About Us

Company Profile

Hangzhou Leading Pharmatech Co., Ltd. was founded in 2014, spearheaded by Hangzhou Kechuang Incubator Co., Ltd. in collaboration with Zhejiang University. The company established the Zhejiang Province Future Science City Public Service Platform for Drug Development and Formulation Evaluation. As the operating entity, it is responsible for the platform’s construction and management, making it a leading national R&D hub for innovative and generic drugs. Rooted in Zhejiang, the company supports biopharmaceutical enterprises nationwide in filing new‑drug and high‑value‑product registration applications and obtaining manufacturing release approvals. It actively develops a one‑stop research service model that meets regulatory requirements for active pharmaceutical ingredients (APIs, excipients, packaging) and their finished dosage forms, encompassing pharmaceutical sciences—including identity and quality control, product development, and stability studies—alongside pharmacodynamics, pharmacokinetics, toxicology, and microbiological research. The company is a public scientific‑technological infrastructure platform under the Zhejiang Provincial Department of Science and Technology and a pilot demonstration enterprise for the Ministry of Industry and Information Technology’s “Mass Innovation and Entrepreneurship” initiative in the manufacturing sector.

The platform boasts an advanced R&D facility spanning nearly 10,000 square meters, equipped with over 400 pieces of cutting-edge equipment and instruments valued at nearly RMB 100 million. All instruments and systems undergo comprehensive compliance optimization and Computer System Validation (CSV). In close collaboration with Zhejiang University and its team of distinguished professors and experts, the company fosters talent development and strengthens technical capabilities, maintaining a core technical team of more than 100 members, including six national drug review experts and eleven provincial-level experts. Furthermore, by providing state-of-the-art research infrastructure and launching strategic projects, the platform attracts a substantial pool of top-tier domestic and international talent and teams, forming a workforce predominantly composed of master’s and doctoral degree holders.

As the company continues to grow and expand, it has aligned itself with global pharmaceutical quality standards and established a CNAS‑accredited quality management system that complies with international standards including those of China, the United States, and the European Union. The company is committed to becoming a one‑stop service platform characterized by “methodological rigor, impartiality, regulatory compliance, and customer satisfaction.”

The platform has established cooperative relationships with approximately 500 biopharmaceutical companies nationwide, making it a highly trusted industry hub for the sector. Its research and development spans areas including oncology, cardiovascular disease, diabetes, immune system disorders, and neuropsychiatric conditions. Over the years, it has been honored with prestigious titles such as National High-Tech Enterprise, Provincial R&D Center, Provincial Specialized, Sophisticated, and Novel Enterprise, Innovative Development Quality Service Platform, and High-Quality Development Award.

Company Profile

Development History

Development History

2013
In May 2013, Zhejiang University and the Yuhang District Government of Hangzhou signed a framework agreement on the joint development of a public service platform for biomedicine, with the initial phase designated to establish an early-stage drug‑likeness evaluation service platform for innovative drugs.
2014
The platform’s establishment, construction, and operation are supported by a laboratory spanning 6,000 m². Equipment investments total RMB 60 million.
2017
The platform has officially launched its external services, offering early-stage drug-likeness assessments covering chemical properties, pharmacological efficacy, pharmacokinetics, and toxicology.
2018
Establish six major biopharmaceutical research service platforms. To date, we have provided services to more than 200 enterprises.
2019
A pilot and demonstration enterprise of the national-level “Mass Innovation and Entrepreneurship” platform for manufacturing. A provincial-level public service demonstration platform for small and medium-sized enterprises. Passed the on-site inspection by the National Administration.
2022
Obtained CMA accreditation. CNAS accreditation. Passed the U.S. FDA on-site inspection.
2023
Through on-site inspections conducted by the National Administration. Expansion of the animal experimentation center and the microbiology laboratory. The platform’s total floor space is nearly 10,000 square meters. A cumulative total of over 500 enterprises have been served.
2024
The U.S. FDA on-site inspection resulted in a zero-defect pass.
2025
Following another surveillance audit and scope‑expansion assessment, the laboratory’s testing capabilities have been expanded to 128 items.

2013

2014

2017

2018

2019

2022

2023

2024

2025

Qualifications Honors

Qualifications Honors

High-Tech Enterprise Certificate

High-Tech Enterprise Certificate

Hangzhou Qinglan Program Enterprises

Hangzhou Qinglan Program Enterprises

Advanced Unit for Innovative Services, 2018

Advanced Unit for Innovative Services, 2018

Advanced Unit for Innovative Services, 2018

Advanced Unit for Innovative Services, 2018

Provincial High-Tech Enterprise Research and Development Center

Provincial High-Tech Enterprise Research and Development Center