Benzinga | Aug 2, 2021 08:10AM EDT

VYNE Therapeutics Reports Approval Of AMZEEG, ZILXI In Chinese Economic Pilot Zone

VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company") today announced that its products AMZEEQ(r) (minocycline) topical foam, 4%, and ZILXI(r) (minocycline) topical foam, 1.5%, have been approved for commercial sale in a pilot program in Hainan Boao Lecheng, China. The drug will be sold in the region by Cutia Therapeutics, which licensed the exclusive rights to market AMZEEQ and ZILXI in Greater China.

The Boao Lecheng International Medical Tourism Pilot Zone was established with the approval of the Chinese State Council as a unique area in China where certain drugs and medical devices not otherwise registered with the National Medical Products Administration (NMPA) can be made available to patients. Drugs and devices that have already been approved for marketing in the U.S., European Union, Japan and other countries or regions can be imported into Boao Lecheng and used in designated medical institutions. The zone was established to provide innovative products available in certain territories outside of China to Chinese citizens who might otherwise travel abroad for medical care.

"We are pleased with Cutia's ongoing efforts to make our topical minocycline products available to patients in China," said David Domzalski, President and CEO of VYNE.

"AMZEEQ and ZILXI were approved for the pilot zone among other innovative dermatology products," said Lele Zhang, CEO of Cutia Therapeutics. "We are looking forward to introducing Chinese patients to AMZEEQ and ZILXI in the Pilot Zone, which may serve as an opportunity to collect real-world data to support an NMPA registration for each product," she said.

VYNE entered into a licensing agreement in 2020 with an affiliate of Cutia Therapeutics ("Cutia"), a privately-owned company in China with a focus in dermatology. Under the terms of the agreement, Cutia has an exclusive license to obtain regulatory approval of, and commercialize, AMZEEQ and ZILXI and VYNE's product candidate FCD105, once approved, in Greater China. In addition to supplying AMZEEQ and ZILXI in the Boao Lecheng International Medical Tourism Pilot Zone, Cutia intends to seek full regulatory approval of both products in China and has recently begun recruiting patients in a Phase 3 trial for AMZEEQ.