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- 2026-06-14 03:51:19
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- Prescription for PAH therapy 'Opsynvi' available at general hospitals'
- by Eo, Yun-Ho Jun 05, 2026 09:35am
- The pulmonary arterial hypertension (PAH) therapy 'Opsynvi' is being prescribed across major tertiary referral hospitals following its inclusion on the reimbursement list.According to industry sources, Janssen Korea’s Opsynvi (macitentan·tadalafil) has passed the drug committee (DC) review at Seoul National University Hospital.The company accepted the 'price below evaluated amount' proposed by the Health Insurance Review and Assessment Service (HIRA)'s Pharmacuetical Reimbursement Evaluation Committee in December last year, and subsequently finalized price negotiations with the National Health Insurance Service (NHIS) in March. Opsynvi obtained a reimbursement listing effective April.Consequently, Opsynvi can be prescribed for the 'long-term management of adult patients presenting with WHO Functional Class II to III PAH.'Opsynvi, which received US FDA approval in March 2024 and Korean MFDS approval in July last year, is a combination therapy containing the PDE5 inhibitor 'Cialis (tadalafil) and the endothelin receptor antagonist (ERA) 'Opsumit (macitentan), improving patient convenience.Opsynvi demonstrated its efficacy through a Phase 3 study named A DUE. The clinical trial was conducted to evaluate and compare the efficacy and safety profiles of the Opsynvi group with those of control groups receiving either Opsumit or Cialis monotherapy. Following 24 months of patient follow-up, Opsynvi demonstrated up to a 29% reduction in the primary endpoint pulmonary vascular resistance (PVR) compared with the Cialis or Opsumit monotherapy groups. As of 2023, the number of PAH patients in South Korea is approximately 3,600, with the mean age of patients being women in their 40s who lead pivotal roles in society and their families. While the 5-year survival rate has vastly improved compared to the past, three out of ten South Korean PAH patients still die within five years.Pulmonary arterial hypertension is a rare, intractable, and progressive disease, where delaying disease deterioration directly impacts patient quality of life and survival. There is no known pharmacotherapy cure, and the mechanism of action (MOA) of conventional agents primarily focuses on alleviating symptoms by dilating the thickened pulmonary arteries.Meanwhile, with the emergence of novel therapeutics, changes are anticipated in the domestic PAH treatment landscape.In June 2025, Bayer's 'Adempas (riociguat)' was added to the reimbursement list nearly 10 years after its domestic regulatory approval, while MSD Korea's 'Winrevair (sotatercept),' a drug selected for the second phase of the 'Approval-Evaluation-Negotiation Concurrent Pilot Program,' is currently undergoing the reimbursement listing process.
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- Global pharma expands K-bio collaborations…open innovation
- by Son, Hyung Min Jun 04, 2026 09:39am
- Collaboration between global pharmaceutical companies and Korean domestic biotech firms is expanding beyond technology in-licensing into a competition over open innovation strategies.While the majority of past collaborations focused on in-licensing late-stage clinical assets, recent trends indicate diversification of collaboration types, including the acquisition of early-stage candidates and platform technologies, as well as the operation of startup incubation programs.According to industry sources on the 3rd, Eli Lilly recently in-licensed 'sonefpeglutide', a novel drug candidate with a GLP-2 mechanism of action from Hanmi Pharmaceutical. Following cooperation agreements signed last year with OliX Pharmaceuticals, Rznomics, and ABL Bio, Lilly is expanding its collaborative scope with Korean biotech companies, including Hanmi Pharmaceutical this year.Obesity to intestinal and metabolic diseases...Expanding portfolioThe recent agreement with Hanmi Pharmaceutical is seen as a signal that Lilly's existing metabolic disease strategy is expanding into broader therapeutic areas.GLP-2 is a gut hormone involved in intestinal mucosal growth and the improvement of nutrient absorption functions. Unlike GLP-1, which focuses on blood glucose control and weight loss, GLP-2 induces intestinal epithelial cell growth, increases intestinal length, and improves nutrient and fluid absorption. Consequently, it is drawing attention as a therapeutic approach to reduce dependence on parenteral nutrition in patients with short bowel syndrome (SBS) who experience nutrient malabsorption following extensive bowel resection.Notably, sonefpeglutide is being developed to extend half-life compared to existing treatments, thereby enhancing administration convenience. Currently in the global market, Takeda’s ‘Gattex (teduglutide)’ is used as a key GLP-2 therapy. However, concerns have been raised regarding its heavy dosing burden (once daily) and the need for improved long-term treatment sustainability. Analysis suggests that Lilly's acquisition of Hanmi’s candidate reflects an intent to dominate next-generation therapeutic options in the orphan gastrointestinal disease sector.Lilly's in-licensing of novel drug candidates from Korean companies, including OliX Pharmaceuticals, Rznomics, ABL Bio, and Hanmi Pharmaceutical.At the same time, this contract aligns with Lilly's broader strategy to expand its portfolio horizon across post-obesity metabolic disease indications. Recent global competition in metabolic diseases is expanding beyond simple glycemic control or weight reduction to encompass metabolic dysfunction-associated steatohepatitis (MASH), cardiovascular disease, chronic kidney disease (CKD), and inflammatory metabolic disorders.Competitor Novo Nordisk is attempting to expand indications for 'semaglutide' beyond obesity management into MASH and cardiovascular disease prevention. Lilly is likewise broadening its therapeutic strategy across the metabolic spectrum, based on its obesity treatment, Mounjaro (tirzepatide). Lilly is evaluating the acquisition of a GLP-2-based asset to expand its portfolio into the intestinal and nutritional metabolism domain.Analysts suggest that Lilly’s technology in-licensing in Korea includes securing an individual transaction, aligning with a strategy to reinforce its existing commercial portfolio and secure next-generation growth vectors.Lilly has historically established an oncology portfolio centered on the breast cancer treatment 'Verzenio (abemaciclib)' and the gastric cancer treatment 'Cyramza (ramucirumab)'. In the immunology sector, it has expanded its commercial base with the psoriasis treatment 'Taltz (ixekizumab)' and the atopic dermatitis treatment 'Ebglyss (lebrikizumab)', and in the metabolic disease sector through diabetes treatments such as 'Jardiance (empagliflozin)' and 'Trulicity (dulaglutide)'.Its previous collaborations are also linked to Lilly's business portfolio. Its partnership with ABL Bio is seen as strengthening oncological competitiveness through the acquisition of a next-generation antibody platform. At the same time, the agreement with OliX Pharmaceuticals aligns with its metabolic disease strategy, expanding into MASH and other indications. The Rznomics RNA editing platform is evaluated as an investment heavily geared toward securing next-generation therapeutic modalities over the long term.From drug in-licensing to incubating...big pharma launches open innovation initiativesGlobal pharmaceutical companies, including Lilly, are broadening their collaborations with domestic biotech firms beyond technology licensing to encompass incubation, early-stage R&D, and global commercialization support.Open innovation programs currently operated by major multinational companies, including Lilly's 'Gateway Labs Korea'Notably, alongside the recent acceleration of technology in-licensing from domestic biotechs, Lilly is supporting the local biotech ecosystem. In collaboration with Samsung Biologics, Lilly is pursuing the establishment of 'Gateway Labs Korea' in Songdo, Incheon.Lilly Gateway Labs is a global incubator program that supports the research and development of startups and biotech companies. The Songdo facility is a collaborative model introduced by Lilly globally for the first time, tasked with helping domestic biotech firms access global R&D networks and commercialization capabilities.The perception of South Korea as a strategic innovation hub is also spreading. This year, Bayer officially launched its domestic biotech startup collaboration program, 'Bayer Co.Lab Connect Seoul'. Serving as the Korean model of the life science incubator program that Bayer has operated in major global innovation hubs, it focuses on providing global expertise in regulatory strategy, commercialization, market access, and pricing, rather than focusing solely on financial funding.BMS is also pursuing open innovation as its core growth strategy. To secure growth drivers following the impending patent expirations of flagship blockbusters like 'Opdivo (nivolumab)' and 'Eliquis (apixaban)', the company has pursued large-scale mergers and acquisitions (M&A) and external technology acquisitions over the past several years.A prime example is its collaboration with Orum Therapeutics. In 2023, BMS signed a degradative antibody conjugate (DAC) technology agreement with Orum Therapeutics to secure a next-generation oncology platform. Concurrently, it is nurturing domestic startups through the 'Seoul-BMS Innovation Square Challenge'. Companies such as Frasier Therapeutics, Illimis Therapeutics, and Galux are receiving support for global networks and commercialization know-how through this program.Novartis is expanding its open innovation collaboration with CHA Biotech in cell and gene therapy (CGT). At the same time, Amgen provides opportunities for domestic biotech startups to enter its facility and supports the operation of 'Bio Days' through its 'Golden Ticket' program.MSD recently signed a MOU with the Korea Health Industry Development Institute (KHIDI) to strengthen cooperation within the domestic biotech ecosystem. At the same time, Roche has established a collaborative framework with KHIDI, Basel Area Business & Innovation, and the Korea Technology Finance Corporation (KOTEC) to support the global expansion of domestic biotech firms.The global view of pharmaceutical companies on South Korea is shifting. While it previously served only as a sales market or a country for late-stage clinical trials, there is a growing consensus that it is a strategic innovation hub capable of early-stage R&D, platform collaborations, and startup incubation.South Korea is the world's second-largest conductor of investigator-initiated trials after the United States, and is evaluated as a market that simultaneously possesses excellent clinical infrastructure, biomanufacturing competitiveness, and rapid adoption of innovation. In fact, BMS established a dedicated Asia-Pacific (APAC) organization this year, restructuring South Korea, Japan, and China as next-generation growth axes. Bayer also noted that its collaborative discussions in Korea have moved past deliberation into the execution phase.Analysis suggests that expanding domestic collaborations by global Big Pharma is linked to a strategic shift regarding 'where to discover innovation and where to drive growth,' rather than simple technology in-licensing. This indicates that the Korean biotech ecosystem is beginning to play a more comprehensive role in the global value chain for novel drug development.
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- Traditional pharmas join in the Dupixent biosimilar race
- by Kim, Jin-Gu Jun 04, 2026 09:39am
- Korean pharmaceutical and biotechnology companies are increasingly entering the race to develop biosimilar versions of Dupixent (dupilumab), a blockbuster biologic with annual global sales approaching KRW 27 trillion.According to industry sources, Daewoong Pharmaceutical signed an agreement on May 28 with Chime Biologics, a global Chinese contract development and manufacturing organization (CDMO), to collaborate on the development, manufacturing, and commercialization of a Dupixent biosimilar. Under the agreement, the companies will leverage Chime Biologics' biologics development and manufacturing capabilities to develop the biosimilar, while Daewoong Pharmaceutical will lead commercialization efforts in major international markets.Daewoong established a dedicated biosimilar business division in June last year, and the Dupixent biosimilar has reportedly been identified as one of its initial strategic targets.Chime Biologics operates KUBio, a modular biologics manufacturing platform, and is regarded as having manufacturing capabilities that meet global cGMP standards required by both the U.S. FDA and the European Medicines Agency (EMA). The company has also expanded partnerships with Korean biotech firms such as MedPacto and Panolos Bioscience.CKD and Samsung Bioepis pursue ‘independent development,’ Daewoong and KyongBo seek ‘joint development’…targets global marketPrior to Daewoong's announcement, Chong Kun Dang (CKD), Samsung Bioepis, and KyongBo Pharmaceutical had already formalized their strategies for entering the Dupixent biosimilar market.In January, CKD received approval to initiate a European Phase I trial for its biosimilar candidate CKD-706. The study will evaluate pharmacokinetic equivalence to Dupixent in healthy adult volunteers while also comparing pharmacodynamics, safety, and immunogenicity. Industry observers assess CKD to be among the most advanced Korean companies in Dupixent biosimilar development.Samsung Bioepis announced at the J.P. Morgan Healthcare Conference 2026 that it had begun development of 7 blockbuster biosimilars, including a Dupixent biosimilar.KyongBo Pharmaceutical signed a comprehensive collaboration agreement with Protium Science in September last year and formally announced its Dupixent biosimilar development program in December.The participating companies are pursuing different development models. CKD has chosen an independent development strategy aimed at maximizing long-term profitability through its own R&D capabilities. Samsung Bioepis is likewise expected to pursue an in-house development approach, in line with its previous biosimilar programs.By contrast, Daewoong Pharmaceutical and KyongBo Pharmaceutical are pursuing joint development. The companies are employing a practical strategy to lower early-stage development risks and improve process efficiency through joint development.Dupixent sales expected to reach USD 30 billion…substance patent to expire around 2030 in major countriesCommercialization strategies are also expected to differ once the companies complete development . Samsung Bioepis is likely to pursue a two-track strategy combining direct sales and global partnerships, similar to its existing biosimilar portfolio.Daewoong plans to leverage the global commercialization experience gained through its botulinum toxin product Nabota to support future marketing of a Dupixent biosimilar. KyongBo Pharmaceutical, which is relatively new to the biologics sector, is expected to explore licensing-out opportunities or co-marketing models with large multinational pharmaceutical companies through its partnership with Protium Science.Dupixent generated USD 17.8 billion in annual sales last year, making it one of Sanofi's most successful products.The drug has maintained strong growth through successive indication expansions across immune-mediated diseases, including atopic dermatitis and asthma. More recently, indications have been expanded to include ▲ chronic rhinosinusitis with nasal polyps (CRSwNP), ▲ prurigo nodularis, ▲ eosinophilic esophagitis (EoE), and ▲ chronic obstructive pulmonary disease (COPD). Industry analysts project that global sales could exceed USD 20 billion (KRW 30.3 trillion) before patent expiration.Dupixent's core composition patents are scheduled to expire between 2029 and 2031 in major markets. Although Sanofi is pursuing an aggressive patent defense strategy through formulation changes and additional patent filings that could potentially extend exclusivity by up to a decade, the market generally expects a large-scale biosimilar market opportunity to emerge around 2030.
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- Hanmi, another mega out-licensing deal on a novel drug
- by Chon, Seung-Hyun Jun 04, 2026 09:39am
- Hanmi Pharmaceutical has secured another novel drug technology transfer agreement with global pharma Eli Lilly after 11 years. With an upfront payment exceeding KRW 100 billion, the deal ranks among the top 10 upfront payments in the Korean pharma and biotech industry. The upfront payment secured by Hanmi Pharmaceutical accounts for 6% of the total contract value. It is a megadeal with one of the highest upfront-to-total deal-value ratios among recent technology transfers by domestic companies.Hanmi Pharmaceutical out-licenses novel drug to Lilly after 11 years...KRW 110B upfront payment ranks in Top 10 on recordHanmi Pharmaceutical announced on June 1st that it has signed an exclusive license agreement with Eli Lilly for the development, manufacturing, and commercialization of its novel biologic candidate, ‘sonefpeglutide’.Hanmi Pharmaceutical will receive a guaranteed upfront payment of $75 million (approximately KRW 110 billion) from Lilly. The company is also eligible to receive up to an additional $1.185 billion (approximately KRW 1.8 trillion) upon achieving clinical development, regulatory approval, and commercialization milestones. Hanmi Pharmaceutical will also receive separate tiered royalties following the product launch.Under this agreement, Lilly secures exclusive global rights for the development, manufacturing, and commercialization of sonefpeglutide, excluding South Korea.AI-generated imageSonefpeglutide is a novel drug candidate developed utilizing LAPSCOVERY, Hanmi Pharmaceutical’s proprietary long-acting platform technology for biologics. Focusing on the biological effects of glucagon-like peptide-2 (GLP-2), including the promotion of intestinal growth, alleviation of inflammation, and protection and regeneration of the intestinal mucosa. Hanmi has conducted various non-clinical studies. The candidate is currently undergoing global Phase II clinical trials for the indication of Short Bowel Syndrome (SBS). Hanmi Pharmaceutical will continue the ongoing global Phase II trial for SBS until its completion, after which Lilly will advance subsequent clinical trials based on the non-clinical and clinical data for sonefpeglutide.This novel drug out-licensing deal between Hanmi Pharmaceutical and Lilly marks the first time in 11 years. In 2015, Hanmi out-licensed its BTK inhibitor, poseltinib, to Lilly for an upfront payment of $50 million. BTK inhibitors act by blocking Bruton's Tyrosine Kinase (BTK), a protein critical to B-cell development. Lilly returned the poseltinib rights in January 2019, citing a failure to demonstrate efficacy in a Phase II clinical trial for patients with rheumatoid arthritis.The upfront payment secured by Hanmi Pharmaceutical through this deal ranks in the top 10 among the past out-licensing agreements signed by domestic pharma and biotech firms. Hanmi Pharmaceutical also holds the record for the largest upfront payment in a technology transfer by a domestic company.In November 2015, Hanmi Pharmaceutical signed an out-licensing agreement with Sanofi for three novel diabetes treatments (efpeglenatide, long-acting insulin, and an efpeglenatide + long-acting insulin combination). The initial upfront payment was valued at EUR 400 million. Although the upfront fee was subsequently reduced to EUR 204 million through an amended contract, it still holds the top spot for historical upfront payments. The long-acting obesity and diabetes treatment that Hanmi out-licensed to Janssen in 2015 for $105 million ranks second on record. The $100 million upfront payment received by SK Biopharmaceuticals in February 2019, when it signed a technology transfer agreement with Arvelle Therapeutics for the epilepsy treatment 'cenobamate,' ranks third historically. The $100 million in upfront fees secured in novel drug licensing deals by companies such as LG Chem, LigaChem Biosciences, and Orum Therapeutics also rank third-highest in historical upfront payments.In January 2024, LG Chem signed a technology transfer agreement with U.S.-based Rhythm Pharmaceuticals for its rare obesity drug candidate, LB54640. The terms of the deal included a $100 million upfront payment, with the total deal value reaching up to $305 million. LB54640 is the world's first oral MC4R agonist, and its Phase I clinical trials confirmed safety as well as a trend toward dose-dependent weight loss.In December 2023, LigaChem Biosciences signed a technology transfer agreement with Janssen Biotech for the development and commercialization of ‘LCB84’. The contract terms stipulated a $100 million upfront payment, a $200 million option exercise fee for sole development, and development, regulatory, and commercialization milestones, bringing the total potential value up to $1.7 billion. LCB84 is an antibody-drug conjugate (ADC) utilizing LigaChem Bio’s next-generation ADC platform technology and a Trop2 antibody in-licensed from Mediterranea Pharma.In November 2023, Orum Therapeutics signed an out-licensing deal with BMS for its novel drug candidate, ORM-6151. The total contract value reached up to $180 million, including a $100 million upfront payment. ORM-6151 is a candidate developed via Orum Therapeutics' proprietary antibody-based protein degrader platform.Chong Kun Dang signed an out-licensing deal with Novartis in November 2023 for its candidate, CKD-510; the $80 million non-refundable upfront payment ranks seventh historically. Factoring in $1.225 billion in development and regulatory milestones, the total deal value scales up to $1.305 billion. CKD-510 is a novel drug candidate discovered and developed by Chong Kun Dang, a highly selective HDAC6 inhibitor engineered with a non-hydroxamic acid platform.Hanmi Pharmaceutical received an upfront payment of $80 million under its 2016 deal with Genentech to transfer its RAF-targeted anticancer technology. In January 2022, ABL Bio secured a non-refundable upfront fee of $75 million upon signing a technology transfer agreement with Sanofi subsidiary Genzyme for ABL301, a bispecific antibody candidate targeting degenerative neurological disorders such as Parkinson's disease.Hanmi Pharmaceutical received upfront fees of $50 million each in its 2015 out-licensing agreements with Eli Lilly and Boehringer Ingelheim. The $50 million upfront payment secured by Yuhan Corporation in 2018 when it out-licensed the oncology drug Leclaza to Janssen also ranks among the highest tiers.Upfront fee accounts for 6% of total deal value...among the highest levels in recent tech transfersThe upfront payment secured through Hanmi Pharmaceutical's latest technology transfer accounts for 6.0% of the total deal value. This represents a highly remarkable proportion, even when compared with historical out-licensing deals.Last year, only one technology transfer deal by a Korean pharma or biotech company achieved an upfront payment proportion exceeding 6.0%, and that was an out-licensing agreement by Hanmi Pharmaceutical.In September of last year, Hanmi Pharmaceutical signed a global technology transfer agreement granting exclusive global development and commercialization rights for ‘Encequidar’ alongside Gilead Sciences and Health Hope Pharma. Under this deal, Health Hope Pharma, which held the global rights to Encequidar outside of Korea, modified its existing strategic collaboration with Hanmi Pharmaceutical to grant Gilead an exclusive global license for product development, manufacturing, and commercialization within the field of virology. Hanmi Pharmaceutical received a non-refundable upfront payment of $2.5 million. Milestone payments tied to development stages were capped at up to $32 million. Although the upfront payment accounted for 7.8% of the total contract value in this instance, the absolute dollar amount of the upfront fee was relatively small.2025 Out-licensing deals by pharmaceutical and biotech companies. UPFRONT PAYMENT (KRW 100 million); TOTAL CONTRACT VALUE (KRW 100 million)Since last year, out-licensing of novel drug candidates has been highly active, driven primarily by biotech firms such as AimedBio, OliX Pharmaceuticals, AbClon, Alteogen, Genome & Company, ABL Bio, Rznomics, NIBEC, Abion, Sovargen, and G2GBio. However, the proportion of upfront payments in these deals remained negligible.In March of last year, Alteogen signed two agreements with MedImmune, the research and development (R&D) subsidiary of AstraZeneca, utilizing its proprietary 'ALT-B4' platform technology. The contract signed with the UK entity was valued at KRW 1.091 trillion, including an upfront payment of KRW 36.4 billion. The contract with the US entity totaled KRW 872.9 billion, including a KRW 29.1 billion upfront payment; for both agreements, the upfront fee accounted for 3.3% of the total contract value.The upfront fees for out-licensing deals signed by ABL Bio, NIBEC, and Abion were limited to 1% of their respective. Companies including AimedBio, OliX Pharmaceuticals, AbClon, Genome & Company, Rznomics, Sovargen, and G2GBio did not disclose the values of their upfront payments.The proportion of an upfront payment relative to the total value of a pharma or biotech out-licensing agreement varies widely. Typically, the closer a novel drug candidate is to commercialization, the higher the upfront fee percentage.The $100 million upfront fee received by Orum Therapeutics from BMS reached 55.6% of the total deal value. Orum Therapeutics’ technology transfer stands out as an example where the upfront payment swelled due to the outright assignment of the novel drug candidate. While conventional pharmaceutical licensing agreements structure payments around milestones triggered by future clinical advancement, Orum Therapeutics significantly maximized its upfront component by fully assigning its rights.The upfront payment for LG Chem’s LB54640 technology transfer accounted for 32.8% of the maximum potential deal value. This indicates that the licensing partner evaluated the growth potential of LB54640 exceptionally highly, allocating a substantial upfront investment.In 2019, the upfront fee proportion for cenobamate, which SK Biopharmaceuticals out-licensed to Arvelle Therapeutics, formed an exceptionally high baseline at 18.9%. Analysts attribute this high-purity contract structure to the elevated probability of commercialization, as cenobamate had already entered the review pipeline at the U.S. Food and Drug Administration (FDA) at the time of the deal.For the three novel diabetes treatments out-licensed to Sanofi by Hanmi Pharmaceutical, which holds the record for the largest upfront fee, the initial upfront component stood at 10.3% of the deal. When the total value of the agreement between Hanmi and Sanofi was subsequently scaled down via an amended contract, the upfront proportion dropped to 7.2%. The long-acting obesity and diabetes treatment that Hanmi out-licensed to Janssen in 2015 also recorded a high upfront proportion of 11.5%. At the time of that technology transfer, the candidate had just wrapped up Phase I clinical testing. Despite being in an early stage of clinical development, the licensing partner assigned an exceptionally high valuation to the asset.In 2020, Alteogen signed a non-exclusive license agreement for its proprietary human hyaluronidase technology (ALT-B4) with a global pharma, with a maximum value of $38.65 billion. However, the deal's upfront payment was $16 million, representing only 0.4% of the potential maximum deal size.
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- Personalized cancer vaccines show promising clinical results
- by Son, Hyung Min Jun 04, 2026 09:39am
- Personalized messenger RNA (mRNA)-based cancer vaccines are drawing increasing attention as a potential new treatment strategy for melanoma after long-term follow-up data confirmed their ability to reduce disease recurrence.Particularly noteworthy is the combination of personalized cancer vaccines with the immuno-oncology drug Keytruda (pembrolizumab). Clinical data demonstrated a long-term reduction in recurrence risk among high-risk melanoma patients following surgery, highlighting the growing clinical feasibility of personalized cancer vaccine approaches.According to industry sources, Moderna and MSD presented five-year follow-up results from the Phase IIb KEYNOTE-942/mRNA-4157-P201 study, which evaluated patients with high-risk stage III and IV melanoma, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.The trial compared adjuvant therapy consisting of intismeran autogene (mRNA-4157/V940), an investigational personalized mRNA neoantigen therapy, plus Keytruda versus Keytruda alone in patients who had undergone complete surgical resection.At a median follow-up of 60.3 months, the combination therapy continued to improve the primary endpoint of recurrence-free survival (RFS) and reduced the risk of recurrence or death by 49% compared with Keytruda monotherapy.The regimen also demonstrated significant benefit in the key secondary endpoint of distant metastasis-free survival (DMFS), reducing the risk of distant metastasis or death by 59%.An exploratory analysis of overall survival (OS) suggested a trend toward improved survival with the combination therapy. However, as there are not yet sufficient cases within the follow-up period, an evaluation of long-term survival benefits is expected to require further observation.MSD’s immuno-oncology drug, ‘Keytruda’In fact, additional analysis showed that the combination therapy promoted the generation and expansion of new T-cell clonotypes compared with Keytruda alone.Long-term follow-up revealed that the combination group had a ratio of newly expanded T-cell clones that was approximately twice as high. This increase in immune response was particularly pronounced among patients who remained recurrence-free. These findings support the hypothesis that personalized neoantigen-based therapies can activate meaningful anti-tumor immune responses.The safety profile remained consistent with previous analyses. The most commonly reported adverse events included fatigue, injection site pain, and chills, and most were Grade 1 or 2 in severity. The incidence of immune-related adverse events was comparable to that observed with Keytruda alone, suggesting that the addition of the vaccine did not substantially increase toxicity.Unlike infectious disease prevention vaccines, cancer vaccines are not intended to prevent cancer development. Instead, they are individualized therapeutic approaches tailored to each patient's tumor characteristics. The process involves analyzing tumor-specific genetic mutations and neoantigens and then designing a treatment that stimulates an immune response against those unique targets.Intismeran autogene is specifically designed using mutation data obtained from a patient's tumor DNA and can incorporate up to 34 personalized neoantigens. The therapy is intended to activate T-cell-mediated immune responses, enabling the immune system to recognize and eliminate cancer cells more effectively.Major pharmaceutical and biotechnology companies are increasingly focusing on personalized cancer vaccines as a means of enhancing treatment outcomes rather than preventing disease. The strategy centers on combining cancer vaccines with immuno-oncology drugs and potentially with other therapeutic platforms such as antibody-drug conjugates (ADCs) to maximize anti-tumor efficacy.Moderna and MSD are currently evaluating the combination of intismeran autogene and Keytruda not only in melanoma but also in a variety of solid tumors, including non-small cell lung cancer (NSCLC), bladder cancer, and renal cell carcinoma. A total of nine Phase II and Phase III clinical programs are currently underway. Patient enrollment has already been completed for certain melanoma and renal cell carcinoma studies, and follow-up clinical trials are also continuing for non-small cell lung cancer as adjuvant therapy and perioperative strategies.
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- AbbVie's 'Rinvoq' receives expanded reimb for ankylosing spondylitis
- by Son, Hyung Min Jun 04, 2026 09:39am
- Product photo of 'Rinvoq' AbbVie Korea (CEO So Young Kang) announced that the scope of national health insurance reimbursement for its selective JAK1 inhibitor, 'Rinvoq (upadacitinib)', has been expanded to include biologic-naive patients with active ankylosing spondylitis, effective from the 1st of this month according to a notification from the Ministry of Health and Welfare (MOHW). Under the expanded reimbursement criteria, Rinvoq can now be reimbursed for adult patients (aged 18 or older) with severe active ankylosing spondylitis who have had an inadequate response to at least three months of treatment with two or more nonsteroidal anti-inflammatory drugs (NSAIDs) or disease-modifying antirheumatic drugs (DMARDs), or who discontinued such medications due to side effects, regardless of their prior treatment experience with biological agents or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs). Rinvoq previously obtained reimbursement in December 2023 for adult patients with active ankylosing spondylitis who showed an inadequate response to or discontinued treatment with one or more TNF-alpha inhibitors or interleukin (IL)-17 inhibitors due to adverse events or contraindications. With this expanded reimbursement, Rinvoq became an oral treatment option that can be initiated earlier, even in biologic-naive patients. Ankylosing spondylitis is a primary spondyloarthritis characterized by chronic inflammation of the spine and sacroiliac joints, primarily onset in the young population in their 10s to 30s. Representative symptoms include chronic pain and stiffness in the lower back and buttock areas, typically worsening in the morning. The pain of ankylosing spondylitis goes beyond mere discomfort, directly impacting overall daily living, including sleep, physical function, and work performance, thereby deteriorating the patient's quality of life. According to statistics from the Health Insurance Review and Assessment Service (HIRA), the number of ankylosing spondylitis patients in South Korea is approximately 56,000 as of 2024 and has been steadily climbing over the past five years. Professor Seung-Jae Hong of the Department of Rheumatology at Kyung Hee University Hospital stated, “Ankylosing spondylitis is a chronic inflammatory disease that frequently manifests in the younger demographic, severely impacting the patient's daily life and quality of life due to pain and stiffness," and added, "Under the domestic reimbursement landscape, JAK inhibitors could only be introduced following the failure of biological therapies, which restricted the formulation of optimal therapeutic strategies.” Professor Hong continued, “The expanded reimbursement criteria for oral JAK inhibitors hold significant clinical value as they establish a pathway to oral treatment post-NSAID therapy without requiring a prior transition through injectable therapies," and added that "Furthermore, given Rinvoq's rapid pain relief and long-term efficacy demonstrated in its clinical trials, it is expected to enhance treatment adherence and improve patient quality of life. As a cost-effective therapeutic option, it will also play a positive role in terms of maximizing the fiscal efficiency of the national health insurance budget.” AbbVie Korea CEO So Young Kang stated, “The development of Rinvoq's expanded reimbursement criteria is significant as it offers ankylosing spondylitis patients to explore a wider range of therapeutic options at an earlier stage," and added, "As a global innovative pharmaceutical enterprise, AbbVie Korea will continue putting efforts to expand the clinical value of innovative therapeutics in alignment with the evolving treatment paradigms and patient unmet medical needs, thereby contributing to enhancing treatment options for patients in South Korea.”
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- Vyloy receives DREC review for reimbursement
- by Eo, Yun-Ho Jun 04, 2026 09:39am
- The reimbursement process for the gastric cancer targeted therapy Vyloy (zolbetuximab) has made significant progress.According to industry sources, Vyloy, Astellas Pharma Korea’s targeted therapy for Claudin 18.2-positive gastric cancer, passed the Health Insurance Review & Assessment Service (HIRA)'s Pharmacoeconomic Evaluation Subcommittee on May 22 and is scheduled to be reviewed by the Drug Reimbursement Evaluation Committee today (June 4).This development appears to have renewed momentum for a reimbursement process that had stalled after the drug passed the Cancer Drug Review Committee in October of last year.Approved in Korea in September 2024, Vyloy initially failed to pass the Cancer Drug Review Committee during its first reimbursement application in February last year. The company immediately resubmitted its application and ultimately secured approval. However, subsequent delays in the reimbursement process have led to expectations that final listing approval may still take considerable time.Vyloy is the world's first approved Claudin 18.2-targeted therapy. It is an immunoglobulin monoclonal antibody that selectively binds to Claudin 18.2, a protein expressed and exposed in gastric cancer cells.The Phase III SPOTLIGHT trial, which served as the basis for approval, showed that the combination of Vyloy and mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil) achieved a median progression-free survival (mPFS) of 10.61 months, compared with 8.67 months in the placebo group. Median overall survival (mOS) was 18.23 months versus 15.54 months, respectively.Similarly, in the GLOW trial, the combination of Vyloy and CAPOX (capecitabine plus oxaliplatin) achieved an mPFS of 8.21 months, reducing the risk of disease progression or death by approximately 31%.Professor SunYoung Rha of Yonsei Cancer Center commented,"Approximately 90% of patients with metastatic gastric cancer are HER2-negative, creating an urgent need for therapies targeting new biomarkers. Given that roughly 40% of HER2-negative patients are reported to be Claudin 18.2-positive, the introduction of Vyloy, which selectively binds to Claudin 18.2, offers a new therapeutic possibility."Meanwhile, the Korean Gastric Cancer Association revised its treatment guidelines published in the Journal of Gastric Cancer (JGC) on January 6, 2025, recommending Vyloy at the highest level for first-line treatment of patients who are HER2-negative and Claudin 18.2-positive.Vyloy has also been listed as a standard treatment option in Japanese gastric cancer treatment guidelines and the European Society for Medical Oncology (ESMO) clinical practice guidelines. In addition, it has been listed as a Preferred Regimen in the U.S. National Comprehensive Cancer Network (NCCN) guidelines, rapidly establishing itself as the global standard-of-care treatment for gastric cancer.
- Company
- Oscotec licenses new autoimmune disease drug to a US company
- by Chon, Seung-Hyun Jun 02, 2026 08:55am
- Oscotec announced on June 1st that it has entered into a technology transfer agreement with U.S. biotech company Agios Pharmaceuticals for its autoimmune disease drug candidate, cevidoplenib.Under the agreement, Oscotec will transfer to Agios the exclusive clinical development and global commercialization rights for cevidoplenib. Oscotec will receive a non-refundable upfront payment of $25 million (approximately KRW 37.5 billion) from Agios. Including future development, regulatory, and commercialization milestones based on specific contract terms, the total potential deal value amounts to $665 million (approximately KRW 1 trillion). Following commercialization, Oscotec will additionally receive separate tiered royalties.Cevidoplenib, which was co-discovered and developed through a collaborative research effort between Oscotec and Genosco, is an oral small-molecule novel drug candidate that selectively inhibits spleen tyrosine kinase (SYK). It has been designed to modulate immune-mediated platelet destruction, a primary pathogenic mechanism in immune thrombocytopenia (ITP). Global Phase II clinical trials for both ITP and rheumatoid arthritis (RA) have been completed.The technology fees, including the upfront payment and milestone payments received from Agios, will be distributed between Oscotec and Genosco at 75% and 25%, respectively, in accordance with the terms of a 2016 agreement between the two companies.Agios is a global biopharmaceutical company focusing on the development and commercialization of therapies for rare diseases. Its primary pipeline includes the pyruvate kinase (PK) activator mitapivat. This drug has secured regulatory approvals as a treatment for adult thalassemia in the United States, the European Union, Saudi Arabia, and the United Arab Emirates, and for adult PK deficiency in the United States and Europe.Taeyoung Yoon, CEO of Oscotec, stated, "Following the completion of the Phase II clinical trials for cevidoplenib, we have discussed out-licensing with multiple companies worldwide. We determined that Agios, a global biopharmaceutical company with outstanding expertise in rare hematologic diseases, is the optimal partner to maximize the therapeutic and commercial value of cevidoplenib."
- Company
- Yuhan’s gains Phase I approval for returned MASH candidate YH25724
- by Lee, Seok-Jun Jun 01, 2026 09:04am
- Yuhan Corp announced on the 29th that it has received approval from the Ministry of Food and Drug Safety to conduct a domestic Phase I trial of its metabolic dysfunction-associated steatohepatitis (MASH) treatment candidate ‘YH25724.’YH25724 is a novel biologic candidate that combines dual mechanisms targeting fibroblast growth factor 21 (FGF21) and glucagon-like peptide-1 (GLP-1). The candidate incorporates Yuhan’s proprietary protein engineering technology together with Genexine’s long-acting antibody fusion platform, HyFc.Preclinical studies have confirmed that the dual action of FGF21 and GLP-1 improves steatohepatitis, exerts anti-fibrotic effects, and reduces hepatocyte damage and liver inflammation.This Phase 1 trial marks the first clinical study of YH25724 in Korea. The study consists of a single-dose part and a 12-week multiple-dose part involving healthy adult participants. Yuhan plans to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).Yeol-Hong Kim, Head of R&D at Yuhan Corp, stated, “We plan to evaluate safety and tolerability across various dose levels in Korean participants and explore preliminary proof-of-concept potential based on pharmacodynamic markers. We plan to start recruitng subjects within this year.”The YH25724 pipeline was originally licensed out to Boehringer Ingelheim in 2019 but was returned in 2025. Since then, Yuhan has resumed in-house development of the candidate.Prior to the return of the program, Boehringer Ingelheim had conducted three Phase I clinical trials evaluating the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of YH25724.
- Company
- Lorviqua shows sustained beneift in 7-year follow up
- by Son, Hyung Min Jun 01, 2026 09:04am
- Pfizer’s non-small cell lung cancer (NSCLC) treatment Lorviqua has demonstrated efficacy in a 7-year follow-up study, confirming its potential for long-term disease control.According to industry sources on the 30th, Pfizer presented 7-year follow-up results from the Phase III CROWN study of Lorviqua (lorlatinib), a targeted therapy for ALK-positive NSCLC, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.ALK-positive NSCLC is a rare genetic subtype accounting for approximately 3–5% of all NSCLC cases. It tends to affect younger patients and is characterized by a high incidence of central nervous system (CNS) metastases during the course of the disease. As a result, long-term disease control and prevention of brain metastases are considered key measures of treatment success.Targeted oral therapies for ALK-positive lung cancer include Pfizer’s first-generation Xalkori (crizotinib), second-generation therapies such as Alecensa (alectinib) and Takeda’s Alunbrig (brigatinib), and third-generation Lorviqua.The global CROWN study directly compared Lorviqua and Xalkori in 296 treatment-naïve patients with advanced ALK-positive NSCLC. Participants were randomly assigned to receive either Lorviqua 100 mg once daily or Xalkori 250 mg twice daily.‘Lorviqua,’ treatment for ALK-positive NSCLCSeven-year follow-up results showed that the median progression-free survival (PFS) in the Lorviqua group remained not reached (NR), while the median PFS in the Xalkori group was 9.1 months. This indicates that more than half of patients treated with Lorviqua maintained treatment benefit without disease progression throughout the follow-up period.At 7 years, progression-free survival rates were 55% in the Lorviqua group versus 3% in the Xalkori group, demonstrating a substantial difference.In particular, for patients who showed no disease progression up to 24 months after receiving Lorviqua, the probability of surviving without disease progression at the 7-year mark was estimated to be 79%.Lorviqua also demonstrated a pronounced benefit in preventing brain metastases. No new cases of intracranial disease progression were reported after 30 months of treatment. The median time to intracranial progression was not reached in the Lorviqua group, compared with 16.4 months in the Xalkori group.Given that ALK-positive NSCLC carries a high risk of brain metastases from early stages and CNS progresses frequently during treatment, durable CNS control is considered highly meaningful in clinical practice.In terms of safety, the adverse event profile remained comparable with the previously reported 5-year follow-up data. Grade 3 or 4 adverse events occurred in 77% of patients receiving Lorviqua and 57% of those receiving Xalkori. However, permanent treatment discontinuation due to treatment-related adverse events (TRAEs) was relatively low at 5% and 6%, respectively. Furthermore, no new treatment-related permanent discontinuations were reported after 26 months in the Lorviqua group.Overall survival (OS), however, has not yet reached the pre-specified analysis threshold, and additional follow-up is ongoing. Accordingly, while these results are significant in that they strengthen the evidence for the potential for long-term disease control, further data will be needed to confirm the ultimate survival benefit.
