Kangzhe Pharmaceutical (00867): Innovative oral small molecule JAK1 inhibitor Povorcitinib included in the list of breakthrough therapeutic varieties

Zhitong Finance App News, Kangzhe Pharmaceutical (00867) issued an announcement. The innovative oral JAK1 inhibitor povorcitinib (proposed Chinese generic name: povorcitinib or product) (povorcitinib or product), a subsidiary of the group, has been approved by the China National Drug Administration (NMPA) Drug Review Center for inclusion in the list of breakthrough treatments. Indications are non-segmental vitiligo in adult patients. This certification is expected to speed up the development and review process of this product.

Povorcitinib is a selective oral small molecule JAK1 inhibitor with patents for substances and uses in specific countries/regions within the region. Povorcitinib is currently undergoing phase 3 clinical trials for non-segmental vitiligo, moderate to severe suppurative hidradenitis (HS), and prurigo nodules in several overseas countries. In addition, phase 2 clinical trials to treat asthma are also ongoing.

The product has now been included in the list of breakthrough therapeutic drug varieties, which is expected to accelerate its R&D and evaluation process in mainland China. If approved for marketing in China, the product is expected to collaborate with Demei Pharmaceutical's innovative drug iLuqu (tiriquizumab injection), the exclusive drug Xiliaotul (polysulfonic acid mucopolysaccharide cream), and the innovative drug Lucotinib phosphate cream, which is currently in the New Drug Application (NDA) stage, to quickly achieve clinical and commercial value, and benefit more patients with skin diseases. In addition, the product will also work with topical lucotinib phosphate cream to provide differentiated and comprehensive treatment options for patients with vitiligo.

On March 31, 2024, the Group signed a cooperation and licensing agreement with InCyte on PovorCitinib through a subsidiary of Demei Pharmaceutical and obtained exclusive licensing rights for research, development, registration and commercialization of products in mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan region and 11 Southeast Asian countries (regions), as well as non-exclusive licensing rights for products produced in the region. The subsidiary company of Demei Pharmaceutical has re-licensed the relevant rights of povorcitinib in regions other than mainland China to the Group (excluding Demei Pharmaceutical and its subsidiaries).