Core Viewpoint - Chongqing Boteng Pharmaceutical Technology Co., Ltd. (referred to as "Boteng Co., Ltd.") announced that its wholly-owned subsidiary, Chongqing Boteng Pharmaceutical Co., Ltd. (referred to as "Boteng Pharmaceutical"), has successfully passed the EU Qualified Person (QP) audit and received a compliance statement from the EU QP, indicating that its quality management system meets EU GMP standards [1] Group 1 - The audit was conducted based on EU GMP Guidelines EudraLex Volume 4, EU Clinical Trial Regulation (536/2014), and GMP for IMP guidelines, covering various aspects such as quality management, production management, facilities, material systems, and packaging and labeling systems at the Chongqing formulation production base [1] - The successful completion of the QP audit allows Boteng Pharmaceutical to provide customized R&D and production services that meet international standards for global clients [1] - The announcement disclosed that the passing of the EU QP audit will not have a significant impact on the current performance of Boteng Co., Ltd. [1]

Core Viewpoint - Boteng Co., Ltd. has successfully passed the EU Qualified Person (QP) audit, indicating that its quality management system meets EU GMP standards and can provide international standard formulation development and production services to global clients [1] Group 1: Audit and Compliance - Boteng Pharmaceuticals, a wholly-owned subsidiary of Boteng Co., Ltd., received a compliance statement from the EU Qualified Person [1] - The audit was conducted based on EU GMP Guidelines EudraLex Volume 4, EU Clinical Trial Regulation (536/2014), and GMP for IMP guidelines [1] - The audit scope included quality management, production management, facilities, material systems, and packaging and labeling systems for injectable, oral solid, and non-sterile semi-solid formulations [1] Group 2: Implications for Business - The successful QP audit signifies that Boteng Pharmaceuticals can now offer customized formulation development and production services that comply with international standards [1]

Core Viewpoint - The company has successfully passed the EU Quality Person audit, indicating that its subsidiary has met EU GMP standards for quality management and production capabilities [1] Group 1: Audit and Compliance - Chongqing Haoyuan has received a compliance audit report issued by the Qualified Person (QP) after a thorough audit covering quality management, production management, facilities, material systems, and packaging and labeling systems [1] - The audit assessed critical aspects such as sterility assurance, computerized systems, data integrity, quality management, and material management [1] Group 2: Organizational Readiness - Chongqing Haoyuan has established an organizational structure, personnel configuration, facilities, and procedures that comply with EU GMP requirements [1] - The successful QP audit signifies that the company's quality management system and production capacity are aligned with EU GMP standards, ensuring high-quality research and production of biopharmaceuticals [1] Group 3: Market Expansion - The achievement of passing the QP audit lays a foundation for the company to expand into domestic and international markets [1] - The successful audit is not expected to have a significant impact on the company's current performance [1]