- LOGIN
- MemberShip
- 2026-04-27 04:08:48
- Policy
- MOHW seeks measures to attract domestic investment
- by Lee, Jeong-Hwan Jul 31, 2025 06:15am
- The government is seeking ways to encourage multinational pharmaceutical companies to strengthen domestic investment, including the establishment of new pharmaceutical production plants in Korea. However, international trade issues and other obstacles remain to be overcome to attract domestic investment from multinational pharmaceutical companies, and it remains uncertain whether practical measures can be established. On the 30th, the Ministry of Health and Welfare announced this plan in response to the National Assembly Health and Welfare Committee's inquiry regarding the current status of domestic investment by global pharmaceutical companies and incentives. The MOHW agreed with the committee in that in order for South Korea to become a pharmaceutical and bio powerhouse, it is essential to not only expand investment by domestic pharmaceutical companies but also attract investment from global pharmaceutical companies. As an example of a global pharmaceutical company establishing a factory or production base in South Korea, the MOHW cited Janssen Vaccines, which operates a biopharmaceutical manufacturing plant in Songdo, Incheon. Another example is Otsuka Pharmaceutical Korea, which operates a factory in Hwaseong, Gyeonggi Province, capable of synthesizing active pharmaceutical ingredients and producing finished pharmaceutical products. The MOHW announced that it will investigate whether multinational pharmaceutical companies are willing to invest in Korea, what their difficulties are, and what incentives would be effective in attracting investment. To this end, the MOHW is expected to meet with the Korean Research-based Pharmaceutical Industry Association (KRPIA) to discuss the multinational pharmaceutical companies’ interest in domestic investment. The MOHW stated, “Domestic investment by global pharmaceutical companies has many positive effects in terms of securing infrastructure and creating jobs,” adding, “We will work with relevant associations to identify the investment intentions and difficulties of global pharmaceutical companies in Korea and come up with measures to attract investment.”
- Company
- MSD Korea begins Januvia drug price difference compensation
- by Son, Hyung Min Jul 31, 2025 06:14am
- Product photo of Januvia products There are changes regarding the Januvia drug price difference compensation issue, which had been stalled for nearly two years. MSD Korea has officially informed the distribution industry that it will begin accepting applications for Januvia compensation starting next month, August 1. However, this compensation is limited to the quantity sold before the transfer of marketing rights to Chong Kun Dang, and whether compensation on sales will be made still requires discussion. According to industry sources on the 31st, MSD Korea sent an official letter to the Korea Pharmaceutical Distributors Association on the 29th, stating that it will begin accepting applications for compensation due to the Januvia drug price reduction starting August 1st. This compensation will apply only to the quantity directly sold by MSD Korea before July 15, 2023, the date when Chong Kun Dang acquired exclusive domestic marketing rights for Januvia. Until now, the disagreement between MSD Korea and Chong Kun Dang regarding Januvia drug price difference compensation had not narrowed, leading to ongoing confusion in the distribution industry and local pharmacies. However, with MSD Korea announcing the compensation procedure for the drug price reduction, it is expected that discussions on compensation will begin. An MSD Korea official said, "We believe a significant portion of the inventory still exists with pharmaceutical distributors and healthcare institutions." They added, "We will proceed with compensation through prompt and accurate procedures to minimize damage." They further added, "We have continuously put efforts into responding responsibly regarding compensation for the price difference due to the Januvia drug price reduction," and explained, "We plan to begin accepting compensation applications starting August 1st and officially proceed with the procedures." However, the party responsible for compensation for sales made after July 15, 2023, the date of the marketing rights transfer, has not yet been determined. The drug prices for the Januvia family products, including Januvia, Janumet, and Janumet XR, were sequentially reduced between September and October 2023 due to patent expirations. MSD Korea stressed its position that it has no responsibility for compensation for the period after September 2023, the time of the Januvia drug price reduction, as Chong Kun Dang took over exclusive sales and revenue rights for Januvia following the marketing rights transfer agreement. Januvia is a DPP-4 inhibitor, containing sitagliptin, used to treat diabetes and is developed by MSD. Following Januvia's launch, MSD and Chong Kun Dang have been jointly promoting these products since 2016. However, in 2023, MSD Korea reorganized its chronic disease business unit to focus on its oncology and vaccine businesses, transferring the rights for the Januvia Family to Chong Kun Dang. Chong Kun Dang has been exclusively handling the domestic sales of Januvia as of July 15, 2023. MSD Korea's position is that since the marketing and revenue rights were already transferred at that time, they bear no responsibility for compensation related to the drug price reduction after September 2023, when the price cut occurred. MSD Korea said, "We transferred all domestic rights, including marketing and manufacturing rights, for Januvia products to Chong Kun Dang in July 2023, transferring exclusive sales and marketing authority," and added, "Accordingly, Chong Kun Dang is responsible for price difference compensation due to drug price reductions that occurred after that point." Chong Kun Dang believes that it is unfair to transfer the responsibility for compensation when the marketing authorization holder had not been officially changed. Therefore, difficulties in negotiation are anticipated. The marketing authorization was indeed transferred to Chong Kun Dang on July 23, 2024, after which the business transitioned to a global direct import structure. An official from the Korea Pharmaceutical Distributors Association said, "As MSD Korea has delivered an official letter stating its position on compensation, Chong Kun Dang is also expected to clarify its stance soon," and added, "It is a desirable direction for both companies to clearly define their areas of responsibility and proceed with compensation." They further commented, "We suffered significant losses by not receiving price difference compensation for over a year. We faced severe difficulties in the middle, and we hope to find an amicable solution."
- Company
- GSK Korea appoints Gunnar Riediger as new General Manager
- by Whang, byung-woo Jul 31, 2025 06:14am
- Gunnar Riediger, new Country President & General Manager of GSK Korea GSK Korea announced on the 30th that it has appointed Gunnar Riediger as its new General Manager, effective August 1. The new GM joined GSK in 2004 through the company's global talent development program, the “Future Leaders Program,” and has led healthcare operations across Latin America for over 20 years. He has held key roles including Vaccines Business Unit Head, BioTech Business Unit Head, and Global Vaccines Market Lead at GSK Brazil. Based on these experiences, as a seasoned leader, Riediger worked to maximize the potential of GSK's pipeline, pioneered innovative market entry strategies, and consistently invested in leadership development programs focusing on challenging thinking and accountability, achieving outstanding results. Ridiger then served as Country President & General Manager of GSK Colombia since 2023, successfully launching key products across the company’s vaccine, specialty medicine, and oncology portfolios. Based on these achievements, GSK Colombia has been recognized as one of the fastest-growing multinational pharmaceutical companies in Colombia in 2024, among other accolades. “I am honored to join GSK Korea, a company that has achieved remarkable results to date,” said Riediger. “I look forward to driving the next chapter of GSK Korea's growth by continuously supplying innovative vaccines and medicines to improve the quality of life for Korean patients and strengthening collaboration to advance Korea’s biopharmaceutical industry.”
- Policy
- MFDS says, abortion drug approval cannot be reviewed
- by Lee, Hye-Kyung Jul 30, 2025 06:16am
- Product photo of Hyundai Pharm filed a marketing authorization application for oral abortion drug 'Mifegymiso Tab (mifepristone·misoprostol)' last year. However, it has been confirmed that, under the current state of legislative void, the review cannot even begin. On the 30th, the Ministry of Food and Drug Safety's (MFDS) Pharmaceutical Approval Management Division responded to an inquiry from specialized journalists, stating, "The review of Mifegymiso Tab can only commence once a legal basis is established, and currently, review is not possible." They added, "Hyundai Pharm also understands that the efficacy, indications, dosage, and administration, etc., can only be set once the allowance and permissible gestational age for medication-induced abortion are clearly defined by law." Mifegymiso is a drug that induces early pregnancy termination. It is already used in over 90 countries, including the United States and France, since the World Health Organization (WHO) designated it as an 'essential medicine' in 2005. In South Korea, Hyundai Pharm signed an exclusive supply agreement with LinePharma UK and submitted its third marketing authorization application in December 2024, following previous submissions in 2021 and 2023. The two previous applications were voluntarily withdrawn due to requests for supplementary data. An MFDS official explained, "The establishment and review of key assessment items, such as efficacy, effect, dosage, administration, and Risk Management Plan, are only possible once the allowance and permissible gestational age for medication-induced abortion are legally defined." They added, "Hyundai Pharm is also aware of this and has agreed through internal discussions that it is difficult to proceed with approval at this time." Under the current legal framework, only surgical abortion methods are permitted, and medication-induced termination lacks a legal basis. Although the Constitutional Court of Korea ruled the abortion ban unconstitutional in 2019, amendments to the Criminal Act and the Mother and Child Health Act have not yet been made, leading to an ongoing legislative void. Consequently, MFDS has not yet taken official action, such as refusing approval or suspending review, for Mifegymiso Tab. It is being formally managed as 'under review.' The official emphasized, "Internal discussions regarding alternative methods, such as conditional approval or restricted use, have not reached a feasible level." The MFDS's position is that it cannot make a judgment alone, as this is an issue that requires prior social consensus, possibly in the form of legal amendments. Hyundai Pharm announced the submission of the Mifegymiso marketing authorization application through a public disclosure on December 31 last year. The disclosure contained results from three clinical trials conducted in the U.S. and Mexico, where Mifegymiso showed abortion success rates of 94.9%, 96.2%, and 97.3%, respectively. Hyundai Pharm explained that these study results demonstrate the effectiveness of the regimen, which involves taking 200mg of oral mifepristone followed by 800mcg of misoprostol, for terminating pregnancies up to 63 days (9 weeks) of gestation. Mifegymiso is a combipack product consisting of one 200mg mifepristone tablet and four 200mcg misoprostol tablets. The method involves first taking mifepristone, which inhibits the action of progesterone (essential for maintaining pregnancy), and then, 1-2 days later, taking misoprostol, which promotes uterine contractions. This is the method for medical abortion up to 63 days (9 weeks) of gestation recommended by the WHO. An official from Hyundai Pharm stated, "There have been no new updates since the marketing authorization application in December 2024." They added, "We are striving to introduce a safe and effective drug based on the results of three clinical trials conducted in the U.S. and Mexico." Meanwhile, in April 2019, the Constitutional Court of Korea ruled the criminal code's abortion ban unconstitutional, citing respect for women's right to self-determination over their bodies. Consequently, abortion procedures became de facto legalized as of January 1, 2021. In the 21st National Assembly, a total of seven bills related to the abolition of the abortion ban, including amendments to the Criminal Act and the Mother and Child Health Act, were proposed but ultimately expired without proper discussion. In the 22nd National Assembly, Democratic Party of Korea lawmakers Nam In-soon and Lee Su-jin recently proposed amendments to the Mother and Child Health Act.
- Company
- Lixiana solely leads DOAC mkt… Xarelto, Eliquis↓
- by Kim, Jin-Gu Jul 30, 2025 06:16am
- (From top left clockwise) Lixiana, Eliquis, Pradaxa, and Xarelto Original direct-acting oral anticoagulant (DOAC) drugs have faced mixed fortunes in the Korean market. Prescription sales of Lixiana (edoxaban) increased by 8% year-on-year, solidifying its lead in Korea’s market. Its market share in the DOAC market expanded to 49%, and the analysis is that Lixiana will continue its lead in the market until the expiration of its substance patent next year. Eliquis (apixaban) and Xarelto (rivaroxaban) showed sluggish performance. Lixiana saw a 30% decline in prescriptions due to price reductions following the launch of generics in the fourth quarter of last year. Xarelto, whose patent expired earlier, has also shown a clear downward trend in sales in recent years. DOAC prescriptions in the first half of the year reach KRW 122.4 billion...Lixiana solidifies sole lead in the market According to the pharmaceutical market research institute UBIST on the 28th, the domestic DOAC market prescription volume in the first half of this year was KRW 122.4 billion. This is a 4% decrease from the KRW 127.1 billion it had rendered in the first half of last year. DOACs are anticoagulants that prevent blood clots by directly acting on blood coagulation factors. They have replaced warfarin, which inhibits vitamin K metabolism, and are increasingly being used in clinical practice. In Korea, Xarelto was approved in 2009, followed by Pradaxa and Eliquis in 2011, and Lixiana in 2015. When the product first appeared, it was commonly referred to as NOAC (New Oral Anticoagulant), but as it has been more than 10 years since its initial approval, it is now called DOAC (Direct Oral Anticoagulant), referring to its mechanism of action that directly acts on coagulation factors. Quarterly major DOAC prescriptions (Lixiana, Eliquis, Eliquis generic, Xarelto, Xarelto generics, Pradaxa) Lixiana has further strengthened its lead in the market. Lixiana’s prescription sales in the first half of this year reached KRW 59.9 billion, an 8% increase from the KRW 55.7 billion in the same period last year. Lixiana was the last DOAC to be released, but the drug quickly increased its prescription sales and has maintained its market leadership since 2019. With an annual growth of around 10%, prescriptions rose from KRW 60.4 billion in 2019 to KRW 117.5 billion last year, nearly doubling in five years. Its share in the total DOAC market expanded to 49% in the first half of this year. This means that Lixiana accounts for nearly half of the KRW 260 billion in the DOAC market. The industry expects the market dominance to continue until the end of next year. The substance patent for Lixiana will expire in November next year. About 20 domestic pharmaceutical companies are expected to release generic versions at that time. Currently, 13 companies have been approved to sell generic versions of Lixiana, including Nexpharm Korea, Dong-A ST, Samsung Pharm, Shinil Pharmaceutical, Shinpoong Pharm, Anguk Pharmaceutical, Ildong Pharmaceutical, Genuone Science, Union Korea Pharm, Korea Prime Pharm, Hutecs Korea Pharmaceutical, and Handok Pharm. In addition, Samjin Pharmaceutical, HLB Pharmaceutical, Theragen Etex, and DongKwang Pharm have filed for an invalidation trial (passive scope confirmation trial) regarding the Lixiana formulation patent. If they win the first trial, they will be able to release generic versions in line with the expiration of the substance patent, like other companies. Furthermore, Alico Pharmaceutical and Korean Drug have been approved to conduct bioequivalence tests for the release of their generic versions of Lixiana. Eliquis·Xarelto sales in clear decline…due to the release of generic versions and drug price cuts On the other hand, Eliquis and Xarelto are in a clear downward trend. The sales decline of both products is analyzed to be affected by patent expirations and the subsequent entry of generics. Eliquis sales fell 30% from KRW 38.8 billion in the first half of last year to KRW 27.1 billion in the first half of this year. This is due to the impact of price reductions caused by the entry of generics. Eliquis’ price was reduced by 30% in September last year. Quarterly prescriptions of Eliquis and Eliquis generics Eliquis generics re-entered the DOAC market in the fourth quarter of last year. Eliquis generics were originally released in June 2019. At that time, generic companies released their products based on the first and second instance rulings in favor of them in patent litigation. However, the situation reversed in April 2021 when the Supreme Court overturned the first and second court rulings. The generic drugs were immediately withdrawn from the market. Following the expiration of Eliquis' substance patent in September last year, the generics returned to the market after three and a half years. Eliquis generics have been expanding prescriptions since their return to the market, reaching KRW 200 million in the fourth quarter of last year, KRW 600 million in the first quarter of this year, and then KRW 1.1 billion in the second quarter. By product, the situation is similar to that before the generics withdrew from the market three and a half years ago. At the time, the top two generic products in terms of prescription sales, Chong Kun Dang’s ‘Liquisia’ and Samjin Pharmaceutical's ‘Elxaban,’ have maintained their positions as the top two generics even after re-entering the market. Xarelto recorded sales of KRW 15.3 billion in the first half of this year, maintaining its prescription sales as in the same period last year. However, the downward trend has been evident since 2021. Compared to KRW 28.9 billion in the first half of 2021, sales have decreased by half in four years. This is due to the entry of generic drugs. Xarelto generics first appeared in the second quarter of 2021. About 40 products were released simultaneously in line with the expiration of Xarelto’s substance patent. Subsequently, prescriptions steadily increased, reaching KRW 4 billion in the first half of 2022, KRW 8 billion in the first half of 2023, KRW 12.4 billion in the first half of 2024, and KRW 13.7 billion in the first half of this year. Quarterly prescriptions of Xarelto and Xarelto generics By product, Hanmi Pharmaceutical's Riroxban recorded KRW 4.3 billion, Samjin Pharm’s Rivoxaban KRW 2.5 billion, and Chong Kun Dang’s Riroxia KRW 2.2 billion. The remaining products had prescription sales of less than KRW 1 billion in the first half. As sales of the original product slowed down, generics expanded their influence, and the market share of generics in the rivaroxaban-containing DOAC market reached 47% as of the first half of this year. Another original product, Pradaxa (dabigatran), is struggling to gain traction in the DOAC market. Pradaxa's prescription sales in the first half of the year were KRW 4.7 billion, a slight decrease from the KRW 4.8 billion in the same period last year.
- Product
- Platforms promote Wegovy's lowest price is ₩390,000
- by Kang, Hye-Kyung Jul 30, 2025 06:10am
- Non-face-to-face treatment platforms are facing backlash from pharmacies after launching activities promoting the lowest prices for non-reimbursable drugs. Doctornow, a leading non-face-to-face medical consultation platform, is being criticized for encouraging price competition for non-reimbursable drugs and causing confusion among consumers. A local pharmacist stated, “Recently, Doctornw has posted promotional content on its social media accounts, such as ‘How to buy diet injections for KRW 200,000 less,’ 'The real way to buy semaglutide diet injections for KRW 390,000,‘ and 'Hair loss medication consultation fee + medication cost: KRW 9,060.’ I believe this is likely to cause distrust and confusion among consumers toward pharmacies.” For example, in a video titled ‘How to buy diet injections for KRW 200,000 less,’ it says, 'Wow! I used to buy weight-loss injections for KRW 600,000, but I was paying KRW 200,000 more. If you don't know the latest way to buy diet injections cheaply, you're losing out 100%. If you know this method, you can get a prescription for KRW 200,000 less, at an unbelievable price!“ The video states that all you need is to access Doctornow. The video explains that you can find the lowest price at a pharmacy near you by clicking ”Find a Pharmacy,“ then clicking ”Get a Prescription" to select a nearby and affordable doctor, going to the hospital for a consultation, and then getting the injection at the lowest-priced pharmacy. However, the video has been criticized for causing consumer distrust and confusion about pharmacies. This pharmacist said, "Doctornow claims that the real price for semaglutide diet injections is KRW 390,000. It suggests that pharmacies are taking a middleman margin. However, the purchase price of the semaglutide diet injection, Wegovy, far exceeds the 390,000 won suggested by Doctornow.” When credit card transaction fees are added to the purchase price, it is practically impossible to meet the criteria for ”buying cheaply and well" suggested by Doctornow. When Dailpharm searched for the lowest price of Wegovy on Doctornow, the price varied depending on the region, but was usually over KRW 430,000. It was found that there are pharmacies in the Gyeonggi area that sell the drug for KRW 394,000 and KRW 395,000, but in the Gyeongsangbuk-do, Chungcheongbuk-do, and Gyeongsangnam-do areas, the price of the non-reimbursable injectable was set around KRW 430,000 to KRW 450,000. Doctornow also presented KRW 9,060 as the lowest hair loss medication consultation fees available. Another pharmacist said, “There are differences between pharmacies when it comes to the price of non-reimbursable drugs. However, I think it is problematic under the Pharmaceutical Affairs Act for non-face-to-face consultation platforms to arbitrarily set the lowest price and misrepresent it as the ‘standard’. Shouldn't sanctions be imposed on the platform for such excessive promotional activities?” Pharmacists also voiced concerns about the institutionalization of telemedicine, as the majority of non-face-to-face prescriptions made are for non-reimbursable drugs for cosmetic purposes. According to a survey conducted by the Guro District Pharmaceutical Association and the Jungnang, Gwangjin, and Gangdong District Pharmaceutical Associations among their members, 46% of pharmacists stated that they had accepted non-face-to-face prescriptions in the past three months. When asked about the proportion of non-face-to-face prescriptions for cosmetic purposes, such as hair loss, weight loss, and eye drops, among the prescriptions received, over 80% of respondents answered that they accounted for the majority of non-face-to-face prescriptions. The associations stated that the majority of pharmacists who accepted non-face-to-face prescriptions in the last three months responded that they were for cosmetic purposes. We are concerned about the reality that non-face-to-face medical consultations are being used as a means to purchase non-reimbursable drugs for cosmetic purposes, such as hair loss, diet, and eye drops, which deviates from the original purpose. We believe that non-face-to-face prescriptions for cosmetic purposes should also be excluded or restricted by the system, similar to psychotropic drugs.” Meanwhile, during her confirmation hearing as nominee for Minister of Health and Welfare, Eun-kyung Jeong stated, “The institutionalization of telemedicine should be aimed at ensuring the stability of medical care and improving primary care, rather than expanding platform profits. During discussions with the National Assembly, appropriate regulatory measures should be discussed to address concerns that platforms will effectively take over clinics and pharmacies or promote profit expansion.”
- Company
- Expanded reimb for Jardiance…management of CRM disease
- by Whang, byung-woo Jul 30, 2025 06:10am
- Product photo of Jardiance Boehringer Ingelheim announced on the 29th that its SGLT2 inhibitor, Jardiance (empagliflozin), will be reimbursed by the National Health Insurance for the treatment of chronic kidney disease (CKD), starting August 1, according to the Ministry of Health and Welfare notification. According to this notification, Jardiance will be reimbursed for the treatment of chronic kidney disease patients who meet all of the following conditions: ▲Being stably treated with an ACE (Angiotensin-converting-enzyme) inhibitor or Angiotensin II receptor blocker at the maximum tolerated dose for at least 4 weeks ▲Having an estimated glomerular filtration rate (eGFR) between 20-75 ml/min/1.73m2 ▲Having a positive urine dipstick test (1+ or more) or a urine albumin/creatinine ratio (uACR) of 200mg/g or more. With this expanded reimbursement, Jardiance will be reimbursed by the National Health Insurance for all three indications: Type 2 diabetes, chronic heart failure, and chronic kidney disease. The expanded reimbursement is expected to strengthen its position as a crucial therapeutic option in the integrated management strategy encompassing cardio-renal-metabolic (CRM) diseases. The latest reimbursement approval is based on the results of the EMPA-KIDNEY Phase 3 clinical study, a large-scale and broad-patient population SGLT2 inhibitor study in the area of chronic kidney disease treatment. The study involved 6,609 chronic kidney disease patients with various underlying causes and comorbidities across the spectrum of CKD severity, regardless of Type 2 diabetes status or the use of renin-angiotensin system inhibitors. The study results showed that Jardiance significantly reduced the relative risk of kidney disease progression and cardiovascular death by 28% compared to placebo. This effect was consistently observed regardless of the presence of diabetes or albuminuria. Notably, unlike previous SGLT2 inhibitor studies, which primarily focused on patients with high urine albumin/creatinine ratio, the EMPA-KIDNEY study included patients with low urine albumin/creatinine ratio, which is significant. Ju-Young Moon, Professor of Nephrology at Kyung Hee University Hospital at Gangdong (Director of Insurance and Legislation at Korean Society of Nephrology), stated, "While it is crucial to detect and initiate treatment for chronic kidney disease at the earliest possible stage, fundamental treatment options available to patients have long been limited," and added, "With the expanded reimbursement of Jardiance, which can slow the progression to end-stage renal disease, more active and efficient treatment becomes possible, and a positive change is expected across the entire treatment environment." Jiyoung Park, Head of CRM Franchise at Boehringer Ingelheim Korea, stated, "It is significant that Jardiance, which has presented the possibility of an integrated approach to cardio-renal-metabolic diseases beyond blood sugar control, can now offer treatment opportunities to more patients by expanding its reimbursement coverage to chronic kidney disease," and added, "We will continue to do our best to expand treatment benefits for patients and contribute to improving the treatment environment based on various clinical evidence and treatment backgrounds."
- Company
- Neurophet partners with Roche for AI tech verification
- by Whang, byung-woo Jul 30, 2025 06:10am
- Neurophet (Co-CEO Jun-gil Bin, Dong-hyun Kim), a specialized AI company in brain disease diagnosis and treatment, announced on the 29th that it has officially signed a joint research agreement with Roche and has begun full-scale collaboration Neurophet has already been sharing data with Roche, and with the official announcement of the collaboration, technical verification and follow-up discussions are expected to proceed rapidly. Through the agreement, Neurophet has secured large-scale clinical data that is difficult to obtain in medical settings, laying the foundation for obtaining medical device certification and reliability verification in each country. Furthermore, starting with this research collaboration, Neurophet aims to pursue additional technologies and business collaboration opportunities with Roche. Neurophet has been expanding its brain imaging analysis business pipeline through collaboration with global big pharma. The company provides quantified analysis results that enable objective evaluation of the efficacy of clinical subjects by analyzing brain MRI (magnetic resonance imaging) and PET (positron emission tomography) image data required in the drug development stage. Such collaboration with big pharma is expected to serve as a key factor in expanding into the global market, going beyond the dissemination of solutions, and will serve as the backbone for Neurophet’s overseas business expansions. Jun-gil Bin, Co-CEO of Neurophet, stated, “Securing a research contract in a situation where it is difficult to obtain large-scale medical data is encouraging. We are pleased to be able to partner with Roche, one of the world’s largest pharmaceutical companies. We will do our best to develop this into a business partnership and utilize it for new technology development and clinical trials in the future.”
- Company
- Attention drawn to reimb status of 'Mounjaro' for diabetes
- by Moon, sung-ho Jul 30, 2025 06:09am
- As the official launch of Mounjaro (tirzepatide, Eli Lilly Korea), approved in Korea as an adjunct therapy for chronic weight management following its indication for adult type 2 diabetes, is imminent, the reimbursement status of the drug is garnering attention. The focus is on whether it will be recognized and reimbursed as the first 'innovative new drug' for a chronic disease. Product photo of MounjaroAccording to pharmaceutical industry sources on the 25th, Eli Lilly Korea recently submitted a reimbursement application for Mounjaro as a 'treatment for adult type 2 diabetes' to the Health Insurance Review & Assessment Service (HIRA). Mounjaro was initially approved for its indication in June 2023 as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes. In August of last year, it was approved as a once-weekly subcutaneous injection as an adjunct therapy to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients. Mounjaro can be used in▲obese patients with an initial Body Mass Index (BMI) of 30 kg/m² or higher, or ▲overweight patients with an initial BMI of 27 kg/m² or higher but less than 30 kg/m², who have at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease). In other words, Mounjaro received indications for both diabetes and obesity treatment. Eli Lilly Korea has decided to prioritize the launch of the 'pre-filled pen' formulation, which was first approved in 2023, due to delays in obtaining approvals for the vial and quick-pen formulations. This is interpreted as a strategy to launch the pre-filled pen first, while continuing to pursue domestic approvals for the vial and quick-pen formulations. Concurrently, Eli Lilly Korea plans to accelerate its efforts to secure reimbursement for Mounjaro for adult type 2 diabetes. For reference, 'Ozempic Prefilled Pen (Ozempic), a semaglutide diabetes treatment from Novo Nordisk Pharma Korea that could compete in clinical settings, is also being re-pursued for reimbursement. Novo Nordisk Pharma Korea attempted to get Ozempic reimbursed in 2023 but withdrew its application during the drug price negotiation process with the National Health Insurance Service, which is considered the final stage. Although it had received conditional reimbursement approval from HIRA's Drug Reimbursement Evaluation Committee (DREC) in the preceding stage and had even agreed on a price with the NHIS, uncertainties regarding product supply in Korea hampered its progress. However, having overcome the supply issue, active reimbursement discussions are now possible. In this situation, Eli Lilly Korea plans to seek reimbursement for Mounjaro by having it recognized as the first 'innovative new drug' for a chronic disease. This means it aims to be the first chronic disease treatment to be listed through the innovative new drug reimbursement process, which has primarily focused on anticancer drugs such as Gilead's triple-negative breast cancer treatment Trodelvy (sacituzumab govitecan). An Eli Lilly Korea official stated, "We have applied for National Health Insurance reimbursement with HIRA, and are currently awaiting deliberation by the DREC." They added, "We expect Mounjaro, a new type 2 diabetes treatment and the first GIP/GLP-1 receptor dual agonist, to provide differentiated clinical value. Therefore, we are doing our best to ensure it can be recognized as the first chronic disease drug to receive flexible application of the ICER value for innovative new drugs." However, the pharmaceutical industry is offering a cautious interpretation regarding the possibility of Mounjaro's reimbursement as an innovative new drug. This implies that there are limitations in applying Mounjaro, a chronic disease treatment, to the innovative new drug eligibility criteria established by the government. For reference, HIRA revised the 'Detailed Evaluation Criteria for Negotiable Drugs (New Drugs)' in August last year, specifying the 'innovativeness' evaluation criteria. This provided a standard for evaluating the appropriate value of new drugs by specifically defining the meaning of 'innovativeness' as one of the ICER value evaluation factors. Consequently, a new drug's innovativeness is recognized only when it satisfies all three of the following conditions: ▲there is no available alternative or therapeutically equivalent product or treatment; ▲significant clinical improvement in final outcome measures, such as extended survival, is recognized ▲it is a new drug approved through MFDS's expedited review (as per Article 35-4, Paragraph 2 of the Pharmaceutical Affairs Act) or a comparable drug recognized by the Committee. A pharmaceutical industry official, who remained anonymous, questioned, "It's uncertain whether Mounjaro can meet the definition of innovativeness established by the government." They added, "Of course, this doesn't mean Mounjaro has no innovative value. However, we need to consider whether it fits the currently established criteria and the government's definition of innovativeness. Consequently, it seems that questions will inevitably follow regarding whether it can be applied."
- Policy
- Will the Korean Avodart+Cialis combos be reimbursed?
- by Lee, Tak-Sun Jul 29, 2025 06:04am
- There is growing interest in whether domestic pharmaceutical companies will succeed in securing reimbursement for the world's first dutasteride and tadalafil combination drug. Currently, this drug is undergoing a new drug reimbursement evaluation process rather than the standard combination drug assessment, as tadalafil is not a reimbursed ingredient. Pharmaceutical companies are seeking the best strategies to provide patients with the treatment options they need. According to industry sources on the 29th, reimbursement reviews are underway for domestically developed dutasteride+tadalafil combination drugs that were approved in January this year. With Dongkoook Pharmaceutical serving as the lead sponsor, Dongkooks’s ‘Uresco Tab,’ Dong-A ST’s ‘Dutana Tab,’ Shinpoong Pharmaceutical’s ‘Avocial Tab,’ DongKoo Bio&Pharma’s ‘Uroguard Tab,’ were approved through a joint clinical trial. The drugs are indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia. Normally, combination drugs composed of previously approved ingredients are priced based on the reimbursement rates of their components. However, since tadalafil is a non-reimbursed ingredient, the dutasteride + tadalafil combination drug is excluded from the standard pricing process and is instead undergoing reimbursement evaluation as a new drug. The combination drugs that undergo standard pricing procedures are eligible for reimbursement 3 months after application, but new drugs require additional time for reimbursement due to cost-effectiveness reviews. Furthermore, as the joint developers had expected reimbursement through the standard pricing process, they did not have enough time to prepare the materials required for a new drug review. Nevertheless, the four companies are joining forces to knock on HIRA's door for their drugs’ reimbursement. However, it seems that more time would be required to submit all the necessary materials, as HIRA recently requested additional supplementary materials. As a result, the concerns of pharmaceutical companies are growing. The joint developers have stated that they will closely coordinate with each other regarding the drug’s domestic launch to establish an optimal strategy. A representative from a related pharmaceutical company stated, “We are doing our best to prepare the material and provide this treatment to patients in need in Korea.”
