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- 2026-06-30 01:03:13
- 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.
- Policy
- Largest-ever drug pricing reeval to be conducted this year
- by Kim, Jung-Ju Jan 02, 2023 06:04am
- The health and pharmaceutical industry is busy preparing various systems and policies for the new year. The reimbursement adequacy reevaluations for listed drugs that had been initiated as a pilot project on choline alfoscerate products settled as an annual policy project and are expected to start full-scale reevaluations on previously notified products. High-priced drugs for pediatric patients will now be eligible for pharmacogenomic evaluation data exemptions (PE exemptions) and subjects for the special calculation system will also be expanded. In addition, the 3rd Comprehensive Plan to Foster the Pharma and Bio Industry will be initiated, and the task force for the development of the service industry that includes the healthcare industry will also be launched within the month and impact the medical and pharmaceutical industry. The National Assembly will discuss the abolition of the sunset clause on state funding for national health insurance and legislation for public late-night pharmacies. Dailypharm prepared a summary of notable changes in the system as well as policy projects that will be made in 2023 in the pharmaceutical and biopharmaceutical industry. First, the conversion factor for medical care facilities will be raised with the start of the new year. The increase rate is 1.6% for hospitals, 2.1% for clinics, 3.0% for oriental medicine hospitals, and 3.6% for pharmacies. Along with this, the health insurance rate will also rise to 7.09% based on those employed. For drug pricing coverage and control, high-priced drugs for pediatric patients may be allowed PE exemptions starting this month. PE exemption may be allowed for drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option; and demonstrates improvement in quality of life or are otherwise approved by the committee. The adjustment in the reference countries used to calculate the foreign adjusted drug price that raised concerns in the pharma and bio industry has been made. The government added Canada to the existing A7 (Japan, France, Germany, Italy, Switzerland, the UK, and the US) to A8. Australia, the country that the industry worried would be included as a reference country, was excluded. The reimbursement reevaluations planned for the year are expected to be the largest ever. The government announced that HIRA will be reevaluating reimbursement on a total of 8 ingredients - Rebamipide, Limaprost alpha-cyclodextrin, oxiracetam, acetyl L carnitine, loxoprofen sodium, levosulpiride, epinastine hydrochloride, sodium hyaluronate eye drops. When adding the efficacy reevaluation set to be conducted on sterepto drugs that received conditional approval for 1 year, the number of drugs subject to reevaluation is increased to 9. The discount rate for the drugs will be finalized in the coming December. In February this year, ingredients subject to reimbursement reevaluations in 2024 will be decided upon and reviewed by the Health Insurance Policy Deliberation Committee. Also, a performance evaluation procedure and management plan for high-priced drugs such as Kymriah and Zolgensma, the so-called 'one-shot treatments', will be prepared within the month. Also, the negotiation period for drugs eligible for the Risk Sharing Agreement (RSA) among PE exemption drugs will be shortened by 30 days through the introduction of a prior discussion system, improving accessibility. Also, the scope of drugs eligible for special calculations will be expanded. A total of 42 new rare diseases and artificial kidney dialysis patients with chronic renal failure will also be applied to special calculations. Also, the administrative dispositions used for the drug serial number reporting system will be raised. From January, HIRA will raise the serial number reporting rate standard for administrative dispositions from 85% to 90% at the time of shipment by wholesalers (including manufacturers and importers that supply third-party licensed items). Therefore HIRA will request administrative dispositions to be made to local governments if the reporting rate becomes less than 90%. Also, the ‘ Regulation on Manufacture and Sales Management of Biological Products, Etc.’ that applied to all biological products will not be categorized into 3 product types. The MFDS plans to make the amendments to the regulation before the 17 of this month. The 3rd Comprehensive Plan to Foster the Pharma and Bio-Industry which had been set as a 5-year project will be implemented this year to support all areas ranging from R&D to business development, investment exports, job creation, and institutional infrastructure. The 'Service Industry Development TF', which sets policy directions to revitalize the service industry, including the field of healthcare, will also be launched in earnest this month. The Ministry of Economy and Finance that oversees the project plans to disclose its 5-year plan for innovating the service industry in March through the TF. During the H1 of the year, a pilot project for the ‘Approval Evaluation-Negotiation Linkage System' will be carried out, and subject drugs will simultaneously undergo three tracks of the drug approval process – MFDS’ safety and efficacy evaluations for marketing authorizations, HIRA’s reimbursement adequacy evaluations, and NHIS’s drug pricing negotiations. In the same period, the National Assembly will discuss whether to abolish the sunset clause for state support of health insurance finances and whether to legislate public late-night pharmacies. Although the contract sales organization (CSO) reporting system is expected to be discussed at the plenary session in the H1 of the year, as the effective date for the law is 1 year and 6 months after the promulgation, its actual application is expected to be possible only in the 2024 2H at the earliest, even if the revisions are made rapidly.
- Policy
- SK Chemicals Riluzole is listed
- by Lee, Tak-Sun Jan 02, 2023 06:04am
- Only tablet type is available for Riluzole, and suspension type is expected to be an alternative for patients with difficulty in swallowing. According to industries on the 1st, SK Chemical's Teglutik Suspension was listed at 134,970 won per bottle. Riluzole, the main ingredient of Teglutik, is used in the treatment of Amyotrophic Lateral Sclerosis (ALS), which is known to delay symptoms by several months. Riluzole is the first drug approved for Lou Gehrig's disease and is most commonly used. There are two products in Korea: Rilutek and Yooritek by Riluzole. Based on IQVIA in 2021, Rilutek showed sales of 3.7 billion won and Yuritech 2.5 billion won. Despite such identical products, Teglutik is introducing them to the domestic market because there is a demand for suspension. Patients with Lou Gehrig's disease have early symptoms of weak tongue and neck muscles, making it difficult to chew and swallow. It was difficult for patients who felt these symptoms to take two tablets of Riluzole daily. Teglutik is a suspension that can be easily taken through oral injections. Patients who are difficult to take directly can be injected through a PEG tube. The drug was developed by the Italian pharmaceutical company Italco Pharma and approved by the U.S. Food and Drug Administration (FDA) in 2018. SK Chemicals has completed patent registration since it was introduced in Korea. The upper limit of the benefit 134,970 won per bottle, is 15 days' worth, which is the same as the existing refining price (4,499 won per day) when converted into daily doses. Since there is no price difference, Teglutik is expected to be useful for patients with symptoms of dysphagia. On the other hand, Sanofi and Yoo Young, which divided the market, are expected to focus on protecting the market this year because they have difficult competitors.
- Policy
- High conc Ultomiris Inj 100mg/mL also approved in Korea
- by Kim, Jung-Ju Jan 02, 2023 06:04am
- Handok received marketing authorization for the orphan drug ‘Ultromiris 100mg/mL(ravulizumab)’ that is used to treat Paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uraemic syndrome (aHUS) and made a step towards supplying the drug in Korea. On the 28th, the Ministry of Food and Drug Safety announced that it had granted marketing authorization for the drug. The drug is a humanized monoclonal antibody (mAb) that specifically binds to the C5 protein and inhibits complement-mediated inflammation and hemolysis, etc. More specifically, the drug is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH), and as a treatment for adult and pediatric patients with atypical hemolytic uraemic syndrome (aHUS) and inhibits complement-mediated thrombotic microangiopathy (TMA). The MFDS explained that the product approved this time is a high-concentration version of the already-approved Ultomiris Inj and has the benefit of being able to reduce the IV infusion time in patients. The MFDS said, “We will continue to make efforts to allow for the prompt provision of treatments with confirmed safety and efficacy based on regulatory science."
