Qilu Pharmaceutical's Anti-HIV Drug Emtricitabine/Rilpivirine/Tenofovir Alafenamide Tablets (Twinovir®) Granted Exclusive Market Approval in China

On July 16, according to the official website of the National Medical Products Administration, Qilu Pharmaceutical's Entrectinib Tablets (Tewino®) for the treatment of HIV-1 (Human Immunodeficiency Virus Type 1) infection received marketing approval, making it the exclusive product approved for marketing in China.

AIDS is a contagious disease caused by the infection of the human immunodeficiency virus (HIV). AIDS cannot be completely cured at present, and patients need to take multiple medications for a long time. Entrectinib Tablets are suitable for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥35kg.

Entecavir, Rilpivirine, and Tenofovir Alafenamide Tablets consist of entecavir, rilpivirine hydrochloride, and tenofovir alafenamide fumarate. Entecavir is a nucleoside reverse transcriptase inhibitor that blocks the synthesis of viral DNA chains. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor that inhibits viral replication by non-competitively inhibiting HIV-1 reverse transcriptase and exhibits broad-spectrum antiviral activity against various HIV-1 subtypes. Tenofovir alafenamide is converted into its active form, tenofovir, in the body, and then further transformed into tenofovir diphosphate through phosphorylation, inducing termination of viral DNA chain replication. The combination of these three drugs has proven efficacy and is a guideline-recommended antiviral treatment regimen for adult and adolescent patients who are new to treatment. The single-tablet formulation is more convenient to take, requiring only one tablet per day, which helps reduce the medication burden on patients and improve adherence.

To meet clinical needs, Qilu Pharmaceutical initiated the development of Entrectinib Tablets. During the research and development process, researchers at Qilu Pharmaceutical successfully resolved multiple technical challenges and conducted a systematic quality comparison between their self-produced product and the originator product. They completed bioequivalence trials in humans, fully ensuring that the self-produced product is equivalent in quality to the originator product and safe and effective for clinical use. Currently, the originator Entrectinib Tablets have not yet been marketed in China, and the approval and market launch of Terrino® provide patients with more diversified and convenient treatment options.

Qilu Pharmaceutical has been deeply engaged in the anti-AIDS field for many years, with several products already on the market, such as Tenofovir Disoproxil Fumarate Tablets, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, and Emtricitabine Capsules. As a Chinese pharmaceutical enterprise, it is fulfilling its responsibility and commitment to solving public health issues. Qilu Pharmaceutical will continue to focus on current unmet clinical needs, researching and launching more high-quality and affordable new drugs, contributing Qilu's strength to the construction of Healthy China.

Editor: Mu Mian

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