Medicilon Passes FDA Inspection, Reinforcing Global R&D Excellence
Shanghai, May 20 – Medicilon Preclinical Research (Shanghai) LLC (“Medicilon”) announces that it has successfully passed an on-site inspection by the FDA. The company receives an official Establishment Inspection Report (EIR) reaffirming its position as a trusted leader in preclinical R&D services. A Milestone of Compliance and Capability The FDA inspection, conducted with meticulous detail, […]
Empowering Innovation in Regenerative Medicine: Medicilon’s ELU42 IND Team Wins Eluciderm’s “Excellent Service Award”
Medicilon has been honored with the “Excellent Service Award” by its client, Eluciderm Inc., in recognition of their exceptional capabilities of Medicilon’s Elu42 IND team and their high-quality contributions to the development of the innovative therapy, Elu42. Testimony from Eluciderm CEO, Dr. Dan Holsworth: Dear Medicilon Elu42 IND team, I wanted to let you know […]
Medicilon Celebrates Nanolattix Group’s T320 ADC Drug Approval in China, the US, and Australia
On March 5th, Nanolattix Group announced that its novel T320-ADC drug has received clinical trial approvals from the National Medical Products Administration (NMPA) of China, the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) of Australia, marking a significant milestone in its global development journey. As a proud R&D partner, Medicilon […]
Medicilon Appoints Dr. Jian Ge as EVP of Preclinical Research Division
Medicilon, a leading pharmaceutical preclinical CRO, announced the appointment of Dr. Jian Ge as Executive Vice President of the Preclinical Research Division. Dr. Ge will focus on optimizing preclinical research capabilities for innovative drugs, and significantly enhancing services for global clients. He will also emphasize research into new targets, new mechanisms, and technologies, while closely […]
Medicilon Supports Moon Biotech’s Groundbreaking MNO-863 Probiotic Drug – Achieves Nearly 10% Weight Loss in 4 Weeks and Secures Dual Clinical Trial Trial Approvals
2025-04-18 Moon Biotech recently has announced that its innovative probiotic drug, MNO-863 enteric-coated capsules, has been approved for clinical trials by China’s NMPA. This follows earlier approval from the U.S. FDA, marking a rare dual greenlight across both major regulatory bodies. Medicilon is proud to have been a trusted R&D partner in this achievement, […]
Zero Defects! Medicilon Supports MeiJi BioPharma’s Oral Paclitaxel Soft Capsule in Gaining FDA IND Approval
2025-04-11 Meiji BioPharma has received FDA approval for its IND application for an oral paclitaxel soft capsule with “zero defects.” This marks the world’s first and only oral paclitaxel soft capsule project to receive clinical trial approval. Medicilon as a long-term partner of Meiji BioPharma, provided comprehensive preclinical R&D services, including formulation development, pharmacodynamics, […]
Global First! Medicilon Powers Tyercan’s Breakthrough Anti-Tumor Protein-Drug Tye1001 to U.S. and China IND Clearance
On February 26, Tyercan announced that its independently developed first-in-class drug, Tye1001, received clinical trial approval from China’s NMPA, following its approval by the US FDA on July 12, 2024. This marks a significant milestone of dual approval in both China and the US. As Tyercan’s partner, Medicilon delivered comprehensive GLP-compliant preclinical services, including pharmacodynamics, […]
Medicilon Supports Partner Nuoyuan Medical Equipment Co., Ltd. in Securing FDA IND Approval for Class 1 Innovation Drug Pemefolacianine
2025-01-07 On December 20, Nanjing Nuoyuan Medical Devices Co., Ltd. (“Nuoyuan Medical”) received FDA approval for an IND application for Pemefolacianine, an innovative Class 1 drug. This marks the first FDA IND approval for a folate receptor-targeted imaging agent developed in China, following Cytalux (OTL-38), the world’s first FDA-approved agent of its kind. Pemefolacianine has […]
A Decade of Collaboration: Medicilon Supports SinoRDA in Achieving Approval for Linaprazan Glurate
2025-01-02 On December 3, Shanghai SinoRDA Science and Technology Co., Ltd., a subsidiary of Guizhou SinoRDA Biotechnology Co., Ltd. (SinoRDA), secured approval from the National Medical Products Administration for its Linaprazan Glurate capsules. This milestone drug, a Category 1 chemical medication, is designed to treat reflux esophagitis. Medicilon, a trusted partner of SinoRDA for over a […]
Medicilon Supports Strategic Partner CGeneTech in Achieving Approval for Next-Generation DPP-4 Inhibitor
2025-01-02 CGeneTech Biopharmaceutical Technology (Suzhou) Co., Ltd. (“CGeneTech”) recently marked a significant milestone with the approval of its innovative Class 1 drug, Sentagliptin Phosphate tablets, for marketing in China. As a strategic partner, Medicilon provided comprehensive preclinical research services that complied with GLP standards, encompassing pharmacodynamics, pharmacokinetics, safety evaluations, and biomarker bioanalysis in Phase I clinical trials. Medicilon’s reliable research system—demonstrating high consistency […]
