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- 2025-12-24 02:10:27
- Policy
- RWD & RWE will be important means of use in post-evaluation
- by Kim, Jung-Ju Nov 11, 2021 06:00am
- Limited replacement is appropriate as a means of supplementing proven RC The quality of the site, which will be the standard, such as standardization of medical records at hospitals where data will be calculated. The task of government insurance authorities and the private sector is to increase patient access to very expensive and innovative new drugs, in other words, to make benefit entry smoother and faster. The government, the National Assembly, and the pharmaceutical community continue to consider revitalizing related systems such as the "the approval-benefit linkage system" and "post-registration evaluation," but the emergence of ultra-high-priced drugs cannot be covered by our evidence-based insurance system. The RWD and the work of processing it as RWE, and the movement and discussion to further systematize the evaluation area after the approach by reflecting the results in the policy are important. However, when this mechanism is actively used, there are many tasks to be prepared in the future, such as eliminating concerns about other harsh regulations or affecting all new drugs in the current system with RCT, and standardizing detailed standards in domestic clinical sites, which are one of private medical institutions. Several panels participated in the Innovation Research Symposium hosted by the HIRA on the 4th. Standards should be prepared at the level of field practice such as detailed standards, and guidelines. Like Kymriah, the emergence of ultra-high-priced drugs makes it possible to predict the future trend direction of new drug development and insurance-listed drugs. Therefore, it is clear that RWD and RWE will be important means of use in post-evaluation to enhance patient access and coverage when second, third, and fourth drugs challenge benefits one after another. On the premise of this justification, panels agree that detailed practical standards such as qualitative standardization and data collection at the current level and different medical records of private medical institutions should be established. Taking the case of Kymriah as an example, Bang Young-joo, an honorary professor at Seoul National University (CEO of Bang & Ock Consulting), said, "Kymriah is a drug that cannot be waited until 1,000 clinical patients are recruited. Since clinical characteristics and recruitment limits are different for each drug, we need to prepare a sample size setting standard. Park Jong-heon, head of the big data operation office at the NHIS, also mentioned the importance of setting practical standards through cases. When the corporation conducted a post-evaluation study of immuno-cancer drugs in the past, it conducted a study by linking health insurance-clinical data, and each hospital had different methods of providing data and doctors. Director Park said, "There are enough laws in place. However, he said, "I think it is necessary to form a sufficient consensus on the importance of RWD and RWE," and emphasized, "Since related guidelines have not been made, micro-linked methods and practical discussions such as standardization are needed." "Another regulation following RCT, limited use" vs "flexibility to enter benefits may be secured" The industry and the government's position on RWD and RWE was quite different. This could be an opportunity to make the hurdle barrier more flexible in the long run, as it is essential for the post-evaluation of ultra-high-priced drugs with high uncertainty, and questions about whether the new drug must be reevaluated as RWD's base production even after entering the benefit. First, Kim Joon-soo, chairman of the KRPIA Policy Committee, mentioned the case that Nice in the UK also prefers RCT and uses RWD limitedly if additional data are required when uncertainty is high in terms of cost effectiveness, such as anticancer drugs and rare disease treatments. Chairman Kim also stressed, "RCT is designed under the condition of pre-blocking for intermediate variables, so RWE is based on daily data, so it is not high in terms of reliability and low in level of evidence due to various environmental conditions and influencing variables." Lee Eun-young, director of Korea alliance of patients organization, said, "RCT is designed to be licensed and registered with data, but I know that RWE has emerged because the design and clinical results do not match at the clinical site. In addition, the government emphasized the justification for application. The government, which has introduced high-priced drugs into salaries, needs to look back on whether they were of appropriate value and reasonable cost afterwards. Choi Kyung-ho, an insurance drug officer at the MOHW, said, "Even if RCT is appropriate, I think RWE is necessary when registering ultra-high-priced drugs like Kymriah."
- Policy
- The MFDS consulted on Expedite Approval of COVID-19 PO
- by Lee, Tak-Sun Nov 10, 2021 05:55am
- The MFDS announced that it is conducting consultations with the company for rapid domestic approval on overseas developed COVID-19 oral treatments on the verge of commercialization. In the case of Molnupiravir, an oral treatment for MSD, the government plans to gradually introduce 404,000 people through a pre-purchase contract in February next year, which is expected to speed up discussions on the introduction of overseas COVID-19 treatments in Korea. Kim Mi-jung, head of the pharmaceutical standards division at the MFDS, briefly met with reporters at Osong on the afternoon of the 9th and made the announcement. Kim said, "In the case of oral treatments of MSD and Pfizer, we are conducting consultations on the scope and schedule of data submission for Expedite Approval," and explained, "However, actual data are not received." Kim added, "In principle, we plan to conduct safety, effectiveness, and quality screening for COVID-19 treatments," adding, "We plan to review them quickly when data are received." Prior to this, Kang Sung-sik, vice president of Pfizer Pharmaceutical's medical department, said at the 2021 Pfizer Press University held online on the 8th, "We are in close consultation with regulatory authorities including the MFDS." Paxlovid is expected to show that the hospitalization and death rate decreased by 89% compared to placebo when taken within three days of symptom onset as a result of interim analysis of phase 2 and 3 released on the 5th. MSD's oral treatment, which the government declared in February next year, also reduced the risk of hospitalization and death by about 50% as a result of a phase 3 interim analysis. Britain approved Molnupiravir, for the first time in the world on the 4th. As Korea promised to introduce it in February, it is expected to speed up its approval review. However, if the submission of data is delayed, it is highly likely to be introduced in Korea through procedures such as Expedite Approval. Kim said at a briefing that day, "Since the enforcement of the Data Limitation Act in July, the submission of a biological equivalence test plan has increased 2.5 times more than usual." Kim said, "If next year's result report is submitted, the MFDS will have more work." In addition, Kim said that she established a "comprehensive evaluation team for constant evaluation of impurities" consisting of about 20 people to prepare impurity evaluation technologies through information sharing with overseas regulators, as well as determine the cause. However, she added that there are no additional impurity issues other than the three Sartan types, which were decided to be recovered due to impurities in Azido in September. She is also considering recruiting about 50 people due to the expansion of overall permit screening work.
- Policy
- The National Assembly speeds up the telemedicine bill
- by Lee, Jeong-Hwan Nov 10, 2021 05:55am
- With the government declaring a phased COVID-19, the National Assembly's Health and Welfare Committee is speeding up its review of amendments to the medical law, which temporarily introduces non-face-to-face treatment. The Welfare Committee plans to propose two amendments to the medical law aimed at legislating telemedicine at the plenary session to be held on the 11th and discuss whether to review the bill subcommittee. There are a total of two telemedicine bills proposed by the National Assembly: Kang Byeongwon of the Democratic Party of Korea and Choi Hye-young of the Democratic Party of Korea. Kang proposed the bill that telemedicine between doctors and patients is not allowed, but indirect medical practices such as non-face-to-face counseling are allowed through remote monitoring. Rep. Choi proposed a plan to allow telemedicine and non-face-to-face prescriptions and preparations only for vulnerable medical sites and vulnerable patients. The Welfare Committee is expected to complete the review of next year's budget by the MOHW, the MFDS, and the KCDA by the middle of this month, and immediately hold a subcommittee to review telemedicine bills. As the National Assembly speeds up telemedicine and non-face-to-face prescription and dispensing bills, related expert groups such as The KMA and the Korean Pharmaceutical Association are also paying keen attention to legislative trends. The KMA has formed a telemedicine response TF to start preparing countermeasures. The pharmaceutical society, which is set to hold the next pharmaceutical presidency election next month, has not formed a TF like the KMA, but is opposed to the legislation of telemedicine and non-face-to-face-to-face dispensing. The KMA, the KDA, and the Korean Pharmaceutical Association issued a joint statement last month and expressed regret over the revision of Kang Byeongwon and Choi Hye-young's medical bill. From the perspective of the pharmaceutical society, telemedicine legislation is a sensitive agenda in that it can promote the generalization of drug delivery and delivery platforms based on the activation of non-face-to-face dispensing. Kim Min-seok, chairman of the Welfare Committee, Kim Sung-joo, secretary of the Democratic Party, and Kang Ki-yoon, secretary of the People's Power, are coordinating the agenda of the subcommittee on bills.
- Policy
- Moderna vaccine produced by SB has been applied
- by Lee, Tak-Sun Nov 09, 2021 05:53am
- The MFDS announced on the 8th that Moderna Korea has applied for permission to manufacture and sell the COVID-19 vaccine SPIKEVAX produced by Samsung Biologics in Korea. The vaccine induces an immune response by injecting antigen genes from COVID-19 in the form of mRNA to produce antigen proteins in the body. The MFDS announced that it will closely review the submitted quality, non-clinical, and clinical data and check the safety and effectiveness of the product to decide whether to approve it. An official from the MFDS emphasized, "We will continue to do our best to quickly supply safe and effective vaccines to the Korean people." Meanwhile, the COVID-19 vaccine developed in Moderna, USA, was approved for import items with SPIKEVAX on May 21.
- Policy
- LG Chem seeks approval for its ‘Zemiglo+SGLT-2i’ combo
- by Lee, Tak-Sun Nov 09, 2021 05:53am
- DPP-4 inhibitor class diabetes drug developed by LG Chem LG Chem has applied for the marketing authorization of a combination drug that combines the DPP-4 diabetes treatment ‘Zemiglo (gemigliptin)’ with an SGLT-2 class inhibitor to the Ministry of Food and Drug Safety. With the new application, whether Zemiglo, one of the most successful locally developed novel drugs, will continue on its success with this new combination therapy is raising attention. According to the industry on the 7th, LG Chem recently applied for the marketing authorization of its dapagliflozin+gemigliptin combination therapy. The product name is known to be ‘Zemidapa,’ coined using the first letters of the two ingredients. LG Chem trademarked the name to the Korea Intellectual Property Office last month. In July last year, LG Chem received approval for a Phase 1 trial protocol that compares the pharmacokinetics, safety, and tolerance of gemigliptin 50mg and dapagliflozin 10mg administered separately and in combination. Also, in February 2020, the company was approved to conduct a Phase III trial that compares the efficacy and safety of metformin+gemigliptin+dapagliflozin with gemigliptin+metformin or dapagliflozin+metformin in Type 2 diabetes patients whose blood sugar level cannot be adequately controlled with metformin alone. The company applied for the approval of its combination drug to the MFDS based on the study results above. Dapagliflozin is the generic name of AstraZeneca’s SGLR-2 inhibitor, ‘Forxiga.’ The three DPP-4i+SGLT-2i combos currently available are all imported finished products. The products are Boehringer Ingelheim's ‘Esglito tab,’ AstraZeneca’s Qtern (saxagliptin monohydrate+ dapagliflozin propanediol hydrate),’ MSD’s ‘Steglujan (ertugliflozin l-pyroglutamic acid + sitagliptin phosphate hydrate). However, the products above have not been approved for insurance reimbursement, and therefore are not being sold fully in the market. However, reimbursement discussions on the drugs have made rapid progress recently, raising expectations that their prices will be listed soon. In fact, AstraZeneca had made joint marketing agreements for its Qtern with Ildong Pharmaceutical. Although no locally developed combo is available yet, DongKoo Bio applied for the approval of a citagliptin+ dapagliflozin combo in the first half of this year, raising the possibility that local products will also receive approval soon. Zemiglo is the 19th homegrown drug that was released in 2012. It recorded ₩35.9 billion in outpatient prescription sales last year. Zemiglo and ‘Zemimet,’ a combination of gemigliptin+metformin that recorded ₩79.9 billion last year, have been leading the domestic diabetes treatment market. The industry analysis is that a combination therapy that uses dapagliflozin will well show competitiveness in the market, as the market share of the gemigliptin ingredient is high in Korea's diabetes treatment market.
- Policy
- Will a recombinant flu vaccine be released in Korea, too?
- by Lee, Tak-Sun Nov 09, 2021 05:53am
- The tetravalent flu vaccine supplied by Sanofi in Korea A gene recombinant influenza vaccine is expected to be released in Korea. Currently, flu vaccines made by using eggs or culturing cells are also on sale in Korea. The MFDS approved a phase 3 clinical trial plan for Sanofi's RIV4 vaccine on the 2nd. RIV4 is an abbreviation for Quardrivalent Recombinant Influenza Vaccine, which, in direct translation, is a quaternary recombinant influenza vaccine. This test is aimed at describing the immunogenicity and safety of quaternary recombinant influenza vaccines compared to quaternary inactivated influenza vaccines in 300 patients aged 18 or older in Korea. A tetravalent recombinant influenza vaccine has not yet been released in Korea. The recombinant influenza vaccine is a new concept vaccine that produces large quantities of antigen proteins cultured in plant-derived cells through gene recombination technology. The U.S. FDA approved Flublok developed by Protein Science in 2013, creating the first trivalent influenza vaccine. Sanofi acquired Protein Science for $650 million in 2017. In 2016, a quaternary recombinant protein vaccine developed by protein appeared, and in November last year, it was also approved by the European Commission. In the United States, the product name is Flublok, but in Europe it is called Supemtek. Sanofi is currently supplying a quaternary flu vaccine to Korea under the product name Vaxigriptetra. This product is a conventional inactivated vaccine using an oil well. So far, there are two types of tetravalent flu vaccines supplied in Korea: the oil well egg method and the cell culture method, and SK Bioscience's SKY Cellflu is a representative cell culture vaccine, and the rest are all fertile eggs vaccines. The quaternary recombinant influenza vaccine, which Sanofi conducts clinical trials in Korea, is known to have a higher preventive effect in the age group over 50s, including three times more antigens than those in oil fertilizer and cell culture vaccines. It is also an advantage that there are no vaccination restrictions on pregnant women or people with egg allergies. As Sanofi is also conducting clinical trials in Korea, industries predict that recombinant vaccines will be available as early as the 2022-2023 season. When a recombinant vaccine is released, the existing vaccine market structure is also expected to change.
- Policy
- "Reference pricing will activate sales of generic drugs"
- by Lee, Jeong-Hwan Nov 08, 2021 05:51am
- A pharmacist-politician Seo Young-Seok of the Democratic Party of Korea criticized the generic drug policy failure of the government, saying that Korea should also aggressively implement the ‘reference pricing system’ used in the US and Europe to break collusive ties between doctors and drug companies and lead the generic policy system on the road to success. The basic notion is that the authorities should implement supply regulations to lower the price of generics while regulating the demand to encourage the increased use of cheaper generics and save NHI finances. Seo said that the pharmaceutical expenses can be drastically reduced by reducing the price of generics through reference pricing and profit control and drastically increasing the use amount through systems such as generic incentives for doctors and pharmacists’ generic substitution. On the 6th, Dailypharm analyzed the joint policy report ‘Suggestions on pharmaceutical policies’ that Seo published with a social co-op ‘GungangBut.’ In the report, Seo said that as of 2019, the finished product market accounts for 19.8 trillion won’s worth of the 22.3 trillion won domestic pharmaceutical industry (finished·API drugs). In particular, only 1.7% of the domestic pharmaceutical companies that manufacture finished products produced more than 500 billion won’s worth of products, and the most, 31.9%, produced less than 1 billion, followed by 20.1% that produced 10 billion to 50 billion won’s worth of products. Seo believes that generics can be the source for reducing NHI finances as it has a lower price with the same efficacy. In this sense, Seo stressed that supply-side regulations that set the price of generic drugs as low as possible, as well as demand-side regulations that encourage the use of inexpensive generic drugs, should be implemented together. For this, Seo said that a mechanism in which a lower price ensures market share is essential for market competition between generic developers to work and encourage pricing competition between the companies. More specifically, Seo asked the government to impose demand regulations so that products that voluntarily cut prices are used in the market instead of the current supply regulations that set generics’ prices in the order of entry. Under the current structure, the lowest-priced generic drugs are not used much because the doctors prescribe a drug from a specific pharmaceutical company regardless of the price level. “The reality is that it is more advantageous for the pharmaceutical companies to maintain their high drug price and give rebates to doctors rather than lower their drug prices. This is why there is no pricing competition between generics, and no health insurance savings are taking place.” As a solution, Seo proposed using the reference pricing system as a policy to reduce NHI expenditures by activating the use of generics. The reference pricing system refers to a system in which a certain reimbursement level is set for all drugs with the same efficacy and that level of the drug price is covered by NHI finances, while the patient bears the difference in high-priced drugs that exceed this. To implement the reference pricing system, Seo said we would first need to establish a decision-making system that goes from doctor's prescriptions - pharmacist's generic substitution and information provision - patient’s information acceptance and selection. She pointed to various reasons such as low trust in generic drugs, quality distrust about low-priced drugs, and infringement of doctors' prescriptions’ rights as to why the generic drug policies have failed and financial savings are not being achieved due. If the reference pricing system is implemented, patients will be prescribed drugs in need regardless of brand or ingredient name, and pharmacists will be required to provide generic substitutions, and patients will be given pricing information based on the reference price. Seo also said that the reference pricing system allows patients to express their opinion in choosing their prescription drugs, and pay an additional fee when choosing a drug that exceeds the reference price or receives an incentive of paying no out-of-pocket cost when choosing a drug below the reference price. “The reference pricing system will ultimately allow the government to reduce NHI finances by inducing pricing competition by breaking collusive ties between doctors and pharmaceutical companies and activating the use of drugs that are priced at the reference price level. It also has the advantage of preventing the mushrooming of generics, regaining the public’s trust, and providing an opportunity to make patient-focused decisions," said Seo. Seo added, “We can also expect the system to eradicate negative pharmaceutical sales activities and contribute to diversifying the domestic industry that is currently focused on generic production without competition. Also, the system will allow Korea to achieve substantiality by diversifying and enriching the industry with R&D-focused companies and generic companies.
- Policy
- Will RWD drive accessibility to ultra-high-priced drugs?
- by Kim, Jung-Ju Nov 08, 2021 05:51am
- Korea’s RSA system is moving to become more of a performance-based mechanism rather than a finance-based system. Performance-based RSA means that the system will be using real-world data (RWD) from clinical practice as real-world evidence (RWE). Ultra-high-priced drugs like Kymriah inj. (tisagenlecleucel) have had difficulties in reimbursement, and the government's RSA expansion attempt may be an important tool that can increase patient accessibility. Ji-Hye Byun (Ph.D. in Social Pharmacy), Head of Evidence-based research at the Health Insurance Review & Assessment Service, presented on ‘Plans for reimbursement management in Korea, including pharmaceuticals using RWD, etc’ at the Innovation Research Symposium, ‘Establishing measures for RWD collection to manage pharmaceutical reimbursement management,' that was hosted by HIRA today (4th). Innovative anticancer therapies like Kymriah are ultra-high-priced drugs with much demand for prompt listing from patients and requests for high prices from pharmaceutical companies. The insurance authorities are having difficulty allowing reimbursement for these innovative drugs that have an ultra-high price despite uncertainties in their effectiveness, safety, and cost-effectiveness. This issue is not just a concern for Korea alone, as the trend in new drug development now turned to focus on high-priced drugs that innovatively treat rare diseases. Advanced countries in insurance or new drug development have also been facing the same issue and pursuing the use of RWD to suit each country. According to ‘The UK’s integrated management and use of RWD (Current and future role of RWE in NICE)' that was presented by the copresenter, Jihyung Hong, Professor of College of Social Science at Gacheon University, the UK has been rapidly reinforcing the state-led data integrated system. Patient accessibility to anticancer drugs or rare disease drugs that have a high uncertainty has been reinforced through the "Managed Access Scheme (MAA)" during which additional data (including RWE) are collected. Under the Cancer Drug Fund (CDF), a separate fund for high-priced anticancer drugs, NHS England and pharmaceutical companies collect additional data to agree upon the details on reimbursement. The reimbursement level and degree of uncertainty collected in over 2 years of managed access are used as a basis to conduct further reassessment, based on which NICE will decide on whether to make a final recommendation. In France, reimbursement for rare disease drugs that have uncertain clinical grounds is not deliberated immediately, but applied a temporary use system ‘ATU,’ and allowed conditional use upon reassessment. The UK, France, Germany, Italy, and Spain are all using RWE to resolve the uncertainty in the decision-making process for Kymriah. Spain uses an RWD (patient registration) system that it established that considers the ‘post-marketing safety-economic evaluation analysis.’ In Korea, HIRA has also been operating an expert advisory council since 2019 and had studied RWD cases in partnership with the Korean Cancer Study Group in the process. Another co-presenter and KCSG president, Professor Dae Young Zang (Division of Hematology-Oncology, Hallym University), presented on the ‘Study on efficacy and safety of gastric cancer drugs using electronic medical records (EMR),’ on the RWD items of ramucirumab (Cyrmanza). As such, Korea is also seeking to manage the whole lifecycle of reimbursed drugs using RWE. RWE is a viable alternative that can overcome the limitations of the current system, including the fact that there is no cost-effectiveness benefit management mechanism for applying results that have changed since reimbursement, lacks data collection suited to the purpose of collecting clinical data for HTA (economic feasibility assessment), and the fact that reassessment will only take place after a certain period passes after the submission due to prospective data collection based on reimbursement notices. During the presentation, Byun proposed several measures for systematically managing reimbursed drugs using RWD. One key example was using an RSA system based on patient unit performance. Korea is currently using an RSA mechanism that is overwhelmingly focused on finances when reimbursing high-priced drugs. The main point of a performance-based RSA that uses RWD is in that the pharmaceutical company's responsibility increases with the high price of its drugs in order for the authorities to meet the continued challenge of reimbursing ultra-high-priced drugs with limited finances.
- Policy
- The introduction of a double price system is empty talk
- by Lee, Jeong-Hwan Nov 08, 2021 05:51am
- When the government responded that it was introducing a double price system instead of opposing the National Assembly's criticism that incentives such as exclusion and suspension of PVA should be given to new domestic drugs, the domestic pharmaceutical industry negatively evaluated it as an "empty talk-style administration." Critics say that PVA has virtually no complementarity and that there are no cases of new domestic drugs that benefit from the double price system. On the 2nd, the domestic pharmaceutical industry is disappointed with the MOHW's position on the issue of "Exclusion and Suspension of New Drugs for Development of Innovative Pharmaceutical Companies," which has become a hot topic during this year's parliamentary audit. Multiple domestic pharmaceutical companies that have domestic new drugs or are about to be released in the future in the development stage are in a position to minimize cases in which domestic new drugs receive reverse discrimination from global new drugs. PVA should reflect the specificity of domestic new drugs that complete the sequential lineup with years of R&D investment after electing the most marketable or fastest-to-market indications. When the health insurance authorities, led by the MOHW, answered that they were already implementing a double price system to support exports of new domestic drugs or innovative pharmaceutical drugs, the domestic pharmaceutical community criticized, saying, "It is a rigid attitude." In particular, the National Health Insurance Service said, "There are many cases in which PVA drug prices have been lowered consecutively for multinational companies other than domestic pharmaceutical companies." When he replied, "There is no reverse discrimination," Korean companies countered, "It is a generalization error of simple statistics." The intention is that it is meaningless to simply compare the number of consecutive PV negotiations with the reverse discrimination of domestic new drugs that actually contributed to reducing health insurance finances. In particular, he pointed out the government's position that domestic companies are supporting domestic new drugs through a double price system instead of PVA incentives. The PVA incentive is a policy for domestic new drugs to grow successfully in the domestic pharmaceutical market, and the government has pushed for a double price system that has no impact on the domestic market. HK inno.N's K-CAB is the only drug currently implementing the double price system, and MA officials in Korea say that most of the new domestic drugs and new domestic drugs to be developed and released are unlikely to benefit from the double price system. They also said that the double price system is not a huge preferential treatment or incentive system because it has to maintain the existing drug price and return the drug price through post-settlement, but there is also administrative work necessary for it. Critics say that the double price system is actually a "nothing burger" for a new domestic drug that has to make profits in the domestic market unless it is a new domestic drug developed for overseas exports. An official from Company A, who owns a new domestic drug, said, "The double price system requires administrative work for both the industrial complex and the pharmaceutical company. In particular, it is a system that does not require applying for a double price system for new domestic drugs, where the domestic market is important, he said. "This is a representative case in which Kanarb quit in the middle because there was no real benefit after implementing the double price system. In the end, there is no double price drug other than K-CAB," he pointed out. An official from Company A said, "PVA incentives are policies for the domestic market, but seeing that they are suddenly pushing for a double price system and supporting new domestic drugs, I felt that it was an inevitable repetition of empty talk." He criticized, "If it is difficult to exclude or suspend PVA, other alternative methods should have been devised, so the double price system is out of the blue."
- Policy
- Taiwanese PharmaEssentia got a business license
- by Lee, Tak-Sun Nov 05, 2021 05:24am
- PharmaEssentia, a Korean subsidiary of PharmaEssentia, a Taiwanese pharmaceutical company, has obtained a drug business license. The first CEO of PharmaEssentia in Korea is Haksun Moon, former representative of Novartis Korea. The MFDS granted PharmaEssentia Korea a drug business license as of the 4th. The first factory is located on the 14920th floor of Sejong-daero, Jongno-gu, Seoul. On the 13th of last month, the company obtained a domestic product license for Besremi (Ropeginterferon alpha-2B), a treatment for rare diseases. Meditip, a licensing agency, was approved because PharmaEssentia was not granted business license. The drug is said to be manufactured at the PharmaEssentia plant in Science Park, Taiwan, and imported from Korea. Besremi also received European EMA approval in 2019, and in June, it applied for approval from the FDA. PharmaEssentia was founded in 2003 under the leadership of Taiwanese Americans and is currently headquartered in Taipei, Taiwan. It has branches not only in Korea, but also in the United States, China, and Japan, and has Asian branches in Hong Kong. orea PharmaEssentia The first CEO of PharmaEssentia Korea is Haksun Moon, former representative of Novartis Korea. CEO Moon, who graduated from Kyung Hee University (Dept. Biology) and obtained a Master of MBA from Sungkyunkwan University, joined Novartis Korea as a CRA in 1994 and worked for more than a decade as the first Korean to become a representative. However, Novartis Korea stepped down after a year as he was involved in illegal rebates, and was later recruited by Helixmith to serve as vice president. CEO Moon also served as the president of a Taiwanese subsidiary when he was in Novartis, so communication with PharmaEssentia's headquarters is expected to be smooth. PharmaEssentia Korea is also known to have recently acquired the domestic copyright of the new drug Klisyri (Tirbanibulin), which is expected to launch a business in Korea in earnest.
