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- 2026-04-21 10:52:50
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- En masse designation of quasi-innovative pharmas?
- by Kim, Jin-Gu Mar 20, 2026 08:55am
- The government is reviewing a pricing incentive scheme for companies deemed equivalent to innovative pharmaceutical firms (“quasi-innovative” companies). Although more than 30 companies are expected to meet the criteria, the actual level of preferential treatment granted to the companies appears limited, leading to criticism that the policy is merely a publicity stunt.According to industry sources on the 19th, the government is considering establishing a new preferential pricing track for “companies equivalent to innovative pharmaceutical firms (quasi-innovative firms).”The government’s policy is to review price preferences to enable solid pharmaceutical companies with potential to advance to the level of innovative pharmaceutical firms at an early stage. These details were revealed during the Health Insurance Policy Deliberation Committee subcommittee meeting on the 11th.The government has proposed R&D investment ratios relative to revenue as the key criterion. Companies with revenue above KRW 100 billion must have an R&D ratio of at least 5%, and companies below KRW 100 billion must have at least 7%. Companies that have received administrative sanctions within the past 5 years under the Pharmaceutical Affairs Act, Fair Trade Act, or Pharmaceutical Industry Act due to rebate-related issues will be excluded.Companies that meet these requirements will receive preferential drug pricing. Preferential pricing will be applied to newly listed generics, and the duration of this preferential treatment is currently under review to be similar to that for innovative pharmaceutical companies. The government also plans to grant temporary special exemptions when adjusting the prices of already listed drugs.This plan is interpreted as a response to the pharmaceutical industry’s backlash against the drug pricing system reform draft released last November. At that time, the government proposed applying price discounts of 68%, 60%, and 55% to innovative pharmaceutical companies based on their R&D ratios. However, criticism arose that the benefits would be concentrated among a select few top companies, while most companies would find it difficult to avoid price reductions.Applying the new criteria would significantly increase the number of companies eligible for preferential pricing.An analysis of 98 listed pharmaceutical companies classified as pharmaceutical firms on the KOSPI and KOSDAQ that will be affected by price cuts found that 32 companies would newly qualify. This excludes holding companies, R&D-focused biotech ventures, and medical device firms that are not affected by price cuts.Conversely, 45 companies failed to meet the criteria. The remaining 21 are companies that had previously been designated as innovative pharmaceutical companies.Among companies with revenue above KRW 100 billion, those meeting the ≥5% R&D ratio include firms such as ▲CMG Pharmaceutical, J▲W Pharmaceutical, ▲SK Bioscience, ▲SK Biopharmaceuticals, ▲Kyungdong Pharm, ▲Kyungbo Pharm, ▲Daehan New Pharm, ▲Dong-A ST, ▲Myung-In Pharm, ▲Samjin Pharm, ▲Sam Chung Dang Pharm, ▲Ahn-Gook Pharmaceutical, ▲Withus Pharmaceutical, ▲Korea United Pharm, ▲Il-Yang Pharm, ▲Jeil Pharmaceuticval, ▲Chong Kun Dang, ▲Kolon Life Science, ▲Hana Pharm, ▲ Hanall Biopharma, ▲Whanin Pharm, ▲Humedix, and ▲Huons. These companies will likely be included as quasi-innovative pharmaceutical companies.On the other hand, companies such as ▲HLB Pharma, ▲Kwang Dong Pharmaceutical, ▲Kukjeon Pharmaceutical, ▲Kukje Pharm, ▲Dai Han Pharm, ▲Dongkook Life Science, ▲Myungmoon Pharm, ▲Binex, ▲Samsung Biologics, ▲Samil Pharm, ▲Celltrion Pharm, ▲Sinsin Pharmaceutical, ▲CTC Bio, ▲Arlico Pharm, ▲RP Bio, ▲Yungjin Pharm, ▲Yuyu Pharma, ▲Reyon Pharmacuetical, ▲ Jinyang Pharm, ▲Kips Pharma, ▲Theragen Etex, ▲Pharmgen Science, ▲Hawil Pharm, ▲Hugel have R&D rations belos 5% as of the end of last year or Q3 last year, and fail to meet the threshold. It will be unlikely for these companies to receive preferential treatment during price cuts.Among companies with revenue below KRW 100 billion, relatively few meet the ≥7% R&D threshold, with only a handful such as ▲Samsung Pharmaceutical, ▲Sam-A Pharmaceutical, ▲Samyang Biopharm, ▲Cellbion, ▲Onconic Therapeutics, ▲ENCell, ▲GL PharmTech, and ▲Prestige Biologics.In fact, within the same revenue bracket, many companies do not meet the criteria for quasi-innovative pharmaceutical firms. These include ▲JW Shinyak, ▲Kyungnam Pharm, ▲Korean Drug Pharm, ▲Dongsung Pharmaceutical, ▲DuChemBio, ▲Vaskan Bio Pharm, ▲Vivozon Pharmaceutical, ▲Samik Pharmaceutical, ▲Seoul Pharma, ▲Sinil Pharmacuetical, ▲Icure, ▲Aprogen Biologics, ▲L&C Bio, ▲Optus Pharmacuetical, ▲Ilsung IS, ▲Cho-A Pharm, ▲Telcon TF Pharmaceutical, ▲TDS Pharm, ▲BNC Korea, ▲ Union Korea Pharm, ▲ Korea Pharma, among others, which have R&D ratios below 7%, making it highly likely they will not receive preferential treatment in the event of drug price reductions.Industry observers emphasize that the actual level of pricing incentives matters more than the number of eligible companies. Even if many firms qualify, limited incentives could render the policy merely symbolic.In the revised reform plan, the government proposed a 60% pricing premium for innovative pharmaceutical companies when listing new generics, with the preferential period extended to up to 4 years. For quasi-innovative companies, a lower level of benefit is expected.It is reported that the government is considering a preferential level of around 50% for quasi-innovative companies. Given that generic prices are currently set at around 58.55%, this implies that price reductions would still be unavoidable even with preferential treatment. The relatively short preferential period of 1+3 years is also criticized as insufficient to provide meaningful incentives.An industry official commented, “The introduction of criteria for quasi-innovative pharmaceutical companies and pricing incentives is positive in itself. However, in reality, it is more of a structure that reduces the extent of price cuts and is far from being a true incentive. It is a scheme designed to include a large number of companies for the sake of appearances, while in reality, it forces them to lower drug prices.”
- Policy
- Bispecific Ab 'Ziihera inj' for biliary tract cancer wins nod
- by Lee, Tak-Sun Mar 20, 2026 08:55am
- 'Ziihera inj'BeOne Medicines Korea's bispecific antibody for biliary tract cancer, 'Ziihera inj,' has obtained final approval. Analysis suggests that the expedited approval was made possible through the GIFT (Global Innovative product on Fast Track) review process. It is expected to provide new therapeutic opportunities for patients with biliary tract cancer.The Ministry of Food and Drug Safety (MFDS, Minister Oh Yu-Kyoung) announced that it has approved the imported orphan drug 'Ziihera inj 300mg (zanidatamab)' on the 19th.Ziihera is an orphan drug indicated for the treatment of adult patients with unresectable, locally advanced, or metastatic HER2-positive (IHC 3+) biliary tract cancer who have previously received at least one systemic therapy.HER2-positive (IHC 3+) refers to a state where HER2, a protein involved in regulating cell growth, is highly overexpressed as determined by an Immunohistochemistry (IHC) test.This drug is a bispecific antibody that simultaneously binds to two different extracellular domains (ECD4 and ECD2) of the HER2 protein. As an antineoplastic agent, its mechanism involves reducing HER2 expression to inhibit the growth of tumor cells. It is the first drug approved in South Korea for this specific indication. Consequently, expectations are high that it will offer a new treatment window for patients suffering from biliary tract cancer.Ziihera inj received expedited review after being designated as the 40th product under the 'Global Innovative product on Fast Track (GIFT)' system. GIFT is a support program designed to accelerate the commercialization of globally innovative medical products by assisting in the early stages of development (clinical trials).An official from the MFDS stated, "We will continue to ensure that new treatments for patients with rare and intractable diseases are supplied promptly, using our expertise in regulatory science, thereby expanding their opportunities for treatment."
- Policy
- Xtandi to list tablet form to defend market ahead of patent expiry
- by Jung, Heung-Jun Mar 20, 2026 08:55am
- Astellas Korea’s prostate cancer drug Xtandi Tab (enzalutamide) is expected to be listed for reimbursement next month. With 3 months remaining before the drug’s patent expiry, the company appears poised to defend its market share by adding the tablet formulation to its reimbursement lineup.This move appears to be an effort to secure a foothold in the tablet prescription market, where no generics have yet been approved, in preparation for generic competition following patent expiry.According to industry sources on the 19th, Astellas will add tablets to Korea’s reimbursement list next month, following the listing of its soft capsule formulation.Unlike the soft capsules approved in 2013, the tablet formulation was approved in December 2024. This means the tablets are entering the reimbursement list approximately 1 year and 3 months after approval.In the case of Xtandi soft capsules, multiple generics have already received approval and are awaiting the expiration of the substance patent on June 27.Alvogen Korea’s Anamide Soft Capsules, Daewon Pharmaceutical’s Enzadex Soft Capsules, Hanall Biopharma’s Enzaloo Soft Capsules, and Menarini Korea’s EnzalX Soft Capsules are expected to be launched.Generic competition is also expected to intensify for the tablet formulation. Companies including Hanmi, Chong Kun Dang, Alvogen Korea, JW Pharmaceutical, and GL Pharma have won passive scope confirmation trials on Xtandi’s composition patents.However, since no generics have yet received marketing approval, entry into the tablet market is expected to lag behind capsules.The newly listed Xtandi Tab will be available in 40 mg and 80 mg strengths, expanding the reimbursement lineup at the same price level as the capsule formulation.According to the market research institution UBIST, Xtandi recorded KRW 38 billion in sales last year, up 26% from KRW 30.2 billion the previous year.However, it appears difficult to sustain this sales growth trend starting in the second half of this year due to the market penetration of generics.
- Policy
- Twice-yearly injectable HIV drug Sunlenca nears approval in Korea
- by Lee, Tak-Sun Mar 20, 2026 08:55am
- AI-generated imageGilead Sciences’ multidrug-resistant HIV treatment Sunlenca (lenacapavir sodium) is reportedly nearing marketing approval in Korea.The drug was designated in March last year for the MFDS GIFT (Global Innovative product on Fast Track) program, and it has recently been reported that the safety and efficacy review has been completed.According to industry sources on the 19th, the MFDS has completed its safety and efficacy assessment of Sunlenca. Once a product passes this stage, only the final approval process typically remains. In addition, products that have undergone safety and efficacy reviews can apply for reimbursement to the Health Insurance Review and Assessment Service (HIRA) under the approval–reimbursement assessment linkage system.Observers predict that if Sunlenca has received a positive determination in the safety and efficacy review, it is highly likely to receive marketing authorization approval in the near future.Sunlenca is a first-in-class capsid inhibitor that targets multiple stages of the HIV replication cycle. It is primarily aimed at patients with multidrug-resistant HIV who have developed resistance to existing treatments and have no further treatment options.It inhibits HIV-1 at multiple points throughout the viral lifecycle, including by interfering with the capsid-mediated nuclear entry of the pre-integration complex and impairing virion production and proper capsid core formation.A key feature of the drug is its twice-yearly injectable dosing, offering improved convenience.This is because it is a “long-acting” formulation that requires only a single injection every 6 months (26 weeks) during the maintenance phase, after an initial phase combined with oral therapy. As a result, it is widely recognized for significantly reducing the psychological burden and inconvenience previously experienced by patients who had to take medication daily.An industry official stated, “Sunlenca is of great clinical significance in that it provides strong viral suppression through a completely new mechanism for these patients. In particular, the fact that it is a long-acting injectable administered once every six months can maximize patient adherence.”Sunlenca has already been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is currently in use. Recently, it has also demonstrated exceptional efficacy as a pre-exposure prophylaxis (PrEP), drawing attention as a potential game-changer, set to reshape the HIV treatment market.The FDA approved Sunlenca in December 2022, following fast-track, breakthrough therapy designation (BTD), and priority review (PR) designations. The EMA approved it earlier in August 2022, and Japan’s PMDA approved it through priority review in August 2023.In Korea, it was designated an orphan drug in December 2024, and on March 4 last year, it was designated as GIFT product No. 46, reflecting the lack of existing treatment options.The indication submitted for its use in Korea is as combination therapy with other antiretrovirals for the treatment of HIV-1 infection in hin adults with multidrug-resistant HIV-1 infection who have a history of treatment failure with current antiretroviral therapy due to resistance, intolerance, or safety issues.
- Company
- Medical device companies gather for KIMES2026
- by Hwang, byoung woo Mar 20, 2026 08:55am
- A four-day Korea International Medical & Hospital Equipment Show (KIMES) 2026 takes off on March 19At the medical device exhibition, the primary topic has emerged from the 'whether to adopt Artificial Intelligence (AI)' to the question of 'how to implement it.'At 'KIMES 2026,' which opened on the 19th, a clear shift in hospital views toward AI acceptance was observed, signaling a rapid migration of the industry's competitive axis.KIMES, celebrating its 41st anniversary, is South Korea's largest medical device exhibition, reflecting global healthcare trends and encompassing the entire industrial ecosystem. This year's event featured 1,490 manufacturers from 41 countries, including 846 domestic and 644 international companies.In this exhibition, major players in ultrasound, diagnostic imaging, endoscopy, and patient monitoring moved beyond standalone hardware to showcase integrated solutions linking diagnosis, treatment, and management. Notably, a 'platform war' is intensifying, with AI serving as the nexus connecting medical data and clinical workflows.Beyond hardware to 'platform' competition…AI-Driven industrial restructuringFirst, global medical device companies presented 'Life-cycle Patient Management' as their core strategy this year.GE HealthCare Korea emphasized a structural continuum from diagnosis to treatment and monitoring by unveiling integrated solutions that combine ultrasound, MRI, and patient monitoring technologies. By presenting ultrasound for quantitative fatty liver analysis, AI-based MRI image reconstruction, and pain-response monitoring during surgery, the company showcased its direction toward data-driven precision medicine.Samsung Medison also placed its platform strategy at the forefront by revealing its next-generation ultrasound brand, 'One Platform.' This structure ensures consistency across the entire examination process through a unified User Interface (UI) and automated features through AI to enhance diagnostic efficiency.These industry leaders are moving past performance competition of individual devices to engage in a full-scale platform battle, one that connects diverse medical data points to facilitate clinical decision-making.The direction of change was also distinct in the diagnostic imaging sector. While the transition from film-based X-rays to digital detectors is complete, advanced equipment such as CT and CBCT (Cone Beam Computed Tomography) is now becoming the standard for medical institutions.Specifically in dentistry, CBCT has effectively become the standard, making 3D-based diagnostics a common practice.Furthermore, the utility of portable X-rays and C-arm systems is expanding into operating rooms and emergency sites, evolving from simple diagnostic tools into procedural support equipment.The most notable change is the improvement in diagnostic efficiency enabled by AI.In the MRI field, there is a clear trend of using AI-based image reconstruction technology to shorten scan times. This is considered a critical factor that not only reduces patient wait times but also increases the number of scans, thereby directly impacting hospital operational efficiency and profitability.An official from SG HealthCare stated, "Reducing MRI scan times is more than just a convenience. It is directly linked to hospital operational efficiency," and "With the introduction of AI, demand for simultaneously improving scan speed and quality is rising rapidly."(Clockwise from top left) Booths of GE HealthCare, Samsung Medison, SG HealthCare, and Waycen"The necessity of AI adoption has grown"…a shift in fieldThe most significant change from this exhibition is the shift in how hospitals perceive medical AI. Industry representatives on-site unanimously noted that the nature of visitor inquiries has changed.In the past, questions primarily focused on hardware specifications or pricing. This year, however, there was a surge in inquiries regarding "whether AI features are applied," "where they are used in practice," and "what effects are observed."Analysis suggests that interest in AI has moved beyond the exploratory phase to the actual implementation review stage. A consensus on the necessity of AI adoption is spreading quickly, particularly among large-scale tertiary hospitals.Questions were raised regarding actual use cases and efficacy in various fields, including AI endoscopy, patient monitoring, and clinical support software, shifting the focus from technical validation to 'practical utility.'However, the market is still in its early stages, with variations in adoption rates among institutions. While some hospitals show aggressive intent to adopt, many others maintain a cautious approach, weighing costs against clinical utility.An official from an AI firm at the site commented, "The necessity for AI is becoming clear, starting with large hospitals. Once this trend solidifies, it is highly likely to influence small and medium-sized hospitals."Numerous technologies that incorporate AI, the current industry mainstay, were on display at medical device booths.Platform competition intensifies…reshaping hospital operationsKIMES 2026 demonstrated that the medical device industry is transitioning from a hardware-centric industry to a 'data-driven platform industry.'While performance and price were the core competitive factors in the past, ▲the new competitive axes include AI-based automation ▲data integration, workflow optimization ▲ensuring continuity of patient care.InBody showed a trend of expanding into primary points of contact, such as pharmacies, by combining digital technology with its body composition analysis solutions. They introduced cases in which measurement data is analyzed in real time and results are presented through visualization, a structure that connects simple measurement to consultation and health management.A view of the InBody booth.This is evaluated as an example of medical devices evolving beyond diagnostic tools into 'data-driven health management platforms.'In particular, AI technology has become a key factor influencing not only diagnostic assistance but also the operational efficiency and revenue structures of hospitals and pharmacies.The industry anticipates that future competition in the medical device market will likely be reorganized around 'platform units' rather than individual equipment.An industry insider stated, "AI is not just a technology. It is an element that changes how hospitals operate," and concluded, "Corporate competitiveness will be determined by how effectively a company can connect and utilize data."
- Company
- MedTech–Pharma alliances intensify as remote monitoring turns profitable
- by Hwang, byoung woo Mar 19, 2026 12:39pm
- As the remote patient monitoring (RPM) market enters a profit-generating phase, competition in the form of alliances between medical device companies and pharmaceutical firms is intensifying.Currently, the domestic RPM market is developing within a framework of alliances between medical device companies and pharmaceutical firms. Seers Technology is partnering with Daewoong Pharmaceutical, Mezoo with Dong-A ST, Huinno with Yuhan Corp, and Wellysis with Samjin Pharmaceutical, forming a competitive landscape among these alliances.Seers Technology is rapidly building references by targeting hospitals with its ward monitoring platform thynC. Mezzue, which is set to list on KOSDAQ in March, is targeting the ward monitoring market with its mobile patient monitoring platform, HiCardi. Wellysis is expanding through wearable ECG devices, while Huinno is growing its business around ECG-based digital healthcare solutions.This surge in collaboration is interpreted as a sign that the RPM market has entered a phase where it is generating revenue. Pharmaceutical companies can expand patient management services based on therapeutic expertise and sales networks, while digital healthcare firms can strengthen data acquisition and platform competitiveness. These aligned interests are accelerating collaboration.RPM market expands beyond ECG to patient management platformsRPM is a digital healthcare technology that continuously measures and manages patients’ vital signs outside hospitals or within general wards.While the initial market was centered on wearable ECG-based arrhythmia detection technology, it has recently been rapidly evolving into a platform format that simultaneously analyzes various vital signs such as heart rate, respiration, body temperature, and physical activity levels.According to market research firm Markets and Markets, the global RPM market is expected to grow from USD 27.7 billion (KRW 41 trillion) in 2024 to USD 56.9 billion (KRW 85 trillion) by 2030, with an estimated annual growth rate of approximately 12–13%.RPM market prospect: Rise from USD 27.7 billion (2024) to USD 56.9 billion (2030) In fact, as hospitals increasingly adopt ward-based monitoring systems, related companies are seeing rapid revenue growth.Industry observers assess that the RPM market is now transitioning from the technology validation phase to the actual commercialization phase.An industry source stated, “Pharmaceutical companies are expanding the market by applying specialized strategies aligned with their therapeutic areas and sales environments. Even those not currently collaborating with medical device companies are closely watching as successful cases emerge.”Hospitals adopt multiple platforms …market expansion phaseHowever, many in the industry view the competition in the RPM market as being closer to a phase of market expansion rather than a zero-sum game for the time being.In fact, some hospitals are adopting multiple RPM platforms simultaneously.An industry insider noted, “While some hospitals adopt only a single solution, others adopt two platforms simultaneously after proof of concept (PoC) has been validated. Since the RPM market is still in its early stages, the structure allows multiple companies to grow together.”Similar to how markets expand when new mechanisms of action enter therapeutic areas, insiders believe the key factor for the RPM market is in increasing the number of hospital beds adopting the technology.As a result, analysts expect the RPM market to grow rapidly over the next 3–5 years, with multiple players expanding simultaneously.Competition in the RPM market is expected to intensify further following upcoming initial public offerings (IPOs) and global expansion.For example, Daewoong Pharmaceutical is pursuing a platform expansion strategy involving multiple partners in addition to Seers Technology, such as Skylabs, iKooB, and Puzzle AI, suggesting that competition may evolve beyond simple partnerships between medical device companies and pharmaceutical firms, into broader digital health alliances.Ultimately, the RPM market may evolve beyond mere collaboration between medical device companies and pharmaceutical firms into a data-driven patient management platform industry.An industry insider stated, “The RPM market is now moving beyond technological competition into a phase of platform competition. How companies build service models based on patient data will determine their future competitiveness.”
- Company
- Se Eun Hwang appointed as the new general manager of CSL Korea.
- by Son, Hyung Min Mar 19, 2026 12:39pm
- Se Eun Hwang, new General Manager of CSL KoreaCSL announced the appointment of Se Eun Hwang, former general manager of Biogen Korea, as the new General Manager of its Korean subsidiary.Effective the 17th, Hwang will oversee overall operations of CSL Korea, leading domestic business strategy, strengthening organizational capabilities, and driving patient-centric corporate operations.Hwang has extensive leadership experience across Korea’s pharmaceutical and biotech industry, covering commercial strategy, market access, and medical affairs.She has successfully driven business growth by building competitive organizations and successfully launching products in Korea’s complex regulatory environment.Before joining CSL, Hwang served as general manager of Biogen Korea, where she established the local organization and led its expansion. During her tenure, she successfully developed reimbursement strategies and achieved market entry for rare disease therapies.Previously, she served as Head of a Rare Disease Franchise at Handok and as Head of Marketing at Abbott Korea, and she also held key positions at JW Pharmaceutical and Hanil Pharmaceutical, gaining experience across the entire pharmaceutical industry. Hwang is a pharmacist by training. She earned an MBA from Sogang University and subsequently obtained a Ph.D. in Clinical Pharmacy from Chung-Ang University, specializing in Social and Health Pharmacy.The newly appointed general manager said, “I am both delighted and feel a strong sense of responsibility taking on this important role, which will allow me to contribute to the lives of patients with rare and severe diseases in Korea through CSL’s innovative portfolio. We will prioritize patient-centric values, maximize organizational capabilities, and work closely with partners to drive new growth at CSL Korea.”Through the leadership appointment, CSL plans to further strengthen its business foundation in Korea and continue efforts to improve the quality of life for patients with rare and severe diseases.
- Company
- Dayvigo targets Zolpidem dominance…Korean commercial launch imminent
- by Eo, Yun-Ho Mar 19, 2026 12:39pm
- An insomnia treatment with a new mechanism of action, ‘Dayvigo,’ is soon to be commercialized in Korea.According to industry sources, Eisai Korea is currently undergoing the approval process with the Ministry of Food and Drug Safety (MFDS) for Dayvigo (lemborexant), a dual orexin receptor antagonist (DORA). Formal approval is anticipated around mid-year.Mechanistically, Dayvigo is classified as an orexin/hypocretin receptor antagonist. It works by inhibiting orexin, which promotes sleep. It is important to note that orexin itself is a neuropeptide in the brain that promotes wakefulness.The drug demonstrated efficacy through two Phase III clinical trials, including the SUNRISE I study.The trials involved 1,006 adult patients from 67 medical institutions in the U.S. and Europe, who were divided into 4 treatment groups. These included 266 patients in the Davigo 5 mg treatment group, 269 in the Davigo 10 mg treatment group, 263 in the zolpidem CR Tab (6.25 mg) treatment group, and 208 in the placebo group. The average age of the patients participating in the study was 63, and 86% were female.Key results showed that most patients in the Dayvigo groups fell asleep within 20 minutes, demonstrating improved sleep onset. In addition, nighttime sleep maintenance time increased by more than 60 minutes compared to baseline.Furthermore, both the low-dose and high-dose groups demonstrated superiority over the placebo group in terms of sleep onset and sleep maintenance. These improvements were particularly pronounced in the Dayvigo 10mg treatment group.Dayvigo received FDA approval in 2019 and is currently prescribed in markets including Europe and Japan.
- Company
- Jeil's subsidiary, Onconic licensing transactions total KRW 10B
- by Chon, Seung-Hyun Mar 19, 2026 12:39pm
- Jeil Pharmaceutical has reached the cumulative technology licensing fees revenue of KRW 10 billion from its R&D subsidiary, Onconic Therapeutics. This steady influx of technology licensing fee stems from the completion of domestic clinical trials, the approval of the new drug Jaqbo, and its successful entry into the Chinese market. Additionally, Jeil Pharmaceutical's revenue surged to KRW 67.1 billion last year as it ramped up sales of Jaqbo.According to the Financial Supervisory Service (FSS) on the 18th, Jeil Pharmaceutical received a total of KRW 1.8 billion in technology licensing fees from Onconic Therapeutics last year. Specifically, the company received KRW 600 million in February, followed by KRW 300 million and KRW 900 million in May and October, respectively.Yearly Cumulative Technology Licensing Fees of Jeil Pharmaceutical's subsidiary Onconic Therapeutics (unit: KRW 1 million, source: Financial Supervisory Service)These payments stem from the settlement of technology export milestones for Jaqbo, which Jeil Pharmaceutical originally out-licensed to Onconic Therapeutics. In March 2023, Onconic Therapeutics signed a technology export deal with the Chinese firm Livzon Pharmaceutical Group for Jaqbo, valued at up to $127.5 million. Under the terms, Onconic received a non-refundable upfront payment of $150 million and is expected to receive up to $112.5 million in milestone payments based on development, regulatory approval, and commercialization stages.In January of last year, Onconic Therapeutics received a $3 million milestone from Livzon following the first patient dosing in China's Phase 3 clinical trial. In March, it billed an additional $1.5 million after completing the transfer of production technology to Livzon.By August, Onconic billed and received a $5 million development milestone within 30 business days. This was achieved by the successful conclusion of Phase 3 trials in China and the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA). A portion of these fees received from Livzon is redistributed to Jeil Pharmaceutical as milestones.Jaqbo is a P-CAB (Potassium-Competitive Acid Blocker) drug, approved in April 2024 as the 37th Korea-developed new drug. P-CAB anti-ulcer agents work by competitively binding with potassium ions to the proton pump, the final stage of acid secretion in gastric parietal cells, thereby inhibiting gastric acid secretion.Jeil Pharmaceutical's revenue history from Jaqbo includes two non-refundable payments of KRW 150 million each in December 2020 and May 2021. In 2022, it received KRW 1 billion in February and another KRW 1 billion in December as Phase 3 clinical milestones. In April 2023, the company received KRW 2.7 billion as a settlement from Onconic’s upfront payment from Livzon (representing 13.5% of the $15 million). In 2024, an additional KRW 600 million was paid over four installments. As of last year, Jeil's cumulative technology licensing fees for Jaqbo totaled KRW 7.58 billion.Jeil Pharmaceutical has also consistently generated revenue from an oncology drug out-licensed to Onconic. For the dual-target anticancer agent JPI-547, the company has secured a total of KRW 2.5 billion. This includes upfront payments of KRW 750 million each in December 2020 and May 2021, plus a KRW 1 billion development milestone received in December 2022. The total amount Jeil Pharmaceutical has collected from Onconic Therapeutics for both Jaqbo and JPI-547 amounted to KRW 10.08 billion.Through Jaqbo domestic sales, Jeil Pharmaceutical achieved expanded sales effects. Jaqbo entered the prescription market in last October after receiving National Health Insurance coverage. Jeil Pharmaceutical and Dong-A ST collaborate on leading marketing and sales. Jaqbo's revenue for Jeil expanded from KRW 8.3 billion in 2024 to KRW 67.1 billion last year.
- Policy
- "MOHW will design the drug pricing policy considering NHI cost"
- by Lee, Jeong-Hwan Mar 19, 2026 12:38pm
- Lee Hyung-hoon, Second Vice Minister of Health and Welfare"We recognize that the pharmaceutical industry has varying opinions regarding government policy. However, the government designs policy by looking at where the public's expectations lie and what their interests are. The necessity of fostering the pharmaceutical industry and the fact that domestic generic drug prices are high are areas where society relatively shares a consensus, and social agreement is required. We are not setting a single specific drug pricing reform plan and trying to force it through. We will repeatedly collect and discuss opinions from the pharmaceutical industry. Since policy can change at any time, there is room to modify the reform plan."Lee Hyung-hoon, Second Vice Minister of Health and Welfare (60, Yonsei University), has drawn significant attention by highlighting the difficulties of reconciling diverse interests in a single policy for drug pricing reform, which primarily focuses on lowering the prices of previously-listed generic drugs.Lee stated that, given South Korea's adoption and operation of a single-payer National Health Insurance system, writing a reform plan that simultaneously achieves the goals of fostering the pharmaceutical industry and ensuring efficient, rational national pharmaceutical expenditures requires considering the interests of both the industry and the public as beneficiaries of health insurance.Meeting with the Korea Special Press Association on the 18th, Vice Minister Lee promised, "Rather than taking the stance of a policy authority, the Ministry of Health and Welfare designs policy by examining public interests. However, we have not finished setting a single drug pricing reform plan. Policy is open and can continue to change. We will communicate with the pharmaceutical industry."This was the Vice Minister's response when asked how the Ministry intends to resolve the industry's backlash against the drug pricing system reform plan announced on November 28 last year.Lee stated that, while agreeing on the necessity of fostering the South Korean pharmaceutical and biotech industry on a global scale to strengthen national competitiveness, the final reform plan would be finalized after collecting opposing opinions from the industry on uniform price cuts.The Ministry intends to listen to the industry's voice and to prepare a revised proposal until the Health Insurance Policy Deliberation Committee deliberates on the reform plan on the 26th.Since releasing the initial draft of the reform plan on November 28 last year, the Ministry has presented a revised draft to the industry on March 11 at the subcommittee. However, the domestic pharmaceutical industry continues to criticize the process as 'closed administration,' citing the failure to specify clear generic price calculation rates, mentioning only a range of 'low-to-mid 40%,' the lack of specific timing and methods for price cuts per item, and the absence of detailed criteria and periods for preferential drug pricing.Lee repeatedly stated that he would gather industry opinions before the committee's final decision. He emphasized that, because pharmaceutical expenditures are funded through the health insurance budget, the government views the drug pricing system considering the efficiency of public insurance premiums."South Korea operates the drug pricing system based on the health insurance finances funded by the mandatory premiums paid by citizens," Lee stated. "Because medical fees and drug prices for both generics and new drugs are operated through health insurance finances, we value the National Health Insurance cost, which represents public expectations."Lee also noted that he recognizes the domestic pharmaceutical industry as a partner in South Korea's efforts to advance to one of the top five global pharmaceutical and biopharmaceutical powers. This is interpreted as a necessity for the administration to communicate and make adjustments to the aspects the industry hopes will be reflected in the reform plan.Lee stated, "Since the Ministry of Health and Welfare also aims to leap into a top-five pharmaceutical and bio-powerhouse as a national task, the pharmaceutical industry is an important partner," Lee explained. "We are discussing the reform plan with the industry. There is a backlash because the industry has more favorable, explicit expectations, but we will continue to communicate. There is room for modification within the system."Lee added, "There may be differing opinions because the industry has its own perspective and expected levels. While the Ministry has its position as a policy authority, we work by looking at where the public views, perspective, and interests lie."Lee stated, "We are open to differing opinions on Ministry policy or points raised by the media. We are not setting one thing and trying to force it through," adding, "Policy can continue to change."Lee concluded by saying, "The need to foster the pharmaceutical industry and the fact that generic prices are high are areas where there is a relatively social consensus. We have carefully considered the drug pricing policy. We are listening to the pharmaceutical industry's opinions," adding, "We fully recognize, acknowledge, and respect the necessity for innovative pharmaceutical companies and the domestic industry to possess national competitiveness and move toward becoming a bio-power. We support and share with the industry's aspiration to expand to a larger global stage."
