Hengxing Pharma: Building a Specialized CRO Platform with Core Capabilities in Pharmacokinetic Services and Bioanalytical Testing

Drug quality is a matter of life and death. The “722 Incident” triggered a major upheaval in China’s generic drug sector, giving rise to an even larger new market: CRO/CDMO (Contract Research Organization/Contract Development and Manufacturing Organization). Hunan EverPro Medical Technology Co., Ltd. (hereinafter referred to as “EverPro Medical”) emerged as a new CRO in the aftermath of this turmoil.

Compliance with laws and regulations is fundamental to the successful launch of new drugs. In the wake of the “722 Incident,” 30 applications suspected of clinical trial data fabrication were rejected, 11 clinical trial institutions and contract research organizations involved in data falsification were placed under investigation, and the remaining 8 registration applications were handled in accordance with relevant regulations. This situation revealed market opportunities and demands to Guo Jianjun, founder of EverPro Medical, who entered the CRO market by focusing on regulatory compliance testing for clinical biological samples, starting with bioanalytical services for generic drug consistency evaluations.

Guo Jianjun, Founder of EverPro Medical

This is also an area of expertise for Guo Jianjun. As the founder of EverPro Medical, Guo Jianjun has over 15 years of research and management experience in the biopharmaceutical industry, specializing in drug metabolism and pharmacokinetics (DMPK), central nervous system (CNS) research, pathology, formulation development, and proteomics. He holds a Ph.D. from Wuhan University, served as a visiting scholar at the University of Konstanz in Germany, and currently serves as a council member of the Hunan Pharmaceutical Association and a corporate representative on the Pharmacokinetics Professional Committee of the Chinese Pharmacological Society. He has published more than 20 SCI-indexed papers and reviews, contributed to the writing of English-language scientific books, and been granted over 20 Chinese national invention and utility model patents.

Prior to founding EverPro Medical, Dr. Guo served as Chief Technology Officer and Vice President at a CRO company in Suzhou. To date, he has led and participated in preclinical pharmacology and toxicology studies for more than 50 new drugs, conducted nearly 100 Phase I clinical and bioequivalence (BE) studies for new drugs and generics, and spearheaded the development of multiple complex injectables.

Cash flow is the lifeblood of a business, and this holds true for startup CROs as well. Guo Jianjun, founder of EverPro Medical, affirmed: “After EverPro Medical was established in 2016, our primary consideration was how to rapidly enter the market to generate cash flow, establish a foothold, and support the company’s subsequent expansion into innovative drug development services.”

EverPro Medical chose to enter the bioanalytical testing sector, an industry with significant barriers in terms of capital, systems, and technology. After its establishment, the company first procured a series of laboratory equipment and gradually built its own quality system. It began accepting external contracts only after its system documentation and other aspects met GLP standards and CNAS-17025 specifications.

Guo Jianjun told VCBeat that, with everything in place, EverPro Medical secured its first order within just four months. At the time, what enabled clients to choose EverPro Medical, a newly established CRO?Guo Jianjun summarized three key points from the aspects of personnel, equipment, materials, methods, and environment:

First, regulatory compliance.

Comprehensive mandatory verification, calibration, and Installation/Operational/Performance Qualification (3Q) activities have been conducted for all instruments and equipment, ensuring that their usage processes and measurement results comply with regulatory requirements and industry standards related to metrological traceability and testing, thereby establishing an interconnected framework of systematicity, standardization, and completeness.

Second, the technical strength and professionalism of the CRO team.

Not only should we help clients solve problems, but also anticipate issues they have not yet considered. By scientifically managing technical risks to demonstrate our technological prowess, we can deliver solutions that are both fast and high-quality.

Currently, the Analytical Testing Center of EverPro Medical employs over 60 R&D personnel, more than 20 of whom hold master’s degrees or higher, while over 80% hold bachelor’s degrees or above. An organizational structure has been established in compliance with the management system requirements of CNCA GLP and ISO/IEC 17025:2017.

Third, the experimental equipment used by CROs must be guaranteed to a certain extent.

EverPro Medical’s Analytical Testing Center is now equipped with nine high-end liquid chromatography-mass spectrometry (LC-MS) systems—including the AB TripleTOF 6600, Waters UPLC TQ-S, AB API 5000, and Agilent GC/MS 7010—as well as microplate readers, drug transdermal diffusion testers, ultra-microbalances with one-millionth precision, and ultra-low temperature sample storage units (from Thermo Fisher Scientific and Haier), among other instruments for biological sample storage and analysis, ensuring optimal equipment performance for clients. Backed by initial capital investment, EverPro Medical has established a comprehensive premium brand image from the outset, leveraging superior equipment, rigorous and professional 3Q (IQ/OQ/PQ) qualification capabilities, and meticulous service standards.

Since its establishment in 2016, EverPro Medical has significantly expanded its business from a sole focus on bioanalytical services to encompass five major sectors: pharmacokinetic and pharmacodynamic services for innovative drugs, complex formulation development services, clinical pharmacology, and pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation.

Currently, bioanalysis and pharmacokinetic/pharmacodynamic (PK/PD) evaluation have evolved into the core business of EverPro Medical. Its dedicated Analytical Testing Center specializes in the bioanalysis of drugs and their metabolites. The facility features independent rooms for sample storage, weighing, dissolution testing, sample pretreatment, mass spectrometry, archives, server hosting, chemical reagents, and warehousing. Equipped with multiple high-end liquid chromatography-mass spectrometry (LC-MS/MS) systems, the laboratory covers an area of 1,800 square meters.

In October 2019, EverPro Medical established a Complex Formulation R&D Center dedicated to the research, development, and industrialization of high-end complex injectables, with a focus on liposomal drug delivery technology and albumin nanoparticle carrier technology. The center covers a total area of 1,600 square meters and comprises 25 laboratories, including areas for formulation R&D, analytical R&D, and pilot-scale production.

The R&D Center for Complex Formulations primarily engages in CRO services for formulation development, CDMO services for formulation manufacturing, and commercial production. It provides clients with end-to-end services covering the entire industry chain, including project initiation, small-scale R&D, scale-up manufacturing, process validation, non-clinical and clinical studies, NMPA/FDA regulatory submissions for 505(b)(2) high-end complex innovative injectables, and batch production. Currently, EverPro Medical has initiated multiple projects for complex generic drugs and innovative medicines (such as albumin-bound paclitaxel), with its product portfolio mainly focused on therapeutic areas including oncology, anti-infectives, analgesics, and gene therapies.

In terms of its business model, EverPro Medical provides both single-sample analysis services for clinical blood samples and a comprehensive drug evaluation system for innovative drugs, assisting clients with the planning and execution of preclinical studies, such as animal trials. Additionally, EverPro Medical offers bundled IND (Investigational New Drug) research services to support clients in filing new drug clinical trial applications.