The product has orphan drug designation for PTCL granted by Japan's Ministry of Health, Labor and Welfare. HUYABIO will complete the development of HBI-8000 for PTCL and ATL in Japan for commercialization by Meiji who will hold exclusive sales and marketing rights. Meiji will pay HUYABIO an upfront and milestones plus royalties on net sales. HUYABIO will manufacture and supply the product to Meiji for initial commercialization.
"This collaboration aligns with Meiji's R&D commitment to oncology to develop new drugs to fulfil unmet needs of patients worldwide. By continually improving our R&D process with innovation, Meiji brings high-value and high-quality drugs to market quickly. Meiji and HUYABIO will cooperate to commercialize HBI-8000, for the benefit of cancer patients," said Daikichiro Kobayashi, President and Representative Director of Meiji Seika Pharma Co, Ltd.
"We are delighted to enter into this partnership with Meiji to bring HBI-8000 to patients with PTCL or ATL. We also look forward to advancing the development of our drug based on its immunomodulatory properties," said Dr. Mireille Gillings. "The agreement reinforces our vision to leverage assets licensed from China for global development and commercialization. Meiji Seika Pharma's strong position in hematologic malignancy will help ensure the drug's success in the Japanese market."
The novel epigenetic drug, HBI-8000, is a member of the benzamide class of histone deacetylase inhibitors, which regulate gene expression through histone modification, which enables the efficacy of increasing other cancer agents such as checkpoint inhibitors. The company was the first to leverage the Tripartite Agreement between China, Japan and South Korea, which allowed Chinese clinical data to be leveraged in the other two countries. Based on clinical results, the Japanese Pharmaceutical and Medical Devices Agency allowed accelerated development of this drug in lymphoma.
About HUYA Bioscience International
HUYABIO is the leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. The Company has emerged as the partner-of-choice for maximizing the value of innovation in China. With the largest team of scientists working with Chinese innovators, HUYABIO identifies and advances promising drug candidates globally and has offices in the US, Japan, South Korea and China.
About Meiji Seika Pharma Co., Ltd.
In order to protect and improve people's health and lives, Meiji Seika Pharma, as a "Speciality and Generic Pharmaceuticals Company," runs its pharmaceutical business in the two main fields, infectious disease and central nervous system disorders, as well as generic drugs. Meiji Seika Pharma strives to respond to diversified medical needs and contributes to the well-being of people worldwide.
SOURCE HUYA Bioscience International