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- 2026-04-10 23:45:48
- Company
- Sanofi consumer healthcare appoints Chung Kyung-hee as CEO
- by Eo, Yun-Ho Jan 09, 2023 06:10am
- Sanofi's Korean subsidiary Consumer Healthcare (Sanofi CHC) division announced on the 5th that it had appointed Chung Kyung-hee as its new CEO. Chung Kyung-hee, the new CEO, has been intensively building his capabilities in various global companies' marketing and digital fields over the past 26 years. From 2020 to May last year, he served as CEO of Pierre Fabre Dermocosmetics Korea, leading in-house cultural innovation to improve the group's overall performance and organizational efficiency. From 2015 to 2020, he led the successful sales growth of major brands such as Aveda, Clinique, and Lab series as a brand general at ELCA Korea. "Based on our past experience, we will do our best to bring out the potential and balanced growth of the CHC division," said new CEO Chung Kyung-hee.
- Policy
- nAMD & DME tx Vabysmo is about to be approved in Korea
- by Lee, Hye-Kyung Jan 09, 2023 06:10am
- The domestic approval of Vabysmo, the first and only dual-specific antibody biological drug related to eye diseases developed by Roche, is imminent. Vabysmo has been approved as an nAMD treatment and DME treatment in more than 40 countries around the world, including the United States, Japan, the United Kingdom, and the European Union, and was approved by the U.S. FDA in January last year. According to industries on the 5th, the Ministry of Food and Drug Safety recently completed a safety and effectiveness review of Vabysmo. If the review is completed without any problems, product approval is expected to take place soon. Vabysmo is the first and only ophthalmic injection approved by the FDA for nAMD and DME simultaneously. Depending on the patient's anatomical evaluation and vision results, vision can be improved and maintained by administering it every one to four months after the first four monthly administrations. It is estimated that more than 40 million patients suffer from one of the neovascular age-related nAMD treatments and DMEs worldwide, and the number of patients is gradually increasing as the population ages and the prevalence of diabetes increases. Until now, the standard therapy for the two diseases had to be administered every one to two months. However, in phase 3 of the Vabysmo global clinical trial, the patient group receiving Vabysmo at intervals of up to 4 months was found to have achieved a non-mean level of vision improvement compared to the patient group receiving Eylea every 2 months. It is evaluated that the convenience of patients has been improved by improving the administration cycle for up to four months. The international journal Nature Review Drug Discovery expects Babysmo's estimated sales to reach $1.129 billion within five years. Currently, four new nAMD drugs licensed in Korea are Avastin, Lucentis, Eylea, and Beovu.
- Company
- Diabetes combination benefits
- by Nho, Byung Chul Jan 06, 2023 05:57am
- SGLT-2 inhibitory diabetes medication (from left to right, Forxiga, Jardiance, Xigduo, Jardiance Duo)As health authorities officially announced the suspension of financial impact analysis on drugs subject to expanding the scope of use, discussions on expanding the benefit standard for diabetes solvents are likely to be postponed up to three years later. According to the industry, the HIRA recently stopped evaluating financial impact analysis reports submitted by individual pharmaceutical companies based on a request to temporarily suspend economic impact analysis on drugs subject to the expansion of the scope of use of insurance drugs by the Ministry of Health and Welfare. The plan to expand the salary standard has a structure in which the HIRA Drug Standards Department listens to related academic societies and internal opinions and confirms the contents. After that, the Ministry of Drug Safety and Standards reports this to the Ministry of Health and Welfare, and the Ministry of Health and Welfare will review whether to lower the drug price based on additional financial needs to the HIRA drug price calculation government. However, the expansion of the standard for diabetes solvents has been conducted by first requesting opinions from pharmaceutical companies and self-reviewing them over the past year, and notified of the request to temporarily revise the financial impact analysis review in mid-December 2022. The industry is taking this as an exception because a financial impact review is an essential administrative requirement for drugs that expand their salary standards. This is because some pharmaceutical companies' confirmation of the HIRA has been set to proceed with the voluntary cut conducted in November, not the financial impact analysis. The future outlook following the aftermath cannot rule out the possibility that the expansion of the combined benefit standard will go to a zero source base if sufficient financial savings due to voluntary cuts are not reflected. In addition, there seems to be room to review the combined benefits once again from 2025 when SGLT-2 and DPP-4 diabetes treatment generic enter in earnest. Considering that the additional finances required for this combined benefit are a banding width of 30 to 50 billion won, the most efficient way to realize this without any separate financial requirements may be to voluntarily cut 5% of the existing drug costs, mainly from the original company. It is not easy to enforce such a method in the face of the patent of the original diabetes treatment, and it is believed that few foreign subsidiaries have submitted such doctors to the Ministry of Health and Welfare so far. Therefore, it is analyzed that the health authorities are more likely to use the compensated amount by waiting for the expiration of the original drug patent within one to three years rather than spending additional finances to expand the combined benefits of diabetes drugs. If the original drug price is reduced by 30% due to ex officio adjustment, the budget will be reduced by about 30 billion to 50 billion, which is interpreted as an intention to turn it into a share of combined benefits. The expansion of salary standards for the combination of diabetes treatment SGLT-2 inhibitor drugs and DPP-4 inhibitor drugs was expected to be applied by the end of this year as it was discussed in 2022 after the diabetes association requested it to the health authorities in 2016. Since then, the HIRA has conducted a financial impact analysis in June by reviewing the pay standards for three-drug therapy such as metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, and SGLT-2+sulfonylurea or insulin combination therapy.
- Company
- Rare RCC drug Welireg may be commercialized in Korea this yr
- by Eo, Yun-Ho Jan 06, 2023 05:57am
- The new rare anticancer drug ‘Welireg’ is expected to be commercialized in Korea within the year. According to industry sources, the Ministry of Food and Drug Safety is currently reviewing approval of MSD Korea’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, ‘Welireg (belzutifan).’ The drug had been designated as an orphan drug in January last year for the treatment of Von Hippel-Lindau disease, and the company applied to receive approval for the indication the same year. In the US, the drug was granted priority review in 2021 and approved. The indication the company applied for in Korea is also for the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET) that do not require immediate surgery. As a HIF-2α inhibitor, Welireg reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis, and tumor growth. The drug’s efficacy was demonstrated through the open-label Study 004 trial which investigated 61 patients with VHL-associated RCC that were diagnosed with at least one measurable solid tumor localized to the kidney. Patients enrolled in the trial had other VHL-associated tumors including CNS hemangioblastomas and pNET. The major efficacy endpoint of the clinical trial was the overall response rate (ORR) in patients with VHL-associated RCC as measured by radiology assessment using RECIST v1.1 as assessed by an independent review committee (IRC). Additional efficacy endpoints included duration of response (DoR) and time to response (TTR). In the study, Welireg showed an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR had not yet been reached, and the DoR among responders that were still responding after at least 12 months was 56%. Median TTR was 8 months. In patients with VHL-associated CNS hemangioblastomas, Welireg showed an ORR of 63%, with a complete response rate of 4% and a partial response rate of 58%.
- Company
- “I strongly recommend Retevmo as first-line treatment”
- by Jan 06, 2023 05:57am
- Reimbursement listing for Lilly’s ‘Retevmo(selpercatinib),’ which opened a new door to treating RET-targeted mutations, is gaining momentum in Korea. If approved for reimbursement, the scope of treatment for patients with RET mutations is expected to broaden significantly. In November this year, the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service set the reimbursement standards for Retevmo in non-small cell lung cancer (NSCLC) and thyroid cancer and is up for deliberation by the Drug Reimbursement Evaluation Committee (DREC). As HIRA announced it will reduce the reimbursement listing period by 30 days for drugs that treat life-threatening diseases like Retevmo, discussion on the drug’s reimbursement is expected to speed up further. Retevmo is the first targeted therapy that targets the RET mutation. The RET gene is in charge of the formation of normal organs as well as the maintenance of various tissues including neural, neuroendocrine, hematopoietic, and male reproductive cells. However, the abnormal activation of RET due to mutations in the RET gene, such as fusion or point mutation causes malignant tumors. The mutation is mostly found in NSCLC, thyroid cancer, and medullary thyroid cancer. In NSCLC, RET mutation occurs in 2 to 6 % of all cases. The drug is already being used actively in the field in Japan, where Retevmo was approved earlier and is being reimbursed. Dailypharm interviewed Professor Kaname Nosaki of the National Cancer Center Japan (Department of Thoracic Oncology) to seek insight into Japan’s treatment experience with Retevmo in RET fusion-positive NSCLC. Professor Kaname Nosaki, National Cancer Center Japan In the interview, Professor Nosaki stressed the need for Retevmo in patients with RET fusion-positive NSCLC. Prior to its introduction, patients had no other option but to use chemotherapy, which has high toxicity. Professor Nosaki said, “With no other targeted therapy available before Retevmo, patients who were identified with RET mutations had no other option but to receive chemotherapy. As expected, due to poor treatment prognosis and low rate of survival, a strong unmet need existed in the field. Retevmo is very necessary for these patients as it has demonstrated excellent clinical efficacy, duration in effect, and excellent safety.” The Japan Lung Cancer Society updated its clinical practice guidelines to strongly recommend the use of Retevmo in patients with RET fusion-positive NSCLC who have no prior treatment experience. The recommendation is based on the LIBRETTO-001 trial that was conducted on 702 patients with advanced or metastatic solid cancer with RET mutations. The objective response rate (ORR) of Retevmo was 85% in patients with no prior chemotherapy experience. Also, 79% of the Retevmo patients showed continued response during the follow-up period (median 7.4 months). The ORR was slightly lower in patients with previous treatment experience but was still 64%. The median duration of response (DoR) was 17.5 months. Professor Nosaki said, “The overall survival (OS) is yet to be reached in the Retevmo trial. We need to continue monitoring the data, but we are positive about the results as the 2-year survival rate of enrolled patients is near 70%. When the OS has not been reached, we evaluate results based on progression-free survival (PFS) or duration of response (DoR), and Retevmo showed good results in the criteria with an mPFS of 18.4 months and DoR of 20.4 months. He emphasized that the use of Retevmo in the first line should be considered after identifying RET mutations in the initial stages of diagnosis in patients with NSCLC. Due to differences in the diagnostic environment, the less common RET mutations are identified relatively later than other mutations. In other words, patients are first searched for major mutations such as EGFR·ALK·ROS1, and those without these mutations are prescribed cancer immunotherapies and then identified for minor mutations. Therefore, patients found with RET mutations at this time may only use Retevmo in the second line. On this, Professor Nosaki said, “Patients with a certain mutation may not respond well to immunotherapies, therefore, treatment sequence is all the more important in these patients. Unexpected toxicity problems may occur when using cancer immunotherapies first then using TKIs, which may lead to pneumonia or liver function deterioration.” He added, “Therefore, if available, it is more appropriate to use the targeted therapy first. Doctors should quickly identify major and minor mutations with next-generation sequencing (NGS) from the early stage of diagnosis to allow patients to be treated with good drugs early on."
- Policy
- PMS standards lowered for Sanofi’s hemophilia drug
- by Lee, Hye-Kyung Jan 06, 2023 05:57am
- The post-marketing surveillance (PMS) term for Sanofi’s hemophilia treatment ‘Eloctate’ and ‘Alprolix’ has been extended, and the number of subjects reduced. With the risk that the items may be canceled if the company fails to complete PMS for the drugs within the term set within the year, the authorities decided to extend the reevaluation term, including the submission of the risk management plan (RMP), by 3 years to collect more cases in consideration of the need for various hemophilia treatments and how they are being used in the field. The Ministry of Food and Drug Safety recently disclosed the results of the Central Pharmaceutical Affairs Council’s Drug Reexamination Subcommittee meeting to adjust the PMS period and the number of subjects for hemophilia treatments. Alprolix and Eloctate received marketing authorization in May and August 2017, respectively, and each is subject to reexaminations by May and August this year, respectively. According to the new ‘Notice on the Standard for Drugs subject to Reexaminations including New Drugs, etc.,’ the company may apply to adjust the number of surveillance subjects after at least half of the period elapses from the date of marketing authorization to the expiration date of the reexamination period until at least one year remains to the expiration date of the reexamination period. Sanofi was unable to sell the half-life extending hemophilia A treatment Eloctate and hemophilia B treatment Alprolix in the market for 3 years due to the transfer and acquisitions process between the previous license-holder UCB Korea and Sanofi, and due to the need to prepare inspection laboratories according to Korea's regulations on imported drugs. The two hemophilia treatments were not designated as rare disease treatments at the time of their approval and were required to collect 600 cases according to the set standards. However, due to their deferred sales in the market and difficulty collecting hemophilia patients, etc., Sanofi applied to adjust the number of surveillance subjects. The MFDS explained, “The company had applied to collect even fewer cases during initial discussions. The 65 and 35 case adjustments the company applied for this time show efforts on the company’s part as well.” According to the grounds for adjustments described by the company, the rate of adverse events was 10%, and the committee members' opinion was that the 65 and 35 people set for PMS would be the minimum target number. Other committee members said, “Hemophilia treatments are mainly used specifically by the Korea Hemophilia Foundation, therefore, it is difficult to collect a lot of cases. Patients mostly visit KHF clinics rather than university hospitals, therefore, not many patients can be enrolled. Therefore, the company seems to have applied to enroll a realistically possible number of subjects for PMS.” The MFDS also said, “The number of subjects for PMS under review will apply when the drugs are not registered as KHF drugs. If the drugs are registered as KHF drugs, the company will be able to collect more information.” Also, the reexamination period for the two drugs will be extended by 3 years each from the previous 6 years. As a result, the PMS period will be 9 years, and the subject number of patients 65 and 35 for Eloctate and Alprolix, respectively. Hemophilia is a rare intractable disease that develops in 1 in 10,000 people worldwide and is a disease that causes hemostasis issues when one of the coagulation factors in the blood is deficient or insufficient. As of 2019, there were 2,509 hemophilia patients in Korea. Among them, the most – 1,746 patients (69.6%) - had factor VIII deficiency, or Hemophilia A, followed by 434 patients (17.3%) with factor IX deficiency, or Hemophilia B.
- Company
- 2 CGRP Migraine New Drugs
- by Eo, Yun-Ho Jan 06, 2023 05:57am
- Teva-Handok's Calcitoninene-related peptide (CGRP) targeted migraine treatment Ajovy has been covered by insurance benefits since January, and it will fight for prescription leadership with Emgality of Lily Korea, which was listed in September last year. The two drugs are in the same family, but there are differences in usage dosage, so choices are being made according to the characteristics of patients with severe migraines. Emgality is a method of administering 240 mg (two consecutive subcutaneous injections of 120 mg each) once, and subcutaneous injections of 120 mg once a month after that. In the case of Ajovy, 225 mg once a month or 675 mg (3 consecutive 225 mg) once every three months is used by subcutaneous injection. The domestic migraine treatment market is smaller than that of patients. The annual prescription amount of Tryptane-based drugs remains at 15.5 billion won as of 2020. However, the prevalence of migraines in Korea is not small at around 6%. According to the 2020 HIRA statistics, 550,000 patients have been treated for migraine headaches, but it is estimated that about 2 million patients have not visited the hospital. As Ajovy and Emgality have been registered as salaries, the market size is expected to expand in the future. Much of the prescription environment has already been created. Currently, Emgality can be prescribed at Big 5 general hospitals such as Seoul National University Hospital and Sinchon Severance Hospital, as well as medical institutions nationwide such as Gangbuk Samsung Hospital, Dongtan Sacred Heart Hospital, and Nowon Eulji University Hospital. Ajovy is also settled in general hospitals such as Asan Medical Center in Seoul and Severance Hospital in Sinchon. Both drugs are carrying out promotional activities through partnerships with domestic pharmaceutical companies. Teva-Handok has signed a joint sales contract with Chong Kun Dang and Lilly with SK Chemicals.
- Company
- Phase 1 of HLB Apixaban was approved
- by Lee, Seok-Jun Jan 06, 2023 05:56am
- HLB Pharmaceutical has received approval from the Ministry of Food and Drug Safety for phase 1 in Korea, which develops the oral thrombosis treatment Eliquis in the form of a long-term continuous injection (HLBP-024). According to the company on the 4th, HLBP-024 is a treatment developed independently based on HLB Pharmaceutical's long-term continuous injection platform (SMEBR). The company expects that it will be possible to develop various pipelines applying uniform particulate manufacturing technology in the future. The company has already succeeded in transferring long-term continuous injection technology for obesity treatment to the platform. This clinical trial is the first clinical trial in Korea to be applied with SMEBR developed by HLB Pharmaceutical in 2019. Safety and pharmacokinetic characteristics are compared after the administration of HLBP-024 and Eliquis to healthy subjects, respectively. Here, the effect and safety of inhibiting blood coagulation are investigated. Equis is a blockbuster drug (3rd in global sales) that sold about 20 trillion won last year. However, the hassle of taking it twice a day, gastrointestinal bleeding, which is a representative side effect of oral thrombosis treatment, and blood clots due to short-term suspension of administration were pointed out. This raised the need to develop long-term continuous injections. Han Yong-hae, CEO of HLB Life Sciences, said, "The long-term continuous injection of Apixaban ingredients has been quickly developed by HLB Pharmaceutical and patented, and it is the only technology in the world that can be developed only by HLB Pharmaceutical." "If clinical trials improve the convenience of taking drugs while having the same effect as existing oral thrombosis treatments, it will grow into a global blockbuster," he said. HLB Pharmaceutical plans to expand to the third phase of globalization in the future based on domestic clinical results. As the technology of the long-term continuous injection platform has been verified, the pipeline will be expanded to various incurable diseases such as obesity, diabetes, and dementia.
- Policy
- Termination of PVA research services
- by Lee, Tak-Sun Jan 06, 2023 05:56am
- With the completion of the study that derived the improvement plan for PVA, attention is being paid to how it will be reflected in the actual policy. The industry expects the maximum cut rate, which is currently limited to 10%, to change. The NHIS also said it would come up with measures to improve the maximum reduction rate through research services. On the 2nd, the "Research on the Performance Evaluation and Improvement of the PVA System" was posted on the Public Institution Management Information Disclosure System (ALIO), which the National Health Insurance Service provided to Ewha Womans University Industry-Academic Cooperation Group (Professor Bae Seung-jin). The study was conducted from June 29 to December 29 last year. The contents of the study consisted of the background of the study, the status of the PVA system, overseas case review, in-depth interviews with stakeholders, scenario analysis, review, and conclusion. The original text was not disclosed. The reason for the non-disclosure is that it contains information on the size of claims, price cuts, and cost-effectiveness of certain drugs, which includes a number of confidential in management and business, and the research results are not disclosed because careful internal review and consultation with related agencies are needed to improve PVA. The results of the study are private, but the study is expected to be reflected in the actual system improvement policy. An NHIS official said, "The research results will be used and reflected in actual policies," and explained, "When the review is completed in the future, the research results can be converted to public." The study is known to have proposed an improved maximum reduction rate and a reference formula reduction rate. The maximum reduction rate of PVA is 10%, and the formula is set based on the rate of increase in actual claims compared to the previous year or expected claims. The average cut rate remained at 4-6%. It was 4.6% in 2017, 4.2% in 2018, 5.6% in 2019, 5.5% in 2020, 6.2% in 2021, and 5.2% as of August last year. In August, Jeong Hae-min, head of the NHIS' drug management office, said, "Research services are being conducted to analyze the overall PVA and come up with a reasonable system improvement plan. It includes adjusting the maximum cut rate and developing a reference formula considering the increase in billing amount." Accordingly, the study is expected to adjust the maximum reduction rate and develop a new reference formula. Meanwhile, PVA was introduced in December 2006 as part of the follow-up management of drug cost optimization measures. The main goal is to prepare a mechanism for lowering the upper limit through negotiations with pharmaceutical companies in order to share financial risks if drug costs have increased at a certain level. Through this, the NHIS is securing the soundness of insurance finances and inducing the proper use of drugs.
- Company
- Celltrion Remsima is licensed in 100 countries
- by Kim, Jin-Gu Jan 06, 2023 05:56am
- Celltrion announced on the 3rd that Remicade biosimilar Remsima has been licensed in 100 global countries 10 years after its domestic approval in 2012. Remsima is a biosimilar of TNF-억제 inhibitors used to treat autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease, psoriasis. It started developing materials in 2006 and obtained permission from the Ministry of Food and Drug Safety for the first time in the world in July 2012. It was licensed in Europe in September 2013 and in the United States in April 2016. It then steadily obtained permits in Canada, Japan, Brazil, Australia, Egypt, and South Africa, and at the end of last year, the number of licensed countries surpassed 100. Remsima is expanding its global territory by expanding licensed countries while securing a stable share in the United States and Europe. According to Celltrion Healthcare, which is in charge of the global supply of Remsima, Remsima has a 53.6% share in the European market in the second quarter of last year. The U.S. market, which is being sold through Pfizer, has a 31.7% market share as of the third quarter of last year. Celltrion is making all-out efforts to expand the global approval and release of Remsima SC with the existing intravenous injection formulation as a subcutaneous injection formulation. Celltrion expects that if Remsima SC settles in the market, its competitiveness will be further strengthened along with the existing Remsima. The Remsima SC currently has licenses in 46 countries. In the U.S., which is considered the world's largest market, the U.S. is undergoing a licensing process to release Remsima SC as a new drug. Subsequent antibody biosimilars such as Herzuma and Truxima are also expanding their scope in licensed countries. As of December last year, including major markets such as the United States and Europe, Herzuma has obtained permits in 92 countries and Truxima in 88 countries. A Celltrion official said, "Remsima is a representative Korean biopharmaceutical that has successfully settled in the global market after overcoming a poor development environment at a time when the concept of biosimilars was unfamiliar. Celltrion will continue to expand its new pipeline of approval for follow-up antibody treatments such as Herzuma, Truxima, Yuflyma, and Vegzelma."
