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- 2026-03-11 11:39:49
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- 'One year anniversary of Adtralza's launch in KOR'
- by Son, Hyung Min Apr 23, 2025 06:12am
- Shin Jung-bum, CEO of Leo Pharma Adtralza, which debuted in the market last year, has been shown to improve the quality of life for atopic dermatitis patients during its first year of domestic launch. Experts note that its effectiveness in areas such as the head and neck, where symptoms are more visible, could lead to broader applications. On the 22nd, LEO Pharma held a press conference at the Andaz Hotel in Apgujeong-dong, Gangnam-gu, Seoul, to celebrate the first anniversary of Adtralza’s launch. Adtralza is a biological agent that selectively acts on interleukin (IL)-13 and was approved for reimbursement in May last year as a treatment for chronic severe atopic dermatitis in adults and adolescents. IL-13 is a key cytokine that triggers symptoms and signs of atopic dermatitis, including immune regulation and skin barrier dysfunction. It is known to be overexpressed in the skin with atopic dermatitis symptoms and is associated with the disease severity. Previously, Dupixent, which inhibits IL-4 and IL-23, and Rinvoq, a JAK inhibitor, were primarily used to treat atopic dermatitis. However, the introduction of Adtralza has expanded treatment options. Given that atopic dermatitis is a chronic condition with no cure and a long treatment duration, diverse treatment options are essential. In particular, since March, switching between JAK inhibitors and biological agents has been approved for reimbursement, leading to predictions that the use of Adtralza may increase in the future. Adtralza has demonstrated efficacy and safety in the Phase III ECZTRA3 and ECZTEND studies. The ECZTRA3 trial compared Adtralza with placebo in patients aged 18 years and older with moderate-to-severe atopic dermatitis who had previously failed to respond adequately to topical therapy or required systemic treatment. The primary endpoints were the proportion of patients achieving an improvement in the Validated Investigator Global Assessment scale for Atopic Dermatitis (IGA) to 0 or 1 at Week 16, and the proportion of patients achieving EASI-75 (75% or greater reduction in the Eczema Area and Severity Index (EASI) score from the baseline) The clinical results showed that Adtralza achieved an EASI-75 response rate of 56.0%, an improvement compared to 35.7% in the placebo group. The proportion of patients with an IGA score of 0 or 1 at Week 16 was 38.9% in the Adtralza group and 26.2% in the placebo group. The ECZTEND study evaluated the long-term efficacy of Adtralza. In the clinical trial, 84.5% of patients treated with Adtralza for 4 years achieved EASI-75. Adtralza also demonstrated efficacy in patients with atopic dermatitis in the difficult-to-treat head and neck area. A key advantage of Adtralza is its convenience of administration. While Dupixent requires administration once every two weeks, Adtralza can be administered once every four weeks in patients with clear or almost clear skin after 16 weeks of treatment, based on the judgment of a healthcare professional. Currently, LEO Pharma is conducting clinical studies on patients with hand eczema and pediatric patients aged two years and older. The company also plans to add a pen-type formulation to further improve patient convenience. Dong-Hoon Lee, professor of Dermatology at Seoul National University Hospital Dong-Hoon Lee, professor of Dermatology at Seoul National University Hospital, said, “Adtralza showed consistent efficacy in real-world studies, as in clinical trials. In particular, it showed improved symptoms in patients who switched to Adtralza from existing treatments.” He added, “Treatment is particularly difficult when atopic dermatitis occurs on the hands or head and neck, but symptoms improved in these patients as well when treated with Adtralza.” Ji-Hyun Lee, professor of dermatology at Seoul St. Mary Ji-Hyun Lee, professor of dermatology at Seoul St. Mary's Hospital, said, “Although biological agents have emerged for atopic dermatitis, lesions often remain in the head and neck area, such as the face and neck. It is known that 17% of patients who are treated with Dupixent experience conjunctivitis. This remains an unmet need for patients who must continue with their social lives.” She added, “Adtralza has been confirmed to reduce EASI scores uniformly across various body areas, including the head and neck and limbs. If visible lesions do not improve, this can significantly impact the quality of life. Since Adtralza has a low incidence of conjunctivitis as a side effect, it may be considered as an alternative to existing treatments like Dupixent if conjunctivitis occurs during their use.” Professor Lee noted, “Currently, there is limited active switching between treatments. However, some patients may benefit from switching, so I anticipate that this will become more common in the future.”
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- Multinational pharma's ave. salaries amount to KRW 100m
- by Son, Hyung Min Apr 22, 2025 05:59am
- Last year, the average annual salary for employees at the Korean subsidiaries of major multinational pharmaceutical companies surpassed KRW 100 million, with Sanofi‑Aventis Korea and Gilead Sciences Korea close to KRW 150 million. According to an analysis of the 2023 audit reports filed by 30 foreign pharma subsidiaries on the Financial Supervisory Service (FSS)’s web board on April 21, the average basic salary per employee amounted to KRW 105.2 million, and 18 of those companies reported average pay above KRW 100 million. The average salary per individual reflect only base salaries as disclosed in the audit reports, excluding fringe benefits, bonuses, performance incentives, and retirement payments are excluded, so actual take‑home pay may differ slightly. 2023 Annual Salaries for Employees at the Korean Subsidiaries of Major Multinational Pharmaceutical Companies Sanofi‑Aventis Korea ranked the highest, with an average annual salary of KRW 147.31 million. Last year, its total salary expense rose 61.8% to KRW 53.62 billion from KRW 33.13 billion in 2022, even though its headcount fell by six to 370 employees. Performance‑related pay also climbed markedly, with the company disbursing KRW 3.29 billion in incentives, up 30.9% from the prior year. Gilead Sciences Korea ranked second, with its average per individual salary rising from KRW 128.60 million in 2023 to KRW 141.32 million last year. Its total payroll expense increased by 14.5%, from KRW 11.61 billion in 2023 to KRW 13.28 billion. Boehringer Ingelheim Korea also saw substantial growth in compensation. With headcount unchanged at 164 employees, its average salary climbed by 9.4% to KRW 139.80 million, and total salary outlays rose by KRW 775.35 million. Pfizer Korea’s average salary jumped to KRW 126.24 million, up roughly KRW 25 million from KRW 99.95 million the year before. The primary driver was a global early‑retirement program (ERP). Pfizer implemented a global restructuring initiative throughout 2023 and into last year in response to a sharp decline in vaccine and therapeutic revenues following the transition to endemic COVID‑19. This strategic decision also led to workforce reductions at its Korean subsidiary. Pfizer Korea's ERP led to a headcount reduction from 454 in 2023 to 404 last year; severance pay paid under that program totaled KRW 5.335 billion, a 279.9% increase over 2023. At Kyowa Kirin Korea, severance costs outstripped total salaries. While the company paid out KRW 8 billion in salaries, it recorded KRW 26 billion in retirement benefits. Kyowa Kirin implemented ERP last year. Kyowa Kirin's Asia‑Pacific restructuring last year included selling its China unit to Hong Kong’s Winhealth Pharma Group and transferring domestic and key Asia promotional and distribution operations to DKSH. Kyowa Kirin sells a portfolio of novel therapies, such as the erythropoiesis‑stimulating agent 'Regpara,' anemia treatment 'Nesp,' and neutropenia therapy 'Neulasta,' and reported stable sales of KRW 92.4 billion in 2022 and KRW 98.3 billion last year. The company says it has restructured to focus on its new pipeline in antibody and cell & gene therapies. Other multinational subsidiaries paying average salaries above KRW 100 million include Viatris Korea, Ipsen Korea, UCB Korea, GSK, Janssen Korea, Ferring Korea, AbbVie Korea, BMS Korea, LundBeck Korea, Abbott Korea, Galderma Korea, and AstraZeneca Korea. Some firms may have higher take‑home pay than reported salary. For example, MSD Korea, which reported an average salary of KRW 67.7 million, logs portions of its R&D and other staff compensation under operational research and development expenses or cost of goods sold rather than base payroll. Otsuka Korea reported KRW 24.7 billion in selling and administrative payroll expenses, contrasting with KRW 47.0 billion. The company recognizes some units' salaries as employee‑related costs because certain departmental salaries are classified under production or R&D.
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- Darzalex SC may be prescribed at general hospitals in KOR
- by Eo, Yun-Ho Apr 22, 2025 05:59am
- The subcutaneous injection formulation of the multiple myeloma drug Darzalex may now be prescribed at general hospitals in Korea. According to industry sources, Janssen Korea's Darzalex SC (daratumumab) has passed the drug committees (DCs) of tertiary hospitals in Korea, such as the Seoul National University Hospital and Seoul Asan Medical Center. Darzalex SC dramatically reduces administration time and infusion-related reactions compared to existing intravenous drugs and is approved for a total of 6 indications and five regimens. It was approved in Korea in 2020. The SC formulation was approved for a total of 6 indications and 5 regimens, including “combination therapy with bortezomib, melphalan, and prednisone (DVMP) for newly diagnosed multiple myeloma patients who are not candidates for autologous stem cell transplant” and “combination therapy with bortezomib, thalidomide, and dexamethasone (DVTd) for newly diagnosed multiple myeloma patients who are candidates for autologous stem cell transplant,” and “combination therapy with lenalidomide and dexamethasone (DRd) for newly diagnosed multiple myeloma patients who are not candidates for autologous stem cell transplants.”. Also, the drug can be used by “patients with relapsed or refractory multiple myeloma who have received at least one prior therapy lenalidomide in combination with dexamethasone (DRd) for;” “patients with multiple myeloma who have received at least one prior therapy with bortezomib and dexamethasone (DVd)” and “patients with refractory multiple myeloma as monotherapy after they have failed at least 3 prior therapies, including each of a proteasome inhibitor and an immunomodulatory agent.” Among the indications, the drug’s reimbursement coverage was extended in February to cover its use as first-line therapy as part of a four-drug combination therapy (DVTd therapy) that includes Darzalex in patients with multiple myeloma who are eligible for autologous stem cell transplant. Darzalex SC is a fixed-dose formulation that can be administered over approximately 3-5 minutes. This is a significant reduction in dosing time compared to the 3.5 to 6.5 hours required for intravenous Darzalex. In addition, the incidence of systemic infusion-related reactions was reduced by two-thirds compared to intravenous Darzalex, which is expected to significantly improve patient convenience and potentially deliver efficiencies in the multiple myeloma treatment setting. Meanwhile, the US-based Halozyme Therapeutics’s human hyaluronidase technology enabled the formulation change of Darzalex. Halozyme and the Korean company Alteogen are companies that are attracting attention globally for their SC formulation change technology. Drug delivery to the subcutaneous tissue has been challenging due to its hyaluronic acid protection. However, the use of “human hyaluronidase” enables the breakdown of hyaluronic acid. The SC formulation change technology enhances the permeability of subcutaneous tissue, allowing the drug to rapidly disperse in the subcutaneous tissue and be absorbed into the bloodstream.
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- Can 'indication-based pricing' become a reality?
- by Moon, sung-ho Apr 22, 2025 05:58am
- With the presence of anti-cancer drugs in the clinical field becoming more prominent in recent years, multinational pharmaceutical companies have been calling for a new reimbursement system. In addition to existing immuno-oncology drugs, the emergence of antibody-drug conjugates (ADCs) has increased the number of treatments that are effective against multiple cancers, and the industry requests different drug prices to be applied for each so-called 'indication.’ In fact, the multinational pharmaceutical industry has been requesting so for the past decade, but it hasn't made much of a difference. However, as obesity drugs have expanded their indications to include diabetes, cardiovascular disease, and metabolic dysfunction-associated steatohepatitis (MASH), the debate is no longer limited to anti-cancer drugs. # According to industry sources on the 21st, immuno-oncology drugs or ADCs with indications for various cancers have recently been introduced into the domestic clinical field, and opinions have been raised that different drug prices should be applied to the same drug for different indications. This method - Indication-based pricing (IBP) - is a further subdivision of value-based pricing (VBP), which states that drug prices should reflect the actual value of drugs. Currently, the single-price policy utilized by Korea’s health insurance system is based on the initial indication. For each additional indication, the existing drug price must be reduced to cover the expanded area of reimbursement. For example, if an A immuno-oncology drug is first approved for lung cancer, and then expands its indications to include gastric and breast cancer, the existing drug price must be reduced through pricing negotiations as its use in practice increases under the current system. In other words, the more you expand reimbursement by adding indications, the more you have to reduce the drug price. The problem is that as the number of therapies with indications for multiple cancers, such as major immuno-oncology drugs and ADCs, grows, so does the demand for their reimbursement, and the current single-price policy cannot accommodate them all. So the more approvals for indications and reimbursement the pharmaceutical companies receive, the more pressure they face to reduce drug prices. As a result, the Korean Research-based Pharmaceutical Industry Association (KRPIA) recently requested the government to launch pilot projects on 'blended pricing' (indication-weighted average price) and 'differentiated reimbursement rates by indication' within the framework of Korea’s risk-sharing agreement (RSA) system. Blended pricing is a system that has been implemented in Italy, France, Japan, and other countries. The idea is to set a single price for a drug, but calculate a weighted average price for each indication based on expected usage and clinical value. The main content is to agree on a single price for the same drug while adding reimbursement in consideration of the increased patient and input of financial resources when the reimbursement standard is extended. The industry request is for the blended pricing system to be introduced first, then the risk-sharing system to be improved by applying differential reimbursement rates by indication. In this regard, Ewha Womans University Professor Jung Hoon Ahn (College of Science& Industry Convergence) recently published a study on 'Reimbursement Policy for Multiple Indication Drugs' sponsored by AstraZeneca. In fact, it reflects the will of the multinational pharmaceutical industry, led by the KRPIA, to introduce the system. “The blended pricing method is highly feasible in the domestic reimbursement and drug pricing environment,” said Professor Ahn. “Blended pricing can be implemented in the legal contract stage, applying it at the risk-sharing agreement scheme stage.” “Blended Pricing can be applied within the risk-sharing framework to reflect the value of drugs per indication while managing the financial risk of drugs with uncertain cost-effectiveness,” he said. ”Combined with a structure that allows for reassessment based on actual usage data or adjustments to reimbursement terms based on indication-specific usage, this can increase policy flexibility and feasibility.” As the multinational pharmaceutical industry has been pushing for the introduction of the program, attention has naturally turned to the government’s acceptance. While the need to introduce the system is well understood, as it has been called for more than a decade, there is also consensus that the agenda is not urgent enough to prioritize and pilot quickly in the course of Korea’s current health insurance system. At the same time, there is also an opinion some companies have been particularly exerting their influence among multinational pharmaceutical companies. There are doubts that the benefits of its institutionalization may be concentrated on certain pharmaceutical companies. This would naturally lead to equity issues with other pharmaceutical companies and the domestic pharmaceutical industry. A law firm advisor who serves as a high-ranking government official gave a sobering assessment, saying, “The multinational pharmaceutical industry has been asking for such a system, but it is doubtful that social consensus can be made on this, regardless of whether the government accepts it or not.” “The key to the indication-based drug pricing system is to accurately predict the usage of each drug,” he said. ”Even now, when discussing expanding the scope of use of a drug, the price is reduced in anticipation of the increased volume. However, when we look at future outcomes, it often doesn't work well,” he said. In other words, it is difficult to introduce blended pricing at a time when even the estimated usage for risk-sharing is not always accurate. It is theoretically possible, but it is difficult to apply it in practice. “If there is a need to introduce the system, the government should prioritize judging its effectiveness through research services,” said HIRA Director Kook-Hee Kim. “No proper monitoring has been made yet. The weighted average should be discussed every time the number of therapeutic indications increases and the impact should be analyzed in various ways,” indicating that it is a long-term challenge.”
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- Zuellig Pharma's performance fluctuates after a brief reboun
- by Son, Hyung Min Apr 21, 2025 05:54am
- Zuellig Pharma Korea, a global pharmaceutical distributor that had experienced ups and downs in its external growth, successfully rebounded last year. Zuellig Pharma's sales declined for 4 consecutive years after recording sales of over KRW 1 trillion in 2020 but showed signs of recovery by taking on the domestic distribution of new drugs from multinational pharmaceutical companies. According to the Financial Supervisory Service on the 18th, Zuellig Pharma's sales last year were KRW 889.3 billion, up 4.8% from the previous year. Operating profit was KRW 4.3 billion, similar to the previous year. Zuellig Pharma is the Korean subsidiary of a Swiss global pharmaceutical distribution company that entered the Korean market in 1998. As the first global distributor to enter the Korean market, it faced strong opposition from the domestic industry. The Korea Pharmaceutical Distribution Association formed the Zuellig Countermeasures Committee and took strong measures to prevent Zuellig Pharma from monopolizing the supply of global pharmaceutical companies' products. Nevertheless, Zuellig Pharma's sales continued to grow until 2021. The company's sales grew steadily from KRW 706.9 billion in 2015 to KRW 889.4 billion in 2016, then to KRW 970.9 billion in 2017. Zuellig Pharma recorded KRW 1.184 trillion in 2019, becoming the third company to exceed KRW 1 trillion in sales after Geo-Yong and Baekje Pharmaceutical. The company maintained its status in the trillion-won club in 2020 with sales of KRW 1.0372 trillion, but sales fell to KRW 910 billion the following year. In 2022, sales amounted to KRW 885.3 billion, a 2.7% decrease from the previous year. In 2023, sales decreased by 4.1% year-on-year to 850 billion won. Zuellig Pharma was hit hard by changes in the drug distribution environment. Before, Zuellig Pharma had grown through exclusive deals with multinational pharmaceutical companies. In particular, domestic drug distributors had to sign wholesale contracts with Zuellig Pharma in order to distribute drugs from multinational pharmaceutical companies. However, major multinational pharmaceutical companies began to utilize the distribution networks of Korean pharmaceutical companies, forging co-promotion agreements with domestic companies, gradually reducing Zuellig Pharma's market share. In addition, domestic pharmaceutical distributors obtained distribution rights through direct contracts with multinational pharmaceutical companies, reducing Zuellig Pharma's main source of revenue. For example, Geo-Yong directly distributes UCB Korea’s allergy treatment Zyrtec, and psoriasis treatment Bimzelx. Geo-Yong is also selling over-the-counter (OTC) drugs from multinational pharmaceutical companies, such as the contraceptive Mercilon. Furthermore, major domestic companies have established new logistics systems such as 3PL and 4PL to enhance their competitiveness. Logistics systems are categorized into four types (1PL/2PL/3PL/4PL) based on their structure. 3PL refers to outsourcing logistics operations to external companies, while 4PL refers to customized services that not only outsource logistics but also provide consulting on suitable logistics systems and IT-related solutions. Larger companies have adopted integrated logistics strategy models, establishing their own logistics IT systems and strengthening order, receivables, and collection management functions. As a result, Zuellig Pharma now faces competition in the utilization of 3PL/4PL logistics systems as well. In particular, domestic companies have equipped themselves with cold chain systems and are distributing major biological products such as Dupixent, putting a brake on Zuellig Pharma's external growth. Operating profit rebounded, but competition intensified In addition to Zuellig Pharma, other global pharmaceutical distribution companies such as DKSH and DB Schenker Korea, as well as domestic firms like Pico Innovation and Bluemtec have established online platforms, intensifying market competition. However, Zuellig Pharma managed to rebound last year with its first sales increase in 4 years. In particular, operating profit has also improved recently. Zuellig Pharma posted operating losses every year from 2017 to 2021. However, in 2022, it returned to profit for the first time in about 7 years with KRW 900 million. In 2023 and last year, it recorded KRW 4.3 billion, showing growth. Zuellig Pharma succeeded in increasing its operating profit by improving its cost ratio along with a reduction in sales and administrative expenses and employee wages. Thanks to its improved performance, Zuellig Pharma emerged from total capital erosion, which had continued for 2 years since 2020. Total capital erosion refers to a state in which a company's deficit grows so large that its surplus runs out and even its paid-in capital is eroded, resulting in negative total capital. Zuellig Pharma was in a state of complete capital erosion in 2020 and 2021, with total capital of – KRW 1.5 billion and -KRW 14.5 billion, respectively. Zuellig Pharma plans to achieve growth in sales and operating profit through the distribution of innovative new drugs. Last year, Zuellig Pharma became responsible for the distribution of the obesity treatment drug Wegovy. Wegovy is a glucagon-like peptide (GLP-1) obesity treatment that recorded sales of over KRW 60 billion in the fourth quarter of last year alone. Zuellig Pharma successfully secured the distribution rights for Wegovy thanks to its experience in distributing the obesity treatment Saxenda. Zuellig Pharma will also be responsible for the domestic distribution of the immuno-oncology drug Libtayo. Libtayo (cemiplimab) is currently approved in South Korea as a first-line monotherapy for advanced non-small cell lung cancer and as a treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) and recurrent or metastatic cervical cancer. Last year, Zuellig Pharma also formed a partnership with European consumer healthcare company Karo Healthcare to target the Asian market and signed a domestic distribution agreement for the athlete's foot treatment Lamisil.
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- Sanofi’s MenQuadfi to be launched soon in Korea
- by Whang, byung-woo Apr 21, 2025 05:54am
- Sanofi's next-generation meningococcal vaccine is set to launch just 1 year after receiving approval in Korea, signaling the start of intense market competition. Pic of MenQuadfi According to industry sources, Sanofi is preparing to launch its invasive meningococcal disease vaccine MenQuadfi in the third quarter of this year. MenQuadfi is a fully liquid vial quadrivalent meningococcal vaccine that prevents meningococcal serotypes A, C, W, and Y, and is approved for a single dose for individuals aged 2 to 55 years. When compared for immunogenicity with existing quadrivalent meningococcal vaccines, MenQuadfi demonstrated non-inferiority for all four serotypes. Unlike Sanofi's existing meningococcal vaccine, which utilized the diphtheria toxid protein, MenQuadfi utilizes the tetanus toxoid protein and has increased antigen amount. Currently available meningococcal vaccines include GSK Korea’s Menveo and Sanofi’s Menactra. Both vaccines are indicated for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W135, and Y. With the launch of MenQuadfi, the competitive landscape is expected to shift from “Menveo vs. Menactra” to “Menveo vs. MenQuadfi.” Sanofi has decided to discontinue Menactra upon the launch of MenQuadfi, but the exact timing of supply discontinuation will be dependent on market inventory levels. A Sanofi representative stated, “We decided to launch MenQuadfi based on the high demand for Menactra in the global market and the expansion of its indications. As a result, we have decided to discontinue Menactra. We will do our utmost to ensure an uninterrupted supply of meningococcal vaccines in the Korean market by adjusting the launch schedule of MenQuadfi in accordance with the depletion of Menactra inventory.” One of the differences between Menactra and MenQuadfi is the age at which they can be administered. Menactra can be administered from 9 months of age, while MenQuadfi is currently available as a single dose for individuals aged 2 to 55 years. However, as the age range for MenQuadfi is being expanded, the vaccine is expected to naturally replace Menactra in the market. In particular, while Menactra contained 4ug of meningococcal serum antigen, MenQuadfi contains 10ug of all four antigens. Meningococcal vaccination costs, from left, GSK Menveo Sanofi Menactra (Data = HIRA Before MenQuadfi’s launch, GSK had already launched Bexsero, a meningococcal group B absorbed vaccine. Bexsero is a vaccine for preventing meningococcal group B infections and differs from the existing Menveo in its scope of prevention. In other words, GSK has introduced a new meningococcal vaccine with a different scope of prevention, while Sanofi has unveiled a next-generation vaccine with enhanced prevention effects. According to IQVIA data, Menveo's sales in 2023 were KRW 52 billion, while Menactra's sales were KRW 5 billion. Given the significant sales gap between the two products, both companies are expected to focus on increasing their market share with the launch of next-generation vaccines. However, meningococcal vaccines are not classified as essential vaccines and are classified as premium vaccines, so price accessibility is expected to be an important factor. According to the Health Insurance Review and Assessment Service's non-reimbursable medical expenses, Menveo costs an average of KRW 142,805, while Menactra costs an average of KRW 142,072.
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- Roche Korea's 'Lunsumio' available at general hospitals
- by Eo, Yun-Ho Apr 21, 2025 05:54am
- Product photo of Lunsumio The first GIFT-designated drug 'Lunsumio' can now be prescribed in general hospitals. According to industry sources, Roche Korea's CD20xCD3 bi-specifc antibody 'Lunsumio (mosunetuzumab)' has passed the drug committee (DC) of Asan Medical Center in Seoul. Lunsumio is the first medicine to be designated as a 'Global Innovative products on Fast Track (GIFT)' and obtained approval from the Ministry of Food and Drug Safety (MFDS) in November 2023. This drug can be prescribed for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more systemic therapies. However, Lunsumio remains a non-reimbursed drug. Roche has applied for the 'approval-assessment package system,' in addition to the GIFT designation, but discussions on reimbursement have yet to progress. FL is a type of non-Hodgkin Lymphoma (NHL) that occurs when cells in the lymph system turn malignant. Because the symptoms of the disease progress slowly, about 80% of the cases are identified at stage III or Stage IV after the disease progresses. The prognosis for patients who relapse is poor. Median progression-free survival (mPFS) is 10.6 years for patients who received first-line treatment; however, mPFS drops to two years with third-line treatments, representing about 20%. Lunsumio is the first-in-class CD20xCD3 bi-specific antibody involving T cells for relapsed or refractory FL. It simultaneously binds to a protein CD3 on the surface of T cells, which are types of white blood cells and immune cells, and protein CD20 of the malignant B cell surface, designed for T cells to target B cells. It is a readily applicable product that can be administered without waiting for manufacturing, and patients can be treated without hospitalization. The administration duration is fixed to eight cycles. During this period, when a patient does not reach complete remission, the drug administration can be extended to 17 cycles. Professor Won Seog Kim of Samsung Medical Center's Hematology and Oncology said, "FL is considered a good type of lymphoma with a life expectancy of 20 years, but as patients experience repeated relapses, the disease becomes aggressive, and the prognosis worsens. Therefore, an effective treatment regimen with expected remission was urgent for patients with FL who have relapsed two or more times."
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- Hope for polycythemia vera, Besremi, makes reimb progress
- by Eo, Yun-Ho Apr 21, 2025 05:53am
- Industry attention is gathering on the insurance reimbursement progress for the polycythemia vera treatment, Besremi. According to industry sources, PharmaEssentia Korea's new drug for polycythemia vera, Besremi (ropeginterferon alfa-2b-njft), has been determined cost-effective by the Health Insurance Review and Assessment Service's Pharmacoeconomic Evaluation Subcommittee. Accordingly, the procedure will proceed depending on whether the company accepts the government's proposal. As Besremi will gain a unique status in the field when listed, the industry expects the company and the government to derive positive results. This is the second attempt for Besremi’s reimbursement listing in Korea. In March 2023, the drug underwent the reimbursement process for refractory or intolerant polycythemia vera but failed to pass the Cancer Disease Review Committee in July of the same year. At the time, the Cancer Disease Review Committee determined that there was insufficient evidence to judge the clinical utility of Besremi as a second-line treatment. In response, PharmaEssentia resubmitted its application for reimbursement in March after adding domestic clinical data on Besremi and supplementing the evidence on the drug’s efficacy as second-line therapy, and the application passed CDDC review in July of the same year. At that time, the Cancer Disease Review Committee established the reimbursement standards for Besremi as a treatment for patients with polycythemia vera without splenomegaly accompanied by symptoms in low-risk groups (limited to patients requiring cytoreductive therapy) and high-risk groups. Besremi is a next-generation interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera. It was developed to improve the purity and tolerability of existing interferons so that it can be administered every two weeks for the first 1.5 years and every four weeks thereafter. It is currently recommended for the treatment of PV in the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of prior treatment history. Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells. According to HIRA data, about 5,000 patients are affected with PV in Korea, and hydroxyurea is mainly used for the majority of patients. However, as the current reimbursed drugs are not curative and there are no new alternatives for patients who fail hydroxyurea treatment, there remains a high unmet need for the disease.
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- Vocabria+Rekambys may be prescribed in general hospitals
- by Eo, Yun-Ho Apr 18, 2025 05:59am
- The long-acting HIV drug Vocabria+Rekambys combination therapy may now be prescribed in general hospitals in Korea. According to industry sources, GSK Korea’s Vocabria (cabotegravir) and Janssen Korea’s Rekambys (rilpivirine) combination passed the drug committees (DCs) of various medical institutions in Korea, including Korea University Anam Hospital, Konkuk University Medical Center, Kyungpook National University Hospital, and Chung-Ang University Hospital. The combination has been gradually expanding its prescription areas before and after the reimbursement listing this month (April). The upper insurance price ceiling for Vocabria 30mg is KRW 16,303 per tablet and KRW 991,882 per vial. The Vocabria+Rekambys combination was approved by the Ministry of Food and Drug Safety in February 2022 as a combination therapy for the treatment of HIV-1 infection in adult patients who are virologically suppressed, have no history of virological failure, and have no known or suspected resistance to cabotegravir or rilpivirine. The advantage of this combination therapy is undoubtedly its convenience in administration. While existing HIV treatments require patients to take a tablet formulation once a day, the two injectable drugs will reduce the frequency of administration to once a month or once every two months with intramuscular injections, increasing satisfaction and reducing the burden on patients. The two drugs were originally developed as oral medications and then were developed into injectable drugs. While this long-acting injectable drug cannot cure HIV infection, it is a treatment that targets white blood cells to help lower and maintain the level of the AIDS virus. Meanwhile, the efficacy and safety of the Vocabria+Rekambys combination therapy was demonstrated in clinical trials in groups that received the drug once every four weeks or once every eight weeks. The combination was approved in Europe in December 2020. In the clinical trial, the most frequently observed adverse reactions in the group that received the Vocabria+Rekambys combination were injection site reactions, headache, fever, nausea, fatigue, asthenia, and myalgia. In addition, the indication for combination therapy has been expanded to include adolescent patients in Europe.
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- KDDF "Continuity is important for support in new drug R&D"
- by Whang, byung-woo Apr 18, 2025 05:57am
- The Korea Drug Development Fund (KDDF), celebrated fourth year since launch, has emphasized its role as a 'supporter' rather than a 'management' in advancing successful new drug development. As it enters its fifth year and reaches a midpoint of the project duration, KDDF has emphasized the need for continuity and a centralized control tower. KDDF Ceo Park Yeong-min On April 17, KDDF Ceo Park Yeong-min held a press briefing to share the KDDF's achievements and future strategies on its fourth anniversary. KDDF program supports the entire drug development lifecycle, including candidate discovery, preclinical studies through Phase 1 and 2 clinical trials, and commercialization. It is a multi‑ministerial R&D initiative with KRW 2.1758 trillion (KRW 1.4747 trillion in government funding and KRW 701.1 billion in private investment) allocated over ten years through 2030. Since its 2021 launch, KDDF has supported 423 pipeline projects and plans to add 128 new projects this year, bringing its total to approximately 550. Ultimately, KDDF aims to strengthen the R&D ecosystem by improving the success rate of early‑stage technologies progressing to later development stages and building biotech venture capabilities. Furthermore, KDDF assists with global partnering and investment attraction to generate practical outcomes such as blockbuster new‑drug approvals and global technology transfers. As it reaches the midpoint of its ten‑year plan, KDDF will focus on enhancing its commercialization support this year alongside ongoing target and modality projects. To achieve these goals, KDDF has increased clinical project funding by 30%, raising support to KRW 4.55 billion for Phase 1 trials and around KRW 9.1 billion for Phase 2 trials. Previously, KDDF capped support at KRW 2 billion for non-clinical stages, KRW 3.5 billion for Phase 1, and KRW 7 billion for Phase 2. Park stated, "We aim to discover globally competitive molecules and will focus on new targets and modalities," and added, "By optimizing our commercialization support, KDDF can pioneer a new R&D model." "We will expand programs to resolve drug‑development bottlenecks and strengthen global competitiveness. KDDF will not merely provide support, but we will establish an efficient R&D structure." During the meeting, KDDF stressed that as a sunsetting program, it requires guaranteed continuity given the long timelines inherent in new‑drug development. Park said, "KDDF is a sunsetting program that must undergo a feasibility reassessment after ten years, which can create inefficiencies in later stages," and added, "Since the government has designated the bio‑pharma industry as a future growth engine, the organization supporting frontline drug development must operate without interruption." KDDF succeeded the previous multi‑ministerial new drug development program, which ran from 2011 until its closure in September 2020, and KDDF then launched in 2021. However, there was a roughly six‑month gap between the predecessor program's end and KDDF's launch, during which small biotech firms reportedly faced support disruptions that delayed their R&D for over six months. Given KDDF's fixed ten‑year timeframe, experts have called for follow‑up measures to ensure domestic drug developers do not abandon projects due to support gaps. Park said, "We need to double the budget for drug development to support more companies. New policy measures, such as supporting potential K‑Big Pharma, are needed so that KDDF could serve as the control tower for Korea's pharmaceutical and biotech industry."
