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- 2026-05-20 22:55:43
- Policy
- The MSI invests ₩420 billion to bio-based technologies
- by Lee, Jeong-Hwan Jan 09, 2020 06:42am
- The government will invest ₩420 billion to foster bio as a next-generation growth industry and invests ₩61.4 billion in finding and verifying new drugs. The budget increased by 10.1% compared to the previous year for the development of bio-based technologies. New drugs, medical devices, brain research, and bio-big data are the areas of intensive investment. On the 7th, the Ministry of Science and ICT said, "It will finalize the implementation plan of the original technology development project in the bio sector in 2020". The bio-innovation strategy established by the governmental department last year influenced the movement of the Ministry of Science and ICT. In particular, this year, we will strengthen our support to secure global technological competitiveness in bio-related core fields such as new drugs, medical devices, and brain research, while actively investing in future bio-convergence technologies such as biobig data, artificial intelligence drug development, and 3D biotissue chips. In accordance with the confirmed implementation plan, on the 8th, the government will announce new tasks in key areas such as new drugs and stem cells and start supporting them in earnest. The government selected the biohealth sector as one of the three new industries last year. Ministry of Science and ICT is fostering biotechnology by establishing an innovative strategy for the biohealth industry, and it is pointed out that SK Biopharm's epilepsy treatments are approved for marketing by the US Food and Drug Administration (FDA). First, the government plans to expand R&D investments to secure global technological competitiveness in biomedical core fields such as new drugs, medical devices, and precision medicine. In order to continue the performance of the new drug field, the government will invest ₩61.4 billion to secure new drug technologies, including new businesses to discover and verify new drug targets. In addition, AI and big data, which are the core engines of the Fourth Industrial Revolution, are expected to be used in the bio sector to transform the medical paradigm, thus supporting the convergence technology. Starting this year, the government plans to build a new 20,000 people scaled bio-data collection and utilization system for research with the relevant ministries (the Ministry of Science and ICT, the Ministry of Health and Welfare, Ministry of Trade and Industry). In addition, the government will continue to invest in the development of new drug technologies using artificial intelligence to drastically reduce the cost and time required for new drug development. New investments will also be made this year in building a next-generation drug evaluation platform. It also invests in the development of treatment technology to overcome diseases directly related to national health, such as dementia caused by aging and infectious diseases that are regularly problematic. From this year, the Ministry of Health and Welfare & the Ministry of Science and ICT will jointly support the cause of dementia, develop the pathogenesis, predict and diagnose early diagnosis, prevent and treat the development of treatment technology, and will also invest in the development and diagnosis of key brain diseases such as brain development disorders, emotional disorders such as depression, and damage to the nervous system. In order to strengthen its ability to respond to infectious diseases, it will invest ₩24.4 billion in developing technologies for preventing and treating infectious diseases, including developing new and emerging virus response technologies. Seo-gon Ko, a director of basic source research policy, said “Biofield is a technology-based industry, and securing core technology leads to the preoccupation of the market, there are also characteristics that new market is developed based on convergence technology, and the government will actively support the development of future medical technologies by combining R&D , artificial intelligence, and big data with bio to preoccupy the global core market”.
- Policy
- ATP-based reduction on immunosuppressant Certican
- by Kim, Jung-Ju Jan 09, 2020 06:24am
- Price of Novartis’ immunosuppressant Certican (everolimus), still in prolonged pricing reduction cancellation litigation with the government, would be reduced based on actual transaction price (ATP) survey result. The pricing reduction on Certican would be enforced after the ongoing litigation reaches its final decision as it still has administrative suspension order in effect. According to pharmaceutical industry sources on Jan. 6, Korea's Ministry of Health and Welfare (MOHW) is planning to announce amended Pharmaceutical Reimbursement Listing and Maximum Reimbursed Price on Jan. 9. The ATP-based pricing reduction refers to the government lowering price of drugs by a rate within ten percent of weighted average value calculated according to the recently surveyed ATP. Previously, the government has decided to alter Certican's pricing as Chong Geun Dang Pharmaceutical exclusively launched a generic, Certirobel, with Preferential Sales Approval. Accordingly, MOHW authorized pricing reduction of Certican in four different doses, based on the principle automatically lowering price of the original when a first generic is listed. Opposing on the government's decision, Novartis filed an administrative litigation and requested suspension of pricing reduction enforcement, which the court accepted and sustained the original pricing. The suspension request has been accepted on Mar. 15, May 31 and June 28 last year for three times, and currently the court's decision to suspend the pricing reduction until 30 days after the final decision on the appeal has been maintained. Certican's pricing has been kept unchanged with the repeated suspension order, but the government has to adjust the original maximum reimbursed price before with the ATP survey result. However, if the pricing reduction is enforced as planned, before the court’s order of suspension, the ATP-based pricing reduction would not be necessary as the first reduction rate is steeper than the ATP-based reduction rate. The government was first planning to lower the drug pricing down to 1,592 won for 0.25 mg, 2,546 won for 0.5 mg, 3,180 won for 0.75 mg and 3,714 won for 1.0 mg.
- Policy
- Reevaluation to first review underperforming drug
- by Kim, Jung-Ju Jan 08, 2020 06:19am
- The government reaffirmed the listed drug reevaluation subject would prioritize drugs with clinical efficacy underperforming than initially expected. Gradually conducted on all subjected drugs, actions following up the reevaluation, such as pricing reduction or reimbursed indication revocation or reduction on drug not reaching expected efficacy agreed on during listed pricing negotiation, would be decided after the result is out. On Jan. 7, Korea’s Ministry of Health and Welfare (MOHW) announced listed drug reevaluation principles, as a part of the National Health Insurance (NHI) Comprehensive Plan, and briefed current status of severe disease treatment-centered insurance coverage enhancement. First, the ministry plans to differentiate reevaluation type and conduct in phases to accommodate diverse properties of various drugs. The drug properties would mean new drug or drug with underperforming efficacy listed for NHI reimbursement through selective reimbursement, high-cost and severe disease treatment, conditional approval or pharmacoeconomic evaluation (PE) exemption tracks. MOHW explained, “The reevaluation would first review drugs not demonstrating expected level of clinical efficacy, while detailed evaluation procedure, criteria and schedule would be open as much as possible to keep them transparent.” And noting on the public’s concern about the objective of the reevaluation, the ministry official stressed “Follow-up actions like resetting reimbursement criteria and pricing, maintaining reimbursement and others would be decided depending on the evaluation outcome. So it does not mean definite revocation of reimbursement.” The official elaborated that each item has a number of indications and actual effectiveness in the field, patient demand and necessity could be different and affect the decision accordingly. The official also added the NHI coverage has been expanded since the announcement of NHI Coverage Enhancement Policy, centering anticancer and rare disease treatment. Total 421 items, including anticancer and rare disease treatments, were listed within a year from the government’s announcement in July 2018 to July last year. For an instance, Biogen’s spinal muscular atrophy (SMA) treatment Spinraza was originally priced at 92.35 million won per vial (5 ml), but the patient copayment went down significantly as it was listed for reimbursement in April last year. According to the government, the treatment is an expensive drug costing a patient approximately 300 million won to 600 million won annually. But NHI reimbursement was granted and copayment ceiling system was applied, which dropped patient copayment to around 5.8 million won a year. The government also cleared reimbursement for Sanofi-Aventis’ novel treatment for severe atopic dermatitis, ‘Dupixent Prefilled Syringe 300 mg’, and brought down copayment to around 5.8 million won like Spinraza. The patient copayment was decreased steeply as it was a first drug to sign newly expanded risk sharing agreement and was applied with copayment ceiling system. When it was still non-reimbursed, a patient had to pay 26 million won annually per patient. MOHW explained, “The NHI coverage would expand but selectively based on feasibility of NHI reimbursement depending on the improvement in clinical efficacy, reimbursement criteria and basic principle of moderate pricing evaluation. Focusing on severe disease treatments with high social demand, the government would continue to expand insurance coverage.”
- Company
- Near miss, tension in the Middle East
- by Kim, Jin-Gu Jan 08, 2020 06:18am
- Amid rising military tensions between the United States and Iran, there is also concern about bad influence on trade between Korea and Iran. In the case of drugs, exports have already been blocked since last year. There is also concern that the resumption of exports will be postponed indefinitely. According to the Korea Customs Service's import and export statistics on the 7th, pharmaceutical products exported from Korea to Iran for the past five years (January 2015-November 2019) totaled $90 million. The annual average is $18 million. Earnings are $20,000 over five years, virtually zero. Compared to Korea's total exports of pharmaceuticals ($ 36.24 million, provisional in 2019), the proportion is small at 0.5%. Imports and Exports of Pharmaceuticals to Iran by Year, Data: Korea Customs Service Exports to Iran steadily increased to $ 13.78 million in 2015, $ 17.9 million in 2016, $ 22.89 million in 2017, and $ 24.5 million in 2018, but dropped sharply to $ 10.95 million last year. Considering that last year's statistics are up to November, a significant decrease is observed. The sharp drop in exports last year was due to US sanctions against Iran. The United States has sanctioned trade with Iran since 2010. However, medicines were classified as 'humanitarian trade items' and recognized as an exception. In 2018, pharmaceutical exports were at an all-time high as sanctions eased. But in last May, the United States raised sanctions. At the same time, it refused to recognize even humanitarian trade items. In fact, the export of medicines to Iran has been blocked. Last October, the International Court of Justice decided that "sanctions could not be imposed on humanitarian trade," but the US still does not follow. Korea is in the same situation. In this situation, the military tension between the United States and Iran is at its peak, and the resumption of humanitarian trade is indefinitely postponed. If the situation prolongs, the pharmaceutical industry will inevitably lose ₩21 billion annually. .A pharmaceutical industry official said, “In recent years, more and more pharmaceutical companies have entered or are advancing into the Middle East .However, the situation has raised concerns not only in Iran but also in the Middle East”.
- Policy
- Generic pricing should be at original’s 40%-45%
- by Lee, Hye-Kyung Jan 08, 2020 06:17am
- The national insurer’s research result claims the volume of generic would increase up to 73 percent to 82 percent if the use of generic is promoted, if the present lump-sum generic pricing reduction is brought down to 40 percent or 45 percent of the original price before patent expiration. Currently, the lump-sum pricing reduction drops generic pricing to 53.55 percent of the initial pricing of the original. To improve pharmaceutical supply structure, the research report recommended three-step enforcement of distribution and new drug-related strategic policies, including; generic pricing reduction policy, generic use promotional policy and pharmaceutical distribution system improving policy. Korea’s National Health Insurance Service (NHIS) recently published a final report of a year-long cosigned study of improving drug supply and purchase program on All Public Information In-One (ALIO) conducted with Sungkyunkwan University’s academic-industry cooperation research team (Principal researcher: Professor Lee Sang-Won of Pharmaceutical Technology & Business Management Department at School of Pharmacy). Also known as ‘Pharmaceutical Product Life-cycle Research Report,’ the study was directly ordered by President Kim Yong-ik of NHIS, who spent 250 million won on the massive research project. According to the report on Jan. 6, the research team has laid down regulatory policy recommendations in categories of pharmaceutical supply structure, generic supply structure, pharmaceutical distribution structure, and Korean-made new drug supply structure. ◆ Pharmaceutical supply structure: The university research team suggested reforming pharmaceutical supply structure to secure financial health of National Health Insurance (NHI), to supply good quality drugs and to expand Korean generic items’ market share. To achieve the goal, the report recommended seven objectives in three categories; improving generic supply structure (generic quality standard strengthening policy, off-patent drug pricing reduction policy, generic use promoting incentive policy); distribution structure (distribution company competitiveness enhancing policy, fair trade order reinforcing policy); and new drug supply structure (corporate R&D investment expanding policy, technology commercialization supporting policies). The team predicted the seven objectives could be implemented in three steps. Starting from generic quality standard enhancing policy, Step 2 off-patent drug pricing reduction policy and generic use incentive policy and Step 3 distribution structure and new drug supply structure shifting policies should follow, the researchers claimed. The Step 1 objective, generic quality standard enhancing policy, was prioritized as it affects the three policy goals overall, which are ‘NHI financial health,’ ‘outstanding drug supply’ and ‘self-sustained medical technology.’ Policies targeting distribution and new drug supply have been assigned under Step 3 objective, because their importance level was apparently lower than that of generic policies. The researchers commented, “The importance of generic quality standard enhancing policy and generic drug pricing reduction policy are very high and they require intricate plan of action. Also they need to consider each interest group’s stance.” ◆ Generic supply structure: The research team stated the present volume of generic use in Korea (61.8 percent as of 2017) should meet the average level of OECD member countries (over 70 percent) to leverage generic supply structure and industry. To realize the goal, bringing down the generic pricing is essential. The report calculated the ratio of generic use in overall drug volume could be raised up to 73 percent to 82 percent, assuming generic use would soar when the price is dropped to 40 percent to 45 percent of the original’s initial price. Previously, the researchers mentioned of three policies—generic quality standard enhancing policy, off-patent drug pricing reduction policy and generic use incentive policy—to achieve the aim to reform pharmaceutical supply structure. The policy objectives of reforming generic supply structure is to lower pricing to the level of competitive market and increasing volume on par with advanced countries, while enhancing the quality of generic items. More detailed objectives of enhancing generic quality includes tightening management standard change after approving and conducting stringent Good Manufacturing Practice (GMP) due diligence. As for the mechanism of drug pricing reduction, the report recommended reforming actual transaction price (ATP)-based drug pricing reduction and lowering drug price on the level of competitive market. For the ATP-based pricing reduction, the study argued the existing system of calculating reduction rate by each item should be changed to calculate by same class medicine. The report elaborated the change would reduce not only a specific item’s pricing, but affect all items in a same class, which would enable supply of low-priced drugs. Then sales of a company with capacity to supply mass amount of low-priced products would surge and eventually push up the efficiency of NHI expenditure management, the researchers added. Moreover, the report said the equal drug pricing system should be abolished and should rather differentiate pricings of generic and original, bringing down the generic pricing from the current level of 53.55 percent of the original pricing to 40 percent to 45 percent level. Basically, the generic pricing would not reach the level of off-patent original pricing. The report added another recommendation to constantly monitor pricing of off-patent drug market and regulate pricing reduction on generic listed for a long time or with pricing unchanged despite multiple listed generics. After enhancing generic’s quality and lowering pricing, incentive policy is recommended to promote further active use of generic. Increasing demand for low-priced drug in the market would ultimately expand volume of generic use and promote price competition. To increase the demand for low-priced drug, the report proposed the following; providing incentive for using more generic to doctor and pharmacist; reforming payment system to adopt capitation; prescription budget cap; or diagnosis related group payment; and lowering patient copayment or providing incentive point. On the other hand, the report also proposed increasing generic use by the purchasing power of the insurer, NHIS. Apparently, the insurer could select and announce a generic item capable of supplying low-priced product among multiple generic items in equivalent class, or set and mandate alternative prescription goal for pharmacist on preferred generic item. ◆ Pharmaceutical distribution structure: The researchers claimed the currently convoluted distribution models should be better sorted out. Depending on a distributor’s business management and scale, the type of distributors should be divided into ‘Total Distributor (owning a nationwide sale network and dealing logistics and commercial distributor),’ and ‘General Distributor (commercial sales),’ and ‘Contract Sales Organization (CSO).’ And the researchers argued idealistic image of Korean drug distributor should be set forth by establishing distributor evaluation index and designating an Innovative Distribution Company based on ‘Special Act on Fostering and Support Pharmaceutical Industry,’ 한국의약품유통협회 회원사 527개 대상 의약품 유통 현황 및 선진화 방안을 위한 설문조사 For the changes to be made, approval management and post-management should be reinforced through distributor license renewal and capital reappraisal, all the while government due diligence and statute reform should follow to prevent expedient direct wholesale, such as abusing authoritative position of healthcare institute. Besides, the report presented tasks to reform structure, regulation and environment of the pharmaceutical supply by adopting ‘Pharmaceutical Purchasing Card’ to set straight wholesale profit margin inflated with unreasonable distribution cost; forming ‘Supply Chain Council’ with pharmaceutical company and distributor’s representative to talk about minimum profit margin; enhancing logistics and minimizing return through improved minimum packaging unit and labeling; and requiring aggregation; fostering distribution and marketing specialists to advance distribution industry. ◆ Korean-made new drug supply structure: The research team stated the supply structure of new drug developed in Korea should be strengthened in both quality and quantity by inducing innovativeness of new drug, and by setting a reasonable supply volume goal based on global level productivity of new drug. Average 19 new drugs are launched annually these days, but only 1.9 items or ten percent of them are made in Korea. To expand supply of Korean-made new drug and improve its innovativeness, the researchers proposed reinforcing Innovative Pharmaceutical Company support system, changing new drug R&D policy, supporting open innovation and fostering development and commercialization capability.
- Company
- Tension on impurity diabetic drugs is for a month
- by Chon, Seung-Hyun Jan 08, 2020 06:17am
- The whole view of the MFDS It's been a month since concerns of impurity Metformin were triggered overseas, but there are still no clear conclusions. Expectations are raised in the pharmaceutical industry that there is no recovery country other than Singapore and that it can only be a surprise. However, there is still a lot of tension that if there is a recovery from the excess of impurities from overseas, there will be an instant spark in Korea. According to the industry on the 5th, no further follow-up measures have been taken at home and abroad for a month after some Metformin recovery measures have been taken in Singapore. Molecular structure of MetforminOn December 4, last year, the Singapore Health Sciences (HSA) surveyed 46 Metformin products sold locally and recovered three products. This is because NDMA above the daily allowance was detected. Shortly after Singapore's recovery, Metformin impurities were investigated in the US and Europe. The US Food and Drug Administration (FDA) has begun investigating the detection of NDMA in Metformin products in the United States. The European Medicines Agency (EMA) has also ordered companies to investigate Metformin's NDMA detection. Japan's Ministry of Health, Labor and Welfare also instructed manufacturers and distributors of Metformin-containing preparations to conduct risk analysis on NDMA incorporation of ingredients and drug products and report the results. A month has passed since then, but no conclusions have been made regarding the recovery of Metformin in countries other than Singapore. No follow-up has been made in Korea yet. This is not the same as the case of Valsartan and Ranitidine. The biggest difference is that both Valsartan and Ranitidine have been preempted in Europe and the United States. Valsartan immediately suspended the sale of products using the drug substance when recovery news came from Europe. Ranitidine began collecting inspections in the country after cases of discontinuation in the United States, and secondly suspended all products after announcing "no problem." In Korea, the MFDS has already submitted the usage data of Metformin preparations from pharmaceutical companies. Last month, the MFDS instructed pharmaceutical companies to submit the production history of the drug containing 'Methformin HCl' and the system for investigation of the active drug substance by the 17th. Pharmaceutical companies submitted the total number of drugs containing Metformin-containing products, items and number of production records, and items and number without production record to the MFDS. The Metformin lineage survey at the MFDS is a preliminary motion in preparation for the detection of impurities. If a problem occurs in a particular drug substance or drug product, the intention is to follow up quickly and accurately based on the results of the systematic investigation submitted by the pharmaceutical company. In the pharmaceutical industry, anxiety continues: "Is there a problem with the drug substance used in products recovered from Singapore?" The MFDS formalized its stance on the 16th to conduct an investigation into Metformin impurities. It is known to look into the NDMA detection potential in the Metformin’s chemical structure and manufacturing environment. The industry points out that there is no standardized Metformin NDMA test, which limits the self-inspection. As soon as possible this week, the MFDS will draw up a test method for detecting N-nitrosodimethylamine (NDMA) in Metformin and present it to pharmaceutical companies. Initially, the plan was planned to be completed by the end of last year, but the schedule was delayed. Given the NDMA test method of Metformin preparation, it is expected to be actively checked in Korea. The pharmaceutical industry is expecting a final conclusion on whether or not to detect NDMA after the preparation of the test method. The possibility of preferentially conducting a collection inspection on the drug substance used in products recovered in Singapore is raised. Metformin's drug product recovered from Singapore has never been imported into Korea. In Singapore, however, it was determined that the recovery of the test results for the drug product, not the drug substance. If Metformin preparations are collected in the US or Europe, the same raw materials or finished drugs can be promptly inspected in Korea. In reality, it is impossible to conduct a full survey on Metformin preparations in Korea. Metformin is the most widely prescribed diabetic drug used as a primary treatment for glycemic control in patients with type II diabetes. There are 642 Metformin-containing products in Korea. Virtually all pharmaceutical companies have Metformin. Metformin is overwhelmingly larger than Valsartan and Ranitidine. According to UBIST data of drug research institutes, the outpatient prescription market of Metformin-containing drugs in 2018 was estimated at ₩420 billion. Ranitidine, which had been suspended from selling all its products, formed a prescription scale of about ₩200 billion, which is more than double the market. The unit price of Metformin is less than ₩100. In terms of usage, it is overwhelmingly higher than Ranitidine. Pharmaceutical companies are already paying attention to domestic and international measures. In the face of massive losses in Valsartan and Ranitidine, there is a strong concern that Metformin can cause irreversible loss if fire breaks out. Some pharmaceuticals are struggling to minimize the damage, saying “NDMA has not been detected by our own tests,” even though the FDA's test method was not proposed. An official of the pharmaceutical company said, “There are no test methods yet, and there are not enough organizations to check, so we did not proceed with NDMA inspection of metformin, and plan to check quickly after the preparation of test method”.
- Policy
- China's "New Law" tightens safety and quality management
- by Kim, Jung-Ju Jan 08, 2020 06:15am
- China is to reinforce overall pharmaceutical management and monitoring regulation covering from pharmaceutical production, launch, clinical trial to counterfeit drug. The so-called ‘New Drug Administration Law’ would mainly focus on safety and quality. China’s National Medical Products Administration (NMPA) had taken the revised law in effect from last month. Considering the time it needs to settle in with the entire system, the new law would be enforced from the beginning of this year. The revision consists of pharmaceutical marketing authorization holder system, clinical trial institute record management, Good Manufacturing Practice (GMP) and Good Storage Practice (GSP) management, review and approval on chemical ingredient, and tightened investigation and prosecution over illegal practice. First, the Drug Marketing Authorization Holder (MAH) system has been toughened stringently. The system stipulates a pharmaceutical company or manufacturer, with registration number-marked drug registration certificates and imported drug registration certificate, should strictly perform the MAH obligations. The authorization holder has liability for the entire life-cycle of a drug from development to production and management to ensure drug safety, efficacy and quality. The new law also tightened clinical trial institute’s record management. The Chinese regulator has adopted a form of pre-management system that would process clinical trial institute certification according the regulation, if it has not been completed before last December. The revised law would also strictly regulate GMP and GSP certification. A company cannot apply for the certification if charged with illegal practice in R&D, production or management, and the Chinese regulator would also conduct on-site audit as stated by the regulation. And the regulator’s review and approval for chemical ingredient manufacturer would be integrated within the existing registration procedure. Each regional regulatory authority has to ultimately enhance drug safety effectively by strictly following the said regulation and also by stringently imposing penalty on illegal practice. The Chinese government plans to promptly set and announce further details of the New Drug Administration Act.
- Company
- Pfizer Korea is looking for a new office
- by Kim, Jin-Gu Jan 07, 2020 06:29am
- Pfizer Korea Myeongdong Office Pfizer Korea is pursuing the sale of its Myeong-dong office, which has stayed for the past 13 years. Location of new office is planning Yeouido, Jamsil or Pangyo. According to the pharmaceutical industry on the 6th, Pfizer Korea is considering the sale of its office and relocation of its office. Currently, Pfizer Korea is located at 110 Toegye-ro, Jung-gu, Seoul (1-11 Hoehyeon-dong 3-ga). An industry official said, “We believe that Pfizer has pursued the sale of the Myeong-dong headquarters since last year, and we have selected a real estate asset manager to manage the sale at the end of last year”. Another official said, "We were thinking about the most suitable place such as Jamsil, Pangyo, or Yeouido, and the company made an internal decision to one of the three recently considering the accessibility and the rental price." The specific sale and transfer dates are not confirmed. However, Pfizer Upjohn is expected to coincide with the launch of a joint venture with Mylan, according to the US Pfizer headquarters plan. Earlier, Pfizer signed a merger and acquisition agreement with Mylan, a generic pharmaceutical company in last July. It is the launch of a joint venture between Pfizer's business division in charge of patent expiry medicine and Mylan. The merger will be finalized this year. The new corporation was named Viatris. As it is a separate corporation, Pfizer Upjohn's Korea subsidiary is reportedly seeking a third place separately from Pfizer. Pfizer Pharmaceuticals moved to the current Myeong-dong office from Gwangjang dong, Gwangjin-gu, Seoul in June 2007. Prior to this, Myeong-dong office was purchased in June 2006. At the time, the purchase price was reported to be ₩58 billion. According to officials from the real estate industry, the price of Pfizer Korea’s Myeongdong offices is currently set at around ₩100 billion to ₩120 billion. Profits of more than ₩60 billion were generated In 13 years.
- Company
- SNU professor investigates new anti-cholesterol medicine
- by Eo, Yun-Ho Jan 07, 2020 06:29am
- 김효수 교수 Researchers in Korea are onto developing a next generation anti-cholesterol medicine. Pharmaceutical industry reported on Jan. 7, a team of Seoul National University researchers led by Professor Kim Hyo-soo is preparing a Phase 1 clinical study on candidate medicine inhibiting cyclase-associated protein 1 (CAP1). Previously, Seoul National University Hospital’s Research-driven Hospital Project—Inflammation/ Metabolism Unit Program led by Professor Kim Hyo-soo and Professor Jang Hyun-duk discovered CAP1 protein essential for protein convertase subtilisin/kexin type-9 (PCSK9) to destroy low-density lipoprotein (LDL)-receptor and identified the mechanism. LDL-cholesterol, when combined with LDL-receptor on the surface of hepatocytes, enters into the hepatocyte through a pathway called clathrin. Then the LDL-cholesterol is broken down, while LDL-receptor moves back to the cell surface and is reused. After then, CAP1 carries PCSK9 combined with LDL-receptor to an intracellular pathway, caveolin, where LDL-receptor is broken down by lysosome without getting reused. In short, PCSK9 is essential for CAP1 to break down LDL-receptor. Interestingly, CAP can be found in every organ of a human body, which means CAP1-inhibiting mechanism could be effective not only for lowering cholesterol level but also for other disease. In fact, the CAP1-inhibitor, currently under investigation by Professor Kim’s team, is targeting for indication on treating fatty liver and cancer. Professor Kim Hyo-soo stated, “With the six-year-long research, we have confirmed possibility of the investigational medicine, and we are planning for a Phase 1 trial on the medicine. Although PCKS9-inhibitor has been commercialized and demonstrated effectiveness, CAP-inhibitor could be another treatment option.” The team has already conducted a study with CAP1-inactivated mice. The outcome found the mice lacking CAP1 had hepatocyte surface with increased LDL-receptor and had significantly lower the level of LDL-cholesterol level in its blood. Also when intentionally breaking down LDL-receptor in liver of mice injected with PCSK9 antibody, the symptom of degraded LDL-receptor has been improved noticeably in mice without CAP1. Moreover, the research team analyzed PCSK9 gene mutation in people with considerably low LDL-cholesterol and found mutated PCSK9 could not properly bind with CAP1 to be functional.
- Company
- Ildong starts distribution of GSK generic drugs
- by Jung, Hye-Jin Jan 07, 2020 06:28am
- From the 6th, Ildong will begin supplying nine OTC drugs from GlaxoSmithKline. Orders from wholesalers and direct-selling pharmacies began on the 3rd, and the products are shipped from the 6th, depending on the order amount Under the co-promotion agreement with GSK, Ildong has sold a comprehensive cold medicine 'Theraflu', an ophthalmic drug 'Otrivin', a smoking cessation drug 'Nicotinell', a hyperhidrosis drug 'Driclor', and an external anti-inflammatory drug 'Voltaren', denture attachments 'Polident', toothpaste 'Sensodyne' and 'Parodontax', and co-band medical expander 'BreatheRight'. Last year, domestic sales of nine products stood at about ₩46 billion. These products have been sold by Dong-wha until last year. Traders are interested in supply prices. In particular, it is common practice for OTC drugs to raise their supply prices when their sales corporation changes. First, pharmacies that deal directly with Ildong will receive their products at prices similar to those offered by Dong-wha. An official at Ildong said, “It is an internal decision that there is no price increase on a direct pharmacy basis. OTC drugs are particularly easy to raise when prices change due to higher drugstore and consumer resistance, but considered pharmacy convenience as much as possible”. On the other hand, the purchase price of wholesalers is likely to be slightly adjusted. Some wholesalers are adjusting their orders because nine items will see a 3% price increase overall. A wholesaler said, “It is reported that the price will increase by 3-4%. The exact price will be known next week.” Unlike reimbursed drugs with a fixed insurance premium, non-paid drugs, over-the-counter drugs, are sold by margins by wholesalers at supply prices set by pharmaceutical companies. In general, wholesalers spend about 8% of their supply on distribution, so over-the-counter drug margins are determined within 8-10%. When wholesaler prices rise, pharmacy sales and consumer prices go up. However, Ildong responded that there will be little price increase due to the high proportion of direct pharmacies. It is because Ildong operates Ildong Shop, a pharmaceutical online mall, and since Ildong is a pharmaceutical company with a high proportion of OTC sales among domestic pharmaceutical companies, most of them are directly dealing with pharmacies. An official of Ildong said, “The high proportion of direct pharmacies is also beneficial to correct the distribution order, in the case of GSK products, we would like to maintain stable sales by increasing the proportion of direct drug sales rather than wholesale supply”.
