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- 2026-05-12 00:18:36
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- Gastric cancer is the first immuno-oncology option available
- by Eo, Yun-Ho Mar 13, 2023 05:53am
- In the field of gastric cancer, attention is paid to whether the first immuno-oncology drug insurance benefit registration can be achieved. As a result of the coverage, it is possible to propose the HIRA in April for Opdivo, an immune anticancer drug with PD-1 inhibitory mechanism, from Ono Korea Pharmaceuticals and Korea BMS Pharmaceuticals. In June 2021, Opdivo added an indication for 'combination therapy with fluoropyrimidine-based and platinum-based chemotherapy as the first-line treatment for advanced or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma' in Korea. It is the first and only approved immune anti-cancer drug in Korea for first-line gastric cancer treatment. This drug failed to pass the HIRA committee in February of last year and submitted a re-application, and passed the cancer disease review committee in June of the same year. If it is presented to the committee in April and passed, it is expected that the first half of the year will be possible at the earliest. Opdivo was also recognized for its benefit adequacy in the UK at the end of last year. The National Institute of Health and Clinical Excellence recently recommended Opdivo for use in chemotherapy-naive patients with PD-L1 expression, HER-2 negative, advanced metastatic gastric cancer or gastroesophageal junction cancer, and esophageal adenocarcinoma. Gastric cancer is currently the second largest cancer after lung cancer, and the need to expand the reimbursement of immuno-anticancer drugs is on the rise. Gastric cancer is a typical cancer type that ranks first in the prevalence of cancer and the fourth leading cause of cancer death in Korea. If detected early, the survival rate is good, but when distant metastasis progresses, the 5-year relative survival rate drops sharply to 5.9%. In particular, HER2-negative gastric cancer patients, who account for 90% of advanced gastric cancer patients, have been receiving chemotherapy as a standard treatment since there has been no newly approved new drug in the first-line treatment for the past 10 years. Opdivo could be an alternative for these patients.
- Policy
- Pfizer’s Cibinqo to undergo NHIS negotiations for reimb
- by Lee, Tak-Sun Mar 13, 2023 05:53am
- (From top to bottom) Dupixent Prefilled Inj., Rinvoq ER Tab., and Cibinqo Tab attempts reimb to treat pediatric and adolescent AD Pfizer has accepted the conditions set by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee for the reimbursement of its Cibinqo Tab (abrocitinib) in Korea. The drug received conditional approval at the DREC meeting that was held on March 2. The committee deemed Cibinqo’s reimbursement will be adequate if the company accepts a price less than the assessed amount. According to industry sources on the 12th, Pfizer accepted DREC’s conditions and is moving on to the pricing negotiation stage with HIRA. DREC’s proposed assessment price is expected to be set at the same level or below the weighted average price of its alternatives. Other JAK inhibitors that are currently available in the market include Olumiant Tab (baricitinib, Lilly) and Rinvoq ER (upadacitinib, Abbvie), therefore, Cibinqo’s price is expected to be set below the weighted average price of these drugs. After the Ministry of Health and Welfare orders pricing negotiations, Pfizer will be conducting negotiations with the NHIS for Cibinqo’s reimbursement. Although the statutory period set for NHIS negotiations is 60 days, if Pfizer accepts a price less than the upper limit set and receives negotiation exclusions, the company can further reduce the NHIS negotiation period to 30 days. If negotiations are completed in a short period of time, the industry expects Cibinqo may be listed for reimbursement in May at the earliest. Currently, Dupixent (dupilumab, Sanofi), Cibinqo, and Rinvoq are undergoing the reimbursement listing process as a treatment for pediatric·adolescent patients with atopic dermatitis. Among the three drugs, Dupixent has been making the most rapid progress. The drug entered negotiations last month and is expected to be listed for reimbursement next month at the earliest. Rinvoq ER, which is already listed as a treatment for atopic dermatitis in adult patients, is also attempting to extend its reimbursement as a treatment for adolescent patients aged 12 years or older with moderate-to-severe atopic dermatitis. Rinvoq ER’s reimbursement to the indication has passed HIRA review by applying the scope of use expansion formula and is set to receive NHIS negotiations soon. As Rinvoq and Cibinqo are both oral JAK inhibitors aiming to receive reimbursement as a pediatric atopic dermatitis treatment, their pricing negotiations will likely be conducted at the same time and be listed at a similar period.
- Company
- GC Pharma begins develop of mRNA flu vaccine candidates
- by Hwang, Jin-joon Mar 10, 2023 05:50am
- GC Pharma researcher is conducting drug research. (Photo by GC Pharma)Invested in mRNA pilot production facilities in Hwasun Vaccine Plant in Jeollanam-do. GC Pharma announced on the 9th that it will apply Acuitas Therapeutics' Lipid Nano Particle (LNP) technology to develop mRNA flu vaccine candidates in earnest. GC Pharma signed an LNP-related Development and Option Agreement with Acuitas in Canada in April of last year. Through the study, the possibility of developing an mRNA flu vaccine was confirmed. We recently exercised our non-exclusive licensing agreement option for the LNP. LNPs safely transport nanoparticles into cells in the body to help mRNA function. It is a key technology required for mRNA-based drug development. The LNP technology owned by Acuitas, a company specializing in the development of LNP delivery systems, was also applied to Pfizer's COVID-19 vaccine COMIRNATY. GC Pharma plans to conduct a phase 1 clinical trial of its mRNA vaccine candidate in 2024. GC Pharma also started investing in mRNA production facilities. It decided to invest in mRNA trial production facilities at its Hwasun plant in Jeollanam-do, which produces the existing flu vaccine.
- Policy
- Industry unsatisfied with the proposed PVA improvements
- by Lee, Tak-Sun Mar 10, 2023 05:50am
- Companies that have released new drugs in Korea have expressed discontent over the measures to improve the price-volume agreement (PVA) system that had been recently disclosed by the National Health Insurance Service. The new measure will put drugs that undergo PVA Type A negotiations at a relative disadvantage. According to the measures for the improvement of the PVA system that were disclosed at a roundtable meeting with the press corp, the improvement contained measures to change the ‘drugs whose claims have increased by 30% or more’ condition for PVA Type A negotiations to ‘drugs whose claims have increased by 10% or more or have claims amount that exceeds KRW 5 billion.’ PVA Type A had currently only been applied to drugs whose annual claims amount increased by 30% or more from the expected claims amount during the 3 years after reimbursement listing. Each company agrees to a certain amount during negotiations with the NHIS. However, if the NHIS applies the additional measures to the system, even drugs whose claims amount had increased by only 10% will be subject to PVA if the total amount exceeds KRW 5 billion. Regarding the measure, an industry official said, “If the KRW5 billion and 10% increase condition is added to PVA Type A, this will come as a burden to companies that develop new drugs in Korea. Adding more price discount mechanisms to homegrown new drugs may discourage the local pharmaceutical companies from developing new drugs.” The official added, “The measure to vary the drug price discount rate according to the claims amount is nothing new as this was previously announced by the NHIS, but the conditions that are being added to PVA Type A require some thought. The NHIS’s improvement plan contains measures to differentiate the price cut rate into three categories according to the magnitude of the claims amount and proposes calculating the maximum discount rate based on a reference formula. In other words, the NHIS plans to differentiate the discount rate according to the claim size. On the other hand, small and mid-sized pharmaceutical companies seem to be looking forward to NHIS’s additional measures. This is because the plan offers measures that raise the annual claims amount of drugs subject to PVA negotiations from KRW 2 billion to KRW 3-5 billion. If this exclusion criteria is applied to products with an annual claims amount of KRW 5 billion as well, most products by small and mid-sized pharmaceutical companies will be excluded from receiving price discounts. Another industry official said, “The research service results that contain HIRA’s proposals have not been disclosed yet, and a working group to promote the system is scheduled to commence in May, so we are not at the stage to guess how the final plan will come about. We will have to internally discuss and weigh the advantages and disadvantages of the proposed measures.”
- Company
- Myelofibrosis New Drug Inrebic
- by Eo, Yun-Ho Mar 10, 2023 05:50am
- Inrebic, a myelofibrosis treatment option born 10 years after Jakavi, is accelerating its steps toward insurance coverage. As a result of the coverage, BMS Pharmaceutical's myelofibrosis treatment Inrebic is in the process of drug price negotiations with the NHIS. Depending on the negotiation date, it is expected that it will be possible to determine whether or not to register in April. Inrebic was approved in Korea in April of last year for the treatment of splenomegaly or symptoms related to primary myelofibrosis, polycythemia vera, and myelofibrosis after essential thrombocythemia in adult patients previously treated with Jakavi. An application for reimbursement was submitted, but in June of last year, it failed to pass the HIRA, after re-application, it passed both the Cancer Disease Review Committee and the Pharmaceutical Reimbursement Evaluation Committee last month. This drug is a JAK-2 inhibitor and is expected to be different from Jakavi, a JAK1/2 inhibitor. Inrebic is the first to obtain approval for an oral once-a-day drug that greatly reduces the burden of spleen volume and symptoms in patients with myelofibrosis who have not had a history of treatment. Myelofibrosis is a rare blood cancer that affects the bone marrow and interferes with the body's normal production of blood cells. Patients suffer from symptoms such as an enlarged spleen, fatigue, itching, weight loss, night sweats, fever, and bone pain, which affect their quality of life. experience symptoms. Jakavi was the only JAK inhibitor approved for the treatment of myelofibrosis, and there was no alternative for patients who failed treatment. Inrevic is a treatment that appeared 10 years after Jakavi in the myelofibrosis market, where there was no second-line treatment option. Inrebic is currently covered through the Cancer Drug Fund in the UK. In 2021, NICE refused to apply Inrebic for NHS coverage. However, CDF recommends the use of Inrebic within its oncology fund for the treatment of splenomegaly or other symptoms associated with the disease in patients with myelofibrosis who have previously been treated with Jakavi.
- Company
- Enbrel's share is 44% and Herceptin's share is 37%
- by Kim, Jin-Gu Mar 10, 2023 05:50am
- Mabthera, Avastin, and Humira similars also saw a sharp rise in market share new product addition effect. The share of biosimilar products in the domestic market is rapidly expanding. Enbrel biosimilars Etanercept increased its market share from 12% in 2018 to 44% last year. Herceptin similars also expanded from 9% to 37% during the same period. ◆Eucept and Remaloce, Enbrel similar, had a 44% market share with sales of 8.1 billion won last year According to IQVIA, a pharmaceutical market research institute, on the 10th, the market for Etanercept ingredient treatment last year was 18.2 billion won. Pfizer Enbrel, the original product, recorded 10.1 billion won and Enbrel biosimilar 8.1 billion won, respectively. In terms of market share, original drugs accounted for 56% and biosimilars 44%. The market share of biosimilars has risen significantly over the past four years. In 2018, Enbrel's biosimilar market share was only 12%, but it increased by 32%p in 4 years, greatly narrowing the gap with the original. LG Chem's Eucept and Samsung Bioepis' Remaloce have been released as Enbrel biosimilars. Last year's sales were 4.1 billion won for Eucept and 4 billion won for Remaloce. Until now, biosimilars have been evaluated as not impacting the domestic market, unlike Europe and the United States. It is analyzed that recently, biosimilar products are gradually increasing their influence in Korea. It is analyzed that new products have been steadily released, centered on Samsung Bioepis and Celltrion, and the preference for similar products has gradually increased in the prescription field. ◆Herceptin-similar market share 9% → 37%/ Avastin similar achieved 21% in 1 year Other biosimilars have also significantly increased their market share recently. In the case of the trastuzumab market, the share of Herceptin biosimilars increased by 28%p in 4 years from 9% in 2018 to 37% last year. Celltrion Herzuma and Samsung Bioepis Samfenet were released as Herceptin biosimilars. Last year, sales were 29 billion won for Herzuma and 5.6 billion won for Samfenet. Herzuma's sales increased 3.7 times in 4 years from 7.7 billion won in 2018 to last year. Samfenet increased 2.5 times in 3 years from 2.2 billion won in 2019. The original Herceptin sales decreased by 25% from 80 billion won in 2018 to 60 billion won last year. Original's market share declined from 91% to 63%. Avastin biosimilars are also rapidly expanding their market share. Samsung Bioepis released the Avastin biosimilar Onbevezy in the fourth quarter of 2021. Onbevezy, which recorded sales of 500 million won in the first year of its release, saw its sales skyrocket to 20.5 billion won last year. As sales soared, Onbevezy's Bevacizumab market share quickly expanded to 21%. Here, Celltrion Vegzelma, Alvogen Korea Alymsys, and Pfizer Korea Pharmaceutical ZIRABEV are aiming to enter the market. If these products are added in earnest, the share of biosimilars in the Avastin market is expected to rise further. Mabthera biosimilars' share in the rituximab market increased from 8% in 2018 to 25% last year. Currently, Celltrion's Truxima is sold alone. Humira biosimilars recorded a 9% market share last year. Samsung Bioepis released Adalloce in the third quarter of 2021, and Celltrion released Yuflyma in the third quarter of last year. Sales last year were 7.6 billion won for Adaloch and 500 million won for Yuflyma. Remicade biosimilars recorded a 38% market share last year. Celltrion Remsima posted 29.3 billion won in sales last year, and Samsung Bioepis Remaloce posted 4.9 billion won in sales. The original Remicade's sales are 55.5 billion won.
- Policy
- Dupixent, Cibinqo, Rinvoq to be reimb for pediatric AD in 1H
- by Lee, Tak-Sun Mar 10, 2023 05:49am
- The three drugs that are attempting to receive reimbursement as a treatment for pediatric·adolescent patients with atopic dermatitis - Dupixent (dupilumab), Cibinqo (abrocitinib), and Rinvoq (upadacitinib) – are expected to be approved for reimbursement within the first half of the year. With all 3 drugs passing the Health Insurance Review and Assessment Service’s deliberations, only the pricing negotiation process with NHIS remains for the three drugs. This is why analysts believe the drugs will be listed for reimbursement within June this year. In the case of Sanofi’s Dupxient Prefilled Inj (200·300mg), the drug’s reimbursement adequacy was accepted by HIRA’s Drug Reimbursement Evaluation Committee on January 12 and has been going through the drug price negotiation process with the NHIS from February. As Dupxient will be reimbursed through the risk-sharing agreement (RSA) system, there is a high possibility that negotiations with the NHIS will focus on the required financial expenditures and the pharmaceutical company’s contribution amount If the negotiations end this month, reimbursement may be applied as early as April and May. Pfizer’s Cibinqo (50·100·200mg) received conditional approval from DREC on March 2. The drug’s reimbursement was deemed adequate when the company accepts a price less than the assessment amount, and the industry expects that it is highly likely that Pfizer will accept the said conditions. This is because another JAK inhibitor and competitor, Abbvie’s Rinvoq ER, is also speeding up its reimbursement process. The company is attempting to expand Rinvoq ER’s reimbursement to its pediatric and adolescent indication and will be carrying out negotiations with the NHIS through the drug price discount formula that is used with the scope of use expansions. Rinvoq ER tab is listed at KRW 21,085 per tablet, and when applied the scope expansion formula, its price may be reduced by up to 5%. Industry analysis is that Cibinqo will likely be listed for reimbursement at Rinvoq’s price as well. The two drugs are both attempting to receive reimbursement as a treatment for patients aged 12 years or older with moderate-to-severe atopic dermatitis. The industry expects that all three drugs may likely be reimbursed within the first half of the year. An industry official said, “In the case of Dupixent, pricing negotiations will be made within the scope of its RSA contract, and pricing negotiations for Cinvinqo and Rinvoq will be conducted together and be applied the same reimbursement standards.”
- Company
- Sales of Kisqali surge, Ibrance decline
- by Jung, Sae-Im Mar 09, 2023 06:00am
- The market for cyclin-dependent kinases (CDK) 4/6 inhibitors that are used to treat metastatic breast cancer have undergone drastic changes last year. Sales of Ibrance, which used to dominate the market, had faltered, while the latecomer Kisqali rapidly expanded its share in the market . According to the market research institution IQVIA on the 8th, the domestic market for CDK 4/6 inhibitors increased 7.1% YoY from KRW 86.5 billion in the previous year to ₩92.6 billion last year. CDK, cyclin-dependent kinases, control cell division and growth. CDK 4/6 inhibitors selectively inhibit CDK 4/6 to suppress the proliferation of cancer cells. These drugs are mainly used to treat hormone receptor (HR)-positive or human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, which accounts for 60% of all breast cancers. Since the introduction of the first-in-class CDK 4/6 inhibitor, Pfizer’s Ibrance (palbociclib), Novartis’s Kisqali (ribociclib), and Lilly’s Verzenio (abemaciclib) are also available in the market. Ibrance, which overtook the market as the 'first-in-class' drug, experienced its first decline in sales last year. Ibrance’s sales fell 14.3% YoY from the KRW 65.6 billion in the previous year to record sales of KRW 56.2 billion last year. The drug, which had shown repeated growth since its launch, faced a decline in sales for the first time in six years. The first CDK 4/6 inhibitor Ibrance was developed by Pfizer and released in Q4 2016 in Korea. The drug offered a new treatment option for patients with HR+/HER2- metastatic breast cancer that were left to use chemotherapy for their disease that cannot be controlled with hormone therapies like aromatase inhibitors. Upon its release, Ibrance was received with high expectations in the market, being the first drug to demonstrate a PFS of over 2 years. Ibrance’s sales rose sharply from KRW 6.6. billion in 2017 to KRW 25.3 billion in 2018, KRW 43.7 billion in 2019, and then KRW 57.3 billion in 2020. The sales decline started with the introduction of its latecomers. Kisqali and Verzenio entered the market in 2020 and started expanding their presence ever since. Among the latecomers, Kisqali has been showing marked growth. Kisqali’s sales rose 143.6% YoY from the KRW 9.7 billion earned in the previous year to record KRW 23.7 billion last year. Although it had the lowest share of the market with annual sales of less than KRW 10 billion until 2021, its sales had risen to the KRW 20 billion range last year and exceeded Verzenio’s sales. The fact Kisqali is the only treatment option among CDK4/6 inhibitors that can be used in premenopausal breast cancer patients seems to have contributed to its rapid growth. Ibrance and Verzenio are only indicated for the treatment of postmenopausal women with metastatic breast cancer. However, Kisqali demonstrated its effect in premenopausal patients in clinical trials. Unlike in the West where premenopausal patients account for less than 30% of the patient population, these women account for 55% of the patient population in Korea, which explains the increased use of Kisqali. However, sales of Verzenio, which have risen sharply in 2021, had also slowed down somewhat. Verzenio’s sales increased 13.7% YoY from the KRW 11.2 billion in the previous year to KRW 12.7 billion last year. Verzenio is seeking to expand its market base this year after it had become the only CDK4/6 inhibitor allowed for use in early breast cancer. The Ministry of Food and Drug Safety additionally approved Vezenio as an adjuvant treatment for patients with HR+ /HER2- type lymph node-positive, early breast cancer at high risk of recurrence. This is the first time a new drug was approved for early breast cancer after the approval of aromatase inhibitors.
- Policy
- Multiple myeloma CAR-T therapeutic agent CARVYKTI, imminent
- by Lee, Hye-Kyung Mar 09, 2023 06:00am
- CARVYKTI compares self -hematopoietic stem cell transplantation (ASCT) after administration of Daratumumab, Bortezomib, Lenalidomide, and DVRD in December last year. The clinical trial was conducted. According to the industry on the 8th, the Ministry of Food and Drug Safety recently completed the safety and validation of Carvykti. If the Efficacy & Safety screening is completed without any problems, product permission will be made soon. CARVYKTI is a T -cell immunotherapy that is derived from BCMA targeted genetic variant. The US FDA has previously been allowed to treat reissue or rebel-resistant multiple myeloma adult patients with four or more treatments, including proteasome inhibitors, immunomodulators, and CD38 monoclonal antibodies. The European Executive Committee (EMA) has granted CARVYKTI a conditional sale of at least three treatments, including immunomodulators, protease inhibitors, and CD38 monoclonal antibodies. Japan has no experience in receiving BCMA target CAR positive T cell injection treatment and has approved Carvykti as a treatment for recurrent or rebellious adult patients with three or more treatments. Korea is also likely to be permitted as a patient treatment that has performed ASCT after the administration of DARATUMUMAB, BORTEZOMIB, Lenalidomide, and DVRD. CAR-T therapeutic drugs that challenge hematopoietic stem cell transplantation include BMS's Breyanzi and Gilead's YESCARTA.
- Company
- Childhood dementia Tx Xenpozyme to soon land in KOR
- by Eo, Yun-Ho Mar 09, 2023 06:00am
- The first childhood dementia treatment is expected to be commercialized in Korea soon. According to industry sources, the Ministry of Food and Drug Safety is conducting the final review to approve Sanofi Genzyme’s treatment for acid sphingomyelinase deficiency (ASMD)m ‘Xenpozyme (olipudase alfa).’ Starting with Japan in March, the drug was also approved in Europe in July and by the US FDA in August and received Breakthrough Therapy designation in the countries. The drug received final review in July and September in Europe and the US, respectively. The efficacy of Xenpozyme, the only existing ASMD treatment, was identified through the ASCEND and ASCEND-Peds trials. The ASCEND trial evaluated the efficacy and safety of Xenpozyme in 36 adult patients with ASMD type A/B or type B. The patients were randomized to receive Xenpozyme or a placebo for 52 weeks (primary analysis). At Week 52, Xenpozyme improved pulmonary function from baseline by 22% in the predicted diffusing capacity of carbon monoxide (DLco). Compared with the 3% improvement shown in the placebo group, the difference between the two treatment arms of 19% was statistically significant. Also, at Week 52, patients treated with Xenpozyme had a mean reduction in spleen volume by 39.5% compared with the 0.5% increase in the placebo group. All patients that were treated with Xenpozyme showed an improvement in one or two primary endpoints. The single-arm ASCEND-Peds trial studied 20 pediatric patients younger than 12 years of age with ASMD type A/B or type B. The primary objective of the trial was to evaluate the safety and tolerability of Xenpozyme for 64 weeks, and the explored efficacy endpoints of progressive lung disease, spleen, and liver enlargement, and platelet count were also explored in the trial. The nine patients who could take the test for DLco in the trial showed a 33% improvement in diffusing capacity after 1 year. The patients also showed a mean reduction in spleen volume of 49%. Meanwhile, ASMD is caused by the lack of an enzyme needed to break down a complex lipid, called sphingomyelin, which accumulates in the liver, spleen, lung, and brain. Patients with ASMD experience enlarged abdomens at 3 to 6 months of birth. The most severely affected patients have profound neurologic symptoms and rarely survive beyond two to three years of age.
