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- 2026-04-03 12:18:20
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- Vemlidy indication extended to children aged 6 and older
- by Whang, byung-woo Jun 25, 2025 06:01am
- Pic of Vemlidy Gilead Sciences Korea announced on the 24th that its hepatitis B treatment Vemlidy (tenofovir alafenamide, TAF) has been approved by the Ministry of Food and Drug Safety for the treatment of chronic hepatitis B in children aged 6 years and older. Vemlidy offers improved renal and bone safety compared to existing chronic hepatitis B treatments. The long-term efficacy and safety profile for hepatitis B, which requires prolonged treatment like chronic diseases, has been demonstrated through various clinical studies, including 8-year clinical data. With this extended indication, Vemlidy has become the only treatment option available in Korea for patients as young as 6 years of age, the lowest age among tenofovir formulations currently available in the country. Previously, treatment options for chronic hepatitis B were limited to ▲entecavir formulations (for patients aged 2 years and older) ▲TDF drugs such as Viread (for patients aged 12 years and older) ▲TAF drugs such as Vemlidy (for adults). However, with the approval, pediatric patients aged 6 years and older weighing at least 25 kg may now access a treatment that has high viral suppression rates confirmed by long-term data and improved outcomes in terms of kidney function and bone density. This indication expansion applies only to Vemlidy and will not apply to its generic version for 4 years from the date of approval. The dosage is the same as for adults: one tablet once daily, regardless of food intake. This indication expansion approval was based on the results of a global clinical trial in pediatric and adolescent patients with chronic hepatitis B (CHB). The study was a randomized, double-blind, placebo-controlled clinical trial involving 88 patients aged 6 to 18 years with chronic hepatitis B. The trial was converted to an open-label design after 24 weeks and continued for 96 weeks. Results showed that the viral suppression rate (HBV DNA
- Company
- K-Bio successfully signs multiple technology transfer deals
- by Son, Hyung Min Jun 25, 2025 06:01am
- In the first half of this year, the Korean pharmaceutical and biotech industry has successfully achieved technology transfers in various areas, including changed formulations for immunotherapy, new obesity drug candidates, and new drug discovery platforms. Companies, such as LigaChem Biosciences and Onconic Therapeutics, have successfully received additional milestones from clinical achievements of previously exported new drug candidates. Technology transport deals continue to yield accomplishments this year According to the Financial Supervisory Service (FSS)'s electronic disclosure system on June 24, Abion posted that it has recently signed a technology transfer agreement with an overseas pharmaceutical company for its 'ABN501,' a new protein antibody drug candidate. The contracting party remains undisclosed. Through this agreement, Abion will conduct non-clinical research on five protein targets, including Claudin 3 (CLDN3), targeted by ABN501, while the contracting party will handle other research, development, and commercialization. The license is valid worldwide. The upfront payment is set at $25 million, with $5 million per targeted antibody. The total contract value amounts to $1.315 billion (approximately KRW 1.8 trillion), including $290 million in development-stage milestones and $1 billion in commercialization-stage milestones. Claudins are a family of protein that regulates the exchange of cellular molecules and maintains cell junctions. While these proteins are typically limited in healthy tissues, they are overexpressed in certain types of solid tumors. Currently, Astellas' Vyloy, which targets Claudin18.2, has been commercialized, drawing significant attention from the domestic and international pharmaceutical and biotech industries to this biomarker. Among them, CLDN3 is known to be overexpressed in small-cell lung cancer, breast cancer, ovarian cancer, and prostate cancer. Abion is currently conducting preclinical studies for ABN501. Clinical results disclosed to date have confirmed the safety of ABN501 through toxicity evaluations, and improved therapeutic effects have also been secured when ABN501 is combined with chemotherapy in preclinical models. Autotelic Bio signed a technology transfer agreement this month with the Brazilian pharmaceutical company Ache for its hybrid fixed dose combination new drug, 'ATB-101'. Autotelic Bio's entry into the Brazilian market follows its signing of an exclusive supply agreement with Chinoin of Mexico in June 2024. ATB-101 is being developed as a combination of olmesartan, used for treating hypertension, and dapagliflozin, used for treating diabetes. Currently, Phase 3 clinical trials are underway in approximately 33 institutions, including Seoul National University Bundang Hospital, for patients with essential hypertension and type 2 diabetes. The composition of ATB-101 has been patented not only in Korea but also in the United States, Japan, Mexico, Brazil, and Russia, allowing the company to exercise exclusive rights upon market entry in these countries. AriBio has successfully achieved the technology transfer of its Alzheimer's disease new drug candidate, AR1001 , for the second consecutive year. This month, the company signed a technology export agreement with Arcera, a global pharmaceutical company established by Abu Dhabi Developmental Holding (ADQ), a sovereign wealth fund of the United Arab Emirates (UAE). The total contract value is $600 million (approximately KRW 820 billion), with the upfront payment remaining undisclosed. AriBio also achieved the technology transfer of 'AR1001' in March of last year. At that time, AriBio received an upfront payment of KRW 120 billion. AR1001 is a multi-target drug directed to the causes of Alzheimer's disease, including PDE5 and toxic proteins. This new drug candidate is an oral treatment that improves Mirodenafil (Mvix), an erectile dysfunction drug similar to Viagra. The basis of AR1001's mechanism is being strengthened, with recent announcements indicating the efficacy of phosphodiesterase-5 (PDE5) inhibitors, such as Viagra and Cialis, in preventing Alzheimer's disease. AR1001's Phase 3 clinical trial is progressing smoothly. AriBio is conducting global Phase 3 clinical studies in the United States, where the first patient was dosed in December 2022, as well as in Korea, the UK, Germany, France, Spain, Italy, Denmark, the Netherlands, the Czech Republic, and China. In April, ABL Bio signed a technology export agreement with GlaxoSmithKline (GSK) for its blood-brain barrier (BBB) shuttle platform, 'Grabody-B,' for the development of new neurodegenerative disease treatments. Through this agreement, ABL Bio will receive a non-refundable upfront payment of 38.5 million pounds (approximately KRW 73.9 billion) and a short-term milestone of 38.6 million pounds. The total contract value amounts to 2.1401 billion pounds(approximately KRW 4 trillion). Under the terms of the agreement, GSK acquires exclusive rights related to the development and commercialization of multiple new target candidates applying ABL Bio's Grabody-B. ABL Bio will transfer its Grabody-B related technology and know-how to GSK, while GSK will be responsible for preclinical and clinical development, manufacturing, and commercialization. The agreement aims to develop multi-target-based therapies using various modalities, including oligonucleotides (such as siRNA and ASO) and polynucleotides, as well as antibodies. ABL Bio is also planning additional technology transfers. The company holds the largest number of bispecific antibody candidates among domestic companies. It currently possesses over seven pipelines, including ABL001 (VEGFxDLL4), ABL111 (Claudin18.2x4-1BB), and ABL503 (PD-L1x4-1BB). Olix·Alteogen have successfully achieved technology transfers Olix and Alteogen have successfully achieved technology transfers for their new drug candidates targeting metabolic dysfunction-associated steatohepatitis (MASH)·obesity, as well as formulation change technology for anti-cancer drugs, respectively. Eli Lilly has challenged the development of new MASH drugs by in-licensing a new drug candidate from the Korean company Olix Pharmaceuticals. Olix announced in February that it had signed a co-development and technology export agreement with Lilly for its MASH and obesity treatment candidate 'OLX75016 (OLX702A)'. The total contract value is $630 million (approximately KRW 911.7 billion). This amount comprises a non-refundable upfront payment, as well as development and commercialization milestones contingent upon clinical progress. Specific details, such as the proportion of the upfront payment, were not disclosed. OLX75016 is a MASH and obesity treatment candidate based on siRNA technology, a type of short double-stranded RNA genetic material within RNA interference technology. OLX75016 is being developed as a subcutaneous (SC) formulation for the treatment of obesity, administered once every three months. Olix is currently conducting a Phase 1 clinical trial of OLX75016 in Australia. The company is also investigating the possibility of combining OLX75016 with new drugs targeting GLP-1 and glucagon. As most MASH treatments target GLP-1, Olix plans to develop a treatment with a differentiated mechanism to enhance synergistic effects with GLP-1 agents. Alteogen signed two exclusive license agreements in March with MedImmune, AstraZeneca's bio R&D subsidiary, for its human hyaluronidase-based subcutaneous (SC) formulation change platform, 'ALT-B4'. The non-refundable upfront payment for the contract signed between Alteogen and MedImmune is KRW 36.4 billion. The development and commercialization milestones amount to KRW 1.0547 trillion. The upfront payment for the contract signed with MedImmune is KRW 29.1 billion, with milestones totaling KRW 843.8 billion. Both agreements include separate sales royalties. Alteogen's proprietary human hyaluronidase-based technology works by increasing the permeability of subcutaneous tissue, allowing for the rapid dispersion of drugs within the tissue and their subsequent absorption into the bloodstream. While drug delivery to subcutaneous tissue has historically been challenging due to the protection of hyaluronan, human hyaluronidase technology enables the degradation of hyaluronan. Existing anti-cancer drugs are primarily administered intravenously (IV), a method criticized for requiring over an hour of administration time. The development of C formulations for anti-cancer drugs is expected to shorten administration time and enhance patient convenience. Currently, the SC formulation of the cancer immunotherapy Keytruda, utilizing Alteogen's technology, has shown non-inferiority compared to the existing IV formulation in its Phase 3 clinical trial. Alteogen is also developing an anti-cancer SC injection formulation with Daiichi Sankyo, a developer of antibody-drug conjugates (ADC). More milestone payment recipients In the first half of the year, many more companies received additional milestone payments from technology transfers. Genomictree recently received a KRW 1 billion milestone payment from 'Shandong Lukang Hao Li You' following the completion of clinical trials for its colorectal cancer diagnostic product 'EarlyTect-C' in China. Genomictree signed a technology transfer agreement in May 2021 with Shandong Lukang Hao Li You, a joint venture established by Orion Holdings and China's Lukang Pharma for the commercialization of its colorectal cancer in vitro diagnostic product in the Chinese market. The total contract value is KRW 6 billion, and Genomictree received an upfront payment (contract payment) of 2 billion KRW in 2021. Shandong Lukang Hao Li You subsequently established production infrastructure for the colorectal cancer in vitro diagnostic product in China. The company commenced clinical trials in 2023 and completed them in January of this year. Based on the recent clinical results, they have applied to the China's 'National Medical Products Administration (NMPA)' for manufacturing approval of the colorectal cancer diagnostic product. LigaChem Biosciences announced this month the receipt of a short-term milestone payment for 'LCB97', an ADC-based new anti-cancer drug out-licensed to the Japanese pharmaceutical company Ono Pharmaceutical. While the exact amount received was not disclosed, the company announced it received more than one-tenth of last year's revenue of KRW 125.9 billion. LigaChem Biosciences has successfully received its third milestone payment from Ono Pharmaceutical, following additional milestone payments in November last year and March this year. LCB97, for which the milestone was received, is an ADC discovered and developed based on LigaChem Biosciences' proprietary ADC platform technology. It targets L1CAM, known to be overexpressed in various solid tumors. The company states that LCB97 has shown excellent anti-cancer efficacy in various tumor mouse models conducted to date. LigaChem Biosciences signed two technology transfer agreements related to ADCs with Ono Pharmaceutical in October last year. These agreements included ▲a contract transferring the exclusive global development and commercialization rights for LCB97 ▲a contract transferring ADC platform technology for multiple targets. The specific contract amount was not disclosed by mutual agreement between the two companies, and the total value of the two contracts exceeds KRW 943.5 billion. Zacubo, a treatment for gastroesophageal reflux disease Onconic Therapeutics completed the technology transfer for the production of Zacubo to its Chinese partner, Livzon Pharmaceutical Group, in March. Through this, Onconic Therapeutics claimed a milestone payment of $1.5 million (KRW 2.2 billion). Onconic Therapeutics signed a technology export agreement for Zacubo with the Chinese pharmaceutical company Livzon Pharmaceutical Group in March 2023. The contract value is up to $127.5 million. Onconic Therapeutics initially received a non-refundable upfront payment of $15 million and is set to receive up to $112.5 million in technology fees based on development, approval, and commercialization milestones. Zacubo is a P-CAB (Potassium-Competitive Acid Blocker)-based treatment for gastroesophageal reflux disease. It was approved as the 37th domestically developed new drug in April last year. Onconic Therapeutics received a milestone payment of $3 million last month following the first patient dosing in Zacubo's Phase 3 clinical trial in China. With the completion of CMC (Chemistry, Manufacturing, and Controls) technology transfer for production, the company is expected to receive further milestone payments.
- Company
- CSL Seqirus partners with Samjin...seeks NIP in Korea
- by Whang, byung-woo Jun 24, 2025 06:02am
- CSL Seqirus Korea and Samjin Pharmaceutical have signed a strategic sales partnership agreement for the domestic distribution of influenza vaccines, sparking attention over whether the two companies can achieve synergistic effects. Samjin Pharmaceutical and CSL Seqirus Korea sign strategic sales partnership agreementOn the 18th, the two companies announced that they had signed a strategic sales partnership agreement for the domestic distribution of the adjuvanted influenza vaccine ‘Fluad Quad Prefilled Syringe’ and the cell-cultured influenza vaccine ‘Flucelvax Quad Prefilled Syringe.” Samjin Pharmaceutical will be responsible for marketing and promoting Fluad Quad and Flucelvax Quad, while domestic distribution will be jointly conducted with CSL Seqirus Korea, which also handles vaccine imports. Through the agreement, Samjin Pharmaceutical and CSL Seqirus aim to achieve synergistic effects in entering the vaccine distribution business and expanding its position in the domestic market. Through the agreement, Samjin Pharmaceutical is focusing on expanding its portfolio from chronic diseases to the vaccine sector. At the signing ceremony, Sang-Jin Kim, President of Samjin Pharmaceutical, said, “Through this collaboration, Samjin Pharmaceutical will be able to expand its business beyond the treatment-oriented business to the prevention-oriented vaccine field.” Currently, Samjin Pharmaceutical owns a lineup of specialty drugs for chronic diseases and pediatric drugs, such as Trestan, and expects the agreement to bring synergy to its existing sales capabilities. A Samjin Pharmaceutical representative said, “For a long time, the company has been striving to provide effective treatments for patients with chronic diseases, who are at high risk for influenza. With our product portfolio focused on chronic disease treatments, we aim to make Fluad Quad, an immune-boosting influenza vaccine, available to the same chronic disease patients we have been focusing on.” Ahead of the flu vaccine season, Samjin Pharmaceutical plans to strengthen education and communication on its vaccine through specialized channels, such as conferences, symposiums, and online webinars for medical professionals. In addition, the company will launch advertisements and campaigns targeting the general public to raise awareness of the importance of vaccination and CSL Seqirus Korea's premium vaccines. A company official emphasized, “We plan to carry out various evidence-based marketing programs to ensure that children's hospitals, pediatricians, and ENT specialists are well aware of the unique features of Flucelvax Quad, a vaccine that can be administered to a wide range of patients from children to the elderly.” CSL Seqirus is targeting the market for influenza vaccines for seniors aged 65 and older In addition, the companies made the strategic decision to target the elderly influenza vaccine market through the partnership. Korea has a National Immunization Program (NIP) in place that provides free influenza vaccines to seniors aged 65 and older, but most of the vaccines currently used in the NIP are quadrivalent vaccines. For this influenza vaccination season, trivalent vaccines are scheduled to be used as part of the NIP. Adjuvant vaccines and high-dose vaccines, which are considered to provide higher protection for the elderly, are not yet included in the NIP. In the case of overseas, the US CDC Advisory Committee on Immunization Practices (ACIP) recommends high-dose adjuvanted vaccines for people aged 65 and older, and there is a trend in developed countries to administer vaccines with improved efficacy compared to standard vaccines for the elderly. In Korea, the need for vaccines tailored to the elderly is emerging due to the aging population and increased risk of influenza, and the pharmaceutical industry is closely eyeing the possibility of including such premium vaccines in the NIP in the future. CSL Seqirus’ decision to partner with Samjin Pharmaceutical is interpreted as a strategic move to secure business synergy with an eye on entering the NIP in the long term. Although it had previously sought to expand into Korea’s domestic market through partnerships with Ilsung Pharmaceuticals and other companies, the company is seeking greater synergy this time through collaboration with Samjin Pharmaceutical, which has solid sales capabilities and a doctors’ network in primary care facilities such as hospitals and clinics. This is because in the long term, increasing the vaccination rate of immune-enhancing vaccines among the elderly and accumulating supporting evidence can ultimately strengthen the case for government adoption. (From left) Photos of CSL Seqirus From CSL Seqirus’ perspective, last year, Sanofi launched a high-dose quadrivalent vaccine, creating a two-way competition between adjuvanted and high-dose vaccines in the domestic influenza vaccine market for the elderly, making it impossible to ignore the partner company’s domestic sales capabilities. While overseas real-world studies have shown that adjuvanted vaccines reduce influenza-related medical utilization more effectively than high-dose vaccines in high-risk elderly populations, their higher prices compared to standard vaccines remain a hurdle to their domestic access, necessitating further accumulation of long-term efficacy data. For Samjin Pharmaceutical, the partnership aligns with its strategic interests, as entering the vaccine business could serve as an opportunity to diversify its portfolio and create new revenue streams. GeeSeung Yoo, Country Head of CSL Seqirus Korea, stated, “We are very excited to partner with Samjin Pharmaceutical, a company with outstanding sales and marketing capabilities. Through this agreement, CSL Seqirus Korea expects to be able to provide its differentiated influenza vaccines, Fluad and Flucelvax, to a broader population.”
- Policy
- Inspections target faulty packaging·labeling of drugs
- by Lee, Jeong-Hwan Jun 24, 2025 06:00am
- The Korean government and local governments will launch inspections targeting pharmaceutical companies with a history of recalls due to faulty packaging or labeling of medicinal products and illegal advertising of GLP-1 obesity drugs, such as Wegovy. For GLP-1 obesity drugs, to prevent misuse and abuse, inspections will focus on handling medical clinics and pharmacies to check for direct-to-consumer advertising of specialized medicines and whether information exceeding the scope of approved indications is being exaggerated or falsely advertised to the general public. Following the inspections, pharmaceutical companies, medical institutions, pharmacies, and wholesalers found to violate these terms will face measures such as administrative guidance or administrative penalties. On June 23, the Ministry of Food and Drug Safety (MFDS) announced that it would conduct planned joint inspection with local MFDS agencies and local governments to strengthen the safety management of medicinal products· biopharmaceutical products·Korean traditional medicines·quasi-drugs·medical devices. This second-quarter joint inspection of medical products will run until June 27. For medicinal products, manufacturers with a history of recalls due to packaging·labeling defects will be inspected, given the continuous occurrence of such recalls. Key inspection points include, ▲Whether the company has implemented follow-up measures and recurrence prevention plans submitted during previous drug recalls ▲Whether follow-up measures from self-inspections related to packaging·abeling processes have been carried out. If follow-up measures are not implemented or violations are confirmed during the inspection, necessary actions, including administrative penalties, will be taken. During the summer, concerns about misuse and abuse are rising due to illegal advertising of specialized medicines, including online posts featuring post-treatment reviews that describe GLP-1 obesity biopharmaceuticals as 'weight loss drugs' or promotional materials placed in patient waiting areas. To prevent the misuse and abuse of obesity treatments, MFDS will focus on handling medical clinics and pharmacies to inspect ▲Whether prescription drugs are being advertised to the general public through various advertising media ▲Whether exaggerated·false information exceeding the scope of approved indications is being released to an unspecified public. If violations are confirmed during the inspection, necessary actions such as administrative guidance or administrative penalties will be taken against the medical clinics, pharmacies, and, if necessary, wholesalers or pharmaceutical manufacturers. For Korean traditional medicines (Hanyak), rigorous quality control is required for high-value herbal ingredients, such as 'Nokyong' and 'Uhwang'. Therefore, manufacturers of these herbal ingredients and manufacturers of hanyak ingredients containing 'Uhwang,' such as 'Uhwangcheongsimwon,' will be inspected. Key inspection points will include ▲Appropriateness of quality control for raw materials and finished products ▲Appropriateness of raw material storage management and finished product manufacturing management. For quasi-drugs, to ensure a safe distribution environment for anti-snoring products used to reduce or suppress snoring noise, manufacturing (importing) companies will be inspected for ▲Performance of quality inspections for raw materials and finished products ▲Microbiological quality control ▲Appropriateness of hygiene management of manufacturing facilities. Additionally, inspections for false·exaggerated advertising will be conducted on sanitary product vendors frequently found with identical advertising violations on numerous online sales sites. If violations are confirmed in advertisements provided by manufacturing (importing) companies, those manufacturers (importers) will also be inspected. As instances of unapproved illegal medical devices being imported through direct overseas purchases or purchasing agencies continue to occur, companies frequently caught importing illegal medical devices at the import·customs clearance stage will be inspected. Key inspection points will include ▲Whether illegally imported medical devices are being illegally distributed ▲Whether return or disposal measures have been taken ▲Other violations of the Medical Devices Act. If inspections confirm violations, such as storing or distributing illegally imported medical devices without returning or disposing of them, necessary actions, including administrative penalties, will be taken. Meanwhile, to enhance the effectiveness of this planned joint inspection, the MFDS conducted pre-training on inspection methods for the '2025 Q2 Medical Products Sector Inspection Officer Training' (6.19.~20.), involving local MFDS agencies and local governments (cities·provinces, cities·counties·provinces).
- Company
- Nubeqa’s indication expanded to msHPC in combo with ADT
- by Whang, byung-woo Jun 24, 2025 06:00am
- Pic of Nubeqa Bayer Korea announced on the 23rd that its oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) has been approved by the Ministry of Food and Drug Safety as part of a two-drug regimen in combination with androgen deprivation therapy (ADT) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). With this expanded indication, Nubeqa can now be used not only as part of a three-drug regimen with ADT and the chemotherapy drug docetaxel but also as part of a two-drug regimen with ADT. This enables more flexible treatment approaches tailored to the individual condition and treatment goals of mHSPC patients. The approval was based on the results of the ARANOTE study, a global Phase III clinical trial evaluating the efficacy and safety of the two-drug regimen combining Nubeqa and ADT in 669 patients with mHSPC. Study results showed that the group treated with Nubeqa+ADT had a 46% statistically significant reduction in the risk of radiographic progression or death compared to the placebo group. This improvement in radiographic progression-free survival (rPFS) was consistent across all groups, including high-risk and low-risk mHSPC patients. Also, analysis of overall survival (OS), the secondary endpoint, showed that the Nubeqa combination therapy group demonstrated potential survival benefits compared to the placebo group, with significant delays in PSA progression, deterioration in quality of life, and progression of pain, thereby demonstrating clinically significant improvements in quality of life. The incidence of treatment-emergent adverse events (TEAEs) was low, with most events occurring at Grade 1 or 2, and no significant differences were observed between treatment groups. Nubeqa is already approved in Korea for use in combination with ADT and docetaxel for the treatment of mHSPC patients and for use in combination with ADT for the treatment of high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). With this third indication, Nubeqa is now available for elderly patients and patients who are not suitable to receive chemotherapy. Professor Jae-Young Joung, Director of the Urologic Cancer Center at the National Cancer Center, said, "In prostate cancer, treatment strategy is critically important and needs to be selected based on the stage of diagnosis, disease stage, and the patient's overall condition. Nubeqa is the only treatment approved as both a three-drug regimen with docetaxel+ADT and as a two-drug regimen with ADT in patients with hormone-sensitive metastatic prostate cancer, so the approval will offer more flexible treatment options tailored to the patient's individual circumstances." He added, “Given its favorable tolerability profile, which reduces treatment burden and may positively impact long-term outcomes, we anticipate that it will rapidly improve treatment access for patients in Korea.” Meanwhile, Nubeqa has been approved as a treatment for mHSPC and nmCRPC in over 85 countries worldwide and has surpassed annual sales of approximately KRW 2.4 trillion as of 2024, rising as a blockbuster therapy.
- Company
- 'Fabhalta' closer to being reimbursed, shaking up inj market
- by Moon, sung-ho Jun 24, 2025 06:00am
- Next month, new oral agent will be introduced to the market for paroxysmal nocturnal hemoglobinuria (PNH). Injectables, such as Soliris and Ultomiris, currently dominate the PNH market. Attention is drawn to whether this oral agent will enhance patient satisfaction, as it offers the convenience of administration compared to the previous treatments. Product photo of FabhaltaAccording to pharmaceutical industry sources, the Ministry of Health and Welfare (MOHW) has recently given an administrative announcement on the revision to the "The detailed measure on the application standards and methods of medical reimbursements," which affects the reimbursement status of the Novartis Factor B inhibitor 'Fabhalta (iptacopan).' If there are no special circumstances, Fabhalta can be approved for reimbursement in July. PNH is currently known as a disease with no fundamental cure. However, the approach to treatment is changing with the development of therapies that inhibit the activity of the complement system. The complement system is a core component of innate immunity, serving as a powerful defense mechanism that directly attacks and destroys pathogens. The complement system includes several pathways, including C3 and C5, and ultimately functions to destroy red blood cells by forming the 'Membrane Attack Complex (MAC).' Previous treatments primarily target the terminal component within the complement system's alternative pathway. Treatment settings have been improved with the introduction of Soliris (eculizumab),' a once every 2 weeks injection, and then, 'Ultomiris (eculizumab),' which can be administered via injection at 8-week intervals. These treatments are still commonly used in clinical practices. Fabhalta works by inhibiting Factor B, a crucial component in the activation of C3. In addition to this novel mechanism, Fabhalta is also the first and only single oral agent for PNH treatment in South Korea, offering the advantage of twice-daily dosing. The efficacy of Fabhalta was confirmed in the Phase 3 APPLY-PNH clinical study, which enrolled 97 adult PNH patients (18 years or older) who had received C5 inhibitors for at least 6 months but still experienced anemia (with average hemoglobin levels below 10 g/dL). In a randomized assignment, 35 out of 97 patients continued C5 inhibitor treatment, while the remaining 62 switched to Fabhalta. The impact on treatment outcomes was assessed over 24 weeks. Clinical results showed that patients who switched to Fabhalta experienced normalized hemoglobin levels starting from week 4, with the effect sustained until week 24. Hemoglobin normalization was observed in approximately two-thirds of patients. Furthermore, four out of five patients exhibited a clinically significant increase in hemoglobin levels, and 95% of patients overcame transfusion dependence. Based on these findings, the MOHW plans to apply reimbursement starting next month for PNH patients meeting specific criteria: ▲adults aged 18 or older with a PNH granulocyte clone size of 10% or more (as measured by flow cytometry) with lactate dehydrogenase (LDH) levels at least 1.5 times the upper limit of normal, and for whom C5 inhibitors (Soliris or Ultomiris injections) cannot be administered due to medical reasons. Additionally, ▲reimbursement will apply if patients have received C5 inhibitors for more than 6 months under reimbursement criteria but have hemoglobin (Hb) levels below 10 g/dL or if there is a need for drug switching due to side effects. As a result, clinical practices expect Fabhalta to be able to resolve unmet medical needs that could not be addressed with conventional treatments. Currently, some PNH patients experience unmet needs such as persistent fatigue, insufficient symptom improvement, and transfusion dependency. Even with C5 inhibition, upstream C3 activation continues, often leading to repeated situations where red blood cells are prematurely removed from the bloodstream in the liver·spleen, necessitating transfusions. As a result, Novartis is expected to establish a dedicated team and focus on addressing these unmet medical needs. Dr. Jun Ho Jang, a professor at Samsung Medical Center Seoul, said, "Factor B is a proximal factor that acts as a gate upstream of C5 in the alternative complement pathway. In other words, inhibiting Factor B affects not only C5 but also C3, significantly improving hemolysis that occurs both intravascularly and extravascularly." Dr. Jang added, "Based on these mechanistic characteristics, the efficacy and safety profile of Fabhalta has not only been confirmed in clinical trials for patients without prior C5 inhibitor treatment experience but also showed superior results in patients who switched from anti-C5 therapy to Fabhalta compared to those who continued anti-C5 therapy." Dr. Jang emphasized, "Fabhalta as a single oral formulation offers high convenience for taking medication. It is favorable that we have an effective treatment option with a new mechanism that did not exist before. A paradigm shift in PNH treatment is expected." Meanwhile, PNH is a chronic, complement-mediated blood disorder, a severe rare disease that can be life-threatening. PNH patients have acquired mutations in some hematopoietic stem cells, leading to the production of red blood cells prone to premature destruction, resulting in intravascular hemolysis (IVH) and extravascular hemolysis (EVH). PNH can cause complications such as thrombosis, renal failure, and pulmonary hypertension, potentially leading to death, with a 5-year mortality rate of 35% and a 10-year mortality rate of approximately 50%. It can also impact the quality of life due to symptoms such as anemia and weakness.
- Company
- Tibsovo may be prescribed at general hospitals in KOR
- by Eo, Yun-Ho Jun 24, 2025 05:59am
- Tibsovo, a targeted cancer drug for cholangiocarcinoma and acute myeloid leukemia, can now be prescribed at general hospitals in Korea. According to industry sources, Servier Korea’s IDH1 (isocitrate dehydrogenase 1) genetic mutation targeting therapy Tibsovo (ivosidenib) recently passed the Drug Committee (DC) review of the ‘Big 5’ tertiary hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital, and Sinchon Severance Hospital, as well as other medical institutions such as Gangnam Severance Hospital, National Cancer Center, and Seoul National University Bundang Hospital. The company has been steadily expanding its prescription area since it received approval from the Ministry of Food and Drug Safety in May last year and officially launched the drug in September of the same year. In addition, as the drug’s indication for cholangiocarcinoma has recently been approved by the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service, expectations are rising for its reimbursement. The drug is indicated for use ▲= in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation in adults aged ≥75 years with comorbidities that preclude the use of intensive induction chemotherapy, or ▲as monotherapy for locally advanced or metastatic cholangiocarcinoma in previously treated adults with IDH1 mutation. Cholangiocarcinoma is a highly aggressive cancer with a poor prognosis, with a 5-year relative survival rate of just 28.9%. In particular, 65% of patients with intrahepatic cholangiocarcinoma are diagnosed at an advanced stage where surgery is not feasible. Tibsovo is the only targeted therapy recommended by the National Comprehensive Cancer Network (NCCN) in the highest category (Category 1) as a second-line treatment for bile duct cancer. According to the Phase III ClarlDHy trial, Tibsovo reduced the risk of disease progression by 63% compared to placebo, with a median progression-free survival (PFS) of 2.7 months (1.4 months in the placebo group). Additionally, the median overall survival (mOS) was 10.3 months in the Tibsovo group, more than twice as long as the 5.1 months in the placebo group. Do-Youn Oh, Professor of Hematology-Oncology at Seoul National University Hospital, stated, “The development of drugs for cholangiocarcinoma has accelerated significantly in recent years. As new drugs are being developed, many companies are also actively working on the development of treatments for cholangiocarcinoma. It is crucial for patients with cholangiocarcinoma to follow the doctors’ guidance and receive appropriate treatment rather than be discouraged, so they can participate in clinical trials and gain access to new treatment opportunities.” Meanwhile, in the Phase III AGILE study that enrolled patients with acute myeloid leukemia, Tibsovo demonstrated improved event-free survival (EFS) when used in combination with azacitidine, and also significantly improved overall survival (OS). The median OS in the Tibsovo-treated group was 24.0 months (7.9 months in the placebo group), and long-term follow-up results showed that the median OS with Tibsovo combination therapy was 29.3 months, over 3.7 times longer than with placebo combination therapy.
- Policy
- Industry expects improved pricing measures by new gov't
- by Lee, Jeong-Hwan Jun 23, 2025 06:01am
- The domestic pharmaceutical industry is closely monitoring the direction of the Lee Jae-Myung administration's preferential drug pricing policy. The industry is most interested in when and how the presidential election pledges, including specific implementation plans for the new drug R&D-linked preferential drug pricing policy and the integration and advancement of the post-marketing drug price management system, will be realized. Multiple pharmaceutical companies believe that the public-private consultation body for the advancement of the drug price system, whose operation has been suspended around the presidential election, must be restarted as soon as possible in order to prompt practical discussions on the presidential campaign pledges. On the 22nd, the pharmaceutical industry expressed expectations that the Lee Jae-Myung administration's inauguration would bring significant changes to the drug price system, which will directly impact the promotion of the pharmaceutical and bio industry. The Ministry of Health and Welfare announced a health insurance operation plan during the previous administration on how it would establish various preferential pricing measures for drugs by domestic pharmaceutical companies. The previous Yoon Suk-Yeol administration's blueprint for drug price regulations was to favor drug prices or to partially defer or exempt drug price reductions of pharmaceutical companies that contributed to improving public health, enhancing the sustainability of health insurance, and developing the national economy. Additionally, the previous government promised to integrate the fragmented post-approval drug price management system into a single framework to address issues such as redundant price reductions that deter new drug development, thereby enhancing predictability for pharmaceutical companies and supporting their business operations. However, multiple pharmaceutical companies have pointed out that there are few actual cases where the previous government's plans have been implemented in practice. In other words, efforts to establish the criteria for preferential drug pricing that can promote new drug development, create jobs, and save national health insurance finances, have been stagnant for over a year. According to industry sources, the only drug price policies that have actually been implemented are regulations that favor the prices of essential medicines manufactured with domestic ingredients and the temporary suspension of the price reduction system based on external reference pricing reevaluations that were about to be implemented. Accordingly, the pharmaceutical industry is closely watching whether the new government will expedite the establishment of national economic development criteria that would allow pharmaceutical companies to receive preferential drug pricing. Given that President Lee Jae-Myung has pledged to implement a preferential policy linking new drug R&D ratios to drug prices, expand measures that take into account the pharmaceutical industry’s social contribution, and modernize the post-management of drug prices in an integrated manner, industry attention is now focused on when and how the Ministry of Health and Welfare and other relevant authorities will initiate specific reforms in the drug pricing system. A representative from a mid-sized domestic pharmaceutical company explained, “The previous administration had repeatedly announced plans to introduce new preferential drug pricing clauses and the reform of the drug pricing system, but in reality, the progress felt slow. Preferential treatment was mainly limited to essential medicines using domestic raw materials, and even then, the number of items actually benefiting from the policy was quite small.” The representative added, “While the implementation of the external reference pricing reevaluation results has been temporarily suspended due to ongoing concerns from pharmaceutical companies, significant concern remains on how it could be reinstated at any time. The key issue is how much and in what direction the new government will diverge from the previous administration's drug price system policies.” Another domestic pharmaceutical company official noted, “The adoption of a drug pricing system that provides greater compensation to pharmaceutical companies that invest heavily in new drug R&D as a presidential election pledge holds significance.” “While policies that provide price advantages to pharmaceutical companies that increase investment in new drugs and make efforts to reduce national health insurance expenditures are important, reducing or eliminating unreasonable drug price reduction mechanisms could have a more substantial impact on pharmaceutical companies.” The official added, “A drug pricing system that adequately reflects the characteristics of the domestic pharmaceutical industry and advanced post-approval drug pricing management policies must be implemented by the new government to enhance pharmaceutical companies' capacity to invest in new drugs. To establish systems that enhance the predictability of the pharmaceutical companies’ business operations, we hope that the new government will first establish a public-private consultation body.”
- Policy
- Generic 'Lixiana' is now in 'active' development in KOR
- by Lee, Hye-Kyung Jun 23, 2025 06:01am
- Korean pharmaceutical companies are actively working on plans to launch their generic version of 'Lixiana Tab 60 mg (edoxaban tosylate hydrate),' a Direct Oral Anti-Coagulant (DOAC) with patent expiry set to November of next year. The Ministry of Food and Drug Safety (MFDS) recently approved Korean Drug Co's application for a bioequivalence trial. This trial is an open-label, randomized, single-dose oral, two-group, two-period, crossover study in healthy adults, comparing "Korea-edoxaban 60mg Tab" with Daiichi Sankyo's 'Lixiana Tab 60mg (edoxaban tosylate hydrate)'. This month, two bioequivalence test approvals have been granted for the development of generic Lixiana. Korea Arlico Pharm received approval for "Arlixaban Tab 60mg" on June 9, before the Korean Drug Co. According to the approval history of bioequivalence tests for generic Lixiana, the MFDS has approved 10 cases. Over ten pharmaceutical companies, including Boryung, Dong-A ST, HK inno.N, Samjin Pharmaceutical, Shinil Pharma, Chong Kun Dang, Kolmar Pharma, Korea Kolmar, Hutecs, and Hanmi Pharmaceutical, have already successfully avoided the patent and secured generic approvals. Seventeen Lixiana generic products are currently listed in the approval registry. Theragen Etex and Dongkwang Pharmaceutical, which filed patent invalidation suits last year, also recently received 'claim upheld' rulings. Korean companies that have successfully avoided the patent will be able to launch their generics when the substance patent expires in November 2026. Late entrants to generic development are actively working to accelerate their generic launches by filing a passive rights scope confirmation trial related to Daiichi Sankyo's pharmaceutical composition patent. Currently, HLB Pharma and Samjin Pharm have filed passive rights scope confirmation trials related to Lixiana's formulation patent in January and March, respectively. The Lixiana patents listed in the MFDS patent registry include a substance patent expiring in November 2026 and a formulation patent expiring in August 2028. Challenges to the Lixiana formulation patent began in 2020. At that time, about 10 companies, including Boryung, filed an invalidation trial aimed at the Lixiana formulation patent in July 2018. Within approximately two years, the challenging companies won the first instance. The victory was confirmed without an appeal from Daiichi Sankyo. Since December 2021, companies including Nexpharm Korea, Dong-A ST, Samsung Pharmaceutical, Shinil Pharma, Shin Poong Pharm, Ahngook Pharm, Ildong Pharmaceutical, Genuone Sciences, Union Korea Pharm, Korea Prime Pharm, Hutecs, and Handok have each obtained generic marketing authorizations. Lixiana has consistently maintained its lead in the DOAC market for a long time, with annual prescription sales exceeding KRW 100 billion. According to pharmaceutical market research firm UBIST, Lixiana's prescription sales in 2023 were KRW 105.3 billion, a 9% increase from KRW 96.7 billion in 2022. In the first half of last year alone, it recorded KRW 55.7 billion in prescription sales. Lixiana first took the market lead in 2019 and has consistently held that position. Analysis suggests that the joint selling synergy with Daewoong Pharmaceutical has positively contributed to the increase in prescription sales.
- Company
- Eylea biosimilar pharmas receive differing injunction ruling
- by Kim, Jin-Gu Jun 23, 2025 06:01am
- Domestic biosimilar companies have launched a full-scale patent lawsuit against Bayer over Eylea. Celltrion and Samsung Bioepis received different preliminary injunction results, leading them to pursue divergent strategies in the main lawsuit. Eylea patent infringement main lawsuits begin in earnest... Celltrion to proceed immediately, Samsung Bioepis’ plan undecided On the 20th, the 61st Civil Division of the Seoul Central District Court held the second hearing regarding the patent infringement lawsuit filed by Bayer against Celltrion. The hearing concluded without any substantive arguments. The court decided to receive additional written statements from both parties and scheduled the next session for August 19. Bayer filed the lawsuit in January last year. The issue is whether Celltrion's Eylea biosimilar, Eydenzelt, infringes on Bayer's domestic patent. Bayer filed the same lawsuit against Samsung Bioepis in May last year. Bayer claims that Samsung Bioepis' Eylea biosimilar, Afilivu, infringes on its patent. However, no trial date has been set yet for the lawsuit against Samsung Bioepis. Opposite preliminary injunction results... Bayer files appeal, Samsung Bioepis files objection The patent infringement lawsuit surrounding Eylea is proceeding in a complicated manner with mixed preliminary injunction decisions from the court. In July last year, Bayer filed preliminary injunction motions against Celltrion and Samsung Bioepis, respectively, for patent infringement. The purpose was to suspend the domestic sale of biosimilars until the final ruling. In February this year, the preliminary injunction results were announced. The court issued conflicting decisions. The preliminary injunction request against Celltrion was dismissed, while the request against Samsung Bioepis was granted. As a result, Celltrion can continue selling Eydenzelt in Korea, while Samsung Bioepis must suspend sales of Afilivu. Due to the conflicting preliminary injunction decisions, the responses of each company also differed. Bayer filed an appeal with the Seoul High Court regarding the Celltrion case. The appeal hearing is scheduled for next month on the 17th. In contrast, Samsung Bioepis opted for an objection procedure instead of filing an appeal. Along with the objection, the company also filed a request for a stay of execution, but it was dismissed. The objection hearing concluded in April this year, and the case is now awaiting the court’s final decision. Nevertheless, Samsung Bioepis has continued to submit supplementary briefs in response. Preliminary injunction appeal, objection, and final ruling... a turning point for the domestic sale of biosimilars The final ruling, the appeal of the preliminary injunction, and the decision on the objection are expected to serve as a turning point in determining the sustainability of domestic biosimilar sales. If Bayer wins the appeal against Celltrion, the domestic sales of Eydenzelt will be suspended. Conversely, if the rejection is upheld as in the first instance, sales will continue as is. In the case of Samsung Bioepis, if the court accepts the objection, sales of its Afilivu can resume. Conversely, if the court dismisses the objection, sales will remain suspended. In this case, Samsung Bioepis is expected to continue the lawsuit by filing an appeal. The ruling on the main lawsuit is expected to tentatively determine whether the two companies can sell Eylea biosimilars. If the court rules that the two biosimilars infringe on Eylea's patent, sales of Eydenzelt and Afilivu in Korea will be suspended. Conversely, if the court rules that there is no patent infringement, sales of the biosimilars will be permitted. The progress of this complex litigation is directly impacting partner companies that copromote the biosimilars as well. Kukje Pharm, which co-markets Celltrion's Eydenzelt, has continued its sales to date. However, Samil Pharmaceutical, which collaborates with Samsung Bioepis, has suspended distribution and sales of Afilivu. Future developments, including the appeal, objections, and final ruling, are likely to influence the sales strategies and revenue of these partner companies.
