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- 2026-03-10 08:28:05
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- 'Januvia generics hit 23% market share in 2 years'
- by Kim, Jin-Gu Oct 30, 2025 06:11am
- Generic versions of the DPP-4 inhibitor class diabetes treatment ‘Januvia (sitagliptin)’ series expanded their market share to 23% just two years after launch. However, analysis indicates their market penetration pace is slower than that of previous cases such as Tenelia (teneligliptin) and Galvus (vildagliptin). Performance among generic manufacturers varied significantly. While most generics recorded quarterly prescription sales below KRW 100 million, Kyongbo Pharmaceutical and Hanmi Pharmaceutical achieved results exceeding KRW 1 billion, strengthening their presence. Januvia generics hit 23% share in 2 years — market penetration slower According to the pharmaceutical market research institution UBIST on the 29th, total outpatient prescriptions for sitagliptin monotherapy and sitagliptin/metformin combinations in Q3 this year reached KRW 28.3 billion, down 6% from KRW 30.2 billion in the same quarter last year. While the sales of original products declined, generics grew. Sales of the original Januvia, Janumet, and Janumet XR fell 14%, from KRW 25.1 billion in Q3 2023 to KRW 21.7 billion this year. Specifically, Januvia dropped from KRW 5.8 billion to KRW 4.5 billion, and sales of Janumet/Janumet XR combined declined from KRW 19.3 billion to KRW 17.2 billion. Since the launch of the generics, the originals have seen a steady downward trend. Just before patent expiry in Q2 2023, total prescriptions for the Januvia series stood at KRW 37.5 billion, but after generics entered in Q4 2023, the figure fell to KRW 26.6 billion, then dropped further 18% by Q3 this year. Meanwhile, generic products saw their combined prescription sales increase by 30% over the past year, rising from KRW 5.1 billion to KRW 6.6 billion. Sales of Januvia generics increased from KRW 1.6 billion to KRW 1.9 billion, while Janumet and Janumet XR generics rose from KRW 3.5 billion to KRW 4.7 billion. Januvia generics were released in September 2023. Following the patent expiration of the long-standing market leader of the KRW 600 billion annual DPP-4 inhibitor market, many generic companies rushed to join in the competition. A total of 89 companies received approval for generics, and 60 of these companies launched products. The overall market share of generics expanded from 17% to 23% within a year. However, the pace of the market penetration is somewhat slower compared to other DPP-4 inhibitor generics like Tenelia and Galvus. Galvus and Galvusmet generics recorded a 42% market share in their first year. In its second year, it further expanded its share to 47%, reaching a level similar to the original. Tenelia and Tenelia M generics surpassed the original with a 54% market share in their first year. This rose to 58% in their second year. Sales of Hanmi·Kyongbo soar... Most other companies record quarterly prescription sales under KRW 300 million Generic companies showed polarized results. Only two companies recorded quarterly prescription sales exceeding KRW 1 billion, while most others fell short of even KRW 100 million. Kyongbo Pharmaceutical reported KRW 1.1 billion in Q3 sales for its combination generics Janustinmet and Janustin XR, nearly doubling from KRW 600 million in the same quarter last year. Cumulative prescriptions for the two products have reached KRW 4.9 billion. Hanmi Pharmaceutical’s Sita and Sitamet XR posted KRW 1 billion, up 25% year-over-year, bringing cumulative prescriptions to KRW 5.8 billion since launch. In contrast, most generics are underperforming. Of the 60 companies that launched products, 41 (68%) posted quarterly sales below KRW 100 million, and 15 companies (25%) recorded less than KRW 300 million. The average Q3 prescription per company stood at approximately KRW 110 million. The reason Januvia generics are struggling to expand their influence is that the DPP-4 inhibitor class diabetes treatment market is already saturated. In this space, Januvia competes with original products such as Zemiglo (gemigliptin), Trajenta (linagliptin), Tenelia (teneligliptin), Suganon (evogliptin), Galvus (vildagliptin), Onglyza (saxagliptin), Nesina (alogliptin), and Guardlet (alogliptin/metformin). Among these, Galvus, Tenelia, and Trajenta have already faced generic competition upon their patent expiry. Furthermore, the DPP-4 inhibitor market has seen a decline in overall prescription volume since the emergence of SGLT-2 inhibitor class diabetes treatments like Forxiga and Jardiance. In this environment, the flood of Januvia and Janumet generics has led to fierce competition and lower-than-expected sales performance.
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- Wegovy prescribed to adolescents for obesity
- by Son, Hyung Min Oct 30, 2025 06:09am
- Novo Nordisk held an event on the 28th at the Courtyard by Marriott Seoul Namdaemun for its obesity treatment drug Wegovy, which has settled as a leading therapy for adult obesity, has expanded its reach into adolescent obesity. Following approvals in the US and Europe, Novo Nordisk’s Wegovy can now be prescribed to patients aged 12 and older in Korea. With this, calls from the medical community on earlier intervention for obesity are gaining traction. Experts describe this approval as “not merely an expansion of indication, but an institutional turning point recognizing adolescent obesity as a chronic disease.” Adolexcent obesity moves out of the treatment blind spot Novo Nordisk held a press conference on the 28th to mark the expanded adolescent indication for its obesity treatment Wegovy (semaglutide 2.4mg), sharing key clinical results and future treatment strategies. Wegovy is a once-weekly GLP-1 (glucagon-like peptide-1) receptor agonist approved last year in Korea for treating adult obesity. With the new indication, it can now be used for adolescent patients aged 12 and above in Korea, emerging as a new treatment option for obesity during the growth years. According to Novo Nordisk, semaglutide 2.4mg is structurally similar to human GLP-1. It regulates overall metabolism not only through weight loss but also by improving blood glucose and lipid levels. Ju Ok Lim, Head of Medical Affairs at Novo Nordisk, said, “Semaglutide 2.4mg demonstrated consistent weight loss effects and safety not only in adults but also in adolescents. The indication expansion will serve as an opportunity to address the treatment gap for adolescent obesity.” Until now, obesity treatments available for children and adolescents aged 12 and older in Korea have been extremely limited. Representative options include the fat absorption inhibitor ‘orlistat’ and the once-daily GLP-1 class injectable ‘Saxenda (liraglutide)’. Latest adult-targeted medications like ‘Qsymia (phentermine/topiramate)’ and ‘Mounjaro (tirzepatide)’ are not yet approved for adolescent use. The approval of Wegovy expands access to weekly therapy-based treatment approaches. Julie Broe Honore, Head of clinical development, medical and regulatory affairs at Novo Nordisk, said, “Adolescent obesity is no longer an individual problem but a public health issue. This expansion of Wegovy's indication marks the first step toward preventing adult metabolic diseases through early intervention.” STEP TEENS study…16% weight reduction & improved cardiovascular risk factors This expansion of Wegovy's indication is based on results from the Phase III STEP TEENS clinical trial conducted in adolescents. The study involved 201 adolescents aged 12-18 who were obese or overweight and had weight-related conditions, conducted over 68 weeks. The average age was 15.4 years, 62% were female, and the racial distribution was 79% White, 8% Black, and 2% Asian. Clinical results showed the Wegovy group achieved an average BMI (Body Mass Index) reduction of 16.1%, demonstrating a significant difference compared to the placebo group, which increased by 0.6%. Approximately 72.5% of patients achieved at least a 5% weight loss, nearly four times higher than the placebo group (17.7%), with an average weight loss of 15.3 kg. Notably, 37.4% of patients achieved a weight loss of 20% or more, demonstrating efficacy in adolescents comparable to that seen in adults. Improvements were observed not only in cardiovascular risk factors like waist circumference, blood pressure, and lipid levels, but also in quality of life (QoL) indicators. Eun-gu Kang, Professor of Pediatrics at Korea University Ansan HospitalThe main adverse reactions reported were gastrointestinal symptoms such as nausea, vomiting, and diarrhea, but most were mild and did not affect growth or pubertal development. Eun-gu Kang, Professor of Pediatrics at Korea University Ansan Hospital, commented, “Beyond weight reduction, the study confirmed metabolic benefits such as LDL cholesterol reduction and improvements in blood pressure and waist circumference, suggesting positive cardiovascular implications.” He further noted, “However, as adolescents are still in the process of growth, long-term follow-up and accumulation of safety data are necessary.” Adolescent obesity rate increases 1.7 times over 10 years Experts unanimously agreed that this approval holds significance in terms of ‘securing treatment accessibility’. According to the ‘2024 Adolescent Health Behavior Survey’ conducted by the Korea Disease Control and Prevention Agency and the Ministry of Education, the obesity rate among middle and high school students rose from 7.5% in 2015 to 12.5% last year, a 1.7-fold increase over 10 years. The overweight/obesity rate for male students is 43.0%, and for female students, 24.6%, the highest among the four East Asian countries, including China, Japan, and Taiwan. The main concern is comorbidities. Around 80% of obese adolescents remain obese into adulthood and often develop one or more metabolic disorders, such as hypertension, diabetes, or dyslipidemia. Yong-hee Hong, Professor of Pediatrics at Soonchunhyang University Bucheon HospitalThis is why experts point out that adolescent obesity should be viewed not as a mere ‘cosmetic issue’ but as a disease requiring early intervention. Yong-hee Hong, Professor of Pediatrics at Soonchunhyang University Bucheon Hospital, emphasized “Obesity is clearly a disease requiring treatment, yet it is often still perceived as a cosmetic issue. This perception must change so that patients who actually need medication can be brought into the healthcare system.” Young-sung Suh, Professor of Family Medicine at Keimyung University Dongsan Hospital and President of the Korean Society for the Study of Obesity, stated, “Obesity is not a matter of willpower but a complex metabolic disorder. At the society level, we will focus on enhancing treatment accessibility while ensuring safe medication use and preventing misuse.” While some raise concerns about muscle loss with GLP-1 agonists, experts see significant clinical benefits due to their fat-focused weight reduction. Lim said, “Some muscle loss may occur with weight reduction, but overall, the health benefits from fat loss are far greater. We will strengthen education and management to enable healthy weight loss alongside the metabolic improvement.” Kang added, “While muscle loss in patients during growth periods requires caution, GLP-1 drugs often yield positive outcomes in body composition changes. Controlling fat mass and maintaining nutritional balance are more important than just body weight numbers.”
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- Reimb for Perjeta as adjuvant therapy under CDDC review
- by Eo, Yun-Ho Oct 29, 2025 06:12am
- The expansion of reimbursement coverage for Perjeta’s use as adjuvant therapy in breast cancer is drawing attention. According to industry sources, Roche Korea’s HER2-positive breast cancer treatment Perjeta (pertuzumab) has been submitted for review by the Health Insurance Review and Assessment Service (HIRA) Cancer Disease Deliberation Committee. Currently, Perjeta is reimbursed for treating HER2-positive metastatic or unresectable locally recurrent breast cancer. In early breast cancer, it is granted selective reimbursement as a neoadjuvant therapy (before surgery), with patients bearing 30% of the cost. However, in the postoperative adjuvant therapy stage—a key treatment step to prevent recurrence—has remained non-reimbursed (100% patient coinsurance) since its indication was added in Korea in 2018, limiting patient access. The recent submission to the National Health Insurance Service's Drug Disease Deliberation Committee is believed to have been significantly influenced by the 10-year long-term follow-up data from the Phase III APHINITY clinical trial, presented at the European Society for Medical Oncology Breast Cancer Conference (ESMO Breast Cancer 2025) last May. This study newly confirmed statistically significant final overall survival (OS) data for the combination of Perjeta and Herceptin (trastuzumab). When Perjeta was administered in combination with Herceptin and chemotherapy, the risk of death in patients with HER2-positive early breast cancer was reduced by 17% compared to the existing Herceptin-chemotherapy combination therapy. Furthermore, the 10-year survival rate in the Perjeta-Herceptin treatment arm was 91.6%, showing an improvement compared to the 89.8% in the control arm. The Perjeta-Herceptin treatment arm also demonstrated greater clinical benefit in patients at high risk of recurrence. Specifically, in a subgroup analysis of patients with lymph node–positive disease, who are at high risk of recurrence, the combination showed a 21% reduction in the risk of death. Furthermore, the benefit in invasive disease-free survival (iDFS) was also maintained, reaffirming the earlier findings of the APHINITY study. It remains to be seen whether Perjeta's adjuvant therapy indication can pass CDDC review and ultimately be granted reimbursement coverage. Meanwhile, the Perjeta and Herceptin combination is currently recommended as Category 1 adjuvant therapy in the U.S. NCCN Guidelines for patients with HER2-positive early breast cancer and lymph node metastasis. It is also recommended as Category 1 adjuvant therapy for high-risk, lymph node–positive patients who achieved pathological complete response (pCR) after neoadjuvant chemotherapy.
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- Will the Indian API cause problems?
- by Kim, Jin-Gu Oct 29, 2025 06:12am
- An impurity issue has emerged as a major variable in the tramadol-acetaminophen combination drug market, valued at approximately KRW 150 billion annually. Following the detection of impurities in three generic products using Indian-sourced active pharmaceutical ingredients (API), the pharmaceutical industry is watching closely for the potential expansion of the impurity issue across all API from India. In this case, the market is expected to be reorganized around products that use non-Indian sourced API. 85% of tramadol DMFs are produced in India...Concerns Over Widespread Impurity Detection According to the Ministry of Food and Drug Safety (MFDS) on October 29, following the excess detection of the impurity NNDT (N-nitroso-desmethyl tramadol) in a tramadol monotherapy product in July, the recall target has recently been expanded to include tramadol + acetaminophen combination products. To date, impurities have been detected in three tramadol + acetaminophen combination products. The MFDS issued recall orders for specific batch number products of: ▲Dongkoo Bio & Pharma’s 'Jimuradol Tab' ▲Ausco Korea Pharma's 'Acetadol Tab' ▲Union Korea Pharm’s 'Atracen Tab.' All three products in which impurities were detected are known to have used India-sourced API. The concern is that a significant portion of the tramadol + acetaminophen combination products currently distributed in South Korea relies on API sourced from India. Currently registered sources of tramadol API: YELLO-India, BLUE-Israel, RED-Switzerland, GREEN-Korea Indeed, examining the Drug Master File DMF status for tramadol-related API shows that 62 of the 73 registered raw material manufacturers (85%) are located in India. The remaining 11 sites include 8 in Israel (11%), 2 in Switzerland (3%), and 1 in Korea (1%). Many domestically supplied products likely rely on Indian-sourced API. KRW 150 Billion Market...Top-selling products not at risk of impurity expected to benefit The three products where impurities were detected have negligible prescription sales. According to pharmaceutical market research firm UBIST, the cumulative prescription sales for these three products combined were less than KRW 400 million in the third quarter of this year. While the market impact is currently limited, analysis suggests that market restructuring will be unavoidable if impurity detection expands across Indian-sourced API. This is because securing new raw material manufacturers outside of India is difficult, and the administrative process for changing API registration alone takes approximately six months, which would lead to a market supply gap. The tramadol + acetaminophen combination market in Korea has seen steady growth in the moderate-to-severe pain treatment sector. It increased by 24% over the last four years, from KRW 120.7 billion in 2020 to KRW 127.1 billion in 2021, KRW 138.2 billion in 2022, KRW 144.6 billion in 2023, and KRW 149.6 billion last year. Cumulative sales reached KRW 114.9 billion in the third quarter of this year. Quarterly prescription sales of tramadol-acetaminophen combination drugs (DARK GREEN: original product, LIGHT GREEN: generic products; unit: KRW 100 million, source: UBIST). The original product, Janssen Korea's Ultracet, recorded cumulative sales of KRW 24.1 billion in the third quarter, a slight decrease from KRW 24.3 billion in the third quarter of last year. Generic products collectively saw a 5% increase in the same period, rising from KRW 86.3 billion to KRW 90.9 billion. The growth of top-selling generics was particularly notable: Samjin Pharm's 'Synerjet' grew by 23%, from KRW 6.9 billion to KRW 8.6 billion; Myung Moon's 'Traphen' grew from KRW 5.2 billion to KRW 6.6 billion; and Genuone Sciences' 'Painless' increased from KRW 4.4 billion to KRW 5.1 billion. In this circumstance, if the impurity issue spreads, non-detected products are expected to quickly replace the market. Currently, the market-leading products are understood to be not at risk. The original product, Ultracet, has registered a Swiss manufacturer as its API supplier. The top generic product, Samjin Pharm's Synerjet, manufactures its finished drug in-house using an Israeli-sourced API. Neither of these two products was requested to submit data in the MFDS's comprehensive investigation of NNDT impurities in tramadol.
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- Fruzaqla expands its role to late-stage colorectal cancer
- by Son, Hyung Min Oct 28, 2025 06:12am
- A new treatment option has been added to the field of metastatic colorectal cancer, which is classified as a refractory condition. Takeda Korea held a press conference on the 27th at the Plaza Hotel in Jung-gu, Seoul, to commemorate the expanded indication of its colorectal cancer drug, Fruzaqla (fruquintinib). Approved in March as a fourth-line therapy, Fruzaqla was approved to extend its indication as a third-line treatment within just 6 months, becoming one of the key success cases of the Ministry of Food and Drug Safety’s fast-track program (Global Innovative drugs on Fast Track). Clinical evidence for Fruzaqla was established through the global Phase III FRESCO trial involving 416 patients with metastatic colorectal cancer. Results showed the median overall survival (OS) in the Fruzaqla group was 9.3 months, extending survival by 2.7 months compared to 6.6 months in the placebo group. The risk of death decreased by 35%, and adverse events were mostly predictable or manageable. Professor Dong-Hoe Koo of the Department of Medical Oncology at Kangbuk Samsung Hospital These results were published in major international journals such as The New England Journal of Medicine (NEJM) and subsequently recommended as Category 2A in the NCCN Guidelines and Grade I, A in the European Society for Medical Oncology (ESMO) guidelines. Professor Dong-Hoe Koo of the Department of Medical Oncology at Kangbuk Samsung Hospital stated, "Fruzaqla has high drug specificity as it does not target unnecessary targets. This enables efficient VEGFR inhibition and sustained drug exposure. Its potential for combination therapy with existing agents is also worth exploring in future clinical studies.“ He further stated, ”The survival benefit of existing treatments had not been substantial compared to the untreated group. Fruzaqla has shown real-world efficacy comparable to clinical trials, suggesting broader clinical utility.” Still high unmet need...“Expectations for improved survival in late-stage patients” South Korea's colorectal cancer incidence rate was 61.1 per 100,000 population in 2022, the second highest after thyroid cancer. Particularly concerning is the incidence rate among individuals under 40, which reached 12.9 per 100,000, the highest in the world. Colorectal cancer is a malignant tumor that develops in the colon or rectum, classified as colon cancer or rectal cancer based on location. Metastatic colorectal cancer refers to tumors that have spread beyond the primary site to other organs. Because the liver is where blood and lymph from the colon converge, it is the most common site of metastasis, and liver metastasis ranks among the leading causes of death in colorectal cancer patients. However, treatment options remain limited compared to other cancer types. Professor Myung-ah Lee of the Department of Medical Oncology at Seoul St. Mary Currently, in metastatic colorectal cancer treatment, after the first-line therapy ‘Nexavar (sorafenib)’ by Bayer, the standard second-line therapies primarily involve ‘Stivarga (regorafenib)’ by Bayer and ‘Avastin (bevacizumab)’ by Roche in combination with Lonsurf (trifluridine/tipiracil) by Taiho Pharmaceutical in Japan. However, as treatment options beyond the third line have been limited, Fruzaqla’ is expected to play a significant role in the treatment space. Professor Myung-ah Lee of the Department of Medical Oncology at Seoul St. Mary's Hospital stated, “Although several novel targeted therapies have emerged, treatment options remain insufficient beyond the third line. Due to the lack of expected efficacy, the difference in survival benefit has been minimal. Stivarga and Lonsurf have not demonstrated the expected level of effectiveness.” “Patients undergoing third-line or later treatment have already been exposed to numerous anticancer drugs, leading to a diminished quality of life. This is largely linked to the toxicity issues of these drugs. For instance, despite being a targeted therapy, Stivarga had a high incidence of adverse reactions that negatively impact quality of life. Given the shortage of drugs that are both less toxic and effective, Fruzaqla is expected to play a greater role.”
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- Hanmi "Phase 3 trial confirms efficacy of GLP-1 drug"
- by Cha, Jihyun Oct 28, 2025 06:11am
- Efpeglenatide is a GLP-1 drug using Hanmi Pharmaceutical Hanmi Pharmaceutical announced on October 27 that its glucagon-like peptide-1 (GLP-1) obesity treatment candidate, 'HM11260C' (efpeglenatide), met primary endpoints in a Phase 3 top-line study in Korea. The results confirmed significant weight-loss efficacy and safety compared with placebo. This Phase 3 trial involved 448 non-diabetic adult patients with obesity. The study aimed to evaluate the superiority of efpeglenatide over placebo in terms of the mean percentage change in body weight and the percentage of subjects achieving 5% weight loss at 40 weeks. According to Hanmi Pharmaceutical, the 40-week analysis showed a statistically significant difference against placebo. The proportion of subjects achieving 5% weight loss was 79.42% in the efpeglenatide group versus 14.49% in the placebo group. The mean percent weight change was -9.75% in the efpeglenatide group versus -0.95% in the placebo group, confirming a least-squares mean difference of -8.13% between the groups. In terms of safety, gastrointestinal adverse events were reported but generally manageable: nausea 16.72% (5.37% with placebo), vomiting 11.71% (2.01% with placebo), and diarrhea 17.73% (4.70% with placebo). Hanmi Pharmaceutical plans to apply for marketing authorization with the Ministry of Food and Drug Safety (MFDS) for efpeglenatide within this year. The company explained, "Although the clinical trial involves dosing and observation up to 64 weeks, we are disclosing the 40-week interim top-line data with a plan for a submission within the year," and added, "We expect to derive improved indicators from continued dosing beyond the data announced now." Efpeglenatide is a GLP-1 drug using Hanmi Pharmaceutical's long-acting platform, 'LAPSCOVERY,' and is the most advanced clinical-stage candidate in the company's obesity and metabolic disease pipeline. It is also the fastest-developing obesity treatment among domestic Korean companies. Hanmi Pharmaceutical initially out-licensed efpeglenatide to Sanofi for diabetes in 2015 for up to €3.9 billion (approximately KRW 5.597 trillion). However, Sanofi returned the rights to the pipeline in June 2020, citing a change in business strategy. In 2023, Hanmi Pharmaceutical officially announced its decision to develop efpeglenatide, initially developed for diabetes, as an obesity treatment, mirroring the strategies of Novo Nordisk and Eli Lilly in repurposing their diabetes drugs. The core of Hanmi's strategy is the creation of a 'Korean GLP-1 Obesity Drug'. The company intends to develop efpeglenatide as a GLP-1 obesity treatment tailored to the characteristics of the Korean obese population, which has a lower proportion of severely obese patients. In a global market where Novo Nordisk and Eli Lilly have established overwhelming dominance, Hanmi Pharmaceutical aims to differentiate through price competitiveness and a stable supply chain. Kim Na-young, Executive Director of Hanmi Pharmaceutical's New Product Development Division, who led the study, stated, "Efpeglenatide, a drug the late founder of Hanmi Group, Lim Sung-ki, was passionate about, has taken a big step toward commercialization as a 'national obesity drug' by yielding effective and safe clinical results in a Korean population study," and concluded, "Efpeglenatide will become a new drug demonstrating diverse potential in the metabolic disease sector, spanning from obesity to diabetes."
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- ADC offers new hope in TNBC treatment gap
- by Hwang, byoung woo Oct 28, 2025 06:11am
- The TROPION-Breast02 study presented at the European Society for Medical Oncology Congress 2025 (ESMO 2025) marks a new turning point in the treatment of triple-negative breast cancer (TNBC). As the first antibody-drug conjugate (ADC) trial to significantly improve both overall survival (OS) and progression-free survival (PFS) in patients who cannot receive immunotherapy, it heralds a change in actual clinical practice. At ESMO 2025, Professor Kyung-Hae Jung of Asan Medical Center emphasized that this study provides the first clinical evidence of survival benefit in a patient population that previously had no options beyond cytotoxic chemotherapy. First Phase III study to improve Overall Survival...beyond cytotoxic chemotherapy dependence Professor Kyung-Hae Jung of Asan Medical CenterTROPION-Breast02 is a Phase III clinical trial comparing Datroway(Dato-DXd) monotherapy with chemotherapy in 644 patients with previously untreated locally recurrent, unresectable, or metastatic triple-negative breast cancer. Progression-free survival (PFS) was 10.8 months in the Datroway group, reducing the risk of disease progression or death by 43% compared to the chemotherapy group (5.6 months) (HR 0.57, p
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- Ultomiris's reimb standards eased for aHUS
- by Son, Hyung Min Oct 27, 2025 06:11am
- Prof. Myung-Gyu Kim of Korea University Anam Hospital (Nephrology) The reimbursement criteria for C5 complement inhibitors in atypical hemolytic uremic syndrome (aHUS) have been eased this month. With this improvement, as the previous criteria had stringent reimbursement conditions, such as the requirement for prior review, patient access is expected to improve. On the 24th, AstraZeneca Korea held a briefing at the Westin Seoul Parnas Hotel to commemorate the relaxation of reimbursement criteria for ‘Ultomiris (ravulizumab)’ in aHUS. Ultomiris is a next-generation C5 complement inhibitor with a half-life approximately four times longer than that of the existing Soliris (eculizumab). While Soliris requires administration every 2 weeks, Ultomiris extends the dosing interval to 8 weeks, improving treatment convenience. aHUS is an acute rare disease where the immune system's complement system becomes overactivated due to a genetic defect, causing thrombotic microangiopathy. This can lead to severe damage to multiple organs, particularly the kidneys. aHUS refers to cases of hemolytic uremic syndrome that occur independently of E. coli infection. When complement component C5 is activated on bacterial surfaces, it generates a membrane attack complex that perforates cell membranes. If this normal immune system process of complement activation continues unchecked, it causes problems in vascular endothelial cells, leading to related diseases. Ultomiris has a mechanism that inhibits this process. Expanded diagnostic and administration criteria enable timely treatment Ultomiris became reimbursable by national health insurance in January for patients with aHUS accompanied by thrombotic microangiopathy (TMA) and kidney damage. Previously, treatment was restricted to patients who had received prior approval through a pre-review process. As this can cause delays leading to disease progression, clinicians have called for a switch to post-approval review to allow faster initiation of therapy. In fact, since the implementation of the aHUS pre-review system, the average reimbursement approval rate has been only 18% (based on cases reviewed from July 2018 to August 2025), often resulting in missed treatment windows. The revised regulations, effective from the 1st of this month, minimize treatment delays by broadening the diagnostic and administration requirements for aHUS patients. Experts evaluate that clarifying the evaluation standards for treatment effectiveness may help maintain treatment continuity. Improvements in Korea The revised criteria specify that TMA activation can now be confirmed if three or more of five hematologic criteria, including thrombocytopenia, are met. Furthermore, reimbursement is also granted if the patient meets the administration criteria, including ADAMTS-13 activity of 10% or higher. Even before test results are confirmed, if the platelet count is 150×10⁹/L or higher, immediate administration is possible after submitting a pre-application form, and the administered dose is covered until the review result is notified. Furthermore, a new treatment pathway has been created as it explicitly states that when a kidney transplant is performed due to end-stage renal failure caused by aHUS, coverage is granted on a case-by-case basis. The criteria for coverage of switching from Soliris to Ultomiris have also been clearly defined. Prof. Myung-Gyu Kim of Korea University Anam Hospital (Nephrology) said, “aHUS can rapidly progress to end-stage renal failure or multi-organ damage within 48 hours, making treatment timing critical to prognosis. The revised criteria reflect global best practices and strengthen evidence for continued therapy in high-risk patients, establishing an environment enabling the rapid design of treatment strategies.”
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- ImmuneOncia speeds commercialization with product-fit plan
- by Hwang, byoung woo Oct 27, 2025 06:10am
- ImmuneOncia is concretizing its ‘commercialization strategy that starts with rare cancers’ as entry points for its immuno-oncology portfolio. ImmuneOncia, a subsidiary of Yuhan Corp that specializes in immuno-oncology, presented new clinical results on its PD-L1 antibody IMC-001 (danvastotug) and CD47 antibody IMC-002 at the European Society for Medical Oncology (ESMO) 2025 Congress, outlining a novel strategy for immuno-oncology drug development. Dailypharm met with Heung-Tae Kim, CEO of ImmuneOncia, in Berlin, Germany, to discuss the significance of these achievements and the company’s future roadmap. “IMC-001 demonstrates immune microenvironment shift in gastric, esophageal, and liver cancer” Heung-Tae Kim, CEO of ImmuneOnciaCEO Kim emphasized the potential of the neoadjuvant (pre-surgery) immunotherapy market at ESMO 2025. He projected that while neoadjuvant immunotherapy is an early field, it will expand as data accumulates. The ‘NeoChance Study (IMC-001)’ presented by the company at ESMO 2025 detailed the results of administering two doses of a PD-L1 antibody preoperatively to patients with resectable gastric, esophageal, and liver cancers. CEO Kim stated, “With just two doses, the tumor's immune environment completely transformed. We directly observed the histological change where tumors, which were essentially immune deserts with almost no immune cells, converted to an inflamed phenotype.” He further stated, “Immune responses were also observed in PD-L1-negative, Microsatellite Stable (MSS) patients. This could provide evidence on its broader applicability in immuno-oncology.” In the study, the 3-year progression-free survival (PFS) and overall survival (OS) rates were 93.8% and 93.8% for gastric cancer, 80.0% and 87.5% for esophageal cancer, and 86.5% and 100% for liver cancer, respectively. Notably, the company is considering expanding its strategy from two doses to three or four doses in combination therapy, as multiple researchers at ESMO advised extending its use in combination with chemotherapy. CD47 signal reinterpreted...“Innate immunity is key” Kim also highlighted the activation of innate immunity as a key differentiator of the CD47 antibody ‘IMC-002’. He explained, “IMC-002 does more than block signals; it induces innate immunity to function strongly in patient groups with tumors with weakened immune-escape mechanisms.” This drug binds near the O-glycosylation site of the CD47 protein, minimizing interaction with red blood cells. CEO Kim stated, “Its minimal hematologic toxicity is the key difference from existing drugs, as it maintains safety even during long-term administration (up to 22 months). IMC-002 simultaneously resolves the toxicity and efficacy issues that caused previous CD47 antibodies to fail.” In actual proteomics analysis, IMC-002 showed more pronounced tumor responses in patient groups exhibiting elevated innate immune-related proteins. Based on this, ImmuneOncia plans to develop predictive biomarkers for future response assessment. From left) Professor Jin-seok Ahn of the Department of Hematology and Oncology at Samsung Medical Center and Professor Sook-ryun Park of the Department of Medical Oncology at Asan Medical Center are photographed with CEO Heung-tae Kim at the ESMO2025 poster presentation site “Immuno-oncology drugs must ultimately prove themselves through commercialization” CEO Kim clearly distinguished the development paths for its two candidates. He stated, “IMC-001 targets the pre-surgery treatment market, while IMC-002 follows an out-licensing global strategy. Both are progressing under structures that concurrently pursue commercialization and export for each candidate.” CEO Kim further revealed, “We plan to seek conditional approval with NK/T-cell lymphoma, a rare cancer, as the first indication, then expand into high tumor mutational burden (TMB-high) cancers and neoadjuvant therapy.” The global PD-1/PD-L1 antibody market is projected to continue growing, and ImmuneOncia aims to enhance the presence of domestically developed immuno-oncology drugs within it. The company is currently preparing to apply for Orphan Drug Designation (ODD) for IMC-001 and is simultaneously discussing technology transfer for IMC-002 with global pharmaceutical companies. Concluding the interview, CEO Kim reflected on the limitations of biotech companies that often remain confined to licensing deals and returns, and stressed that developing new drugs actually used by patients is the company's reason for being. While expressing ambition for ImmuneOncia to pioneer the commercialization model for domestic immuno-oncology drugs, CEO Kim added, “We will become a company evaluated not by its technology alone, but by its therapies.”
- Company
- AstraZeneca set for leadership shift after 2 years
- by Eo, Yun-Ho Oct 27, 2025 06:10am
- AstraZeneca Korea sees a leadership shift after approximately two years. According to industry sources, Sehwan Chon (51), CEO of AstraZeneca Korea, will resign at the end of this month (October). Consequently, Eldana Sauran, currently a Regional Commercial Director of Oncology Unit at AstraZeneca, is expected to be appointed as the interim CEO of the Korean subsidiary, effective November 1st. Chon led AstraZeneca Korea for two years following his appointment in December 2023. Before that, he served as Business Unit Director (BUD) of the Cardiovascular, Renal, and Metabolism Business Unit at AstraZeneca Korea until August 2020. He was then promoted to lead the Indonesian subsidiary in September of that year before returning as the Korean CEO. Meanwhile, Chon, a finance expert, graduated from Korea University with a degree in Business Administration and completed his MBA at the Wharton School of the University of Pennsylvania. He also previously worked at the global accounting and consulting firm, PWC. Chon entered the pharmaceutical industry as a Finance Manager at Abbott Korea and subsequently built expertise not only in finance but also in R&D and Business Development by working at Novartis Headquarters, its U.S. subsidiary, and AstraZeneca Korea.
