- LOGIN
- MemberShip
- 2026-04-09 21:05:43
- Company
- FDA accepts NDA for HLB’s rivoceranib
- by Lee, Seok-Jun Jul 18, 2023 05:29am
- HLB’s hepatocellular carcinoma treatment ‘rivoceranib’ has now entered FDA’s review. Yang-Gon Jin, Chairman of the HLB Group, announced on the morning of the 17th that “HLB’s US subsidiary Elevar received an ‘NDA Filing Acceptance’ letter from the FDA.” Elevar submitted a new drug application (NDA) for rivoceranib on May 16 after completing a global Phase III study evaluating the efficacy and safety of rivoceranib+camrelizumab therapy. The FDA assigned a target action date of May 16, 2024, under the Prescription Drug User Fee Act (PDUFA). Therefore, the decision will be made for the new drug within 10 months. With the FDA’s acceptance of the NDA, the company plans to accelerate preparations for commercialization, such as expanding drug sales licenses and establishing joint marketing execution strategies. Also, the company is preparing for the on-site scheduled on-site FDA CMC (Chemical Manufacturing and Controls) inspection together with Jiangsu Hengrui Medicine. HLB holds the global patent for the targeted anticancer therapy rivoceranib. HLB Life Sciences holds the sales rights for rivoceranib in Korea and partial profit rights for the drug in Europe and Japan. Jiangsu Hengrui Medicine owns the sales rights in China. Elevar Therapeutics, Inc. holds global rights in all other regions.
- Company
- Boehringer Ingelheim releases SGLT2+DPP4 combo Esgliteo
- by Jung, Sae-Im Jul 18, 2023 05:29am
- On the 17th, Boehringer Ingelheim announced it had launched its type 2 diabetes treatment ‘Esgliteo (empagliflozin+linagliptin)’ in Korea. Esgliteo is a fixed-dose combination of Boehringer Ingelheim’s original SGLT-2 inhibitor ‘Jardiance (empagliflozin)’ and DPP-4 inhibitor ‘Trajenta (linagliptin). The company developed a small-sized drug – 8.1mm in diameter - to improve the convenience in intake and medication adherence for patients that difficulty taking pills. Two options - 10mg/5mg, and 25mg/5mg – of Esgliteo are offered for patients who need further blood sugar control. Esgliteo is now the only fixed-dose dual combination drug of an SGLT2 inhibitor and DPP-4 inhibitor that was released in Korea with reimbursement. Esgliteo demonstrated a superior blood sugar-lowering effect as well as therapeutic benefit that exceeds the effect shown by each individual ingredient. The complementary mechanism of action allows the combination drug to provide an excellent blood sugar control effect. According to a Phase III clinical trial, Esgliteo showed an improved blood glucose reduction effect at 24 weeks compared to empagliflozin and linagliptin monotherapy in type 2 diabetic patients who experienced insufficient glycemic control on metformin. After the Ministry of Health and Welfare issued a notification on its reimbursement, Esgliteo was listed and granted reimbursement from May 1st. Type 2 diabetes patients whose HbA1c is 7% or higher after using a two-drug regimen for over 2-4 months can use Esgliteo with reimbursement if he or she wishes to use it as part of a three-drug regimen that includes metformin. Ina Hwang, Head of Marketing at Boehringer Ingelheim Korea, said, ” In line with the rising importance of combination therapy for Type 2 diabetes, We are pleased to be able to offer Esgliteo, which offers the treatment benefits of both active ingredients with improved convenience in intake for Type 2 diabetes patients in Korea.”
- Company
- SGLT-2i Envlo may be prescribed at general hospitals
- by Eo, Yun-Ho Jul 18, 2023 05:29am
- Daewoong Pharmaceutical’s SGLT-2 inhibitor, ‘Envlo’ can be prescribed at general hospitals in Korea. According to industry sources, the diabetes treatment Envlo (Enavogliflozin) that was released with reimbursement in May passed the drug committees (DCs) of various medical institutions in Korea including the Samsung Medical Center and Korea University Anam Hospital. Envlo, which was approved as the 36th new homegrown drug, is the first SGLT-2 inhibitor class diabetes drug that a Korean pharmaceutical company succeeded development and localization of. Priced at KRW 611, Envlo may be used as ▲monotherapy, ▲metformin combination therapy, and metformin and gemigliptin combination therapy in Korea. At a dose of 0.3mg, which is 1/30th the dose of other same-class treatments, Envlo demonstrated more than equivalent blood glucose-lowering effects and safety. Also, the drug was found to improve cardiovascular risk factors such as weight, blood pressure, and lipids. The company has applied for the DC review for Envlo at various major medical institutions around the nation and plans to further extend its prescription area in the future. Meanwhile, Daewoong Pharmaceutical received marketing approval for its envagliflozin+metformin combination, ‘Envlomet ST Tab.’ recently. In line with Korea’s trend that expands the use of SGLT-2 inhibitors, the company is preparing an Envlo-based combination drug lineup for diabetes as well.
- Company
- MSD Korea expands ERP to all departments
- by Jung, Sae-Im Jul 17, 2023 05:30am
- MSD Korea, which had notified the closure of the General Medicine division that sold the diabetes treatment Januvia, has extended the conditions for its early retirement program (ERP). With the company’s large-scale layoff raising conflicts with employees and the low rate of applications, the company seems to have changed its tactics to reshuffling. According to industry sources on the 15th, MSD Korea announced introduced a broader ERP program that allows a wider range of subjects to apply for early retirement with expanded conditions. The changed conditions allow employees from all departments, not only the General Medicine division but all divisions. The excess severance pay was also raised to a maximum of KRW 120 million. As excess severance pay, employees that served ▲ less than 5 years will receive KRW 70 million, ▲ 5 years or over will receive 100 million, and ▲ 15 years or over will receive KRW 120 million. In addition, 20 early applicants will additionally receive KRW 10 million. For example, if an employee who has worked for 15 years applies for ERP, he or she will receive an additional KRW 120 million as excess severance pay, equivalent to 40 months’ worth of monthly basic salary. If he or she is an early applicant, he or she will receive up to KRW 130 million. This is the highest amount offered in the industry. The previous conditions for ERP presented by MSD Korea were ▲an employee in the GM division, ▲basic severance pay of 2n+10 (service year*2+10 months of basic monthly pay), ▲ basic severance pay limit set as 48 months, and ▲excess severance pay of KRW 200 million. The conditions of being ▲an employee in the GM division and ▲excess severance pay of KRW 200 million conditions were extended significantly. The application deadline is July 20th. The resignation date of GM unit employees will be July 31st, and others August 31st. GM employees who applied for voluntary retirement through ERP last month will also benefit from the raised standards. In addition, they will be paid an additional 10 million won regardless of whether they applied early or not. On the reason the background of why the ERP was expanded, MSD Korea said, "After the decision was made to close our GM business, we have been seeking the best way to support our employees. Ahead of the organizational restructuring that will take place on August 1st, we carefully reviewed the opinions and suggestions of our various employees and decided to expand the ERP and severance package. We have been carrying out an external career support program while offering an improved ERP package for our internal business organizations and CO (Commercial Operations) units from July 10th to 20th,”
- Policy
- Multiple Rxs for newly reimbursed drugs
- by Lee, Tak-Sun Jul 17, 2023 05:30am
- Pfizer Korea’s atopic dermatitis drug New drugs such as Cibinqo Tab (Pfizer Korea), a treatment for atopic dermatitis, and Newmaco S, a treatment for high triglycerides, which were listed in July, were included in the list of cost-effective, high-dose oral drugs. If multiple prescriptions are made for low content, the cost of claiming benefits can be reduced by exceeding the upper limit for high-content products. Cibinqo Tab, a treatment for atopic dermatitis in adolescents and adults that inhibits JAK1, was listed as reimbursement through NHIS negotiations on July 1. As for the JAK1 inhibitor, it is the second drug to be covered after AbbVie's Rinvoq ER 15mg for the treatment of atopic dermatitis in adolescents aged 12 years and older. Three doses of 50mg, 100mg, and 200mg are listed for this drug, but you should pay attention to multiple prescriptions for 50mg and 100mg products. In the case of Cibinqo 50mg, the upper limit is 11,087 won, which exceeds the upper limit of 100mg (17,739 won) and 200mg (25,942 won) when prescribed twice or 4 times. If 100mg is prescribed twice, it exceeds the upper limit of 200mg and is subject to reduction. Yuyu Pharmaceutical's 500mg product 'Newmaco S 500mg', which was first introduced among omega-3 preparations, should also be careful of multiple prescriptions. This is because multiple prescriptions exceed the upper limit of the previously listed 1000mg product Newmaco S. The upper limit of Newmaco S Soft Cap 500mg is 198 won, and the upper limit of Newmaco Soft Cap is 297 won. These items are reviewed and adjusted by the difference in drug price that occurs when they are replaced with the upper limit price for high content. Along with this, Gabape Capsule 100mg of Hanpoong, Kuhnletal SR Cap 100mg (Cilostazol) of Kunil Biopharmaceuticals, Prelin 25mg of Myungmoon, and Tamsu SR of Youngpoong are also added to the target items for cost-effective oral medications, so multiple prescriptions should be taken into consideration.
- Company
- BsAb lymphoma treatment Lunsumio will soon land in KOR
- by Eo, Yun-Ho Jul 17, 2023 05:30am
- The new bispecific antibody treatment for lymphoma, ‘Lunsumio’, will soon land in Korea. According to industry sources, the Ministry of Food and Drug Safety is in its last stages of review for the product approval of Roche Korea's follicular lymphoma drug Lunsumio (mosunetuzumab), which was designated as the first drug subject to Korea’s Global Innovative products on Fast Track (GIFT) system. Lunsumio was approved by the US Food and Drug Administration in December last year for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. The drug is a CD20xCD3 T-cell engaging bispecific antibody that binds to two different targets on cells - the immune T-cells that attack tumor cells and malignant B cells - to connect the immune cells with cancer cells. In Korea, the drug was designated as an orphan drug last year and was also designated an orphan drug by the US FDA and the EU EMA. Lunsumio demonstrated its potential through positive results from the Phase II GO29781 study of Lunsumio in people with follicular lymphoma. Study results showed that Lunsumio’s ORR was 80%(72/90), and the majority (57%) of patients maintained responses for at least 18 months. A complete response of 60% (54/90) was also observed in these patients with a median duration of response (DOR) was 22.8 months. Meanwhile, the GIFT program provides support from the initial development stage of innovative new drugs to allow faster commercialization of new drugs. The program may allow drugs to reduce the approval review period by up to 75%. Drugs subject to GIFT can receive various support that accelerates commercialization, including ▲support for regulatory approval, ▲rolling review, ▲close communication between the reviewer and developer through product presentation and supplementary briefing sessions, and ▲expert consulting by regulation experts.
- Company
- Danicopan has been designated for GIFT
- by Eo, Yun-Ho Jul 17, 2023 05:30am
- Danicopan, a combination partner of Soliris, was designated as a GIFT at the same time as this orphan drug designation. The Ministry of Food and Drug Safety recently announced that AstraZeneca's Danicopan (ALXN2040) will be designated as an orphan drug and GIFT in Korea. Danicopan, a candidate for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), has been designated as an orphan drug for PNH treatment in the United States and Europe and has been selected as a breakthrough therapy by the US FDA and as a PRIME target by the European EMA. Danicopan demonstrated efficacy as a potential complementary treatment in patients with PNH who experienced clinically significant extravascular hemolysis in the phase 3 ALPHA study. This is the first case in which factor D inhibitors have confirmed positive effects in phase 3 clinical trials. A prespecified interim analysis compared hemoglobin levels with a placebo after 12 weeks of treatment, resulting in a statistically significant improvement. According to the study, Danicopan and Ultomiris combination therapy showed statistically and clinically significant improvement in treatment parameters. These indicators include improvements in hemoglobin levels, blood transfusions, and fatigue scores, and a functional evaluation of chronic disease treatment, from the start of treatment. Danicopan is conducting research on combination therapy for C5 inhibitors, such as Soliris and Ultomiris. Lee Jong-Wook, a professor of hematology at Seoul St. Mary's Hospital who participated in the ALPHA study, explained, "The therapeutic effect of C5 inhibitors on PNH has been proven. However, although the number is small, patients still suffer from the burden of blood transfusion due to anemia and extravascular hemolysis." Meanwhile, GIFT is a program that supports innovative drugs from the beginning of clinical development so that they can be commercialized quickly, and can shorten the approval review period by up to 75%. GIFT recipients will receive support for rapid commercialization, such as support for the preparation of approval materials, application of a rolling review that reviews prepared materials first, close communication between reviewers and developers such as item briefings and supplementary briefings, and professional consulting related to regulations.
- Policy
- Will Koselugo’s reimb listing pick up speed in Korea?
- by Lee, Tak-Sun Jul 17, 2023 05:30am
- AstraZeneca is bracing up its battle to receive reimbursement approval for its Koselugo (selumetinib, AZ) within the year. The company’s new neurofibromatosis drug was unable to pass review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee last year. AstraZeneca submitted its 3rd supplementary material and RSA proposal recently. Whether the agenda will be reviewed at HIRA’s DREC meeting and determined adequate for reimbursement is receiving attention. According to industry sources on the 16th, AZ withdrew its previous drug listing and reimbursement price application for Koselugo in January and submitted a new application in February. Koselugo received a non-reimbursement decision from DREC last March. It was the only drug that received a non-reimbursement decision among all drugs that were reviewed by DREC last year. Unwaivered, the company continued its attempt to pass HIRA’s gates. Due to a lack of treatment options for neurofibromatosis, the demand for treatment in the area from the HCPs and patients has been high. Neurofibromatosis is a rare disease that presents abnormalities of the skin, nervous system, bones, and soft tissues. Around 4,900 patients are known to be ailing from the disease in Korea. The only available treatment option for neurofibromatosis until now had been surgical removal. However, as complete excision of these tumors is difficult, the possibility of relapse always remains even after surgery. The Phase II SPRINT study that became the basis for Koselugo’s approval showed that Koselugo reduced tumor size by over 20% in 68% of the patients that received the drug, and achieved its primary endpoint of ORR. Also, 82% of the patients that showed a partial response had sustained responses lasting at least 12 months. The issue is Koselugo’s price. It is an expensive drug that costs 200 million won a year. Therefore, industry prospects were that its reimbursement listing would only be possible if the company submits a solid RSA plan in addition to its proof of effect. Determined to receive reimbursement, the company had continuously submitted supplementary data even after the non-reimbursement decision last year and is continuing on its attempt this year by submitting a new reimbursement application. In April, the company changed its application drug price and applied for expedited listing. Since then, the company has submitted supplementary data three times and has persistently knocked on the DREC’s door. More recently, the company had also prepared a risk-sharing agreement plan as a reimbursement failsafe for the government. Starting this year, the insurance authorities have been applying the expedited listing process to treatments for diseases that threaten the quality of life of children. In this aspect, there is a higher chance that Koselugo will get listed faster if the pharmaceutical company submits a solid plan on how it would share the burden of high prices. Therefore, attention is focusing on whether Koselugo can overcome last year’s non-reimbursement decision and expedite its listing this year.
- Policy
- Gov’t starts researching generic drug pricing policy in 2H
- by Lee, Jeong-Hwan Jul 14, 2023 05:39am
- The Ministry of Health and Welfare has started research to improve the generic drug price system in the second half of this year. The industry expects that the authorities will likely prepare and implement a system to reduce the price of generic drugs as soon as the research is complete. The research will mainly investigate the need to change the ’20 listed drugs’ standard used to differentiate the drug price of same-ingredient drugs and the 53.55% generic drug price discount rate that is applied after the expiry of the original drug’s patent. Recently, the Ministry of Health and Welfare signed a private contract with Professor Dong-sook Kim’s research team at Kongju National University for the project, ‘Preparing measures to improve the drug price system for generic drugs'. KRW 50 million won was invested into the research service. The MOHW presented creating a healthy competitive market for generic drugs as its research purpose and claimed that too many generics are still being introduced to the market despite the implementation of a stepped drug pricing system that discounts the price of drugs depending on whether or not the standard requirements are met. The main purpose of the study is to compare the drug pricing system and price level of Korea’s generic drugs with those of 8 overseas countries (Japan, France, Germany, Italy, Switzerland, the United Kingdom, the United States, and Canada) and to establish a rational generic drug management plan. More specifically, the research will compare the number of pharmaceutical companies and the total number of generic drug items listed in Korea and abroad. Also, Korea’s generic drug price level will be compared with those abroad, and the team will investigate the current status of the generic drug contol systems abroad and analyzed premium pricing systems implemented overseas for generic drugs. To devise measures used to manage generic drugs, the team will also analyze the current generic drug pricing system in Korea. Also, the team will investigate whether the ’20 product’ limit applied to differentiate the drug price discount rate from 53.55% to 38.69% is adequate, and whether it is appropriate to maintain the 53.55% standard for calculating the price of generics compared to the price before the original’s patent expires, and whether it is necessary to differentiate the price between patent expired original drugs and generic drugs. An analysis of the average percentage of claims filed for each generic drug according to their order of listing and the appropriate number of generics per ingredient will also follow. Also, the team will seek ways to improve the drug price premium system by studying cases where multiple generics were simultaneously listed after the patent expiry of a blockbuster new drug. In other words, the authorities are determined to prevent the recurrence of cases in which more than 100 generics are listed in the health insurance, as in the case of the SGLT-2 inhibitor diabetes drug Forxiga (dapagliflozin) generics. The Ministry of Health and Welfare plans to come up with a plan to improve the current drug pricing system based on the appropriate number of generic drugs and level of drug price compared to the original analyzed by the research team. In addition, the research will also look over the systemic improvements that should follow the new drug pricing policy in terms of drug demand and prescriptions. After a literature review to search for prior studies conducted in the area, the research team will collect the opinions from experts and the pharmaceutical industry, and then investigate the current status of the pharmaceutical industry and drug price levels in other countries through data such as IQVIA. The research schedule is, after signing the agreement within this month (July), the team will provide an investigator’s interim report in October, based on which the Ministry of Health and Welfare, Health Insurance Review and Assessment Service, and National Health Insurance Service will conduct advisory meetings and finalize the report by December. The MOHW said, "This study will improve the soundness of Korea’s pharmaceutical industry by maintaining price competition at an appropriate level between pharmaceutical companies and preventing the proliferation of generic drugs. The study is also expected to strengthen the sustainability of health insurance finances by allowing efficient expenditure of medicines. This will help Korea establish a generic drug pricing system that induces research and development for new drugs." “We also expected the measure to strengthen the sustainability of health insurance finances by allowing efficient drug expenditures.”
- Policy
- Enhertu passed the cancer dz review board after a retrial
- by Lee, Tak-Sun Jul 14, 2023 05:39am
- After a retrial in the first half of last year, the anticancer drug Enhertu, which passed the Cancer Disease Review Committee, met another hurdle: passing the Pharmaceutical Reimbursement Evaluation Committee. Enhertu, which succeeded in setting reimbursement standards at the end of the review committee's reexamination in May, was not presented to the Pharmaceutical Reimbursement Evaluation Committee, which was held three times afterward. According to the industry on the 11th, Enhertu's Daiichi Sankyo submitted data to HIRA a day late, which requested PE supplementary data earlier this month. Currently, Enhertu is in PE, and it is expected to be submitted to the committee by taking steps such as the RSA sub-committee. The PE data was submitted on the 5th and is currently awaiting deliberation. Accordingly, it is expected that Enhertu's submission to the Pharmaceutical Reimbursement Evaluation Committee will be decided according to the deliberation results. Currently, it is difficult to estimate when the drug benefit evaluation committee will be presented. Enhertu, which applied for reimbursement in November last year, began reviewing patients' prompt reimbursement. In February, through a national consent petition, 50,000 people agreed to the demand for the benefit, and it was referred to the National Assembly. It is indicated for the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2-based therapies. It is also indicated for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received two or more therapies, including anti-HER2 therapy. The petitioner for Enhertu reimbursement strongly requested health insurance approval, saying that Enhertu is called the last hope for breast cancer patients and that it is difficult to use because it is an expensive drug that costs about 5 million won per injection. The HIRA reviewed the reimbursement standards for Enhertu for the first time in March. However, in the case of gastric cancer indications, the cancer disease review committee decided to re-deliberate without reaching a conclusion due to the weak evidence and the high price of the applied drug. Still, it was not that the salary standard setting failed, but that it was re-examined, so I was able to continue my hopes. Afterward, Daiichi Sankyo submitted supplementary data and managed to set the salary standard at the cancer screening meeting held in May. In order for the reimbursement to be applied, there are still procedures, such as passing through the Drug Evaluation Committee and then negotiating with NHIS. In many cases, it took a long time to pass the drug evaluation committee after the reimbursement standard was established. In the case of Keytruda, an immuno-oncology drug, it was presented to the Drug Evaluation Committee within six months. Accordingly, there is an opinion that the reimbursement review process for anti-cancer drugs, which must pass through two consecutive committees, should be improved to expedite reimbursement. However, the HIRA draws a line against this argument, saying that the cancer disease review committee, which sets reimbursement standards, and the drug evaluation committee, which determines the adequacy of reimbursement, have distinctly different functions. However, given that Enhertu's petition for expedited reimbursement is a drug that has been referred to the National Assembly, there is a prospect that it will not take long for Enhertu to be presented to the Drug Evaluation Committee. The rare re-discussion by the Cancer Disease Review Committee is an interpretation that the insurance authorities are also conscious of the speed of reimbursement. Daiichi Sankyo also said, "We are actively discussing with the government authorities for the prompt reimbursement of Enhertu, putting the patient's wishes first." Attention is focusing on whether Enhertu, which is facing the drug evaluation committee, will quickly go through the reimbursement process as patients wish.
