million CNY, a decrease of 17.8% year-on-year, with a gradual recovery projected in subsequent years [6]. - Operating profit is forecasted to drop to 76 million CNY in 2025, reflecting a 52.0% decline, but is expected to rebound significantly in 2026 [6]. - Net profit attributable to the parent company is projected to be 57 million CNY in 2025, down 53.7% from the previous year, with a recovery anticipated in 2026 [6]. - The company’s gross margin is expected to decrease to 49.3% in 2025, with a gradual improvement in the following years [6]. R&D and Product Pipeline - The company has 42 ongoing R&D projects, including 21 innovative drugs and 21 generic drugs, with several key products in the NDA review stage [12]. - The small nucleic acid drug YKYY015 and YKYY029 are undergoing clinical trials in both China and the US, indicating strong development activity [12]. - The company has also received FDA approval for its RSV and VZV mRNA vaccines, showcasing its expanding product portfolio [12].