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- 2026-04-03 22:55:23
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- AstraZeneca Korea recertified Innovative Pharma Company
- by Whang, byung-woo Jan 07, 2025 06:05am
- AstraZeneca Korea announced today that it has successfully extended its certification as a 2024 Innovative Pharmaceutical Company by the Ministry of Health and Welfare. This marks the third consecutive recertification since the company was first certified in 2018, and recognizes the company's steady R&D investments and achievements made through global collaborations. With the extension, AstraZeneca Korea will be maintaining its status as an Innovative Pharmaceutical Company for another three years, until 2027. The Innovative Pharmaceutical Company certification system, which is organized by the Ministry of Health and Welfare, is based on the ‘Special Act on Fostering and Supporting the Pharmaceutical Industry,’ which reviews companies with high R&D investment ratios and excellent performance in developing new drugs. Certified companies can receive various support, including points for R&D support, preferential drug pricing, and tax benefits. Through its Open Innovation strategy, AstraZeneca Korea has been strengthening its collaboration with local researchers and companies to contribute to the development of the Korean pharmaceutical industry. In particular, the approval of durvalumab for the first-line treatment of biliary tract cancer in 2022 resulted from clinical trials led by local researchers and is considered a successful global collaboration model. Also, AstraZeneca Korea was recognized for its rapid response to the health crisis during the COVID-19 pandemic. The company invests around 20% of its annual revenue in clinical research, with more than 180 clinical studies underway in Korea. In addition, the company has continued to invest in R&D by conducting clinical trials on next-generation innovative drugs such as antibody-drug conjugates (ADCs), radioconjugates, and cell gene therapies in Korea. “The extension of the Innovative Pharmaceutical Company certification is an achievement of our long-standing collaboration with the Korean healthcare industry,” said Sehwan Chon, Country President of AstraZeneca Korea. ”We will continue to work closely with Korean research institutes and companies to create a patient-focused healthcare ecosystem and expand our innovative pipeline.” Chon added, “We look forward to further collaborating with the government, academia, and industry to raise the global profile of Korea's healthcare industry.”
- Product
- Will doctor-pharmacist conflict reignite?
- by Kim JiEun Jan 07, 2025 06:05am
- With candidate Joo Soo-ho, who advocates for the selective dispensing of drugs, advancing to the runoff election for the new president of the Korean Medical Association, a potential conflict between the medical community and the pharmaceutical association is expected. In the 43rd presidential election of the Korean Medical Association, which was held on Thursday, candidates Taek-woo Kim (No.1) and Soo-ho Joo (No.3) advanced to the runoff. As neither candidate received a majority of the votes, a runoff election will be held on the 7th and 8th to determine the final winner. The Korean Pharmacists Association is paying close attention to the outcome of this election. Depending on which candidate wins the election, the relationship between the medical association and the pharmacists’ association may change in the future. The current KPA executives, under Kwang-Hoon Choi, have not been at odds with the KMA. The previous KMA executives, led by Pil-Soo Lee, had also a relatively peaceful relationship with Choi’s KPA executives. When Lee stepped down earlier this year, the election of Hyun-Taek Lee, who had been at odds with KPA, created a tense atmosphere, but Lim, who focused on doctor-government conflicts, was eventually impeached and forced to leave his post early. With the KMA holding an early election due to the retirement of the previous president, the timing of the inauguration of the new KPA and KMA coincided, and attention was focused on the change in the tide between Young-hee Kwon’s executives and the new KMA executive. The medical community is wary of Kwon, who has been advocating for the introduction of International Nonproprietary Name prescription during her service as president of the Seoul Pharmaceutical Association. One after another, candidates for the presidency of the Korean Medical Association have voiced their opposition to Kwon's core campaign promise and long-awaited initiative. In particular, candidate Soo-ho Joo, who was selected as a runoff voter in the first round of the election, is noted for his stance against INN prescriptions and the need to introduce a selective dispensing system. “It is unfair for doctors to be held responsible for any accidents that may occur from the pharmacists’ choice of generic drugs from random pharmaceutical companies,” said Joo in a recent position paper, adding, ”The most effective way to minimize public inconvenience and reduce health insurance financial leakage by reducing dispensing fees is the selective dispensing system.” “We need to fix the wrong system and eliminate unsustainable systems. We already know what we need to change: the mandation of long-term care institutions, a single-payer insurance system, and the separation of prescribing and dispensing. We already know what we need to change. Now it's just a matter of taking action.” If Joo is ultimately elected president of the KMA, he is likely to be at odds with the Kwon and her KPA administration. It is also expected to have an impact on the bills currently in the National Assembly related to the activation of generic substitution and INN prescriptions. Currently, there is a bill introduced by Representative Yoon Kim to introduce INN prescribing for drugs with unstable supply and demand, as well as a bill to activate generic substitution by Representative Byung-Deok Min. “As Kwon has presented INN prescription as one of her key pledges for the presidential election, she will have no choice but to speak out and move to promote the policy,” said a pharmaceutical industry insider. ”INN prescriptions are unacceptable to the medical community. So if the militant candidate wins the KMA election, he may create a conflict with the KPA in the future. It will be important to see how Kwon can convince the government and the public despite the opposition from the medical community.”
- Opinion
- [Reporter's View] Switching of drugs reimbursable
- by Eo, Yun-Ho Jan 06, 2025 05:57am
- When a patient chooses one medication and switches to another, reimbursement does not cover the latter. Non-reimbursable drug switching has been a long-standing issue in South Korea. At the end of last year, a long-standing issue in one field was resolved. The Ministry of Health and Welfare (MOHW) granted approval for drug switching for patients with rheumatoid arthritis who discontinued treatment because of a lack of response to either tumor necrosis factor-alpha (TNF-α) inhibitors or JAK inhibitors. It is a victory. Until now, the government has been stating that reimbursement would be challenging because of the lack of clinical evidence relating to JAK inhibitor drug switching. However, organizations like the Korean College of Rheumatology have continuously submitted reports and evidence about prescription practices of drug switching. Ultimately, the government reconsidered the issue and reached a favorable decision. At that time, the MOHW stated, "The MOHW has decided to provide insurance coverage for drug switching between JAK inhibitors in the treatment of rheumatoid arthritis after referencing approval cases in both South Korea and overseas, textbooks, guidelines, clinical research articles, and academic (experts) consultations. However, an issue is still remaining. Concerns persist regarding drug switching between JAK inhibitors for atopic dermatitis. When a patient uses biological agents, such as interleukin-based agents, or oral agents, such as JAK inhibitors, and then switches to another medication, reimbursement is no longer provided. Even if a patient experiences side effects during the course of the initial treatment and does not benefit from the treatment, one cannot easily switch to another medication. Like drug switching for rheumatoid arthritis, drug switching for atopic dermatosis may lack direct clinical evidence. However, clinical practices have been suggesting opinions on this matter. The Korean Atopic Dermatitis Association submitted an opinion report to the MOHW requesting drug switching to be covered with reimbursement when treating atopic dermatitis. Furthermore, the association clarified that there are no differences in therapeutic status between biologic agents and oral medication through the guideline revision made in 9 years. Ultimately, at the end of last year, the government resumed reviewing reimbursement coverage for atopic dermatitis drug switching. The time is ticking. It is important that the government decide quickly on a result that the majority can agree to. If the government hesitates, it will take a long time. Furthermore, companies must put efforts into increasing the volume of use and finance.
- Policy
- Zolgensma shows 94% effect during post-evaluations
- by Lee, Tak-Sun Jan 06, 2025 05:56am
- The spinal muscular atrophy (SMA) treatment Zolgensma (onasemnogene abeparvovec) showed promising results suited to its high price. The use of the once-daily, one-shot treatment, which has an insurance cap set at KRW 2, requires a post-marketing evaluation to measure its cost-effectiveness. According to industry sources on the 5th, Zolgensma Inj was approved for reimbursement in August 2022 and was administered to 21 patients by November last year, 18 of whom have received outcome evaluations. 17 of the 18 patients showed significant improvement, with 1 patient failing to receive the drug due to death. The Health Reviews and Assessment Service recently released the results of the Zolgensma Inj performance evaluation that contained the results above. The performance evaluations for Zolgensma Inj are conducted before dosing and every 6 months following administration for up to five years. Failure was defined as: a) permanent ventilation or death; b) CHOP-INTEND score not improving by at least 4 points from pre-dose baseline; or c) a decrease in CHOP-INTEND of at least 4 points or HFMSE of at least 3 points on two consecutive response assessments, even if the b) improvement was achieved. However, a significant improvement after treatment was considered to have occurred if there was an increase in motor function test scores, even if the patient’s outcome falls within the criteria for treatment failure. Spinal muscular atrophy is a genetic disorder caused by problems in the part of the nervous system that controls the movement of the voluntary muscles. Zolgensma is designed to deliver a functional copy of the SMN1 (survival motor neuron 1) gene into cells via transfection. It promotes the survival and function of the transgenic motor neurons by alternatively expressing the SMN protein in the motor neurons. The majority of patients receiving Zolgensma are infants less than 24 months old. The 9 additional outcomes reported by the panel were also all infants at 24 months of age. Eight of these patients showed significant improvement from 12 to 24 months. One patient showed a decrease in HFMSE of more than 3 points at the 24-month evaluation and was required to confirm motor function via HFMSE at the next review, and if necessary, submit video evidence to confirm the HFMSE score. A total of 21 patients had received Zolgensma Inj by November of last year when the post-evaluation was conducted, the agency said. Of these, the results of 18 patients were disclosed because 3 are yet to receive the 6-month post-evaluations. One of the 18 patients showed treatment failure with death, and 17 showed significant improvement, rendering the effectiveness rate to 94.4%. As high as the drug’s price is, with an insurance price ceiling set at KRW19.817,269, the drug has been showing a clear effect. The patient’s out-of-pocket cost for the drug is KRW 5.98 million (10% coinsurance rate) for a single dose with health insurance.
- Company
- 1st RSV preventive inj 'Beyfortus' can be prescribed
- by Eo, Yun-Ho Jan 06, 2025 05:56am
- Product photo of Beyfortus The first injectable antibody drug approved in South Korea to prevent respiratory syncytial virus (RSV), 'Beyfortus,' is now available for prescription at general hospitals. According to industry sources, Sanofi Korea's Beyfortus (nirsevimab) has passed the drug committees (DC) of medical centers, including Seoul National University Hospital, Cha University Gangnam Medical Center, Korea University Anam Hospital, Korea University Ansan Hospital, Cha University Bundang Medical Center, and Pusan National University Yangsan Hospital. Beyfortus was approved by the Ministry of Food and Drug Safety (MFDS) in May as an injectable antibody to prevent RSV. It can be administered to all newborns and infants during their first RSV season. Beyfortus can also be given to infants under 24 months who are at high risk for severe RSV disease during their second RSV season. The Phase 3 MELODY study, which was the basis of Beyfortus approval, showed that the lower respiratory infection by RSV was reduced by 74.5% in the Beyfortus-treated group. This study evaluated the effectiveness of Beyfortus in 3012 infants born after 35 weeks during their first RSV season. The effectiveness in preventing RSV infections requiring medical attention was assessed until 150 days after the Beyfortus administration. Based on the Beyfortus real-world evidence demonstrated in the interim results from the national immunization program in Galicia, Spain, infants six months or younger who were administered Beyfortus had an 82% reduction in hospitalization due to RSC compared to non-administered infants. "Individuals of all ages can be contracted with RSV, but 90% of infants under 2 years old become infected. When infected, a mild cold symptom can advance to lung infections, possibly leading to hospitalization," Ki Wook Yun, Professor of Seoul National University College of Medicine, explained. "When infants without completely developed bronchial tubes contract RSV, symptoms can be worse. It could result in socioeconomic loss in addition to affecting family members." Yun added, "Since taking care of one's hygiene was the only RSV prevention available, there were unmet needs for RSV prevention. With the availability of injectable antibody drug, active RSV prevention is expected to be possible."
- Company
- Balversa may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Jan 06, 2025 05:56am
- The new bladder cancer drug Balversa may now be prescribed in Korea’s Big 5 tertiary hospitals in Korea. According to industry sources, Janssen Korea's FGFR-inhibiting urothelial carcinoma (bladder cancer) drug Balversa (erdafitinib) recently passed the drug committees (DCs) of tertiary hospitals including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. In addition, the drug’s prescription codes have been generated at major medical institutions across the country, including Kangnam Sacred Heart Hospital, GangNeung Asan Hospital, Hallym University Kangnam Sacred Heart Hospital, National Cancer Center, Keimyung National University Hospital, Ulsan National University Hospital, Korea Cancer Center Hospital, and Chonnam National University Hwasun Hospital. Balversa was approved by the Ministry of Food and Drug Safety in January 2022, but it is still not reimbursed in Korea. But expectations have been rising since Janssen submitted a reimbursement application for Balversa at the end of last year. As such, it remains to be seen if Balversa will be reimbursed by the end of the year and become a viable treatment option in Korea. Specifically, the drug is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with FGFR2 or FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy, which includes platinum-based chemotherapy, or whose disease has progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. However, the approval of PD-1 and PD-L1-directed immuno-oncology agents in the first- and second-line settings that followed Balversa’s approval led to the need for Balversa to demonstrate efficacy in patients who previously received these agents. The situation was addressed with the publication of Balversa’s Phase III THOR trial study, which demonstrated a prolonged overall survival (OS) benefit with Balversa over chemotherapy in patients with metastatic urothelial carcinoma with FGFR3/2 gene alterations whose disease progressed after first-line treatment with immuno-oncology agents. In the study, Balversa prolonged overall survival (OS) compared with chemotherapy in patients with metastatic urothelial carcinoma. Results showed that over a median follow-up of 15.9 months, the mOS was 12.1 months in the Balversa arm, reducing the risk of death by 36% compared with the 7.8 months in the chemotherapy arm. Based on these findings, the U.S. Food and Drug Administration granted Balversa formal approval in January, but with a more restricted indication than originally approved. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) also recently recommended expanding Balversa’s indication. Janssen Korea has additionally submitted the results from the THOR study to Korea’s Ministry of Food and Drug Safety. Therefore, the company may start the reimbursement progress in earnest for Balversa in the second half of the year. Therefore, it remains to be seen whether Balversa will be able to go beyond landing in medical institutions and gain insurance reimbursement in Korea. Meanwhile, bladder cancer is one major cancer that has lacked a targeted therapy option. Balversa is the first targeted anti-cancer drug for bladder cancer with a novel mechanism of action that inhibits fibroblast growth factor receptor (FGFR). FGFR is a biomarker involved in cancer cell growth that is associated with various cancers. FGFR mutations are particularly common in bladder cancer, with 20 to 30% of patients carrying mutations.
- Policy
- MFDS’s 2nd GIFT drug Nefecon applies for reimbursement
- by Lee, Tak-Sun Jan 06, 2025 05:56am
- Nefecon (micronized budesonide), the only drug approved by the U.S. FDA to treat lgA (immunoglobulin A) nephropathy, has applied for domestic health insurance reimbursement coverage in Korea. The drug was approved in November last year as its 2nd GIFT (Global Innovative Drug Fast Track) drug, MFDS’s fast track program. According to industry sources on the 3rd, the application for reimbursement determination of Nefecon enteric capsules 4 mg was recently submitted to the Health Insurance Review and Assessment Service. Nefecon is a drug used to treat primary IgA nephropathy in adults with a urinary protein-to-creatinine ratio of 1.5 or greater who are at risk of rapid progression. The drug was approved by the US FDA last year under the brand name Tarpeyo in December 2021 as the first and only IgA nephropathy treatment. The drug was developed by Calliditas Therapeutics AB based in Sweden. Everest Medicines has exclusive rights for the drug’s sale in Korea and China, Hong Kong, Macau, Taiwan, and Singapore through an exclusive license agreement with the original developer. Budesonide, the active ingredient, is commercially available in Korea. It is used for asthma, chronic obstructive pulmonary disease, and allergic rhinitis under the trade names Pulmicort and others. The original developer repurposed the ingredients and developed it for the first time as a treatment for IgA nephropathy. IgA nephropathy is a disease that occurs when immune complexes including IgA are deposited in the glomeruli of the kidneys, causing an inflammatory response, and is said to affect more than 9,000 patients in Korea. Symptoms can range from asymptomatic microscopic hematuria to rapidly progressive kidney failure. Treatment for lgA nephropathy is generally conservative and includes blood pressure control, the use of renin-angiotensin system blockers to reduce proteinuria, and lifestyle modification. Immunosuppressive drugs may then be used if the condition worsens. There is no fundamental cure that targets the disease. Nefecon is an expensive drug; it costs nearly KRW 20 million per month in the U.S., therefore, its financial sharing is expected to be a key issue during reimbursement reviews. However, the absence of a cure for IgA nephropathy may affect the reimbursement review.
- Company
- Lily's 'Jaypirca' launches in KOR
- by Whang, byung-woo Jan 03, 2025 06:28am
- Product photo of Jaypirca Lily Korea announced on January 2 that Jaypirca (ingredient name: pirtobrutinib), a treatment for mantle cell lymphoma (MCL), was launched in South Korea on December 26. To date, Jaypirca is the first reversible Bruton's tyrosine kinase (BTK) inhibitor of any kind. Jaypirca was approved by the Ministry of Food and Drug Saftey (MFDS) in August 2024 for its efficacy and effects as a 'monotherapy for adult patients with relapsed or refractory MCL previously received at least two treatments.' Before the approval of Jaypirca, there was no drug approved in South Korea for patients with relapsed or refractory MCL whose symptoms advanced after previously receiving a BTK inhibitor. Jaypirca is the first reversible BTK inhibitor to demonstrate clinical significance in patients with relapsed or refractory MCL who have undergone one or more BTK treatments. It selectively inhibits BTK with a 300-fold greater selectivity than any other kinases (98%) in a preclinical study. The basis for approval was the BRUIN Phase 1/2 clinical trials, which evaluated the effectiveness and safety of Jaypirca in patients with relapsed or refractory MCL who had previously received one or more BTK inhibitors. The primary analysis set (PAS), involving 90 patients who had previously been treated with one or more BTK inhibitors, had an overall response rate (ORR) of 56.7% and a duration of response (DoR) of 17.6 months. The most common adverse reactions after the Jaypirca treatment were fatigue (26.3%), decreased neutrophil count (22.8%), diarrhea (22.1%), and bruising (21%). The rate of discontinued treatment due to adverse reactions was 1.2%. The rate of reduced volume of treatment due to adverse reactions was 3.3%. Previously, Jaypirca was approved under the FDA's Accelerated Approval in January 2024 based on the response rate results. In South Korea, in June 2024, it was designated an orphan drug as the monotherapy for patients with relapsed or refractory MCL previously treated with BTK inhibitors. Last month, Jaypirca was the only drug considered for the reimbursement review by the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) to receive a reimbursement criteria decision. The remaining steps are the Drug Reimbursement Evaluation Committee (DREC) review, drug price negotiations with the National Health Insurance Service (NHIS), and a review from the Health Insurance Policy Review Committee. "The launch of Jaypirca is expected to expand the treatment opportunity for patients with MCL who couldn't continue treatment because there has been no alternative medication after the disease progressed after previous therapies," Mira Kyon, Head of Lily Korea Oncology Division, stated. "Lily will continue to put efforts into providing better patient treatment opportunities and suggesting new paradigms to blood cancer therapies."
- Company
- Will Fabhalta settle as a PNH treatment option in Korea?
- by Eo, Yun-Ho Jan 03, 2025 06:27am
- Whether another PNH treatment option will be born is gaining attention in Korea. According to industry sources, Novartis Korea has submitted a reimbursement application for its oral paroxysmal nocturnal hemoglobinuria (PNH) treatment Fabhalta (iptacopan). PNH is a rare disease with an estimated incidence of 1.5 per million people worldwide. The treatment of this disease has historically relied on C5 inhibitors. Soliris (eculizumab) was first approved in Korea in 2010 and Ultomiris (ravulizumab) was approved in 2022 for PNH. Both are C5 inhibitors that inhibit the terminal C5 in the alternative pathway of the complement system involved in the body's immunity and are injected intravenously. However, in April last year, Empaveli (pegcetacoplan), a subcutaneous injectable that binds to C3 and C3b and inhibits the complement chain reaction, was approved, followed in August by Fabhalta, an oral factor inhibitor. Mechanistic limitations of C5 inhibitors, ‘extravascular hemolysis’ PNH begins with a genetic deficiency in red blood cells, which leads to intravascular hemolysis (IVH) and extravascular hemolysis (EVH). Such type of hemolysis can soon lead to thrombosis and bone marrow failure, which can be life-threatening. This is why it is important to control hemolysis to treat PNH, and while the current standard of care for PNH, C5 inhibitors, reduce the risk of thromboembolism by controlling intravascular hemolysis, they have limitations in limiting extravascular hemolysis. This is why the reimbursement of factor B inhibitor Fabhalta is gaining interest. Factor B is an alternative pathway upstream of C5, as well as C3 and C3b, and its inhibition can comprehensively control not only IVH but also EVH. In fact, Fabhalta has shown efficacy in treatment-naïve patients. In the APPOINT-PNH study on treatment-naïve PNH patients, 19 of 33 patients achieved hemoglobin levels of 12 g/dL or higher without red blood cell transfusions. In addition, 92% of patients had shown a clinically significant increase in hemoglobin levels of 2 g/dL or more, and 63% of patients sustained a hemoglobin level of 12 g/dL or higher without transfusion. Over the 24-week study period, hemoglobin levels continued to increase, with normalized hemoglobin levels reached at week 20 and sustained through week 24. In addition, 98% of patients overcame transfusion dependency. “When C5 inhibitors first appeared, experts said they brought a paradigm shift in the treatment of PNH,” said Dr. Junho Jang, Dr. Jun Ho Jang, Professor of Medicine, Department of Hematology-Oncology, Samsung Medical Center. “However, C5 inhibitors still have limitations in controlling extravasation hemolysis (EVH).” He added, “Fabhalta represents another paradigm shift in the treatment of PNH. Its mechanism of action, which inhibits factor B, involves factor B at the top of the alternative complement pathway, which can control both intravascular and extravascular hemolysis. It has shown encouraging results in clinical trials.”
- Policy
- 'Pivlaz Inj' makes another attempt to be reimb in KOR
- by Lee, Tak-Sun Jan 03, 2025 06:27am
- 'Pivlaz Inj,' which is supplied·distributed in South Korea by Handok, has been submitted for another attempt at reimbursement. The marketing authorization for Pivlaz was approved in South Korea in December 2023. Then, the company applied for reimbursement but voluntarily withdrew the reimbursement application in June 2024. According to industry sources on January 2, the reimbursement application for Pivlaz Inj (clazosentan disodium) was submitted to the Health Insurance Review and Assessment Service (HIRA). Pivlaz Inj, a selective endothelin receptor antagonist, received Korean marketing authorization on December 7, 2023, for the indication to prevent cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms in adults who had undergone clipping or coiling treatment for aneurysmal subarachnoid hemorrhage. Cerebral vasospasm after aneurysmal subarachnoid hemorrhage increases the risk of death in patients by twofold. Prevention and treatment are crucial because they accompany serious complications, such as local paralysis, language impairment, and decreased cognition. However, treatment for the disease has been difficult because there has been no medication available for it. In Phase 3 clinical trial (AC-054-305), involving patients who had undergone coiling treatment for aneurysmal subarachnoid hemorrhage, Pivlaz showed a statistically significant reduction in the percentage of mortality due to delayed ischemic neurologic deficit or all-cause associated with cerebral vasospasm in the 10mg/h treatment. The percentage for the placebo group was 28.8% (32/111 cases), and that of the 10mg/h treatment group was 13.6% (14/103 cases). Before the approval in South Korea, the Central Pharmaceutical Affairs Advisory Committee (CPAC) determined that the drug's concurrent use with nimodipine lacked a basis for the drug's benefit and, unlike in Japan, a trial result comparing the drug to nimodipine, which is a standard therapy in South Korea, is needed. However, during reconsideration by the CPAC, a comprehensive result from an additionally submitted document demonstrating a comparison with nimodipine and the company's plan to secure documents in Korean was evaluated. The CPAC has concluded that clazosentan monotherapy (excluding its concurrent use with nimodipine) will be approved based on Japan's Phase 3 clinical trial results. The company applied to HIRA for reimbursement after obtaining approval. However, it withdrew the approval in June. Recently, it was reported that the company attempted reimbursement again with strengthened documents. Nxera Pharma Korea obtained the domestic approval for Pivlaz. Nxera Pharma Korea is a Japanese multinational company that acquired the Pivlaz developer, Swedish pharmaceutical company Idorsia Pharmaceuticals. In April 2024, the company changed its name from Sosei Group to Nxera Pharma. On April 12, 2024, Handok signed an agreement with Nxera Pharma Korea for the domestic supply and marketing of 'Pivlaz.' Handok plans to launch Pivlaz this year. To achieve this goal, the company must pass the reimbursement review. It draws attention to whether Handok, which has been focusing on strengthening new drug competitiveness in the rare diseases field, will achieve business goals by potentially obtaining reimbursement for Pivlaz.
