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- 2026-04-08 13:42:22
- Company
- Alecensa prepares to solidify its lead in lung cancer mkt
- by Son, Hyung-Min Feb 23, 2024 05:49am
- Alecensa is showing a strong position in the targeted therapy market for ALK-positive lung cancer in Korea. Last year, Alecensa generated KRW 34.9 billion in sales, far outpacing the runner-up, Takeda Alunbrig's KRW 13.6 billion. As the only ALK-targeted therapy that has demonstrated efficacy in early-stage lung cancer, Alecensa is likely to continue its lead in the market for the foreseeable future. According to the market institution IQVIA on the 22nd, Alecensa sold KRW 34.9 billion last year, up 0.5% from KRW 34.7 billion in 2022. Alecensa's sales have been on a steady rise since surpassing KRW 5 billion in Q3 2019 and have posted average quarterly sales of over KRW 8 billion since 2021. Alecensa is a second-generation ALK-positive targeted therapy developed by Roche. Targeted therapies for ALK-positive cancer are classified into 3 categories: first-generation drugs like Pfizer’s Xalkori; second-generation drugs like Roche’s Alecensa and Takeda’s Alunbrig; and third-generation drugs like Pfizer’s Lorviqua. With the possibility rising for Alecensa’s use in early-stage lung cancer, the drug is expected to continue solidifying its lead in the market According to clinical data presented at last year's European Society for Medical Oncology Congress 2023 (ESMO 2023), Alecensa showed effect as adjuvant chemotherapy. In the clinical trial, Alecensa improved disease-free survival (DFS) over platinum-based chemotherapy. The Alecensa-administered group showed a 76% reduction in recurrence or death and a 78% reduction in the risk of CNS progression or death. Although Alecensa does not yet own an indication for early-stage lung cancer in Korea if it adds the indication, the drug will likely remain the market leader for some time. Takeda's Alunbrig posted sales of KRW 13.6 billion last year, up 23.6% YoY. Alunbrig's sales have been growing steadily since surpassing KRW 2 billion in Q3 2021. Alunbrig's strength is that it can be taken once daily with or without meals. In the case of Alecensa, 4 capsules need to be taken twice daily, for a total of 8 capsules per day. Also, Alunbrig is available in 3 different strengths to help patients find the right dose. Pfizer's Lorviqua generated KRW 11.7 billion in sales last year, a 216.2% increase from 2022. Lorviqua, which was released in the Korean market in Q1 2022, has posted more than KRW 3 billion in sales since Q3 2022 after a level period of KRW 200 million in sales in Q1 and Q2. Lorviqua’s sales rise started in full swing after being granted reimbursement as a second-line treatment for ALK-positive lung cancer in September 2022. Currently, Lorviqua is only available for patients who have failed with the use of Xalkori, Alunbrig, or Alecensa. Pfizer is currently seeking to expand its reimbursement to the first line. On the other hand, Pfizer's Xalkori was the only ALK-targeted therapy to see a sales decline. Xalkori generated KRW 9.9 billion in sales last year, which was a 13.1% YoY decline. After generating KRW 8 billion in sales in Q1 2019, Xalkori’s sales plummeted to KRW 4.8 billion in Q2. The decline in Xalkori sales is related to the release of second- and third-generation targeted therapies. These drugs demonstrated a higher effect with improved safety over Xalkori. Second- and third-generation targeted therapies are said to have lower drug toxicity, fewer adverse events, and better efficacy than first-generation drugs. Also, Second- and third-generation targeted therapies also have the advantage of a greater penetration rate into the central nervous system (CNS), including the brain.
- Company
- Alteogen expands license agreement with MSD
- by Kim, Jin-Gu Feb 23, 2024 05:49am
- Alteogen officially announced on the 22nd that it will receive an additional USD 20 million (approximately KRW 26.7 billion) from the multinational pharmaceutical giant MSD under the terms of their modified agreement. In June 2020, Alteogen signed a non-exclusive licensing agreement with MSD for its proprietary human hyaluronidase technology (ALT-B4). At the time, The upfront payment was USD 160 million. MSD is using the technology to develop a subcutaneous (SC) formulation of Keytruda (pembrolizumab). Alteogen explained that the original agreement had been modified into an exclusive agreement. The company will grant exclusive licensing rights to the Keytruda line of products that MSD is developing by adding ALT-B4. However, the non-exclusive agreement will continue to apply to non-KEYTRUDA development projects. As part of the modified agreement, Alteogen will receive an additional USD 20 million in payments independent of the original upfront payment. This amount represents 93% of Alteogen's consolidated sales revenue of KRW 28.8 billion last year. The additional milestone payments Alteogen could receive have also been expanded. Alteogen was previously eligible to receive up to USD 3.865 billion in milestone payments based on regulatory approval, patent extension, and cumulative net sales of the Keytruda family of subcutaneous injection formulations that are applied to the ALT-B4 technology. The modified agreement increases the maximum amount of milestones Alteogen is eligible to receive by USD 432 million to USD 4.298 billion (KRW 5.7 trillion). A condition for royalties based on commercial sales has also been added. Alteogen will receive a percentage of sales of the Keytruda product line each year as royalties even after the agreement period for the patent term, until March 2040. An official from Alteogen said, "We expect to receive the additional payment under the modified agreement on or before the 25th of next month.”
- Company
- 2 ADC drugs being discussed for reimb after Enhertu
- by Eo, Yun-Ho Feb 23, 2024 05:49am
- Trodelvy and Padcev are now being considered for follow-up discussions in the Economic Evaluation Committee. The two next-generation ADC drugs following ‘Enhertu’ draw attention as they are currently being considered reimbursement listing in South Korea. Gilead Science Korea’s Trodelvy (Sacituzumab govitecan), used to treat triple-negative breast cancer (TNBC), and Astellas Pharma Korea’s Padcev (enfortumab vedotin), used to treat bladder cancer, have cleared the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA). The drugs are now being considered for follow-up discussions in the Economic Evaluation Committee. The two drugs are known as antibody-drug conjugates (ADCs) and have demonstrated improved benefits compared to existing therapies in clinical trials. However, determining their domestic prices is challenging due to their high pricing. ‘Enhertu (trastuzumab deruxtecan)’ set a precedent as ADC drugs. In May of last year, Enhertu cleared the review by the Cancer Diseases Review Committee, and within eight months, it passed the Drug Reimbursement Evaluation Committee (DREC). Currently, Enhertu has entered the negotiations for drug pricing. The clearance of Enhertu by DREC may indicate positive outcomes for Trodelvy and Padcev. Considering Enhertu’s limited flexibility in price range during cost-effectiveness evaluation, DREC's approval of Enhertu this round suggests government proposed an ICER value in the mid-to-late range of 50 million won. Trodelvy and Padcev may have a higher chance of positive outcomes. Of course, the course of listing may depend on the results of their clinical evaluation and values. It will be interesting to see the outcomes for two ADC drugs awaiting review from the DREC this year after clearing the Cancer Disease Review Committee. Trodelvy is the first Trop-2 targeting ADC. It is comprised of monoclonal antibody that binds Trop-2, an antigen expressed on cell surfaces, and a TOP1 inhibitor payload ‘SN-38’ that destroys cancer cells. Trodelvy, a second-line or later therapy for patients with metastatic triple-negative breast cancer, is the only approved treatment, excluding cytotoxic chemotherapy, by the Ministry of Food and Drug Safety (MFDS) for use in the entire patient population regardless of genetic mutations or biomarkers. The National Comprehensive Cancer Network (NCCN) guidelines classify Trodelvy as Category 1 for second-line or later therapy in adult patients with metastatic triple-negative breast cancer. Padcev has a Category 1 priority recommendation in the NCCN guidelines. Padcev is a novel treatment option for urothelial cancer patients who have disease progression or relapsed following cancer immunotherapy and platinum-containing chemotherapy and are not eligible for previous standard-of-care treatment options. In March of last year, Padcev was approved in Korea as a monotherapy for patients with locally advanced or metastatic urothelial cancer who had previous experience with platinum-containing chemotherapy or PD-1 or PD-L1 inhibitors.
- Policy
- Competition intensifies in 3-combo drug mkt for COPD·asthma
- by Lee, Tak-Sun Feb 23, 2024 05:48am
- GSK’s triple therapy for COPD, Competition in the market for three-drug combinations used to treat COPD (chronic obstructive pulmonary disease) and asthma has become somewhat complicated. Kolon Pharma’s Trimbow, which was introduced in January, triggered the competition, and GSK’s Trelegy Ellipta, which had enjoyed its sole lead in the market till then, strengthened its line-up in response. According to industry sources on the 22nd, GSK Trelegy Ellipta will be reimbursed for the treatment of asthma in addition to COPD starting next month. The Ministry of Health and Welfare issued a pre-announcement of the amendment to the revised drug reimbursement standards that Trelegy Ellipta will be reimbursed for the treatment of "severe asthma that is not adequately controlled with a combination of moderate-or high-dose inhaled corticosteroids and a long-acting inhaled beta-2 agonist,” starting on March 1st. With the reimbursement, Trelegy Ellipta’s competitivity in the market will increase further as it will be available for severe asthma in addition to its existing indication for moderate-to-severe COPD in adults. Trelegy Ellipta had been dominating the Korean market with its low drug price but is now facing competition with Kolon Pharm's Trimbow inhaler which was introduced in January. Moreover, the new inhaler can be used for both asthma and COPD. With Trelegy Ellipta’s reimbursement also extended to COPD, the two drugs will now be fully engaged in a one-on-one competition. The price of Trelegy Ellipta is slightly less expensive. Its price remains the same at KRW 45,602 per box even with the coverage expansion. Trimbow is only KRS 1,000 more expensive, at KRW 46,669. However, Trimbow seems to have scored a win by obtaining a higher price than Trelegy Ellipta. Trimbow has both asthma and COPD indications, and was regarded as an alternative to Novartis’s triple therapy ‘Enerzair Breezhaler 150/50/160μg’ (upper limit price KRW 65,502) for asthma and ‘Trelegy Ellipta (upper limit price (upper limit price KRW 45,602)’ for COPD, and was priced below 90% of the weighted average price of the two drugs. If Trimbow only owned an indication for COPD, its price would have been set lower than that of Trelegy Ellipta, however, owning the two indications allowed for the drug to receive a price higher than that of Trelegy Ellipta. Therefore, the competition between the two drugs are likely to begin in earnest due to their similar indications and prices. In addition to adding the asthma indication Trelegy Ellipta, GSK was successful in receiving reimbursement for its higher-dose Trelegy 200 Ellipta Inhaler to the list this time. However, Trelegy Ellipta 200® Inhaler is only used for asthma. Therefore, its alternative, ‘Enerzair Breezhaler 150/50/160μ (upper limit price KRW 74,115)’ became the basis for its pricing negotiations. As a result, Trelegy Ellipta 200® Inhaler was listed at KRW 65,500 per box, after accepting a price below 90% of its alternative. With the reimbursement extension for its Trelegy Ellipta and the new listing of the Trelegy Ellipta 200®, GSK will now be able to adopt a two-track strategy in Korea’s asthma inhaler market. Industry analysis is that the new additions will contribute to broadening the choice for patients in Korea, with the lower-priced Trelegy Ellipta and the higher-priced, higher-dose Trelegy Ellipta 200. Also, GSK voluntarily reduced the price of its 2 inhaled single-agent products to help ease the financial burden of the patients. The price of Arnuity 100 Elipta (fluticasone furoate) for asthma was reduced from KRW 19,973 to KRW 17,376, and Incruse Elipta (umeclidinium bromide) for COPD was reduced from KRW 38,438 to KRW 34,978. The measure is considered to have been made in strategic response to the introduction of Kolon’s triple therapy product. Going forward, a key question for the triple combination market is whether AstraZeneca will introduce its Breztri Aerosphere in the market. The drug received conditional approval from the Drug Reimbursement Evaluation Committee in May of last year, that its reimbursement would be adequate if it is priced below the assessed value. The company has since applied for reevaluation to DREC, but no results have been disclosed since. However, when listed, it would be difficult for Breztri Aerosphere, which only has an indication for COPD, to receive a price higher than that of Trelegy Ellipta, which currently has the lowest price.
- Policy
- Gov't 'Too soon to price immune-oncology drugs by indication
- by Lee, Jeong-Hwan Feb 22, 2024 05:49am
- MOHW Director Chang-Hyun Oh(left) and NHIS Deputy Minister Hae-Min Jung is explaining the administrative procedures for the indication-specific drug pricing system The Ministry of Health and Welfare has reaffirmed its stance that it will use the health insurance finances saved by the follow-up management measures, including reevaluation of benefit adequacy and reevaluation of the reimbursement standards and conditions, to reimburse drugs that have proven their innovativeness, such as immuno-oncology and targeted-anticancer drugs. Regarding introducing a differentiated drug pricing system for immuno-oncology drugs by indication in Korea, the NHIS said that more social consensus is needed and that it would first need to gather patients' opinions on paying different prices for the same drug by cancer type and spend the administrative costs required to change the health insurance claims system, such as assigning separate billing codes. Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, and Hae-Min Jung, head of the Department of Drug Management at the NHIS, made such comments at a forum discussion on the 10-year achievements and challenges of the introduction of immuno-oncology drugs that was hosted by Rep. Jong-sung Lee of the People Power Party on the 20th. Regarding the future insurance coverage of anti-cancer drugs, Oh said that he would focus on strengthening patient access, especially for cancer types with no reimbursed treatment. To this end, Oh urged pharmaceutical companies seeking reimbursement to thoroughly prepare a financial sharing plan. The implication is that immuno-oncology drugs are relatively expensive, so pharmaceutical companies need to take on a drastic range of financial sharing in order to get their drugs reimbursed quickly. In particular, Oh promised to operate the reimbursement system with the concept that reimbursing immuno-oncology drugs strengthens essential medical care. "We have already announced an essential medical care policy that saves healthcare finances that are being leaked or overused for use as additional resources. In the pharmaceutical field, we will also mobilize follow-up management systems such as reevaluation of reimbursement adequacy and reevaluation of reimbursement standards and conditions to rationalize expenditures and reduce unnecessary finances, and reflect them in innovative drug prices." He added, "Foreign countries would not have applied immuno-oncology reimbursement at once either. Korea is also just going through the due process. Due to their high price, the companies need to take special care in submitting the financial-sharing plan to accelerate their reimbursement. We are expanding coverage of cancer types for immuno-oncology drugs, and will prioritize patient access to immuno-oncology drugs.” Jung explained that to enable the indication-specific drug pricing system, changes would need to be made to Korea’s health insurance claims system, such as assigning a separate billing code and preparing a separate refund plan for differences in patients’ out-of-pocket expenses. In other words, consultations with relevant organizations and social consensus are further needed to introduce the indication-specific drug pricing system. Jung also raised the need to collect patients' opinions, as insurance drug prices may increase when additional cancer types are added to the reimbursement list. "If the indication-specific drug pricing system is introduced, drug prices may increase when other cancers are added for reimbursement. We also need to consider whether patients will be willing to accept different out-of-pocket costs for different cancers. The patient-specific flexibility and price opacity when signing risk-sharing agreements need to be considered.” Jung added, "The single price-weighted average price method also requires separate codes for each indication, and it is difficult to predict usage, which can lead to the need for later settlement of prices. Multi-year multi-indication systems are also quite rare overseas. Therefore, some uncertainties lie in indication-specific contracts, so it is important to consider whether the industry will be willing to accept these variables.” "The realization of the multi-indication reimbursement system should be a collaborative effort between relevant organizations, patients, and the government; It requires discussions on ensuring patient access to care, as well as the clinical innovativeness of the drug, the financial capacity of national health insruance, and administrative costs associated with the separate billing codes."
- Company
- Yuhan ‘confirms the safety and efficacy of its allergy drug
- by Son, Hyung-Min Feb 22, 2024 05:49am
- Yuhan Corp announced on Tuesday that the results of the Phase 1a clinical trial of its allergy drug candidate YH35324 were published in the SCI-ranked International Journal of Immunopharmacology. YH35324 is a novel anti-immunoglobulin E (Anti-IgE) class Fc fusion protein drug. Its main mechanism of action improves allergy symptoms by reducing the level of free IgE in the blood. The Phase 1a clinical trial was the first time YH35324 was administered to humans (First-In-Human (FIH)). The study was conducted from September 2021 to January 2023 in allergy medicine departments of 4 Korean university hospitals and included a total of 68 patients. The study was conducted in two parts: Part A evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of YH35324 in a stepwise dose escalation manner compared to placebo or omalizumab 300 mg. Part B evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of YH35324 or omalizumab in patients with elevated serum total IgE levels (>700 IU/mL). Results demonstrated that YH35324 was well tolerated and safe at all doses, and was pharmacokinetically dose proportional. Also, YH35324 demonstrated more potent and sustained IgE inhibitory activity compared to placebo or omalizumab on serum-free IgE, a key pharmacodynamic biomarker. The notable factor was that Part B results demonstrated an excellent safety profile and more potent and sustained serum-free IgE inhibition compared to existing therapies, even in patients with elevated serum total IgE levels (>700 IU/mL). Part A top-line results from the Phase Ia study were previously presented at the 2023 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress last year. The top-line results of Part B top-line will be presented as a poster at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2024 Annual Meeting this year. Dr. Hae-Sim Park, Professor of Allergy at Ajou University Hospital, who was the corresponding author for the paper, said, “YH35324 is an anti-IgE trap (Fc fusion protein). Not only was this trial the first successfully completed multicenter trial by Korean multicenter researchers, but it also showed encouraging results. We look forward to YH35324 being developed as a new treatment for patients with allergic diseases worldwide." Yeol-Hong Kim, R&D President of Yuhan Corp, said, “We are currently conducting a Phase 1b trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of YH35324 in repeated doses in healthy individuals with atopic dermatitis or patients with mild allergies, and will soon begin evaluating YH35324 in patients with moderate-to-severe atopic dermatitis.” Yuhan Corp licensed in the technology for YH35324 from GI Innovation in July 2020. The candidate substance is currently being researched and developed in collaboration with the two companies. Its global rights outside of Japan are held by Yuhan Corp, and GI Innovation transferred the Japanese sales rights for the drug to Maruho, a leading Japanese dermatology company, in October 2023.
- Company
- Samsung Bioepis starts Global P1T for Keytruda biosimilar
- by Kim, Jin-Gu Feb 22, 2024 05:49am
- Samsung Bioepis announced today that it has initiated a global Phase I clinical trial for a biosimilar of Keytruda (pembrolizumab), the world's No. 1 selling drug. The product, which is being developed under the name SB27, is the 11th biosimilar in Samsung Bioepis' pipeline. Samsung Bioepis has recruited 135 volunteer patients with NSCLC in 4 countries, including South Korea, for the Phase I study, which will compare the pharmacokinetics, efficacy, and safety of SB27 to the original drug. Keytruda is MSD's immuno-oncology drug. After confirming the drug’s effect in multiple solid tumors, MSD has been expanding its indication to various solid tumors, including melanoma, non-small cell lung cancer, breast cancer, and gastric cancer. The drug topped the global market last year. According to MSD, Keytruda generated USD 25 billion (KRW 33.1 trillion) in sales last year, up 19% from USD 20 billion (KRW 26.7 trillion) it had posted in 2022. In Korea, Keytruda continued to lead overall sales, posting KRW 398.7 billion in sales last year. This is the 4th consecutive year that Keytruda has held the lead in the domestic pharmaceutical market, after first taking the lead in 2020 with sales of KRW155.7 billion. Il-Sun Hong, the Product Evaluation Team lead at Samsung Bioepis, said, “Based on the global clinical trial operation know-how we have accumulated so far, we will do our best to complete clinical trials promptly so that we can provide patients with more treatment options as soon as possible.” With the development of the Keytruda biosimilar, Samsung Bioepis has now expanded its biosimilar pipeline to 11 products. Currently, the company is selling 7 biosimilars in the global market and has completed clinical trials on 3 products. The 7 types currently on the market are ▲SB4(Enbrel biosimilar) ▲SB2(Remicade biosimilar) ▲SB5(Humira biosimilar) ▲SB3(Herceptin biosimilar) ▲SB8(Avastin biosimilar) ▲SB11(Lucentis biosimilar), and ▲SB12(Soliris biosimilar). The 3 others that have completed clinical trials and are awaiting commercialization are ▲SB15(Eylea biosimilar) ▲SB16(Prolia biosimilar), and ▲SB17(Stelara biosimilar).
- Company
- Pfizer’s Zavicefta, sole CRE antibiotic in KOR, gets reimb
- by Son, Hyung-Min Feb 22, 2024 05:49am
- From the left, Professor Lee Dong-gun, Professor Yoon Young-kyung, and Pfizer Korea Medical Lead Choi Heeyeon. A new antibiotic has been added to the insurance reimbursement listing a year after Zerbaxa. Zavicefta, developed by Pfizer, is the only antibiotic that can be used to treat carbapenem-resistant Enterobacteriaceae (CRE). Experts have stressed the use of this drug only when necessary because there is a growing number of patients with antibiotic resistance. Pfizer Korea hosted a press conference at JW Marriot Seoul on the 21st to commemorate the reimbursement coverage of the new antibiotic drug, Zavicefta. Zavicefta is a combination of ‘ceftazidime,’ a third-generation cephalosporins-class antibiotic, and ‘avibactam,’ used to maintain microbial clearance. Zavicefta is the only antibiotic that can treat CRE infections in Korea. It can be used for treating patients with Gram-negative infections, including CRE. Starting on February 1st, Zavicefta has been covered by reimbursement for the treatment of gram-negative infections such as carbapenem-resistant Enterobacteriaceae, according to the Ministry of Health and Welfare (MOHW) announcement. Zavicefta is covered by reimbursement under one of the following conditions: ▲Complicated intra-abdominal infections, ▲Complicated urinary tract infections, ▲Pneumonia contracted within the hospital that is unresponsive to antibiotic treatment or when there is proof of multi-drug resistant P. aeruginosa or carbapenem-resistant Enterobacteriaceae. Zabicefta demonstrated non-inferiority compared to standard therapy in phase 3 clinical trials enrolling patients with various infections. In the RECLAIM study enrolling patients with complicated intra-abdominal infection, the clinical cure rate of the Zabicefta treatment group was 82.5%, similar to the 84.9% of the meropenem treatment group. In the RECAPTURE study enrolling patients with complicated urinary infections, the clinical cure rate of the Zabicefta was 90.3%, showing non-inferiority to the 90.4% of doripenem. Furthermore, Real World Data (RWD) has demonstrated the effectiveness of Zavicefta. In a clinical study involving patients with CRE infections and immune suppression, Zabicefta showed a clinical cure rate of 64.4% in patients with complicated intra-abdominal infection, 88.3% in patients with complicated urinary tract infections such as pyelonephritis, and 68.4% in patients with pneumonia contracted within the hospital such as ventilator-related pneumonia. Based on these results, the 2022 Infectious Diseases Society of America (IDSA) guidelines recommended Zavicefta as a preferred treatment option for CRE or complicated urinary tract infections, including difficult-to-treat pyelonephritis-related Enterobacteriaceae. Due to the growing number of CRE patients, the need to manage patients with antibiotic resistance is urgent Experts have raised concerns about the prevalence of multi-drug resistant infections and the growing number of resistant patients, emphasizing the need to secure adequate treatment options. New treatments are necessary when a patient develops antibiotic resistance, but there is concern that patients may eventually run out of treatment options. “It has been nine years since Zavicefta was developed. Upon reviewing patient cases, the rate of resistance stands at 10%,” Professor Yoon Young-kyung from the Department of Infectious Diseases at Korea University Anam Hospital stated. “In light of the growing number of antibiotic-resistant patients, it is recommended that Zavicefta should be used for patients with absolute needs to prolong its effectiveness,” Yoon emphasized. CRE infections that show resistance to carbapenem-class antibiotics are becoming prevalent globally. The number of CRE patients, 5,717 in 2017, doubled to 11,954 in 2018. Subsequently, it surpassed 23,000 in 2021 and recorded 30,546 in 2022, according to the Korea Disease Control and Prevention Agency (KDCA). “Medications used to treat infectious diseases are different from those used to treat conditions like diabetes or hypertension, where treatment begins after diagnosis, minimizing misuse. However, with antibiotics, there's a concern for misuse. Therefore, healthcare professionals and academia need to collaborate in exploring ways to use antibiotics appropriately,” Professor Lee Dong-gun of the Department of Infectious Diseases at Seoul St. Mary's Hospital said.
- Company
- K-made anticancer drugs Leclaza, Rolontis show sales growth
- by Chon, Seung-Hyun Feb 22, 2024 05:49am
- New anticancer drugs developed by Korean pharmaceutical companies are showing a steady growth path in the market. Yuhan’s Leclaza, a lung cancer treatment, surpassed 20 billion won in annual sales, becoming the first domestically developed anticancer drug to achieve this. Hanmi’s Rolontis, a treatment for neutropenia, reached 10 billion won in sales just two years after its launch. Last year, Leclaza generated 22.6 billion won in sales, showing a 40.3% year-over-year (YoY) growth, according to a drug market research company IQVIA on the 21st. Leclaza is the 31st domestically developed new drug approved in Korea for treating non-small cell lung cancer (NSCLC) in January 2021. Leclaza entered the prescription market after its reimbursement listing in July 2021. The following year after its launch, Leclaza’s sales surpassed 10 billion won, reaching 16.1 billion won. Last year, Leclaza surpassed 20 billion won in sales. Qauterly Leclaza sales trend (Unit: 1 million won, Source: IQVIA). Leclaza was the first domestically developed anticancer drug to surpass annual sales of 10 billion won and later achieved sales of over 20 billion won. Domestically developed new anticancer drugs receiving approval before Leclaza are Il-Yang Pharm's Supect, Dong-A Pharm's Milican, Chong Kun Dang's Camtobell, Samsung Pharm’s Riavax, and Hanmi Pharm's Olita. None of these drugs have exceeded annual sales of 10 billion won. The expanded reimbursement of Leclaza as a first-line treatment will likely drive rapid market growth. Initially, Leclaza was approved as a second-line treatment for locally advanced or metastatic NSCLC that had developed acquired resistance due to a specific genetic mutation (T790M) following the administration of first or second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI). Then, Leclaza has received approval for use as a first-line treatment. Last June, the Ministry of Food and Drug Safety (MFDS) approved the application for approval of changes for expanding the use of Yuhan’s Leclaza to a ‘first-line treatment of NSCLC.’ Yuhan submitted an application to the Ministry of Health and Welfare (MOHW) for Leclaza’s reimbursement as a first-line treatment. The MOHW approved Leclaza’s reimbursement expansion to include its use as a first-line treatment last month. Starting this year, Leclaza became available for health insurance reimbursement as a ‘first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations.’ The MOHW has estimated that granting reimbursement of Leclaza as a first-line treatment option will require an additional budget of 88.1 billion won. Numerically, there is potential for Leclaza’s sales to surpass 1 trillion won next year. However, competition is expected to increase due to expanded reimbursement of Tagrisso, a similar drug in the same class. Hanmi’s Rolontis generated 11.4 billion won in sales last year, expanding three times compared to its 2022 sales of 3.2 billion won. Rolantis became the second domestically developed new anticancer drug, after Leclaza, to exceed annual sales of 10 billion won. Quarterly Rolontis sales trend (Unit: 1 million won, Source: IQVIA). Rolontis is administered to cancer patients who have undergone myelosuppressive chemotherapy as a treatment of neutropenia or as a preventative measure. Rolontis belongs to a granulocyte colony-stimulating factor (G-CSF) class, which stimulates granulocytes to enhance neutrophil production. It shows a mechanism of action similar to Amgen’s blockbuster drug, Neulasta. After it generated its first sales in Q1 of 2022, Rolontis showed a steady growth in sales. It surpassed 2 billion won in sales last Q1; later, it surpassed 3 billion won in the previous Q4. After its launch, Rolontis generated a cumulative sales of 14.6 billion won. Rolontis is a domestically developed new drug that also received approval from the U.S. Food and Drug Administration (FDA). In 2012, Hanmi Pharm made a technology transport of Rolontis to Spectrum. In September 2021, it won FDA approval under the U.S. product name of Rolvedon. Initially, Rolvedon secured FDA approval after Spectrum Pharmaceutical acquired Rolvedon’s technology transport. Following the approval, Assertio Holdings, a pharmaceutical company specializing in the central nervous system, pain, and inflammation, acquired Spectrum in April last year.
- Policy
- ‘Gavreto’ withdrawn from KOR amid reimb rejection
- by Lee, Hye-Kyung Feb 21, 2024 05:45am
- BPM made a decision to discontinue selling and developing Gavreto in all countries except the United States and China. ‘Gavreto Cap. 100mg (pralsetinib),’ previously managed by Roche Korea, will be withdrawn from the Korean market. In February 2023, Roche announced its decision to terminate the global partnership agreement with Blueprint Medicines Corporation (BPM), the drug’s original developer. Furthermore, Gavreto did not clear the reimbursement hurdle, leading to the voluntary withdrawal of its Biologics License Application (BLA). Gavreto will no longer be available in South Korea as BPM, the original developer of Gavreto, does not hold a division in Korea, and a search for a new partner has been unsuccessful. “Gavreto has not been prescribed since June 2023, and there are currently no patients using the drug,” Roche Korea said reporting to the Ministry of Food and Drug Safety (MFDS) recently. “The company has 134 in stock, with the last import date being April 11th.” Gavreto was granted a BLA approval in South Korea for its use as a treatment for non-small cell lung cancer (NSCLC) on March 29th, 2022. As targeted therapies for RET(REarranged during Transfection) gene mutation, Gavreto and ‘Retevmo Cap. (selpercatinib)’ were expected to be competitors in the market. However, the two drugs went different paths in Korea. Retevmo was deemed suitable for reimbursement by the Cancer Drug Review Committee of the Health Insurance Review and Assessment Service (HIRA). Gavreto, on the other hand, received a non-reimbursement decision. However, Retevmo failed to be listed for reimbursement due to unsuccessful drug pricing negotiations with the National Health Insurance Service (NHIS). Currently, there are no RET-targeted therapy that are eligible for reimbursement. RET, which is one of the essential imaging biomarkers for cancer, can cause malignant tumors by a fusion with another gene or point mutations. Certain types of cancers, including lung cancer, breast cancer, and colorectal cancer, are associated with RET mutations. The frequency of RET mutations in NSCLC is about 2-6%, while RET fusion mutations in thyroid cancer are reported to be up to 40%. “While there is no identical drug to Gavreto available, a similar formulation called Retevmo with the same indication is available in the market,” Roche stated. “Considering the small number of eligible patients for this indication, it appears appropriate to use targeted therapy for RET gene mutations within the same class.” The withdrawal of Gavreto is not limited to South Korea. “On January 8th of this year, BPM made a decision to discontinue selling and developing Gavreto in all countries except the United States and China,” said Roche. “(In South Korea), we plan to voluntarily withdraw the BLA after completing the import discontinuation reporting process.”
