Chinese innovative drugs are moving quickly toward globally synchronized development, multi-country IND filings, and out‑licensing. But regulatory standards diverge, GLP requirements, animal welfare rules, and data formats differ significantly across markets: leaving companies in a bind: repeat the studies and pay in cost and time, or reuse existing data and risk deficiency letters, or outright rejection, from overseas reviewers.
Seven years after its IPO, Medicilon has supported nearly 700 INDs to secure clinical approvals from NMPA, FDA, Australia’s TGA, EMA and other European authorities. How has the company built a preclinical research system acceptable across jurisdictions — one that delivers “one study, multiple country submissions”?
Multi-Country Credentials: The Foundation of Global IND Filings
Years of refinement and repeated inspections have produced a multi-country compliance credential matrix, ensuring one set of high-quality data meets NMPA, FDA, OECD, and TGA requirements simultaneously.
- NMPA GLP: first certified in 2011; 10+ successful re-inspections; 9 service categories covered, supported by 29,000 m² of standardized GLP laboratories.
- FDA GLP: inspected by the FDA in 2012 and repeated audits confirm our quality system, raw data traceability and study execution fully meet FDA expectations.
- OECD GLP: certified in Mexico and Hungary in 2025, making study reports broadly acceptable across OECD member countries.
- AAALAC International Animal Welfare Certification: Medicilon Preclinical Research fully accredited in 2009; the Boston R&D Center fully accredited in 2026.
- Japan PMDA: passed an on-site project inspection in 2025, with data recognized by the Pharmaceuticals and Medical Devices Agency.
- CNAS Accreditation: Our analytical testing center obtained CNAS recognition in 2024, delivering internationally accepted test data for pharmacology, toxicology and DMPK studies.
- BSL-2/ABSL-2 Lab Registration: In 2025, Medicilon is the first laboratory in Shanghai to obtain an ABSL-2 certificate for non-human primate studies, and a one-stop preclinical platform holding both ABSL-2 and BSL-2 registrations — enabling evaluation of viral and gene therapies and other high-biosafety products.
- Digital compliance: Provantis GLP Tox, LIMS, EMPOWER, Chromeleon, and WinNonlin, with SEND output and CTD/eCTD packages aligned with NMPA, FDA, and OECD — from raw data to global dossier.
Embrace Global Regulatory Shifts : Build NAMs Alternative Testing Platform
Reflecting the global move toward alternative methods — the FDA’s push to reduce animal testing, NMPA’s “Pioneer Program” — Medicilon has built a New Approach Methodologies (NAMs) platform. Its “human cell models – AI prediction – organoids” system combines organoids, organ-on chip, PBPK modeling, and AI-ADMET to improve human-relevance prediction, reduce reliance on animal studies, and provide stronger scientific evidence for global filings.
Upfront Design : One Study to Support Worldwide Filings
Execution is where this is delivered. Medicilon designs studies to multi-country requirements from the outset rather than retrofitting them at filing time. Species selection, endpoints, sample collection, documentation, and raw data retention are all aligned with NMPA, FDA, OECD, and TGA guidelines. From a single set of raw data, Medicilon generates multiple compliant reports and submission packages — removing the risk, at source, of data being rejected overseas.
Proven Track Record : Nearly 700 IND Approvals Powering Global Filings & Out‑Licensing
This integrated compliance model has been validated across hundreds of projects.
Medicilon has supported nearly 700 new drug candidates obtain clinical trial approvals from NMPA, FDA, TGA and EMA. The portfolio includes 90 multi‑country filing projects and 77 China‑U.S. dual filings.
Globally recognized preclinical data has also become a strong negotiating asset in out-licensing. Medicilon has supported 27 Chinese innovative drugs in completing licensing deals, including YL201, a B7-H3-targeting ADC from MediLink Therapeutics licensed to Roche; JYB1904, a long-acting IgE antibody from Jeyou Pharma licensed to RAPT Therapeutics; and HRS-7535, a GLP-1 receptor agonist from Hengrui Pharma licensed to Kailera Therapeutics, spanning ADCs, monoclonal antibodies, peptides, and small molecules.
Medicilon will continue to sharpen its global compliance capabilities so that candidates can rely on one set of high-quality preclinical studies to file INDs across multiple countries — and move faster from Target to IND.A
