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- 2026-05-14 05:31:34
- Company
- Impinzi's indication of biliary tract cancer
- by Nov 16, 2022 06:10am
- AstraZeneca Korea announced on the 14th that its immune anticancer drug "Imfinzi" has received additional approval from the Ministry of Food and Drug Safety for biliary tract cancer. Imfinzi can be used as a combination therapy with Gemcitabine and Cisplatin in the primary treatment of patients with locally advanced or metastatic biliary tract cancer. It is the first indication of the first treatment of biliary tract cancer. The approval of this additional indication was based on a phase 3 TOPAZ-1 study that evaluated the effectiveness of lymphoid combination therapy compared to existing chemotherapy (Gemcitabine and Cisplatin) in 685 patients with local progressive or metastatic biliary tract cancer who have no treatment experience and cannot be resected through surgery. The first evaluation variable is the overall survival rate (OS), and the second evaluation variable is the progression-free survival rate (PFS), the objective response rate (ORR), the response duration (DoR), and the patient report results. As a result of the study, Imfinzi group improved the overall survival rate by 20% compared to the placebo group. At the time of two years, the survival rate of the impingement group was 24.9%, and the placebo group was 10.4%. The median PFS value was 7.2 months for Impinzi, which was 25% better than 5.7 months for the placebo group. The ORR of Imfinzi group was 26.7% (91 cases), of which 2.1% (7 cases) was confirmed to be complete, and partial reactions were observed in 24.6% (84 cases). The most common abnormalities were anemia (48.2%), zone (40.22%), constipation (32%), and neutrophil reduction (31.7%), and the Impinzi group (75.7%) and the placebo group (77.8%) were similar. In a recently confirmed additional analysis, Imfinzi group confirmed the overall survival rate, which improved to 24% compared to the placebo group. The total survival rate at the time of two years was also consistently 23.6% and 11.5% in the impingement group and the placebo group, respectively. Based on these findings, the NCCN recommends Imfinzi as the standard treatment (Category 1) in the primary treatment for local progressive or metastatic biliary tract cancer. "Biliary cancer is cancer with a poor prognosis, with no clear symptoms and a recurrence rate of 60-70%, and Korea has a relatively high incidence of biliary tract cancer in the world," said Oh Do-yeon, a general researcher at TOPAZ-1 at Seoul National University Hospital.
- Opinion
- [Reporter's view] APAP price increase should be quick
- by Lee, Tak-Sun Nov 16, 2022 06:10am
- The government is rushing to raise the upper limit of Acetaminophen which supply and demand are unstable due to COVID-19. The government's plan is to end the review and negotiations as early as this month to reflect the increase plan next month. As the supply and demand of cold medicine continue throughout the year and a large-scale COVID-19 epidemic is expected at the end of the year, we should hurry to raise the price of medicine to expand supply. If the existing procedure is followed, the weak price increase will not be realized until February next year at the earliest, but it is likely to be too late then. It is worrisome that a hasty agreement will be reached in accordance with the unreasonable rapid processing policy. The upper limit of Acetaminophen 650mg is listed at 43 won to 51 won. Some say that it should be more than 100 won, twice as much as this price. First of all, it is necessary to analyze the cost data of individual pharmaceutical companies and come up with a suitable increase plan. We can't just keep up with the position of pharmaceutical companies. Safety measures are also needed so that an increase in weak prices can lead to supply expansion. Therefore, as the price has risen, it is necessary to expand the supply in proportion to it. If the government emphasizes only expedited processing, the government will not be able to avoid criticism that it only raised prices without practical benefits. It is bound to be a burden for the HIRA and the NHIS, which hold the key to analysis and negotiation. As the increase in the weak price is for the people exposed to COVID-19, a wide agreement is urgently needed. If it is difficult to reach an agreement with only mutual interests, it seems that there is no need to stick to swift action. This is because, although this issue is special, equity for other drugs must also be considered.
- Policy
- Negotiations on Strepto, concluded in the early 20% range
- by Lee, Tak-Sun Nov 15, 2022 05:39am
- Major pharmaceutical companies of the anti-inflammatory enzyme Streptokinase and Streptodornase have reportedly reached an agreement with the NHIS in redemption negotiations. The recovery rate, which has been an issue, is said to be in the early 20% range. It is interpreted as the result of the two sides' concessions to each other. According to the industry, major pharmaceutical companies such as the NHIS, Hanmi Pharmaceutical, and SK Chemicals, which held negotiations for the return with a deadline of the 14th, succeeded in reaching an agreement on the last day. Hanmi Pharmaceutical and SK Chemicals are ranked first and second in sales in related markets and are currently leading clinical re-evaluations. The recovery rate agreed by the two sides is said to be in the early 20% range, which is higher than that of the Choline alfoscerate sanctions that previously negotiated the recovery. Until now, pharmaceutical companies have stuck to less than 20% and the NHIS has stuck to more than 20%. The shorter recovery period than the Choline alfoscerate formulation seems to have affected it. As negotiations with major pharmaceutical companies have been concluded, the results of the negotiations are expected to be reported to the Committee this month without renegotiation. There are many opinions within the government that there is an extension of the negotiations on the premise of a settlement this month, but there is no renegotiation. The HIRA conducted sanctions evaluations on Streptokinase and Streptodornase and concluded that the evaluation would be suspended for one year only for items agreed to be recovered negotiations based on the results of clinical re-evaluation. In order to avoid the deletion of benefits, pharmaceutical companies had to agree on redemption negotiations with the NHIS. It is interpreted that the negotiations have been concluded without taking time, given that the final clinical re-evaluation results will be released next year. The analysis also reflected that class action lawsuits, such as choline alfoscerate pharmaceutical companies, will not have much profit. This is because the annual prescription is only 20 billion won, and when the clinical re-evaluation result report is released next year, the salary status will be sorted out. Major pharmaceutical companies have reached an agreement this time, but some consignment production pharmaceutical companies are said to have decided to accept the deletion of benefits without any intention of negotiation. A total of 37 pharmaceutical companies are subject to negotiation, and it is not known exactly how many companies agreed.
- Opinion
- [Reporter’s View] Advanced new drugs, reimb, and patients
- by Eo, Yun-Ho Nov 15, 2022 05:39am
- Some drugs can be prescribed regardless of mutation or receptor status at certain stages of a disease. Other drugs can be prescribed regardless of disease if a certain gene mutation is identified in the patient. As such, the field of pharmaceuticals is evolving at a rapid pace. New drugs that are no longer attached to a specific disease are emerging, introduced as all-comers or disease-agnostic drugs. And the emergence of these drugs is heralding a paradigm shift. However, the new drugs are not easily granted reimbursement in Korea. Due to the broad application of the drugs, the government has to consider how their increased use volume may raise financial concern. For all-comer drugs, further concerns remain. Some raise doubts about their efficacy, on how they can be effective regardless of the gene targeted by their mechanism of action. However, although the efficacy may vary, these drugs have proven their effect as all-comer drugs and obtained approval from the Ministry of Food and Drug Safety. The case is not so different for disease-agnostic drugs that target gene mutations either. And the development of precision medicine is heralding the shift in the prescriptions from ‘disease’ to ‘gene,’ announcing the arrival of the era of personalized medicine. Existing targeted therapies, immunotherapies, as well as tumor-agnostic therapies that were listed this year have also suffered much in the course of expanding their scope of reimbursement. Not only because the drugs are expensive but because each drug needs to reconduct value assessments and estimate their increase in usage volume. This is the main framework that supports Korea's health insurance system. While prudence in financial spending is important, the government also needs to consider the demand of the patients and make some compromises. Times have changed. Patients and their families no longer solely depend on their doctors to make decisions. They search papers for new drugs in clinical trial databases like clinicaltrial.gov. Therefore the question remains, how should Korea embrace these advanced new drugs in the future?
- Company
- Tecentriq approved as adjuvant treatment for NSCLC
- by Nov 15, 2022 05:38am
- On the 14th, Roche Korea announced that its anti-PD-L1 immuno-oncology drug Tecentriq (atezolizumab) was approved as adjuvant therapy following resection in patients with early-stage non-small-cell-lung cancer, and became the first immunotherapy to receive approval for the indication. Tecentriq may now be used as an adjuvant treatment following complete resection and platinum-based chemotherapy in adult patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher on tumor cells (TC). With this approval, Tecentriq became the first cancer immunotherapy to be approved as adjuvant therapy in early-stage NSCLC in Korea. The indication extension was approved based on findings from an interim analysis of Phase 3 IMpower010 trial. Tecentriq was found to result in a 57% reduction in the risk of disease recurrence or death compared with best supportive care (BSC) in patients with stage II to IIIA NSCLC with PD-L1 expression of 50% or higher Also, the disease-free survival (DFS) benefit derived with adjuvant Tecentriq over BSC was consistently observed across most of the subgroups analyzed on the trial, including histology and disease stage. The overall survival (OS) data remain immature for this population, but a trend toward improved survival with atezolizumab over BSC was observed with a stratified HR of 0.43. The median OS and subgroup analysis results at 46 months showed that Tecentriq reduced the risk of disease recurrence or death 57% compared with best supportive care (BSC) in subject patients. The safety profile of Tecentriq was consistent with what has previously been observed with the Tecentriq monotherapy, and no new safety signals were observed. Grade 3-4 adverse effects (AEs) that were most frequently reported in the Tecentriq arm were increased ALT (2%), pneumonia (1%), and increased AST. Based on the data, the U.S. National Comprehensive Cancer Network (NCCN) guideline recommends Tecentriq as adjuvant therapy (Category 2), and the American Society of Clinical Oncology (ASCO) also recommends Tecentriq as adjuvant therapy in its guideline for adjuvant therapy in early-stage lung cancer patients. Sang-We Kim, Professor of Oncology at Asan Medical Center, said, “Around half of NSCLC patients experience recurrence after surgery, some of which at an untreatable state. With immuno-oncology drugs that had been mainly prescribed in metastatic NSCLC now available for use in the early stages of the disease, NSCLC patients in Korea that have a high rate of PD-L1 expression can have the opportunity to reduce their chance of recurrence after surgery and chemotherapy.”
- Company
- CR of AML new drug candidates is identified in Phase 1/2
- by Kim, Jin-Gu Nov 15, 2022 05:38am
- Hanmi Pharmaceutical announced on the 14th that it has confirmed cases of complete response (CR) in various dose groups as a result of phase 1/2 clinical trials of Tuspetinib (HM43239), which is being developed as an AML treatment. Aptose was recently introduced at the KOL webinar, "As a result of the global phase 1/2 for patients with recurrent or refractory acute myeloid leukemia, we confirmed CR cases in all of the various doses (80 mg, 120 mg, 160 mg) of HM43239." Aptose will present details of the study at the 64th ASH in New Orleans, the U.S., from the 10th to the 13th of next month. HM43239 is an oral MKI administered once a day that targets major kinases acting in myelogenous malignant tumors. It was designated as a fast-track development drug by the FDA in May. In 2018, it was also designated as a rare drug. According to the successful results of this clinical trial, Aptose plans to expand clinical trials with single-administration therapy and combination-administration therapy in the future. In the extended clinical trial of single administration therapy, the efficacy of HM43239 120mg will be confirmed in the AML patient group, including patients with FLT3 mutations who do not respond to existing FLT3 inhibitors. In addition, it plans to conduct a combined clinical trial with HM4323980mg and Venetoclax, an existing AML treatment.
- Company
- Merck KGaA has appointed Christoph Hamann
- by Nov 15, 2022 05:38am
- Christoph Hamann, General ManagerMerck Biopharma Korea announced on the 10th that it has appointed Christoph Hamann as the new general representative of its business unit. Harman served as general manager of Merck Biopharma in Malaysia, Singapore, and Brunei, and as Managing Director in Malaysia. Since joining Merck in 2009, he has built various careers through strategic and commercial work in major markets such as Germany, Switzerland, and the United States. In particular, he showed excellent performance as an infertile franchise leader in Europe and vice president of global business development, playing an important role in business development and management at the global and national levels. Including this inauguration in Korea, it will have business experience in a total of seven countries. General Manager Harman majored in economics at the University of Virginia in the United States, and before joining Merck, he spent nine years in investment banking and consulting. "We expect that Korea Merck Biopharma's leadership in the special care sector will be further strengthened by Christian Hamann, a general manager with about 22 years of experience and expertise in various industries, including pharmaceuticals," said the Merck Biopharma division said.
- Policy
- The vaccine fund will be increased by ₩40 billion
- by Lee, Jeong-Hwan Nov 14, 2022 06:07am
- Expectations in the pharmaceutical industry are soaring as the National Assembly's Health and Welfare Committee decided to increase next year's budget for the "K-Global Vaccine Fund" to 50 billion won, up 40 billion won from the government's plan. As the Ministry of Health and Welfare is constantly sending signals to the pharmaceutical community to focus on developing domestic vaccines and new drugs based on Korean bio funds, attention is being paid to whether the budget approved by the Welfare Committee will pass the plenary session. Looking at the Ministry of Health and Welfare's budget plan for next year, which was recently approved by the Welfare Committee, the budget for supporting the development of the pharmaceutical industry increased sharply from 44.07 billion won to 11.128 billion won. Among them, the largest increase in budget is the "K-Global Vaccine Fund" project. The government had set aside 10 billion won, a reduction of 40 billion won from this year's budget, as a global vaccine fund budget. During the screening process, the 10 billion won budget was too small, which could dampen private investment, followed by demands from welfare committee members for an increase. The move is aimed at providing aggressive R&D investment support for pipelines that are likely to succeed among vaccine and new drug candidates preparing for domestic and foreign clinical trials for the purpose of final marketing approval and market launch. The Welfare Committee adopted a 50 billion won bill among the plans to increase the fund budget by 20 billion won from 10 billion won to 30 billion won and increase it by 40 billion won to 50 billion won. The remaining gateway is the Special Committee on Budget and Accounts. If the plenary session is passed without reduction adjustment in the special committee on the budget and settlement, the vaccine fund budget, which is increased by 40 billion won compared to the government's plan, is expected to be operated from next year. The domestic pharmaceutical industry is voicing its voice that the National Assembly and budget authorities should agree to a review without reduction in order to increase the possibility of developing native vaccines and new drugs. The Ministry of Strategy and Finance urged the government to avoid tightening its fiscal stance in the vaccine fund sector to achieve the goal of fostering the domestic pharmaceutical bio industry. An official from A Pharmaceutical Company in Korea said, "Unlike expected, the Welfare Committee voted to increase the amount by 40 billion won. "It is encouraging that they seem to agree on the need to foster the pharmaceutical bio-industry and develop blockbuster domestic vaccines and new drugs," he said. "The resolution to increase the amount is the same as this year's budget, and support for vaccines and new drugs, which may be possible only when the budget is passed as it is, will be able to become a reality," he expected. An official from A said, "I understand that the Ministry of Health and Welfare and the welfare committee members are greatly aware of the importance of the vaccine fund budget. He said, "I think I felt the need for a native vaccine starting from COVID-19," adding, "The Ministry of Economy and Finance, which is a financial authority, should sympathize with this urgency and work hard to pass the budget without reduction." An official from company B in Korea also said, "The increase has been decided, but this game is from now on when the Special Committee on Budget and Accounts begins." He said there are concerns that the reduction will be inevitable as the government is tightening its fiscal stance. "However, the government's vision to grow the pharmaceutical bio-industry as a new engine is a goal it has put forward every year." "It is time to realize our will in this budget review," he said. "The vaccine fund business is in the form of receiving private investment compared to government investment. If government investment increases, private investment will be able to be activated in proportion, he said. "The National Assembly and the Ministry of Economy and Finance should recognize that pharmaceutical companies equipped with clinical trials at home and abroad are waiting for R&D support."
- Company
- Adding AUS as a drug price reference country raise concerns
- by Nho, Byung Chul Nov 14, 2022 06:07am
- The health authorities are known to be considering including Canada and Australia as reference countries for drug pricing reevaluations. Currently, the Ministry of Health and Welfare, Health Insurance Review and Assessment Service, and the National Health Insurance Service refer to drug prices of G7 countries - US, UK, Germany, Switzerland, Italy, France, and Japan – for evaluations and assessments. Adding the two countries, which are considered to be those with the lowest drug price, is expected to raise some issues. From what has been known so far, the government is planning to include Canada and Australia as reference countries and use the drug prices of the counties as standard, but if their use extends to the pricing of new drugs introduced from abroad and new drugs developed in Korea, this may deprive patients of their right to treatment and drive local pharmaceutical companies into a crisis. In Korea, the price of generic drugs is set at 53.55% of the original version. This is slightly higher than that in other countries, ranking 4th among OECD member countries. However, this relatively higher price is only applied to some original and generic drugs and is interpreted to be a strange phenomenon arising from Korea’s odd brand name-based prescription structure rather than ingredient name. According to a booklet issued by Canada’s new drug pricing review committee that was disclosed at the recent NA Audit, the reimbursement listed price of drugs such as Plavitor, Viread, and Simvastatin is 3 to 14 times higher in Korea compared to those in the US. However, rashly concluding that the generic drug price in Korea is higher than those of reference countries without considering how the higher insurance price set for new drugs from multinational pharmaceutical companies during initial listing affected the generic price, may likely cause distortion of the drug price system. As such, applying such an invasive drug price reduction policy of adding Canada and Australia as reference countries following the unilateral drug price reduction that was applied in 2012 and the satisfaction of ‘self-bioequivalence and DMF registration’ requirement, may severely harm and distort the development of the pharmaceutical and bio industry that is regarded as the new growth engine of the future. According to one research institute, some of the generics sold in Australia are sold at a price 1/5th of that in Korea, therefore, the possibility that adding Australia as a reference country may cause a collapse in Korea’s drug pricing system cannot be ruled out. More importantly, Canada and Australia, the countries that the health authorities are considering adding as drug price reference countries are not even new drug developers. Based on US FDA data, 66 new drugs were developed in the US, 25 in Europe, 6 in Japan, and 2 in China over the past 5 years. Just like Korea, Canada and Australia have been unable to overcome the FDA’s high barrier and receive new drug approvals in the US. An industry official emphasized, “As we have learned overcoming the swine flu and COVID-19, establishing and fostering pharmaceutical and bio sovereignty is essential and must be pursued in the long-term. Therefore, applying the short-sighted measure of reducing generic drug price just to save KRW 1.5 trillion in the short term is not the answer.” Currently, the external size of Korea’s pharmaceutical and bio industry is about KRW 27 trillion, and the proportion of original and generic drugs is about 6:4. However, in the case of original prescription drugs, it is not an exaggeration to say that multinational pharmaceutical companies dominate the market as it accounts for over 90% of the original drugs marketed in Korea. Another industry official said, “With the absence of a preferential pricing policy for domestic new drugs, cutting generic drug prices can only be interpreted as a short-sighted policy on the government's part that will only hand over Korea’s pharmaceutical and bio sovereignty to foreign companies." Meanwhile, health authorities and the pharmaceutical industry have not reached a conclusion and is still discussing adding Canada and Australia to the reference countries, but have made a consensus in calculating the average monthly exchange rate using the average exchange rate of 1 to 36 month prior to the pricing negotiations.
- Company
- Heart failure drug Entresto makes KRW 10 bil in Q3
- by Kim, Jin-Gu Nov 14, 2022 06:07am
- Pic of Entresto Novartis’ chronic heart failure treatment ‘Entresto’ is growing rapidly. Its quarterly sales first exceeded KRW 10 billion in 5 years since its release in Q3 this year. The analysis is that its rapid growth was due to its de facto domination of the market. However, with the nearing entry of ▲SGLT-2 class diabetes treatments, ▲new chronic heart failure treatments, ▲Entresto generics, various prospects are being raised on whether Entresto will be able to maintain its growth rate. ◆Quarterly prescriptions of Entresto exceed KRW 10 billion…2.6 time growth in 3 years According to the market research institution UBIST on the 12th, Entresto’s Q3 prescriptions amounted to KRW 10.5 billion. This is a 21% increase from KRW 8.6 billion in Q3 last year and a 2.6-time increase from the same period 3 years ago in Q3 2019. Entresto is a drug used to reduce the risk of death and hospitalization in patients with left ventricular (LV) dysfunction. As a combination of neprilysin inhibitor sacubitril and an angiotensin receptor blocker (ARB) valsartan, it has a double mechanism of action. where sacubitril works on the neurohormonal system and reinforces the heart protection effect and valsartan blocks the angiotensin II receptor. Novartis received approval for the drug in Q2 2016 and released the drug with reimbursement in Q4 2017. Until now, no suitable treatment existed for chronic heart failure before Entresto. ACE or ARB inhibitors were mainly prescribed with not much effect. Quarterly prescriptions of Entresto (Unit: KRW 100 million, Data: UBIST) Entresto’s sales rose rapidly based on its sole lead in the field of chronic heart failure. After recording KRW 6.3 billion in its first year of release in 2018, its sales surged to KRW 15 billion in 2019, KRW 23.5 billion in 2020, then to KRW 32.3 billion in 2021. Its cumulative sales recorded KRW 29.2 billion in Q3 this year. At this pace, its sales are expected to reach nearly KRW 40 billion by the end of the year. ◆SGLT-2 inhibitors, new treatments, and generics knock to enter the heart failure treatment market However, varying prospects are being made on how long this growth will last. The biggest variable is that the SGLT-2 class antidiabetics were approved for the heart failure indication. The Korean Society of Heart Failure (KSHF) published a newly revised Heart Failure Clinical Practice Guidelines and recommended SGLT-2 inhibitors as a main treatment regardless of the patient’s diabetic status in all areas of chronic heart failure. The SGLT-2 inhibitors specified in the guidelines are limited to 'Jardiance (empagliflozin)' and ‘Forxiga (dapagliflozin).’ If reimbursement is also extended to chronic heart failure after the amendment of the guidelines, the market is expected to grow further. Pic of Forxiga(left), Jardiance (right) SGLT-2 inhibitors have a larger scope of indication than Entresto. Entresto can be used in patients with heart failure with reduced ejection fraction, heart failure with mildly reduced EF, and heart failure with preserved ejection fraction. On the other hand, Entresto cannot be used for HFpEF. Therefore, if Jardiance and Forxiga are reimbursed, they will compete with Entresto in the heart failure market. On the other hand, there is also a prospect on the possibility of combined prescription using SGLT-2 inhibitors and Enhertu based on study results that showed improved prognosis with combined use. In that case, sales of Entresto and Jardiance/Forxiga will all rise in synergy. Pic of VerquvoAnother variable is the introduction of new chronic heart failure treatments with a new mechanism of action. Currently, Bayer has announced the release of ‘Verquvo (vericiguat).’ Bayer received approval for Verquvo in Korea in December last year and submitted an application for reimbursement in August this year. Verquvo is a drug with a new mechanism of action. Entresto blocks the harmful effects from the natural neurohormonal system activated by myocardial and vascular dysfunction. Verquvo improves myocardial and vascular function by stimulating the synthesis of intracellular cyclic guanosine monophosphate (cGMP) that regulates vascular tone, cardiac contractility, and cardiac remodeling. Also, the possible entry of Entresto’s generics can also act as a big variable in Entresto’s sales growth. 13 Korean pharmaceutical companies have won the first trial against Novartis on Entresto’s patent and were qualified to release Entresto generics. If the companies succeed in releasing Entresto generics, their price will automatically be discounted by 30%. One year after its release, the price will be further reduced to 53.55% from the existing price.
