|R&D |R&D Pipeline
14th New drug in Korea, “Noltec”, a treatment for Acid-related diseases
- “Noltec tab”(Ilaprazole), the nation’s first PPI agent and the 14th new indigenous drug
- “Noltec tab” is a PPI(Proton Pump Inhibitor) agent and underwent the multinational clinical trial, and was launched in Korea after its first debut in China.
- Registered the substance patent globally in the United States, EU, China, Japan, etc., acquiring the intellectual property right
- The market share and sales are expected to increase on the back of the addition of the indication for reflux esophagitis.
The development of “Noltec”, the nation’s 14th new indigenous drug, dates back to 1987 which is before the 88 Olympic Games were held in Seoul, and is the result of the efforts over more than 2 decades to create the growth engine and cope with the introduction of the substance patent in 1987 for the first time nationwide.
Noltec represents the culmination of constant and intensive R&D as part of major state-funded projects such as the leading technology development project(G7 project) driven forward by the Ministry of Science and Technology in 1992 and new drug development project led by the Ministry of Health and Welfare in 1998, and has come into limelight for its efficacy even before the launch as the nation’s 14th new indigenous drug.
As a result, Noltec provides the strongest inhibition of gastric acid secretion among the PPI agents currently available in the market and has proven excellent efficacy providing the lasting effect with a single dose per day. Noltec added the indications of reflux esophagitis, and has achieved drastic sales growth and sharp increase of the share in the market for esophageal ulcer drugs.
As the reflux esophagitis incidents have increased with a recurrence rate of 80%, the market for reflux esophagitis drugs – which comprise more than 80% of all anti-ulcer drugs – has seen an increasing need for constant maintenance therapy.
Meanwhile, South East Asia and Korea has seen a shift in focus from gastric ulcer/duodenal ulcer treatment drugs to reflux esophagitis drugs. This has led to higher marketability and value of “Noltec”, creating an opportunity for this new drug to gain ground in global market beyond South East Asia.
Nolte makes foray into peptic ulcer market worth KRW 600 billion
Noltec has made foray into peptic ulcer market worth approximately KRW 600 billion and accounting for 80% of PPI agents on the back of the addition of the indication for reflux esophagitis, moving beyond the market valued at KRW 40 billion. As a result, Noltec, which has the most excellent efficacy and longest lasting effect among the PPI agents, is expected to rake in huge amounts in sales comparable to those of the existing major products simply by adding the indication for reflux esophagitis.
18th Korea’s New Drug – SUPer + effECT treatment “SUPECT”
SUPECT(API: Radotinib) is Asia’s 1st Chronic Myeloid Leukemia (CML) treatment which solely developed by technicians of IL-YANG Pharm. “SUPECT” had obtained its material patent in US, Canada, New Zealand, Australia, Singapore, Indonesia, Malaysia, Mexico, Vietnam, EURASIA (9 notions including Russia) and etc. Upon its approval of 1st line-treatment on October 27th, 2015, it is ready to expend its value for the Global market. Current global market of Leukemia is about 10 billion UDS, and there are only 4 2nd generation of CML treatments including “SUPECT”. In 2003, material
“Blood”, peer-reviewed medical journal published by American Society of Hematology and “Thomson Reuters”, a major multinational mass media and information announced “SUPECT” as most famous and competitive new drug.
The globally famous medical journal, ‘Blood’ introduced “SUPECT” for its great efficacy and cost effectiveness. ‘Blood’ also mentioned “Interestingly, in South Korea, where annual prices for TKIs range from $21,000 to $28,000, market competition may have worked well, perhaps because of the approval by the Korean health authorities of radotinib (annual prices $21,500), a locally discovered and developed TKI.” ‘Blood’ strongly point out “We propose to begin the dialogue by organizing regular meetings, involving all parties concerned, to address the reasons behind high cancer drug prices and offer solutions to reduce them.”, due to continuously increasing price of “Gleevec” from Norvatis since 2001 and high prescription price of 2nd generation treatments, Tasigna(Norvatis) and Sprycel(BMS). With together, a major multinational mass media, ‘Thomson Reuters’ evaluated “SUPECT” as one of four ‘New promising cancer drug’ among all ‘Oncology’ related drug that had been approved throughout the world.
First publication on SCI international journal – Haematologica Cost-effective contrast to efficacy among TKI products / Great efficacy proven
“SUPECT” has been published on SCI International Journal, “Haematologica” with title of “Efficacy and safety of radotinib in chronic phase chronic myeloid leukemia patients with resistance or intolerance to BCR-ABL1 tyrosine kinase inhibitors”, which contains efficacy and safety of Leukemia treatment 『SUPECT』 by 12 month. In journal, introduced 『SUPECT』 as “Cost-effective contrast to its efficacy” and conclude “a cost-effective tyrosine kinase inhibitor, which can improve accessibility to the drug and increase compliance and adherence to treatment, may be necessary in emerging regions.” Moreover, the journal evaluated “Adverse events were generally transient and managed by dose reduction or interruption”, which means the safety of “SUPECT” has been proved for long-term administration.
Ilyang Pharmaceutical’s vaccine
manufacturing plant in Eumseong
Full-fledged operation of control tower for vaccine development in various fields Top priority is to export the vaccines to countries with low vaccine availability, as well as Korea
Ilyang Pharmaceutical’s vaccine plant is built on a land covering an area of 89,256㎡(about 27,000 pyong) with the gross floor area of 13,361㎡(4,000 pyong) and has established the vaccine manufacturing line with an annual production capacity of 60 million doses. Ilyang Pharmaceutical operates the vaccine bulk production plant, which is not many worldwide, and the vaccine
Equipped with the latest production facilities and systems, Ilyang Pharmaceutical’s vaccine plant manufactures the excellent vaccine bulk, playing a pivotal role in ensuring undisrupted supply of excellent vaccines nationwide and exporting the vaccines to foreign countries where the vaccine availability and coverage remain low.
Ilyang Pharmaceutical is carrying on vaccine business without any error by fully leveraging on its well-recognized new drug development capability and R&D technology, and will take the lead in turning Korea to the powerhouse of preventive medicine, as well as help promote the advancement of domestic pharmaceutical industry, by operating the control tower for vaccine development in various fields. As a leader in R&D and technology for medicine, Ilyang Pharmaceutical has mapped out perfect plans and made preparations for technology and information-intensive vaccine business, and is pouring all energy for vaccine development to help usher in new future. Ilyang Pharmaceutical will make utmost effort to evolve into a global provider of vaccines, helping promote the health of the public and humanity, and create better future.
‘IY7640’, super antiviral substance
Designated as the research target of TEPIK(Transgovernmental Enterprise for Pandemic Influenza in Korea)
Ilyang Pharmaceutical developed the innovative antiviral substance and is proceeding with new drug development amid the heightened fear of virus such as the new swine flu and H7N9 bird flu in China. The antiviral substance, developed by Ilyang Pharmaceutical, has entirely different mechanism of action compared to Tamiflu, the anti-viral agent, and was found in animal experiments to have better efficacy than Tamiflu. Particularly, this antiviral substance was found to have a very excellent effect on Tamiflu resistant virus, which paves the way for the advancement of domestic pharmaceutical technology and acquisition of anti-viral agent sovereignty from the standpoint of national security. This antiviral substance(IY7640) developed by Ilyang Pharmaceutical was obtained quickly through the high-throughput screening system, and was found to have a wide range of antiviral effect on most influenza virus infecting the human body. In addition, the group of mice administered with Ilyang Pharmaceutical’s new antiviral agent(IY7640) showed a survival rate of more than 80% which proves the very excellent antiviral effect on the resistant virus, while the group of mice administered with the conventional Tamiflu died completely. Along with that, Ilyang Pharmaceutical’s ‘IY7640‘ was designated as the research target of the “Transgovernmental Enterprise for Pandemic Influenza in Korea (TEPIK/President: Professor Kim Woo-joo)” led by the government. As a result, the new drug development will be pushed forward at a transgovernmental level with the research grant of government. It has been successfully proven to the government officials that this new anti-viral substance has excellent efficacy and totally different mechanism of action than the existing agents made from shikimic acid and provides strong antiviral effect even on Tamiflu resistant virus, and furthermore, the technology incorporated into this innovative anti-viral substance has been well-recognized by the evaluation committee.
New bio drug - Cytokine-based product and peptide drug development
Ilyang Pharmaceutical developed the cytokine material that has a market worth in excess of approximately $65 billion and launched 4 types of research reagents. Moreover, it filed the application for the functions and capabilities that could become apparent based on the change of form and applications after conducting the research and verification. The 4 types of research reagents, which were launched by Ilyang Pharmaceutical, will be used in a variety of applications for bio-drug development in global medical community to cure intractable diseases. Ilyang Pharmaceutical is proceeding with the research into the various functions of cytokine with an aim to develop the nation’s first cytokine treatment drug as the multinational pharmaceutical companies are recently spurring the development of cytokine-based drugs for the treatment of intractable diseases, and furthermore, is on track to develop the production process needed to put the products onto the market. Cytokine, one of the proteins inside the body, is a substance involved in human signal transmission, stimulates or inhibits human body's immune system, and induces the production of antibodies that combat the external antigen to control and adjust the defense system of human body. In addition, cytokine is a substance necessary for congenital and adaptive immune response and has wide applications in R&D, such as anti-cancer immunotherapy, rheumatoid arthritis, hematopoietic function, recovery of tissue, treatment of brain disorders, cell growth, etc., and therefore is considered the best options for BIO drugs used to treat intractable diseases. Along with that, Ilyang Pharmaceutical is accelerating its drive to develop protein and peptide drugs based on its patented peptide material. Peptide has low biological toxicity and excellent selectivity and is easy to operate. Furthermore, peptide can be chemically synthesized and therefore can be easily researched and applied in various fields such as the medicine, new materials, nano science, molecular imaging, drug delivery, etc. For those reasons, the proportion of peptide drugs approved by the FDA has increased rapidly.