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- 2026-03-14 00:31:33
- Company
- Power of K-combos...Rosuzet leads outpatient Rx drug market
- by Chon, Seung-Hyun Jul 19, 2023 05:20am
- Hanmi Pharmaceutical’s new combination drug Rosuzet is ruling the outpatient prescription market in Korea. Rosuzet became the first domestically developed drug to lead quarterly outpatient prescriptions sales. Sales of HK Inno.N’s new drug ‘K-cab’ also continued to grow, taking part in the lead owned by domestically developed drugs in the outpatient prescription market. According to the market research institution UBIST, Hanmi Pharmaceutical’s Rosuzet recorded the most in outpatient prescriptions in Q2 with KRW 43.8 billion. Its sales rose 19.5% YoY and overtook the lead in quarterly prescriptions for the first time. Viatris’s Lipitor, which had held the lead until Q1 last year, was overtaken for the first time. By monthly prescriptions, Lipitor’s monthly prescriptions had exceeded Rosuzet’s by KRW 300 million until April. At the time, Lipitor’s posted sales of KRW 14.1 billion and Rosuzet KRW 13.8 billion. However, Rosuzet beat Lipitor (KRW 12.6 billion) by KRW 2.2 billion, posting KRW 14.8 billion in sales from May. Rosuzet maintained a KRW 2.1 billion sales gap with Lipitor with prescription sales of KRW 15.2 billion in June. Rosuzet is the first drug developed by a domestic pharmaceutical company to lead quarterly prescriptions in Korea. Rosuzet, which was released at the end of 2015, is a combination drug for hyperlipidemia that contains rosuvastatin and ezetimibe. Rosuzet has been continuing rapid growth in the market benefitting from its preoccupation of the market and the rising popularity of the statin and ezetimibe combination. Rosuzet’s prescription sales rose twofold in 3 years from KRW 24.9 billion in Q2 2020, continuing strong growth. Rosuzet’s sales exceeded KRW 100 billion for 3 consecutive years from 2020 and reserved the ‘KRW 100 billion sales club’ for the 4th consecutive year by making KRW 85.3 billion in 1H this year. Until this year, Lipitor had never lost its lead. Lipitor maintained its lead until Q1 this year, posting sales of KRW 49.2 billion, which is KRW 7.7 billion more than the second-runner Rosuzet. However, in Q2 this year, prescriptions had dropped 25.1% YoY and fell to 4th place. In 1H, Lipitor recorded KRW 87 billion in cumulative outpatient prescription sales, slightly ahead of Rosuzet (KRW 85.3 billion). Lipitor, which was introduced to the domestic market in 1999, is an atorvastatin-based dyslipidemia treatment. Although it continued to exert a strong influence in the prescription drug market despite the entry of its generics after patent expiry, its growth slowed down recently. HK Inno.N’s new drug K-cab has also continued to make strong sales. K-cab posted sales of KRW 38.5 billion in Q2, up 19.9% YoY and ranking 3rd in outpatient prescriptions. K-cab, which was released in March 2019, is a new -CAB (potassium-competitive acid blocker) class drug for gastroesophageal reflux disease (GERD). It has a new mechanism of action that inhibits gastric acid secretion by competitively binding to the proton pump and potassium ion located in the final stage of acid secretion. K-cab exceeded KRW 100 billion in prescriptions in its 3rd year of release in 2021 and recorded sales in the KRW 100 billion range for 2 consecutive years. K-cab made prescriptions of KRW 74.1 billion in the 1H this year, also heralding a record that exceeds KRW 100 billion won for three consecutive years. In addition to being approved for the treatment of erosive and non-erosive GERD, then gastric ulcer, K-cab acquired additional indications as an antibiotic combination therapy for the eradication of Helicobacter pylori in patients with peptic ulcer and/or chronic atrophic gastritis, and as maintenance therapy after treatment of GERD. Initially, the drug was granted reimbursement for the GERD and gastric ulcer indication among the 5, and was additionally granted reimbursement for the other indications. Therefore, K-cab's sales growth is expected to continue to increase further. Among domestically developed new drugs, Daewoong Bio’s brain function enhancer Gliatamin’s prescriptions rose 26.0% YoY in Q2 to record KRW 38.5 billion and rank 2nd in outpatient presciptions. Gliatamin’s increased its influence in the prescription market despite difficulties faced due to narrowed reimbursement standards, controversy over its efficacy, and the government's order to initiate negotiations to redeem the reimbursed claims amount. Chong Kun Dang Gliatirin, which also contains choline alfoscerate, also continued its high march in Q2, up 14.5% YoY and posting KRW 27.8 billion in prescription sales . Daiichi Sankyo’s anticoagulant Lixiana also sold KRW 25.9 billion in Q2 this year, an 8.6% increase YoY, and ranked among the top. Lixiana’s sales in 1H were KRW 52.4 billion and are expected to exceed KRW 100 billion for the first time in annual prescription sales this year.
- Company
- Will GC Pharma enter the US blood product market in 2013?
- by Chon, Seung-Hyun Jul 19, 2023 12:28am
- GC Pharma has challenged the US immunoglobulin blood product market worth 13 trillion won. For the past 13 years since it officially entered the US market in 2010, it has experienced growing pains such as failure to obtain permits and delays, but has attempted to enter the US market again. According to the industry on the 18th, GC Pharma submitted a BLA for its immunoglobulin blood product ALYGLO to the US Food and Drug Administration (FDA). ALYGLO applied for approval for primary immunodeficiency indication. GC Pharma satisfied all efficacy and safety evaluation parameters according to FDA guidelines in the North American phase 3 clinical trial completed in 2020. In the phase 3 clinical trial, ALYGLO was administered to 48 patients with primary immunodeficiency for 12 months, and the efficacy and safety were confirmed. ALYGLO is a liquid-type immunoglobulin preparation purified from plasma fractions. It is used to treat primary immunodeficiency diseases such as congenital immunodeficiency syndrome and immune thrombocytopenia. According to GC Pharma, the US immunoglobulin market is estimated at about 12.5 trillion won. With the recent increase in autoimmune diseases, the demand for immunoglobulins is continuously increasing. GC Pharma explained, “The blood product, which requires large-scale facility investment and advanced production experience, is known to frequently have a supply shortage because producers are very limited.” It is the confidence that ALYGLO will be able to secure sufficient market competitiveness if it enters the US market. This is the third attempt by GC Pharma to apply for FDA approval for a blood product. GC Pharma applied for approval of the IVIG-SN 5% product to the FDA at the end of 2015. FDA approval was expected at the end of 2016, but in November 2016, the FDA pointed out that the manufacturing process-related data should be supplemented. In September 2017, GC Pharma's approval was delayed again due to a request for additional supplementation of manufacturing process data. GC Pharma planned to enter the US market first with 5% products and later with 10% products undergoing clinical trials. However, as the approval of the 5% product was delayed, the company changed its strategy to release the 10% product, which has greater marketability, to the US market first. GC Pharma completed phase 3 clinical trials in North America for IVIG-SN10% ALYGLO in 2020 and submitted an application for product approval to the FDA in February 2021. However, in February of last year, it received a notice from the FDA to postpone the approval of the product. Due to the COVID-19 situation, a non-face-to-face evaluation was conducted in the fourth quarter of 2021, but the FDA decided to postpone the approval because of the need for an on-site inspection of the production facility. From April 17th to 28th, the FDA inspection team conducted an inspection of production facilities and quality systems such as fractionation, stagnation, and finished products of IVIG-SN at GC Pharma's Ochang plant. After completing the GMP inspection of the Ochang plant, GC Pharma resubmitted an application for permission after consulting with the FDA. The FDA's product approval process goes through a preliminary review after receiving the BLA, sets a target date for completion of the review, and starts the review process in earnest if the data is appropriate. A GC Pharma official said, “We are aiming to obtain product approval early next year and launch it in the US market in the second half of the year.” He said, “We will become a global leader in blood products based on our entry into the US market in the future.” If GC Pharma receives FDA approval for ALYGLO, it will enter the US market for the first time since its foundation. Yearly sales of Green Cross blood products (left) and percentage of sales (right) (unit: KRW 100 million, %, source: Financial Supervisory Service) Blood products, including immunoglobulins, are GC Pharma's core business areas. Last year, GC Pharma's blood product sales amounted to 420.4 billion won, accounting for 23.7% of the company's total sales. GC Pharma's blood product sales grew only 12.4% over the past 9 years from 341.5 billion won in 2013. Sales of blood products last year fell short of 429.6 billion won in 2019 and 425.4 billion won in 2018. The share of blood products in GC Pharma's sales reached 43.0% in 2013, but fell to the 30% level in 2014 and fell to the 20% level from 2020. Over the past nine years, the sales portion of blood products has declined by 19.4%. Blood product export growth is slow. Last year's GC Pharma blood product export performance was 90.9 billion won, up 48.3% from the previous year. However, considering that blood product exports recorded more than 100 billion won for four consecutive years from 2017 to 2020, a breakthrough in overseas markets is urgently needed. GC Pharma recorded 90.9 billion won in exports of blood products last year. If ALYGLO enters the US market, the proportion of overseas sales is expected to increase. In 2010, GC Pharma announced the entry of blood products into the US market. GC Pharma signed a contract with ASD Healthcare in 2010 to export blood product IV Globulin SN and hemophilia treatment GreenGene F worth a total of $480 million over three years. However, when the clinical trial period was delayed than originally planned, the memorandum of understanding with ASD Healthcare was also terminated in September 2015. GC Pharma also faced setbacks in its hemophilia treatment plan to enter the US market. In October 2016, GC Pharma decided to suspend the US clinical trial of GreenGene F, a recombinant hemophilia A treatment that is undergoing phase 3 clinical trials in the US. In 2012, it announced its withdrawal after 4 years of entering phase 3 clinical trials. The reason for the discontinuation of clinical trials in the United States was pointed out as “deterioration in business feasibility.” Due to the nature of rare diseases, the recruitment of new patients was slow, leading to delays in clinical trials and the emergence of competitive drugs with long duration of action. Due to GC Pharma's delay in entering the US market, the blood product supply strategy has also changed. Initially, GC Pharma sought to enter the blood product market through a local plant in North America. Green Cross Holdings spent 210 million Canadian dollars (about 187 billion won) in 2017 to complete the blood product plant in Montreal, Quebec, Canada. The plant, built on a land area of 63,000 square meters, has a process for producing blood products such as IV Globulin and albumin by fractionating up to 1 million liters of plasma per year. However, the North American subsidiary was liquidated as the US approval of IVIG-SN, a blood product, was delayed more than expected. In July 2020, Green Cross Holdings sold two of its North American blood products affiliates to Spain's Grifols, the world's largest blood products company, for a total of $460 million. GCBT (Green Cross BioTherapeutics), a subsidiary of Green Cross North America (GCNA), was sold for 189.1 billion won, while another US subsidiary, GCAM (Green Cross America), was also handed over. GCBT is a blood derivatives plant built by GC in Canada. GCAM is a corporation that supplies plasma in the US. It has 12 blood centers in the US. Initially, a structure in which GCBT would produce blood derivatives with raw plasma made from blood secured by GCAM was conceived, but the business strategy was drastically revised in consideration of the uncertainty caused by changes in business conditions. In the case of GCBT in Canada, although facility investment has been completed, it has been receiving manpower and technical support from GC Pharma's headquarters for commercial operation since 2018 due to a lack of local bio-production process experts. In this situation, as Grifols actively sought out the acquisition, the sale was carried out in a flash. GC Pharma is said to have recovered most of its investments in GCBT and GCAM. If ALYGLO obtains FDA approval, it will be produced at GC Pharma's Ochang plant and sold through GC Biopharma USA, a US GC Pharma subsidiary. A GC Pharma official said, "Immune globulin use in the United States is expected to increase further due to the increase in autoimmune diseases due to the aging population and improved awareness of the diagnosis and treatment of congenital immunodeficiency syndrome." “We expect to improve the situation of limited product supply,” he predicted.
- Company
- GC Pharma, reapplying to FDA for approval of immunoglobulin
- by Chon, Seung-Hyun Jul 19, 2023 12:20am
- Green Cross Ochang Factory GC Pharma planned to enter the US market first with 5% products and later with 10% products undergoing clinical trials. However, as the approval of the 5% product was delayed, the company changed its strategy to release the 10% product, which has greater marketability, to the US market first. GC Pharma completed phase 3 clinical trials in North America for IVIG-SN10% 'ALYGLO' in 2020 and submitted an application for product approval to the FDA in February 2021. However, in February of last year, it received a notice from the FDA to postpone the approval of the product. Due to the COVID-19 situation, a non-face-to-face evaluation was conducted in the fourth quarter of 2021, but the FDA decided to postpone the approval because of the need for an on-site inspection of the production facility. From April 17th to 28th, the FDA inspection team conducted an inspection of production facilities and quality systems such as fractionation, stagnation, and finished products of IVIG-SN at GC Pharma's Ochang plant. A GC Pharma official said, “We are aiming to obtain product approval early next year and launch it in the US market in the second half of next year.
- Company
- FDA accepts NDA for HLB’s rivoceranib
- by Lee, Seok-Jun Jul 18, 2023 05:29am
- HLB’s hepatocellular carcinoma treatment ‘rivoceranib’ has now entered FDA’s review. Yang-Gon Jin, Chairman of the HLB Group, announced on the morning of the 17th that “HLB’s US subsidiary Elevar received an ‘NDA Filing Acceptance’ letter from the FDA.” Elevar submitted a new drug application (NDA) for rivoceranib on May 16 after completing a global Phase III study evaluating the efficacy and safety of rivoceranib+camrelizumab therapy. The FDA assigned a target action date of May 16, 2024, under the Prescription Drug User Fee Act (PDUFA). Therefore, the decision will be made for the new drug within 10 months. With the FDA’s acceptance of the NDA, the company plans to accelerate preparations for commercialization, such as expanding drug sales licenses and establishing joint marketing execution strategies. Also, the company is preparing for the on-site scheduled on-site FDA CMC (Chemical Manufacturing and Controls) inspection together with Jiangsu Hengrui Medicine. HLB holds the global patent for the targeted anticancer therapy rivoceranib. HLB Life Sciences holds the sales rights for rivoceranib in Korea and partial profit rights for the drug in Europe and Japan. Jiangsu Hengrui Medicine owns the sales rights in China. Elevar Therapeutics, Inc. holds global rights in all other regions.
- Company
- Boehringer Ingelheim releases SGLT2+DPP4 combo Esgliteo
- by Jung, Sae-Im Jul 18, 2023 05:29am
- On the 17th, Boehringer Ingelheim announced it had launched its type 2 diabetes treatment ‘Esgliteo (empagliflozin+linagliptin)’ in Korea. Esgliteo is a fixed-dose combination of Boehringer Ingelheim’s original SGLT-2 inhibitor ‘Jardiance (empagliflozin)’ and DPP-4 inhibitor ‘Trajenta (linagliptin). The company developed a small-sized drug – 8.1mm in diameter - to improve the convenience in intake and medication adherence for patients that difficulty taking pills. Two options - 10mg/5mg, and 25mg/5mg – of Esgliteo are offered for patients who need further blood sugar control. Esgliteo is now the only fixed-dose dual combination drug of an SGLT2 inhibitor and DPP-4 inhibitor that was released in Korea with reimbursement. Esgliteo demonstrated a superior blood sugar-lowering effect as well as therapeutic benefit that exceeds the effect shown by each individual ingredient. The complementary mechanism of action allows the combination drug to provide an excellent blood sugar control effect. According to a Phase III clinical trial, Esgliteo showed an improved blood glucose reduction effect at 24 weeks compared to empagliflozin and linagliptin monotherapy in type 2 diabetic patients who experienced insufficient glycemic control on metformin. After the Ministry of Health and Welfare issued a notification on its reimbursement, Esgliteo was listed and granted reimbursement from May 1st. Type 2 diabetes patients whose HbA1c is 7% or higher after using a two-drug regimen for over 2-4 months can use Esgliteo with reimbursement if he or she wishes to use it as part of a three-drug regimen that includes metformin. Ina Hwang, Head of Marketing at Boehringer Ingelheim Korea, said, ” In line with the rising importance of combination therapy for Type 2 diabetes, We are pleased to be able to offer Esgliteo, which offers the treatment benefits of both active ingredients with improved convenience in intake for Type 2 diabetes patients in Korea.”
- Company
- SGLT-2i Envlo may be prescribed at general hospitals
- by Eo, Yun-Ho Jul 18, 2023 05:29am
- Daewoong Pharmaceutical’s SGLT-2 inhibitor, ‘Envlo’ can be prescribed at general hospitals in Korea. According to industry sources, the diabetes treatment Envlo (Enavogliflozin) that was released with reimbursement in May passed the drug committees (DCs) of various medical institutions in Korea including the Samsung Medical Center and Korea University Anam Hospital. Envlo, which was approved as the 36th new homegrown drug, is the first SGLT-2 inhibitor class diabetes drug that a Korean pharmaceutical company succeeded development and localization of. Priced at KRW 611, Envlo may be used as ▲monotherapy, ▲metformin combination therapy, and metformin and gemigliptin combination therapy in Korea. At a dose of 0.3mg, which is 1/30th the dose of other same-class treatments, Envlo demonstrated more than equivalent blood glucose-lowering effects and safety. Also, the drug was found to improve cardiovascular risk factors such as weight, blood pressure, and lipids. The company has applied for the DC review for Envlo at various major medical institutions around the nation and plans to further extend its prescription area in the future. Meanwhile, Daewoong Pharmaceutical received marketing approval for its envagliflozin+metformin combination, ‘Envlomet ST Tab.’ recently. In line with Korea’s trend that expands the use of SGLT-2 inhibitors, the company is preparing an Envlo-based combination drug lineup for diabetes as well.
- Company
- MSD Korea expands ERP to all departments
- by Jung, Sae-Im Jul 17, 2023 05:30am
- MSD Korea, which had notified the closure of the General Medicine division that sold the diabetes treatment Januvia, has extended the conditions for its early retirement program (ERP). With the company’s large-scale layoff raising conflicts with employees and the low rate of applications, the company seems to have changed its tactics to reshuffling. According to industry sources on the 15th, MSD Korea announced introduced a broader ERP program that allows a wider range of subjects to apply for early retirement with expanded conditions. The changed conditions allow employees from all departments, not only the General Medicine division but all divisions. The excess severance pay was also raised to a maximum of KRW 120 million. As excess severance pay, employees that served ▲ less than 5 years will receive KRW 70 million, ▲ 5 years or over will receive 100 million, and ▲ 15 years or over will receive KRW 120 million. In addition, 20 early applicants will additionally receive KRW 10 million. For example, if an employee who has worked for 15 years applies for ERP, he or she will receive an additional KRW 120 million as excess severance pay, equivalent to 40 months’ worth of monthly basic salary. If he or she is an early applicant, he or she will receive up to KRW 130 million. This is the highest amount offered in the industry. The previous conditions for ERP presented by MSD Korea were ▲an employee in the GM division, ▲basic severance pay of 2n+10 (service year*2+10 months of basic monthly pay), ▲ basic severance pay limit set as 48 months, and ▲excess severance pay of KRW 200 million. The conditions of being ▲an employee in the GM division and ▲excess severance pay of KRW 200 million conditions were extended significantly. The application deadline is July 20th. The resignation date of GM unit employees will be July 31st, and others August 31st. GM employees who applied for voluntary retirement through ERP last month will also benefit from the raised standards. In addition, they will be paid an additional 10 million won regardless of whether they applied early or not. On the reason the background of why the ERP was expanded, MSD Korea said, "After the decision was made to close our GM business, we have been seeking the best way to support our employees. Ahead of the organizational restructuring that will take place on August 1st, we carefully reviewed the opinions and suggestions of our various employees and decided to expand the ERP and severance package. We have been carrying out an external career support program while offering an improved ERP package for our internal business organizations and CO (Commercial Operations) units from July 10th to 20th,”
- Company
- BsAb lymphoma treatment Lunsumio will soon land in KOR
- by Eo, Yun-Ho Jul 17, 2023 05:30am
- The new bispecific antibody treatment for lymphoma, ‘Lunsumio’, will soon land in Korea. According to industry sources, the Ministry of Food and Drug Safety is in its last stages of review for the product approval of Roche Korea's follicular lymphoma drug Lunsumio (mosunetuzumab), which was designated as the first drug subject to Korea’s Global Innovative products on Fast Track (GIFT) system. Lunsumio was approved by the US Food and Drug Administration in December last year for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. The drug is a CD20xCD3 T-cell engaging bispecific antibody that binds to two different targets on cells - the immune T-cells that attack tumor cells and malignant B cells - to connect the immune cells with cancer cells. In Korea, the drug was designated as an orphan drug last year and was also designated an orphan drug by the US FDA and the EU EMA. Lunsumio demonstrated its potential through positive results from the Phase II GO29781 study of Lunsumio in people with follicular lymphoma. Study results showed that Lunsumio’s ORR was 80%(72/90), and the majority (57%) of patients maintained responses for at least 18 months. A complete response of 60% (54/90) was also observed in these patients with a median duration of response (DOR) was 22.8 months. Meanwhile, the GIFT program provides support from the initial development stage of innovative new drugs to allow faster commercialization of new drugs. The program may allow drugs to reduce the approval review period by up to 75%. Drugs subject to GIFT can receive various support that accelerates commercialization, including ▲support for regulatory approval, ▲rolling review, ▲close communication between the reviewer and developer through product presentation and supplementary briefing sessions, and ▲expert consulting by regulation experts.
- Company
- Danicopan has been designated for GIFT
- by Eo, Yun-Ho Jul 17, 2023 05:30am
- Danicopan, a combination partner of Soliris, was designated as a GIFT at the same time as this orphan drug designation. The Ministry of Food and Drug Safety recently announced that AstraZeneca's Danicopan (ALXN2040) will be designated as an orphan drug and GIFT in Korea. Danicopan, a candidate for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), has been designated as an orphan drug for PNH treatment in the United States and Europe and has been selected as a breakthrough therapy by the US FDA and as a PRIME target by the European EMA. Danicopan demonstrated efficacy as a potential complementary treatment in patients with PNH who experienced clinically significant extravascular hemolysis in the phase 3 ALPHA study. This is the first case in which factor D inhibitors have confirmed positive effects in phase 3 clinical trials. A prespecified interim analysis compared hemoglobin levels with a placebo after 12 weeks of treatment, resulting in a statistically significant improvement. According to the study, Danicopan and Ultomiris combination therapy showed statistically and clinically significant improvement in treatment parameters. These indicators include improvements in hemoglobin levels, blood transfusions, and fatigue scores, and a functional evaluation of chronic disease treatment, from the start of treatment. Danicopan is conducting research on combination therapy for C5 inhibitors, such as Soliris and Ultomiris. Lee Jong-Wook, a professor of hematology at Seoul St. Mary's Hospital who participated in the ALPHA study, explained, "The therapeutic effect of C5 inhibitors on PNH has been proven. However, although the number is small, patients still suffer from the burden of blood transfusion due to anemia and extravascular hemolysis." Meanwhile, GIFT is a program that supports innovative drugs from the beginning of clinical development so that they can be commercialized quickly, and can shorten the approval review period by up to 75%. GIFT recipients will receive support for rapid commercialization, such as support for the preparation of approval materials, application of a rolling review that reviews prepared materials first, close communication between reviewers and developers such as item briefings and supplementary briefings, and professional consulting related to regulations.
- Company
- "Cibinqo secures solid data in atopic dermatitis"
- by Jung, Sae-Im Jul 13, 2023 05:35am
- 'Cibinqo (abrocitinib),' the third JAK inhibitor to be introduced for atopic dermatitis in Korea, will be reimbursed starting this month. Healthcare professionals have expressed high expectations for Cibinqo, as the drug has accumulated robust data in treating severe atopic dermatitis. On the 11th, the Korean pharmaceutical company Hanmi Pharmaceutical held a press conference to celebrate the reimbursement of Cibinqo, an oral atopic dermatitis treatment, at the Seoul Dragon City Hotel in Yongsan-gu, Seoul. Professor Yong-Hyun Jang of the Department of Dermatology at Kyungpook National University Hospital explained the background and significance of Cinbinqo's reimbursement for atopic dermatitis in Korea. Professor Yong-Hyun Jang of the Department of Dermatology at Kyungpook National University Hospital is presenting at the press conference celebrating the reimbursement and listing of Cibinqo Cibinqo is a Janus kinase 1 (JAK1) inhibitor that was approved by the Ministry of Food and Drug Safety in November 2021. It is also the 4th JAK inhibitor in Korea and 2nd JAK class treatment to be introduced by Pfizer. Unlike Xeljanz, which is used only for ulcerative colitis, Cibinqo can also be used for the treatment of severe atopic dermatitis. Cibinqo was granted reimbursement this month. The 50mg, 100mg, and 200mg doses of Cibinqo were listed at KRW 11,087, 17,739, and 25,942 respectively. The ceiling price is known to be set at 88% of the calculated average price of its substitutes. With the listing of Cibinqo, patients with severe atopic dermatitis now have a much wider range of new treatment options. In addition to the biological agent ‘Dupixent’ that was first introduced, 3 JAK inhibitors – the already-reimbursed Olumiant (baricitinib) and Rinvoq (upadacitinib), and Cibinqo – are now available for use in Korea. Among these treatments, Dupixent, Rinvoq, and Cibinqo can be used in adolescent patients aged 12 and above. Although being a latecomer, Cibinqo received recognition for having acquired solid data in atopic dermatitis from various clinical trials. 6 Phase III clinical trials, including JADE DARE, JADE COMPARE, and JADE TEEN, have been conducted. Cibinqo was the first drug that attempted to directly compare (head-to-head) its efficacy and safety with the biological agent Dupixent, and Cinbinqo was observed for the possibility of deterioration upon dose reduction or discontinuation of treatment after initial response, and evaluated on its ability to recover from the reaction. By confirming the drug’s effect on patients that showed no response to Dupixent, the company accumulated grounds for patients to switch to Cibinqo. The rapid improvement of itch, which was observed in various clinical trials of Cibinqo, is expected to significantly improve patient’s quality of life. Jang explained, "Itch is a very important symptom in atopic dermatitis. It causes patients to scratch their skin, weakens the skin barrier, and exacerbates inflammation as a secondary reaction. Cibinqo showed a rapid and significant improvement in itch from the day after initial administration, increasing patients' quality of life. Also, more patients reached the target response rate for the Eczema Area and Severity Index (EASI). We believe Cibinqo will benefit patients who are suffering from severe itch." Cibinqo has also demonstrated additional benefits in patients who did not respond to Dupixent. The JADE EXTEND study investigated the effect of switching to Cibinqo from Dupixent in patients who received Dupixent in the JADE COMPARE study. The patients were further divided into those that responded to Dupixent and those that didn’t respond to Dupixent. In the arm that did not respond to Dupixent, 80% achieved EASI-75 (75% improvement based on the Eczema Area and Severity Index). Also, 77% achieved an improvement of 4 points or more on the Peak Pruritus Numerical Rating Scale (PP-NRS). This is expected to serve as evidence when companies of JAK inhibitors apply for reimbursement extensions to cover patients switching from Dupixent. Jang stated, "Unlike other JAK inhibitors, Cibinqo holds significance as it conducted various studies solely in the field of atopic dermatitis, which is significant. With the basis for switching treatments established, we expect reimbursement extensions to follow in the near future. We are currently collecting various opinions in academia as well.”
