SHENZHEN, China--(BUSINESS WIRE)--Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (SZSE: 002399, HKEx: 9989), a China-based global pharmaceutical company targeting high-mortality diseases with significant unmet medical needs, announced exciting regulatory milestones in both the marketed pharmaceutical business and its pipeline development.
On the marketed product front, Hepalink’s Inhixa brand enoxaparin sodium injection has obtained the approval for marketing in Switzerland. This achievement marks that after successfully marketing enoxaparin in the European Union countries, the company has further expanded beyond EU, and is accelerating the full coverage of the European market. Hepalink is the largest China-based and third largest global manufacturer and marketer of enoxaparin sodium injection, which has been approved in 36 and sold in 19 countries, with a global market share of 6.5%, based on 2019 worldwide sales according to Frost & Sullivan.
On the innovative pipeline front, Hepalink’s strategic partner Resverlogix Corp. ("Resverlogix") (RVX.TO) announced that the U.S. Food & Drug Administration (FDA) has accepted its BETonMACE2 clinical plan for RVX-208 (apabetalone) as a registration enabling study. Hepalink has the Greater China rights of RVX-208. RVX-208 has been granted the Breakthrough Therapy Designation by the FDA in January 2020. Key written development points from a recent meeting with the FDA include the following:
Filing of a New Drug Application (NDA) with the FDA is possible following unequivocal efficacy at an interim analysis of BETonMACE2
All or most BETonMACE2 patients to receive top standard of care, including maximized use of SGLT2 inhibitors (SGLT2i)
BETonMACE2 to increase enrichment of chronic kidney disease (CKD) patients, potentially including those with lower baseline renal function
Based on BETonMACE results, the FDA encouraged the evaluation of a non-alcoholic fatty liver disease (NAFLD) subgroup as well as related exploratory endpoints
The agreement achieved with the FDA on the pivotal clinical trial design is expected to enhance the current and ongoing partnership discussions for RVX-208.
Founded by a group of seasoned polysaccharide-chemists with scientific insights and profound understanding of immunology, Hepalink is a leading China-based pharmaceutical company with global businesses in pharmaceutical, innovative biotech and CDMO sectors. Hepalink has built up a portfolio of both leading drugs in the anticoagulant and antithrombotic therapeutic areas and innovative drug candidates focusing on diseases with an immune system disorder axis, including oncology, autoimmune, metabolic and other areas.