China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving marketing approval from the Finland National Agency for Medicines for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval marks a significant expansion of the company’s market presence in Europe. The targeted indications include 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.
Drug Profile
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 EB virus. The originator drug was first filed for marketing in the US in June 1989. Poly’s generic version has undergone rigorous pre-qualification procedures by the World Health Organization (WHO) and has received market approvals in multiple countries, including the US, UK, France, Germany, and others.
Global Approvals
Poly’s generic version of Cytovene-IV has achieved widespread market acceptance, with approvals in Holland (February 2014), Germany (April 2014), Hong Kong (January 2015), France (December 2016), the UK (February 2017), China (May 2018), the US (December 2018), Cyprus (February 2020), Thailand (April 2020), Italy (April 2021), Costa Rica (April 2022), and Sweden (October 2022). The latest approval in Finland further solidifies Poly Pharm’s position as a global provider of essential medications.
Future Implications
The approval in Finland underscores Hainan Poly Pharm’s commitment to expanding its global footprint and providing accessible treatments for cytomegalovirus infections. This move is expected to enhance the company’s market presence in Europe and contribute to the broader availability of ganciclovir for patients in need.-Fineline Info & Tech
