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- 2026-04-04 15:20:52
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- GLP-1’s expansion has only just begun
- by Son, Hyung Min Jan 16, 2026 08:52am
- SGLT-2 inhibitors, which began as treatments for type 2 diabetes, have established themselves as standard-of-care (SOC) after demonstrating clinical efficacy in major metabolic diseases such as heart failure and chronic kidney disease.Beyond blood glucose control, they have demonstrated cardiovascular and renal protective effects and the potential to improve long-term prognosis. As a result, they are regarded as having reshaped the treatment paradigm itself, beyond being drugs for specific diseases.Now, GLP-1–based therapies are taking over that baton.GLP-1 drugs have expanded their indications from type 2 diabetes to obesity, cardiovascular disease, kidney disease, and metabolic dysfunction–associated steatohepatitis (MASH), evolving into comprehensive treatment options covering the full spectrum of metabolic disease. Recently, their potential has even been discussed in Alzheimer’s disease, addiction disorders, and cancer prevention, raising the possibility that GLP-1 drugs could evolve into a systemic therapeutic platform rather than a single-disease therapy.This shift is most clearly evident in Novo Nordisk's ‘Ozempic/Wegovy (semaglutide)’ and Eli Lilly's ‘Mounjaro (tirzepatide)’, the leading GLP-1 drugs in the global market. While both drugs originated in diabetes, they have since differentiated themselves through distinct strategies for expanding indications and selecting mechanisms, broadening their respective domains.Building on the clinical and commercial success of GLP-1 drugs, domestic and multinational pharmaceutical companies are accelerating efforts to simultaneously pursue indication expansion and next-generation mechanism development, significantly broadening the scope of the GLP-1 market. The industry is now watching closely whether GLP-1 drugs can move beyond their single category as obesity treatments to become the core pillar for metabolic diseases overall.Beyond obesity and diabetes to cardiovascular, renal, and liver diseases... the current state of GLP-1 expansionThe expansion of indications for GLP-1 receptor agonists is already translating into actual approvals and late-stage clinical results.Originally developed for obesity and type 2 diabetes, GLP-1 drugs are now extending into cardiovascular disease, kidney disease, and MASH, positioning themselves as treatment options covering the entire spectrum of metabolic disorders.Notably, semaglutide expanded its therapeutic scope beyond obesity and diabetes treatments by securing evidence for reducing major adverse cardiovascular events (MACE).By accumulating clinical evidence encompassing not only diabetes patients but also high-risk cardiovascular populations, GLP-1 therapies have clearly demonstrated their potential to contribute to long-term prognosis improvement beyond weight loss.In addition, it has expanded into chronic kidney disease (CKD), strengthening its presence in a field once pioneered by SGLT-2 inhibitors.More recently, accelerated approval for MASH has pushed GLP-1 drugs into liver disease territory.Their mechanistic strengths in terms of weight loss, improved insulin resistance, and anti-inflammatory effects have translated into reduced hepatic fat accumulation and improved fibrosis, making them a promising new option in an area with limited therapeutic choices.Tirzepatide is also rapidly expanding its footprint. Beyond obesity and diabetes, it has secured approval for obstructive sleep apnea (OSA) and continues clinical development in cardiovascular and renal disease.Its strategy centers on managing obesity-related complications simultaneously, leveraging its strong weight-loss efficacy.This demonstrates how GLP-1 agonists are evolving beyond merely treating obesity-associated conditions to become therapies capable of modulating the pathophysiology of the disease itself.From single-mechanism drugs to multi-agonists … evolves to a ‘platform technology’If indication expansion represents the competition over what can be treated, diversification of mechanisms and delivery methods represents competition over how to treat. The GLP-1 market has already moved beyond single-mechanism competition and entered the development phase for multi-agonist combination therapies that target multiple receptors simultaneously.Early GLP-1 drugs focused on appetite suppression and satiety enhancement. However, dual and triple receptor agonists that simultaneously modulate various hormone receptors involved in metabolic regulation, such as glucagon-like peptide-1 (GLP-1), glucagon (GCG), and amylin receptor agonists, have recently emerged in succession.This multi-agonist approach differentiates itself by maximizing weight loss effects while also targeting lipid metabolism improvement, increased energy expenditure, and long-term metabolic stability.Dual GLP-1/GIP agonists, represented by Mounjaro, simultaneously promote insulin secretion and improve insulin resistance, while triple GLP-1/GIP/GCG agonists are evaluated as a strategy to further enhance weight loss and metabolic improvement effects.With the addition of GLP-1/amylin combination strategies, the GLP-1 class itself is effectively being redefined not as a single drug class but as a therapeutic platform. Recently, Novo Nordisk completed clinical trials for its platform therapy ‘CagriSema (semaglutide/caglinotide)’ and submitted a marketing application to the U.S. Food and Drug Administration (FDA). The mechanism aims for additional effects, such as delayed glucose absorption in the intestine, by combining semaglutide with caglinotide.Competition over delivery methods is also underway. While most currently commercialized obesity treatments are injectables, new delivery options like long-acting injections, oral formulations, and patches have entered the clinical stage.Oral GLP-1 agents, in particular, are seen as a key variable that could significantly expand treatment accessibility by reducing the psychological burden associated with injections. This holds the potential to broaden the target population for obesity treatment from specialized care settings to routine chronic disease management.Novo Nordisk and Lilly are leading in this area. Novo Nordisk has already secured approval for its oral Wegovy formulation, while Lilly has completed clinical trials for ‘Oroforglifron’ and submitted its FDA application. Unlike Mounjaro, Oroforglifron utilizes a single GLP-1 receptor agonist.Long-acting injectables are also rapidly entering late-stage clinical trials. Amgen's ‘MariTide’ uses an amino acid linker to conjugate two GLP-1 molecules with a fully human monoclonal anti-human GIPR antibody. This is known to produce greater weight loss effects than GLP-1 monotherapy.Since existing GLP-1 obesity treatments like Saxenda, Wegovy, and Zepbound became global blockbuster drugs, the pharmaceutical industry has been racing to develop new formulations. The existing drug Saxenda requires once-daily administration, while Wegovy and Zepbound require weekly injections. This is why a long-acting injectable formulation is expected to gain a competitive edge in terms of treatment convenience if commercialized.In Phase II clinical trials, MariTide demonstrated a maximum 20% weight loss rate at week 52 in non-diabetic obese patients. Based on this data, Amgen has fully launched the global Phase III clinical study, MARITIME. Amgen also plans to initiate Phase III studies this year for atherosclerotic cardiovascular disease (ASCVD), heart failure (HF), and obstructive sleep apnea (OSA).Domestic and multinational pharmaceutical companies are actively joining this trend. Multinational pharmaceutical firms are pursuing strategies to preempt next-generation standard treatments through multi-mechanism pipelines, while domestic pharmaceutical and biotech companies are also joining the global competition by leveraging dual/triple receptor agonists and novel delivery technologies.Ultimately, the competition in GLP-1 mechanisms and delivery methods is converging toward simultaneously fulfilling efficacy, convenience, and long-term manageability. This suggests that GLP-1 therapies are establishing themselves not as a temporary trend, but as a core platform for chronic metabolic disease treatment that will endure for decades to come.Latecomers are conducting clinical trials focused on differentiating themselves from existing drugs in areas like administration convenience, quality of weight loss, and preventing rebound effects. Next-generation obesity drugs that enable greater weight loss with a single dose are analyzed to potentially surpass existing drugs in administration convenience. With indications poised to expand, the value of obesity drugs is also being set against the benchmark of an average weight loss rate of 20%.
- Company
- GSK 'Omjjara' expecting to get reimbursement greenlight
- by Eo, Yun-Ho Jan 15, 2026 08:47am
- Product photo of Ojjaara/OmjjaraPreviously failed at its first attempt, the new drug 'Omjjara' for treating myelofibrosis is eying another chance.According to sources, GSK Korea's myelofibrosis treatment, Omjjara (momelotinib), is expected to be reviewed by this year's first Drug Benefit Evaluation Committee (DBEC) of the Health Insurance Review and Assessment Service (HIRA) today (January 15).Omjjara passed the Cancer Drug Review Committee (CDRC) in March of last year. However, during the mediating process for the DEBC consideration, there has been a difference of opinion between GSK and HIRA regarding the designation of a substitute medicine for drug pricing, which has suspended the listing process. After that, GSK supplemented its documents last year, discussed with HIRA, and reached a positive conclusion for DBEC consideration. It will be watched to see whether Omjjara will succeed in finalizing the reimbursement listing process.Omjjara has a triple mechanism of action that blocks JAK1, JAK2, and ACVR1 (activin A receptor type 1). In the treatment of myelofibrosis, inhibiting JAK1 and JAK2 can improve a patient's systemic symptoms and reduce enlarged spleen, while inhibiting ACVR1 can help alleviate anemia by decreasing hepcidin expression.Anemia management is a key unmet need in the treatment of patients with existing myelofibrosis. Anemia, which increases transfusion dependency, is a problem beyond simple dizziness and can lead to severe, life-threatening conditions depending on its severity.Based on the Phase 3 SIMPLIFY-1 and MOMENTUM clinical studies, Omjjara was shown to significantly reduce transfusion dependency and improve major symptoms, such as splenomegaly, in myelofibrosis patients with anemia, regardless of prior JAK inhibitor therapy.In the SIMPLIFY-1 study, which confirmed the clinical efficacy and safety of Omjjara compared to Jakavi (ruxolitinib) in a first-line treatment setting for myelofibrosis patients who had no prior experience with JAK inhibitors, Omjjara demonstrated non-inferiority to ruxolitinib in spleen volume response at week 24, the primary endpoint.The transfusion independence (TI) rate for each patient group was 66.5% in the Omjjara group and 49.3% in the ruxolitinib group, indicating that transfusion dependency was significantly lower in the Omjjara group.Professor Seo-Yeon Ahn of the Department of Hematology-Oncology at Chonnam National University Hwasun Hospital stated, "JAK inhibitors previously used for drug treatment of myelofibrosis showed effects in alleviating splenomegaly and systemic symptoms. However, there were unmet needs such as worsening anemia or increasing transfusion dependency. Omjjara has confirmed significant clinical value in the prognosis of myelofibrosis patients and managing anemia."
- Opinion
- [Reporter’s View] Need rationale to establish a new fund
- by Lee, Jeong-Hwan Jan 15, 2026 08:47am
- The Ministry of Health and Welfare has made clear its intention to secure approximately KRW 1 trillion in savings for the National Health Insurance (NHI) system by implementing a drug pricing reform centered on a dramatic reduction in generic drug reimbursement rates (from 53.55% to the low 40% range).At the same time, the ministry has announced plans to expand reimbursement coverage for innovative new medicines in order to strengthen patient access.Domestic pharmaceutical companies, whose operations rely heavily on generics as a primary revenue source, are criticizing this move, calling it “health insurance administration that cuts domestic generic drug prices to pay for multinational pharma’s innovative new drugs.”Their opposition stems from the fact that the announced pricing reform includes virtually no price-reduction mechanism for new drugs, while the government continues to send positive signals toward expanding reimbursement for increasingly expensive high-priced innovative drugs.Critics argue the policy has failed to strike a balance within the limited health insurance budget between domestically produced generics and innovative drugs largely supplied by multinational pharmaceutical companies.As a result, it is becoming increasingly clear that expanding reimbursement for new drugs, fostering the domestic generics industry, and maintaining the sustainability of the NHI system are difficult goals to achieve simultaneously under a single insurance budget.Amid this situation, the proposal by Jung-gu Kang, President of the Health Insurance Review and Assessment Service (HIRA), is drawing renewed attention.At a policy briefing held on January 12 under Minister of Health and Welfare Eun-Kyoung Jeong, Kang strongly advocated for a new approach to expanding reimbursement for ultra-high-priced drugs such as anticancer drugs and treatments for rare and intractable diseases.He reiterated the need to establish a separate fund dedicated exclusively to reimbursing ultra-high-priced “one-shot” curative therapies that demonstrate near-complete disease remission after a single administration.Kang had already raised this idea in his New Year’s address in 2025, proposing a separate fund for ultra-high-priced drugs with limited cost-effectiveness in order to improve patient access.The intent is to create a separate funding source outside the national health insurance budget to increase the coverage rate for high-cost treatments used for severe diseases.Discussions on establishing a separate fund for ultra-high-priced new drugs have been raised by multiple lawmakers in the 20th, 21st, and current 22nd National Assemblies, with several lawmakers introducing bills on the matter.A prime example is the bills to amend the National Health Insurance Act and the Lottery Act to allow the National Health Insurance Service to receive lottery revenue allocations as stipulated by the Lottery Fund Act.Minister Jeong believes it is necessary to consolidate the Ministry of Health and Welfare's position and rationale based on Kang's proposal and the pending legislative bills in the National Assembly. This would involve creating a separate fund dedicated to covering the reimbursement of ultra-high-priced treatments costing hundreds of millions to billions of won, thereby alleviating the burden on the NHIS budget.Prior to her appointment as Minister, during her confirmation hearing, Jeong had expressed some skepticism regarding the establishment of a separate fund for rare diseases.At the time, Jeong stated, “If the required finances exceed the fund's size due to factors like the application of high-cost treatments, flexible management could become difficult. Rather than establishing a separate fund, the priority should be given to continuously expanding reimbursement coverage.”Now, with domestic pharmaceutical companies strongly opposing the generic price cuts for KRW 1 trillion in NHIS savings, Jeong’s more forward-looking review of a separate fund may be necessary to avoid criticism that the government is simply ‘wringing a dry towel’ through drug price controls.Just as the ministry is aggressively considering the establishment of a Regional Healthcare Development Fund to strengthen local, essential, and public healthcare, a similar approach should be applied to the dual mission of expanding access to ultra-high-priced medicines and fostering Korea’s pharmaceutical and biotech industry.
- Policy
- Companies do not renew Xeljanz generic licenses
- by Lee, Tak-Sun Jan 15, 2026 08:47am
- Pfizer’s rheumatoid arthritis drug Xeljanz TabDespite the five year await for Xeljanz’s patent expiry, an increasing number of companies are abandoning sales of the generic versions of their rheumatoid arthritis treatment ‘Xeljanz.’This is largely attributed to drastic changes in the competitive landscape compared to the time of development. Some in the industry point to the negative consequences of so-called “blind approvals,” where companies follow competitors without question.According to the Ministry of Food and Drug Safety (MFDS) on the 14th, the license for Youngil Pharm’s Youngil Tofacitinib Tab 5 mg (tofacitinib aspartate) expired on the 14th and was removed from the product registry. This marks the 29th tofacitinib product to expire without renewal.By March, an additional six products are scheduled to expire, suggesting that more companies may forgo renewal.Of the 45 products that remain approved, only 14 have been listed for reimbursement.This situation reflects how the market environment changed dramatically during the 5-year wait for the original product’s substance patent expiry.Generic manufacturers attempted to bypass the extended substance patent by developing salt variants. Had this strategy succeeded, launch would have been possible after November 23, 2020, instead of waiting until the original substance patent expired on November 23, 2025.However, after legal disputes, the Supreme Court ruled in favor of the originator, Pfizer. The latecomers who received approval in 2020 had to wait until the substance patent expiry date of November 23, 2025.As a result, companies spent five years unable to launch, merely waiting for patent expiry. When the patent finally expired in November last year, several companies launched their products.However, the market had changed substantially compared to five years earlier. While Xeljanz became a blockbuster product generating sales in the KRW 10 billion range due to expanded reimbursement, its growth faced limitations as strong competitors emerged.New JAK inhibitors like Lilly's Olumiant and AbbVie's Rinvoq have entered the market since then. According to 2024 UBIST outpatient prescription data, Xeljanz recorded KRW 14.3 billion, Olumiant KRW 17.1 billion, and Rinvoq KRW 26.1 billion, showing Olumiant and Rinvoq surpassed Xeljanz in terms of sales.Furthermore, to counter latecomers, Pfizer released a more convenient extended-release formulation for Xeljanz, making it even harder for competitors to challenge it. The extended-release formulation, Xeljanz XR Tab 11mg, also holds a patent valid until March 12, 2035.As a result, more generic manufacturers are choosing not to renew their approvals despite the original drug’s substance patent expiry.Some point out that this incident highlights one of the drawbacks of the ‘blind approval’ system for latecomers. Many domestic pharmaceutical companies operating primarily in generics tend to develop products simply in line with the original drug’s patent expirations.Moreover, under Korea’s patent-linkage system, the first generic applicants that successfully bypass patents are granted nine months of market exclusivity. This has triggered a rush of follow-the-leader development, where competitors simply follow suit once a rival starts developing a generic.An industry executive commented, “In the case of some Xeljanz generics, the market has certainly changed, but fundamentally, the problem lies in companies blindly following competitors instead of pursuing independent business strategies, which has now backfired.”
- Company
- The evolution of next-gen cancer drugs continues
- by Son, Hyung Min Jan 15, 2026 08:47am
- If cytotoxic chemotherapy, targeted therapies, and immuno-oncology drugs once reshaped the cancer treatment paradigm, the latest trends in anticancer drug development are rapidly shifting toward next-generation approaches.The focus has moved toward more precise targeting strategies that improve efficacy while minimizing damage to normal tissues. In this process, antibody–drug conjugates (ADCs), bispecific and multispecific antibodies, and radiopharmaceuticals have emerged as core modalities in oncology R&D.Furthermore, the development axis is expanding to include targeted protein degraders (TPDs) and cell and gene therapies (CGTs). Consequently, the competition for new oncology drugs is no longer just about individual drugs; it is being restructured into a competition of modalities, encompassing platforms and delivery technologies.This shift is not merely a trend; it also represents the direction of R&D capital allocation, on how global pharmaceutical companies are simultaneously concentrating their M&A, licensing, and partnerships.This shift extends beyond technological trends, as confirmed by where global capital and transactions are actually concentrated. According to the market research institution Evaluate, the global prescription drug market is projected to reach USD 1.7 trillion by 2030, with growth driven by emerging modalities such as ADCs, multispecific antibodies, RNA-based therapies, gene and cell therapies, and radiopharmaceuticals.Ultimately, from the perspective of big pharma, the growth axis in oncology over the next decade must be designed not by filling pipelines one indication at a time, but by preemptively securing platforms that can be expanded across multiple cancer types upon commercialization.DailPharm examined how the oncology development landscape is being reshaped around ADCs, bispecific antibodies, and radiopharmaceuticals, modalities that have already proven their market impact.Precision drug delivery becomes standard therapy... ADC market competition intensifiesThe first modality to drive market momentum has been ADCs. ADCs are therapeutics designed to deliver cytotoxic drugs (payloads) more selectively to tumors. They do this by linking the payload to an antibody that binds to specific antigens on the surface of cancer cells via a linker. This precision delivery strategy combines the selectivity of targeted therapies with the killing power of chemotherapy while minimizing damage to normal cells.The drug symbolizing this field is Daiichi Sankyo and AstraZeneca's ‘Enhertu (trastuzumab deruxtecan)’. Enhertu's sales surged from KRW 3.72 trillion in 2023 to approximately KRW 5.6 trillion in 2024, proving that ADCs can evolve into blockbuster therapies rather than remain as late-line treatment options.Enhertu’s expansion across breast, gastric, and non-small cell lung cancer demonstrates the core strength of ADC platforms. Once the delivery system gains clinical trust, pipeline value can grow exponentially through indication expansion. Enhertu has already achieved standard-of-care status in each of its approved indications.Following HER2, the market's focus has shifted to another target, with TROP-2 taking center stage. The emergence of Daiichi Sankyo and AstraZeneca's Datroway (datopotamab deruxtecan) and Gilead’s Trodelvy (sacituzumab govitecan) has reinforced market confidence through strong sales growth.Trodelvy grew 24% year-over-year from USD 1.063 billion in 2023 to USD 1.315 billion in 2024. This signifies that TROP-2-targeted ADCs have moved beyond potential and are now being validated through actual prescriptions and sales. Notably, they have demonstrated consecutive successes in HR+/HER2- and triple-negative breast cancer.The reason ADCs are no longer just hit products for specific companies but have become a competitive axis across the entire industry lies in their high technological barriers and scalability. Given the complex combination of antibody, platform, linker, and payload required, it is difficult to solve all the puzzles through in-house development alone.Consequently, global pharmaceutical companies are adopting a strategy of concurrently pursuing acquisitions, partnerships, and licensing to rapidly internalize proven components. Payload competition has also intensified. While microtubule inhibitors (Microtubule-disrupting agent Monomethyl Auristatin E, MMAE) dominated early ADCs, topoisomerase-1 (TOP1) inhibitor payloads are now expanding. Meanwhile, drugs like Astellas’ Padcev (enfortumab vedotin) continue to leverage MMAE payloads in combination with immunotherapy to seek synergies.Ultimately, the decisive factor for ADCs is shifting from the fundamental skill of precise delivery to how rapidly they can expand indications and combination therapies.Bispecific antibodies expand from blood cancers to solid tumors … multispecific antibodies enter the arenaBispecific and multispecific antibodies represent the next evolutionary stage of antibody-based cancer therapy.Early development focused primarily on hematologic malignancies, where redirecting T cells toward tumor cells is easier to implement, and clinical efficacy can be demonstrated more rapidly.Starting with Amgen’s Blincyto (blinatumomab), followed by Roche’s Lunsumio (mosunetuzumab) and Columvi (glofitamab), Johnson & Johnson’s Tecvayli (teclistamab) and Talvey (talquetamab), and AbbVie’s Epkinly (epcoritamab), most bispecific antibodies initially gained approval in blood cancers.However, the landscape is changing. Leveraging accumulated clinical experience and manufacturing know-how, bispecific antibodies are now expanding into solid tumors.Solid tumors have long been considered a challenging domain due to their complex tumor microenvironment (TME), limited immune cell infiltration, and the difficulty of managing toxicity in normal tissues. Nevertheless, some bispecific antibodies gained approval or entered late-stage clinical trials for solid tumors, signaling that bispecific platforms are no longer confined to hematologic malignancies.Some experts interpret this as a process where bispecific antibodies are establishing themselves not as a technology for a single indication, but as an anti-cancer platform premised on indication expansion.The fundamental concept of bispecific antibodies lies in simultaneously targeting two different targets. They adopt a structure where a single antibody binds to two different antigens, or simultaneously binds to two different epitopes on the same antigen.This enables the simultaneous pursuit of increased binding affinity, enhanced signal blockade, and immune cell induction effects, which are outcomes difficult to achieve with monoclonal antibodies alone. Particularly in oncology, the core strategy involves simultaneously capturing tumor cell antigens and immune cell antigens to direct the immune response to the tumor site.Recently, pharmaceutical companies globally have begun actively developing multispecific antibodies that target three antigens simultaneously, beyond bispecific antibodies. This is not merely about adding one more target; it represents an attempt to combine elements like tumor targeting, immune activation, and immune checkpoint inhibition within a single molecule to achieve more sophisticated immune modulation.This approach aims to embed the combination strategy using immuno-oncology drugs within a single molecule. If successful, it is expected to simultaneously enhance treatment convenience and efficacy.Another reason multispecific antibodies are gaining attention is their potential to cross the blood-brain barrier (BBB). The BBB is considered a major challenge in anticancer drug development. While drug delivery to the brain is critical for treating CNS metastases or primary brain tumors, most antibodies and small-molecule drugs face limitations in crossing the BBB.Multispecific antibodies offer the potential to cross the BBB via receptor-mediated transcytosis by incorporating structures that bind to specific receptors present on the BBB surface. Consequently, they are also gaining attention as a next-generation anticancer strategy targeting CNS tumors or brain metastases.Furthermore, recent antibody designs increasingly combine antibodies that bind to antigens regulating immune cell activity with those that bind tumor-specific antigens. This aims to enhance immune activation while reducing non-specific toxicity.For example, one approach targets both antigens regulating T-cell activation signals and tumor-specific antigens simultaneously. This design amplifies immune responses exclusively within the tumor microenvironment. This represents an attempt to structurally mitigate the systemic toxicity issues of existing immune checkpoint inhibitors and is considered a particularly meaningful approach in the field of solid tumors.In summary, bispecific and multispecific antibodies are no longer technologies confined to hematologic malignancies. Building on validated mechanisms and clinical experience in blood cancers, the field has entered a stage of actively pursuing indication expansion into solid tumors.Simultaneously, the evolution of antibody-based anticancer platforms is evident through the addition of multi-target strategies, including triple antibodies, BBB-permeable designs, and precision-linking structures between immune cells and tumor cells. This symbolically demonstrates that anticancer therapy is moving beyond the era of targeting single targets, advancing to a sophisticated stage where tumors, immunity, and delivery pathways are designed simultaneously.Radiopharmaceuticals: from diagnosis to therapy… big pharma M&A fuels growthThe third major oncology R&D axis is radiopharmaceuticals. This approach involves administering compounds conjugated with radioactive isotopes, which reach the target and then emit radiation to damage the tumor. The shift of a market historically dominated by diagnostics toward therapeutic applications represents one of the most dramatic changes in recent years.While estimates from market research institutions vary, the consensus is that the radiopharmaceutical market will expand over the medium to long term. Some reports even suggest it could grow to around USD 10 billion this year. More significant than the numbers is that this growth expectation is actually triggering M&A and partnerships among multinational pharmaceutical companies.With beta-particle-based ligand therapies now on the track to commercialization, the global industry is shifting its focus to alpha-particle-based therapies, which offer higher energy, shorter range, and more precise killing power.Leading candidates include Actinium-225 and Astatine-211. These are gaining attention as next-generation targeted therapies because they possess a shorter range and higher LET (Linear Energy Transfer) compared to the existing beta-particle-based lutetium-177. This allows for precise targeting of cancer cells while minimizing damage to surrounding healthy tissue.Novartis, developer of Lutathera and Pluvicto, acquired radiopharma developer Mariana. AstraZeneca partnered with Fusion Pharmaceuticals. The US, Canada, and Europe are already treating the securing of actinium production and purification infrastructure as a national-level strategy.BMS acquired RayzeBio for USD 4.1 billion in late 2023 and formalized the completion of the acquisition in February 2024, integrating the radiopharmaceutical platform into the group.Notably, Lilly signed a joint development agreement with Aktis Oncology even after acquiring Point Biopharma. Recently, Lilly participated as an anchor investor in Aktis’ IPO process, reaffirming its commitment to positioning radiopharmaceuticals as a long-term growth pillar. Through the PointBio acquisition, Lilly secured the prostate cancer treatment candidate PNT2002 and the neuroendocrine tumor treatment candidate PNT2003.Radiopharmaceuticals are attractive because they enable indication expansion through combinations of targets (ligands/antibodies) and isotopes. Furthermore, if a value chain extending from diagnosis to therapy (theranostics) is established, platform lock-in effects can be anticipated.Simultaneously, the demanding industrial infrastructure requirements, including isotope supply chains, manufacturing (CMC), logistics, and administration infrastructure, are interpreted as driving a stronger tendency among global pharmaceutical companies to internalize capabilities through acquisitions rather than simple partnerships.Ultimately, the rapid reshaping of the oncology development landscape is not merely a succession of individual companies launching new drugs. While ADCs offer precision delivery, bispecific antibodies provide multi-target and immune engagement, and radiopharmaceuticals deliver targeted radiation. Each presents distinct solutions, but all believe that those possessing platforms are required to design the next pipeline.If cytotoxic, targeted, and immuno-oncology therapies formed the major pillars of treatment, the decisive factor now is securing which modality on that foundation and expanding it quickly. The success or failure of R&D hinges not on individual compounds but on modality (platform) competitiveness. Big pharma's acquisitions, investments, and technology deals signal that this competition is already fully underway.
- Company
- 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.
