SaiFu Pharma Announces GLP Certification for Nine Key Preclinical Safety Evaluation Services, Strengthening Its One-Stop CRO Platform

VCBeat (WeChat ID: vcbeat) recently learned that Guoke Saifu Hebei Pharmaceutical Technology Co., Ltd. (Saifu Pharmaceutical Safety Assessment Center) has been awarded the Good Laboratory Practice (GLP) certification for all nine categories of non-clinical drug safety evaluation studies by the National Medical Products Administration (NMPA).

SaiFu Pharma’s recent GLP certification marks a further enhancement of its one-stop pharmaceutical CRO service platform.

On June 4, 2003, China officially issued the Good Laboratory Practice (GLP) regulations and conducted pilot inspections of preclinical safety evaluation laboratories for pharmaceuticals across the country for the first time. The inspected test items included various toxicity studies performed under laboratory conditions using experimental systems, such as single-dose toxicity studies, repeat-dose toxicity studies, reproductive toxicity studies, genotoxicity studies, carcinogenicity studies, local toxicity studies, immunogenicity studies, dependence studies, toxicokinetic studies, and other studies relevant to the safety evaluation of pharmaceuticals.

Preclinical drug safety evaluation is the most critical component of new drug development. Only laboratories accredited under Good Laboratory Practice (GLP) are qualified to conduct various toxicity studies, making GLP accreditation a key competitive differentiator among pharmaceutical contract research organizations (CROs). To date, approximately 70 laboratories in China have obtained GLP certification; however, about half of these GLP-certified laboratories hold approvals for only seven or fewer study types.

Moreover, GLP laboratories impose stringent requirements on equipment, facilities, and personnel, resulting in substantial operational costs that are often prohibitive for ordinary enterprises. Consequently, most GLP laboratories in China have strong government affiliations, such as the National Institutes for Food and Drug Control (NIFDC), the Academy of Military Medical Sciences, or the Safety Evaluation Center of the Shanghai Institute of Materia Medica. As a non-governmental third-party GLP laboratory, Saifu Pharmaceutical’s Safety Evaluation Center has obtained approval qualifications for nine safety assessment projects, demonstrating its considerable strength and capabilities.

Guoke Saifu Hebei Pharmaceutical Technology Co., Ltd., which has recently obtained Good Laboratory Practice (GLP) accreditation, is a wholly-owned subsidiary of Saifu Pharmaceutical Group dedicated to preclinical drug safety evaluation and serves as one of the core components of the Group’s one-stop service platform. Established in 2017 and commencing trial operations in July 2018, the center leverages the resources of national-level drug R&D institutions such as the Institute of Drug Innovation of the Chinese Academy of Sciences and the National Beijing Center for New Drug Evaluation. In accordance with the most advanced international zoning control concepts, it has developed nearly 10,000 square meters of functional laboratories and experimental animal housing facilities.

Saifu Pharmaceutical’s Safety Assessment Center primarily conducts non-clinical safety evaluation studies of drugs (biologics, chemical drugs, and traditional Chinese medicines) and medical devices under Good Laboratory Practice (GLP) conditions, as well as GLP-compliant pharmacological, efficacy, and pharmacokinetic studies. Adhering to the GLP regulations of the NMPA, OECD, and FDA, the center is capable of concurrently carrying out comprehensive non-clinical safety evaluation studies for dozens of drugs or medical devices.

During this GLP certification inspection, experts organized by the Center for Food and Drug Inspection of the National Medical Products Administration conducted a rigorous review of the Safety Assessment Center’s organizational structure and personnel, test facilities, quality assurance system, and study conduct, granting high recognition to the Center’s GLP system and standardized management. Through this certification, SaiFu Pharma has obtained the following qualifications:

Mr. Liu Yang, Chairman of the Company, stated, “Safety is a key and core issue in drug development. Preclinical safety evaluation studies serve as the final safeguard to ensure the safety of first-in-human dosing. Countries around the world attach great importance to non-clinical drug safety evaluation research. GLP certification is a critical measure by which nations strictly require pharmaceutical R&D institutions to conduct non-clinical drug safety evaluation studies in a standardized manner.”

Saifu Pharmaceutical Group’s Drug Safety Evaluation and Research Center took only about one year from trial operation to achieving accreditation, earning high recognition from experts of the National Medical Products Administration (NMPA) inspection team. This achievement indirectly reflects the extensive experience, strong capabilities, and robust execution of the GLP center’s technical team, while also demonstrating that its quality standards have reached the level of leading domestic CRO institutions. Saifu Pharmaceutical Group now possesses the technical capacity to provide one-stop CRO services for biologics, chemical drugs, and traditional Chinese medicines. The GLP center will collaborate with other technical departments within the group to deliver efficient, high-quality, and professional integrated services to clients.

Among the nine experimental qualification approvals granted to SaiFu Pharma’s Safety Assessment Center, dependency testing is a relatively scarce service offered within approved GLP laboratories. According to incomplete statistics, there are currently fewer than five GLP laboratories in China capable of conducting dependency studies. The acquisition of this qualification by SaiFu Pharma’s Safety Assessment Center further solidifies the group’s core competitiveness.

It is reported that the Safety Assessment Center of Pharmaron is currently undergoing qualification certification for its final study, the “carcinogenicity study.” It is expected to obtain the approval for this study type in the near future, thereby achieving a “grand slam” of all 10 GLP-certified study categories and becoming one of the few comprehensive GLP laboratories in China capable of conducting all ten types of studies.

In light of global drug R&D demands, technical pain points, and the current state of the industry, the technical team at Saifu Pharmaceutical’s Non-Clinical Safety Evaluation Center has built comprehensive multi-disciplinary service capabilities and further leveraged its extensive project experience and drug review expertise to focus on developingEvaluation of Cell-Based Therapies、Evaluation of Neuropsychiatric Drugs、Pediatric Drug EvaluationThree Featured Platforms.

In the evaluation of neuropsychiatric drugs, the GLP Center of Saifu Pharmaceutical Group is one of the few GLP institutions in China capable of conducting systematic studies on physical and psychological dependence. This signifies that Saifu Pharmaceutical Group can provide more professional and standardized GLP services to pharmaceutical companies in related fields.

In addition to preclinical drug safety evaluation, Saifu Pharmaceutical Group also operates business divisions covering pharmaceutical R&D consulting, pharmacology and efficacy studies, drug metabolism analysis, bioanalytical testing, pharmaceutical sciences, formulation development, and clinical research. This enables the company to provide one-stop professional pharmaceutical R&D services to drug developers. Beyond therapeutics, Saifu Pharmaceutical also offers specialized safety evaluation services for medical devices, food, pesticides, cosmetics, and new chemical substances.

Currently, more than half of the team at Saifu Medicine hold master’s degrees or higher and have over ten years of experience working in national-level Good Laboratory Practice (GLP) centers. Nearly 30 team members hold doctoral degrees or have overseas study backgrounds. The team includes more than ten experts who serve as drug review specialists, GLP inspection specialists, and medical device evaluation specialists. Researchers at the group’s centers have successfully completed toxicology evaluations for pharmaceutical products from more than 400 domestic and international enterprises, undertaking a cumulative total of over 1,200 pharmacological, efficacy, and toxicology assessment projects. All these projects have passed reviews by the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA). Furthermore, the team has led multiple major special projects on new drug innovation, as well as key projects under the National High-Tech Research and Development Program (863 Program), the National Basic Research Program (973 Program), and the National Natural Science Foundation of China.

Regarding the future, Liu Yang, Chairman of Saifu Medicine, stated that the group will fully leverage its industry resources, technological capabilities, and team of experienced experts to further enrich its product portfolio and specialized service offerings. It will focus on serving innovative drug R&D enterprises and pharmaceutical companies transitioning toward innovation, with the aim of becoming a world-class, one-stop pharmaceutical CRO service provider.

Saifu Pharmaceutical Group is a contract research organization (CRO) specializing in drug development outsourcing services. Its personalized service capabilities cover the entire process from drug developability assessment and preclinical evaluation to clinical studies. Service offerings include pharmaceutical R&D consulting, drug developability screening, formulation research, pharmacodynamics studies, drug metabolism analysis, preclinical safety evaluation, clinical trials, bioanalytical testing, generic drug consistency evaluation, post-marketing re-evaluation, and drug registration submissions. The company provides a one-stop, full-industry-chain platform for various drug development needs to pharmaceutical enterprises and R&D institutions. Saifu Pharmaceutical Group has been honored with titles such as National High-Tech Enterprise, Beijing Science and Technology SME, and Zhongguancun High-Tech Enterprise.

Currently, SaiFu Pharmaceutical Group operates a suite of testing facilities, including the GLP Center for Drugs in Gu’an (Southern Beijing), the Druggability Evaluation Center in Shenzhen, the Physicochemical Testing Center in Beijing, the Small Molecule Bioanalysis Center in Benxi, the Drug Testing and Analysis Laboratory co-established with Shandong University, the Clinical Research Center in Beijing, and four self-built GCP clinical trial bases at Grade 3A hospitals. The Group has established strategic partnerships with Nanjing GenScript, Liuhe Ningyuan, and Guangdong Lion Pharmaceutical, among others, and has jointly established laboratories with PerkinElmer, Tsinghua University, and the Chinese Academy of Sciences, providing professional services to the pharmaceutical R&D sector in China and globally.