Edivirine Tablets Included in Priority Review List for Expanded Indication

On November 20th, CDE (China Drug Evaluation) announced that Edivirine tablets, developed by Jiangsu Addy Pharmaceutical Co., Ltd. (hereinafter referred to as "Addy Pharma"), have been included in the priority review list for an expanded indication. This drug is intended for use in combination with nucleoside reverse transcriptase inhibitors (NRTIs) and is indicated for two types of adult patients infected with type 1 human immunodeficiency virus (HIV-1): (1) treatment-naïve patients and (2) virologically suppressed patients without treatment failure history who require an alternative treatment regimen.

Edivirine tablets belong to the third-generation non-nucleoside reverse transcriptase inhibitors (NNRTIs) used in the treatment of HIV. They inhibit the replication of HIV-1 by non-competitively binding to the HIV-1 reverse transcriptase. Edivirine tablets were initially approved by the National Medical Products Administration on June 28, 2021, for the treatment of treatment-naïve adult patients with HIV-1 infection in combination with NRTIs.

In the year of its launch, Edivirine tablets were recommended in the "Chinese Guidelines for Diagnosis and Treatment of HIV/AIDS 2021" and were successfully included in the "National Medical Insurance Catalog" in 2021. Edivirine tablets can be used in combination with other antiviral drugs, taken once daily on an empty stomach, with a dosage of 150mg per dose (two tablets, 75mg/tablet).

In April of this year, clinical trial data from the phase 3 study ACC007-301 evaluating Edivirine in combination with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV) with 3TC and TDF were published in The Lancet Regional Health – Western Pacific journal. The study aimed to compare the efficacy and safety of the two combination regimens. The results demonstrated that the antiviral efficacy of the Edivirine group was comparable to that of the EFV group, with better immune restoration and overall good safety in the Edivirine group.

Additionally, Addy Pharma also possesses another anti-HIV product, Enomotide tablets. Enomotide tablets are the first domestically developed triple-combination single-pill fixed-dose anti-HIV drug with independent intellectual property rights. This drug combines Edivirine tablets with two nucleoside backbone drugs, tenofovir disoproxil fumarate (TDF), and lamivudine (3TC). Enomotide tablets were approved by the National Medical Products Administration in January this year for the treatment of treatment-naïve adult patients with HIV-1 infection.

According to Addy Pharma's 2023 semi-annual report, the sales revenue of these two anti-HIV drugs reached 32.8266 million yuan in the first half of the year, representing a year-on-year growth of 317.70%. The inclusion of Edivirine tablets in the priority review list for an expanded indication is expected to further accelerate their market expansion.