|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.
|20/05/12||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|
|20/05/12||GEM183||Direct renin inhibitor (DRI)||Blood pressure control and/or prevention of heart failure in patients with chronic hemodialysis||i.v.||Small molecule||Preclinical||Injectable formulation of GEM182 (oral formulation in phase-2b), is also being developed for potential use for better blood pressure control and/or prevention of heart failure by chronic intravenous treatment three times per week via vascular access established in patients with chronic hemodialysis. Renin inhbitor may be suitable for such patients who often exhibit hyperreninemia potentially due to residual function of juxtaglomerular apparatus as well as reduced renal blood flow after start of the hemodialysis. Although dialysis patients are mostly unavoidable from hypertension, no optimal treatment has been available yet. GEM183 can fulfill such such rapid growing huge unmet medical needs.
Licensing discussion is available except for China.
|20/05/12||GEM182||Direct renin inhibitor (DRI)||Hypertension （HP）, diabetic nephropathy （DKD）, chronic hemodialysis, heart failure||Oral||Small molecule||HP : Phase 2 ready, DKD: Phase 3 ready||A 2nd generation DRI with better renoprotective effects than ACEi/ARB. Better hypotensive effects than aliskiren is expected due to higher BA, less variability and no food effect following oral treatment. Prolonged renal localization, blood pressure independent renoprotection and positive effect on renal blood flow are evidenced by DRIs. In clinical trials of GEM182 in T2DM patients with microalbuminuria, dose-dependent UACR reduction and increases in remission rate from albuminuria were also seen.
This compound have been developed as mono-therapy (not combined with ACEi/ARB). Therefore, GEM182 has no safety issues seen in aliskiren's ALTITUDE trial due to RAS dual brockade.
Injectable formalution is also developed (ref. GEM183).
Licensing discussion is available except for China.
|20/05/11||GEM181||Selective HDAC8 inhibitor||Solid tumor||Oral||Small molecule||Phase 1||Through several mechanisms exhibited tumor inhibitory activity against many cancers, especially with high HDAC8 protein expression.
Advantages of GEM181
- Able to pass the BBB
- Suppresses angiogensis
- Side effects less than those of curretly marketed drugs
- Simple synthetic method