Medicilon Receives International Accreditation Again! Successfully Obtains OECD GLP Certificate
Recently, Medicilon has officially obtained the Good Laboratory Practice (GLP) certificate issued by Mexico, a member country of the Organization for Economic Co-operation and Development (OECD). Medicilon also has passed the GLP on-site inspections conducted by Hungary, another member country of the OECD. Following the recent FDA and PMDA GLP audit , this success further […]
【White Paper】Navigating the DMPK Gauntlet: A Strategic Analysis of the Interconnected Challenges Shaping the Future of Drug Development
1.0 Executive Summary & Introduction The Drug Metabolism and Pharmacokinetics (DMPK) landscape is at a critical inflection point, shaped by the convergence of four powerful and interconnected forces: scientific complexity, technological disruption, regulatory and geopolitical upheaval, and intense business pressures. The traditional paradigms that once guided preclinical development are no longer sufficient. The rise of […]
Medicilon: Innovating Globally at CMC-China Expo 2025
CMC-China Expo 2025 August 1, 2025–The CMC-China Expo 2025, themed “Breakthrough, Symbiosis, and Globalization,” opened today at the Suzhou International Expo Centre. The conference gathers biopharmaceutical experts and executives to foster collaboration on innovative technologies and explore future industry development, addressing key topics to drive high-quality growth in the biopharmaceutical sector. Top 20 Preclinical CROs […]
Novamab Announces NMPA CDE Approval of IND for LQ036, the World’s First Inhaled Nanobody for Moderate-to-Severe Asthma
Novamab has announced that the CDE of the NMPA has approved its IND application for LQ036, the world’s first inhaled nanobody for moderate to severe asthma. LQ036 is a recombinant anti-IL-4Rα single-domain antibody nebulizing solution produced in Pichia pastoris. Medicilon leveraged its dedicated Inhalation Formulation R&D Platform to deliver high quality services for the inhalation […]
【White Paper】Patient-Derived Xenograft Organoids: Advancements and Applications in Precision Oncology
Download our PDX Model poster presented at AACR 2025 1. Background of PDX-Derived Organoids 1.1 Historical evolution Patient-derived xenograft (PDX) models, pioneered in the 1960s by Rygaard and Poulsen, marked a significant advancement in oncology by preserving human tumor genetics in immunodeficient mice [1]. These models facilitated in vivo drug resistance studies but were hindered […]
China &US Dual Filing Secured! Medicilon Supports Sungening’s SG-1001 in Achieving FDA IND Clearance
June 27, 2025– SG-1001, an antifungal developed by Sungening, has received IND clearance from the U.S. FDA to initiate Phase I clinical trials. It follows its earlier clinical approval in China, making a significant milestone, dual IND clearances in both countries. This milestone not only marks a critical step in Sungening’s global strategy but also […]
Peptide Therapeutics: Preclinical Strategy
The CBA China Annual Conference 2025 successfully concluded in Suzhou on June 28, gathering over 30,000 professionals across 120+ forums to explore technological advancements and global collaboration. Dr. Hanjun Zou, TFM of Medicilon Chuansha, presented “Peptide Therapeutics: Preclinical Strategy,” detailing non-clinical research strategies for peptide drugs to accelerate their development and to improve treatment options. […]
【Blog】PDX-Derived Organoids: How This Mini-Tumor Transforming Cancer Research?
Imagine if we could grow tiny versions of a patient’s tumor in the lab, acting almost exactly like the real thing. PDXOs, the lab-growing 3D models, are not just cool science, they are changing how we discover and test disease treatment. Download our PDX Model poster presented at AACR 2025 So, what exactly are PDXOs? […]
Medicilon Highlights at the 2025 CBA-China Conference
June 28, 2025 –The Chinese Biopharmaceutical Association (CBA-China) Annual Conference concluded successfully in Suzhou, gathering over 1200 leaders from political, industrial, academic, and research sectors to explore technological advancements and global collaboration. Medicilon at CBA-China 2025: Showcasing Innovation & Global Leadership As a leading full-service preclinical R&D CRO, Medicilon actively participated in the CBA-China 2025 […]
Medicilon Supports BIOTIME in Securing Dual China-US Approvals for CDC7 Inhibitor BIOT-006
In April 2025, BIOTIME announced that its CDC7 inhibitor, BIOT-006, has received clinical trial approval from the U.S. FDA, following approval from China NMPA in March. No CDC7 inhibitor has yet been marketed globally to date. Medicilon, BIOTIME ‘s strategic partner, provided end-to-end preclinical R&D services for BIOT-006, from drug discovery to IND filing. This […]
