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- 2025-12-17 22:05:11
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- Eylea high-dosage PFS formulation wins nod in Korea
- by Whang, byung-woo Aug 29, 2025 06:04am
- Bayer Korea announced on August 28 that it has received domestic approval for 'Eylea PFS 8mg (aflibercept),' a pre-filled syringe formulation, from the Ministry of Food and Drug Safety (MFDS). The indication for 'Eylea PFS 8mg' has been approved the same as that for the existing Eylea vial formulation. Now, it can be administered more simply and accurately. This drug is indicated for the treatment of visual impairment due to neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). Additionally, the Eylea PFS 8mg comes with Bayer's PFS device, OcuCLICK. OcuCLICK is designed to mechanically inject the recommended dose of 0.07ml precisely into the vitreous cavity, helping to shorten injection preparation time for healthcare professionals and minimize dosing errors. This mechanism enhances the accuracy and convenience of the procedure, providing a safe administration environment for both patients and healthcare providers. Eylea 8mg has a molar dose four times higher than the previous version, allowing it to maintain an effective concentration in the eye for an extended period. After monthly injections for the initial three months, the injection interval can be extended up to 20 weeks, depending on the patient's condition. The latest PFS formulation is expected to reduce the number of injections for patients, thereby easing their treatment burden, while also improving the efficiency of procedures for healthcare professionals. Hyun-Mi Han, Lead of Ophthalmology Therapy Portfolio at Bayer Korea, stated, "Eylea PFS 8mg is a significant advancement that not only improves patients' treatment experience but also brings about a groundbreaking shift in the medical paradigm," and added, "As a leader in the ophthalmology field, Bayer will continue to provide innovative solutions that reduce the burden on patients and healthcare professionals, in response to the growing demand from patients with nAMD and DME due to the super-aging population." Meanwhile, Eylea PFS 8mg has been approved and launched in major markets, including the EU, Japan, and Canada, and is being utilized in real-world clinical practice.
- Company
- "200-day extension for the CMV preemptive therapy Prevymis"
- by Whang, byung-woo Aug 28, 2025 06:10am
- Prevymis (letermovir), a treatment for preventing cytomegalovirus (CMV) infection in allogeneic hematopoietic stem cell transplant patients, is bringing in another paradigm shift as it has entered the '200-day extension criteria.' This drug's influence is expected to grow as the National Health Insurance (NHI) coverage period has been extended from the previous 100 days post-transplant to 200 days. DailyPharm met with Professor Dong-Gun Lee of Seoul St. Mary's Hospital's Division of Infectious Diseases (President of the Korean Society of Infectious Diseases) to discuss the significance of Prevymis's reimbursement and future challenges. The launch of Prevymis has brought a paradigm shift in infection management Professor Dong-Gun Lee of Seoul St. MaryCMV is a type of herpesvirus that lies dormant in the human body. Although it's common enough that 95% of Korean adults are seropositive for its antibodies, it is one of the most fatal infections for patients with weakened immunity due to hematopoietic stem cell transplantation or other factors. Notably, CMV is reactivated in about two-thirds of patients within the first three to four months post-transplant. This can lead to serious complications such as pneumonia, gastroenteritis, retinitis, myelitis, and myelosuppression, and in some cases, can result in death. Prevymis was approved by the Ministry of Food and Drug Safety (MFDS) in 2018 and approved for reimbursement in Korea in September of the same year. It is regarded as leading a paradigm shift from a preemptive therapy, defined as administering antiviral drugs to prevent infection, to a preventive therapy using Prevymis. Professor Lee explained, "Typically, in 5 out of 10 allogeneic hematopoietic stem cell transplant patients, CMV is reactivated, and they endure lengthy anti-cancer treatments of up to 9 months and multiple hospitalizations before transplantation." He added, "Among existing antivirals, ganciclovir is an intravenous injection, requiring re-hospitalization for administration. Even with the oral valganciclovir, severe side effects like leukopenia often made it difficult to avoid hospitalization." In this context, Professor Lee explained, Prevymis, which is available in both injectable and oral formulations and has a low toxicity burden, made it possible to continue preventive treatment without hospitalizing the patient. It is particularly praised for its significant role in improving patient survival rates and treatment success rates by reducing the CMV reactivation rate to less than one-third of what it was, thereby significantly delaying the occurrence of CMV disease and the associated risk of death. According to Professor Lee, when Prevymis was administered preventively, the reactivation rate within 100 days was lowered to about 5-6% in a U.S. clinical trial, and it was confirmed to be around 12-13% in data from Seoul St. Mary's Hospital. Professor Lee stated, "If acute graft-versus-host disease (GVHD) occurs within approximately 100 days post-transplant, the patient's immune function is compromised, not only leading to CMV reactivation but also increasing the risk of other infections." He added, "If CMV is prevented during this period with Prevymis, the occurrence of CMV infection and related complications can be reduced." Extended Prevymis Administration Shows Clear Efficacy, Prevents CMV Reactivation There were also limitations to the 100-day prevention regimen with Prevymis. While the CMV reactivation rate decreased from the previous 50% to approximately 11-12% when Prevymis was administered for up to 100 days, the reactivation rate rose again once the drug was discontinued. Data from Seoul St. Mary's Hospital showed that approximately one-third of patients experienced CMV reactivation between 100 and 200 days after completing the 100-day prevention regimen. This means that since immunosuppression persists for up to six months post-transplant, and the risk of other viral or fungal infections remains high, patients can be exposed to various infection risks if there is a gap in preventive medication. Professor Lee emphasized, "Extending the administration period to 200 days lowers the reactivation rate that occurs after 100 days to about 11%." He added, "This means that depending on how long Prevymis is administered, the timing of CMV reactivation can be delayed accordingly." Based on this, the criteria for Prevymis reimbursement were expanded from 100 days to 200 days, effective June 1. Reimbursement is limited to high-risk adult patients who are CMV seropositive after allogeneic hematopoietic stem cell transplantation. Professor Lee stated, "High-risk groups include patients with GVHD or those who received high-intensity conditioning regimens, and these are the patients eligible for the 200-day extended administration." He added, "In fact, more than 7-8 out of 10 hematopoietic stem cell transplant patients at Seoul St. Mary's Hospital fall into the high-risk group, and most of them receive extended Prevymis administration for up to 200 days." In a pivotal Phase 3 study, which served as the basis for Prevymis's expanded reimbursement, the patient group that continued the prevention regimen for up to 200 days showed a 16.1% lower incidence of CMV infection compared to the placebo group. It also demonstrated a safety profile comparable to that of the placebo group during long-term administration. Professor Lee emphasized, "During the recovery period, when immunity is compromised, there is a high risk of co-infections with other infectious diseases (respiratory viruses, other bacteria or viruses, and fungal infections) in addition to CMV. Extending Prevymis administration to 200 days to prevent CMV reactivation until the immune system recovers can also contribute to reducing the possibility of co-infections." Despite expanded reimbursement criteria, unmet needs remain However, challenges still exist. According to the reimbursement criteria, extended administration beyond 200 days is not possible for patients who are not classified as high-risk. In clinical practice, the high-risk status is meticulously evaluated around the 100-day mark to decide whether to extend the administration. The problem arises in cases where patients are not high-risk at 100 days and stop taking the drug, only to see their risk increase later due to GVHD or other factors. Professor Lee pointed out that under the current criteria, Prevymis cannot be re-administered to the same patient once it has been stopped. This results in an unmet need, as patients who require ongoing treatment are unable to receive it. He stated, "Although continued administration would be clinically beneficial, there are actual cases where we cannot use Prevymis due to concerns about reimbursement cuts," and added, "Ultimately, these patients are exposed to the risk of CMV reactivation when their immunity is suppressed." Overseas, there are reports of re-administering Prevymis within 200 days after a temporary treatment with other drugs. However, Professor Lee advised that this is not easy in Korea due to concerns about reimbursement cuts, necessitating additional institutional improvements. Finally, as President of the Korean Society of Infectious Diseases, Professor Lee emphasized the need for a change in the public perception of preemptive or preventive drug administration for infectious diseases, which is often viewed as drug misuse or abuse. Professor Lee explained, "For patient groups with severely compromised immunity, such as transplant or cancer patients, treating the disease after it has occurred is too late and dangerous," and added, "Preventive treatment for diseases with a high risk of onset is a matter of life and death for patients." Professor Lee added, "Perceiving this as drug misuse overlooks the characteristics of infectious diseases and the reality of high-risk patients. Given that a significant portion of antibiotic misuse is in non-medical areas like livestock farming, we need to adjust the perception that attributes the cause of antibiotic resistance solely to doctors' misuse."
- Company
- Kolon Pharma's active portfolio expansion…new drug·co-dev
- by Son, Hyung Min Aug 28, 2025 06:10am
- Kolon Pharma is increasing its efforts to secure competitiveness in immunology and oncology by combining new drug in-licensing with in-house R&D. Following the introduction of treatments for chronic obstructive pulmonary disease (COPD) and allergies, the company has recently secured a new drug for hypoparathyroidism. Kolon Pharma plans to continuously expand its portfolio through its own pipelines and co-development of new anti-cancer drugs. Active In-Licensing of Drugs for Immune Diseases According to industry sources, on August 27, Kolon Pharma recently secured the exclusive domestic sales rights for 'YORVIPATH,' a treatment for hypoparathyroidism, from Ascendis Pharma of Denmark. YORVIPATH is an innovative new drug that received approval in Europe in 2023, the U.S. in 2024, and Australia this year. Hypoparathyroidism is a rare disease in which a lack of parathyroid hormone (PTH) disrupts the balance of calcium and phosphorus in the blood. Until now, patients have relied on taking dozens of calcium and active vitamin D tablets a day, but this has been problematic due to the long-term strain on the kidneys and incomplete symptom control. YORVIPATH is characterized by a mechanism that addresses the fundamental cause of the disease by naturally secreting PTH over 24 hours. Following its FDA approval, over 3,000 patients are receiving treatment as of Q2 2025. Commercialization is also expanding in Europe and Australia. COPD dual comb therapyKolon Pharma's new drug-licensing strategy has already been proven effective in immunological diseases, such as COPD and allergies. The company in-licensed the COPD combination products Foster (dual comb therapy) and Trimbow (triple comb therapy) from Italy's Chiesi, securing domestic approval in 2019 and establishing them in the market after reimbursement. In 2020, Kolon Pharma introduced Bilastine from Spain's Faes Farma, creating a new dynamic in the domestic allergy treatment market. Bilastine is a new antihistamine drug that is currently sold in over 100 countries. Kolon Pharma has also in-licensed new drugs in the gastroenterology and dermatology sectors. In 2011, the company launched Clipper SR Tabs, a locally-acting oral steroid for ulcerative colitis, in Korea. In 2012, Kolon Pharma also introduced Veregen Ointment, an HPV (human papillomavirus) treatment based on green tea extract, strengthening its dermatology and urology drug lines. Veregen Ointment has established itself as a differentiated treatment option, as it has been proven to not only treat common warts but also reduce the recurrence rate. Kolon Pharma Continues Co-Development and In-house New Drug Development Efforts Kolon Pharma is not stopping at simply in-licensing in the immunological field. The company is also strengthening its own capabilities in new drug development. In 2023, Kolon Pharma signed a co-development agreement with GBiologics for GB930, a treatment for systemic lupus erythematosus. Kolon Pharma signed a co-development agreement with Gbiologics for the treatment of systemic lupus erythematosus GB930 is a new drug candidate based on a stabilized galectin-9 protein, which has a dual-action mechanism that simultaneously suppresses B cells and plasmacytoid dendritic cells. The two companies aim to submit an Investigational New Drug (IND) application to the U.S. FDA and are also open to global out-licensing opportunities. Kolon Pharma is also venturing into the development of new anti-cancer drugs. Last year, the company partnered with Estrium, a small molecule drug development company, to co-develop AON-MB23, a new drug for triple-negative breast cancer (TNBC). AON-MB23 is a new drug candidate that offers new possibilities for TNBC, for which treatment options are limited. Preclinical studies are underway to submit an IND in 2027. TNBC is an aggressive subtype that accounts for 15-20% of all breast cancers, making it an area of great interest in the global market due to high treatment demand. Additionally, Kolon Pharma partnered with Aptamer Sciences last year to co-develop the Antibody-Drug Conjugate (ADC) candidate 'AST-203.' The two companies plan to conduct clinical studies on AST-203 to secure a pancreatic cancer indication. AST-203 targets the TROP2 protein, which is primarily expressed in breast, pancreatic, gastric, and lung cancers. This new drug candidate has a mechanism that selectively binds to TROP2-positive tumors, penetrates the cell, and releases the cell-division-inhibiting drug MMAE, thereby inducing cancer cell death. In addition to co-development, Kolon Pharma is also securing its medium- to long-term growth engines through in-house new drug development. Active compound identification and optimization for PBS203, an in-house development project, was completed in 2021, and the project entered the CMC (Chemistry, Manufacturing, and Controls) and preclinical stages in 2022. After submitting an IND in 2023, it entered the clinical stage, with clinical trials having been underway since last year. Currently, PBS203 is in clinical trials for solid tumors, including pancreatic and colorectal cancer. Kolon Pharma is also developing PBL201 and PBL211 for major solid tumors, such as pancreatic cancer and melanoma.
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- New ADC drug introduced…expands treatment options
- by Son, Hyung Min Aug 28, 2025 06:09am
- New global drugs are awaiting entry into Korea’s antibody-drug conjugate (ADC) market one after another. Following Daiichi Sankyo Korea's application for domestic approval of the ADC anticancer drug ‘Datroway,’ AbbVie Korea is also proceeding with the approval process for its ovarian cancer-targeted ADC ‘Elahere.’ The industry anticipates that the commercialization of these two new drugs will significantly accelerate the competitive landscape for ADCs in Korea. According to industry sources on the 25th, Daiichi Sankyo Korea has completed its application for the domestic approval of its ADC anticancer drug Datroway and is awaiting approval. The indication is for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. The company expects approval early next year. ADC anticancer drug Datroway Dartroway is an ADC being co-developed by Daiichi Sankyo and AstraZeneca. AstraZeneca has prior experience commercializing the HER2-targeted ADC ‘Enhertu’ with Daiichi Sankyo. Previously, AstraZeneca secured the development and sales rights for Enhertu through a total USD 6.9 billion (KRW 8.418 trillion) contract with Daiichi Sankyo. In 2020, AstraZeneca paid Daiichi Sankyo USD 1 billion (KRW 1.22 trillion) as an upfront payment to obtain the development rights for Datroway. The total contract value, including development milestones and commercialization milestones, amounts to USD 6 billion (KRW 7.32 trillion). TROP2, which Datroway targets, is rapidly emerging as a global ADC target. The TROP2 protein is overexpressed in various cancers, including breast cancer and non-small cell lung cancer. Datroway binds to this protein and delivers a cytotoxic drug into cancer cells, inducing cell death. It maintains the efficacy of existing cytotoxic anticancer drugs while reducing damage to normal cells. The first novel drug to reach commercialization with this mechanism was Gilead's Trodelvy. Trodelvy has been approved as a TROP2-targeted breast cancer treatment in the US, Europe, and South Korea. Subsequently, Datroway entered the market, adding indications for breast cancer and non-small cell lung cancer. Datroway demonstrated efficacy in the Phase III TROPION-BREAST01 clinical trial. This study was a randomized 1:1 trial comparing the Datroway group with the investigator-selected chemotherapy group (eribulin, vinorelbine, capecitabine, or gemcitabine) in patients with previously treated, unresectable or metastatic hormone receptor-positive (HR+/HER2-) breast cancer. The study included 723 patients with a median age of 56 years. Key endpoints included progression-free survival (PFS), defined as the time without disease progression as assessed by blinded independent central review (BICR) per RECIST 1.1, and overall survival (OS), defined as the time from treatment initiation to death. Results showed the median PFS in the Datroway group was 6.9 months. This was longer than the 4.9 months observed in the chemotherapy group. Although the OS data were immature, a trend favoring Datoray was observed. AbbVie's first ADC ‘Elahere nears domestic commercialization ADC anticancer drug Elahere AbbVie is also awaiting approval for a new ADC. AbbVie has applied for domestic approval of ‘Elahere’ targeting the ovarian cancer indication. AbbVie acquired Elahere in November 2023 by purchasing the US biotechnology company Immunogen for USD 10.1 billion (approximately KRW 13.1 trillion). Elahere is an ADC targeting ovarian cancers expressing FRα (folate receptor alpha). Its mechanism involves delivering the potent cytotoxic drug DM4 into cancer cells to destroy the tumor. It is particularly gaining attention as a new option for ovarian cancer patients resistant to platinum-based anticancer drugs. This treatment was also designated as an orphan drug in Korea this January. For epithelial ovarian cancer, which accounts for 90% of ovarian cancers, taxane-based drugs like paclitaxel and platinum-based anticancer drugs like carboplatin and cisplatin are primarily used. However, for recurrent ovarian cancer resistant to platinum-based drugs, response rates to standard chemotherapy have generally been low, significantly limiting improvements in survival rates. Elahere demonstrated its potential as a new alternative through the Phase III MIRASOL study, conducted in patients with platinum-resistant ovarian cancer. The confirmatory Phase III MIRASOL study enrolled 453 patients with platinum-resistant epithelial ovarian cancer. The trial compared the Elahere group with the standard chemotherapy group. At a median follow-up of 30.5 months, Elahere demonstrated an improvement in median PFS of 5.59 months compared to 3.98 months in the standard therapy group. This represented a 37% reduction in the risk of disease progression or death. The objective response rate (ORR), which measures the proportion of patients with tumor size reduction over a set period, was also higher in the Elahere group at 41.9%, compared to 15.9% in the standard therapy group. Overall survival (OS) was also longer with Elahere at 16.85 months, reducing the risk of death by 32% compared to 13.34 months in the standard therapy group. Regarding safety, eye-related adverse events, fatigue, and abdominal pain were reported, but these were generally considered manageable. Based on these results, Elahere received full approval in the United States in March of last year and obtained marketing authorization in Europe in November of the same year.
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- Jaypirca’s reimbursement imminent in Korea
- by Eo, Yun-Ho Aug 27, 2025 06:07am
- The BTK inhibitor Jaypirca is likely to be listed for reimbursement soon. According to Dailypharm coverage, the National Health Insurance Service (NHIS) and Lilly Korea recently completed price negotiations for Jaypirca (pirtobrutinib), a treatment for relapsed or refractory mantle cell lymphoma (MCL). As a result, Jaypirca’s reimbursement agenda is scheduled to be submitted to the Health Insurance Policy Deliberation Committee in September, with listing expected in October. Jaypirca was approved by the Ministry of Food and Drug Safety in August last year as a monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received two or more treatments, including a BTK inhibitor. Prior to its approval, there were no approved medications available for patients with relapsed or refractory MCL whose disease progressed after treatment with existing BTK inhibitors in Korea. Jaypirca is the first and only reversible BTK inhibitor that has demonstrated clinical efficacy in patients with relapsed or refractory MCL following treatment with one or more BTK inhibitors. It also exhibits a 300-fold higher selectivity for BTK compared to most kinases (98%) included in preclinical studies. The BRUIN Phase I/II clinical trial, the study that became the grounds for Jaypirca’s approval, evaluated the clinical efficacy and safety of Jaypirca in adult patients with relapsed or refractory mantle cell lymphoma who had previously received treatment with one or more BTK inhibitors. In the primary analysis set (PAS) of 90 patients who had previously received treatment with one or more BTK inhibitors, the overall response rate (ORR) was 56.7%, with a median duration of response (DoR) of 17.6 months. The most common adverse reactions following Jaypirca administration were fatigue (26.3%), neutropenia (22.8%), diarrhea (22.1%), and bruising (19.0%). The incidence of treatment discontinuation due to adverse reactions was 1.2%, and the incidence of dose reduction due to adverse reactions was 3.3%. Meanwhile, based on the response rate results, Jaypirca was approved through the U.S. FDA's accelerated approval process in January last year. In Korea, it was designated as an orphan drug in June last year for use as monotherapy in adult patients with relapsed or refractory MCL who had previously received treatment with a BTK inhibitor.
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- Targeted therapies and antibody drugs enter clinical trials
- by Son, Hyung Min Aug 27, 2025 06:07am
- Korea’s pharmaceutical and biotech industry is accelerating new drug development for pancreatic cancer, a cancer regarded as one of the most intractable cancers. Onconic Therapeutics, Prestige Biopharma, and Aptamer Sciences have each started clinical trials, making their bid into the field. The company plans to test the commercial viability of various mechanisms in the area, including antibody-drug conjugates (ADCs), targeted anticancer agents, and antibody-based novel therapies. Pancreatic cancer is difficult to detect at an early stage and has a poor prognosis, with a five-year survival rate of only 12.6 percent — the lowest among the nation’s top ten cancers. Given the limited success seen with existing therapies, there is a growing consensus that the development of new drugs is urgently needed. Onconic Therapeutics applies to initate Phase II trial in Korea According to industry sources on the 26th, Onconic Therapeutics has recently submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety for a Phase II clinical trial of its anticancer drug candidate Nesuparib. Nesuparib is a novel drug candidate with a dual mechanism of action, simultaneously inhibiting poly (ADP-ribose) polymerases (PARPs) and tankyrases (TNKS). The compound is currently being evaluated as both a monotherapy and as combination therapy across multiple indications, including pancreatic, endometrial, and gastric cancers. It has also been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for pancreatic and gastric cancers. Onconic Therapeutics has confirmed the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) for its anticancer candidate in a Phase Ib clinical trial involving patients with advanced or metastatic pancreatic cancer. This multicenter, open-label, Phase Ib dose-escalation study enrolled up to 48 patients with locally advanced or metastatic pancreatic cancer. Participants were divided into two cohorts - Arm A, which received Nesuparib in combination with the FOLFOXIRI regimen (oxaliplatin, leucovorin, irinotecan, and 5-fluorouracil (5-FU)), and Arm B, which received Nesuparib in combination with gemcitabine and nab-paclitaxel. Onconic Therapeutics described the results of the Phase Ib trial as encouraging and announced its intention to present the findings at upcoming major international oncology conferences. New antibody drug development active in the industry… companies also see potential in combination therapies Korea’s pharmaceutical and biotech industry is stepping up its efforts in the field, with companies pursuing a wide range of new drug candidates, including antibody-drug conjugates (ADCs) and novel antibody therapies. Aptamer Sciences recently unveiled preclinical data for its ADC candidate AST-203, which targets TROP2, a protein commonly expressed in breast, pancreatic, gastric, and lung cancers. AST-203 selectively binds to TROP2-positive tumors, penetrates cells, and releases the microtubule inhibitor MMAE to induce tumor cell death. Structurally, AST-203 is composed of an anti-TROP2 antibody linked to the cytotoxic microtubule-inhibiting payload MMAE via a VC-PAB linker. MMAE is the same payload used in Padcev, the ADC therapy developed by Astellas and Seagen. ADC therapy TROP2 acts as an intracellular calcium signal transducer involved in cell proliferation and survival. Among TROP2-targeting new drugs, only two commercialized products exist: Gilead's ADC Trodelvy and Daiichi Sankyo/AstraZeneca's Datroway. Both products have only secured indications for breast cancer. Because TROP2 is highly expressed in breast, non-small cell lung, colorectal, and pancreatic cancers, the later entrants have been actively conducting clinical studies to tackle such major solid tumors. Aptamer Sciences is leveraging its proprietary ADC platform, “Aptamer,” to address the limitations of conventional ADCs. Aptamers are roughly one-tenth the size of antibodies, enabling deeper penetration into tumor tissue and faster delivery to target cells, enhancing therapeutic efficacy. In preclinical studies using tumor spheroid models (three-dimensional cultured cell aggregates), AST-203 demonstrated a 6.7-fold higher tumor penetration rate compared with Trodelvy. Prestige Biopharma has entered a clinical trial in the U.S for its antibody drug candidate PBP1510. PBP1510neutralizes the PAUF protein, a key driver overexpressed in pancreatic ductal adenocarcinoma (PDAC) that is a major target in pancreatic cancer. Through its Phase I trial, the company aims to assess the safety and tolerability of PBP1510 in combination with gemcitabine. NeoImmuneTech's NT-I7 received FDA orphan drug designation this year for pancreatic cancer. NT-I7 is an anti-cancer drug candidate targeting IL-7, which organizes T-cell development and function, and targets various indications. Immuno-oncology drugBeyond pancreatic cancer, NT-I7 previously received ODD from the FDA for CD4 lymphopenia (2019), progressive multifocal leukoencephalopathy (2020), and glioblastoma (2023). NeoImmuneTech is currently conducting a Phase II trial evaluating NT-I7 in combination with Keytruda. The trial enrolled 50 patients with previously treated metastatic colorectal cancer and 48 with pancreatic cancer. Interim data showed partial responses (PRs) in three of the 48 pancreatic cancer patients, with a median overall survival (OS) of 11.1 months.
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- Co-promotion discussed for the diabetes drug Mounjaro
- by Kim, Jin-Gu Aug 27, 2025 06:07am
- Product photo of Mounjaro The possibility of a co-promotion partnership between Eli Lilly and Korean pharmaceutical companies for 'Mounjaro,' the treatment of diabetes and obesity, continues to be discussed. While Lilly Korea officially maintains a 'direct sales' policy, it is reported that they are also conducting undiscloed discussions for potential partnerships. It is anticipated that the decision on co-promotion will become clearer around the time Mounjaro becomes reimbursed for the diabetes indication. According to industry sources on August 26, Lilly Korea recently discussed the possibility of co-promoting Mounjaro with approximately ten domestic pharmaceutical companies. Key major pharmaceutical companies with nationwide sales networks are said to have participated in the discussions, exchanging ideas by proposing their sales strategies to Lilly Korea. However, Lilly Korea's official position of 'direct sales' remains unchanged. An official from Lilly Korea stated, "At the time of launch, Lilly will handle direct sales, and distribution will primarily be through distributors who have direct dealings with Lilly." In other words, it is interpreted as a move to maintain the principle of direct sales while leaving the door open for collaboration with domestic pharmaceutical companies through simultaneous undisclosed discussions. The pharmaceutical industry believes that Mounjaro's 'indications' are the reason why two sales models are being considered simultaneously. Mounjaro currently holds three indications: ▲Improving glycemic control in adult patients with Type 2 diabetes ▲Chronic weight management in adult patients ▲Treating moderate-to-severe obstructive sleep apnea in obese adults. With patient groups categorized for diabetes and obesity, the sales strategy must be differentiated. This situation differs from the global market. In the U.S., the same active ingredient (tirzepatide) is marketed separately as an obesity drug called 'Zepbound' and a diabetes drug called 'Mounjaro.' In Korea, however, it was approved as a single product under the name Mounjaro, without using the name Zepbound. Mounjaro is therefore sold as both an obesity and a diabetes drug. The consensus in the industry is that discussions regarding a co-promotion partnership with domestic pharmaceutical companies are focused on the diabetes treatment indication. It is reported that the diabetes indication was a key topic of discussion during the negotiation process. The pharmaceutical industry anticipates that Lilly Korea will pursue reimbursement for Mounjaro's diabetes treatment indication, targeting the first half of next year. If reimbursement is approved, it would be possible to separate the sales strategies for the diabetes and obesity markets. This means that Mounjaro for obesity treatment could be sold exclusively by Lilly Korea's in-house sales team. At the same time, a co-promotion system could be established with a domestic pharmaceutical company for Mounjaro's diabetes treatment. Consequently, the co-promotion partner is expected to be known around the time reimbursement is secured. The high market potential of Mounjaro is the reason for the strong interest from Korean pharmaceutical companies. Mounjaro achieved record-breaking sales in the global market immediately after its launch. As a diabetes drug, its globalsales reached $5.198 billion (approximately KRW 7 trillion) in the second quarter of this year. Zepbound, initially launched as an obesity drug, generated $3.381 billion (approximately KRW 4.7 trillion) in sales. In just three months, the combined sales of the two products amounted to nearly KRW 12 trillion. Considering Mounjaro's significant presence in both the diabetes and obesity markets, it is likely that Korean pharmaceutical companies will find it difficult to pass up this strategic opportunity. A co-promotion partnership could immediately lead to external growth and a synergistic effect with their existing diabetes treatment portfolios. The high potential for future indication expansion beyond diabetes and obesity is also an attractive factor. Currently, GLP-1 class drugs like Mounjaro and Wegovy are being actively investigated in clinical trials for conditions such as MetabolicDysfunction-Associated Steatohepatitis (MASH), cardiovascular diseases, and kidney diseases.
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- CKD aims at developing next-generation·new anti-cancer drug
- by Son, Hyung Min Aug 26, 2025 06:06am
- Chong Kun Dang is speeding up investment in the new anti-cancer drug sector. The company aims to commercialize anti-cancer drugs by advancing its in-house pipelines for Antibody-Drug Conjugates (ADCs) and Cell and Gene Therapies (CGTs). Additionally, Chong Kun Dang is securing domestic rights for new drugs, including Chimeric Antigen Receptor T-cell (CAR-T) therapies, cancer vaccines, and targeted therapies. Accelerating Commercialization of New Anti-cancer Drugs...In-licensing New Drugs enters into Late-Stage Clinical Trials According to industry sources on August 26, patient enrollment in the Phase 2 clinical trial of namodenoson, a targeted therapy for which Chong Kun Dang holds domestic rights in Korea, has recently exceeded half of its target. In 2016, Chong Kun Dang signed an exclusive domestic supply and sales agreement for namodenoson with Israel's Can-Fite BioPharma. Namodenoson is a selective A3 adenosine receptor (A3AR) agonist with a mechanism that suppresses the progression of fibrosis. This new drug candidate has demonstrated safety and anti-tumor activity in preclinical models of pancreatic cancer. The current Phase 2a trial is a multi-center, open-label study evaluating the safety and pharmacokinetic (PK) activity of namodenoson in patients with advanced pancreatic adenocarcinoma whose disease has progressed after previous treatment. Patients are administered 25mg of namodenoson orally twice a day in 28-day cycles, and favorable safety results have been observed. Currently, namodenoson is being investigated in a Phase 3 clinical trial for hepatocellular carcinoma, a Phase 2b trial for Metabolic Dysfunction-Associated Steatohepatitis (MASH), and the Phase 2a trial for pancreatic cancer. It has received Orphan Drug Designation in the U.S. and Europe. It has also been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) as a second-line treatment for hepatocellular carcinoma. Its potential has also been confirmed for various other cancers, including colon cancer, prostate cancer, and melanoma. Chong Kun Dang has also secured the rights for a new CAR-T drug candidate. In June, Chong Kun Dang invested KRW 12.2 billion in the biotech company AbClon in Korea, becoming its second-largest shareholder with a 7.33% stake through a third-party share allocation capital increase. It was the first time in Chong Kun Dang's history that it has made an external investment of over KRW 10 billion. AbClon is a new drug development company co-founded by Korean and Swedish researchers in 2010 and was listed on the KOSDAQ in 2017. It has a diverse pipeline of drugs targeting various cancers, including gastric, colorectal, prostate, and hematological cancers, with products such as the HER2-targeted antibody therapy (AC101), bispecific antibody-based immunotherapy (AM105), and the CAR-T therapy (AT101). Chong Kun Dang has secured the priority right for the domestic sales of AbClon's hematological cancer CAR-T therapy, 'AT101,' which is under development. The company plans to expand its collaboration in the co-development and commercialization of CAR-T and bispecific antibody new drugs in the future. AT101 has entered a Phase 2 clinical trial, with the goal of submitting an expedited approval application in 2025. The two companies also plan to co-develop new drugs targeting HER2-targeted CAR-T (AT501), PSMA, CD30, and 4-1BB. Chong Kun Dang also has high hopes for the cancer vaccine sector. A Phase 3 clinical trial for the cancer vaccine 'Tedopi,' for which Chong Kun Dang holds sales rights, is underway in patients with non-small cell lung cancer. Chong Kun Dang in-licensed the domestic rights for Tedopi from OSE Immunotherapeutics, a company based in France, in 2019. Tedopi is a cancer vaccine for patients who have failed immunotherapy. A study in patients with advanced and metastatic lung cancer who failed previous treatments showed that Tedopi reduced the risk of death by 41% compared to chemotherapy. The confirmatory Phase 3 clinical trial is ongoing, and a study in pancreatic cancer patients is also being conducted. Active In-house Anti-Cancer Drug Clinical Trials In addition to securing new drug rights, Chong Kun Dang expects to see synergies with its own in-house anti-cancer drugs in the medium to long term. The company entered the ADC anti-cancer drug development field last February by signing a technology introduction agreement with Synaffix, a company based in the Netherlands, securing the rights to use three of its platform technologies. Recently, the company's ADC also successfully entered the clinical stage. The FDA approved the Phase 1/2a clinical trial plan (IND) for Chong Kun Dang's ADC new drug candidate, 'CKD-703,' last month. CKD-703 targets the hepatocyte growth factor receptor (c-Met), which is overexpressed in cancer cells, and is being developed for the treatment of solid tumors, such as non-small cell lung cancer. c-MET targeted by CKD-703 is a protein expressed by the epithelial-mesenchymal transition (MET) gene. c-MET is one of the proteins that transmit signals to cells and is considered a key cancer-causing gene, linked to the development of various solid tumors, including non-small cell lung, colorectal, gastric, and liver cancer. It is known that c-MET mutations are found in 6% of non-small cell lung cancer patients. With intense competition among subsequent products, including Daiichi Sankyo's 'Enhertu,' Astellas' 'Padcev,' and Gilead's 'Trodelvy,' Korean companies are also finally entering the clinical stage and are now at the point of verifying their commercialization potential as latecomers. Along with securing opportunities for global co-development through technology exports, some companies are also demonstrating their competitiveness by initiating clinical trials directly in global markets, such as the U.S. To date, there are no approved ADC new drugs that target c-Met, with AbbVie's 'Teliso-V' being the closest to commercialization. AbbVie achieved positive results in a Phase 2 trial announced last year and has since applied for accelerated approval to the FDA based on these findings. Amid the global competitive landscape, Chong Kun Dang plans to prove its commercialization potential by differentiating itself in areas such as toxicity management and treatment response rates. In April of last year, the company also signed a license-in agreement with Curigin, an RNAi-based gene therapy development company, for its candidate compound 'CA102,' which carries a bispecific shRNA. Chong Kun Dang has secured the global rights for Curigin's anti-cancer candidate 'CA102' and plans to proceed with exclusive R&D and commercialization, with superficial bladder cancer as its first indication.
- Company
- Expanded indication for Kisqali in early breast cancer
- by Son, Hyung Min Aug 26, 2025 06:05am
- Kisqali On August 22, Novartis Korea (CEO and President Byeong-jae Yoo) announced that its CDK 4/6 inhibitor, Kisqali, was approved for a new indication from the Ministry of Food and Drug Safety for use as an adjuvant therapy in patients with HR+ (hormone receptor-positive)/HER2- (human epidermal growth factor receptor 2-negative) Stage II and III early breast cancer who are at high risk of recurrence. Kisqali has now expanded indications from advanced and metastatic breast cancer to include early breast cancer, thereby broadening treatment options. The current expanded indication is based on the results of the global Phase 3 clinical trial, NATALEE. The NATALEE study was a randomized, multi-center, open-label clinical trial involving a total of 1,010 patients with HR+/HER2- early breast cancer from 20 countries worldwide. It evaluated the efficacy and safety of the Kisqali combination therapy group compared to the endocrine therapy monotherapy group. Clinical results showed that the primary endpoint, invasive disease-free survival (iDFS), was 88.5% for the Kisqali combination therapy group and 83.6% for the endocrine therapy monotherapy group at the 4th year, showing an absolute improvement of 4.9 percentage points. This gap widened over time, as the difference was 2.7 percentage points at the 3-year mark (90.8% vs. 88.1%). The risk of invasive disease progression or death was reduced by 28.5% in the Kisqali combination therapy group compared to the endocrine therapy monotherapy group. A consistent effect was observed regardless of lymph node involvement. Professor Yeon Hee Park of the Department of Hematology and Oncology at Samsung Medical Center said, "Patients with HR+/HER2- early breast cancer are still exposed to a risk of recurrence even with existing treatments, and a relapse has a high probability of progressing to distant metastasis, which is a great burden for patients," and added, "Through the NATALEE study, Kisqali showed an effect in reducing the risk of recurrence across a broad patient population, regardless of lymph node involvement. The confirmed superior tolerability due to its low-dose design is a significant advance in clinical practice." Byeong-jae Yoo, CEO and President of Novartis Korea, said, "Kisqali is an innovative drug that has demonstrated improved survival rates in the treatment of metastatic breast cancer. With this expanded indication for early breast cancer in Korea, we hope to reduce the burden of recurrence risk for patients and provide better treatment outcomes," and added, "Novartis will continue to lead patient-centered innovation and play a leading role throughout the breast cancer treatment journey in Korea." Kisqali was initially approved by the Ministry of Food and Drug Safety in October 2019 for the treatment of HR+/HER2- advanced or metastatic breast cancer in ▲pre-menopausal, peri-menopausal, or post-menopausal women as a first-line endocrine therapy in combination with an aromatase inhibitor and in ▲post-menopausal women as adjuvant therapy in combination with fulvestrant for first-line endocrine therapy or after disease progression on endocrine therapy.
- Company
- Will companies pass Korea due to Trump’s drug price reform?
- by Moon, sung-ho Aug 26, 2025 06:05am
- Since Trump took office, the US has designated the pharmaceutical industry as its core strategic industry and is working to reshape the industry with the US at its center. The goal is to significantly lower drug prices in the U.S., the world's largest pharmaceutical market. However, the “Most-Favored-Nation Pricing (MFN)” policy recently announced by the U.S. health authorities is causing tension not only in Korea’s pharmaceutical industry but also in clinical settings. #This is because there is a possibility that global pharmaceutical companies may reconsider their plans to launch new drugs in Korea due to the U.S. MFN policy. The clinical field is also closely monitoring the future direction of U.S. policy, as it could affect patients' access to new drugs. In May, U.S. President Trump signed an executive order to promote the MFN policy. The MFN policy aims to lower the prices of prescription drugs in the United States to the lowest level among major developed countries. The target drugs include high-priced treatments (such as anticancer drugs and immunotherapy drugs) with the highest annual expenditures under Medicare Part B, the U.S. health insurance program. The plan is to determine U.S. drug prices by referencing the lowest drug prices among OECD countries with per capita GDP (GDP) of 60% or more of the U.S. level. This aims to alleviate the burden of drug prices in the U.S. while preventing other countries from supplying drugs at prices significantly lower than those in the U.S. On the 31st of last month, President Trump went so far as to give 17 multinational pharmaceutical companies a “60-day deadline” to lower drug prices in the United States to overseas levels. Specifically, the companies include AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Eli Lilly, Merck Germany (EMD Serono), Genentech, Gilead, GSK, Johnson & Johnson, Merck (MSD), Novartis, Novo Nordisk, Pfizer, Regeneron, and Sanofi. The multinational pharmaceutical companies responded immediately to the pressure. Eli Lilly has decided to raise the price of its obesity treatment, Mounjaro (tirzepatide), in the UK. Specifically, the price of Mounjaro in the UK will be increased by up to 170%. The private price of Mounjaro will rise from the current GBP 92-122 (approximately KRW 173,000-229,000) per month to GBP 133-330 (approximately KRW 249,000-620,000). At the same time, insulin prices in the US will be reduced by 70%, with a cap on patient copayments set at USD 35 per month. Novo Nordisk has also decided to lower the US price of its diabetes treatment Ozempic (semaglutide). The monthly price will be reduced from USD 1,000 (approximately KRW 1.39 million) to USD 499 (approximately KRW 620,000). Other multinational pharmaceutical companies may also follow, lowering their prices in the US and raising prices in other countries. With the US drug price reduction policy becoming a reality, the domestic pharmaceutical industry is also reacting sensitively. This is because the launch of new drugs by global pharmaceutical companies could be linked to this policy. The most notable point is whether South Korea will be included as a reference country. Given that the policy states that “the U.S. price will be determined by referring to the lowest drug price among OECD countries with a per capita GDP of 60% or more of the U.S.,” the prevailing opinion is that South Korea and Japan will be excluded from the reference countries. However, there are predictions that South Korea could become an MFN target country if PPP (purchasing power parity-based GDP) is applied, leading to heightened tension among multinational pharmaceutical companies considering new drug launches in Korea. With no specific details on the application of reference countries or other measures announced, tension is growing across the entire domestic pharmaceutical industry. The Ministry of Health and Welfare and the Health Insurance Review and Assessement Service are closely monitoring the U.S. government's policy announcements and considering future response strategies. A KRPIA official stated, “The U.S. government has not disclosed specific application methods, such as reference countries, for its MFN drug pricing policy, so the situation is currently uncertain. If South Korea is used as an international reference price standard, it could affect not only the sustainability of domestic drug pricing policies but also patients' access to treatment.” Although not yet evident on the surface, there are opinions within multinational pharmaceutical companies that they have begun to hesitate about launching new drugs in Korea. This is because it would be difficult to publicly announce a delay in the launch of new drugs in Korea due to the uncertainty surrounding the MFN policy. A representative from a multinational pharmaceutical company stated, “There are opinions that a specific company has put new drug approval negotiations on hold at the headquarters level, but this has not been publicly disclosed yet. However, there is concern that the global market views the Korean pharmaceutical market as taking a fairly conservative approach to pricing innovative new drugs.” As a result, the U.S. MFN drug pricing policy has become a major issue at events held by pharmaceutical companies seeking to launch their products in Korea and receive reimbursement. Interest is focused on why some companies are attempting reimbursement despite the uncertain situation. Junil Kim, General Manager of Astellas Korea, explained, “It is true that companies selling their products in the U.S. market are facing difficulties in receiving Korean drug prices due to MFN-related issues. Astellas, which accounts for nearly 50% of its sales in the U.S., is no exception.” In the clinical field as well, there is a growing consensus that concerns surrounding the introduction of new drugs due to global pharmaceutical companies' MFN pricing policies are valid. This is expected to spark debate over the “Korea passing” issue for new drugs in the future. If the situation intensifies, there are concerns that it could lead to delays in access to innovative new drugs, reduced treatment options for patients, and increased financial burdens on patients in Korea. In the long term, this is also expected to jeopardize the competitiveness of conducting clinical trials in Korea in the global market. The Korean Society of Gastroenterology pointed out in its own medical policy forum that “there is a possibility that excessively low drug pricing policies could trigger the ‘Korea passing’ phenomenon, leading to the withdrawal of global pharmaceutical companies from the Korean market.” "Despite receiving approval in Korea as a treatment for ulcerative colitis, Eli Lilly's Omvoh was not released in Korea due to an unreasonably low drug price proposed during price negotiations. A policy is needed that ensures patient access to treatment while maintaining the sustainability of the health insurance budget. Rather than pursuing excessive drug price cuts that could lead to market withdrawal, a strategic approach that promotes the introduction of new drugs from a long-term perspective should be devised.”
