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- 2026-04-04 13:44:22
- Company
- Introduction of new PNH drugs…expanding competition landscape
- by Son, Hyung Min Dec 30, 2025 07:00am
- The competition landscape for Paroxysmal Nocturnal Hemoglobinuria (PNH) treatment market in South Korea has intensified with the introduction of a new C5 complement inhibitor.The market, which was dominated by AstraZeneca's C5 inhibitors 'Soliris (eculizumab)·Ultomiris (ravulizumab)', is expected to see full-scale competition from new mechanism treatments, including C3·Factor B·Factor D inhibitors. Industry observers anticipate that the key criteria for selecting PNH treatments will shift from mechanism alone to factors such as administration convenience, including dosing intervals and formulations.Roche's PNH treatment 'Piasky (crovalimab)'According to industry sources on December 27, the Ministry of Food and Drug Safety (MFDS) approved Roche's PNH treatment, 'Piasky (crovalimab)', on December 24. Piasky is a C5 complement inhibitor developed by Roche. This drug works by administering a low dose subcutaneously (SC) every 4 weeks, which then recirculates in the blood to inhibit complement activity continuously.Piasky obtained U.S. FDA approval in June last year and was commercialized in Europe in August of the same year. In South Korea, it was designated as an orphan drug in February of last year.The basis of approval is the results of the Phase 3 COMMODORE 2 study. COMMODORE 2 was a randomized, open-label, active-controlled non-inferiority trial comparing Piasky directly with the current standard of care, AstraZeneca's Soliris, in PNH patients aged 13 and older weighing at least 40 kg.The primary endpoints of the trial were transfusion avoidance and hemolysis control rates. The secondary endpoints included breakthrough hemolysis, hemoglobin stabilization, changes in fatigue, and safety.In the studies, the hemolysis control rate from week 5 to week 25 was 79.3% in the Piasky group and 79.0% in the Soliris group, successfully meeting the criteria for non-inferiority.The proportion of patients who avoided red blood cell transfusions from baseline to week 25 was also similar, at 65.7% and 68.1%, respectively. The incidence of breakthrough hemolysis tended to be lower in the Piasky group (10.4%) than in the control group (14.5%), and there was no significant difference between the two groups in the proportion of patients maintaining stable hemoglobin levels.In terms of safety, the Piasky group had an approximately 6% incidence of serious adverse events, with epistaxis, pneumonia, and infusion-related reactions as the primary reports. The overall adverse event profile was similar to that of existing C5 inhibitors.C3 and Factor B...Competition over 'Mechanism + Convenience' begins in full-scaleFollowing the domestic approval of Piasky, the PNH treatment market is expected to shift from the existing C5-inhibitor-dominated structure into a phase of competitive diversification in mechanisms.PNH is a rare disease caused by acquired genetic mutations. While multiple mutations in hematopoietic stem cells can lead to blood cancers, PNH occurs when a mutation develops in the X-linked PIGA gene.PNH is reportedly a disease without a fundamental cure. However, with scientific advances, the development of treatments that inhibit complement activation is changing the therapeutic approach. The complement system is a core element of innate immunity, a robust defense that directly attacks and destroys pathogens. This system consists of various pathways, such as C3 and C5, and ultimately forms the membrane attack complex (MAC) to destroy red blood cells.Until now, treatments inhibiting C5, located at the terminal pathway of the complement system, have been primarily used. The treatment environment improved with the introduction of Soliris, an injectable administered every two weeks, followed by Ultomiris, which can be administered every eight weeks. Many patients still manage the disease based on these treatments.Recently, the competitive axis has widened with the addition of Handok's C3 inhibitor 'Empaveli (pegcetacoplan)', Novartis's Factor B inhibitor 'Fabhalta (iptacopan)', and AstraZeneca's Factor D inhibitor 'Voydeya (danicopan)'. Each drug targets a different stage in the complement system. They have been designed to employ strategies to address unmet needs, such as extravascular hemolysis (EVH), may persist even after C5 inhibition.From left, PNH treatments 'Empaveli (pegcetacoplan)', 'Fabhalta (iptacopan)', 'Voydeya (danicopan)'Analysts suggest that the future market landscape will likely be driven more by administration convenience than by differences in efficacy.The dosing structure of Voydeya is complex requiring co-administration with a C5 inhibitor. However, it offers the advantage of potentially easier compliance management.For Fabhalta, its oral formulation is a strength, offering greater dosing convenience than injectables. This treatment is particularly effective for treating anemia and EVH.Empaveli poses burden of twice-weekly subcutaneous injections, but it remains an option for patients who can expect clinical effects from direct inhibition at the C3 stage. Experts evaluate it as a sufficiently effective option for patients who do not have a strong aversion to injections.Empaveli was developed by the U.S. company Apellis Pharmaceuticals, while Swedish Orphan Biovitrum (Sobi) holds the rights outside the United States. Handok signed a strategic partnership agreement with Sobi in 2023 to introduce Empaveli into the Korean market.
- Company
- Merz selected as SDGBI ‘Excellent Group’
- by Hwang, byoung woo Dec 30, 2025 07:00am
- Merz Aesthetics Korea announced on the 29th that it has been selected as an ‘Excellent Group’ in the ‘2025 Sustainable Development Goals Business Index (SDGBI).’Following its entry into the ‘Outstanding Group’ of the domestic SDGBI last year, the company advanced one step further this year to be named in the ‘Excellent Group.’The SDGBI is a management analysis index based on the UN SDGs (United Nations Sustainable Development Goals), published by the UN SDGs Association since 2016. It is a sustainable management analysis index used to measure corporate implementation of SDGs.The index evaluates companies across four sectors—social, environmental, economic, and institutional—using 12 criteria and 48 indicators. These include environmental initiatives, socioeconomic impact, governance and institutional improvements, ESG-related financial activities, and the establishment of innovative infrastructure.Reflecting the characteristics of the medical aesthetics industry, Merz has developed its own ESG Index, aligned with the UN SDGs, and practices ESG management from a structured, long-term perspective.The UN SDGs Association annually evaluates ESG management performance based on the ESG Index. Its results showed that Merz has solidified its ESG management foundation, achieving an overall ‘A’ rating in the environmental, social, and institutional categories for 2 consecutive years since 2023. This year, such an achievement led to its nomination in the SDGBI Excellent Group.In particular, Merz is known to have received high scores for strengthening supply chain sustainability and creating social value tailored to the medical aesthetics sector.Merz practices ESG management throughout its supply chain, including carbon emission reduction and waste management. By obtaining approval for room-temperature storage (1–25°C) of its products, Merz reduced energy consumption associated with cold-chain logistics while enhancing product stability during distribution.In addition, Merz introduced eco-friendly packaging, reducing box size by 34% to conserve resources and improve shipping efficiency, thereby lowering carbon emissions during transportation.The removal of plastic trays is expected to reduce global plastic usage by approximately 12.77 tons annually.To prevent medical device reuse and strengthen waste management, Merz has also operated the Ultherapy PRIME™ / Ultherapy ESG-Certified Clinic Campaign. This initiative expanded an existing used tip disposal campaign, implemented since 2018, into a broader ESG-driven program to encourage wider participation among hospitals and clinics.In the social domain, Merz has carried out various social contribution activities based on its corporate mission, “Look Better, Feel Better, Live Better.”From an organizational perspective, the company fosters an employee-centric culture and supports work–life balance through diverse internal programs. Structured capability development initiatives are provided to promote continuous growth, while the Merz Employee Council (MEC) plays a central role in strengthening employee-driven organizational culture, embedding ESG principles throughout the entire organization.Su-Yeon Yu, General Manager of Merz Aesthetics, said, “This nomination is the result of the responsible management practices Merz has consistently pursued, as well as the collective efforts of all our employees. We will continue to lead the medical aesthetics industry toward sustainability through differentiated ESG management as a trusted company.”
- Policy
- 8 items, including Infanrix, will be discontinued next year
- by Jung, Heung-Jun Dec 29, 2025 08:55am
- Product photo of GSK's Infanrix-IPV+Hib Inj, Yuhan Corporation's Bambec Tab, and Hanall Biopharma's Cortisolu InjectionEight items, including GSK's hexavalent combination medicine (included in the National Immunization Program (NIP)), will be discontinued for supply starting next year. On the 2nd of next month, the list of items subject to supply suspension, along with their scheduled dates, will be shared on the drug utilization review (DUR) system.The Health Insurance Review and Assessment Service (HIRA) the list of items reported to be suspended for next year's production, imports, and supply shared with relevant organizations and associations.According to the relevant association on December 26, eight items from seven companies, including Eisai Korea, GSK, and Hanall Biopharma, will be discontinued for supply next year.The included items are ▲Hanall Biopharma's Cortisolu Injection (hydrocortisone sodium succinate) ▲Daewoo Pharm's Tobeson Eye Drops (tobramycin, dexamethasone) ▲Tai Guk Pharm's Hyrosone Cream (hydrocortisone) and Gammarin D Liquid ▲Yuhan Corporation's Bambec Tab 10mg (bambuterol hydrochloride) ▲Genuone Sciences' Pencivir Cream (penciclovir) ▲GSK's Infanrix-IPV+Hib Inj ▲Eisai Korea's Plegridy Pen Inj Starter Pack (peginterferon beta-1a, recombinant), among others.Infanrix-IPV+Hib is a hexavalent combination vaccine supplied for the NIP for infants. It is a vaccine that simultaneously prevents meningitis, pertussis, and polio.The relevant vaccination market has been split between Sanofi's Pentaxim and Infanrix. Following the discontinuation of Infanrix on June 30 of next year, demand is expected to shift to Pentaxim from the second half of the year.The list of pharmaceuticals subject to discontinued supply (January 2026): ▲Hanall Biopharma's Cortisolu Injection (hydrocortisone sodium succinate) ▲Daewoo Pharm's Tobeson Eye Drops (tobramycin, dexamethasone) ▲Tai Guk Pharm's Hyrosone Cream (hydrocortisone) and Gammarin D Liquid ▲Yuhan Corporation's Bambec Tab 10mg (bambuterol hydrochloride) ▲Genuone Sciences' Pencivir Cream (penciclovir) ▲GSK's Infanrix-IPV+Hib Inj ▲Eisai Korea's Plegridy Pen Inj Starter Pack (peginterferon beta-1a, recombinant), among others.Eisai Korea's Plegridy Pen Inj is a new drug for relapsing multiple sclerosis that received domestic approval in 2016 and was listed for reimbursement in 2017. As a recombinant treatment for a rare disease, the decision to discontinue supply was made approximately 10 years after its introduction. Supply will be discontinued starting June 30 of next year, the same time as Infanrix.Hanall Biopharma's Cortisoru Inj will be discontinued starting July 1 of next year. As a corticosteroid, it is expected to be replaced by more than 20 other drugs available in the same therapeutic class.With AstraZeneca’s decision to withdraw Bambec Tab. from the market 31 years after its domestic approval, Yuhan Corporation will also cease sales and supply after December of next year.Bambec Tab is a long-acting beta-adrenoceptor agonist (LABA) used to treat asthma, chronic bronchitis with bronchospasm, emphysema, and other lung diseases. Since combination therapies have been increasingly used for asthma treatment recently, the decline in market competitiveness is considered the reason for the withdrawal.The HIRA plans to provide information on the eight items scheduled for discontinuation next year to physicians and pharmacists through the DUR system on the 2nd of next month.
- Company
- Oral Wegovy enters market...prompts change in market strategy
- by Choi Da Eun Dec 29, 2025 08:54am
- The emergence of ‘oral Wegovy’ in the global obesity treatment market, which has long been dominated by injectable GLP-1 therapies, is expected to intensify competition for companies in Korea and abroad. Domestic pharmaceutical and biotech firms are shifting their development focus beyond simple formulation competition, eyeing niche strategies like muscle loss improvement.According to industry sources, Novo Nordisk's oral obesity treatment, Wegovy (semaglutide), received approval from the U.S. Food and Drug Administration (FDA) on the 22nd (local time).The oral version converts the company’s injectable GLP-1 class obesity therapy into a once-daily pill, eliminating key drawbacks of the injectable version, such as the need for refrigerated storage and the hassle of self-injection. Novo Nordisk plans to launch the product in the U.S. market in early January next year.Eli Lilly, which developed the GLP-1/GIP dual receptor agonist obesity drug Mounjaro, is also preparing to commercialize its oral GLP-1 therapy orforglipron. The company recently submitted a new drug application to the FDA, and industry observers expect a full-scale duopoly to emerge starting next year.The introduction of oral obesity drugs is widely seen as a potential game-changer for a market previously dominated by injectables. This is because it could significantly improve patient accessibility by reducing the psychological aversion to injections. Indeed, competition to develop oral GLP-1s is accelerating, particularly among global big pharma.Korean pharmaceutical companies are also developing GLP-1–based obesity drugs, but their commercialization timelines are likely to lag behind global frontrunners. As a result, incremental formulation improvements, as well as strategies aimed at reducing side effects associated with injectable or oral therapies, are gaining prominence. Approaches targeting multiple mechanisms beyond GLP-1 alone, such as inhibiting muscle loss and improving comorbid metabolic disorders, are also drawing attention.Daewoong Pharmaceutical is pursuing a non-injectable competitive edge with a microneedle patch-based obesity therapy. The microneedle patch reduces pain and needle phobia, allows room-temperature storage, and offers logistical advantages in distribution and handling. The absence of syringe waste is also cited as an additional benefit.A key feature of the microneedle patch is its potential to overcome the low bioavailability that has been a limitation of oral formulations. Oral drugs suffer significant peptide loss during passage through the digestive tract, requiring larger doses of active ingredients to achieve weight loss effects, which can increase the risk of side effects.According to human pharmacokinetic data released by Daewoong Pharmaceutical in August last year, the bioavailability of its microneedle patch was over 80% compared to injectables. This represents a significant improvement compared to the absorption rate of conventional patch formulations, which was around 30%.Hanmi Pharmaceutical has adopted a strategy to simultaneously improve muscle loss and gastrointestinal side effects, which are considered major limitations of GLP-1 class obesity drugs. The company is developing new drug candidates such as ‘HM15275’, which minimizes muscle loss while achieving weight loss effects, and ‘HM17321’, a muscle-increasing obesity treatment.Development of oral treatments is also active in Korea. However, as oral formulations are already well established in the global market, Korean companies are increasingly prioritizing early-stage technology licensing over direct competition with finished products. Some companies are concurrently pursuing joint development or license-out strategies targeting global pharmaceutical companies from the early clinical stages.Ildong Pharmaceutical's GLP-1 oral obesity treatment candidate ‘ID110521156’ showed an average weight loss of 9.9% and a maximum of 13.8% in the 200mg dose group in its Phase I clinical trial topline results. Weight loss effects of 5.5% and 6.9% on average over 4 weeks were also confirmed in the 50mg and 100mg dose groups, respectively. Based on these results, Ildong Pharmaceutical is preparing to enter global Phase II clinical trials and is targeting technology transfer to offset rising development costs at later clinical stages.DND Pharmatech is developing the oral GLP-1 drug ‘MET-002o’ based on its proprietary oral drug delivery platform ‘ORALINK’. Its partner company, Metsera, is conducting a Phase I clinical trial in North America.Industry expectations are growing for next-generation obesity therapies that go beyond simple weight-loss metrics to comprehensively address long-term use, side-effect management, and post-treatment weight regain.An industry official commented, “Convenience in administration has long been considered a key competitive factor in obesity therapies requiring long-term administration. The launch of oral Wegovy goes beyond a simple formulation change and improvements in efficacy and side effects. It is prompting Korean companies to fundamentally reassess their technology-licensing approaches and development strategies.”
- Company
- Reimb for Eylea expanded to 8mg formulation in KOR
- by Hwang, byoung woo Dec 29, 2025 08:54am
- Chong Kun Dang is expected to gain additional momentum in its clinic-focused sales strategy for Bayer’s macular degeneration treatment Eylea (aflibercept) following the expansion of its reimbursement coverage.According to Bayer Korea on the 26th, Eylea pre-filled syringe 8 mg (Eylea PFS 8mg) will be reimbursed by national health insurance starting January 1.Under the Ministry of Health and Welfare notification, reimbursement for Eylea PFS 8 mg applies to ▲ patients with subfoveal choroidal neovascularization due to age-related macular degeneration (AMD), ▲ diabetic macular edema (DME) patients with hemoglobin A1C (HbA1C) ≤10% and a minimum central retinal thickness ≥300µm.Eylea 8mg is a formulation with a molar dose four times higher than the existing Eylea 2mg, enhancing the duration of efficacy. It is administered monthly for the initial three months, after which the dosing interval can be extended up to 20 weeks based on the patient's condition.Notably, Eylea PFS 8mg incorporates the pre-filled syringe device ‘OcuClick’ technology. OcuClick is mechanically designed to precisely deliver the recommended dose (0.07ml) into the vitreous cavity, reducing procedure time for healthcare providers and minimizing administration errors.The reimbursement expansion is expected to positively impact Chong Kun Dang’s penetration into the clinic-level ophthalmology market.On the 16th, Chong Kun Dang and Bayer Korea signed a domestic distribution and sales agreement for Eylea. Under the agreement, Chong Kun Dang will exclusively handle sales, marketing, and distribution of the entire Eylea 2mg and 8mg product line in clinics.This partnership reflects the two companies’ aligned strategic interests.Chong Kun Dang aims to expand its existing lineup of ophthalmic products by leveraging the strong market position of Eylea, while Bayer expects synergies from Chong Kun Dang’s sales and marketing capabilities amid intensifying competition due to the emergence of biosimilars.Currently, three Eylea biosimilars are approved in Korea: ▲Samsung Bioepis' Afilivu, ▲Celltrion's Eydenzelt, and ▲Sam Chun Dang Pharm’s Vgenfli.Although Samsung Bioepis' Afilivu was the first to enter the market, its expansion stalled temporarily due to the aftermath of patent disputes. However, it recently won its appeal in the second trial and has now entered full-scale competition preparation.Celltrion's Eydenzelt is known to have gained a first-mover advantage in the market during Samsung Bioepis's patent dispute. Latecomer Sam Chun Dang Pharm is pursuing a lower drug pricing strategy compared to the other two companies.While Sam Chun Dang Pharm is adopting a direct sales strategy, Samsung Bioepis and Celltrion are targeting the domestic market through collaborations with Samil Pharmaceutical and Kukje Pharm, respectively.Chong Kung Dang – Bayer Korea’s Eylea co-promotion agreement signing ceremonyAgainst this backdrop, Bayer appears to have determined the need to partner with a domestic pharmaceutical company to strengthen its presence beyond tertiary hospitals and into clinics.Existing partnerships, including Bayer’s collaboration with Chong Kun Dang for Kerendia in chronic kidney disease with type 2 diabetes, likely influenced the decision.High-dose Eylea’s ability to extend dosing intervals up to 20 weeks may significantly reduce treatment burden for both physicians and patients in clinic settings.Young-joo Kim, CEO of Chong Kun Dang, stated, “Chong Kun Dang has already accumulated sales and marketing capabilities in ophthalmology based on a diverse product lineup. Leveraging our expertise and sales strength in ophthalmic diseases, we will actively promote Eylea's proven efficacy and safety to further expand its market presence.”JinA Lee, CEO of Bayer Korea, remarked, “Through our partnership with Chong Kun Dang, we aim to further enhance patient access to Eylea, which has led the anti-VEGF market for over a decade. Building on our strong collaboration, we will continue to deliver reliable treatment options to patients with retinal diseases and healthcare professionals in Korea, and consistently contribute to improving patients' quality of life.”
- Company
- ADC shows new potential in lung cancer
- by Son, Hyung Min Dec 29, 2025 08:54am
- An antibody-drug conjugate (ADC) targeting TROP-2 has confirmed new potential in non-small cell lung cancer. Amid repeated setbacks in lung cancer clinical trials involving major ADC candidates such as Trodelvy and Datroway, attention is focused on whether this achievement could mark a turning point for reevaluating TROP-2 ADCs.According to industry sources on the 29th, China's Sichuan Kelun Biotech, a partner of MSD, recently secured significant results in a Phase III clinical trial for first-line treatment of non-small cell lung cancer (NSCLC) using the TROP-2-targeted antibody-drug conjugate (ADC) ‘sasituzumab tirumotecan’ in combination with the immunotherapy drug 'Keytruda (pembrolizumab).MSD previously licensed the ADC candidate sacituzumab tirumotecan from Kelun Biotech in 2022.Sacituzumab tirumotecan consists of a ▲TROP-2–targeting monoclonal antibody, a ▲ topoisomerase-1 (TOP1) inhibitor payload, and a ▲ novel hydrolyzable linker. The ADC has a relatively high drug-to-antibody ratio (DAR) of approximately 7.4, designed to enhance intratumoral drug delivery.These results were derived from an interim analysis of the ongoing Phase III OptiTROP-Lung05 study conducted in China.OptiTROP-Lung05 compared the combination therapy of satisutuzumab tirumotecan and Keytruda versus Keytruda monotherapy in previously untreated non-small cell lung cancer (NSCLC) patients with a PD-L1 tumor proportion score (TPS) ≥1%.According to Kelun, the study met its primary endpoint of improved progression-free survival (PFS), with a positive trend also observed in overall survival (OS). The company plans to discuss regulatory approval for the lung cancer indication with Chinese regulatory authorities.This achievement is significant as it represents the first instance where a combination therapy of an ADC and an immuno-oncology drug has met the primary endpoint in a Phase III clinical trial for first-line non-small cell lung cancer. However, some note that caution is needed in its interpretation due to the study design, as Keytruda monotherapy, rather than the current global standard of Keytruda plus chemotherapy, was used as the control arm.The current global standard of care primarily involves Keytruda combined with chemotherapy, leading to an analysis suggesting that direct comparison data with combination chemotherapy is needed to clearly define its clinical position.Kelun and MSD are aggressively pursuing the expansion of sacituzumab tirumotecan’s lung cancer indications. In China, the ADC has already received approval for second-line treatment of EGFR-mutated NSCLC, marking its third approved indication within China alone. This approval was supported by Phase III data showing improvements in both PFS and OS versus chemotherapy. Nevertheless, because OptiTROP-Lung05 enrolled only Chinese patients, its applicability to global first-line lung cancer practice remains limited. MSD is therefore advancing a broader global development strategy, currently conducting over 10 registrational trials for sacituzumab tirumotecan, 5 of which are global Phase III studies. To date, MSD has not announced any official plans for a first-line NSCLC trial using Keytruda plus chemotherapy as the comparator.More refined patient-selection strategies are also underway. MSD’s TroFuse-007 trial is evaluating sacituzumab tirumotecan plus Keytruda versus Keytruda monotherapy in PD-L1 TPS ≥50% NSCLC patients. This patient group has historically been classified as having limited additional benefit from combination chemotherapy, making this trial a key test of the ADC combination strategy's distinctive benefit.MSD and Kelun aim to position sacituzumab tirumotecan as a “workhorse” within the TROP-2 ADC class. To support its development, MSD recently secured up to USD 700 million in funding through a royalty agreement with Blackstone.A history of setbacks for TROP-2 ADCs in lung cancerDespite the recent success, the prevailing industry view remains that TROP-2 ADCs still need to prove they can deliver consistent survival benefits in lung cancer.Indeed, given that TROP-2 ADCs from Gilead and AstraZeneca/Daiichi Sankyo previously suffered consecutive setbacks in lung cancer trials, whether sacituzumab tirumotecan can fully overcome this history of failure will be a key question moving forward.Gilead’s ‘Trodelvy’TROP-2 is a cell surface protein overexpressed in various epithelial-derived solid tumors, including triple-negative breast cancer. It is known to be involved in tumor proliferation, invasion, and metastasis. TROP-2 ADCs induce anticancer effects by selectively binding to cancer cells expressing this protein and delivering cytotoxic agents into the cells.However, unlike TROP-2 ADCs that have demonstrated efficacy and gained approval in breast cancer, they have repeatedly failed to prove effectiveness in lung cancer.Gilead’s Trodelvy (sacituzumab govitecan) achieved blockbuster status in triple-negative breast cancer but failed to replicate this success in lung cancer.The Phase III EVOKE-01 trial compared Trodelvy with docetaxel in patients with stage IV metastatic NSCLC who had received prior treatment. The primary endpoint was overall survival (OS).Ultimately, Trodelvy failed to achieve statistical significance in OS, only showing a trend toward efficacy in some secondary endpoints. Based on these results, Gilead halted its strategy to expand the indication into lung cancer.AstraZeneca and Daiichi Sankyo also faced similar challenges. Their jointly developed ‘Datroway (datopotamab deruxtecan)’ was seen as Daiichi Sankyo's second ambitious project after ‘Enhertu (trastuzumab deruxtecan),’ which reshaped the ADC market, but it failed to deliver expected results in lung cancer trials.ADC therapy ‘Datroway’The Phase III TROPION-Lung01 study compared datopotamab and docetaxel in a 1:1 ratio in patients with previously treated advanced or metastatic non-squamous NSCLC.The results showed improvement in progression-free survival (PFS) in some patient subgroups, but failed to demonstrate a significant difference in overall survival (OS). Notably, only limited efficacy was observed in the non-squamous patient subgroup, revealing limitations for expanding the indication.Based on these results, both companies withdrew their marketing applications in Europe following the withdrawal in the US. This decision followed pre-submission discussions with regulatory authorities, who determined the clinical significance was insufficient. Subsequently, AstraZeneca and Daiichi Sankyo are re-evaluating biomarker-based patient selection strategies and exploring potential combination therapies with targeted agents.Industry analysts attribute these failures to the limitation of directly applying the success formula that the companies experienced with breast cancer to lung cancer. Key factors cited include the high intratumoral heterogeneity in lung cancer and the less clear correlation between TROP-2 expression levels and treatment response compared to breast cancer. Additionally, managing cumulative toxicity with repeated dosing was also seen as a burden.Consequently, contrary to initial expectations that TROP-2 ADCs would be a universal platform expandable to all solid tumors, it is becoming clear that success varies dramatically depending on the specific indication. Against this backdrop, the recent confirmation of efficacy for sasituzumab tirumotecan in China is being viewed as a meaningful proof-of-concept that may reopen the door for TROP-2 ADCs in lung cancer.
- Company
- Preventive RSV antibody shot poised for NIP inclusion
- by Son, Hyung Min Dec 26, 2025 08:41am
- The need to include the RSV preventive antibody injection Beyfortus, which began immunization in Korea this February for infants and young children, in the National Immunization Program (NIP) is being raised.As the inclusion of a new category, ‘preventive antibodies,’ within the traditionally vaccine-focused NIP system emerges as a key policy issue, economic evaluation and cost-effectiveness have emerged as key decision-making criteria.According to industry sources on the 26th, a recent policy discussion forum held at the National Assembly to improve management measures for respiratory infections in infants and young children highlighted cases from major countries that have already incorporated RSV preventive antibodies for infants into their NIP frameworks. The discussions emphasized the significant disease burden RSV imposes on infants and young children.At the forum, Young-rae Sohn, Director General of the Department of Healthcare Safety and Immunization at the Korea Disease Control and Prevention Agency (KDCA), stated, “We plan to review its support in Korea based on economic evaluation and cost-effectiveness analysis. As this could become the first case of including a preventive antibody as a new category within the National Immunization Program, we are discussing it with particular caution.”This stance was reaffirmed during the National Assembly audit in October. Seung-kwan Lim, Commissioner of the KDCA, noted that there is growing social demand and academic support for RSV preventive antibodies, adding that the agency plans to assess priorities and the necessity of introducing such preventive measures into next year’s immunization program.To this end, the KDCA has secured research funding to generate scientific evidence evaluating RSV disease characteristics, efficacy of preventive antibodies, and cost-effectiveness, with results expected by the end of next year.A consistent theme across these discussions is the importance of economic evaluation and cost-effectiveness analysis. Such assessments are essential for allocating limited NIP budgets efficiently and serve as foundational evidence for policy decisions aimed at protecting all newborns and infants from RSV. The need for rigorous analysis is particularly pronounced when considering the inclusion of new preventive modalities in a national program.The RSV preventive antibody currently under consideration for NIP inclusion is Sanofi’s Beyfortus (nirsevimab), which began administration in Korea earlier this year. Beyfortus is a monoclonal antibody indicated for all newborns and infants entering their first RSV season, as well as high-risk children up to 24 months of age, offering broad preventive coverage. A single injection provides protection for at least five months, effectively covering an entire RSV season.Results from research evaluating the cost-effectiveness of Beyfortus have already been reported in Korea.According to the study, the Beyfortus prevention strategy for infants entering or in their first RSV season and for infants and young children during their second RSV season (up to 24 months of age) proved more efficient than existing prevention strategies in terms of reducing healthcare costs and caregiver productivity loss.Notably, over 90% of the overall health improvement benefits were observed in full-term infants under 1 year of age, providing evidence supporting the validity of a universal RSV prevention strategy for all infants. This economic evidence is expected to serve as a key resource in future discussions regarding the introduction of Beyfortus into the National Immunization Program (NIP).Internationally, countries that have already introduced Beyfortus into their NIPs have reported reductions in the risk of RSV-related hospitalizations.Chile, the first country in the Southern Hemisphere to adopt Beyfortus into a nationwide NIP, published real-world evidence based on data from 157,709 infants. The study showed a 76.41% reduction in hospitalization risk due to RSV lower respiratory tract infection and an 84.94% reduction in ICU admission risk. Importantly, while 13 RSV-related infant deaths were recorded during the same period in the previous year, no RSV-related deaths occurred among infants who received Beyfortus.Similar outcomes were confirmed in Galicia, Spain, the first region globally to introduce Beyfortus into its NIP. Interim analysis results published in The Lancet medical journal last May found that the RSV hospitalization rate among infants under 6 months who received Beyfortus decreased by 82% compared to the unvaccinated group.Regarding this, Professor Soo-han Choi of the Department of Pediatrics at Pusan National University Hospital stated, “While the World Health Organization (WHO) has previously issued vaccination policy recommendations centered on vaccines, in May 2025, it proposed that all countries adopt prevention strategies including preventive antibodies for infant RSV prevention.”He added, “While Korea's National Immunization Program (NIP) policies have primarily focused on vaccines, the recent initiation of discussions on incorporating RSV preventive antibodies into the NIP is highly encouraging. If RSV preventive antibodies are included in the NIP, universal preventive benefits will be provided to all infants, leading to a substantial reduction in the national burden of RSV disease.”
- Company
- Pharmaceutical patent listings 10%↑…MNCs↑· domestic↓
- by Kim, Jin-Gu Dec 26, 2025 08:40am
- The number of new pharmaceutical and biological patents listed this year totaled 264, up 10% from last year.A stark contrast has seen between multinational companies and domestic Korean firms. New patent listings by multinational pharmaceutical companie rose from 187 to 215 within a year, driven largely by Pfizer Korea's various patent registrations related to its COVID-19 vaccine, Comirnaty.In contrast, listings by domestic pharmaceutical companies decreased from 54 last year to 49 this year. Hanmi Pharm, Chong Kun Dang, Daewoong Pharmaceutical, and Jeil Pharmaceutical registered five or more new patents.264 new patents in 2025…4 out of 5 registered by multinational companiesAccording to the MFDS on December 26, 264 new patents have been added to the official patent list this year.This is a 10% increase from last year’s 241. With less than five days remaining in the year, the number has already surpassed last year's total. Aside from 2022, this year has seen the highest level of patent activity in the last decade. In 2022, research and development for new drugs and drug repurposing spiked due to the COVID-19 pandemic, resulting in a record 278 new patent listings.Yearly new patent listing counts (unit: KRW 100 million, source: MFDS): GREEN-multinational companies, SKY BLUE-Domestic Korean companies.While patent listings by Korean subsidiaries of multinational companies increased, those by domestic companies declined.Multinational companies accounted for 215 (81%) of the patents listed this year. A total of 31 multinational companies registered at least one new patent, with the group's total volume increasing by 15% compared to 187 listings in 2023.Meanwhile, 17 domestic companies registered 49 patents, a 9% decrease from 54 registered last year. This marks the third-lowest annual patent count for domestic firms in the past decade.Attention drawn to patent listings of Pfizer's 'Comirnaty'·Lilly's 'Mounjaro' Pfizer Korea recorded the highest number of listings among multinational companies, registering 49 new patents this year alone.Pfizer focused on protecting its COVID-19 vaccine, Comirnaty, registering 36 related patents this year. Pfizer listed 13 cases the previous year.Additionally, the company added eight patents for Prevenar 20, its next-generation pneumococcal conjugate vaccine, which expands serotype coverage from 13 to 20. Other Pfizer listings included three patents for the migraine treatment Nurtec, one for the prostate cancer drug Talzenna, and one for the COVID-19 treatment Paxlovid.2025 New Patent Listings by Multinational Pharmaceutical Companies: (from top) Pfizer Pharmaceuticals Korea-Prevenar 20, Comirnaty, Nurtec; Eli Lilly Korea-Mounjaro, Trulicity, Taltz; Alvogen Korea-Adlarity, Vazkepa; Roche Korea- Itovebi, Evrysdi, Phesgo; Astellas Pharma Korea-Vyloy, Xtandi; Janssen Korea-Balversa; MSD Korea-Winrevair, Capvaxive; Recordati Korea-Isturisa; Handok Teva-Uzedy; BMS Korea-Augtyro; Novartis Korea-not specified; Sanofi-Aventis-not specified; Ipsen Korea-Bylvay; Takeda Pharmaceuticals Korea-Fruzaqla; Korea Otsuka Pharmaceutical-Abilify Asimtufii; Medison Pharma Korea-Amvuttra, and more.Eli Lilly Korea followed with 18 listings, primarily focusing on its GLP-1 portfolio for obesity and diabetes. This included 12 patents for the obesity treatment Mounjaro, which was launched this year, and four for the diabetes treatment Trulicity. One patent was also listed for the severe psoriasis treatment Taltz.Alvogen Korea registered 17 new patents, including 14 for Adlarity, a long-acting patch for Alzheimer's disease. Roche Korea also registered 17 patents, including six for the targeted breast cancer therapy Itovebi, four for the spinal muscular atrophy (SMA) treatment Evrysdi, and four for Phesgo (a subcutaneous formulation combining Herceptin + Perjeta).Astellas Pharma Korea and Janssen Korea each listed 13 cases; AbbVie Korea has 12; MSD Korea has 8; Recordati Korea and Teva-Handok each have 7; and BMS and Novartis each have 6.Domestic companies listed series of patents for flagship follow-on products...Hanmi>CKD>Daewoong/JeilAmong domestic pharmaceutical companies, patent listings by Hanmi Pharm, Chong Kun Dang, Daewoong Pharmaceutical, and Jeil Pharmaceutical were noteworthy.Hanmi Pharm registered seven new patents, including two for Sildapa (a sitagliptin·dapagliflozin combination for diabetes), three for a sitagliptin·dapagliflozin·metformin triple combination, one for the anti-inflammatory Rheuma Gel (ketoprofen), and one for Hanmi Tams ODT (tamsulosin), an orally disintegrating formulation for prostatic hyperplasia.Chong Kun Dang registered six patents, five of which were related to Cantabell-A, a triple combination therapy (candesartan·amlodipine·atorvastatin) for hypertension and hyperlipidemia.2025 New Patent Listings by Domestic Korean Companies: Hanmi Pharm-Sildapa M, Sildapa, Rheuma Gel, Hanmi Tams OD; Chong Kun Dang Pharm-Cantabell A, GTEC; Daewoong Pharmaceutical-Fexuclue; Jeil Pharmaceutical-Fetroja, Lonsurf; JW Pharmaceutical-Tavalisse; Taejoon Pharmaceutical-Diqua, Suprep; SAMOH Pharm-Voxzogo; Korea United Pharm-Cilo Duo, Rabeduo; HK inno.N-K-CAB; DuChemBio-ProstaSeek; LG Chem-Zemidapa; Vivozon Pharma-Unafra; Synex-Ledaga Gel; Shinpoong Pharm-Hyal Plus; Hankook Korus Pharm-Hyalos; Pharmbio Korea-Orafang; Handok-Vyxeos; Hyundai Pharm-DM Duo.Daewoong Pharmaceutical listed five patents for its internally developed novel drug, Fexuclue. Jeil Pharmaceutical registered five patents: three for the cephalosporin antibiotic Fetroja and two for the metastatic colorectal·gastric cancer treatment Lonsurf. Fetroja, developed by Japan's Shionogi, is a cefiderocol antibiotic effective against multidrug-resistant bacteria; Jeil introduced it to the Korean market, obtaining approval in February and listing the patents in June.Additionally, JW Pharmaceutical and Taejoon Pharmaceutical each listed 4, SAMOH Pharm and Korea United Pharm each listed 3, and HK inno.N and DuChemBio each listed 2. Companies including LG Chem, Vivozon Pharma, Synex, Shinpoong, Hankook Korus Pharm, Pharmbio Korea, Handok, and Hyundai Pharm each registered one patent.
- Policy
- Imjudo, Imfinzi, Xpovio in reimb discussions with NHIS
- by Jung, Heung-Jun Dec 26, 2025 08:40am
- Imjudo (tremelimumab) and Imfinzi (durvalumab) are in price negotiations with Korea’s National Health Insurance Service (NHIS), bringing the drugs closer to reimbursement listing.Once they clear the final hurdle with the NHIS, Imjudo will be newly reimbursed for use in combination with Imfinzi in hepatocellular carcinoma, while Imfinzi is expected to secure a reimbursement expansion for use in combination with gemcitabine and cisplatin in biliary tract cancer.According to industry sources on the 26th, the NHIS is conducting price negotiations for three new drugs and two coverage expansion items.These drugs all passed the Drug Reimbursement Evaluation Committee in November. AstraZeneca Korea is negotiating the reimbursement of both Imjudo and Imfinzi simultaneously.If negotiations conclude as expected, Imfinzi will secure reimbursement for two combination regimens at once: combination therapy with Imjudo and the GemCis (gemcitabine + cisplatin) regimen.AstraZeneca is expected to expand Imfinzi’s use beyond its previous focus on lung cancer into liver cancer and biliary tract cancer.AstraZeneca is expected to expand Imfinzi prescriptions, previously focused on lung cancer, to include liver and bile duct cancers.Additionally, new drugs under negotiation include Janssen Korea's Balversa Tab 3, 4, 5mg (erdafitinib) and Takeda Korea's Takhzyro Prefilled Syringe 300mg (lanadelumab).Balversa Tab, a new targeted therapy for bladder cancer, received reimbursement adequacy approval for treating adult patients with locally advanced or metastatic urothelial carcinoma. Takhzyro Prefilled Syringe received reimbursement adequacy approval for preventing attacks of hereditary angioedema in adults and adolescents. Both products are now awaiting final price agreements.Xpovio 20 mg Tab (selinexor) from Antengene, which received reimbursement expansion approval alongside Imfinzi in November, has also entered price negotiations. Xpovio was approved for reimbursement expansion for use in combination with bortezomib and dexamethasone in adult patients with multiple myeloma who have received at least one prior therapy.However, unlike the other products, Xpovio’s approval came with a conditional clause stipulating that reimbursement expansion is deemed appropriate only if the company accepts a price at or below the evaluated price. If the company is unable to accept the proposed price, there remains a possibility that negotiations could break down.
- Policy
- Second generic for prostate cancer drug Xtandi approved
- by Lee, Tak-Sun Dec 26, 2025 08:40am
- Pharmaceutical companies are rapidly entering the generic market for the prostate cancer treatment ‘Xtandi (enzalutamide)’, which has a market worth approximately KRW 50 billion.Following Alvogen Korea's initial product approval last January, Daewon Pharmaceutical has also successfully obtained approval for its generic drug. These products are expected to establish patent strategies targeting launch after the substance patent expires next June.The Ministry of Food and Drug Safety approved Daewon Pharmaceutical's ‘Enzadex Soft Cap 40mg’ on the 23rd. This product is the second generic drug containing the active ingredient enzalutamide.The first generic was Alvogen Korea's ‘Anamide Soft Cap 40mg’, approved last January. A common feature of both Alvogen Korea and Daewon Pharmaceutical's products is that they import the finished drug from Taiwan.Enzadex Soft Cap is indicated for ▲ treatment of asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC), ▲ treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel, ▲ treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (mHSPC), ▲combination therapy with androgen deprivation therapy (ADT) for the treatment of patients with hormone-sensitive metastatic prostate cancer (mHSPC), ▲treatment of patients with high-risk hormone-sensitive non-metastatic prostate cancer (nmHSPC) who have experienced biochemical recurrence (BCR). These indications are identical to those of the original Xtandi Soft Cap 40mg.Xtandi’s formulation patent is set to expire on June 27 next year. However, a formulation patent valid until September 11, 2033, remains a key barrier to generic entry. As a result, multiple generic manufacturers have initiated legal actions to challenge or circumvent the formulation patent.Starting with Alvogen Korea in August, GL Pharma, Hanmi Pharmaceutical, Chong Kun Dang, JW Pharmaceutical, and Kuhnil Pharmaceutical have filed passive scope confirmation trials aimed at clearing the formulation patent hurdle.Industry analysts suggest that if the formulation patent is successfully overcome, generics could enter the market as early as June next year.Astellas' Xtandi competes in the first-line prostate cancer treatment market against drugs like Erleada (apalutamide, Janssen) and Zytiga (abiraterone, Janssen).Notably, since November 2023, the patient coinsurance rate has decreased from 30% to 5%, leading to increased usage. According to the pharmaceutical market research institution IQVIA, Xtandi's sales surged from KRW 23 billion in 2019 to KRW 43.2 billion in 2023.As the market expands, domestic pharmaceutical companies are also eagerly entering the prostate cancer treatment market. Hanmi Pharmaceutical has already moved aggressively by launching Abiteron Tab 500 mg, the first generic version of Zytiga, to secure early market share.With Xtandi’s patent expiry approaching, many generic manufacturers are now closely monitoring the opportunity. Generic companies are simultaneously advancing patent litigation strategies and regulatory approvals, aiming for early entry in June next year.Meanwhile, Astellas has preemptively obtained approval for Xtandi Tab, a new formulation last year, to counter the wave of emerging generic drugs. This appears to be a strategy to dilute the market impact of generic drugs by introducing a new formulation product.
