|20/06/18||GEM194||PDE4 inhibitor||Autoimmune dermal disorders （bullous pemphigoid, psoriatic arthritis）||Oral||Small molecule||Phase 1||GEM194 is the best-in-class PDE4 inhibitor having potentially a wider therapeutic index compared to clinically efficacious and marketed PDE4 inhibitors such as apremilast and roflumilast. Bullous pemphigoid (BP) is chronic autoimmune skin disorder resulting in generalized, pruritic, bullous lesions in elderly patients currently treated with corticosteroids and multiple antibacterial agents. Anti-inflammatory profile of PDE4 inhibition associated with multiple immune- and inflammatory cells is anticipated to taper doses of systemic corticosteroid. Opportunities exist to extend clinical development for other inflammatory dermal indications such as psoriatic arthritis.||問合せ|
|20/06/18||GEM193||PDE4 inhibitor||NASH||Oral||Small molecule||Phase 1||GEM193 was efficacious in reducing plasma ALT levels, hepatic fibrosis area, TG levels in an animal model of NASH. In addition, GEM193 exhibited anti-obesity and anti-diabetic properties in vivo. PDE4 enzyme is expressed not only in disease-relevant cell population, but also in ubiquitously whole body and its inhibition results in anti-inflammatory, anti-fibrotic and anti-metabolic effects that fit favorable profile as a monotherapy for NASH.||問合せ|
|20/06/18||GEM191||Potentiation of detrusor contraction||Underactive bladde||Oral||Small molecule||Phase 1||Detrusor underactivity is a main cause of underactive bladder, which causes multiple lower urinary tract symptoms such as residual urine and urinary tract infection. GEM191 potentiates detrusor contraction and shows no impact on bladder storage function or urethral function. Stratified analysis clearly indicates efficacy to reduce residual urine in patients with detrusor underactivity.||問合せ|
|20/06/15||GEM190||Lipase inhibition, α-amylase inhibition, aldehyde dehydrogenase (ALDH) activation and anti-oxidant capacity increase||Overweight and obesity Alcohol and tobacco smoke toxicity||Oral||Natural product||Clinical||GEM190 is a combination of two purified plant extracts in a form of oral liquid food supplement developed for appetite and weight control. Also, it reduces alcohol and tobacco smoke toxicity by activation of aldehyde dehydrogenase (ALDH) and increasing anti-oxidant capacity. In overweight and obese patients, GEM190 showed significant suppression of appetite and reduction of body weight and body fat as well as it had a beneficial effect on fluid distribution during weight loss, as observed in 12-week treatment. Increased ALDH activity in PBMC was observed already after 24 hours after initiation of GEM190 administration. GEM190 may provide a salvage solution in populations known to be particularly susceptible to a build-up of excess acetaldehyde, such as having a ALDH2*2 genetic mutation. GEM190 claims are under two PCT applications.||問合せ|
|20/06/05||GEM-CVD05||Immune-modulate and slow down the hyperactive active immune system from attacking lung cells (and other solid organs)||Prevention of Respiratory Falure by Treating Acute Respiratory Disease Syndrome Resulting from COVID-19 and other viral pandemics||Refer to Note*||Protein**||Phase 3 ready***||1. Treatment of blood/MSCs, Tregs, NK cells with GEM-CVD05 to improve their homing to patients’ lungs, thereby enabling those cells to slow down the hyperactive immune attack on the lungs to help prevent deaths from respiratory failure.
2. Treatment of cells such as stem cells enabling them to home/engraft more effectively to the bone marrow and accelerating immune reconstitution with ‘younger’ immune cells for improved viral infected cell killing.
*Infusion with blood, or MSCs, Tregs, NK cells to improve efficacy, safety and cost of care outcomes
**Used to treat MSCs, Blood, Tregs, NK cells , Stem Cells to Prevent deaths from respiratory failure
***Phase 2 study for other indication has been completed.
|20/06/05||GEM189||Nanoliposome-encapsuled Radionucleotide||*Recurrent Glioblastoma，**Multiple tumor||Intra- tumoral||Radio- nucleotide||*Phase1, **Preclinical||Radionuleotide in GEM189 is ideal one for the treatment of solid Tumors. It delivers a high dose of radiation directly to the tumor while sparing normal, healthy brain tissue, stays at the tumor for several days and Effect lasts for several days and then dissipates. No serious adverse events observed to date.
Key advantages over External Beam Radiation Therapy:
-At least 500 Gy,
-Single 4-day hospitalization
-Able to more effectively treat tumor margins
- Limited toxicity
-Able to verify successful delivery with SPECT scan
|20/06/05||GEM188||Dual inhibitor of ROCK and new target kinase||Glaucoma; ocular hypertension||Small molecule||Topical eye drop||Preclinical||GEM188, a dual ROCK/new target kinases inhibitor, had shown more effective in intraocular pressure lowering than competitor netarsudil in magnetic bead-induced and hypertonic saline-induced ocular hypertensive models. Moreover, GME188 also showed lower eye irritation than netarsudil in New Zealand White rabbit. The plasma exposure by eye drops dosing was less than that by iv dosed with NOAEL. The preclinical studies including GMP-compliance production, GLP toxicology, etc., is ongoing in 2020.||問合せ|
|20/05/30||GEM187||Mesenchymal stem cell||Rheumatoid Arthritis （RA）, Inflammatory Bowel Disease （IBD）, COVID-19||Implant （allo- genic）||Cell||IND||GEM187 is a fresh (non-frozen) human allogenic umbilical cord tissue derived mesenchymal stem cells (hUC-MSC) product.
- Proprietary manufacturing process with no risk of contamination.
- “Youngest” adult MSC with robust proliferation capacity.
- Highly scalable to achieve enough cells.
- Superior biological functions: optimal cell viability and biological functions maintained for therapeutic use.
|20/05/29||GEM186||Innate Immune System Activator||Solid tumor||i.t.||Microbial||Phase 1||Co-activation of multipole innate immune pathways in tumor dendritic cells.
Dose dependent anti-tumor activities in allogenic models.
Low systemic risk
|20/05/12||GEM184||GPR40 full agonist||Obesity, diabetes, NAFLD/NASH||Oral||Small molecule||Phase 1||A first-in-class GPR40 full agonist stimulating multiple islet (insulin, glucagon) and gut hormones (GLP-1, GIP, and PYY). GEM184 is much more effective in improving glucose control than DPP-4 inhibitors and in preclinical models. In addition to glucose-lowering effects, GEM184 effectively decreases body weight in overweigh condition via stimulating gut hormones. By binding to a site independent of the fasiglifam binding site, GEM184 induces a similar therapeutic efficacy with much lower exposure (~1/270) compared to fasiglifam in diabetic models. A lower plasma exposure mitigates the risk of side effects including liver toxicities reported with fasiglifam. In addition, glucagon an GLP-1 stimulation by GEM184 induces therapeutic benefits on NAFLD/NASH conditions, in which DPP4 inhibitor and SGLT2 inhibitor were almost ineffective.||問合せ|