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- 2025-12-21 04:29:44
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- Will the external reference pricing reevals be resumed?
- by Kim, Jin-Gu Jul 04, 2025 06:06am
- Tensions are rising in the pharmaceutical and biotech industry amid speculation that the external reference pricing reevaluations may be pushed forward again in the second half of this year. The industry is reacting sensitively, as the proposal previously discussed by the consultative body could lead to large-scale drug price cuts if adopted as is. External reference pricing reevaluation that was scheduled for this year... specific promotion schedule unclear According to industry sources on the 3rd, there is a possibility that the external reference pricing reevaluations will be pushed forward again in the second half of this year. Once the organizational restructuring is complete with the appointment of the Minister of Health and Welfare, it is expected that discussions on external reference pricing reevaluations will resume. The Lee Jae-myung administration has nominated Jeong Eun-kyung (60), former head of the Korea Disease Control and Prevention Agency, as Minister of Health and Welfare. With the appointments of the first and second vice ministers already finalized, the reorganization of the MOHW will be mostly complete once Jeong passes her confirmation hearing and is officially appointed as minister. This has led to speculation that the MOHW will accelerate its efforts to revive policies that have been effectively put on hold since the state of emergency was declared at the end of last year. Discussions on reevaluating foreign drug prices began in earnest at the end of 2023. The government formed a task force (TF) with the participation of the pharmaceutical industry and held a total of 10 meetings until July last year. The meetings discussed the foreign drug price reference standards, the targets for reevaluation, and the implementation date. It was decided to lower domestic drug prices in line with the adjusted average prices of the 6 countries with the highest and lowest prices among the A8 countries (the US, Japan, Germany, the UK, France, Switzerland, and Italy). The price cut will apply to 22,920 drugs listed on the drug reimbursement list, which will be divided into three categories and re-evaluated every three years. However, there were still some areas where no consensus was reached. These include the method of referencing Germany and Canada's drug prices. Ultimately, the pharmaceutical industry proposed to the government that the drug price reference standards for Germany and Canada be changed and that the drug price reduction rate be reduced by 50%. The government had originally planned to announce its final proposal by the end of last year and conduct the reevaluation in the first half of this year. It then planned to begin full-scale drug price adjustments in the second half of this year. However, all discussions were suspended after the state of emergency was declared at the end of last year. This situation continued until recently due to the impeachment of the president and early presidential elections. An industry official said, “As far as I know, there have been no official or unofficial discussions on the external reference pricing reevlautions since the last meeting last year. A new Director of the Division of Health Insurance Benefits has been appointed, but the situation remains the same.” Various scenarios proposed, ranging from “including integrated post-marketing management measures” to “excluding Germany and Canada” The pharmaceutical industry appears to be feeling burdened by the mere fact that related discussions may be restarted. An industry official said, “Although the continued uncertain state is unsettling, it is better than having a definite implementation schedule. There is an underlying hope that the discussions stay suspended for a long time.” With the implementation schedule and details still unclear, various scenarios are being raised. Some predict that the plan for the external reference pricing reevlautions will be included in the integrated post-marketing management plan and be renegotiated from scratch. This prediction is gaining traction given that President Lee Jae-myung promised to integrate and advance Korea’s post-marketing management of drug prices. In addition, there are predictions within and outside the MOHW that the government will partially accept the pharmaceutical industry's opposition. The government is expected to partially accept the pharmaceutical industry's opposition to the German and Canadian drug price reference methods and either exclude those two countries or change the reference method. On the other hand, there are also predictions that the government will push ahead with the reevaluation as originally planned. In this case, significant opposition is expected as considerable damage to the pharmaceutical industry is anticipated. A pharmaceutical industry official said, “Discussions on various pressing issues have been suspended. At present, it is difficult to predict when and how they will resume. However, it seems likely that discussions will resume in some form in the second half of this year.” The official added, “Among these, concerns about the resumed external reference pricing reevaluations are particularly high. If the re-evaluation proceeds as previously discussed, the damage is expected to be very significant. If the government decides to proceed with this, it must first once again engage in discussions with the pharmaceutical industry.”
- Company
- Lilly launches Ebglyss in Korea… sparks competition
- by Son, Hyung Min Jul 03, 2025 06:12am
- Professor Hyun-Chang Ko of the Department of Dermatology at Pusan National University Yangsan Hospital The official launch of Lilly's Ebglyss has expanded treatment options for atopic dermatitis patients in Korea. With the arrival of Ebglyss, the number of biological agents available for the treatment of atopic dermatitis in Korea has increased to three. Experts welcomed the emergence of diverse treatment options but emphasized that there is still room for improvement in terms of patient access, due to the inability to switch between different classes of drugs. On the 2nd, Lilly Korea held a press conference at the Plaza Hotel in Jung-gu, Seoul, to commemorate the domestic launch of Ebglyss. Ebglyss is a new biological agent that selectively blocks interleukin (IL)-13, a cytokine that is a major cause of atopic dermatitis. This treatment was approved in August last year as a treatment for moderate-to-severe atopic dermatitis in adults and adolescents aged 12 years and older (weighing 40 kg or more) who are not adequately controlled with topical treatments or for whom these treatments are not recommended, and was granted reimbursement starting this month. Previous atopic dermatitis treatments included Dupixent, which inhibits IL-4 and IL-13, the Janus kinase (JAK) inhibitor Rinvoq, and Adtralza, which targets IL-13. However, the introduction of Ebglyss has expanded treatment options. As atopic dermatitis is a chronic condition with no cure and a long treatment period, diverse treatment options are essential. Ebglyss has demonstrated efficacy and safety in Phase III clinical trials, including ‘ADvocate-1,’ 'ADvocate-2,‘ and 'ADhere.’ In the ‘ADvocate-1’ and ‘ADvocate-2’ studies evaluating Ebglyss monotherapy, the Ebglyss group achieved an EASI-75 response rate of 58.2% and 52.1% during the induction period (0–16 weeks), compared to 16.2% and 18.1% in the placebo group. The EASI-90 rate was 38.3% and 30.7% in the Ebglyss group, respectively, while the placebo group was 9% and 9.5%. EASI measures the severity and spread of atopic eczema. Also, after one year of maintenance therapy, the EASI-75 achievement rate in the severity group at Week 52 was 81.7%, and the EASI-90 ratio was 66.4%. These figures were higher than those in the placebo group (66.4% and 66.4%, respectively). In terms of safety, the most common adverse reactions were conjunctivitis (6.9%), injection site reactions (2.6%), allergic conjunctivitis (1.8%), and dry eyes (1.4%). Most adverse reactions were mild or moderate and did not lead to treatment discontinuation. Professor Hyun-Chang Ko of the Department of Dermatology at Pusan National University Yangsan Hospital commented, “Dupixent can be administered at two-week intervals, but extending the interval tends to reduce its efficacy. Ebglyss demonstrated sustained clinical efficacy and safety even with monthly maintenance therapy. Its long-lasting therapeutic effect also offers the advantage of greater convenience in administration.” He added, “In particular, Dupixent had a high rate of erythema and conjunctivitis, and this rate was lower in the pivotal clinical trial for Ebglyss. In terms of safety, Ebglyss did not show any notable adverse reactions compared to the placebo group.” Despite the emergence of various treatments, unmet needs remain Ebglyss is the third biological agent to enter this market. With the introduction of Ebglyss, patients, following Dupixent from Sanofi and Adtralza from Leo Pharma. However, some experts say that despite the introduction of various treatments, there are still unmet medical needs. According to domestic atopic dermatitis guidelines, systemic treatment is strongly recommended for patients with moderate-to-severe atopic dermatitis. However, while the proportion of moderate-to-severe patients among domestic atopic dermatitis patients increased from 30.9% in 2002 to 39.7% in 2019, the prescription rate for systemic immunosuppressants in this patient group remained at just 5%. Professor Min-kyung Shin of the Department of Dermatology at Kyung Hee University Medical Center, Min-kyung Shin, a professor of dermatology at Kyung Hee University Medical Center, said, “The effectiveness and side effects of each treatment may vary depending on the age and immune status of patients with severe atopic dermatitis. We are treating patients in consideration of their response to side effects such as latent tuberculosis, as well as whether the treatment can help with comorbidities, patient preferences, and clinical phenotypes.” Shin added, “Even though biological agents and JAK inhibitors are reimbursed in Korea, many patients are unable to receive optimal treatment due to financial burdens. Although it is possible to switch between biological agents and JAK inhibitors, it is still not possible to switch between treatments within the same class, so there is room for improvement.”
- Company
- Will twice-yearly Bayer's 'Eylea' become available in KOR?
- by Eo, Yun-Ho Jul 03, 2025 06:12am
- Product photo of Eylea Twice-yearly administration of 'Eylea,' used to treat eye disease, is anticipated to be possible in South Korea. The Ministry of Food and Drug Safety (MFDS) is conducting a review of the expanded indication for the administration of Bayer Korea's high-dose Eylea (aflibercept) 8 mg at intervals of up to 6-months. The approval is expected in the second half of this year. The detailed indication under review is vision disorder due to neovascular or wet age-related macular degeneration (nAMD) or diabetic macular edema (DME). Eylea 8 mg is an anti-vascular endothelial growth factor (VEGF) with increased sustainability achieved by increasing the molar dose of the existing 2 mg product by four times. This drug's 6-month interval administration obtained expanded approval from the European Commission (EC). The efficacy of Eylea's long-term administration was demonstrated through the PULSAR study, which involved macular degeneration, and through the PHOTON study, which involved DME. In the extension period (weeks 96-156) of both studies, patients randomized to Eylea 8mg at week 0 maintained their vision and anatomical improvements. Notably, 24% of nAMD patients and 28% of DME patients maintained their final treatment interval at six months after three years. The safety profile of Eylea 8mg remained favorable throughout the three years in both studies, consistent with the established safety profile of Eylea 2mg. No new safety issues were observed in the long-term safety data from either study. The data includes patients who switched from Eylea 2 mg to 8 mg at week 96. Meanwhile, high-dose Eylea was approved in South Korea in 2024 and received insurance reimbursement starting in October of the same year. The current reimbursement criteria include patients with nAMD and DME who meet the conditions of Hemoglobin A1c (HbA1c) 10% or less and a minimum central retinal thickness of 300 µm. The current dosing interval involves monthly injections for the first three months, which can then be extended up to 16 weeks, based on the doctor's judgment, following the results of a vision or anatomical examination.
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- Pharma tries to flip the returned out-licensing of new drugs
- by Son, Hyung Min Jul 03, 2025 06:11am
- New drug candidates from Korean pharmaceutical companies, which were previously returned after technology transfer, are now re-entering the clinical stage and proving their potential. Attention is focused on whether these candidates will re-label their past failures and demonstrate technological potential. According to industry sources on July 2, NOBO Medicine and Hanmi Pharmaceutical disclosed the Phase 2 clinical trial results for Poseltinib, a hematological cancer treatment under co-development. These results were presented last month at the International Conference on Malignant Lymphoma (ICML) held in Lugano, Switzerland. Poseltinib Revives after Technology Transfer Return...Targets Unmet Needs in Lymphoma Poseltinib is a Bruton's tyrosine kinase (BTK) inhibitor initially developed by Hanmi Pharmaceutical in 2010 and subsequently out-licensed to Eli Lilly in 2015 for up to US$690 million (approximately KRW 893 billion). BTK inhibitors are drugs that reversibly bind to the protein binding site of the BTK enzyme, which regulates the function of B cells and myeloid cells, thereby inhibiting its catalytic reaction. After in-licensing Poseltinib from Hanmi Pharmaceutical, Eli Lilly conducted a Phase 2 clinical trial in patients with rheumatoid arthritis but discontinued it due to a lack of confirmed efficacy. Poseltinib failed to demonstrate efficacy in clinical trials where key endpoints included improvement in rheumatoid arthritis symptoms and the incidence of drug-related adverse events. Consequently, Lilly returned the technology transfer rights to Hanmi Pharmaceutical in 2019. Hanmi Pharmaceutical signed a joint development agreement for Poseltinib with domestic biotech venture NOBO Medicine (formerly Genome Opinion) in October 2021, entering the hematological cancer treatment market. NOBO Medicine has been conducting investigator-initiated clinical trials for patients with relapsed and refractory Diffuse Large B-cell Lymphoma (DLBCL) using a triple combination therapy combining Poseltinib with Roche's Columvi and BMS's Revlimid at Seoul National University Hospital. The industry discussed the possibility of transitioning Poseltinib and developing it for hematological cancers, such as lymphoma and leukemia. It is because Janssen's BTK inhibitor Imbruvica was already launched as a treatment for mantle cell lymphoma, and sufficient safety and tolerability results had been confirmed for Poseltinib. The recently announced clinical results are from two studies: ▲Relapsed and refractory Diffuse Large B-cell Lymphoma (DLBCL) ▲Relapsed and refractory Primary Central Nervous System Lymphoma (PCNSL). DLBCL is the most common type of aggressive lymphoma, accounting for approximately 30-40% of all non-Hodgkin lymphoma patients. While the remission rate for first-line treatment is high, the prognosis is poor for relapsed or refractory patients who do not respond to existing therapies. Therefore, it has led to a continuous demand for treatments with new mechanisms of action. In the DLBCL trial, the Poseltinib combination therapy with Columvi and Revlimid achieved an objective response rate (ORR), measuring the proportion of patients who had a treatment response, such as tumor size reduction, of 84.1%. The complete response rate (CRR), representing the proportion of patients whose cancer completely disappeared, was 58.5%. In terms of safety, significant adverse events reported included Grade 3 or higher neutropenia (68.7%), cytokine release syndrome (4.8%), and cardiac arrhythmia (3.6%). RocheFor the PCNSL trial, the two companies replaced Columvi with Roche's antibody-drug conjugate (ADC) drug Polivy, an anti-cancer agent. PCNSL is a rare type of non-Hodgkin lymphoma that originates in the central nervous system, specifically in the brain and spinal cord, accounting for the majority of CNS lymphomas. This disease is difficult to treat, has a high recurrence rate, and treatment options are particularly limited in elderly patients. As it frequently recurs even after conventional chemotherapy or radiation therapy, there is a significant unmet medical need for new drug candidates with superior brain penetrability. Clinical results showed that the Poseltinib + Polivy + Revlimid combination therapy had an ORR of 55.6% and a CRR of 33.3%. The median progression-free survival (PFS), the period patients lived without their disease worsening, was 6.3 months. Although the number of enrolled patients was small at 10, these results are considered significant given the challenging indication of central nervous system lymphoma. The median overall survival (OS) has not yet been reached, and the 6-month survival rate was 88.9%. Patients were tracked without treatment discontinuation, and only one case of severe adverse event, neutropenia (11%), occurred. NOBO Medicine explains that Poseltinib, which works by selecting multiple kinases including BTK and TEC, demonstrates blockade of bypass pathways, high brain penetrability, and a low side effect profile. Yuhan·Daewoong·TiumBio, and Others Continue New Drug Clinical Trials Yuhan Corp, Daewoong Pharmaceutical, and TiumBio are also continuing clinical trials for their returned drug candidates, aiming for re-licensing or in-house commercialization. Yuhan Corp announced in March that it had received notification of termination of its technology transfer agreement and return of rights for 'YH25724', a MASH (Metabolic Dysfunction-Associated Steatohepatitis) new drug candidate, from Boehringer Ingelheim. In July 2019, Yuhan Corp signed a technology transfer agreement for YH25724 with Boehringer Ingelheim. YH25724 is a dual agonist that simultaneously targets GLP-1 and FGF21, and a technology transfer agreement was signed at the preclinical stage. Yuhan Corp announced its intention to continue developing its MASH new drug. Yuhan Corp stated, "Based on the potential to address unmet medical needs of patients and positive safety results from clinical trials, we are considering continuing the development of this candidate." Daewoong Pharmaceutical is continuing the development of 'Bersiporocin', an idiopathic pulmonary fibrosis (IPF)treatment, which was previously out-licensed to China's CS Pharmaceutical. In March, CS Pharmaceutical notified Daewoong Pharmaceutical of its intent to terminate the contract. Bersiporocin is an anti-fibrotic new drug candidate that inhibits PRS, affecting collagen production, and works by suppressing the excessive production of collagen that causes fibrosis. IPF is a type of interstitial pneumonia characterized by progressive fibrosis of the lung parenchyma. Currently, available treatments offer only limited therapeutic effects, capable only of delaying the disease, thus leaving significant unmet needs. Bersiporocin's Phase 1 clinical trial, conducted in 2022 in Korea and Australia with a total of 162 healthy adults, confirmed its safety and characterized its pharmacokinetic properties, including absorption, distribution, and metabolism in the body. The following year, Daewoong Pharmaceutical received approval for a multinational Phase 2 clinical trial and is evaluating the efficacy and safety of Bersiporocin in IPF patients aged 40 and above. This trial includes patients who are currently receiving or have discontinued approved treatments. TiumBio was notified in March this year by the Italian pharmaceutical company Chiesi of the termination of their contract and return of rights for the respiratory disease treatment development program 'NCE401'. In 2018, TiumBio signed an agreement to transfer NCE401 to Chiesi, along with an upfront payment of US$1 million. NCE401 was being developed as a new drug candidate for respiratory diseases designed to target transforming growth factor-beta (TGF-ß). However, Chiesi reportedly failed to identify a suitable candidate molecule. TiumBio's clinical trials for TU2218, which is produced using the same platform and developed as an anti-cancer drug, are progressing smoothly. TU2218 simultaneously blocks the pathways of TGF-ß and vascular endothelial growth factor (VEGF), both known to hinder immunotherapy activity. This mechanism aims to maximize the efficacy of immunotherapies. TiumBio unveiled the results of its Phase 2 clinical trial for TU2218 in combination with MSD's immunotherapy 'Keytruda' at the American Society of Clinical Oncology (ASCO) meeting held in Chicago last month. The recently disclosed trial represents early cohort results from an ongoing study in patients with head and neck cancer and biliary tract cancer. Clinical results showed that the TU2218 + Keytruda combination therapy resulted in a partial response (PR), where tumor size decreased beyond a certain standard, in 7 out of 11 patients with head and neck cancer. Stable disease (SD), characterized by no significant change in tumor size or condition, was observed in one patient. In the biliary tract cancer cohort, 4 out of 23 patients showed PR, and 7 showed SD.
- Company
- SK Bioscience invests billions in the post-pandemic era
- by Chon, Seung-Hyun Jul 03, 2025 06:10am
- SK Bioscience has taken proactive steps to discover new growth engines in preparation for the post-pandemic era. The company has invested KRW 81.5 billion to expand its vaccine plant in Andong and approximately KRW 300 billion for the acquisition of a German CDMO biotech company. The construction of its headquarters, research center, and factory in Songdo, which required an investment of KRW 300 billion, is in its final stages. SK Bioscience has recovered most of its investment by selling its stake in Novavax, which it acquired for KRW 110.2 billion. According to industry sources on the 2nd, SK Bioscience recently held a completion ceremony to celebrate the expansion of its pneumococcal vaccine production facility at its vaccine manufacturing plant, L-House, in Andong, North Gyeongsang Province. The expanded facility will be used as a manufacturing base for GBP410, a 21-valent pneumococcal vaccine candidate jointly developed with Sanofi. SK Bioscience President Jaeyong Ahn (fifth from left) and Sanofi Executive Vice President Thomas Triomphe (sixth from left) and other key executives from both companies are cutting the ribbon to mark the completion of the facility Through the expansion, SK Bioscience has secured approximately 4,200 square meters (1,300 pyeong) of new space by expanding the existing vaccine manufacturing facility at L House. The facility will be used as a production base for GBP410 and is expected to obtain certification from the US Food and Drug Administration (FDA) for its compliance with current Good Manufacturing Practice (cGMP) standards. This is the first large-scale expansion of SK Bioscience's Andong vaccine plant since its establishment. SK Bioscience invested KRW 200 billion in 2012 to construct the L House in Andong. The L House is equipped with core technologies and production facilities for cell culture, bacterial culture, and genetic recombination, enabling it to produce most vaccines that can be developed domestically. SK Bioscience has invested an additional KRW 81.5 billion for the expansion of the L House thereafter. GBP410 was jointly developed by SK Bioscience and Sanofi since 2014. It is a protein-conjugated vaccine candidate created by conjugating a specific protein to pneumococcal capsular polysaccharides, which cause pneumonia, acute otitis media, and invasive diseases. The conjugate method is known to provide the highest preventive efficacy among commercially available pneumococcal vaccines. GBP410 is currently undergoing global Phase III clinical trials in Australia, the US, and South Korea, targeting approximately 7,700 infants (6 weeks old) to adolescents (17 years old). SK Bioscience and Sanofi confirmed the efficacy and safety of GBP410 in a Phase II clinical trial that ended in August last year. In a comparison between GBP410 and the control vaccine, Pfizer's “Prevenar 13,” among 140 children aged 12–15 months and 712 infants aged 42–89 days, GBP410 demonstrated equivalent immunogenicity compared to the control vaccine. No serious adverse events related to the vaccine were reported in terms of safety. SK Bioscience plans to invest approximately KRW 200 billion by 2024 to expand the manufacturing facilities of L House, which possesses state-of-the-art vaccine production facilities such as cell culture, bacterial culture, genetic recombination, and protein conjugation, and to establish new platform facilities for mRNA and next-generation viral vectors. Apart from this expansion, SK Bioscience has purchased an additional 99,130 square meters of land in the Gyeongbuk Bio 2nd General Industrial Complex, which is currently under construction in Maegok-ri, Pungsan-eup, Andong, near the existing L-House site, and plans to further expand its manufacturing facilities. SK Bioscience is actively investing to secure new growth opportunities based on the cash accumulated through its COVID-19 vaccine contract manufacturing (CMO) activities during the pandemic. SK Bioscience announced in June that it had signed an agreement with Germany SK Bioscience acquired IDT Biologika in Germany in October last year. Through its wholly-owned subsidiary established in Germany, it acquired a 60% stake in IDT Biologika held by the German pharmaceutical and biotechnology company Klocke Group. SK Bioscience acquired IDT Biologika for a total of KRW 370 billion. SK Bioscience purchased two existing shares of IDT Biologika for KRW 222.6 billion and one new share for KRW 122.1 billion. Additionally, SK Bioscience acquired three existing shares of Technik-Energie-Wasser Servicegesellschaft mbH (TEW), a subsidiary of IDT Biologika, for KRW 22.3 billion, securing a 60% stake in TEW. The initial acquisition price for IDT Biologics by SK Bioscience was set at KRW 339 billion. Klocke Group retained a 40% stake in IDT Biologics and acquired a 1.9% stake in SK Bioscience, nd the prices of the existing shares of IDT Biologics and TEW increased slightly thereafter.. KK Bioscience decided to issue 1,519,543 new shares worth KRW 75.7 billion to the Klocke Group through a third-party allocation of new shares. The funds SK Bioscience will invest in the acquisition of IDT Biologika are estimated at KRW 294.3 billion. Founded in 1921, IDT Biologika is a large biotech company that operates contract manufacturing businesses in Germany and the United States. It has a track record recognized by more than 10 key drug regulatory agencies in the United States and Europe, and produces bulk and finished products for vaccines and biopharmaceuticals across all stages from clinical trials to commercialization, along with process and analytical method development. The company employs approximately 1,800 people. The acquisition of IDT Biologika has already shown tangible results. SK Bioscience's first-quarter sales reached KRW 154.6 billion, a sevenfold increase from 22.3 billion won in the same period last year. SK Bioscience recorded sales of KRW 61.6 billion in the third quarter of last year, but with IDT's sales reflected, sales jumped to KRW 156.8 billion in the fourth quarter, exceeding KRW 150 billion for two consecutive quarters. Of SK Bioscience's KRW 154.6 billion in sales in the first quarter, IDT’s sales accounted for KRW 118.3 billion, or 76.5%. SK Bioscience SK Bioscience is investing KRW 300 billion in Songdo, Incheon, to establish a new base. SK Bioscience signed a land purchase agreement with the Incheon Free Economic Zone Authority in December 2021. The agreement involves the construction of a global R&PD (Research & Process Development) center on a 34,138.8 square meter (approximately 9,216 pyeong) site in the 7th block, Sr14 lot of the expanded Incheon Technopark in Songdo-dong, Incheon. SK Bioscience has signed a contract with the Incheon Free Economic Zone Authority to acquire land and buildings worth KRW 33 billion. The newly established global R&PD center will house laboratories, factories, and offices for basic research, process development, and production in the vaccine and bio fields. Through the establishment of the global R&PD center, SK Bioscience plans to actively expand its global bio CDMO business and secure new platforms, while strengthening collaboration with international organizations, domestic and foreign bio companies, and research institutions. The company selected Songdo for the project due to its advantageous location, including proximity to the airport, connectivity with the existing Andong plant, and potential for synergy with nearby industrial complexes. SK Bioscience also secured cash by recovering contract manufacturing payments it made through equity investment and the disposal of its stake in its COVID-19 vaccine partner Novavax. SK Bioscience acquired 6.5 million shares of Novavax for KRW 110.2 billion in August 2023. It secured a 5.5% stake by participating in Novavax's third-party allocation of new shares. SK Bioscience plans to explore various collaborations, including utilizing Novavax's immune adjuvant ‘Matrix M,’ and to advance the development of its own vaccines. SK Bioscience's equity investment also aims to replace unpaid amounts from COVID-19 contract manufacturing payments with the equity investment. SK Bioscience will not pay Novavax’s equity acquisition price in cash. Instead, part of the unpaid amounts that Novavax owes SK Bioscience will be used as funds for acquiring shares. Accounting-wise, Novavax will pay SK Bioscience KRW 110.2 billion of the unpaid amount, with which SK Bioscience will acquire the shares. At the time, Novavax agreed with SK Bioscience to reduce the debt from USD 195 million to USD 154 million. After the equity investment, the debt size decreased to USD 65 million. SK Bioscience sold 5.5 million shares of Novavax stock for KRW 105.3 billion last year. The per-share sale price was KRW 19,147. As of the end of last year, SK Bioscience holds 1 million shares of Novavax stock. Applying Novavax's stock price of USD 6.3 as of the 1st, the stock valuation amounts to USD 6.3 million.
- Company
- AbbVie Korea launches new glaucoma treatment 'XEN 63'
- by Whang, byung-woo Jul 03, 2025 06:08am
- Product photo of XEN 63AbbVie Korea announced on July 1 that it has launched XEN 63, a new option for glaucoma treatment in patients whose intraocular pressure (IOP) is not controlled by previous glaucoma surgery or existing medicines. With the expansion of the XEN Gel Implant portfolio, including XEN 45, patients now have a wider range of personalized treatment options. According to recent statistics from the Health Insurance Review & Assessment Service (HIRA), the number of patients diagnosed with glaucoma in Korea reached over 1.2 million as of 2024, representing a more than 25% increase over 5 years from 2019 (970,000 patients). The XEN Gel Implant is a small gelatin tube designed to reduce IOP by creating a new channel to drain fluid out of the eye. Primary treatment for glaucoma involves medication. However, a study of 1,046 glaucoma patients in Korea showed that approximately 27.4% of patients did not use prescribed medications properly, indicating low patient adherence. This can increase the risk of disease progression or vision loss. Dr. Kyung-Rim Sung of the Department of Ophthalmology at Asan Medical Center in Seoul, stated, "The XEN Gel Implant is a treatment option that minimizes the surgical burden while considering both treatment efficacy and safety for glaucoma patients whose IOP was not adequately controlled with existing treatments." Dr. Sung added, "With the domestic introduction of XEN 63, which has a 63-micron inner diameter, following the 45-micron XEN 45, we expect to provide a wider range of treatment options for patients requiring surgical intervention." The XEN Gel Implant, a treatment option for patients whose IOP is not controlled by existing therapies, is a 6mm long, small tube-shaped gel implant. It can be inserted through Minimally Invasive Glaucoma Surgery (MIGS), which minimizes the incision size compared to traditional glaucoma filtration surgery. The newly launched XEN 63 is designed to have lower outflow resistance, with an inner diameter (63 μm) 1.4 times wider than that of its predecessor, XEN 45. The design makes it a suitable treatment option for patients requiring greater IOP reduction. XEN 63 demonstrated significant treatment outcomes in a multi-center, non-randomized, non-controlled prospective clinical study evaluating the efficacy and safety of XEN 63 in 80 patients with primary open-angle glaucoma whose IOP was not controlled by existing medication. Jiho Kang, Country Medical Director at AbbVie Korea, said, "Approximately 45% of glaucoma patients experience disease progression despite receiving medication. XEN 63, as a new treatment option for these patients, can provide stable and effective personalized treatment," and added, "AbbVie Korea is committed to offering more suitable treatment options for glaucoma patients in South Korea based on the XEN Gel Implant portfolio."
- Company
- Leclaza combination therapy takes over Europe
- by Moon, sung-ho Jul 03, 2025 06:07am
- Leclaza (lazertinib), a new lung cancer drug developed by Yuhan Corporation, has been officially included in the European Society for Medical Oncology (ESMO) guidelines. Reflecting the latest clinical study findings, Leclaza in combination with Rybrevant (amivantamab, Johnson & Johnson) has been included as a first-line option in the guidelines. #According to industry sources on the 30th, the European Society for Medical Oncology recently updated and announced its “Living Guidelines” for advanced epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The ESMO Living Guidelines, which reflect the latest research findings, evaluate treatment options based on the ESMO-MCBS (ESMO Magnitude of Clinical Benefit Scale, a tool for assessing the value of anticancer drugs) score and the ESCAT (ESMO Scale for Clinical Actionability of Molecular Targets, a scale for ranking the clinical relevance of genetic mutations as targets for cancer treatment) mutation-drug matching score. Accordingly, the Living Guidelines included the combination therapy of Leclaza and Rybrevant as a first-line treatment option, along with Tagrisso (osimertinib) monotherapy and Tagrisso+chemotherapy. This can be seen as a reflection of the results of the Phase III MARIPOSA study released at the European Lung Cancer Congress (ELCC) in March. According to the MARIPOSA Phase III study, the risk of death was reduced by 25% in the Leclaza-Rybrevant combination therapy group compared with the Tagrisso (osimertinib, AstraZeneca) monotherapy group (HR=0.75, 95% CI: 0.61–0.92, P
- Policy
- Pressures to reform Korea's drug pricing system
- by Lee, Tak-Sun Jul 02, 2025 06:10am
- President Trump's signing of the executive order on May 12 to lower prescription drug prices in the United States to the same level as other countries has deepened the concerns of Korea’s authorities as well. This is because the U.S. Pharmaceutical Research and Manufacturers of America and others are demanding that Korea raise drug prices and improve its system. If the U.S. government directly demands improvements to Korea's drug pricing system during tariff negotiations, this may increase the new government's concerns as there will be no clear solutions to resolving the issue, On the 27th (local time), the Pharmaceutical Research and Manufacturers of America (phRMA) submitted a statement to the US Trade Representative (USTR) urging the improvement of unfair drug pricing policies by foreign governments, including South Korea, as leverage in trade negotiations. The USTR claimed that Korea imposes difficult review requirements on foreign pharmaceutical companies, delays market entry, and suppresses drug prices below fair market value. This statement gained attention because it was released after President Trump signed an executive order on May 12, known as the most-favored-nation (MFN) policy. The MFN policy aims to lower the price of prescription drugs in the US to the same level as other countries. Under the executive order, the US Secretary of Health and Human Services must establish a program that allows US patients to purchase drugs directly from pharmaceutical companies at MFN prices. In its statement, the phRMA identified South Korea, Australia, Canada, France, Germany, Italy, Japan, Spain, the United Kingdom, and the European Union as countries with unfair drug pricing policies. These countries are likely to become MFN countries, which will serve as a reference for U.S. drug price reductions. It is analyzed that the Trump administration is likely to demand that MFN countries, with which the US pharmaceutical industry is currently engaged in tariff negotiations, improve their drug pricing systems in order to push through the reduction of prescription drug prices in the US. When President Trump signed the MFN policy executive order, he instructed the USTR and the Department of Commerce to take action to prevent other countries from unfairly lowering their drug prices below market prices. The Korean government is concerned that the US MFN policy will result in ‘Korea Passing,’ where companies bypass Korea when making new drug releases and withdraw from the market. However, during Trump's first term, the US drug price reduction policy was abandoned due to opposition from US pharmaceutical companies, so the situation requires continued monitoring. However, if the US actually demands improvements to the drug pricing system during tariff negotiations, there are no clear measures that South Korea can take in response, which is expected to increase the South Korean government's concerns. The measures the South Korean government can take include significantly adjusting the ICER (Incremental Cost-Effectiveness Ratio) threshold, and expanding risk-sharing agreement programs to adjust prices. However, given the high proportion of drug expenditures in the health insurance budget, there are limits to regulatory relaxation. Flexible application of the ICER threshold or expansion of RSA programs has already been implemented last year as part of efforts to compensate for the value of innovative new drugs. If the U.S. government pushes for significant improvements to the drug pricing system under the guise of trade pressure, the new government's health authorities would have few cards to play, leaving them with even more challenges ahead. A government official stated, “We are currently monitoring and closely watching the U.S. government's implementation of the MFN policy. We are preparing for the worst-case scenario, such as the withdrawal of U.S. pharmaceutical companies' products from the market.”
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- ‘TNF-α inhibitors, a cornerstone for rheumatoid arthritis'
- by Whang, byung-woo Jul 02, 2025 06:09am
- Rheumatoid arthritis is a chronic autoimmune condition that causes inflammation in the joints, leading to pain and deformity. Its prevalence in Korea is estimated to be approximately 0.5–1% Recently, with the development of new treatments and improved awareness of the disease, early diagnosis rates are on the rise. In fact, over the past 5 years, the number of rheumatoid arthritis patients diagnosed in Korea has increased by more than 30%, with the elderly aged 50 and older accounting for 79% of all patients, highlighting the aging population. Sang-Heon Lee, Professor of Rheumatology, Konkuk University Medical CenterAs a result, it has become important to go beyond simple treatment and focus on addressing elderly patients. Professor Sang-heon Lee of the Rheumatology Department at Konkuk University Hospital, an expert with the latest insights in the field, emphasized the importance of selecting the right treatment and management for the growing number of elderly patients with rheumatoid arthritis. According to Professor Lee, rheumatoid arthritis was once considered incurable, but with the advent of new treatments, perceptions have changed, increasing early diagnosis and treatment of the disease in general. Professor Lee said, “With the message that rheumatoid arthritis is a treatable disease spreading, early diagnosis rates are also increasing. In the past, we only checked the condition of the patient's joints with the naked eye, but the development of imaging diagnostic technologies such as joint ultrasound and MRI, rendered early diagnosis possible.” Another change is that, along with the overall aging population, the proportion of elderly patients with rheumatoid arthritis is also increasing. Professor Lee explained that elderly patients require a multifaceted approach to treatment, including management of complications, compared to younger patients. He emphasized, “Just as machines lose functionality over time, elderly patients often have multiple comorbidities due to the decline of various bodily functions. Complications such as cardiovascular disease, cerebrovascular disease, and diabetes are common, and immune function is also impaired, so caution is necessary when using immunotherapy agents.” 10 Years since the launch of Simponi IV Formulation, GO-FURTHER study results gain attention The emergence of TNF (tumor necrosis factor)-α inhibitors is an indispensable part of the paradigm shift in the treatment of rheumatoid arthritis. These drugs have been used in clinical practice for more than 25 years and are still considered effective in treating approximately 70% of all patients. Professor Lee stated, “The various treatment options developed since then have established themselves as alternatives for patients not adequately treated with TNF-α inhibitors. As such, TNF inhibitors remain the cornerstone of rheumatoid arthritis treatment. Even after patent expiry, biosimilars for TNF-α inhibitors are being launched most actively.” Among such TNF-α inhibitors, Simponi (golimumab) was introduced in Korea in 2012 as a subcutaneous (SC) injection formulation, and in May 2015, an intravenous (IV) injection formulation was launched, offering faster symptom improvement, longer dosing intervals, and easier monitoring by healthcare professionals, and establisehd a strong market presence. Professor Lee explained, “Simponi IV is a TNF-α inhibitor developed as a fully human monoclonal antibody, offering superior antibody purity and significantly reduced injection-related adverse reactions. While infliximab requires approximately two hours for administration, Simponi can be administered in about 30 minutes, and the dosing interval is every two months, significantly reducing the number of clinic visits.” Professor Lee is particularly interested in the advantages of Simponi for the increasing number of elderly patients with rheumatoid arthritis. A subanalysis of the GO-FURTHER study showed that Simponi IV showed more improvement in elderly patients aged 65 years or older. Specifically, in a subanalysis of the GO-FURTHER study that divided patients with active rheumatoid arthritis into two groups—those under 65 years of age and those 65 years of age and older—Simponi demonstrated higher initial symptom improvement compared to the placebo group in the elderly patient group during the first 6 months. At week 14, 61.0% of patients achieved ACR20, which was approximately six times higher than the placebo group (11.1%), and at Week 24, 69.5% of patients achieved ACR20, demonstrating significant clinical value of Simponi compared to the placebo group (33.3%). Professor Lee said, “Although the overall numerical differences were not significant in younger patients, there were more meaningful differences in response speed and response rates in high-risk patients. Elderly patients often have reduced physical function due to inflammation, so when they respond to treatment, the improvement is much greater. In this regard, Simponi has clinical advantages for elderly patients.” In terms of safety, Simponi IV did not show any new concerns in elderly patients. He said, “Generally, super-elderly patients over the age of 70 are at high risk of infection, so careful monitoring is necessary regardless of the drug used. The safety data for Simponi in elderly patients is generally consistent with previous reports, and injection-related side effects were rare and mostly mild.” “More treatment options emerge for rheumatoid arthritis... TNF-α inhibitors remain the cornerstone” From a broad perspective, the development of new drugs with various mechanisms of action for the treatment of rheumatoid arthritis has led to a wider range of options. In this regard, Professor Lee predicted that TNF-α inhibitors will remain competitive due to their accumulated treatment experience and safety data. Professor Lee stated, “At present, TNF-α inhibitors will continue to maintain their position as the cornerstone of rheumatoid arthritis treatment because of their over 25 years of accumulated clinical experience and identification of most major side effects, which allow physicians to prescribe them with confidence.” While new oral treatments like JAK inhibitors have emerged, concerns about long-term safety mean that TNF-α inhibitors remain the most trusted treatment option at this point. “JAK inhibitors are highly effective, but as they regulate intracellular signaling, there are concerns about long-term safety, such as cancer development. At least 5 to 10 years of additional data will be required to verify this.” In addition, Professor Lee emphasized the importance of personalized treatment for rheumatoid arthritis. He explained, “While most patients are initially prescribed TNF-α inhibitors as first-line therapy, they may not be suitable for all patients. In cases where there are contraindications for TNF-α inhibitors, such as a history of tuberculosis or heart failure, alternative medications with different mechanisms of action are considered.” Ultimately, the strategy of selecting the optimal medication based on the patient's individual condition and risk factors, and switching medications when necessary, is crucial. Finally, the professor noted, “While anyone can prescribe medications, managing complications or the progression of comorbidities associated with aging, as well as appropriately addressing side effects, requires the experience and knowledge of specialized medical professionals. Early treatment that strongly suppresses inflammation in the initial stages can prevent disease recurrence and enable long-term management. Therefore, it is crucial to extinguish the inflammatory ‘sparks’ in the early stages through prompt treatment.”
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- K-CAB·Entresto awaiting the Supreme Court rulings
- by Kim, Jin-Gu Jul 02, 2025 06:09am
- Patent disputes involving blockbuster drugs, K-CAB (tegoprazan) and Entresto (valsartan/sacubitril), are reaching their final stages. Observations suggest that the Supreme Court's final ruling could come as early as the second half of this year. K-CAB's annual prescription sales amount to KRW 200 billion, while Entresto's are KRW 70 billion. In other words, the patent barriers for these blockbuster drugs could be lifted, depending on the Supreme Court's decision. K-CAB Crystal Form and Substance Patent Disputes Head to Supreme Court… Will KRW 200 Billion Patent Barrier Be Lifted? Product photo of K-CABAccording to the pharmaceutical industry on July 2, HK inno.N and generic companies are awaiting the Supreme Court's ruling in their disputes over K-CAB's substance patent and crystal form patent. For the crystal form patent, generic companies won both the first and second instances. Approximately 80 companies filed declaratory judgment actions to circumvent K-CAB's crystal form patent and won in the first instance. Generic companies continued their winning streak in the second trial following HK inno.N's appeal. HK inno.N, having lost in the second trial, chose to appeal to the Supreme Court. Cases were successively filed with the Supreme Court starting in March this year. In May, a presiding Supreme Court Justice and the presiding panel were assigned. The panel is currently reviewing the legal arguments for the appeal. Industry observers predict that a Supreme Court ruling could come as early as this year. In contrast, in the substance patent dispute, HK inno.N has consistently won. The Intellectual Property Court of Korea has issued successive rulings in favor of HK inno.N since May this year. Generic companies that lost in the second trials have submitted appeals to the Supreme Court. In some appeals, the Supreme Court's final judgment has already been rendered. In May, the Supreme Court dismissed the appeals filed by generic companies without deliberation, upholding the original judgment. Dismissal without deliberation is a system in which the Supreme Court rejects an appeal without conducting a full review of the merits if it determines that there are no specific grounds, such as legal violations, in the original judgment. However, an analysis suggests it is difficult to interpret this as HK inno.N having definitively secured victory in the substance patent dispute. This is because if generic companies present arguments different from those of LitePharmTech and HLB Pharmaceutical, there remains a possibility for the Supreme Court to initiate a full review of the merits. In such a case, some view that the final ruling could change. The timing of the early launch for generics will be determined by the Supreme Court's final ruling on both the crystal form patent and substance patent disputes. This means that the patent barrier for K-CAB, which has grown to an annual market size of KRW 200 billion, could be lifted as early as this year. K-CAB's substance patent is set to expire in August 2031, and its crystal form patent is scheduled to expire in March 2036. If the Supreme Court rules in favor of the generic companies in both the substance patent and crystal form patent disputes, generic companies could launch their products immediately. In contrast, if, as in the first and second instances, generic companies win the crystal form patent dispute and HK inno.N wins the substance patent dispute, the generic launch date would be August 2031. If the Supreme Court rules in favor of HK inno.N in both the crystal form patent and substance patent disputes, a generic launch would not be possible until 2036. Entresto Patent Dispute Nearing Conclusion with One Case Each Pending in 2nd·3rd Trials...Crystal Form Patent Appeal is Key Product photo of EntrestoThe Entresto patent dispute is also heading towards its final stages. Generic companies filed invalidation and declaratory judgment actions against six Entresto patents starting in January 2021. Generic companies won all cases in the first trial. After losing in the first trial, Novartis appealed three of the six patents. Novartis lost the appeal related to the use patent. Novartis subsequently appealed to the Supreme Court but received a dismissal without deliberation ruling in April last year. With this, generic companies have overcome the use patent, which expires in July 2027. Novartis also lost the appeal related to the crystal form patent and appealed to the Supreme Court. In April this year, the deliberation period expired. This means that, unlike the use patent dispute, a full review of the merits will proceed, and a ruling could potentially come within the year. The appeal for the salt·hydrate patent is still pending in the second trial. A hearing date has not yet been set. Industry observers predict that once a ruling is issued for the crystal form patent appeal, a ruling of similar conclusion will follow. If the crucial crystal form patent appeal ruling is handed down this year, the possibility of a generic early launch will further increase. Entresto's crystal form patent is set to expire in September 2040. The salt·hydrate patent is set to expire in November of next year. Suppose the Supreme Court rules in favor of the generic companies in the crystal form patent appeal, as in the first and second instances. In that case, the challenging companies can launch their products immediately. Although the salt·hydrate patent dispute is still ongoing, the product launch becomes possible based on the victory in the first trial. Once the salt/hydrate patent expires in November next year, related risks will also be resolved. Dukarb Patent Dispute Nearing Conclusion...Will Zemiglo Dispute End in 2nd Trial? Patent disputes surrounding Boryung's hypertension combination drug Dukarb (fimasartan/amlodipine) and LG Chem's diabetes treatment Zemiglo (gemigliptin) are also nearing their conclusions. In the case of Dukarb, a Supreme Court ruling was recently issued. The Supreme Court remanded the Dukarb patent invalidation lawsuit appeal on the 26th of last month. This overturned the second trial ruling and sided with the generic companies. Following the Supreme Court's decision, the Dukarb patent dispute will be re-litigated at the original court, the Intellectual Property Court of Korea. The pharmaceutical industry expects that since the Supreme Court found legal issues in the second trial's judgment, the Intellectual Property Court of Korea is highly likely to overturn its previous ruling and side with the generic companies. Once the Intellectual Property Court of Korea issues ruling, the Dukarb patent dispute, which has lasted over four years, will effectively conclude. If generic companies secure a final victory at the Intellectual Property Court of Korea, the launch of generics for Dukarb's core 30/5mg dosage product will become possible. Dukarb was launched in four dosages: ▲30/5mg ▲30/10mg ▲60/5mg ▲60/10mg. Among these, the 30/5mg dosage is reported to account for over 60% of Dukarb's total sales. Furthermore, the combination composition patent, which is at the heart of the Dukarb dispute, applies only to this dosage. Generic companies launched Dukarb generics after the expiration of the fimasartan single-agent (Kanarb) substance patent in February 2023. However, generics for the 30/5mg dosage could not be launched due to the combination composition patent. As a result, Dukarb generics have struggled to gain traction in the prescription market. In Q1 this year, the combined prescription sales of Dukarb generics amounted to only KRW 700 million. The Zemiglo patent dispute is nearing its second trial ruling. The Intellectual Property Court of Korea has scheduled the verdict for the Zemiglo patent invalidation lawsuit for the 21st of next month. Generic companies filed invalidation trials and declaratory judgment actions against the Zemiglo use patent starting in May 2023. Generic companies prevailed in the first instance. The Intellectual Property Trial and Appeal Board issued rulings in favor of the generic companies in April and September 2024, respectively. LG Chem appealed. Generic companies also won in the subsequent appeal. The Intellectual Property Court of Korea sided with the generic companies in the appeal against the declaratory judgment ruling. LG Chem decided not to appeal this ruling to the Supreme Court. The appeal against the patent invalidation ruling is scheduled for a verdict next month. Some in the industry predict that even if generic companies win in the second trial, LG Chem will likely forgo appealing to the Supreme Court. This is because LG Chem had already lost and chose not to appeal the previous judgment related to the declaratory order. This ruling could significantly accelerate the launch of Zemiglo generics. The Zemiglo use patent, challenged by generic companies, expires in October 2039. In addition to this patent, two other patents remain: a salt·hydrate patent that expires in October 2031 and a substance patent that expires in January 2030.
