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- 2026-05-05 08:11:39
- Policy
- The RSA track to include drugs for chronic diseases, asthma
- by Lee, Tak-Sun Mar 07, 2024 07:15am
- The Risk Sharing Agreement (RSA) will cover chronic and severe diseases that cannot be treated with substitute drugs and result in irreversible deterioration in the quality of life. It was announced last year as part of ‘The drug pricing system to ensure fair-value compensation for innovative new drugs.’ Since the announcement, the RSA has covered several drugs to treat chronic and severe disorders. The committee will now develop detailed guidelines to ensure the implementation of these measures. The Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) will hold a meeting on the 7th to review the guidelines, according to the industry sources on the 6th. The current RSA only applies to anticancer and orphan drugs treating life-threatening severe diseases without substitute drugs. However, there were cases where the RSA covered other severe diseases besides orphan drugs. For instance, ‘Dupixent inj,’ a drug used to treat severe atopic dermatitis, and the severe asthma drug ‘Nucala’ have been covered by health insurance reimbursement via RSA. The government will additionally apply RSA to drugs treating chronic and severe diseases to provide better patient insurance benefits. The government will promptly implement this measure because RSA has already covered several drugs for treating severe diseases, and the administrative work only includes developing detailed guidelines. This is the first measure to implement ‘The drug pricing system to ensure fair-value compensation for innovative new drugs,’ announced last year. Therefore, once the DREC reaches an agreement, it is expected that drugs for treating chronic and severe diseases causing irreversible deterioration in the quality of life, including generalized pustular psoriasis, interstitial lung disease, hereditary angioedema, and severe asthma, will be covered by RSA and later, those drugs will likely be reimbursement listed. The DREC, which will be held on the 7th, will also review the reimbursement appropriateness of Fasenra Pre-filled Syringe Inj. (benralizumab, AZ), used for treating severe eosinophilic asthma. Fasenra Pre-filled Syringe Inj. received a reimbursement status via RSA at the DREC last September. However, it did not receive a non-reimbursement decision. On the other hand, Nucala (mepolizumab, GSK), a severe eosinophilic asthma treatment similar to Fasenra, was successfully listed for reimbursement via RSA. Whether Fasenra will clear the reimbursement appropriateness and the expansion of the RSA measure is to be watched.
- Opinion
- [Reporter’s View] On MFDS’s new drug management team
- by Lee, Hye-Kyung Mar 06, 2024 06:03am
- A new drug management support team will be established under the Ministry of Food and Drug Safety’s Pharmaceutical Safety Bureau. According to the 'Partial Amendment of the Enforcement Rules of the Ministry of Food and Drug Safety and its Affiliated Institutions' that was released by the MFDS on February 7, the MFDS will newly establish a drug safety management team using the total payroll costs system. As such, the MFDS is expected to reorganize and make personnel appointments to reflect the amendments in the near future. The role of the Pharmaceutical Management Support Team will focus on managing items with unstable supply and demand. The duties of the head of the Pharmaceutical Management Support Team include overseeing the procurement policies for medical products in response to public health crises, operating the Safety Management and Supply Committee, establishing and operating information systems, approving emergency use of drugs, designating, managing, and stabilizing the supply of national essential medicines, operating the drug supply forecast system, managing the targets for reporting production and supply interruptions, and managing Korea Orphan & Essential Drug Center projects. The Pharmaceutical Management Support Team will also take over some of the tasks currently handled by the Pharmaceutical Policy Division. The team will also represent the MFDS at the public-private consultative meetings held to respond to unstable drug supply and demand, which have been held 13 times so far. The imbalance in the supply and demand of medicines has intensified since COVID-19, and through the public-private consultative meeting, measures for distribution management and administration are being explored. The MFDS monitors the unstable supply and demand items and simultaneously requests pharmaceutical companies to cooperate with production while seeking measures to support drugs that have supply disruptions due to problems such as unavailability. As such, there is consensus on the need to separately manage drug supply and demand instabilities. It is a positive sign that the MFDS plans to separate the Pharmaceutical Management Support Team from the Pharmaceutical Policy Division to manage items with unstable supply and demand. However, unlike the Narcotics Prevention and Rehabilitation Team, whose team leader is appointed from 4th Grade or above, the head of the Pharmaceutical Management Support Team can be a 5th Grade official. The team is supposed to be in charge of encouraging pharmaceutical companies to manufacture and provide administrative support to stabilize the supply of medical products to respond to public crises, but instead of a Director with a Grade 4 clearance or higher, a Grade 5 Deputy Director would be in charge. Although they can manage, it would have been nice to have a Deputy Director take charge of the team and make viable promises to pharmaceutical companies. In addition, the Pharmaceutical Management Support Team will have a set term and will end on January 31, 2027. After the term, the team’s tasks will be reassigned to the Pharmaceutical Policy Division. However, when looking at the roles taken by the Pharmaceutical Management Support Team, the team seems to be an indispensable department that has a close relationship with medical institutions, pharmacies, and pharmaceutical companies. The MFDS’s decision to reorganize its structure to manage the unstable supply and demand of drugs is laudable, but thoughts are required on whether a 3-year temporary team with a team leader at the level of a 5th-grade official will be able to function as intended.
- Company
- Rare drug Ultomiris posts KRW 40 billion in sales in 3 yrs
- by Nho, Byung Chul Mar 06, 2024 06:03am
- Becoming a KRW 40 billion blockbuster in just 3 years since its launch, the growth potential of AstraZeneca’s Ultomiris Inj (ravulizumab) is gaining industry-wide attention. The biological orphan drug Ultomiris Inj. is considered to be the successor to Soliris Inj. (eculizumab) with significant improvements in dosing convenience. The drug was approved in June 2021 at a reimbursed price of KRW 5,598,942 for the 30 ml vial and is indicated for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome. By Q3 2021, 2022, 2023, Ultomiris has generated sales of KRW 19.5 billion, KRW 43.1 billion, and KRW 37.8 billion, respectively. Ultomiris is administered every 8 weeks as a maintenance dose (through intravenous infusion 2 weeks after administering a loading dose based on body weight). In contrast, Soliris is dosed with weekly intravenous infusions for the first 4 weeks, followed by a 5th dose 7 days after the fourth dose, and then every 2 weeks thereafter. While Ultomiris is a follow-on to Soliris, it is notable that Soliris still maintains sales as a blockbuster drug that posts sales in the KRW 10 billion range, by securing indications such as systemic myasthenia gravis and neuromyelitis optica spectrum disorder. Soliris had generated KRW 43.8 billion to KRW 43.9 billion in sales in 2019-2020 before the launch of Ultomiris. Since then, it has maintained sales of KRW 31 billion, KRW 10.1 billion, and KRW 6.4 billion through Q3 in 2021, 2022, and 2023, respectively. In addition, Soliris has undergone two drug price cuts from KRW 6,138,844 in February 2017 and is currently priced at KRW 5,132,364 per 30ml vial. PNH is a life-threatening rare blood disease characterized by the destruction of red blood cells by the complement component that is part of the immune system. Without treatment, 4 out of 10 patients die within 5 years after diagnosis. In Korea, around 200 patients suffer from PNH. Until Ultomiris’s launch in Korea in 2012, Soliris was the only treatment for PNH and was shown to improve the 5-year survival rate by 95.5%. Meanwhile, Ultomiris’s efficacy was demonstrated through 2 prospective studies (Study 301 and Study 302) that were conducted on PNH patients. In both studies, Ultomiris demonstrated non-inferiority compared to Soliris in the primary efficacy endpoints of avoidance of the need for transfusions, LDH normalization, and LDH change rate, as well as in the secondary endpoints of LDH change rate, change in the quality of life (FACIT-Fatigue), breakthrough hemolysis, and proportion of patients with stabilized hemoglobin. In addition, a preference assessment study that was conducted as an extension study in patients with paroxysmal nocturnal hemoglobinuria who were previously treated with both Soliris and Ultomiris showed that 93% of patients preferred Ultomiris.
- Company
- Reimb for Verzenio in early breast cancer undergoes review
- by Eo, Yun-Ho Mar 06, 2024 06:03am
- Verzenio, the first CDK4/6 inhibitor to apply for insurance reimbursement in early breast cancer, is taking the second step to extend its reimbursement coverage. According to a report, the agenda of reimbursing Lilly Korea’s Verzenio (abemaciclib) will be presented to the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee today (March 6). Therefore, the industry’s attention is on whether Verzenio will succeed in its second reimbursement attempt. The company had difficulty reaching the CDDC stage during its first attempt for reimbursement in early breast cancer. After a long 6-month wait after submitting the application, the case reached the CDDC deliberation stage in May last year, but no standards were set. The company resubmitted the reimbursement application 5 months later to HIRA in October. The same month, a petition was posted on the Cheong Wa Dae National Petition Board, “Petition requesting reimbursement for the targeted therapy Verzenio in early breast cancer.” Also, the application was backed by additional clinical evidence.: 5-year monarchE data that was presented at the 2023 European Society for Medical Oncology (ESMO) Congress. This was a follow-up study to the 4-year data presented at the Annual San Antonio Breast Cancer Symposium Annual and Lancet Oncology in December 2022. Results showed that the gap between the Verzenio arm and the control arm (endocrine therapy alone) in the primary clinical endpoints of invasive disease-free survival (IDFS) and distant recurrence-free survival (DRFS) widened further in year 5 compared to year 4. At year 5, the primary endpoint, the difference in invasive disease-free survival (IDFS), was approximately 8% between the two arms. This suggests that even after completing treatment with Verzenio for a limited period of time, 2 years after the surgery, the treatment benefit continued to year 5. Other than the letrozole generic that is used as endocrine therapy, it is the only new drug available for HR+/HER2- type early breast cancer. The drug’s indication was expanded on November 18th, 2022 as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy. More specifically, the drug is indicated for a very limited range of patients with ▲ patients with 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes, and tumor size of 5 cm or larger, or ▲histological grade 3 disease. Keun Seok Lee, Professor of the Center for Breast Cancer at the National Cancer Center, said, “The Verzenio and endocrine therapy combination is recommended with a high level of evidence in major national and international practice guidelines as adjuvant therapy for patients at high risk of recurrence. With various clinical studies and major academic society reviews confirming its clinical utility, we need to enable rapid access to the treatment through prompt reimbursement to improve the survival of patients at high risk of recurrence.”
- Company
- Cash cow ‘bepotastine’ to face reimb re-evaluation
- by Chon, Seung-Hyun Mar 06, 2024 06:02am
- In facing re-evaluation of ‘bepotastine’ for reimbursement in the upcoming year, pharmaceutical companies fear its impact. The market size for bepotastine has increased by more than 50% in just two years during the pandemic and endemic, labeling bepotastine as a new cash cow. However, there are concerns that the companies may face financial loss if drugs containing bepotastine as an active ingredient receive negative results from the re-evaluation, such as reduced reimbursement or removal. According to industry on the 6th, the Ministry of Health and Welfare (MOHW) recently held the Health Insurance Policy Review Committee, where they reported on drugs that will be re-evaluated for reimbursement appropriateness in 2025. Next year, the reimbursement appropriateness of eight active ingredients, including olopatadine, clematis radix plus trichosanthes root plus prunella spike, bepotastine, spherical adsorptive carbon, artemisia Herb extract, L-ornithine- L-aspartate, and chenodeoxycholic acid-ursodeoxycholic acid, will be determined through the re-evaluation. The MOHW explained, “We have selected eight active ingredients. Five active ingredients have been listed for an extended time, and three active ingredients are currently under clinical re-evaluation by the Ministry of Food and Drug Safety (MFDS)." The MOHW will perform a comprehensive analysis and evaluation of drugs based on clinical research article results, clinical usefulness, cost-effectiveness compared to substitute drugs, and the overall increase in insurance benefits for society. The compiled data will be reviewed by experts, and the MOHW will decide whether to maintain, reduce, or remove reimbursement. The industry is particularly interested in hearing results from the MOHW’s re-evaluation of the appropriateness of reimbursement for bepotastine because the market has expanded significantly recently. Pharmaceutical companies may face financial loss if the drugs containing bepotastine receive negative results from the re-evaluation, such as reduced reimbursement or removal of indication. Annual outpatient prescription sales for bepotastine (unit: 100 million won, source: UBIST). Bepotastine is a drug used to treat perennial allergic rhinitis, chronic hives, and pruritus accompanied by skin disorders. The prescription market for bepotastine experienced rapid growth during COVID-19 and endemic. According to UBIST, a pharmaceutical market research agency, the out-patient prescription market size for bepotastine was 70.2 billion won last year, an increase of 17.7% from the previous year. The prescription market size for bepotastine stayed mainly the same between 2018 and 2021, generating 45.3 billion won and 45.3 billion, respectively. However, it reached 59.7 billion won in 2022, showing a growth of 31.8%, and even greater last year. The prescription market size for bepotastine expanded to 55.2% in the past two years. Since the end of 2021, there has been a significant surge in demand for nasal discharge treatment, which is one of the remedies to alleviate symptoms of COVID-19. This is due to the increasing number of people testing positive for COVID-19, with hundreds of thousands of new cases daily. Even after the pandemic, there are still many COVID-19-positive patients and growing patients with influenza or the common cold, leading to even greater demand for bepotastine. Dong-A Pharmaceutical’s Twolion dominates the prescription market for bepotastine. Twolion’s prescription sales were 10.7 billion won, up 11.7% from the previous year. In two years, it has increased 33.1% from 8.1 billion won in 2021. Mitsubishi Tanabe Pharma’s Talion is the original medicine with bepotastine as an active ingredient. Initially, Dong-A ST marketed Talion, but Mitsubishi Tanabe Pharma withdrew from the Korean market after its patent expired at the end of July. Since then, Dong-A Pharmaceutical received approval for Twolion, a generic version of Talion, and Dong-A ST is responsible for its marketing. Daewon Pharm’s Bepostarbi recorded 4.9 billion won in prescription sales last year, a 29.1% increase in just two years since making 3.8 billion in 2021. Dong Kook Pharmaceutical’s Bepotan accumulated 3.7 billion won in prescription sales, up 47.0% from two years ago. The prescription sales for Medica Korea’s Galion were merely 1.4 billion in 2021 but recorded 3.3 billion won last year, more than doubling the size. Only two of the eight active ingredients survived the reimbursement re-evaluation conducted last year by the MOHW. The MOHW conducted re-evaluation of reimbursement on eight ingredients, including rebamipide, levosulpiride, loxoprofen sodium, limaprost alfadex, epinastine hydrochloride, oxiracetam, acetyl-L-carnitine hydrochloride, and hyaluronic acid (HA) eye drops. Only two of the ingredients, rebamipide and levosulpiride, maintained their reimbursement prices since the drugs proved clinical usefulness. Loxoprofen sodium, limaprost alfadex, and epinastine hydrochloride are the three active ingredients receiving reimbursement cuts. Loxoprofen sodium’s indication, ‘Reducing fever and pain relief for acute upper respiratory inflammation,’ will be excluded from receiving the reimbursement. For limaprost alfadex, the reimbursement will not cover its indication, one of the two, for ‘Improving ischemic symptoms such as ulcer, pain, and cold sensation that are associated with thromboangitis obliterans.’ Oxiracetam and acetyl-L-carnitine hydrochloride were excluded from the current re-evaluation because the MOHW had already stopped allowing reimbursement for those two ingredients due to inadequate demonstration of their effectiveness based on the MFDS’s clinical re-assessment. The decision for hyaluronic acid (HA) eye drops has been postponed until reimbursement criteria for all disposable eye drops are established.
- Company
- Dupixent, 1st biologic approved for pruritic rash indication
- by Son, Hyung-Min Mar 05, 2024 05:49am
- Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center. As Dupixent is approved to treat prurigo nodularis (nodular itchy rash), the drug emerged as the only available treatment option among biologic agents. Previously, there were limited treatment options for treating prurigo nodularis, a condition that causes extreme itchiness. Sanofi hosted a press conference at Novotel Ambassador Seoul Gangnam on the 28th to commemorate the company’s expansion of Dupixent indications to treat prurigo nodularis. Dupixent is a biological agent designed to target interleukin (IL)-4 and IL-13 signaling pathway, biomarkers of type 2 inflammation, and regulates the symptoms. The drug has shown effects in inflammatory diseases such as atopic dermatitis and eosinophilic esophagitis. Moreover, Dupixent secured an expanded indication for prurigo nodularis. Last December, Dupixent was approved in Korea for treating moderate to severe prurigo nodularis in patients aged 18 years and older who had inadequate responses to or were not recommended for a topical treatment. Prurigo nodularis is a chronic dermatitis associated with type 2 inflammation. It is known to significantly impact a patient’s quality of life more than any other inflammatory skin disease due to extreme itchiness. High-dosage topical steroids are commonly prescribed for the treatment, but their long-term use can pose safety risks. These risks include dermal atrophy, infection, blurry vision, and vision deterioration. The introduction of Dupixent, which has confirmed efficacy and safety, may improve patient’s quality of life. This approval was based on the PRIME and PRIM2 Phase 3 clinical studies. The studies included 311 patients aged 18 and older with prurigo nodularis. The primary endpoint was the proportion of patients who achieved scores of 4 points or greater reduction in the Worst-Itch Numeric Rating Scale (WI-NRS) at 12 weeks and 24 weeks. In PRIME clinical results, the patients who received Dupixent showed nodule reduction at 12 weeks and 24 weeks. At 24 weeks, 48% of patients with Dupixent showed an improvement in their condition measured by a WI-NRS score of 4 points and a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S). Therefore, the improvement by Dupixent treatment was significantly greater than the 18% observed in the placebo group. Furthermore, the PRIME2 clinical study also demonstrated that 45% of patients who received Dupixent showed an improvement by a WI-NRS score of 4 points or more and a score of 0 or 1 point in the IGA PN-S, a significantly higher proportion of patients with improvements compared to the 16% in the placebo group. Throughout the first 24 weeks, Dupixent displayed a consistent safety profile that is similar to what is known from other indications. “Prurigo nodularis is often associated with type 2 inflammatory diseases such as atopic dermatitis and asthma. Almost half of the patients with prurigo nodularis also have atopic disease. Dupixent is the only biologic agent available for targeting this disease,” Professor Ahn Ji Young, affiliated with the Department of Dermatology at the National Medical Center, said. “Over 60% of patients suffer from sleep-related deterioration due to chronic itch, which is often linked to psychological disorders such as depression or anxiety,” Ahn added. “The previous treatment options for prurigo nodularis were limited. Therefore, the introduction of biologic agent that is effective and has fewer side effects can improve the quality of life of the patients,” Ahn emphasized.
- Product
- KPA, “to discuss ingredient prescribing in upcoming FAPA"
- by Kim JiEun Mar 05, 2024 05:49am
- The Korean Pharmaceutical Association (KPA) held ‘The 70th General Meeting of Senior Representatives’ for 2024. Kwang-Hoon Choi, President of the Korean Pharmaceutical Association (KPA), has announced that he would assign the proposal for active ingredient prescribing as the priority agenda for the Federation of Asian Pharmaceutical Associations (FAPA) Congress, which is scheduled to be held in October this year. Choi aims to convince the Korean citizens and the government to support active ingredient prescribing. In preparation for this proposal, the KPA is discussing with the government to simplify the substitute drug post-notification procedures. During ‘The 70th General Meeting of Senior Representatives’ on the 28th, KPA (President: Kwang-Hoon Choi) voted to partially revise last year’s KPA presidential election rules. Moreover, a Q&A session was held with the senior representatives and the executive branch to discuss current issues involving pharmacists During the meeting, KPA reviewed seven items, including ‘Revising the election rules for President of KPA and head of branch office,’ and reached decisions. The election rules were decided during last year’s meeting for senior representatives, but the rules were partially revised and finalized during this year’s meeting. In addition, KPA finalized the following matters: ▲2023 audits, and the approval of annual revenue and annual expenditure budget ▲Voting rights for the review of the 2024 business plan ▲Voting rights for the review of the 2024 approval of annual revenue and annual expenditure budget ▲Confirmation of the vice president’s position ▲Approval of a new member of the board of directors ▲Consideration of suggestions from the regional branch. Moreover, the management reports and audits of 2023 regarding KPA’s affiliated agencies, including K-Pharm news, Korea Institute for Pharmaceutical Policy Affairs (KIPPA), and Korea Pharmaceutical Information Center (KPIC), have been reported. During the meeting, the senior representatives voiced many questions about the welfare of the pharmacist society and current policies. The questions were mainly about resolving drug shortages, the system for transferring prescriptions, a system crash during the public transfer of prescriptions, and KPA’s support for introducing active ingredient prescribing. Furthermore, several representatives expressed their concerns regarding KPA’s affiliated agencies, such as KPIC and KIPPA, and ongoing businesses. Regarding KIPPA, there were concerns raised about the malfunctioning KIPPA website and the lack of research on current issues faced by pharmacists. Several senior representatives raised concerns about KPIC’s ongoing business for developing a cloud-based PSP system, which aims to be accomplished by the end of this year. Upon receiving questions and comments from the senior representative regarding the issue, Choi stepped forward and explained KPA’s stand and the association’s strategy. “With the expansion of telemedicine prescribing, there has been an increasing need for active ingredient prescribing. The KPA executive branch continues to support this proposal,” Kwang-Hoon Choi, President of the KPA, stated. “KPA regards simplifying the substitute drug post-notification procedures as a stepping stone for the next step and is discussing this issue with the government. During the FAPA Seoul congress, we aim to prioritize the proposal for active ingredient prescribing as an agenda and gain support from the Korean citizens and the government,” Choi added.
- Company
- Kolon Life Science appeals to the Supreme Court for Invossa
- by Nho, Byung Chul Mar 05, 2024 05:49am
- On the 28th, Kolon Life Sciences decided to appeal to the Supreme Court against the manufacturing and sales license revocation ruling that had been made for its knee osteoarthritis cell gene therapy Invossa-K Inj (“Invossa”). In its appeal to the court, Kolon Life Sciences explained, "While we respect the court's decision, we will strive to restore the scientific achievements and value of Invossa, the world's first gene therapy for osteoarthritis, by correcting the misunderstandings that arose regarding the product’s legal principles and safety at the appellate court.” In 2019, Kolon Life Sciences filed an administrative suit to seek the court’s ruling on the illegality and injustice of the MFDS’s decision to revoke Invossa’s marketing authorization but lost both the first and second trials. Kolon Life Sciences acknowledged that there was an error in indicating the origin of the cells for the 2nd liquid, which was the main substance at the time of the application and approval of Invossa. However, since all non-clinical and clinical trials were conducted with the same cells in all stages before its authorization, the company believes the safety and efficacy of Invossa have been verified by the MFDS, and based on which the company plans to continue its vigorous defense in the final appeals following the first and second appeals. Kolon Life Sciences emphasized that the outcome of the administrative proceedings is completely unrelated to the Phase III clinical trial being conducted by Kolon TissueGene in the U.S. and that it decided to proceed with the final trial to correct the misinformation related to Invossa and restore its scientific value. Accordingly, regardless of the outcome of the administrative proceedings, Kolon TissueGene's Phase III clinical trial on TG-C (formerly known as Invossa) in the U.S. is proceeding according to plan. The company is enrolling and dosing 1,020 patients in the U.S., with the last 150 patients enrolled as of January 2024. In addition, TG-C was approved by the U.S. Food and Drug Administration (FDA) in December 2023 to expand its indication to Degenerative Disc Disease (DDD), in addition to being evaluated in Phase II clinical trials for knee osteoarthritis. In October 2023, Kolon Life Sciences was acquitted on appeal in the second trial of a criminal case against company executives who were charged with obstruction of justice against the Ministry of Food and Drug Safety (MFDS), resolving allegations that the company engaged in intentional manipulation and concealment. Long-term follow-up of patients from 2019 to the present has also shown no direct causal relationship between tumor development and treatment with Invossa.
- Company
- Hugel receives FDA approval for its botulinum toxin Letybo
- by Nho, Byung Chul Mar 05, 2024 05:48am
- On the 4th, Hugel, a global total medical aesthetics company, announced that the company has received marketing approval from the U.S. Food and Drug Administration (FDA) on February 29th for 50 units and 100 units of its botulinum toxin Letybo (Korean brand name: Botulax). The FDA approval of Letybo represents a strong affirmation of Hugel's product quality and credibility, as it has met the rigorous standards of one of the world's leading regulatory authorities. It also further underscores the company’s global leadership position. With the approval, Hugel has become the first and only Korean company and one of the top 3 players globally that have obtained market approvals in the 3 major global aesthetic markets—the United States, China, and Europe. To date, it has received marketing approvals in a total of 63 countries and has continued to expand its global coverage. The United States is the world's largest medical aesthetic market, accounting for over 50% of the total market. According to data from global research firms Decision Resource Group and the Boston Consulting Group, the market is expected to continue to grow, by nearly twofold from KRW 3.25 trillion in 2023 to KRW 46.36 trillion by 2031. Hugel is currently in the process of finalizing its market penetration strategy, aiming to commercially launch the product by the middle of this year. The launch of Letybo in Canada last year laid a solid foundation for the company’s entry into the North American market, setting the stage for accelerated penetration into the U.S. market. A Hugel official said, “As a leading global medical aesthetic company, we are delighted to be able to release Letybo in the United States, the world's largest and yet still fast-growing market. We will build on our unparalleled performance and leadership in Korea, as well as our comprehensive academic programs, to add value and differentiate ourselves in the industry."
- Company
- New multiple myeloma Ab ‘Elrexfio’ expects to enter KOR
- by Eo, Yun-Ho Mar 05, 2024 05:48am
- Pfizer Korea ‘Elrexfio,’ a new bispecific antibody to treat multiple myeloma, is expected to become commercially available soon. Pfizer Korea has applied for approval of Elrexfio (elranatamab) last year, and it is currently under review by the Ministry of Food and Drug Safety (MFDS), according to industry sources. Elrexfio is expected to be commercially available in the first half of this year. Last August, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Elrexfio. Elrexfio indication is now approved for patients with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Elrexfio binds bispecific B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T-cells and activates T cells by engaging the cells, resulting in myeloma cell death. It is a BCMA-directed agent that can be administered subcutaneously, with once-weekly dosing and biweekly long-term dosing after 24 weeks of initial treatment. The phase 2 MagnetisMM-3 clinical study demonstrated efficacy of Elrexfio. In the clinical study, Elrexfio showed significant responses as the first BCMA-targeted treatment for patients with relapsed or refractory multiple myeloma who had received many prior therapies. The overall response rate (ORR) of 97 patients with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy before Elrexfio administration was 58%, and approximately 82% of the patients maintained the response for at least nine months. The median first response time was 1.2 months. Furthermore, the FDA has granted ‘Breakthrough Therapy Designation’ and ‘Orphan Drug Designation’ to Elrexfio. It has received conditional approval from the European Medicines Agency (EMA) and is currently under review for approval in South Korea and Japan.
