Boryung Pharmaceutical Co., Ltd Technology Information No . 1
Indication(적응증) Essential hypertension
New drug(신약) (Ingredients) Kanarb® (Fimasartan)
IMD(개량신약) (Ingredients)
Biomedicine (Ingredients)
Etc.
Item description Kanarb® (Fimasartan) 60mg, 120mg - Best in Class ARB anti-hypertension drug
Novel Angiotensin-II Receptor Blocker with Strong & Superior blood pressure lowing effect with lowest adverse events in ARBs.
a. Categories: Rx (Prescription drug) b. Ingredient(&strength): Fimasartan (60mg, 120mg, Film coated tablet) c. Uses: Essential hypertension d. Dosage: Once a day e. Bullet points: 1. Strong Binding Affinity to AT1 receptor 2. Showing strong, superior & stable blood pressure lowering effect comparing to other ARBs 3. Excellent safety profile and high (98.3%) overall compliance rate 4. Large scale of global clinical trials (around 40,000 subjects) with various ethnic groups (Asian, Caucasian, Hispanic) 5. Excellent Market Performance : No 1 ARB in Korea (U$40Mil in 2016) : Licensed-out to 55 countries Development status - CTD dossier, Zone II& IVb stability are completed. - Marketed in 13 countries including Korea, Russia, Mexico and Singapore - Kanarb Value-Up franchises and pipelines 1) Franchises : Kanarb Plus® (+HCTZ), Dukarb®(+Amlodipine), Tuvero®(+Rosuvastatin) 2) Pipelines : Atorvastatin Combo, Triple Combo(+AML/RSV), Triple Combo(+AML/HCTZ), Antidiabetics Combo Plans for Out-Licensing or joint R&D or investment - Finding our-licensing partner for Kanarb franchises and pipelines Patent - Compound / Manufacturing / Formulation / Indication and etc…
2
Essential hypertension
Todula® (Cilnidipine)
Item description Todula® (Cilnidipine) 10mg - The 4th GENERATION CCB, hypertension drug. Reduce the side effect of L type calcium channel blockers with dual (L-type and N-type) channel CCB, Todula®
a. Categories: Rx (Prescription drug) b. Ingredient(&strength): Cilnidipine (10mg, Film coated tablet) c. Uses: Essential hypertension d. Dosage: 10mg a day (QD) e. Bullet points: 6. Comparable BP lowering effect comparing to Amlodipine 7. Reducing Tachycardia, Ankle edema which is well known L-type CCB such as Amlodipine. 8. Significant reducing mean 24-hour BP in the total patient sample 9. Reno-protective effect through N-type calcium channel blocking Development status - CTD dossier, Zone II& IVb stability are completed. - Marketed in Korea, Japan
Plans for Out-Licensing or joint R&D or investment - The license right of 24 countries are already captured by Boryung’s partners S.KOREA, JAPAN, PHILIPPINES, THAILAND, SINGAPORE, HONG KONG, MALAYSIA, TAIWAN, UAE, LEBANON , JORDAN, KUWAIT, QATAR, OMAN, SUDAN, IRAQ, KSA, YEMEN, BAHRAIN, GUINEA, GHANA, MOROCCO, ALGERIA, EGYPT, LIBYA, TUNISIA, BENIN - The other territories are opend (Brazil is not available, Termsheet completion)
Patent -Expired
3
Nausea and Vomiting
Aloxi Generic (Palonosetron) -Patent non infringement
Item description Palonosetron non-infringement Gx. – Be the first player in the palanosetron market, the biggest market among the serotonin receptor!! No use and risk of disodium EDTA and non-infringement of Aloxi®which is valid until 2024(it depends on the market patent status). a. categories: Rx (Prescription drug) b. Ingredient(&strength): Palonosetron Hydrochloride (0.075mg/1.5ml, 0.25mg/5ml) c. Uses: A04AA05 Alimentary tract and Metabolism-Serotonin (5HT3) antagonists d. Dosage: Refer to the attached profile e. Bullet point: No#1. 5HT3 product and new composition (No Disodium EDTA), Be free from adverse events of disodium EDTA such as Hypoglycemia, reducing of calcium concentration etc Development status - Marketed in Korea
Plans for Out-Licensing or joint R&D or investment - The license right of 24 countries are already captured by Boryung’s partners China and South East Asia
Patent - Composition - 10-2014-0186039
4
Dry Eye disease Sleep aids
Eye-Spa® (Steamed eye mask)
Item description EYE-SPA® (Steam Eye mask) – Now it’s time to let your eyes rest & much plentiful moisture Stable temperature control, comforting your eyes with plentiful moisture a. Categories: General Healthcare product b. Ingredient: Carbon powder, Saline solution, Loess powder, Pulp c. Uses: Dry eye syndrome, sleep aids d. Dosage: 20min compressing e. Bullet point: Patented composition for plentiful steam releasing, Safe and stable temperature control to eyes and glabella as well. Steam releasing comparison test: https://youtu.be/P82lrOaxlzU
Development status - Marketed in Korea
Plans for Out-Licensing or joint R&D or investment - Sole distribution contract is opened.
Patent - Manufacturing - 10-2013-0135881
5
Antacid
Gelfos®M (Aluminum Phosphate gel)
Item description GelfosÂŽM - Put your spoon down and try the sachet type fast AlPO 4 Antacid suspension sachet Faster than Tablet, Convenient more than Liquid bottle, take it in a car, dark midnight and outside easily. a. Categories: OTC (over the counter) drug b. Ingredient(&strength): Aluminum phosphate gel+Magnesium hydroxide, Simethicone; 0.70 FL OZ (20g)/sachet (4sachets/box) c. Uses: heartburn, gastric hyperacidity, gastric discomfort, gastric fullness, nausea, vomiting, gastric pain and dyspepsia d. Dosage: 20g(0.7 FL OZ) X 3 times a day e. Bullet points: 1. Stop to use the slow tablet antacid, Stop to use the spoon for liquid antacid. Try the fast & portable sole AlPO4 suspension. 2. Better safety and efficacy than Aluminum hydroxide 3. Reducing the side effect of aluminum type antacid by the combination of Mg hydroxide. 4. Always be the No.1 antacid in every launched markets (Korea, Taiwan, China), US FDA approved. Development status - Marketed in Korea, China, US, Taiwan - US FDA approved - TOP antacid in China, Korea and Taiwan
Plans for Out-Licensing or joint R&D or investment - wish to find US mainstream distribution business partner
Patent - Expired
6
Histamine-2 Besto® receptor (Lafutidine) Antagonist/ Treatment gastric symptoms related acid disorder; acute/ chronic gastritis, gastric/duodenal ulcer, GERD Item description Besto® (Lafutidine) 10mg - The most potent and protective H2RA effect a. Indication : Gastric/Duodenal/Stomal Ulcer, GERD, Gastric mucosal Lesions associated with gastritis, H. pylori eradication, Preanesthetic medication b. Mechanism : H2 Receptor Antagonist with different structural formula ,Capsaicin Sensitive Sensory Nerve CGRP-Mediated Action c. Bullet points i. The most potent effect (as much as 10 times of Ranitidine) in H2RA market and it can also secure the stand along market in H2RA. ii. Long lasting gastric acid secretion Inhibition by two mechanisms (The most potent H2 receptor antagonistic effects comparing to others) iii. Gastro protective effects by stimulating the mucosa Development status - CTD dossier, Zone II& IVb stability are completed. - Marketed in Korea, Japan
Plans for Out-Licensing or joint R&D or investment - The license right of 10 countries are already captured by Boryung’s partners SOUTH AFRICA, NAMIBIA, BOTSWANA, ZIMBABWE, UGANDA, TANZANIA, NIGERIA, ETHIOPIA, RWANDA AND KENYA. - The other territories are open
Patent -Expired
7
Health supplement
Boryung Krill Oil Omega-3®
Boryung Krill Oil Omega-3®
Item description Boryung Krill Oil Omega-3® - The ONLY 100% SOLVENT-FREE among all Omega-3 market” a. Strength : 500mg, 1000mg b. Composition : 100% Krill Oil (Can be differentiated upon the distributors and markets need) c. Bullet points i.Enzyme reaction technology: No solvents were used during manufacturing procedure. Only 100% solvent-free Halal approved. ii. Better absorption rate compared to Fish oil iii. Concrete control of HDL and LDL. iv. 5 patents and 5 certificates [GMP(2013), HACCP(2014), ISO19001(2014), HALAL(2014) and GOED(2012)]. Development status - Master Dossier preparing.
Plans for Out-Licensing or joint R&D or investment - The other territories are open
Patent - Korea, Japan, USA, Canada, China
8
Dry Eye disease Sleep aids
Eye-Spa® (Steamed eye mask)
Item description EYE-SPA® (Steam Eye mask) – Now it’s time to let your eyes rest & much plentiful moisture Stable temperature control, comforting your eyes with plentiful moisture a. Categories: General Healthcare product b. Ingredient: Carbon powder, Saline solution, Loess powder, Pulp c. Uses: Dry eye syndrome, sleep aids d. Dosage: 20min compressing e. Bullet point: Patented composition for plentiful steam releasing, Safe and stable temperature control to eyes and glabella as well. Steam releasing comparison test: https://youtu.be/P82lrOaxlzU
Development status - Marketed in Korea
Plans for Out-Licensing or joint R&D or investment - Sole distribution contract is opened.
Patent - Manufacturing - 10-2013-0135881
9
Wrinkle care cosmetics
Lafente® (HA+Adenosin+Collagen_EGF )
Item description LAFENTE® (Microneedle wrinkle care patch) – Stop the serum and deliver the wrinkle care ingredients into the skin directly Delivers Hyaluronic acid, Adenosine, EGE and collagen into the dermis layer without causing pain (No surgery, No pain) a. categories: Cosmetic b. Ingredient: HA + Collagen + Adenosine + EGF (350um) c. Uses: Wrinkle care (anti-aging) d. Dosage: twice a week X 4w e. Bullet point: 13kinds of manufacturing technology patents, various non-clinical and clinical, Marketed in US and selected “Most innovative Beauty product in 2014” by Forbes magazine Development status - Marketed in Korea, China, US, Taiwan - The stability study will be completed til 1H 2017
Plans for Out-Licensing or joint R&D or investment - All territories could be considerable.
Patent 13 kinds of patents - Method of manufacturing microstructure / KR, PCT (JP, CN, EP) - Process for preparing microstructures / KR, PCT (JP, CN, EP) etc.