Chiheal Aikang Pharma is a joint venture between Chiheal Biomed and Aikang Weijian Pharma, established with shared investments and operating as a subsidiary under Chiheal Biomed's control. Serving as a pivotal component within Chiheal Biomed's drug development continuum, Chiheal Aikang Pharma is oriented towards both domestic and international pharmaceutical landscapes. It fully inherits and leverages its business strengths in clinical trials and regulatory submissions. By capitalizing on the natural synergies between the technical aspects of the two companies in the drug development services spectrum, it has emerged as a leading domestic platform for clinical CRO services.

一、 BUSINESS

◆ Clinical Research CRO Services：

The specific content of clinical business includes clinical medical data design and writing, clinical/medical monitoring, third-party clinical inspections, clinical trials, and post marketing drug vigilance services. The clinical core team adheres to the advantages of over 20 years of professional experience in the field of drug research and development, and has significant clinical research advantages in the fields of psychiatry, respiratory, anesthesia, infection, and digestion. At the same time, we have rich project experience in clinical research on drug metabolism with high technical difficulties, such as long-term injection formulations, endogenous substances, inhalation formulations, and highly variable drugs. Provide professional CRO service support for domestic and foreign pharmaceutical enterprises, research and development institutions, etc.

The company has currently completed and is currently conducting drug clinical trial research projects, and its cooperative clinical bases are distributed in well-known tertiary hospitals in Beijing, Xi'an, Wuhan, Taiyuan, Zhengzhou, Xiamen, and other places. Among them, thanks to years of close cooperation with Capital Medical University, Beijing You'an Hospital, Beijing Shijitan Hospital, Tiantan Hospital Anzhen Hospital and other clinical research institutions affiliated with Capital Medical University, such as PI, have good cooperative relationships.

In addition, the company has long cooperated with multiple excellent clinical centers in China in terms of single center clinical resources such as BE/I phase, and multiple projects have passed on-site inspections by national and provincial drug regulatory departments.

◆ Registration and declaration service：

The company regards service quality as the foundation of its business and adheres to the service philosophy of "professionalism, focus, and concentration". It has created a service team with comprehensive knowledge, excellent technology, and rich experience, and treats every project of customers with a professional operation mode, making every service a benchmark and turning every project into a high-quality product. The core team has successively provided services to excellent domestic and foreign pharmaceutical enterprises such as Xi'an Lipang Pharmaceutical, China Resources Shuanghe Pharmaceutical, Huangcheng Xiangfu Pharmaceutical, Taiwan Jianqiao Xinyuan, Yide Biotechnology, etc.

二、 Business advantages

Team：

Our team encompasses professionals with extensive experience in key technical roles, averaging over 6 years of industry experience. With a well-structured team and enhanced business capabilities, we are poised to address even the most intricate clinical projects. Our expertise spans pharmaceuticals, medicine, clinical operations, bio-sample analysis, inspections, on-site verification, and more. This seasoned team is committed to delivering excellence in navigating the complexities of diverse clinical projects.

Market Registration：

We possess a distinct business advantage in drug market registration, demonstrating a profound understanding of pharmaceutical registration regulations and effective communication capabilities with the China National Medical Products Administration (NMPA). All clinical data for registration purposes adheres to the M4 format, aligning seamlessly with the evolving trends in China's regulatory framework for drug registration. This strategic approach ensures that our clients navigate future registration evaluations smoothly, guaranteeing a successful outcome for their submissions.

We have implemented a standardized clinical management system aligned with the latest Good Clinical Practice (GCP) requirements, encompassing a project team responsible for adherence to a comprehensive quality system. Our approach involves project-wide responsibilities, ensuring the implementation of standardized Standard Operating Procedures (SOPs) across the entire operational chain. Utilizing an online research and development document management system, we promptly collect and organize clinical data, facilitating a seamless process for the ultimate project submission and registration.

Contact us：

Contact address：Rooms 601-603, 6th Floor, Zhongdu Science and Technology Building, No. 35 West Fourth Ring South Road, Fengtai District, Beijing

Telephone： 010-52894249