Integrated Platform
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Integrated Platform
We have established all essential functionalities throughout the drug development process, from early-stage screening and discovery, preclinical research, clinical development, CMC to pilot manufacturing.
R&D
We successfully established a comprehensive R&D platform for antibody discovery and engineering, in vivo and in vitro efficacy evaluation, druggability assessment, achieving an efficient drug development process
3
years
From target selection to investigational new drug (IND) submission
* Outpacing the industry average of approximately five to six years, according to Frost & Sullivan
Clinical Development
From protocol to proof: Delivering compelling clinical outcomes
170
+
Collaborative clinical trial sites
2.3
years
From first patient enrolment of the first-in-human trial to registrational trial stage
* Significantly outpacing the industry average of 6.4 years, according to Frost & Sullivan
Strategic and adaptive clinical strategy design
We design clinical development and registration strategies based on the project's characteristics to achieve differentiated and efficient regional deployments in China and worldwide.
Rapid progression of clinical development
We develop comprehensive clinical plans that facilitate rapid market entry through underserved indications and maximize clinical potential through broad indication expansion.
Expertise in navigating regulatory pathways
Our clinical team is adept in navigating complex regulatory pathways in major countries and regions to expedite the timetable for drug registration. We constantly monitor new registration trends and plan for multicenter trials to achieve global registration with optimized allocation of efforts and resources.
CMC and Pilot Manufacturing
We seamlessly integrate formulation process development, technology transfer, and contract manufacturing technical support, leveraging advanced facilities and technology to significantly reducing cycle times while ensuring adherence to the most stringent quality standards and rigorous manufacturing practices.
6
months
Complete GMP-compliant bulk drug substance production
12
months
Prepare CMC-related IND submission materials
Efficient Antibody Development Platform
A comprehensive and highly efficient antibody drug development platform has been established, including process development, analytical method development, quality control and pilot GMP-compliant manufacturing.
Comprehensive quality control system
We operate a comprehensive quality control system that spans all key stages of our R&D and manufacturing processes. This system is meticulously established and refined in accordance with rigorous regulations and guidelines in China, the U.S., and Europe.
Manufacturing facilities
Our pilot GMP-compliant manufacturing facility houses production lines with a scale of 200L or 500L disposable bioreactors to support the early-stage clinical development of our drug candidates.
Leads Biolabs © Nanjing Leadsbiolabs Co., Ltd. | Su ICP No. 18069235