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- 2026-04-03 12:18:23
- Company
- EU revises pharma package law for the first time in 20 years
- by Kim, Jin-Gu Jun 11, 2025 06:02am
- The European Union (EU) is pushing for revisions to its “Pharmaceutical Package” law on major drugs for the first time in 20 years. The core of the revision, which is now awaiting final approval by the European Parliament, can be summarized as expanding the exclusivity of innovative drugs and strengthening supply obligations within Europe. In addition, measures such as exempting relevant intellectual property rights are being promoted to improve access to biosimilars and generics. According to the Korea Biotechnology Industry Organization on the 10th, the European Council (EC) recently agreed to the European Commission's revision of the “Pharmaceutical Package.” The only remaining procedure is the final approval by the European Parliament. The Pharmaceutical Package, established in 1965, forms the foundation of pharmaceutical laws in Europe. The last revision was in 2004. However, over the past 20 years, issues regarding pharmaceutical access have been consistently raised, particularly in certain countries. In response, in April 2023, the European Commission drafted a revision to the pharmaceutical package law. The revision focuses on three main points: extending protection for innovative drugs, imposing a supply obligation for pharmaceuticals, and supporting the early entry of generics and biosimilars. First, to protect innovative medicines, additional incentives will be provided to companies that develop and produce them. Specifically, companies producing innovative medicines will be granted an 8-year data exclusivity period. During this period, competing companies will not be able to access the development data for the medicine. Additionally, companies producing innovative medicines will be eligible for a 1-year regulatory market protection benefit. This benefit may be extended to 2 years if certain conditions are met. Furthermore, a new provision (56A) will be added to strengthen supply obligations. EU member states will be able to impose obligations on drug marketing authorization holders to ensure that their patients have sufficient access to necessary drugs. Early market entry for generics and biosimilars will also be supported. To this end, the provisions known as the “Bolar exemption” are clarified. The Bolar exemption recognizes exemptions from certain requirements, allowing generic and biosimilar manufacturers to conduct clinical trials and prepare regulatory documents for patented drugs. This revision ensures the availability of generic and biosimilar drugs on the first day after patent expiration. Once a patent or exclusive period expires, competitive products (generic drugs) can be launched immediately without bureaucratic delays. If a drug is sold after patent expiry, its generic and biosimilar manufacturers can complete the submission of a Health Technology Assessment (HTA) beforehand. Furthermore, they can participate in national tenders through hospital contracts even before the exclusive rights of the original manufacturer expire.
- Company
- Pfizer launches 'Prevenar 20' for adults aged 18 years+
- by Whang, byung-woo Jun 11, 2025 06:01am
- Product photo of Prevenar 20 Pfizer Korea (CEO and President Dong-wook Oh) announced on June 10 that its 'Prevenar 20,' a 20-valent pneumococcal conjugate vaccine for adults, was launched in early June, and it is now available for vaccination for individuals aged 18 years and older. Prevenar 20 will be supplied to the Korean market for adults through a co-promotion and distribution partnership between Pfizer Korea and Chong Kun Dang. The two companies have maintained a partnership since their initial domestic distribution agreement for Prevenar 13 in 2017. Through this new partnership for Prevenar 20, they aim to strengthen their position in the adult vaccine market and continue efforts to enhance vaccine accessibility. Prevenar 20 is a pneumococcal conjugate vaccine that was approved by the Ministry of Food and Drug Safety (MFDS) on October 31, 2024. Compared to the 13-valent vaccine, Prevenar 20 has added seven additional pneumococcal serotypes. Among domestically approved pneumococcal conjugate vaccines, it contains the most serotypes (as of 10/31/2024). It can be used for preventing invasive pneumococcal disease and pneumonia caused by pneumococcus in all ages postnatal 6 weeks or above (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F). The Korean Society of Infectious Diseases (KSID) has recently announced new recommendations for the pneumococcal conjugate vaccine as part of its revised 2025 guidelines for adult vaccination. KSID's adult immunization board has recommended sequential vaccination with PCV20 or PCV15, followed by PPSV23, for adults aged 65 and older and for high-risk individuals aged 19-64. This high-risk group includes patients with chronic diseases, cerebrospinal fluid leakage or cochlear implants, immunocompromised patients, and individuals with functional or anatomical asplenia. Chan-woo Song, Vice President of the Primary Care Business Unit at Pfizer Korea, said, "We are delighted to further strengthen our long-standing partnership with Chong Kun Dang through this co-promotion and distribution partnership for Prevenar 20." He added, "This collaboration between our two companies has expanded the opportunity for Prevenar 20 to be made available to more adults." Young-Joo Kim, CEO of Chong Kun Dang, said, "Based on the partnership that began with Prevenar 13, we find it meaningful to be able to supply the newly launched adult Prevenar 20 in Korea," and added, "Both companies will continue to collaborate to contribute to the development of the domestic vaccine market and strive to provide a healthier future for more patients." Meanwhile, the safety, tolerability, and immunogenicity of Prevenar 20 were confirmed through global clinical trials. In the United States and Sweden, 3,902 adults aged 18 and older who had no prior pneumococcal vaccine history were divided into three age groups: 18-49 years, 50-59 years, and 60 years or older. Individuals aged 60 and above received either Prevenar 20 or PCV13+PPSV23, while those aged 18-59 received either Prevenar 20 or PCV13. Based on the primary immunogenicity endpoint, which was OPA GMT in adults aged 60 and older, Prevenar 20's non-inferiority was confirmed for the 13 serotypes shared with Prevenar 13. Non-inferiority was also confirmed for 6 out of the seven additional serotypes compared to PPSV23. Furthermore, the frequency and severity of local and systemic reactions occurring within 10 days after vaccination with Prevenar 20 or PCV13 were similar.
- Company
- "Atopic dermatitis treatment…personalized trt. is the key"
- by Whang, byung-woo Jun 11, 2025 06:01am
- "Significant changes are being brought to atopic dermatitis treatment. which can be described as a 'major shift.' As it is a complex disease with various factors involved, establishing criteria for personalized treatment regarding which therapeutic agent to use for each patient is necessary." Atopic dermatitis is one of diseases whose treatment landscape has undergone significant changes in recent years. As atopic dermatitis is a chronic skin condition with complex etiologies, its treatment has historically been challenging. However, the recent emergence of various novel drugs, such as biologics and JAK inhibitors, has diversified treatment options. During a meeting with Daily Pharm, Dr. Ga-Young Lee, a Professor at Kangbuk Samsung Hospital's Department of Dermatology, stressed the necessity of personalized treatment options for advancing the treatment environment of atopic dermatitis. "Introduction of new atopic dermatitis drugs offers hope to patients who gave up on treatment due to side effects" Atopic dermatitis is a chronic skin inflammation caused by a complex interplay of genetic factors, immune dysfunction, and impaired skin barrier function. Professor Ga-Young Lee at Kangbuk Samsung HospitalNotably, the quality of life issue for patients with severe atopic dermatitis is particularly acute. Because the disease affects the whole body, patients experience severe itching and pain, leading to sleep disturbances and psychological stress, which significantly disrupt their daily lives. In this context, the shift of the atopic dermatitis treatment landscape with the advent of new drugs is assessed as offering hope to patients. Dr. Lee explained, "With the emergence of various new drugs, such as biologics and JAK inhibitors, patients who were previously neglected due to side effects from steroid treatments or treatment abandonment are now returning to the hospital," and Dr. Lee added, "Now, diverse treatment options are available, enabling personalized treatment tailored to each patient's condition and needs." Biologics and JAK inhibitors are two main pillars of atopic dermatitis treatment, with the choice of therapy being made based on patient severity, treatment speed, side effects, and economic burden. Dr. Lee said, "It's difficult to decide on a single approach, but strategies can vary depending on the patient's severity." Dr. Lee noted, "For severe patients with extensive systemic involvement, injectables are primarily considered, but for those requiring rapid treatment, JAK inhibitors might be more suitable." For severe patients with an EASI score of 30 or higher and extensive systemic involvement, injectables such as dupilumab or tralokinumab are used. For cases requiring rapid treatment, JAK inhibitors like Cibinqo (abrocitinib) are an option. Indeed, Cibinqo has shown a rapid onset of action (the time it takes to see treatment effects) in clinical studies. In the JADE MONO-2 study, 200mg monotherapy demonstrated significantly greater itch improvement compared to placebo within 24 hours of the first dose. The JADE MONO-1 study also demonstrated significant improvement in skin symptoms by week 12 compared to the placebo. "There are patients who say their symptoms improved significantly within a week or even the very next day after taking Cibinqo, which highlights its fast onset," Dr. Lee stated. "This advantage makes Cibinqo a consideration for those who need quick relief or young adults entering the workforce." Dr. Lee also said, "Cibinqo showed good efficacy even in cases where symptoms were confined to the face and neck. While there are concerns about herpes as a side effect of JAK inhibitors, Cibinqo has shown relatively fewer side effects, making it safe." She added, "Considering that drug price is also an important factor, the availability of various dosages is a strength of Cibinqo." Currently, Cibinqo offers three dosage options: 50mg, 100mg, and 200mg, allowing for adjustment based on weight or condition. Dr. Lee explained that patients whose condition is controlled with 200mg can gradually reduce their dosage to 100mg or 50mg. "For patients with impaired kidney function, even if severe, it's difficult to use high doses, so sometimes only 50mg is prescribed. For lighter female patients or adolescents, high doses may be unnecessary," Dr. Lee said. "In such cases, treatment can be started with 100mg and adjusted down to 50mg. Therefore, having three dosage options is a significant advantage, as it allows for personalized patient treatment." "Reimbursement criteria of atopic dermatitis has a limitation, expanded criteria for rapid treatment is necessary" Another change concerning atopic dermatitis treatment is the approval of inter-class switching between biologics and JAK inhibitors. Regarding this, Dr. Lee advised that inter-class switching (between therapeutic regimens) is necessary to ensure treatment flexibility. Dr. Lee stated, "The current reimbursement criteria for switching therapies only allow coverage when switching between biologics and JAK inhibitors, which doesn't align with clinical practices," and explained, "There are patients who need to switch from biologics to JAK inhibitors, and conversely, there are cases where switching from JAK inhibitors to biologics is necessary." Especially with the emergence of new atopic dermatitis drugs, personalized treatment should be possible. However, as data have not yet fully accumulated, some consider that improvements are needed to allow for trying and switching to therapies within the same class but with different targets and effects. "In recent meetings with overseas medical professionals, issues related to switching therapies were raised, and no other country had as restrictive criteria as Korea," Dr. Lee said. "While there may be limitations within Korea's national health insurance system, in my opinion, I believe there needs to be a greater variety of options for drug switching." Dr. Lee also pointed out that the 'special cases criteria' for atopic dermatitis are excessively stringent compared to conditions like psoriasis. Dr. Lee stated, "For psoriasis, reimbursement is approved if there's no effect even after 3 months of treatment, but for atopic dermatitis, 'special cases criteria' is only possible for severe patients with an EASI score of 23 or higher," and suggested, "If 'special cases criteria' are applied only to severe patients with a 10% co-payment, mild or moderate patients don't receive treatment benefits. The system should be improved to allow partial reimbursement support for moderate patients as well." Additionally, Dr. Lee emphasized the need for systematically established treatment guidelines tailored to patient conditions, mentioning the necessity of clear treatment criteria and personalized guidance, including biomarkers and lesion location. Finally, Dr. Lee stressed, "While the atopic dermatitis treatment landscape is rapidly advancing, continuous management and treatment are currently the main focus rather than a complete cure." Dr. Lee concluded, "With specialized medical professionals, it's important to maintain and improve the patient's quality of life continuously."
- Policy
- Speculation high over the new Minister of Health and Welfare
- by Lee, Jeong-Hwan Jun 10, 2025 06:05am
- (clockwise from the upper left) Former KDCA head Eun-kyung Jeong; former MOHW vice minister Sung-il Yang; Democratic Party of Korea’s Health and Medical Care Special Committee chair Cheong-hee Kang; lawmakers In-soon Nam, former lawmaker Hyun-young Shin, lawmaker Yoon Kim, lawmaker Hyun-hee Jeon Speculation is rife over who will become the first Minister of Health and Welfare in Lee Jae-myung's administration. Eun-kyeong Jeong, former Commissioner of the Korea Disease Control and Prevention Agency, who served as the chief campaign advisor for Democratic Party candidate Jae-myung Lee, is widely expected to be appointed as the next Minister of Health and Welfare. However, no official nomination has been confirmed as of yet. As a result, several names are being mentioned for the position of Minister of Health and Welfare, ranging from former public officials to former and current members of the Democratic Party of Korea. According to political circles on the 8th, the candidates for the position of MOHW include former KDCA head Eun-kyung Jeong; former MOHW vice minister Sung-il Yang; Democratic Party of Korea’s Health and Medical Care Special Committee chair Cheong-hee Kang; lawmakers In-soon Nam, Hyun-hee Jeon, and Yoon Kim, and former lawmaker Hyun-young Shin. Former KDCA head Jeong is credited with contributing to the Moon Jae-in administration's success in fighting COVID-19 on the front lines as well as to the election of Jae-myung Lee as president. Jeong, who has been consistently mentioned as the next MOHW minister before and after the presidential election, has stated that she will return to her position as a clinical professor of family medicine at Seoul National University College of Medicine after the election. During the presidential election period, Jeong herself repeatedly reaffirmed that her participation in the election was driven by the intention to contribute to the nation and its people amidst the turmoil caused by the declaration of martial law. In addition, Sung-il Yang, who entered public service after graduating from Seoul National University with a degree in social welfare and passing the 35th civil service examination, is also mentioned as a candidate. During the recent presidential election, he was active in Lee Jae-myung's think tank and, and served as the co-chair of the welfare policy subcommittee, devising strategies for the health insurance system reform and promoting the health industry. Specifically, Yang is considered to have played a key role in Lee’s campaign as chair of the Economic Growth Committee's Pharmaceutical and Bio Health Committee, chair of the Basic Social Policy Committee's Basic Care Subcommittee, and head of the Special Committee on Citizens with Disabilities. Cheong-hee Kang, Chair of the Democratic Party of Korea’s Health and Medical Care Special Committee who has practical experience as an insurance reimbursement director at the National Health Insurance Service and president of the Korea Public Tissue Bank, was also actively involved in Lee’s presidential campaign. Kang, who is a doctor by profession, ran for office in the 22nd general election in the Gangnam district of Seoul. Among the current members of the National Assembly, In-soon Nam, a four-term Democratic Party lawmaker; Hyun-hee Jeon, a three-term lawmaker; and Yoon Kim, a first-term lawmaker and medical doctor, have been mentioned as potential candidates for Minister of Health and Welfare. Nam served as the head of the functional headquarters in Lee Jae-myung’s presidential campaign, Jeon as a co-chair of the campaign committee, and Kim as the deputy head of the policy headquarters, all contributing significantly to the campaign’s victory. Hyun-young Shin, a former lawmaker who was elected as the Democratic Party of Korea’s No.1 proportional representative in the 21st National Assembly, is also being mentioned as a potential candidate. Shin, a former doctor who served on the NA Health and Welfare Committee, served as the spokesperson for the General Election Headquarters during the presidential election.
- InterView
- 'Viatris will lead market with innovation and leadership'
- by Whang, byung-woo Jun 10, 2025 06:04am
- “Viatris Korea is pursuing growth through two pillars: a core brand-focused business and new pipelines. Based on the pillars, we expect to secure growth momentum once again on a global scale.” Viatris Korea is working to strengthen its position in the domestic market by introducing a global innovative pipeline and driving continuous growth with its existing key product portfolio. While striving to maintain its leadership in the chronic disease treatment market with products such as Lipitor, the company is also planning a two-track strategy to add innovation for future growth. Dailypharm met with Bill Schuster, Representative Director & Country Manager of Viatris Korea, who is entering his third year in office, to hear about the company's growth strategy and mid- to long-term plans. Bill Schuster marks third year as CEO: "Organizational culture is key to growth” Since Bill Schuster took office, Viatris Korea has actively pursued changes to improve its organizational culture and strengthen its market response. Bill Schuster, Representative Director & Country Manager of Viatris Korea"In his first year as CEO in 2023, he focused on fostering a voluntary and participatory organizational culture led by employees, forming a task force centered on junior and mid-level managers, and working to redefine the company’s core values and principles of conduct." Schuster described his leadership style as “transformational leadership.” He explained, “I have not only strived to provide direction for our members but also to empower them with motivation and autonomy to achieve our shared vision." He added, "After experiencing the Great East Japan Earthquake, I came to realize the importance of work-life balance. Since then, I have led by example as a leader, fostering a culture that values and promotes work-life balance."’ A notable aspect of this transformation is the hospital-centric “Go-to-Market” strategy, which strengthens market response around Schuster's leadership. “At Viatris, we have delineated roles by focusing on the hospital channel ourselves while assigning our partners to the clinic channel, thereby eliminating redundant sales structures across the two.” He added, “By strengthening key field-oriented functions, we go beyond being just a sales organization and seek to forge strategic partnerships.” As part of such strategy, the company has strengthened collaborations with Jeil Pharmaceutical in the cardiovascular disease treatment sector and with SK Chemical in the pain management treatment sector. He stated, “We have significantly expanded our hospital channel workforce and established a Key Account Management (KAM) system to provide tailored management for major hospitals and distribution channels. Additionally, we are identifying new opportunities with small and medium-sized hospitals through our Sales Account Management (SAM) system.” These efforts align with Viatris Korea's portfolio. While its major therapeutic agents, such as Lipitor, which ranks first in the single-agent market for dyslipidemia, and Norvasc, which ranks first among CCB (calcium channel blocker) class hypertension treatments, hold high market shares, the company is also facing challenges due to the emergence of new treatment options. In response, Schuster emphasized the expansion of the “base business centered on core brands.” He stated, “South Korea has one of the fastest aging populations in the world, so the demand for chronic diseases such as cardiovascular and pain conditions is expected to continue to grow. In response, Viatris plans to carry out initiatives that raise disease awareness and improve treatment access.” This also includes strengthening market responsiveness through artificial intelligence (AI) and digital strategies. Schuster said, “We are preparing a system that leverages AI technology to precisely analyze marketing performance and optimize resource allocation.” He added, “A pilot project is currently underway, with full-scale implementation targeted for 2025.” He added, “We will leverage AI to analyze customer channel preferences and market trends and develop tailored communication strategies to deliver optimal information to both patients and healthcare professionals. In particular, we plan to actively adopt digital healthcare technologies to support more effective disease management for patients, especially in the areas of cardiovascular health and chronic pain.” Viatris Korea secures growth momentum with customized capabilities for new drug launches "In particular, Viatris Korea is laying the foundation for introducing global innovative drug pipelines into the domestic market, with the aim of establishing new growth engines for the future." Notably, the acute pain treatment 'Meloxicam (MR-107A-02)' and the low-dose contraceptive patch 'XULANE LO' have shown positive effects in global Phase III clinical trials, raising expectations. Specifically, Meloxicam is anticipated to arise as a non-opioid alternative and a new first-line treatment option for moderate to severe acute pain. XULANE LO, a low-dose estrogen patch requiring a once-weekly application, is also receiving positive evaluations for its market potential. The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the second half of 2025. If Viatris Korea maintains its existing core business while introducing new drugs over the next few years, concerns about the sustainability of the company’s long-term growth will be resolved. Schuster emphasized, “While we already possess some of the necessary capabilities, we have determined that this is the time to enhance and expand our internal systems and personnel in preparation for future launches. Therefore, building the capabilities to execute new pipelines over the next few years will be a critical task.” Currently, Viatris Korea has all the core functions, including development, approval, and compliance, and is capable of handling processes such as bridging clinical trials and approval applications with its own capabilities. However, the company plans to nurture a dedicated organization internally to establish launch strategies, secure market recognition, and handle customer communication in preparation for the launch of new drugs. He added, “We aim to become a partner that goes beyond simply importing and selling drugs, and instead works to build a scientific and institutional foundation in Korea in the mid-to long- -term, we will not hesitate to make the necessary investments and collaborations to achieve this.” Finally, he added, “Viatris Korea is committed to sustainable growth in the domestic market and will actively introduce global innovations to contribute to the local healthcare environment. We will continue to fulfill our responsibility as a company that enables patients to lead healthier lives.”
- Company
- Polycythemia vera drug 'Besremi' nearing end of reimb review
- by Eo, Yun-Ho Jun 10, 2025 06:04am
- PharmaEssentia Korea The polycythemia vera (PV) treatment 'Besremi' has entered the final stage of an insurance reimbursement review process. The Ministry of Health and Welfare (MOHW) has recently ordered the National Health Insurance Service (NHIS) to initiate drug price negotiation for PharmaEssentia Korea's Besremi (ropeginterferon alfa-2b). If the company succeeds in negotiation, the drug will be approved for reimbursement in the second half of this year. It is to be watched whether Besremi will be successful in its second attempt. The company underwent the reimbursement process in March 2023 for the treatment of hydroxyurea-refractory/resistant polycythemia vera. However, Besremi did not overcome the Cancer Disease Review Committee (CDRC) hurdle. At the time, the CDRC determined that Besremi lacked evidence for clinical utility as a second-line treatment. After that, PharmaEssentia added Besremi's domestic clinical documents, supplemented efficacy evidence as a second-line treatment, and re-submitted the reimbursement application in March last year. In the same year, it passed the CDRC in July. It passed the review by the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC) last month. Besremi is a next-generation interferon designed to selectively eliminate Janus kinase 2 (JAK2) gene, which causes polycythemia vera. With the improvement made to purity and tolerability of the previous interferon agents, this drug was designed to be taken once every 2 weeks for the initial 1.5 years, then once every 4 weeks. Besremi is now recommended by the National Comprehensive Cancer Network (NCCN) and the European LeukemiaNet (ELN) as treatment for polycythemia vera regardless of previous therapy history. Meanwhile, polycythemia vera is a rare blood cancer where somatic cell mutation in bone marrow causes abnormal activation of bone marrow function, resulting in the overproduction of red blood cells. According to the HIRA documents, the number of patients in Korea with the disease is about 5,000, and hydroxyurea is used in most patients. However, polycythemia vera is a disease with high unmet needs because the current drugs that are covered by reimbursement cannot treat the underlying causes of the disease, and no alternative treatment options exist when patients fail hydroxyurea treatment.
- Company
- Celltrion’s Stelara biosimilar Qoyvolma gains EU approval
- by Kim, Jin-Gu Jun 10, 2025 06:03am
- Celltrion announced on the 9th that ‘Qoyvolma,’ its biosimilar version of the autoimmune disease treatment Stelara (ustekinumab) has received marketing authorization from the European Commission (EC). Qoyvolma has been approved with the addition of ▲'ulcerative colitis (UC)' to the existing indications of ‘Steqeyma,' another Stelara biosimilar previously approved by Celltrion, which is indicated for ▲plaque psoriasis, ▲psoriatic arthritis, and ▲Crohn's disease (CD). With this approval, Celltrion now holds two biosimilars of Stelara. Celltrion plans to strategically leverage the two products with different indications to flexibly address the complex patent landscape across European countries and expand its market share. The company expects that the addition of Qoyvolma will enhance its competitiveness in the ustekinumab market by expanding indications, as Steqeyma’s sales have been growing rapidly in Europe upon its launch. Steqeyma is a new biosimilar treatment that was released in Europe and the US in November last year and March this year, respectively. In Europe, it has been launched in five major countries (Germany, Spain, the UK, Italy, and France) as well as the Netherlands, and has already secured bids in tenders, marking the beginning of its market penetration. In the US, it has signed contracts with two of the top five prescription drug reimbursement management companies (PBMs), which account for about 90% of the total insurance market, and is in negotiations with other PBMs. Celltrion plans to continue expanding its market share in the global ustekinumab market to drive sales growth. According to IQVIA, a pharmaceutical market research firm, the global market size for ustekinumab is estimated to be approximately USD 21.66 billion (approximately KRW 30.32 trillion) as of 2024. A Celltrion official stated, “With the recent approval of Qoyvolma, we will be able to further strengthen our coverage of the ustekinumab market in Europe. Given that Steqeyma, which was launched earlier, is already showing positive growth trends in the global ustekinumab market including Europe, we will make every effort to leverage the complementary strengths of both products to expand market share and drive sales growth.”
- Company
- Next-gen oral breast cancer drugs near commercialization
- by Son, Hyung Min Jun 09, 2025 05:53am
- The arrival of next-generation oral selective estrogen receptor degraders (SERDs) is imminent. At the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 which was held in Chicago, USA, from the 30th of last month to the 4th, multinational pharmaceutical companies simultaneously disclosed the results of their Phase III clinical trials for their oral SERD candidates. At this conference, Pfizer's vepdegestrant and AstraZeneca's camizestrant both presented positive research results. SERDs are primarily used as a treatment option for patients with breast cancer who are resistant to endocrine therapy. Until now, AstraZeneca's Faslodex, an injectable drug, had been the main option. Following this, Menarini's 'Orserdu' emerged as the first oral SERD option, and Lilly completed clinical trials for ‘Inluriyo ‘and submitted an application for its regulatory approval. If latecomers Pfizer and AstraZeneca both succeed in commercializing their products, it is expected that the SERD market will see greater utilization of oral treatment options. #Oral SERD using PROTAC technology… green light lit to its commercialization AstraZeneca announced at the conference that the combination therapy of camizestrant and CDK4/6 inhibitors demonstrated statistically significant improvements in progression-free survival (PFS). Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors are treatment options for patients with hormone receptor (HR)-positive, HER2-negative breast cancer. Representative CDK4/6 inhibitors include Pfizer's Ibrance, Lilly's Verzenio, and Novartis's Kisqali. Camizestrant applies Proteolysis-targeting chimera (PROTAC) technology to targeted protein degradation (TPD) drugs. TPD is a next-generation drug candidate that harnesses the cell’s own protein degradation system to selectively eliminate target proteins. While traditional small molecule drugs inhibit protein function, TPD drugs are known to offer superior therapeutic effects without resistance issues because they fundamentally degrade and eliminate the disease-causing proteins. TPD drugs have the advantage of being able to target over 80% of disease-causing proteins that conventional small-molecule compounds cannot regulate. The Phase III SERENA-6 trial evaluated the efficacy of maintaining the standard treatment regimen of aromatase inhibitors (anastrozole or letrozole) combined with CDK4/6 inhibitors or switching to camizestrant combination therapy in patients with HR-positive, HER2-negative advanced breast cancer who developed ESR1 mutations during first-line therapy. According to the investigator assessment, the camizestrant combination therapy reduced the risk of disease progression or death by 56% compared with standard therapy. The median progression-free survival (PFS) in the camizestrant combination therapy group was 16.0 months, significantly longer than the 9.2 months in the standard therapy group. This improvement in PFS was consistent across various subgroups, including age, race, region, and the timing of ESR1 mutation detection and type. Additionally, the camizestrant combination therapy was shown to significantly delay the onset of deterioration in quality of life. According to exploratory analysis, the camizestrant combination therapy reduced the risk of deterioration in quality of life (global health status/QOL) by 47% compared to the aromatase inhibitors (AI) combination therapy. At the time of this interim analysis, data on key secondary endpoints—including time from randomization to second disease progression or death (PFS2) and overall survival (OS)—were not yet mature. However, the camizestrant combination therapy showed a trend toward prolonged treatment benefits based on PFS2. The clinical trial will continue to evaluate OS, PFS2, and other key secondary endpoints in the future. Presentation of SERENA-6 trial results at ASCO 2025 (Source: AZ). Pfizer announced the results of its Phase III VERITAC-2 study of ‘vepdegestrant,' an oral SERD drug candidate developed in collaboration with Arvinas. Pfizer acquired Arvinas' pipeline in 2021 and is currently conducting joint research. Arvinas' platform PROTAC (PROTAC) was, for a period, widely regarded as synonymous with TPD technology. The VERITAC-2 study is a Phase III clinical trial evaluating the efficacy of vepdegestrant in 624 patients with estrogen receptor (ER)+/HER2- advanced or metastatic breast cancer who have progressed on CDK4/6 inhibitors and endocrine therapy. Patients were randomly assigned to the vepdegestrant or Faslodex group in a 1:1 ratio. The primary endpoint was PFS, assessed by blinded independent central review (BICR) in patients with estrogen receptor 1 mutation (ESR1m) and all patients. Overall survival (OS) was a key secondary endpoint. Clinical trial results showed that the median PFS in the ESR1 mutation patient group treated with vepdegestrant was 5.0 months, compared to 2.1 months in the Faslodex group. The vepdegestrant group showed a reduction in disease progression or death by 43%. The most common treatment-emergent adverse events (TEAEs) in the vepdegestrant group were fatigue (15.6%), increased ALT (9.8%), increased AST (10.4%), and nausea (8.8%). However, all these rates were lower than those in the Faslodex group. The research team evaluated, “Vepdegestrant demonstrated overall good tolerability, with a low discontinuation rate due to adverse events. These results support vepdegestrant’s potential as an oral treatment option for patients with previously treated ER+/HER2- advanced or metastatic breast cancer.
- Company
- K-Bio unveils new cancer drug outcomes at the ASCO meeting
- by Son, Hyung Min Jun 09, 2025 05:53am
- The Korean pharmaceutical and biotech industry has unveiled additional clinical outcomes of drug candidates, such as immunotherapy for cancer, targeted anticancer agents, and bispecific antibodies, under development. Major Korean companies, including Daewha Pharmaceutical, LG Chem, Onconic Therapeutics, ImmuneOncia, and Tium Bio, unveiled their trial results of new anticancer drugs at the American Society of Clinical Oncology (ASCO 2025) annual meeting, which started on May 30 and lasted 4 days in Chicago, U.S. 'FOTIVDA' monotherapy is more effective than Optivo combination therapy LG Chem, through its U.S.-based subsidiary AVEO Oncology ("AVEO"), unveiled the results of the Phase 3 TiNivo-2 study evaluating 'FOTIVDA' monotherapy. Anticancer drug FOTIVDAAVEO received approval for FOTIVDA from the European Medicines Agency (EMA) in 2017 and the U.S. Food and Drug Administration (FDA) in 2021. LG Chem acquired AVEO for $571 million (approximately KRW 700 billion) in 2022. In the previous TiNivo-2 clinical trial, which assessed the clinical possibility of combination therapy, the FOTIVDA + Opdivo combination failed to show improved progression-free survival (PFS) compared to FOTIVDA monotherapy. The latest analysis is a follow-up result from the second-line treatment setting. It evaluated the potential of FOTIVDA monotherapy in 153 patients with renal cell carcinoma who had failed prior treatment with Opdivo+Yervoy or a VEGFR (vascular endothelial growth factor receptor) targeted therapy+immunotherapy combination. Patients were randomly assigned in a 1:1 ratio to either the FOTIVDA monotherapy group or the FOTIVDA + Opdivo group. Clinical results showed that in the Opdivo+Yervoy failure group, the PFS for FOTIVDA monotherapy was 9.2 months, which is similar to the 9.3 months observed for the FOTIVDA+Opdivo group. The objective response rate (ORR) was higher for FOTIVDA monotherapy at 32.4%, compared to 24.2% for the FOTIVDA+Opdivo group. Differences were more pronounced in the patient group that had failed prior VEGF targeted therapy+immunotherapy. In this group, the PFS for FOTIVDA monotherapy was 7.4 months, which was 2.5 months longer than the 3.9 months for the combination group. ORR was recorded at 22.0% for the monotherapy group and 9.5% for the combination therapy group. The researchers stated, "Subgroup analysis of the TiNivo-2 study showed that FOTIVDA monotherapy demonstrated greater efficacy than FOTIVDA + Opdivo. The addition of Opdivo to FOTIVDA did not show a significant benefit, consistent with previous clinical results." Daehwa Pharmaceutical unveils oral paclitaxel Phase 3 clinical trial results Daewha PharmaceuticalDaehwa Pharmaceutical has unveiled the results of a multinational Phase 3 clinical trial for Liporaxel, an improved oral formulation of the injectable anti-cancer drug paclitaxel. Liporaxel is a modified new drug that converts injectable paclitaxel into an oral formulation through Daehwa's proprietary lipid-based DHLASED platform technology. Liporaxel's strength is its convenience of administration. Paclitaxel, an intravenous (IV) formulation and a first-generation cytotoxic anticancer drug, is known for its long administration time and various side effects, such as vomiting, nausea, and hair loss. In clinical trials, Liporaxel demonstrated improvements in side effects, such as hair loss and peripheral neuropathy, compared to the paclitaxel IV formulation. Being free from infusion-related side effects is also a key strength of Liporaxel. The recently disclosed Phase 3 clinical study aimed to prove the non-inferiority of Liporaxel compared to injectable paclitaxel in 549 patients with metastatic breast cancer. Clinical results showed that Liporaxel achieved a median PFS of 10.02 months, demonstrating non-inferiority compared to injectable paclitaxel's 8.45 months. Overall survival (OS) was similar, with Liporaxel at 32.95 months and injectable paclitaxel at 32.46 months. ORR and disease control rate (DCR) were higher in the Liporaxel group. In terms of safety, Liporaxel showed a lower occurrence rate of peripheral neuropathy, hypersensitivity reactions, musculoskeletal and connective tissue disorders, and infusion-related reactions compared to injectable paclitaxel. The researchers emphasized, "Liporaxel demonstrated equivalent efficacy to injectable paclitaxel, along with good tolerability and manageable toxicity. These results indicate that Liporaxel is an effective and convenient alternative to injectable paclitaxel for patients with HER2-negative metastatic breast cancer." Major biotech companies unveil immunotherapy·targeted anticancer drug clinical outcomes ASCO 2025 site (source=ASCO).TiumBio presented the results of its Phase 2 clinical trial of combination therapy containing 'TU2218,' an immunotherapy candidate, in combination with MSD's immunotherapy Keytruda. TU2218 simultaneously blocks the pathways of transforming growth factor-beta (TGF-ß) and vascular endothelial growth factor (VEGF), which are known to inhibit immunotherapy activity. This mechanism aims to maximize the efficacy of immunotherapies. The recently disclosed trial represents early cohort results from an ongoing study in patients with head and neck cancer and biliary tract cancer. Clinical results showed that the TU2218+Keytruda combination therapy resulted in a partial response (PR) in 7 out of 11 patients with head and neck cancer, with stable disease (SD) observed in 1 patient. In the biliary tract cancer cohort, 4 out of 23 patients achieved a PR and 7 showed SD. Onconic Therapeutics shared updates on two ongoing clinical trials for 'Nesuparib,' a targeted anticancer drug under development, at this conference. Nesuparib is a new drug candidate with a dual mechanism that simultaneously inhibits poly ADP-ribose polymerase (PARP) and Tankyrase. Onconic Therapeutics unveiled progress from its Phase 1b clinical trial in metastatic pancreatic cancer. This multicenter, open-label, Phase 1b dose-finding study is recruiting up to 48 patients with locally advanced or metastatic pancreatic cancer. The trial is divided into Group A Nesuparib+FOLFIRI therapy (oxaliplatin, leucovorin, irinotecan, fluorouracil) and Group B Nesuparib+gemcitabine+albumin-bound paclitaxel. The primary objectives of the trial are to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to identify the optimal combination therapy based on safety. The Phase 1 trial is being conducted. Additionally, Onconic Therapeutics is also confirming the potential of Nesuparib in recurrent endometrial cancer. The clinical study, named PENELOPE, is being conducted to verify whether adding Nesuparib to Keytruda maintenance therapy improves PFS after treatment with paclitaxel+carboplatin+Keytruda. Patient enrollment began in the fourth quarter of last year. ImmuneOncia revealed clinical outcomes for its immunotherapy candidate IMC-002. IMC-002 works by blocking the signals between CD47 on cancer cells and macrophages. The results disclosed are preliminary findings from an ongoing Phase 1b clinical trial in patients with hepatocellular carcinoma. The trial is evaluating the tolerability and safety of IMC-002 in combination with Lenvima, which is used to treat hepatocellular carcinoma. Among 10 evaluable patients, the ORR was 30%, and the DCR was 70%. The median time to progression (TTP) was 8.3 months. The researchers said, "The efficacy and a safety profile were confirmed when IMC-002 20mg/kg in combination with Lenvima was administered every 3 weeks."
- Company
- 1st patient enrolled in Phase 2 FDA trial of 'Nugel' in KOR
- by Lee, Seok-Jun Jun 09, 2025 05:51am
- Shaperon announced on June 5 that a Phase 2 Part 2 U.S. Food and Drug Administration (FDA) clinical trial for its atopic dermatitis drug 'Nugel' has enrolled the first patient for clinical trials being conducted in South Korea. This trial is a multinational clinical trial evaluating Nugel's safety and efficacy in 177 patients across 12 clinical sites in South Korea and the United States. In South Korea, the first meetings for initiating the clinical trial have been recently completed at major hospitals, including △ Seoul National University △ Seoul National University Bundang Hospital. The first patient was enrolled at Seoul National University Bundang Hospital. Shaperon representative said, "Researchers involved in Korean clinical trials are anticipating significant results from Part 2 clinical trial, based on superior data confirmed in Part 1 clinical trial. In the United States, patients have been recruited since March, and so far, over 40 patients have completed registration. Shaperon aims to secure the final clinical result report and plans to finish drug administration in all patients within the first half of next year. 'Nugel,' developed by Shaperon, is a first-in-class medicine for atopic dermatitis. Superior safety and continuous anti-inflammatory effects are expected compared to existing treatments. In the Phase 2 Part 1 FDA clinical trial, Nugel demonstrated superior efficacy and higher safety compared to a placebo. Furthermore, this drug recorded superior results in terms of primary endpoints, which are 'EASI50' and 'IGA-TS,' compared to existing treatments.
