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- 2025-12-21 09:32:50
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- Zuellig Pharma's performance fluctuates after a brief reboun
- by Son, Hyung Min Apr 21, 2025 05:54am
- Zuellig Pharma Korea, a global pharmaceutical distributor that had experienced ups and downs in its external growth, successfully rebounded last year. Zuellig Pharma's sales declined for 4 consecutive years after recording sales of over KRW 1 trillion in 2020 but showed signs of recovery by taking on the domestic distribution of new drugs from multinational pharmaceutical companies. According to the Financial Supervisory Service on the 18th, Zuellig Pharma's sales last year were KRW 889.3 billion, up 4.8% from the previous year. Operating profit was KRW 4.3 billion, similar to the previous year. Zuellig Pharma is the Korean subsidiary of a Swiss global pharmaceutical distribution company that entered the Korean market in 1998. As the first global distributor to enter the Korean market, it faced strong opposition from the domestic industry. The Korea Pharmaceutical Distribution Association formed the Zuellig Countermeasures Committee and took strong measures to prevent Zuellig Pharma from monopolizing the supply of global pharmaceutical companies' products. Nevertheless, Zuellig Pharma's sales continued to grow until 2021. The company's sales grew steadily from KRW 706.9 billion in 2015 to KRW 889.4 billion in 2016, then to KRW 970.9 billion in 2017. Zuellig Pharma recorded KRW 1.184 trillion in 2019, becoming the third company to exceed KRW 1 trillion in sales after Geo-Yong and Baekje Pharmaceutical. The company maintained its status in the trillion-won club in 2020 with sales of KRW 1.0372 trillion, but sales fell to KRW 910 billion the following year. In 2022, sales amounted to KRW 885.3 billion, a 2.7% decrease from the previous year. In 2023, sales decreased by 4.1% year-on-year to 850 billion won. Zuellig Pharma was hit hard by changes in the drug distribution environment. Before, Zuellig Pharma had grown through exclusive deals with multinational pharmaceutical companies. In particular, domestic drug distributors had to sign wholesale contracts with Zuellig Pharma in order to distribute drugs from multinational pharmaceutical companies. However, major multinational pharmaceutical companies began to utilize the distribution networks of Korean pharmaceutical companies, forging co-promotion agreements with domestic companies, gradually reducing Zuellig Pharma's market share. In addition, domestic pharmaceutical distributors obtained distribution rights through direct contracts with multinational pharmaceutical companies, reducing Zuellig Pharma's main source of revenue. For example, Geo-Yong directly distributes UCB Korea’s allergy treatment Zyrtec, and psoriasis treatment Bimzelx. Geo-Yong is also selling over-the-counter (OTC) drugs from multinational pharmaceutical companies, such as the contraceptive Mercilon. Furthermore, major domestic companies have established new logistics systems such as 3PL and 4PL to enhance their competitiveness. Logistics systems are categorized into four types (1PL/2PL/3PL/4PL) based on their structure. 3PL refers to outsourcing logistics operations to external companies, while 4PL refers to customized services that not only outsource logistics but also provide consulting on suitable logistics systems and IT-related solutions. Larger companies have adopted integrated logistics strategy models, establishing their own logistics IT systems and strengthening order, receivables, and collection management functions. As a result, Zuellig Pharma now faces competition in the utilization of 3PL/4PL logistics systems as well. In particular, domestic companies have equipped themselves with cold chain systems and are distributing major biological products such as Dupixent, putting a brake on Zuellig Pharma's external growth. Operating profit rebounded, but competition intensified In addition to Zuellig Pharma, other global pharmaceutical distribution companies such as DKSH and DB Schenker Korea, as well as domestic firms like Pico Innovation and Bluemtec have established online platforms, intensifying market competition. However, Zuellig Pharma managed to rebound last year with its first sales increase in 4 years. In particular, operating profit has also improved recently. Zuellig Pharma posted operating losses every year from 2017 to 2021. However, in 2022, it returned to profit for the first time in about 7 years with KRW 900 million. In 2023 and last year, it recorded KRW 4.3 billion, showing growth. Zuellig Pharma succeeded in increasing its operating profit by improving its cost ratio along with a reduction in sales and administrative expenses and employee wages. Thanks to its improved performance, Zuellig Pharma emerged from total capital erosion, which had continued for 2 years since 2020. Total capital erosion refers to a state in which a company's deficit grows so large that its surplus runs out and even its paid-in capital is eroded, resulting in negative total capital. Zuellig Pharma was in a state of complete capital erosion in 2020 and 2021, with total capital of – KRW 1.5 billion and -KRW 14.5 billion, respectively. Zuellig Pharma plans to achieve growth in sales and operating profit through the distribution of innovative new drugs. Last year, Zuellig Pharma became responsible for the distribution of the obesity treatment drug Wegovy. Wegovy is a glucagon-like peptide (GLP-1) obesity treatment that recorded sales of over KRW 60 billion in the fourth quarter of last year alone. Zuellig Pharma successfully secured the distribution rights for Wegovy thanks to its experience in distributing the obesity treatment Saxenda. Zuellig Pharma will also be responsible for the domestic distribution of the immuno-oncology drug Libtayo. Libtayo (cemiplimab) is currently approved in South Korea as a first-line monotherapy for advanced non-small cell lung cancer and as a treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) and recurrent or metastatic cervical cancer. Last year, Zuellig Pharma also formed a partnership with European consumer healthcare company Karo Healthcare to target the Asian market and signed a domestic distribution agreement for the athlete's foot treatment Lamisil.
- Company
- Sanofi’s MenQuadfi to be launched soon in Korea
- by Whang, byung-woo Apr 21, 2025 05:54am
- Sanofi's next-generation meningococcal vaccine is set to launch just 1 year after receiving approval in Korea, signaling the start of intense market competition. Pic of MenQuadfi According to industry sources, Sanofi is preparing to launch its invasive meningococcal disease vaccine MenQuadfi in the third quarter of this year. MenQuadfi is a fully liquid vial quadrivalent meningococcal vaccine that prevents meningococcal serotypes A, C, W, and Y, and is approved for a single dose for individuals aged 2 to 55 years. When compared for immunogenicity with existing quadrivalent meningococcal vaccines, MenQuadfi demonstrated non-inferiority for all four serotypes. Unlike Sanofi's existing meningococcal vaccine, which utilized the diphtheria toxid protein, MenQuadfi utilizes the tetanus toxoid protein and has increased antigen amount. Currently available meningococcal vaccines include GSK Korea’s Menveo and Sanofi’s Menactra. Both vaccines are indicated for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W135, and Y. With the launch of MenQuadfi, the competitive landscape is expected to shift from “Menveo vs. Menactra” to “Menveo vs. MenQuadfi.” Sanofi has decided to discontinue Menactra upon the launch of MenQuadfi, but the exact timing of supply discontinuation will be dependent on market inventory levels. A Sanofi representative stated, “We decided to launch MenQuadfi based on the high demand for Menactra in the global market and the expansion of its indications. As a result, we have decided to discontinue Menactra. We will do our utmost to ensure an uninterrupted supply of meningococcal vaccines in the Korean market by adjusting the launch schedule of MenQuadfi in accordance with the depletion of Menactra inventory.” One of the differences between Menactra and MenQuadfi is the age at which they can be administered. Menactra can be administered from 9 months of age, while MenQuadfi is currently available as a single dose for individuals aged 2 to 55 years. However, as the age range for MenQuadfi is being expanded, the vaccine is expected to naturally replace Menactra in the market. In particular, while Menactra contained 4ug of meningococcal serum antigen, MenQuadfi contains 10ug of all four antigens. Meningococcal vaccination costs, from left, GSK Menveo Sanofi Menactra (Data = HIRA Before MenQuadfi’s launch, GSK had already launched Bexsero, a meningococcal group B absorbed vaccine. Bexsero is a vaccine for preventing meningococcal group B infections and differs from the existing Menveo in its scope of prevention. In other words, GSK has introduced a new meningococcal vaccine with a different scope of prevention, while Sanofi has unveiled a next-generation vaccine with enhanced prevention effects. According to IQVIA data, Menveo's sales in 2023 were KRW 52 billion, while Menactra's sales were KRW 5 billion. Given the significant sales gap between the two products, both companies are expected to focus on increasing their market share with the launch of next-generation vaccines. However, meningococcal vaccines are not classified as essential vaccines and are classified as premium vaccines, so price accessibility is expected to be an important factor. According to the Health Insurance Review and Assessment Service's non-reimbursable medical expenses, Menveo costs an average of KRW 142,805, while Menactra costs an average of KRW 142,072.
- Company
- Roche Korea's 'Lunsumio' available at general hospitals
- by Eo, Yun-Ho Apr 21, 2025 05:54am
- Product photo of Lunsumio The first GIFT-designated drug 'Lunsumio' can now be prescribed in general hospitals. According to industry sources, Roche Korea's CD20xCD3 bi-specifc antibody 'Lunsumio (mosunetuzumab)' has passed the drug committee (DC) of Asan Medical Center in Seoul. Lunsumio is the first medicine to be designated as a 'Global Innovative products on Fast Track (GIFT)' and obtained approval from the Ministry of Food and Drug Safety (MFDS) in November 2023. This drug can be prescribed for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more systemic therapies. However, Lunsumio remains a non-reimbursed drug. Roche has applied for the 'approval-assessment package system,' in addition to the GIFT designation, but discussions on reimbursement have yet to progress. FL is a type of non-Hodgkin Lymphoma (NHL) that occurs when cells in the lymph system turn malignant. Because the symptoms of the disease progress slowly, about 80% of the cases are identified at stage III or Stage IV after the disease progresses. The prognosis for patients who relapse is poor. Median progression-free survival (mPFS) is 10.6 years for patients who received first-line treatment; however, mPFS drops to two years with third-line treatments, representing about 20%. Lunsumio is the first-in-class CD20xCD3 bi-specific antibody involving T cells for relapsed or refractory FL. It simultaneously binds to a protein CD3 on the surface of T cells, which are types of white blood cells and immune cells, and protein CD20 of the malignant B cell surface, designed for T cells to target B cells. It is a readily applicable product that can be administered without waiting for manufacturing, and patients can be treated without hospitalization. The administration duration is fixed to eight cycles. During this period, when a patient does not reach complete remission, the drug administration can be extended to 17 cycles. Professor Won Seog Kim of Samsung Medical Center's Hematology and Oncology said, "FL is considered a good type of lymphoma with a life expectancy of 20 years, but as patients experience repeated relapses, the disease becomes aggressive, and the prognosis worsens. Therefore, an effective treatment regimen with expected remission was urgent for patients with FL who have relapsed two or more times."
- Company
- Hope for polycythemia vera, Besremi, makes reimb progress
- by Eo, Yun-Ho Apr 21, 2025 05:53am
- Industry attention is gathering on the insurance reimbursement progress for the polycythemia vera treatment, Besremi. According to industry sources, PharmaEssentia Korea's new drug for polycythemia vera, Besremi (ropeginterferon alfa-2b-njft), has been determined cost-effective by the Health Insurance Review and Assessment Service's Pharmacoeconomic Evaluation Subcommittee. Accordingly, the procedure will proceed depending on whether the company accepts the government's proposal. As Besremi will gain a unique status in the field when listed, the industry expects the company and the government to derive positive results. This is the second attempt for Besremi’s reimbursement listing in Korea. In March 2023, the drug underwent the reimbursement process for refractory or intolerant polycythemia vera but failed to pass the Cancer Disease Review Committee in July of the same year. At the time, the Cancer Disease Review Committee determined that there was insufficient evidence to judge the clinical utility of Besremi as a second-line treatment. In response, PharmaEssentia resubmitted its application for reimbursement in March after adding domestic clinical data on Besremi and supplementing the evidence on the drug’s efficacy as second-line therapy, and the application passed CDDC review in July of the same year. At that time, the Cancer Disease Review Committee established the reimbursement standards for Besremi as a treatment for patients with polycythemia vera without splenomegaly accompanied by symptoms in low-risk groups (limited to patients requiring cytoreductive therapy) and high-risk groups. Besremi is a next-generation interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera. It was developed to improve the purity and tolerability of existing interferons so that it can be administered every two weeks for the first 1.5 years and every four weeks thereafter. It is currently recommended for the treatment of PV in the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of prior treatment history. Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells. According to HIRA data, about 5,000 patients are affected with PV in Korea, and hydroxyurea is mainly used for the majority of patients. However, as the current reimbursed drugs are not curative and there are no new alternatives for patients who fail hydroxyurea treatment, there remains a high unmet need for the disease.
- Company
- Vocabria+Rekambys may be prescribed in general hospitals
- by Eo, Yun-Ho Apr 18, 2025 05:59am
- The long-acting HIV drug Vocabria+Rekambys combination therapy may now be prescribed in general hospitals in Korea. According to industry sources, GSK Korea’s Vocabria (cabotegravir) and Janssen Korea’s Rekambys (rilpivirine) combination passed the drug committees (DCs) of various medical institutions in Korea, including Korea University Anam Hospital, Konkuk University Medical Center, Kyungpook National University Hospital, and Chung-Ang University Hospital. The combination has been gradually expanding its prescription areas before and after the reimbursement listing this month (April). The upper insurance price ceiling for Vocabria 30mg is KRW 16,303 per tablet and KRW 991,882 per vial. The Vocabria+Rekambys combination was approved by the Ministry of Food and Drug Safety in February 2022 as a combination therapy for the treatment of HIV-1 infection in adult patients who are virologically suppressed, have no history of virological failure, and have no known or suspected resistance to cabotegravir or rilpivirine. The advantage of this combination therapy is undoubtedly its convenience in administration. While existing HIV treatments require patients to take a tablet formulation once a day, the two injectable drugs will reduce the frequency of administration to once a month or once every two months with intramuscular injections, increasing satisfaction and reducing the burden on patients. The two drugs were originally developed as oral medications and then were developed into injectable drugs. While this long-acting injectable drug cannot cure HIV infection, it is a treatment that targets white blood cells to help lower and maintain the level of the AIDS virus. Meanwhile, the efficacy and safety of the Vocabria+Rekambys combination therapy was demonstrated in clinical trials in groups that received the drug once every four weeks or once every eight weeks. The combination was approved in Europe in December 2020. In the clinical trial, the most frequently observed adverse reactions in the group that received the Vocabria+Rekambys combination were injection site reactions, headache, fever, nausea, fatigue, asthenia, and myalgia. In addition, the indication for combination therapy has been expanded to include adolescent patients in Europe.
- Company
- KDDF "Continuity is important for support in new drug R&D"
- by Whang, byung-woo Apr 18, 2025 05:57am
- The Korea Drug Development Fund (KDDF), celebrated fourth year since launch, has emphasized its role as a 'supporter' rather than a 'management' in advancing successful new drug development. As it enters its fifth year and reaches a midpoint of the project duration, KDDF has emphasized the need for continuity and a centralized control tower. KDDF Ceo Park Yeong-min On April 17, KDDF Ceo Park Yeong-min held a press briefing to share the KDDF's achievements and future strategies on its fourth anniversary. KDDF program supports the entire drug development lifecycle, including candidate discovery, preclinical studies through Phase 1 and 2 clinical trials, and commercialization. It is a multi‑ministerial R&D initiative with KRW 2.1758 trillion (KRW 1.4747 trillion in government funding and KRW 701.1 billion in private investment) allocated over ten years through 2030. Since its 2021 launch, KDDF has supported 423 pipeline projects and plans to add 128 new projects this year, bringing its total to approximately 550. Ultimately, KDDF aims to strengthen the R&D ecosystem by improving the success rate of early‑stage technologies progressing to later development stages and building biotech venture capabilities. Furthermore, KDDF assists with global partnering and investment attraction to generate practical outcomes such as blockbuster new‑drug approvals and global technology transfers. As it reaches the midpoint of its ten‑year plan, KDDF will focus on enhancing its commercialization support this year alongside ongoing target and modality projects. To achieve these goals, KDDF has increased clinical project funding by 30%, raising support to KRW 4.55 billion for Phase 1 trials and around KRW 9.1 billion for Phase 2 trials. Previously, KDDF capped support at KRW 2 billion for non-clinical stages, KRW 3.5 billion for Phase 1, and KRW 7 billion for Phase 2. Park stated, "We aim to discover globally competitive molecules and will focus on new targets and modalities," and added, "By optimizing our commercialization support, KDDF can pioneer a new R&D model." "We will expand programs to resolve drug‑development bottlenecks and strengthen global competitiveness. KDDF will not merely provide support, but we will establish an efficient R&D structure." During the meeting, KDDF stressed that as a sunsetting program, it requires guaranteed continuity given the long timelines inherent in new‑drug development. Park said, "KDDF is a sunsetting program that must undergo a feasibility reassessment after ten years, which can create inefficiencies in later stages," and added, "Since the government has designated the bio‑pharma industry as a future growth engine, the organization supporting frontline drug development must operate without interruption." KDDF succeeded the previous multi‑ministerial new drug development program, which ran from 2011 until its closure in September 2020, and KDDF then launched in 2021. However, there was a roughly six‑month gap between the predecessor program's end and KDDF's launch, during which small biotech firms reportedly faced support disruptions that delayed their R&D for over six months. Given KDDF's fixed ten‑year timeframe, experts have called for follow‑up measures to ensure domestic drug developers do not abandon projects due to support gaps. Park said, "We need to double the budget for drug development to support more companies. New policy measures, such as supporting potential K‑Big Pharma, are needed so that KDDF could serve as the control tower for Korea's pharmaceutical and biotech industry."
- Company
- Expanded reimbursement for 'Lorviqua' expected soon
- by Eo, Yun-Ho Apr 17, 2025 05:57am
- Product photo of Lorviqua The non-small cell lung cancer treatment 'Lorviqua' is expected to receive expanded insurance reimbursement after many attempts. According to industry sources, Pfizer Korea has recently signed an agreement with the National Health Insurance Service (NHIS) regarding drug pricing negotiations for the third generation ALK cancer drug Lorviqua (lorlatinib) as a first-line treatment of anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC. Such accomplishment took 10 months since the breakdown of the drug price negotiations in May 2024, and then Pfizer had filed for reimbursement again. Pfizer immediately filed for general listing, which passed the last Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) last year. Even after reapplication, the reimbursement process has been slow. Analysis suggests that the government postponed the decision because Lorviqua was initially contracted as a total expenditure-capped RSA, then switched to a general listing. Earlier in January 2024, when the process for expanded reimbursement had been in process, Pfizer had filed for general medicine reimbursement. Of note, ALK cancer drugs, including the first-generation drug 'Xalkori (crizotinib)' and the second-generation drugs 'Alecensa (alectinib)' and 'Zykadia (ceritinib),' are all general listing medications. During the negotiations, Pfizer suggested switching to a general listing during the negotiation. However, the government insisted that "negotiations for the total expenditure-capped RSA must be completed before the company can move on to the next step." As a result, the negotiations ultimately failed. Meanwhile, Lorviqua is a drug designed to penetrate the blood-brain barrier (BBB). The drug has been assessed as having clinical significance based on the long-term follow-up results of the CROWN study, which was recently presented at the ASCO. The study results showed that Lorviqua reduced the disease progression and death risk by 81% compared to crizotinib, and 60% of treated patients were alive without disease progression even after five years. The risk of brain metastasis was reduced in 94% of the treated patients, with only 4 out of 114 patients who did not previously had brain metastasis developing it after being treated with Lorviqua.
- Company
- Lundbeck Korea appoints Brad Edwards as first foreign CEO
- by Whang, byung-woo Apr 17, 2025 05:57am
- Brad Edwards, new CEO of Lundbeck Korea On the 1st, Lundbeck, a global pharmaceutical company specializing in the treatment of brain diseases, announced on the 16th that it has appointed Brad Edwards as its first foreign CEO in 23 years since the establishment of its Korean subsidiary. The new CEO is a professional with extensive experience and expertise gained from 25 years of service at various multinational pharmaceutical companies, including Schering-Plough, Pfizer, Shire, and Takeda. Recently, he served as the Head of Plasma Derived Therapies (Growth and Emerging Markets) at Takeda in Singapore. Since joining Shire in 2014, Edwards has gained extensive experience through Shire's extensive rare disease portfolio. He has since served as the General Manager of Takeda Australia and New Zealand. Also, as a board member of Medicines Australia, he has contributed to shaping the external policy environment in Australia to improve patients' access to treatments for rare diseases. With the appointment of the new CEO, Lundbeck expects his extensive experience and in-depth knowledge in the field of rare diseases to play a crucial role in preparing Lundbeck Korea for its expansion into the field of neuro-rare diseases. CEO Brad Edwards said, “I am honored to have the opportunity to work in Korea by joining Lundbeck and am looking forward to joining Lundbeck's ‘Focused Innovator’ strategic journey.” He added, “I will work to reinforce Lundbeck Korea's position in the field of neuroscience and drive the company's expansion into other areas where there is an unmet medical need.” He added, “I am looking forward to learning more about the Korean culture, working closely with my colleagues at Lundbeck, and, above all, contributing to the development of treatments that have a real impact on Korean patients.” Lundbeck Korea is a multinational pharmaceutical company headquartered in Copenhagen, Denmark, and specializes in brain disease treatments, researching and developing treatments for neurological and psychiatric diseases. Representatively, the company owns the antidepressants Lexapro (escitalopram oxalate) and Brintellix (vortioxetine hydrobromide), Alzheimer's disease treatment Ebixa (memantine hydrochloride), and Parkinson's disease treatment Azilect (rasagiline mesylate).
- Company
- Vantive Korea to become kidney disease therapy leader
- by Whang, byung-woo Apr 17, 2025 05:57am
- Vantive, a spinoff of Baxter that was newly launched as an independent company, is embarking on a full-scale market penetration based on its manpower in the field of kidney treatment. In the long term, the company plans to provide solutions to become a company that provides life-sustaining organ therapy, beyond kidney treatment. Kwanghyuk Im, General Manager of Vantive Korea Vantive Korea held a meeting on the 16th to commemorate its launch in Korea and share the company's goals and strategies. Vantive was launched in February as a spin-off of Baxter's Renal Care and Acute Care Business Unit and seeks to be a company focusing on “Vital Organ Therapy.” The spin-off was made to establish a clearer business strategy by responding quickly to rapidly changing healthcare needs and focusing on innovation in each company's area of expertise. Vantive plans to present its business direction based on its legacy of leading innovation in kidney care for the past 70 years, with its mission “Extending lives, expanding possibilities.” Kwanghyuk Im, General Manager of Vantive Korea, said, “Vantive is a vital organ therapy company that aims to raise the standards of kidney and life-sustaining organ treatment,” Im added, “We will not only provide disease treatment solutions but also strive to remove obstacles in the treatment process from the beginning to the end as a companion in our patient’s treatment journey.” However, at the time of the spinoff, Vantive's business activities were not much different from those of Baxter's existing renal business unit. Some argue that the direction of a long-term plan is important for a company to differentiate itself as a standalone company. In this regard, Im said, “Baxter's business structure was diverse, so it was not easy for the company to invest in or conduct research and development (R&D) in a particular business under such circumstances. As Vantive has a major mission of long-term treatment for life support, we expect to be able to make more focused and differentiated investments." Im added, “We cannot reveal specific plans for new products, but we are soliciting various R&D ideas on a global scale to improve products and services. We fully expect there to be new innovations.” Vantive plans to provide innovative products, digital-enhanced solutions, and advanced services to support dialysis at home and in hospitals, as well as treatment options to support the kidney and vital organ functions of critically ill patients. In addition, the company aims to combine an automated peritoneal dialysis (APD) system with a digital patient management platform in the field of peritoneal dialysis to enable healthcare professionals to make patient-specific decisions quickly and accurately based on automatically transmitted data. “Vantive is working to improve the patient's treatment experience and reduce the inconvenience experienced during the treatment process,” said Im. ”We want to reduce the burden of treatment through patient-centric services such as a 24-hour consultation service for peritoneal dialysis patients and direct delivery of dialysis fluid to their homes.” In addition, Vantive plans to lead the advancement of critical care through multi-organ treatment, including continuous renal replacement therapy (CRRT). In the future, the company plans to pursue innovations that can be applied to the treatment of sepsis and organ failure, such as lung and liver failure. “We plan to expand our activities to raise awareness of end-stage renal disease and improve the dialysis environment, as well as sponsor the Kidney Camp for Children and other various social contribution programs,” said Im. ”We will work to provide better treatment experience at various points of contact between patients and healthcare professionals, fulfill our corporate social responsibility, and create sustainable change.”
- Company
- Expanded indication for Iclusig as a first-line treatment
- by Whang, byung-woo Apr 17, 2025 05:57am
- Product photo of Iclusig On the 16th, Korea Otsuka Pharmaceutical (CEO Sung-ho Moon) announced that Iclusig (ingredient name: ponatinib) can now be used in combination with chemotherapy for treating adult patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL). This expanded indication has expanded Iclusig's use of scope from a third-line or higher treatment for Ph+ ALL to Ph+ ALL first-line treatment. Previously, Iclusig was approved for the treatment of adult patients with chronic, accelerated, or blast phase chronic myeloid leukemia (CML) or Ph+ ALL who were refractory to other tyrosine kinase inhibitors (TKIs), as well as for the treatment of adult patients with T315I-positive chronic, accelerated, or blast phase CML or T315I-positive Ph+ ALL. This expansion of indications follows the expedited approval by the U.S. FDA in March 2024 for combining therapy comprised of Iclusig and chemotherapy to treat newly diagnosed Ph+ ALL patients. It has also led to an expansion of its indications in South Korea. Through this, Iclusig can now be used in Korea as a first-line treatment for adult Ph+ ALL patients in combination with chemotherapy for up to 20 cycles. The PhALLCON trial, which served as the basis for this approval, was a Phase 3 trial (randomized, open-label) conducted at 77 institutions across 17 countries. The study evaluated the efficacy and safety of the combination of ponatinib (brand name: Iclusig) with low-intensity chemotherapy versus the combination of the first-generation TKI imatinib (brand name Glivec) with low-intensity chemotherapy in 245 newly diagnosed adult Ph+ ALL patients. Study results showed that the primary evaluation endpoint, the MRD-negative complete remission (MRD-neg CR) rate at the end of induction therapy (12 weeks), was 34.4% in the Iclusig group, approximately twice as high as the 16.7% observed in the imatinib group. Furthermore, the median progression-free survival (PFS) was significantly longer in the Iclusig group at 20.0 months compared to 7.9 months in the imatinib group. In terms of safety, Iclusig demonstrated manageable tolerability. The treatment discontinuation rate due to adverse events was reported to be 12% (n=20/164) patients in the Iclusig group and 12% (n=10/81) in the imatinib group. The incidence of treatment-related serious adverse events was 20.9% (n=34/163) in the Iclusig group and 19.8% (n=16/81) in the imatinib group. Korea Otsuka Pharmaceutical representative stated, "Iclusig demonstrated superior MRD-neg CR and stable drug tolerability compared to the conventional therapy, such as the first-generation TKI, when used as a first-line treatment for patients with Ph+ ALL," and added, "Based on this expansion of indication, Iclusig, which was used for three or more line of treatments, is available as a first-line treatment option."
