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- 2026-04-03 19:52:01
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- Opdivo prolongs survival in urothelial carcinoma
- by Whang, byung-woo Feb 18, 2025 05:53am
- The emergence of new drugs such as immuno-oncology drugs in the first-line treatment of urothelial carcinoma, have refined treatment strategies in the area. With the number of options available in the clinical setting increasing, there is also growing concern over when and which treatment to select for the patients. However, experts believe that the choice of treatment that can maximize the effectiveness of the treatment is important, as the prognosis of urothelial carcinoma is still worse than that of other urologic cancers. Jong Jin Oh, Professor of Urology, Seoul National University Bundang Hospital Professor Jong Jin Oh, Professor of Urology at Seoul National University Bundang Hospital, who has the latest knowledge in the field, emphasized the need for institutional support for the emergence of new drugs that prolong the overall survival of patients with urothelial carcinoma. Urothelial carcinoma is a cancer that starts in the urothelial cells that line the inside of the bladder, and 90% of tumors that occur in the urinary tract are urothelial carcinoma. It is the most common type of bladder cancer, accounting for about 90% of all bladder cancer diagnoses. Even if patients undergo surgery, their life expectancy is not long, and the average overall survival period is just over one year, especially for patients with metastases. “In the first diagnosis, about 10% of patients with metastatic urothelial carcinoma are confirmed to have metastatic disease, and if adding patients whose cancer progressed or metastasized, 20-30% of all patients are confirmed to have metastatic disease,” said Professor Oh. “There may be microscopic metastases that are not detected by imaging tests, so the actual proportion of metastatic urothelial carcinoma may be higher than the confirmed proportion.” The chemotherapy combination of cisplatin and gemcitabine (GemCis) had been the representative treatment option. However, Professor Oh explained that the combination had clear limitations, such as response rate and toxicity. “The percentage of patients responding to gemcitabine is not high, and the duration of response is very short, less than a year, and the toxicity is strong, so patients cannot continue treatment for a long time,” said Professor Oh. ”Since urothelial carcinoma is a tumor that occurs in the urinary tract, many patients have reduced renal function, such as by having their kidneys or bladder removed.” The emergence of immune checkpoint inhibitors for urothelial carcinoma is expected to extend survival In this situation, the emergence of new drugs, including immune checkpoint inhibitors, is expected to extend patient survival. One of the recent changes is the approval of Opdivo (nivolumab) in combination with cisplatin and gemcitabine as a first-line treatment for unresectable or metastatic urothelial carcinoma in July. Looking at the Phase III CheckMate-901 trial, which was the basis for the approval of Opdivo, at a median follow-up period of 33.6 months, the median overall survival (mOS), the primary endpoint, was 21.7 months with the combination of Opdivo and chemotherapy, which was significantly longer than the 18.9 months with the combination of cisplatin and gemcitabine, and reduced the risk of death by 22%. “Opdivo is the first immuno-oncology drug approved for the first-line treatment of metastatic urothelial carcinoma. The combination of Opdivo and gemcitabine has extended the overall survival by about 3 months compared to the existing gemcitabine monotherapy,” said Professor Oh. ”This means that we have an opportunity to extend the expected life expectancy that has been around one year with the existing treatment to about one and a half years.” So, how has the actual prescription experience been for domestic patients? Professor Oh expected that Opdivo would play a role in the situation where most patients with metastatic urothelial carcinoma first experience lymph node metastasis. He said, “In the subgroup with lymph node-only metastases, the rate of complete remission of metastatic lesions was much higher with Opdivo than with gemcitabine therapy, and the duration was also much longer. As the study confirmed very good effects, I think it is an effective treatment that can be considered as a first-line treatment for patients with lymph node metastases. In fact, in the CheckMate-901 subgroup analysis, patients with lymph node-only metastases were compared between the combination of Opdivo and gemcitabine and Gemcitabine alone, and the median overall survival was 46.3 months for the combination of Opdivo and gemcitabine and 24.9 months for gemcitabine alone. In response, Professor Oh said, “Lymph nodes are where the immune response is most active in our bodies, so it is thought that their response rate to immuno-oncology drugs such as Opdivo will be high. Patients with cancer that has spread to other organs have a much lower level of activity, but patients with lymph node-only metastasis have a relatively good overall condition, which may have a positive impact on treatment outcomes as they can receive treatment as planned. In conclusion, in the first-line treatment of metastatic urothelial carcinoma, if the patient has a low tumor burden or lymph node metastasis alone, Professor Oh believes the relatively less toxic Opdivo-Gemcitabine regimen may be a useful option among the first-line treatment options. "Will increase Opdivo’s use in lymph node metastasis alone and as adjuvant therapy" In particular, Professor Oh focused on Opdivo’s use as adjuvant therapy based on the CheckMate-274 study. “Currently, the standard adjuvant therapy for urothelial carcinoma is GemCis, but there are cases where patients undergo surgery after chemotherapy and the results of the biopsy are not good. In this case, the effectiveness of adjuvant gemcitabine therapy is low, and the disease usually recurs within 6 months,” explained Professor Oh. “Since other therapies that can be tried outside of standard treatment for GemCis have not yet been established, this is a very unfavorable case, and we expect that the post-operative adjuvant therapy of Opdivo will be used most actively in such patients.” However, Opdivo as adjuvant therapy for urothelial carcinoma is not reimbursed by Korea’s health insurance. Professor Oh stressed the need for reimbursement of new drugs that can benefit patients with urothelial carcinoma, who have a short overall survival period and therefore are in urgent need of treatment. He said, “For patients with poor post-operative biopsy results, we are trying to use Opdivo as adjuvant therapy if conditions permit. Since there is no alternative to adjuvant Opdivo therapy, patients are very desperate so healthcare professionals believe the drug is absolutely necessary.” Finally, Professor Oh said, “The complete remission rate is about 40-50% with standard chemotherapy, but it can be improved to 60-70% with new drugs. I see the significance of its use as adjuvant therapy, and I hope that many patients will be able to use the drug without burden through prompt reimbursement.”
- Policy
- Lorviqua, Tevimbra, Pemazyre enter NHIS negotiations
- by Lee, Tak-Sun Feb 18, 2025 05:53am
- Pfizer Three items, including Lorviqua (lorlatinib, Pfizer Korea), Tevimbra Inj 100 mg (tislelizumab, BeiGene Korea), and Pemazyre (pemigatinib, Handok), are currently under negotiations with the National Health Insurance Service. These drugs were deliberated by the Health Insurance Review and Assessment Service Drug Reimbursement Evaluation Committee (DREC) on January 9 and were deemed adequate for reimbursement. According to industry sources on the 17th, the National Health Insurance Service updated the website with information on drug price negotiations for 3 items. The National Health Insurance Service discloses information on the progress of negotiations for new drugs, drugs exempt from drug price negotiations, and drugs with expanded indications on its website. Upon the Ministry of Health and Welfare's negotiation order, the NHIS begins drug price negotiations with individual pharmaceutical companies. However, drugs for which the company has accepted the assessed amount to receive drug price negotiation exemptions will only be subject to negotiations on the expected claim amount. Among the 3 items currently under negotiations, Tevimbra and Pemazyre are expected to have entered into negotiations with the NHIS as expected, as they were recognized by the DREC as adequate for reimbursement without conditions. However, Lorviqua Tab, which is applying for the reimbursement extension as a first-line treatment for anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer, was judged by DREC to be “appropriate for reimbursement extensions if the company accepts a price less than the evaluated amount,” so NHIS negotiations for the drug was only possible after the pharmaceutical company accepted the condition. Pfizer is expected to accept the 'below the evaluation price' proposed by DREC and will again try to win the bid through negotiations with the National Health Insurance Service, as it did last year. Last year, the drug price negotiations broke down due to disagreements over the adjustment of the expenditure cap under the Expenditure Cap type of Risk Sharing Agreement (RSA). The Expenditure Cap type is a system in which the pharmaceutical company refunds the excess amount of the claim to the National Health Insurance Service if it exceeds the set total amount (cap). For this reason, in the case of Lorviqua, the profit earned by the pharmaceutical company also changes depending on how the total amount is set when expanding reimbursement. Pfizer has applied to terminate the RSA contract with NHIS and wants to expand the reimbursement without an expenditure cap. Therefore, it is expected that the termination of the RSA contract and the financial sharing plan will be the key to reaching an agreement during negotiations. Meanwhile, Tevimbra is a treatment for esophageal squamous cell carcinoma from the Chinese pharmaceutical company BeiGene Korea, and Pemazyre, which is imported by Handok, is a treatment for FGFR2 fusion or rearrangement cholangiocarcinoma. If these products reach an agreement with the NHIS, they will be added to the drug reimbursement list after reporting to the Ministry of Health and Welfare's Health Insurance Policy Review Committee.
- Company
- Samsung Bioepis’s Prolia and Xgeva biosimilars approved
- by Chon, Seung-Hyun Feb 18, 2025 05:53am
- Pic of Samsung Bioepis Headquarters Samsung Bioepis' two bone disease treatment biosimilars have passed the US and European hurdles. Samsung Bioepis announced on the 16th that it has obtained marketing authorizations for its two biosimilar versions of Prolia and Xgeva, which are bone disease treatments, from the US Food and Drug Administration (FDA) and the European Commission (EC). Prolia and Xgiva are biopharmaceuticals developed by Amgen, and the two were developed by varying the dose and dosage cycle of the main ingredient, denosumab. Prolia is used as a treatment for osteoporosis, and Xgeva is approved for the prevention of skeletal system symptoms in patients with bone metastases and the treatment of giant cell tumors of bone. Last year, global sales of Prolia and Xgeva reached a total of USD 6.599 billion (KRW 9.7 trillion). Samsung Bioepis obtained separate marketing authorizations for each indication, just like the original drug. The Prolia biosimilar was licensed under the brand name Ospomyv in the US and Obodence in Europe. The Xgeva biosimilar was licensed under the name Xbryk in both the US and Europe. Samsung Bioepis has successfully commercialized 10 biosimilar products in the United States and 11 in Europe. A Samsung Bioepis official said, “We will continue to work to meet the unmet medical needs of patients around the world through the development of biosimilars in various disease areas.”
- Company
- Celltrion gains EU approval for Eylea biosimilar Eyedenzelt
- by Chon, Seung-Hyun Feb 17, 2025 05:53am
- On February 14, Celltrion announced that it had secured the marketing authorization for the Eylea biosimilar Eyedenzelt from the European Commission. Two months after receiving the recommendation for marketing authorization from the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) in December, the drug was granted the final approval. Eyedenzelt is approved for the original drug's major indications to treat wet (neovascular) age-related macular degeneration (wAMD), retinal vein occlusion, diabetic macular edema (DME), and myopic choroidal neovascularization. In 2023, Eylea recorded sales of approximately KRW 13 trillion globally. Celltrion confirmed the equivalence of Eyedenzelt compared to the original drug based on the global phase 3 trials involving 348 patients with DME. Celltrion obtained approval from the Ministry of Food and Drug Safety (MFDS) in May and is currently working on the sales. In December, Celltrion received a recommendation from the EMA's CHMP for European marketing authorization of biosimilars, including Eyedenzelt, Actemra, Prolia, and Xgeva. Celltrion plans to expand its biosimilar portfolio to bone diseases and eye diseases, in addition to previously established autoimmune diseases and anticancer agents, through the approval of biosimilars, including Eyedenzelt. "Given the marketing authorization of Eyedenzelt, we can now expand product portfolio areas in the European market and speed up the launch in the global market," a Celltrion representative said. "As we expect to secure more approvals through the marketing authorization recommendation for biosimilars, Celltrion will strive to quickly launch the products and strengthen strategies to gain market dominance."
- Policy
- Daewoong’s P-CAB Fexuclue completes first PVA
- by Lee, Tak-Sun Feb 17, 2025 05:53am
- Daewoong Pharmaceutical's new drug for gastroesophageal reflux disease, ‘Fexuclue,' has agreed to complete negotiations through the price-volume agreement system with the National Health Insurance Service for the first time since its reimbursement listing. Before negotiations, Daewoong Pharmaceutical was known to have wanted to apply the reimbursement system rather than a price cut, so the outcome of the negotiations is drawing attention. According to industry sources on the 16th, Daewoong Pharmaceutical's ‘Fexuclue Tab 10, 40mg’ and Daewoong Bio's ‘We Cab Tab 10, 40 mg.’ which contain identical ingredients, have completed price-volume agreement negotiations. The PVA system allows the NHIS and pharmaceutical companies to negotiate and reduce the maximum insurance price of drugs with increased usage by up to 12.5% this year. The aim is to save Korea’s national health insurance finances. The type of negotiation applied to Fexuclue this time is Type A, which is carried out when the amount of claims in the same product group with the expected claims amount agreed with the NHIS increases by 30% of the expected claims amount. Fexuclue, which was listed for reimbursement in July 2022, recorded a prescription volume of KRW 12.9 billion in the first year of its release based on UBIST and then grew exponentially to record a prescription volume of KRW 78.8 billion last year (2024). In particular, the analysis shows that the product’s growth accelerated after signing a copromotion agreement with Chong Kun Dang in April last year In response, the NHIS selected Fexuclue as a drug subject to PVA monitoring in the fourth quarter of last year, and negotiations began in early December of that year upon the Ministry of Health and Welfare’s order. Before negotiations, it was reported that Daewoong Pharmaceutical wanted to apply the refund-type agreement like its competitor ‘K-CAB (HK Inno.N).’ The refund-type agreement is a system that maintains the maximum insurance price of a drug while returning the difference to the National Health Insurance Service. When exporting the drug overseas, this can be advantageous as the drug’s listed price is higher than the actual price. Currently, K-CAB is the only product that has signed a refund-type PVA system. In 2015, Boryung’s hypertension drug Kanarb entered into a refund-type agreement, but in 2018, it chose to lower the maximum insurance price instead of extending the contract. On the other hand, K-CAB entered into a refund-type agreement in 2021 and extended the agreement at the end of last year. As a result, its ceiling price of KRW 1,300 per tablet was maintained when it was first listed in 2019. Fexuclue is listed at KRW 939, which is 70% of the price of K-CAB. If the ceiling price is lowered through the PVA, the gap between K-CAB and Fexuclue will widen further. However, the relatively low price of the drug may be advantageous in sales competition between products, so it is interesting to see what kind of agreement Daewoong and the NHIS have reached. P-CAB (potassium-competitive acid blocker) class drugs like Fexuclue are characterized by a longer duration of efficacy due to their longer half-life than PPIs, making them effective for controlling nighttime acid secretion. It is easy to take because it only needs to be taken once a day, regardless of meal intake, and its market size has been rapidly increasing. Currently, in addition to K-CAB and Fexuclue, ‘Ja Q Bo (Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical),’ a new domestic drug with the same mechanism of action (P-CAB), has also been listed for reimbursement, making it a three-way competition.
- Company
- COVID-19 vaccination and corporate productivity
- by Whang, byung-woo Feb 17, 2025 05:53am
- A study has been published showing that although the COVID-19 pandemic has transitioned into the post-COVID-19 era, there is a significant difference in productivity loss depending on whether or not one has been vaccinated. Analysis showed that the productivity loss caused by not receiving COVID-19 vaccination amounts to about KRW 5.6 trillion, which is more than 3 times the medical expense. Hankil Lee, Professor of College of Pharmacy at Ajou University On the 14th, Hankil Lee, a professor at the College of Pharmacy at Ajou University Hospital, who presented on the topic of “The Losses Caused by COVID-19 and the Socio-Economic Impact of Vaccination,” said that COVID-19 infections are still causing serious socioeconomic losses. Five years after the World Health Organization (WHO) declared COVID-19 a pandemic, various assessments are being made on the economic impact of COVID-19. The research presented on this day was conducted by the College of Pharmacy at Ajou University and analyzed the socioeconomic effects of COVID-19 vaccinations. First, a domestic study (based on the National Health Insurance Service's big data) that estimated productivity losses and medical expenses for the employed population found that the social loss caused by COVID-19 in 2023 amounted to about KRW 7 trillion. Specifically, of the 25.16 million employed people aged 18-64, about 9.8 million received outpatient care, about 140,000 received inpatient care, and 1,539 died. Based on this, the estimated direct medical expenses were about KRW 1.4 trillion, of which outpatient care costs were KRW 540 billion, inpatient care costs were KRW 220 billion, and sequelae treatment costs were KRW 450 billion. The key to the study is how much COVID-19 vaccinations can reduce such socio-economic losses. A research team at Ajou University analyzed the effects of COVID-19 vaccination on 10,000 employees of a large Korean company (Samsung Electronics) and found that the vaccination could reduce medical expenses and productivity losses. The research results showed that the COVID-19 vaccine Spikevax JN.1 from Moderna reduced medical expenses and productivity losses by KRW 1.1 billion per 10,000 employees. When this is converted to the total 120,000 employees of the company, it is estimated that the cost savings can amount to KRW 13 billion. In addition, assuming that the cost of employing one employee was KRW 120 million, the loss of productivity for the company when an employee did not get vaccinated was KRW 340 million, but when the vaccination rate reached 70%, the loss decreased to KRW 240 million, resulting in an economic gain of KRW 160 million. “This is the first study to estimate the socioeconomic costs of COVID-19 infections from a national perspective using the latest data sources in Korea,” said Professor Lee. ”Looking at the trend in COVID-19 infection rates in 2024, the scale of productivity losses is expected to increase further.” Lee added, “COVID-19 infection is still causing serious socioeconomic burdens, and vaccination of employees may be an effective strategy to reduce corporate losses and cut costs.”
- Company
- Vyloy with CDx issue resolved will launch in March
- by Whang, byung-woo Feb 17, 2025 05:52am
- The gastric cancer treatment Vyloy (zolbetuximab), which overcame the issue of companion diagnostics, will soon challenge the market. Reimbursement coverage with the National Health Insurance remains to be solved, but it has already received favorable assessments in the clinical practices. Despite launching as a non-reimbursed drug, it is likely to be prescribed more frequently. On February 14, Astellas Pharma Korea hosted a press conference to announce the launch of its claudin-18.2-targeting gastric cancer therapy, Vyloy. Dr. Sun Young Rha, Professor in the Department of Oncology at Younsei Cancer Center.Vyloy is a first-in-class treatment for patients with HER2-negative gastric cancer as a first-line treatment. It is the world's first anticancer agent to target claudin-18.2. In South Korea, Vyloy was approved by the Ministry of Food and Drug Safety (MFDS) as a 'First-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with claudin-18.2-positive, HER2-negative unresectable, locally advanced, or metastatic gastric adenocarcinoma or esophageal cancer.' Dr. Sun Young Rha, Professor in the Department of Oncology at Younsei Cancer Center, Vyloy, who was the presenter for the event, said, "About 90% of the patients with metastatic gastric cancer are found to be HER2-negative. Therefore, patients were desperate for a medicine that targets a new biomarker." Dr. Rha explained, "About 40% of the HER2-negative patients are reported to be claudin-18.2-positive. Vyloy, which selectively targets claudin-18.2, introduced a new treatment option." The basis of Vyloy approval, the Phase 3 SPOTLIGHT trial showed that the median progression-free survival (mPFS) of a combination therapy containing mFOLFOX6 (oxaliplatin, leucovorin, 5-Fluorouracil, leucovorin) was 10.61 months, which was higher than 8.67 months of the placebo group. The medial overall survival (OS) was 18.23 months, higher than 15.54 months of the placebo group. In the GLOW study, the patient group treated with Vyloy in combination with CAPOX (oxaliplatin and capecitabine) recorded a mPFS of 8.21 months, which lowered the disease progression or death risk by approximately 31%. Despite these results, Vyloy's launch in South Korea had been postponed due to the issue of companion diagnostics last year. At that time, claudin-18.2-positive patients needed to be identified for the use of Vyloy. CDx used to diagnose Claudin-18.2 has been considered for evaluation as a new healthcare technology. After that, it was reviewed by the expert committee twice, and CDx was determined to be an existing technology. Consequently, Vyloy has been scheduled to launch on March 3. Dr. Hye Seung Lee, Professor in the Department of Pathology at Seoul National University Hospital, said, "Claudin-18.2 protein targeted by Vyloy is specifically expressed in certain cancer types, such as gastric cancer. It provides high specificity towards abnormal cells." Lee added, "Consistent results can be obtained, and fast analysis can be achieved with claudin-18.2, so we can quickly identify the patient group with expected treatment effects." The remaining issue is the reimbursement. Astellas Pharma Korea plans to secure reimbursement soon. However, at its first meeting for 2025 on February 12, the Cancer Disease Review Committee (CDRC) decided that 'reimbursement criteria are not set' for Vyloy. Dr. Rha said, "Obtaining reimbursement will not be easy, but there are only a few treatments with such benefits for gastric cancer. We are considering ways to build data to identify the drug's effectiveness in Korean patients." Regarding this, before the approval of Vyloy, Astellas Pharma Korea has been openly providing the EAP program openly so that patients who need the treatment can use the drug promptly. Currently, 51 patients have been registered in 10 medical centers. Astellas Pharma Korea representative said, "The clinical usefulness of Vyloy is non-debatable, and the company is preparing with utmost efforts for the cost aspect." Adding, "How the drug is used in clinical practices is also important; thus, by collaborating with institutes participating in the EAP program, we will strive to build data so that patients can benefit clearly."
- Company
- Columvi can be prescribed at Big 5 hospitals in KOR
- by Eo, Yun-Ho Feb 17, 2025 05:52am
- ‘Columvi,' the first bispecific antibody treatment option for lymphoma, may be prescribed at general hospitals in Korea. According to industry sources, Roche Korea's CD20-CD3 bispecific antibody for diffuse large B-cell lymphoma (DLBCL) Columvi (glofitamab) has passed the drug committees (DCs) of the Big 5 general hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. However, Columvi is currently a non-reimbursed drug. Its reimbursement application was reviewed by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in July and December but was unable to set reimbursement standards at the time. Since prescription codes have been generated for the drug in many medical institutions, it will be interesting to see if Columvi can complete the reimbursement process within the year. Columvi was approved in Korea in December 2023 for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy. The drug is a third-line treatment option for DLBCL, like Novartis’s chimeric antigen receptor (CAR)-T-cell therapy Kymriah (tisagenlecleucel). The two drugs have different benefits; therefore the choice will likely be based on each patient's condition and circumstance. Columvi demonstrated efficacy in Phase I/II NP30179 trial in 155 patients with relapsed or refractory DLBCL after two or more prior systemic therapies. Results showed that Columvi achieved a complete response (CR) of 40% and an overall response rate(ORR) of 52%. The efficacy was also consistent across all subgroups. The most common adverse event was cytokine release syndrome (CRS). At the 2024 Congress of the European Hematology Association (EHA 2024), the company unveiled the results of the Phase III STARGLO study, which demonstrated an improvement in overall survival (OS) with Columvi. The STARGLO study enrolled patients with relapsed or refractory (R/R) diffuse DLBCL who were not eligible to receive an autologous stem cell transplant after one or more prior systemic therapies, or who had received two or more prior systemic therapies. In the primary analysis (median follow-up 11.3 months), Columvi and gemcitabine+oxaliplatin (GemOx) combination significantly improved the primary endpoint of OS with a 41% lower risk of death compared to rituximab+GemOx. Seok Jin Kim, Professor of Hematology and Oncology at Samsung Medical Center, said, "There had been much unmet need in DLBCL for more effective third-line treatment options for patients who fail first-line or experience repeated relapses. We expect the introduction of Columvi to significantly improve the outcomes for patients with relapsed or refractory lymphoma in Korea."
- Company
- Expanded indication sought for Novartis 'Kisqali' in KOR
- by Eo, Yun-Ho Feb 14, 2025 05:58am
- Product photo of Kisqali Early breast cancer indication of a CDK4/6 inhibitor 'Kisqali' is expected to be introduced in South Korea. According to industry sources, Novartis has recently submitted an application to the Ministry of Food and Drug Safety (MFDS) for Kisqali (ribociclib)'s expanded indication to treat early breast cancer. It is currently being reviewed for approval. Early breast cancer indication for Kisqali was approved in the United States and Europe in September and November last year, respectively. Once it's approved in South Korea, the competition against Lilly Korea's Verzenio (abemaciclib) is expected to expand. Verzenio is currently seeking reimbursement for early breast cancer. Kisqali was demonstrated to improve survival in hormone-positive/HER2-negative (HR+/HER2-) early breast cancer. The 4-year follow-up NATALEE study of Kisqali was presented during the recent European Society for Medical Oncology Congress 2024 (ESMO Congress 2024), showing its benefits. The 4-year landmark analysis results from the NATALEE study showed that during the median value of 44.2 months, the Kisqali combination therapy group had invasive Disease Free Survival (iDFS) of 88.5%, which was 4.9% higher than 83.6% of the group treated with endocrine therapy alone. Previously, in the 3-year analysis result, the Kisqali combination therapy group and endocrine therapy alone group had 90.8% and 88.1%, respectively. Considering that the two groups showed a difference of 2.7%, Kisqali's effect on reducing the risk of relapse has increased. However, it would require more time to accumulate further evidence on overall survival (OS). During the follow-up period of a median value of 44.2 months, mortality events showed no statistical difference due to few instances. However, the Kisqali group showed a slightly more positive trend. Meanwhile, regarding early breast cancer indication, Verzenio's first attempt to be considered for the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) has been uneasy. After 6 months of waiting after submitting a reimbursement document, Verzenio was reviewed in May 2023, but the result was 'reimbursement criteria not set.' Five months later, Lilly reapplied for reimbursement to the HIRA in October. The drug was considered for the CDRC review in March 2024, but the result was the same. After that, Lilly again applied for the reimbursement and is awaiting the CDRC review date.
- Policy
- Vivozon’s VVZ-2471 patent registered in China
- by Lee, Jeong-Hwan Feb 14, 2025 05:58am
- On the 23rd, Vivozon (CEO: Doo-hyun Lee), a company specializing in the development of innovative new drugs, announced that it completed registering the product patent for its oral non-narcotic analgesic VVZ-2471, which is being developed as a treatment for pain and addiction, and its derivatives in China. This is the company’s third patent registration abroad, following the United States and South Africa. Vivozon is also undergoing the patent registration process in other major countries. This patent contains content that ensures VVZ-2471’s exclusive rights in China and the protection of related compounds based on its superior analgesic effect and differentiated effect compared to existing compounds. VVZ-2471 is a new drug candidate discovered by the company’s proprietary multi-target drug discovery technology. It has been confirmed to have an analgesic effect as well as an effect on treating drug addiction. Vivozon is conducting clinical trials to develop it as a treatment for neuropathic pain in Korea and as a treatment for drug addiction in the United States. In particular, Vivozon received IND approval for a Phase II clinical trial for VVZ-2471 in June last year for patients with post-herpes zoster neuralgia in Korea. The company plans to widely use the 38th homegrown new drug Unafra Inj. (Opiranserin hydorochloride), which was granted marketing authorization from the Ministry of Food and Drug Safety last year, along with its oral analgesic candidate VVA-2471. “We expect the results of VVZ-2471’s Phase III clinical trial in Korea to be available within this year,” said a Vivozon representative. ”The patent registration in China recognizes the analgesic effect of VVZ-2471 in the market, where there is no non-narcotic analgesic with efficacy comparable to that of narcotic analgesics.” He also said, “Our goal is to develop VVZ-2471 as a non-narcotic oral analgesic for acute and chronic pain and lead the global analgesic market along with Unafra Inj.” Meanwhile, Vivozon is conducting a Phase II clinical trial to develop VVZ-2471 as a drug addiction treatment to address the serious social issue of addiction and abuse of narcotic analgesics (opioids) such as fentanyl in the United States. To this end, Vivozon is applying for research funds from the National Institute on Drug Abuse (NIDA) under the National Institutes of Health (NIH) and is cooperating with local drug addiction treatment experts.
