Hengrui Medicine's Class 1 new drug SHR8008 Capsule's second indication was approved for clinical use

Recently, Hengrui Medicine announced that its class 1 new drug SHR8008 capsules has been approved by the National Medical Products Administration to carry out a phase III clinical trial for the treatment of acute vulvovaginal candidiasis.

This is the second indication after SHR8008 capsules were approved to carry out clinical research for recurrent vulvovaginal candidiasis (RVVC) in 2020.

Vulvovaginal candidiasis (VVC) is an inflammatory disease caused by a fungal infection dominated by Candida albicans.

Approximately 75% of women will suffer from VVC once in their lifetime, and 40% to 50% will relapse again.
The clinical manifestations may include genital itching, burning pain, increased vaginal discharge, painful urination, etc.
, which seriously affects the quality of life.

At present, the clinical application of existing treatment methods is limited, and there is an urgent need to develop a new generation of safer and more effective oral antifungal drugs.

SHR8008 is a new type of oral azole antifungal drug originally developed by Mycovia Company.
It is significantly better than the commonly used azole antifungal drugs in inhibiting the fungal CYP51 enzyme.

In 2019, Hengrui Pharmaceuticals spent 110 million US dollars to introduce the product and obtained the exclusive rights to clinical development, registration, production and marketing of the compound in China.

Clinical trials have shown that SHR8008 has shown good safety and tolerability in multiple study populations.

From the results of Phase II clinical studies, SHR8008 can effectively treat acute VVC attacks.

Based on the above results, Hengrui Medicine plans to carry out a phase III clinical study of SHR8008 in the treatment of acute vulvovaginal candida disease in China, to further evaluate the effectiveness and safety of SHR8008 capsules in the treatment of acute VVC, and to provide more treatment for patients with acute VVC Clinical choice.

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