Core Viewpoint - 康龙化成's stock rose over 7% following the announcement of successful FDA inspection of its Shaoxing facility, marking a significant milestone in its compliance with international quality standards [1] Group 1: Company Achievements - 康龙化成's Shaoxing facility received the Establishment Inspection Report from the FDA, confirming it passed the quality inspection [1] - This is the first time the Shaoxing active pharmaceutical ingredient (API) production base has passed the FDA's pre-approval inspection for new drugs [1] - Following the successful inspection of the Ningbo facility in April 2025, this marks another achievement for 康龙化成 in ensuring its production facilities meet FDA standards [1] Group 2: Market Implications - The successful FDA inspection indicates that 康龙化成's quality system is aligned with international standards, enabling it to supply commercialized innovative drug APIs to the US and global markets [1] - Currently, 康龙化成 has four commercialized API production bases in China, the UK, and the US that have all passed FDA inspections, allowing it to provide tailored production solutions for different markets [1]

Core Viewpoint - 康龙化成's subsidiary successfully passed the FDA's cGMP pre-approval inspection, marking a significant milestone in its ability to produce commercialized innovative drug APIs for the US and global markets [1] Group 1: FDA Inspection and Approval - 康龙化成 (300759.SZ) announced that its wholly-owned subsidiary, 康龙化成（绍兴）药业有限公司, underwent an FDA cGMP pre-approval inspection from May 29 to June 4, 2025 [1] - The inspection covered multiple GMP systems, and the facility successfully passed the FDA's on-site quality check, confirming compliance with US drug cGMP quality standards [1] - This marks the first time the Shaoxing API commercial production base has passed the FDA's new drug pre-approval inspection, following the successful inspection of the Ningbo API production facility [1] Group 2: Global Market Readiness - The successful inspection indicates that 康龙化成's quality system is aligned with international standards, enabling the company to continuously supply commercialized innovative drug APIs to the US and global markets [1] - Currently, 康龙化成 has four commercialized API production bases located in China, the UK, and the US, all of which have passed FDA inspections [1]

Core Viewpoint - 康龙化成's subsidiary, 康龙化成(绍兴)药业有限公司, successfully passed the FDA's pre-approval inspection, confirming its compliance with cGMP standards, which enhances its capability to supply commercialized innovative drug APIs globally [1][2]. Group 1 - 康龙化成(绍兴) underwent an FDA cGMP pre-approval inspection from May 29 to June 4, 2025, covering various quality and production systems [1]. - The establishment inspection report confirmed that 康龙化成(绍兴) met the cGMP quality standards set by the FDA, marking the first successful pre-approval inspection for its API production base [2]. - This achievement indicates that 康龙化成's quality systems are aligned with international standards, enabling it to supply commercialized innovative drug APIs to the US and global markets [2]. Group 2 - 康龙化成 aims to be a trusted and responsible high-quality partner in the global pharmaceutical market, contributing meaningfully to clients' success [3]. - The successful FDA inspection reflects the company's commitment to adhering to the highest international quality standards and validates the effective operation of its quality management system [3]. - This milestone is expected to have a positive and far-reaching impact on 康龙化成's continued expansion in the global innovative drug CDMO sector [3].

Core Viewpoint - 康龙化成's wholly-owned subsidiary, 康龙化成（绍兴）药业有限公司, successfully passed the cGMP pre-market inspection by the FDA, confirming compliance with U.S. drug quality standards [1] Group 1: FDA Inspection Details - The inspection took place from May 29 to June 4, 2025, covering various GMP systems including quality management, material management, production management, equipment facilities, packaging and labeling, and laboratory control systems [1] - 康龙绍兴 has received the FDA's on-site inspection report, affirming that its production facilities meet U.S. cGMP quality standards [1] Group 2: Significance of the Approval - This marks the first time 康龙化成's Shaoxing API commercial production base has passed the FDA's pre-approval inspection [1] - This follows the successful FDA inspection of 康龙化成's Ningbo API production workshop in April 2025, indicating a positive trend for the company's API production facilities in China [1]

Core Viewpoint - 康龙化成's subsidiary 康龙绍兴 successfully passed the FDA's pre-approval inspection, confirming its compliance with cGMP standards, which enhances its capability to supply commercialized innovative drug APIs to the US and global markets [1][2]. Group 1 - 康龙绍兴 underwent a pre-approval inspection by the FDA from May 29 to June 4, 2025, covering various GMP systems including quality, material management, production, equipment, packaging, labeling, and laboratory control [1]. - The FDA's Establishment Inspection Report confirmed that 康龙绍兴's production facility passed the quality inspection, meeting the cGMP quality standards required for drug production [2]. - This marks the first time 康龙绍兴's API commercial production base has passed the FDA's pre-approval inspection, following the successful inspection of the 宁波 facility in April 2025 [2]. Group 2 - 康龙化成 now has four commercial API production bases located in China, the UK, and the US that have all passed FDA inspections, enabling the company to provide innovative drug API production solutions tailored to different markets [2].

Core Insights - 康龙化成's subsidiary 康龙化成（绍兴）药业有限公司 successfully passed the cGMP pre-approval inspection by the FDA, confirming compliance with U.S. drug quality standards [1][2] - This marks the first successful FDA pre-approval inspection for the company's raw material drug commercialization production base in Shaoxing, following the successful inspection of the Ningbo facility in April 2025 [2] - With all four of the company's raw material drug production bases in China, the UK, and the US now FDA-approved, 康龙化成 is positioned to provide commercialized innovative drug active pharmaceutical ingredients (APIs) for global markets [2] Summary by Sections FDA Inspection - 康龙绍兴 received an Establishment Inspection Report from the FDA, confirming that its production facility passed the quality inspection [2] - The inspection covered various GMP systems including quality management, material management, production management, equipment facilities, packaging and labeling, and laboratory control systems [1] Market Position - The successful FDA inspection indicates that 康龙化成's quality systems are aligned with international standards, enabling the company to continuously supply commercialized innovative APIs to the U.S. and global markets [2] - The company now has the capability to offer commercialized production solutions for innovative drug APIs tailored to different markets [2]

Core Viewpoint - 康龙化成's subsidiary successfully passed the FDA's cGMP pre-approval inspection, confirming compliance with U.S. drug quality standards [1] Group 1: FDA Inspection Details - 康龙化成 (Shaoxing) Pharmaceutical Co., Ltd. underwent an FDA cGMP pre-approval inspection from May 29 to June 4, 2025, covering quality systems, material management systems, and production management systems [1] - The inspection report from the FDA confirmed that the production facility met the necessary standards and received FDA certification [1] Group 2: Significance of the Approval - This marks the first time the Shaoxing API commercial production base has passed the FDA's new drug pre-approval inspection [1] - This follows the successful inspection of the Ningbo API production workshop in April 2025, indicating a positive trend for the company's API production facilities in China [1]