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- 2025-12-23 11:37:52
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- Will Phesgo be listed with pricing premiums as a biobetter?
- by Eo, Yun-Ho Sep 04, 2023 05:04am
- Whether another biobetter after Nexviazyme will be receiving premium pricing in Korea is gaining attention. According to industry sources on the 30th, Roche Korea’s subcutaneous fixed-dose combination injection Phesgo (pertuzumab, trastuzumab) that combined ‘Perjeta’ and ‘Herceptin’ has passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation committee review. Therefore, after undergoing the Drug Reimbursement Evaluation Committee review, Roche will sign agreements with the National Health Insurance Service regarding the supply and quality control obligations for Phesgo. If successfully listed, Phesgo will become the first anticancer drug and the second drug to benefit from the biobetter preferential treatment plan. In 2016, the government announced a plan to provide preferential pricing for biosimilars and biobetters, which are improved versions of already approved biopharmaceuticals, that have contributed to the improvement of Korea’s healthcare. In the case of Nexviazyme, In consideration of how biobetters are more difficult to develop compared to incrementally modified drugs (chemical drugs), the overall price of Nexviazyme was set at the 100-120% range of the original drug. However, since the implementation of the system, no drug has benefitted until now, and Nexviazyme became the first drug to benefit from the 1st. Phesgo was recognized for its innovation in improving patient convenience and reducing treatment time by changing the IV-injected Herceptin and Perjeta into a fixed-dose subcutaneous injection and was named the first biobetter approved for cancer in Korea. Metastatic HER2-positive breast cancer patients who had received maintenance therapy with IV Herceptin and Perjeta injections every three weeks may reduce their administration and monitoring time by 90% from 270 minutes (90min+180min) to 20 minutes (5min+15min) when switching to Phesgo. Also, as Phesgo is a subcutaneous formulation injected in the thigh rather than into the veins, it can reduce blood vessel and nerve damage that can be caused by repeated intravenous injections. The NCCN guidelines state that Phesgo can be used in the place of Perjeta and Herceptin, In fact, in the UK, 90% of patients treated with Herceptin and Perjeta switched to Phesgo within a year after its launch. Therefore. If listed, a significant number of patients receiving Herceptin-Perjeta treatment are expected to switch to Phesgo as well.
- Company
- Can Koselugo pass the Pharmaceutical Evaluation Committee?
- by Eo, Yun-Ho Sep 04, 2023 05:04am
- Koselugo, a new drug for pediatric neurofibroma, is once again awaiting discussion for listing on insurance benefits. Attention is focused on whether AstraZeneca Korea's neurofibromatosis new drug Koselugo, which was decided for re-discussion at HIRA last month, will be presented to the committee on the 7th. Koselugo failed to reach an agreement at the committee last month even though the pharmaceutical company submitted supplementary data and a risk-sharing plan. This disease begins in childhood with milk-coffee spots measuring 1 to 3 cm. Afterward, they experience symptoms such as optic nerve glioma (brain tumor) around the age of 6 and scoliosis between the ages of 6 and 10. In adults, Lisch nodules, which are hamartomas that occur in the iris, are most commonly found. The possible part can be removed surgically or treated with chemotherapy or radiation. However, even after surgery, most cases recur, and most of them are major surgeries, putting a significant burden on both the medical staff and patients. In particular, recurrences are frequent in pediatric patients, so even after multiple surgeries, they have to take painkillers and often suffer from speech and motor difficulties. Koselugo is a treatment jointly developed by AstraZeneca and MSD. It inhibits the growth of cell lines by blocking MEK activity. In the SPRINT phase 2 clinical trial, which served as the basis for approval, Koselugo achieved ORR, the primary endpoint, by reducing tumor size by more than 20% in 68% of administered patients. Additionally, 82% of patients who showed a partial response maintained the response for over 12 months. Among patients who did not receive treatment, half experienced disease progression after 1.5 years, but only about 15% of patients who used Koselugo experienced disease progression even after 3 years.
- Company
- Enhertu posts KRW 7.4 bil in H1 sales without reimb
- by Kim, Jin-Gu Sep 01, 2023 05:44am
- Daiichi Sankyo Korea’s HER2-positive breast cancer treatment ‘Enhertu (trastuzumab deruxteca); has raised sales of over KRW 7 billion in H1 this year without reimbursement. According to the market research institution IQVIA on the 31st, Enhertu posted sales of KRW 7.4 billion in H1 this year, making KRW 2.2 billion in Q1 and KRW 5.2 billion in Q2. Even without reimbursement listing, sales of the drug had exceeded KRW 7 billion. This indicates the many breast cancer patients in need of the treatment. The non-reimbursed cost of Enhertu is known to be in the KRW 5 million range per injection. Enhertu is an antibody-drug conjugate (ADC) that was approved by the Ministry of Food and Drug Safety in September last year. It is used to treat HER2-positive breast cancer. More specifically, Enhertu is indicated to treat unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting, and locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Also, in December, the drug’s indication was extended to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. However, the drug is making small progress in terms of reimbursement listing. The drug passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review after redeliberation in May, but remains pending thereafter, without being deliberated at the 4 subsequent Drug Reimbursement Evaluation Committee meetings that followed. The next DREC meeting will be held on September 7th, but whether Enhertu will be deliberated then remains unknown. Patients have been long awaiting its reimbursement listing, to the extent that a public petition had been registered on its coverage. The petition was filed in January this year and received 50,000 consents on its need in only 5 days. The agenda was then referred to the National Assembly’s Health and Welfare Committee and started the reimbursement listing process. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. Results showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of overall survival (OS), the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1. Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab. Results showed that Enhertu met its main efficacy outcome with a confirmed objective response rate (ORR) of 60.9% % (95% CI, 53.4-68.0) and a mPFS of 16.4 months.
- Company
- Two targeted anticancer therapies fail reimb in KOR
- by Eo, Yun-Ho Sep 01, 2023 05:44am
- Two anticancer drugs that target a very small number of lung cancer patients with EGFR exon 20 insertion mutation for which existing TKIs were ineffective, were both unable to receive reimbursement in Korea. According to industry sources, no reimbursement standards were set for both Takeda Pharmaceuticals Korea’s ‘Exkivity (mobocertinib)’ and Janssen Korea’s ‘ Rybrevant (amivantamab)’ w at the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee meeting that had been held on the 30th. This is the second time Rybrevant failed to establish reimbursement standards at the CDDC level. EGFR exon 20 insertion mutations in NSCLC are so rare that it is found in only 2% of all NSCLC patients harboring EGFR mutations in Korea. With no suitable treatment available for the specific condition, even the NCCN guidelines have only been recommending platinum-based chemotherapy for the patients. And even this is subject to reimbursement cuts. Although lung cancer in itself is not a rare disease, NSCLC with EGFR exon 20 insertion can be classified as a rare condition. Unlike other common EGFR mutations, NSCLC patients with EGFR exon 20 insertion mutations have a 75% higher risk of death, a 5-year survival rate of 8%, and a life expectancy of less than 2 years. However, with both drugs failing to pass the CDDC barrier, it would take some time for Korea to have extended treatment for EGFR exon 20 insertion mutation NSCLC. The key is whether the condition will be recognized for its rarity during reimbursement evaluations and the drugs be accepted as a rare cancer treatment. Meanwhile, Exkivity demonstrated its efficacy through a Phase I/II study. In the study, patients who were treated with Exkivity showed an objective response rate (ORR) of 28% and a median duration of response (DoR) of 17.5 months. In particular, the median time to response after Exkivity treatment was 1.9 months, demonstrating the rapid effect of the drug from initial treatment. Rybrevant showed an ORR of 40% in a Phase I trial, during which the drug demonstrated a complete response of 4% and a partial response of 36%.
- Company
- Released next-generation growth hormone drug
- by Kim, Jin-Gu Aug 31, 2023 05:25am
- The domestic growth hormone drug market, which is rapidly growing, has faced a variable with the release of new products by major companies. LG Chem, the No. 1 company in the market, replaced the existing Eutropin with the next-generation product, Eutropin S, further solidifying its leading position, followed by Dong-A ST and Pfizer. In particular, Pfizer plans to add NGENLA, a once-a-week medication, to its lineup starting next month. Depending on the success of this product, considerable changes are expected in the growth hormone market in the future. Expected to exceed 250 billion won in the growth hormone market, successful replacement of LG Chem’s Eutropin S generation. According to IQVIA, a pharmaceutical market research institute, on the 29th, the size of the domestic growth hormone drug market in the first half of last year was 135.6 billion won. It increased by 18% from 114.6 billion won in the first half of last year. The domestic growth hormone drug market is rapidly growing in recent years. The market, which was worth 145.7 billion won in 2019, exceeded 150 billion won in 2020 and 200 billion won in 2021. Last year, it further expanded to 238.6 billion won. In the case of this year, it recorded 130 billion won in the first half alone and is expected to expand to more than 250 billion won by the end of the year. It was found that related sales of major companies increased together. LG Chem's combined sales of Eutropin and Eutropin S increased by 19% in one year from 42.1 billion won in the first half of last year to 50 billion won in the first half of this year. LG Chem received permission for Eutropin S in April last year. Then, at the end of last year, sales began in earnest. Compared to existing products, the expiration date has been increased from 18 months to 24 months. LG Chem explains that the expiration date has been extended, improving supply stability and making it possible to check the remaining capacity. It is an analysis that it succeeded in a natural generational change with existing products. Sales of Eutropin S increased from 5.5 billion won in the fourth quarter of last year to 19.3 billion won in the first quarter of this year and 19.7 billion won in the second quarter. Existing Eutropin sales decreased to 15.5 billion won, 5.5 billion won, and 4.9 billion won during the same period. In the case of combined sales, it has been on an upward trend since the addition of new products. Pfizer, No. 3 in the market, announces the release of NGENLA once a week. LG Chem's Eutropin/Eutropin S, Dong-A ST's Growtropin II, and Pfizer's Genotropin/Genotropin goquick pen are rapidly catching up. In particular, the increase in related sales of the two companies was found to be greater than that of LG Chem, the market leader. Dong-A ST's Growtropin II posted sales of 33.2 billion won in the first half. Compared to 21.2 billion won in the first half of last year, it increased by 57% in one year. Growtropin II, which exceeded 10 billion won in quarterly sales in the first quarter of 2022, exceeded 15 billion won in sales in the first quarter of this year, and quarterly sales are about to reach 20 billion won. Pfizer's Growtropin series is showing even greater sales growth. The combined sales of Growtropin and Genotropin goquick pen increased by 86% in one year from KRW 14.1 billion in the first half of last year to KRW 26.3 billion in the first half of this year. Genotropin, a cartridge-type product, increased by 48% from KRW 8 billion to KRW 11.8 billion, and Genotropin goquick pen, a pen-type product, increased 2.4 times from KRW 6.1 billion to KRW 14.5 billion. It is analyzed that sales of Genotropin goquick pen, a next-generation product, are gradually expanding as the domestic supply of the two products stabilizes after 2020. Pfizer plans to add a new product to its lineup. Pfizer received permission for NGENLA Prefilled Pen Injection in January of this year. This product will be applied for reimbursement from next month. NGENLA is a product that lengthens the half-life by modifying the molecule of Genotropin. If the existing Genotropin was administered daily, NGENLA is administered once a week. However, the indication is limited to the treatment of growth failure in children (3 years of age or older) due to pituitary growth hormone secretion disorders. Pfizer plans to continue supplying Genotropin even if a new treatment is released, as NGENLA has a smaller indication range than Genotropin. In addition, Merck's Saizen increased sales by 27% from 16.1 billion won in the first half of last year to 20.4 billion won in the first half of this year. Sales of Novo Nordisk Norditropin nordiflex plunged from 16.3 billion won in the first half of last year to 1.1 billion won in the first half of this year. Norditropin is known to have been discontinued in Korea since the third quarter of last year. The company initially announced the timing of domestic resupply at the end of November last year but corrected it to say that it is currently undecided. In the first half of the year, sales of Cyzen Korea Scitropin decreased by 8% from 3.8 billion won to 3.4 billion won, and Ferring Zomacton's sales increased from 1.1 billion won to 1.2 billion won.
- Company
- Hemophilia drug Hemlibra’s sales rise twofold with reimb
- by Chon, Seung-Hyun Aug 31, 2023 05:25am
- Sales of JW Pharmaceutical’s hemophilia drug ‘Hemlibra’ have surged recently. The reimbursement extensions that had been made for the drug in May had increased the number of eligible patients, raising sales by over twofold. According to the pharmaceuticals research institution IQVIA, Hemlibra’s sales in 1H this year were KRW 5.7 billion, up 61.6% YoY. Hemlibra’s Q1 sales rose 15.3% YoY to KRW 2.1 billion, and Q2 sales rose 112.0% YoY to KRW 3.6 billion. Hemlibra is a genetic recombinant drug functioning as a routine prophylaxis agent for hemophilia A caused by coagulation factor VIII deficiency. The drug employs the bispecific antibody technology which simultaneously binds to factor IX and factor X. Unlike previous coagulation factor VIII preparations, Hemlibra is the only non-factor therapy option, the injection is injected subcutaneously once every 4 weeks. It was developed by Chugai Pharmaceutical, a Japanese subsidiary of the multinational pharmacuetical company Roche. JW Pharmaceutical secured the domestic development and sales rights for Hemlibra in Korea in 2017 and received approval from the Ministry of Food and Drug Safety in 2019. Quarterly sales of Hemlibra (Unit: KRW 1 million, Data: IQVIA) The reimbursement extension was what contributed to Hemlibra’s rapid rise in Q2 sales. Since May, Hemlibra has also been reimbursed for ‘patients aged 1 years or older with hemophilia A and do not have factor VIII inhibitors.’ Hemlibra was first reimbursed for ‘severe hemophilia A patients with inhibitors in May 2020, and has been extended to cover patients without inhibitors from May this year.’ According to JW Pharmaceutical, there are about 1,700 patients hemophilia A patients in Korea. Among them, approximately 70% of patients have severe hemophilia A. Among patients with severe hemophilia A, the overwhelming majority have no factor VIII inhibitors. The company explains that more than 60% of domestic hemophilia A patients are now eligible to receive reimbursement for Hemlibra. Hemlibra's sales surged 68.4% in Q2 compared to the previous quarter even though the reimbursement was only applied for 2 two months since May. Since its domestic release in 2020, Hemlibra’s cumulative sales have reached KRW 22.7 billion, exceeding KRW 20 billion in 3 years. The company predicted that usage would also increase rapidly with the broad reimbursement extension. Last year, Hemlibra's global sales amounted to CHF 3.82 billion (about KRW 5.7 trillion), a 27% increase compared to the previous year (CHF 3.02 billion). Currently, more than 20,000 patients in 144 countries around the world are using Hemlibra. JW Pharmaceutical expects the drug to provide great treatment benefits to patients based on its proven efficacy and safety in large-scale clinical trials. In the HAVEN1 trial that was conducted on patients with inhibitors, prophylactic treatment with Hemlibra reduced the annual bleeding rate (ABR) to 3.3 times, which is a 79% reduction compared to existing prophylactic bypassing agents. In the HAVEN3 trial, which was conducted on patients without inhibitors, Hemlibra demonstrated a 68% reduction in ABR to 1.5 compared to coagulation factor VIII prophylactic treatments. In a study that compared the effects of Hemlibra in patients with and without inhibitors, both showed similar effects and long-term effectiveness. The purpose of prophylaxis (maintenance therapy) as the standard treatment for hemophilia patients is to prevent bleeding while maintaining the patient's blood coagulation factor VIII’s activity at a certain level. Hemlibra was found to maintain a constant concentration. The company also added that Hemlibra’s safety was demonstrated through various clinical trials. The HAVEN 1-4 trials showed that most side effects among patients who received Hemlibra were mild injection site reactions.
- Company
- The obesity market doubled in 5 years
- by Chon, Seung-Hyun Aug 31, 2023 05:25am
- Saxenda widens the gap with Qsymia. The imminent release of large products such as Wegovy. The domestic obesity market is expanding at a rapid pace. As demand for weight loss through pharmaceuticals increases, the market size has more than doubled in the past five years. Saxenda's quarterly sales exceeded 20 billion won and its market share approached 50%. With the imminent release of large-scale products such as Mounjaro and Wegovy, which are popular overseas, a reorganization of the market is expected in the future. According to IQVIA, a pharmaceutical research institute, on the 31st, the size of the domestic obesity treatment market in the first half of last year was 96.7 billion won, a 17.9% increase from the same period last year. The obesity market grew 24.5% from the previous year to 44.4 billion won in the first quarter, and reached 52.3 billion won in the second quarter, a 12.9% increase from the previous year, reaching the largest size ever. This is the first time that the obesity treatment market has exceeded 50 billion won in quarterly sales. The obesity market continues to grow steadily, increasing by 39.2% over the past three years from 37.6 billion won in the second quarter of 2020. Compared to 24.3 billion won in the second quarter of 2018, it has increased by 115.2% in 5 years. As satisfaction with recently introduced obesity treatments has increased, the number of people trying to lose weight using medications has also increased significantly. Novo Nordisk's Saxenda led the expansion of the obesity treatment market. Saxenda occupied about half of the obesity treatment market and operated a robust monopoly system. In the first half of last year, Saxenda's sales increased 53.3% from the previous year to 39.6 billion won. Saxenda's sales in the first quarter increased 53.0% from the previous year to 15.9 billion won, and in the second quarter, sales increased 53.5% to 23.7 billion won, exceeding 20 billion won in quarterly sales for the first time. Saxenda, released in Korea in 2018, is the world's first obesity treatment drug approved as a GLP-1 (Glucagon-Like Peptide 1) analog. It has the same ingredients as Victoza (ingredient name: liraglutide), which is prescribed for type 2 diabetes patients, but the usage and dosage are different. Saxenda enjoyed explosive popularity as it was recognized as relatively safe because it works by the exact mechanism as GLP-1 in the human body to suppress appetite and induce weight loss. Saxenda has been leading the obesity treatment market for 19 consecutive quarters since taking the lead in the obesity treatment market with sales of 5.6 billion won in the fourth quarter of 2018, immediately after its launch. Saxenda's sales gap with the new product Qsymia narrowed to 800 million won in the first quarter of 2021, but the gap has widened significantly since then with even more rapid growth. In the second quarter of last year, Saxenda's sales gap with Qsymia reached 14.9 billion won. Saxenda's sales share in the obesity treatment market in the second quarter reached 45.3%. Qsymia recorded sales of 8.8 billion won in the second quarter, up 12.2% from the previous year, but the gap with leader Saxenda widened significantly. Qsymia, released at the end of 2019, is a drug with the same ingredient that Alvogen Korea secured domestic sales rights in the United States in 2017. It is a combination of Phentermine Hydrochloride and Topiramate. Alvogen Korea signed a joint sales contract with Chong Kun Dang at the end of 2019 and began domestic sales in earnest. Qsymia threatened its lead by increasing its market share to 18.4% in the first quarter of 2021, but its share has since stagnated. Qsymia's market share in the second quarter was 17.0%, significantly lower than Saxenda. The industry predicts that the market will change significantly in the future with the emergence of significant obesity treatments that have proven commercial feasibility overseas. Last April, the Ministry of Food and Drug Safety approved Novo Nordisk's Wegovy. Wegovy is a GLP-1 analog from the same family as Saxenda. Novo Nordisk improved Saxenda from once daily administration to once weekly administration. After Wegovy was launched in the U.S. market, demand soared to the point where it was out of stock. It is so popular that even Ozempic, a diabetes treatment with the same ingredients and usage method, is sold out. Eli Lilly Mounjaro received approval from the Ministry of Food and Drug Safety last June. Mounjaro is a next-generation GLP-1 analog that activates both GLP-1 and GIP receptors with once-weekly administration. Mounjaro has been approved as a treatment for type 2 diabetes and is expected to secure an indication for obesity treatment in the future. Mounjaro, which received US approval last year, recorded sales of 2 trillion won in the first half of this year. If Mounjaro is approved as an obesity treatment, it is expected to spark an obesity treatment craze along with Novo Nordisk's Wegovy.
- Company
- Reimb for the petitioned ADC drug Enhertu unclear
- by Eo, Yun-Ho Aug 31, 2023 05:25am
- Reimbursement discussions for the anticancer drug ‘Enhertu’ that received 50,000 consents in a national petition are making slow progress. Daiichi Sankyo Korea’s HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan), which finally passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review after redeliberation in May, remains pending, undeliberated at the 4 subsequent Drug Reimbursement Evaluation Committee meetings. The next DREC meeting will be held on September 7th, but whether Enhertu will be deliberated then remains unknown. The drug is currently receiving review at the pharmacoeconomic evaluations subcommittee level, but no conclusion has yet been reached on the drug’s cost-effectiveness. However, with the review nearing the 150-day deadline at HIRA’s level, how the discussion will progress is gaining much attention. For reimbursement, Daiichi Sankyo was known to have prepared various plans to reduce the financial burden, such as by presenting the drug price of Enhertu at the lowest level in the world and considering applying the risk-sharing agreement (RSA) scheme. However, due to the significant efficacy of Enhertu that was demonstrated through a Phase III trial, which had not been small compared to other existing treatments, the government is having difficulty calculating an appropriate drug price. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of OS, the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1 Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab. Results showed that Enhertu met its main efficacy outcome with a confirmed objective response rate (ORR) of 60.9% % (95% CI, 53.4-68.0) and an mPFS of 16.4 months. Enhertu was approved by the Ministry of Food and Drug Safety in September last year based on the DESTINY-Breast01 and DESTINY-Gastric01 trials. In Korea, Enhertu is indicated to treat ▲ unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting and ▲ locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Also, in December, based on the DESTINY-Breast03 trial, the drug’s indication was expanded to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
- Company
- Leclaza’s cumulative sales reach KRW 30 bil in 2 yrs
- by Chon, Seung-Hyun Aug 30, 2023 05:32am
- Yuhan Corp’s new anticancer drug, ‘Leclaza’ is gradually expanding its influence in the domestic market. The drug exceeded KRW 30 billion in cumulative sales in only 2 years since its domestic release. Prescriptions are also expected to increase further if the company receives reimbursement for its newly added indication as a first-line treatment. According to the market research institution IQVIA on the 25th, Leclaza posted sales of KRW 10.3 billion in 1H, up 49.5% YoY. In Q1, sales increased by 57.4% YoY to KRW 5.1 billion and then increased by 42.5% YoY to reach KRW 5.2 billion in Q2. Leclaza is a non-small cell lung cancer treatment that was approved as Korea’s 31st homegrown novel drug in January 2021. Leclaza entered Korea’s prescription market in earnest with its reimbursement listing in July 2021. In Q3 and Q4 2021, it recorded sales of KRW 1.5 billion and KRW 2.5 billion, respectively. Last year, the drug had raised KRW 16.1 billion, exceeding the annual sales of KRW 10 billion mark in its second year of release. Since its release, cumulative sales have been estimated to be around KRW 30.2 billion. The drug exceeded KRW 30 billion in cumulative sales within 2 years of its release in Korea. Quarterly Leclaza sales (Unit: KRW 100 million, Data: IQVIA) Leclaza is considered to have made a smooth start in the market. Anticancer drugs that are usually used in large medical institutions, can only be prescribed after the drug passes each institution’s drug committee, therefore, it takes a considerable amount of time before sales are generated after the initial stage of release. With the added pressure of having to directly compete with outstanding new drug products from multinational pharmaceutical companies, it is not easy for new anticancer drugs developed in Korea to achieve commercial results. Leclaza passed the drug committee of major large medical institutions in Korea and is accelerating its market penetration efforts. The drug is expected to expand further into the market if it receives reimbursement approval as a first-line treatment. It was first approved as a second-line treatment for patients with locally advanced or metastatic NSCLC who developed resistance to a specific gene (T790M) after being treated with 1st generation or 2nd generation EGFR-TKIs. Also, the drug was recently approved as a first-line treatment. The Ministry of Food and Drug Safety approved the change in permission to expand the indication of Leclaza to ‘first-line treatment of non-small cell lung cancer.’ The first-line approval comes 2 years and 5 months after its initial approval in Korea. Leclaza showed statistically significant improvement in progression-free survival (PFS) over existing treatments in a global Phase III trial (LASER 301) that was conducted on 393 locally advanced or metastatic NSCLC patients with EGFR mutations. The trial results were presented at the European Society for Medical Oncology Asia Congress that was held last year in Singapore. The drug has also confirmed its efficacy and effect in the real world. Real-world data (RWD) from a retrospective study that was published on Lung Cancer analyzed the efficacy and safety of Leclaza on 103 patients who received Leclaza at Yonsei Cancer Center and the National Cancer Center from January 2021 to August 2021. Subject patients were EGFR T790M mutation-positive NSCLC patients who developed resistance after being previously treated with EGFR-TKI that received Leclaza. 90 of the 103 patients received Leclaza as a second or third-line treatment. The patients’ primary efficacy endpoint in the study, median progression-free survival (mPFS), was 13.9 months. This was consistent with the mPFS of 11.1 months confirmed in LASER201, the study that became the basis of Leclaza’s approval. The objective response rate (ORR) was 62.1%, slightly higher than the 55.3% observed in the LASER201 study. In terms of safety, the drug was also well-tolerated, similar to previous studies. The company had recently applied for the reimbursement of Leclaza as a first-line treatment to the health authorities in Korea. Also, the company plans to provide Leclaza free of charge until the drug is granted reimbursement through an Expanded Access Program (EAP). The drug costs KRW 6 million per month.
- Company
- Sales of Taxol & Genexol rise together
- by Kim, Jin-Gu Aug 30, 2023 05:31am
- Sales of Taxol and Genexol, which contain paclitaxel, rose together in 1H this year. After the sales companies for the two drugs were switched, competition between Boryeong, which has Taxol, and HK Inno.N, which owns Genexol, have been intensifying. According to the industry research institution IQVIA on the 30th, Taxol posted sales of KRW 5.1 billion 1H this year. This is a 29% YoY increase from the KRW 3.9 billion it had made in 1H last year. Taxol is a cytotoxic anticancer drug that contains paclitaxel. It is widely used for various types of cancers including ovarian cancer, breast cancer, lung cancer, and gastric cancer. It is still widely used even 30 years after its approval in 1996. Taxol’s sales, which had been steadily declining until last year, rebounded this year. Its sales had fallen from KRW 10.5 billion in 2019 to KRW 9.5 billion in 2020, to KRW 9 billion in 2021, then to KRW 7.7 billion in 2022. However, in the 1H this year, its sales performance increased by 29% YoY, signaling a rebound. The industry analysis is that Boryung’s joining as a sales partner had been the main contributor to Taxol’s sales rebound. Boryung had started Taxol’s sales in Q1 this year. It is analyzed that Boryung, which owns solid sales power in the anticancer drug area, led Taxol’s sales rebound. Genexol, the No. 1 product in the paclitaxel market and a generic version of Taxol, also saw an increase in sales in the 1H this year. Genexol's sales in the 1H this year were KRW 12 billion, up 12% YoY from the 10.7 billion won it had made in 1H last year. Genexol is being sold by HK Inno.N this year. Until last year, Boryung was in charge of copromoting Genexol with Samyang Holdings. However, Boryung chose to jointly sell Taxol instead of Genexol this year, and Samyang Holdings joined forces with HK Inno.N for its Genexol. The competition between the two products has intensified after the joint sales partners for the products had changed at the same time. In fact, Taxol’s quarterly sales surged from KRW 1.9 billion in Q4 last year to KRW 2.9 billion immediately after Boryung joined in Q1 of this year. However, its sales then fell slightly to KRW 2.2 billion in Q2. Genexol’s sales had fallen from KRW 6.4 billion in Q4 last year to KRW 5.8 billion in Q1 this year with the partner change. However, sales increased to KRW 6.1 billion in Q2. The pharmaceutical industry expects the competition between the two to intensify further in Q3 and thereafter. Boryung and HK Inno.N already own experience selling Taxol and Genexol in the past. HK Inno.N co-promoted Genexol from 2001 when Samyang Holdings developed Genexol as a paclitaxel generic to 2013. Then, the companies joined forces for the first time in 10 years earlier this year. Boryung had jointly sold Taxol with BMS from 2008 to 2015. The company then jointly sold Genexol until last year. During this period, Genexol surpassed the original Taxol and took over the lead in the market.
