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- 2026-10-12 17:41:58
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- Policy
- Will there be a designation for "ultra-innovative pharma"?
- by Jung, Heung-Jun Oct 12, 2026 08:36am
- A proposal has been made to establish an "Ultra-Innovative Pharmaceutical Company" designation, positioned one level above the existing Innovative Pharmaceutical Company category, to intensively foster domestic drugmakers capable of developing global blockbuster therapeutics.Minister of Health and Welfare Jeong Eun Kyeong also agreed on the need for an ultra-innovative company category, saying the Ministry of Health and Welfare (MOHW) will review detailed support mechanisms and implementation methods.Representative Han Jia of the People Power Party.On the 8th, Representative Han Jia of the People Power Party urged the government, during the MOHW's parliamentary audit, to establish proactive support measures to meet its stated target of creating three blockbuster drugs.Rep. Han stated, "The Lee Jae Myung administration has declared initiative to generate three blockbuster novel drugs. However, across 35 ongoing healthcare R&D projects, KRW 106.3 billion was slashed compared to planned budgets, and 156 executing institutions saw their R&D funding cut without prior notification."Rep. Han continued, "Eighty-seven projects faced budget cuts without any performance evaluation," pointing out that "this runs counter to the stated ambition of producing blockbuster novel drugs."Rep. Han also argued that for domestic companies to develop global novel therapies, they must have the financial strength to sustain large-scale clinical trials and build global clinical and distribution networks.Lawmaker Han said, "Over the 27 years since 1999, not a single domestically developed drug has become a blockbuster. Capital capacity to conduct clinical research is vital, as are global clinical networks and distribution channels."Citing the stark disparity in R&D expenditure between multinational corporations and domestic pharmaceutical companies, Rep. Han underscored the problematic nature of the R&D budget cuts.Rep. Han pointed out that "Roche invests KRW 20.4 trillion annually in R&D, whereas the top 10 domestic pharmaceutical firms combined invest around KRW 2.2 trillion, a nearly tenfold gap," adding, "The government must, at least, refrain from cutting healthcare R&D budgets."Rep. Han also called for scaling up the government-sponsored Phase 3 clinical trial support fund. Lawmaker Han said, "While establishing a Phase 3 clinical trial fund deserves positive recognition, its capital size is significantly inadequate. Rather than establishing a mega-fund, the government created a mini-fund."Rep. Han especially emphasized the necessity to look beyond the government's current Innovative Pharmaceutical Company framework and intensively cultivate "frontier companies" capable of spearheading the global market.Related to this, Rep. Han proposed introducing an "Ultra-Innovative" category that is positioned higher than the existing Innovative and Semi-Innovative tiers to provide full-scale support.Rep. Han highlighted, "While diversified investments are necessary, concentrated investments are essential to cultivate industry giants. Rather than settling for semi-innovative and innovative designations, we must create a new tier for ultra-innovative enterprises," adding, "The government must run alongside industry by offering groundbreaking tax incentives, regulatory easing, and global partnerships. The pharmaceutical sector also needs frontier leaders like Samsung Electronics or SK Hynix."Calls continued for a collaborative public-private framework to advance global novel drug development jointly.Rep. Han stressed, "Companies cannot accomplish this alone, nor can the government succeed through its efforts alone," adding, "Only when the government and industry join hands can we secure position in the global pharmaceutical market."Rep. Han further requested, "Please review the implementation of the Ultra-Innovative Pharmaceutical Company category, report on strategies to foster frontier enterprises through a comprehensive audit, and present measures to restore the reduced R&D budget."Minister Jeong agreed that the government must strengthen support for the new drug and biopharmaceutical sectors.Minister Jeong stated, "We agree that innovative support and structural reform are required for the novel drug and bio industries," adding, "Regarding the failure to secure the R&D budget, our efforts were insufficient." Minister Jeong concluded by stating, "We agree that there is a need for an ultra-innovative company framework. The ministry will review how to operationalize it and report back."
- Company
- Korean companies also adopt aggressive patent defense strategies
- by Kim, Jin-Gu Oct 12, 2026 08:36am
- An aggressive patent defense strategy once used primarily by multinational pharmaceutical companies is gaining traction among Korean drugmakers. Rather than waiting for generic competitors to challenge their patents, originator companies are increasingly initiating proceedings themselves.Traditionally, pharmaceutical patent disputes have begun with generic companies filing invalidation petitions or passive trials to confirm the scope of patent rights, which the originator responded to. Recently, however, Korean originator companies have also begun leveraging aggressive administrative trials as a means of patent defense.Chong Kun Dang files positive scope confirmation trials against GL Pharm Tech and other generic competitors...Hyundai Pharm filed similar petitions earlier this yearAccording to industry sources on the 10th, Chong Kun Dang recently filed positive trials to confirm the scope of patent rights against four companies, including GL Pharm Tech, that have obtained approval for generic versions of its hypertension combination treatment Telminuvo.A positive trial to confirm the scope of patent rights is a proceeding initiated by a patent holder to determine whether a competitor's product falls within the scope of its patent. It is the counterpart to a passive confirmation trial, typically initiated by a generic manufacturer seeking to establish that its product falls outside the patent's scope.Chong Kun Dang has asked the Intellectual Property Trial and Appeal Board (IPTAB) to determine whether the approved generics fall within the scope of Telminuvo's formulation patent. The petitions are understood to have been filed to clarify ambiguities in GL Pharm Tech's claim that its generic version does not infringe the patent.Telminuvo is a fixed-dose combination of telmisartan and S-amlodipine for hypertension. Since its approval in 2013, it has remained one of Chong Kun Dang's flagship products, generating annual prescription sales of approximately KRW 50 billion to KRW 60 billion. The company has recently strengthened the pipeline by adding a lower-dose combination to its lineup.Earlier this year, Hyundai Pharm also initiated positive confirmation trials to defend patents covering its dementia combination treatment DM Duo. It filed petitions against SS Pharm in January and Boryung Biopharma in March, although it withdrew both in April.Until now, such petitions by Korean originator companies have been sporadic. One of the few notable precedents dates back about a decade, when Daewoong Pharmaceutical took similar action.In October 2016, Daewoong filed a positive confirmation trial against Gastiin CR, a sustained-release mosapride tablet developed by Korea United Pharm, seeking confirmation that the product fell within the scope of its formulation patent. The petition was dismissed the following year, and the two companies subsequently settled the related patent dispute.Multinationals including Novartis, Regeneron, and Eisai have led aggressive patent defense strategies.Positive patent-scope confirmation trials have been relatively uncommon in Korea. Even those that have been filed have largely been initiated by multinational pharmaceutical companies seeking to counter the market entry of Korean competitors.In January 2022, Novartis filed positive confirmation trials against four companies—Kyongbo Pharmaceutical, Korea United Pharm, Ahn-gook Pharmaceutical and Ahngook New Pharm—that had launched generic versions of its diabetes treatment Galvus. Novartis sought a determination of whether those products fell within the scope of its compound patent.In March 2023, US-based Regeneron filed a positive confirmation trial involving a compound patent against Samsung Bioepis, which was developing a biosimilar of the age-related macular degeneration treatment Eylea. That June, Novartis filed two positive confirmation trials concerning formulation patents against Celltrion, which was developing a biosimilar of its asthma and urticaria treatment Xolair.In October 2024, Eisai filed a positive confirmation trial involving a method-of-use patent against Boryung, which had developed a generic version of the company’s cancer treatment Lenvima. The petition was withdrawn in May last year.Industry observers expect the use of positive confirmation trials to spread further among Korean pharmaceutical companies.Having grown largely through generics, Korean drugmakers have historically had relatively few occasions to challenge competing products as patent holders. But the landscape is changing as more domestic companies introduce independently developed new drugs, incrementally modified drugs and fixed-dose combinations. With a growing number of flagship products protected by proprietary patents, companies are increasingly turning to positive confirmation trials to protect those assets.Concerns over declining profitability following drug pricing reform may also be contributing to the trend. As price cuts for generics and previously listed drugs make it harder to sustain earnings, pharmaceutical companies have greater incentive to assert their patent rights to protect the markets for their independently developed products.Filing a positive confirmation trial does not automatically prevent a competing product from being sold. Nevertheless, the procedure is considered a proactive defensive tool because it allows patent holders to challenge whether a competitor's product falls within the scope of their rights and secure a basis for potential future enforcement.
- InterView
- [Reporter’s View] Generic regulations alone cannot transform ecosystem
- by Jung, Heung-Jun Oct 12, 2026 08:36am
- Following the drug pricing system reform, regulatory measures have been established to manage generic drug prices and market disruptions. The pricing formula calculation rate was reduced from 53.55% to 45%, and the tiered price-cut system was further strengthened. Multi-product listing management was introduced, and price reductions are underway through the re-evaluation of upper limit reimbursement prices for previously listed drugs.It is now difficult to expand revenue by holding multiple identical generics and continuously expanding product items.However, raising barriers in the drug pricing system alone will not drive the pharmaceutical industry toward innovation. Potential shifts in generic-driven competition outside the pricing regulatory framework must also be closely examined.For example, the contract sales organization (CSO) sector. If a market dynamic persists in which prescription volume is secured through aggressive promotional competition rather than product differentiation or R&D, goals cannot be realized, no matter how tight the drug pricing policy is.While economic incentives for generics are reduced through drug pricing mechanisms, indirect pathways that generate profit through excessive commercial promotion must also be addressed.During the Ministry of Health and Welfare (MOHW)'s parliamentary audit yesterday (the 7th), Democratic Party of Korea Representative Nam In-soon pointed out issues surrounding CSO sales commission rates reaching as high as 60%. Rep. Nam urged the MOHW to conduct a comprehensive inspection to address abnormal commission rates driven by sales-promotion races.Calls to strengthen oversight of Civil Society Organizations (CSOs) have increased. As the government reviews potential measures, authorities must remain accountable until a sound pharmaceutical ecosystem is fully established.Of course, strengthening regulatory control over industry structures alone is insufficient. Definite incentives and rewards must be provided on the other side. The government has introduced preferential pricing policies for companies that invest in R&D through designated Innovative and Semi-Innovative Pharmaceutical Company frameworks.This helps distinguish research-oriented companies from non-R&D companies. The question remains, however, whether corporate-level incentives alone can encompass the full spectrum of pharmaceutical innovation.Not all pharmaceutical companies can develop global first-in-class novel drugs. Furthermore, developing a novel chemical entity does not represent the entirety of innovation.Developing incrementally modified drugs (IMDs) that improve patient compliance, introduce novel formulations, or enhance therapeutic efficacy is also a critical step in which domestic companies build R&D capabilities toward novel drug discovery.Alongside enterprise-level, status-based incentives, the ministry should consider more granular evaluation frameworks, compensation models, and development support tailored to each product's innovativeness.To move drug pricing reforms beyond reducing generic volume and lowering healthcare expenditures to fundamentally transforming industrial fundamentals, follow-up policies that incentivize research must be established.Policy must reflect that investing in R&D and manufacturing superior products is more profitable in the long term than multiplying generic portfolios and channeling expenditures into aggressive sales promotions.
- Policy
- MOHW cites budget limits for drugs excluded from fast-track listing
- by Jung, Heung-Jun Oct 12, 2026 08:36am
- With the government planning to select 5 at most of the 14 products that applied for its fast-track reimbursement pilot program for rare disease treatments, concerns have been raised that follow-up measures are needed for the remaining unselected itemsLawmakers have also called for the program's performance to be assessed based on the entire time patients wait from regulatory approval to actual reimbursement, rather than solely on the duration of HIRA's assessment and National Health Insurance Service (NHIS) negotiations.During the Ministry of Health and Welfare (MOHW) NA audit on the 8th, People Power Party lawmaker So-hee Lee questioned the ministry about its plans for products excluded from the fast-track reimbursement pilot program.Lee said, “Fourteen products applied for the pilot program, but no more than five will be selected. That leaves nine products without a place in the program. What follow-up measures will the government take to ensure patient access to these treatments?Health and Welfare Minister Eun-kyeong Jeong said the ministry would carefully evaluate the applications before selecting eligible products, but stressed that budget constraints render it difficult to include every treatment in the fast-track program.Jeong said, “We will thoroughly assess all 14 products before making our selections. We also review new treatments for rare and serious diseases on an ongoing basis, reimbursing around 50 new drugs each year.”She added, “While we empathize with the desire to expand coverage, financial constraints leave us with no choice but to consider priorities and cost-effectiveness.”Lee also called for changes to the criteria used to evaluate the pilot program.“The program should not be judged simply on whether it meets the 100-day target. Instead, we need to assess how much the total waiting time from regulatory approval to actual reimbursement has been reduced and identify any remaining bottlenecks,” Lee said, requesting that the ministry submit a detailed analysis to her office.
- Policy
- Preferential drug pricing not enough for emerging innovative pharmas
- by Jung, Heung-Jun Oct 08, 2026 09:00am
- During a National Assembly audit, calls have emerged for stronger support for “emerging (semi)” innovative pharmaceutical companies, a new intermediate category introduced below innovative pharmaceutical companies.The argument is that preferential drug pricing and government R&D support are not enough to help the semi-innovative companies advance to fully innovative pharmaceutical company status.In response, the Ministry of Health and Welfare (MOHW) said it would gather industry feedback through a public-private consultative body before implementing the new system and review whether additional support measures are needed.During the National Assembly audit of the MOHW on the 7th, People Power Party lawmaker Tae-ho Kim agreed to the government’s policy of dividing innovative pharmaceutical companies into “emerging (semi-innovative)” and “leading (innovative)” categories and providing support according to their stage of growth, but criticized the lack of support offered to the emerging category.Kim said, “I understand the government’s intention to build a growth ladder for pharmaceutical companies by dividing them into emerging and leading categories. But in practice, it seems as if several of the lower rungs of that growth ladder have been removed, then coined ‘emerging’ in name only.”“I’m not sure whether telling companies to jump higher after removing the footholds is really a policy designed to help them grow, or simply a test of how well they can jump,” he added.Support for companies in the emerging category is largely limited to government R&D programs and preferential drug pricing, while excluding benefits available to existing innovative pharmaceutical companies—including tax incentives, special provisions for the construction of research facilities and exemptions from certain charges.Kim said, “We should be helping these companies conduct more research so that they can grow into innovative companies, but this could instead reduce their capacity to invest in research. Can this really serve as a growth ladder?”Health and Welfare Minister Eun-kyeong Jeong responded that the emerging category is being newly introduced as an intermediate step toward full innovative pharmaceutical company status and that support measures would be refined as the program is implemented.Jeong said, “Since this is a new category, we first need to evaluate participating companies and then consider improvements to the system step by step. The emerging category is intended to serve as an intermediate stage toward innovative pharmaceutical company status, with certain forms of support helping companies grow along the way.”Jeong cited preferential treatment under the revised drug pricing system as one of the main reasons for introducing the new category. She nevertheless acknowledged the gap in support between emerging and fully innovative companies and said the government would consider additional measures as the program develops.Jeong said, “I understand that the point is that we need appropriate support measures tailored to different types of companies, creating a pathway from startups to emerging companies and ultimately innovative pharmaceutical companies. We will design the system more carefully and refine it based on industry feedback gathered through the public-private consultative body.”Kim asked the ministry to submit a comparative analysis before the comprehensive audit, including supplementary measures to support clinical development and research funding for emerging innovative pharmaceutical companies.
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