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- 2026-04-11 01:23:52
- Company
- Bayer and Boryung are competing in the aspirin market
- by Nho, Byung Chul Jan 04, 2023 05:32am
- In the market for aspirin-based cardiovascular treatments, Bayer Aspirin Protect 100 mg was found to be the undisputed No. 1. According to medical distribution performance data, Aspirin Protect recorded 18.8 billion won last year and is leading the market while maintaining the appearance of banding worth 20 billion won. Aspirin Protect's sales in 2018, 2019, and 2020 are 22.5 billion, 19.1 billion, and 17.1 billion won and cumulative sales by 3Q in 2022 are 15 billion won, which is likely to surpass 20 billion won this year. The second place was Boryung Biopharma's Astrix, which recorded 12.8 billion won in performance last year. During the same period, Astrix's appearance is 15.4 billion won, 14.6 billion won, and 13.4 billion won, and the cumulative total until 3Q is 9.2 billion won, which is expected to generate similar sales to the previous year. The market share of the two products was 45,31%, which dominated 76% of the market. The third and fourth places are Hanmi Pharmaceutical and Yuhan Corporation aspirin, which recorded sales of 3.3 billion won and 1.7 billion won last year. The market share of Hanmi and Yuhan is formed at about 8/4%. Products ranked 5th to 10th show performance of around 100 million to 300 million, and the fact that they are virtually meaningless competition is another characteristic of the aspirin cardiovascular treatment market. The drug prices of Aspirin Protect and Astrix, which were approved by the Ministry of Food and Drug Safety in 2001 and 2009, are 77 won each, the highest registered price among the same-component drugs, and the insurance price of Aspirin of Hanmi and Yuhan is 61 won per person. Aspirin, a representative antiplatelet drug, prevents coronary artery occlusion by inhibiting cyclooxygenase in the arachidonic acid pathway and inhibiting the production of thromboxane A2, a thrombus-causing substance. It lowers the morbidity and mortality of angina at a dose of 75 mg to 325 mg per day and is also used for other myocardial infarctions and strokes. In the case of secondary prevention of ischemic stroke, aspirin and clopidogrel are used, and aspirin and warfarin are prescribed to prevent stroke by atrial fibrillation. According to the CHEST guidelines, appropriate preventive drugs can be administered depending on the presence or absence of a history of stroke, transient ischemia, and the number of risk factors. For aspirin allergy patients, Clopidogrel, Ticagrelor, Prasugrel, etc. can be used. Meanwhile, aspirin is used as a fever and anti-inflammatory painkiller for high doses (250 mg, 300 mg, 500 mg), and low doses (75 mg, 81 mg, 100 mg) are used to prevent blood clots.
- Company
- Will Tagrisso finally be reimb in the 1st line after 4 yrs?
- by Eo, Yun-Ho Jan 04, 2023 05:32am
- Whether the third-generation targeted anticancer drug Tagrisso will be able to receive reimbursement expansions in 2023 is gaining attention According to industry sources, AstraZeneca Korea submitted additional supplementary data to extend reimbursement of its EGFR mutation-positive non-small cell lung cancer (NSCLC) treatment to the first line at the end of last year after submitting its application in October last year. Therefore, whether Tagrisso’s reimbursement application will pass the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review and be finally extended to the first line after 4 years remains to be seen. Tagrisso, which added its first-line indication in December 2018 in Korea, attempted to extend its reimbursement to the indication in 2019. However, upon review by the Cancer Disease Deliberation Committee in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of Tagrisso in NSCLC patients in the first-line was disclosed. Although AstraZeneca submitted the full FLAURA data and expressed their will to accept most of the cost-sharing plan proposed by the government afterward, the reimbursement fell through due to opposition from committee members (specialists) that raised the issue of the drug’s clinical efficacy. The new item the company brought in to support Tagrisso’s effect in 2023 is the results from the FLAURA China study that confirmed improved OS in Asians. In the FLAURA China trial that studied a cohort of Chinese patients, 71 patients were randomly assigned to the Tagrisso-treated group and 65 patients to the control group. In particular, patients in the control group were switched to use Tagrisso in the second line if their condition progressed to T790m-positive NSCLC, and 22 of the 65 patients in the control group thus continued treatment with Tagrisso. Results showed that The median OS in the Tagrisso group was 33.1 months, 7.4 months longer than the 25.7 months in the control group. Also, the risk of death was reduced by 15.2%. Also, the company added the Japanese real-world data that it had presented at ‘ESMO Asia Congress 2022.’ The real-world study evaluated the effect of Tagrisso in the first-line in clinical practice in 660 NSCLC patients with EGFR mutations from 2018 to 2020. 583 of the patients received Tagrisso in the first line, and the other 76 received another EGFR-targeted cancer therapy. Actual measurement was taken every 6 months in the 583 patients that received Tagrisso. The median follow-up period was 24.6 months. The real-world study results showed that the median progression-free survival (mPFS) in patients that were administered Tagrisso was 20.0 months. This is even longer than the mPFS of 18.9 months that had been identified in the global Phase III trial of Tagrisso. By mutation, Tagrisso’s mPFS in patients with exon19 deletions was 23.5 months. In those with L858R mutations, the PFS was 17.0 months. In terms of overall survival, the median OS was 33.1 months in the Tagrisso arm, 7.4 months longer than the 25.7 months in the control group, and the risk of death was found to be reduced by 15.2%. Meanwhile, the largest obstacle that blocked Tagrisso from receiving reimbursement in the first line was the Asian subgroup analysis results of the FLAURA trial. Tagrisso’s Os in the trial was 38.6 months, a significant extension of 6.8 months over its first-generation comparators ‘Iressa (gefitinib)’ and ‘Tarceva (erlotinib)’. The results were encouraging, considering that Tagrisso was the first EGFR TKI to demonstrate efficacy in the first line and that cross-over prescription was allowed for research ethics in patients with confirmed T790 mutations while receiving treatment with its first-generation comparators. However, the issue lay in the hazard ratio (HR) of the Asian subgroup analysis. HR was 0.995 when separately analyzing the Asian that received Tagrisso. An HR of 0.995 means that the difference between Tagrisso and the control group is 0.005, which could be interpreted as that there is virtually no difference between Tagrisso and its comparator. This was why the academic society raised the opinion that ‘Tagrisso’s OS in Asians, including Koreans, cannot be trusted in the first line,’ and the opinion had a dominant influence on the results of the CDDC review.
- Policy
- Approval of Pfizer’s JAK inhibitor Xeljanz Srup imminent
- by Lee, Hye-Kyung Jan 04, 2023 05:32am
- Pfizer’s JAK inhibitor ‘Xeljanz Syrup (tofacitinib citrate) 1mg/mL’ may soon receive marketing authorization in Korea. According to industry sources on the 3rd, the Ministry of Food and Drug Safety completed the safety and efficacy review for the marketing authorization application Pfizer Korea submitted for Xeljanz Syrup. Generally, items receive marketing authorization soon after MFDS completes the safety and efficacy review. Three items, 5mg and 10mg strengths of ‘Xeljanz Tab’ and 11mg strength of ‘Xeljanz XR,’ which are tablet formulations, are currently approved in Korea. The drug that completed the safety and efficacy review this time is a syrup formulation that can be used to treat polyarticular course juvenile idiopathic arthritis (pcJIA) in pediatric patients and adolescents ages 2 years or older. By weight, patients with pcJIA weighing 10kg-20kg will take 3.2mL of Xeljanz Syrup twice a day, those weighing 20kg-40kg will take 4mL of Xeljanz Syrup twice a day, and those weighing 40kg or more will take 5mL of Xeljanz Syrup twice a day. The tablet formulation of Xeljanz was only prescribed to pediatric patients weighing 40kg or more, but the syrup formulation has the benefit of being allowed to be prescribed regardless of weight. Xeljanz is the first and only JAK inhibitor in Europe to be approved to treat polyarticular JIA and pediatric psoriatic arthritis (PsA). The drug is currently approved by the EU to treat adults with moderate to severe rheumatoid arthritis, adults with psoriatic arthritis, adults with moderate to severe ulcerative colitis, children from 2 years of age with active polyarticular juvenile idiopathic arthritis (pJIA) or juvenile psoriatic arthritis.
- Company
- ablbio will receive 32 billion won in technical fee
- by Jan 04, 2023 05:32am
- 1 trillion won technology export contract in January last year...Get 150 billion won in total. ablbio announced on the 2nd that it will receive $25 million (31.7 billion won) in short-term stages following the first administration of the dual antibody "ABL301" from Sanofi. The milestone is 594.2% of ablbio's sales of 5.3 billion won as of the end of last year. According to the contract, ablbio will receive the milestone within February 14. ABL301 is a candidate substance for the treatment of degenerative brain diseases such as Parkinson's disease, which ablbio exported technology to Sanofi in January last year. According to the contract, when ablbio completes the preclinical and phase 1 clinical trial, Sanofi proceeds from the subsequent stages. Sanofi has the right to develop and commercialize in markets around the world. The total amount of contracts, including $75 million in down payment, amount to $1.06 billion. Among them, the short-term milestone is $45 million, which is received according to the progress of ABL301's preclinical and phase 1 clinical development. In September last year, it received $20 million (25.4 billion won) as it completed a non-clinical toxicity test. As a result, ablbio will receive all the short-term milestones. Currently, the amount that ablbio receives from Sanofi amounts to 120 million dollars (152.5 billion won), including the down payment. ABL301 is a new drug substance that inhibits the accumulation of alpha-synuclein, the cause of Parkinson's disease, and IGF1R target BBB shuttle platform Grabody-B technology developed by ablbio is applied. This increased the transmittance by binding the receptor IGF1R that can pass through the vascular barrier to the end of the antibody, proving the BBB transmittance was 13 times higher than that of the sole antibody in animal experiments. On top of that, Parkinson's disease is fundamentally treated by adding a receptor that inhibits the accumulation of alpha-synuclein, known as the cause of Parkinson's disease.
- Company
- CTLA-4 inhibitor Imjudo is expected to commercialize
- by Eo, Yun-Ho Jan 04, 2023 05:32am
- The second CTLA-4 inhibition mechanism is expected to be commercialized in Korea this year. According to related industries, the Ministry of Food and Drug Safety is reviewing for approval of CTLA-4 inhibitor Imjudo, a combination therapy partner of AstraZeneca Korea's PD-L1 inhibitor Imfinzi. The combination therapy of Impinzi and Imjudo was approved by the U.S. FDA in October last year as a treatment for unstoppable hepatocellular carcinoma. The combination therapy is the only double immuno-cancer treatment approved so far for the primary treatment of liver cancer. The drug was recently approved by Japan's Ministry of Health, Labor, and Welfare, and EMA CHMP also expressed its support for approval. Combination therapy is a single Tremelimumab Regular Interval Durvalumab (STRIDE) strategy in which Impinzi is administered once and then Impinzi is administered at regular intervals every four weeks. The combination therapy demonstrated OS benefits by reducing the risk of death by 22% compared to the control Nexavar monotherapy in phase 3 clinical HIMALAYA study. The overall survival rate in the third year was 31% in the Impinzi and Imjudo combination therapy group and 20% in the sorafenib monotherapy group. Imjudo combination therapy was recently added to lung cancer indications in the United States. In phase 3 clinical POSEIDON study, which was the basis for permission, the patient group who received a combination of Impinzi, Imjudo, and platinum-based chemotherapy had a 23% lower risk of death than various chemotherapy controls. The overall survival rate in the second year was 33% in the combined group and 22% in the control group. Meanwhile, Imjudo is conducting phase 3 studies on combination therapy with an impingement in several types of cancers, including topical liver cancer (EMERALD-3 study), small cell lung cancer (ADRIATIC study), and bladder cancer (VOLGA and NILE study).
- Policy
- Koselugo is the only non-reimbursed drug among 21
- by Lee, Tak-Sun Jan 03, 2023 05:41am
- The Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC) reviewed 21 items last year, among which only 1 failed to pass deliberations and be determined non-reimbursable. This non-reimbursed drug was the neurofibroma treatment ‘Koselugo Cap.’ Among the other 20, 9 were recognized to be adequate for reimbursement, and 11 received a partial nod under the condition that reimbursement is adequate if the company accepts a price lower than the assessed price for their drugs. Upon review of the products that filed applications for reimbursement based on results of the 12 DREC meetings that were held in 2022 on the 2nd, Dailypharm found that only 1 of the 21 products that received review was determined non-reimbursable. Koselugo Cap failed to pass the DREC review last March. Since then, AstraZeneca submitted supplementary data and reapplied for Koselugo’s reimbursement, and is expected to undergo receive another DREC review in the near future. The 9 items that were deemed adequate for reimbursement were: Kymriah Inj, 5 items including Resyno-ONE Inj, Loviqua Tab, Zogensma Inj, Emgality, Zerbaxa Inj, 10 items including Azelblock Tab, Ajovi Prefilled Syringe Inj·Auto Injector Ing, and 2 items including Reba-eye Eye Drops 2%. Other than the 10 azelnidipine-containing items including Azelblock Tab and the 2 items including Reba-eye Eye Drops 2%, all other drugs that passed the DREC review succeeded in reimbursement listing. In the case of the 2 items including Reba-eye Eye Drops 2%, the reimbursement agenda for the drugs passed DREC review in December and is undergoing NHIS pricing negotiations. 11 Items that received conditional approval last year were: Ryaltris Sanal Spray Sol, Sonazoid Inj, Dopa Check Inj, 4 items including Fexclue Tab, Dorenion Patch·Dohesive Patch, Reyvow Tab, Epclusa Tab, Bosevi Tab, Doveprella Tab, Trimbow Inhaler, and Erleada Tab. Among the drugs, all 8 drugs other than Reyvow Tab, Trimbow Inhaler, and Erleada Tab succeeded in reimbursement. Reyvow Tab was found to have not accepted DREC’s condition. In the case of Trimbow Inhaler, and Erleada Tab, the drugs received the conditional nod from DREC in October and December, respectively, therefore final results on their reimbursement are expected to be heard soon.
- Opinion
- [Reporter's view] Expectations for Revlimid
- by Eo, Yun-Ho Jan 03, 2023 05:41am
- The maintenance therapy of Revlimid, a treatment for multiple myeloma, has been on the insurance benefit list since the new year of 2023 after more than four years of waiting. Revlimid maintenance therapy has simply had a lot of ups and downs. Since 2019, BMS Pharmaceutical Korea has actively carried out the registration process, but there has been no progress in discussions. Revlimid was submitted to the deliberation committee, which attracted attention in September 2019, June 2020, and September last year due to the introduction of the CAR-T treatment Kimriah, but the result was a failure. The NCCN recommends Revlimid maintenance as the highest level of preferred treatment in both transplantable and impossible patients, and ESMO guidelines also recommend it as the only maintenance after autologous hematopoietic stem cell transplantation. Continuous administration of drugs for a kind of prevention is not a concept that was originally absent. In chronic diseases, drugs have already been taken with the concept of management rather than treatment, and in some cases, the reason for the existence of drugs, such as anticoagulants, is prevention. The problem comes from the emergence of adjuvant therapy and maintenance therapy in the field of chemotherapy. The reason why it is difficult to appear is the price. Everyone knows, but even if cancer is cured, it is scary to recur. There are also diseases with a recurrence rate of nearly 80%, depending on the cancer type. Since it is an era of high-priced drugs, prescribing anticancer drugs that are leading the trend for prevention and applying insurance benefits to them is bound to be a burden for health authorities. Existing anticancer drugs are steadily adding adjuvant and maintenance indications, and new anticancer drugs, which are the first indications of adjuvant therapy, are also being approved one after another. In this regard, the registration of benefits for Revlimid maintenance therapy has considerable meaning. Pharmaceutical companies are now able to put their expectations on adjuvant therapy and maintenance therapy indications, which have been only looking at distant mountains in their hands. Revlimid's voluntary drug reduction is already being discussed, but maintenance and adjuvant therapy here is a task to be solved. Since recurrence and metastasis increase the mortality rate of cancer, the specificity of each drug and patient situation should be considered. Of course, the government, pharmaceutical companies, and stakeholders should make efforts to find an agreement that takes into account the Korean health insurance system and the pharmaceutical industry ecosystem.
- Company
- SK Chemical introduces Lou Gehrig's treatment Teglutik
- by Lee, Seok-Jun Jan 03, 2023 05:41am
- On the 2nd, SK Chemical announced it will be launching ‘Teglutik,’ a Lou Gehrig's disease treatment that was developed by the Italian pharmacuetical company, Italfarmaco, in Korea. The drug is indicated for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neuromuscular disease that is also referred to as Lou Gehrig's disease, and is characterized by progressive degeneration of motor nerve cells and can lead to the paralysis of the limbs and respiratory muscles Teglutik, which contains riluzole, was approved by the Ministry of Food and Drug Safety in May last year as a treatment used to extend life or delay time to tracheostomy in patients with ALS. With no cure currently available for Lou Gehrig's disease in the market, treatment is performed to slow down the symptoms with drugs like Teglutik. Teglutik comes in a suspension formulation, which allows easier intake among patients suffering from difficulty swallowing. The company believes its improved convenience in intake will be of benefit in treating Lou Gehrig's disease. Hyun-Sun Park, Head of SK Chemical’s Pharma Planning Division, said, “We expect the introduction of Teglutik to bring synergy to the company’s well-established portfolio in neurodegenerative disease that includes products such as Wondron Patch and Ongentys Cap.
- Policy
- The fast track of tx for serious dz without a substitute
- by Lee, Tak-Sun Jan 03, 2023 05:40am
- Prior consultations will be newly established before the main negotiation to quickly register anticancer drugs without alternative drugs and treatments for severe and rare diseases. Accordingly, the negotiation period for the drug will be reduced from 60 days to 30 days. The NHIS announced on the 30th some revisions to the drug price negotiation guidelines containing such information. According to the amendment, among PE drugs, drugs that are evaluated as RSA (Expenditure Cap drugs or Refund) will have a negotiation period of 30 days. These drugs, etc. can be consulted in advance before the main negotiation if ordered by the Minister of Health and Welfare. Accordingly, the target drugs may undergo prior consultation by providing data to the NHIS 15 days before submission to the HIRA Drug Benefit Evaluation Committee to determine their benefit adequacy. Therefore, in this negotiation, the negotiation period will be reduced from 60 days to 30 days. The NHIS has decided to apply the guidelines from January 1 next year. Earlier, the HIRA also supported the introduction of a preliminary consultation system by specifying drugs that can omit submission of economic evaluation data through the "revision of regulations on evaluation criteria and procedures such as whether drugs are eligible for medical care benefits." According to the revision, the standard for PE omission drugs is established that "the target patients are few." There are no products or treatments with equal therapeutic positions as drugs used in children, and cases of clinically significant improvement in quality of life have been added to be recognized by the committee. As Canada is included in the drug price reference country, PE can be omitted for drugs that are publicly paid in more than three of the eight foreign countries (Japan, France, Germany, Italy, Switzerland, the United Kingdom, the United States, and Canada). This was also applied to the detailed evaluation criteria for drugs subject to negotiation, such as new drugs, which are the HIRA internal guidelines. All of them will go into effect on January 1 next year.
- Policy
- Will Koselugo, a new neurofibroma drug be reimbursed next ye
- by Lee, Tak-Sun Jan 03, 2023 05:40am
- "Koselugo (Selumetinib, AstraZeneca), the first drug used for childhood neurofibromatosis, a rare disease, is stepping up its challenge." Although he had a hard time at the HIRA in March, efforts to register health insurance have continued since then, such as supplementing data and reapplying for benefits. Starting next year, expectations for the registration are growing as the drug price negotiation period for drugs designated as drugs subject to rapid screening, such as Koselugo, is shortened. According to the industry on the 30th, Koselugo has continued its efforts to register benefits by submitting supplementary data since it was non-reimbursement in March. Since then, the HIRA has also conducted a review by listening to related academic opinions and reviewing standards. It is known that Koselugo's existing drug decision application was recently withdrawn and a new drug decision application was submitted. Koselugo is interpreted as a willingness to continue its efforts to register benefits next year. Starting next year, drugs designated by the Ministry of Food and Drug Safety as life-threatening or critical treatments such as Koselugo will speed up benefit screening and negotiations. The HIRA and the NHIS recently revised related guidelines to provide data to the NHIS in advance for drugs used for life-threatening diseases from next year, moving the negotiations forward by about 30 days. As a result, if Koselugo retries and passes the drug evaluation committee, the pace of registration is expected to accelerate. Patients' opinions on Koselugo are also greater than ever. Neurofibroma has relied on symptomatic treatment without proper treatment. About half of Type 1 patients experience PN, which can occur anywhere in the body along the nerves, and the range of motion is limited depending on the location and size of the nerve or causes pain and appearance problems. If a tumor develops inside, it compresses the internal organs, and most of the tumors are positive and grow slowly, but some are malignant or are likely to lead to breast cancer in women. The prevalence is around one in 3,000 people. Koselugo achieved the primary evaluation index ORR by reducing tumor size by more than 20% in 68% of administered patients in clinical trials. In addition, 82% of patients who showed partial reactions continued to respond for more than 12 months. Half of the patients who did not receive treatment suffer from disease progression after 1.5 years, and only 15% of the patients who used Koselugo developed the disease up to 3 years ago. As the drug approaches 200 million won a year, it is urgent to register health insurance benefits to reduce the economic burden on patients. Insurance authorities are cautious about analyzing cost effects as high drug prices have a significant impact on their finances.
