China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving technical review approval from the Medical Products Agency of Sweden for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval is for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including those with AIDS, and for the prevention of CMV disease in organ transplant recipients at risk of CMV infection.
Ganciclovir: Mechanism and Development History
Ganciclovir, a guanine nucleoside derivative similar to aciclovir, is effective in inhibiting all herpesviruses and blocking the pathological changes of normal lymphocytes caused by the Epstein-Barr (EB) virus. The originator drug was first filed for marketing in the US in June 1989. Poly’s generic version of ganciclovir has achieved significant regulatory milestones globally, passing the World Health Organization’s (WHO) pre-qualification procedures in December 2012.
Global Regulatory Approvals
Poly’s ganciclovir has gained market approval in multiple countries, including Holland in February 2014, Germany in April 2014, Hong Kong in January 2015, France in December 2016, the UK in February 2017, China in May 2018, the US in December 2018, Cyprus in February 2020, Thailand in April 2020, Italy in April 2021, and Costa Rica in April 2022. The product also passed the Generic Quality Consistency Evaluation (GQCE) in China in December 2020.
Future Outlook in Europe
With the technical approval in Sweden, Poly’s ganciclovir has entered the review and approval release stage for product characteristics summary, instructions, and labels in Sweden, Denmark, Finland, Norway, and Austria. Upon approval, the drug will be eligible for marketing in these countries, further expanding Poly Pharm’s presence in the European market.-Fineline Info & Tech
