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- 2026-03-14 05:56:50
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- Schizophrenia drug Invega Hafyera lands in general hospitals
- by Eo, Yun-Ho Jul 13, 2023 05:35am
- The long-acting formulation of the schizophrenia drug ‘Invega’ has landed in general hospitals in Korea. According to industry sources, Invega Hafyera 1092mg/1560mg (paliperidone palmitate), Janssen Korea’s extended-release injectable suspension for patients with schizophrenia that is injected every 6 months, has passed the drug committees of medical institutions in Korea, including Seoul Asan Medical Center. Janssen has been continuously working to create a prescription environment since it was listed for reimbursement in May. Invega Hafyera was approved by the Ministry of Food and Drug Safety in September 2022. The 1-month extended-release injectable formulation of the same drug, Invega Sustenna, had been approved in July 2010 and granted reimbursement in November 2015. With reimbursement, the drug is covered for all patients with schizophrenia in Korea, including first-episode patients. The 3-month extended-release injectable formulation, Invega Trinza, was approved in June 2016 and is being reimbursed from September 2016. Invega Hafyera is indicated for use in patients who have been adequately treated with: Invega Sustenna (once-a-month extended-release injectable suspension) for at least 4 months; or Invega Trinza (every-three-month extended-release injectable suspension) for at least one three-month cycle. Patients who wish to switch to Invega Hafyera from Invega Sustenna 156mg receive Invega Hafyera 1092mg, and those switching from Invega Sustenna 234mg receive Invega Hafyera 1560mg as an initial dose. In the case of Invega Trinza 546mg and 819mg, patients may switch to Invega HafyeraTM 1092mg, and 1560mg, respectively. The safety and tolerance of the every-six-month injectable Invega Hafyera were confirmed through the PSY3015 study. Se Hyun Kim, Professor of Psychiatry at Seoul National University Hospital, said, “Invega Hafyera can offer a broader range of benefits to patients who have seen a stable effect with Invega Sustenna or Invega Trinza. The new formulation offers an opportunity to lower the barrier to injectable treatments for schizophrenia patients in Korea.” Kim added, “The long-acting injectable formulation allows continuous treatment with its stable medication adherence and improved convenience, and can provide benefits such as returning to society and regaining confidence for patients with schizophrenia.” In schizophrenia, the risk of worsening or relapsing symptoms is high with low medication adherence. The long-acting injectable formulations offer a benefit in that aspect as it improves medication adherence over oral formulations, reduce medical cost and relapse or rehospitalization rates, improve symptoms and social function of the patients (when switching to a long-acting injectable formulation), and offer convent administration. The treatment guidelines for schizophrenia in Korea allow long-acting injectable formulations to be administered to patients in all patients, from early to chronic stages.
- Company
- Samsung Biologics, cumulative order amt exceeded 2 trillion
- by Hwang, Jin-joon Jul 11, 2023 05:41am
- Panoramic view of Samsung BiologicsSamsung Biologics announced on the 10th that it has signed a main contract for biopharmaceutical consignment manufacturing (CMO) worth 511.1 billion won from global pharmaceutical company Novartis. Through this contract, the cumulative amount of orders received this year increased to 2.3387 trillion won. This contract with Novartis was signed one year after the letter of intent (LOI) of 100 billion won in June last year. Samsung Biologics and Novartis signed a main contract with a size that is five times larger than the previous LOI. Samsung Biologics signed a CMO contract worth 1.2 trillion won with global pharmaceutical company Pfizer on the 4th before signing a large-scale contract with Novartis. The amount of orders received from Pfizer and Novartis alone amounts to 1.7 trillion won. This is similar to last year's total order amount of 1.7835 trillion won. Samsung Biologics is increasing large-scale, long-term contracts while securing major global big pharma customers. It has secured 13 of the top 20 global pharmas as customers. Samsung Biologics is strengthening its ability to win orders based on its competitiveness in the global No. 1 production capacity (CAPA), speed, and quality. Samsung Biologics started with the 30,000-liter plant 1 in 2011 and expanded the 154,000-liter plant 2 in 2013. In 2015, a third plant with a capacity of 180,000 liters was built. Starting in 2020, construction began on the 240,000-liter class 4 plant, the world's largest single plant, and began full operation last month. The total production capacity is 604,000 liters. Samsung Biologics started construction of its 5th plant in April to preemptively respond to the market's demand for biopharmaceutical CMO. Completion is targeted for April 2025. When completed, the total production capacity will be 784,000 liters. Through process innovation, Samsung Biologics has shortened the technology transfer period, which is essential for biopharmaceutical production, to three months, half of the industry average. Process optimization was carried out through a specialized technology transfer team. The deployment success rate of Samsung Biologics is over 98%. A batch refers to a biopharmaceutical production unit. The cumulative number of regulatory approvals was 231. Samsung Biologics is strengthening its capabilities to respond to the demand for next-generation drugs such as antibody-drug conjugates (ADCs). In April of this year, it invested in Araris Biotech, an ADC treatment technology development company, through the Life Science Fund. It also plans to have an ADC production facility by 2024. Samsung Biologics plans to actively respond to the blockbuster drug market, such as Alzheimer's treatment. Based on the world's largest production capacity, it plans to expand orders by focusing on products that require mass production and products that newly expand indications. It plans to win orders for the 5th plant targeting Alzheimer's treatment, which has a lot of unmet demand. An official from Samsung Biologics said, "We have expanded our global bases, mainly in North America, to narrow the physical distance with our customers and provide prompt services." "We opened a sales office in New Jersey in March of this year following San Francisco in October 2020 to provide services to global customers," he said.
- Company
- ‘Leclaza will be free as first-line Tx until reimbursement'
- by Kim, Jin-Gu Jul 11, 2023 05:41am
- Wook-Je Cho, CEO of Yuhan Corp announced that it will be providing its anticancer drug ‘Leclaza (lasertinib)’ for free as a first-line treatment until its reimbursement is extended to cover first-line treatment. Cho announced the company’s launch of the Early Access Program (EAP) at a press conference it had held on the 10th at the Seoul Plaza Hotel to celebrate Leclaza’s approval as a first-line treatment in Korea. Leclaza is Korea's 31st homegrown novel drug that was approved for the treatment of NSCLC in January 2021. At the time of its approval, the drug was approved as a second-line treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs. Last month, the company received additional approval for Leclaza as a ‘first-line treatment for non-small-cell lung cancer. Cho said, “The company will return a certain proportion of its profits to support the treatment of lung cancer. We will allow free access to Leclaza (as a first-line treatment) for patients suffering from lung cancer until the drug is applied reimbursement." In other words, the company will be providing Leclaza for free as a first-line treatment to all patients that wish to use the drug in the first line until the use is covered by reimbursement. Cho emphasized, “Regardless of the amount, all patients who need and want Leclaza will be able to benefit from our EAP.” Also, Cho dismissed the concerns that the EAP could violate fair competition with its competitors, saying "We feel confident because we have no alternative purpose." “Many patients with EGFR-positive NSCLC have been filing one petition after another through the National Assembly, the Ministry of Health and Welfare, and the President's Office. Many patients cannot afford to use Leclaza because the drug costs KRW 100 million a year without insurance reimbursement. After the drug was approved as a first-line treatment, we decided that it was right to provide its benefit faster to more patients.” “Carrying on the spirit of our founder, Dr.Ilhan New, we will be giving back our profits to society through the EAP. Regarding issues of compliance that have been voiced, we feel confident in providing EAP because we have no alternative purpose.”
- Company
- 'Leclaza effective as 1st-line treatment in Koreans'
- by Kim, Jin-Gu Jul 11, 2023 05:41am
- On the morning of the 10th, Professor Jin-Hyoung Kang of Medical Oncology at the Catholic University of Korea Seoul St. Mary's Hospital, said, "LASER 301,' the global Phase III clinical trial on Leclaza (lazertinib), is the only study that demonstrated the drug's efficacy as a first-line treatment for EGFR mutation-positive non-small cell lung cancer patients in Korea,” during a press conference held to celebrate Leclaza's approval as first-line treatment at Seoul Plaza Hotel. Leclaza is Korea's 31st homegrown novel drug that was approved for the treatment of NSCLC in January 2021. At the time of its approval, the drug was approved as a second-line treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs. Last month, the company received additional approval for Leclaza as a ‘first-line treatment for non-small-cell lung cancer. During the conference, Professor Byoung-Chul Cho of Medical Oncology at the Yonsei Cancer Center explained the results of the LASER 301 Phase III clinical trial, which served as the basis for the approval of Leclaza as a first-line treatment. Among the total of 393 patients worldwide that were enrolled in the trial, 258 were Asians, and 172 of those were Korean patients. Cho emphasized that there were no significant differences between the overall results and the results in Asian patients. Professor Byoung-Chul Cho of Medical Oncology at the Yonsei Cancer CenterCho said, "The median progression-free survival (mPFS) in the Leclaza arm was 20.6 months, which is a statistically significant improvement compared with the 9.7 months in the gefitinib arm. The mPFS in Asian patients were consistent with those of the overall global patient population." “The subgroup analysis of patients with EGFR mutation subtypes also yielded noteworthy results. In patients with exon 19 deletion mutation, the mPFS in the Leclaza arm was 20.7 months, compared with the 10.9 months in the gefitinib arm. In patients with exon 21 L858R substitution mutation, the mPFS for the Leclaza arm was 17.8 months, compared with the 9.6 months in the gefitinib arm." "The results are encouraging. Leclaza demonstrated superior antitumor effect even in patients with an exon 21 L858R substitution mutation, who are known to have a relatively poorer prognosis than those with an ex19del mutation. Leclaza showed consistent results regardless of EGFR mutation subtypes.” Kang also mentioned the therapeutic benefits of Leclaza in Korean patients. He particularly highlighted the fact that although a higher proportion of patients with brain metastasis or the L858R mutation - factors known to have a poor prognosis - were present in Korean patients, the results were similar or even slightly better. Kang explained, "The LASER 301 trial included 172 Korean patients, and among them, one-third already had brain metastasis before the trial began. The investigator-assessed mPFS in the gefitinib arm was 9.6 months, compared with the 20.8 months in the Leclaza arm." Professor Jin-Hyoung Kang of Medical Oncology at the Catholic University of Korea Seoul St. Mary"These PFS results were consistently observed even in the subgroup of patients with brain metastasis. The safety data were also consistent with the previously reported clinical results." Kang noted, "Leclaza is the first treatment to demonstrate therapeutic benefits in a clinical trial that included a significant number of patients among the third-generation EGFR TKIs. The investigator-assessed mPFS of Korean patients with ex19del mutation in the Leclaza arm was approximately 2 years (23.3 months)." “The mPFS of Korean patients with exon 21 L858R substitution mutation who were treated with Leclaza was 17.8 months, compared with the 9.6 months in the gefitinib arm. Leclaza showed consistent effect regardless of type of EGFR mutation in all Korean patients, just as in the global patient population." Kang added that not enough data has been accumulated yet to determine overall survival (OS), which is another major endpoint. “Regarding the much-anticipated OS data, the follow-up period is still too short to obtain sufficient overall survival data. Only 29% of the data has been obtained so far.”
- Company
- Pricing negotiations for Spinraza's reimb begin in KOR
- by Eo, Yun-Ho Jul 11, 2023 05:41am
- The spinal muscular atrophy treatment ‘Spinraza’ has finally entered the last stage of its reimbursement extension in Korea. According to Dailypharm coverage, Biogen is undergoing drug pricing negotiations with the National Health Insurance Service for its SMA treatment Spinraza (nusinersen). Also, another SMA treatment, Roche Korea’s ‘Eveysdi (risdiplam)’ has passed the NHIS’s Drug Reimbursement Evaluation Committee review and has started pricing negotiations almost at the same time with Spinraza. Discussions on the reimbursement and reimbursement extension of SMA treatments had seemingly made rapid progress due to rising demand for the abolition of Spinraza’s discontinuation standards, however, the discussions became prolonged as the requested range of reimbursement was broader than what the government and pharmaceutical companies had expected. Spinraza is currently reimbursed for the treatment of 5q Spinal Muscular Atrophy in patients that satisfy all of the following conditions: ▲received genetic diagnosis of 5q SMN-1 deficiency or mutation; ▲had onset of SMA-related clinical symptoms and signs at the age of 3 or less; and ▲ are not using permanent ventilators. In other words, only patients whose symptoms have been found before the age of 3 were allowed reimbursement until now. The reimbursement extensions currently under discussion aim to expand that age limit to ‘the age of 18 or less.’ At the time, the government had planned to proceed with discussions on the reimbursement listing of Evrysdi after agreeing on the scope of extended reimbursement for Spinraza, and both drugs entered into final negotiations. Whether the SMA drugs that have now entered the last hurdle to their reimbursement in Korea after various twists and turns, will be able to reach the finish line remains to be seen. The SMA treatments currently available in Korea with reimbursement are as follows: Spinraza, and Novartis Korea’s one-shot treatment ‘Zolgensma (onasemnogene abeparvovec-xioi).’ Spinraza is injected using a syringe directly into the cerebrospinal fluid (CSF), and Zolgensma is injected as an intravenous infusion. Evrysdi, which is attempting to be newly reimbursed, is an oral formulation that can reduce the socioeconomic burden borne by SMA patients and their caregivers such as school/work interruption, transportation costs, and nursing care that accompany the required injections. Also, Evrysdi can reduce drug costs for infant patients through customized prescriptions by age and weight.
- Company
- Yuhan provides Leclaza with 6 million won per month for free
- by Kim, Jin-Gu Jul 11, 2023 05:40am
- Leclaza Regarding Yuhan's providing free medicines to patients until the first treatment of Leclaza is covered by insurance, Yuhan said, "It is not an act of inducing patients and there is no problem under the Fair Trade Act." On the 10th, Yuhan held a press conference for permission for the first treatment of Leclaza at the Plaza Hotel in Seoul. On this day, CEO Cho Wook-je announced the free supply of Leclaza through the Expanded Access Program. Yuhan Corporation launches large-scale 'EAP' for the first time as a domestic pharmaceutical company EAP is a humanitarian system that provides treatment opportunities by supplying new drugs free of charge to patients who do not have adequate treatment. Usually, instead of patients participating in clinical trials, new drugs are administered more rapidly. According to Article 34 of the Pharmaceutical Affairs Act, 'drugs for clinical trials shall not be used for purposes other than clinical trials. However, if the approval of the Minister of the Ministry of Food and Drug Safety falls under each of the following subparagraphs, the relevant drug may be used for purposes other than clinical trials.' At this time, the exceptions are limited to 'patients with life-threatening serious diseases such as terminal cancer or acquired immunodeficiency syndrome' or 'emergency patients prescribed by Prime Minister Ordinance, such as life is in jeopardy or there is no alternative treatment method'. Based on this clause, Yuhan Corporation's plan is to supply Leclaza's first-line clinical trial drug to patients. If the clinical trial for the first treatment of Leclaza is conducted in the form of a researcher's clinical trial, Leclaza will be supplied to the participating patients. Yuhan had already operated EAP in the same way until Leclaza was approved as a second-line treatment and reimbursement was applied. In the pharmaceutical industry, Leclaza's EAP operation is seen as the first attempt among domestic pharmaceutical companies. This is because it is the first drug developed by a domestic company for an expensive and life-threatening treatment such as cancer. Cho Wook-je, CEO of Yuhan Corporation, said, "Because the drug is so expensive, there are many people who find it difficult to use Leclaza due to economic conditions. We will provide it free of charge through EAP until Leclaza is officially covered by reimbursement." The scale will be determined upon request from medical staff treating lung cancer on site.” "Tagrisso and Leclaza both use EAP as non-reimbursed drugs, and there is no problem with fair competition" Some criticize Yuhan's plan to use Leclaza for sympathy, saying that it violates fair competition. It is criticized that, as in the case of Novartis Glivec in the past, support for drug prices through EAP can be seen as an act of luring patients. Regarding this, Yuhan Corporation said, “It is different from the Glivec case,” and drew a line, saying, “We operated the same program until the benefit was applied after the second treatment was approved, but there was no problem.” Gleevec In 2013, Novartis stopped subsidizing the cost of Glivec, a leukemia treatment. Until just before that, Novartis subsidized 5% of the drug cost for patients taking Glivec. Since 95% of the cost of leukemia treatment was supported by health insurance finances, patients took Glivec virtually free. In June 2013, when the release of a large number of generic products was announced ahead of the expiration of the Glivec patent, Novartis decided to stop supporting the drug price. It is based on the judgment that supporting the price of Glivec even though a generic with the same ingredients has been released can be considered an act of attracting patients and can constitute an unfair trade act under the Fair Trade Act. If the competitive drug Tagrisso is covered, it is likely to be seen as an act of attracting patients, but since both drugs are not covered by insurance as the first-line treatment, there is no problem under the Fair Trade Act. An official from Yuhan Corporation said, "We understand that supporting the cost of medicines with the benefit applied is against fair competition. The case of Gleevec falls under this category." Once the reimbursement is decided, the free provision ends immediately. At this time, the patient has to pay all of his or her own expenses.” The official said, "The monthly cost of Leclaza alone is about 6 million won. According to the PFS results, if the drug is administered continuously for 20 months, the amount that the patient will have to bear will exceed 120 million won." It is purely a decision for the patient. From the company or doctor's point of view, there is nothing to take 10 won." "There will be more participants than in the second treatment... Lexraza is provided without size restrictions" Yuhan expects that the number of patients participating in EAP related to the first treatment will increase compared to the second treatment. According to Yuhan Corporation, around 10 patients participated in EAP after Leclaza's second-line treatment was approved and until insurance coverage was applied. It is explained that the number of participants was not large because the process from approval to reimbursement was fast and the procedure for participating in EAP was complicated. The key is when the primary treatment benefit is applied. The longer it takes for coverage of Leclaza to expand as a first-line treatment, the more patients are expected to participate in the compassionate use program. Yuhan plans to provide Leclaza in any size, no matter how long it takes to get paid. An official from Yuhan Corporation said, "It is impossible to estimate how many patients will participate in the program. Therefore, it is currently unknown how much the related budget will be. However, we expect more patients to participate than in the second treatment." AstraZeneca, which has a competitive drug, seems to refrain from the official response. However, AstraZeneca Korea explained that it is not considering a separate legal response against Yuhan Corporation. An official from AstraZeneca Korea said, “We are doing our best to increase the accessibility of patients who use Tagrisso in Korea,” and “We are reviewing ways to work for patients.”
- Company
- Will the non-reimbursed Gavreto vanish in Korea?
- by Jung, Sae-Im Jul 10, 2023 05:21am
- The possibility that the new RET-targeted anticancer therapy ‘Gavreto (pralsetinib)’ will vanish without ever being released in Korea has been rising. With Roche giving up sales rights for Gavreto, the prospects of its reimbursement listing in Korea had also gone up in smoke. As Blueprint Medicines, the original developer of Gavreto, does not have a branch in Korea, the company would need to find a new partner to market the drug in Korea, which is more easily said than done. According to the Health Insurance Review and Assessment Service, the Drug Reimbursement Evaluation Committee determined Gavreto inadequate for reimbursement and made a ‘non-reimbursement’ at its 7th 2023 DREC meeting that was held on the 6th. Drugs that receive a non-reimbursement decision, not a conditional pass or re-discussion decision, must reapply for reimbursement with supplementary materials. As such drugs need to undergo all the steps for reimbursement again, the time to their reimbursement listing becomes delayed indefinitely. Also, it is unclear which pharmaceutical company will reapply for Gavreto’s reimbursement in the future. Before, Roche Korea was in charge of its approval and distribution in Korea. Roche had paid $775 million upfront for Gavreto’s global sales right in all countries excluding China. However, in March, only 2 years and 7 months after signing the agreement, the company returned the rights for Gavreto to Blueprint due to lower sales expectations. With the termination of the collaboration, Roche will be supplying Gavreto until February next year. To continue supply, the original developer Blueprint Medicines will need to directly supply the drug or find a new partner. Without its own Korean subsidiary, the realistic alternative for Blueprints would be to resume supply through a new partner. So far, there has been no word on Gavreto’s new partner. Roche Korea submitted an application for the reimbursement of Gavreto in November last year. However, its discussions fell through after the global termination of the collaboration was announced ahead of its CDDC review. Roche Korea was unable to continue the drug pricing negotiations for the drug in a situation where it was unclear which company would continue marketing the drug. As a result, Gavreto’s reimbursement standards were not set at the CDDC meeting, resulting in its non-reimbursement by DREC. The market conditions are also working against Gavreto. Its competitor, Lilly's 'Retevmo (selpercatinib)', passed DREC review in May and is set to be reimbursed soon. The reimbursement listing timing for Retevmo and Gavreto, both of which received domestic approval in the same month, widened significantly in the reimbursement listing process. Unlike Retevmo, which passed the Drug Committees (DCs) of major general hospitals in January of this year, Gavreto was unable to even be registered for prescriptions. At this rate, it is highly likely that Retevmo will dominate the domestic RET mutation-targeting therapy market. In addition, Gavreto recently voluntarily withdrew its thyroid cancer indication in the U.S. With Retevmo already owning the indication, Gavreto lost the opportunity to extend its indication to the area. This signifies the lower profit expected for Gavreto in Korea. Previously, sales of Retevmo surpassed Gabretto in global sales, reducing the sales expectations for Gavreto. It seems that it will not be easy to find a pharmaceutical company that will sell Gavreto in this situation, as the patient group is small, sales expectations are low, and reapplications need to be made for its reimbursement. If Gavreto goes through the withdrawal process at this pace, Retevmo will become the only targeted anti-cancer drug that can treat RET mutation-positive cancer in Korea. RET is one of the major emerging biomarkers that induce cancer. It causes malignant tumors through fusion mutations or point mutations. RET mutations are partially found in several cancer types, including lung cancer, breast cancer, and colorectal cancer. The rate of RET mutations in non-small cell lung cancer is about 2 to 6%, and RET fusion mutations have been reported in up to 40% of thyroid cancers.
- Company
- 3 new asthma drugs resumed discussion on reimbursement
- by Eo, Yun-Ho Jul 10, 2023 05:21am
- Three new asthma drugs, which had been uninsured for at least three years, started the insurance benefit listing process, but only one drug made progress. According to related industries, Handokteva's eosinophilic asthma treatment Cinqair passed the HIRA Pharmaceutical Reimbursement Evaluation Committee. However, GSK Korea's Nucala and Korea AstraZeneca's Fasenra were not considered. These drugs are interleukin (IL)-5 antagonists and have a mechanism of reducing the level of eosinophils, a type of leukocyte involved in the induction of asthma. It received attention at the time of approval as a valid treatment option that did not exist before but was not included in the reimbursement list due to drug price issues. Drugs with the same mechanism started the listing process again at the same time, but the reason for the different results is believed to be that only Cinqair followed the general listing track. For the remaining drugs, companies are known to want to apply a risk-sharing agreement. It remains to be seen whether the two unlisted drugs of this evaluation committee can find a compromise with the government and continue the listing process. There are no registered drugs for severe asthma since Novartis Korea's Xolair entered insurance coverage in 2020. The disease area of 'asthma' looks the same, but three drugs and Xolair are prescribed for allergic asthma. There is a difference in the details of the indications. However, by the government's standards, Xolair became the target of comparison, and the drug's price was unbearable for three new biologics, so the reimbursement listing process was suspended.
- Company
- New AML drug Vyxeos can be prescribed at general hospitals
- by Eo, Yun-Ho Jul 10, 2023 05:21am
- The new drug ‘Vyxeos’ that was introduced to Korea by Handok Pharmaceuticals may now be prescribed at general hospitals in Korea, According to industry sources, Vyxeos (daunorubicin+ cytarabine), a treatment for adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC), has passed the drug committees (DCs) meetings of several medical institutions in Korea including the National Cancer Center, Samsung Medical Center, Seoul National University Hospital, and Asan Medical Center, and Sinchon Severance Hospital. However, Vyxeos is yet to be reimbursed in Korea. Its reimbursement agenda had been deliberated by the National Health Insurance Service’s Cancer Disease Deliberation Committee last month, but the committee was unable to set the reimbursement standards. Vyxeos was developed by a global pharmaceutical company Jazz Pharmaceuticals headquartered in Ireland, and Handok owns the exclusive rights to its sales in Korea. The overall prognosis of adults with therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) is poor, and t-AML or AML-MRC patients have demonstrated low remission rates and shorter overall survival (OS) after intensive chemotherapy compared to other AML patients. Intensive chemotherapy, the 7+3 regimen of cytarabine and daunorubicin, had remained the standard therapy for over 50 years since its introduction in the 1970s. This is why an unmet need existed in the field for some time. Vyxeos is a liposomal formulation of a fixed combination of daunorubicin and cytarabine in a 1:5 molar ratio. Vyxeos liposomes accumulate and persist at a higher concentration in the bone marrow, where they are preferentially taken up intact by leukemia cells, maximizing synergistic antitumor activity. In a Phase III trial that demonstrated the efficacy of Vyxeos, the median overall survival of patients with t-AML or AMLM-MRC that were treated with Vyxeos was 9.6 months, which was longer compared with the 6 months in patients that received the 7+3 arm. Also, 48% of the Vyxeos-treated patients achieved complete remission (CR) and complete remission with incomplete neutrophil or platelet recovery (CRi), which was higher than the 33% in the 7+3 arm. The safety profile in both arms was similar.
- Company
- Daiichi's sales rose & Astellas' sales fell
- by Jung, Sae-Im Jul 10, 2023 05:20am
- Among Japanese pharmaceutical companies that have entered the domestic market, 4 out of 7 subsidiaries with settlements in March expanded their sales. Daiichi Sankyo Korea's sales reached 253.2 billion won, ranking first among Japanese pharmaceutical companies. As a result of analyzing the performance for the 2022 business year (April 1, 2022, to March 31, 2023) of 7 pharmaceutical companies with settlements in March submitted to the Financial Supervisory Service on the 10th, the total sales amounted to KRW 1,115.4 billion, up from 11,557 in the previous year. decreased by 3% compared to the billion won. During the same period, operating profit fell 18% from 97.9 billion won to 80.2 billion won. 4 out of 7 companies succeeded in expanding their top line. Four companies saw an increase in operating profit. More than half improved performance, but the decline in performance at a particular company affected overall performance. Daiichi Sankyo Korea posted 253.2 billion won in sales last year, up 3% from the previous year. It surpassed Astellas Pharmaceuticals Korea and rose to No. 1 among Japanese pharmaceutical companies (including the December settlement). Operating profit fell 16% to 22.1 billion won. Lixiana·Sevikar sales made stable performance.. Since last year, it has been taking on a new challenge with the approval of the anti-cancer drug Enhertu. There were also changes in the members of the organization, such as increasing the number of experts in anticancer drugs. As a result, selling and administrative expenses increased and operating profit decreased. Enhertu is a next-generation antibody-drug conjugate (ADC) that has proven efficacy not only in HER2-positive but also in HER2-low-expressing breast cancer for which there was no treatment. In May, HER-2-positive breast cancer and stomach cancer passed the HIRA committee and benefits became possible. If the benefit is applied within the year, it is expected to have a great impact on Daiichi Sankyo Korea's sales. Takeda Pharmaceutical Korea and Astellas Korea Pharmaceutical, which cost about 200 billion won, obtained conflicting results last year. Takeda Pharmaceutical Korea saw an increase in sales and a decrease in operating profit, while Astellas Pharmaceutical Korea saw a decrease in sales and an increase in operating profit. Last year, Takeda Pharmaceutical Korea's sales were 249.6 billion won, up 8% from the previous year. Operating profit fell 6% to 7.6 billion won. Anticancer drugs such as Zejula, Alunbrig, and Ninlaro contributed to sales expansion with steady growth. However, the decrease in operating profit was mainly due to the increase in the cost of sales. Last year, Takeda Korea's cost of sales was 177 billion won, up 13 percent from 156.4 billion won the previous year. Astellas Pharmaceutical Korea recorded 232.2 billion won in sales last year, down 6% from the previous year. Representative products, such as Betmiga and Harnal, are continuously declining in sales. Instead, the company is pinning its hopes on Xospata, a leukemia drug that succeeded in applying for reimbursement last year. Saving on SG&A expenses, operating profit increased by 16% last year to KRW 17.6 billion. Eisai's sales decreased by 34% from 212.9 billion won in 2021 to 140.5 billion won last year. During the same period, operating profit also decreased by 77% to 5.2 billion won. Sales of existing products such as Lenvima have declined, while new drugs such as Jyseleca have not yet generated significant sales in the market. Eisai, which exceeded 200 billion won in annual sales for the first time in 2019, fell back to the 100 billion won level in three years. Lecanemab is a promising new drug that will bring Eisai back. Lecanemab, jointly developed by Biogen and Eisai, is a drug that can fundamentally treat Alzheimer's disease and is expected to exceed 1 trillion won in global sales by 2027. Lecanemab, which received conditional approval from the FDA last year, was recently approved as an official drug, raising expectations for commercialization. In particular, Eisai, not Biogen, is leading the commercialization of Lecanemab. Eisai submitted an application for domestic approval of Lecanemab last month. Santen Korea recorded 120.2 billion won and 16.9 billion won in sales and operating profit, up 10% and 6%, respectively. Mitsubishi Tanabe Korea had the same sales as the previous year, but its operating profit increased by 7%. Ono Pharma recorded sales of 50.1 billion won, up 23% last year thanks to the growth of the immuno-oncology drug Opdivo.
