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- 2025-12-20 16:09:59
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- PKU drug Sephience receives orphan drug designation in KOR
- by Eo, Yun-Ho Jul 07, 2025 06:10am
- Sephience, a new drug for phenylketonuria (PKU), a rare metabolic disorder, has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety recently announced so through a public notice. Specifically, the drug is indicated for the treatment of hyperphenylalaninaemia (HPA) in adult and pediatric patients with phenylketonuria (PKU). Sephience (sepiapterin), which was developed by U.S. biopharmaceutical company PTC Therapeutics, recently received marketing authorization from the European Commission and is currently undergoing approval procedures with the U.S. FDA. More specifically, the drug is an oral formulation of tetrahydrobiopterin, a critical enzyme cofactor involved in the metabolism of various biological substances. Tetrahydrobiopterin is known to reduce phenylalanine levels in the blood of patients with phenylketonuria. The efficacy of Sephience was confirmed in the Phase III APHENITY trial. In the trial, the phenylalanine levels in the sepiapterin arm decreased by an average of 63%. In detail, 84% of patients achieved phenylalanine levels below 360 µmol/L, which is the target level according to treatment guidelines, and the majority of participants successfully controlled their levels. Meanwhile, phenylketonuria is an autosomal recessive metabolic disorder caused by a deficiency of the enzyme that breaks down phenylalanine, which is present in proteins at levels of 2% to 5%. This deficiency leads to seizures and developmental disorders. Patients born with this congenital deficiency of the enzyme are known to have congenital impairments compared to the general population, resulting in intellectual disabilities, light brown skin and hair, and seizures. Early diagnosis and treatment during infancy are essential, and patients are required to follow a lifelong diet restricted in phenylalanine. If left untreated, elevated phenylalanine levels in the blood can lead to hyperphenylalaninemia, causing severe damage to the brain, liver, heart, and kidneys over time.
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- ‘Need to institutionalize reinvestment of funds into R&D'
- by Kim, Jin-Gu Jul 07, 2025 06:09am
- A recommendation was made for the implementation of a system that reinvests the savings from drug price reductions by pharmaceutical and biotech companies into R&D for new drugs and ensures a fixed price during the early stages of a new drug's market launch. Professor Jeonghoon Ahn of the Department of Convergence Health Sciences at Ewha Womans University stated in an issue report published by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) on the 3rd, “Post-marketing price management and R&D support must be designed to achieve policy coherence,” and proposed, “A predictable environment must be established to build a virtuous cycle in the pharmaceutical and biotech industry.” “Reinvesting savings from drug price cuts into R&D…differentiated price cut rates should be applied based on investment scale” Professor Ahn emphasized the need to move away from the dichotomy of viewing drug price cuts as a simple cost-cutting measure. He explained that a system should be established to encourage companies to reinvest the funds saved from drug price cuts into R&D. Professor Ahn proposed the institutionalization of a “drug price cut reinvestment system” as an alternative. He predicted that this system would enable efficient fiscal management without stifling industrial growth. Specifically, he proposed ▲differentiating drug price reduction rates based on the scale of a company's R&D investment, ▲institutionalizing the reinvestment of funds saved through drug price reductions into R&D, and ▲establishing a new program where the government and private sector jointly support high-risk stages of research such as Phase III clinical trials and allow recover of a certain portion of their support through sales upon success. Ahn also said that a system to guarantee the initial drug price of new drugs for a certain period of time is necessary. Similar to Japan's “price maintenance premium” system, this system guarantees drug prices for a certain period of time after the launch of a new drug and limits excessive price reductions during the patent period. Ahn also suggested that government-funded R&D should be reflected in drug pricing by allowing cost-based pricing for new drugs, and that a risk-sharing agreement should be established to enable companies to recover their investment. “Failed research should also be granted tax credits... Overall improvement of tax incentives is necessary” Along with improving the drug pricing system, Professor Ahn diagnosed that overall improvement of tax policies is necessary. In particular, he emphasized that failed research should also be included in tax credits, considering the possibility of failure in new drug development. In addition, he argued that tax support should be expanded for costs incurred during Phase III clinical trials, such as patient recruitment, CRO contracts, and data analysis. Furthermore, he noted the need for flexibility across the board in the system, including: ▲recognition of costs for purchasing clinical trial drugs and animals as material expenses; ▲clarification of criteria for verifying overseas clinical trial costs; and ▲relaxation of registration requirements for research institutes engaged in commissioned or joint R&D. Additionally, they suggested that the following issues should be reviewed: ▲reflecting the payment structure for each clinical stage in tax laws; ▲applying an exception to the minimum corporate tax rate based on the scale of R&D investment; ▲expanding the scope of tax credit carryover; ▲applying preferential tax rates on patent revenues earned through the introduction of a patent box system; and ▲shortening the depreciation period for research equipment. Professor Ahn said, “Given the high level of uncertainty in the pharmaceutical and bio industry, there must be substantial tax incentives for companies to decide on bold investments from a long-term perspective,” adding, “Tax and drug price systems must be organically linked for a virtuous cycle of R&D reinvestment to function.” “Risks of new drug development must be mitigated through predictable systems…Post-marketing management system needs reform” Professor Ahn pointed out that the current post-marketing drug price management system causes uncertainty in companies' R&D decision-making. Ahn criticized that the price-volume price linkage system and the actual transaction price reduction system are operated in a fragmented manner, resulting in repeated price reductions for certain items. They also pointed out that the drug price calculation and reduction criteria are unclear, making it difficult for companies to predict. To address these issues, he emphasized the need for structural improvements, including: ▲integrating the implementation timeline of the post-marketing drug price management system; ▲introducing an “R-zone” in the actual transaction price-based price reduction system; and ▲mitigating the concentration of price reductions on specific drug formulations. Professor Ahn stated, “The drug price management system and tax support measures must be designed in a predictable form so that companies can confidently invest in new drug development. This could lead to the enhancement of technological capabilities and global competitiveness in the domestic pharmaceutical and biotechnology industry.”
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- 'Tecentriq' reattempts at lung cancer adjuvant therapy reimb
- by Eo, Yun-Ho Jul 04, 2025 06:06am
- Product photo of Tecentriq 'Tecentriq,' immunotherapy for cancer, will be submitted again for expanded insurance reimbursement of adjuvant therapy for lung cancer. According to our press coverage, Roche Korea applied for expanded reimbursement of its PD-L1 inhibitor Tecentriq (atezolizumab) and is awaiting review by the Cancer Disease Review Committee (CDRC) of the Health Insurance Review & Assessment Service (HIRA). It is their third attempt. The detailed indication that the company is applying for expanded reimbursement is 'adjuvant therapy after resection and platinum-based chemotherapy for Stage II-IIIA non-small cell lung cancer (NSCLC) where PD-L1 is expressed in 50% or more of tumor cells (TC).' Tecentriq was first submitted to the CDRC in May 2023; however, at that time, reimbursement criteria for the drug had not been established. Then, the company made a second attempt, but it did not pass the CDRC in July of last year. At that time, Roche presented overall survival (OS) improvement results at the American Society of Clinical Oncology (ASCO) meeting, but the company did not receive the outcome. Consequently, it is to be watched whether Tecentriq receives a different outcome at the third attempt. Meanwhile, Tecentriq is indicated for various types of lung cancer and was the first immunotherapy to be approved for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide (chemotherapy). Furthermore, it continues to conduct various clinical studies to address unmet medical needs in advanced or metastatic NSCLC, either as a monotherapy or in combination with other targeted therapies, chemotherapy, or immunotherapies. NSCLC is a key lung cancer type that accounts for approximately 85-90% of lung cancer, which is the leading cause of cancer death in Korea. A significant number of patients are diagnosed at the locally advanced or metastatic stage, and about half of NSCLC patients who undergo complete resection still experience cancer recurrence after surgery. NSCLC poses a heavy burden on these patients.
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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.”
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- 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.”
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- 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.
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- 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
