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- 2026-05-07 20:29:01
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- Leclaza posts sales of KRW 25 bil in 2 years in Korea
- by Chon, Seung-Hyun May 24, 2023 05:32am
- Yuhan Corp’s anticancer drug ‘Leclaza’ is making good sales in the Korean market, and raised sales of KRW 5.1 billion in Q1 alone. Its efficacy and safety were confirmed in the real world in actual patients at the time of treatment, and the drug is gradually expanding its market influence ahead of its approval as a first-line treatment. According to the market research institution IQVIA on the 23rd, Leclaza’s sales were KRW 5.1 billion in Q1, up 57.4% YoY. It is also a 12.9% increase from the KRW 4.5 billion made in the previous quarter. Leclaza is an NSCLC treatment that was approved as the 31st homegrown novel drug in January last year. It is a 3rd generation EGFR TKI that inhibits the proliferation and growth of lung cancer cells. It is currently approved as a treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs. The drug entered the market in earnest after being listed for reimbursement in the National Health Insurance Service in July 2021. The drug recorded sales of KRW 1.5 billion and KRW 2.6 billion in Q3 and Q4, respectively. Last year, its quarterly sales had risen to the KRW 4 billion range, and continued growing this year. Cumulative sales made during the 2 years since the release of Leclaza totaled KRW 25.2 billion. Leclaza Leclaza posted sales of KRW 16.1 billion last year, breaking the sales record made by homegrown new anticancer drugs in Korea. Other homegrown new anticancer drugs that were approved before Leclaza include Il-Yang Pharmaceuticals’ Supect, Dongwha Pharm’s Milican, Chong Kun Dang’s Camtobell, Sam Sung Pharmaceutical’s Riavax, Hanmi Pharmaceutical’s Olita. None of the products have exceeded annual sales of KRW 10 billion. At the current rate, Leclaza may likely exceed annual sales of KRW 20 billion this year. Leclaza is considered to have made a smooth start in the market. Anticancer drugs that are usually used in large medical institutions, can only be prescribed after the drug passes each institution’s drug committee, therefore, it takes a considerable amount of time before sales are generated after the initial stage of release. With the added pressure of having to directly compete with outstanding new drug products from multinational pharmaceutical companies, it is not easy for new anticancer drugs developed in Korea to achieve commercial results. Leclaza passed the drug committee of major large medical intuitions in Korea and is accelerating its market penetration efforts. The drug is expected to expand further into the market if it receives approval in the first line. In March, Yuhan Corp applied for approval of Leclaza as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation to the Ministry of Food and Drug Safety. Leclaza demonstrated its efficacy over existing treatments in a global Phase III trial (LASER 301) that was conducted on 393 locally advanced or metastatic NSCLC patients with EGFR mutations. The trial results had been presented at the European Society for Medical Oncology Congress that was held last year in Singapore. The company has also been accumulating evidence of its efficacy and effect in the real world. Lim Sun Min, Professor of Oncology at Yonsei Cancer Center, and Beung-Chul Ahn, Professor of Oncology at the National Cancer Center, recently published real-world data (RWD) on how Leclaza confirmed its safety and efficacy in practice in the journal, Lung Cancer. This was the first-ever real-world study results announced since Leclaza’s approval, The research team conducted a retrospective study on 103 patients with EGFR T790M mutation-positive NSCLC patients who developed resistance after being previously treated with EGFR-TKI that received Leclaza from January 2021 to August 2022 at Yonsei Cancer Center and the National Cancer Center. 90 of the 103 patients received Leclaza as a second or third-line treatment. The patients’ primary efficacy endpoint in the study, median progression-free survival (mPFS), was 13.9 months. This was consistent with the mPFS of 11.1 months confirmed in LASER201, the study that became the basis of Leclaza’s approval. The objective response rate (ORR) was 62.1%, slightly higher than the 55.3% observed in the LASER201 study. In terms of safety, the drug was also well-tolerated, similar to previous studies. The research team explained, “ The real-world study reaffirmed the consistent effect and efficacy of Leanza as a second-line treatment for EGFR T790M mutation-positive NSCLC patients in practice.” Yuhan Corp has invested a total of KRW 93 billion in the Phase III trial for Leclaza. According to the Financial Supervisory Service, as of the end of the first quarter, Yuhan Corp reflected KRW 93 billion of Leclaza’s development cost as intangible assets. In 2019, the Financial Supervisory Service set a standard that only R&D projects that have technical feasibility, including those for new drugs, shall be accepted as accounting assets. The FSS suggested that R&D costs can be turned into assets after initiating Phase III trials for new drugs and receiving approval for its Phase I trial for biosimilars. As for generic drugs, they can be capitalized after their bioequivalence test plan is approved. Under such standards, Leclaza’s development costs of KRW 32.6 billion were first recognized as intangible assets in Q4 2020. Its development costs were reflected as intangible assets after its Phase III trial began in earnest. Leclaza’s development cost intangible asset increased to KRW 61.4 billion by the end of 2021, and then rose to KRW 88 billion last year, with the added KRW 26.6 billion last year. In Q1 this year, an additional KRW 5 billion was invested as clinical expense.
- Company
- Merck retrieves rights to PD-L1 antibody Bavencio in Korea
- by Eo, Yun-Ho May 23, 2023 05:54am
- The long-standing collaboration that had existed between the Korean subsidiaries of Merck and Pfizer Korea for the immunotherapy ‘Bavencio’ has come to a close. According to industry sources, the companies are in the process of handling the rights for the PD-L1-inhibiting immunotherapy Bavencio (avelumab) in Korea as Merck retrieved the global rights for the drug. As a result, Pfizer Korea’s Bavencio-related personnel (marketing, sales) will also be reassigned to different posts. The two companies have jointly developed and marketed Bavencio after forging a partnership in 2014. Also, the ongoing processes for expanding reimbursement to the first-line in urothelial cell cancer will be carried out by Merck Korea alone from now on. Currently, Bavencio passed the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee review in April last year, but no news has yet been heard on its deliberation by the Drug Reimbursement Evaluation Committee. Bavencio was first approved in Korea as a monotherapy to treat adult patients with metastatic Merkel cell carcinoma (mMCC) in 2019. The indication was granted insurance reimbursement in October 2020. Since then, the drug has additionally been approved as a first-line maintenance monotherapy in August 2021 for patients with locally advanced or metastatic urothelial carcinoma who have not progressed after using platinum-based chemotherapy. Pfizer, which let go of its rights for Bavencio, announced its plans to acquire the anticancer drug company Seagen. This merger between Pfizer and Seagen, which was officially announced in March, is worth USD 43 billion (about KRW 56 trillion) and is considered to be the largest among global pharMaceutical and bio-industry M&A transactions this year. Known for its global expertise in antibody-drug conjugates (ADC), Seagen is considered a leader in the new drug development industry. Its oncology pipeline has 4 anticancer drugs: Adcetris, Padcev, Tivdak, and Tukysa. Pfizer expects the merger to bring sales growth through royalties and collaboration related to the development of ADC anticancer drugs.
- Company
- RWD results reaffirm Leclaza’s efficacy in practice
- by Chon, Seung-Hyun May 23, 2023 05:54am
- Professor Lim Sun Min (right) and Professor Beung-Chul Ahn (left) are presenting Leclaza study results Study results that confirm the efficacy and safety of Yuhan Corp's new anticancer drug ‘Leclaza’ in the real world has been released. Lim Sun Min, Professor of Oncology at Yonsei Cancer Center, and Beung-Chul Ahn, Professor of Oncology at the National Cancer Center, met with reporters at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association head office in Seocho-gu, Seoul on the 22nd to introduce the real-world data (RWD) that confirms the efficacy and safety of Leclaza in practice. This was the first-ever real-world study results announced since Leclaza’s approval, and was published in the journal, Lung Cancer. Leclaza is an NSCLC treatment that was approved as the 31st homegrown novel drug in January last year. It is a 3rd generation EGFR TKI that inhibits the proliferation and growth of lung cancer cells. It is currently approved as a treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs. The research team conducted a retrospective study on 103 patients with EGFR T790M mutation-positive NSCLC patients who developed resistance after being previously treated with EGFR-TKI that received Leclaza from January 2021 to August 2022 at Yonsei Cancer Center and the National Cancer Center. 90 of the 103 patients received Leclaza as a second- or third-line treatment. The patients’ primary efficacy endpoint in the study, median progression-free survival (mPFS), was 13.9 months. This was consistent with the mPFS of 11.1 months confirmed in LASER201, the study that became the basis of Leclaza’s approval. The objective response rate (ORR) was 62.1%, slightly higher than the 55.3% observed in the LASER201 study. In terms of safety, the drug was also well-tolerated, similar to previous studies. The research team explained, “ The real-world study reaffirmed the consistent effect and efficacy of Leanza as a second-line treatment for EGFR T790M mutation-positive NSCLC patients in practice.” Leclaza also showed similar efficacy in patients with the Exon19 deletion mutation (Exon19del) and the L858R substitution mutations (L858R), and the team saw no decrease in efficacy in patients whose dose was reduced. Professor Lim said, “The study holds significance for being results from the first real-world study that confirmed the efficacy and safety profile of Leclaza in NSCLC patients in Korea’s actual prescription environment.“ Lim added, “Study results showed consistent data with LASER201, the trial that was conducted for Leclaza’s approval. Along with other clinical data, these RWD results will be actively used as grounds for prescribing Leclaza to patients in practice.” In the study, Leclaza’s treatment effect was also significant in patients with brain metastasis as in the LASER201 study. The mlPFS (median intracranial progression-free survival) was 17.1 months, and ORR was 57.6%. Professor Ahn said, “Brain metastasis is found in about 25% of NSCLC patients upon diagnosis, and the condition is so common that 50% of patients eventually experience brain metastases as the condition progresses. This is why a drug’s effect in NSCLC with brain metastasis is a very important consideration in prescribing drugs for NSCLC in the field.” Professor Ahn added, "In the real-world study, Leclaza has consistently demonstrated its antitumor effect in NSCLC patients with brain metastases, and we are thus accumulating evidence to further prescribe Leclaza for those patients in Korea.”
- Company
- SGLT2 lowers BP, but more evidence is needed to use it alone
- by Hwang, Jin-joon May 23, 2023 05:50am
- Professor Cho Ik-Seong of Severance Hospital is giving a presentation (photo by Dailypharm) There was an opinion that there is still insufficient evidence for the use of the sodium-glucose cotransporter-2 (SGLT-2) inhibitor, a treatment for type 2 diabetes and heart failure, for the treatment of hypertension. It can be expected to lower blood pressure in patients with heart failure or diabetes, but it is difficult to use it alone for the treatment of hypertension. Professor Cho Ik-Seong of Severance Hospital held a hypertension drug treatment update session at the '2023 Korean Society of Hypertension Spring Conference' held at EXCO in Daegu on the 20th and said, "SGLT-2 inhibitors are a drug that is attracting attention in the field of diabetes and heart failure. · For patients suffering from high blood pressure, it can act as a weak blood pressure drug," he said, "but more data are needed to use it only for high blood pressure." Famous drugs for SGLT-2 inhibitors include AstraZeneca's 'Forxiga' and Eli Lilly/Boehringer Ingelheim's 'Jardiance'. Recently, Daewoong Pharmaceutical's 'Envlo', Donga ST's 'Sugadapa', LG Chem's Zemidapa, and Chong Kun Dang's Exiglu M have been released, causing a sensation in the diabetes treatment market. SGLT-2 inhibitor drugs are evaluated as next-generation treatments globally because they have not only blood sugar-lowering effects but also cardiovascular disease prevention, weight loss, and blood pressure-lowering effects. According to the 2021 Diabetes Guidelines, in the case of type 2 diabetes accompanied by heart failure, treatment with proven cardiovascular benefit is considered first. Even in the presence of atherosclerotic cardiovascular disease, SGLT-2 inhibitors are used in combination therapy. The Korean Heart Failure Association completely revised the guidelines last year and recommended the administration of SGLT-2 inhibitors to reduce hospitalizations or cardiovascular deaths due to heart failure, regardless of diabetes mellitus. The fact that SGLT-2 inhibitors have the effect of lowering blood pressure can be confirmed through various studies. According to the 'phase 3 study on the blood pressure and blood sugar lowering effect of dapagliflozin versus placebo on antihypertensive combination therapy in patients with type 2 diabetes' published in the international journal The Lancet, the SGLT-2 inhibitor Dapagliflozin-administered group had lower blood pressure than the placebo control group. The Hypertension Society also acknowledges that SGLT-2 inhibitors lower blood pressure. In the hypertension treatment guidelines, SGLT-2 inhibitors have a blood pressure-lowering effect, so care should be taken to see if the dose of antihypertensive drugs needs to be adjusted. Professor Ik-Sung Cho explained, "In patients without heart failure but with diabetes and high blood pressure, the use of SGLT-2 inhibitors lowered SBP by about 8 compared to placebo." Professor Cho continued, "Looking at the results of studies on patients suffering from both diabetes and heart failure, SGLT-2 inhibitors can lower SBP by 4 to 7 and diastolic blood pressure (DBP) by 1.5 to 2." -2 inhibitors are effective in lowering blood pressure, but it seems difficult to use them only for hypertension.”
- Company
- AZ runs a neurofibromatosis disease awareness campaign
- by Jung, Sae-Im May 22, 2023 05:42am
- AstraZeneca Korea announced on the 18th that it had conducted the 'Twinkling a Light for NF-1 Campaign' for its executives and employees to support domestic neurofibromatosis patients in celebration of 'World Neurofibromatosis Awareness Day'. The Children's Cancer Foundation designated May 17 every year as World Neurofibromatosis Awareness Day to raise social interest in neurofibromatosis. Worldwide, various activities are conducted every year to increase treatment access for patients with neurofibromatosis and support their overcoming disease. AstraZeneca Korea held in-house lectures, disease infographic exhibitions, etc. to better understand pediatric patients with neurofibromatosis in Korea, and executives and employees carried out a campaign to deliver messages of hope and commitment to improve the domestic treatment environment. Neurofibromatosis is a rare disease that causes developmental abnormalities in the nervous system, bones, and skin due to genetic mutations. The cafe-au-lait-spot is characteristic, and axillary/inguinal spots and Leish nodules, which are small hamartomas, appear on the iris. Accurate clinical diagnosis of neurofibromatosis type 1 can usually be made before the age of 10, and symptoms tend to intensify with age. About 20 to 50% of patients with type 1 neurofibromatosis experience plexiform neurofibroma, which can occur anywhere in the body except for the brain and spinal cord. Depending on where it occurs, it causes pain as well as various body deformities or damage to vision, hearing, and cognitive abilities. Surgical resection was the only fundamental treatment for neurofibromatosis. In the case of plexiform neurofibroma, it appears in various irregular shapes and is difficult to completely remove, leaving the risk of tumor recurrence even after surgery. AstraZeneca Korea received approval for Koselugo, the first type 1 neurofibromatosis treatment in Korea, in May 2021. Koselugo, the only treatment for neurofibromatosis type 1 to date, reduced the tumor size by more than 20% in 68% (34 out of 50) of patients administered in global clinical studies, and among them, 82% (28 patients) showed a response of more than 12 months. showed lasting results. Cheol-Woong Kim, Executive Director of AstraZeneca Korea's Rare Disease Division, said, "Through the Neurofibromatosis Awareness Day event, it was an opportunity to properly understand neurofibromatosis disease and think about what AstraZeneca Korea executives and employees can do for patients." said.
- Company
- Hana Pharm, signed a sub-license agreement for Byfav
- by Lee, Seok-Jun May 22, 2023 05:42am
- Hana Pharm announced on the 18th that it had signed a sub-license contract with Hyphens Pharma of Singapore for the exclusive rights to Byfavo 20mg, an anesthetic new drug. This contract is the first achievement of local partnering while Hana Pharm received licenses for six Southeast Asian countries from German PiON in 2020 and was in the process of obtaining licenses for each country. Byfavo 20mg has indications for surgical sedation that can be used for endoscopic sedation in addition to induction and maintenance of general anesthesia, which is the indication for 50mg. Hyphens Pharma of Singapore is a major pharmaceutical company in Singapore with branches in five major Southeast Asian countries and about 500 employees. Choi Tae-hong, CEO of Hana Pharm, said, "Partnering was made with Hyphens Pharma, which has excellent capabilities in the gastroenterology market in Singapore. We will accelerate the timing of approval and release in Singapore as much as possible and use it as a bridgehead to enter the Southeast Asian endoscopic sedation market."
- Company
- New formulations for schizophrenia are being commercialized
- by Eo, Yun-Ho May 22, 2023 05:42am
- According to related industries, new long-acting formulations of existing schizophrenia treatment drugs, such as Abilify and Invega, are being released one after another. Lundbeck and Otsuka Pharmaceutical obtained US FDA approval for Abilify Asimtufii, which is administered once every two months, last month. Abilify Asimtufii confirmed its efficacy through a clinical study comparing 266 patients with schizophrenia to Abilify Maintena. In pharmacokinetic analysis, Abilify Asimtufii induced plasma aripiprazole concentrations similar to those of once-monthly Abilify Maintena. Janssen's Invega Hafyera is a 6-month long-acting drug that is commercialized more quickly. After obtaining US FDA approval in 2021, the drug was approved in Korea in 2022, and insurance benefits were applied from this month. Invega Hafyera is eligible for reimbursement only when patients have been treated with Invega sustenna for at least 4 months or with Invega Trinza for at least one cycle. Invega Hafyera, which is administered every six months, has confirmed its safety and tolerability profile through PSY3015 clinical trials. Professor Kim Se-hyeon of the Department of Psychiatry at Seoul National University Hospital said, "We expect that patients with schizophrenia will be able to enjoy the benefits of returning to society and restoring confidence in life by continuing treatment with stable drug compliance and convenience through long-acting injections." said.
- Company
- “Need to increase support for new AI drugs in Korea”
- by Jung, Sae-Im May 22, 2023 05:42am
- “Although artificial intelligence (AI) new drug development ecosystem is being created in Korea, there are still many areas that we are lacking at a global level in terms of manpower or investment scale. Chinese companies that were established around the same time received more than KRW 500 billion in investments, while Korean companies only received KRW 87.8 billion, which delayed their growth. It's time to make efforts to expand this ecosystem while building success stories through step-by-step collaboration.” Wooyeon Kim, Head of Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA)’s AI New Drug Development Support Center stressed so at the ‘Pharmaceutical-Bio AI Innovation Forum’ that was held at Lotte Hotel Seoul in Sogong-dong on the 19th. Wooyeon Kim, Head of the AI New Drug Development Support Center At the event, which was hosted by KPBMA, Kim explained that Korea’s AI drug development market has grown steadily over the past 5 years, forming a virtuous cycle ecosystem. Companies and research centers are actively collaborating with AI new drug development companies. There were 88 cases of such collaborative efforts being made for drug repositioning, target discovery, and candidate substance discovery including partnerships between ▲ Boryung Pharmaceutical - Oncocross ▲ Samsung Seoul Medical Center - NetTargets ▲ Dong-A ST - Pharos iBio, etc. The government has also been continuing its efforts. Ministry of Science and ICT has been investing a total of KRW 18 billion for the discovery of innovative new drugs using AI for 5 years since 2022. The Ministry of Health and Welfare is also planning to build a Korean-style Rosetta Fold (an AI-applied protein structure prediction and analysis platform) next year and promote technology matching between pharmaceutical companies and AI companies. In addition, supports for projects such as medical big data construction and AI-based new drug development education are also being carried out. However, Korean AI drug development companies are still experiencing difficulties in securing talent and attracting investment. The stark difference stands out when compared to the global environment. Kim cited the cases of Standigm, a Korean company, and XtalPi, a Chinese company. Although the two companies were founded at a similar foundation time and owned similar levels of technology. However, Standigm had received KRW 87.8 billion in investments while XtalPi attracted 6 times as much, which was KRW 533.8 billion. XtalPi has 700 professionals, which is 10 times more than the 54 experts at Standigm. On this, Kim said, “Although the two companies were established at a similar period, XtalPi has achieved far much on the global stage due to its overwhelming investment and manpower over Standigm. In this graph that shows the growth rate of each company, XtalPi has shown faster growth.” In order to revitalize the ecosystem, Kim saw the need to accumulate successful collaboration cases in each stage of development, and encouraged research on matching supply and demand in the area. "There should be more cases that show companies that drug development can be accelerated and efficiency increased through the use of AI in the industry." Kim added, "This difference is more due to the difference in investment and manpower rather than technology. Although the AI drug development ecosystem in Korea has grown considerably, we are still lacking in many, many areas.” Kim also asked for the government’s closer attention in the field as global competition is taking place. He said, "A lot of investment is being made, mainly in the US and China, for the development of new AI drugs. Korea should also make bold investments and accumulate results step by step." Kim stressed that Korea should also strive to nurture convergent talents that understand AI. Kim said, "Demand for talent training is very high. More than 3,800 people attended the 385 hours of lectures that were conducted at our center. In particular, as convergence is very important in this field, we need to establish a system that continues to nurture convergent talent."
- Company
- Attempts to develop new drugs for hypertension
- by Hwang, Jin-joon May 22, 2023 05:41am
- Opinions were raised that it would be difficult for candidates under development as new drugs for hypertension, such as Baxdrostat, Aprocitentan, and Firibastat, to replace existing drugs. It is expected that it will fill the unmet demand rather than take the place of the prescribed treatment. Choi Ung-gil, professor at Konkuk University Chungju Hospital, is giving a presentation. (photo by Dailypharm) Professor Woong-Gil Choi of Chungbuk National University Hospital held a hypertension drug treatment update session at the '2023 Korean Society of Hypertension Spring Conference' held at COEX in Daegu on the 20th and said, "Major hypertension drug candidates are existing drugs rather than replacing drugs already prescribed in clinical settings. It will be a drug that can help the unfilled part.” The reason why the development of a new antihypertensive drug is needed is that it is a method to treat treatment-resistant hypertension. Professor Woong-Gil Choi explained, "Although the treatment control rate of hypertension has improved a lot, there is no further development after exceeding 70%." According to Professor Choi, major antihypertensive drug candidates include Baxdrostat, Aprocitentan, and Firibastat. Baxdrostat is a candidate substance secured by AstraZeneca, a global pharmaceutical company when it acquired CinCor Pharma, a US bio company. It is a new drug candidate for hypertension in the class of aldosterone synthase inhibitors (ASI). The efficacy of Baxdrostat in lowering blood pressure was confirmed in phase 2 clinical trial (BrigHTN) conducted on patients with treatment-resistant hypertension. In phase 2 clinical trial (HALO) conducted for uncontrolled hypertension patients taking up to two blood pressure medications, statistical significance was not achieved in the primary endpoint, but systolic blood pressure was reduced in subgroup analysis. Phase 3 clinical trials are expected to begin at the end of this year. Professor Choi said, “Baxdrostat appears to be relatively beneficial for hypertensive hypertension,” and “it is expected to give benefits to patients with primary aldosterone and metabolic syndrome.” Aprocitentan is a new drug candidate for hypertension being jointly developed by global pharmaceutical company Janssen and Swiss bio company Idorsia. It is an endothelin receptor antagonist. Applications for product approval were submitted to the FDA and EMA in December of last year and January of this year, respectively. Clinical data of Baxdrostat (Photo by Dailypharm) Aprocitentan has been confirmed to have a significant blood pressure-lowering effect in patients whose hypertension is not well controlled despite taking three or more existing treatments in phase 3 clinical trials (PRECISION). Professor Choi explained, "Although Aprocitentan has a stronger blood pressure lowering effect when used with other drugs, care should be taken about the fact that edema occurred after using the drug compared to placebo." Firibastat is a candidate material being developed by Quantum Genomics, a French biotech company. Firibastat is a candidate in the class of brain aminopeptidase A inhibitors. It is a mechanism that suppresses the production of angiotensin 3 in the brain's renin-angiotensin system (Brain RAS). Firibastat's efficacy with statistical significance was confirmed until the phase 2 clinical trial was conducted for patients with treatment-resistant hypertension. Afterward, it failed to achieve the primary evaluation index in phase 3 clinical trial (FRESH). Quantum Genomics is revising its development strategy to find new indications after the early termination of clinical trials. Professor Choi predicted, “There are still many cases of treatment-resistant hypertension, but if the development of a new drug for hypertension is successful, it will be possible to increase the treatment effect by adding it to existing drugs.”
- Company
- Forxiga price cut enforcement suspension extended
- by Jung, Sae-Im May 19, 2023 05:48am
- A decision on whether to suspend the execution of drug price cuts for AstraZeneca Korea’s diabetes treatments Forxiga and Xigduo is expected to be decided at the end of this month at the earliest. The temporary suspension period, originally until May 19, is also extended. On the 16th, the first division of the Seoul Administrative Court held an interrogation date for the suspension of drug price cuts filed by AstraZeneca Korea against the Ministry of Health and Welfare. The court, which conducted a private interrogation, decided to decide whether to quote a suspension of execution between the end of this month and the beginning of next month. As the court’s decision on whether to suspend enforcement is over 19 days away, the temporary suspension period for drug price cuts is also expected to be extended. Previously, the court had temporarily maintained the drug price until May 19, the scheduled date of the suspension trial. Forxiga and Xigduo, SGLT-2 inhibitors, are blockbuster products that raise outpatient prescriptions worth 90 billion won yearly as Dapagliflozin-based diabetes treatments. However, as a number of generics containing dapagliflozin were registered for reimbursement last month, they were subject to drug price cuts. The Ministry of Health and Welfare announced that it would cut the prices of Forxiga and Xigduo drugs by 30% from May 1 following the listing of generics. AstraZeneca Korea objected to this and filed an administrative lawsuit and at the same time applied for suspension of execution. As Forxiga and Xigduo also have indications for chronic heart failure and chronic nephropathy that have not expired patents, listing generics with only diabetes indications cannot be the basis for lowering original drug prices. It also argued that if the suspension of execution is not accepted, there is a risk of damage that is difficult to recover. If the court accepts the company's argument, the company can avoid losses of about 27 billion won a year until the prominent lawsuit is decided. In many cases, it takes more than three years from the citation of the suspension of execution to the cancellation of the drug price cut to the Supreme Court, so the company can prevent losses of tens of billions of won. However, it can be a burden that the judiciary's decision on the drug price cut enforcement suspension has been pointed out one after another it is fragmentary. In Korea's drug pricing system, which does not differentiate drug prices according to indications, questions are being raised as to whether the company's claims of inconsistency in price cuts due to inconsistency in drug prices are reasonable. This is because if the Ministry of Health and Welfare wins the prominent lawsuit after citing the suspension of execution, it will not be able to avoid criticism that the court cited the application for suspension of execution too broadly.
