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- 2026-03-10 07:37:39
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- 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.
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- New cardiomyopathy drug joins the fray… Camzyos’s competitor
- by Son, Hyung Min Dec 24, 2025 08:09am
- A new option has entered the U.S. market for obstructive hypertrophic cardiomyopathy (oHCM). Attention is focused on the potential shift in treatment paradigms and market dynamics as a competitor emerges in the cardiac myosin inhibitor class, a space largely dominated by Bristol Myers Squibb's (BMS) ‘Camzyos (mavacamten)’.On the 22nd, U.S. biotech company Cytokinetics announced that its drug ‘Myqorzo (aficamten)’ received approval from the U.S. Food and Drug Administration (FDA) for improving exercise capacity and symptoms in adults with symptomatic oHCM. This marks the first FDA approval in Cytokinetics’ history.Myqorzo is an allosteric modulator that reversibly inhibits the contractile activity of cardiac myosin that works by reducing excessive myocardial contraction and left ventricular outflow tract (LVOT) obstruction, placing it in the same class as the already marketed drug Camzyos.Ironically, this competitive landscape has historical ties. Cytokinetics was involved in the development of Camzyos through its collaboration with MyoKardia in 2012. MyoKardia was later acquired by BMS for USD 13.1 billion. As a result, Camzyos received FDA approval in 2022, becoming the first myosin inhibitor for oHCM.This approval is based on results from the Phase III SEQUOIA-HCM clinical trial. After 24 weeks of treatment, the Myqorzo group showed a significant improvement in peak oxygen consumption (pVO₂) of 1.8 mL/kg/min compared to baseline, versus 0.0 mL/kg/min in the placebo group. Consistent efficacy was observed across key subgroups, including age, gender, and beta-blocker use.Regarding safety, no treatment discontinuations due to worsening severe heart failure or low left ventricular ejection fraction (LVEF) were reported during therapy. However, due to its mechanism of inhibiting myocardial contraction, the warning about the risk of heart failure remains in place.Like Camzyos, Myqorzo carries a boxed warning regarding heart failure risk and is only available through a Risk Evaluation and Mitigation Strategy (REMS) program. It also requires LVEF monitoring via echocardiography before and during treatment.“Will the monopoly break?”... Competition intensifies in the targeted therapy marketCurrently, the targeted therapy market for oHCM is effectively monopolized by Camzyos. Approved by the FDA in 2022, Camzyos is the world's first cardiac myosin inhibitor and is widely credited with changing the treatment paradigm for oHCM, where drug options were previously limited.Until now, the only drug options available for HCM treatment were chronic disease medications like beta-blockers and calcium channel blockers. While these drugs could indirectly manage HCM symptoms, if symptoms did not improve, there were no treatment options other than surgery. The arrival of Camzyos opened a new path for targeted HCM therapy.Camzyos has also demonstrated strong commercial performance. According to BMS, the drug surpassed USD 600 million in annual sales in 2024 and continues to grow this year. Its status as the only FDA-approved myosin inhibitor for oHCM to date has underpinned its market dominance.Despite this, attention is now turning to the potential differentiation between the two drugs. Myqorzo highlights several advantages, including ▲ simple and flexible dose adjustment ▲ no need for drug-drug interaction monitoring ▲ predictable pharmacokinetic properties. Some investment analysts suggest these features could make Myqorzo a more user-friendly option, particularly for newly diagnosed or treatment-naïve patients.Market observers believe that while Myqorzo is unlikely to rapidly overturn Camzyos’ dominance, gradual competition is expected, especially in newly diagnosed and early-treatment populations. Given that oHCM is a chronic condition requiring long-term therapy, dosing convenience and monitoring burden are likely to be key factors influencing real-world prescribing decisions.Myqorzo is scheduled for commercial launch in the U.S. in January 2026. Pricing has not yet been disclosed, but its strategy relative to Camzyos—currently priced at approximately USD 100,000 per year—is expected to play a crucial role in determining the pace of market penetration.Attention is focused on whether the oHCM treatment market can shift from a Camzyos monopoly to a competitive landscape among myosin inhibitors, and on whether Myqorzo can successfully establish itself in actual clinical practice.
- Company
- Samsung Bioepis wins JPN approval for autoimmune disease biosimilar
- by Choi Da Eun Dec 24, 2025 08:06am
- Samsung Bioepis has received marketing authorization from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its biosimilar version of Stelara (ustekinumab), a treatment for autoimmune diseases. The approved product, developed under the project name SB17 (ustekinumab), will be marketed in Japan under the product name “ウステキヌマブBS皮下注45mgシリンジ「ニプロ」”.Stelara is an autoimmune disease treatment that works by inhibiting the activity of interleukin (IL)-12 and IL-23. It holds various indications, including plaque psoriasis, psoriatic arthritis, and ulcerative colitis. It is a leading blockbuster biologic, generating annual sales of approximately KRW 15 trillion (USD 10.361 billion) in the global market.Samsung Bioepis headquarters./ Photo=Samsung BioepisSamsung Bioepis plans to launch the product in Japan in May 2026 through its local commercial partner, Nipro Corporation. The two companies signed a partnership agreement in June to commercialize the product in Japan. This marks Samsung Bioepis’ first collaboration with a local company for entry into the Japanese market.Byoungin Jung, Vice President of Regulatory Affairs at Samsung Bioepis, said, “Through this approval, we expect to improve treatment access for Japanese patients with autoimmune diseases while also establishing an important foothold for further global expansion as a leading biosimilar company.”Meanwhile, Samsung Bioepis conducted a global Phase III clinical trial of SB17 from July 2021 to November 2022, involving 503 patients with plaque psoriasis across eight countries. This trial confirmed the clinical equivalence of SB17 to the original product in terms of efficacy and safety.Subsequently, Samsung Bioepis launched this biosimilar in Europe and the United States under the brand name Pyzchiva® through its marketing partner Sandoz. In Korea, it is sold directly by Samsung Bioepis under the brand name Epyztek®.
- Company
- Hemlibra improves joint health and physical activity in hemophilia patients
- by Lee, Seok-Jun Dec 23, 2025 08:00am
- JW Pharmaceutical announced on the 22nd that patients with hemophilia A who switched to prophylactic treatment with Hemlibra (emicizumab) showed improvements in joint health indicators as well as increased levels of physical activity.Hemlibra is an innovative new drug that mimics the function of coagulation factor VIII, which is deficient in patients with hemophilia. It is the only treatment for hemophilia A that can be used in both patients with antibodies resistant to existing treatments (Factor VIII products) and non-antibody patients. Another key feature is its sustained preventive effect with subcutaneous administration as infrequently as once every four weeks. In May 2023, health insurance reimbursement in Korea was expanded to include non-antibody severe hemophilia A patients aged one year and older. In October 2025, Hemlibra was also added to the World Health Organization’s Essential Medicines List (EML) and the Essential Medicines List for Children (EMLc).A research team led by Professor Rebecca Kruse-Jarres of the Department of Hematology and Oncology at the University of Washington in the United States is conducting the ‘BEYOND ABR Study’ to evaluate changes in joint health and physical activity when patients with hemophilia A switch to Hemlibra.The team presented interim analysis results in poster format at the 67th Annual Meeting of the American Society of Hematology (ASH 2025), held in Orlando, USA, over four days starting on the 6th (local time). Unlike previous studies that primarily evaluated bleeding reduction effects, the BEYOND ABR study uniquely observed joint function and physical activity.The study enrolled 136 patients with moderate-to-severe hemophilia A who did not possess antibodies against conventional Factor VIII products.A total of 88 patients were included in the analysis of joint health using the Hemophilia Joint Health Score (HJHS). HJHS is a clinician-assessed measure evaluating the function and mobility of major joints such as the knees, ankles, and elbows. Scores range up to 120 points, with lower scores indicating better joint health. The analysis showed that the mean HJHS improved from 10.1 points at baseline—reflecting generally mild joint damage—to 2.8 points at 12 months after switching to Hemlibra. Among all patients analyzed, 23 patients (26.1%) experienced an improvement of 4 points or moreFurthermore, the 27 ‘target joints’ (joints prone to recurrent bleeding) identified in 15 patients before the study initiation at baseline were no longer observed at the 12-month mark after switching to Hemlibra, with no recurrence of repeated bleeding.Physical activity levels also showed improvement. The research team comprehensively assessed patients' walking and physical activity at various intensities using the International Physical Activity Questionnaire (IPAQ). As a result, the proportion of patients classified as ‘low physical activity’ according to IPAQ criteria decreased from 30.8% (32 out of 104) to 23.4% (22 out of 94) at 12 months post-switch. Conversely, the proportion of patients in the ‘high physical activity’ category increased from 44.2% (46 out of 104) to 52.4% (54 out of 103) at 3 months post-switch and remained at 50.0% (47 out of 94) at 12 months.The proportion of patients experiencing no bleeding also remained stable. Between weeks 25 and 48 after Hemlibra administration, 105 out of 134 patients (78.4%) reported no bleeding requiring treatment. Furthermore, at the 6-month follow-up, 125 out of 130 patients (96.2%) stated they preferred Hemlibra over their previous Factor VIII prophylaxis.JW Pharmaceutical plans to accumulate additional long-term observational data through follow-up and expand the evidence base that can be utilized in establishing treatment strategies in actual clinical practice.A JW Pharmaceutical representative stated, “This study presents interim analysis results confirming the bleeding prevention efficacy of Hemlibra in patients switching from conventional Factor VIII prophylaxis, along with changes in joint health and activity indicators. It provides meaningful clinical data to address key concerns, joint status, and exercise performance, key considerations when deciding whether to switch therapies.”
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- K-Bios acquire US plants to mitigate tariff risks
- by Chon, Seung-Hyun Dec 23, 2025 08:00am
- Korea’s flagship biotech companies, Samsung Biologics and Celltrion, are moving in tandem to acquire manufacturing plants in the United States. Following Celltrion, Samsung Biologics has made a decisive move by acquiring a multinational pharmaceutical manufacturing facility with an investment exceeding KRW 400 billion. These two companies—Korea’s largest biotech exporters to the U.S.—are leveraging strong profitability to pursue large-scale mergers and acquisitions (M&A) as a preemptive strategy to mitigate tariff risks.Samsung Biologics acquires GSK plant in the U.S. for KRW 410 billion...first overseas investmentAccording to industry sources on the 22nd, Samsung Biologics signed an agreement with GSK to acquire a biologics manufacturing facility formerly operated by Human Genome Sciences (HGS), located in Rockville, Maryland. Samsung Biologics America, the U.S. subsidiary of Samsung Biologics, will invest $280 million (approximately 410 billion won) to acquire the facility. The asset acquisition process is expected to be completed within the first quarter of 2026.Human Genome Sciences' biopharmaceutical production facility in Rockville, Maryland, USAThe Rockville production facility is a 60,000-liter API manufacturing plant located in the heart of Maryland's biocluster. It consists of two manufacturing buildings. The facility is equipped with infrastructure capable of supporting antibody drug production at various scales, from clinical development to commercial manufacturing.This marks Samsung Biologics' first overseas plant acquisition. Samsung Biologics currently operates five plants in Songdo, Incheon. All five plants were constructed using internally sourced funds.Since its inception, Samsung Biologics has sequentially built Plant 1 (30,000 liters), Plant 2 (155,000 liters), and Plant 3 (180,000 liters). In October 2022, just 23 months after groundbreaking, it launched Plant 4, which boasts the world's largest manufacturing capacity (240,000 liters) for a single plant. With the start of operations at the 180,000-liter Plant 5 last April, Samsung Biologics' total manufacturing capacity expanded to 785,000 liters. Samsung Biologics invested KRW 5.9089 trillion in the construction of Plant 5.The GSK plant Samsung Biologics is acquiring this time is not large in scale compared to the domestic plants it built itself or the investment amounts involved. Samsung Biologics invested over KRW 2 trillion each in the construction of Plants 4 and 5.Samsung Biologics explained, “This acquisition establishes a dual-source production system connecting Songdo, Korea, and Rockville, USA, providing flexible and stable production options to global customers.” The company plans to expand its collaboration base with North American customers and enhance its ability to respond to regional supply environment changes, thereby further elevating its CDMO competitiveness.Samsung Biologics' acquisition of the US plant is analyzed as a strategy to preemptively mitigate tariff risks.South Korea and the U.S. agreed at the APEC summit in Gyeongju last October to apply Most-Favored-Nation (MFN) treatment in the pharmaceutical sector. This means domestically manufactured drugs in the U.S. will receive MFN treatment, similar to Japan and the EU, with tariffs capped at a maximum rate of 15%.According to the detailed agreement released last month, the White House announced a Joint Fact Sheet (JFS) from the Korea-U.S. summit stating that tariffs on Korean pharmaceuticals would not exceed 15%. It was confirmed that any tariffs imposed on pharmaceuticals would not exceed a 15% tariff rate. Generic drugs would be subject to zero tariffs. Nevertheless, industry players note that future tariff uncertainties remain.Celltrion acquires Lilly plant for KRW 460 billion... resolves tariff risk for top two U.S. exportersFrom the perspective of domestic pharmaceutical and biotech companies, building factories locally in the U.S. is the most realistic and optimal strategy to eliminate tariff risk.Celltrion has taken the most proactive steps in preparation for U.S. tariffs. In September, Celltrion USA, a subsidiary of Celltrion, signed a definitive agreement to acquire a biopharmaceutical manufacturing facility located in Branchburg, New Jersey, from ImClone Systems Holdings, a subsidiary of Eli Lilly. The acquisition price is approximately USD 330 million (about KRW 460 billion). In addition to the plant acquisition cost, Celltrion plans to invest a total of KRW 700 billion, including initial operating expenses.Celltrion received approval from Ireland's competition authorities last October and completed the final review by the U.S. Federal Trade Commission (FTC) in November. These two reviews are key procedures where regulatory agencies assess whether combining corporate assets could harm market competition, representing the final hurdle determining the deal's success.With these acquisitions, Korea’s leading biotech exporters have invested over KRW 1 trillion to secure U.S. production bases, effectively insulating themselves from tariff risks.According to the Ministry of Food and Drug Safety (MFDS), Korean pharmaceutical exports to the U.S. reached USD 1.49 billion (approx. KRW 2 trillion) last year, accounting for 16.1% of Korea’s total USD 9.28987 billion pharmaceutical exports. Finished pharmaceutical products accounted for USD 1,298.99 million (87.1%), while active pharmaceutical ingredients (APIs) amounted to just USD 192.19 million (16.9%. Samsung Biologics and Celltrion dominate this export volume.Samsung Biologics recorded US regional sales of KRW 1.1741 trillion out of its total sales of KRW 4.5473 trillion last year, representing 25.8%. The proportion of Samsung Biologics' sales to the US was 28.5% in 2022 and 26.3% in 2023. Samsung Biologics calculates regional sales based on the location of its CDMO clients. Its cumulative third-quarter U.S. sales reached KRW 1.6482 trillion, already surpassing last year's total exports. U.S. sales accounted for 38.8% of Samsung Biologics' cumulative third-quarter revenue of KRW 4.2484 trillion.Celltrion Regional Sales (Unit: KRW 1 billion, Source: Celltrion)Celltrion has secured 11 FDA approvals in the U.S. Its North American biologics revenue reached KRW 1.045 trillion last year. While Celltrion's North American sales decreased by 11.3% from KRW 709.5 billion in 2022 to KRW 629.2 billion in 2023, they surged 66.1% year-on-year last year, surpassing KRW 1 trillion for the first time. In Q3 alone this year, North American exports surged to KRW 265 billion, more than three times the figure from the same period last year, driven by biosimilar expansion and preemptive shipments ahead of tariff risks.Securing new revenue streams through U.S. manufacturing bases... Generous investments with cash accumulated from high-purity performanceBoth Samsung Biologics and Celltrion avoided tariff risks while securing new revenue streams by establishing U.S. manufacturing bases.Samsung Biologics acquired the Rockville production facility, inheriting contracts for existing products manufactured there and securing a stable supply of large-scale contract manufacturing (CMO) volumes. The company explained that by retaining all 500+ local employees with operational experience and expertise, it established a system that preserves manufacturing continuity and operational stability post-acquisition.Celltrion secured a stable revenue base from the outset by acquiring Lilly's plant and taking over the existing CMO volume of active pharmaceutical ingredients (APIs) previously produced by Lilly. Celltrion anticipates that once the manufacturing line conversion is completed, following post-acquisition validation and re-approval procedures, full-scale production of its own products and CMO volume supply to Lilly will commence next year. This is expected to yield tangible results, structurally mitigating U.S. tariff risks while improving manufacturing efficiency and expanding profitability.Samsung Biologics and Celltrion were able to flexibly secure U.S. manufacturing bases thanks to cash reserves accumulated through high performance.Samsung Biologics recorded cumulative sales of KRW 4.2484 trillion and operating profit of KRW 1.6911 trillion during the first three quarters of this year. Its operating profit margin reached 39.8% relative to sales. Samsung Biologics held KRW 922.1 billion in cash and cash equivalents as of the end of the third quarter.Celltrion posted cumulative sales of KRW 2.8323 trillion and operating profit of KRW 693.3 billion for the first three quarters of this year. This represents an operating profit margin of 24.5%. Celltrion's cash and cash equivalents totaled KRW 810 billion as of the end of the third quarter.
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- Reimb remains urgent for severe alopecia areata treatment
- by Eo, Yun-Ho Dec 22, 2025 08:54am
- The South Korean government shows intent to expand hair-loss reimbursement, drawing industry attention to the related measures to follow.Recently, during a policy briefing for the Ministry of Health and Welfare (MOHW), President Lee Jae Myung stated that hair loss is not merely a cosmetic issue but a disease that can affect an individual's quality of life, dignity, and even their survival. The awareness of a problem has been proposed that hair loss, long dismissed as an issue of aesthetics and grooming, must be re-evaluated from a public health perspective.Notably, the daily lives of patients with severe alopecia areata are severely affected compared to those with hormonal or age-related hair loss.Severe alopecia areata is an autoimmune disorder characterized by the loss of scalp hair, as well as eyebrows, eyelashes, and body hair. Patients experience extreme social stigma and psychological distress due to these physical changes, which often lead to professional disadvantages, social isolation, and mental health issues such as depression and anxiety.While the Janus kinase (JAK) inhibitor 'Olumiant (baricitinib)' is approved in Korea for severe alopecia areata, the process for expanding its reimbursement has faced prolonged delays.Olumiant is an oral, reversible, selective JAK inhibitor already covered by national health insurance for atopic dermatitis and rheumatoid arthritis. In September 2024, the developer, Eli Lilly, applied for reimbursement expansion for three indications: pediatric atopic dermatitis, severe alopecia areata, and pediatric idiopathic arthritis.The issue lies in the different speed of progression of the reimbursement reviews for these indications. In the case of pediatric atopic dermatitis, reimbursement was finalized just two months after it was reported to the MOHW, following discussions by the Drug Reimbursement Criteria Subcommittee.In contrast, despite completing subcommittee discussions and the ministry report, the review of severe alopecia areata has remained stalled for approximately 5 months, with no procedural progress. Given that a financial impact review order is typically issued within one month of a report to the ministry, this delay is considered highly unusual.The severe alopecia areata indication has faced the longest delay among the three simultaneous applications. While the pediatric idiopathic arthritis application concluded with a non-reimbursement decision at the criteria-setting stage, severe alopecia areata remains in a prolonged 'under review' status. Despite identical product and application dates, a significant disparity in reimbursement access has emerged by specific indication.Under the current system, different officials are assigned to review each indication. Consequently, the actual processing speed varies significantly based on individual workloads, review sequences, and policy priorities. This structure means that, even for the same drug, a patient's access to reimbursement can change simply based on 'which reviewer is assigned to a specific indication'.For patients, it is difficult to understand why access to treatment for a drug with the same mechanism and active ingredient differs solely based on the government's internal review order across various indications. For those with severe alopecia areata, where social isolation and mental burden are high due to the nature of the disease, reimbursement delays are not merely administrative issues but matters that affect their entire lives.Professor Yong Hyun Jang, a professor of dermatology at Kyungpook National University Hospital (Insurance Director of the Korean Dermatological Association), stated, "Alopecia areata is not a cosmetic issue but an autoimmune disease caused by immune abnormalities. In severe stages, if the treatment window is missed, recovery becomes difficult. Despite the existence of clinically proven treatments, many patients cannot start therapy due to cost or are forced to stop mid-treatment for financial reasons."Professor Jang emphasized, "Treatments for severe alopecia areata must be viewed as essential medical care to protect a patient's daily life and mental health, not as cosmetic improvement. Discussions on poclies are necessary to improve access to treatments that have sufficient clinical evidence."
