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 […]
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. […]
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 […]
BIK Therapeutics and Medicilon Sign Strategic Collaboration Agreement to Accelerate Oncology Drug Innovation.
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 […]
Medicilon Passes FDA Inspection, Reinforcing Global R&D Excellence
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”
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 […]
