证券代码：002294 证券简称：信立泰 编号：2026-002 关于 SAL0150 药品临床试验申请获得受理的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 近日，深圳信立泰药业股份有限公司（下称"公司"）收到国家药品监督管 理局核准签发的受理通知书，公司自主研发的创新药 SAL0150 片（项目代码： SAL0150）临床试验申请获得受理。 现就相关信息公告如下： 一、药品基本情况 药品名称：SAL0150 片 申请事项：境内生产药品注册临床试验 深圳信立泰药业股份有限公司 自受理之日起 60 日内，未收到药审中心否定或质疑意见的，申请人可以按 照提交的方案开展临床试验。 公司本次提交的申请为 SAL0150 用于 2 型糖尿病及其并发症、肥胖或超重 的临床试验申请。 二、其他相关情况 SAL0150 是具有自主知识产权的口服长效药物，预计可以实现≥一周一次 的口服给药频次，对于肥胖、2 型糖尿病及其并发症等具有良好的治疗效果，安 全性较优，若能研发成功并获批上市，将有望为患者提供新的用药选择，满足未 被满足的临床需求，并进一步丰富公司慢病领域的创 ...

Core Viewpoint - The company, Sinopharm (002294.SZ), has received a notice of acceptance from the National Medical Products Administration for its clinical trial application of the innovative drug SAL0150, aimed at treating type 2 diabetes and its complications, as well as obesity or overweight conditions [1] Group 1 - The clinical trial application for SAL0150 has been officially accepted [1] - SAL0150 is developed independently by the company [1] - The application targets type 2 diabetes and its complications, along with obesity or overweight [1]

Core Viewpoint - The company has received acceptance from the National Medical Products Administration for the clinical trial application of its innovative drug SAL0150, aimed at treating type 2 diabetes and its complications, as well as obesity or overweight conditions [1] Group 1: Drug Development - SAL0150 is an oral long-acting medication with independent intellectual property rights, expected to allow for administration once a week or longer [1] - If successfully developed and approved for market, SAL0150 could enhance the company's pipeline of innovative products in the chronic disease sector [1] Group 2: Market Impact - The drug development cycle is lengthy and carries high risks, with uncertainties from clinical trials to market approval [1] - There is no immediate impact on the company's performance in the short term due to the nature of drug development [1]

Core Viewpoint - The company, Xinlitai, has received approval from the National Medical Products Administration for its clinical trial application of the innovative drug SAL0150, which is intended for the treatment of type 2 diabetes and its complications, as well as obesity or overweight conditions [1] Group 1: Drug Development - SAL0150 is an innovative drug developed by the company that possesses independent intellectual property rights [1] - The drug is expected to allow for an oral administration frequency of once a week or more [1] - Following the acceptance of the clinical application, the drug must still obtain implied permission for clinical trials and must adhere to national drug registration regulations to conduct these trials [1] Group 2: Market Impact - The clinical trial's success is necessary for the drug to be registered and submitted for approval [1] - The drug development cycle is lengthy and carries high risks, with various factors influencing the timeline from clinical trials to market launch [1] - There is uncertainty regarding the short-term impact on the company's performance due to the drug's development stage [1]

Group 1 - The A-share market continues to show strength in innovative drug concept stocks, with notable gains from companies such as Bibot-U nearing the daily limit and reaching a new high, and Yuandong Bio rising over 9% [1] - The National Medical Products Administration (NMPA) is set to support the "China debut" of innovative drugs, with plans to implement a data protection system for drug trials and establish exclusive market periods for pediatric and rare disease medications by 2026 [1] - The NMPA has announced further optimization of the review and approval process for urgently needed foreign drugs already on the market to meet the pressing clinical needs of patients [1] Group 2 - Notable stock performances include Bibot-U with a 19.95% increase, Yuandong Bio up 9.33%, and Hongbo Pharmaceutical rising 8.16%, among others [2] - The total market capitalization for Bibot-U is 22.3 billion, while Yuandong Bio stands at 11.5 billion, and Hongbo Pharmaceutical at 4.867 billion [2] - Year-to-date performance shows Bibot-U leading with a 70.89% increase, followed by Hongbo Pharmaceutical at 16.74% and Lai Mei Pharmaceutical at 7.59% [2]

Core Viewpoint - The innovative drug ETF Tianhong (517380) has seen significant trading activity and growth, indicating a strong interest in the innovative drug sector, which is experiencing a historic surge in IPOs and commercialization efforts [1][4]. Group 1: ETF Performance - As of January 8, 2026, the innovative drug ETF Tianhong (517380) recorded a transaction volume of 18.58 million yuan, with the tracked index HSSSHID rising by 0.92% [1]. - The latest scale of the innovative drug ETF Tianhong reached 1.578 billion yuan, with a total of 1.962 billion shares, both marking all-time highs since its inception [2]. - The net inflow of funds into the innovative drug ETF Tianhong was 89.42 million yuan, the highest since April 2025 [3]. Group 2: Market Trends - The innovative drug sector is experiencing a "volume and price increase" opportunity, with the top ten constituent stocks of the ETF heavily weighted towards leading companies like WuXi AppTec and HengRui Medicine, benefiting from a surge in business development (BD) transactions and breakthroughs in AI drug development [3]. - In 2025, the innovative drug sector achieved a historic explosion, with over 30 biotech companies successfully listed in A-shares and Hong Kong, and more than 50 companies awaiting approval, reflecting unprecedented capital activity [4]. - The sector has transitioned from mere speculation to substantial commercialization, becoming a benchmark sector with both growth potential and certainty in the current bull market [4]. Group 3: Institutional Insights - Southwest Securities noted that in early 2025, Hong Kong companies began achieving BD, leading to a rise in the innovative drug sector; a government report in March emphasized support for innovative drugs and medical devices, further boosting A-share performance [5]. - The sector experienced a significant price increase following a major BD deal worth 1.25 billion USD in May, but faced a high-level adjustment by the end of the third quarter [5]. - The firm predicts that in 2026, the innovative drug sector will shift from a broad rally to a selective stock market [5].

Important Matters - Pritchard has achieved a significant breakthrough in LCP film technology, being the only company in China to do so, and is collaborating with overseas clients for applications in brain-computer interfaces [1] - Zhongtian Rocket's small guided rocket products primarily serve military trade, with product gross margins fluctuating between 35% and 40% [1] - CIMC's subsidiary is providing liquid oxygen storage tanks and other equipment in the commercial aerospace sector, with expected revenue and orders exceeding 100 million yuan by 2025 [1] - Gaode Infrared is supplying infrared detector cores for commercial aerospace and satellite applications [1] - Zhongfu Shenying's M55J-grade carbon fiber is undergoing application verification in satellite structural components [1] Investment and Operations - Dazhong Mining plans to invest 3.688 billion yuan in a 20 million tons per year lithium mining and selection project [1] - Zhongkuang Resources has commenced trial production for a high-purity lithium salt project with an annual output of 30,000 tons [1] - Cuiwei Co., Ltd. has indirectly invested 150 million yuan in Super Fusion through its subsidiary fund [1] - Huagong Technology has launched a self-developed silicon photonic chip for 1.6T optical modules [1] - Gaomei Co., Ltd. has formed small batch orders for composite tungsten wire tendon ropes [1] - Xinlitai's innovative drug SAL0145 injection has had its clinical trial application accepted [1] - Hengrui Medicine's innovative drug Rilaforpu α injection has been approved for market launch, with no similar products approved domestically or internationally [1] - Yifan Pharmaceutical's wholly-owned subsidiary has received a registration acceptance notice for Yihuang Decoction granules, with no similar products from the same prescription available domestically [1] Partnerships and Collaborations - Taisheng Wind Power has formed strategic partnerships with multiple arrow manufacturers [2] - Guangqi Technology's subsidiary has signed batch production contracts totaling 264 million yuan for metamaterials with four clients [2] - Lingyi Intelligent Manufacturing has reached a strategic cooperation agreement with Qiangnao Technology [2] Performance - Zhongke Lanyun expects a net profit increase of 367%-377% year-on-year in 2025, driven by significant fair value changes from investments in Moer Thread and Muxi Co., Ltd. [2] - Kangchen Pharmaceutical anticipates a net profit increase of 243%-315% year-on-year in 2025 [2] - Chuanjinno expects a net profit increase of 144%-173% year-on-year in 2025 [2] - Beifang Navigation forecasts a net profit increase of 86.32%-137.14% year-on-year in 2025 [2]

Group 1 - The core point of the article is that the company Xinlitai has announced that its self-developed siRNA innovative drug SAL0145 injection has received acceptance for clinical trial application by the National Medical Products Administration, which is intended for the treatment of MASH. If approved, it will enrich the innovative product pipeline in the chronic disease sector [2] Group 2 - The drug SAL0145 is positioned to address a significant medical need in the chronic disease treatment area, indicating potential market opportunities for the company [2] - The acceptance of the clinical trial application marks a critical step in the drug development process, highlighting the company's commitment to innovation in the pharmaceutical industry [2] - The announcement reflects the ongoing trend of increasing investment in research and development for innovative therapies within the healthcare sector [2]

Core Viewpoint - The company, Xinlitai (002294.SZ), has received a notice of acceptance from the National Medical Products Administration for its innovative drug SAL0145 injection, which targets Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) [1] Group 1: Product Development - SAL0145 is an innovative drug developed by the company, aimed at treating MASH, a severe form of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) [1] - MASH affects approximately 30% of the adult population globally, and if left untreated, it can progress to cirrhosis or liver cancer, posing significant health risks to patients [1] - Preclinical studies indicate that SAL0145 has the potential to treat MASH, and successful development and approval could provide new treatment options for patients, addressing unmet clinical needs [1] Group 2: Market Implications - The approval of SAL0145 would enrich the company's pipeline of innovative products in the chronic disease sector, potentially enhancing its market position [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial application of its innovative drug SAL0145 injection, which is intended for the treatment of MASH [1] Group 1 - The clinical trial application for SAL0145 has been accepted, indicating progress in the drug development process [1] - SAL0145 is a siRNA drug developed by the company, showcasing its capability in innovative drug research and development [1] - The drug has independent intellectual property rights, highlighting the company's commitment to proprietary research [1]