China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the health regulatory body in Denmark for its generic version of Roche’s Cytovene-IV (ganciclovir). This approval marks another milestone in the global expansion of Poly Pharm’s product portfolio, targeting the treatment of cytomegalovirus retinitis in immunocompromised patients, including those with AIDS, and the prevention of cytomegalovirus disease in organ transplant recipients at risk of infection.
Therapeutic Profile
Ganciclovir, a guanine nucleoside derivative similar to aciclovir, is a potent inhibitor of viruses of the herpes family and can block the pathological changes caused by the Epstein-Barr virus. The originator drug was first approved in the US in 1989. Poly Pharm’s generic version has undergone rigorous testing and regulatory scrutiny, ensuring its efficacy and safety.
Global Regulatory Milestones
Poly Pharm’s generic ganciclovir has achieved significant regulatory milestones. The drug passed the World Health Organization’s (WHO) pre-qualification procedure in December 2012 and subsequently gained market approval in Holland in February 2014 and Germany in April of the same year. From 2015 to 2022, Poly Pharm’s ganciclovir has also secured market approvals in Hong Kong, France, the UK, China, the United States in 2018, Cyprus, Thailand, Italy, Costa Rica, Sweden, and Finland.
Future Outlook
The approval in Denmark further solidifies Hainan Poly Pharm’s position as a global player in the generic pharmaceutical market. With its proven efficacy and safety profile, Poly Pharm’s ganciclovir is poised to address significant unmet needs in the treatment and prevention of cytomegalovirus infections. The company’s ongoing efforts to expand its market presence underscore its commitment to providing accessible and high-quality medications to patients worldwide.-Fineline Info & Tech
