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- 2025-12-17 22:05:11
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- 'Rezurock' for cGVHD enters NHIS drug price negotiation
- by Eo, Yun-Ho Oct 20, 2025 06:08am
- Product photo of Rezurock 'Rezurock,' a treatment for the treatment of chronic graft-versus-host disease (cGVHD), has entered the last stage for insurance reimbursement listing. Sanofi Korea and the National Health Insurance Service (NHIS) are currently under negotiations for the drug pricing of the ROCK2 inhibitor 'Rezurock (belumosudil). Rezurock is a pharmaceutical that received Fast Track designation from the U.S. Food and Drug Administration (FDA). It was approved in Korea in August of last year and launched as a non-reimbursed drug in November. Rezurock is notable for selectively inhibiting ROCK2, a signaling pathway modulating chronic graft-versus-host disease (cGVHD)'s inflammatory response and fibrotic process. cGVHD is a complication that occurs in half of patients who received autologous stem cell transplantation. Patients with cGVHD may be few due to the disease's nature, but the disease occurs in half of the patients who receive the transfer. It is a severe and life-threatening disease that requires treatment. cGVHD is a major factor that accounts for 37.8% of the deaths of blood cancer patients, excluding recurrence. Notably, the treatment of chronic cGVHD is becoming more important as the cases of hematopoietic stem cell transplant are increasing every year in Korea (a total of 1,794 cases as of 2023). 42% of the transplant patients experience chronic cGVHD on average within 3 years, and 66% of the patients already experience acute cGVHD. However, there is a gap in the treatment strategy. Steroids, recommended as a first-line treatment in both Korean and overseas treatment guidelines, are difficult for long-term use. When used for an extended period, it may cause osteoporosis, joint damage, organ failure, hypertension, upset stomach, and growth suppression. Ninety-six percent of patients with chronic cGVHD use steroids as their first-line treatment. 70% of patients receive second-line treatment, and about 50% pursue third-line treatment. Currently, there are no effective third-line treatment options available when second-line treatments fail, forcing patients to rely on combinations of steroids and immunomodulator drugs. Furthermore, 97% of patients with cGVHD who receive steroid treatment experience one or more side effects, and the most frequent side effect is infection (79.5%). Infections in multiple organs significantly lower a patient's quality of life. A host immune response in the lung or liver is fatal. It is to be watched whether Rezurock will become a solid new treatment option with the reimbursement coverage. Meanwhile, Rezurock's clinical trial involved patients who failed to respond to two or more lines of systemic therapy. Patients treated with Rezurock recorded an overall response rate (ORR) of 75%, demonstrating superior effects compared to conventional treatment. Notably, in areas where improvement is difficult with conventional therapy, such as joints, liver, and lung, it also showed ORR of 71%, 39%, and 26%, respectively. Professor Hee-Je Kim in the Department of Hematology at Seoul St. Mary's Hospital (Hematology Hospital's Director) said, "42% of patients with cGVHD have symptoms across the whole body, leading to significant worsening of quality of life. Since the host response that occurs in lung and liver can critically affect patients with blood cancer, treatments that would effectively manage such response have been in need."
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- Enhertu redefines the standard in early-stage breast cancer
- by Hwang, byoung woo Oct 20, 2025 06:08am
- The antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan, T-DXd) has taken center stage as a new cornerstone in the treatment strategy for early-stage breast cancer. Both the DESTINY-Breast05 and DESTINY-Breast11 trial results that were presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin showed significant results, positioning T-DXd as a potential new standard of care across both neoadjuvant (pre-surgical) and adjuvant (post-surgical) settings. Professor Dr. Charles E. Geyer of the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center T-DXd reduces risk of recurrence by 53% compared to Kadcyla as postoperative adjuvant therapy DESTINY-Breast05 is a Phase III head-to-head trial directly comparing Enhertu with the standard therapy Kadcyla (trastuzumab emtansine, T-DM1) in patients with HER2-positive early breast cancer who had residual invasive disease after neoadjuvant therapy (chemotherapy and targeted therapy before surgery). Professor Dr. Charles E. Geyer of the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, who presented the data at ESMO, emphasized, “In high-risk patients with residual disease, T-DXd demonstrated a clear survival benefit over T-DM1.” At the interim analysis, 3-year invasive disease-free survival (IDFS) was 92.4% for T-DXd (95% CI 89.9–94.4) versus 83.7% for T-DM1 (80.2–86.7), reflecting a 53% reduction in risk of events (HR 0.47, p
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- 'Keytruda+Padcev' proposed as a new standard trt for MIBC
- by Hwang, byoung woo Oct 20, 2025 06:07am
- Keytruda (pembrolizumab) and Padcev (enfortumab vedotin) have demonstrated synergistic effects in muscle-invasive bladder cancer (MIBC), opening up new possibilities. Analysis suggests that the combination of enfortumab vedotin and pembrolizumab may shift the perioperative standard of care for MIBC patients who are ineligible for or refuse cisplatin. The KEYNOTE-905/EV-303 results were presented at the ESMO Congress 2025. On October 18 (local time), the Phase 3 KEYNOTE-905/EV-303 results (LBA2) were presented at the ESMO Congress 2025 (European Society for Medical Oncology). The study evaluated the combination of Padcev and Keytruda before and after radical cystectomy + pelvic lymph node dissection (RC+PLND), the current standard of care, in MIBC patients who were ineligible for or refused cisplatin. Perioperative EV + pembrolizumab combination therapy improved the survival index significantly선 Professor Christof Vulsteke of AZ Maria Middelares Hospital in Belgium delivered the Phase 3 clinical trial results as an oral presentation during the Presidential Symposium I. Professor Christof Vulsteke of AZ Maria Middelares Hospital in Belgium The study randomized 344 patients ineligible for or refusing cisplatin, comparing the Padcev + Keytruda combination therapy group (170 patients) with the surgery-only control group (174 patients). Patients were tracked for a median follow-up of 25.6 months. The study results showed that the Padcev + Keytruda combination therapy demonstrated statistically significant improvements in event-free survival (EFS), overall survival (OS), and pathological complete response rate (pCR) compared to RC+PLND monotherapy. First, EFS was significantly improved in the combination group, with the median not yet reached, compared to 15.7 months in the control group (Hazard Ratio [HR] 0.40; 95% CI 0.28–0.57; P < 0.0001). Overall survival (OS) also showed a statistical advantage in the combination group, with the median not yet reached, compared to 41.7 months in the control group (HR 0.50; 95% CI 0.33–0.74; P = 0.0002). This performance garnered significant applause during the presentation of EFS and OS results. The pCR also showed a stark difference: 57.1% in the combination arm versus 8.6% in the control arm, a difference of nearly 48 percentage points (P < 0.000001). Event-free survival (EFS) was significantly improved in the combination group, with the median not yet reached, compared to 15.7 months in the control group (Hazard Ratio [HR] 0.40; 95% CI 0.28–0.57; P < 0.0001). Professor Vulsteke said, "This study is the first randomized Phase 3 result to clearly demonstrate a survival benefit from perioperative combination therapy in patients with resectable, cisplatin-ineligible MIBC," and explained that "the Padcev + Keytruda combination demonstrated the potential to replace the existing chemotherapy-centric treatment paradigm." The median age of the patients was 74, and the reasons for cisplatin ineligibility varied, including reduced kidney function, hearing impairment, and neuropathy. However, the benefit of the Padcev + Keytruda combination was consistently maintained across subgroup analyses by age and comorbidity. However, the incidence of Grade 3 or higher adverse events was higher in the combination group (71.3%) compared to the control group (45.9%), emphasizing the importance of patient selection and management during clinical application. "Clarity needed on stage-specific contribution of treatment before and after surgery" Jonathan Rosenberg, Professor at Memorial Sloan Kettering Cancer Center in the U.S.Jonathan Rosenberg, Professor at Memorial Sloan Kettering Cancer Center in the U.S., who participated as a guest speaker, said, "This study showed impressive results with an HR for both EFS and OS in the range of 0.4-0.5 in elderly and cisplatin-ineligible or refusing patients," and assessed that "the Padcev + Keytruda combination is ready to become a realistic new standard of care." Professor Rosenberg further stressed, "Clearly defining the contribution of treatment in the neoadjuvant and adjuvant stages, and optimizing therapy through circulating tumor DNA (ctDNA) analysis, will be important future tasks." Regarding the management of relapsed and metastatic patients, he suggested, "Platinum-based chemotherapy may still be considered the standard for patients who relapse early after Padcev + Keytruda," and proposed that "research into new treatment orders is needed in the post-EV combination era." Experts analyzed that, based on these results, the focus of bladder cancer treatment is shifting from traditional cisplatin chemotherapy to EV-based combination therapy, assessing this as a signal for a paradigm shift in the treatment of MIBC.
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- Alecensa achieves 81-month median overall survival
- by Hwang, byoung woo Oct 20, 2025 06:07am
- Roche's ALK inhibitor Alecensa (alectinib) has demonstrated long-term survival benefits exceeding 7 years in patients with ALK-positive advanced non-small cell lung cancer (NSCLC). In the final overall survival (OS) analysis of the Phase III ALEX study, Alecensa showed a clear survival benefit over existing treatments, reaffirming its status as the standard first-line therapy. ALEX Study Final Results (LBA73) Presentation Median survival 81 months...“Changes the patient survival curve in the first-line treatment landscape” According to the updated ALEX results (LBA73) presented on October 17 (local time), the median OS with Alecensa was 81.1 months (95% CI 62.3–NE) compared to 54.2 months (95% CI 34.6–75.6) with crizotinib, representing an improvement of approximately 27 months. Professor Tony S.K. Mok of the Chinese University of Hong Kong, who presented the findings, stated, “Alecensa reduced the risk of death by about 22% (HR 0.78, 95% CI 0.56–1.08). Although OS was a secondary endpoint, the improvement is clinically meaningful and clearly directional.” Professor Tony S.K. Mok, The Chinese University of Hong KongImportantly, the final analysis confirmed sustained survival benefits even among patients with brain metastases. Professor Mok stated, “Among patients with brain metastases who received radiotherapy, median OS reached 92 months with alectinib versus 39 months with crizotinib, which is more than double.” Additionally, in patients with brain metastases who had not undergone radiation therapy, alectinib showed a survival period of 47 months, demonstrating a clear advantage over crizotinib (approximately 24 months). Furthermore, in the patient group without brain metastases, the median survival period reached 94 months with alectinib treatment, drawing a long-term survival curve exceeding 7 years. Professor Mok emphasized, “Alectinib's efficacy was maintained regardless of brain metastasis status or prior radiotherapy. The strong CNS penetration of alectinib likely contributed to this durable control and fundamentally changed the survival trajectory for these patients.” Response duration 4 times longer… Long-term treatment tolerability also ‘good’ The duration of response (DoR) in the alectinib group was 42.3 months (95% CI 31.3–51.3), approximately 4 times longer than the 11.1 months (95% CI 7.9–13.0) observed in the crizotinib group. Prof. Mok said, “This once again demonstrates alectinib's strength in providing a long and stable treatment response. Safety analysis also showed it maintained a stable safety profile during long-term administration.” The 7-year OS rate was 48.6% with Alecensa and 38.2% with crizotinib. Compared to the historical chemotherapy era (median survival ~8 months), this represents a tenfold improvement. “The fact that half of the patients with advanced lung cancer survived for more than 5 years demonstrates a complete paradigm shift in first-line treatment.” Professor Christine M. Lovly, Vanderbilt University, USAHowever, Professor Christine M. Lovly of Vanderbilt University in the US, who led the invited discussion that followed the presentation, also mentioned some limitations of the study. Professor Lovly pointed out, “25% of the crizotinib group subsequently used alectinib, and this crossover made it difficult to achieve statistical significance (p=0.132).” Nevertheless, Professor Lovly stated, “The trend toward survival extension is clear, and the consistent benefit observed in patients with brain metastases is undeniable. The ALEX study is a landmark study that ushered in the era of ALK inhibitors. Now, we must evolve toward precision therapy that reflects molecular characteristics such as TP53 mutations and baseline ctDNA status.” Concluding the presentation, Professor Mok said, “The ALEX study sets a new benchmark—showing that 7-year survival is now an attainable goal for ALK-positive lung cancer patients. Alecensa will continue to extend survival safely and stably as the first-line standard of care.”
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- Ipsen's Bylvay is officially launched in Korea
- by Son, Hyung Min Oct 20, 2025 06:06am
- From the left: Professor Ji-hyu Seo (Gyeongsang National University Hospital), Professor Seok-hee (Asan Medical Center), and Professor Hong Ioh (Severance Hospital) Ipsen Korea is introducing a treatment for progressive familial intrahepatic cholestasis (PFIC), an extremely rare hereditary liver disease, to the domestic market. This launch opens new hope for pediatric patients who previously had no treatment option beyond liver transplantation. Bylvay has been selected as the first product under Korea’s “Simultaneous Review & Negotiation Pilot Program,” which streamlines approval and reimbursement procedures. The drug has been covered by national health insurance since October 2025, representing a symbolic step forward in improving access to rare-disease therapies. On October 18, Ipsen Korea held a press conference at Sofitel Seoul Lotte World to commemorate the product’s domestic launch. Bylvay is the first oral treatment option for PFIC. Approved in the US and Europe in 2021, it has since gained approval in major countries. In Korea, it received approval in 2023 and became reimbursed starting this October. Professor Hong Koh of the Department of Pediatrics at Severance Hospital stated, "Although Bylvay was selected as the first drug for the parallel pilot program, the process was far from smooth. Discussions involving experts should begin at the initial approval stage. That's the only way to shorten the review period.” I am pleased that Bylvay’s approval and insurance coverage have improved patients' access to treatment. I hope the pilot program is institutionalized quickly so it applies not only to PFIC patients but also to other drugs. Many drugs are left unapproved. I hope these many treatments can reach children as soon as possible.“ ” Liver transplant isn't always the answer...use of Bylvay will increase" PFIC is a rare hereditary liver disease that impairs bile flow in the liver, causing progressive liver damage and liver failure. PFIC is a very rare disease, with only about 30 patients known to exist in Korea. Caused by genetic mutations, PFIC presents with key symptoms including jaundice, severe itching, and poor weight gain. It is typically recognized during infancy or childhood. Treatment may involve supportive care, medication, or surgery, but most patients ultimately require a liver transplant. Bylvay works by inhibiting the intestinal bile acid transporter (IBAT). Through selective inhibition of IBAT, it prevents the reabsorption of bile acids from the intestines into the liver and increases their excretion through the intestines. This lowers the concentration of bile acids in the body and helps improve symptoms such as itching caused by cholestasis. Professor Seak-hee Oh of the Department of Pediatrics at Seoul Asan Medical Center said, “When bile acid levels exceed 400-500, patients cannot sleep even for an hour. In clinical practice, we observed these levels drop by half when using Bylvay.” “Liver transplantation isn't always the answer. Deaths also occur even after transplantation. Ultimately, the best approach for PFIC patients is to avoid liver transplantation altogether. I believe Bylvay’s arrival could shift the treatment paradigm.” Bylvay reaffirmed its efficacy this year through long-term follow-up data from the existing pivotal studies PEDFIC 1 and 2. In the clinical setting, 15 patients showed a response at week 24, 14 of whom experienced improvement in pruritus, 5 experienced decreased serum bile acids, and 4 patients achieved both response criteria. A significant proportion of FIC1-deficient patients with PFIC Type 1 showed improvement in pruritus when taking Bylvay, and most patients exhibited this response regardless of serum bile acid levels. Furthermore, the reduction in serum bile acids and improvement in pruritus persisted from baseline through Week 96. Ji-hyun Seo of the Department of Pediatrics at Gyeongsang National University Hospital stated, “Persuading stakeholders and reaching consensus to introduce this high-priced overseas drug was no easy task. The introduction of Bylvay represents a meaningful achievement where the efforts of the government, patients, and the pharmaceutical company bore fruit. The value of Bylvay is immense simply because it allows children to avoid liver transplantation.”
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- Rosuzet and K-CAB maintain dual lead…Paxlovid sales surge
- by Chon, Seung-Hyun Oct 17, 2025 06:18am
- Homegrown drugs continue to dominate the top ranks of the outpatient prescription market. Quarterly outpatient prescriptions of the new combination therapy Rosuzet and the new drug K-CAB both surpassed KRW 50 billion, firmly maintaining a two-top system. Meanwhile, Livalozet continued its steep growth trajectory, and Paxlovid saw a sharp rise in prescriptions following its reimbursement listing. According to the pharmaceutical research institution UBIST, Hanmi Pharmaceutical's hyperlipidemia combination drug Rosuzet recorded the highest outpatient prescription sales of KRW 58.9 billion in the third quarter. Rosuzet’s prescriptions grew 11.0% compared to the third quarter of last year and increased 5.3% from the previous quarter. Since becoming the first domestically developed drug to top Korea’s outpatient prescription market in Q1 2023, Rosuzet has held the No. 1 position for seven consecutive quarters. From 2021 to 2023, it ranked No. 2 overall and topped the annual outpatient prescription sales for the first time last year. Launched in late 2015, Rosuzet is a fixed-dose combination of rosuvastatin and ezetimibe. Statin-ezetimibe combinations are seeing soaring demand in prescribing practices due to their excellent efficacy in lowering low-density lipoprotein cholesterol and their relatively low cost burden. Since 2020, Rosuzet has consistently generated over KRW 100 billion in annual prescriptions, reaching KRW 210.3 billion in 2023, and became the first domestically developed drug ever to exceed KRW 200 billion in annual prescriptions. Cumulative sales for the first three quarters of 2025 reached KRW 169.2 billion, up 10.2% year-on-year, making another over KRW 200 billion a year record highly likely. HK Inno.N’s new drug K-CAB ranked second with KRW 56.1 billion in Q3 prescriptions, up 11.4% year-on-year. Its cumulative total for the first three quarters reached KRW 160.8 billion, a 13.1% increase versus the same period last year. Approved in 2018 as Korea's 30th domestically developed new drug, K-CAB is a ‘Potassium-Competitive Acid Blocker (P-CAB)’ for treating gastroesophageal reflux disease (GERD). Its mechanism of action involves competitively binding to the proton pump and potassium ions at the final stage of acid secretion in gastric wall cells, thereby inhibiting gastric acid secretion. K-CAB has sequentially secured 5 more indications, including erosive and non-erosive GERD, gastric ulcers, H. pylori eradication in combination with antibiotics for peptic or chronic atrophic gastritis, and maintenance therapy after GERD treatment. With its rapid onset of action and dosing flexibility of use regardless of meals, K-CAB continues to post robust growth. It first exceeded KRW 100 billion in 2021, its third year on the market, and has now achieved over KRW 100 billion annually for four consecutive years. Having already surpassed KRW 100 billion in the first half of this year, K-CAB is poised to break the KRW 200 billion mark for 2025. JW Pharmaceutical’s dyslipidemia combination drug Livalozet posted KRW 31.0 billion in Q3, up 29.0% year-on-year, ranking ninth overall. Livalozet contains pitavastatin and ezetimibe. Launched in October 2021, Livalozet has maintained steep growth since its release. Its prescription surged in 2022 with sales of KRW 31.8 billion, soaring to KRW 93.3 billion in both 2023 and last year. With cumulative third-quarter prescriptions reaching KRW 85.3 billion, a 27.7% year-on-year increase, Livalozet is poised to surpass KRW 100 billion this year. Pfizer’s COVID-19 treatment Paxlovid ranked fifth overall with KRW 47.7 billion in outpatient prescriptions for Q3 alone. Paxlovid is an oral antiviral that inhibits replication of the COVID-19 virus and is primarily prescribed to high-risk patients at risk of severe disease progression. Initially supplied free of charge by the government, the drug transitioned to general hospital prescriptions after public procurement ended in mid-2024. Since October last year, Paxlovid has fully entered the prescription market following its inclusion in the National Health Insurance reimbursement list. The maximum insurance price ceiling was set at KRW 941,940, with the patient's copayment set at 5%. Paxlovid made its full debut in the prescription market in the fourth quarter of last year, generating KRW 4.1 billion in prescription sales. In the second quarter of this year, it recorded KRW 11.4 billion in prescription sales, surpassing KRW 10 billion, and in the third quarter, it jumped more than fourfold compared to the previous quarter. Paxlovid's cumulative prescription sales for the third quarter reached KRW 67.3 billion. This rapid surge is attributed to the sharp increase in COVID-19 patients combined with Paxlovid's high price point. Paxlovid surpassed KRW 10 billion in monthly prescription sales for the first time in August, with KRW 17.4 billion, and last month it topped the overall market with KRW 24.9 billion, shaking up the entire prescription landscape. AstraZeneca's anticancer drug Tagrisso saw its third-quarter outpatient prescription amount reach KRW 52.2 billion, a 43.0% increase year-on-year. Its cumulative prescription performance for the third quarter was KRW 142.4 billion, a 47.2% increase. Tagrisso is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). EGFR-TKIs are targeted anticancer drugs prescribed to patients with metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations. Since last year, Tagrisso, along with Yuhan Corporation's Leclaza, has had its reimbursement expanded to include ‘first-line treatment for locally advanced or metastatic non-small cell lung cancer with specific genetic mutations’. While anticancer drugs are predominantly prescribed to hospitalized patients, Tagrisso's oral formulation has significantly boosted its outpatient prescription volume. Tagrisso's prescription sales surged from KRW 21 billion in Q4 2023 to KRW 32.3 billion in Q1 last year, maintaining its upward trajectory to exceed KRW 50 billion in Q3 this year.
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- DLBCL drug Monjuvi may be prescribed at Big 5 Hospitals
- by Eo, Yun-Ho Oct 17, 2025 06:11am
- Handok's newly introduced drug ‘Monjuvi’ may now be prescribed at tertiary hospitals in Korea. According to industry sources, Monjuvi (tafasitamab), a treatment for diffuse large B-cell lymphoma (DLBCL) introduced by Handok from Incyte, has passed the Drug Committee (DC) reviews at the Big 5 medical institutions in Korea - Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Severance Hospital. Approved in Korea in June 2023, Monjuvi is indicated for adult patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplantation and have failed at least one prior therapy, first in combination with Revlimid (lenalidomide), and then on its own as monotherapy. Monjuvi is a humanized IgG monoclonal antibody that targets CD19, a cell surface antigen protein expressed on B lymphocytes. However, Monjuvi is currently a non-reimbursed drug. It was submitted to the Health Insurance Review and Assessment Service's Cancer Disease Review Committee last April, but failed to establish reimbursement criteria. Therefore, it remains to be seen whether Monjuvi will succeed in securing reimbursement and be prescribed in practice.. The efficacy of Monjuvi was demonstrated in the L-MIND study, which reported an objective response rate (ORR) of 58%, including a 40% complete response rate and an 18% partial response rate. The treatment also demonstrated a favorable safety profile, enabling patients to receive therapy in an outpatient setting without requiring hospitalization. Meanwhile, diffuse large B-cell lymphoma (DLBCL) is one of the most common subtypes of lymphoma. It is a rapidly progressive cancer with a poor prognosis, known to recur in 20-25% of patients following standard combination chemotherapy.
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- "Switzerland and Korea partner up for bio-ecosystem"
- by Son, Hyung Min Oct 17, 2025 06:11am
- Conradin Cramer, Mayor of Basel, Switzerland As the global pharmaceutical industry is restructuring around collaboration, Switzerland and South Korea are strengthening their partnership to build an innovation ecosystem. The vision is to establish a model of joint innovation, based on efficient resource and mutual trust, rather than a simple technology exchange. On October 16, Roche Korea hosted a media day at its headquarters in Gangnam-gu, Seoul, with Switzerland's City of Basel and the Embassy of Switzerland in Korea, to share global partnering strategies and success stories for building a bio-ecosystem. Switzerland, despite its small territory —about 40% the size of South Korea — and a population of around 9 million, has produced numerous leading global pharmaceutical companies. In particular, the City of Basel is home to over 800 life science companies, including Roche, Novartis, and Ferring Pharmaceuticals. Basel is also home to 'BaseLaunch,' a venture builder that supports bio-ventures and represents Europe. So far, 11 companies in the BaseLaunch portfolio have attracted over $800 million (approximately KRW 1 trillion) in investment from European and U.S. venture funds. Switzerland has also been recognized as the world's most innovative country for 15 consecutive years in the World Intellectual Property Organization (WIPO)'s Global Innovation Index. Conradin Cramer, Mayor of Basel, stated, "City of Basel's strength is not just its world-class research, but also its accessibility. Universities, hospitals, and public institutions are all within walking distance. This proximity facilitates rapid decision-making and network formation." He emphasized, "Innovation does not remain confined to one country's economy. Competence and mutual respect are essential factors for achieving goals. We look forward to collaboration between Switzerland and Korea, and partnership collaboration between Roche and Korean partner companies." "Korean Companies Show Global Competitiveness in ADC and Alzheimer’s New Drugs" (from left) Ezat Azem, General Manager of Roche Korea; Harm-Jan Borgeld, Head of Asia Partnering Group; Andrea Clementi, Head Swiss Business Hub Korea; Christof Kloepper, Basel Area Business & Innovation Roche, founded in 1892, is one of the major global pharmaceutical companies, with innovative achievements across chronic diseases, oncology, rare diseases, immunological diseases, and ophthalmology. Last year, the company's revenue recorded 60.495 billion Swiss Francs (approximately KRW 96 trillion). Roche is also focusing on bolstering its next-generation pipeline across various markets. Harm-Jan Borgeld, Head of Roche's Asia Partnering Group, who oversees the Asian markets including Korea, Japan, and China, explained that Korean companies are effectively developing both Best-in-Class and First-in-Class new drug candidates. He particularly assessed that Korea holds strengths in Antibody-Drug Conjugates (ADCs) and early-stage Alzheimer's disease. Harm-Jan Borgeld stated, "We have confirmed the competitiveness of Korean companies in ADCs. We see strong interest in promising new drug candidates, especially those pursuing bispecific antibody-ADCs that can target multiple solid tumors rather than a single indication. The market competitiveness of Korean companies is also evident in the components of ADCs: the payload, the linker, and the platform technology. Furthermore, Korea holds promising candidates for Alzheimer's disease treatments." He added, "For Korean companies to build contact points with global companies, they must understand the interests of partnering companies. In particular, the pitching points of each new drug candidate are particularly important. Most projects are in the Phase 1 to Phase 2 stage, and companies that pitch well accurately present their most advanced compounds. Most importantly, successful progress in preclinical animal models is essential." Borgeld stressed that companies developing a Best-in-Class drug must be able to clearly explain the potential of their acquired data, along with an analysis of competing drugs. Borgeld said, "Late entrants must identify which data has potential compared to competitors. They must also pay attention to the progress of competitors," and added, "Preparation related to manufacturing and production must also be strong. Companies should be able to explain their manufacturing plan for the antibody compound." Ezat Azem emphasized, "For Korean companies to enter the global market, it is essential to meet various international standards first. By narrowing the gap with international standards, the possibility of collaboration with global companies will increase. Like in Switzerland, cooperation among industry, academia, and government is needed."
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- Expanded reimb prospect for 5 indications of 'Tevimbra'
- by Eo, Yun-Ho Oct 16, 2025 06:21am
- Product photo of Tevimbra The cancer immunotherapy 'Tevimbra' is gathering attention over whether it will receive expanded reimbursement following its previous success in the esophageal cancer indication. According to industry sources, five indications for BeOneMedicines Korea's PD-1 inhibitor immunotherapy Tevimbra (tislelizumab) are expected to be considered by the upcoming Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA). In April, Tevimbra became the first immunotherapy to receive reimbursement for esophageal cancer. Following this, it has added five new indications for solid tumors, including esophageal cancer, gastric cancer, and non-small cell lung cancer. BeOneMedicines has submitted a reimbursement application concurrently with its application for Tevimbra's expanded indication. The indications are ▲first-line combination therapy for unresectable, locally advanced, or metastatic esophageal cancer ▲first-line combination therapy for unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma ▲two types of first-line combination therapy, and second-line monotherapy for non-small cell lung cancer. Since BeOne Medicines is quickly proceeding with reimbursement procedures for additional indications, Tevimbra's role is expected to expand across various cancer types in Korea. Expectations are particularly high due to BeOne Medicines' previous track record of successfully concluding negotiations with the government by advocating for 'fair drug pricing' since its initial listing. It remains to be seen whether BeOne Medicines can uphold its company philosophy of 'providing innovative new drugs at a reasonable price and leaving no patient behind.' Meanwhile, the efficacy and safety of Tevimbra were proven in various indications through the RATIONALE clinical trial series (RATIONALE-303, 304, 305, 306, 307). Notably, in studies of esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma, Tevimbra demonstrated clinical benefits in the overall patient population. The trials showed consistent results in pre-specified subgroups based on PD-L1 expression.
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- ‘Leclaza combo extends survival without chemotherapy’
- by Son, Hyung Min Oct 15, 2025 11:37am
- Professors Sun Min Lim and Byoung Chul Cho of Yonsei Cancer Center’s Department of Medical Oncology “The MARIPOSA study is the first clinical trial to significantly extend overall survival using two targeted therapies without chemotherapy. Discussions on EGFR-mutated lung cancer treatment will now shift to focus on overall survival.” During a recent interview with Dailypharm, Professors Byoung Chul Cho and Sun Min Lim of Yonsei Cancer Center’s Department of Medical Oncology expressed so regarding the results of the MARIPOSA trial that evaluated the combined use of Leclaza (Lazertinib) and Rybrevant (amivantamab)’, agreeing it will trigger a paradigm shift in treatment. Leclaza (lazertinib), developed by Yuhan Corporation, is a third-generation EGFR tyrosine kinase inhibitor (TKI) that targets exon 19 deletions and exon 21 L858R mutations in EGFR-positive non-small cell lung cancer (NSCLC). Johnson & Johnson secured global rights to Leclaza and has conducted clinical studies evaluating the efficacy of Leclaza in combination with Rybrevant, a targeted therapy option targeting exon 20 and MET mutations. In the trial, the Leclaza + Rybrevant group demonstrated a statistically significant improvement in survival duration compared to the Tagrisso (osimertinib) group (p-value less than 0.005). Specifically, the median overall survival (OS) for the Leclaza + Rybrevant group was not reached (42.9-NE). In contrast, the Tagrisso group showed an OS of 36.7 months. Considering the survival rate distribution between the two groups, the Leclaza + Rybrevant group is expected to extend OS by at least 12 months compared to the Tagrisso group. These study results were recently published in the New England Journal of Medicine (NEJM), drawing significant attention from the academic community. Professor Cho explained, “The MARIPOSA study is the first clinical trial to significantly extend survival using only two targeted therapies without chemotherapy. While discussions on EGFR-mutated lung cancer have previously focused on progression-free survival (PFS), the focus will now shift to OS.” Professor Lim also stated, “In actual clinical settings, the third-generation TKI combo regimen showed rapid response and early symptom relief. If initial side effects are appropriately managed and prevented, treatment can be sufficiently continued on an outpatient basis. Ultimately, helping patients survive long-term with effective drugs is the top priority of treatment.” The professors saw that the most significant distinguishing feature of this study was the confirmation of a ‘qualitative change in the mechanism of resistance.’ Professor Byoung Chul Cho of Yonsei Cancer Center’s Department of Medical Oncology Professor Cho emphasized, “Not only did the frequency of resistance occurrence change, but the genetic and biological characteristics of the tumor itself changed. This suggests that the treatment fundamentally altered tumor biology, contributing to improved OS beyond merely extending the duration of treatment.” He further explained, “The MARIPOSA study demonstrated consistent OS improvement in both Asian and non-Asian patient populations. In contrast, the FLAURA2 study, which evaluated the efficacy of Tagrisso plus chemotherapy, showed a limited OS improvement in the Asian patient cohort.” He projected, “Combining chemotherapy has limitations in that it cannot fundamentally alter the biological characteristics of the tumor. Therefore, the detailed Asian data from MARIPOSA to be presented at ESMO Asia is expected to show different results compared to FLAURA2.” Professor Lim said, “In the detailed analysis of FLAURA2, no OS improvement was observed in the Asian cohort, excluding Chinese patients. Considering that the previous FLAURA study on Tagrisso monotherapy also failed to confirm OS improvement in Asian patients, racial differences may remain a persistent point of debate. Differences in drug response between races will become an important discussion point going forward.” Side effect management and formulation improvements increase potential for sustained treatment... “Combination therapy will ultimately become the standard” Researchers also note that recent studies have demonstrated manageability for skin-related adverse reactions, a common side effect of combination therapy. For Leclaza + Rybrevant, skin rash and paronychia are identified as major adverse reactions. Professor Cho stated, “According to the recently published COCOON study, preventive use of antibiotics, scalp lotions, and moisturizers reduced moderate to severe skin rashes by nearly half. If managed well during the initial 12 weeks, patients' quality of life also improves significantly.” Professor Lim emphasized, “We provide a management manual to patients and caregivers from the initial stages of treatment,” stressing that “prevention-focused management is key to ensuring treatment adherence.” Also, Professor Lim believed that the convenience of administration would significantly improve with the introduction of the subcutaneous injection formulation of Rybrevant. A drawback highlighted in the combination therapy of Leclaza + Rybrevant is that the injectable form of Rybrevant may reduce administration convenience. EGFR-targeted therapies, including Leclaza, Tagrisso, Boehringer Ingelheim's Giotrif (Afatinib), Pfizer's Vizimpro (dacomitinib), Roche's Tarceva (Erlotinib), and AstraZeneca's Iressa (gefitinib), are all oral medications. Rybrevant, however, is an intravenous (IV) formulation requiring a hospital visit once every three weeks for administration that lasts over an hour. This has raised concerns that it may hinder treatment convenience for non-small cell lung cancer patients. Janssen plans to maximize the synergy of combination therapy through the introduction of Rybrevant’s subcutaneous (SC) injection formulation. Professor Sun Min Lim of Yonsei Cancer Center’s Department of Medical Oncology Professor Lim stated, “In the PALOMA-2 study evaluating the potential of Rybrevant SC, the SC formulation showed infusion-related reactions reduced to one-seventh compared to IV, while demonstrating equivalent efficacy. Approval has already been granted in Europe, and U.S. approval is imminent. If introduced in Korea as well, the new formulation will significantly reduce the burden on patients.” She continued, “Beyond simply reducing administration time and increasing convenience, the SC formulation has the potential to alter the patient's immune environment itself. Our research team is currently preparing a study directly comparing the immunological differences between Rybrevant SC and IV administration.” She also noted, "The most important factor for patients is the survival period. As long as the data supports this, change in the field is only a matter of time. Delays in approval and reimbursement preventing patients from immediately benefiting from the latest treatments represent an institutional challenge that needs resolution.“ Professor Cho explained, ”While some hesitate to use combination therapy, citing concerns about Leclaza’s adverse reactions or reduced administration convenience, most issues can be resolved through dose adjustment and proactive management. The results of the PALOMA-2 and COCOON studies support this." He added, “The average age of EGFR-mutated lung cancer patients is mid-60s, about 10 years younger than the general lung cancer patient population. While caution is needed for combination therapy in those over 80, factors like treatment willingness, self-management capability, underlying conditions, and metastasis patterns are more critical criteria than age itself.” He stated, “If a patient has brain metastases but demonstrates strong treatment intent and good self-management capability, combination therapy should be prioritized. When Tagrisso first improved OS by six months eight years ago, some initially urged caution, but it eventually became the global standard. While some clinicians still prefer monotherapy, considering patient demand and the proliferation of data, combination therapy will likely establish itself as the new standard of care.”
