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- 2026-03-10 05:36:44
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- Global pharma R&D direction based on M&A trend
- by Son, Hyung Min Jan 14, 2026 09:32am
- Mergers and acquisitions (M&A) have become a survival strategy in the pharmaceutical industry.Throughout 2025, the M&A trends of global pharmaceutical companies revealed not just simple acquisitions, but the very direction of R&D aimed at securing future growth engines.As pipeline acquisition, platform technology integration, and rapid clinical capability building have become central to M&A strategies, R&D planning is undergoing a structural transformation.As of 2026, these changes have become even more pronounced. In oncology drug development, new mechanisms such as radiopharmaceuticals, antibody-drug conjugates (ADCs), and multispecific antibodies are rapidly emerging and swiftly replacing existing standard treatment areas.Another key growth axis is metabolic disease. GLP-1-based novel drugs, which have led the obesity treatment market, are now evolving beyond simple weight loss into metabolic platform therapies encompassing cardiovascular, renal, and hepatic diseases. This shift in the obesity treatment paradigm is ultimately redefining therapeutic strategies for metabolic diseases overall and rewriting the expansion potential of the global market.In this feature, DailyPharm will examine ▲R&D strategies revealed through 2025 M&A trends ▲the rapid reshaping of the oncology development landscape ▲and the expanding innovation driven by GLP-1–based metabolic therapies, in order to forecast the future direction of global R&D paradigms.The return of major deals…2025 emphasized direction over scaleLooking at major M&A deals closed last year, the largest was Johnson & Johnson's USD 14.6 billion (approximately KRW 21 trillion) acquisition of US biopharmaceutical company Intracellular Therapies.Through this acquisition, J&J added the FDA-approved schizophrenia and bipolar disorder treatment Caplyta (lumateperone) to its pipeline. Caplyta is characterized by high serotonin 5-HT2A receptor occupancy and low dopamine D2 receptor occupancy. These features serve as important benchmarks in selective neurotransmitter targeting and drug development. J&J projected Caplyta to generate annual sales exceeding USD 5 billion.Other mega-deals exceeding USD 10 billion included Novartis’ acquisition of RNA therapeutics company Avidity Biosciences (USD 12 billion) and Pfizer’s acquisition of Metsera (USD 10 billion) to secure GLP-1–based candidates.A common theme across these transactions is their focus on next-generation platforms and pipeline scalability rather than short-term revenue expansion.CNS, RNA therapeutics, GLP-1 class drugs, and metabolic dysfunction-associated steatohepatitis (MASH) are all considered areas with significant potential impact upon clinical success and ease of indication expansion.This signals that Big Pharmas are prioritizing and concentrating on certain future markets amid a global environment of heightened uncertainty.Looking at investment trends by disease area, oncology still holds the largest share, but its growth has slowed.According to data from market research firm EY, the size of oncology-related M&A reached approximately USD 109 billion in 2023 but plummeted to USD 68 billion in 2024. Last year, it increased to USD 95 billion, driven by global pharmaceutical companies introducing new drugs with novel mechanisms of action.This trend reflects not a contraction in oncology R&D, but rather the fact that new mechanisms such as ADCs, radiopharmaceuticals, and multispecific antibodies have already been largely absorbed into the internal pipelines of large companies.In other words, the analysis suggests that in the oncology field, strategic alliances or joint development at the technology platform level are now preferred over acquiring individual candidate compounds.Conversely, the CNS sector showed relatively stable investment flows. This, including Johnson & Johnson's major deal, demonstrates that central nervous system disorders are still recognized as an area with both long-term growth potential and unmet medical needs. Many global pharmaceutical companies are shifting their portfolios to focus on rare immune diseases.The most notable change in 2025 M&A is the resurgence of immunology and metabolic disease sectors. Deal size for immunology rose from USD 46 billion in 2024 to USD 65 billion in 2025, while metabolic disease expanded from USD 31 billion to USD 51 billion over the same period.Notably, Novo Nordisk's acquisition of Akero (USD 5.2 billion) and Roche's acquisition of 89bio (USD 3.5 billion) were both transactions aimed at securing metabolic disease pipelines, including MASH.This clearly demonstrates that GLP-1-based obesity treatments are evolving into a platform therapeutic strategy extending beyond simple weight loss to target cardiovascular, hepatic, and renal diseases. Some analysts suggest the next stage of obesity drug competition will be a battle spanning the entire metabolic disease spectrum.Refined new drug development strategies amid persistent uncertaintyThe global pharmaceutical industry’s M&A activity in 2025 is widely regarded as a year that clearly revealed mid- to long-term R&D strategy direction rather than simple scale expansion.Considering both deal size and target disease portfolios, global pharmaceutical companies embarked on structural reorganization to secure platform technologies and future therapeutic areas, going beyond merely bolstering individual pipelines.However, the most significant characteristic of the M&A deals concluded in 2025 was the shift in focus away from aggressive acquisitions centered on anticancer drugs, as seen in the past, towards areas with relatively assured long-term growth potential, such as metabolic diseases, CNS, and rare diseases.Furthermore, last year's M&A trends show a clearer strategic focus compared to the previous year.The largest deal concluded in the global pharmaceutical industry in 2024 was Vertex Pharmaceuticals' acquisition of Alpine Immune Sciences for USD 4.9 billion (approximately KRW 7.03 trillion). This is a significantly smaller scale compared to the multiple USD 10 billion-plus deals of 2023.The 2024 M&A market is generally assessed as a year dominated by caution toward large acquisitions. Global pharmaceutical companies opted for a strategy of selectively acquiring relatively smaller companies instead of making big bets like in the past, then growing their corporate value through internal capabilities.This is the so-called ‘bolt-on strategy’. This approach involves acquiring small-to-mid-sized biotech companies possessing core platforms or promising pipelines, then combining them with in-house R&D, clinical, and commercialization capabilities. This method disperses risk while incrementally increasing the likelihood of success.Against this backdrop, the resurgence of multiple USD 10 billion-plus deals in 2025 suggests that global pharmaceutical companies are moving from a phase of uncertainty into one of selective conviction.However, unlike in 2023, capital is no longer being deployed indiscriminately. Investment is now concentrated solely in disease areas, mechanisms, and platforms that have been clearly validated, signaling that the nature of M&A itself has become far more sophisticated.
- Company
- ‘MenQuadfi advances meningococcal disease prevention’
- by Son, Hyung Min Jan 14, 2026 09:32am
- “Considering how the global trend is focusing on immunization across a wide range of age groups, including infants, adolescents, and young adults, the arrival of MenQuadfi, which can be administered to a broad population, represents a major advance in meningococcal preventive healthcare.”Professor Jin-soo Lee, Department of Infectious Diseases, Inha University HospitalOn the 13th, Sanofi held a press conference at the Plaza Hotel in Jung-gu, Seoul, to commemorate the domestic launch of the meningococcal vaccine MenQuadfi. At the event, Professor Jin-soo Lee of Inha University Hospital's Department of Infectious Diseases presented clinical data on MenQuadfi and predicted that it would have high practical value in clinical use.”MenQuadfi is a quadrivalent protein-conjugated vaccine that can protect against meningococcal serogroups A, C, W, and Y. It can be administered as a single dose to individuals aged 6 weeks to 55 years. The vaccine was approved in April last year and officially launched in the domestic market this January.This vaccine is the only meningococcal vaccine in Korea approved and demonstrated efficacy and effectiveness against meningococcal serogroup A in infants aged 6 weeks to under 24 months. It features a liquid formulation that can be administered directly without separate dilution or mixing, enhancing convenience for healthcare providers. Its vaccination schedule is as follows: a total of 4 dose series for infants aged 6 weeks to under 6 months; a total of 2 dose series for infants aged 6 months to under 24 months; and a single dose for individuals aged 2 to 55 years.Meningococcal disease has long been recognized as a major global public health concern. This infection is a Class 2 notifiable disease with a fatality rate of approximately 10-14%, affecting 500,000 people worldwide every year.Key symptoms include headache, fever, neck stiffness, vomiting, and decreased consciousness, sometimes accompanied by petechiae or petechial rash. Given that 11–19% of recovered patients may experience sequelae such as hearing impairment, cognitive impairment, or neurological disorders, the importance of prevention for this infection is paramount.Because meningococcal disease spreads through droplets or direct contact, vaccination is recommended for individuals in group settings. Representative examples include new military recruits before training and university freshmen residing in dormitories.Vaccination is also recommended for travelers or residents in high-incidence regions, such as the African meningitis belt, and pilgrims traveling to Mecca in Saudi Arabia. Also, vaccination is recommended for individuals with immune system disorders like complement deficiencies and those with anatomical or functional asplenia.Unlike Sanofi's previous meningococcal vaccine, which utilized diphtheria protein as the carrier, MenQuadfi employs tetanus toxoid protein and features increased antigen content (compared to the previous in-house vaccine containing 4 μg each of the meningococcal serogroup polysaccharide antigens A, C, W, and Y; MenQuadfi contains 10 μg each).In clinical trials, MenQuadfi demonstrated non-inferiority to the existing quadrivalent meningococcal vaccine in terms of immunogenicity across all four serogroups. Indeed, when MenQuadpi was administered to individuals aged 10 to 55 years, the seroprotection rates were 94.7% for serogroup A, 95.7% for serogroup C, 96.2% for serogroup W, and 98.8% for serogroup Y.In studies involving children aged 2–9 years, MenQuadfi also demonstrated non-inferiority compared with existing quadrivalent vaccines, with seroprotection rates ranging from 86% to 99%. When co-administered with other pediatric vaccines, MenQuadfi maintained stable immunogenicity.Professor Lee said, “The World Health Organization (WHO) recommends that each country select an appropriate vaccine and establish an immunization strategy based on the prevalent meningococcal serogroups and disease patterns within their borders. In Korea, meningococcal vaccination is recommended for people living in crowded environments, such as those living in dormitories. As travel and work-related visits to high-incidence regions such as Africa continue to increase, the importance of vaccination for individual safety is becoming even greater.”He added, “Given the risk of rapid disease progression, the arrival of MenQuadfi, which provides broad coverage, represents a major advance in preventive medicine. Although early symptoms are nonspecific, meningococcal disease can progress to sepsis and meningitis within hours, making vaccination paramount.”
- Policy
- 3-month import suspension for PCV 'Prevenar 20'
- by Lee, Tak-Sun Jan 14, 2026 09:32am
- Product photo of 'Prevenar 20 Pre-filled Syringe' The imported pneumococcal vaccine 'Prevenar 20 Pre-filled Syringe' will be subjected to a three-month suspension of import operations starting on the 12th. However, no issues are expected regarding its supply.This is interpreted as having sufficient existing imported inventory. As this vaccine is the most in-demand in the pneumococcal vaccination market, concerns about supply instability arose following the import suspension.The Ministry of Food and Drug Safety (MFDS) announced that the import operations for Prevenar 20 Pre-filled Syringe (Pneumococcal 20-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) will be suspended for three months, from the 12th of this month to April 11th.The administrative measure was issued in accordance with relevant laws after it was confirmed in June last year that needles of a different specification than the authorized ones were being used.At that time, the MFDS distributed a safety letter ordering a temporary suspension of use. Pfizer faced significant challenges just as it launched a new product.However, after the issue was resolved, the product was initially supplied to the market through co-promotion with Chong Kun Dang. In October of that year, the supply was expanded as it was selected for the National Immunization Program (NIP) for infants from 2 months to children under 5 years of age. Once chosen for the NIP, eligible recipients can receive the vaccination free of charge.Concerns arose following the news of the sudden import suspension, but it has been confirmed that there are no issues with the supply.The MFDS stated, "Currently, there are no cases reported to the MFDS regarding the supply of this item," and added, "It has been confirmed by the company that there are no supply-related issues."Because this vaccine is used in the NIP and adult vaccinations are increasing, it seems that sufficient inventory was secured before the suspension. However, some question the effectiveness of the administrative measure, noting that if inventory is adequate, a fine should have been imposed rather than an import suspension.Prevenar 20 is the first new pneumococcal vaccine introduced by Pfizer in 14 years, adding seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) to the previously available Prevenar 13.This vaccine is expected to replace the existing Prevenar 13. While competing products include Prodiax 23 and Vaxneuvance, Prevenar 20 is anticipated to take No.1 in the market, given that the previous Prevenar 13 has dominated with an outstanding market share.
- Policy
- Keytruda reimb extended… estimated claims of KRW 2 trillion
- by Jung, Heung-Jun Jan 14, 2026 09:31am
- While coverage has been strengthened with the expansion of reimbursement this month of the immuno-oncology drug Keytruda (pembrolizumab), the reimbursement expansion is expected to generate a record-high projected claims amount of KRW 238.4 billion, lighting warning signals for the management of Korea’s National Health Insurance finances.At the end of last year, the Ministry of Health and Welfare announced estimates that approximately KRW 1 trillion would be saved through its drug pricing system reform.However, when viewed in terms of net financial impact, the increase in claims for this single drug now accounts for roughly 20–25% of the savings generated from price cuts on listed generics.This is why calls are growing for stronger post-listing control, as more multi-indication blockbuster drugs enter Korea’s reimbursement system.According to industry sources on the 13th, the estimated reimbursement claims for MSD Korea’s immuno-oncology drug Keytruda represent the largest amount ever recorded, exceeding the KRW 2.2 trillion recorded for Paxlovid.This reflects the significant impact the drug is expected to have on national health insurance finances. Previously, Keytruda had been reimbursed for four cancer types, including non-small cell lung cancer. However, starting this year, reimbursement has been expanded to cover 17 regimens across nine cancer types, including head and neck cancer.The number of patients covered is expected to gradually increase from 3,258 to 6,680. Accordingly, the projected claim amount is expected to rise from KRW 178.8 billion in the first year to KRW 238.4 billion.In 2022, Keytruda successfully expanded coverage for first-line treatment of non-small cell lung cancer, among other indications. At that time, the Ministry of Health and Welfare estimated annual claims of KRW 1.762 trillion.Since then, Keytruda, which already generates annual sales exceeding KRW 400 billion as a single product, has continued to expand its reimbursement coverage, growing its market presence.The fact that coverage, previously concentrated on NSCLC, now extends to various cancer types, including female cancers, is welcome news for patients. However, the burden on health insurance finances is inevitably growing.The NHIS also states it will strengthen post-monitoring in consideration of the financial impact. As similar cases are expected to increase gradually, it is also contemplating enhanced post-approval management measures.An NHIS official said, “For new drugs with expanded reimbursement coverage, post-management is conducted through the price-volume linkage system. While other institutions may also have financial management measures in place, NHIS is considering additional post-management strategies as well.”
- Policy
- MFDS approves Servier’s Voranigo Tab in KOR
- by Lee, Tak-Sun Jan 14, 2026 09:31am
- The Ministry of Food and Drug Safety (MFDS, Minister Yu-kyoung Oh) announced on the 13th that it has approved Servier’s imported orphan drug ‘Voranigo Tab (vorasidenib) 10mg·40mg.’This drug is indicated for the treatment of Grade 2 astrocytoma or oligodendroglioma that have a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) gene mutation in pediatric and adult patients aged 12 years and older weighing at least 40 kg, following surgery, including biopsy, major resection, or complete resection.A biopsy refers to the procedure in which a portion of tissue or cells is collected and examined under a microscope for diagnostic purposes.IDH (Isocitrate Dehydrogenase) mutations cause the abnormal production of excessive metabolic substances (2-HG), which promote the growth and survival of cancer cells.Astrocytoma and oligodendroglioma are types of gliomas, tumors arising from glial cells in the brain and spinal cord. Gliomas are a major category of brain tumors.Voranigo is an IDH-targeted therapy that inhibits mutated IDH1 and IDH2, thereby reducing the production of the carcinogenic substance 2-hydroxyglutarate (2-HG) and suppressing tumor cell proliferation. The Ministry of Food and Drug Safety expects the new approval to provide a new treatment opportunity for patients with brain tumors that are positive for IDH1 or IDH2 mutations.
- Policy
- Reimb re-evaluation active ingredient results to be unveiled
- by Jung, Heung-Jun Jan 14, 2026 09:31am
- The announcement of active ingredients subject to this year's reimbursement re-evaluation is expected to change slightly from the previously mentioned seven ingredients. This is due to changes in the re-evaluation selection criteria.According to industry sources on the 14th, an agenda regarding the 2026 reimbursement re-evaluation is scheduled to be tabled at tomorrow's Drug Benefit Evaluation Committee (DBEC) meeting.Furthermore, the re-evaluation selection criteria are expected to be discussed. The criteria regarding the number of countries where the drug is listed and the scale of the claimed amount will be removed. Ingredients that need re-evaluation of their clinical usefulness are expected to be included.When the government announced the drug price system reform plan last November, it pre-announced a restructuring of the criteria to include: ▲ active ingredients for which health authorities in A8 countries have initiated clinical or reimbursement adequacy re-evaluations ▲ cases where data or clinical evidence conflicting with previously reported efficacy has been published ▲ medications for which the necessity of re-evaluation has been suggested by academic societies and experts.This means that instead of classifying by listing countries or claim scale as in the past, active ingredients assessed to require a review of clinical usefulness will be designated for re-evaluation.The Health Insurance Review and Assessment Service (HIRA) is expected to listen to the opinions of institutions and academic societies and further strengthen its monitoring role regarding changes in claiming trends.If the reimbursement re-evaluation criteria are revised after passing through the DBEC and the Health Insurance Policy Review Committee, the preparation of additional procedures, such as an expert advisory committee for reviewing ingredient designation, is also anticipated.Additionally, the results of the reimbursement re-evaluation will be simplified to either "reimbursement exclusion" or "selective reimbursement." This means that the breakthrough of maintaining reimbursement through voluntary drug price cuts by pharmaceutical companies will no longer exist.If clinical adequacy cannot be proven, it is expected to lead to either an exit from insurance coverage or a change in patient co-payments.The seven ingredients discussed as targets for this year's re-evaluation at last year's HIPDC subcommittee were Ginkgo biloba leaf dried extract, dobesilate calcium hydrate, kallidinogenase, meglumine gadoterate, diacerein, Afloqualone, and octylonium bromide.Because the reimbursement re-evaluation criteria are changing, some fluctuations are expected in the seven ingredients selected based on the previous criteria. Meanwhile, this DBEC meeting is the first since the replacement of the 10th-term members. The committee has launched with 74 members, including Professor Seung Hyuk Choi of Samsung Medical Center, Professor Kim Seong-hwan of Seoul St. Mary's Hospital, Professor Seh-Hyon Song of Kyungsung University College of Pharmacy, and Professor Hyunah Kim of Sookmyung Women's University College of Pharmacy.
- InterView
- Omjjara effective for high-risk myelofibrosis… access should be expanded
- by Son, Hyung Min Jan 13, 2026 06:59am
- “High-risk myelofibrosis patients with cytopenia have a clear unmet need due to the lack of appropriate treatment options. Omjjara is an option for these patients. This is why its reimbursement coverage is necessary.”Professor Sung-Eun Lee, Department of Hematology, Seoul St. Mary’s HospitalProfessor Sung-Eun Lee of the Department of Hematology at Seoul St. Mary’s Hospital emphasized the unmet needs in the myelofibrosis treatment landscape and the necessity of improving access to new therapies in a recent interview with DailyPharm.Myelofibrosis is a rare hematologic malignancy belonging to the chronic myeloproliferative neoplasm and is considered the most clinically severe condition within this group. Chronic myeloproliferative neoplasms are categorized based on the presence or absence of chromosomal abnormalities. Philadelphia chromosome–negative polycythemia vera and essential thrombocythemia generally show relatively slow progression.However, approximately 20% of patients with these conditions may progress to myelofibrosis and secondary acute leukemia over time, at which point the prognosis deteriorates rapidly.One of the most critical prognostic factors is hemoglobin level. Myelofibrosis is a disease where the bone marrow, the body's blood cell factory, is gradually replaced by fibrotic substances like collagen or reticulin, leading to a decline in normal hematopoietic function. As a result, blood cell production and maturation are disrupted, causing anemia.When anemia is present, the patient's quality of life significantly declines. Reports indicate that myelofibrosis patients with anemia have a survival rate approximately 3 to 4 times lower than those without anemia. For this reason, managing anemia is a major therapeutic goal in myelofibrosis treatment.In September last year, GSK’s Omjjara (momelotinib) received approval from the Ministry of Food and Drug Safety for the treatment of adult patients with intermediate- or high-risk myelofibrosis with anemia (including primary myelofibrosis, post–polycythemia vera myelofibrosis, and post–essential thrombocythemia myelofibrosis), thereby expanding treatment options.Omjjara differentiates itself through a unique mechanism of action. In addition to inhibiting JAK1 and JAK2 like conventional JAK inhibitors, it also inhibits ACVR1. This novel approach normalizes iron metabolism through suppression of hepcidin overexpression, a key cause of anemia.The introduction of Omjjara is expected to reshape myelofibrosis treatment strategies. However, as reimbursement coverage has not yet been granted, access to the drug remains limited for transfusion-dependent myelofibrosis patients in Korea.Professor Lee stressed the need to improve access to new treatments, emphasizing that myelofibrosis is a disease where patients can maintain social and daily life while undergoing treatment, and thus should not be restricted in all aspects of life.Q. Myelofibrosis is a relatively unknown rare blood cancer. Could you introduce the disease?Myelofibrosis is a disease closely associated with molecular genetic abnormalities, most commonly involving JAK2, CALR, and MPL mutations. JAK2 mutations are most frequent, followed by CALR and MPL mutations. Prognosis varies depending on the mutation type. Patients with CALR mutations generally have a relatively favorable prognosis, while so-called “triple-negative” patients are known to have the poorest prognosis. However, current clinical practice does not differentiate treatment strategies based on mutation subtypes.This disease presents with distinct symptoms and significantly impairs patients' quality of life. The course varies greatly depending on the patient's risk group and disease stage. As it is a functional disorder, there is currently no treatment that fundamentally halts disease progression. Therefore, selecting the appropriate treatment strategy based on patient status and risk assessment is critical.Median survival for intermediate- and high-risk patients is only 2 to 3 years, whereas early-stage patients may survive for more than 7 to 8 years. However, many patients are diagnosed only after symptoms develop, meaning many patients are already in the intermediate or high-risk group at diagnosis. In particular, patients with marked cytosis or the presence of blasts tend to show rapid disease progression.Q. How is myelofibrosis currently treated?The only curative treatment for myelofibrosis is hematopoietic stem cell transplantation. However, myelofibrosis predominantly affects elderly patients and is often accompanied by comorbidities, resulting in poorer post-transplant outcomes compared to other acute hematologic malignancies. Therefore, transplant candidates are selected very carefully based on age, general condition, comorbidities, performance status, and donor availability.For patients ineligible for transplantation, the primary treatment goals are to reduce splenomegaly and alleviate systemic symptoms. In this setting, JAK-STAT pathway inhibitors such as Omjjara, ruxolitinib, and fedratinib are used, each with distinct efficacy and characteristics. Because symptoms and clinical characteristics vary among patients, drug selection is personalized for each individual patient.Furthermore, securing a donor and improving the patient's overall condition prior to transplantation often requires a certain amount of time. During this period, drug therapy serves as a bridge to maintain the patient's condition in a stable state until transplantation.Q. What are the unmet needs in the current myelofibrosis treatment landscape?Historically, treatment options were limited for myelofibrosis. Ruxolitinib was effectively the only first-line therapy, followed by fedratinib. However, both drugs are difficult to use in patients with severe anemia or platelet counts below 50,000/µL.Anemia, in particular, has a profound impact on quality of life. Transfusion-dependent patients often require one or two units of blood per month and must spend 4–5 hours at the hospital for each transfusion. As the transfusion date approaches, systemic fatigue and weakness from anemia make mobility difficult. Patients often experience a pattern where daily functioning temporarily improves immediately after a transfusion, only to deteriorate again.When adverse reactions occur during treatment or the effect is insufficient, switching medications is necessary, but the limited alternatives have also been a major challenge in clinical practice. Consequently, patients who failed existing treatments or required additional therapy often had no options other than participating in clinical trials.Q. Omjjara was approved in Korea last September. Could you explain the clinical evidence supporting its approval?Unlike existing therapies, Omjjara has a mechanism of action that is favorable for anemia improvement and was therefore developed and approved specifically for myelofibrosis patients with cytopenia, an area with the greatest unmet need. Clinically, it can also be considered a treatment option for patients with severe thrombocytopenia, and improvements in anemia indicators are being observed in actual clinical practice.The SIMPLIFY-1 trial directly compared Omjjara with ruxolitinib and demonstrated non-inferiority in key endpoints such as spleen volume reduction. It also demonstrated clinically meaningful results in anemia-related parameters, providing the basis for the subsequent MOMENTUM study, which focused on anemia improvement and reduction in transfusion dependency.From a safety perspective, no new adverse effects of significant concern were identified compared to previous trials. While caution is required for infection management as with all JAK inhibitors, this falls within the familiar domain of healthcare providers treating hematologic malignancies and is deemed manageable in routine clinical practice.Q. Could you share any memorable patient cases or instances where notable changes occurred after using Omjjara?In Korea, experience with Omjjara has been accumulated through the Expanded Access Program (EAP), both as an initial treatment option or subsequent therapy after existing treatments in patients with myelofibrosis accompanied by anemia.Omjjara has also been used as a bridging therapy maintain stable conditions in patients awaiting hematopoietic stem cell transplantation. In one case, a patient with a baseline hemoglobin level below 8 g/dL and high transfusion requirements achieved recovery to approximately 11 g/dL after starting Omjjara. Furthermore, Omjjara is also being considered as an important treatment option for elderly patients for whom transplantation is difficult and who require long-term disease management.Q. What recommendations would you make to improve treatment access for myelofibrosis patients?Although myelofibrosis is a rare disease with a small patient population, unmet medical needs are substantial in clinical practice. In Korea, issues affecting large populations tend to receive more attention, while the voices of patients with rare, severe diseases are often overlooked. Consequently, the rarer and intractable the disease, the harder it is to secure reimbursement for new treatments.However, the unmet need is clear for high-risk myelofibrosis patients with cytopenia, as they lack appropriate treatment options. Furthermore, even intermediate-risk patients may experience changes in the clinical characteristics of their disease, making it crucial to secure multiple treatment options.Omjjara has accumulated robust clinical data in these patient populations. If reimbursement coverage is granted, patients who were previously constrained by repeated transfusions may be able to continue treatment more stably and return to daily life. Since myelofibrosis is a disease that allows patients to maintain social and daily activities while undergoing treatment, improving access to treatment will help ensure that patients are not forced to limit every aspect of their lives because of the disease itself.Currently, some patients continue Omjjara treatment through expanded access programs or at their own expense. Given the unmet needs in clinical practice, it is hoped that an environment will be established in which Omjjara can be introduced for more patients at the appropriate time.
- Company
- RNAi 'Amvuttra' to enter the final reimb process soon
- by Eo, Yun-Ho Jan 13, 2026 06:58am
- The RNAi therapeutic 'Amvuttra' is facing its final hurdle in insurance reimbursement listing process.According to sources, the Ministry of Health and Welfare (MOHW) recently ordered a drug price negotiation to the National Health Insurance Service (NHIS) for Amvutra (vutrisiran). Amvutra is a new treatment for hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN), developed by Alnylam Pharmaceuticals and introduced to the Korean market by Medison Pharma Korea.Accordingly, discussions are expected to begin once the NHIS negotiation team is formed. Amvutra previously passed the Health Insurance Review and Assessment Service's (HIRA) Drug Reimbursement Evaluation Committee in December last year.Amvutra was designated as an orphan drug by the Ministry of Food and Drug Safety (MFDS) in November 2023 and received final approval in November last year.Amvutra is administered by subcutaneous injection once every 3 months. This drug targets and silences specific messenger RNA (mRNA) to block the production of both wild-type and mutant transthyretin (TTR) protein.The efficacy of Amvutra was demonstrated through the HELIOS-A Phase 3 study. The Phase 3 trial enrolled 164 hATTR-PN patients with polyneuropathy across 22 countries. These patients were randomly assigned to either the Amvutra group (122 patients), receiving 25mg via subcutaneous injection every three months, or the 'Onpattro (patisiran)' group (42 patients), receiving 0.3mg/kg via intravenous injection every three weeks.Amvutra's efficacy was assessed by comparing its data with placebo data from the APOLLO study, which evaluated the efficacy and safety of Onpattro in a patient population similar to that in HELIOS-A.As a result, during the 9-month treatment period, the Amvutra group experienced less severe neurological impairment and showed improved quality of life compared to the placebo group. In the 10-meter walk test, which assesses a patient's walking speed and motor ability, the time taken by the vutrisiran group showed almost no change. NT-proBNP, a biomarker used to evaluate cardiac function, also showed improvement.Meanwhile, hATTR-PN, which affects approximately 1 in 100,000 people, is a disease caused by mutations in the transthyretin gene. It is characterized by systemic multiple autonomic neuropathies, including cardiac, gastrointestinal, and ophthalmic. Vyndaqel stabilizes the transthyretin protein.Generally, symptoms such as pain, paresthesia, and paralysis begin in the lower extremity nerves, where abnormal proteins tend to accumulate, eventually spreading to the upper body and affecting other organs, such as the heart, kidneys, and eyes. Life expectancy is 7 to 12 years on average from the onset of symptoms.
- Company
- Ferring and Hanmi to co-market Minirin and Nocdurna
- by Kim, Jin-Gu Jan 13, 2026 06:58am
- Ferring Korea and Hanmi Pharmaceutical will jointly market the desmopressin-based nocturia-enuresis treatments Minirin Tab and Nocdurna Sublingual Tab.On the 12th, the two companies announced that they had signed a co-marketing agreement for the two products. Under the agreement, Ferring Korea will be responsible for sales and marketing at general hospitals, while Hanmi Pharmaceutical will oversee sales and marketing at small-to-mid-sized hospitals with fewer than 300 beds, as well as clinics from January this year. All domestic distribution will be handled by Hanmi Pharmaceutical.Minirin is a synthetic analogue of the antidiuretic hormone vasopressin that works by reducing nighttime urine production and is used to alleviate nocturia symptoms. It is the standard treatment for primary nocturnal enuresis in children (aged five and older) and is also used to improve symptoms associated with nocturnal polyuria, a major cause of adult nocturia.Nocdurna is a low-dose sublingual tablet formulation of Minirin developed for the treatment of adult nocturia. It is designed to reduce the risk of hyponatremia, which is of particular concern in elderly patients. The sublingual formulation also improves medication convenience and bioavailability.Min-jung Kim, CEO of Ferring Korea, said, “This new partnership with Hanmi Pharmaceutical will further solidify the market leadership of Minirin and Nocdurna, which currently hold the No.1 market share, and enable their stable provision to more patients.”Jae-hyun Park, CEO of Hanmi Pharmaceutical, commented, “We are very pleased to be able to provide clinically validated nocturia symptom treatments to Korean patients through our partnership with Ferring Korea. Leveraging Hanmi’s extensive hospital network and field expertise, we will strive to ensure more patients experience the clinical benefits of Minirin and Nocdurna.”
- Company
- MenQuadfi emerges…SK-Sanofi shakes up meningococcal vacc mkt
- by Hwang, byoung woo Jan 13, 2026 06:58am
- The competition for next-generation vaccines has begun as SK Bioscience, in partnership with Sanofi, launches the next-generation meningococcal vaccine, MenQuadfi, into the market.The key differentiator for MenQuadfi is that it can be administered from as early as 6 weeks of age, significantly expanding the vaccination age for infants compared to existing products. This is viewed as a strategic move to secure portfolio leadership by preoccupying the early stages of the pediatric vaccination schedule.Product photo of MenQuadfiSK Bioscience recently cooperated with Sanofi's Korean subsidiary to launch the quadrivalent meningococcal conjugate vaccine 'MenQuadfi (MenACWY-TT).'MenQuadfi is a vaccine that can be administered to individuals aged 6 weeks to 55 years, preventing invasive meningococcal disease (IMD) caused by the major meningococcal serogroups A, C, W, and Y.It was initially authorized for ages 2 and older, then its indications were expanded at the end of August last year to include infants from 6 weeks to under 2 years of age, based on the results of the MET42 and MET61 studies.MenQuadfi contains 10μg of antigen for each of the four meningococcal serogroups (A, C, W, and Y). User convenience of this drug was improved as a fully liquid formulation that can be administered immediately without the need for separate dilution or mixing.Among the A, C, W, and Y meningococcal vaccines approved in Korea, MenQuadfi is the only product that includes serogroup A and can be used for infants aged 6 weeks to under 24 months. SK Bioscience will be responsible for the domestic distribution and supply for infants and children.Meningococcal infection is transmitted through respiratory secretions such as nasal mucus or saliva and can even be transmitted by asymptomatic carriers. Consequently, major countries such as the U.S., U.K., Australia, and Canada include meningococcal vaccines in national immunization programs or operate them as routine vaccinations based on official recommendations, focusing on infants, children, and adolescents.In Korea, the Korea Disease Control and Prevention Agency (KDCA) recommends vaccination for high-risk groups, including immunocompromised individuals, laboratory workers, new military recruits, university dormitory residents, those traveling to or staying in endemic areas, and contacts during an outbreak.Currently, the meningococcal vaccine market in Korea is relatively small. As of 2023, based on IQVIA data, the total market size is less than KRW 10 billion.The competitor the SK Bioscience and Sanofi joint force must overcome is GSK. Before the launch of MenQuadfi, Sanofi had a meningococcal vaccine called Menactra. Still, its market share was smaller than that of Menveo, GSK's vaccine against invasive meningococcal disease caused by serogroups A, C, W, and Y, which offers the same preventive effects (vaccination ages differ).GSK is currently targeting the market through a two-track vaccination strategy using Bexsero, a multicomponent meningococcal group B vaccine launched in 2024, and Menveo.Sanofi has decided to withdraw Menactra alongside the launch of MenQuadfi. In a situation where the market is small and a next-generation vaccine with broader protection has emerged, the company has concluded that there is no need to maintain a vaccine with the same level of protection. Regarding the exact timing of discontinuing Menactra supply, the company stated it remains flexible, depending on the market inventory.From SK Bioscience, which is in charge of domestic distribution and supply, it is expected to employ a strategy to increase market share through competition with GSK while maintaining its existing Menactra market.Positive aspects also exist. Through MenQuadfi, SK Bioscience has added another domestic distribution collaboration product with Sanofi to its market lineup.According to SK Bioscience's IR materials, the company is engaged in extensive cooperation ranging from National Immunization Program (NIP) vaccines to premium vaccines, including the pediatric 6-in-1 DTaP vaccine Hexaxim, the adult Tdap vaccine Adacel, and the RSV antibody Beyfortus.Following Hexaxim's entry into the NIP and the introduction of Avaxim in 2025, distribution performance for Sanofi-related vaccines rose from KRW 7.5 billion in the third quarter of 2024 to KRW 11.1 billion in the third quarter of 2025.Given that Beyfortus has begun full-scale operations for the winter season, these results are expected to grow further in 2026.The company plans to strengthen a preemptive prevention strategy against major pediatric infectious diseases based on its portfolio that includes both vaccines and preventive antibodies.In terms of R&D, this collaboration is predicted to strengthen further, as the company is currently in Phase 3 development of a 21-valent pneumococcal vaccine with Sanofi.Jaeyong Ahn, CEO of SK Bioscience, stated, "With the introduction of MenQuadfi, the options for preventing invasive meningococcal disease in infants and children in Korea have expanded," adding, "We will strengthen the infectious disease prevention setting based on global partnerships and continue to supply vaccines that can contribute to public health."
