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- 2026-04-17 08:54:41
- Policy
- ₩11 trillion is organized in supplementary budget
- by Lee, Jeong-Hwan Mar 06, 2020 06:06am
- The government will finalize the revised supplementary budget for COVID-19 at ₩11.7 trillion and submit it to the National Assembly. The budget details include reinforcing infectious disease prevention system, restoration of damages to small business owners, support for public welfare and employment, and support for stagnant local economy. In particular, the government organized a total of ₩2.1 trillion in the compensation for damages to COVID-19 medical institutions and pharmacies. Clinics, hospitals and pharmacies are eligible for payment. Direct compensation of ₩350 billion, loan support of ₩400 billion, and loss compensation reserve of ₩1.35 trillion will be given to the hospitals, clinics, and pharmacies that actively participated in the defense. On the 4th, the Ministry of Economy and Finance announced its revised supplementary budget for minimizing the impact of COVID-19 and overcoming. The Ministry of Economy and Finance recognizes that it is an economic emergency state due to COVID-19, and plans to go beyond existing emergency support to make efforts for stability of people and economic vitality. ₩11,700 billion revised supplementary budget has been finalized by the Ministry of Economy and Finance. First of all, it raised ₩2.3 trillion to reinforce and enhance the quarantine system such as quarantine, diagnosis and treatment of infectious diseases. The government will invest ₩2.4 trillion to support the recovery of small business owners, ₩3 trillion in public welfare and employment stability, ₩800 billion in recovery of stagnant local economy, and ₩3.2 trillion in tax revenues. Measures and scale of additional budget The Ministry said that the COVID-19 response would be given priority as the basis for urgency, feasibility, and time limit, while minimizing the number of projects to obtain additional budget. The financial resources will be raised to ₩700 billion, including surplus level of the Bank of Korea and ₩700 trillion for free funds, and ₩10.3 trillion for government bonds. In detail, the budget for reinforcing and upgrading the defense system (₩2.3 trillion) will amount to ₩100 billion for strengthening the capability to respond to infectious diseases, and ₩2.2 trillion for compensation for loss of medical facilities for COVID-19 victims and support for living expenses for the quarantine. For support for recovery of damaged SMEs and small business owners (₩2.4 trillion), The Ministry raised ₩1.7 trillion to expand loans and ultra-low interest rate loans to victims, small businesses, and ₩600 billion to support employment retention of small businesses and lower rents, and support ₩100 million for damage stores and traditional markets. The public welfare and employment security support (₩3 trillion) budget is estimated at ₩2.4 trillion for low-income consumption coupons, special care coupons, and senior citizens' job coupons, ₩600 billion to expand youth employment incentives, successful employment packages, and Durunuri. Regional economic recovery support (₩800 billion) budget included ₩100 billion for special support for regional employment in the affected areas, ₩200 billion for the issuance of regional gift certificates, ₩500 billion for local financial reinforcement, and support for elementary, middle, and high quarantine requirements. The budget is to be specially allocated for the Daegu and Gyeongbuk budgets. ◆Reinforcement and enhancement of the quarantine system=The main project of supplementary budget is to expand the negative pressure room on the nationally designated inpatient treatment bed and to provide national aid for the transportation of ambulances to infected patients.. The KCDC will invest ₩9.8 billion to reinforce the testing capabilities of new infectious diseases and to expand inspection and analysis equipment. In preparation for the outbreak of large-scale new infectious diseases, a total of ₩4.5 billion was added to add two specialty infectious diseases hospitals with negative pressure wards. The budget for the establishment of a virus research institute affiliated with the KCDC to study new viruses and strengthen the response system is ₩3 billion. ◆Compensation for Loss of Damaged Medical Institutions =₩350 billion in compensation for the loss of medical institutions resulting from the implementation of the government's quarantine measures and ₩400 billion for financial support for management stabilization. The cost of living support and paid leave will be provided to the employer for ₩80 billion. In preparation for the increase in the cost of indemnity for medical institutions in the future, the preliminary reserve of ₩1,350 billion was reinforced. In particular, the Ministry plans to provide support for the mask support plan quickly, with a reserve fee, but will gradually increase support in consideration of supply and demand trends. More than 130 million copies will be provided free of charge to medical workers, daycare centers, kindergartens, elementary schools, and low-income families nationwide by April. We also support the reinforcement of mask production facilities for smooth supply, with Daegu and Gyeongbuk supplying 8.98 million of masks. Key investment direction of additional budget ◆Support for the recovery of the damaged SMEs and small business owners. The company raised 100 trillion won in emergency management fund loans for small business owners & SMEs and raised 100 billion won to support capital investment funds for rehabilitation of SMEs in Daegu and Gyeongbuk. ◆Daegu-Gyeongbuk Special Assistance=The Ministry has organized ₩6 billion for the construction of a medical infrastructure for special assistance in the Daegu-Gyeongbuk COVID-19. The goal is to reinforce the quarantine system by establishing a hospital specializing in infectious disease in Yeongnam area and expanding 15 negative pressure beds. Emergency funds of ₩1.4 trillion will be provided to local SMEs and small business owners. A total of ₩1 billion was provided to support the recovery of the local exonomy and damaged stores.
- Company
- MFDS clears varicella vaccine license for GC Pharma
- by Lee, Seok-Jun Mar 06, 2020 06:06am
- GC Pharma announced on Mar. 4 its chickenpox vaccine ‘Varycella’ injection has recently won an item license from Ministry of Food and Drug Safety for the Korean market. Like other existing chickenpox vaccines, the company stated Varycella is a live attenuated varicella virus vaccine. The Korean company was able to push up the production yield significantly by improving the productivity. And also it increased the content of live varicella virus and enhanced stability of the product as well. In Phase III transnational clinical trial conducted in Korea and Thailand with infants aged either over or under 12 months, Varycella injection confirmed its non-inferiority against reference vaccine. GC Pharma aims to penetrate the USD 2.3 billion-worth global varicella vaccine market with Varycella injection. The Head of Development Department at GC Pharma, Lee Jaewoo said, “We are committed to contribute to lessen the social strain and cost of varicella prevalence around the world by providing upgraded varicella vaccine. Besides supplying to the Korean market, the company plans to target the global market after passing the World Health Organization’s Prequalification (PQ).”
- Company
- Industry fears sales ban as NDMA risk in metformin rekindled
- by Chon, Seung-Hyun Mar 06, 2020 06:06am
- The risk of impurity found in metformin could resurface due to another warning from the U.S.-based private research firm. The pharmaceutical industry’s concern deepens as the same research firm that warned about ranitidine risk last year published the metformin analytic data. Already pharmaceutical companies fear global health authorities would order a complete sales ban on metformin after they collect and probe the products. ◆ Valisure “16 out of 38 metformin batches showed NDMA exceeding acceptable level” According to industry sources on Mar. 3, Valisure, a private research institute based in the U.S., has detectd cancerous N-nitrosodimenthylamine (NDMA) exceeding acceptable level of daily intake in some metformin products, which used in the U.S. as antidiabetic drugs. Valisure investigated NDMA in 38 metformin production batches manufactured by 22 pharmaceutical companies, following the liquid chromatography-mass spectrometry (LC-MS) protocol. Apparently, Valisure has found NDMA exceeding acceptable level of daily intake in 16 batches from 11 companies. One of the batches had NDMA content level 16.5 times higher than the acceptable daily intake level of 96 ng. Valisure has requested the U.S. Food and Drug Administration (FDA) to recall the metformin products containing levels of NDMA in excess of the daily acceptable intake limit. Valisure’s list of metformin production batch found containing NDMA exceeding the acceptable level of daily intake (96 ng) (Source: Valisure Citizen Petition on Metformin) The analytic findings from the firm contrast from the statement issued a month ago by FDA. On Feb. 3, the U.S. health regulator informed their analysis on 10 metformin products distributed in the U.S. market found two products with low level of NDMA content, which the regulator recommended not to use. ◆ Industry tenses up as Valisure warned of risk of ranitidine and nizatidine last year The pharmaceutical industry is keenly watching the private research firm, because Valisure first warned of impurity found in ranitidine last year. Housed in New Haven, CT, Valisure operates online pharmacies in 38 states in the U.S. and regularly publishes analytic findings regarding pharmaceutical safety. Interestingly, Valisure’s metformin impurity risk warning is similar to the actions taken for ranitidine impurity risk. FDA issued a statement last year announcing the presence of low levels of NDMA in ranitidine drugs like Zantac, but did not mention a specific plan to recall the product. Since then, Valisure disclosed their own investigation showing high levels of NDMA in ranitidine drugs including Zantac, and requested FDA to recall the products. As a result, majority of ranitidine drugs were detected with unacceptable level of NDMA and the drugs were recalled in the U.S. and Europe. Valisure also urged FDA to initiate investigation on nizatidine by presenting findings of NDMA in the drug. Korea’s Ministry of Food and Drug Safety (MFDS) also decided to ban sales and recall 13 nizatidine products in last November due to the presence of excessive level of NDMA. Such development of the decisions by global health regulators is the reason the pharmaceutical companies are tensed up about MFDS’ actions following the metformin analysis. The risk of NDMA in metformin was first raised from Singapore. On Dec. 4 last year, Singapore’s Health Sciences Authority (HSA) recalled three items out of 46 metformin-containing drugs they have tested. The result confirmed high levels of NDMA exceeding the acceptable daily intake level. MFDS is currently probing NDMA in metformin active ingredient and finished products. Although it has already been three months since the Singaporean health regulator spoke of the risk in metformin, the Korean ministry has not yet revealed the investigation outcome. In last December, MFDS had pharmaceutical companies to submit record of using metformin. And on Jan. 15, the ministry presented NDMA testing methodology for metformin. The ministry is still probing NDMA contamination in collected active metformin ingredients. Over a month has passed since FDA has presented the interim result of metformin-NDMA investigation, but the Korean health regulator has not even mentioned of a next step. Three days after the news of Zantac detected with NDMA in the U.S., MFDS announced interim test result of NDMA level in Zantac on last Sept. 16 and said the impurity has not been detected. But for the ranitidine issue, the Korean government ordered sales ban on the product in a mere of 10 days. MFDS official stated, “Currently an inspection on contamination in metformin is ongoing.” The ministry is reviewing NDMA contamination in over 900 metformin samples. ◆ Pharmaceutical companies anxious of stringent actions like ranitidine or valsartan risk Clearly, the pharmaceutical industry is edgy on the MFDS-confirmed level of NDMA in metformin from Korea and their response, because Korean regulator’s action on NDMA-detected drug so far has been more stringent than that of the U.S. or European regulators. MFDS has banned sales of finished product that used the controversial active ingredient at least once since January of 2015. Many of the products were probably banned from the market even if the controversial active ingredient was not used recently. In the U.S., only the products using active ingredient from Zhejiang Huahai Pharmaceutical were recalled by batches. An order of complete sales ban on the product was never given. The level of action taken by European health regulator was on par. While every ranitidine product was banned in Korea, pharmaceutical companies voluntarily recalled the products by batches in the U.S. and Europe. Whereas 13 nizatidine products were banned from sales in Korea, Japan only recalled a number of the products and the U.S. and Europe have not given a recall order. The Korean regulator has decide to recall specific batches of nizatidine with high levels of NDMA, but those products were temporarily banned from sales until the recall was completed. Valisure pointed out the level of NDMA in metformin varies depending on each batch, although they were manufactured by a same company. They argued the pharmaceutical substance could be the unstable factor. The MFDS’ decision to weed out ranitidine products was made because ‘ranitidine has an unstable quality, therefore, it is always exposed to the risk of generating NDMA.’ A tremendous chaos in the whole of pharmaceutical industry would be inevitable if the ministry is to take actions as stringent as before when it finds high levels of NDMA in some of metformin. According to pharmaceutical market research firm UBIST, pharmaceuticals with metformin generated 473.2 billion won last year from outpatient prescription. The market continues to grow as the volume has doubled since 2014. Pharmaceutical companies argue the Korean regulator should take similar level of actions as the U.S. or Europe, even if they find high levels of NDMA in some of metformin available in Korea. Especially because a research was published claiming NDMA found in valsartan and ranitidine would not be harmful to human body. In last December, MFDS stated, “Reviewing individual dose and administration period of patients actually taking finished product containing valsartan manufactured from Huahai Pharmaceutical with NDMA, the possibility of causing cancer was low enough to ignore.” FDA also issued a statement last November, “The risk of causing cancer by NDMA detected in ranitidine is close to the risk exposed from having barbecued meat or smoked meat.” A pharmaceutical company insider urged, “Regardless of unconfirmed harm of pharmaceuticals detected with NDMA, the produces were banned from sales and recalled. Accordingly, pharmaceutical companies had to endure immense loss and the public’s apprehension has deepened. On products with impurities found in the future, the Korean government should order a batch-basis recall like the U.S. and European government have.”
- Opinion
- [Reporter’s view] Did they act honorably?
- by Kim, Jin-Gu Mar 06, 2020 06:05am
- Companies willing to develop COVID-19 treatment (or vaccines). Recently, press releases of this kind have increased in the reporter's mailbox. With the spread of the COVID-19 crisis, many pharmaceutical companies are jumping into the development of drugs or vaccines. But some do not seem pure intentions. It is obviously expected to float stocks. For example, Company A is developing a new drug that suppresses Cytokines, claiming it could be used to treat COVID-19. In addition, it added that it applied for an emergency clinical trial plan with the Ministry of Food and Drug Safety. Company B, which is developing a new antiviral drug, has announced that it has applied for approval for therapeutic use by the MFDS to administer a candidate substance that has not yet completed phase I clinical trials to COVID-19 confirmed patients. Company C that develops the TB vaccine is also working on developing a COVID-19 vaccine. The company will develop a universal COVID-19 vaccine that is not related to virus mutations with its immune booster technology. For other bioventures, the content of the press release is much the same. The three words are 'COVID-19', 'therapeutics' and 'development'. The rest is only convincing. Words such as 'IND' or 'NDA' are effectively not found anywhere else. It's hard to find out more about research and development. It does not explain how much work has been done on the treatment or vaccine and how effective the study has been. That's the reason for doubting the intention of some bioventures. There is no way to know if they have the capacity to develop COVID-19 medications or vaccines and how you are preparing for development. It's just a company's claim and a one-sided possibility. Most press releases are documented in a form close to 'copy & paste'. Posted on major Internet portals, the stock market reacts immediately. The media and the stock market have long established a symbiotic relationship. All three companies in the previous case have benefited significantly. Some stocks have hit the ceiling. I have a feeling of déjà vu. Let's go back to the 2015 MERS outbreak and as far back as the 2003 SARS outbreak. As it is, the corona virus was the cause. At that time, many companies announced that they would start developing drugs and vaccines. Of course, the stock price went up as a bonus. However, no one has ever succeeded in developing a cure or vaccine. I wonder how many companies that have declared their development have continued their research and development so far. Recently in China, a company called BrightGene Bio-Medical Technology lied about COVID-19 remedies and bought embarrassment. The company has said it has successfully mass-produced 'Remdesivir', which is expected to be a potential COVID-19 drug. Related stocks surged. It is said to have increased by nearly 60% over a month. The Shanghai SE came out. It was countered that it failed to obtain Remdesivir's manufacturing approval from Chinese pharmaceutical authorities. Not only did it lack qualifications, the Shanghai SE also made it clear that it was not capable of mass production. After all, BrightGene's share price plummeted 20% in one day. It is said that it has been steadily falling since then. Of course, I believe that not all pharmaceuticals that are involved in the development of COVID-19 medications have distributed the press release with a bad way as BrightGene. Certainly, there are companies that have been quietly working on COVID-19 treatments in difficult circumstances. Justice will assert itself. As time goes by and the COVID-19 outbreak is settled, Corporate conscience will be revealed. The headwinds at that time must be handled by the companies themselves. The media also needs to be self-reflection. Keep in mind that an uncritical paste article without fact check can be damaging to someone.
- Are we short on treatments for over 5000 COVID-19 patients?
- by 박상준 Mar 05, 2020 06:34am
- As of 4 p.m. on Mar. 4, the number of confirmed COVID-19 cases in Korea has reached 5,328. The public is now closely watching the supply capacity of insurance-covered treatments. Apparently, the half of the reimbursed treatment list is imported from overseas. Fortunately, the healthcare sources report the pharmaceutical supply shortage is not an imminent concern at the moment as reimbursed items have plenty of stocks and Korean-made alternative options are available as well. From Mar. 1, Health Insurance Review and Assessment Service (HIRA) has been disclosing the information of COVID-19 treatment distributors. The 35 COVID-19 treatments with amended reimbursement standard, as notified by Ministry of Health and Welfare (MOHW), include interferon as a supplementary therapy for virus infection treatment, antiviral medication Ribavirin and immunoglobulin. Kaletra, imported by AbbVie Korea, is considered to be a tentative candidate of COVID-19 treatment. Although the number of infected patients is soaring, multinational companies’ items are solely depended on imports. This is why the public is keen on the reserved stock. Kaletra supplier AbbVie Korea’s official explained, “Kaletra is manufactured overseas and is imported to Korea. There exists a concern of reserved stock of the item, but AbbVie is striving to promptly respond to the global public health crisis.” The official added, “The company is committed to supply treatment urgently to countries with rapid transmission of the infection. And the effort continues through providing stable supply of experimental option for treatment of confirmed COVID-19 patients.” The company ensured the supply shortage is not at an alarming level as it is also working closely with the World Health Organization (WHO) and global health authorities. Other multinational companies have issued similar statements. GlaxoSmithKline (GSK) is currently supplying orally inhaled influenza treatment Relenza Rotadisk as a treatment option for COIVD-19. Sources reported the reserved stock of the treatment could be provided to over 2 million patients. Industry insider elaborated, “Relenza for 2.5 million patients were imported in 2015, and they would expire in 10 years. In case of various nationwide infectious disease outbreak and novel influenza, the Korean government has secured emergency pharmaceuticals for 30 percent of the overall population.” “Relenza was also part of it, and about 2 million patients worth of stocks are reserved under the government’s management,” the insider added. Apparently, the shortage is not an imminent issue if COVID-19 is contained at the current level or spreads only slightly more. Roche Korea, supplying interferon-based virus infection treatment supplementary, Reoferon and Pegasys , has reserved one-year worth of their stocks. Roche stated the reserved stock of two imported interferon medications would last for three to four quarters, based on the past average volume. As the use of the treatment has not skyrocketed since the COVID-19 outbreak, the supply of the products would be under control assuming the present condition continues. The company explained there are multiple companies manufacturing and importing interferon medications, and also the treatment needs would not be focused on one specific item as there has not been a confirmed treatment for COVID-19. An immunoglobulin treatment, IV-Globulin S injection, provided by GC Pharma also predicted, “As the company manufactures 100 billion won worth of volume annually in Korea, the medication stock would not run short.” Regarding the issue, Ministry of Food and Drug Safety (MFDS) noted, “We are constantly checking with pharmaceutical companies about the supply shortage via Korea Orphan and Essential Drug Center. We are not at the level to be concerned of.”
- Policy
- COVID-19 Special Committee announced a“Pincette Meeting”
- by Lee, Jeong-Hwan Mar 05, 2020 06:34am
- The National Assembly's COVID-19 Countermeasures Special Committee is the first to resolve the issue of 'Daegu hospital bed & medical facilities shortage' and 'mask shortages' and will hold a 'Pincette Meeting' for about 4 hours. The committee decided to receive a report on issues related to the lack of mask supply to the MFDS, the Ministry of Economy & Finance, the Ministry of Health, and the Ministry of SMEs and Startups, and to Daegu quarantine and medical care to the Office for Government Policy Coordination, the Ministry of the Interioir & Safety, and the Ministry of Welfare on the second meeting, which will be held at 9 am on the 5th Looking at the second agenda, they discuss about the shortage of Daegu beds and medical facilities for about two hours from 9 am to 11 am. After 11am to 1pm, they will report on the current shortage of mask supply. The management group of the ruling/the opposition parties also agreed to the schedule and contents of the third meeting as the infectious disease situation is urgent. The opening date is set for the morning of the scheduled session of the second week of March. The intention is to operate flexibly in response to changes in the national parliamentary schedule. The agenda of the 3rd meeting is about entering and responding to Chinese students and to report the issue of urgent care problems caused by the adjustment of the academic schedule (postponement of entrance and departure). The target institution is the Ministry of Education. On the 4th, the special committee’s management group discussed plans to conduct public hearings on the agenda for the 2nd and 3rd special meetings after consultation during the break. The committee had its first meeting since its launch on the 2nd. The special committee, which elected Democratic Party Kim Jin-pyo as its chairman, put their heads together and form a solution. The Special Committee agreed to operate a “ Pincette Meeting” on key issues such as masks with Daegu and Gyeongbuk, which are the most affected by infectious diseases, but there were also signs of conflict over the government's responsibility for preventing infectious diseases. It is expected that the progress of the second and third meetings will determine whether the Special Committee should overcome the disagreement and succeed in establishing effective policies in future meetings.
- Policy
- Remdesivir, clinical trial of 195 patients with COVID-19
- by Lee, Tak-Sun Mar 05, 2020 06:33am
- Gilead Science's 'Remdesivir', which is attracting attention as a treatment for COVID-19, is conducting clinical trials on a total of 195 patients in Korea. There are three medical institutions with clinical trials: Kyungpook National University Hospital, National Medical Center, and Seoul Medical Center. The Ministry of Food and Drug Safety approved the Phase III clinical plan of Remdesivir of Gilead Science Korea, which will be conducted for patients with moderate to severe COVID-19. The test will begin this month. First, randomized trials are conducted in moderate patients to evaluate the safety and antiviral activity of Remdesivir compared to standard treatment. The total number of target subjects was 600 (including overseas), of which 120 were domestic. The primary efficacy endpoint was the rate of subjects discharged up to 14 days post-dose. Clinical trials will be conducted at Seoul Medical Center (Professor Mi-young Ahn, Infectious Medicine), National Medical Center (Professor Bum-sik Jin, Infectious Medicine), and Kyungpook National University Hospital (Professor Shin-woo Kim, Infectious Medicine). Clinical trials in critical patients are also conducted in the same institution. The total number of target subjects is 400 (including overseas), but the number of domestic subjects is 75. Severe patient trials are conducted in randomized trials to evaluate the safety and antiviral activity of Remdesivir without comparison with conventional treatment. The proportion of subjects whose fever and oxygen saturation were normalized until 14 after administration was used as the primary efficacy endpoint. Remdesivir is a candidate for nucleotide analogues that has shown extensive antiviral activity in in vitro and in vivo animal models of new viral pathogens such as Ebola, MERS and SARS. Remdesivir was given to the first patient infected with Corona19 in the United States, which showed improvement. Currently, 761 patients are in clinical trials in Wuhan, China.
- Company
- 86% of generics for erectile dysfunction are domestic
- by Chon, Seung-Hyun Mar 05, 2020 06:33am
- The sales rate of generic products developed in Korea in the erectile dysfunction market is very high. Hanmi pharm's Palpal is one of hottest items, and Chong Kun Dang's Cendom continued to rise. Domestically developed drugs account for 86% of the erectile dysfunction drug market, and the influence of domestic products is expanding. According to IQVIA, a drug research agency on the 2nd, the market for erectile dysfunction drugs last year was 5.3%, up 5.3% year-on-year. It is growing continuously every year, from ₩98 billion in 2016 to ₩104.5 billion in 2017 and ₩108.2 billion in 2018. Hanmi's Palpal still showed its unrivaled position in the market. Palpal's sales last year were up to ₩22.4 billion, an increase of 7.0%. In the overall market for erectile dysfunction drugs, Palpal's market share is nearly 20%. Palpal, which was released shortly after Viagra's patent expired in 2012, sells most since beating Viagra in 2013 and Cialis in 2015, respectively. Sales of Major Erectile Dysfunction Therapeutics (Unit: KRW million,%, Source: IQVIA) Palpal has more than doubled the sales of its original product, Viagra (₩9.6 billion). Considering that Palpal is less than half the price of Viagra, it can be calculated that the actual sales volume is more than four times. In recent years, Chong Kun Dang's Cendom (generic for Cialis) sells well. Cendom sold ₩10.4 billion, up 8.7% from last year. Among the total erectile dysfunction treatment products, Cendom is the only product that has exceeded annual sales of ₩10 billion. Cendom, which was released after the Cialis patent expired in September 2015, gradually surpassed Cialis in 2017 as its market share gradually increased. Last year, it was overtaking even Viagra. Hanmi Pharm The progress of Hanmi Pharm's Gugu (generic for Cialis) was also noticeable. Gu gu's sales reached 4th place last year, reaching ₩7 billion, an increase of 13.7% over the previous year, and it beated Cialis for the first time since release. Three generics including Palpal, Cendom, and Gugu, accounted for more sales than the original drugs. Viagra and Cialis continued to decline last year, beghind in generics. Viagra's sales last year were ₩9.6 billion, down 2.3% year-on-year. Cialis fell 1.0% from ₩6.5 billion in 2018 to ₩6.4 billion last year. Among domestically sold erectile dysfunction treatment products, there are two products of Viagra and Cialis, and they sold a total of ₩16 billion last year. Bayer's Levitra announced the withdrawal of the domestic market in April. New drugs and generic products released by domestic companies account for a total of 86.0%. After 83.3% in 2017 and 84.8% in 2018, the market share is increasing. Domestically developed new drug products, such as SK Chemicals' 'Mvix' and 'Mvix S', and Dong-A ST's 'Zydena', also generate annual sales of ₩6 billion. In the domestic pharmaceutical market, generics continue to strengthen in the erectile dysfunction treatment market. In general, it is extremely unusual for generics to exceed sales of original drugs. That's because it's not easy for generics to surpass the reliability established by original products over time. Recently, in Korea, new drugs whose patents of multinational pharmaceutical companies have expired are increasing. According to UBIST, Last year, Lipitor’s outpatient prescription amount was ₩17.6 billion, an increase of 8.4%. Since 2014, the prescription amount have risen for six consecutive years. Sanofi's anti-thrombotic drug Plavix, last year's prescription performance was ₩88.9 billion, an increase of 17.3%. Prescription amount for Plavix increased 28.1% in two years from ₩69.4 billion in 2017. Original drugs, such as AstraZeneca's Crestor, Boehringer Ingelheim's Twynsta, Ezai's Aricept and Novartis' Exforge, also showed a rise in prescriptions from last year. Due to the nature of the original drug and generic insurance cap, the focus on the original increases. On the other hand, in the non-reimbursed drug market, where suppliers such as erectile dysfunction drugs set the price, it is analyzed that generics have increased their market share by aggressively operating at lower prices than the original drugs. Looking at the sales of erectile dysfunction treatments by company, Chong Kun Dang is facing a challenge to Hanmi Pharm. Sales Trend of Erectile Dysfunction Therapeutics by Company (Unit: KRW 1 million,%, Source: IQVIA) Hanmi Pharm recorded 25.8% of the total market last year with sales of ₩29.4 billion with Palpal and Gugu. The gap was widened with latecomers with a growth rate of 8.5% year-on-year. Chong Kun Dang recorded 6.1% year-on-year growth with the joint venture of ₩11.3 billion in three generics: Cendom, Cengla, and Yaila. Chong Kun Dang succeeded Hanmi Pharm with a 11.5% market share. Chong Kun Dang is gradually expanding its influence in the Viagra market even though it has fallen behind competitors. Chong Kun Dang signed a business alliance with Bayer in 2007 and renamed Levitra under the name of Yaila, failing to enter the Viagra generic market in 2012. Chong Kun Dang entered the Cialis market shortly after clearing his partnership with Bayer in 2015, and in 2017 launched Cengla, generic for Viagra, five years later than its competitors. Cengla's sales last year stood at ₩1.9 billion, ranking third among the generics for Viagra after Palpal and Nurigra. In 2018, Chong Kun Dang was licensed under Yaila, which previously sold Levitra. Chong Kun Dang is the only company that has all three generic drugs for erectile dysfunction. Pfizer made a joint venture between Viagra and Viagra L film last year at ₩10.1 billion. Chong Kun Dang was the second-largest market share, down 3.3% from the previous year. Sales of two types of erectile dysfunction treatment drugs, SK Chemicals and Daewoong Pharmaceuticals, exceeded Cialis, and ranked 4th and 5th, respectively.
- Company
- Janssen Korea breaks through KRW 300 bln for the first time
- by An, Kyung-Jin Mar 05, 2020 06:33am
- Janssen Korea’s yearly sales revenue (left) and operating profit (right) (Unit: KRW 100 million) Source: Financial Supervisory Service and Yuhan IR Janssen Korea broke through the 300 billion won-line in Korea for the first time. Leveraged by outstanding performance of star products like Remicade, Simponi and Stelara, the global pharmaceutical company manifested impressive sales revenue and operating profit. According to performance data of last fourth quarter provided by Yuhan on Mar. 2, Janssen Korea has made overall 311 billion won last year with 17.5 percent increase from the previous year. 36 years since the Korean office was founded, Janssen Korea has for the first time generated more than 300 billion in a year. The operating profit was surged by 111.7 percent and reached 37.9 billion won. Compared to 38.7 billion won made in 2007, last year was the second most profitable year. However, the figure could change in coming months as it is from tentative data before an audit by an accounting firm. According to the partnership investment deal inked between Yuhan and the U.S.-based Johnson and Johnson (J&J) in May of 1983, Janssen Korea was established. J&J owns 70 percent of the share (746,760 shares), and Yuhan as a second largest shareholder owns the rest of 30 percent (320,040 shares) of the share. Due to equity method, Yuhan has been disclosing its associate, Janssen Korea’s business performance via quarterly IR data since the second quarter of 2014. Yuhan receives a set ratio of dividend from Janssen’s net profit. Yearly sales revenue of Janssen Korea’s major pharmaceutical products (Unit: KRW 100 million) Source: IQVIA Autoimmune disease treatments like Remicade (infliximab), Simponi (golimumab) and Stelara (ustekinumab) have led the massive revenue hike. Pharmaceutical market research firm IQVIA found the three products have generated total of 99.3 billion won last year with 14.1-percent increase. Compared to 2015, the revenue volume has leapt by 93.3 percent. The sales revenue of interleukin antagonist Stelara showed the steepest surge. Making 22.2 billion won last year, Stelara’s sales volume was boosted by 54.2 percent. The figure has quadrupled since 2015. The company’s top seller, Remicade also made 46 billion won last year with 2.0-percent increase than the year before. Although the yearly increase was not so significant, Remicade is the company’s biggest cash cow as it leads the TNF-alpha inhibitor market in Korea. Remicade’s follow-on TNF-alpha inhibitor Simponi has been absorbing the market share fast since its release in 2013. Simponi also climbed up 13.0 percent last year and generated 31.0 billion won. The medication, available in both subcutaneous and intravenous injections, stepped up above Pfizer’s Enbrel and sold the third most volume in the TNF-alpha inhibitor market.
- Company
- Boryung Bio releases 'self-sufficient' quadrivalent vaccine
- by An, Kyung-Jin Mar 05, 2020 06:33am
- Boryung DTaP-IPV Vaccine On Mar. 2, Boryung Biopharma announced the release of ‘Boryung DTaP-IPV Vaccine’ for infants and children. ‘Boryung DTaP-IPV Vaccine’ is a quadrivalent vaccine consisting of DTaP vaccines preventing diphtheria, tetanus and pertussis and inactivated polio vaccine (IPV) against poliomyelitis. Total six doses is required when administering single DTaP vaccine and IPV separately on six-month-old or younger infants, but the combination vaccine could ease the administration by reducing the number of dose down to three. Boryung Biopharma official claimed, “For the first time as a Korean pharmaceutical company, the company has successfully manufactured DTaP-IPV combination vaccine in its own production facility.” As DTaP-IPV combination vaccine requires infants to get shots exactly at second, fourth and sixth month, securing a stable supply of the vaccine is crucial. The combination vaccine has been only supplied by multinational companies and some infants have reportedly missed the right timing of the immunization as vaccine supply was unavailable due to problem in importing procedure or distribution channel. Seven years since the pipeline was set on, Boryung Biopharma was able to develop and manufacture self-sufficient ‘Boryung DTaP-IPV Vaccine.’ According to the provided data, the Korean company has initiated four-year-long transnational clinical trial, including Korea, and confirmed equivalent level of efficacy with compared group in first and second efficacy evaluation. And adverse drug reaction or event did not show significant difference. Based on the clinical result, the Korean-manufactured combination vaccine won Ministry of Food and Drug Safety’s (MFDS) approval last August. Vaccine Division of Boryung Biopharma stated, “Made in Korea’s first ever vaccine manufacturing facility, the newly released ‘Boryung DTaP-IPV Vaccine’ would provide essential vaccine supply. We hope to contribute in reducing medical industry’s struggle with insufficient supply of DTaP-IPV vaccine and in easing the immunization process for infants and their parents.” From last January, National Immunization Program (NIP) has included ‘Boryung DTaP-IPV Vaccine.’ Infants aged two, four and six months may receive free shots of the vaccine at a public health center or designated medical institute in Korea.
