Hainan Poly Pharm Co., Ltd (SHE: 300630), a China-based pharmaceutical company, has announced that it has received marketing approval from Health Canada for its generic version of Roche’s Cytovene-IV (ganciclovir). This development marks a significant step for the company as it expands its international footprint in the generic drugs market.
Indications and Importance of Ganciclovir
The generic ganciclovir is intended for the treatment of cytomegalovirus retinitis in immunocompromised patients, including those with AIDS, and for the prevention of cytomegalovirus disease in organ transplant recipients who are at risk of cytomegalovirus infection. Ganciclovir, a guanine nucleoside derivative similar to aciclovir, is known for its ability to inhibit all herpesviruses and block the pathological changes of normal lymphocytes caused by the EB virus.
Regulatory Milestones and Global Reach
The originator drug was first filed for marketing in the US in June 1989. Hainan Poly Pharm’s generic version has passed several regulatory hurdles, including the World Health Organization’s (WHO) pre-qualification procedures in December 2012. Since then, the company has gained market approval in the Netherlands in February 2014, was waived through in Germany in April of the same year, and has obtained market approvals in multiple other countries since January 2015.
Conclusion
The marketing approval from Health Canada for Hainan Poly Pharm’s generic version of Cytovene-IV (ganciclovir) is a testament to the company’s commitment to providing access to high-quality, cost-effective medications globally. This approval not only broadens the company’s product portfolio but also reinforces its position as a competitive player in the international generic drugs market.-Fineline Info & Tech
