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- 2025-12-18 07:29:03
- Policy
- Imlunestrant becomes first reviewed after new drug approval
- by Lee, Hye-Kyung Feb 06, 2025 05:56am
- The first application for a new drug license has been submitted since the fee for drug approval was raised to KRW 410 million. According to industry sources on the 6th, the multinational pharmaceutical company Eli Lilly applied for an marketing authorization for its breast cancer drug 'Inrulio (imlunestrant)' to the Ministry of Food and Drug Safety on Jan. 31. This is the first new drug application filed since the MFDS drastically improved its new drug approval review process and revised the new drug approval review fee. The MFDS implemented the New Drug Approval Innovation Plan on January 1, 2025, and introduced various improvements to increase the transparency and predictability of the approval process. The biggest change is the introduction of a preliminary consultation process. Previously, discussions could only be held after the submission of a new drug application, but now preliminary consultations can be held before submission to prepare for the approval process. This allows companies to get an early indication on the direction of data required for their new drug approval applications and minimize unnecessary supplement requests. Lilly has also already held one preliminary consultation session for Inrulio and the MFDS is currently finalizing the establishment of a dedicated team for its review within its organization. In addition, during the first and second rounds of supplement requests, a process has been added to allow pharmaceutical companies to pre-register supplement materials and request a clarification meeting. This will allow the MFDS to provide clear guidelines, and a final meeting will be held at the final review stage, which is expected to increase the consistency and efficiency of the approval process. Based on such innovative measures, the MFDS aims to shorten the review period for new drugs to 295 days or less, and in particular, the GMP survey period has been significantly shortened from 12 months to 90 days. This is expected to speed up the time for new drug releases. Lilly's Inrulio is the domestically licensed name for imlunestrant, an oral selective estrogen receptor degrader (SERD). The drug is being developed for the treatment of patients with estrogen receptor-positive (ER+), and hormone receptor 2-negative (HER2-) advanced breast cancer. Results from the recently announced Phase III EMBER-3 trial showed that imlunestrant provided a statistically significant improvement in progression-free survival (PFS) compared to standard-of-care endocrine therapy (SOC ET). In particular, patients with estrogen receptor 1 (ESR1) mutations experienced a 38% reduction in tumor worsening compared to conventional therapy. In addition, the combination of imlunestrant and the CDK4/6 inhibitor Verzenio (abemaciclib) reduced the rate of tumor worsening by 43% compared to monotherapy, with a median progression-free survival of 9.4 months compared to 5.5 months for imlunestrant alone. The findings were published in the New England Journal of Medicine (NEJM) and presented at the San Antonio Breast Cancer Symposium (SABCS). This application is the first to be submitted since the implementation of the new drug approval innovation plan and will be an important test of how quickly and efficiently the MFDS’s new approval process will work. The MFDS had said, “ We will establish a review system that stands at the global level through the new drug approval innovation plan. The review process with increased transparency and predictability will contribute to strengthening the competitiveness of Korea’s pharmaceutical industry.” “This is a positive sign that the domestic new drug review process is evolving to a global level,” said a pharma and bio-industry official. ”If the new drug launch period is shortened through this innovation plan, domestic patients will be able to access innovative treatment options more quickly.” Another industry expert said, “If the MFDS's expedited approval process works smoothly, not only global pharmaceutical companies but also domestic biotech companies will be able to more actively engage in new drug development,” and “Increasing the efficiency of the new drug approval process will have a positive impact on the entire industry.”
- Policy
- Reimb imminent for switching between atopic dermatitis drugs
- by Lee, Tak-Sun Feb 05, 2025 05:53am
- Switching between atopic dermatitis drugs may be reimbursed soon. This is because the National Health Insurance Service has completed its review through the preliminary drug price reduction system, and all that remains is the National Health Insurance Service's negotiations. As the expected claim amount is not large, the negotiations are expected to be completed without difficulty. According to industry sources on the 3rd, the Health Insurance Review & Assessment Service (HIRA) has completed its review on expanding reimbursement to cross-administration between biological drugs and JAK inhibitors through the preliminary drug price reduction system and reported it to the Ministry of Health and Welfare. The review was completed after the Drug Reimbursement Evaluation Committee, which was held on January 9, recognized the appropriateness of the reimbursement benefits and collected opinions from pharmaceutical companies. Relevant pharmaceutical companies have not submitted separate objections on the agenda. In the case of expanding the scope of use, if the expected additional claim is less than KRW 1.5 billion, the drug price reduction will not be applied, and if it is between KRW 1.5 billion and 10 billion, a preliminary price reduction will be applied, and if it is over KRW 10 billion, drug price negotiations will be conducted. This cross-administration between biological drugs and JAK inhibitors was subject to a preliminary drug price reduction, and the drug price reduction rate for individual products was determined according to the formula. The target items include biologics such as Dupixent (dupilumab) and Adtralza (tralokinumab), and JAK inhibitors such as Rinvoq (upadacitinib), Olumiant (baricitinib), and Cibinqo (abrocitinib). If approved, most patients will be switching from biological drugs to JAK inhibitors, which will likely lead to an increase in the amount of claims for JAK inhibitors. However, the amount of additional claims is not expected to be high. Accordingly, industry insiders believe that the drug price reduction rate may well be determined based on the formula without drug price negotiations, Even if the NHIS enters drug price negotiations, the industry believes that it will be easy to reach an agreement as the level of the expected additional claims amount will be low. It is analyzed that cross-administration may be reimbursable from March at the earliest after being reported to the Health Insurance Review and Assessment Service. Meanwhile, the current reimbursement standard requires that patients with severe atopic dermatitis who have used biological agents or JAK inhibitors to have first administered the first-line treatment for 3 months and meet the criteria of Eczema Area and Severity Index (EASI) 23 or higher to switch to other drugs. The regulations made it difficult to immediately replace the drug even if side effects occur or the treatment is ineffective, so healthcare professionals have urged the government to reimburse cross-administration without conditions. Health authorities have been considering expanding reimbursement of cross-administration between biological agents and JAK inhibitors since last year.
- Policy
- Low-dose nicergoline continues to be popular
- by Lee, Hye-Kyung Feb 05, 2025 05:52am
- Although it does not indicate the primary treatment of dementia, companies continue to receive approval for their low-dose nicergoline products. .The Ministry of Food and Drug Safety (MFDS) approved Reyon Pharm’s ‘Nicechol Tab .10mg’ on the 3rd .This is the second approval this year, following the approval of the ‘Neurogoline Tab .10mg’ in January .Nicergoline is an α1-adrenergic receptor antagonist that dilates blood vessels to increase arterial blood flow, inhibits platelet aggregation by enhancing neurotransmitter function, and promotes metabolic activity .니세르골린 10mg 용량 허가 품목. Among low-dose nicergoline, Hanmi Pharm’s ‘Nicegoline Tab .10mg’ was the only drug to be approved after 27 years, following Ildong Pharmaceutical's original nicergoline product, ‘Sermion Tab.’ However, new products are being approved lately as the 30mg high-dose product is emerging as a substitute for 'choline alfoscerate,' which is currently subject to clinical and reimbursement reevaluation .Pharmaceutical companies are additionally applying for marketing authorization after demonstrating bioequivalence between its 10 mg and its already-approved 30mg product through comparative dissolution tests .The 10 mg dose is used to ▲ improve the loss of motivation caused by chronic cerebral circulatory disorders that accompany the aftereffects of cerebral infarction, ▲arteriosclerotic headaches in the elderly, and ▲as an adjunctive therapy for hypertension .The 5 to 10 mg dose is administered orally three times a day before meals .So far, a total of 15 nicergoline 10 mg products and 38 high-dose products have been approved in Korea .In the case of primary prevention and treatment of dementia, it is possible to increase the dose up to 60 mg after the initial 30 mg prescription, so it is interpreted that pharmaceutical companies have set out to secure approval for a variety of doses by obtaining approval for not only for high doses but also low doses .Nicergoline 30 mg is indicated for ▲the primary treatment of the following dementia syndromes associated with primary degenerative vascular dementia and mixed dementia: memory impairment, concentration disorder, judgment disorder, and lack of initiative .Meanwhile, according to global market research firm QYreserach, the global nicergoline market is expected to grow at an annual average rate of 16.6% to reach USD 2.3547 billion (about KRW 3.14 trillion) by 2029.
- Policy
- 3-way race starts in faslodex mkt with new generic entry
- by Lee, Tak-Sun Feb 03, 2025 05:52am
- Breast cancer treatment A new generic company entered the fulvestrant drug market that has been a battle between the original’s owner AstraZeneca and the first generic developer Boryung. The new entrant, Korus Pharm, will spark three-way competition in the market with its product being reimbursed this month. According to industry sources on the 31st, Korus Pharm’s breast cancer treatment, ‘Elbracan Inj (fulvestrant ) will be reimbursed from this month. The original fulvestrant is AstraZeneca’s Faslodex Inj, which was released in 2008 in Korea. The competition started after Boryung first released the generic version, ‘Fulvet Inj.’ in 2022. Elbracan, which is being released this time, differs from the other two and the fact that it is manufactured domestically. Elbracan is manufactured at Korus Pharm’s Chuncheon manufacturing plant. On the other hand, Faslodex Inj and Fulvet Inj. are imported finished drugs. Another point is the difference in the drug price. Elbracan’s price has been adjusted to 53.55% of the highest insurance price, which is KRW 288,194 per pack. On the other hand, the premium pricing term for Faslodex and Fulvet has been extended and has not yet been reduced to the level of 53.55%. The premium pricing benefit is scheduled to end in August this year. As a result, the price of Faslodex has remained at 70% of the original first-year price, at KRW 376,724 since the generic’s entry. The price of Boryung’s Fulvet has been maintained at KRW 357,888 with the innovative pharmaceutical company premium. The Elbracan listed this time is about KRW 80,000 to 90,000 cheaper, so it will be interesting to see how the lower price will affect the market competition in the early stages of its entry. Meanwhile, the launch of the generic product Ibrance (Palbociclib) that is used in combination with Faslodex is expected to intensify the onslaught of domestic generic products in the Faslodex-Ibrance combination market as Kwangdong Pharmaceutical and Daewoong Pharmaceutical have been granted approval for their respective Ibrance generic products. Boryung has also been expanding its portfolio of breast cancer treatment drugs, including last year signing a contract with Bixink Therapeutics to jointly market and sell the breast cancer drugs Nerlynx (neratinib) and Fulvet (fulvestrant).
- Policy
- Will external reference pricing reevals be further delayed?
- by Lee, Jeong-Hwan Feb 03, 2025 05:52am
- The Ministry of Health and Welfare plans to concentrate on advancing the regulations on the post-management of generic drug pricing that are being redundantly implemented in Korea. Regarding the introduction of the external reference pricing that has been gaining industry-wide attention, the MOHW reaffirmed its stance on its necessity, but that it will take steps to slow down the process, such as going through discussions with the pharmaceutical industry. The government has shown some consensus to the opinion that in addition to the postmarketing regulations that are already in place such as the Price Volume Agreement (PVA) scheme and actual transaction price reduction system, adding the external reference pricing reevaluations are conducted will pose a burden on the domestic pharmaceutical industry. On the 2nd, Joong-Kyu Lee, Director of the Bureau of Health Insurance Policy at MOHW, explained the post-marketing drug pricing policies that will be conducted this year at a meeting with the Korea Special Press Association. First, Director Lee explained the MOHW’s plans for managing the overall postmarketing drug price control system this year. In addition, Lee also expressed its intention to look into the appropriate timing for the implementation of the external reference pricing reevaluations. If implemented, the external reference pricing reevaluations will lead to additional drug price cuts for many generics, which is why many domestic pharmaceutical companies that base their business on generics are paying attention to the specific implementation method and timing of the system. Director Lee plans to incorporate the external reference pricing reevaluations into the process of improving the postmarketing drug price control system, which had been operated individually and partially in an unreasonable manner, so that the individual systems can be linked flexibly and efficiently in consultation with the pharmaceutical industry, experts, etc. In particular, considering how Korea’s pharmaceutical industry generates profit through generic manufacturing sales and exports, Lee also mentioned the need to improve the system for generic drug pricing. “The United States is a country that imports generics, so the price share is low, but the Korean pharmaceutical industry produces generics, so the share is high,” said Lee. ”And as the proportion of doctors’ prescriptions for the original drug is not low, so drug expenditure management is necessary on the government’s part.” Lee also said, “We are looking at how to improve redundant post-marketing drug price control measures in place, which is double and triple layered. The pharmaceutical industry is talking about the fact that the re-evaluation is intertwined, making it difficult to predict when and how much drug prices will be reduced, such as when the price of drugs that have been reduced after PVA negotiations undergo actual transaction price reevaluations.” Director Lee also promised to strive to compensate prices for innovative drugs by balancing the weight between post-marketing drug price control and innovative drug price compensation. This is in line with the MOHW’s plan to advance the mechanism for post-marketing control of drug costs to improve the sustainability of the health insurance finances last year. “Post-marketing drug price control is necessary (despite the pharmaceutical industry's appeals). However, the system itself does also need to be modified,” he said. ”Our internal judgment is that it would be better to strike a balance between post-marketing drug price control and rewarding innovation value.” Lee added, “We will be implementing external reference drug pricing. However, we plan to conduct this while overhauling the post-marketing drug pricing system. If our intentions play out, we may be able to conduct the external reference pricing reevaluations concurrently. All these options are being discussed.”
- Policy
- 'Lixiana' patent expires next year, good news for
- by Lee, Hye-Kyung Jan 24, 2025 05:51am
- Product photo of As the patent of 'Lixiana (edoxaban),' a Direct Oral Anti-Coagulant (DOAC), is set to expire, generic companies are entering the competition. On January 21, the Ministry of Food and Drug Satefy (MFDS) approved bioequivalence tests, which are open-label, randomized, two groups, single time-point, cross-over Phase 2 trials involving healthy adult study participants oral administration on an empty stomach, for Hanlim Pharm's 'Edoxaban' and Daiichi Sankyo Korea's 'Lixiana Tab 60 mg.' The Lixiana patents listed in the Ministry of Food and Drug Safety's (MFDS) patent registry are two types: the substance patent, which is set to expire on November 2026, and the composition patent, which is set to expire on August 2028. For the Lixiana composition patent, 10 companies, including Boryung, Dong-A ST, HK inno.N, Samjin Pharm, Shinil Pharma, Chong Kun Dang, Kolmar Pharma, Kolmar Korea, Hutex, and Hanmi Pharmaceutical, have successfully avoided the patent through passive rights scope confirmation trials. Korean companies that won patent avoidance can launch their generics when the substance patent expires in November 2026. To meet this schedule, these companies have been applying for approvals of generic Lixiana and bioequivalent tests since 2023. Dong-A ST was the first to obtain approval for its generic version of Lixiana in 2021. However, despite winning patent avoidance, the company did not meet the requirement for being the first request for trial, so it failed to obtain a right to priority sale. Without a right to priority of sale, 12 companies, including Genuone Sciences, Genu Pharma, Hutex Korea Pharmaceutical, Handok, Shinil Pharma, Ahngook Pharm, Shinpoong Pharm, Nexpharm Korea, Samsung Biologics, Korea Prime Pharm, and Union Korea Pharm, have received approvals for 29 generic products. Additionally, as companies such as CMG Pharmaceutical, Hanlim Pharm, Theragen Etex, and Vivozon conduct bioequivalence tests, competition intensifies in the generic market even before product launches. Lixiana has been ranked top for a long time in the DOAC market, with yearly prescription sales of KRW 100 billion. According to a pharmaceutical market research firm, UBIST, Lixiana's prescript sales for 2023 amounted to KRW 105.3 billion, up 9% from KRW 96.7 billion in 2022. It recorded KRW 55.7 billion in the first half of last year. Lixiana has maintained a leading position in the market since it ranked first in 2019. Analysis suggests that joint sales with Daewoon have contributed positively to the increase in prescription sales.
- Policy
- Hokunalin Patch has been removed from Korea’s reimbursement
- by Lee, Tak-Sun Jan 24, 2025 05:51am
- Hokunalin Patch, asthma and bronchitis deodorant based on tulobuterol, will be removed from the reimbursement list. The move was made upon the expiry of the item’s marketing authorization last month. As a result, only domestic generic versions of the drug are available in South Korea. According to industry sources on Jan. 22, Abbott's 3 versions of Hokunalin Patch (0.5 mg, 1 mg, and 2 mg) will be removed from the reimbursement list on Jan. 1 next month. The drug's domestic license expired on Jan. 1. The medication is an adhesive strip that is applied to the skin. It is characterized by its 24-hour effectiveness after a single application. In particular, it is used for infants and children suffering from asthma as well as acute and chronic bronchitis, as it has fewer side effects than oral medications and can be used from the age of 6 months. Abbott has already announced that it will discontinue the domestic supply of Hokunalin in 2022. The reasons included the end of the contract with the manufacturer and the rising cost of raw materials. However, the company had maintained the domestic marketing authorization for the drug, and with the expiration of the license and the removal from the reimbursement list, Hokunalin Patch will disappear into history. However, there is a six-month grace period before August 1 to apply for insurance reimbursement benefits. The withdrawal of Hokunalin from the domestic market was also due to the emergence of generic drugs. Generic versions of the drug have been available since 2010, and 19 pharmaceutical companies currently maintain licenses. The use of Tulobuterol Patch has been increasing due to the recent surge in respiratory diseases. In response, the government designated the transdermal tulobuterol patch as a national essential medicine in November 2023. In addition, in March last year, the upper insurance price limit was raised by up to 27.2% to address the supply-demand imbalance. However, the field reports that there is still a shortage of tulobuterol deodorant. The number of products being withdrawn is also increasing. From August 2023 to January this year, 21 products from nine pharmaceutical companies did not renew their licenses. “Tulobuterol patch is a product with a high production cost and not much profit,” said an industry official. ”Recently, the price of raw materials has risen, and due to intensified competition between generic companies, more and more companies are leaving.”
- Policy
- Govt plans to expand CDMO capacity by 2.5 times
- by Lee, Hye-Kyung Jan 24, 2025 05:51am
- The government plans to expand Korea’s CDMO manufacturing capacity 2.5 times by 2032 to become the No. 1 global CDMO by 2032. It will also support domestic companies with a 'megafund' by expanding the size of the K-Bio-Vaccine Fund, currently at KRW 600 billion, to over KRW 1 trillion. The government launched the National Bio Commission in anticipation of the global bio market growing to KRW 3.3 trillion by 2027. According to the 'Vision and Mission of the National Bio Commission (draft)’ released at the first meeting, the government will quickly create mega funds worth more than KRW 1 trillion, such as the K-Bio-Vaccine Fund, for early investment and scale-up of bio companies, and build a growth ladder by expanding policy finance and trade insurance support, including preferential interest rates and expanded loan limits. To promote R&D activities of companies, the government will activate M&As and expand tax credits by adding bio-related technologies such as bio buffer and bio jet fuel to the list of national strategic technologies. Also, it will support corporate growth by expanding support bases such as K-Biodesk and Boston CIC (Cambridge Innovation Center) in major overseas countries, along with management consulting and overseas certification support. Sung-hyuk Yoon, Director General of the Ministry of Trade, Industry and Energy “The KRW 1 trillion megafund will be based on the KRW 50 billion Korea Fund for startups in the bio sector, the KRW 300 billion fund created by the Ministry of Health and Welfare, and the KRW 100 billion fund dedicated to green bio and food tech by the Ministry of Agriculture, Food and Rural Affairs,” said Sung-hyuk Yoon, Director General of the Ministry of Trade, Industry and Energy's Advanced Industry Policy Bureau. The K-Bio-Vaccine Fund, which the government has been funding since 2023, is worth KRW 306.6 billion. The third and fourth funds are currently being established, and if the fifth fund is added this year, it will total KRW 600 billion. To expand private investment, the government will reactivate M&A by abolishing the obligation to sell VC stakes and providing loan guarantees for acquisition funds, and expand tax credit benefits by adding bio-related technologies such as bio buffers and bio aviation oil to the list of national strategic technologies. In addition, by 2032, domestic CDMOs plan to expand their production capacity to 2.5 times the current level. “The production capacity of CDMOs in Songdo, Incheon is about 870,000 liters,” said Yoon, adding, ”Domestic CDMOs such as Samsung Biologics are planning to invest KRW 21 trillion, and if this amount is executed, the production capacity will increase to 2.16 million liters by 2032, making it possible to rank first in the world in terms of sales and capacity.” To support the manufacturing base of domestic biotech companies that have the technology to discover new drug candidates but do not have production facilities, the government plans to utilize five public CDMOs already established to help them commercialize their technologies, including cell line manufacturing, sample, and finished product production. In addition, the government will build a Korean bio cluster. It plans to promote convergence between various fields such as red, green, white, and blue bio by linking high-tech medical complexes, R&D zones, and industrial complexes nationwide, and create an ecosystem that runs from R&D to commercialization by attracting key institutions (universities, research institutes, companies, and hospitals). In addition to establishing a 'Bio Cluster Commission’ under the National Bio Committee, it will jointly utilize regional equipment, experts, and startup support programs through a 'virtual platform' connecting 20 clusters, and expand exchanges with leading clusters overseas. “The health and medical sector has been investing and industrializing for so long that there are currently about 18 clusters across the country,” said an MOHW official. ”We cannot physically gather all of them like the Boston cluster in the United States, so we will create a system to share resources based on the virtual platform, such as the facilities, equipment, and incubation centers that each cluster has.”
- Policy
- If atrial fibrillation develops, Rx 'Omega-3' API
- by Lee, Hye-Kyung Jan 23, 2025 05:54am
- Product photo of Kuhnil The administration of the active ingredient 'omega-3-acid ethyl esters90,' which is used for treating dyslipidemia, will be permanently discontinued if a patient develops atrial fibrillation. Starting February 10, the Ministry of Food and Drug Safety (MFDS) will modify the approval specification based on the results of the European Medicines Agency (EMA)'s safety assessment and monitoring of 'omega-3-acid ethyl esters90.' Last year, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) agreed to add atrial fibrillation (irregular, rapid contraction of the heart) as a common side effect to the product information for medicines containing omega-3. The review result of a Periodic Safety Update Single Assessment (PSUSA) procedure conducted by the PRAC highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular disease or cardiovascular risk factors treated with omega-3 compared to placebo. The atrial fibrillation risk is highest with a dose of 4g per day. EMA concluded that if atrial fibrillation develops, omega-3 treatment should be permanently discontinued. The MFDS also concluded to reflect such change on the approval specification for omega-3-acid ethyl esters (monotherapy) and will include the clause, 'atrial fibrillation has been reported to be a common side effect' in the adverse reaction section. Additionally, the MFDS will add a clause that 'a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular disease or cardiovascular risk factors is observed. If atrial fibrillation develops, omega-3 treatment should be permanently discontinued' in the general safety section. Omega-3-acid ethyl esters90 is the only prescription medicine available containing omega-3 fatty acids and Kuhnil's 'Omacor' in the original drug. 56 Omacor generics have been approved. Omacor is a medicine made of omega-3 fatty acids extracted from fish oil. It is used for the treatment of hypertriglyceridemia. According to a pharmaceutical market research firm, UBIST, Omacor's outpatient prescription sales were reported to be KRW 34.6 billion.
- Policy
- MFDS approves immune thrombocytopenia drug Tavalisse
- by Lee, Hye-Kyung Jan 23, 2025 05:54am
- The Ministry of Food and Drug Safety (MFDS) announced on the 20th that it has approved Tavalisse Tab 100 mg (fostamatinib sodium hydrate), an orphan drug used to treat immune thrombocytopenia in adults. Adult immune thrombocytopenia is an autoimmune disease in which antibodies against platelets are produced and platelets are destroyed in the spleen, resulting in petechiae and purpuric spots on the skin. Tavalisse inhibits the activation of spleen tyrosine kinase (Syk), which inhibits the production of antibodies against platelets, thereby preventing platelet destruction while also interfering with platelet ingestion by macrophage. Spleen tyrosine kinase is a non-receptor tyrosine kinase that is widely present in blood cells and plays an important role in activated signal transduction within beta cells of the pancreas. The MFDS said, “We expect the treatment to provide a new treatment opportunity for patients with adult immune thrombocytopenia who have had an inadequate response to previous treatments,” the agency said. In July 2023, Tavalisse was designated as a priority review target and fast-tracked for rapid introduction into Korea. In particular, JW Pharmaceutical applied for health insurance reimbursement benefits to the Health Insurance Review and Assessment Service last year using the approval-evaluation linkage system. JW Pharmaceutical signed a contract with Japan's Kissei Pharmaceutical in 2021 for the domestic distribution right to Tavalisse. The original developer is the U.S. company Rigel Pharmaceutical, and Kissei acquired the development and exclusive commercialization rights for the Korean, Japanese, Chinese, and Taiwanese markets in 2018. “We will continue to make the best efforts to quickly supply new treatments to patients with rare and intractable diseases based on our regulatory science expertise, to expand treatment opportunities for the patients,” said the MFDS.
