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- 2026-03-10 04:11:09
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- 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.
- Policy
- PNH drug 'Piasky Inj' for adults·children wins nod
- by Lee, Tak-Sun Dec 26, 2025 08:39am
- The Ministry of Food and Drug Safety (MFDS), led by Minister Yu-Kyoung Oh, announced that it granted approval of 'Piasky (crovalimab)', a new orphan drug from Roche used for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and pediatric patients aged 12 and older who weigh 40 kg or more, on December 24.PNH is an acquired hematopoietic stem cell disorder characterized by hemolytic phenomena (hemoglobin escapes from red blood cells) that causes release of dark-colored urine during the night.'Piasky Inj' is an orphan drug that inhibits complement-mediated intravascular hemolysis in patients with PNH. Complement proteins assist the immune response by attacking pathogens such as bacteria and viruses.As a complement protein C5 inhibitor, this drug prevents the binding of C5 to abnormal red blood cells produced by hematopoietic stem cell disorders, thereby protecting the cells from lysis.Piasky is the first treatment approved for pediatric use in South Korea, and it is expected to significantly broaden the therapeutic landscape for both adult and adolescent patients (12 years and older).The MFDS stated that it will make every effort to ensure that new treatments for rare diseases are rapidly made available based on its regulatory science expertise, thereby expanding clinical opportunities for patients.
- Company
- 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.
- Policy
- Expanded reimb for Keytruda·Dupixent
- by Jung, Heung-Jun Dec 24, 2025 08:08am
- As the review of expanded reimbursement for Keytruda (pembrolizumab) and Dupixent (dupilumab) has passed the Health Insurance Policy Review Committee (hereafter referred to as the committee) today (DEC 23), the out-of-pocket cost will drop by up to 95% starting next year.The committee also finalized a restructuring of the compensation system for clinical laboratory testing CDMOs, the formulation of an adjustment system for relative value units, and the launch of an 'innovative pilot project for community-based primary care', set for the second half of next year.The Ministry of Health and Welfare (MOHW) approved expanding health insurance coverage for Keytruda and Dupixent during the committee. While Keytruda was previously covered for four cancer types, including non-small cell lung cancer (NSCLC), coverage will now extend to 17 therapies across nine additional cancer types.Specifically, the expanded coverage includes head and neck cancer, gastric cancer, esophageal cancer, endometrial cancer, small bowel cancer, biliary tract cancer, colorectal cancer, triple-negative breast cancer (TNBC), and cervical cancer.For patients meeting the eligibility criteria for these expanded indications, the annual out-of-pocket cost per patient is expected to drop significantly, from approximately KRW 73.02 million to KRW 3.65 million (with a 5% co-payment for monotherapy).Dupixent, which was previously covered for chronic severe atopic dermatitis, will also be covered for severe Type 2 inflammatory asthma starting in January. The annual cost for severe asthma patients is expected to decrease from KRW 15.88 million to approximately KRW 4.76 million (based on a 30% co-payment).The committee also concluded this year's reimbursement re-evaluation for eight therapeutic ingredients. The reimbursement for spherical adsorptive carbon and artemisia herb extract will be maintained due to price reductions.2025 Reevaluation Results for Pharmaceutical Reimbursement Appropriateness: Reimbursement maintained for 1. olopatadine hydrochloride 2. Clematidis Radix-Trichosanthes Root-Prunella Spike 3. Bepotastine…Drug price reduced and reimbursement maintained for 7. spherical adsorptive carbon and artemisia herb extract (upon voluntary requests for drug price reduction by pharmaceutical companies).The oral formulation of L-aspartate-L-ornithine will remain covered, though its reimbursement criteria will be restricted to hepatic encephalopathy. For three other ingredients, including sulglicotide, the evaluation has been deferred on the condition that a portion of the reimbursement will be recouped if clinical trials fail to prove efficacy.Abolition of clinical lab management fees... new institution-specific fees establishedThe compensation structure for CDMO clinical laboratory testing will be reformed. The consignment fee, which overlaps with existing testing fees, will be abolished, and new fees specific to the CDMO institutions will be established. Furthermore, the billing and payment system will be improved to prevent diagnostic fee discounting.The CDMO fee criteria will be determined based on ▲the current management fee ▲the respective roles of the institutions ▲the financial impact during the regular RVU adjustment process. The KRW 240 billion saved from the abolition of the management fee will be reallocated to increase reimbursement for under-compensated areas, such as consultation fees.Examples of Lab Fee Adjustments: Examples of over-compensated areas, and actual adjustments will depend on finalized cost data. Under-compensated areas within clinical lab testing will not face fee cuts but will be prioritized for balance adjustments.The MOHW plans to revise relevant CDMO regulations in the first half of next year and implement the changes in alignment with the regular relative value unit adjustment cycle. Certification standards for clinical laboratory testing will also be updated.Regular adjustment of the relative value unit (previously updated every 5-7 years)To rationalize the fee compensation system, the government will formulate a regular adjustment model for the relative value unit. Previously, relative value unit restructuring occurred every 5 to 7 years, which critics argued failed to reflect rapid changes in medical practice.The government will review under-compensated and over-compensated services based on medical cost analysis and adjust them to balanced fees.In particular, funds from adjusting for over-compensation in areas such as clinical laboratory tests and imaging (CT and MRI) will be redistributed to under-compensated basic medical services, such as consultation and hospitalization fees at clinics and hospitals. Funds will also be directed toward strengthening compensation for essential healthcare, including surgeries and care that are severe·emergency and pediatrics·deliveries.Medical cost analysis results for relative adjustment...Low margins for drug administration and dispensingThe committee discussed the 2023 medical cost analysis results calculated by the Medical Cost Analysis Committee. These results will serve as the foundation for the 2026 regular RVU adjustments. The '2023 Fiscal Year Cost Analysis Report', which for the first time includes cost-to-revenue ratios by healthcare institution type and specific fee items, is scheduled for publication in the first quarter of next year.The analysis was expanded to include tertiary hospitals and clinics in addition to general hospitals. The report calculated the cost-to-revenue of reimbursements following the establishment of standardized medical cost calculation guidelines.Key findings regarding the cost-to-revenue ratio for covered services (based on tertiary hospitals) showed that clinical laboratory fees (192%), special radiologic imaging fees (169%), and radiation therapy fees (274%) had relatively high profit margins compared to costs.Conversely, drug administration and dispensing fees (11%), basic physical therapy (33%), and basic consultation fees (63%) generated significantly lower revenue than costs.'Innovative Pilot Project for Community-based Primary Care' to launch in JulyThe pilot project will launch next year, initially targeting patients aged 50 and older who require integrated management, with plans for gradual expansion.Under this project, registered patients can receive personalized preventive care, disease and medication management, and lifestyle coaching at their designated clinics, linked to their health check-up results. When necessary, patients can be referred to appropriate medical institutions or receive home-based primary care.Clinics that complete the required training are eligible to participate. Institutions capable of providing multi-professional, multidisciplinary team support can join as hub institutions.The government will introduce the 'Primary Care Functional Enhancement Integrated Fee', which compensates for 'patient registration and continuous management efforts' rather than traditional fee-for-service. The MOHW also plans to pilot multidisciplinary team-based service support and performance-based rewards.The pilot program is scheduled to run for three years, from July 2025 to 2028, with plans to expand its scope to additional regions and institutions starting in 2029.
- Policy
- Gov't to enforce non-face-to-face care Medical Service Act
- by Lee, Jeong-Hwan Dec 24, 2025 08:07am
- Following a Cabinet meeting today (December 23), the South Korean government is set to announce an amendment to the Medical Service Act that formally institutionalizes non-face-to-face care. The Ministry of Health and Welfare (MOHW), led by Minister Jeong Eun Kyeong, is the primary department overseeing this transition.Currently operating as a pilot program, non-face-to-face care will officially take effect one year from the date of announcement, in accordance with the supplementary provisions of the Act. This means that December 24, 2026, will mark the official date when non-face-to-face care becomes a permanent, legalized system in South Korea.This legislative reform comes 15 years after the first amendment proposal was submitted during the 18th National Assembly in 2010.The core principle of the Act is that non-face-to-face care will be centered on returning patients and primary care clinics.First-time patients are also eligible for non-face-to-face care, but with specific caveats. Based on MOHW standards, they can only apply for services within their residential area and will be subject to restrictions on the types of drugs prescribed and the total number of prescription days allowed.For the first time, a provision for the delivery of pharmaceuticals outside of pharmacies will be legalized. This applies to specific groups, including residents of islands or remote areas, long-term care recipients, registered persons with disabilities, patients confirmed with Class 1 or 2 infectious diseases, and patients with rare diseases.Prescribing narcotics or psychotropic substances via non-face-to-face care is strictly prohibited. Additionally, the use of electronic prescriptions will be officially institutionalized specifically for non-face-to-face care services.The National Assembly maintained that while the principle of in-person treatment remains paramount, this legislation provides the legal grounds to supplement care via non-face-to-face care. It also establishes the Minister of Health and Welfare’s authority to manage and supervise non-face-to-face care services via online platforms.Those intending to provide or operate a non-face-to-face care platform must report to the MOHW. Furthermore, if the number of platform subscribers exceeds a certain threshold, the operator must apply for official certification from the MOHW Minister.The MOHW Minister reserves the power to revoke certification if a platform obtains it through fraudulent means or fails to meet the required certification standards.The platforms are prohibited from interfering with a physician’s professional medical judgment, encouraging the misuse or abuse of medical services or pharmaceuticals, brokering, inducing, or instigating collusion in violation of the Pharmaceutical Affairs Act.Furthermore, the platforms are prohibited from demanding or receiving financial incentives, goods, or other economic benefits from medical professionals or pharmacies in exchange for patient or prescription referrals.Prohibited provisions also include recommending or inducing patients to choose specific medical institutions, pharmacies, or medical devices.Both doctors and pharmacists are now mandatorily required to use and verify the Drug Utilization Review (DUR) system when prescribing or dispensing narcotics and psychotropic substances during both in-person and non-face-to-face care consultations. Failure to comply will result in a fine of up to KRW 1 million. This provision was institutionalized as a safeguard during the legalization of non-face-to-face care.Meanwhile, an amendment to the Pharmaceutical Affairs Act aimed at prohibiting non-face-to-face care platforms from concurrently operating as pharmaceutical wholesalers (which was expected to pass alongside the telemedicine bill) remains pending in the National Assembly. The timeline for its final approval remains uncertain.
- Policy
- The implications of Keytruda’s reimb expansion
- by Jung, Heung-Jun Dec 24, 2025 08:06am
- MSD Korea’s immune checkpoint inhibitor Keytruda (pembrolizumab) is expected to complete the process of expanding its reimbursed indications at the Health Insurance Policy Deliberation Committee (HIPDC) meeting scheduled for today (the 23rd).Following approval by the committee, Keytruda’s reimbursement will be significantly expanded from January next year, increasing from the current 7 indications across 4 cancer types to 18 indications spanning 13 cancer types.This marks the culmination of a process that began with the reimbursement application in 2023—nearly three years in the making. Beyond the numerical addition of reimbursement for 9 additional cancer types and 11 new indications at once, the decision signifies enhanced treatment accessibility for previously underserved cancer types.It also stands as a significant precedent, having found a breakthrough for expanding reimbursement indications under the existing RSA framework before the government’s formal introduction of its indication-specific drug pricing system.According to industry sources on the 23rd, the National Health Insurance Service's Health Insurance Review and Assessment Service (HIRA) will vote on expanding Keytruda's reimbursement indications at its meeting today at 2 PM.Starting next January, Keytruda will be reimbursed for gastric cancer, esophageal cancer, endometrial cancer, colorectal cancer, squamous cell carcinoma, cervical cancer, breast cancer, small cell lung cancer, and bile duct cancer. Previously, reimbursement was applied to 7 indications across 4 cancer types: non-small cell lung cancer, Hodgkin lymphoma, melanoma, and urothelial carcinoma.While coverage was previously concentrated on non-small cell lung cancer, the expansion will now allow insurance coverage for a broader range of patients, including those with women’s cancers such as endometrial, breast, and cervical cancer.Furthermore, for several cancer types, including endometrial cancer, small cell lung cancer, and bile duct cancer, reimbursement will be extended to patients with MSI-H (microsatellite instability-high) tumors, significantly improving access for patient groups that had previously been excluded from treatment options.A milestone in multi-indication coverage ahead of indication-based pricingKeytruda, which received a multi-indication approval, has long been at the center of discussions surrounding the potential introduction of an indication-based pricing (IBP) system in Korea.While the government recently announced plans to introduce IBP through a drug pricing system reform, concrete measures have yet to be finalized. In this context, Keytruda's case can be seen as an example where the Health Insurance Review and Assessment Service (HIRA), the National Health Insurance Service (NHIS), and the pharmaceutical company found a broad solution for expanding coverage within the current Reimbursement Strategy Agreement (RSA) framework.With several other multi-indication therapies awaiting reimbursement review, this case is expected to serve as a reference model for future reimbursement decisions, regardless of whether IBP is formally adopted.Keytruda currently holds approvals for 18 cancer types and 35 indications, so further attempts to expand reimbursement coverage are anticipated going forward.Of course, this expansion of Keytruda's indications does not eliminate the need for IBP. How the government's drug pricing system will accommodate blockbuster drugs with multiple indications remains an unresolved policy challenge.However, the significance of Keytruda's recent coverage expansion lies in its active use of RSA to achieve results effectively approaching an indication-based pricing system. The case is meaningful not only for enhancing patient access to treatment but also for clarifying the extent to which existing reimbursement mechanisms can be leveraged to address complex multi-indication therapies.
