Company Profile
AnnJi Pharmaceutical Co., Ltd. is a clinical-stage, new drug company dedicating to the development of first-in-class small molecules and focusing on indications with highly unmet needs in the therapeutic areas of neurology, dermatology, and inflammatory disorders.
4 assets are currently on our developmental pipeline.
- AJ101 is a topical cream formulation being developed for the treatment of acne vulgaris. The active ingredient in AJ101 is a novel androgen receptor degradation enhancer. Results from our global Phase 1 and 2 studies in patients with acne demonstrated that AJ101 was well-tolerated while significantly reduced the inflammatory acne lesion counts. Patients treated with AJ101 showed a higher response rate as defined by Investigator Global Assessment compared to placebo controls.
- AJ201 is a NCE being developed for the treatment of spinal and bulbar muscular atrophy (SBMA), a neurodegenerative disease associated with abnormal aggregation of the androgen receptor (AR) protein. It was granted 3 FDA orphan drug designations for the treatments of SBMA, HD and SCA. Phase 1 clinical trial in healthy volunteers is ongoing and anticipated to be completed in the first half of 2021.
- AJ302 is a novel selective histone deacetylase 6 inhibitor (HDAC6i) under development for the prevention and/or treatment of chemotherapy-induced peripheral neuropathy (CIPN). Phase 1 clinical trial is expected to be initiated in 2021.
- AJ303 is a novel first-in-class compound with anti-fibrotic and anti-inflammatory properties currently under development for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases.
Our goals are to translate and develop unique, innovative, and highly differentiated drug therapies and to engage global collaborators and business partners in late-stage product development and commercialization.
Product / Service
A. AJ101 is a topical cream formulation being developed for the treatment of acne vulgaris. The active ingredient in AJ101 is a novel androgen receptor degradation enhancer that effectively decreases the level of androgen receptor (AR) mediated by the ubiquitin-proteasome system through activation of the Nrf1 pathway. In addition, AJ101 displayed anti-inflammatory/antioxidant properties and reduced the expression of extracellular matrix (ECM) proteins in fibroblasts. Results from our global Phase 1 and 2 studies in patients with acne demonstrated that AJ101 was well-tolerated while significantly reduced the inflammatory acne lesion counts. Patients treated with AJ101 showed a higher response rate as defined by Investigator Global Assessment compared to placebo controls. Current efforts are directed to confirm the efficacy of AJ101 in large-scale pivotal clinical studies and to explore potential indications in other androgen and AR-related skin disorders.
Clinical Development of AJ101
Completed Phase 2 clinical trials in the US and Taiwan to assess the safety and efficacy of AJ101 in patients with acne vulgaris.
B. AJ201 is a new chemical entity being developed for the treatment of spinal and bulbar muscular atrophy (SBMA), a neurodegenerative disease associated with abnormal aggregation of the androgen receptor (AR) protein with a polyglutamine (polyQ) stretch. At the molecular levels, AJ201 exerts multiple cellular effects, activating nuclear factor erythroid 2-related factor 2 (Nrf2) in response to oxidative damages, Nrf1 to enhance the ubiquitin proteasome system (UPS)-mediated degradation, as well as heat shock factor 1 (Hsf1) to promote protein folding. In an animal model of SBMA, AJ201 alleviated behavioral defects in motor functions, ameliorated muscle atrophy, reduced the accumulation of mutant AR aggregates in muscles and activated the expression of antioxidant enzymes.
Clinical Development of AJ201
- Granted 3 FDA orphan drug designations to AJ201 for the treatments of SBMA, HD and SCA.
- Phase 1 clinical trial in healthy volunteers is ongoing and anticipated to be completed in the first half of 2021.
C. AJ302 is a novel selective histone deacetylase 6 inhibitor (HDAC6i) under development for the prevention and/or treatment of chemotherapy-induced peripheral neuropathy (CIPN). AJ302, selected for its safety profile and drug-like physiochemical properties, can substantially reduce drug toxicity commonly associated with non-selective HDAC inhibitors that deacetylate histone proteins in the genome. Recent studies have indicated that HDAC6 may be a drug target for the protection and regeneration of damaged peripheral nerves by enhancing microtubule-based axonal transport and mitochondrial dynamics. Scientists at AnnJi have demonstrated that AJ302 increased α-tubulin acetylation in microtubule, promoted neurite outgrowth and branching in paclitaxel-induced dorsal root ganglion (DRG) neurons in vitro. In a rat model of CIPN, AJ302 was shown to reverse paclitaxel-induced mechanical allodynia in a dose-dependent manner. The improvement in sensory functions was sustained after the treatment stopped.
Clinical Development of AJ302
Phase 1 clinical trial is expected to be initiated in 2021.
D. AJ303 is a novel first-in-class compound with anti-fibrotic and anti-inflammatory properties currently under development for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases. Using human primary cell-based models of pulmonary and renal fibrotic diseases, AJ303 was shown to decrease the levels of inflammatory cytokines, epithelial-mesenchymal transition markers, as well as extracellular matrix (ECM) proteins, in which their aberrant expressions are thought to drive the fibrosis. In bleomycin-induced rodent models of IPF, AJ303 was shown to reduce the levels of TGF-β and IL-6 in the bronchoalveolar lavage fluid and the fibrotic lesions (scars) in the lung. In addition, AJ303 has a favorable ratio of plasma to lung tissue distribution in non-clinical pharmacokinetic studies.
Business Interests
R&D Collaboration, Licensing, Investment
Contact Info
Elvis CC Yang
Senior Manager
elvis.yang@ajpharm.com
886-2-2365-5677 ext. 301