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- 2025-12-22 13:05:16
- Opinion
- [Reporter's View] Healthcare AI and diversity·expandability
- by Whang, byung-woo Mar 28, 2025 06:37am
- During the 'KIMES 2025,' held last week, artificial intelligence (AI) gained the most attention. The exhibition booths were filled with companies that showcased AI at the forefront, including hospital systems and diagnostic imaging to patient monitoring, chatbot consultations, and electronic medical records (EMR). Large booths prominently displayed slogans like 'AI-based' and 'AI solution,' drawing visitors’ attention to the cutting-edge AI technologies. With AI emerging as a spearhead of technological innovation, this emphasis was anticipated at the recent KIMES event. However, upon closer inspection, there were also elements of disappointment. Most of the AI technologies exhibited by these companies focused on aiding image interpretation and enhancing diagnostic accuracy. For instance, AI systems trained on existing medical imaging data from CT, MRI, and X-ray scans are being used to quickly and accurately identify specific diseases. Of course, in clinical settings, rapid and accurate diagnosis is critical, and a detailed review of each company’s AI innovations does reveal clear differentiators in their approaches. Although exhibition booths are limited in fully showcasing the company's strengths, one common question we encountered during our coverage was, "So, what's different?" This reaction suggests growing skepticism about whether the AI focus at this year's KIMES represents a departure from previous years. Recently, the government, industry, and the healthcare sector have all been touting the growth potential of digital healthcare and AI-driven medical innovation. Despite ongoing advancements, challenges remain with AI technology diversity. A conservative perspective still exists regarding their practical applications. As global medical device companies integrate AI into their products, domestic startups still face the challenge of overcoming capital gaps through technological advancement. Achieving diversity in AI technology is clearly a collective challenge that requires collaboration among companies, the government, and hospitals. A key hurdle is the limited accessibility of data. Due to privacy protections and legal constraints, medical data is confined mainly to major hospitals and select research institutions. To develop diverse AI solutions, diverse data from various medical institutions, patient populations, and lifestyle sources are essential. There is an urgent need to create an ecosystem that securely de-identifies such data for industrial use. It also includes accelerating the standardization of AI technologies. Differing computer systems, EMR formats, and data processing methods across hospitals impede the scalability of AI solutions. It is imperative to proactively establish related interfaces and data standards that facilitate seamless collaboration between AI companies and hospitals. Reflecting on KIMES 2025, it is clear that simply declaring 'we have adopted AI' is no longer enough to achieve differentiation. Instead, the focus must shift to 'diversity' so that AI is integrated throughout healthcare settings. Industry, policymakers, and the healthcare community must address this challenge together. We look forward to seeing even more diverse AI solutions at next year's KIMES event.
- Company
- LigaChem Biosciences invests ₩36.6B in its UK partner
- by Cha, Jihyun Mar 27, 2025 05:54am
- LigaChem Biosciences announced on the 21st that it will invest USD 25 million (about KRW 36.6 billion) in its partner, UK-based Iksuda Therapeutics, to participate in management. The first USD 15 million was invested in the fourth quarter of last year. The additional USD 10 million will be invested in the middle of this year. After the investment is completed, LigaChem Biosciences will secure a 26.6% stake in Iksuda. In addition to this equity investment, LigaChem Biosciences has also secured the right to purchase the shares of Iksuda’s existing major investors and the actual rights to the Iksuda pipeline. LigaChem Biosciences has signed an agreement with existing major investors so that the company can purchase the investors’ shares within 3 years at the investment principal. This will enable LigaChem Biosciences to secure up to 73.9% of Iksuda’s shares. This means that LigaChem Biosciences will be able to substantially lead the management of Iksuda and the development of its pipeline. Based on this investment, LigaChem Biosciences plans to accelerate the clinical development of Iksuda's ADC pipeline to bring it to the global market sooner. In particular, the company plans to speed up the technology transfer of HER2-ADC and expand and conduct additional multinational clinical trials targeting patients resistant to existing ADC competitors in the market to increase the value of the pipeline. Iksuda has introduced technologies for multiple substances from LigaChem Biosciences. It has a number of pipelines, including LCB14 (HER2-ADC), LCB73 (CD19-ADC), and IKS04 (CanAg-ADC) and IKS012 (FRα-ADC) acquired through platform technology transfers. Iksuda is working to license out a number of programs in their clinical stages, including LCB14 and LCB73, which were developed by LigaChem Biosciences, to global pharmaceutical companies. “Through this investment, we plan to focus on early clinical development and commercialization of the pipelines of both companies by utilizing the abundant clinical development capabilities of Iksuda with its specialty in the ADC field,” said Yong-Zu Kim, CEO of LigaChem Biosciences. “In addition to this investment, we plan to further strengthen open innovation to secure future growth engines to achieve VISION 2030 sooner.”
- Company
- ADC mkt leader Daiichi-Sankyo's R&D drive
- by Whang, byung-woo Mar 27, 2025 05:54am
- Daiichi-Sankyo, a company leading the antibody-drug conjugate (ADC) market, is expanding its R&D capacity through the 'Expand & Extend'-based strategy. Daiichi-Sankyo plans to focus on expanding and strengthening access through the DXd-ADC platform, which is a basis for the company's chief pipeline. Daiichi-Sankyo's chief ADC drug is Enhertu (ingredient: trastuzumab deruxtecan). Currently, Enhertu is approved in most countries for the treatment of HER2-positive breast cancer, gastric cancer, and non-small cell lung cancer (NSCLC). Recently, Enhertu received an expanded indication from the U.S. Food and Drug Administration (FDA) for the treatment of patients with 'HER2-low metastatic breast cancer who have been treated with one or more endocrine therapy sessions' and expanded its market impact. The DXd-ADC platform has been the basis of this achievement. Daiichi-Sankyo, launched after a merger between Daiichi and Sankyo, strengthened ADC technology based on a synergy between Sankyo's monoclonal antibody (mAb) technology and Daiichi's anticancer agent payload and linker technology. Previously, conventional ADCs have been limited in therapeutic effects due to ▲Lack of payload diversity ▲Heterogeneity in drug conjugation sites ▲Linker instability ▲Restrictions on the number of drugs that can be conjugated. The DXd-ADC platform gained attention because it offered improved anticancer effects and overcame existing ADC limitations. The DXd-ADC platform has been used to expand the pipeline in addition to Enhertu based on seven technological strengths, including ▲High-potency payloads ▲High drug-to-antibody conjugation ratios ▲Uniform binding between the drug and antibody. Enhertu, jointly-developed by Daiichi-Sankyo and AstraZeneca, secured the most indications and ranked the top among new ADC drugs. Enhertu recorded the highest sales in the U.S. market last year, with U.S. sales reaching 282.4 billion yen, a 36.0% increase year-over-year, and the U.S. market is expected to account for 49.0% of Enhertu's total sales in 2024. In South Korea, Daiichi-Sankyo Korea recorded sales of KRW 274 billion in 2023, the highest among Japanese pharmaceutical companies operating in South Korea. Given Enhertu's growth, its overall sales are projected to exceed KRW 300 billion in 2024. Global Sales of Major ADCs in 2023 and 2024 (unit: KRW 100 million) Daiichi-Sankyo is preparing for a new drug that is Enhertu's follow-up…focusing on expanding the pipeline Daiichi-Sankyo has been employing a '5 DXd-ADC & Next Wave' strategy, focusing its R&D capacity on five ADCs in the oncology sector and the 'Next Wave' pipeline, including products for rare diseases and vaccines. Daiichi-Sankyo's chief pipeline includes ▲TROP2-directed Dato-DXd (datopotamab deruxtecan) ▲HER3-directed HER3-DXd (patritumab deruxtecan) ▲B7-H3-directed I-DXd (ifinatamab deruxtecan) ▲CDH6-directed R-DXd (raludotatug deruxtecan). A Trop-2-directed antibody drug, Datroway, is Enhertu's follow-up drug, and it was approved by the Food and Drug Administration (FDA) in January as a breast cancer medication. Datroway is soon to be launched. Datroway can be used as a treatment for hormone receptor (HR)-positive and human epidermal growth factor 2 (HER)-negative breast cancer. Furthermore, patritumab deruxtecan is a drug candidate that is expected to receive approval this year. Clinical trials of patritumab and ifinatamab are being conducted involving patients with lung cancer and ovarian cancer, respectively. In addition, Daiichi-Sankyo is focusing on securing next-generation growth drivers by developing innovative therapies in the specialty drug and vaccine sectors, leveraging its proprietary modality technology. Jeong-tae Kim, CEO of Daiichi-Sankyo KoreaDaiichi-Sankyo has unveiled its 'Expand & Extend' strategy to provide the DXd-ADC pipeline to patients quickly. The 'Expand' strategy aims to establish a DXd-ADC treatment approach for breast and lung cancers and subsequently expand its indications to earlier treatment stages and a broader range of cancer types. Meanwhile, the 'Extend' strategy encompasses the development of next-generation ADCs and new modalities that maximize platform effects through combination therapies and formulation changes. Thus ultimately providing additional treatment options beyond DXd-ADC therapy. Jeong-tae Kim, CEO of Daiichi-Sankyo Korea, stated, "As of 2024, over 40 of our global clinical studies have been conducted in South Korea, and two Korean medical institutions have been selected among 15 Phase 1 clinical sites across eight countries, contributing from the earliest stages of clinical research." "We plan to launch four ADCs and targeted cancer agents and have substantially prepared and put efforts into leaping as a leader in the oncology sector. For instance, providing treatment options to more patients," Kim added, "In addition to distributing pharmaceuticals, we will provide pragmatic hope by leading innovations in collaboration with Korean medical communities and acting as a bridge with the headquarters."
- Company
- Alopecia areata drug Litfulo may be prescribed hospitals
- by Eo, Yun-Ho Mar 27, 2025 05:54am
- The new drug for alopecia areata, Litfulo, has landed in general hospitals in Korea. According to industry sources, Pfizer Korea's new Janus kinase (JAK) inhibitor Litfulo (ritlecitinib) has passed the drug committees (DCs) of medical institutions such as Severance Hospital, Jeonbuk National University Hospital, and Chungnam National University Hospital. The company seems to be gradually expanding its prescription area upon the drug’s official launch earlier this month. As the first drug approved for the treatment of alopecia areata in Korea for adolescent patients, Litfulo was approved by the Ministry of Food and Drug Safety in September last year. Alopecia areata is an autoimmune disease that causes patchy or complete hair loss on the scalp, face, or body. It has underlying immune-inflammatory pathogenesis and occurs when the immune system attacks the body's hair follicles, causing hair loss. An increasing number of patients have been treated for alopecia areata over the past decade, from 154,380 in 2013 to 178,009 in 2023. In general, most patients with mild cases of alopecia areata recover naturally or respond well to treatment, but commonly recur, with about 40-80% of patients experiencing recurrence within one year. “The launch of a new treatment option has brought hope to patients who have been suffering from alopecia areata for a long time and have had an unmet need. For us as healthcare professionals, the fact that a new, safe option has emerged holds significance,” said Chong-Hyun Won, a professor of dermatology at Asan Medical Center in Seoul. Meanwhile, Litfulo was approved based on the global Phase IIb/III ALLEGRO trial. The proportion of patients with a score of 20 or less on the Severity of Alopecia Tool (SALT), the primary endpoint, at Week 24, was 23% for the treatment group, which was statistically significant compared to the 2% for the placebo group.
- Company
- Ja Q Bo ₩9B, K-CAB ₩8.2B, Fexuclue ₩4.7B
- by Chon, Seung-Hyun Mar 27, 2025 05:54am
- Homegrown P-CAB class new drugs for gastroesophageal reflux disease (GERD) have begun to generate export sales. Onconic Therapeutics’ Ja Q Bo generated significantly more overseas sales than domestic sales due to the effect of its licensing out deals. HK Inno.N's K-CAB and Daewoong Pharmaceutical's Fexuclue have begun to generate export sales in earnest with their overseas launch. As P-CAB class new drugs demonstrated their marketability in the domestic market through commercial success, overseas sales are expected to grow with the increase in the number of export countries. According to the Financial Supervisory Service on the 25th, Onconic Therapeutics' Ja Q Bo generated KRW 14.8 billion in sales last year. Onconic Therapeutics, which was established in May 2020, is a new drug developer subsidiary of Jeil Pharmaceutical. Onconic Therapeutics was launched after receiving technology transfer of new drug candidates for gastroesophageal diseases and a new drug candidate for anticancer drugs from Jeil Pharmaceutical. As of the end of last year, Jeil Pharmaceutical holds a 46.28% stake in Onconic Therapeutics. Onconic Therapeutics was listed on the KOSDAQ market in December last year. Onconic Therapeutics completed clinical trials for Ja Q Bo, a P-CAB (potassium-competitive acid blocker) class new drug, and received approval for the drug as the 37th homegrown new drug in April last year. Antiulcer drugs in the P-CAB class inhibit gastric acid secretion by competitively binding to proton pumps and potassium ions located at the final stage of acid secretion in gastric parietal cells. Annual export sales of homegrown P-CAB class new drugs Last year, exports accounted for 60.8% of Ja Q Bo's sales, amounting to KRW 9 billion. Ja Q Bo began domestic sales in October last year after being listed for reimbursement in the National Health Insurance, recording KRW 5.8 billion in domestic sales. Ja Q Bo's export performance last year was due to the inflow of milestone payments from the results of the licensing-out agreement. Onconic Therapeutics has signed licensing out deals for Ja Q Bo in 21 countries. Onconic Therapeutics signed a licensing out deal with the Mexican pharmaceutical company Laboratorios Sanfer in September last year. The contract is worth up to USD 127.5 million. Onconic Therapeutics will receive an initial non-refundable upfront payment of USD 15 million and up to USD 112.5 million in milestone payments for development, licensing, and commercialization milestones. Onconic Therapeutics transferred Ja Q Bo to an Indian company in May last year. The Indian company has secured exclusive rights to the development, licensing, production, and post-launch commercialization of Ja Q Bo. The terms of the contract with the other party have not been disclosed. Ja Q Bo generated KRW 21.1 billion in exports in 2023. Onconic Therapeutics signed a licensing-out agreement for Ja Q Bo with Livzon Pharmaceutical Group, a Chinese pharmaceutical company, in March 2023. The contract size is up to USD 127.5 million. Onconic Therapeutics will receive a USD 15 million non-refundable upfront payment and up to USD 112.5 million in milestone payments for development, licensing, and commercialization. Onconic Therapeutics generated KRW 19.7 billion in sales in the first quarter of 2023. Sales of K-CAB, a new P-CAB class drug that first entered the domestic market, and Fexuclue have also been increasing gradually overseas. HK Inno.N’s K-CAB recorded KRW 8.2 billion in exports last year. This is the overseas sales of the finished drug, excluding technology fees and milestone payments. Although the overseas sales share in K-CAB's total sales of KRW 168.9 billion is negligible, the export value is continuously increasing. K-CAB recorded its first export performance of KRW 900 million in 2022 and KRW 5.5 billion in overseas sales in 2023. K-CAB was approved as the 30th homegrown new drug in 2018. HK Inno.N signed a technology export agreement with the Chinese pharmaceutical company Luoxin in 2015 and has been pushing K-CAB's overseas expansion in earnest. The contract with Luoxin is conditional on receiving a total of USD 18.5 million in technology fees upon achievement of each stage specified in the contract, including the down payment, clinical development, licensing, and commercialization. HK Inno.N In February 2019, the company signed an agreement with the Mexican pharmaceutical company Carnot to export the finished K-CAB drug to 17 Latin American countries. The contract is worth USD 84 million over 10 years, including the product supply price. HK Inno.N has since signed export contracts for K-CAB with Indonesia, Thailand, the Philippines, Mongolia, Singapore, Vietnam, Malaysia, the United States, and Canada. In January of last year, it signed a contract with Australian pharmaceutical company Southern XP to export K-CAB to Australia and New Zealand. K-CAB has been launched in 15 countries. The countries where K-CAB has been launched include China, the Philippines, Mongolia, Mexico, Indonesia, Singapore, Peru, Chile, the Dominican Republic, Nicaragua, Honduras, Guatemala, El Salvador, and Colombia. K-CAB's export performance has been boosted by its start of sales in Mongolia, China, the Philippines, and other countries starting in 2022. K-CAB set new export records in the third and fourth quarters of last year, with exports of KRW 2.5 billion and KRW 3.8 billion, respectively. K-CAB's cumulative export performance from 2022 is estimated to total at KRW 13.9 billion. This is the sales volume of K-CAB supplied by HK Inno.N. Therefore, the company estimates that the sales generated from local prescriptions on-site would be much higher. K-CAB is considered to be making a smooth start in the overseas market based on its marketability recognized in Korea. K-CAB's domestic sales last year reached KRW 160.7 billion. Daewoong Pharmaceutical's Fexuclue recorded KRW 4.7 billion in exports last year. In 2023, the company recorded its first export value of KRW 400 million, which increased more than tenfold last year. Fexuclue is the second domestically developed P-CAB class drug introduced, following K-CAB. Fexuclue is a homegrown new drug that Daewoong Pharmaceutical has successfully developed with its proprietary technology for 13 years since 2008. Daewoong Pharmaceutical Fexuclue first went on sale overseas in the Philippines in August 2023 and has begun generating export sales. Fexuclue has also been launched in Mexico, Ecuador, and Chile. Fexuclue has entered the market in 30 countries, including South Korea, or is about to enter the market. The countries that have applied for product licenses are 11 countries, including China, Brazil, and Saudi Arabia. Daewoong Pharmaceutical has signed export contracts for Fexuclue in 14 countries, including India and the United Arab Emirates. Fexuclue also made a smooth start in the domestic market. Fexuclue obtained approval from the Ministry of Food and Drug Safety in December 2021 and began full-scale sales after being listed for reimbursement with the National Health Insurance in July 2022. Fexuclue posted KRW 97.2 billion in domestic sales last year. Combined with its export performance, the company posted a total sales of KRW 102 billion, exceeding KRW 100 billion in sales for the first time in 3 years since its launch.
- Company
- Abbott, the undisputed CGM leader seeks to expand mkt
- by Whang, byung-woo Mar 26, 2025 06:01am
- Abbott, a leading player in the continuous glucose monitoring (CGM) market, is seeking to expand its influence through collaboration with a medical data platform. The goal is to provide an improved blood glucose management solution that goes beyond simply collecting data and provides a comprehensive analysis of the patient's condition. On the 25th of this month, Abbott Korea held a press conference and announced its data integration plan with Lab Connect, a medical data platform from the digital healthcare company iKooB. FreeStyle Libre 2 is a product from Abbott's Libre portfolio that allows users to check their blood glucose levels in real-time every minute, anytime, anywhere through Bluetooth. Currently, more than 6 million people in about 60 countries are using it, and is reimbursed in more than 40 countries. Nan Hee Kim, Department of Endocrinology and Metabolism, Korea University Ansan Hospital As it allows for continuous monitoring of blood sugar levels, patients can automatically receive a smartphone alarm when their blood glucose level is low or high, and can check changes in blood sugar levels according to your food intake and exercise, allowing patients to respond quickly and appropriately to changes in blood sugar levels. On this day, Professor Nan Hee Kim of the Department of Endocrinology and Metabolism at Korea University Ansan Hospital, said, “Diabetes is a chronic condition that must be managed throughout one's life, which is why steady management is important. The introduction of CGMs such as Freestyle Libre 2 has improved the quality of life of the patients and increased their understanding of blood sugar changes, enabling more efficient blood sugar management.” The company’s collaboration with iKooB is also aimed at reinforcing Freestyle Libre2’s blood glucose monitoring system. “Our partnership with iKooB is a demonstration of Abbott's commitment to providing a seamless blood glucose management solution,” said Seung-ho Kang, General manager of Diabetes Care at Abbott Korea. ”By integrating Freestyle Libre 2 and Lab Connect’s data, we will be able to further understand the patient's condition and provide treatment direction in the digital ecosystem.” Kang added, “When data-based, customized treatment becomes possible, this is expected to improve treatment efficiency and have a positive impact on preventing complications and improve the patients' quality of life.” iKooB and Lab Connect are both platforms that provide practical assistance to both medical staff and patients through a data-based approach. Jae Hyung Cho, CEO of iKooB (Department of Endocrinology, Seoul St. Mary’s Hospital) Through the partnership, healthcare professionals may comprehensively review patients' Freestyle Libre 2 data on the Lab Connect platform and establish an optimal, personalized treatment plan by analyzing the integrated health data. In addition, diabetic patients can receive a blood glucose-related data report and education from healthcare professionals, including a 14-day blood glucose trend analysis. “CGM is actively prescribed as a standard of care for patients with chronic diabetes, and its use can be maximized when integrated with other health data,” said Jae Hyung Cho, CEO of iKooB (Department of Endocrinology, Seoul St. Mary’s Hospital). ”The partnership between iKooB and Abbott will further enhance the efficiency of diabetes management.” Meanwhile, the reimbursement for Freestyle Libre 2 has been extended to cover continuous glucose monitoring systems for pregnant women with diabetes who require insulin treatment since November last year. This revision of the reimbursement standards and relevant notices has enabled for pregnant women with diabetes undergoing insulin treatment to use continuous glucose monitoring (CGM) devices, which provide real-time blood glucose levels, with reimbursement. Previously, CGM devices were only reimbursed for patients with type 1 diabetes.
- Company
- Cosentyx’s reimb for hidradenitis suppurativa unclear
- by Eo, Yun-Ho Mar 26, 2025 06:01am
- Discussions regarding the expansion of insurance reimbursement coverage for Cosentyx, a treatment option for hidradenitis suppurativa that emerged a decade after Humira, remain stalled. Novartis Korea applied then voluntarily withdrew the application for its interleukin (IL)-17A inhibitor Cosentyx (secukinumab) to extend its reimbursement to hidradenitis suppurativa (HS) in 2023 due to lack of progress. In November of the same year, the company submitted a reimbursement application again, after Cosentyx was recommended as a first-line biologic treatment option for patients with moderate-to-severe to hidradenitis suppurativa and those who have not responded sufficiently to existing systemic treatments in the European Hidradenitis Suppurativa Foundation (EHSF) guidelines that was presented at the 2024 European Association of Dermatology and Venereology (EADV 2024) Annual Congress. However, with the end of March 2025 near, discussions on expanding the reimbursement coverage of Cosentyx to hidradenitis suppurativa remain stalled. Currently, AbbVie Korea’s Humira (adalimumab) is virtually the only treatment option available for hidradenitis suppurativa in korea. Humira, a TNF-alpha inhibitor, may be prescribed with reimbursement ▲if there are lesions in two or more areas even after more than one year after diagnosis, or ▲if there is insufficient treatment effect or side effects even after 3 months of antibiotic treatment. As Cosentyx is a different IL inhibitor with a different mechanism of action that is also recommended as a first-line treatment, it can be a useful option for the management of hidradenitis suppurativa. Therefore, the industry’s eyes are on whether Cosentyx’s indication for the treatment of hidradenitis suppurativa, which has been approved for 3 years now, will be reimbursed this year. Meanwhile, Cosentyx has demonstrated its clinical utility through the Phase III SUNNY (SUNSHINE, SUNRISE) trial, which was conducted on 1,084 patients with moderate-to-severe hidradenitis suppurativa. Results showed that the HiSCR achievement rate in the Cosentyx’s group was 45% in the SUNSHINE study and 42% in the SUNRISE study when the drug was administered every 2 weeks at 16 weeks of treatment, which was a significant improvement compared to the placebo group’s 34% and 31%, respectively. In the SUNRISE study, even when the drug was administered every 4 weeks, the HiSCR achievement rate for Cosentyx was 46%, which was significantly higher than the 31% in the placebo group, and the HiSCR achievement rate of Cosentyx improved steadily until the 52nd week of treatment. Cosentyx also showed significant effects in improving patients' pain. According to the results of the SUNNY study, the NRS30 achievement rate at Week 16 of treatment was 39% in the group that received Cosentyx every 2 weeks and 36% in the group that received it every 4 weeks. On the other hand, only 27% of the placebo group achieved NRS30. Also, by week 52 of treatment, 79.6% of the Cosentyx arm who were administered Cosentyx every 2 weeks and 72.7% of those who were administered every 4 weeks did not experience disease exacerbation.
- Company
- Leclaza-Rybrevant combo rises as first-line treatment option
- by Moon, sung-ho Mar 26, 2025 06:01am
- The Leclaza-Rybrevant combination therapy, which has emerged as a standard treatment for lung cancer, is expected to be used in earnest in the domestic clinical market. This is because the larger hospitals have launched patient programs for the combination, based on results showing that the combination thearpy’s progression-free survival (PFS) period exceeds that that of Tagrisso (osimertinib, AstraZeneca) with longer overall survival (OS). # According to the medical community on the 24th, Janssen has launched a Patient Assistance Program (PAP) for the Leclaza (lasertinib, Yuhan Cor) and Rybrevant (amivantamab) combination therapy, which was approved by MFDS for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation. To improve patient access to this newly approved thearpy, the pharmaceutical company will provide partial support for drug costs with the approval of the Korea Blood Disease and Cancer Foundation. The Leclaza-Rybrevant combination therapy is attracting more attention because of the preannouncement of the Phase III MARIPOSA study, in which the combination therapy extended OS by more than a year compared to the existing standard treatment, Tagrisso monotherapy. According to the Phase III MARIPOSA trial abstract released by the European Lung Cancer Society prior to its annual congress (ELCC 2025) scheduled to be held from the 26th, the Leclaza-Rybrevant combination therapy was found to be superior to Tagrisso monotherapy in terms of OS by more than 12 months. Since Tagrisso recorded an OS of 38.6 months in the FLAURA study, which because the basis of its approval, this can be interpreted as that the OS of Leclaza + Rybrevant combo exceeds 50 months. The OS of the Leclaza + Rybrevant group had not reached the median value at 37.8 months of follow-up, but the OS of the Tagrisso monotherapy arm was 36.7 months, showing that the risk of death in the Leclaza + Rybrevant combination group was 25% lower. (HR=0.75, 95% CI 0.61-0.92, P
- Policy
- Vocabria·Rekambys newly listed…expanded reimb for Xeljanz
- by Lee, Jeong-Hwan Mar 26, 2025 06:00am
- Product photos of Vocabria, Xeljanz, and FexuclueThe HIV treatments Vocabria (cabotegravir) and Rekambys (rilpivirine) will be newly added to the National Health Insurance reimbursement list next month. The scope of reimbursement will be expanded for Pfizer's autoimmune diseases treatment Xeljanz (tofacitinib), Novartis' Cosentyx (secukinumab), and Daewoong's erosive gastroesophageal reflux disease treatment Fexuclue (fexuprazan). On March 20, the Ministry of Health and Welfare (MOHW) announced this on the administrative notification board regarding the 'Draft for Partial Revision to the Criteria and Scope of National Health Insurance (Pharmaceuticals).' The revision will be implemented on April 1, and the MOHW will collect opinions until the 24th. For HIV therapies, in addition to the conventional cocktail regimen, PrEP and three products, including Vocabria Tab 30 mg, Vocabria injections, and Rekambys injections, have been added to the National Health Insurance reimbursement list. Reimbursement is applicable only when the drugs are administered within the approved indications. The ceiling prices for Vocabria Tab 30 mg is KRW 16,303 per tablet, for Vocabria injections is KRW 991,802 per vial, and for Rekambys injections is KRW 434,550 per vial. The National Health Insurance reimbursement criteria will be added to oral tofacitinib, such as Xeljanz, to include juvenile idiopathic arthritis. Oral tofacitinib can be used to treat children (age 2 to 17) diagnosed with juvenile idiopathic arthritis according to the ILAR criteria (2001 revision), including ▲Polyarticular arthritis that affects five or more joints ▲Extended oligoarthritis ▲Psoriatic arthritis ▲Those who discontinued treatments due to inadequate response to one or more biological agent or side effects. After 6 months of usage, an additional 6-month usage will be approved if an assessment indicates a decrease of over 30% in the number of inflammatory joints compared to the initial administration timepoint. After that, the evaluation will be carried out every 6 months, and when the assessment result in the first 6 months is maintained, consistent administration will be approved. If a patient diagnosed with juvenile idiopathic arthritis before age 17, beyond the scope, subsequently uses a medication that meets the reimbursement criteria after turning 17, reimbursement will be applied. Cosentyx received an expanded reimbursement scope for chronic severe plaque psoriasis, lowering the age threshold from 18 years or older to 6 years or older. For Fexuclue, the reimbursement criteria for the 10 mg oral formulation has been updated to include "improvement of gastric mucosal lesions in acute and chronic gastritis." Additionally, for orally administered triple combination therapy for antidiabetic medications, 'triple combination therapy containing dapagliflozin+sitagliptin+metformin' has been added to reimbursed ingredients of an SGLT‑2 inhibitor, a DPP‑4 inhibitor or a biguanide product. Furthermore, the reimbursement criteria for the ENT product Ryaltris Nasal Spray Sol (olopatadine+mometasone furoate) will be expanded due to changes in its MFDS-approved labeling. Although the previous approval limited its use to patients aged 12 and older, the age range has now been extended to 6 years and above. Consequently, reimbursement is granted only for seasonal allergic rhinitis in adults and adolescents aged 12 or older, while children aged 6 to 11 will cost 100% copay. As the inclusion of the gastrointestinal drug Irricol Tab to the listing is anticipated, the existing oral product Irribow Tab (ramosetron HCl 2.5 μg and 5 μg) has been added to the reimbursement criteria.
- Company
- Beijing Hanmi Pharm posts two-fold sales·three-fold profit
- by Kim, Jin-Gu Mar 26, 2025 06:00am
- Beijing Hanmi Pharmaceutical, a local subsidiary of Hanmi Pharm in China, posted sales that approximately doubled over the past four years. The net income for the year increased more than threefold. Despite staggering performance last year, the company anticipated to be a temporary one. According to the Financial Supervisory Service on March 24, Beijing Hanmi Pharmaceutical recorded sales of KRW 385.6 billion last year. It rose by 89% compared to KRW 203.5 billion in 2020, when sales decreased due to COVID-19. The net income for the year rose 3.2-fold, from KRW 22.9 billion to KRW 74.2 billion. Beijing Hanmi Pharmaceutical has been posting sales increases since 2020. In 2020, the Chinese government closed its border in response to the COVID-19 spread. During this period, Beijing Hanmi Pharmaceutical sales decreased by 20%, and its net income for the year decreased by 39%. However, since then, Beijing Hanmi Pharmaceutical has repeated sales hikes every year until 2023. Beijing Hanmi Pharmaceutical However, sales and net income for the year were slow last year. The company explained the slowdown was caused by respiratory infections in China during the 2023-2024 period. In Q4 2023, China experienced a pneumonia outbreak caused by mycoplasma. Consequently, Beijing Hanmi Pharmaceutical's sales rose primarily due to its key product, 'Itanzing.' The company explained that the sales decrease last year was affected by this. In addition, last year, a delay in the influenza season in China compounded the situation. Typically, influenza would peak in the fourth quarter; however, the outbreak was delayed this winter. The company explained that sales temporarily declined during this period. This year, the company's performance is expected to rebound. With the flu season being delayed from Q4 last year to Q1 this year, products like 'Itanzing' are expected to generate sales. Additionally, issues related to uncollected receivables for Runmeikang are expected to normalize in the first half of the year. Following resolving a management dispute, Beijing Hanmi Pharmaceutical reinstated Lim Jong-yoon as company chairman. On February 14, Beijing Hanmi Pharmaceutical held a board meeting and appointed Lim as chairman. Previously, Lim led Beijing Hanmi for 12 years, but during the dispute, he stepped down from the chairman position, subsequently serving only as a board member.
