Regulatory filing with China’s National Medical Products Administration requests approval for Jublia for treatment of onychomycosis, a fungal toenail infection.
San Diego, CA, USA – March 9, 2021 – 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.”
AIM is a joint venture between HUYABIO International and the Tianjin Institute of Pharmaceutical Research. AIM identifies and evaluates medical opportunities from outside of China. The joint venture utilizes the Tianjin Institute of Pharmaceutical Research’s infrastructure in China and HUYABIO’s global network to accelerate the development of products for the China market.
About HUYABIO International
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the company has become a partner of choice to accelerate product development and maximize value globally.
Bob Goodenow, PhD