中文
 
+
Zhejiang Haichang Biotech Co., Ltd.


Company Profile

Zhejiang Haichang Biotech Co., Ltd.

Zhejiang Haichang Biotech Co., Ltd., Haichang Biotech is a global trailblazer committed to pushing the boundaries of biomedical technologies to better human health. With a strong emphasis on independent innovation and a solid global intellectual property right foundation, we drive the discovery and development of cutting-edge drug delivery systems. Our expertise lies in nucleic acid technologies. We actively contribute to the evolution of mRNA vaccine, small nucleic acid drugs, and complex injections.

 

Our broad product pipelines span various fields, encompassing infectious disease prevention, tumor immunotherapy, antitumor therapy, analgesia and more.

 

Headquartered in Hangzhou Biopharma Town, we have a local heart with a global reach. We blend groundbreaking technologies with international market opportunities, while adapting to the fast-paced biotech evolution. Our mission is to improve global health and well-being. Uniting research and development, manufacturing, marketing, and services, we strive towards a healthier, brighter future for all. 

Culture and Mission
  • Innovate to empower, we forge a brighter future for patients. With an unwavering commitment to improving health worldwide, we redefine treatment landscapes to fulfill clinical needs, safeguarding the well-being and the lives of all.

Development History
From 2013 to 2017
From 2018 to 2021
From 2022 to Now
Development history
01
2013-2017

Phase I: Focusing on 505(b)(2) modified drugs, featuring the research and development of the QTsome® nucleic acid formulation platform

● 2013: Company founded

● 2014: R&D team and early laboratory established

● 2016: laboratory for complex formulations established 

● 2017: Pre-A financing completed 

Development history
02
2018–2021

Phase II: Focusing on development of innovative nucleic acid drugs for the QTsome® platform and commercialization of chemical liposome formulations

● 2018: Strategic collaboration with Rexahn on HC0301 and completion of Series A financing

● 2019: Regional partnership with Dr. Reddy’s Laboratories for HC007 in the U.S.

● 2020:
Further collaboration with Rexahn;
acquisition of U.S.-based WGI;
Recognized as a Technology Innovation Board-supported enterprise;
Series A+ financing completed

● 2021: IND approval for HC0301 by U.S. FDA (Dec); simultaneous China-EU submission of HC007

03
2022–Present
Phase III: Commercialization, Global Expansion, and Regulatory Approvals

● 2022:
Broke ground on nucleic acid drug manufacturing facility (Apr);
completed Series B+ financing (Jun);
IND approval for HC009 by U.S. FDA (Oct)

● 2023:
HC0301 granted Orphan Drug Designation by U.S. FDA (Sep);
Domestic marketing approval of HC007 in China (Oct)

● 2024:
Apr: NMPA approval for HC0301 to enter clinical trials
May: Inauguration of Hong Kong subsidiary Whiteoak Pharmaceuticals Limited
Jul: HC007 granted marketing authorization in the European Union
Jul: Selected for the 2024 First Batch of National Key Biomanufacturing Demonstration Projects
Aug: First batch of HC007 shipped to the EU
Sep: Designated as a National-level “Little Giant” Enterprise specializing in high-tech innovation

● 2025: IND approval for HC016 by U.S. FDA and CN NMPA

Core Team
+86-571-26262022