Medicilon Supports BIOTIME in Securing Dual China-US Approvals for CDC7 Inhibitor BIOT-006

Preclinical CRO

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 […]

BIK Therapeutics and Medicilon Sign Strategic Collaboration Agreement to Accelerate Oncology Drug Innovation.

Preclinical CRO

May 13, 2025 –BIK Therapeutics, a South Korean biotech company pioneering next-generation oncology therapies, has entered a strategic collaboration with Medicilon to accelerate preclinical development of its lead candidates. Under the agreement, Medicilon will provide BIK Therapeutics with integrated preclinical research services, including pharmacokinetics, toxicology, and oncology pharmacology research. This includes key studies such as […]

Boston Innovation Meets ADME Precision

Smarter ADME Screening. Flexible Bundle. Greater Confidence. Flexible Screening Panels That Evolve With Your Pipeline. We get it – early discovery is fast-moving and complex. That’s why our bundled in vitro ADME panels are designed for your workflow, whether you choose one, two, or a full suite. Speed, Clarity, and Tailored Flexibility. and we are […]

Medicilon Passes FDA Inspection, Reinforcing Global R&D Excellence

Preclinical CRO

Shanghai, May 20, 2025 – 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 […]

Empowering Innovation in Regenerative Medicine: Medicilon’s ELU42 IND Team Wins Eluciderm’s “Excellent Service Award”

Preclinical CRO

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

Preclinical CRO

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—Developing PDX-Derived Organoid Models for Efficacy Evaluation of Anticancer Therapies (Download)

PDX-derived organoids combine the genetic fidelity of patient tumors with the scalability and speed of in vitro platforms—delivering a powerful model for evaluating therapeutic response. These models enable:🔷 More accurate efficacy prediction🔷 Reduced translational gaps🔷 Faster iteration for lead optimization This approach strengthens the bridge between preclinical data and clinical outcomes—empowering oncology researchers to make […]

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

Preclinical CRO

  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

Preclinical CRO

  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, […]

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Preclinical CRO

【BRIDGE】Medicilon XDC Innovation Forum · Seoul 2026

Preclinical CRO

Medicilon’s Formulation CDMO Platform Advances Taiji Group’s Next-Generation RNA Polymerase Inhibitor DSC158A Tablets to Clinical Stage

Preclinical CRO

TPD CN-US Dual Filing Milestone: Medicilon’s One-Stop Platform Helps Gluetacs Secure Dual Approval for GT818, a First-in-Class RSK Degrader

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