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]

Core Viewpoint - Yuan Dong Biotech (688513.SH) announced that its subsidiary, Shuo De Pharmaceutical, received two on-site inspection reports from the US FDA, passing with zero deficiencies, which indicates compliance with FDA standards and supports the acceleration of its ANDA product approval process in the US [1] Group 1 - Shuo De Pharmaceutical successfully passed its second FDA on-site inspection, marking the first inspection of its nasal spray production line [1] - The inspected product is Naloxone Hydrochloride Nasal Spray, with FDA FEI number 3018360274 [1] - The successful inspection reflects the company's adherence to production management quality systems and regulatory compliance, facilitating the implementation of its internationalization strategy [1]

成都苑东生物制药股份有限公司 关于自愿披露全资子公司硕德药业通过美国 FDA 现场检查的公告 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。 证券代码：688513 证券简称：苑东生物 公告编号：2025-080 FDA FEI：3018360274 成都苑东生物制药股份有限公司（以下简称"公司"）全资子公司成都硕德 药业有限公司（以下简称"硕德药业"）分别于 2025 年 5 月 6 日至 9 日、5 月 16 日至 22 日接受了来自美国食品药品监督管理局（以下简称"FDA"）的现行药品 生产质量管理规范（cGMP）现场检查和生物研究监测（BIMO）现场检查，系 盐酸纳洛酮鼻喷剂的批准前检查。 近日，硕德药业收到美国 FDA 出具的两份现场检查报告（即 EIR， Establishment Inspection Report），硕德药业以零缺陷（no 483）通过了上述现场 检查。现就相关情况公告如下： 一、本次检查的基本情况 检查事由：药品批准前检查（ PAI） 涉及产品：盐酸纳洛酮鼻喷剂 涉及生产线：鼻喷剂生产线 ...

Core Viewpoint - The company has successfully passed the FDA's cGMP and BIMO inspections for its product, Naloxone nasal spray, which is expected to expedite the approval process for its ANDA products in the U.S. market and support its internationalization strategy [1] Group 1 - The company's wholly-owned subsidiary, Chengdu ShuoDe Pharmaceutical Co., Ltd., underwent FDA inspections from May 6 to 9 and May 16 to 22, 2025 [1] - The inspections resulted in a "zero defect" outcome (no 483), indicating compliance with FDA standards in production management quality systems and operational compliance [1] - The positive inspection results are anticipated to accelerate the approval timeline for the company's ANDA products in the U.S. [1]

Core Viewpoint - Yuan Dong Biological announced on November 24 that the company will disclose the number of shareholders at specific points in time in its periodic reports [2] Group 1 - The company will provide updates on shareholder numbers in its regular financial disclosures [2]

Core Insights - The company reported Q3 2025 revenue of 365 million yuan (-1.55%) and a net profit attributable to shareholders of 83.59 million yuan (+18.52%, including stock incentive expenses), with a non-GAAP net profit of 69.19 million yuan (+27.85%, including stock incentive expenses), indicating a significant profit surprise due to new product launches and controlled investment in generic drug R&D [1] Group 1: Business Performance - The main business has reached a turning point, with expectations for a return to high growth. The impact of the tenth batch of national procurement has pressured H1 2025 performance, but the second half is expected to benefit from a low base, gradually alleviating procurement pressures [2] - Core products such as Butorphanol, Nalbuphine, and Oxazepam have entered a rapid growth phase, with Q3 2025 operational trends expected to continue and accelerate [2] Group 2: Internationalization and Innovation - The company has achieved breakthroughs in internationalization, with the Naloxone nasal spray production line passing FDA pre-approval inspections with zero defects and awaiting the final inspection report. Exclusive commercialization agreements have been signed with agents in the U.S. and Canada [2] - Strategic control of Chaoyang Pharmaceutical has strengthened the innovation engine, with the company increasing its stake to 51.48% and integrating its core pipeline into the company's innovation system [3] - The progress of Chaoyang's pipeline is promising, with the core product HP-001 showing good safety in Phase I clinical trials and demonstrating "Best-in-Class" potential [3] - The company has also made breakthroughs in independent R&D, with multiple projects entering clinical trials, including the ADC drug YLSHO03 and the third-generation calcium channel modulator EP-02260 [3] Group 3: Investment Outlook - The company is rapidly launching new products while actively adjusting R&D investments in generics. Despite the significant impact of the tenth batch of national procurement, the company is expected to unlock stock incentive profit assessment indicators for the year [4] - Profit forecasts have been adjusted, with expected net profits for 2025-2027 at 277 million, 339 million, and 423 million yuan, representing year-on-year growth of 16.2%, 22.5%, and 24.7% respectively [4] - The rapid progress of Shanghai Chaoyang's innovative drugs has led to an adjustment in valuation models, with a target market value of 14.6 billion yuan and a target price of 82.5 yuan, maintaining a "strong buy" rating [4]

Investment Rating - The report maintains a "Strong Buy" rating for the company with a target price of 82.5 CNY [2][10]. Core Insights - The company's main operations continue to improve, with significant progress in innovative drug development. The third quarter of 2025 saw a revenue of 365 million CNY, a slight decrease of 1.55%, while the net profit attributable to shareholders increased by 18.52% to 83.59 million CNY, and the non-GAAP net profit rose by 27.85% to 69.19 million CNY [2][4]. Financial Performance - Total revenue projections for the company are as follows: 1,350 million CNY for 2024, 1,376 million CNY for 2025, 1,683 million CNY for 2026, and 2,106 million CNY for 2027, with year-on-year growth rates of 20.8%, 2.0%, 22.3%, and 25.2% respectively [5][11]. - The net profit attributable to shareholders is projected to be 238 million CNY in 2024, 277 million CNY in 2025, 339 million CNY in 2026, and 423 million CNY in 2027, reflecting growth rates of 5.1%, 16.2%, 22.5%, and 24.7% respectively [5][11]. - Earnings per share (EPS) are expected to increase from 1.35 CNY in 2024 to 2.40 CNY in 2027 [5][11]. Strategic Developments - The company has strategically increased its stake in Shanghai Chaoyang Pharmaceutical to 51.48%, enhancing its innovative drug pipeline and R&D capabilities in cutting-edge technologies such as molecular glue and PROTAC [4]. - The core product HP-001 (molecular glue) has shown promising safety in phase I clinical trials, with symptom improvement observed in patients, indicating "Best-in-Class" potential [4]. - The company has also received IND approval for its ADC drug YLSHO03 and is set to initiate phase I clinical trials [4]. Market Position - The company is positioned to benefit from the rapid release of new products and the management of generic drug R&D investments, despite facing challenges from the tenth batch of national procurement [10]. - The internationalization of its formulations has seen breakthroughs, with the naloxone nasal spray production line passing FDA inspections and awaiting final reports [10].

Market Overview - The chemical pharmaceutical sector experienced a decline of 1.44% on November 19, with Hainan Haiyao leading the drop [1] - The Shanghai Composite Index closed at 3946.74, up 0.18%, while the Shenzhen Component Index closed at 13080.09, unchanged [1] Stock Performance - Notable gainers in the chemical pharmaceutical sector included: - Shanhe Pharmaceutical (300452) with a closing price of 15.07, up 9.04% and a trading volume of 390,200 shares, totaling 586 million yuan [1] - ST Suhao (600200) closed at 1.02, up 5.15% with a trading volume of 429,200 shares [1] - ST Jingfeng (000908) closed at 66.8, up 5.02% with a trading volume of 354,800 shares [1] - Major decliners included: - Muan Nanhai (000566) with a closing price of 7.20, down 10.00% and a trading volume of 2,192,500 shares, totaling 1.625 billion yuan [2] - Sitaili (603520) closed at 10.66, down 6.74% with a trading volume of 315,600 shares [2] - Yatai Pharmaceutical (002370) closed at 7.79, down 6.59% with a trading volume of 1,044,700 shares [2] Capital Flow - The chemical pharmaceutical sector saw a net outflow of 2.278 billion yuan from institutional investors, while retail investors contributed a net inflow of 2.139 billion yuan [2] - The top stocks by net inflow from institutional investors included: - Changshan Pharmaceutical (300255) with a net inflow of 71.90 million yuan, accounting for 6.20% of total inflow [3] - Xingqi Eye Medicine (300573) with a net inflow of 70.33 million yuan, representing 12.29% [3] - Shanhe Pharmaceutical (300452) with a net inflow of 68.13 million yuan, making up 11.62% [3]