Maryland, USA and Hangzhou, China, January XX, 2025；– Zhejiang Innoforce Pharmaceuticals Co., Ltd. ('Innoforce”), a premier CDMO (Contract Development and Manufacturing Organization) for Advanced Therapy Medicinal Products (ATMPs) that operates both in China and USA, with its affiliate Innoforce U.S., Inc., has successfully passed the EU Qualified Person (QP) audit, obtaining GMP compliance statement..

美国马里兰州和中国杭州，2025年1月XX日；–浙江Innoforce制药有限公司（“Innoforce”）是先进治疗药品（ATMPs）的主要CDMO（合同开发和制造组织），在中国和美国均设有分支机构Innoforce U.S.，Inc.，已成功通过欧盟合格人员（QP）审核，获得GMP合规声明。。

The statement covers five key platforms: plasmid DNA, nucleic acid therapeutics (mRNA, saRNA, circRNA), lipid nanoparticles (LNPs), viral vectors, and cell therapies. This milestone marks the first EU QP-issued GMP certification in China covering such a comprehensive range of advanced therapy products..

该声明涵盖五个关键平台：质粒DNA，核酸疗法（mRNA，saRNA，circRNA），脂质纳米颗粒（LNPs），病毒载体和细胞疗法。这一里程碑标志着中国首次获得欧盟QP颁发的GMP认证，涵盖了如此全面的先进治疗产品。。

Building on its ISO9001 certification, this achievement showcases Innoforce’s commitment to rigorous international standards, ensuring facilities, equipment, and process meet global GMP requirements. It positions the company to better serve global partners with GMP manufacturing and process development support..

在ISO9001认证的基础上，这一成就展示了Innoforce对严格国际标准的承诺，确保设施、设备和工艺符合全球GMP要求。它使公司能够更好地为全球合作伙伴提供GMP制造和流程开发支持。。

What Auditors and Partners Are Saying

审计师和合作伙伴所说的

The QP audit team commented Innoforce’s operational excellence: 'Innoforce has already established a quality system that meets EU GMP standards. The company employees are professional, proactive and easy to communicate. The facility is well-organized and clean; effectively prevents risks of contamination and cross-contamination.

QP审计团队评论了Innoforce的卓越运营：“Innoforce已经建立了符合欧盟GMP标准的质量体系。公司员工专业、积极主动、易于沟通。设施整洁有序；有效防止污染和交叉污染风险。

Documentation management system is comprehensive with good documentation practice and meets data integrity requirements.” The audit concluded with no major or critical observations..

文档管理系统全面，具有良好的文档实践，满足数据完整性要求。”审计结束时没有重大或关键的观察结果。。

Long-term collaborators echoed this sentiment: 'Innoforce’s quality standards and consistent performance make it a trusted partner. This EU GMP compliance statement reinforces its ability to drive innovation and deliver projects at a world-class level.”

长期合作者也认同这种观点：“Innoforce的质量标准和始终如一的表现使其成为值得信赖的合作伙伴。这份欧盟GMP合规声明加强了其在世界级水平上推动创新和交付项目的能力。”

CEO Statement

首席执行官声明

Dr. Dewan Zeng, CEO of Innoforce, commented: 'Obtaining EU QP GMP compliance statement underscores our dedication to global compliance and quality. This milestone enhances our ability to provide partners with end-to-end CDMO solutions, supporting clinical and commercial success.”

Innoforce首席执行官曾德万博士评论道：“获得欧盟QP GMP合规声明突显了我们对全球合规和质量的承诺。这一里程碑增强了我们为合作伙伴提供端到端CDMO解决方案的能力，支持临床和商业成功。”

Global Reach and Growing Impact

全球范围和日益增长的影响

Innoforce has established collaborations with over 50 partners on hundreds of projects.  Its Hangzhou facility has undergone multiple audits from clients and partners across the U.S., Europe, and China, receiving widespread recognition and accolades for its quality and excellence.

Innoforce与50多个合作伙伴就数百个项目建立了合作关系。其杭州工厂接受了来自美国、欧洲和中国客户和合作伙伴的多次审核，因其质量和卓越而获得广泛认可和赞誉。

With this statement, Innoforce solidifies its role as a leading global CDMO for ATMPs, poised to meet the needs of a rapidly evolving market.

通过这一声明，Innoforce巩固了其作为ATMPs领先的全球CDMO的角色，以满足快速发展的市场的需求。

About Innoforce

关于Innoforce

Innoforce is a premier CDMO focusing on Advanced Therapy Medicinal Products (“ATMP”).  We have developed comprehensive technology platforms to enable end-to-end manufacture of high-quality plasmid DNA, RNA, LNP, exosomes, viral vectors, and cell therapeutics. Our state-of-the-art facility is designed to meet the cGMP standards of the FDA, EMA, and NMPA.

Innoforce是领先的CDMO，专注于高级治疗药品（“ATMP”）。我们开发了全面的技术平台，可以端到端制造高质量的质粒DNA，RNA，LNP，外泌体，病毒载体和细胞疗法。我们最先进的设施旨在满足FDA、EMA和NMPA的cGMP标准。

We have also implemented rigorous policies and procedures to safeguard our clients’ IP. Innoforce is led by an industry-seasoned management team with extensive experience leading multiple innovative products from development to commercialization in the US, EU, and China. Our goal is to accelerate the development and commercialization of innovative products globally..

我们还实施了严格的政策和程序来保护客户的知识产权。Innoforce由一支经验丰富的管理团队领导，该团队拥有丰富的经验，在美国、欧盟和中国领导多种创新产品从开发到商业化。我们的目标是加速全球创新产品的开发和商业化。。

With our expertise in process development and manufacturing, Innoforce can be a trusted partner from R&D through commercialization.

凭借我们在工艺开发和制造方面的专业知识，Innoforce可以成为从研发到商业化的值得信赖的合作伙伴。