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On January 5, the website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that Hengrui Medicine has submitted a new drug marketing application for SHR8008 capsules
.
SHR8008 is a new type of antifungal drug introduced by Hengrui Medicine from Mycovia Pharmaceuticals with over US$100 million
Screenshot source: CDE official website
SHR8008 (oteseconazole) is a novel oral azole antifungal drug developed by Mycovia, which can inhibit the fungal CYP51 enzyme with high specificity
.
According to an earlier press release from Mycovia, SHR8008 is designed to have higher selectivity, fewer side effects and better efficacy than currently available antifungal drugs
In June 2019, Hengrui Medicine entered into a partnership with Mycovia and obtained the exclusive rights of the drug in Greater China (Mainland China, Hong Kong, Macau and Taiwan) to develop and commercialize SHR8008 for the treatment or prevention of a range of fungi Diseases, including recurrent vulvovaginitis candidiasis, onychomycosis, and invasive fungal infections
.
In November 2021, Hengrui Medicine announced that SHR8008 met the protocol-preset superiority standard in a Phase 3 clinical study called SHR8008-302
.
This is a randomized, double-blind, double-dummy, fluconazole parallel-controlled, multicenter Phase 3 clinical trial to evaluate the efficacy and safety of SHR8008 capsules in the treatment of acute vulvovaginal candidiasis (VVC)
The results of the Phase 3 clinical study showed that the cure rate of SHR8008 in the treatment of acute vulvovaginal candidiasis was significantly better than that of the control group, reaching the primary endpoint of the trial
.
Hengrui Medicine stated in its announcement in November 2021 that the company will submit a communication application for the new drug listing of the drug to CDE in the near future
In addition, Hengrui Medicine is conducting another randomized, double-blind, fluconazole-controlled, multicenter Phase 3 clinical trial called SHR8008-301, which aims to evaluate SHR8008 capsules in the treatment of recurrent vulvovaginal Candida Efficacy and safety of the disease (RVVC)
.
It is worth mentioning that in the United States, the FDA has accepted the new drug marketing application of oteseconazole for the treatment of recurrent vulvovaginal candidiasis and granted it priority review status, with a PDUFA target date of January 27, 2022
.
Mycovia said in a press release that, if approved, oteseconazole would be the first FDA-approved drug for the treatment of RVVC
Publicly available information shows that many women worldwide are affected by acute vulvovaginal candidiasis and recurrent vulvovaginal candidiasis
.
It is hoped that SHR8008 (oteseconazole) will be approved soon, bringing new treatment options to female patients
references:
references:[1] China National Medical Products Administration Center for Drug Evaluation (CDE).
[2] Mycovia Pharmaceuticals Announces Completion of Partner Jiangsu Hengrui Pharmaceuticals' Phase 3 Clinical Study Evaluating Oteseconazole for Treatment of Acute Vulvovaginal Candidiasis (VVC) in China Retrieved Nov.
[3] Hengrui Medicine's announcement on the introduction of products from Mycovia in the United States.
[4] Announcement of Hengrui Medicine on the Progress of Drug Clinical Trials.
Retrieved Nov.
04, 2021, from http:// 11-05
