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- 2026-03-14 11:09:48
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- Xospata passed the first hurdle to increasing benefits
- by Eo, Yun-Ho May 08, 2023 05:41am
- After submitting the application for expansion of Xospata's benefits, the Health Insurance Review and Assessment Service's Cancer Disease Review Committee succeeded in setting the reimbursement standard. As a result, attention is focused on future procedures such as the schedule for submission to the Pharmaceutical Reimbursement Evaluation Committee. As Xospata is a PE drug, in the case of insurance coverage expansion, it is necessary to go through the drug price negotiation process with the Health Insurance Corporation. Xospata has been approved as monotherapy for patients with FLT3 mutation-positive relapse or Acute Myeloid Leukemia, but the current reimbursement standard allows up to four cycles only for patients eligible for allogeneic hematopoietic stem cell transplantation. There are no specific reasons to limit the dosing cycle of Xospata except for financial issues. Looking at the ADMIRAL clinical study of this drug, it was designed with no restriction on the administration period, and it is recommended as 'Category 1' in the NCCN Guidelines without any limitation on the period. The best treatment for patients with acute myeloid leukemia is hematopoietic stem cell transplantation, but there is a high risk of recurrence, and transplantation is difficult in many cases because there are many elderly patients. In the case of patients who cannot undergo hematopoietic stem cell transplantation, which is excluded from the current reimbursement standard, there is no suitable treatment alternative other than Xospata, so they remain on chemotherapy developed over 40 years ago. The Korea Leukemia Patients Association commented immediately after the review committee, "There are many patients with acute myeloid leukemia aged 70 years or older who are unable to undergo transplantation due to lack of physical strength or high non-insured hematopoietic stem cell transplantation costs. Such allogeneic hematopoietic stem cell transplantation is impossible. FLT3 Xospata is used in patients with mutation-positive relapsed or refractory acute myeloid leukemia." "The government authorities and the relevant pharmaceutical companies should expeditiously carry out follow-up procedures such as scheduled deliberation committee, drug price negotiation, and deliberation by the Health Insurance Policy Deliberation Committee so that the reimbursement standard for Xospata, a treatment for acute myeloid leukemia, can be expanded as soon as possible," he urged.
- Company
- New polycythemia vera drug Besremi may be prescribed
- by Eo, Yun-Ho May 08, 2023 05:40am
- The Taiwanese pharmaceutical company PharmaEssentia’s first new drug ‘Besremi’ can now be prescribed in general hospitals in Korea. According to industry sources, PharmaEssentia’s polycythemia vera treatment, Besremi (Ropeginterferon alfa-2b) passed drug committee reviews of tertiary hospitals in Korea including Seoul National University Hospital and Asan Medical Center. The company submitted an application for the reimbursement of its drug on March 28 and is undergoing the reimbursement process in Korea. If listed, the drug is expected to quickly lead to actual prescriptions in the field. 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. It has a short survival period and is so fatal that 10~15% of patients with polycythemia vera develop myelofibrosis or leukemia within 10 years. Although hydroxyurea had been used as the standard of care, it was difficult to fundamentally cure the disease with hydroxyurea, and patients who could not be treated with hydroxyurea had limitations as there were practically no drugs available for them in Korea’s domestic reimbursement environment. Besremi is an interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera. In Korea, the drug received approval in October 2020 to treat low-risk and high-risk patients with polycythemia vera without symptomatic splenomegaly. The drug demonstrated its potential as a radical treatment for polycythemia vera in patients who had not received cytoreduction therapy or received less than 3 years of treatment with hydroxyurea. Therefore, whether the only interferon treatment option approved for polycythemia vera will be born in Korea is receiving attention. Besremi demonstrated its efficacy and safety in the Phase III PROUD/CONTINUATION-PV trial that was conducted on polycythemia vera patients. Trial results showed that 53% of the patients in the Besremi arm achieved a complete hematological response, an improvement compared with the hydroxyurea patient arm (38%). The hematologic and molecular response rates at 72 months were also high, at 80.4% and 65.3% in low-risk and high-risk patients, respectively. Regardless of their risk, patients treated with Besremi did not require phlebotomy even 6 years after administration. Sung-Soo Yoon, Professor of Hemato-Oncology at Seoul National University Hospital, said, “Polycythemia vera is currently left unattended in the blind area of reimbursement in Korea. Patients that show no response to hydroxyurea, the current standard of care, had no appropriate treatment and had no option but to wait for their condition to progress further.” He added, “Korea’s clinical practice guidelines recommend interferon and ruxolitinib as second-line treatment for patients who show intolerance or are refractory to hydroxyurea, but both drugs are currently unreimbursed, and other interferon treatments have withdrawn from the Korean market. Therefore, as the only treatment option available, Besremi is in urgent need of reimbursement.” Besremi is recommended as a first-line or second-line treatment for polycythemia vera in the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of previous treatment experience.
- Company
- Merck establishes a bio-production facility in Daejeon
- by Jung, Sae-Im May 08, 2023 05:40am
- (From left) Minister of Trade, Industry and Energy Lee Chang-yang, Merck Life Science CEO Matthias Heinzel, Daejeon Metropolitan City Mayor Lee Jang-woo Merck Life Sciences establishes a bio raw material production facility in Korea. Merck Lifesciences announced on the 3rd that it has signed a memorandum of understanding (MOU) with the Ministry of Trade, Industry and Energy and Daejeon Metropolitan City to establish a production facility for raw and subsidiary materials used in the new Asia-Pacific bioprocess in Korea. The bio-process production facility scheduled to be established in Daejeon will support the pharmaceutical/bio ecosystem in the Asia-Pacific region and focus on producing products for biotech and pharmaceutical customers. Along with this, the company and the city of Daejeon will support biotech companies that have moved into the Daedeok Research Complex in Daejeon and will expand research cooperation with leading universities in Korea. Matthias Heinzel, CEO and Member of the Board of Directors of Merck Life Sciences said, "Korea is an emerging world leader in the biotechnology industry, and this MOU is a commitment to actively support our customers in the Asia Pacific region through close cooperation with the government. "The production facility being tested will play an essential role in meeting the demand for bioprocessing in the Asia-Pacific region, while also serving as an important hub for the development of Korea's biopharmaceutical industry." said. Minister of Trade, Industry, and Energy Lee Chang-yang said, "This cooperation is expected to serve as an opportunity for our biopharmaceutical industry to take a leap forward as a national high-tech industry."
- Company
- AbbVie Korea merges with Allergan Korea
- by Jung, Sae-Im May 07, 2023 08:37pm
- AbbVie Korea announced on the 2nd that it will complete the integration of domestic corporations with Allergan Korea on May 1st and launch as a single corporation. The domestic corporation merger is a follow-up to the announcement of the merger and acquisition of Allergan by the global headquarters in May 2020. It plans to integrate the entire business operation management system and take a new leap forward with 'one AbbVie'. As part of the integration process, AbbVie Korea recently expanded its existing office space and renovated it into a smart office to integrate the two companies workspaces. Since the announcement of the global acquisition of Allergan in 2020, the two companies have been operating employee programs such as Culture Week, company-wide training program, and Possibilities Week together every year, integrating corporate culture into a unified AbbVie. With this domestic corporation integration, the total number of AbbVie Korea employees will be about 330 as of May. As a leader in the field of immunology, AbbVie has successfully launched Humira, a treatment for autoimmune diseases, Skyrizi, a treatment for psoriasis, and Rinvoq, which is expanding its treatment to include rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, atopic dermatitis, and ulcerative colitis. introduced domestically. In addition, it is supplying innovative treatments such as Maviret, a treatment for hepatitis C, and Venclexta, a treatment for chronic lymphocytic leukemia and acute myeloid leukemia. The integration will include Allergan's Ozurdex treatment for diabetic macular edema and uveitis, Combigan treatment for glaucoma, Ganfort and XEN Gel implant medical devices for eye diseases, as well as Botox for stroke-related upper extremity spasticity and chronic migraine headache treatment, which will be included in AbbVie's specialty medicines business. widen Allergan esthetic provides differentiated brand programs and educational opportunities in the medical esthetic business, such as botulinum toxin preparation Botox, hyaluronic acid filler Juvedern, and coolsculpting, and provides new growth opportunities. Kang So-young, CEO of AbbVie Korea, said, "We are pleased to have successfully completed the operation management system and corporate integration process of both companies." We expect that we will be able to maximize the synergy effect by integrating each other's professional capabilities and experiences, as well as expanding the treatment area."
- Company
- BeigeneKR's hematologic cancer drug Brukinsa, covered from M
- by Jung, Sae-Im May 04, 2023 05:50am
- BeigeneKR announced on the 2nd that Brukinsa, a treatment for Waldenstrom's macroglobulinemia (WM), will be covered from this month. Brukinsa reimbursement applies to monotherapy in adult patients with Waldenstrom's macroglobulinemia who have received one or more prior therapies. Brukinsa is a second-generation BTK inhibitor that targets BTK. Existing patients with Waldenstrom's macroglobulinemia were treated with chemotherapy that damages normal cells as well as cancer cells. Brukinsa improved both efficacy and side effects by targeting the BTK protein through the malignant B-cell receptor (BCR). Waldenstrom's macroglobulinemia is a rare type of non-Hodgkin's lymphoma. It mainly occurs in the elderly. The main pathogenesis is the infiltration of lymphoid plasma cells secreting monoclonal immunoglobulin M (IgM) into the bone marrow. Increased IgM causes blood viscosity to rise, resulting in symptoms such as blood flow disorders, headaches, nosebleeds, retinal hemorrhages, and cerebral hemorrhages. Anemia, thrombocytopenia, and neutropenia due to bone marrow involvement are also common. Some patients experience fever, night sweats, or unexplained weight loss. Brukinsa reduced median IgM levels by 79% in a phase 3 trial in patients with WM. The event-free rate at 18 months for patients who achieved a complete response (CR) or very good partial response (VGPR) was 93%. Brukinsa also has indications for ▲MCL and ▲MZL. However, the two indications failed to pass the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service.
- Company
- Erleada can be prescribed at general hospitals in Korea
- by Eo, Yun-Ho May 04, 2023 05:50am
- The new prostate cancer drug ‘Erleada’ can now be prescribed at general hospitals in Korea According to industry sources Janssen Korea’s metastatic hormone-sensitive prostate cancer (mHSPC) treatment Erleada (apalutamide) passed the drug committees (DCs) of tertiary hospitals in Korea including the Seoul National University Hospital and Asan Medical Center, including emergency DC meetings, a total of 60 medical institutions generated a prescription code for Enhertu. With the drug’s reimbursement listing last month, the approval is expected to quickly lead to actual Erleada prescriptions in the field. Erleada is an androgen receptor targeted agent and a latecomer that belongs to the same class of drugs as Zytiga (abiraterone)’ and ‘Xtandi (enzalutamide).’ The drug safety and efficacy in the Phase III TITAN trial in 1,052 patients with mHSPC. Despite the fact that about 40% of the patients assigned to the placebo group continued treatment with Erleada during treatment, the risk of death in the Erleada group was 35% lower than that of the placebo group. Overall survival (OS) at 48 months was 65% in the Erleada group and 52% in the placebo group. Also, when excluding the effect of patients who switched medication from the placebo group to Erleada, the risk of death in the Erleada group was 48% lower than that of the placebo group. Meanwhile, according to the National Cancer Registration Statistics Program, the number of patients diagnosed with prostate cancer in 2020 was 16,815, ranking third in men following lung cancer (19,657) and stomach cancer (17,869). The number surpassed that of colorectal cancer (16,485). In addition, among the 5 major male cancers (lung cancer, stomach cancer, prostate cancer, colorectal cancer, and liver cancer), only the rate of prostate cancer has been increasing, and at an annual average rate of over 5%.
- Company
- Daewoong is accelerating its global expansion
- by Kim, Jin-Gu May 04, 2023 05:50am
- A view of Daewoong Pharmaceutical’s Hyangnam factory (above) and Daewoong Bio’s Hyangnam factoryDaewoong Pharmaceutical Group is speeding up CAPA expansion. In order to speed up its global expansion, it decided to invest 250 billion won in establishing two new factories this year alone. Daewoong Pharmaceutical plans to expand its botulinum toxin production capacity to 3.6 times the previous level by constructing a third plant for Nabota. Daewoong Bio will expand its scope from the production and sales of raw materials and finished pharmaceuticals to the global CDMO business by establishing a new microorganism-only plant. ◆Production capacity increased 3.6 times with the establishment of the 3rd factory in Nabota, Will the utilization rate decrease to 150%? According to the pharmaceutical industry on the 4th, Daewoong Pharmaceutical has begun construction of a third plant exclusively for producing Nabota, a botulinum toxin. Daewoong Pharmaceutical plans to complete the construction by 2024 at a cost of 103.6 billion won. The third factory located in Hyangnam-eup, Hwaseong-si, Gyeonggi-do has an annual production capacity of 13 million vials. The production capacity of the existing Nabota Plants 1 and 2 was 5 million vials. This means that after 2024, Nabota production capacity will expand to 3.6 times the current level. Daewoong Pharmaceutical explained that it is setting out to establish a new plant to respond to the expanding global demand for Nabota. Daewoong Pharmaceutical achieved sales of 142.1 billion won with Nabota last year. It increased by 79% compared to 79.6 billion won in 2021. In particular, exports of Nabota increased 2.3 times in one year to 109.8 billion won. The production capacity of Daewoong Pharmaceutical's Hyangnam plant, including Nabota, has steadily expanded since 2018. It more than doubled in four years from 5.8 billion won in 2018 to 6.2 billion won in 2019, 9.3 billion won in 2020, 10 billion won in 2021, and 14.4 billion won last year. The utilization rate has already exceeded 100%. 159% in 2018, 156% in 2019, 149% in 2020, 143% in 2021, and 165% last year. The utilization rate of the entire Hyangnam plant is also steadily maintained at 150-160%. This means that even though factories are operating beyond their limits, the situation continues to be difficult to meet demand. In particular, in February 2021, Daewoong Pharmaceutical's US partner, Evolus, signed a three-way agreement with Medytox and AbbVie to eliminate risks associated with local sales of 'Jubo (Nabota's US product name)', and exports are rapidly increasing. Daewoong Pharmaceutical launched Nabota in the UK in September of last year, aiming to enter the European market in earnest. Daewoong Pharmaceutical obtained product approval from the EC in October 2019. It has been registered in 62 countries around the world so far and plans to release products in 9 European countries, China, Egypt, Chile, Australia, New Zealand, Singapore, and Malaysia. Daewoong Bio, entering the global CDMO business with the construction of a new plant, expects synergy with Daewoong Pharmaceutical. Daewoong Bio also announced an expansion of its production capacity recently. Daewoong Bio announced in January that it would build a microbe-based plant. At the same time, it announced that it would enter the global CDMO business. It plans to expand its business area from the production of existing raw materials and finished drugs. Daewoong Bio is operating its Hyangnam and Anseong factories in Korea. The production capacity of the Hyangnam plant is 200,000 liters per year. It has production lines dedicated to raw materials, UDCA, and Fexuclue, which are raw materials for Ursa. The Anseong plant has an annual production capacity of 400 million tablets and produces Gliatamine, Atorvastatin, and Clopidogrel. The new plant, with an investment of 146 billion won, is expected to serve as an outpost for the global CDMO business. In the pharmaceutical industry, there is a prospect that the CDMO business structure from Daewoong Pharmaceutical to Daewoong Bio will be completed. Daewoong Pharmaceutical obtained permission for an advanced regenerative medicine cell processing facility from the Ministry of Food and Drug Safety in July last year. Daewoong Pharmaceutical has been able to speed up the development of cell and gene therapy products by obtaining permission for cell processing facilities in addition to the existing high-tech biopharmaceutical manufacturing and management businesses such as human tax cells. If Daewoong Pharmaceutical's Yongin Bio Center provides services such as the development and quality testing of cell and gene therapy products, it is expected that Daewoong Bio's new plant will be able to complete the CDMO business structure in charge of the production of related products. It is analyzed that both Daewoong Pharmaceutical and Daewoong Bio made a bold investment decision at the group company level in the construction of a new plant. The 103.6 billion won invested in Daewoong Pharmaceutical's new plant construction amounts to 14% of its equity capital (741.2 billion won) at the end of last year. Daewoong Bio plans to invest 40% of its equity capital (365.1 billion won) in the construction of a new plant at the end of last year.
- Company
- Rare diseases still left neglected in Korea’s healthcare
- by Eo, Yun-Ho May 04, 2023 05:49am
- Patients with rare diseases suffer due to the rarity of their disease. Even when treatments are available, the drugs have difficulty receiving reimbursement as it is difficult to prove cost-effectiveness and predict financial expenditures for the drugs due to the small number of patients. The government is well aware of such difficulties. This is why it has attempted to improve access to rare disease treatments through various systemic improvements. However, the situation has not improved much. Among the 6,000 to 7,000 rare diseases known worldwide, only about 6% have available treatments developed. This is because it is difficult to secure statistical significance of the data due to the small number of patients and limited clinical data. This is why even the small number of rare diseases for which treatments have been developed is a pie in the sky in terms of reimbursement. In this sense, the ‘Study on the current status of access to rare disease treatments in Korea and measures to strengthen their coverage' that was recently announced by Professor Jong-Hyeok Lee of Chung-Ang University College of Pharmacy is attracting attention. Results of the study suggest that there are still many blind spots that remain unattended for rare disease treatments. Reimbursement rate remains at 33% for orphan drugs ineligible for special calculation exemptions First, when analyzing the reimbursement status of the total of 136 orphan drugs that were approved over the past 10 years (2012-2021), the reimbursement rate for anticancer drugs rose to 58% after measures were implemented to strengthen coverage for 4 major severe diseases that began in 2013. In the case of rare disease treatments, the rate is only 51%. In particular, the rate for orphan drugs that are not subject to special calculation exemptions is only 33.3%, indicating the existence of the neglected areas, or blind spots that remain, in the area of rare diseases. In addition, the period required for reimbursement was about 22 months for drugs subject to special calculation exemptions, while it was 34 months for those ineligible for special calculation exemptions, showing the significant difference. Such results show that Korean patients' access to rare disease drugs is still limited, and the process is time-consuming. ◆Lacks application of RSA and PE exemptions The RSA (Risk Sharing Agreement) and the pharmacoeconomic evaluation exemption (PE exemption) system, which are special systems established for the reimbursement of new drugs, were also found to be rarely applied to rare diseases. Reimbursement evaluation results of the drugs analyzed in the study showed that the special systems were mainly applied to anticancer drugs. The RSA and PE exemptions were only applied to 30% and 22% of the rare disease drugs, respectively. All in all, the limited scope of application of the special systems was affecting access to treatments for patients with rare diseases. Supported by such study results, the industry has been requesting that the government allow individual deliberations to be made for drugs that are not subject to the special calculation exemption but are chronically debilitating diseases as orphan drugs not subject to the special calculation exemption system cannot receive the systemic benefits for reimbursement (only 2 products have received benefits from the system). Meanwhile, the Ministry of Health and Welfare held public-private consultative body meetings to improve the drug pricing system with the National Health Insurance Service, Health Insurance Review and Assessment Service, and three pharmaceutical organizations. After 5 meetings, the MOHW is known to be preparing to announce the final measure to improve the drug pricing system. The ultimate purpose of preparing the 'Innovative New Drug Compensation Plan' by the 2nd Vice Minister Min-soo Park of the MOHW for the implementation of ‘Yoon Administration’s National Policy Tasts’ is not on increasing the value of drugs that are already reimbursed, but to fulfilling the fundamental purpose of allowing drugs that have not yet entered the system (received reimbursement benefits) to enter the system. Therefore, to expand access to rare disease treatment as listed as a national task by the Yoon administration, it is hoped that a practical and effective systemic improvement will be made rather than superficial attempts.
- Company
- Will Verzenio succeed in expanding benefits
- by Eo, Yun-Ho May 03, 2023 05:38am
- Attention is focusing on whether Verzenio will succeed in expanding early breast cancer insurance benefits. According to the related industry, the agenda to expand reimbursement for early breast cancer with a high recurrence risk of Verzenio, a breast cancer treatment with CDK4/6 inhibitory mechanism of Lilly Korea, is expected to be presented to the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service next month. Verzenio was approved by the Ministry of Food and Drug Safety in November last year as an adjunctive treatment for early breast cancer patients at high risk of recurrence of positive HR+/HER2- type lymph nodes, as an indication for combined administration with endocrine therapy. The clinical efficacy of this drug was confirmed through the monarchE study, a clinical study conducted on patients with HR+/HER- lymph node-positive early breast cancer who had a high risk of recurrence. In this clinical trial, Verzenio was conducted on patients with a low survival rate due to a high risk of recurrence among early breast cancer patients. Specifically, a very limited group of patients with ▲ four or more lymph node metastases, ▲ one to three lymph node metastases with a tumor size of 5 cm or more, and ▲ a grade 3 histological grade participated in the study. MonarchE 4-year follow-up data was announced at the San Antonio Breast Cancer Symposium Annual Conference in December last year. As a result of the study, Verzenio + endocrine therapy reduced the risk of recurrence and death by about 34% compared to endocrine therapy alone, and the risk of distant recurrence and death was also reduced. reduced by about 34%. Early breast cancer has a high risk of recurrence in the first 1 to 2 years after surgery. Therefore, unlike metastatic breast cancer, which requires continuous treatment, active treatment early after surgery minimizes the risk of recurrence and improves long-term prognosis. Verzenio is also administered only 2 years after surgery. The reason why the 4-year follow-up data announced in December of last year drew attention is that the IDFS and DRFS improvement results of Verzenio in the 4th year compared to the 2nd and 3rd years were more strengthened. Professor Joo-Hyeok Son of the Department of Oncology at Severance Hospital said, "The gap in invasive disease-free survival rate and remote recurrence-free survival rate between Verzenio + endocrine therapy and endocrine therapy alone continued to widen until the 4-year follow-up period, which was consistent with Verzenio even after completing adjuvant therapy after surgery for 2 years. "This suggests that Neo's treatment benefits may continue." Verzenio's benefit is recognized in HTA countries such as the UK and Canada.
- Company
- Boryung fails 3 of 5 patent challenges
- by Kim, Jin-Gu May 03, 2023 05:38am
- Boryung's omnidirectional patent challenge strategy on orignial anticancer drugs has been making slow progress. Since the end of 2021, Boryung filed patent challenges on 5 anticancer drugs, and lost or voluntarily withdrew 3 of those claims. Despite the strong drive it has been making for its anticancer drug business with plans to launch generics earlier by avoiding or invalidating patents, industry analysis is that the company would inevitably have to change its plans as it failed to cross the threshold of the first trial for several of its challenges already. ◆ Boryung fails first trial for Cabometyx but succeeds in deleting the original company’s patent paragraphs #iAccoridng to industry sources on the 13th, the Korea Property Trial and Appeals Board decided to dismiss the claims Boryung filed to invalidate the substance patent of Ipsen’s liver cancer treatment ‘Cabometyx (cabozantinib).’ Although it was Boryung’s loss on the surface, the analysis is that this is not the case in reality. This is because Ipsen, the original company, voluntarily deleted all of the paragraphs that were subject to the IPTAB’s review. Boryung initially sought to invalidate Cabometyx’s formulation patent paragraphs 1 to 25. Amid the ongoing dispute, Ipsen corrected the patent. Among paragraphs 1 to 27 in its patent, Ipsen voluntarily deleted paragraphs 1 to 25, which Boryung claimed were invalid. Due to the deletion, the subject to rule upon disappeared and the related disputes came to an end. Externally, the trial ended with IPTAB dismissing Boryung's request for trial as the subject itself to claim invalidity has disappeared and the company’s request did not meet the formal requirements. Industry analysis is that although Boryung lost on the surface, it succeeded in removing the risk factor for patent infringement. This means that even if a generic is released before the patent expires in February 2032, Boryung will not be infringing on the original drug’s patent. However, from Boryung's point of view, it is regrettable as the company cannot receive the generic exclusivity rights by winning the patent trial. To make up for this, Boryung is known to be considering requesting an additional trial to challenge Cabometyx’s two remaining patents. The remaining two crystalline patents expire in January and April 2030, respectively. If the company succeeds in invalidating or avoiding either patent, it will obtain one of the requirements for generic exclusivity. ◆Boryung loses first patent trial over Ibrance and appeals... voluntarily withdraws claims for Tasigna Since 2021, Boryung has filed patent trials for five anticancer drugs including Cabometyx. The other 4 include Eisai's liver cancer treatment 'Lenvima (lenvatinib)', BMS' acute lymphocytic leukemia treatment 'Sprycel (dasatinib)', Novartis' leukemia treatment 'Tasigna (nilotinib)', and Pfizer's breast cancer treatment 'Ibrance (palbociclib).’ Among the trials, the company failed the first trial after challenging Ibrance's crystalline patent. Boryung originally planned to release the generic early after avoiding Ibrance's crystalline patent, which expires in February 2034, but the plan was put to a stop with the failed trial. This is why Boryung appealed the decision of the first trial and dragged the case on to receive a second trial. The patent challenge to Tasigna ended with Boryung's voluntary withdrawal of its claims. In April last year, Boryung requested an omnidirectional trial on Tasigna’s four patents. However, in March, Boryeong voluntarily withdrew its trial. The pharmaceutical industry pointed to the company’s discontinuation of Tasigna’s generic drug development as the cause. On the other hand, the company won the challenge for the patent for the crystalline form of Sprycel. In June last year, Boryung ruled in favor of its trial to confirm the passive scope of rights for the patent. With the ruling, Boryung became one step closer to the early release of its Sprycel generic. In addition, the company had challenged Lenvima's patent but has not received results. As a result, the company has failed 3 of 5 the patent challenges it had filed against original anticancer drugs.
