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- 2025-12-23 22:35:25
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- 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.
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- 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%.
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- 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.
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- 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.
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- ‘Korea’s low reimb of orphan drugs needs to be improved’
- by Eo, Yun-Ho May 03, 2023 05:38am
- Study results have shown that Korea has low access to rare disease treatments. The Korean Research-based Pharmaceutical Industry Association (KRPIA) recently announced study results that stress Korea’s need to improve its reimbursement system in consideration of the characteristics held by rare diseases and rare disease treatments based on the ‘Study on the current status of access to rare disease treatments in Korea and measures to strengthen their coverage'. The results were derived from the research Professor Jong-Hyuk Lee from Chung-Ang University’s College of Pharmacy conducted as a principal investigator last year on the present status of access to rare disease treatments in Korea and measures to strengthen their coverage. The research analyzed the drugs in terms of usability –designation and marketing authorization of orphan drugs, and accessibility – reimbursement listing and medical expense support. The study pointed out how Korea defines orphan drugs and rare disease drugs separately and gives them different statuses and benefits, and that this disparity leads to the irrational result of drugs that are already approved as orphan drugs being unable to benefit from the system during the reimbursement evaluation process. In Korea, the reimbursement rate for orphan drugs (136) approved during the last decade (2012-2021) was 52.9%. When compared with similar research results overseas, this is a considerably lower level than that in Germany (93%) or France (81.1%). Also, it was noted that the average time required for orphan drugs or anticancer drugs to receive approval in Korea was 27.4 months, compared to 19.5 months in France and 18.6 months in Italy. Also, by analyzing the reimbursement rates of 136 orphan drugs approved in Korea according to special calculation exemption classification status, the study found that rare disease treatments(51.1%) and items ineligible for the special calculation exception (33.3%) showed lower reimbursement rates than anticancer drugs (57.6%). In other words, although the special calculation exemption system reduces the patient's burden for orphan drugs of rare diseases that are designated for special calculations, the system rather acts as an obstacle for diseases that are not subject to the special calculation exemption system that seeks to receive reimbursement. Korea's expenditures on orphan drugs is also 3.6%, which is lower than the OECD median of 6.8%, which is at the lower end among OECD countries. This shows the need for Korea to spend more on orphan drugs.
- Company
- Boryung signed a contract to establish a joint venture with
- by Kim, Jin-Gu May 02, 2023 05:36am
- Boryung announced on the 26th that it signed a contract to establish a joint venture (JV) with Axiom Space of the United States on the 25th (local time) to jointly promote the space business. Boryung CEO Kim Jeong-kyun, who visited the United States on an economic mission to the United States, signed a JV establishment contract with Axiom Space Chairman Kam Ghaffarian to jointly promote space projects in low-earth orbit. Axiom Space is an American company specializing in the space industry. Axiom is developing technology to carry out more missions in outer space more safely, including developing next-generation spacesuits that astronauts will wear on the moon in NASA's third Artemis mission. Boryung made a strategic investment of $60 million in Axiom Space last year. Then, in order to efficiently promote the project, detailed discussions related to the JV began in March. The JV will be established in Korea and plans to complete the establishment process within the first half of this year. Boryung and Axiom Space jointly invest at a ratio of 51:49, respectively. Based on Axiom Station, which will replace ISS, all business areas using Axiom's technology and infrastructure will be jointly promoted in Korea. Axiom Space will promote its business with exclusive rights in Korea for private and public space projects. It will be responsible for the astronaut business, joint manufacturing, construction, infrastructure-related businesses, including next-generation Korean modules, and all R&D and experimental activities at the space station. Boryung said, "This means that there is a channel that can utilize the low-earth orbit infrastructure, which has not been available in Korea," and expects that "this will serve as an opportunity to meet the numerous research and development demands arising from the microgravity environment in the future." The contract was signed during President Yoon Seok-yeol's state visit to the United States, with CEO Kim Jeong-gyun participating in an economic delegation. The Korean government is promoting the establishment of the Korea Aerospace Administration, a government control tower, along with the successful launch of the Nuri and Danuri with the goal of becoming one of the 7 significant powerhouses in space. am. “The establishment of this joint venture will serve as a foundation for both companies to share future visions for space development beyond a strategic investment relationship and design them together,” said CEO Jungkyun Kim. I will create an opportunity to contribute to development,” he said. CEO Kim was recently appointed a director of Axiom Space and joined the board of directors. Axiom announced that it had appointed three directors, including CEO Kim Jung-kyun, former CIA chief intelligence officer Jeanne Tisinger, and former US space operations commander John W. "Jay" Raymond. CEO Kim plans to participate in the decision-making process for the growth and business planning of Axiom Space as a member of the board of directors along with the best experts leading the US government and space industry, which is the 'Care In Space' project promoted by Boryeong. It is expected to be a great asset in accelerating the promotion and growth of
- Company
- Eylea Prefilled Syringe can be prescribed at GHs in KOR
- by Eo, Yun-Ho May 02, 2023 05:36am
- The pre-filled syringe formulation of Eylea can now be prescribed at general hospitals in Korea. According to industry sources, Bayer Korea's Wet Age-Related Macular Degeneration (wAMD) treatment 'Eylea Pre-filled Syringe,’ which was released with insurance reimbursement in October last year, has passed the drug committee reviews of tertiary hospitals in Korea, including the Seoul National University Hospital and Asan Medical Center. As a prefilled injection formulation, Eylea Pre-filled Syringes reduce preparation time for drug administration by allowing injection of a more accurate single dose than the existing Eylea vial formulations. The formulation offers easier administration with a 1mL glass syringe and a larger barrel and plunger button. Also, the luer-lock adaptor section that prevents the syringe and needle is transparent, allowing the user to check the needle attachment status. The Eylea Prefilled Syringe formulation is approved and reimbursed for all indications that are approved for the vial formulation. The company explained that Eylea’s sales have grown faster in European countries after the release of the pre-filled syringe formulations. In this sense, the company believes that the introduction of the Eylea Prefilled Syringe will serve as an opportunity to further solidify its position in the domestic anti-VEGF market. According to IQVIA, the domestic macular degeneration treatment market recorded KRW 126.3 billion last year, which is a 14% YoY increase from KRW 111.1 billion raised in the previous year. Eylea had broken its own annual sales record again with sales of KRW 80.4 billion last year. This is a 14% increase from the KRW 70.5 billion raise in Eylea set another record last year with annual sales of 80.4 billion won. This is a 14% increase from 70.5 billion won it had raised in 2021.
- Company
- Exkivity, an exon 20-targeted anti-cancer drug, can be presc
- by Eo, Yun-Ho May 02, 2023 05:35am
- Exkivity, an anticancer drug targeting EGFR exon 20 insertion mutations, can be prescribed at general hospitals. According to related industries, Exkivity, a treatment for non-small cell lung cancer with an EGFR exon 20 insertion mutation of Takeda Pharmaceutical Korea, passed the Drug Committees of the National Cancer Center, Seoul National University Hospital, and Samsung Seoul Hospital. As the insurance benefit registration process is currently in progress, it seems to focus on creating a prescription environment. Exkivity targets the same biomarker as Janssen Korea's Rybrevant, but with the difference that it is an oral drug. EGFR Exon 20 insertion mutation is a new biomarker that has recently attracted attention in the field of non-small cell lung cancer. Currently, available anticancer drugs are suitable for Exon19 deletion or Exon21 L858R substitution mutation, which are commonly found in EGFR mutations but are still in a blind spot for EGFR Exon20. Meanwhile, Rybrevant proved its efficacy through a phase 1/2 study conducted on 114 non-small cell lung cancer patients with an EGFR exon 20 insertion mutation who had previously received platinum-based chemotherapy. Clinical results, in the patient group who took Rybrevant 160 mg, the ORR evaluated by IRC was 28% and the mDOR was 17.5 months. In particular, the median reaction time after administration of Rybrevant was 1.9 months, confirming that the drug's effect appears quickly from the beginning of treatment. mPFS was 7.3 months and mOS was 24.0 months. The safety profile was also found to be favorable. The most common adverse reactions were diarrhea, rash, and fatigue, which can be managed by adjusting the dose.
