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- 2026-04-28 17:33:59
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- New RSV prophylaxis is entering KOR…expanded infant protection
- by Son, Hyung Min Mar 13, 2026 09:06am
- The prevention strategy for infant respiratory syncytial virus (RSV) is expected to expand rapidly in South Korea.As global pharmaceutical companies are proceeding with regulatory approval processes for maternal vaccines and new antibody injectables, a new competitive landscape is beginning to take shape. RSV vaccine 'Abrysvo'According to industry sources on the 13th, Pfizer Korea has summitted application for the approval of 'Abrysvo,' its RSV vaccine. Approval is anticipated within the first half of this year.Abrysvo is a vaccine that targets the F protein, a major surface protein of RSV. It is specifically designed based on the pre-fusion (pre-F) form of the F protein, which the virus uses to penetrate cells.The pre-F protein is known to be the most effective antigen for inducing neutralizing antibodies, as it represents the viral structure just before cell binding and entry. Abrysvo induces an immune response using a protein that stabilizes this specific structure.Designed as a bivalent vaccine targeting both major RSV subtypes (A and B), Abrysvo uses a maternal immunization strategy. In this approach, antibodies generated by the mother following vaccination are transferred through the placenta to protect the infant after birth.RSV is a leading respiratory virus causing pneumonia and bronchiolitis. While it can infect individuals of all ages, infection rates are particularly high in infants. Globally, approximately 90% of children are infected with RSV before age two. For some, it progresses to severe lower respiratory tract disease, making it a primary cause of infant hospitalizations.Clinical evidence for Abrysvo was secured through the Phase 3 MATISSE study. The results showed that maternal vaccination during late pregnancy significantly reduced the risk of severe RSV-related lower respiratory tract disease in infants within six months of birth.Regarding safety, commonly reported adverse reactions included injection site pain, headache, myalgia, and nausea.Abrysvo is established as a preventive option in major overseas markets. In the U.S., it was approved in 2023 for the prevention of RSV-LRTD in infants via maternal vaccination (32–36 weeks) and for adults aged 60 and older. Last year, the indication was expanded to include adults aged 18 and older.Upcoming competition in RSV prevention strategy for children: Vaccines vs. Antibody InjectionsAntibody therapy, 'Enflonsia (clersrovimab),' for RSV prevention MSD has also entered the infant RSV prevention market.MSD Korea recently submitted an approval application to the Ministry of Food and Drug Safety (MFDS) for 'Enflonsia (clersrovimab),' an RSV preventive antibody injection for neonates and infants. The company anticipates approval by the second half of this year.Unlike vaccines, antibody injections deliver antibodies directly into the body, providing immediate protective effects following administration.Enflonsia is a long-acting monoclonal antibody targeting the F protein. It is designed to maintain preventive efficacy for approximately five months with a single dose, covering the typical RSV season from autumn to the following spring.Notably, Enflonsia was developed as a fixed-dose (105mg) treatment regardless of body weight, which is evaluated as a feature that increases convenience for pediatric prevention programs.In the Phase 2b/3 CLEVER study, a single administration of Enflonsia reduced the incidence of RSV-related LRTD by 60.5% and the risk of RSV-related hospitalization by 84.3%.Furthermore, the Phase 3 SMART study involving high-risk infants confirmed its preventive efficacy and a safety profile similar to 'Synagis (palivizumab),' the existing RSV preventive antibody.Antibody therapy 'Beyfortus' for RSV preventionIf Abrysvo and Enflonsia are approved, they are expected to compete with other long-acting RSV preventive antibodies.Currently, 'Beyfortus (nirsevimab),' an RSV preventive antibody developed by Sanofi, has already entered the infant market.Beyfortus is launching in Korea this year and is garnering attention as a major infant RSV prevention option.Previously, AstraZeneca's Synagis was used for RSV prevention, but its short half-life necessitated multiple doses during the RSV season. In contrast, Beyfortus is a long-acting antibody with an extended half-life, allowing for full-season protection with a single administration.Recent international studies have also compared the effectiveness of these different prevention strategies. A large-scale population-based study in France comparing maternal vaccines and infant antibody strategies found that the Beyfortus group had a lower risk of RSV-related hospitalization.Additionally, a surveillance study conducted in the U.S. showed that Beyfortus was 81% effective in preventing RSV-related hospitalizations, with efficacy maintained for approximately 4 to 7 months. Researchers found that while both strategies reduce RSV-related hospitalizations, antibody-based prophylaxis provided greater protection against severe disease.
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- Leclaza launches in Germany, accelerates Europe entry
- by Cha, Ji-Hyun Mar 13, 2026 09:06am
- Photo of Yuhan Corp’s Leclaza (source: Yuhan Corp)Leclaza, a lung cancer drug developed by Yuhan Corporation, has successfully entered the health insurance reimbursement system in Germany, the largest pharmaceutical market in Europe. This listing is expected to accelerate Leclaza’s entry into other European countries.According to the biotech industry on the 12th, Germany’s Federal Joint Committee (G-BA), responsible for evaluating health insurance reimbursement in Germany, assigned billing codes 761990MO and 761990MP to Leclaza 80 mg and 240 mg, respectively, starting this month. Billing codes are assigned after drug price negotiations are finalized, enabling hospitals to bill health insurance for the medication after prescribing it.Leclaza is a third-generation treatment for non-small cell lung cancer (NSCLC) targeting epidermal growth factor receptor (EGFR) mutations. It received approval in Korea in January 2021 as the country's 31st domestically developed new drug. The combination therapy of Leclaza and Rybrevant received approval from the U.S. Food and Drug Administration (FDA) in August 2024 as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed EGFR exon 19 deletion or exon 21 L858R substitution mutation.Later, at the end of 2024, the European Commission (EC) also approved the Lecelaza and Johnson and Johnson’s Rybrevant combination therapy as a first-line treatment for EGFR-mutated NSCLC. Subsequently, in July of last year, the G-BA determined that the combination therapy had sufficient clinical value to qualify for health insurance reimbursement.Under Germany’s Social Code Book V (SGB V), new drugs can enter the market immediately after receiving marketing authorization. Within approximately 6 months, the G-BA evaluates the drug’s clinical benefit, after which price negotiations with health insurers begin. Negotiations typically conclude within another 6 months, after which hospital billing codes are assigned.The G-BA ultimately determined that the combination therapy of Leclaza and Rybrevant positively impacts survival rates for lung cancer patients. It particularly noted a relatively pronounced survival benefit in the patient group aged 65 and under. The G-BA estimated the annual number of patients expected to receive treatment in Germany to be between 1,250 and 3,025.Germany is widely regarded as one of the most stringent countries in Europe in terms of drug pricing decisions. However, Lazertinib entered the reimbursement system relatively smoothly, being recognized for its clinical value. Once prescriptions gain traction in the German market, it is expected to positively influence drug pricing negotiations and insurance listings in other European countries as well.Once sales expand in major European countries, Yuhan Corporation is expected to receive additional licensing fees. Yuhan has not yet received the USD 30 million milestone payment for Leclaza’s approval in Europe. In addition, if sales grow in the European market, the company will receive royalties based on a certain percentage of sales according to the licensing agreement.Yuhan Corporation's total licensing revenue over the 7 years from 2019 to last year amounted to KRW 460 billion. Of this amount, cumulative licensing revenue from Lazertinib technology transfer alone has reached approximately USD 275 million, including upfront payments and development and regulatory milestones.Yuhan Corporation received a non-refundable upfront payment of USD 50 million when it licensed Leclaza to Janssen Biotech, a Johnson & Johnson subsidiary, in November 2018. Subsequently, a USD 35 million milestone was paid in 2020 when the clinical trial for the combination therapy of Rybrevant and Leclaza began. The company received an additional USD 65 million the same year when patient enrollment for the clinical trial began.The company continued to generate milestone revenues thereafter based on progress in development and regulatory approvals. A USD 60 million milestone was triggered by the 2024 U.S. Food and Drug Administration (FDA) approval. Last year, the company received additional milestone payments of USD 15 million for Japanese approval and USD 45 million for Chinese approval.
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- Polivy makes 3rd bid for reimbursement…DREC review imminent
- by Eo, Yun-Ho Mar 13, 2026 09:06am
- Attention is focused on whether Polivy, the first new first-line treatment for diffuse large B-cell lymphoma (DLBCL) in 20 years, will succeed on its third attempt to obtain reimbursement listing in Korea.According to industry sources, Roche Korea's Polivy (polatuzumab vedotin), a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), is expected to be submitted to the Health Insurance Review and Assessement Service's Drug Reimbursement Evaluation Committee next month (April).It remains to be seen whether progress can be made approximately 8 months after passing the Cancer Disease Deliberation Committee last July.Originally, Polivy sought reimbursement in 2021 for its first approved indication as a third-line therapy, in combination with the BR regimen (bendamustine + rituximab), but the application failed to pass CDDC review at that time.Later, in the first half of 2023, Roche submitted a reimbursement application for first-line therapy using Polivy in combination with R-CHOP therapy (rituximab, cyclophosphamide, doxorubicin, and prednisone). However, this application also failed to pass the Cancer Disease Deliberation Committee in February 2024.Expectations are high for Polivy's latest reimbursement attempt. Roche has submitted additional follow-up analysis results with a 60.9-month follow-up period from the POLARIX study, which evaluated the effectiveness of Polivy in combination with Pola-R-CHP as a first-line treatment for DLBCL.The study, presented at the American Society of Hematology (ASH 2024) annual meeting, has been regarded as the first clinical trial in 20 years to expand the standard first-line treatment for DLBCL. Key results show patients receiving Polivy combination therapy demonstrated a clear improvement in overall survival (OS) compared with those treated with the existing standard therapy, R-CHOP.The lymphoma-related mortality rate was 9.0% in the Polivy combination therapy group and 11.4% in the R-CHOP control group. At approximately 5 years after treatment initiation, the mortality risk in the Polivy combination therapy group decreased by 15%, an improvement over the previous 3-year follow-up result (6% risk reduction).In addition, patients receiving the Polivy combination therapy (38.7%) required follow-up treatments (radiation therapy, systemic chemotherapy, or CAR-T cell therapy) about 25% less frequently than those in the R-CHOP control group (61.7%).Meanwhile, diffuse large B-cell lymphoma (DLBCL) is an aggressive type of blood cancer and the most common form of non-Hodgkin lymphoma. In South Korea, the number of new patients diagnosed with DLBCL is estimated to reach 5,000 each year.Accounting for the highest proportion of non-Hodgkin lymphomas, diffuse large B-cell lymphoma is an aggressive lymphoma requiring immediate treatment due to its rapid progression. Although more than half of patients respond well to treatment and achieve remission, 30–40% of patients either fail to respond to the standard therapy R-CHOP or experience relapse after first-line treatment.Despite the fact that most patients experience relapse within two years and that survival is only about six months upon relapse, making it a highly lethal disease, relapsed/refractory diffuse large B-cell lymphoma remains an area with limited effective treatment options.
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- Quadrivalent meningococcal vaccine 'MenQuadfi' prescribed at gen hospitals
- by Eo, Yun-Ho Mar 12, 2026 08:35am
- Sanofi Korea's MenQuadfiThe quadrivalent meningococcal vaccine 'MenQuadfi' is now available by prescription at major general hospitals.According to industry sources, Sanofi Korea's MenQuadfi (Meningococcal Polysaccharide Tetanus Toxoid Conjugate Vaccine), indicated for the prevention of invasive meningococcal disease (serogroups A, C, Y, and W), has passed the Drug Committees (DC) of 23 medical institutions nationwide. These include tertiary general hospitals such as Seoul National University Hospital and Asan Medical Center, as well as medical institutions, including Kyung Hee University Hospital at Gangdong, Konkuk University Medical Center, National Medical Center, and Soonchunhyang University Hospital.MenQuadfi was approved in Korea last April, and this drug is given as a single-dose administration in individuals aged 6 weeks to 55 years.Notably, MenQuadfi is the only vaccine in Korea approved with proven efficacy against meningococcal serogroup A in infants aged 6 weeks to less than 24 months. A key feature of the product is its ready-to-use liquid formulation, which eliminates the need for reconstitution or mixing, thereby enhancing convenience for healthcare providers. The immunization schedule consists of four doses for infants aged 6 weeks to less than 6 months, two doses for those aged 6 months to less than 24 months, and a single dose for individuals aged 2 to 55 years.Meningococcal disease has been pointed out as a significant global public health concern. Classified as a Group 2 legal infectious disease with a fatality rate of approximately 10–14%, it affects 500,000 people worldwide annually.Primary symptoms include headache, fever, neck stiffness, vomiting, and altered consciousness, often accompanied by petechiae or purpura fulminans. The importance of prevention is signified by the fact that 11–19% of survivors suffer from long-term sequelae, including hearing loss, cognitive impairment, and neurological disorders.Since meningococcal disease is transmitted via respiratory droplets or direct contact, vaccination is highly recommended for individuals entering communal living environments. Typical candidates include military recruits and first-year college students who plan to live in dormitories.Furthermore, vaccination is advised for travelers or residents in high-incidence areas such as the African meningitis areas, as well as pilgrims traveling to Mecca, Saudi Arabia. Other recommended groups include individuals with immune system disorders, such as complement deficiencies, and those with anatomical or functional asplenia.Meanwhile, in clinical trials, MenQuadfi demonstrated non-inferiority across all four serogroups compared to existing quadrivalent meningococcal vaccines. Specifically, in the 10–55 age group, the seroprotection rates for MenQuadfi were 94.7% in Group A, 95.7% in Group C, 96.2% in Group W, and 98.8% in Group Y.Additionally, studies in children aged 2–9 years confirmed non-inferiority to existing quadrivalent vaccines, with seroprotection rates ranging from 86% to 99%. The vaccine also demonstrated stable immunogenicity when co-administered with other pediatric vaccines.
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- SK Biopharmaceuticals' Chinese joint venture pushes for listing
- by Cha, Ji-Hyun Mar 11, 2026 08:28am
- SK Biopharmaceuticals’ Chinese joint venture appears to be accelerating preparations for an initial public offering (IPO). This follows SK Biopharmaceuticals’ board approval late last year for pre-IPO investment in the joint venture and changes to the clinical development contract for an improved drug candidate in China. Observers note that SK Biopharm can simultaneously expect the benefits of expanding its China business and increasing its stake value through the joint venture's listing.According to industry sources on the 10th, SK Biopharm's board of directors in November last year approved two agenda items: a crossover investment in its Chinese joint venture, Ignis, and amendments to the agreement for the clinical development in China of an improved new drug owned by Ignis. Both proposals passed with unanimous support from outside directors.Ignis serves as SK Biopharmaceuticals’ strategic outpost for the Chinese market. In 2021, SK Biopharmaceuticals established Ignis together with China-based global investment firm 6 Dimensions Capital (6D). At the time of its launch, Ignis raised USD 180 million in Series A funding, the largest Series A investment in China’s pharmaceutical industry that year. Investors included Ruentex Group, KB Investment, WTT Investment, Abu Dhabi sovereign wealth fund Mubadala Investment Company, HBM Healthcare Investments, and Goldman Sachs.At the time, SK Biopharmaceuticals transferred the China rights to 6 central nervous system (CNS) assets, including its self-developed epilepsy drug cenobamate and sleep disorder treatment solriamfetol, to Ignis and acquired equity worth USD 150 million in the venture. Under the contract, SK Biopharmaceuticals also secured revenue streams, including a USD 20 million non-refundable upfront payment, USD 15 million in milestone payments tied to development, approval, and sales stages, as well as sales royalties. As of the end of September last year, SK Biopharm held 41% of Ignis shares, making it the largest shareholder.Industry observers view the latest board approval as a signal linked to Ignis’s IPO plans. Crossover investments are typically a funding method used by unlisted companies preparing for IPOs to attract institutional investors. Considering Ignis is pursuing a listing, this crossover investment decision is interpreted as a move to enhance its corporate value and establish an investment foundation before the IPO. Ignis is known to have formed an advisory team and proceeded with IPO preparations around the first half of last year to pursue a listing on the Hong Kong Stock Exchange (HKEX).At the same time, the revision of the clinical development agreement for the improved drug is seen as a measure to accelerate clinical trials in China and secure a more efficient commercialization pathway. China’s regulatory system, particularly regarding clinical trial sponsors and approval procedures, is heavily localized, requiring development structures tailored to local requirements. Analysts say the flexible adjustment of the contract structure reflects an effort to expedite clinical development and regulatory approval in line with the local regulatory environment.Ignis Pipeline Overview (Source: Ignis)Market expectations place the potential Ignis IPO around the first half of this year. If Ignis successfully lists on the Hong Kong exchange as planned, its growth trajectory is expected to accelerate. The influx of IPO capital could strengthen short-term funding for the China launch of cenobamate and solriamfetol, while in the longer term supporting development of additional CNS assets transferred from SK Biopharm as well as Ignis’s own pipeline.Ignis secured favorable conditions for entering the Greater China market after receiving new drug application (NDA) approvals from China’s National Medical Products Administration (NMPA) in December last year for both cenobamate and solriamfetol. With over 11 million epilepsy patients in China, the market is estimated to be worth USD 1.1 billion as of 2024. The number of patients with obstructive sleep apnea is estimated to exceed 170 million. With the two approvals, Ignis aims to expand access to treatments for CNS disorders in Greater China and provide new therapeutic options for local patients.Ignis has also applied for authorized generics for cenobamate and solriamfetol as part of a strategy to secure early market share. Authorized generics are identical versions of the original drug marketed with the permission of the original drug’s company. T This strategy allows companies to respond to competing generics after patent expiration while simultaneously targeting the price-sensitive segments of the market.In addition to licensed assets, Ignis is advancing its own drug development programs. The company recently completed dosing of the first patient in a Phase I clinical trial of ‘IGS01’, its internally developed candidate for levodopa-induced dyskinesia (LID) in Parkinson’s disease. IGS01 is a small-molecule drug candidate belonging to the positive allosteric modulator (PAM) class targeting the M4 muscarinic receptor, which regulates brain neurotransmission. This development signifies Ignis's evolution beyond merely commercializing acquired assets into a CNS biotech company with its own pipeline and R&D capabilities.The benefits SK Biopharmaceuticals stands to gain from Ignis's growth are clear. As Ignis's largest shareholder, SK Biopharmaceuticals is expected to see the value of its stake rise to hundreds of billions of won. Furthermore, by securing the massive Chinese market, it can diversify its portfolio, moving beyond its current business structure that is heavily dependent on the United States, which accounts for more than 90% of its revenue.An SK Biopharmaceuticals official stated, “We understand that Ignis is preparing for a listing on the Hong Kong stock exchange, but the specific timeline is confidential and difficult to confirm.”
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- 'Datroway' launches in Korea…breast cancer ADC
- by Son, Hyung Min Mar 11, 2026 08:28am
- A Trop-2-directed antibody-drug conjugate (ADC), Datroway, obtained domestic approval, introducing a new treatment option to breast cancer. Based on clinical results, which show improved progression-free survival (PFS) compared with existing cytotoxic anticancer drugs. Attention is drawn to the possibility of expansion of the TROP2 ADC-based treatment strategy to triple-negative breast cancer (TNBC) beyond HR+/HER2- breast cancer.ADC anticancer drug 'Datroway'According to industry sources on the 11th, the Ministry of Food and Drug Safety (MFDS) approved Datroway (datopotamab deruxtecan), developed by AstraZeneca and Daiichi Sankyo, as a breast cancer treatment.The specific indication is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.AstraZeneca paid $1 billion (approx. KRW 1 trillion) in upfront fees alone to secure the development rights for Datroway from Daiichi Sankyo in 2020. The total contract value, including development and commercialization milestones, amounts to $6 billion (approx. KRW 7 trillion).Datroway's target TROP2 is rapidly emerging as a core target in global ADC development.The TROP2 protein is known to be overexpressed in various cancer types, including breast cancer and non-small cell lung cancer (NSCLC). Datroway's mechanism of action involves binding to this protein and delivering cytotoxic drugs directly inside cancer cells to induce apoptosis. It is designed to maintain the efficacy of conventional cytotoxic chemotherapy while reducing damage to healthy cells.The basis for this approval is the Phase 3 TROPION-Breast01 study. This study was conducted on 732 patients with unresectable or metastatic HR-positive, HER2-negative breast cancer.Patients were randomized 1:1 into the Datroway group (365 patients) and the physician's choice of chemotherapy (TPC) group (367 patients).Datroway was administered intravenously at a dose of 6 mg/kg every three weeks, while the control group received an investigator's choice of chemotherapy among eribulin, capecitabine, vinorelbine, or gemcitabine.Primary endpoints included progression-free survival (PFS) and overall survival (OS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 criteria. Objective response rate (ORR), duration of response (DOR), and disease control rate (DCR) were set as key secondary endpoints.The median PFS in the Datroway group was 6.9 months. This was an improvement over the 4.9 months in the chemotherapy group, reducing the risk of disease progression or death by 37%.The ORR was 36.4% in the Datroway group and 22.9% in the chemotherapy group, while the median DOR was 6.7 months and 5.7 months, respectively.Median OS was 18.6 months in the Datroway group and 18.3 months in the chemotherapy group, with no statistically significant difference at the time of analysis.In terms of safety, the most commonly reported adverse events were stomatitis, nausea, fatigue, alopecia, constipation, vomiting, and dry eye.Serious adverse events occurred in 3.1% of patients treated with Datroway. Major serious AEs included interstitial lung disease (ILD, 1.1%), vomiting (0.6%), diarrhea (0.6%), and anemia (0.6%). Fatal outcomes occurred in 0.3% of patients, with ILD cited as the cause.Potential as a first-Line treatment for triple-negative breast cancer (TNBC)TROP2-targeted ADCs are creating a new competitive landscape in breast cancer treatment. Currently, the first drug of this mechanism to be commercialized is Gilead's 'Trodelvy' (sacituzumab govitecan). Trodelvy has been approved for the treatment of TNBC in the U.S., Europe, and South Korea.Datroway has entered the market, pursuing indication expansions focused on breast cancer and non-small cell lung cancer.Both treatments show promise as first-line treatments for TNBC.In previously untreated metastatic TNBC, primary treatment options have been limited, except for the immune checkpoint inhibitor 'Keytruda' (pembrolizumab). Analysis suggests that, for PD-L1-negative patients who lack other options besides chemotherapy, the role of TROP2-targeted ADCs is likely to expand.In the Phase 3 TROPION-Breast02 study, Datroway significantly improved both PFS and OS compared with conventional chemotherapy in the first-line treatment of metastatic TNBC, where immunotherapy is difficult.The study results showed a PFS of 10.8 months for the Datroway group and 5.6 months for the chemotherapy group, nearly a twofold difference. OS was 23.7 months and 18.7 months, respectively, and both metrics were statistically significant.ADC anticancer drug 'Trodelvy'Trodelvy also demonstrated efficacy. The Phase 3 study, named ASCENT-03, compared Trodelvy with chemotherapy.In the study, Trodelvy had a median PFS of 9.7 months, compared with 6.9 months for chemotherapy. It was also shown to reduce the risk of disease progression or death by 38%.While OS was not yet mature at the time of the primary analysis, a trend of a continuously widening gap in PFS2 between the treatment and control groups has been confirmed, raising the possibility of future OS improvement.Gilead is also conducting the ASCENT-04 study to evaluate the efficacy of the Trodelvy + Keytruda combination. This combination has reportedly achieved PFS improvement compared to chemotherapy + Keytruda. Expects suggests that Trodelvy + Keytruda is highly likely to become the new standard of care for first-line TNBC treatment, regardless of PD-L1 expression levels.
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- PAH drug Winrevair may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Mar 09, 2026 08:53am
- The new pulmonary arterial hypertension (PAH) drug Winrevair is beginning to gain prescribing access at major hospitals in Korea.According to industry sources, MSD Korea’s activin signaling inhibitor (ASI) Winrevair (sotatercept has passed the drug committee (DC) reviews at leading tertiary hospitals, including Samsung Medical Center and Seoul National University Hospital.At the same time, MSD is currently conducting landing procedures at about 20 major medical institutions nationwide.Winrevair is a first-in-class innovative drug with a new mechanism of action, emerging 20 years after sildenafil, which targets the NO–sGC–cGMP pathway, was introduced in 2005. The drug is currently selected for the second phase of Korea’s ‘Approval-Evaluation-Negotiation Concurrent Pilot Program’ and is undergoing reimbursement procedures, but no significant progress has been made so far.Pulmonary arterial hypertension is a particularly challenging area for new drug development. Unlike existing treatments focused on dilating blood vessels, Winrevair improves vascular remodeling, the fundamental cause of the disease.Consequently, no comparable therapeutic alternative is available. If Winrevair is evaluated within the existing economic assessment framework, it would be compared to treatments developed two decades ago. This situation naturally delays the listing process. This challenge is not unique to Winrevair but is one commonly faced by drugs included in the parallel pilot program. Nearly 200 days have already passed since Winrevair received approval from Korea’s Ministry of Food and Drug Safety.Therefore, attention is now focused on whether Winrevair will successfully complete the reimbursement listing process and ultimately establish itself as a treatment option for patients.Winrevair received regulatory approval based on the STELLAR clinical trial. This study evaluated the efficacy and safety of Winrevair in 323 adult patients with pulmonary arterial hypertension (PAH) classified as WHO functional class (WHO-FC) II or III. During the 24-week study period, patients received Winrevair or a placebo in combination with their existing therapy once every three weeks.Results showed that Winrevair increased the 6-minute walk distance by 40.8 meters (Hodges–Lehmann estimate) compared with placebo at Week 24. It also reduced the risk of clinical worsening or death by 84%.In addition, significant improvements were observed across 8 secondary endpoints, including WHO-FC, pulmonary vascular resistance (PVR), and the heart failure biomarker NT-proBNP, compared with placebo.Wook Jin Jeong, President of the Korean Society of Pulmonary Hypertension (Professor of Cardiology at Gachon University Gil Medical Center), said, “Winrevair is a treatment with a new mechanism of action that restores abnormal pulmonary vascular structure toward normal. Based on the latest evidence, updated global clinical guidelines now present it as an option for combination therapy in the early phases of treatment. This approval broadens the treatment options available to pulmonary arterial hypertension patients in Korea.”
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- Pharma labor groups voice "job security concerns" ahead of drug pricing reform
- by Kim, Jin-Gu Mar 06, 2026 08:44am
- Gemini 생성 이미지.As the government's drug pricing reform plan is soon to be finalized, labor groups in the pharmaceutical industry visited the Blue House (Presidential Office) to voice concerns regarding the policy's potential impact on employment.According to pharmaceutical industry sources on the 5th, the Pharmaceutical and Cosmetics Division of the Federation of Korean Chemical Workers' Unions (FKCU), under the Federation of Korean Trade Unions (FKTU), recently hosted a meeting with the Secretary to the President for Health and Welfare and the Secretary for Labor at the Presidential Office. The meeting was attended by Jang-hoon Lee, Chairman of the Pharmaceutical and Cosmetics Division, along with members of the FKTU's External Cooperation Headquarters.During a phone call with DailyPharm, Chairman Lee stated, "Organized by the FKTU, we met with the Secretary to the President for Health and Welfare and for Labor. We delivered our opinions on the drug price reductions from the perspective of workers." "We expressed concerns that if the government forces through the drug price reductions, it will undermine job security and hurt job creation," he said, "Regarding this, the Presidential Office responded that they could not provide a definitive answer at this time."The drug pricing reform plan was originally scheduled to be finalized through a resolution of the Health Insurance Policy Deliberation Committee last month; however, the schedule was postponed once due to continued backlash from the pharmaceutical and labor sectors. The government plans to hold a meeting in March to finalize the proposal, which includes the calculation rate for reductions in generic drug prices. Within the industry, a schedule is being discussed to pass the plan through the subcommittee on the 11th and reach a resolution at the plenary session in mid-March.Labor groups maintain that the government must consider the impact on industry and employment as it finalizes the reform plan. However, as specific details of the reform have not been disclosed, they plan to determine the intensity of their response after monitoring the HIPDC's discussion process.Regarding this, pharmaceutical labor unions under the FKCU will hold a two-day resolution rally starting on the 10th to fight for victory in the 2026 wage and collective bargaining agreements. Their response to the drug pricing reform is also expected to be discussed at this meeting.Chairman Lee stated, "Although this meeting is intended for the 2026 wage negotiations, discussing the direction of the union's response will be a major topic because concerns regarding the drug price reductions are great. Chairmen of the FKTU and the FKCU are also scheduled to attend, and we will review countermeasures together."The possibility of a joint response with the pharmaceutical and biotech industry has also been raised. Chairman Lee added, "I understand that the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) is also discussing countermeasures," adding, "It is reported that various methods, such as a national signature campaign or a public petition, are being considered. We are exploring ways to respond jointly with the Association."On January 29, the FKTU issued a statement opposing the government's drug pricing reform, stating, "A hasty reform that excludes workers can protect neither the health insurance finances nor the pharmaceutical industry."At the time, the FKTU criticized, "We express deep concern that the drug pricing reform currently pursued by the government is being unilaterally pushed forward without sufficient social discussion and agreement," adding, "Indiscriminate drug price reductions are highly likely to eventually lead to a deterioration of labor conditions and layoffs. Policies that threaten the survival rights of workers will, in the long term, undermine the public's access to medicines and right to health.""As an organization representing National Health Insurance subscribers, we cannot tolerate policy decisions made through closed-door and desk-bound administration while excluding workers, patients, and the public," adding, "The government must transparently disclose the basis and financial effects of the drug pricing reform and immediately establish a social discussion structure where the opinions of stakeholders are substantially reflected."The FKTU concluded, "We will fulfill our responsible role to ensure that the interests of health insurance subscribers and the survival rights of workers are harmoniously reflected in the future drug pricing reform discussion process," adding, "We clearly state that we will never slip any attempts to cause a retreat in labor conditions or job insecurity under the disguise of this policy."
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- US-Iran tension hits business trips for medical device Middle East projects
- by Hwang, byoung woo Mar 06, 2026 08:44am
- AI이미지 제작Although military tensions between the United States and Iran are escalating and destabilizing the Middle East, it appears that no direct setbacks have yet emerged in the operations of South Korean medical device companies established in thes regions.However, the industry is closely watching the situation, as factors such as overseas business trips and flight operations could have a short-term impact.According to the Korean medical device industry, medical AI companies and aesthetic·medical device firms currently active in the Middle East are monitoring the situation with local partners and medical institutions. So far, no direct disruptions to business operations have been identified.An official from Medical AI Company A, which operates in the Middle East, stated, "Upon checking with local partners and medical staff, there have been no particular changes in hospital operations or collaborative projects. We currently judge that there are no major setbacks to our business progress."An official from Company B also stated, "Our Middle East operations are primarily focused on Saudi Arabia, and we believe the likelihood of these military tensions directly affecting our business is low. As Saudi Arabia's medical digital transformation policy is being pursued as a long-term national strategy, it is unlikely to be suspended due to short-term variables."The situation suggests it is difficult to predict the outcome at this stage as local companies and hospitals continue to operate normally. An official from KOTRA's Dubai Trade Center stated in a call with DailyPharm, "As the conflict has only recently begun, there is currently no major impact on local companies or businesses. The UAE government also appears to be maintaining a normal daily routine as much as possible." They added, "While impact may appear if the situation is prolonged, no specific business disruptions or corporate inquiries have been received so far."Business trips and flight variables are variables…identified as short-term risksHowever, what companies are concerned about is not the local business itself, but the travels.As the Korean Ministry of Foreign Affairs has placed a Level 4 travel ban on Iran (effective March 5, 2026) and issued a Special Travel Advisory (Level 2.5) for seven other countries, including the UAE and Saudi Arabia, the burden on overseas business trips has increased significantly. This is particularly relevant for medical device companies, which often require Korean personnel to visit in person for local sales, medical staff training, and equipment installation.The industry also considers the psychological burden on employees with families, who may be hesitant to travel to the Middle East during a conflict, regardless of whether flights are operational. One industry official noted, "While local hospitals and partners are operating as usual, there is psychological pressure regarding movement, separate from the resumption of flights."The industry is particularly focused on the schedule following Ramadan. Ramadan is a religious period where Muslims fast from sunrise to sunset, and this year it is expected to continue until March 19, 2026. Generally, the Middle Eastern medical device market sees its most active sales activities begin after this religious period.In fact, visits from overseas companies typically increase around April for Abu Dhabi Global Health Week 2026, scheduled for April 7–9.The official from Company B stated, "Many domestic companies set the April to June period after Ramadan as a 'sprint month' and actively conduct overseas sales," adding, "We are currently keeping a close eye on the situation while considering various variables."The KOTRA official added, "Because medical exhibitions and events in the Middle East are organized after Ramadan, company visits are naturally high during this time," and concluding, "If the conflict stabilizes quickly, scheduled plans may proceed normally."
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- Amgen immediately reapplies for Imdelltra’s reimbursement in Korea
- by Eo, Yun-Ho Mar 06, 2026 08:44am
- The bispecific antibody anticancer drug ‘Imdelltra’, which faced an initial setback in its reimbursement journey in Korea, is immediately making another attempt.According to industry sources, Amgen Korea recently resubmitted its application for reimbursement listing of Imdleltra (tarlatamab), a treatment for relapsed or refractory extensive-stage small cell lung cancer (SCLC).This comes less than 2 months after the drug failed to establish reimbursement criteria at the Health Insurance Review and Assessment Service’s Cancer Drug Deliberation Committee in January, highlighting the company’s strong commitment to securing coverage.With rapid reorganization and swift action, attention is now on whether Imdelltra can succeed in obtaining reimbursement status and emerge as a treatment option in the underserved small-cell lung cancer field.Approved domestically last May, Imdelltra is a bispecific antibody therapy targeting ‘Delta-like ligand 3 (DLL3)’, which is expressed in 85-96% of small cell lung cancer patients. The DLL3 antigen is typically distributed within normal cells but abnormally expressed on the surface of cancer cells in neuroendocrine tumors, including small cell lung cancer.Imdelltra binds to both the DLL3 antigen on cancer cells and the CD3 antigen on T cells, inducing T cells to kill cancer cells. Crucially, it acts directly on the antigens of T cells and cancer cells, independent of Major Histocompatibility Complex Class I (MHC-1) expression, a key mechanism tumors use to evade immune detection, making it effective even against cancer cells that escape immune surveillance.The drug demonstrated efficacy in the DeLLphi-301 clinical trial, a Phase II study involving adult patients with extensive-stage small-cell lung cancer whose disease had progressed after at least two prior treatments, including platinum-based chemotherapy.Study results showed Imdelltra demonstrated a significant objective response rate. The objective response rate in 100 patients treated with Imdelltra 10mg was 40%, and 58% of responders (23/40) maintained responses for more than 6 months.Furthermore, the median overall survival (OS) in the Imdelltra 10mg group was 14.3 months, and the median progression-free survival (PFS) was 4.9 months. Treatment-related adverse events in the Imdelltra 10mg group were mostly low grade, with grade 3 or higher adverse events occurring in 29% of patients in Parts 1-2 and 15% of patients in Part 3 of the trial.Based on these results, the National Comprehensive Cancer Network (NCCN) recommends Imdelltra monotherapy as a preferred regimen for platinum-resistant patients and an alternative recommended regimen for platinum-sensitive patients. Additionally, the American Society of Clinical Oncology (ASCO) also strongly recommends Imdelltra monotherapy for patients whose disease has relapsed after chemotherapy.Meanwhile, small cell lung cancer (SCLC) accounts for approximately 10-15% of all lung cancer patients and is characterized by rapid cancer cell proliferation, leading to widespread metastasis within a short period. It is known that 6 to 7 out of 10 patients are diagnosed at the extensive stage, where cancer cells have metastasized to the opposite lung or other organs.Currently, the main treatment options for extensive-stage small cell lung cancer are limited to chemotherapy and immunotherapy, and the choices become even more limited when treatment progresses beyond the third line. Although the initial response rate to chemotherapy in small-cell lung cancer patients is relatively high, it often does not last long, and the disease tends to progress rapidly. Particularly in refractory or resistant patients whose disease progressed within 6 months after the last chemotherapy treatment, the response rate to traditional chemotherapy drops below 10%, creating a high demand for new treatment options.
