The manufacturing center for exported heparin sodium commenced its operation
2002
Passed the on-site Good Manufacturing Practice (GMP) inspection by the China Food and Drug Administration (CFDA)
2005
Passed the inspection for the certification by the U.S. Food and Drug Administration (FDA)
Enoxaparin sodium injection (Prolongin®) approved by China’s National Medical Products Administration (NMPA, formerly CFDA) as the first generic enoxaparin in China
2008
In the aftermath of the Baxter incident, Hepalink passed two on-site inspections by the U.S. FDA and became the only supplier of standardized heparin APIs in the U.S. At that point, Hepalink supplied over 95% of the APIs for heparin injections in the U.S., effectively alleviated the shortage of such life-saving drug
Hepalink’s heparin sodium product granted the Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)
2009
Participated in the amendment of the United States Pharmacopeia’s monograph on heparin sodium. The amended United States Pharmacopeia was published and took effect on Oct 1, 2009
2014
Acquired SPL Acquisition Corp. in the U.S. This acquisition strengthened Hepalink’s leadership position in the supply of heparin sodium API, further enhanced Hepalink’s vertically integrated capabilities in the global manufacturing, development, and sales of traceable heparin API. This acquisition also marks Hepalink’s entry into the pancreatin market and the beginning of the company’s global operations
2016
Enoxaparin sodium injection (Inhixa/Neoparin) approved in the EU as the company’s first biosimilar product in the region and the company began to build a team for the EU market
2018
Acquired Duopule and its subsidiary Techdow, thus completed the vertical integration of the entire heparin industrial chain with end-to-end coverage from APIs to heparin injections
2020
All SKUs of enoxaparin sodium injection (Prolongin®) marketed in China passed the Bioavailability Equivalence Evaluation of the Quality and Efficacy of Biosimilar, and became the first product that passed the evaluation in China at the time
2023
The company's enoxaparin sodium injection product (Enoxaparin Sodium Injection, USP) was approved by the U.S. Food and Drug Administration (FDA) and subsequently launched in the U.S. market.
Enoxaparin sodium injection (Prolongin®) became the first enoxaparin product selected by the 8th Centralized National Procurement in China.
^
CDMO and Innovative Drug Business
2015
Invested in Resverlogix, a Canadian biopharmaceutical company dedicated to the research and development of novel cardiovascular drugs, and obtained the development and commercial rights for the breakthrough therapy apabetalone (RVX-208)
Entered the CDMO business with the acquisition of Cytovance Biologics, Inc, a leading developer and manufacturer of large molecule pharmaceuticals in North America
2016
Established joint venture OncoVent with the partner company OncoQuest in China to advance the clinical development of the monoclonal antibody oregovomab in China for the treatment of ovarian cancer
2017
Invested in Kymab Group Limited, a UK-based biotech specializes in the development of monoclinal antibodies
2018
Invested in Curemark, LLC in the U.S. to advance the development of pancreatin injections for the treatment of neurological disorders
Established joint venture with Aridis Pharmaceutical Inc. to advance the clinical development of tosatoxumb (AR-301) and AR-101 in China
Under the leadership from Hepalink, Cytovance generated profit for the first time
2020
Began the production of key enzymes used in the two mRNA vaccines against COVID-19 globally
2021
Hepalink’s stake in Kymab Group Limited acquired by Sanofi, generating a 263% return on investment
Initiated a global multicenter Phase III trial of tosatoxumab (AR-301) and began dosing Chinese patients in the trial
