【Company Profile】

Jiangsu Value Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Jiangsu Wanlue") is a Contract Research Organization (CRO) specializing in drug clinical and non-clinical pharmacokinetics (DMPK) research. Characterized by its expertise in low-energy radioisotope (¹⁴C, ³H) labeling technology, the company provides comprehensive technical services and regulatory consulting for pharmaceutical companies throughout the new drug research and development process.

【Technical Services: Radioactive ADME Studies】

Jiangsu Wanlue has accumulated specialized experience in the field of low-energy radioisotope (Carbon-14, Tritium) ADME (Absorption, Distribution, Metabolism, Excretion) studies, particularly possessing practical expertise in human ¹⁴C-ADME research.

• Project Experience: The company's core team has participated in completing projects involving the use of ¹⁴C-labeled innovative drugs to study metabolic pathways and mass balance in humans, demonstrating a deep understanding of guidelines related to drug metabolite safety evaluation.

• Technical Extension: The company has established research methodologies for studying the in vivo metabolism of macromolecules (such as antibodies, Antibody-Drug Conjugates or ADCs) and absorbable medical devices in animals using ¹⁴C and ³H labeling, covering types like PEG conjugates and polysaccharides. This technology offers a methodological option for the non-clinical study of such complex drugs.

【Technology Platforms and Service Capabilities】

1. QWBA Technology Platform:
   In 2018, the company established a Quantitative Whole-Body Autoradiography (QWBA) experimental platform. This platform supports the study of tissue distribution for both small and large molecule drugs in whole animal bodies and allows for preliminary estimation of human radiation dosimetry based on generated data, providing reference information for radioactive ADME studies.

2. Non-clinical ADME Studies:
   The company offers non-clinical ADME studies covering a variety of animal species, including mice, rats, guinea pigs, rabbits, pigs, dogs, and monkeys. Services include pharmacokinetic parameter analysis of parent drugs and metabolites, investigation of tissue distribution characteristics, exploration of in vivo biotransformation pathways (metabolite profiling), determination of mass balance and excretion rates, providing data support for the pharmacodynamic and toxicological evaluation of new drugs.

3. Clinical Bioanalysis Laboratory:

   • System Operation: The laboratory is constructed and operated with reference to relevant NMPA and FDA regulations and guidelines.

   • Information Management: Utilizes the Watson LIMS system for process management, including automated data capture from balances, electronic laboratory records, and report generation.

   • Analytical Methods: Bioanalytical methods for over 120 drugs have been established. Project ISR (Incurred Sample Reanalysis) pass rates are consistently high.

4. Dosing and Sampling Models:
   The laboratory can accommodate various administration routes, including oral, intravenous, ocular, nasal, and intra-articular, and supports the collection of diverse biological matrices such as whole blood, bile, and cerebrospinal fluid. Surgical models, including intravenous cannulation, bile duct cannulation, and tumor-bearing mice, can be established.

【Core Team and Qualifications】

• Professional Background: Founder Dr. Gu Zheming participated in the work related to the "Guidelines for Non-clinical Pharmacokinetics Study of Drugs" (2015 version) and the "Guidelines for Validation of Quantitative Analysis Methods for Biological Samples" in the Chinese Pharmacopoeia (2015 version).

• Team Composition: Core members have experience working in the bioanalytical departments of generic pharmaceutical companies. Multiple team members have received relevant technical training and possess an awareness of GLP regulations. The QA leader has work experience in a US GLP laboratory.

• Qualification Status: The company's laboratory covers nearly 5000㎡ and has obtained essential qualifications including the "Radiation Safety Permit" and the "Permit for Laboratory Animal Use". It achieved results meeting acceptance criteria in the national inter-laboratory comparisons in 2017 and 2018.

【Project Experience】

To date, the company has collaborated with over 130 domestic clients and undertaken nearly 200 projects. Among completed innovative drug projects, over 80 have obtained IND/NDA approval from NMPA, and more than 10 projects have obtained IND approval from the US FDA.

Jiangsu Wanlue is dedicated to providing professional pharmacokinetic research technical services to pharmaceutical companies, supporting the new drug research and development process.