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- 2026-05-01 00:58:01
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- HLB shares plummet upon 2nd FDA rejection of rivoceranib
- by Cha, Jihyun Mar 25, 2025 05:54am
- The shares of HLB Group affiliates plummeted as HLB's new drug for liver cancer failed to enter the US market again. The total market capitalization of HLB Group stocks evaporated by over KRW 3 trillion in a single day. However, this did not cause a simultaneous drop in domestic bio stocks. HLB Group's 10 listed affiliates evaporate by KRW 3 trillion in a single day upon receiving a second Complete Response Letter (CRL) According to the Korea Exchange on the 22nd, HLB closed at KRW 46,500 on the 21st. This is a 29.97% drop from the previous trading day. The day before, HLB's share price plunged to the price floor immediately after the opening and remained at this price until the closing time. The market capitalization evaporated by KRW 2.6147 trillion in a single day as the stock price hit the floor. HLB's market capitalization was KRW 8.7241 trillion based on the closing price on the 20th, but it plunged to KRW 6.1095 trillion based on the closing price on the 21st. HLB's share price fell sharply after its new drug for liver cancer failed to enter the US market. HLB said on its official YouTube channel at 3 a.m. on the 21st that it had received a CRL from the US Food and Drug Administration (FDA) for its rivoceranib+camrelizumab. In May last year, the company received a CRL completed the supplementary work, and submitted the required documents for a second review, but received another CRL. Upon the news of HLB’s CRL receipt was announced, the share prices of HLB Group’s stocks fell across the board. HLB Global, HLB Life Sciences, HLB Pharma, and HLB PanaGene all recorded the lowest opening price on the 21st. The opening prices of HLB affiliates on the 21st were KRW 2,535 for HLB Global, KRW 5,990 for HLB Life Sciences, KRW 17,100 for HLB Pharma, and KRW 1,665 for HLB PanaGene, down 29% from the previous trading day. HLB bioStep and HLB Innovation also opened at a price 26% lower than the previous day's closing price. HLB Genex and HLB Science opened at a price 21% and 15% lower than the previous day's closing price. The ten HLB Group’s listed affiliates showed a downward trend throughout the day. HLB (-29.97%), HLB Life Sciences (-29.94%), and HLB Pharma (-29.92%) closed at the floor price. HLB Global (-18.09%), HLB Genex (-15.54%), HLB Science (-14.95%), HLB bioStep (-14.71%), HLB PanaGene (-14.32%), HLB Therapeutics (-7.37%), and HLB Innovation (-6.60%), also closed at a low price. As a result, KRW 3.3226 trillion of the total market capitalization of HLB Group shares was lost in a single day. As of the closing price on the 20th, the market capitalization of the 10 listed affiliates of HLB Group totaled KRW 12.924 trillion. As of the closing price on the 21st, the total market capitalization of these affiliates was KRW 8.7698 trillion. As of the closing price on the 21st, KRW 8 trillion of the market capitalization of HLB Group stocks had evaporated compared to the end of last month. The stock prices of HLB Group's listed affiliates suddenly soared on the 27th of last month. The analysis was that the rise was the result of the combined expectations for new drug approvals and the successive stock purchases of HLB Group Chairman Yang-gon Jin, the owner. At the time, the total market capitalization of HLB Group stocks reached KRW 16.5843 trillion. A similar situation occurred last year when the company received its first CRL. The total market capitalization of the 9 HLB Group’s listed affiliates, excluding HLB Genex, which the company acquired at the end of last year, fell by KRW 5.274 trillion from the previous day on May 17 last year, when the news of the failure to obtain approval for the use of rivoceranib+camrelizumab was announced. At an online press conference on the morning of the 21st regarding the CRL notification, Chairman Yang-gon Jin said, “I think that the shareholders as well as our employees at HLB Group are disappointed by the receipt of this CRL. I would like to express my regrets about this and will actively communicate through meetings after the shareholders' meeting.” However, HLB’s situation did not affect the domestic bio-sector. On the 21st, Sam Chun Dang Pharm, Kolon TissueGene, and LigaChem Biosciences showed a strong trend despite the news of the CRL for rivoceranib+camrelizumab. On the 21st, the closing price of Sam Chun Dang Pharm was KRW 188,800, up 7.64% from the previous day. The closing prices of Kolon TissueGene and LigaChem Biosciences on the 21st also rose 6.88% and 1.72%, respectively, from the previous day. Peptron (+4.29%), PharmaResearch (+2.35%), and Hugel (+1.21%) also closed up. This is in contrast to a past case in which the failure of a company to receive approval for a new drug dampened investment sentiment in the entire biotech industry. Domestic biotech stocks fell in tandem shortly after the announcement of the suspension of the clinical trial of SillaJen's liver cancer treatment 'Pexa-Vec' in 2019 and the failure of its clinical trial on Helixmith's diabetic neuropathy (DPN) gene therapy ‘Engensis' (VM202) in 2020. As a result, investor sentiment froze, and biotech stocks experienced dark ages for a while. Acquired from Bukwang Pharmaceutical in 2018, final data released at ASCO last year demonstrated OS extension Rivoceranib is an oral targeted anticancer drug of the vascular endothelial growth factor receptor 2 (VEGFR2) inhibitor class, which is involved in the formation of new blood vessels in tumors. The drug was developed in 2005 when US-based Elevar Therapeutics bought the global rights to rivoceranib from the Advenchen Laboratories. Bukwang Pharmaceutical, which recognized the potential of rivoceranib, secured the rights to sell the drug in Korea, Europe, and Japan from Elevar Therapeutics in 2009. HLB Life Sciences acquired the development rights to rivoceranib from Bukwang Pharmaceutical in 2018 for KRW 40 billion. HLB then acquired the product patent rights for rivoceranib in 2020 and capitalized on it as its material. HLB has been developing a rivoceranib+camrelizumab combination therapy with Jiangsu Hengrui Pharmaceuticals as a treatment for liver and stomach cancer. Camrelizumab, which was developed by Jiangsu Hengrui Pharmaceuticals, is an immuno-oncology drug that inhibits the PD-1 protein expressed on the surface of immune cells (T cells), preventing them from binding to the PD-L1 receptor on the surface of cancer cells and activating immune cells. HLB applied for an NDA to the FDA in May 2023 for the rivoceranib+camrelizumab combination as a first-line treatment for liver cancer. The results of the Phase III CARES-310 study, which was presented by HLB and Jiangsu Hengrui Pharmaceuticals at the 2022 European Society for Medical Oncology (ESMO) Congress, were presented as grounds for its approval. The clinical trial was conducted to compare the efficacy and safety of lenvatinib and camrelizumab with that of Bayer's Nexavar, which is the current standard of care for liver cancer. In the study, rivoceranib+camrelizumab recorded a median overall survival (mOS) of 22.1 months, showing improved results compared to Nexavar’s 15.4 months. This result showed a longer OS than the 19.2 months found with Roche's combination therapy of the immuno-oncology drug Tecentriq and the targeted-oncology drug Avastin, which has been approved as a first-line treatment for liver cancer, and the OS of 16.4 months for AstraZeneca's combination therapy of the immuno-oncology drug Imfinzi and Imjudo. The clinical trials for the combinations comparing the respective combinations with Nexavar monotherapy. The progression-free survival (PFS) of rivoceranib+camrelizumab was 5.6 months, and the objective response rate (ORR) was 33.1%. HLB also released final results that were even better than the clinical phase III trial results previously announced at the American Society of Clinical Oncology (ASCO) meeting last year. According to the results announced by HLB at the ASCO Annual meeting in May last year, the OS of rivoceranib+camrelizumab was 23.8 months, which was longer than the previous results of 22.1 months. HLB has included the additional improved data during re-submission to the FDA.
- Company
- The first RSV vaccine 'Arexvy' to launch in May in Korea
- by Whang, byung-woo Mar 25, 2025 05:54am
- As the launching date of Arexvy, known as the first respiratory syncytial virus vaccine, has been announced, the company aims to challenge a market share. Product photo of ArevyAccording to industry sources on March 22, GSK Korea has confirmed the launching date of the RSV-LRTD vaccine, Arexvy, as May. Arexvy received approval from the Ministry of Food and Drug Safety (MFDS) at the end of December 2024 for the 'Prevention of lower respiratory tract disease (LRTD) caused by RSB in adults over 60 years of age and older.' Approval of Arexvy was based on results from two Phase 3 studies, 'RSV OA=ADJ-006' and 'RSV OA=ADJ-004,' involving adults 60 years of age and older. The study results showed that during the first RSV season, Arexvy significantly lowered the RSV-LRTD risk by 82.6% and severe RSV-LRTD risk by 94.1% in participants 60 years of age and older compared to placebo. Furthermore, the efficacy of the vaccine regarding RSV-A-associated LRTD increases and RSV-B-associated LRTD increases were 84.6% and 80.9%, respectively. Arexvy has quickly secured the rank as the blockbuster product in the global market based on its first-in-class RSV vaccine title. The drug's influence in South Korea is gaining attention. If Arexvy launches in May, vaccination using the drug will likely begin in June, considering hospital landing settings. The remaining issue is how much the health authority considers RSV disease burden in seniors. Health authorities in major countries recommend RSV vaccination. However, the Center For Disease Control (CDC)'s Advisory Committee on Immunization Practices (ACIP) has narrowed the scope of vaccination. Previously, ACIP recommended vaccination in all adults of 60 years and older after consulting doctors. The ACIP has recently reduced the scope to adults 75 years and older or adults 60 to 74 years who have a high possibility of developing severe symptoms. In South Korea, some view that people would be less interested in Arexvy than the antibody injection for young children, Beyfortus (nirsevimab). Professor A from a department of infectious disease at one of the tertiary general hospitals in Seoul said, "Theoretically, RSV may likely affect those who are immune-compromised or older age. However, vaccines may not likely gain attention like those for newborns and young children," adding, "An additional investigation and evaluation may be needed to determine the potential impact since an adequate evaluation on disease burden has not been thoroughly established yet." In other words, even if a RSV vaccine targeting seniors are released, it may not immediately expand market compared to those targeting young children. Yet, potential demand may increase after the introduction of vaccine, as there has been little interest in the RSV vaccine for seniors. Considering these factors, GSK Korea will likely focus on raising awareness of RSV prevention along with Arexvy's launch. Hyunji Kwon, GSK Korea's Vaccine Business Unit Head, said, "RSV infection poses a significant physical and economic burden on high-risk groups, such as seniors. GSK will put efforts into preventing adult infections and relieving the disease burden of Korean patients after the successful launch of Arexvy."
- Policy
- New law proposed for the cancer and rare disease fund
- by Lee, Jeong-Hwan Mar 25, 2025 05:54am
- A bill to establish a new fund for cancer and rare diseases to strengthen patient access to ultra-high-priced drugs has been proposed to the National Assembly. The fund will be raised through transfers and deposits from other funds, such as the lottery fund. On the 24th, National Assembly member Myeong-ok Seo (People Power Party), a member of the National Assembly's Health and Welfare Committee, announced that she had submitted a bill to establish the Cancer Management Fund and the Rare Disease Management Fund. The main points of the bill include ▲the establishment of a cancer management fund for the prevention and treatment of cancer (amendment to the Cancer Management Act), ▲the establishment of a rare disease fund for the prevention and treatment of rare diseases (amendment to the Rare Disease Management Act), ▲the establishment of a basis for the establishment of the fund in the National Finance Act (amendment to the National Finance Act), and ▲the establishment of grounds for the use of the lottery fund (amendment to the Lottery Tickets and Lottery Fund Act). According to the data that Rep. Seo received from the Health Insurance Review and Assessment Service, it took an average of 332 days for an anticancer drug to be listed for reimbursement in Korea from 2014 to 2024. In particular, in the case of anticancer drugs for blood cancer and lung cancer, there were cases where it took 600 to 800 days to listing. To address this, the UK operates an anticancer drug fund and a rare drug fund. Italy also has a rare disease drug fund that is financed with 5% pharmaceutical sales promotional expenses and government funds. Although there have been attempts to establish a new cancer management fund in Korea, the attempts have been frustrated by the opposition of financial authorities, with repeated calls on the need for realistic solutions to raise necessary finances. “Currently, about KRW 85 billion of the National Health Promotion Fund is being spent on cancer prevention and treatment, so it is not impossible to use it as the source of funding as it is while using a portion of the lottery proceeds, which have been increasing rapidly recently,” explained Seo. According to recent reports, lottery sales have risen by an average of KRW 450 billion per year since 2020. Next year, lottery ticket sales are expected to exceed KRW 8 trillion for the first time in history. “In a situation where it is becoming structurally difficult to apply health insurance reimbursement to treatments for patients with cancer and rare diseases, the establishment of the fund is a matter directly related to the lives of the people,” said Rep. Seo. “I hope that the bill will prompt forward-looking discussions.”
- Company
- 'Xeljanz' reimbursed for juvenile idiopathic arthritis
- by Eo, Yun-Ho Mar 24, 2025 05:52am
- Product photo of Xeljanz'Xeljanz' has become the first JAK inhibitor to be reimbursed for the treatment of juvenile idiopathic arthritis. The Ministry of Health and Welfare (MOHW) has recently announced on the administrative notification board regarding the 'The Criteria and Scope of National Health Insurance (Pharmaceuticals)' that the reimbursement criteria for Pfizer Korea's Xeljanz (tofacitinib) will be expanded from April. Xeljanz can be used to treat children (age 2 to 17) diagnosed with juvenile idiopathic arthritis according to the ILAR criteria (2001 revision), including ▲Polyarticular arthritis that affects five or more joints ▲Extended oligoarthritis ▲Psoriatic arthritis ▲Those who discontinued treatments due to inadequate response to one or more biological agent or side effects. After 6 months of usage, an additional 6-month usage will be approved if an assessment indicates a decrease of over 30% in the number of inflammatory joints compared to the initial administration timepoint. After that, the evaluation will be carried out every 6 months, and when the assessment result in the first 6 months is maintained, consistent administration will be approved. This reimbursement approval is the first among the JAK inhibitors. To date, 'Olumiant (baricitinib)' secured the same indication in September last year but is still non-reimbursed. Similarly, 'Rinvoq (upadacitinib)' has not been domestically approved for treating idiopathic arthritis. Following the patent expiration of Xeljanz, Pfizer has made efforts to increase product competitiveness by changing formulations in many ways. In 2020, the company launched an extended-release formulation with fewer administrations for various arthritis treatments. In 2023, Pfizer also launched a syrup formulation that is more convenient to administer to pediatric patients. It is to be watched whether Xeljanz, with an opportunity to take the market share, prescription will increase in the idiopathic arthritis area. Meanwhile, the efficacy of Xeljanz was demonstrated through the Phase 3 'JIA-I' trial. The study compared the effectiveness and safety of the drug to a placebo in 225 patients aged 2 years and above and those aged 18 years and below. In the study, Xeljanz tablet or syrup formulation (dosage depending on the weight range; 5 mg was administered less than twice a day) was administered for 18 weeks. Patients (142 individuals) who reached the JIA ACR 30 (symptom improvement over 30%) were divided into Xeljanz and placebo groups. The results at week 44 confirmed that the symptom worsening in the Xeljanz group (29%, 72 individuals) was significantly lower than those in the placebo group (53%, 70 individuals). During the same period, the rate of reaching the JIA ACR30∙50∙70 (30∙50∙70% symptom improvement) was higher in the Xeljanz group. Physical function measured by the Childhood Health Assessment Questionnaire (CHAQ) also confirmed significant improvement in the Xeljanz group (-0.11) compared to the placebo group (0.00).
- Company
- RSV vaccine Beyfortus lands in Big 5 Hospitals in Korea
- by Eo, Yun-Ho Mar 24, 2025 05:52am
- The respiratory syncytial virus (RSV) preventive antibody injection ‘Beyfortus’ has landed in the Big 5 tertiary hospitals in Korea. According to industry sources, Sanofi Korea's Beyfortus (nirsevimab) has passed the drug committees (DCs) of the Big 5 tertiary hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Severance Hospital. In addition, the drug has also landed at medical institutions such as Gangnam Severance Hospital, Korea University Anam Hospital, Korea University Ansan Hospital, Bundang Severance Hospital, and Pusan National University Yangsan Hospital. Also, Beyfortus vaccination has begun at local clinics since February. SK Bioscience is in charge of Beyfortus’s promotional activities for medical institutions at the clinic level. Beyfortus is an RSV preventive antibody injection that received approval from the Ministry of Food and Drug Safety in May last year and can be administered to all newborns and infants who are entering their first RSV season. Also, children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season may receive Beyfortus. Previously, RSV prevention products for infants and toddlers in Korea were only administered to high-risk infants and toddlers, such as premature babies, who are at high risk of severe RSV disease. However, Beyfortus is different in that it can be administered to all infants and toddlers. According to the Phase III MELODY trial, which was the basis for the approval of Beyfortus, RSV lower respiratory tract infections were reduced by 74.5% in the Beyfortus-administered arm. This study evaluated the efficacy of Beyfortus against RSV infection with medical management up to 150 days after administration in 3,012 infants born after 35 weeks of gestation in their first RSV season. In addition, according to the interim results of the national vaccination program being implemented in Galicia, Spain, real-world evidence of Beyfortus, hospitalizations due to RSV in infants under 6 months of age who received Beyfortus were reduced by 82% compared to infants who did not receive Beyfortus. Ki-Wook Yoon, a Professor at Seoul National University Hospital, said, “RSV can infect people of all ages, but 90% of infants under the age of 2 are infected. When infected, it can lead to mild cold symptoms to hospitalization due to lung infection. Infants whose bronchial tubes are not fully mature can have more severe symptoms when they are infected with RSV, which can cause losses not only for family members but also to the society and economy.” He added, “Until now, RSV prevention was limited to personal hygiene practices, showing a clear unmet demand for RSV. However, we expect that active RSV prevention will become possible with the introduction of the preventive antibody injection.”
- Policy
- Tepmetko, Tevimbra granted reimbursement in Korea
- by Lee, Tak-Sun Mar 24, 2025 05:52am
- Tepmetko Tab 225mg (tepotinib, Merck Korea). New anticancer drugs Tepmetko and Tevimbra will be included in the list of reimbursed drugs as of April 1 in Korea. In addition, the economic burden on the patients is expected to be significantly reduced as the co-insurance rate for abiraterone acetate drugs such as Zytiga has been reduced for the first-line treatment of castration-resistant prostate cancer. The Health Insurance Review & Assessment Service has announced a revision to the notice regarding the drugs prescribed and administered to cancer patients and has entered the opinion survey period. The effective date is April 1. According to the revision, Tepmetko 225 mg (tepotinib, Merck Korea) is granted reimbursement for patients with locally advanced or metastatic non-small cell lung cancer with MET exon 14 deletion. HIRA said, “We set the reimbursement criteria by considering factors such as the fact that the applied drug is a drug with a clear target and can provide patients with another treatment option, and is a drug deemed necessary for medical treatment.” Tepmetko is the only MET-mutated anticancer drug that is covered by the National Health Insurance in Korea. According to the diagnosis of 1,020 patients with non-small cell lung cancer in Korea, 1.9% of patients were confirmed to have MET exon 14 deletion. In Phase II clinical trial which added a confirmatory test arm, Tepmetko showed an ORR of 51.4% (95% CI, 45.8-57.1), mPFS of 11.2 months (95% CI, 9.5-13.8), and mOS of 19.6 months (95% CI, 16.2-22.9), confirming its high therapeutic effect. This drug is recommended in major textbooks and guidelines of overseas academic societies. The insurance ceiling price of Tepmetko is reportedly KRW 76,500 per dose. It has signed a refund-type and expenditure cap-type Risk Sharing Agreement (RSA) to share the drug’s financial burden. Tevimbra Inj (tislelizumab, BeiGene Korea) is indicated as a monotherapy for patients with unresectable, relapsed, locally advanced, or metastatic oesophageal squamous cell carcinoma who are unable to continue platinum-based chemotherapy or who have relapsed or progressed within 6 months after receiving prior platinum-based chemotherapy. However, reimbursement is granted for patients who have not received treatment with an immune checkpoint inhibitor such as a PD-1 inhibitor. As an immuno-oncology drug that has a PD-1 inhibitory mechanism of action, its reimbursement listing in April will allow the drug to become the first immuno-oncology drug to be covered for esophageal cancer in Korea. The maximum amount of this drug is KRW 1,206,000 per bottle. Like Tepmetko, it is applied the refund type and expenditure cap type RSA. Meanwhile, the co-insurance rate for abiraterone acetate formulations such as Zytiga will be reduced from 30% to 5% for the first-line treatment of castration-resistant prostate cancer. Abiraterone is available not only as the original Zytiga (Janssen Korea) but also as generic versions supplied by Hanmi Pharmaceutical and Ace Pharmaceutical. This reduction in the co-insurance rate is also related to the entry of generics. The National Health Insurance Service said, “The reimbursement of the ‘next-generation hormone drug (all-trans retinoic acid, ATRA)’ for metastatic hormone-sensitive prostate cancer will gradually decrease the number of patients eligible for this treatment. The price of the drug has been reduced upon the listing of generics, etc, and the coinsurance rate for ‘abiraterone acetate + prednisolone’ as a first-line treatment for castration-resistant prostate cancer will be reduced from 30% to 5%." The ATRA-class next-generation hormone drug is Janssen's Erleada. Erleada was listed for reimbursement in April 2023.
- Policy
- How Tevimbra was reimbursed in Korea first
- by Lee, Tak-Sun Mar 24, 2025 05:52am
- BeiGene Korea's Tevimbra will be reimbursed in Korea from next month as a second-line treatment for esophageal squamous cell carcinoma, a type of esophageal cancer. It is the first immuno-oncology drug to be covered for esophageal cancer. In particular, the drug is drawing attention as it was covered in South Korea before the A8 countries (the United States, the United Kingdom, Germany, France, Italy, Switzerland, and Japan) known as the government’s reference countries for reimbursement coverage. The reason why the drug received prompt reimbursement in Korea is that the insurance authorities have taken into account Korea’s situation, where the prevalence of esophageal cancer is relatively higher than in other countries, and that the pharmaceutical company, BeiGene Korea, also presented a reasonable drug price. According to industry sources on the 21st, Tevimbra (tislelizumab, BeiGene Korea) will be reimbursed starting next month for unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma that has relapsed or progressed during or after previous platinum-based chemotherapy. It is the first PD-1 inhibitor-based immuno-oncology drug to be covered by the National Health Insurance for esophageal cancer. Squamous cell carcinoma accounts for the largest proportion of esophageal cancer, accounting for 91% of esophageal cancer cases. In particular, its prevalence is reportedly higher in East Asia compared to that in North American and European countries. Its prognosis is also poor. Most cases are detected when the disease has progressed to a significant degree, so the survival rate is not high. According to data from the Korea Central Cancer Registry, the 5-year relative survival rate for esophageal cancer from 2017 and 2021 was only 42.8%. Platinum-based chemotherapy is mostly used as the first-line treatment for esophageal cancer, and docetaxel is used as the second-line or later treatment. Compared to existing anticancer drugs, immuno-oncology drugs have shown significant improvements in overall survival but are not widely used because they are not reimbursed by the National Health Insurance. Due to this situation, the health authorities reportedly have given high scores for Tevimbra in terms of its clinical utility. Experts at the Drug Reimbursement Evaluation Committee said, “Compared to the chemotherapy group, Tevimbra showed a significant improvement in overall survival and is safer with a lower risk of side effects than chemotherapy. Currently, there are no immuno-oncology drugs reimbursed for esophageal squamous cell carcinoma in Korea, and due to the many limitations in treatment options, Tevimbra’s introduction is necessary.” Such expert opinions were heavily reflected in the review of the drug's adequacy of reimbursement. “The fact that the number of esophageal cancer patients in Korea is higher than in the US and Europe and that the prognosis is poor was taken into consideration,” said a HIRA official. “It was difficult to assess the drug because it was not listed for reimbursement in the A8 countries and was not mentioned in major reference textbooks, but the review was conducted with a focus on the drug’s clinical aspects.” Of course, there were results from clinical studies that showed significant improvements in overall survival and progression-free survival, but there were relatively few references to textbooks or other such materials. However, there was a clinical practice guideline - the NCCN guidelines in the United States – which recommended the drug as a second-line or higher monotherapy. The company’s proposal of a reasonable drug price was also granted for the drug’s prompt reimbursement. BeiGene Korea was recognized for its cost-effectiveness by submitting the results of a pharmacoeconomic evaluation compared to docetaxel and the results of a cost-utility analysis using RSA plans (refund and expenditure cap type). BeiGene Korea has announced that it will offer a low drug price to ensure the rapid supply of Tebipembrolizumab. It is reported that the drug will be supplied at a 10% discount from existing treatments in the United States. Currently, the only immuno-oncology drugs that are undergoing the reimbursement process for esophageal cancer are Keytruda and Opdivo. They have been approved as first-line treatments, not second-line treatments. However, unlike these drugs, Tevimbra has the advantage of being able to be used regardless of PD-L1 expression. Tevimbra is an anticancer drug developed in China in 2019. The domestic approval was granted in November 2023, and the drug was successfully listed for reimbursement in 1 year and 4 months. Its price is KRW 1,206,000 per bottle, and it is expected to cost about KRW 9.65 million per year. If the 5% co-insurance rate is applied, the annual drug cost for the patients will be reduced to about KRW 480,000, which is a relatively low price for an immuno-oncology drug.
- Company
- Bispecific multiple myeloma drug 'Talvey' can be prescribed
- by Eo, Yun-Ho Mar 21, 2025 06:00am
- Product photo of Talvey New bispecific multiple myeloma drug 'Talvey' can now be prescribed at general hospitals. According to industry sources, Janssen Korea's Talvey (talquetamab) has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center and Seoul National Univeristy Hospital, and medical institutes, including Pusan National University Hospital and Chung-Ang University Hospital. Talvey was approved by the Ministry of Food and Drug Safety (MFDS) as a monotherapy for adult patients with relapsed or refractory multiple myeloma who have received over three prior lines of treatments, including proteasome inhibitors, immune modulators, and anti-CD38 monoclonal antibody. Multiple myeloma is a type of cancer with the number of patients increased by over 60% in the past 10 years. Many patients with multiple myeloma experience relapse. According to a cohort study, multiple myeloma patients who had received more than three types of treatments, including anti-CD38 monoclonal antibody, demonstrated an overall response rate (ORR) of below 30%, with short life expectancy and poor prognosis. Consequently, patients needed a treatment option with a new mechanism. Talvey is a first-in-class bi-specific antibody drug approved in South Korea, targeting CD3 receptor and G protein-coupled receptor class C group 5 member D (GPRC5D). It can be administered to patients who had previously used proteasome inhibitors, immune modulators, or anti-CD38 monoclonal antibodies. The efficacy of Talvey was demonstrated through the global clinical trial, 'MonumenTAL-1 study.' The study results showed that 143 patients who do not have prior treatment experience with T-cell redirecting therapy were treated with Talvey 0.4 mg/kg every week. The patients treated with Tarvey had an ORR of 74.1% and a stringent complete response (sCR) of 24%. Patients demonstrated 10% complete response (CR) and 26% very good partial response (VGPR). Meanwhile, bispecific antibody drugs are immune cell therapy consisting of two monoclonal antibodies that recognize targeted antigens and T cells of multiple myeloma. For instance, bispecific IgG2 kappa antibody, consisting of two monoclonal antibodies that recognize B-cell maturation antigen (BCMA) and CD3 antigens, is commonly used. It is a new therapy that directly delivers cytotoxicity-triggering T-cells into multiple myeloma cells expressing BCMA. Bispecific antibodies approved in South Korea include Pfizer's 'Elrexfio (elranatamab)' and Janssen's 'Tecvayli (teclistamab),' and Talvey. These drugs remain as non-reimbursed drugs.
- Company
- Prevnar 20 added to the National Immunization Program
- by Whang, byung-woo Mar 21, 2025 05:59am
- Pfizer is signaling full-fledged competition with the addition of its new pneumococcal vaccine, Prevnar 20, to the National Immunization Program (NIP) for children. 프리베나20 제품사진According to industry sources on the 21st, the Korea Disease Control and Prevention Agency recently reviewed the introduction of PCV20 NIP for children during the 1st Korea Expert Committee on Immunization Practices meeting. As a result, the committee decided that PCV20 would be introduced under the NIP, for the same target population and standard immunization schedule as for PCV13 and PCV15, which were already covered through the NIP. Initially, it was widely believed that the entry of Prevnar 20 into the NIP would be delayed to next year because the Public Procurement Service announced a plan to execute a tender for the purchase of Prevnar 13, but discussions progressed with Pfizer compromising its price with the government. At the meeting, the committee allowed the cross-vaccination of Prevnar 20 as an exception for the additional immunization after completing basic immunization with Prevnar 13. Currently, the vaccine price and immunization practice for pneumococcal vaccines are fully covered by the government for children under the age of 12. Both Prevnar 13 and Prevnar 20 are administered once to adults aged 18 or older, but infants and those who have not received the basic vaccination are required to receive multiple doses at regular intervals depending on the number of months. For example, Prevnar 13 is administered 3 times at 0.5 mL per dose at 2, 4, and 6 months of age in infants up to 6 months of age, so those who started this vaccination with Prevnar 13 may receive subsequent vaccination with Prevnar 20. In fact, Prevnar 20 is indicated for “Infants, children, and adolescents who have received at least 1 dose of Prevnar/Prevnar 13 may switch to Prevnar 20.” Prevnar 20 is a new pneumococcal vaccine that Pfizer has introduced in 14 years, and it is a vaccine that adds 7 serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F) to the previously supplied Prevenar13. The industry believes that although Prevnar 13 is already on the market, the weight will naturally shift to using Prevnar 20. Pfizer is expected to accelerate preparations for the launch as the pediatric NIP, which had been a concern for the launch, has been resolved. The industry expects the launch of Prevnar 20 to take place in April, and the sales of Prevnar 20 for infants and toddlers will be maintained by Korea Vaccine, which was previously in charge of sales of Prevnar 13. The company is likely to employ a sales strategy that naturally absorbs the market share of its predecessor, Prevnar 13. In the case of Vaxneuvance, the company’s strategy is important as its competitor entered the market just one year after its launch. It is predicted its company will seek opportunities in the timing when people switch from Prevenar 13 to another vaccine. During the media seminar that was held last year for Vaxneuvance, Jaeyoung Cho, Executive Business Unit Director of Vaccines at MSD, said, “The number of infants and toddlers receiving their initial dose of the pneumococcal vaccine, which is covered through NIP, as well as those switching from the existing 13-valent vaccine to Vaxneuvance have been increasing.” “Like Vaxneuvance, which was also applied to the NIP upon its release, we expect Prevnar 20 to quickly expand its influence in the market,” said a vaccine industry official. ”Since both Prevnar 13 and 20 are Pfizer vaccines, the switching hurdle is relatively low, so MSD would likely be considering countermeasures.”
- Policy
- Enhertu’s reimb may be extended to gastric cancer
- by Lee, Tak-Sun Mar 21, 2025 05:59am
- The number of patients who can use the new antibody-drug conjugate (ADC) anticancer drug ‘Enhertu Inj (trastuzumab deruxtecan, Daiichi Sankyo Korea), which has been reimbursed since April last year, is expected to be expanded to cover eligible gastric cancer patients. This is an expansion in the scope of existing patients eligible for reimbursement. The Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee voted on the 19th to expand the reimbursement coverage of Enhertu. Enhertu is a next-generation ADC that combines a monoclonal antibody with the same structure as trastuzumab, which binds to a specific target receptor overexpressed on the surface of cancer cells, and a topoisomerase I inhibitor payload with a tumor-selective cleavable linker, which is a novel and highly potent mechanism of action. The drug is expected to have a higher therapeutic effect than existing anticancer drugs. The drug was added for reimbursement in April last year by applying a flexible incremental cost-effectiveness ratio (ICER) threshold, an indicator of economic efficiency. As a result, the patient's burden from annual medication costs was reduced from KRW 80 million to KRW 4 million. At the time, the reimbursement standard for gastric cancer patients was set as locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction that satisfies all three conditions. The conditions were: patients who ①failed two or more prior therapies, including trastuzumab (Herceptin) +(fluorouracil or capecitabine)+cisplatin; ②have HER2 overexpression (IHC 3+ or 'IHC 2+ and FISH+ or SISH+’) metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; and ③have an ECOG performance status (PS) of 0 or 1. This expansion of the reimbursement standard this time will extend the scope of the drugs limited to cisplatin in the first condition to other platinum-based anticancer drugs. As a result, it is expected that not only cisplatin but also patients with gastric cancer who have failed to receive oxaliplatin (original Eloxatin) will be able to receive Enhertu with reimbursement. “Enhertu’s reimbursement expansion agenda extends the conditions limited to cisplatin among platinum-based anticancer drugs in the existing reimbursement standards to other platinum-based anticancer drugs,” said a HIRA official. “This is expected to further expand patient access.” The applications for which the reimbursement standards have been established at this meeting will be reviewed by the Drug Reimbursement Evaluation Committee to determine their reimbursement adequacy.
