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- 2025-12-20 05:49:15
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- Expanded patent dispute over cancer drug 'Xtandi'
- by Kim, Jin-Gu Aug 20, 2025 06:22am
- Product photo of Xtandi The number of companies challenging the patent for Astellas' prostate cancer treatment, 'Xtandi (enzalutamide)', has expanded to six. Attention has been drawn to the fact that major pharmaceutical companies, such as Chong Kun Dang, Hanmi Pharmaceutical, and JW Pharmaceutical, have joined this latest patent challenge. According to the pharmaceutical industry on August 19, Hanmi Pharmaceutical filed a petition for trial to confirm the scope of rights against Astellas for Xtandi's composition patent on August 18. As a result, the total number of companies that have filed circumvention trials against Xtandi's composition patent has increased to six. Earlier, Alvogen Korea was the first to file the trial on the 1st of this month, followed by Chong Kun Dang, JW Pharmaceutical, GL Pharma, and Kuhnil, where all filed the same trial. The pharmaceutical industry is paying attention to the fact that major pharmaceutical companies, such as Chong Kun Dang, Hanmi Pharmaceutical, and JW Pharmaceutical, have successively joined this patent challenge. This is because there have not been many cases where major pharmaceutical companies have simultaneously challenged patents for anti-cancer drugs. Typically, there is a high preference for prescribing original anti-cancer drugs, especially in large hospitals. Domestic pharmaceutical companies, which have strong sales capabilities for chronic disease treatments in clinics, have been hesitant to challenge patents for anti-cancer drugs for this reason. Furthermore, even if they succeeded in a patent challenge and launched a generic, the profits generated were not significant, making major pharmaceutical companies even more reluctant. There have been cases of patent challenges for liver cancer treatments like 'Lenvima (lenvatinib),' 'Cabometyx (cabozantinib),' and breast cancer treatment 'Ibrance (palbociclib).' However, these were sporadic challenges primarily led by Boryung, which has a separate oncology business unit, or Samyang Biopharm, which specializes in the generic oncology business. In the case of the oncology drug patent, Hanmi Pharmaceutical was the only company challenging the 'Nexavar (sorafenib) patent.' Meanwhile, in the patent challenge for the prostate cancer treatment Xtandi, major pharmaceutical companies like Chong Kun Dang, Hanmi Pharmaceutical, and JW Pharmaceutical have successively filed trials. If they win this trial, generic competition is expected to intensify after the substance patent expires in June 2026. Xtandi is Astellas' prostate cancer treatment, protected by two patents: a substance patent that expires in June 2026 and a composition patent that expires in September 2033. The plan for the generic companies is to circumvent the composition patent, which expires in 2033, and then launch their generics early around the expiration of the substance patent in 2026. Astellas received approval for Xtandi Soft Cap in 2013. Last year, it added two dosages of Xtandi tablets. Xtandi competes with Janssen's 'Erleada (apalutamide)' and 'Zytiga (abiraterone)' in the first-line prostate cancer treatment market. Recently, 'Akeega (abiraterone·niraparib),' a new first-line treatment, was launched. Akeega is a drug that combines Zytiga with Takeda's Zejula (niraparib). Recent trends indicate that while Zytiga's sales are declining following the launch of generics, Xtandi and Erleada are on an upward trend. According to pharmaceutical market research firm IQVIA, Xtandi's sales increased by 1.9 times in four years, from KRW 23 billion in 2019 to KRW 43.2 billion in 2023. It is estimated to have generated sales of around KRW 50 billion last year.
- Company
- Dapa N with Forxiga's indication leads the mkt by surprise
- by Kim, Jin-Gu Aug 20, 2025 06:22am
- Product photo of Forxiga and Dapa N Prescription sales of HK inno.N's 'Dapa N,' which received transfer of Forxiga indications, have surged in the SGLT-2 inhibitor diabetes treatment market. It has risen to the top of the dapagliflozin monotherapy market. Analysis suggests that this success is attributed to Dapa N's transition in indications, including chronic heart failure, following the withdrawal of the former market leader, Forxiga, from the Korean market. With the reimbursement scope for chronic kidney disease recently expanded in the second half of the year, Dapa N's upward trend is expected to continue for some time. HK inno.N's Dapa N Prescription Sales Jump from KRW 300 Million → KRW 2.5 Billion in a Year According to the pharmaceutical market research firm UBIST on August 18, HK inno.N's Dapa N recorded prescription sales of KRW 2.5 billion in Q2, a significant increase from KRW 300 million in the same period last year. Dapa N showed sluggish performance in its early launch, with sales remaining below KRW 500 million for six consecutive quarters after its release in Q2 of 2023. Notably, even after Forxiga's indications were transferred to Dapa N in April of last year, it did not immediately lead to an increase in prescription sales. At that time, AstraZeneca Korea withdrew Forxiga's product approval while simultaneously granting clinical data, thereby transferring Forxiga's indications to Dapa N. Quarterly Prescription Sales Performance by Key Dapagliflozin Monotherapies (unit: KRW 100 million, source: UBIST) Index: RED-HK inno.N However, an analysis shows that Dapa N's growth has become steep since Q4 of last year. Its prescription sales, which were below KRW 500 million, surged to KRW 1.2 billion in Q4 of last year, KRW 2.3 billion in Q1 of this year, and KRW 2.5 billion in Q2. This is analyzed as a shift in the focus of prescriptions towards Dapa N, as the distribution volume of Forxiga gradually decreased in Korea. After deciding to withdraw Forxiga from Korea at the end of 2023, AstraZeneca Korea halted the supply of new inventory in the second half of last year, only distributing existing stock domestically. Dapa N Leads After Forxiga's Departure… Will Upward Trend Continue with Expanded Reimbursement? During this process, Dapa N became the leader in the dapagliflozin monotherapy market. In Q1, with Forxiga completely withdrawn, Dapa N recorded KRW 2.3 billion in prescription sales, surpassing Boryung's Trudapa (KRW 1.3 billion) to take the lead. In Q2, it further widened the gap with Trudapa. The pharmaceutical industry expects Dapa N's growth momentum to continue for some time, as its reimbursement scope was expanded to include chronic kidney disease last month. As of July 1, the government expanded Dapa N's reimbursement to patients with non-diabetic chronic kidney disease. The conditions for reimbursement are: concurrent administration with other standard kidney disease treatments for patients ▲Who have been stably treated with an ACE inhibitor or Angiotensin II receptor blocker at the maximum tolerated dose for at least 4 weeks ▲Who have an eGFR of 20–75ml/min/1.73㎡ ▲Who have a positive urine dipstick test (1+ or more) or a uACR of 200mg/g or more. The key factor is the performance of other dapagliflozin monotherapies. The fact that the reimbursement scope for 15 products from 9 pharmaceutical companies has become identical to Dapa N's since last month is expected to be a significant factor. Previously, Dapa N was the only one to hold indications for chronic heart failure and chronic kidney disease, in addition to diabetes. Starting last month, products from 9 companies, including ▲Boryung's Trudapa ▲Hanmi Pharmaceutical's Daparon ▲KyungDong Pharmaceutical's Dapajin ▲Chong Kun Dang's Exiglu ▲Daewon Pharmaceutical's Dapawon ▲Dong-A ST's Dapapro ▲Samik Pharmaceutical's Difaglu ▲Daewoong Bio's Forxidapa ▲Nex Pharm Korea's Floga, now have the same indications as Dapa N. SGLT-2i Monotherapy Market Has Expanded 3%...Jardiance 25%↑·Envlo 16%↑ The SGLT-2 inhibitor monotherapy market, including Dapa N, grew by 3% from KRW 40.5 billion in Q2 of last year to KRW 41.8 billion in Q2 of this year. Boehringer Ingelheim's Jardiance (empagliflozin) and Daewoong Pharmaceutical's Envlo (inavogliflozin) performed well. Jardiance's prescription sales increased by 25% over one year, rising from KRW 16.1 billion to KRW 20.1 billion. Envlo's sales increased by 16% in the same period, from KRW 2.5 billion to KRW 2.9 billion. It appears that the market gap left by Forxiga has been filled by Jardiance, Envlo, and Forxiga's generics. Quarterly Prescription Sales Performance by Key Dapagliflozin Monotherapies (unit: KRW 100 million, source: UBIST) Index: BLUE-AstraZeneca This market is expected to shift again in October of this year when Jardiance's substance patent expires. Currently, around 50 pharmaceutical companies have received approval for Jardiance generics and are ready for launch. The industry anticipates a repeat of the fierce generic competition in the diabetes treatment market.
- Company
- Reimb for 'Padcev' combo as a 1st-line treatment reapplied
- by Whang, byung-woo Aug 19, 2025 06:12am
- Will 'Padcev+Keytruda' combination therapy overcome the reimbursement hurdle in the area of metastatic urothelial cancer, where the first-line treatment option had not been available? In terms of treatment effectiveness, there is no disagreement among experts that, in the long term, it is a first-line standard treatment option. With Astellas now taking proactive steps, reimbursement entry will ultimately be the key factor. Astellas Pharma Korea held a press conference on August 18 to celebrate the first anniversary of the domestic approval of Padcev (enfortumab vedotin) in combination therapy for first-line metastatic urothelial carcinoma Astellas Pharma Korea held a press conference on August 18 to celebrate the first anniversary of the domestic approval of Padcev (enfortumab vedotin) in combination therapy for first-line metastatic urothelial carcinoma and shared its future strategy. The Padcev + Keytruda combination therapy was approved by the Ministry of Food and Drug Safety (MFDS) last July for the first-line treatment of locally advanced or metastatic urothelial carcinoma. The basis for the approval was the Phase 3 KEYNOTE-A39/EV-302 clinical trial. The results, which evaluated the efficacy of the Padcev + Keytruda combination therapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma, showed that it approximately doubled both the overall survival (OS, 31.5 months) and the progression-free survival (PFS, 12.5 months) compared to platinum-based chemotherapy. Professor Jeong Min Cho of the Department of Oncology at Ewha Womans University Mokdong Hospital explained, "Metastatic urothelial carcinoma is a type of cancer with a very low survival rate of 14.3%, giving it a poor prognosis similar to highly fatal lung cancer." She added, "Due to its aggressive nature and the high proportion of elderly patients, the patient's condition often deteriorates rapidly during the early stages of treatment." Professor Jeong Min Cho of the Department of Oncology at Ewha Womans University Mokdong Hospital Professor Cho continued, "The Padcev first-line combination therapy has been confirmed to show therapeutic effects similar to those in clinical studies in clinical practice, establishing itself as an option that can provide a powerful treatment response in the early stages of treatment." A year after its approval, the demand from the field for the Padcev + Keytruda combination therapy is for expanded access through reimbursement. On this day, Professor Cho said, "In clinical practice, we are constantly getting inquiries from patients about whether it's covered by insurance." In addition to the drug's efficacy, hurdles such as the cost burden create apparent limitations in treatment access. Professor Cho emphasized, "It is often difficult to recommend to patients due to the high cost burden, and I feel heavy-hearted that we cannot provide the best treatment opportunity on time." She stressed, "As Padcev is recommended as the top first-line option in major global guidelines, institutional support is urgently needed in Korea as well." Currently, Astellas has reportedly re-applied to the health authorities for reimbursement for both the Padcev + Keytruda combination therapy and Padcev monotherapy for first-line and later treatment of metastatic urothelial carcinoma. It is also known to have proactively submitted a proposal for sharing financial burdens. This is interpreted as a move to secure reimbursement for both combination therapy and monotherapy simultaneously, in preparation for submission to the upcoming Cancer Disease Review Committee in September. However, a view exists that a company's strategy is crucial because it is a combination of two new drugs still acts as a stumbling block. Baek So-young, Managing Director of Medical Affairs at Astellas, stated, "One might think that reimbursement would be faster for second-line or later treatments, but in reality, it takes a long time to get cancer drug reimbursement in Korea." She explained, "We applied for first-line reimbursement because we believe it provides an opportunity to save more patients." Baek added, "In terms of opening a new path for combination therapy of new drugs, the company is open to all options," and concluded, "If there is a will to reimburse Padcev, a methodological agreement can be reached through negotiation. As of now, the company has not set any restrictions."
- Company
- Will Wegovy patients switch to Mounjaro? Doctors skeptical
- by Moon, sung-ho Aug 19, 2025 06:11am
- With the anticipated launch of Lilly Korea's diabetes and obesity treatment Mounjaro (tirzepatide) in mid-August, its full-scale competition with Novo Nordisk's Wegovy (semaglutide) is expected to unfold. Amid the imminent competition, the issue of whether to switch between the two drugs has emerged as a key point of contention in clinical settings. #According to industry sources on the 11th, Lilly Korea plans to launch Mounjaro Pre-filled Pen (tirzepatide, hereinafter referred to as Mounjaro) 2.5 and 5 mg for patients with type 2 diabetes and obesity in Korea in mid-August. Mounjaro is currently used in Korea as an adjunct to diet and exercise (as monotherapy or combination therapy) to improve blood glucose control in adult patients with type 2 diabetes, as well as in adult patients with obesity (initial BMI ≥ 30 kg/m2) or one weight-related comorbidity (hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease) for chronic weight management as an adjunct to a low-calorie diet and exercise therapy. For both indications, the recommended starting dose is 2.5 mg once weekly (for treatment initiation, not for blood glucose control or weight management), followed by 5 mg once weekly starting at week 4. If additional dose adjustment is required, increase by 2.5 mg after at least 4 weeks of treatment at the current dose, with a maximum dose of 15 mg once weekly. The attention is now focused on the competition between Wegovy and Mounjaro in clinical practice. A key point of interest in this process is whether patients previously treated with Wegovy will switch to Mounjaro. Although there are no direct comparative studies, based solely on the results revealed during the development process, the weight loss effect of Mounjaro appears to be more pronounced. Considering this, some patients who were previously receiving Wegovy may express a willingness to switch to Mounjaro. In response, Lilly Korea stated that the decision to change the type of medication or treatment method prescribed to patients should be made through discussion between healthcare professionals and patients. A representative from Lilly Korea stated, “We have not conducted any studies on switching from GLP-1 RA to Mounjaro for chronic weight management on our own. However, we have a Phase IV clinical trial called SURPASS-SWITCH-2, which involved switching from GLP-1 RA (semaglutide, dulaglutide, or liraglutide) to Mounjaro in adult patients with type 2 diabetes for 12 weeks. The study was not designed to provide long-term results, efficacy comparisons, or optimal switching strategies, as these may vary depending on individual characteristics." In clinical practice, not many patients are expected to switch from Wegovy to Mounjaro, considering how the initial dose of Mounjaro is 2.5 mg. Chul-Jin Lee, President of The Korean Society For the Study of Obesity (Joeun Family Clinic), said, “explained, “Just because Mounjaro has been launched does not mean that patients who were previously receiving Wegovy will easily switch treatments in the short term. This is because patients who were receiving high doses of Wegovy may experience relatively lower efficacy when switching to 2.5 mg of Mounjaro.” Lee said, “If Mounjaro is released, it should be offered first to new patients. The 2.5 mg dose has an advantage in terms of price for patients as it is not covered by insurance, but for the 5 mg dose and above, the volatility of the range of the non-reimbursed price must also be considered.” Meanwhile, the supply price for Mounjaro has recently been finalized. The currently known domestic supply prices for Mounjaro are KRW 278,066 for 2.5mg, KRW 369,307 for 5mg, and KRW 521,377 for both 7.5mg and 10mg. The dosage forms to be launched in Korea this month are 2.5mg and 5mg. For reference, when Novo Nordisk launched Wegovy in Korea last year, the supply price was set at KRW 372,025 per month regardless of dosage. Accordingly, patients who receive Wegovy as a non-reimbursable drug, mainly at outpatient clinics, must pay an average of KRW 500,000 to 600,000 per month. Considering this, when the supply price is taken into account, the non-reimbursed price of 2.5 mg of Mounjaro is expected to be cheaper than Wegovy, but 5 mg is expected to be priced similar to the monthly cost of Wegovy.
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- PARP inhibitor 'Lynparza' reattempts prostate cancer reimb
- by Eo, Yun-Ho Aug 18, 2025 06:03am
- Product photo of LynparzaAttention is focused on whether there will be progress in the expanded reimbursement of the PARP inhibitor 'Lynparza' for prostate cancer. According to industry sources, AstraZeneca Korea's PARP (Poly ADP-ribose polymerase) inhibitor Lynparza (olaparib) is expected to be considered for the Health Insurance Review & Assessment Service (HIRA)'s Cancer Disease Review Committee next month (September). The indications for review are two: ▲Treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) who have experienced disease progression after treatment with a novel hormonal agent ▲Combination therapy with abiraterone and prednisolone in adult patients with newly diagnosed mCRPC who have not received prior chemotherapy. This is Lynparza's second attempt to get reimbursement for its prostate cancer indication. AstraZeneca had previously tried in 2022 to get reimbursement for BRCA-mutated prostate cancer, but the application was withdrawn after failing to reach an agreement during the post-Cancer Disease Review Committee procedure. Therefore, it remains to be seen if this second round of reimbursement discussions will be successful. Meanwhile, the efficacy of Lynparza in prostate cancer has been proven through two Phase 3 trials: the PROfound study and the PROpel study. A subgroup analysis of the PROfound study in mCRPC patients with BRCA1/2 mutations showed that in patients who had progressed after prior abiraterone or Xtandi (enzalutamide) treatment, Lynparza significantly improved radiographic progression-free survival (rPFS) to a median of 9.8 months, compared to 3.0 months for the control group. Overall survival (OS) was also improved, with a median of 20.1 months versus 14.4 months for the control group. The PROpel study evaluated the combination therapy of Lynparza and abiraterone in mCRPC patients who had not received prior chemotherapy. The study showed that the combination therapy reduced disease progression or the risk of death by 34% compared to abiraterone monotherapy. The median rPFS was extended by 8.2 months in the combination group, reaching 24.8 months compared to 16.6 months in the abiraterone monotherapy group.
- Company
- Four CAR-T therapies to compete for 'Kymriah's mkt position'
- by Whang, byung-woo Aug 18, 2025 06:02am
- With the third new CAR-T therapy, 'Yescarta,' obtaining marketing authorization in Korea, market competition for treating relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) is anticipated. With Kymriah (tisagenlecleucel) from Novartis Korea being the only option currently reimbursed, the impact of Yescarta, which has shown prominence in the global CAR-T market, is highly anticipated. Furthermore, with the expected approval of Curocell's next-generation CAR-T therapy, Rimqarto, this year, various factors are expected to be considered in the choice of DLBCL treatments. Product photo of YescartaThe Ministry of Food and Drug Safety (MFDS) announced the marketing authorization for Gilead Sciences Korea's Yescarta (axicabtagene ciloleucel) on the 13th. Yescarta received authorization for the treatment of 'adult patients with Diffuse Large B-cell Lymphoma (DLBCL) who relapse or are refractory within 12 months of first-line chemoimmunotherapy' and 'adult patients with relapsed or refractory DLBCL and Primary Mediastinal B-cell Lymphoma (PMBCL) after two or more lines of systemic therapy.' Administration is required to be performed only at certified medical institutions, and certified medical institutions must have tocilizumab readily available on-site. The authorization also specifies that at least two doses of tocilizumab per patient must be secured before Yescarta administration in case treatment for Cytokine Release Syndrome (CRS) is needed. Yescarta is currently a leading therapy in the CAR-T treatment market. This is because Yescarta has secured a broader range of indications than Kymriah, which is limited to third-line therapy. First approved by the U.S. FDA as a third-line therapy in October 2017 and by the EU in 2018, Yescarta has since expanded its scope to include second-line therapy. In 2021, it became available to treat follicular lymphoma. In terms of sales, its revenue surged by 67%, from $695 million (approximately KRW 966.4 billion) in 2021 to $1.16 billion (approximately KRW 1.6127 trillion) in 2022. The growth continued, reaching $1.498 billion (approximately KRW 2.0827 trillion) in 2023, a 29% increase from the previous year. However, since the rapid growth of late entrants like Carvykti (ciltacabtagene autoleucel, Janssen) and Breyanzi (lisocabtagene maraleucel, BMS) starting last year, the pace of revenue increase has slowed. In its recently announced Q2 sales for this year, Gilead reported that Yescarta recorded $393 million (approximately KRW 550 billion), a 5% decrease from the previous year. The reason for the anticipation surrounding Yescarta is its indication. Kymriah's indication is for 'adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy.' For this reason, Gilead Sciences Korea is reportedly planning to prepare for reimbursement for the newly approved second-line therapy, rather than the third-line therapy, as Kymriah is already reimbursed for the third-line setting, making reimbursement for Yescarta at this stage less difficult. While new drugs of bispecific antibodies are receiving approval and reimbursement, CAR-T therapies still hold a preemptive treatment status. If Yescarta receives reimbursement, it is expected to quickly establish itself in the domestic market, given its global influence. Curocell Prepares for Rapid Commercialization…"Efficacy and Supply Still the Advantages" Another variable is that Curocell's Rimqarto is awaiting approval. Rimqarto has been selected as the second drug for the Ministry of Health and Welfare's 'Concurrent Application-Evaluation-Negotiation Pilot Program' and is currently undergoing review by the MFDS. While there are observations that the approval might be delayed beyond the initially expected third quarter due to delays in the review process, as it is the first domestically developed next-generation CAR-T therapy in Korea, the prevailing view is that approval will likely happen within the year. Once approved, it is expected to have an advantage in reimbursement entry because the reimbursement evaluation and price negotiation will be conducted simultaneously with the MFDS approval application process. In particular, the company is preparing for rapid commercialization by establishing a comprehensive solution, 'CUROLINK,' which tracks and manages the entire process from prescription to administration in real time. However, Rimqarto must keep Yescarta's approval in check, as it has the same indication as Kymriah. Concerning this, Curocell's position is that its competitiveness will remain valid because, when compared to Curocell's Rimqarto, Yescarta, and Kymriah are still inferior in terms of supply period, efficacy, and safety in the domestic market. A Curocell official stated, "Yescarta's entry into the Korean market and the emergence of other competing products like bispecific antibodies are always open possibilities," and added, "Yescarta still requires sending the patient's blood overseas for CAR-T manufacturing and then re-importing it into Korea, placing it in an inferior position compared to Curocell's Rimqarto in terms of rapid supply." Furthermore, according to an IR document released by Curocell, Yescarta showed a complete remission in 54% of patients who participated in the clinical trial. In contrast, Rimqarto's clinical trial showed a complete remission in 67% of participants. The Curocell official explained, "Yescarta's CR rate of 54% was far superior to Kymriah's 40%, which led to a decrease in Kymriah's sales and an increase in Yescarta's sales. However, when Breyanzi, with a CR rate of 53%, entered the market with a similar CR rate to Yescarta, it began to share the market, causing a slight decrease in Yescarta's sales." And added, "Considering this, Rimqarto's CR rate of 67% is higher than both Yescarta and Breyanzi. Given that this is a one-time reimbursed treatment for late-stage cancer patients, We believe Rimqarto will have a competitive advantage in the market."
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- New Praluent dosage form available at general hospitals
- by Eo, Yun-Ho Aug 18, 2025 06:02am
- A new dosage form of the PCSK9 inhibitor ‘Praluent’ may be prescribed at general hospitals in Korea. According to industry sources, a pen formulation of Sanofi-Aventis Korea's primary hypercholesterolemia and mixed dyslipidaemia treatment Praluent (alirocumab), Praluent Pen 300mg inj, has been approved by the Drug Committees (DCs) of tertiary hospitals in Korea, including Seoul National University Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital. Praluent Pen Inj 300mg maintains similar LDL-C lowering effects to the existing dosages while enabling administration at four-week (Q4W) intervals, thereby improving treatment convenience and patient compliance. This drug is the only PCSK9 inhibitor in Korea available in three doses (75 mg, 150 mg, and 300 mg), and all doses are indicated for reducing cardiovascular risk in patients with atherosclerotic cardiovascular disease (ASCVD). PK/PD studies confirmed the LDL-C-lowering efficacy of Praluent Pen 300mg, with LDL-C reduction effects observed as early as day 3 after a single dose of Praluent Pen 300mg injection, reaching a maximum average reduction of 73.7% by day 22. This LDL-C-lowering effect was maintained for up to 43 days, demonstrating a longer duration of effect compared to the existing Praluent 75mg Pen (8 days) and 150mg (15 days). Praluent 300 mg has been listed for reimbursement in Korea since April. As a result, Praluent Pen Inj may be used with reimbursement when administered in addition in ▲patients with primary hypercholesterolemia and mixed dyslipidemia who have received insufficient response to combination therapy with statins and ezetimibe (LDL-C levels not reduced by at least 50% from baseline or LDL-C ≥ 100 mg/dL) and statin intolerance ▲Patients with atherosclerotic cardiovascular disease who have received maximum tolerated doses of statins and ezetimibe but have had an inadequate response (LDL-C levels not reduced by at least 50% from baseline or LDL-C ≥ 70 mg/dL). In a Phase III trial (CHOICE 1) involving patients who were taking the maximum tolerated dose of statins, patients who were taking the maximum tolerated dose of statins in combination with other lipid-lowering agents, and patients who were not taking statins, the starting does of Praluent Pen 300 mg Inj demonstrated efficacy, long-term safety profile, and tolerability. According to the study, at week 24, the LDL-C reduction effect of Praluent 300 mg Inj plus statin therapy compared to placebo was 58.8%, showing a statistically significant result compared to the placebo group (0.1% reduction). In the case of its indication for atherosclerotic cardiovascular disease, the drug demonstrated efficacy iin the ODYSSEY OUTCOMES study. The study included 18,924 adult patients with acute coronary syndrome (ACS), including myocardial infarction and unstable angina. The results showed that Praluent significantly reduced the risk of major adverse cardiovascular events (MACE) by 15% compared to the placebo group. A trend toward a reduction in all-cause mortality was also observed as a secondary endpoint, which was nominally significant in hierarchical statistical testing. In addition, y, LDL-C achieved its maximum reduction effect at week 4 of Praluent treatment and maintained an average reduction of 54.7% after 4 years of treatment. LDL-C reduction was observed in 89% of patients receiving high-intensity statins in combination with Praluent.
- Company
- Will Korean companies join in on the sales of obesity drugs?
- by Kim, Jin-Gu Aug 18, 2025 06:02am
- With the domestic launch of the GLP-1 class obesity treatment Mounjaro (tirzepatide) near, its sales and marketing competition with Wegovy (semaglutide) is already heating up. Lilly has completed preparations for the launch by hiring over 30 additional medical and marketing representatives to handle sales of Mounjaro. Additionally, the possibility of joint sales with domestic pharmaceutical companies is being raised. Novo Nordisk has countered by reducing the domestic supply price of Wegovy by up to 40%. Their discussions on joint sales with Chon Kun Dang are also reportedly ongoing. Mounjaro to be released next week, adds 30 sales staff... Large-scale launch symposium announced According to industry sources on the 14th, Lilly's Mounjaro will be distributed in Korea starting next week. Lilly recently sent a notice to major domestic distributors stating that its supply will begin on the 18th. Hospitals and clinics are expected to receive the product two days later on the 20th. Given the product's record-breaking sales abroad, Lilly Korea is also highly anticipating its launch. In preparation for the launch of Mounjaro, Lilly has hired over 30 additional employees dedicated to sales and marketing for the product. A large-scale launch symposium is also planned. Lilly intends to hold an in-person symposium on the 25th and 26th, followed by an online symposium on the 27th. The company has gone to great lengths to invite Bruno Halpern, the next president of the World Obesity Federation and chief director of the Obesity Centre of Hospital 9 de Julho, São Paulo in Brazil, as a keynote speaker. For now, Lilly Korea plans to directly sell Mounjaro, but the possibility of joint sales with domestic pharmaceutical companies remains open. In the pharmaceutical industry, one major domestic pharmaceutical company is consistently coming up as a potential joint sales partner for Mounjaro. There is speculation that the product may be launched under Lilly directly, then potentially transition to joint sales in the future. The company plans to actively promote Mounjaro's higher weight loss efficacy compared to Wegovy. Mounjaro demonstrated superior weight loss efficacy in the SURMOUNT-5 clinical trial, a head-to-head trial that compared Mounjaro with Wegovy. In the trial, the average weight loss rate at week 72 in the Mounjaro treatment group (10mg or 15mg) was 20.2%, compared to 13.7% in the Wegovy treatment group (1.7mg or 2.4mg), demonstrating a relatively improved weight loss rate. There is also high anticipation in the medical community. A hospital search application is promoting “how to book the lowest-priced hospital for Mounjaro.” Numerous posts promoting advance reservations for Mounjaro are also searchable on major portals and social media platforms. A representative from Lilly Korea stated, “Based on our global experience with the launch of Mounjaro in various countries and our deep understanding of the domestic market accumulated over more than 40 years, we will do our best to help patients with diabetes and obesity in Korea lead better lives with Mounjaro.” Wegovy’s domestic supply price reduced by up to 40% in response...Possibility of joint sales with Chong Kun Dang Ahead of the official launch of Wegovy, Novo Nordisk has responded with a price reduction for Wegovy. Novo Nordisk announced that it will reduce the price of Wegovy by up to 40% starting from the 14th. Excluding the highest dosage of 2.4mg, the prices will be reduced by 40% for 0.25mg, 30% for 0.5mg, 20% for 1.0mg, and 10% for 1.7mg. The price of 0.25mg, which will be reduced by 40%, is expected to be between KRW 200,000 and 220,000. This is analyzed as securing price competitiveness compared to Mounjaro. The supply prices for Mounjaro are ▲2.5 mg KRW 278,066, ▲5 mg KRW 369,307, and ▲7.5 mg and 10 mg KRW 521,377. The 2.5 mg and 5 mg doses will be initially supplied to Korea. The possibility of joint sales with Chong Kun Dang continues to be raised. Its possibility of partnering with Chong Kun Dang for Wegovy’s sales has also been consistently raised. Novo Nordisk and Chong Kun Dang have been in discussions regarding joint sales of Wegovy up until recently, and it is reported that they are nearing a final decision. However, both companies have drawn the line, saying that “nothing has been finalized yet.” If Chong Kun Dang is confirmed as a co-promoter for Wegovy and Mounjaro also signs a contract with a domestic pharmaceutical company, the competitive landscape is expected to expand from a head-to-head battle between two multinational pharmaceutical companies to include domestic pharmaceutical companies as well. The pharmaceutical industry is closely watching how quickly Mounjaro can catch up to Wegovy, which has effectively dominated the market. Wegovy quickly dominated the obesity treatment market after since launch in Korea in October last year. According to pharmaceutical market research firm IQVIA, Wegovy recorded sales of KRW 79.4 billion in the first quarter of this year. Wegovy's market share in the overall obesity drug market reached 73.2%. Wegovy surged to the top of the obesity drug market with sales of KRW 60.3 billion in the fourth quarter of last year, immediately after its launch. Wegovy has also contributed to the expansion of the market size. Prior to its launch in the third quarter of last year, the domestic obesity treatment market size was only KRW 47.4 billion, but it expanded to KRW 93.8 billion in the fourth quarter of last year, nearly doubling in just over three months.
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- "Winrevair, gamechanger for pulmonary arterial hypertension"
- by Whang, byung-woo Aug 18, 2025 06:01am
- Winrevair (sotatercept), a new mechanism treatment for pulmonary arterial hypertension that has emerged after over 20 years, has been approved in Korea. Consequently, competitive market is expected. Although reimbursement remains a challenge, it is expected to change the treatment paradigm for pulmonary hypertension, a disease with significant unmet needs, by addressing the fundamental cause of the disease. Dr. Wook-Jin Chung, President of the Korean Society of Pulmonary HypertensionMSD Korea held a press conference on August 12, celebrating the approval of Winrevair and highlighting the drug's role and value. Pulmonary hypertension is not simply a state of constricted blood vessels. It is a disease of structural narrowing where the walls of the pulmonary arterioles thicken and their lumens become constricted, making it different from general hypertension. Dr. Wook-Jin Chung, President of the Korean Society of Pulmonary Hypertension (Professor of Cardiology at Gachon University Gil Medical Center), explained, "Pulmonary hypertension patients suffer from shortness of breath, cough, fatigue, and fainting as the disease advances. However, due to a complex diagnostic process, patients experience a diagnostic odyssey that can take up to three years." "Pulmonary hypertension patients experience such severe shortness of breath that even walking becomes difficult, leading to serious limitations in all aspects of daily life, including exercise, childcare, housework, and social activities. In severe cases, it can be fatal, with a risk of sudden death." For high-risk patients, the probability of death within one year exceeds 20%, and approximately 30% of domestic patients still die within five years of diagnosis. Until now, phosphodiesterase-5 (PDE5) inhibitors and calcium channel blockers (CCBs) have been used, but they have only been effective in controlling symptoms. Dr. Chung said, "Pulmonary hypertension is both a rare, intractable disease and a chronic condition, so there was an urgent need for a treatment strategy that could restore a healthy daily life to patients." In relation to this, the newly approved Winrevair is generating high expectations because it approaches the fundamental cause of the disease. Winrevair is the first-in-class Activin Signaling Inhibitor (ASI), utilizing the 'Activin' pathway, which is one of the pathogenic mechanisms of pulmonary hypertension. This treatment demonstrates the potential for reverse remodeling by inhibiting the proliferation of abnormally thickened blood vessels, thereby reversing the remodeling of pulmonary arterioles and the right ventricle. In a study of 323 pulmonary hypertension patients, the Winrevair group's 6-minute walk distance (6MWD) increased by 40.1 m, while the placebo group's decreased by 1.4 m. Additionally, Winrevair reduced the risk of clinical worsening or death from all causes related to pulmonary hypertension by 84%. Kyung-hee Kim, Chairperson of the Clinical Guidelines Committee of the Korean Society of Pulmonary Hypertension, said, "Experts from the clinical guidelines committees in Europe and the United States have recommended the addition of ASI when updating pulmonary hypertension treatment guidelines," and added, "The Korean Society of Pulmonary Hypertension is also reviewing the inclusion of ASI in the pulmonary hypertension treatment guidelines in Korea." Dr. Kyung-hee Kim, Chairperson of the Clinical Guidelines Committee of the Korean Society of Pulmonary HypertensionWinrevair was approved through the Ministry of Food and Drug Safety's 'Concurrent Approval-Evaluation-Negotiation Pilot Program' and has quickly entered the reimbursement review process. The Ministry of Health and Welfare (MOHW) has been running the 'Concurrent Approval-Evaluation-Negotiation Pilot Program' since 2023 to improve access to treatment for life-threatening, severe, and rare diseases. The project conducts approval, reimbursement evaluation, and drug price negotiations simultaneously, aiming to shorten the time required for new drugs to be included in the National Health Insurance list. Dr. Chung emphasized, "For patients to benefit from Winrevair, it must be quickly covered by national health insurance." He added, "Even if the treatment is expensive, and its efficacy has been proven overseas, efforts are necessary to ensure it can be used, even if strict criteria are applied."
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- Imfinzi denied reimb for bile duct cancer for the 3rd year
- by Eo, Yun-Ho Aug 14, 2025 06:13am
- Attention is focused on whether there will be progress in the reimbursement process for Imfinzi for bile duct cancer, which has remained non-reimbursed for three years now. According to industry sources, the Health Insurance Review and Assessement Service's Drug Reimbursement Evaluation Committee may likely review the agenda of expanding the reimbursement of AstraZeneca Korea's PD-L1 inhibitor immunotherapy Imfinzi (durvalumab) for bile duct cancer in the second half of the year. In the harsh environment of bile duct cancer, where the average survival period was just over seven months, the emergence of Imfinzi brought about a change in the treatment landscape. Imfinzi demonstrated more than a twofold improvement in overall survival rate compared to the standard chemotherapy regimen at the three-year mark, and in a subgroup analysis of Korean patients, it proved to provide even better survival benefits than the overall patient population. Countries such as Canada, the United Kingdom, Australia, Japan, and Taiwan quickly reimbursed Imfinzi in recognition of its clinical innovation. In the case of the United Kingdom, considering the poor reality of bile duct cancer treatment and the fact that Imfinzi is the first first-line treatment for bile duct cancer, the ICER threshold was applied flexibly by exceptionally weighting the quality-adjusted life years (QALY) during the pharmacoeconomic evaluation process. However, in South Korea, reimbursement barriers remain, limiting patients' access to treatment. It has been three years since Imfinzi was approved by the Ministry of Food and Drug Safety as a first-line treatment for metastatic bile duct cancer. The indication for bile duct cancer was approved by the Cancer Review Committee in November 2024, but there has been no significant progress to date. Jung-yong Hong, Professor of Hematology and Oncology at Samsung Medical Center, said, “The ultimate goal of the government, pharmaceutical companies, and medical professionals is to provide Imfinzi’s treatment benefits, proven as standard therapy, to bile duct cancer patients as quickly as possible. Measures to strengthen institutional flexibility must be explored to enhance treatment access for bile duct cancer patients.”
