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- 2025-12-22 13:08:39
- Company
- Varying sales of Korean subsidiaries of multinational pharma
- by Son, Hyung Min Apr 15, 2025 05:54am
- The 2024 sales performance of multinational pharmaceutical companies' subsidiaries in South Korea varied. Pfizer Korea, MSD Korea, and Gilead Sciences Korea experienced a significant drop in sales due to the impact of COVID-19 becoming endemic. Novo Nordisk saw substantial external growth following the launch of new drugs for diabetes and obesity, while AbbVie also achieved growth by advancing new drugs for immune-related disorders. According to the Financial Supervisory Service (FSS) on the 15th, the sales of the 31 major multinational pharmaceutical companies' subsidiaries in South Korea decreased by 5.5% from KRW 9.717 trillion in 2023 to KRW 9.187 triillion last year. Among the 31 Korean subsidiaries, sales declined at 13 companies, including Pfizer, MSD, AstraZeneca, Viatris, Bayer, Gilead, Lilly, Kyowa Kirin, Ferring, UCB Pharma, Menarini, Guerbet, and Biogen. The company with the largest decline in sales was Pfizer Korea. Last year, Pfizer Korea's sales amounted to KRW 783.7 billion, down 50.3% compared to the previous year. During the same period, operating profit dropped by 57%, from KRW 63.8 billion to KRW 27.2 billion. This was the first time in four years since 2020 that Pfizer Korea's sales fell below KRW 1 trillion. Pfizer Korea was hit directly by a decline in sales due to the endemic phase. Pfizer Korea succeeded in joining the KRW 1 trillion sales club in 2021 through its COVID‑19 vaccine 'Comirnaty' and treatment 'Paxlovid,' but its sales dropped as COVID‑19 stabilized. Pfizer began developing an mRNA vaccine in March 2020 in partnership with Germany's BioNTech as COVID‑19 spread globally. The collaboration between BioNTech, which possesses mRNA technology, and Pfizer, with its extensive global clinical experience, resulted in successful synergy. Consequently, Pfizer Korea's sales increased significantly. The company's sales reached KRW 1.6940 trillion in 2021, exceeding KRW 1 trillion for the first time, and then surged to KRW 3.2254 trillion in 2022. Compared to its 2020 sales, the company saw a 723% increase within two years. However, companies' sales declined as governments announced COVID-19 transitioning into the endemic phase in 2023. Pfizer Korea's sales in 2023 amounted to KRW 1.6018 trillion, a 50% decrease from the previous year, and last year, its sales fell short of maintaining the KRW 1 trillion mark at KRW 783.7 billion. Last year's sales represent a 76% decrease compared to 2022 when the highest sales performance was recorded. MSD Korea also experienced a sales decline of nearly KRW 100 billion from the previous year due to the impact of COVID‑19. MSD Korea's sales last year were KRW 667.8 billion, a 12.2% decrease compared to the prior year. Although the company developed the COVID‑19 therapeutic 'Lagevrio' during the pandemic, its sales declined as the situation transitioned to an endemic phase. MSD Korea explained that the current sales performance reflects the combined effects of decreased COVID‑19 cases and a strategic shift toward focusing on innovative drugs and vaccines. Korean MSD is not only driven by its chief immuno-oncology product, Keytruda, but is also expecting growth from vaccines and innovative new drugs. The company is preparing for domestic launches later this year, including a first‐in‐class pulmonary arterial hypertension activin signal inhibitor, 'Winrebair,' and the first adult customized pneumococcal vaccine, 'Capvaxive.' Gilead's sales last year reached KRW 319.8 billion, a 16.7% decrease compared to the previous year. Analysis suggests that Gilead's sales declined as its COVID‑19 therapeutic, Bekluri, decreased prescription volume. Bekluri is used for patients hospitalized with severe COVID‑19 who have an oxygen saturation of 94% or lower or require supplemental oxygen therapy. The sales of AstraZeneca, the first company to develop a COVID‑19 vaccine, also decreased slightly. AstraZeneca Korea's sales fell by 5.7%, from KRW 639.3 billion in 2023 to KRW 602.7 billion last year. Driven by the domestic launch of its COVID‑19 vaccine, AstraZeneca Korea recorded sales of KRW 655.3 billion in 2021, marking a 31.6% increase compared to the previous year. However, with the emergence of follow-on vaccines from companies such as Pfizer, Moderna, and Janssen, sales slightly decreased to KRW 615.1 billion in 2022. Last year, AstraZeneca Korea decided to withdraw its SGLT-2 inhibitor Forxiga from the market. The withdrawal of a product that had recorded over KRW 50 billion in annual sales significantly impacted overall sales decline. In contrast, the external prescription volume for the non–small cell lung cancer therapy Tagrisso reached KRW 136.8 billion last year, a 52.9% increase compared to the previous year. Additionally, sales declined at several companies, including Biogen Korea (–61.6%), Kyowa Kirin Korea (–29.9%), Viatris Korea (–5.2%), Bayer Korea (–3.6%), Korea Ferring (–2.5%), Korea Lilly (–2.2%), Korea Menarini (–2.0%), Korea UCB Pharma (–1.6%), and Guerbet Korea (–0.1%). New obesity drugs·new drugs for immune diseases are growing, sales surges for Novo Nordisk·AbbVie Meanwhile, innovative new drugs have been performing strongly, resulting in substantial increases in sales for Novo Nordisk, AbbVie, and Sanofi. Novo NordiskNovo Nordisk Korea’s sales increased by 63%, from KRW 230.2 billion in 2023 to KRW 374.7 billion last year. Operating profit rose by 65% during the same period, from KRW 8.3 billion to KRW 13.7 billion. Wegovy drove the growth in Novo Nordisk’s sales. According to market research firm IQVIA, Wegovy recorded KRW 60.3 billion in sales in just one quarter following its launch in October last year. Wegovy, which was approved in South Korea in April 2023, is a GLP‑1 agent containing semaglutide that has demonstrated efficacy in reducing HbA1c levels and body weight. Novo Nordisk developed Wegovy as a once‑weekly obesity treatment after observing weight loss effects during clinical trials of its GLP‑1 diabetes drug candidates. The sales growth of Novo Nordisk’s diabetes products also contributed to overall performance. According to market research firm UBIST, the GLP‑1 agent liraglutide and the insulin degludec combination product, Xultophy, recorded sales of KRW 15.1 billion last year, up 26% compared to the previous year. In addition, the once‑weekly insulin product Tresiba and the insulin combination product Ryzodeg recorded sales of KRW 38.0 billion and KRW 31.3 billion last year, up 3% and 7%, respectively. Sanofi also demonstrated notable growth, with its Korean subsidiary’s sales reaching KRW 529.6 billion last year, an 18.1% increase compared to the previous year. Sanofi expanded its overall market presence through the steady growth of its original products. The antithrombotic agent Plavix recorded sales of KRW 128.5 billion last year, up 2% compared to the previous year. Prescriptions for the insulin product Toujeo reached KRW 27.2 billion last year, an 11% increase over 2023, while the antiarrhythmic agent Multaq achieved sales of KRW 12.4 billion, up 14%. SanofiSanofi is also anticipating robust growth for its biologic Dupixent. Sanofi expects Dupixent's sales to increase further. Dupixent also received expanded approval for chronic obstructive pulmonary disease (COPD) earlier this year. Current COPD treatment guidelines, both domestic and international, now include recommendations for Dupixent. According to market research firm IQVIA, Dupixent's sales reached KRW 143.2 billion in 2023, making it a mega blockbuster product. AbbVie Korea also experienced double-digit growth last year. AbbVie Korea's sales increased by 32%, from KRW 234.7 billion in 2023 to KRW 308.9 billion last year. AbbVie Korea also experienced double-digit growth last year. AbbVie Korea's sales increased by 32%, from KRW 234.7 billion in 2023 to KRW 308.9 billion last year. The strong market positioning of Rinvoq and Skyrizi contributed to substantial growth in AbbVie Korea's sales. Rinvoq, a JAK1-selective inhibitor, was approved in Korea in 2020 for the treatment of rheumatoid arthritis. After that, Rinvoq was approved in 2021 for atopic dermatitis and expanded its indications in 2022 and 2023 to include ulcerative colitis and Crohn's disease, respectively. With the addition of new indications, Rinvoq's sales have begun to climb. According to market research firm UBIST, Rinvoq's sales increased by 450%, from KRW 1.4 billion in 2021 to KRW 7.7 billion in 2022. After breaking KRW 10 billion in early 2023, Rinvoq's sales reached KRW 26.1 billion last year, setting a new sales record. AbbVie AbbVie Korea is also expecting strong growth from 'Skyrizi,' a biologic that targets interleukin (IL)-23, in addition to Rinvoq. Skyrizi was initially approved in 2019 as a treatment for plaque psoriasis, followed by approval in 2022 for psoriatic arthritis, and last year for palmoplantar pustulosis. According to IQVIA, Skyrizi's sales are on a steep upward trend. Skyrizi's sales increased from KRW 8.4 billion in 2021 to KRW 16.5 billion in 2022 and KRW 27.6 billion in 2023. As of 2023, the combined sales of Rinvoq and Skyrizi have surpassed KRW 50 billion. A successful generational transition from Humira in the autoimmune disease sector is being made.
- Opinion
- [Reporter's View] 'Korea Passing' related to new drugs
- by Eo, Yun-Ho Apr 14, 2025 05:57am
- The same term can be interpreted differently. In the pharmaceutical industry, 'Korea Passing' is not a matter of diplomatic conflicts. The issue is not analogous to the United States and North Korea alienating South Korea, but it related somewhat to a single multinational pharmaceutical company alienating South Korea due to drug pricing in other countries. Therefore, the Korean health authority opposes using the term 'Korea Passing' in the pharmaceutical industry. However, the number of cases is increasing. Several pharmaceutical countries have temporarily halted the reimbursement process or given up in South Korea due to China and Canada. When asked about their official reasons, the responses mainly were 'related to company's internal matters.' This financial issue, which is the chief concern of the 'Korea Passing,' in turn exacerbates problems related to 'drugs,' which directly affect human health. It is of utmost concern that more 'drugs in the market cannot be used in practices.' Interestingly, such a 'Korea Passing' issue is often transformed into an 'internal matter.' Although the government and the industry may have different stances, the term 'Korea Passing' implicating 'patriotism' comes as a burden. Since it is generally conceived that 'new drug=multinational companies,' company's statements such as "we will not sell drugs in South Korea because drug pricing in South Korea is too low" impose a burden. To claim such a statement, companies should admit that they are not putting patients first. They may blame the Korean system. However, the Korean subsidiaries of these companies should acknowledge that they have not put Korean patients first. Also, they should question themselves, 'Have we tried our best?' The Korean government cannot avoid being responsible. New drugs that patients most need are primarily products from multinational pharmaceutical companies. Instead voicing concerns for the future of the Korean industry, the government overlooks patients in South Korea. The government should not approach this issue of confidential drug pricing without being flexible since it does not put more financial burden. It is an unavoidable issue a country with a small market size, like South Korea, faces. The government initiated expanding the risk-sharing agreement (RSA) despite opposing opinions from non-governmental organizations. The government must strive to minimize the effect of 'Korea Passing' to resolve remaining conflicts. Despite such concerns, companies must put forward responsibility related to the 'drug' itself when communicating with their headquarters for 'bringing their companies' drugs to South Korea' amid the process of improving the system.
- Company
- ImmuneOncia seeks opportunity in the PD-1 market
- by Cha, Jihyun Apr 14, 2025 05:57am
- “PD-(L)1 antibodies are the backbone of immuno-oncology drugs. In the future, immuno-oncology developers will be divided into companies with PD-(L)1 drugs and those without. ImmuneOncia will commercialize its own PD-(L)1 drug and continue to grow based on this.” Heung-Tae Kim, CEO of ImmuneOncia, said so about the company's growth strategy and vision when Dailpharm met with him at the company's headquarters in Magok-dong, Gangseo-gu, Seoul. The company aspires to take the lead in the immuno-oncology market by launching actual products, not just licensing out new drug candidates. Heung-Tae Kim, CEO of ImmuneOncia ImmuneOncia was established in 2016 as a joint venture company between Yuhan Corp and US-based Sorrento Therapeutics. In late 2023, Yuhan acquired all of Sorrento's shares and currently holds a 67% stake in the company. Yuhan acquired the entire stake in Sorrento after Sorrento lost a 200 billion-dollar lawsuit and filed for bankruptcy. ImmuneOncia seeking to IPO with its technology and proprietary pipeline. Kim is a medical oncologist and an authority in the field of oncology with experience in academia, healthcare, and government. After graduating from Seoul National University School of Medicine and earning his M.D. from the same graduate school, Kim served as a professor at Dankook University School of Medicine and trained at the National Cancer Institute (NCI). He has then served at the National Cancer Center for more than 17 years, holding key positions such as Director of the Clinical Trials Center, Director of the Lung Cancer Center, Director of the Office of Planning and Coordination, and Deputy Director. For 4 years, he served as the head of the planning team that oversaw the National Cancer Control Planning Board, the only national R&D project on cancer in Korea, and is credited with dramatically improving the level of cancer research in Korea. Kim joined ImmuneOncia in 2021. With more than 30 years of clinical experience, Kim emphasizes the commercialization of new drugs. He believes that true drug development entails bringing a drug to market and making it safe and effective for patients. Kim explained that it is important to contribute to patient treatment by launching new drugs directly rather than realizing early profits or spreading risks through technology exports. This is why Kim advocated for the launch of Leclaza (lasertinib), a drug for non-small cell lung cancer that he had led a clinical trial in, in the Korean market after initiating a monotherapy Phase III trial. “In 2018, Janssen, a Johnson & Johnson subsidiary, introduced lasertinib from Yuhan Corp. If Janssen failed the lasertinib-amivantamab combination trial, lasertinib would have disappeared from the market,” explained Kim. ”I convinced the company that if lasertinib was to survive, Yuhan should conduct a monotherapy trial in Korea and sell it on its own.” “By launching Leclaza in Korea, Yuhan Corp has secured a stable revenue base while also gaining brand value as a global drug developer. When I first came to ImmuneOncia, most people were against the idea of bringing a drug to market, but now everyone agrees that it is necessary to commercialize new drugs,’ he added. ImmuneOncia's goal is to bring immuno-oncology drugs to market. Cancer cells evade immune cell attacks by using a trick called immune checkpoints to block immune cell attack signals and disguise themselves as normal cells. Immuno-oncology drugs block this evasion, allowing immune cells to work properly and effectively attack the cancer cells. ImmuneOncia currently has a pipeline of immuno-oncology drugs, including IMC-001, which targets PD-L1, IMC-002, which targets CD47, and IMC-201, which targets CD47 and PD-L1. Of these, IMC-001 is the most advanced in development. IMC-001 demonstrated excellent efficacy and safety in a Phase II monotherapy trial, with an objective response rate (ORR) of 79% and a complete response rate (CR) of 58%. However, some have questioned the possibility of success of new immuno-oncology drugs. With multiple PD-(L)1 therapies on the market, the question is whether the immuno-oncology market is already saturated. Currently, there are 10 drugs in the PD-(L)1 class approved by the U.S. Food and Drug Administration (FDA), eight of which are approved domestically. In particular, Merck's (MSD) Keytruda has expanded its indications to more than 30, including lung cancer, melanoma, renal cell carcinoma, and bladder cancer, making it a dominant player in the immuno-oncology market. Kim's answer is clear: the immuno-oncology market will continue to expand, and there are still opportunities for strategic approaches. “The PD-(L)1 market will continue to grow through combination therapies. There are only 20 PD-(L)1 drugs licensed in China, and the fact that China continues to develop new PD-(L)1 drugs shows the growth of the market.” ImmuneOncia's plan for tapping into the PD-(L)1 market as a late entrant is to go niche. Instead of focusing on common cancers, where competition is fierce, ImmuneOncia's strategy is to first gain approval in rare cancers where no one else is developing, i.e., where there are fewer treatment options, and then expand indications to solid tumors, based on biomarkers. “It's hard to get initial approval, but once you do, it's fairly easy to add indications,” said Kim, ”Some have asked whether we could go niche and achieve meaningful results, but I believe I can create our market.” ImmuneOncia expects to commercialize IMC-001 in 2029. The company is implementing a comprehensive strategy for commercialization and early market entry. The license agreement stipulates that the parent company, Yuhan, will be the exclusive distributor in Korea. This means that Yuhan will be in charge of drug price and reimbursement listing, sales, inventory management, etc. after approval. After the approval of IMC-001, the company plans to accelerate the development of next-generation antibodies. The company plans to strengthen its position in the immuno-oncology market by expanding its development area to include a pipeline of bispecific immuno-oncology drugs. Kim explained, “ImmuneOncia is also implementing a 'franchise antibody' strategy to continuously discover and develop next-generation antibodies based on its own PD-(L)1 drug.” IMC-002 is also a key part of ImmuneOncia's pipeline. In 2021, ImmuneOncia transferred the development and commercialization rights for IMC-002 to 3D Medicines in China for a total worth of USD 470.5 million, including an upfront payment of USD 8 million. The drug is in Phase Ib clinical trials based on its mechanism that blocks CD47 and macrophage signaling in cancer cells. A few years ago, CD47-targeted immuno-oncology drug was considered the next big target after PD-(L)1. CD47 is overexpressed in most cancers, whereas PD-(L)1 is only effective in a subset of cancers, so targeting CD47 was likely to overcome the limitations of existing therapies. The ability to block the earliest stages of immune privilege was also highlighted as a differentiating feature of CD47-targeted immuno-oncology drugs. However, the mood has changed somewhat. Global big pharma companies such as AbbVie, Gilead Sciences, and Pfizer have stopped developing CD47-targeted immuno-oncology drugs. There had been skepticism on whether CD47 class drugs can become the next generation of immuno-oncology drugs without overcoming their side effects or efficacy issues. Kim believes that the big pharma's discontinuation can be an opportunity for ImmuneOncia. To solve the problem of side effects of CD47-targeted immuno-oncology drugs, ImmuneOncia has been focusing on discovering antibodies that can selectively bind to cancer cells and normal cells. And the company’s result is IMC-002. IMC-002 binds strongly to cancer cells while barely binding to red blood cells. ImmuneOncia will present efficacy and safety data from the Phase Ib trial of IMC-002 at the American Society of Clinical Oncology (ASCO) Congress in June. “I think this is an opportunity to boom up the CD47 market, which has been somewhat stagnant. I believe IMC-002 could be a game-changer that can address the efficacy and safety issues that were an issue with CD47 drugs. 'Changing the standard of cancer treatment By bringing Korea's 1st immuno-oncology drug.' This is the slogan that Kim created upon joining ImmuneOncia. It means that he aims to change the standard of cancer treatment by creating Korea's 1st immuno-oncology drug. He engraved this phrase on the company's business card. It is not just a slogan, but an expression of his determination to make it a reality. Kim is committed to leveraging the IPO to accelerate clinical trials of ImmuneOncia’s key pipeline drugs and commercialize the first domestic immuno-oncology drug. Kim said, “If ImmuneOncia succeeds in developing the first domestic immuno-oncology drug, we expect to have a strong brand value as the company that launched the second Leclaza. Based on our technological excellence and differentiated R&D capabilities, we will lead innovation in the immuno-oncology field and provide high value to prospective investors.”
- Company
- Alesion 1% may be prescribed in general hospitals in KOR
- by Eo, Yun-Ho Apr 14, 2025 05:56am
- ‘Alesion LX 1% Eye Drop,’ an antiallergic drug for allergic conjunctivitis, may now be prescribed at general hospitals in Korea. According to industry sources, Santen’s Alesion LX 1% Eye Drops, Korea's first eye drop that contains 1 mg epinastine hydrochloride, have passed the drug committee (DC) reviews of medical institutions in Korea, including the Sinchon Severance Hospital. Alesion LX Eye Drops 1% is regarded to have addressed the issue of reduced tear volume, which had been a limitation of existing treatments, by increasing the epinastine dose from 0.05% to 0.1%. Since first launching of Allegion LX Eye Drops in Japan in 2013, the 0.05% formulation was approved in Korea on June 26, 2020 and launched in February 2021. In addition, the high-concentration formulation, Alesion LX Eye Drops 1%, which was released in November 2024, offered a longer-lasting effect due to increasing the amount of ocular tissue transfer. Epinastine, the active pharmaceutical ingredient of the drug, strongly acts on H1 histamine receptors but weakly binds to muscarinic receptors, so it has fewer side effects of reducing tear volume, which is an advantage for patients with dry eyes. Alesion LX, a preservative-free formulation, has a similar composition to the tears of healthy people, providing a comfortable sensation when instilled. In a clinical trial comparing Alesion LX Eye Drops 1% with epinastine hydrochloride eye drops 0.05% that contains 0.5 mg of epinastine hydrochloride, the itching score improved in the Alesion LX Eye Drops 1% group. In a clinical trial that compared Alesion LX Eye Drops 1% with placebo, the itching score and conjunctival hyperemia score also improved. Epinasertine hydrochloride is mainly available in tablet form in Korea and is used for bronchial asthma and allergic rhinitis. The only eye drop products available for allergic conjunctivitis are Santen's Alesion and AbbVie's Relestat Eye Drops. Meanwhile, the current incidence of allergic conjunctivitis is 21%, which is higher than that of diabetes, and the number of patients has been increasing by 4.5% annually, reaching 2.5 million. It occurs throughout the year due to its seasonality and year-round nature. Although it occurs regardless of age, adults account for 75% of all patients. In particular, patients with perennial allergic conjunctivitis, which lasts all year round, require long-term treatment but have experienced difficulties in treatment due to the side effects of existing treatments, such as worsening dry eye due to a decrease in tear volume.
- Company
- KPTA and Pharmexcil to sign MOU to expand Korea-India trade
- by Kim, Jin-Gu Apr 14, 2025 05:56am
- The Korea Pharmaceutical Traders Association announced on the 10th that it has agreed to mutually cooperate with the Pharmaceutical Export Promotion Council of India (Pharmexcil), which participated in the 'CPHI JAPAN 2025' exhibition held on the 10th, to expand pharmaceutical trade and promote the development of the health industry in both countries. The two associations agreed to sign an MOU at the BHARAT Health Expo, which will be held in India from September 4 to 6 this year. The main contents of the MOU include: ▲Mutual exchange of the latest information on licensing, regulations, and investment in both countries; ▲Stable supply of essential medicines; ▲Trade promotion through the discovery of potential buyers; ▲Support for trade activities through participation in major exhibitions and the holding of seminars and forums. India is one of the world's 3 largest API manufacturers, producing about 20% of the world's total API. It is reported to have a market worth USD 50 billion (KRW 73 trillion) with an average annual growth rate of 9%. According to statistics from the Korea Pharmaceutical Traders Association, South Korea imported about USD 360 million worth of pharmaceuticals from India as of 2023. In addition, the Korea-India Comprehensive Economic Partnership Agreement (CEPA), which came into effect in 2010, is expected to reduce tariffs on exports. South Korea has high-quality control capabilities, including being listed on the EU White List, being a member of the International Convention on Harmonisation (ICH), and being listed on the WHA-listed Authorities (WLA), so the MOU is expected to robustly establish the export base of domestic pharmaceutical companies. “The Indian pharmaceutical market is expected to grow to about USD 130 billion (about KRW 189 trillion) by 2030,” said Hyung-Seon Ryu, chairman of the Korea Pharmaceutical Traders Association. ”The MOU between the two organizations will increase the export of Korean pharmaceuticals to India and help secure a stable supply chain for essential drugs in Korea, further vitalizing exchanges and cooperation between the two countries.”
- Company
- "Jardiance's role in total management of CRM: next 10 years"
- by Whang, byung-woo Apr 11, 2025 06:01am
- Boehringer Ingelheim Korea's recent history aligns with the growth of its SGLT-2 inhibitor Jardiance (empagliflozin). Jardiance began as a treatment for type 2 diabetes and demonstrated benefits for cardiovascular-renal-metabolism (CRM), being the first among SGLT2 inhibitors, achieving a total management milestone. As the Phase 3 EMPA-REG OUTCOME clinical study, announced in 2015, marks its 10th anniversary, the company is pursuing another turning point. For the BPM corner, Daily Pharm met with PM Eun-Hee Cho of the CRM business unit (Type 2 diabetes) and PM Gyujin Lee (Chronic heart failure, chronic kidney disease) and heard about this year's strategy and initiatives for Jardiance. Jardiance provides a diabetes-heart-kidney total management…the company challenges the market with its 'one-team' strategy Jardiance, which received domestic approval in August 2014, has gradually expanded its indications from type 2 diabetes to chronic heart failure and chronic kidney disease. Nine years after its domestic launch and ten years after its initial clinical presentation, Jardiance has already achieved a high market share in the diabetes treatment market. As the business unit name suggests, its main strategy focuses on total management under the concept of CRM. PM Cho stated, "Although Jardiance has a 10-year history as a treatment for diabetes, unfortunately, the rate at which domestic diabetes patients reach the target blood glucose level (6.5%) is still insufficient," adding, "Since the expanded reimbursement for triple combination therapy in 2022, there has been an opportunity to increase patient accessibility in the diabetes area." PM Cho said, "With the increasing number of diabetes patients experiencing co-morbidities and complications, we believe that Jardiance can play an even more critical role. We expect that expanding indications and reimbursement for chronic heart failure and chronic kidney disease will provide additional growth drivers." As PM Cho noted, Jardiance has already established growth momentum thanks to the addition of new indications and expanded reimbursement scope. Last October 2023, Jardiance was approved for the chronic kidney disease indication, and since February, reimbursement has been applied for chronic heart failure with spectrum ejection, further enhancing its influence. PM Lee stated, "In the past year, guidelines in various areas have been continuously updated. Through discussions at academic conferences, including updates of the 2023 European Society of Cardiology (ESC) Guidelines for the treatment of chronic heart failure and the 2024 Kidney Disease Improving Global Outcome (KDIGO) Guidelines for treating chronic kidney disease, we have observed that Jardiance's influence is expanding." (From left) PM Eun-Hee Cho and PM Gyujin Lee at Boehringer Ingelheim Korea Currently, within the business unit, each PM is responsible for different indications for Jardiance. But overall, the company sets a strategy under the concept of CRM. Overall, rather than differentiating by indication, the company focuses on positioning Jardiance as a chief drug within a CRM total management strategy. PM Cho said, "While PMs play a representative role for the product, since Jardiance is company's chief, various departments collaborate to set the direction," adding, "Ultimately, the approach has been organized to effectively deliver CRM benefits with a patient-centric focus, as patients are our ultimate customers." Furthermore, PM Lee emphasized, "From the PM’s perspective, the most important task is how to clearly communicate the advantages of Jardiance and differentiate it in the market," and added, "We are approaching this from a 'one-team' perspective to provide comprehensive treatment options rather than differentiating by indication." Jardiance faces introduction of generic drugs…"Will maintain our original drug position" Although Jardiance has been steadily increasing its influence, there are other concerns related to the emergence of generics following the patent expirations of other SGLT‑2 inhibitors. The Jardiance patent is also expected to expire in October. Regarding this, the company anticipates that, ahead of celebrating the 10th anniversary of Jardiance's domestic launch next year, the primary goal in the diabetes area will be to solidify its position as an original drug. PM Cho stated, "The benefits of CRM total management have reached a relatively mature stage. Jardiance has a differentiating factor and an opportunity since it is the only original SGLT‑2 inhibitor with all major indications in the Korean market. Emphasizing these strengths is the core strategy for this year." "Although there are concerns regarding Jardiance generics, based on past experiences, we can anticipate it to some extent," PM Cho added, "Considering that SGLT‑2 inhibitors have already been widely adopted, we expect that the market entry speed of a generic version of Jardiance will be relatively slow, but we plan to actively communicate with key stakeholders." Product photo of JardianceIn addition, the business unit plans to secure growth momentum by capitalizing on indications such as chronic kidney disease, for which reimbursement has not yet been applied. PM Lee said, "Because early diagnosis of chronic kidney disease is a major challenge, we plan to focus on activities that raise disease awareness through company-wide campaigns aimed at improving recognition of the condition," and added, "Given the ongoing optimism from the nephrology community regarding expanded reimbursement for chronic kidney disease, we are also working internally to ensure that SGLT2 inhibitors become reimbursed." Despite the challenge posed by the emergence of generics, both PMs believe that the original drug, Jardiance, maintains a significant presence in the face of increasing market competition. The PMs view Jardiance as still having substantial value as an 'all-around player' capable of realizing the concept of CMR. The company plans to solidify its market-leading position and establish the momentum of a new decade ahead of the 10th anniversary of its domestic launch. PM Cho said, "Our first objective this year is to accelerate the expansion of reimbursement for chronic kidney disease to enable more proactive engagement with healthcare providers," and added, "We aim to establish and communicate the history of the past decade through the clinical data and real-world prescribing experience accumulated with our original SGLT2 inhibitor." PM Lee further remarked, "In addition to its role as a treatment for effective glycemic control, Jardiance became a key drug for type 2 diabetes addressing cardiac and renal complications," and added, "We will continue to work to reinforce Jardiance's role as a long-term treatment option in the domestic market."
- Company
- Reimbursement negotiation on track for Bimzelx
- by Whang, byung-woo Apr 11, 2025 06:01am
- As the reimbursement negotiations process for Bimzelx (bimekizumab), a new psoriasis treatment, is picking up speed, the drug is soon expected to enter the market in earnest. Pic of Bimzelx According to industry sources on the 10th, UCB Korea is in drug price negotiations for Bimzelx's entry into the reimbursement list. After receiving approval for Bimzelx on August 29, UCB Korea applied for reimbursement to the Health Insurance Review and Assessment Service (HIRA) the very next day, with the aim of entering reimbursement within this year. The company passed HIRA’s Drug Reimbursement Evaluation Committee review in February, which paved the way for its drug pricing negotiations 7 months after receiving approval. The industry predicts that Bimzelx will complete negotiations as early as June and that reimbursements will be applied at the latest in the second half of the year. Bimzelix is the first biologic therapy to dual inhibit interleukin-17A and interleukin-17F (IL-17A and IL-17F). IL-17A and IL-17F are key cytokines that trigger the inflammatory process in psoriasis, and Bimzelix selectively and directly targets and inhibits them simultaneously. In BE READY trial, the global Phase 3 clinical study that became the basis for the approval, 90.8% of patients in the Bimzelx group achieved PASI 90 at Week 16, and 68.2% of patients achieved PASI 100. In a clinical trial that compared Bimzelx with another biological agent, there was a clear difference in the percentage of patients who achieved complete clearance of skin lesions at Week 16, which is referred to as 'PASI 100'. Specifically, ▲BE VIVID: Bimzelx 59%, ustekinumab (Stelara) 21% ▲BE SURE: Bimzelx 60%. 8%, adalimumab (Humira) 23.9% ▲BE RADIANT: Bimzelx 61.7%, secukinumab (Cosentyx) 48.9%, etc. “It's been a long time since biologics have been available on the market, and there are still patients suffering despite having tried all biologics,” said Professor Ki Hun Jeong, Department of Dermatology at Kyung Hee University Hospital. ”The emergence of a new treatment option that is highly effective for patients with severe psoriasis is very meaningful in that aspect.” Currently, UCB Korea signed a distribution agreement with Geoyeong to prepare for Bimzelx’s launch, and some hospitals are reportedly working on landing the drug through their respective drug committees (DCs). The company will act in earnest once the drug is reimbursed in Korea. This is because there are already several reimbursed psoriasis treatment options on the market and a drug cannot exert any influence in Korea as a non-reimbursed drug. Reimbursement status of major psoriasis treatments So, where would Bimzelix fit in among the many available psoriasis treatment options in Korea? Experts predict that it will be prescribed more often to patients who have developed resistance to other treatments or new patients. Professor A of the Department of Dermatology at a tertiary hospital in Seoul said, “Some patients have already developed resistance to several of the major treatments and are using the last treatment. In such cases, the emergence of new options is welcome news. However, considering the situation of resistance and other factors, I don't think patients who were previously using existing treatments will switch to Bimzelx.” He also emphasized that “Bimzelx will likely be prescribed to new patients, on the condition that it is reimbursed. Due to the nature of psoriasis, there are issues of resistance, so there is also a complementary role between treatments, despite the competition.” Considering these points, it seems that Bimzelx’s earlier reimbursement than drug price, which was initially the concern, will be a key factor in market competition. The burden of treatment costs for patients with severe psoriasis has been reduced in general with the eased criteria for special calculation of reimbursement. At the previous meeting, Shim Il, Managing Director of UCB Korea, said, “We are aware of the drug price as there are already other available treatments. We will do our best to ensure prompt reimbursement of our drug.”
- Product
- Paxlovid transition to general health system effective June
- by Apr 11, 2025 06:01am
- Product photo of Paxlovid Paxlovid, a treatment for COVID-19, will be transitioned to the general healthcare system starting in June. The free supply previously provided to centers designated for COVID-19 treatment (prescribing facilities) will be terminated entirely due to stock depletion. According to local pharmacists, on the 9th, various local public health centers recently announced that they would discontinue new supplies. The public health centers stated, '"Although the government has been supplying Paxlovid through both market distribution and government-supplied stocks, new supplies from the government are scheduled to discontinue starting in June due to exhaustion of stock.' The announcement is interpreted as a plan to transition Paxlovid entirely to the general healthcare system after the government-held stocks expire at the end of May. Pharmacy's applications and distribution for remaining stock are still ongoing. Pharmacist A stated, "I ordered four units through the public health center,” and added, “We placed the order as a precaution since there have still been occasional COVID-19 cases," and added, "I am now concerned about how to place Paxlovid orders once it transitions to the general healthcare system." Concerns over placing Paxlovid orders during the transition to the general healthcare system continue. Pharmacist B, who operates a Paxlovid-dedicated pharmacy, commented, "We received notice from the public health center that free supply will be discontinued at the end of May," and added, "This means that the distribution channels will be switched to a single market channel, but the specifics on orders are still undecided." Since October 25 of last year, when health insurance coverage for Paxlovid was first applied, a portion has been transitioned to the general healthcare system so that all clinics and pharmacies can handle it. However, the high price of KRW 950,000 per package (30 tablets) remains a significant burden, as discussed among pharmacists. Pharmacist B explained, "We have inquired with several wholesalers, but they all responded that there is currently no stock available," and added, "Since the acquisition cost is KRW 941,940, nearly KRW 950,000, I am concerned that pharmacies might end up bearing the stock, which would be problematic." Pharmacists point out that wholesalers have not yet released clear policies on the return of Paxlovid, raising concerns that without such policies, they could incur losses due to non-returnable stock. Pharmacist C also remarked, "Once the government's free supply of Paxlovid is depleted, the number of pharmacies ordering it will inevitably decrease," adding, "While it would be ideal if COVID-19 does not resurge, in the event of another outbreak, the burden of inventory and the inconvenience of dispensing for patients are expected to be unavoidable." However, the co-payment fee remains at approximately KRW 47,090 per package, maintaining the current level of around KRW 50,000. Earlier, Lee Jung Kyu, Director of the General Bureau of Health Insurance Policy at the Ministry of Health and Welfare (MOHW), stated, "In order to minimize gaps in practices due to the system transition and to efficiently utilize the purchased stock, the Korea Disease Control and Prevention Agency (KDCA) plans to maintain both market distribution and government supply for awhile," and added, "With health insurance coverage for COVID-19 treatments, we expect that patients will be able to use these treatments stably in response to COVID-19 resurges, and we will continue working to expand health insurance coverage for essential treatments needed in society."
- Policy
- NHIS opens a non-reimbursement information portal
- by Lee, Tak-Sun Apr 11, 2025 06:01am
- The National Health Insurance Service (NHIS) announced that it will launch a 'non-reimbursement information portal' on the 10th to help people easily understand information on non-reimbursed items at a glance to improve their right to know and promote rational medical use. Unlike reimbursed items, where prices and standards of care are set by law, those of non-reimbursed items are set by medical institutions autonomously, so people have difficulty making medical choices because they do not have enough information about whether the prices of the non-reimbursed medical services are reasonable and safe. In response, the NHIS explained that it has established the 'Non-Reimbursement Information Portal' to provide comprehensive information on the safety and effectiveness of major items, symptoms, and treatments for each disease, in addition to price information on non-reimbursed items, to support people make informed medical choices. In addition, the Ministry of Health and Welfare has strengthened access so that people can more easily and reasonably access medical services by collecting non-reimbursement information from various institutions, including the National Health Insurance Service, Health Insurance Review and Assessment Service, the Korea Human Resource Development Institute For Health & Welfare, and the Korea Disease Control and Prevention Agency. The Ministry of Health and Welfare has added a menu on: Understanding non-reimbursement, Taking non-reimbursed services with information, and Statistics on non-reimbursed items. Users can easily check key information at a glance on the landing page. Starting with a guide to non-reimbursed care and an introduction to non-reimbursed care systems that could help people make appropriate and rational choices when using non-reimbursed care, the website shows prices for each non-reimbursed item, medical fees for major diseases and surgeries (reimbursement + non-reimbursement), results of safety and effectiveness evaluations of non-reimbursed items, and various statistical results related to non-reimbursed care. It also provides a shortcut service for each institution that allows users to check videos that help them manage their health, information on diseases related to non-reimbursable items, and details on the information provided. The information provided by this non-reimbursement information portal includes 1,064 non-reimbursement items, 91 diseases, and 54 health technology reevaluation results, and the information will continue to be expanded through continuous analysis and evaluation, as well as strengthened cooperation with specialized institutions. The price information provided by the non-reimbursement information portal is based on information collected through the non-reimbursement reporting system, which has been in effect since 2023. Under the non-reimbursement reporting system, hospitals are required to submit items, amounts, and treatment details to the National Health Insurance Service twice a year (March and September), and clinics once a year (March). “By providing comprehensive non-reimbursed medical information through the non-reimbursement information portal, we expect to strengthen access to non-reimbursement information and contribute to ensuring that people can use the non-reimbursed medical services they need at an appropriate cost, safely and reasonably,” said NHIS President Ki-Suck Jung. Jung added, “We plan to continue our efforts to help people use medical services rationally and reduce the burden of medical expenses.”
- Company
- Reimbursement listing of Handok’s Doptelet near
- by Son, Hyung Min Apr 11, 2025 06:00am
- Doptelet, Handok’s newly introduced drug, is close to being listed for insurance reimbursement in Korea. According to industry sources, Handok has accepted the conditions presented by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service for Doptelet (avatrombopag), a treatment for immune thrombocytopenia (ITP) and 'thrombocytopenia in patients with chronic liver disease scheduled for surgery,' and is in the negotiation stage with the National Health Insurance Service.'' Handok introduced Doptelet from the global biopharmaceutical company SOBI. The drug is an oral thrombopoietin receptor agonist (TPO-RA) used to help treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) when other treatments have It is used in various countries, including the United States, Europe, Australia, and Japan, and was approved by the US Food and Drug Administration (FDA) in June 2019 and the European Medicines Agency (EMA) in January 2021 for the treatment of immune thrombocytopenia. Doptelet offers a new option for both patients new to and those already experienced with TPO-RA treatment for chronic immune thrombocytopenia. The results of the Phase III 302 Study showed that the cumulative number of weeks with a platelet response (platelet count of 50,000/μL or higher) in the Doptelet group was 12.4 weeks (median), which was significantly longer than the 0 weeks (median) in the placebo group, and that 65.6% of patients in the Doptelet group showed a rapid platelet response on day 8 of treatment. These results were consistent regardless of whether or not the patient had previous TPO-RA treatment experience. A retrospective analysis of patients who switched from existing TPO-RA to Doptelet also showed that Doptelet had excellent therapeutic effects. In an analysis of a total of 44 patients in the United States, 93% of patients who switched to Doptelet reached a platelet count of 50,000/μL or higher, and 86% of patients reached a platelet count of 100,000/μL or higher. In particular, in patients who did not see sufficient effects with existing TPO-RA, the platelet count (median) increased from 28,000/uL to 88,000/uL after taking Doptelet. Doptelet has also demonstrated its efficacy in patients with chronic liver disease who are having difficulty undergoing invasive procedures due to thrombocytopenia. The results of the ADAPT-1 and ADAPT-2 trials showed that the percentage of patients with chronic liver disease and thrombocytopenia of less than 40,000/uL who did not require platelet transfusions or rescue therapy after the procedure was 22.9% and 34.9%, respectively, in the ADAPT1 and ADAPT2 placebo groups. In contrast, 65.6% and 68.6% of the patients in the Doptelet group did not require platelet transfusions or rescue therapy in the ADAPT-1 and ADAPT-2 trials, respectively. In patients with 40,000/uL to 50,000/uL, 88.1% and 87.9% of patients in the Doptelet group did not require platelet transfusions or rescue therapy, while 38.2% and 33.3% of patients in the placebo group did not require platelet transfusions or rescue therapy in each clinical trial. Meanwhile, following the strategic partnership last year, Handok established a joint venture with SOBI in April this year. Handok-Sobi develops and sells rare disease drugs in Korea, with Handok and Sobi holding 49% and 51% of the shares, respectively. And Handok's newly introduced drug, ‘Doptelet,' is nearing insurance reimbursement listing in Korea.
