Group 1 - The company has received the drug registration certificate for Brexpiprazole tablets from the National Medical Products Administration, marking a significant milestone for the product [1][2] - Brexpiprazole tablets are indicated for the treatment of adult schizophrenia and are classified as a Class 4 chemical drug with a shelf life of 12 months [1][2] - The product is the first domestically approved generic drug under the new registration classification, equivalent to passing the consistency evaluation [2][4] Group 2 - Brexpiprazole was originally developed by Otsuka Pharmaceutical Co., Ltd. and was approved for sale in the U.S. in July 2015, with the product expected to be imported into China by June 2024 [2] - Currently, only the original Otsuka product is available in the domestic market, with sales amounting to approximately 160,000 yuan in the first half of 2025 [2] - The approval of Brexpiprazole tablets is not expected to have a significant impact on the company's recent performance, although uncertainties may arise during the production and sales phase [4]

Core Viewpoint - Yuan Dong Bio has received approval from the National Medical Products Administration for the drug registration certificate of Brupiprazole Tablets [2] Company Summary - The drug approved is named Brupiprazole Tablets, indicating a significant milestone for Yuan Dong Bio in expanding its product portfolio [2]

关于自愿披露布瑞哌唑片获得药品注册证书的公告 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。 成都苑东生物制药股份有限公司（以下简称"公司"）于近日收到国家药品监 督管理局（以下简称"国家药监局"）核准签发的《药品注册证书》，现将相关情 况公告如下： 证券代码：688513 证券简称：苑东生物 公告编号：2025-081 成都苑东生物制药股份有限公司 一、药品基本情况 药品名称：布瑞哌唑片 剂型：片剂 规格：1mg、2mg、4mg 注册分类：化学药品 4 类 药品有效期：12 个月 上市许可持有人：成都苑东生物制药股份有限公司 生产企业：成都苑东生物制药股份有限公司 药品注册标准编号：YBH29902025 受理号：CYHS2402228、CYHS2402229、CYHS2402230 证书编号：2025S03610、2025S03611、2025S03612 药品批准文号：国药准字 H20256114、国药准字 H20256115、国药准字 H20256116 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查 ...

Core Viewpoint - Yuan Dong Biotech (688513) has received approval from the National Medical Products Administration for the registration of its drug, Brexpiprazole Tablets, which is indicated for the treatment of adult schizophrenia [1] Company Summary - The approved drug, Brexpiprazole, contains the active ingredient brexpiprazole and is specifically aimed at treating adult patients with schizophrenia [1]

Core Viewpoint - Yuan Dong Biotechnology (688513.SH) has received the drug registration certificate from the National Medical Products Administration (NMPA) for its drug, Brexpiprazole tablets, which are indicated for the treatment of adult schizophrenia [1] Group 1: Product Development - Brexpiprazole tablets contain the active ingredient Brexpiprazole and were originally developed by Otsuka Pharmaceutical Co., Ltd. [1] - The drug was approved for marketing in the United States in July 2015 under the brand name Rexulti® and is expected to be imported into China by June 2024 [1] Group 2: Market Position - Currently, the only available product in the domestic market is the imported original drug, and Yuan Dong's product is the first domestically approved generic drug under the new registration classification, which is considered to have passed the consistency evaluation [1]

Core Viewpoint - The approval of the drug Brupiprazole tablets by the National Medical Products Administration signifies compliance with drug registration requirements, although it is not expected to have a significant impact on the company's recent performance [1] Group 1: Drug Approval Details - The drug name is Brupiprazole tablets, available in dosages of 1mg, 2mg, and 4mg [1] - It is classified as a Class 4 chemical drug with a validity period of 12 months [1] - The active ingredient is Brupiprazole, indicated for the treatment of adult schizophrenia [1] Group 2: Impact on Company Performance - The approval of Brupiprazole tablets is not anticipated to have a major impact on the company's recent financial performance [1]

- The report introduces two key tracking indicators: "Large Order Transaction Amount Proportion" and "Net Active Buy Amount Proportion" [7] - The "Large Order Transaction Amount Proportion" is designed to capture the buying behavior of large funds. It is calculated by identifying large orders from transaction data and computing the proportion of large buy orders' transaction amounts relative to the total daily transaction amount [7] - The "Net Active Buy Amount Proportion" reflects investors' active buying behavior. It is derived by distinguishing active buy and sell transactions from transaction data, calculating the net active buy amount (active buy amount minus active sell amount), and expressing it as a proportion of the total daily transaction amount [7] Factor Backtesting Results - For individual stocks, the top 10 stocks with the highest 5-day average "Large Order Transaction Amount Proportion" include Xinhua Du (90.6%, 99.2% percentile), Beichen Industrial (89.1%, 98.8% percentile), and Zhongyou Engineering (88.8%, 100.0% percentile) [9] - For individual stocks, the top 10 stocks with the highest 5-day average "Net Active Buy Amount Proportion" include Senying Windows (22.3%, 100.0% percentile), Huitong Group (20.0%, 100.0% percentile), and Yuandong Biotech (19.6%, 100.0% percentile) [10] - For broad-based indices, the 5-day average "Large Order Transaction Amount Proportion" ranges from 71.7% (Shanghai 50 Index) to 74.3% (China Securities 500 Index), while the "Net Active Buy Amount Proportion" ranges from -5.2% (Shanghai 50 Index) to 1.9% (China Securities 500 Index) [12] - For industries, the 5-day average "Large Order Transaction Amount Proportion" is highest in the banking sector (80.6%, 86.5% percentile) and lowest in the electronics sector (70.8%, 16.4% percentile). The "Net Active Buy Amount Proportion" is highest in the steel sector (7.9%, 75.8% percentile) and lowest in the banking sector (-14.6%, 3.3% percentile) [13] - For ETFs, the top 10 ETFs with the highest 5-day average "Large Order Transaction Amount Proportion" include Guotai CSI A500 ETF (92.3%, 36.1% percentile) and Guotai SSE 10-Year Treasury Bond ETF (90.7%, 89.3% percentile) [15] - For ETFs, the top 10 ETFs with the highest 5-day average "Net Active Buy Amount Proportion" include Southern SSE STAR Chip ETF (27.5%, 100.0% percentile) and E Fund Hang Seng Dividend Low Volatility ETF (23.6%, 99.6% percentile) [16]

Core Viewpoint - Chengdu Yuandong Pharmaceutical Co., Ltd. announced that its wholly-owned subsidiary, Chengdu ShuoDe Pharmaceutical Co., Ltd., successfully passed the FDA's pre-approval inspections for its Naloxone nasal spray product with zero deficiencies [1][2]. Group 1: Inspection Details - The FDA inspections took place from May 6 to 9 and May 16 to 22, 2025, focusing on current Good Manufacturing Practices (cGMP) and BioResearch Monitoring (BIMO) [1]. - The inspections were conducted for the Naloxone nasal spray product, specifically on the nasal spray production line [1]. - The inspection concluded with a zero deficiency report (no 483), indicating compliance with FDA standards [1]. Group 2: Product and Company Impact - This inspection marks the second time ShuoDe Pharmaceutical has undergone an FDA inspection and the first for its nasal spray production line [1]. - The successful inspection is expected to expedite the approval process for the company's submitted Abbreviated New Drug Applications (ANDA) in the U.S. and support the implementation of its internationalization strategy [1].

Core Viewpoint - The company, Yuandong Biotech (688513.SH), announced that its wholly-owned subsidiary, Chengdu Shode Pharmaceutical Co., Ltd., successfully passed FDA inspections for its naloxone nasal spray, receiving zero deficiencies in the reports [1] Group 1 - The FDA conducted current Good Manufacturing Practice (cGMP) inspections and Bioresearch Monitoring (BIMO) inspections from May 6 to May 9 and May 16 to May 22, 2025 [1] - The inspections were part of the approval process for the naloxone nasal spray [1] - Chengdu Shode Pharmaceutical received two Establishment Inspection Reports (EIR) from the FDA, indicating compliance with regulatory standards [1]

Core Viewpoint - The company, Yuandong Biotech (688513.SH), announced that its wholly-owned subsidiary, Chengdu Shode Pharmaceutical Co., Ltd., successfully passed FDA inspections for the production of Naloxone nasal spray with zero deficiencies [1] Group 1 - The inspections conducted by the FDA included Current Good Manufacturing Practice (cGMP) and Bioresearch Monitoring (BIMO) [1] - The inspections took place from May 6 to May 9 and May 16 to May 22, 2025 [1] - The company received two Establishment Inspection Reports (EIR) from the FDA confirming the successful inspections [1]