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- 2025-12-21 04:26:57
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- Tibsovo may be prescribed at general hospitals in KOR
- by Eo, Yun-Ho Jun 24, 2025 05:59am
- Tibsovo, a targeted cancer drug for cholangiocarcinoma and acute myeloid leukemia, can now be prescribed at general hospitals in Korea. According to industry sources, Servier Korea’s IDH1 (isocitrate dehydrogenase 1) genetic mutation targeting therapy Tibsovo (ivosidenib) recently passed the Drug Committee (DC) review of the ‘Big 5’ tertiary hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital, and Sinchon Severance Hospital, as well as other medical institutions such as Gangnam Severance Hospital, National Cancer Center, and Seoul National University Bundang Hospital. The company has been steadily expanding its prescription area since it received approval from the Ministry of Food and Drug Safety in May last year and officially launched the drug in September of the same year. In addition, as the drug’s indication for cholangiocarcinoma has recently been approved by the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service, expectations are rising for its reimbursement. The drug is indicated for use ▲= in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation in adults aged ≥75 years with comorbidities that preclude the use of intensive induction chemotherapy, or ▲as monotherapy for locally advanced or metastatic cholangiocarcinoma in previously treated adults with IDH1 mutation. Cholangiocarcinoma is a highly aggressive cancer with a poor prognosis, with a 5-year relative survival rate of just 28.9%. In particular, 65% of patients with intrahepatic cholangiocarcinoma are diagnosed at an advanced stage where surgery is not feasible. Tibsovo is the only targeted therapy recommended by the National Comprehensive Cancer Network (NCCN) in the highest category (Category 1) as a second-line treatment for bile duct cancer. According to the Phase III ClarlDHy trial, Tibsovo reduced the risk of disease progression by 63% compared to placebo, with a median progression-free survival (PFS) of 2.7 months (1.4 months in the placebo group). Additionally, the median overall survival (mOS) was 10.3 months in the Tibsovo group, more than twice as long as the 5.1 months in the placebo group. Do-Youn Oh, Professor of Hematology-Oncology at Seoul National University Hospital, stated, “The development of drugs for cholangiocarcinoma has accelerated significantly in recent years. As new drugs are being developed, many companies are also actively working on the development of treatments for cholangiocarcinoma. It is crucial for patients with cholangiocarcinoma to follow the doctors’ guidance and receive appropriate treatment rather than be discouraged, so they can participate in clinical trials and gain access to new treatment opportunities.” Meanwhile, in the Phase III AGILE study that enrolled patients with acute myeloid leukemia, Tibsovo demonstrated improved event-free survival (EFS) when used in combination with azacitidine, and also significantly improved overall survival (OS). The median OS in the Tibsovo-treated group was 24.0 months (7.9 months in the placebo group), and long-term follow-up results showed that the median OS with Tibsovo combination therapy was 29.3 months, over 3.7 times longer than with placebo combination therapy.
- Policy
- Industry expects improved pricing measures by new gov't
- by Lee, Jeong-Hwan Jun 23, 2025 06:01am
- The domestic pharmaceutical industry is closely monitoring the direction of the Lee Jae-Myung administration's preferential drug pricing policy. The industry is most interested in when and how the presidential election pledges, including specific implementation plans for the new drug R&D-linked preferential drug pricing policy and the integration and advancement of the post-marketing drug price management system, will be realized. Multiple pharmaceutical companies believe that the public-private consultation body for the advancement of the drug price system, whose operation has been suspended around the presidential election, must be restarted as soon as possible in order to prompt practical discussions on the presidential campaign pledges. On the 22nd, the pharmaceutical industry expressed expectations that the Lee Jae-Myung administration's inauguration would bring significant changes to the drug price system, which will directly impact the promotion of the pharmaceutical and bio industry. The Ministry of Health and Welfare announced a health insurance operation plan during the previous administration on how it would establish various preferential pricing measures for drugs by domestic pharmaceutical companies. The previous Yoon Suk-Yeol administration's blueprint for drug price regulations was to favor drug prices or to partially defer or exempt drug price reductions of pharmaceutical companies that contributed to improving public health, enhancing the sustainability of health insurance, and developing the national economy. Additionally, the previous government promised to integrate the fragmented post-approval drug price management system into a single framework to address issues such as redundant price reductions that deter new drug development, thereby enhancing predictability for pharmaceutical companies and supporting their business operations. However, multiple pharmaceutical companies have pointed out that there are few actual cases where the previous government's plans have been implemented in practice. In other words, efforts to establish the criteria for preferential drug pricing that can promote new drug development, create jobs, and save national health insurance finances, have been stagnant for over a year. According to industry sources, the only drug price policies that have actually been implemented are regulations that favor the prices of essential medicines manufactured with domestic ingredients and the temporary suspension of the price reduction system based on external reference pricing reevaluations that were about to be implemented. Accordingly, the pharmaceutical industry is closely watching whether the new government will expedite the establishment of national economic development criteria that would allow pharmaceutical companies to receive preferential drug pricing. Given that President Lee Jae-Myung has pledged to implement a preferential policy linking new drug R&D ratios to drug prices, expand measures that take into account the pharmaceutical industry’s social contribution, and modernize the post-management of drug prices in an integrated manner, industry attention is now focused on when and how the Ministry of Health and Welfare and other relevant authorities will initiate specific reforms in the drug pricing system. A representative from a mid-sized domestic pharmaceutical company explained, “The previous administration had repeatedly announced plans to introduce new preferential drug pricing clauses and the reform of the drug pricing system, but in reality, the progress felt slow. Preferential treatment was mainly limited to essential medicines using domestic raw materials, and even then, the number of items actually benefiting from the policy was quite small.” The representative added, “While the implementation of the external reference pricing reevaluation results has been temporarily suspended due to ongoing concerns from pharmaceutical companies, significant concern remains on how it could be reinstated at any time. The key issue is how much and in what direction the new government will diverge from the previous administration's drug price system policies.” Another domestic pharmaceutical company official noted, “The adoption of a drug pricing system that provides greater compensation to pharmaceutical companies that invest heavily in new drug R&D as a presidential election pledge holds significance.” “While policies that provide price advantages to pharmaceutical companies that increase investment in new drugs and make efforts to reduce national health insurance expenditures are important, reducing or eliminating unreasonable drug price reduction mechanisms could have a more substantial impact on pharmaceutical companies.” The official added, “A drug pricing system that adequately reflects the characteristics of the domestic pharmaceutical industry and advanced post-approval drug pricing management policies must be implemented by the new government to enhance pharmaceutical companies' capacity to invest in new drugs. To establish systems that enhance the predictability of the pharmaceutical companies’ business operations, we hope that the new government will first establish a public-private consultation body.”
- Policy
- Generic 'Lixiana' is now in 'active' development in KOR
- by Lee, Hye-Kyung Jun 23, 2025 06:01am
- Korean pharmaceutical companies are actively working on plans to launch their generic version of 'Lixiana Tab 60 mg (edoxaban tosylate hydrate),' a Direct Oral Anti-Coagulant (DOAC) with patent expiry set to November of next year. The Ministry of Food and Drug Safety (MFDS) recently approved Korean Drug Co's application for a bioequivalence trial. This trial is an open-label, randomized, single-dose oral, two-group, two-period, crossover study in healthy adults, comparing "Korea-edoxaban 60mg Tab" with Daiichi Sankyo's 'Lixiana Tab 60mg (edoxaban tosylate hydrate)'. This month, two bioequivalence test approvals have been granted for the development of generic Lixiana. Korea Arlico Pharm received approval for "Arlixaban Tab 60mg" on June 9, before the Korean Drug Co. According to the approval history of bioequivalence tests for generic Lixiana, the MFDS has approved 10 cases. Over ten pharmaceutical companies, including Boryung, Dong-A ST, HK inno.N, Samjin Pharmaceutical, Shinil Pharma, Chong Kun Dang, Kolmar Pharma, Korea Kolmar, Hutecs, and Hanmi Pharmaceutical, have already successfully avoided the patent and secured generic approvals. Seventeen Lixiana generic products are currently listed in the approval registry. Theragen Etex and Dongkwang Pharmaceutical, which filed patent invalidation suits last year, also recently received 'claim upheld' rulings. Korean companies that have successfully avoided the patent will be able to launch their generics when the substance patent expires in November 2026. Late entrants to generic development are actively working to accelerate their generic launches by filing a passive rights scope confirmation trial related to Daiichi Sankyo's pharmaceutical composition patent. Currently, HLB Pharma and Samjin Pharm have filed passive rights scope confirmation trials related to Lixiana's formulation patent in January and March, respectively. The Lixiana patents listed in the MFDS patent registry include a substance patent expiring in November 2026 and a formulation patent expiring in August 2028. Challenges to the Lixiana formulation patent began in 2020. At that time, about 10 companies, including Boryung, filed an invalidation trial aimed at the Lixiana formulation patent in July 2018. Within approximately two years, the challenging companies won the first instance. The victory was confirmed without an appeal from Daiichi Sankyo. Since December 2021, companies including Nexpharm Korea, Dong-A ST, Samsung Pharmaceutical, Shinil Pharma, Shin Poong Pharm, Ahngook Pharm, Ildong Pharmaceutical, Genuone Sciences, Union Korea Pharm, Korea Prime Pharm, Hutecs, and Handok have each obtained generic marketing authorizations. Lixiana has consistently maintained its lead in the DOAC market for a long time, with annual prescription sales exceeding KRW 100 billion. According to pharmaceutical market research firm UBIST, Lixiana's prescription sales in 2023 were KRW 105.3 billion, a 9% increase from KRW 96.7 billion in 2022. In the first half of last year alone, it recorded KRW 55.7 billion in prescription sales. Lixiana first took the market lead in 2019 and has consistently held that position. Analysis suggests that the joint selling synergy with Daewoong Pharmaceutical has positively contributed to the increase in prescription sales.
- Company
- Eylea biosimilar pharmas receive differing injunction ruling
- by Kim, Jin-Gu Jun 23, 2025 06:01am
- Domestic biosimilar companies have launched a full-scale patent lawsuit against Bayer over Eylea. Celltrion and Samsung Bioepis received different preliminary injunction results, leading them to pursue divergent strategies in the main lawsuit. Eylea patent infringement main lawsuits begin in earnest... Celltrion to proceed immediately, Samsung Bioepis’ plan undecided On the 20th, the 61st Civil Division of the Seoul Central District Court held the second hearing regarding the patent infringement lawsuit filed by Bayer against Celltrion. The hearing concluded without any substantive arguments. The court decided to receive additional written statements from both parties and scheduled the next session for August 19. Bayer filed the lawsuit in January last year. The issue is whether Celltrion's Eylea biosimilar, Eydenzelt, infringes on Bayer's domestic patent. Bayer filed the same lawsuit against Samsung Bioepis in May last year. Bayer claims that Samsung Bioepis' Eylea biosimilar, Afilivu, infringes on its patent. However, no trial date has been set yet for the lawsuit against Samsung Bioepis. Opposite preliminary injunction results... Bayer files appeal, Samsung Bioepis files objection The patent infringement lawsuit surrounding Eylea is proceeding in a complicated manner with mixed preliminary injunction decisions from the court. In July last year, Bayer filed preliminary injunction motions against Celltrion and Samsung Bioepis, respectively, for patent infringement. The purpose was to suspend the domestic sale of biosimilars until the final ruling. In February this year, the preliminary injunction results were announced. The court issued conflicting decisions. The preliminary injunction request against Celltrion was dismissed, while the request against Samsung Bioepis was granted. As a result, Celltrion can continue selling Eydenzelt in Korea, while Samsung Bioepis must suspend sales of Afilivu. Due to the conflicting preliminary injunction decisions, the responses of each company also differed. Bayer filed an appeal with the Seoul High Court regarding the Celltrion case. The appeal hearing is scheduled for next month on the 17th. In contrast, Samsung Bioepis opted for an objection procedure instead of filing an appeal. Along with the objection, the company also filed a request for a stay of execution, but it was dismissed. The objection hearing concluded in April this year, and the case is now awaiting the court’s final decision. Nevertheless, Samsung Bioepis has continued to submit supplementary briefs in response. Preliminary injunction appeal, objection, and final ruling... a turning point for the domestic sale of biosimilars The final ruling, the appeal of the preliminary injunction, and the decision on the objection are expected to serve as a turning point in determining the sustainability of domestic biosimilar sales. If Bayer wins the appeal against Celltrion, the domestic sales of Eydenzelt will be suspended. Conversely, if the rejection is upheld as in the first instance, sales will continue as is. In the case of Samsung Bioepis, if the court accepts the objection, sales of its Afilivu can resume. Conversely, if the court dismisses the objection, sales will remain suspended. In this case, Samsung Bioepis is expected to continue the lawsuit by filing an appeal. The ruling on the main lawsuit is expected to tentatively determine whether the two companies can sell Eylea biosimilars. If the court rules that the two biosimilars infringe on Eylea's patent, sales of Eydenzelt and Afilivu in Korea will be suspended. Conversely, if the court rules that there is no patent infringement, sales of the biosimilars will be permitted. The progress of this complex litigation is directly impacting partner companies that copromote the biosimilars as well. Kukje Pharm, which co-markets Celltrion's Eydenzelt, has continued its sales to date. However, Samil Pharmaceutical, which collaborates with Samsung Bioepis, has suspended distribution and sales of Afilivu. Future developments, including the appeal, objections, and final ruling, are likely to influence the sales strategies and revenue of these partner companies.
- Company
- K-BIO expands its presence at the international convention
- by Son, Hyung Min Jun 23, 2025 06:01am
- Korean pharmaceutical and biotech companies showed their presence at the BIO International Convention 2025 (BIO USA 2025), the world's largest biotech business event. Major domestic pharmaceutical and biotech firms from South Korea attended the BIO USA 2025, held in Boston, USA, from June 16 to 19, showcasing their new drug pipelines and Contract Development and Manufacturing Organization (CDMO) technological capabilities. According to the Korea BIO on June 21, over 20,000 participants from 70 countries attended this year's BIO USA. Among them, the number of Korean attendees exceeded 1,300, marking the third consecutive year that South Korea has been the largest participating country from overseas. BIO USA is the world's largest pharmaceutical and bio exhibition, serving as a platform for global pharmaceutical and biotech companies and research institutions to explore opportunities for new drug pipelines, technology transfer, and collaborative research. Over 300 Korean companies participated in this year's event. Samsung Biologics expressed its commitment to expanding collaborations with global pharmaceutical companies through this event. Samsung Biologics plans to increase its production capacity by securing drug manufacturing contracts from pharmaceutical companies ranked among the top 20 to top 40 globally. Samsung Biologics has signed a total of 5 new contracts based on public disclosures this year alone. Starting with a $1.41 billion (approximately KRW 2 trillion) contract signed with a European pharmaceutical company in January, the company continued to secure new orders globally, including those from the U.S., Asia, and Europe. Samsung Biologics currently holds 17 out of the top 20 global pharmaceutical companies as clients. Through core competencies based on overwhelming production capacity, quality, and numerous track records, its cumulative total orders since its establishment have exceeded approximately $18.2 billion. Lotte Biologics announced the securing of new contracts through BIO USA. The company held a Contract Manufacturing Organization (CMO) agreement signing ceremony for antibody drugs with the British biopharmaceutical company Ottimo Pharma. This ceremony took place at the Lotte Biologics booth at the Boston Convention & Exhibition Center in the United States. Lotte Biologics announced the securing of new contracts through BIO USA Through this agreement, Lotte Biologics will produce the drug substance (DS) for Ottimo Pharma's new antibody drug, 'Jankistomig,' at its biotech campus in Syracuse, New York. Ottimo Pharma is a company developing a new drug with a PD1/VEGFR2 bispecific antibody mechanism, aiming to extend the lives of patients with cancer. Established in 2020, it has offices in the UK. Lotte Biologics offers CDMO services at the Syracuse biotech campus, including drug cell line development and large-scale contract manufacturing. Furthermore, it aims to operate Plant 1 within its Songdo Bio Campus starting in 2027. Plant 1 is a large-scale biopharmaceutical manufacturing facility with a production capacity of 120,000 liters, enabling it to secure significant global contracts. Celltrion held over 150 meetings at this event, discussing various collaboration strategies with global pharmaceutical and bio-companies. Notably, beyond CDMO and biosimilars, the company showcased various potential partnership opportunities for its pipelines under development, including antibody-drug conjugates (ADCs), multispecific antibodies, novel antibodies, and peptide new drugs. Celltrion also discussed open innovation aimed at finding promising technologies related to new drug development. Celltrion plans to thoroughly review the meetings held at this BIO USA to identify potential collaborators with growth potential and capabilities. Celltrion is pursuing the development of new ADC drugs. Earlier this year, Celltrion disclosed the preclinical results of its ADC candidate 'CT-P71'. CT-P71 utilized the ADC platform of the Korean ADC development company Pinotbio. CT-P71 is an ADC therapeutic agent under development targeting general solid tumors, including bladder cancer. It targets Nectin-4, a cell surface protein overexpressed in various solid tumors such as urothelial carcinoma and breast cancer. Celltrion also received approval for a Phase 1 clinical trial of CT-P70. CT-P70 is an ADC therapeutic agent targeting solid tumors such as non-small cell lung cancer, specifically targeting 'c-MET,' which, when activated in cancer cells, induces tumor growth. Korean companies promoted R&D competitiveness for new drug development This year, 51 companies participated in the Korea Section, operated by the Korea Bio Association, introducing technologies and pipelines across the entire biotech industry, including contract manufacturing, clinical services, materials/components/equipment business, new drug development, and platforms. Over 450 consultations were held throughout the exhibition hall. Notably, 24 pre-registered companies garnered attention from global partners through technology presentations at the Open Stage within the Korea Section. This year, both the number of participating companies and the exhibition space expanded compared to the previous year. A special area for materials, components, and equipment business was also operated separately, showcasing the competitiveness of Korea's biotech industry supply chain. Photo of BIO USA 2025 Korea Section (source=Korea BIO organization) In this event, Korean companies also focused on promoting their competitiveness in new drug development. Through BIO USA, Aptamer Sciences actively discussed strategic collaborations with major ADC-specialized companies in North America, Europe, and China, exploring concrete cooperation opportunities such as joint development, clinical collaboration, expansion into new indications, and technology transfer. Aptamer Sciences has proprietary ADC platform technology, ApDC (Aptamer Drug Conjugate). ApDC is a next-generation precision drug delivery platform that utilizes aptamers instead of antibodies, using an in-house modified nucleic acid technology. According to Aptamer Sciences, anti-cancer drugs developed using the ApDC platform have demonstrated various advantages in comparative experiments with ADC anti-cancer drugs, including rapid drug action through quick internalization into target cells after surface binding, excellent permeability into tumor tissue, rapid targeting after administration in animal models, and consequently, superior anti-tumor efficacy. Currently, Aptamer Sciences is expanding its platform to allow conjugation with various mechanisms of action beyond cytotoxic drugs, including radioisotopes, targeted protein degraders (TPDs), and immunostimulants. GI Innovation introduced its new pipelines and global business strategy as its next growth engines. GI Innovation unveiled its GI-128, which utilizes macrophages (a next-generation target gaining attention in the immunotherapy field), along with a trispecific pipeline that aims to surpass the rapidly emerging aPD-(L)1/VEGF bispecific antibodies in the global market. GI Innovation's newly introduced pipeline features a trispecific antibody structure that fuses a self-discovered aPD-L1 antibody with a VEGF antibody and a macrophage engager. It is evaluated as having a differentiated mechanism of action by overcoming the limitations of bispecific antibodies and activating tumor-immune responses. SK Biopharmaceuticals is engaging in artificial intelligence (AI)-driven drug discovery through a business agreement with PhnyX Lab. Through this agreement, the two companies plan to jointly develop customized solutions based on PhnyX Lab's generative AI solution 'Cheiron', automating tasks such as literature search, data analysis, and document creation required in the new drug development process. The agreement signing ceremony took place at the SK Biopharmaceuticals exhibition booth. (from left) Changho Yu, SK Pharmaceuticals VP/Chief Strategy Officer & Head of Strategy Division and Minseok Bae, CEO of PhnyX Lab Notably, SK Biopharmaceuticals plans to accelerate its 'AI Transformation' of the new drug development process, primarily focusing on automating tasks such as preparing regulatory documents required at the clinical entry stage, thereby advancing it with the use of AI. Through this, SK Biopharmaceuticals aims to maximize R&D productivity and significantly reduce the time and cost associated with development and approval. Samjin Pharmaceutical, making its first official corporate presentation at this year's BIO USA, showcased its competitiveness in developing new anti-cancer drugs, including ADCs. Currently, the company is developing various candidates, including ▲solid tumor therapeutic candidates 'SJN301' and 'SJN309' ▲antibody-drug conjugate (ADC) projects 'SJA20' and 'SJA70' ▲immune/inflammatory disease therapeutic candidate 'SJN314'.
- Policy
- Handok and JW’s new imported drugs reimbursed from July
- by Lee, Tak-Sun Jun 23, 2025 06:00am
- Tavalisse (JW Pharmaceutical) and Doptelet (Handok) will both be reimbursed for ITP from next month In July, four new drugs, including an oral drug for paroxysmal nocturnal hemoglobinuria (PNH), a new biological agent for severe atopic dermatitis, and a new drug for immune thrombocytopenia (ITP), will be reimbursed by health insurance and be available with coverage for patients. On the 19th, the MOHW announced the establishment of reimbursement standards for four new drugs, including Fabhalta Cap 200 mg (Iptacopan hydrochloride monohydrate, Novartis Korea), a new drug for the treatment of PNH. The reimbursement will take effect on the 1st of next month. In addition to Fabhalta Cap 200 mg, a treatment for severe atopic dermatitis, Ebglyss Autoinjector 250 mg (lebrikizumab-lbkz, Lilly Korea), ‘Doptelet Tab 20mg (avatrombopag maleate, Handok),’ and ‘Tavalisse Tab 100·150mg (fostamatinib sodium hydrate, JW Pharmaceutical).’ Fabhalta Cap 200 mg is an oral treatment for paroxysmal nocturnal hemoglobinuria and is expected to be more convenient than the injectable drugs that have been used until now. In addition, its hemolysis control effect is expected to be better than existing C5 inhibitors (Soliris and Ultomiris). PNH is a rare condition that affects about 1.5 people per 1 million worldwide. Until now, Soliris (eculizumab) and Ultomiris (ravulizumab) have been the main C5 inhibitors used for PNH. In November last year, Empaveli (pegcetacoplan, Handok), a subcutaneous injection that binds to C3 and C3b to inhibit the complement cascade, was also approved for reimbursement. The reimbursement of the new oral drug Fabhalta is expected to improve access to treatment and offer better therapeutic effects. Ebglyss Autoinjector 250 mg is reimbursed for adult (18 years of age or older) and adolescent (12 to 17 years of age, weighing 40 kg or more) patients with chronic severe atopic dermatitis whose symptoms have persisted for three years or more. This drug is the third biological agent for atopic dermatitis, following Dupixent (dupilumab) and Adtralza (tralokinumab). Ebglyss has demonstrated clinical efficacy and safety profiles through a Phase III clinical trial and is expected to become a first-line treatment option for atopic dermatitis patients in Korea. Doptelet Tab and Tavalisse Tab will be reimbursed for the treatment of adult chronic immune thrombocytopenia (ITP) that is unresponsive to corticosteroids and immunoglobulin. ITP is an autoimmune disease in which the immune system mistakes platelets for viruses and attacks them, causing platelet counts to fall below normal levels and increasing the risk of bleeding. As a result, patients may experience easy bruising and frequent bleeding, which in severe cases can lead to cerebral hemorrhage or gastrointestinal bleeding. According to the ITP Clinical Practice Guidelines issued by the Korean Society of Hematology, steroids and immunoglobulins are recommended as first-line treatments, while splenectomy or thrombopoietin-receptor agonists (TPO-RA) are recommended as second-line treatments for chronic ITP patients. With rare disease drugs imported by domestic pharmaceutical companies such as Handok and JW Pharmaceutical now reimbursed, industry eyes are on how the drugs will be received in the market.
- Company
- "6-in-1 vaccine Hexaxim may enhance preventive effect of NIP
- by Whang, byung-woo Jun 23, 2025 06:00am
- "Hexaxim is Korea's first hexavalent vaccine. It is expected to play a crucial role in helping protect children's health." Following the inclusion of Hexaxim, a hexavalent (6-in-1) DTaP vaccine, in the National Immunization Program (NIP) this year, the medical field is holding high hopes for increased convenience of immunization and improvement in vaccination rates. The analysis is that since immunization through NIP has already been conducted, the field is already experiencing practical benefits, such as a reduced number of immunizations. It is believed that, in the long term, Hexaxim will lessen the burden of hospital visits for caretakers, alleviate the stress of infant injections, and prevent the skipping of immunizations. Dr. Byung Wook Eun, Professor of Department of Pediatrics at Nowon Eulji Medical CenterDaily Pharm met with Dr. Byung Wook Eun, a professor at Nowon Eulji Medical Center, and listened to the background of the introduction of Hexaxim and its potential effects. Hexaxim is Korea's first and only fully liquid hexavalent fully liquid formulation vaccine, preventing six diseases, including diphtheria, tetanus, pertussis (DTaP), inactivated polio vaccine (IPV), Haemophilus influenzae type b (Hib), and hepatitis B (HepB), with a single injection. As of January 2, it has been officially introduced into the NIP, allowing the previous separate administration of the pentavalent (5-in-1) vaccine (DTaP-IPV-Hib) and the monovalent Hepatitis B vaccine to now be given in a single shot. According to Dr. Eun, since the introduction of Hexaxim into the NIP, there has been an increase in inquiries regarding new vaccination schedules and methods in actual clinical settings. Dr. Eun said, "With the introduction of the hexavalent vaccine, the vaccination schedule differs from the existing pentavalent vaccine, leading to many questions from both guardians and medical staff regarding vaccination criteria, interchangeability, and delayed vaccinations." Hexaxim is already a proven vaccine overseas, having received its first approval in Europe in 2013. It is now used in over 120 countries worldwide and is recommended as a mandatory vaccination in more than 40 countries, including Europe, Canada, and Australia. Dr. Eun explained, "The immunogenicity and safety of Hexaxim against all six infectious diseases through global clinical studies, including those conducted in Korea," and added, "In Korea, non-inferiority related to immunogenicity was confirmed through a clinical trial comparing the Hexaxim vaccination group with the group receiving the existing pentavalent DTaP combination vaccine concurrently with the monovalent Hepatitis B vaccine." Fewer injections due to schedule changes help improve convenience The introduction of Hexaxim has brought significant changes to the infant vaccination schedule. Previously, infants needed to receive the Hepatitis B vaccine at 0, 1, and 6 months of age and the pentavalent DTaP vaccine at 2, 4, and 6 months. However, starting this year, the schedule has changed. After the first Hepatitis B vaccination immediately after birth, infants will now receive Hexaxim at 2, 4, and 6 months, with no additional vaccination at 1 month. Dr. Eun stressed that "The introduction of Hexaxim reduces the total number of vaccinations by two, bringing the total to four injections." He added, "The hexavalent DTaP vaccine can administer six antigens at once, which can help improve vaccination rates compared to administering individual vaccines separately." However, as with any new vaccine introduction, there's some initial confusion in the field. Dr. Eun explained that there have been inquiries regarding the switching to the hexavalent vaccine at 6 months if the infant has already received the pentavalent combination vaccine at 2 or 4 months. The Korea Disease Control and Prevention Agency (KDCA) is addressing this confusion with clear guidelines. Dr. Eun stressed, "According to KDCA's official guidelines, DTaP-containing vaccines vary by manufacturer. Therefore, for the primary 3-dose series, it is recommended to administer vaccines from the same manufacturer consistently." Dr. Eun also said, "However, since most newborns are currently starting their vaccinations with Hexaxim, inquiries about interchangeability will gradually decrease in the future," and added, "There are also questions about vaccination age and intervals. Hexaxim's recommended vaccination schedule is at 2, 4, and 6 months of age (8-week intervals), with the recommended age for the first dose being 8 weeks (2 months of age)." However, in unavoidable circumstances, the first dose can be administered as early as 6 weeks of age. While a 2-month (8-week) interval is generally recommended, the vaccination schedule can be adjusted to a minimum of 4-week intervals. For example, if the first dose was given at 3 months of age, the second dose can be given 4 weeks later. Dr. Eun stated, "If there are any changes to the vaccination schedule, it is crucial to consult with a healthcare professional to get guidance on the timing and vaccine selection." There are, however, exceptional cases where Hexaxim cannot be administered. For instance, newborns born to mothers who are positive for the Hepatitis B virus must receive Hepatitis B immunoglobulin and the Hepatitis B vaccine within 12 hours of birth. These high-risk infants also require additional Hepatitis B vaccine doses at 1, 2, and 6 months of age, thus excluding them from the Hexaxim program. Furthermore, infants who have already completed their second Hepatitis B vaccination by 1 month of age cannot switch to Hexaxim and must continue their remaining vaccinations with the existing combination of the pentavalent vaccine and the Hepatitis B vaccine. "Hexaxim with increased preventive effects... high hopes for increasing vaccination rates" Dr. Eun stated that concerns about Hepatitis B antibody formation, which were previously raised by some, have been addressed through research. In the previous schedule, Hepatitis B vaccine was administered at 0 and 1 months of age. However, with the Hexaxim schedule, the 1-month vaccination is omitted, changing the schedule to 0-2-4~6 months. Regarding this, Dr. Eun responded, "The 0-2-4~6 month Hepatitis B vaccination schedule using Hexaxim showed immunogenicity similar to the existing 'pentavalent vaccine+Hepatitis B vaccine' schedule," and added, "Although the hexavalent vaccine includes a Hepatitis B component in addition to the existing pentavalent combination vaccine, its safety profile was confirmed to be similar to separate administrations." One of the anticipated effects of including Hexaxim in the NIP is an improvement in vaccination rates. Dr. Eun said, "Because a hexavalent vaccine can introduce six antigens in one shot, it can help improve vaccination rates compared to administering individual vaccines separately," and added, "Currently, infant primary vaccination rates exceed 90%, but we expect to push this figure higher with Hexaxim's introduction." As mentioned earlier, the reduced number of vaccinations helps prevent delayed vaccinations, which in turn can lead to a higher 'right-time vaccination rate,' thereby completing vaccinations at the recommended period, thus improving overall vaccination rates. Indeed, improvements in vaccination rates have been observed in other countries after the introduction of hexavalent combination vaccines. In Australia, after the hexavalent vaccine was included in their NIP, the vaccination rate for infants aged 12 months increased from 84.9% in 2009 to 92.6% in 2018. Lastly, Dr. Eun added, "Misinformation about vaccines can lead to a drop in vaccination rates, and previously well-managed infectious diseases could potentially re-emerge," and urged, "We hope the public would utilize the NIP to help protect children's health."
- Policy
- Rapid adjustment of insurance prices for rare drugs granted
- by Lee, Hye-Kyung Jun 20, 2025 06:08am
- Verorab (pictured above), for which a price adjustment has been completed in response to exchange rate fluctuations, and Ivexproglycem (pictured below) for which a price adjustment application is currently under negotiations. The insurance price ceiling adjustment term for insured drugs supplied by the Korea Orphan Drug Center (KOEDC) is expected to be significantly reduced from the initial 8-9 months to around 4 months. Previously, it took at least 8-9 months to adjust the price cap, raising concerns about supply disruptions and financial losses for the center, so the government decided to take proactive measures to resolve the issue by significantly simplifying the price adjustment process for urgently needed drugs. During a meeting with journalists from the Ministry of Food and Drug Safety’s press corps on the 17th, the KOEDC said that it is operating a consultation system to promptly adjust reimbursement price ceilings for publicly procured orphan drugs in order to ease the supply burden caused by sharp exchange rate fluctuations. The KOEDC added that it adjusted the insurance price ceiling for Verorab through the system in January. The insurance price of Verorab was KRW 63,000 before the adjustment, but after the adjustment, it was raised by 65.9% to 104,887 won. According to the center, most orphan drugs are highly dependent on overseas imports, and import prices are sensitive to exchange rate fluctuations. However, the reimbursement ceiling was fixed, so there was a structural problem where the center had to continue supplying the drugs at a loss when the exchange rate rose sharply. According to the center, the exchange rate has risen by about 20% in the last three years, and in the case of some items, the KOEDC incurred losses of more than KRW 100 million per case. This has directly impacted patients' access to treatment. When the center delays or suspends supply due to budget constraints, patients experience treatment gaps because there are no domestic alternatives for orphan drugs. As a result, patient groups and relevant experts have consistently raised the need for system improvements. Kim Ki-young, Director of KOEDC, explained, “There has been around a 20% fluctuation in exchange rates over the past 3 years. For orphan drugs distributed in the market based on the reimbursement price ceiling, the increased costs have led to losses exceeding KRW 100 million per drug. In practice, the total budget for drug purchases has decreased, which has also caused disruptions in the supply of subsequent orphan drugs.” In response, the center established an exceptional price adjustment procedure in collaboration with the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, the Health Insurance Review and Assessment Service (HIRA), and the National Health Insurance Service (NHIS). This streamlined process applies exclusively to publicly procured items that meet specific criteria. It significantly shortens the price ceiling adjustment period from several months to within 10 days, thereby minimizing supply disruptions and ensuring continuity of patient care. Notable examples of the expedited adjustment procedure include Verorab, which was adjusted in January this year, and Ivexproglycem, which is currently undergoing price adjustment. Kim said, “Previously, adjustments to the reimbursement price ceiling took eight to nine months due to various procedures, which inevitably resulted in losses for the center. The MFDS requested cooperation from the MOHW to establish a procedure to correct supply instability so that adjustments can be made quickly in response to exchange rate fluctuations.” Just like with exchange rate increases, price adjustments are also promptly made in the event of a decrease. Director Kim said, “If an exchange rate drop results in a surplus, the revised amount can be reflected starting on the first day of the following month. This new cooperative framework enables more reasonable adjustments and contributes to the stability and sustainability of public procurement by government agencies.” In addition, KOEDC is pursuing various policies to improve access to orphan drugs. Key initiatives include operating patient assistance programs in partnership with pharmaceutical companies and providing free or cost-based supply of drugs for which price negotiations are delayed. Also, the center is working to establish overseas supply chains to introduce medications for self-treatment and is running an early distribution program for pediatric orphan disease treatments.
- Company
- Cream JAKi Delgocitinib to be commercialized in Korea
- by Eo, Yun-Ho Jun 20, 2025 06:06am
- JAK inhibitors will soon be available for hand eczema in Korea as well. The Ministry of Food and Drug Safety is currently conducting a final review of LEO Pharma Korea's treatment for moderate-to-severe chronic hand eczema (CHE), Anzupgo (delgocitinib). When approved, the drug is expected to be officially commercialized in the second half of the year in Korea. Anzupgo was officially approved in Europe in November last year and is currently awaiting approval from the US FDA. This cream formulation is known as a pan-JAK inhibitor, as it targets JAK1, 2, and 3, as well as TKY2. The efficacy of Anzupgo has been demonstrated through the DELTA FORCE and DELTA 2 clinical trials, which directly compared Anzupgo with GSK's alitretinoin (Toctino). In the DELTA FORCE study, the Hand Eczema Severity Index (HECSI) score from baseline to week 12 of delgocitinib demonstrated superiority over alitretinoin capsule, meeting the primary endpoint. The DELTA 2 study included 473 patients with moderate-to-severe chronic hand eczema (CHE). Study participants were assigned to either the delgocitinib cream group or the placebo cream group and received treatment twice daily for 16 weeks. The primary endpoint was set as an IGA-CHE score of 0/1 at Week 16 of treatment. The primary secondary endpoints included IGA-CHE and the Hand Eczema Symptom Diary (HESD) assessed at Weeks 4 and 8 of treatment. The results showed that the delgocitinib group achieved significant improvement in chronic hand eczema at Week 16 compared to the placebo group, meeting the primary and primary secondary endpoints. Chronic hand eczema can be triggered by various factors such as irritants, allergies, genetic predisposition, and occupational exposure. It often leads to recurring inflammation, peeling, cracking, and pain, significantly impacting daily life. However, to date, effective topical treatments specifically targeting hand eczema remain limited. In many cases, patients show insufficient response even to corticosteroids or immunosuppressants, underscoring the ongoing need for new therapeutic alternatives. Meanwhile, LEO Pharma obtained exclusive rights in 2014 from the Japanese company Japan Tobacco to develop and commercialize a topical delgocitinib cream for dermatological indications worldwide, excluding Japan.
- Policy
- SGLT2 Jardiance likely to receive expanded reimb for CKD
- by Lee, Tak-Sun Jun 20, 2025 06:06am
- Product photo of JardianceThe SGLT-2 inhibitor Jardiance (empagliflozin, Boehringer Ingelheim) is expected to be reimbursed for the treatment of chronic kidney disease (CKD). This drug is currently reimbursed for the treatment of diabetes and chronic heart failure. If expanded reimbursement is approved for CKD, the volume of usage is likely to be increased. Furthermore, its market presence is expected to be strengthened in the SGLT-2 inhibitors market. According to industry sources on June 19, the agenda related to Jardiance's expanded reimbursement to include CKD passed the Drug Reimbursement Evaluation Committee (DREC) held on the 12th. Once it undergoes the National Health Insurance Service's simplified negotiation process and reports to the Health Insurance Policy Deliberation Committee, Jardiance is anticipated to be reimbursed for treating CKD. Since the company already completed drug price estimation process, reimbursement may be approved as early as July 1. It has been reported that Jardiance's expanded reimbursement for CKD was approved for the pre-drug price reduction program for expanded usage scope drugs. This program is designed to quickly enhance patient access to treatments by omitting the cost-effectiveness evaluation and applying a pre-reduction rate table, with a maximum 5% reduction in the ceiling cap, considering the estimated additional claim amounts due to the expanded reimbursement criteria. If a drug's ceiling price is adjusted via this program, its company will only have to undergo negotiations related to supply requirements, such as those required for other reimbursed medicines. Jardiance's company applied to the Health Insurance Review & Assessment Service (HIRA) for expanded reimbursement for Jardiance's CKD indication in the first half of last year. Jardiance was the first SGLT-2 inhibitor to file. Jardiance Tab 10mg is currently indicated for the treatment of 1. Type 2 diabetes mellitus, 2. chronic heart failure, and 3. chronic kidney disease. Jardiance Tab, which was listed for reimbursement as a diabetes treatment in 2017, has also been reimbursed for chronic heart failure since February 2024. Since January this year, the reimbursement criteria have been expanded, allowing patients with heart failure with preserved ejection fraction (HFpEF) who have symptoms and signs of heart failure and a left ventricular ejection fraction exceeding 40% to receive national health insurance benefits. Currently, the only SGLT-2 drugs covered for diabetes and chronic heart failure patients, besides Jardiance, are Forxiga (dapagliflozin) and HK inno.N's DapaN Tab, which transferred Forxiga's indications. However, there is currently no drug reimbursable for CKD. If the reimbursement expansion procedure for Jardiance is completed, it is expected to be the only SGLT-2 inhibitor with coverage for CKD reimbursement. The efficacy of Jardiance has been demonstrated through clinical trials, showing a statistically significant 28% relative risk reduction in the progression of kidney disease or cardiovascular death compared to placebo. The clinical trials that Jardiance significantly reduced a relative risk in the progression of kidney disease or cardiovascular death compared to placebo by 28%. The expanded scope of use will provide advantage in competition with generic drugs. Jardiance's substance patent expires in October this year. Therefore, tens of domestic generic drugs are likely to enter the market. Jardiance, jointly sold by Boehringer Ingelheim and Yuhan, recorded outpatient prescription sales of KRW 66.3 billion last year, according to UBIST.
