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- 2026-04-03 22:55:23
- Policy
- New Year's drug pricing policy highlights
- by Lee, Tak-Sun Jan 03, 2025 06:27am
- The new drug pricing system in 2025 is expected to be volatile due to Korea’s political turmoil. Whether the external reference pricing reevaluations and re-evaluation of the listed PE exemption drugs, which were reviewed or discussed last year, will be carried out this year is also the focus of attention. However, as most of the detailed measures for 'Reflecting the Innovative Value of New Drugs and Improving the Drug Pricing System for Health Security' have been revised, the revisions are expected to be implemented in earnest this year. In particular, the partial revision of the 'Criteria for the Determination and Adjustment of Drugs (administrative notice issued in October 2024), which contains the most relevant contents, is likely to be applied before March, and it is expected that the preferential measures for homegrown new drugs will be applied this year. Dailypharm has collected the drug pricing policies and systems that will be applied this year, which are as follows. 2025 Drug Reimbursement Adequacy Reevaluations The drug reimbursement adequacy reevaluations that began in 2020 will continue this year. This year, 8 ingredients will be subject to review: olopatadine hydrochloride; clematis root-trichosanthis radix-prunella vulgaris L; bepotastine; spherical absorptive carbon; artemisia princeps leaf extract; l-Ornithine-l-Asparate; sulglycotide; and chenodeoxycholic acid-ursodeoxycholic acid trihydrate magnesium salt. Among them, the 3-year average claims amount for the artemisia princeps leaf extract has been the highest at KRW 112.5 billion, so the outcome of the reevaluation is expected to be of interest. There are 142 artemisia princeps leaf extracts listed on the reimbursement list, including Dong-A ST’s original, Stillen Tab. If the reimbursement adequacy for the ingredient is not recognized in this year's reevaluations, it is expected to hit the relevant pharmaceutical companies hard. In particular, the artemisia princeps leaf extract is also undergoing MFDS’s bioequivalence reevaluations, so the reimbursement adequacy reevaluations will have a further impact. In addition, the results of the reimbursement of olopatadine hydrochloride, worth KRW 66.4 billion, and bepotastine, worth KRW 54.8 billion, are also gaining attention. The reimbursement adequacy reevaluations are expected to begin in earnest in March after the Health Insurance Review and Assessment Service report at the beginning of the year. Price-Voume Agreement system’s maximum reduction rate raised to 12.5% In October last year, the Ministry of Health and Welfare announced a partial amendment to the 'Criteria for Determining and Adjusting Drug Prices' to raise the maximum reduction rate for drugs subject to PVA negotiations from 10% to 15%. However, the adjustment rate stays at the 12.5% level until December 31, 2025, which is a lower rate, given the early stage of its implementation. Therefore, the maximum reduction rate of 12.5% is expected to be applied upon the notification of the amendment this year. As the maximum reduction rate is 2.5% higher than the current 10%, the intensity of losses the companies will bear due to drug price cuts is expected to be greater. Preferential treatment for homegrown new drugs developed by Korea Innovative Pharmaceutical company Similarly, if the amendments to the 'Criteria for Determining and Adjusting Drug Prices' are promulgated, preferential drug pricing for domestically developed new drugs will also be then applied. In particular, non-inferior new drugs by Korea Innovative Pharmaceutical Companies will be priced at the ‘lower of the highest price of the upper limit of alternative drugs or the amount added to the weighted average price of substitute drugs (X100/53.55, approximately 1.8 times).’ This is expected to be significantly higher than the current price, which is set below the weighted average price of alternative drugs, resulting in higher profit margins for drugs covered by the proposal. It will be interesting to see if Shinpoong Pharmaceutical's 'Hyal Flex Inj' will receive preferential treatment. On the other hand, homegrown new drugs will be able to apply the dual pricing system when negotiating their price, paving the way for them to enter overseas markets at higher prices. Preferential measures for national essential medicines that use domestic raw materials In addition to the preferential plan for homegrown new drugs, a preferential plan for national essential medicines that use domestic ingredients will also be established. It will also be applied when some amendments to the MOHW’s 'Standards for Determination and Adjustment of Pharmaceuticals' are published. Specifically, it has been decided that nationally essential medicines that use domestic raw materials will be considered to have met all the criteria for preferential pricing. In addition, a (68/53.55 - 1)×100% premium will be added to the calculated amount, which would render the price of eligible drugs higher than now. The government expects this to increase the domestic self-sufficiency rate of national essential medicines. Designation of 7 new Korea Innovative Pharmaceutical Companies Designation as a Korea Innovative Pharmaceutical Company serves as the basis for premium pricing during drug reimbursement listings. Therefore, the ‘innovative’ title is directly linked to profits. This year, Dong-A ST, Amgen Korea, Onconic Therapeutics, Curocell, Hahnall Biopharma, SK Bioscience, and SK Biopharm were newly designated, bringing the total to 49 companies recognized as Korea Innovative Pharmaceutical Companies. On the other hand, as 4 pharmaceutical companies were eliminated during the recertification process for Korea Innovative Pharmaceutical Companies in June last year, they will unable to receive incentives such as drug pricing premiums that they had been previously granted as existing innovative pharmaceutical companies. The government plans to improve the criteria for the decertification of innovative pharmaceutical companies this year. In particular, it is expected to ease the certification requirements for rebates. New subjects added for prescreening for reimbursement benefits The government has recently been actively adjusting the drugs that are subject to pre-review for reimbursement benefits, and last year, reimbursement of Strensiq Inj and Soliris-Ultomiris for the PNH (paroxysmal nocturnal hemoglobinuria) indication was converted to general review. As of this month, Ultomiris for the atypical hemolytic uremic syndrome indication will require prior authorizations. Soliris had been the drug that required prior authorizations in the atypical hemolytic uremic syndrome category, which has been controversial due to its low prior authorization rate. Therefore, it will be interesting to see if the addition of Ultomiris will change the landscape. As a result, Soliris, Ultomiris, Spinraza, Zolgensma, Crysvita, Evrysdi, and Luxturna, and drugs used for immune tolerance therapy must pass prior authorization to be reimbursed.
- Policy
- Prices for Vyndamax, Ocrevus in negotiations with NHIS
- by Lee, Tak-Sun Jan 03, 2025 06:27am
- Pfizer's cardiomyopathy drug Vyndamax Cap and Roche's multiple sclerosis drug Ocrevus Inj are undergoing drug price negotiations with the National Health Insurance Service (NHIS) in Korea. Therefore, it will be interesting to see if the drugs will be able to finalize negotiations and their reimbursement listing agenda be submitted to the Health Insurance Policy Review Committee in January. According to industry sources on the 2nd, the NHIS recently added Ocrevus Inj (ocrelizumab) and Vyndamax Cap 61 mg (tapamidis) to the list of drugs subject to drug price negotiations. Ocrevus Inj was deliberated to be adequate for reimbursment at the 11th Drug Reimbursment Evaluation Committee (DREC) meeting that was held in November last year, during which the DREC stated that its reimbursement benefits are appropriate when the company accepts a price less than the evaluated amount. It is understood that as Roche has begun negotiating the drug price with the NHIS, it accepted the lower price and passed HIRA’s review stage. The drug is an injection that is administered twice a year and is considered to be a drug that dramatically improves the convenience of dosing for patients with multiple sclerosis. It has received domestic marketing authorization in May last year. Upon its approval, the company immediately applied for reimbursement benefits to the HIRA. Multiple sclerosis is a disease that affects the central nervous system, which consists of the brain, spinal cord, and optic nerve, and is an autoimmune disease characterized by the patient's immune system attacking healthy cells and tissues. There are reportedly about 1,800 patients affected with multiple sclerosis in Korea. Ocrevus Inj is a recombinant humanized monoclonal antibody (mAb, IgG1) that selectively targets B cells expressing CD20 and has the ability to inhibit MS by reducing the number and function of B cells. In particular, the drug is considered to be more convenient to administer than existing therapies because the initial dose of 600 mg is divided into two intravenous infusions, followed by a single dose of 600 mg every six months. The U.S. FDA approved Ocrevus in 2017 for the treatment of relapsing-remitting or new-onset progressive MS. The annual cost of Ocrevus in the U.S. is USD 70,000, which is more than KRW 10 million. Given its heavy burden on health insurance finances, the company’s financial sharing is expected to rise as the issue during drug price negotiations. Vyndamax Cap passed the drug review committee in October last year. Although it did not pass the DREC review in April 2023, upon the company’s reattempt, it was finally able to pass the HIRA stage. The drug is gaining attention as the only treatment for ATTR amyloidosis with cardiomyopathy (ATTR-CM), which is a transthyretin-mediated amyloidosis. ATTR-CM is a devastating and fatal disease with a median survival of 2 to 2.5 years without adequate treatment but has been known to have shown poor treatment outcomes because it is mistaken for simple heart failure or due to a lack of available treatment options. In the Phase III ATTR-ACT study, Vyndamax demonstrated efficacy in reducing cardiovascular events and improving the 6-minute walk test in patients with ATTR-CM. As the two drugs have entered negotiations with the NHIS, it will be interesting to see if they will be finalized this month and placed on the reimbursement agenda. Usually, new drug reimbursement is reported as a HIPDC agenda and then is reviewed on the first of the following month. Whether the two drugs, which are considered to improve the quality of life of patients as the only treatment options in their respective areas, will be able to be reimbursed with the start of the new year is gaining attention.
- Policy
- Orphan drug 'Voxzogo' wins nod
- by Lee, Hye-Kyung Jan 02, 2025 06:11am
- Product photo of Voxzogo The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on December 31 that it has approved 'Voxzogo (vosritid),' an orphan drug used to treat achondroplasia in children over four months whose growth plates are not closed. Achondroplasia is a bone growth-related genetic disease caused by a mutation in the FGFR3, a gene regulating cartilage cell proliferation and division. This drug suppresses the overactivation of FGFR3 (fibroblast growth factor receptor 3) in children with achondroplasia, inducing proliferation and division of cartilage cells, ultimately stimulating bone formation within the cartilage. Previously, there were no treatments available for children with achondroplasia. The approval of the medication is expected to offer a new treatment opportunity for children with the disease. Voxzogo is the 10th drug to receive the 'Global Innovative products on Fast Track (GIFT)' designation (July 2023). The MFDS quickly reviewed the case to make it readily available to clinical practices in South Korea. The MFDS stated, "Using our expertise in regulatory science, we will strive to quickly deliver new treatments for patients with intractable diseases so that patients can have more treatment opportunities."
- Policy
- Changes made to the drug approval system in the new year
- by Lee, Hye-Kyung Jan 02, 2025 06:11am
- Various changes will be made to the drug approval and management system in the new year of 2025, including the new drug approval innovation plan. On December 31st, the Ministry of Food and Drug Safety (MFDS) announced the changes that will be enforced from January, including ▲ the implementation of a new drug approval innovation plan ▲ reform of the GMP evaluations ▲ recognition of written inspection results during the triennial inspection of drug manufacturing sites. With the implementation of the new drug approval and review innovation process from January 1 next year, a new drug approval application fee of KRW 410 million will be charged. The increased fee will be used to establish a dedicated team for each item, expand the number of face-to-face consultations and review between the company and the approval authorities up to 10 times (currently up to 3), and shorten the manufacturing and quality control evaluation and on-site inspection of new drug manufacturing plants (within 90 days). The MFDS announced that it will support the rapid commercialization of new drugs by operating a fast, transparent, and predictable approval review system based on expertise so that it can be completed within 295 days from the application to the issuance of the marketing authorization. GMP evaluation for drug approval and registration will also be reorganized. GMP evaluation will be replaced with GMP certificates for imported raw material drug master files (DMF), which will significantly shorten the processing period (120 days → 20 days). The materials for GMP evaluation that need to be submitted when applying for a drug marketing authorization will be consolidated and adjusted from 11 types to 4 types The MFDS said, “We expect that this rationalization of the GMP evaluation regulations required for drug license and registration will enable us to quickly and stably supply safe and effective drugs with verified safety to people in Korea.” In addition, a system that allows periodic GMP inspections of low-risk drug manufacturing facilities to be written inspections will be implemented next year. In principle, when a drug manufacturing plant undergoes a three-year periodic inspection after being certified as being GMP compliant, it is required to undergo an on-site inspection, but if the risk is low, such as there is no history of significant changes according to the results of the preliminary assessment of the manufacturing plant, the system will be improved so that the GMP compliance certification can be extended up to 2 years with a written inspection without undergoing an on-site inspection. For reference, an on-site inspection would need to be conducted after the 2-year extension. The MFDS has prepared specific measures for the operation of written inspections other than on-site inspections and plans to hold industry briefings in the first half of next year and implement them in the second half of the year. In addition, when extending the GMP certificate of conformity through on-site inspections, the criteria for calculating the validity period will be revised from 3 years from the end of due diligence to 3 years from the day after the expiration date of the existing validity period, so that the 3-year validity period can be fully guaranteed. On December 30, the MFDS revised two notices, the “Rules on the Safety of Drugs (Prime Ministerial Decree)” and “Regulations on the Registration of Pharmaceutical Raw Materials” and “Regulations on the Manufacturing and Quality Control of Pharmaceuticals” to reorganize the GMP evaluation and periodic inspection conducted for drugs. “We expect the new systems implemented in 2025 to help promote public health and develop the pharmaceutical industry, and plan to continue operating the drug licensing and management system rationally in accordance with changes in the policy environment, with public safety as our top priority,” said the MFDS.
- Company
- Yuhan’s anticancer drug Leclaza secures European approval
- by Cha, Jihyun Jan 02, 2025 06:10am
- Pic of Yuhan Corp Yuhan Corp’s new anti-cancer drug Leclaza (Lazertinib) has crossed the European threshold. The European Commission (EC) approved the drug a month after receiving a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). As a result, the company will receive a USD 30 million European launch milestone. According to industry sources on the 31st, the EC granted final marketing authorization to the combination of Yuhan Corp’s non-small cell lung cancer drug Leclaza and Johnson & Johnson's Rybrevant (amivantamab) as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutation. The CHMP had previously issued a positive opinion recommending approval of the combination on March 14th. The final approval of the combination comes just 1 month after the CHMP's recommendation. The approval is based on results from the Phase III MARIPOSA study. In the study, the combination of Rybrevant-Leclaza reduced the risk of disease progression or death by 30% compared to Tagrisso (osimertinib) monotherapy. In addition, progression-free survival (PFS) was 23.7 months, compared to 16.6 months with osimertinib, and duration of response (DOR) was 25.8 months, 9 months longer than Tagrisso's 16.8 months. Even in high-risk patients with TP53 mutations, brain metastases, or liver metastases, the combination of Rybrevant and Leclaza demonstrated a consistent PFS benefit over Tagrisso, with a trend toward superior overall survival (OS). This renders Leclaza the first homegrown anticancer drug to be marketed in Europe following approval in the U.S. The Rybrevant-Leclaza combination was previously approved by the U.S. Food and Drug Administration (FDA) in August. In Korea, it was approved by the Ministry of Food and Drug Safety in January 2021 for the treatment of non-small cell lung cancer. As the Rybrevant-Leclaza combination passed the European threshold, the company will receive the European launch milestone of USD 30 million (approximately KRW 44.2 billion). This brings the total amount received from Janssen for the export of Leclaza technology to USD 240 million (approximately KRW 353.7 billion). In November 2018, the company received USD 50 million in upfront payment for the export of Leclaza’s technology. In April 2020, Yuhan Corp received a milestone payment of USD 35 million from Janssen. At that time, Johnson & Johnson paid Yuhan Corp an additional milestone payment after initiating clinical trials for the Rybrevant and Leclaza combination. In November 2020, Johnson & Johnson paid an additional milestone of USD 65 million to Yuhan Corp as it began recruiting patients for the trial. Subsequent successful completion of the trial and FDA approval resulted in an additional USD 60 million in additional milestone payments. Sales royalties are also expected to be recognized once the Rybrevant-Leclaza combination is launched in Europe. The royalty rate on sales of Leclaza is expected to be in the range of 10% to 12%. Lung cancer is the leading cause of cancer-related death, which causes an estimated 1.8 million deaths worldwide each year. Patients with non-small cell lung cancer, which is targeted by the Rybrevant-Leclaza combination, account for 80-85% of lung cancer patients. In addition, Yuhan Corp may receive additional milestones upon regulatory approval in Japan, China, and other Asian countries. The total amount of additional technology fees that Yuhan may receive for future development and sales of Leclaza amounts to USD 740 million.
- Policy
- ICER threshold for anticancer drugs set same as in 2024
- by Lee, Tak-Sun Jan 02, 2025 06:10am
- The Health Insurance Review and Assessment Service released the results of the incremental cost-effectiveness ratio (ICER) of drugs submitted for pharmacoeconomic evaluation from 2019 to 2023, which has shown a decrease in the maximum ICER threshold set for anticancer drugs. The ICER threshold did not appear to have changed much from the previous year, as the review results of the breast cancer drug Enhertu, which was reimbursed in April and was known to have significantly exceeded the ICER threshold, were not reflected in the results. On December 30, HIRA released the ICER threshold values of 19 drugs evaluated from 2019 to 2023. At the end of every year, HIRA discloses the past 5-year ICER values from the previous year. According to the evaluation results, the median threshold value of 8 general drugs was KRW 27.66 million, ranging from KRW 12.06 million to KRW 36.1 million. In the case of the 8 anticancer drugs, the median threshold was KRW 39.93 million, ranging from KRW 25.88 million to KRW 47.92 million. For the 3 rare disease drugs, the median threshold was not disclosed to avoid identifying individual drug evaluation results. However, the minimum threshold was KRW 23.61 million and the maximum threshold was KRW 39.97 million. Compared to the ICER threshold published in 2023, there is less fluctuation, around KRW 10 million. The data released the previous year were based on ICER thresholds for 20 drugs evaluated from 2018 to 2022. Its results showed that the median price of 5 general drugs was KRW 25.67 million, ranging from KRW 17.78 million to KRW 35.29 million. At the time, the median ICER threshold of the 10 anticancer drugs was KRW 39.99 million, ranging from KRW 24.96 million to KRW 47.92 million, and the median ICER threshold of the 5 rare disease drugs was KRW 39.97 million, ranging from KRW 23.61 million to KRW 47.29 million. Compared to this year's results, the median ICER threshold of general drugs increased by KRW 1.99 million, while the minimum threshold decreased by KRW 5.72 million. The maximum value increased by KRW 0.81 million. In the case of anticancer drugs, the median ICER threshold decreased by KRW 60,000, while the minimum ICER threshold increased by KRW 0.92 million. The maximum remained the same. For rare disease drugs, the minimum ICER threshold remained the same, while the maximum ICER threshold decreased by KRW 7.32 million. The maximum ICER threshold for anticancer and rare disease drugs remained the same or decreased from the previous year. In August, HIRA revised the detailed evaluation criteria for drugs subject to negotiations, including new drugs, to establish an innovativeness requirement for drugs subject to flexible ICER threshold evaluations. Previously, the ICER threshold was “not to be used as an explicit threshold, but to be used flexibly for evaluations by referring to the results of previous deliberations that consider the severity of the disease, the burden of disease on society, the impact on quality of life, and innovation.” Upon revision, a new drug's innovativeness is recognized if it meets all 3 of the following requirements: ▲ there is no substitute or therapeutically equivalent product or treatment; ▲ a significant clinical improvement is identified in the outcome indicator, such as prolongation of survival; ▲ it falls under Article 35(4)(2) of the Pharmaceutical Affairs Act and is recognized by the MFDS as a new drug or equivalent drug approved through expedited review by the MFDS. A flexible review of high-priced new drugs is expected with the clarification of the flexible ICER threshold evaluation requirements. In April, HIRA reviewed and granted reimbursement for the breast and gastric cancer drug Enhertu Inj (trastuzumab deruxtecan, Daiichi Sankyo). At the time, it was reported that Enhertu’s ICER threshold greatly exceeded the maximum value of the existing ICER threshold set for anticancer drugs. Last year and this year, the maximum ICER threshold for anticancer drugs was KRW 47.92 million. Accordingly, it is expected that the ICER value in 2025, which will reflect the results of this year's evaluations, will show a significant increase in the ICER threshold set for anticancer drugs.
- Company
- K-Bio to showcase CDMO·new drugs at the JP Morgan
- by Son, Hyung Min Jan 02, 2025 06:10am
- The Korean pharmaceutical and biotech industry is set to participate in the new year's first global event, the JP Morgan Healthcare Conference. Attention has been drawn to what the Korean pharmaceutical and biotech industry will accomplish during the event, which will include discussions of blockbuster technology transfers and partnering agreements. According to industry sources on January 2, Samsung Biologics, Lotte Biologics, Celltrion, Bridge Biotherapeutics, Onconic Therapeutics, and others will attend the JP Morgan Healthcare Conference. The Healthcare Conference, hosted by the US investment bank JP Morgan, is the largest pharmaceutical and biotech industry investment event, where venture capitals (VC) and hedge funds attend. The event will be held in San Francisco, US, for four days from January 8. Korean CDMO companies gear up to land contracts During the event, Samsung Biologics, Lotte Biologics, Celltrion, and other participants will showcase their contract development and manufacturing organization (CDMO) competitiveness. Samsung Biologics will showcase its biopharmaceutical CDMO competitiveness based on its new manufacturing plant, Plant 5, which will be completed in April. The company is constructing a plant at the Bio Campus in Songdo, Incheon, for antibody-drug conjugates (ADC) production, which is aimed to be completed within this year. Samsung Biologics currently has a total production capacity of 600,000 liters. The company has invested KRW 1.98 trillion in constructing Plant 5 in Songdo. Samsung Biologics will hold a total capacity of 784,000 liters across Plant 1-5. Celltrion will showcase its new drug development achievements, including a new ADC anti-cancer drug, and CDMO vision. The company unveiled the new ADC drug result of the Phase 1 clinical trial at the 'World ADC 2024' held in November last year. Celltrion Celltrion is conducting a clinical trial for 'CT-P70,' an ADC candidate product for non-small cell lung cancer (NSCLC), and 'CT-P71,' which targets many solid cancer indications, including bladder cancer. The safety of these new drug candidates has been confirmed in a phase 1 clinical trial and a pre-clinical trial, respectively. Additionally, Celltrion will initiate the business operations of its subsidiary, 'Celltrion BioSolutions,' which was launched in December 2024. Celltrion aims to build manufacturing facilities and a research center and generate sales from 2028. Lotte Biologics will attend the conference and plans to showcase its CDMO competitiveness. The company plans to build three bio plants in Songdo by 2023 with a total production capacity of 360,000 liters for antibody pharmaceutical production. The new Plant 1 will have a cell culture system and an API system for producing clinical agents. The company will design a 3,000-liter bioreactor capable of fulfilling the demand for both stainless steel bioreactors (cell culture system) and high-potent active pharmaceutical ingredients (HPAPI). Lotte Biologics aims to achieve global biopharmaceutical production competitiveness by investing up to KRW 4.6 trillion by 2030. To showcase achievements in new drug development…will this result in out-licensing opportunities? Onconic Therapeutics and Bridge Biotherapeutics have been officially invited to the JP Morgan Healthcare Conference, where they will showcase their competitiveness in new drug development. Onconic Therapeutics launched 'Ja Q Bo Tab,' a P-CAB for the treatment of gastroesophageal reflux disease (GERD), last year. Ja Q Bo Tab has been designated the 37th new drug in Korea. Additionally, Onconic Therapeutics successfully out-licensed Ja Q Bo to twenty-one foreign countries. Onconic Therapeutics plans to focus on holding strategic meetings with global pharmaceutical companies and investors during the upcoming JP Morgan Healthcare Conference. In addition to Ja Q Bo, the company plans to introduce the targeted anticancer agent, 'nesuparib,' to the global market. Onconic Therapeutics has been developing 'nesuparib,' a dual-targeting inhibitor of PARP·tankyrase, as the follow-up pipeline after Ja Q Bo. Bridge Biotherapeutics plans to present its key R&D projects, including the idiopathic pulmonary fibrosis (IPF) treatment candidate 'BBT-877,' and potential company growth strategy. BBT-877 is an innovative new drug candidate that selectively inhibits the new targeted protein autotaxin. Autotaxin is a protein involved in pathophysiological mechanisms, such as tumorigenesis, by binding with receptors in the cell. Bridge Biotherapeutics has completed enrolling 120 patients in the Phase 2 clinical trial for BBT-877. The comparative Phase 2 clinical trial will evaluate the effectiveness, safety, and drug tolerance by administering BBT-877 and placebo in patients with IPF. STCube will hold business meetings with multinational pharmaceutical companies to out-license 'nelmastobart.' The company is developing the candidate immune checkpoint inhibitor nelmastobart, which targets a new biomarker, BTN1A1. BTN1A1 is a protein that regulates the immune responses to cancer cells by suppressing the activity of T cells, which are immune cells. This biomarker is not expressed in healthy cells but is strongly expressed in cancer cells. BTN1A1 expression is mutually exclusive to that of PD-L1. By targeting BTN1A1, STCube is developing an immune checkpoint inhibitor that could be a new treatment option for intractable cancer. D&D Pharmatech will showcase the glucagon-like peptide 1 (GLP-1) receptor agonist for obesity. In November, D&D Pharmatech began the clinical trial for DD02, an oral GLP-1 drug for obesity, through its US partner, Metsera. D&D Pharmatech also plans to showcase the new drug candidate for treating MASH, DD01, which is undergoing a phase 2 clinical trial.
- Opinion
- [Reporter’s View] The dilemma of companion diagnostics
- by Whang, byung-woo Dec 31, 2024 05:56am
- A drug is available but unusable. This is the story of the Claudin 18.2 targeted gastric cancer drug Vyloy (zolbetuximab). This is not the typical situation where a breakthrough drug is approved but is inaccessible due to its high price. The problem is companion diagnostics (CDx). In order to use a Vyloy, which targets Claudin 18.2, it is essential to first confirm that the patient's tumor is Claudin 18.2 positive. For this reason, the MFDS approved the companion diagnostic device, VENTANA CLDN18 (43-14A) RxDx Assay from Roche Diagnostics Korea, on the same day that Vyloy was approved. However, the device’s launch in Korea has been delayed due to the issue of whether the companion diagnostic technology requires evaluation as a new health technology. In Korea, new biomarkers must pass a new health technology evaluation by the National Evidence-based healthcare Collaborating Agency (NECA) before they can be used in practice. Late last month, the National Evidence-based healthcare Collaborating Agency (NECA) held a meeting of its expert evaluation committee to discuss Vyloy’s companion diagnostic agenda and put the decision on hold. Whether the Claudine 18.2 companion diagnostic will be classified as an existing technology for reimbursement determination or a new technology for NECA’s new health technology evaluations is expected to be decided upon early next year. As the process is bound to take time, the industry expects the process to take up to 15 months if the companion diagnostic receives new health technology evaluations. Clinics had been preparing to prescribe Vyloy upon its launch next January, but this has become impossible. Astellas is also reportedly struggling to decide on the timing of the drug’s launch. For now, experts have believed Vyloy holds significance in the treatment of gastric cancer. It could be a turning point in the treatment of locally advanced or metastatic gastric cancer in Korea, where treatment options have been limited. In particular, the number of patients who can benefit from the treatment is not small, with 30 to 40 percent of new patients testing positive for Claudin 18.2. The Vyloy case is likely to be repeated in the future, given the development of new drugs, such as cancer drugs that target specific targets. This is why experts are calling for an overhaul of the current companion diagnostic system. As technology advances, changes to the system are essential. We need to take a long-term view to allow patients to benefit from new drugs as quickly as possible.
- Policy
- Once-weekly insulin 'Awiqli' wins nod in KOR
- by Lee, Hye-Kyung Dec 31, 2024 05:56am
- Product photo of Novo NordiskA once-weekly insulin to treat patients with adult diabetes has been approved in South Korea. On December 23, the Ministry of Food and Drug Safety has approved Novo Nordisk's 'Awiqli Pre-Filled Pen 700 Units/mL (insulin icodec, recombinant).' This drug is a once-weekly subcutaneous injection of insulin, providing a more convenient treatment option than the daily injections of conventional insulin. Patients with type 1 diabetes must use Awiqli in combination with bolus insulin to meet their insulin requirements during meals. For type 2 diabetes, Awiqli can be administered as a monotherapy or in combination with oral antidiabetic agents, GLP-1 receptor agonists, and bolus insulin. According to the results of the 'Advisory on the Safety·Effectiveness of Insulin Formulations' released by the Central Pharmaceutical Affairs Advisory Committee (CPAC) on December 24, discussions highlighted the unmet medical needs of type 1 diabetes patients who face daily inconveniences from lifelong injections and the potential benefits of a once-weekly injection regimen. "Long-term maintenance agent will benefit patient convenience and drug adherence," a committee member stated. "We have a previous case of sustained osteoporosis treatment with extended treatment interval." However, concerns were raised that the once-weekly formulation does not maintain consistent blood levels and exhibits a rapid release between days 2 and 4, which increases the risk of hypoglycemic episodes. It was noted that careful management is necessary to mitigate these risks of hypoglycemic episodes. The committee recommended establishing measures to prevent overlooking the risks of hypoglycemic episodes. "Data indicate that the drug does not show pharmacokinetic variations based on albumin levels, considering normal albumin concentrations and the drug's peak plasma concentration," the MFDS stated. "Overall, all committee members agreed on recognizing the drug's safety and effectiveness. However, it is essential to emphasize caution regarding the risk of hypoglycemic episodes in the provided instructions for use," the CPAC chairperson commented. The MFDS concluded that while Awiqli is not subject to a conditional Phase 4 approval, it will require post-marketing surveillance (reexamination) and the implementation of a Risk Management Plan (RMP) as part of its approval conditions.
- Policy
- Approval of the 48hr Nurtec ODT for migraine imminent in KOR
- by Lee, Hye-Kyung Dec 31, 2024 05:55am
- ‘Nurtec (Rimegepant),’ which is used for both the treatment and prevention of migraine, will soon receive marketing authorization in Korea. According to industry sources on the 31st, the Ministry of Food and Drug Safety completed the safety and efficacy review of Pfizer's Nurtec Oral Disintegrating Tablet 75 mg. Pfizer submitted a marketing authorization application for Nurtec last year, and upon the completion of the safety and efficacy review, the drug is expected to be approved soon in Korea. Nurtec is the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the prevention and treatment of acute migraine in adults in the U.S. in 2021, and is approved in Israel, Kuwait, the United Arab Emirates, Europe, and China as an oral acute and prophylactic treatment for migraine. Pfizer acquired the US-based neurological disease-specializing company Biohaven and its pipeline of calcitonin gene-related peptide (CGRP) inhibitors including zavegepant, in May for USD 11.6 billion. Nurtec restores pain to normal in acute migraine patients within an hour, with efficacy lasting up to 48 hours. The drug is an orally disintegrating tablet that is administered under the tongue without water, allowing easy intake. When Nurtec was approved in China in January this year, the approval was based on the results of a Phase III study (NCT04574362) conducted in South Korea and China. The trial met its primary endpoint of freedom from pain and resolution of most migraine-related most bothersome symptoms (MBS), including nausea, sound phobia, or photophobia, in 2 hours after oral administration. In the Phase III study, which included 1,431 patients at 13 centers in South Korea, including Seoul National University Hospital, and 73 centers in China, pain relief 2 hours after dosing was 20% with Nurtec and 11% with placebo, and improvement in migraine-related MBS was 50% with Nurtec and 36% with placebo.
