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- 2026-05-07 20:36:42
- Policy
- The 1st results of the pharmaceutical benefit re-evaluation
- by Lee, Tak-Sun Sep 01, 2023 05:43am
- The HIRA does not plan to disclose the first results of the benefit re-evaluation reviewed by the committee on this day. After notifying the pharmaceutical company of the results, we plan to receive objections and then disclose the results during the second review. According to HIRA and the pharmaceutical industry on the 31st, the results of this year's salary adequacy reevaluation review will be discussed as an agenda item at the committee meeting held on the 6th. The ingredients subject to re-evaluation this year are Hyaluronic acid eye drops; Rebamipide, Limaprost Alfadex, Loxoprofen Sodium Hydrate, Levosulpiride, and Epinastine, etc. Among these, the market size of Hyaluronic acid eye drops, which are used for artificial tears, is the largest at approximately 200 billion won, drawing high interest from the industry. As there is great interest in Hyaluronic acid eye drops, the results are also unpredictable. However, in the pharmaceutical industry, as there is strong opposition from medical staff and there are opinions that benefits should be maintained for elderly patients, it is expected that benefits will be maintained after social discussion. An industry insider declined to comment, saying, “There is sufficient evidence for the effectiveness of Hyaluronic acid eye drops, but I don’t know how to judge it.” There are many predictions that other re-evaluation targets will not be deleted altogether even if there are reimbursement restrictions for some indications. In the case of Rebamipide, which is used for gastritis and gastric ulcers, there are many papers on its efficacy against gastric ulcers, so it is expected that reimbursement will not be maintained. The analysis also shows that there is sufficient clinical evidence for one of the two indications for Limaprost Alfadex, represented by Opalmon. The HIRA plans not to disclose the results of the first deliberation of this committee, but to notify only pharmaceutical companies. We plan to receive objections, reconsider them, and then make the results public. Last year, after the appeal, the committee deliberation was made public in October.
- 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.
- Policy
- Cold medicine bills increased by 90% due to the coronavirus
- by Lee, Tak-Sun Aug 31, 2023 05:25am
- Jeong Hae-min, head of the NHIS Pharmaceutical Management Department, is answering questions at the Professional Journalists Due to the increase in confirmed cases of COVID-19 last year, cold medicine bills alone increased by 90% compared to the previous year. Based on the past five years, claims for COVID-19-related drugs were the highest in 2022. The NHIS conducted negotiations on linking usage and drug price reduction for 36 items related to COVID-19 and agreed on a reduction rate by applying a correction plan. The NHIS Pharmaceutical Management Office announced this at a meeting with the Professional Journalists Council on the 29th. According to NHIS, as a result of analyzing the billing amount for 2,637 cold medicine and antibiotic items last year, cold medicine billing amounted to 664.5 billion won and antibiotic billing amounted to 1.0575 trillion won. This is an increase of 90.1% and 24.0%, respectively, compared to the previous year. When looking at trends over the past five years, the number of pharmaceutical bills related to COVID-19, which was approximately 1.5 trillion won from 2018 to 2019, decreased to 1.2 trillion won from 2020 to 2021 but recovered to 1.7 trillion won last year. The NHIS also applied this COVID-19 drug while conducting PVA ‘Type C’ negotiations this year. Jeong Hae-min, head of the Pharmaceutical Management Department, explained, "Starting in June, we have supported a stable supply of cold medicines by easing the reduction rate of cold medicines and antibiotics monitored by the Ministry of Food and Drug Safety through the COVID-19 medicine correction plan derived through consultation with the Pharmaceutical Association." As a result of the negotiations, 'multi-type' negotiations were conducted on 36 items related to COVID-19 (18 pharmaceutical companies, 22 same product groups), and an overall agreement was reached. The NHIS plans to prepare guidelines for coordination and negotiation in response to the situation in which some essential medicines have become unprofitable due to the rise in raw material prices after the coronavirus outbreak, preventing smooth supply and repeatedly being sold out. It has been pointed out that the data submitted for mediation negotiations is based on HIRA's withdrawal prevention drug application data, so the amount of data is large and complex, putting a large burden on the company. Accordingly, the NHIS explains that it has been forming a consultative body with the Pharmaceutical Association since March to discuss and collect opinions from companies, simplify submitted data, and determine the ratio of general management costs and profits to be reflected in cost analysis. The 7th council discussion was held until August, and the plan is to compile the collected opinions establish mediation negotiation guidelines around October, and hold a company briefing session.
- 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.
- Policy
- NHIS may cover high-priced new drugs with refund-type RSA
- by Lee, Tak-Sun Aug 31, 2023 05:25am
- The National Health Insurance Service is planning to improve the Risk Sharing Agreement (RSA) Scheme and is also discussing measures to improve the Price-Volume Agreement (PVA) system to reflect rewards for the innovative value of new drugs. The Department of Drug Management at NHIS said so at a press conference with correspondents on the 29th. Hae Min Jung, Director of the Department of Drug Management at NHIS, said “We are reflecting the results of the research service that was conducted to improve the RSA system, and advancing the system to achieve both the rapid listing of high-priced drugs and financial soundness of NHI finances. The demand for expansion of RSA subjects has been increasing, so we are planning to expand the drugs eligible to apply for performance-based refund-type RSA from one-shot treatments to high-priced drugs. We are also considering improving related systems, such as by new types of financial sharing plans.” Jung also added that discussions are underway with relevant organizations and the industry to come up with measures to reduce the administrative burden. Also, additional projects will be carried out for the post-marketing control of drugs that waived the submission of pharmacoeconomic evaluation data, which HIRA is seeking to improve. Jung said, “One of the results of the research service suggested the need for post-marketing management and system improvement for drugs were exempted from the submission of pharmacoeconomic evaluation data. Therefore, we plan to refer to the results of the research service on ‘Preparing measures to improve the PE exemption system’ that has been carried out by HIRA this year and come up with additional improvement tasks.” Since December 2013, when RSA was first implemented, to August 1, 2023, 68 drugs and 123 items have received reimbursement in Korea through the RSA system, and the RSA contract for 18 drugs and 26 items has been terminated. The amount refunded by pharmaceutical companies under the RSA system amounted to KRW 328.1 billion in 2022, and the refund amount has been increasing in line with the rise in the number of RSA contracts signed over the past five years. Hae Min Jung, Director of the Department of Drug Management at NHIS, is answering questions at a press conference held on the 29th The NHIS is seeking to improve the RSA system to manage high-priced drugs. As of 2022, 14 high-priced drugs costing more than KRW 300 million per person a year had filed claims of KRW 179.3 billion, which is around KRW 420 million per patient. This accounts for around 0.8% of total drug expenditures (KRW 22.9 trillion) spent by the NHIS. 37 drugs cost more than KRW 100 million per person a year, and the claims amount of the drugs amounts to KRW 348 billion. Due to these high-priced drugs, drug expenditures in health insurance finances have been increasing by more than KRW 1 trillion every year and reached KRW 22.9 trillion in 2022. This is why NHIS is seeking ways to share the financial risks through the RSA system when listing high-priced drugs, and to minimize the increase in drug costs by reducing prices of drugs that showed a rapid increase in usage through PVA negotiations. The government is also discussing measures for applying preferential treatment to innovative new drugs when applying PVA. This part is being carried out as part of the 'Measures to Improve the Insurance Drug Price System for Appropriate Compensation for the Innovative Value of New Drugs' that is being carried out by the Ministry of Health and Welfare. Jung said, “Improvement plans, such as appropriate compensation for the innovative value of new drugs, may be announced through the Health Insurance Policy Deliberation Committee meeting at the end of September at the earliest. The plan also includes the PVA part, which includes the pharmaceutical companies’ request that new drugs that meet the innovativeness requirements should be exempt from negotiations when they are subject to PVA 3 times in a row. Whether the requests were accepted will be clear when the final plan is disclosed at the end of September.”
- Opinion
- [Reporter’s View] M&A storm blows through industry
- by Lee, Seok-Jun Aug 30, 2023 05:32am
- At a dinner party with a second-generation owner in his 40s, I asked what the company’s goal is for the second half of the year. It was sort of an icebreaker question to warm up the party atmosphere. What I expected was a routine response, such as 'we will be building growth engines by investing in R&D or facilities', ‘we will promptly develop new products into blockbusters’, 'We will maximize profitability by reducing costs', or 'We will increase efficiency in management through the integration of the organization and personnel relocation.’ But the response he gave was completely unexpected. “We plan to prepare for an M&A.” The simple response indicated how the industry has changed over the years. The perception of M&As in the pharmaceutical industry has changed in line with the generation shift in its management, which has been passed on from the founder to second or third generation owners. The plan was also specific. The owner knew the characteristics of the business structure, the stake of the largest shareholder, and the market cap of the companies he was eyeing. He said, “There are many old pharmaceutical companies with weak governance structures. If they can create synergy with our company, there is no reason not to consider an M&A. We are considering several candidates. Our company has a lot of cash, so we can buy companies whose largest shareholder's stake is around 10-15%. The era of selling generics to grow the company is now in the past. Instead of paying commissions for CSO sales, M&A is more cost-effective.” ' I also asked another second-generation owner in his mid-50s whether he had plans for M&As as well. ‘Of course’ was the answer. He said, "If the need for M&A was recognized in the past, this is now the time to act on it." Citing the case of GC Pharma and Ildong Pharmaceutical, he emphasized that being tied to past relationships will only hinder efficient business management. “Whether the owner can lead his/her employees well is a core competency required for owners. You may miss opportunities if you give up M&As because you have known each other for a long time. If GC Pharma and Ildong Pharmaceutical's big deal had occurred, it would have been another milestone for the pharmaceutical industry. At that time, the deal was criticized as a hostile takeover, but the view on M&As has now changed. It has now become one of the pillars of business management." To collect a more collective opinion of the industry, I continued to ask the same question to second and third generation owners on their opinion of M&As. Most of the owners had a positive attitude towards M&As. Some also hinted at specific plans, such as a specific pharmaceutical company and accompanying financing plans. However, a conservative mindset regarding M&As remains in the industry still. There are cases where companies acquire bioventures, cosmetics, and functional health food companies as a means of business diversification, but large-scale M&As between pharmaceutical companies are rare. PharmaResearch and CTC Bio, which have been fighting over shares, is the M&A possibility that currently exists in the field. The change is palpable. Following the attitude of its second and third generation owners, the companies’ attitude towards M&A has changed to take on a more pro-M&A stance. Times have changed, and things that seemed impossible in the past are now being taken for granted. In this context, could it be that an M&A storm is blowing through the industry? At least, the second and third generation owners' perspectives are more pro-M&A for sure. Although M&As are not the answer for everything, if it can be considered as a means of business management and used wisely, it has ample potential to bring another boom in the pharmaceutical industry.
- 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.
