HUYABIO International And Tianjin Institute of Pharmaceutical Research Joint venture Submits Chinese New Drug Application For efinaconazole as Jublia™
SAN DIEGO, March 9, 2021 /PRNewswire/ -- HUYABIO International (HUYABIO), the leader in accelerating global development of China's pharmaceutical innovations, today announced that its joint venture with Tianjin Institute of Pharmaceutical Research has submitted a New Drug Application to the Chinese National Medical Products Administration's Center for Drug Evaluation. The joint venture, AIM, was established with the intent of advancing innovative medicines. The application requests approval of a topical formulation of the antifungal drug, efinaconazole, as Jublia™, for the treatment of onychomycosis.
Jublia is the first triazole-based topical formulation approved for the treatment of onychomycosis, a common and destructive fungal infection of the toenails. Other topical treatments lack efficacy and oral treatments are limited by drug interactions and serious safety concerns. Jublia is considered the treatment of choice for patients with mild to moderate cases or who cannot tolerate oral treatments.
This drug is already approved in Japan, the United States, Canada, Korea, Taiwan, Hong Kong and Macau, where it is sold under the brand names Clenafin™ or Jublia. AIM licensed exclusive rights in China from the originator company, Kaken Pharmaceuticals, in February 2019.1
Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, "This submission represents an important milestone for HUYABIO and AIM as we work with partners such as Kaken to bring products to the Chinese market. Jublia addresses a significant need as an effective topical treatment for onychomycosis and a promising alternative to more toxic systemic therapies. We plan additional regulatory filings in the future."
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SOURCE HUYABIO International