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- 2026-06-11 15:37:34
- Policy
- ‘Pricing reform should not be finalized without reporting to NA’
- by Lee, Jeong-Hwan Mar 11, 2026 08:29am
- Rep. Sunmin Kim of the Rebuilding Korea Party criticized the Ministry of Health and Welfare, saying it should not move forward with approving and implementing a drug pricing reform plan— which primarily involves lowering generic drug prices— by having it approved by the Health Insurance Policy Review Committee without reporting to the National Assembly.Kim effectively put the brakes on the ministry after it attempted to proceed with the March schedule for subcommittee and full meetings of the Health Insurance Policy Deliberation Committee (HIPDC) without including any mention of the drug pricing reform plan in its 2026 annual policy briefing to the National Assembly, despite the issue being of the utmost concern to the pharmaceutical industry.National Assembly Health and Welfare Committee Joomin Park of the Democratic Party of Korea also agreed with Kim on the need for a separate briefing on the reform plan. Addressing Health and Welfare Minister Eun Kyeong Jeong, Park said, “Because this is a very important issue, it would be appropriate to provide an additional briefing at the committee’s plenary meeting after concluding your discussions on the reform plan.”At the full committee meeting on the 10th, Minister Jeong responded affirmatively to Rep. Kim's procedural remarks and Chairman Park's request for an additional briefing on the drug pricing system reform plan, saying the ministry would comply.Consequently, it is highly likely that the MOHW will provide a separate briefing on the direction of the drug pricing system reform plan at the full committee meeting of the National Assembly's Welfare Committee this month (March), after subcommittee discussions and before the full committee vote.Currently, the ministry plans to hold a one-point HIPDC subcommittee meeting on March 11, followed by further discussion at another subcommittee meeting on March 18, before bringing the reform plan to the HIPDC plenary meeting on March 26 for approval. This plan includes lowering the pricing calculation rate for already listed generic drugs from the current 53.55% to the 40% range.The pharmaceutical industry has criticized the proposal as a mechanical, across-the-board “lawnmower-style” price cut, presenting 48% as their absolute bottom line for the generic drug calculation rate.With the gap between the MOHW and the pharmaceutical industry over the reform plan showing no signs of narrowing, Rep. Kim raised the issue through a procedural remark as the MOHW attempted to pass the plan without reporting it to the National Assembly.Rep. Kim stated, “After reviewing the MOHW's briefing materials, I question what the most pressing issue in current healthcare policy actually is. From what I understand, the drug pricing system reform is the topic most intensely discussed in the media and policy circles recently.”Kim continued, “I hear that tomorrow and next week, the HIPDC subcommittee will finalize the generic drug price reduction ratio. Following HIPDC deliberations at the end of March, discussions are proceeding with the goal of implementation next January. Yet, such an important policy report was not included among today’s key briefing items.”Kim added, “At this rate, there are concerns that the government could proceed with the drug pricing reform without reporting it to the relevant standing committee of the National Assembly. Therefore, I ask the Chairman to ensure that the MOHW clearly reports on the drug pricing system reform currently being pursued during today's briefing.”When Chair Park asked Minister Jeong whether she could provide an immediate briefing on the reform plan, Jeong replied, “We plan to hold about two more discussions in the HIPDC subcommittee to further coordinate opinions and gather more diverse input from the industry. As the proposal has not yet been finalized, we will review the progress and provide either a written report or a separate briefing.”In response, Park demanded that the MOHW prepare to provide an additional briefing at the committee’s plenary session, given the critical nature of the drug pricing system reform plan being pursued by the MOHW.Park stated, “Since additional processes and procedures remain (regarding the reform plan), individual briefings are fine, but because this is an extremely important issue, it would be better to provide an additional report at the committee’s plenary meeting once the discussions are complete.
- InterView
- [Reporter’s View] Precision over severity required for the GMP regulation
- by Hwang, byoung woo Mar 11, 2026 08:29am
- The system for revoking GMP (Good Manufacturing Practice) compliance certification is approaching a turning point.This policy, often referred to as a “one-strike-out” rule, reflects the government’s intention to apply a zero-tolerance principle against companies that obtain GMP certification through intentional data manipulation or fraudulent means.The system was born in response to incidents of arbitrary manufacturing, where companies falsified manufacturing records and produced drugs disregarding established procedures.The government’s intent is understandable. GMP is the most fundamental system underpinning trust in the pharmaceutical industry, and it is only natural that strict standards are applied to quality control in the manufacturing process.Some evaluations suggest that implementing this system has elevated the status of quality control organizations within pharmaceutical companies and provided an opportunity to reorganize their data and documentation management systems.However, as time passes, new questions have emerged in the field. There is growing reflection on whether strong regulations are actually functioning in a way that strengthens the quality culture.Some in the industry point out that the regulatory structure, which fails to sufficiently differentiate the types and severity levels of GMP violations, may not align with on-site realities.Questions are being raised about whether it is reasonable for intentional quality manipulation or serious manufacturing violations to be discussed within the same regulatory framework as simple management oversights, without distinguishing their relative gravity.For these reasons, discussions are currently underway in the National Assembly to amend the Pharmaceutical Affairs Act, proposing the introduction of intermediate measures within the system for revoking GMP certification. The core focus is on refining the units of administrative penalties that can be imposed for GMP violations beyond the current system.There is also growing interest in whether such discussions can preserve the intent of the system while adding greater regulatory precision.In fact, global pharmaceutical regulatory environments have recently been moving toward risk-based management. This approach determines the level of response by comprehensively considering factors such as the intent of the violation, its impact on patient safety, and the likelihood of recurrence.Compared to the US or Europe, which apply regulations in stages depending on the severity of the violation, the one-strike-out system has drawn criticism that it could excessively stifle the field, regardless of its necessity.Of course, this does not mean deregulation is the solution. Pharmaceutical quality regulation is an area where public trust can collapse from a single incident.Therefore, what matters more than the intensity of regulation itself is its precision. Quality regulation should function not as a system that stifles the field, but as one that strengthens a culture of quality.The GMP one-strike system also faces the same question. Beyond delivering a strong message, it needs to be examined whether it actually functions as a policy that improves real quality standards.Ultimately, what matters is not the mere existence of regulation, but the direction it creates. This reporter hopes that the proposed reform will bring the precision needed to both breathe life into the industry and safeguard the final bastion of pharmaceutical safety.
- Company
- SK Biopharmaceuticals' Chinese joint venture pushes for listing
- by Cha, Ji-Hyun Mar 11, 2026 08:28am
- SK Biopharmaceuticals’ Chinese joint venture appears to be accelerating preparations for an initial public offering (IPO). This follows SK Biopharmaceuticals’ board approval late last year for pre-IPO investment in the joint venture and changes to the clinical development contract for an improved drug candidate in China. Observers note that SK Biopharm can simultaneously expect the benefits of expanding its China business and increasing its stake value through the joint venture's listing.According to industry sources on the 10th, SK Biopharm's board of directors in November last year approved two agenda items: a crossover investment in its Chinese joint venture, Ignis, and amendments to the agreement for the clinical development in China of an improved new drug owned by Ignis. Both proposals passed with unanimous support from outside directors.Ignis serves as SK Biopharmaceuticals’ strategic outpost for the Chinese market. In 2021, SK Biopharmaceuticals established Ignis together with China-based global investment firm 6 Dimensions Capital (6D). At the time of its launch, Ignis raised USD 180 million in Series A funding, the largest Series A investment in China’s pharmaceutical industry that year. Investors included Ruentex Group, KB Investment, WTT Investment, Abu Dhabi sovereign wealth fund Mubadala Investment Company, HBM Healthcare Investments, and Goldman Sachs.At the time, SK Biopharmaceuticals transferred the China rights to 6 central nervous system (CNS) assets, including its self-developed epilepsy drug cenobamate and sleep disorder treatment solriamfetol, to Ignis and acquired equity worth USD 150 million in the venture. Under the contract, SK Biopharmaceuticals also secured revenue streams, including a USD 20 million non-refundable upfront payment, USD 15 million in milestone payments tied to development, approval, and sales stages, as well as sales royalties. As of the end of September last year, SK Biopharm held 41% of Ignis shares, making it the largest shareholder.Industry observers view the latest board approval as a signal linked to Ignis’s IPO plans. Crossover investments are typically a funding method used by unlisted companies preparing for IPOs to attract institutional investors. Considering Ignis is pursuing a listing, this crossover investment decision is interpreted as a move to enhance its corporate value and establish an investment foundation before the IPO. Ignis is known to have formed an advisory team and proceeded with IPO preparations around the first half of last year to pursue a listing on the Hong Kong Stock Exchange (HKEX).At the same time, the revision of the clinical development agreement for the improved drug is seen as a measure to accelerate clinical trials in China and secure a more efficient commercialization pathway. China’s regulatory system, particularly regarding clinical trial sponsors and approval procedures, is heavily localized, requiring development structures tailored to local requirements. Analysts say the flexible adjustment of the contract structure reflects an effort to expedite clinical development and regulatory approval in line with the local regulatory environment.Ignis Pipeline Overview (Source: Ignis)Market expectations place the potential Ignis IPO around the first half of this year. If Ignis successfully lists on the Hong Kong exchange as planned, its growth trajectory is expected to accelerate. The influx of IPO capital could strengthen short-term funding for the China launch of cenobamate and solriamfetol, while in the longer term supporting development of additional CNS assets transferred from SK Biopharm as well as Ignis’s own pipeline.Ignis secured favorable conditions for entering the Greater China market after receiving new drug application (NDA) approvals from China’s National Medical Products Administration (NMPA) in December last year for both cenobamate and solriamfetol. With over 11 million epilepsy patients in China, the market is estimated to be worth USD 1.1 billion as of 2024. The number of patients with obstructive sleep apnea is estimated to exceed 170 million. With the two approvals, Ignis aims to expand access to treatments for CNS disorders in Greater China and provide new therapeutic options for local patients.Ignis has also applied for authorized generics for cenobamate and solriamfetol as part of a strategy to secure early market share. Authorized generics are identical versions of the original drug marketed with the permission of the original drug’s company. T This strategy allows companies to respond to competing generics after patent expiration while simultaneously targeting the price-sensitive segments of the market.In addition to licensed assets, Ignis is advancing its own drug development programs. The company recently completed dosing of the first patient in a Phase I clinical trial of ‘IGS01’, its internally developed candidate for levodopa-induced dyskinesia (LID) in Parkinson’s disease. IGS01 is a small-molecule drug candidate belonging to the positive allosteric modulator (PAM) class targeting the M4 muscarinic receptor, which regulates brain neurotransmission. This development signifies Ignis's evolution beyond merely commercializing acquired assets into a CNS biotech company with its own pipeline and R&D capabilities.The benefits SK Biopharmaceuticals stands to gain from Ignis's growth are clear. As Ignis's largest shareholder, SK Biopharmaceuticals is expected to see the value of its stake rise to hundreds of billions of won. Furthermore, by securing the massive Chinese market, it can diversify its portfolio, moving beyond its current business structure that is heavily dependent on the United States, which accounts for more than 90% of its revenue.An SK Biopharmaceuticals official stated, “We understand that Ignis is preparing for a listing on the Hong Kong stock exchange, but the specific timeline is confidential and difficult to confirm.”
- Policy
- MOHW agrees to relax convenience store medicine policy
- by Lee, Jeong-Hwan Mar 11, 2026 08:28am
- The Ministry of Health and Welfare (MOHW) has cast a vote in favor of an amendment to the Pharmaceutical Affairs Act that legislates the '20-item limit' on the number of safe household medicine items, currently prescribed by the Pharmaceutical Affairs Act, to a Presidential Decree (Enforcement Decree) to allow for lower-level legislation.The Ministry also expressed support for a provision that eases the '24-hour operation' requirement, which is a mandatory registration criterion for sales outlets, in eup, myeon, and dong where there are no pharmacies or safe household medicine sales outlets.In addition, the Ministry presented a specific proposal to delay enforcement by one year from implementation date to prepare for various matters related to institutional improvement, such as the establishment of subordinate statutes.The bill currently under discussion is facing significant backlash from the pharmacist community, as it could lead to the complete removal of regulations on the number of safe household medicine items in convenience stores and to the expansion of the sale of general medicines outside pharmacies. However, with the competent MOHW expressing support, the likelihood of its passage has increased.In addition to the MOHW, the Korean Society of Oriental Pharmacy, the Korea Alliance of Patients Organizations, the Consumers Union of Korea, and the Korea Association of Convenience Store Industry also supported the legislation. The Korean Pharmaceutical Association was the only organization to oppose the bill.On the 10th, the amendment to the Pharmaceutical Affairs Act, proposed by Representative Han Ji-ah of the People Power Party, is planned to be tabled at the plenary session of the National Assembly's Health and Welfare Committee.Rep. Han Ji-ah's stands that fixing the number of safe household medicine items in the Pharmaceutical Affairs Act is hindering the ability to respond flexibly and administratively to changes in the pharmaceutical market and environment, as well as to public demand.This is the reason for introducing a bill that provides a delegation provision, allowing the number of safe household medicine items to be determined by Presidential Decree.Rep. Han's proposal also includes a provision to establish the basis for the installation and operation of a Pharmaceutical Policy Deliberation Committee under the Minister of Health and Welfare.Easing the 20-item upper limit on safe household medicine items... Ministry supports, Pharmaceutical Association opposesThe Ministry supported the provision delegating the regulation of the 20-item limit for convenience store medicines, which is currently fixed in the Pharmaceutical Affairs Act, to a Presidential Decree.The MOHW also submitted a supportive opinion on relaxing the 24-hour operation requirement and the registration criterion for sales outlets on a limited basis in eup, myeon, and dong areas where there are no pharmacies or safe household medicine sales outlets, to improve accessibility to safe household medicines.However, the MOHW stated that the enforcement date should be adjusted to 1 year after promulgation to prepare for various matters related to institutional improvement, such as the establishment of subordinate statutes.The Korean Society of Oriental Pharmacy also agreed with the amendment to reorganize the safe household medicine system.The Korea Alliance of Patients Organizations and the Consumers Union also supported it. The Consumers Union also expressed the view that it is appropriate to determine the regulation on the number of items through an Enforcement Rule, an Ordinance of the Ministry of Health and Welfare, rather than a Presidential Decree.The Korea Association of Convenience Store Industry supported the bill while suggesting a modification that would require the MOHW to designate the number of household medicine items after receiving advice from a committee.The Korean Pharmaceutical Association strongly opposed. They pointed out that although various systems to supplement medically underserved areas, such as public late-night pharmacies, health clinics, and the designation of special locations, are already in place, the management and operation of safe household medicine sales outlets and special locations remain insufficient.The Korean Pharmaceutical Association argues that, rather than indiscriminately expanding the convenience store medicine system, the priority should be to evaluate whether the management systems of existing programs are functioning properly and to reorganize the system to ensure safe use.The Korean Pharmaceutical Association stated, "To resolve the pharmacy accessibility of residents in medically underserved areas such as farming and fishing villages, special locations can already be designated according to the Pharmaceutical Affairs Act, and a system is in place to allow the purchase of medicines through designated special locations. Currently, medicine is also accessible through 1,895 health clinics nationwide," and emphasized, "In particular, considering the increase in cases of acetaminophen poisoning, the lack of management of sales outlets and the increase in cases of non-compliance with requirements, and the trend of strengthening regulations abroad, we actively oppose the expansion of safe household medicine items at this point as it is a policy that directly contradicts national health."Establishment of Pharmaceutical Policy Deliberation Committee...Ministry of Health and Welfare, Ministry of the Interior and Safety, etc., all opposedThe MOHW and the Ministry of the Interior and Safety opposed the provision establishing a Pharmaceutical Policy Deliberation Committee, arguing that it would create an environment in which pharmaceutical-related matters, such as medicines, could be discussed regularly.The logic is that, since the Central Pharmaceutical Affairs Council exists and is established, installed, and operated by the MFDS, the establishment of an additional body is unnecessary.The Ministry of the Interior and Safety stated, "The Pharmaceutical Policy Deliberation Committee is an advisory committee under the MOHW, but considering the purpose of the Act on the Establishment and Operation of Committees Under Administrative Agencies, it is necessary to consider plans to expand the functions of the Central Pharmaceutical Affairs Council or utilize the policy advisory committees within the MOHW rather than establishing a separate committee."The Korean Pharmaceutical Association and the Korean Medical Association also submitted opposing views.The Korean Pharmaceutical Association opposed it, stating, "The role of the Pharmaceutical Policy Deliberation Committee in the bill is managed by the Pharmaceutical Policy Division of the MOHW," adding, "The policy planning and drafting are performed by the Ministry's Division of Pharmaceutical Policy, while the Pharmaceutical Policy Deliberation Committee performs policy deliberation and advice. In practice, this would lead to discussing the same matter twice, causing inefficiency and making the responsibility and subject of policy decisions unclear."The Korea Medical Association said, "Since the Central Pharmaceutical Affairs Council (CPAC) is already running, establishing a separate Pharmaceutical Policy Deliberation Committee would be a redundant installation of a committee performing similar functions, which is a waste of administrative power," adding, "There are concerns that it could lead to role conflicts between committees and inefficiency in the policy-making process."
- Company
- 'Datroway' launches in Korea…breast cancer ADC
- by Son, Hyung Min Mar 11, 2026 08:28am
- A Trop-2-directed antibody-drug conjugate (ADC), Datroway, obtained domestic approval, introducing a new treatment option to breast cancer. Based on clinical results, which show improved progression-free survival (PFS) compared with existing cytotoxic anticancer drugs. Attention is drawn to the possibility of expansion of the TROP2 ADC-based treatment strategy to triple-negative breast cancer (TNBC) beyond HR+/HER2- breast cancer.ADC anticancer drug 'Datroway'According to industry sources on the 11th, the Ministry of Food and Drug Safety (MFDS) approved Datroway (datopotamab deruxtecan), developed by AstraZeneca and Daiichi Sankyo, as a breast cancer treatment.The specific indication is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.AstraZeneca paid $1 billion (approx. KRW 1 trillion) in upfront fees alone to secure the development rights for Datroway from Daiichi Sankyo in 2020. The total contract value, including development and commercialization milestones, amounts to $6 billion (approx. KRW 7 trillion).Datroway's target TROP2 is rapidly emerging as a core target in global ADC development.The TROP2 protein is known to be overexpressed in various cancer types, including breast cancer and non-small cell lung cancer (NSCLC). Datroway's mechanism of action involves binding to this protein and delivering cytotoxic drugs directly inside cancer cells to induce apoptosis. It is designed to maintain the efficacy of conventional cytotoxic chemotherapy while reducing damage to healthy cells.The basis for this approval is the Phase 3 TROPION-Breast01 study. This study was conducted on 732 patients with unresectable or metastatic HR-positive, HER2-negative breast cancer.Patients were randomized 1:1 into the Datroway group (365 patients) and the physician's choice of chemotherapy (TPC) group (367 patients).Datroway was administered intravenously at a dose of 6 mg/kg every three weeks, while the control group received an investigator's choice of chemotherapy among eribulin, capecitabine, vinorelbine, or gemcitabine.Primary endpoints included progression-free survival (PFS) and overall survival (OS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 criteria. Objective response rate (ORR), duration of response (DOR), and disease control rate (DCR) were set as key secondary endpoints.The median PFS in the Datroway group was 6.9 months. This was an improvement over the 4.9 months in the chemotherapy group, reducing the risk of disease progression or death by 37%.The ORR was 36.4% in the Datroway group and 22.9% in the chemotherapy group, while the median DOR was 6.7 months and 5.7 months, respectively.Median OS was 18.6 months in the Datroway group and 18.3 months in the chemotherapy group, with no statistically significant difference at the time of analysis.In terms of safety, the most commonly reported adverse events were stomatitis, nausea, fatigue, alopecia, constipation, vomiting, and dry eye.Serious adverse events occurred in 3.1% of patients treated with Datroway. Major serious AEs included interstitial lung disease (ILD, 1.1%), vomiting (0.6%), diarrhea (0.6%), and anemia (0.6%). Fatal outcomes occurred in 0.3% of patients, with ILD cited as the cause.Potential as a first-Line treatment for triple-negative breast cancer (TNBC)TROP2-targeted ADCs are creating a new competitive landscape in breast cancer treatment. Currently, the first drug of this mechanism to be commercialized is Gilead's 'Trodelvy' (sacituzumab govitecan). Trodelvy has been approved for the treatment of TNBC in the U.S., Europe, and South Korea.Datroway has entered the market, pursuing indication expansions focused on breast cancer and non-small cell lung cancer.Both treatments show promise as first-line treatments for TNBC.In previously untreated metastatic TNBC, primary treatment options have been limited, except for the immune checkpoint inhibitor 'Keytruda' (pembrolizumab). Analysis suggests that, for PD-L1-negative patients who lack other options besides chemotherapy, the role of TROP2-targeted ADCs is likely to expand.In the Phase 3 TROPION-Breast02 study, Datroway significantly improved both PFS and OS compared with conventional chemotherapy in the first-line treatment of metastatic TNBC, where immunotherapy is difficult.The study results showed a PFS of 10.8 months for the Datroway group and 5.6 months for the chemotherapy group, nearly a twofold difference. OS was 23.7 months and 18.7 months, respectively, and both metrics were statistically significant.ADC anticancer drug 'Trodelvy'Trodelvy also demonstrated efficacy. The Phase 3 study, named ASCENT-03, compared Trodelvy with chemotherapy.In the study, Trodelvy had a median PFS of 9.7 months, compared with 6.9 months for chemotherapy. It was also shown to reduce the risk of disease progression or death by 38%.While OS was not yet mature at the time of the primary analysis, a trend of a continuously widening gap in PFS2 between the treatment and control groups has been confirmed, raising the possibility of future OS improvement.Gilead is also conducting the ASCENT-04 study to evaluate the efficacy of the Trodelvy + Keytruda combination. This combination has reportedly achieved PFS improvement compared to chemotherapy + Keytruda. Expects suggests that Trodelvy + Keytruda is highly likely to become the new standard of care for first-line TNBC treatment, regardless of PD-L1 expression levels.
- Opinion
- [Desk’s View] On exempting innovative pharmas from price cuts
- by Lee, Tak-Sun Mar 10, 2026 08:56am
- Fostering the pharmaceutical and biotech industry while ensuring the soundness of the national health insurance budget is no easy task.The two are intertwined like a double-edged sword. Cutting drug prices indiscriminately to save money risks stifling the industry, yet allowing skyrocketing drug prices to go unchecked in the name of industry growth will quickly drain the health insurance coffers.That is why the government’s push to cut generic drug prices is undoubtedly a card played as the health insurance coffers are running dry. Yet, it is equally impossible to neglect the pharmaceutical and biotech industry, which is only now beginning to gain stature.The ‘Korea Innovative Pharmaceutical Company’ certification system emerged after long deliberation between fostering industry and maintaining fiscal soundness. The government aimed to identify and nurture the so-called ‘pharmaceutical companies capable of developing new drugs’ through this certification.However, 15 years have passed since the system's establishment in 2011, and one can't help but wonder if it has effectively achieved its original goal of fostering companies. The number of certified innovative pharmaceutical companies has now risen to 49, yet very few have developed drugs capable of competing on the global stage.The pharmaceutical industry claims the current certification doesn't offer ‘significant enough benefits to push promising companies forward.’ Rather, it's seen as merely ‘enough to keep them afloat within their group.’The most significant benefit pharmaceutical companies perceive from the Innovative Pharmaceutical Company certification is preferential drug pricing. Holding this title grants preferential treatment in pricing calculations for first generics or incrementally modified new drugs. For instance, while a standard company's first generic listing is priced at 59.5% of the highest price, an Innovative Pharmaceutical Company can set its price at 68%. Considering that drug prices directly translate to sales revenue, this means that certified companies can earn 7.5% more than non-innovative companies.However, this pricing preference is only a temporary benefit. After one year, the premium disappears, and “non-innovative” pharmaceutical companies end up with the same drug prices as the certified innovative ones.Even so, starting from the same line with even a slightly higher price is undeniably advantageous. This is why many pharmaceutical companies celebrate or despair over the results of the innovative pharmaceutical company review, which takes place every two years.If the innovative pharmaceutical company certification system is to better fulfill its purpose of ‘screening and fostering’ firms, the direction should be to tighten the review standards while expanding the benefits.In other words, the government should identify companies that truly have the capability to develop new global drugs while providing full support until they actually develop them.Some argue that innovative pharmaceutical companies should be exempt from unilateral price cuts made for listed drugs. From the perspective of fostering domestic pharmaceutical companies, this isn't entirely wrong. But would any company spend tens or hundreds of billions of won on new drug R&D while facing the risk of declining sales just to be saved from price cuts on existing drugs? Just for the title of being a certified innovative pharmaceutical company?However, even such benefits, if granted only to the 49 certified innovative pharmaceutical companies, would trigger backlash from non-innovative companies. There is already distrust in the field regarding the standards used to certify innovative pharmaceutical companies.But still, current discussions on drug price cuts for already-listed products and on reforming the innovative pharmaceutical company system need to be somewhat aligned. Rather than pushing through generic drug price cuts in a hasty manner despite strong opposition from the industry, perhaps it would be better to take a little more time and discuss them along with substantive benefits for innovative pharmaceutical companies. At the same time, the criteria for selecting innovative pharmaceutical companies should be reorganized so that they are truly centered on companies that genuinely engage in R&D.From a cautious standpoint, that may be the only way to both foster the industry and maintain health insurance sustainability.
- Policy
- Contaminated COVID vaccines, national petition for special investigation
- by Lee, Jeong-Hwan Mar 10, 2026 08:55am
- Minister of Health and Welfare Jeong Eun KyeongFollowing confirmation by disease control authorities of negligence in the management of foreign substances in COVID-19 vaccines, a national petition has been filed requesting the appointment of a Special Prosecutor to investigate the allegations.With multiple opposition lawmakers raising accountability issues against Minister of Health and Welfare Jeong Eun Kyeong, attention has been drawn to the progress of the petition.On the 6th, a petition was field on the National Assembly's e-People service stating, "We request the introduction of a Special Prosecuter to clearly investigate the foreign substance issues reported during the COVID-19 vaccine management process and the appropriateness of the administrative response."The petitioner demanded a Special Prosecutor investigation into the entire process of reporting and responding to foreign substances in COVID-19 vaccines. The request includes verifying the legality of reporting, recall, and quality control procedures; determining accountability; and conducting a full-scale investigation into potential external pressure or conflict-of-interest involvement.Furthermore, the petitioner urged the National Assembly to disclose the full results of the investigation, improve systems to prevent recurrence, and restore the public's right to know and trust in public health.According to the 'Diagnostics and Analysis of COVID-19 Response Status' report released by the Board of Audit and Inspection of Korea (BAI) on the 23rd of last month, the Korea Disease Control and Prevention Agency (KDCA) failed to notify the Ministry of Food and Drug Safety (MFDS) of foreign substance reports. Instead, they handled the issue by informing only the manufacturers and did not suspend vaccination with the same batch numbers despite the risk.Specifically, between March 2021 and October 2024, the KDCA received 1,285 reports of foreign substances in COVID-19 vaccines from medical institutions but bypassed the MFDS, opting to receive investigation results directly from manufacturers.While the majority of these cases (835, 65%) involved rubber stopper fragments due to usage errors, 127 cases (9.9%) involved hazardous foreign substances, including mold, hair, and silicon dioxide.Notably, because no suspension of administration was ordered for the vaccines containing hazardous substances, approximately 14.2 million doses from those specific batch numbers continued to be administered even after the reports were made.Based on the BAI announcement, the petitioner argued, "There is a need for an independent verification of potential deficiencies in the management and reporting systems, and whether the actions of the KDCA and MFDS complied with relevant laws and manuals," adding, "An objective investigation is also required regarding whether external pressure or conflict-on-interest interests influenced policy decisions during the reporting and management process."The petitioner further asserted, "It must be clarified whether the administrative agency's judgments were made based on public health principles or influenced by specific organizations or companies. Given that this matter directly affects national health, it is difficult to restore trust solely through internal executive branch investigations. The facts and accountability must be clarified through an investigation independent of political interests."Separate from the national petition, the opposition party is holding the Minister of Health and Welfare accountable for the contaminated COVID-19 vaccines.The People Power Party (PPP), citing the BAI report that contaminated vaccines were administered due to management failure during the pandemic, requested that Rep. Choo Mi-ae (Democratic Party), Chairperson of the Legislation and Judiciary Committee, cooperate in holding an emergency inquiry.Shin Dong-wook, Senior Supreme Council Member of the PPP, pointed out during a Supreme Council meeting on the 5th, "We requested the Democratic Party to hold an emergency inquiry into the BAI at the Legislation and Judiciary Committee, but Chairperson Choo is refusing, stating without reason that the committee cannot be convened."Rep. Na Kyung-won, the designated opposition lead for the Legislation and Judiciary Committee, also posted on Facebook yesterday, "According to KDCA data, there were 485,576 reports of adverse reactions, 2,802 deaths, and 1,285 reports of foreign substances. However, vaccinations were not stopped." Rep. Na added, "I will demand an emergency meeting of the Legislation and Judiciary Committee, the immediate withdrawal of government appeals [in vaccine lawsuits], the resignation of former Commissioner Jeong, and a parliamentary investigation."Rep. Kim Mi-ae, the PPP executive secretary of the Health and Welfare Committee, also stated at a PP meeting, "The status of COVID-19 vaccine management is a total failure that seriously threatens national health. It is a clinical experiment conducted by the state on innocent citizens." Rep. Kim urged Minister Jeong, who was the KDCA Commissioner at the time, to "take immediate responsibility, resign, and fully cooperate with the investigation."
- Policy
- Will Briviact become the next Vimpat? Generics near early listing
- by Jung, Heung-Jun Mar 10, 2026 08:55am
- Attention is focusing on whether generics will be listed first in the reimbursement market, in which the third-generation epilepsy treatment Briviact (brivaracetam) failed to enter.If 7 generic manufacturers, including Chong Kun Dang, Daewoong Pharmaceutical, and Samjin Pharmaceutical, secure reimbursement listing, competition among generic companies is expected in the reimbursed market without the original drug.Generic companies targeting Briviact’s vacancy are on the verge of securing reimbursement listing. AI-generated image.On the 5th, the Drug Reimbursement Evaluation Committee recognized the reimbursement adequacy of 29 epilepsy treatment products containing brivaracetam from 7 domestic pharmaceutical companies. Chong Kun Dang (Briveta Tab), Daewoong Pharmaceutical (Brivatop Tab), Bukwang Pharmaceutical (Bukwang Brifil Tab), Whanin Pharm (Briva Tab), Samjin Pharmaceutical (Bricetam Tab), Myung In Pharmaceutical (Buripam Tab), and Hyundai Pharmaceutical (Brilact Tab) are expected to proceed with listing procedures after price negotiations and review by the Health Insurance Policy Deliberation Committee. The original product is UCB Korea's Brivact, which received domestic approval in 2019. However, it failed to secure reimbursement listing when attempting to enter the insurance market and reportedly did not submit post-marketing surveillance (PMS) data last year. With its patent expiring last February, a series of generic approvals followed. Having passed the DREC hurdle, the generic versions are now on the verge of entering the reimbursement system.If price negotiations are finalized, a unique scenario could unfold where generics secure reimbursement listing before the original drug.Should generics gain early listing, it would mirror the case of UCB Pharma's other epilepsy treatment, ‘Vimpat (lacosamide)’.Vimpat, which was approved in Korea in 2010, ultimately failed to obtain reimbursement listing due to pricing issues, while generic versions of companies such as SK Chemicals’ Vimsk entered the reimbursement market first.According to the market research institution UBIST, Vimsk recorded sales of KRW 4.5 billion last year, marking 32% growth from KRW 3.4 billion the previous year. Its prescription performance has steadily increased over 4 years, from KRW 2.3 billion in 2021.The 7 companies preparing to list brivaracetam generics are also expected to attempt market entry using the same formula.The ultimate question is whether they can clear the drug price hurdle that the original failed to overcome.
- Opinion
- [Reporter’s View] Era of drugs better known than diseases
- by Son, Hyung Min Mar 10, 2026 08:55am
- A notable shift has recently emerged in clinical practice where drug names are increasingly being known before the diseases they treat.For example, when discussing obesity treatment, many people now think first of ‘Wegovy (semaglutide)’ or ‘Mounjaro (tirzepatide)’ rather than the disease itself. A similar trend is emerging for major immune disorders like atopic dermatitis. This change is also evident in the field of cancer treatment. It is now commonplace to hear specific drug names mentioned before the broader category of immuno-oncology drugs.Whereas diseases were traditionally recognized first, followed by treatments, we now frequently see drugs becoming symbolic markers that define or represent the disease itself.This shift cannot be explained simply by increased brand recognition. As more new drugs actually shift treatment paradigms, these therapies have taken on the role of driving disease awareness.For certain conditions, the emergence of specific treatments has altered diagnostic and therapeutic strategies, leading the drug name to become synonymous with the disease's treatment.The role of pharmaceutical companies has also evolved. Whereas disease awareness preceded the introduction of treatments, it is now common for disease awareness activities to proceed alongside new drug development. With treatment development and disease education occurring simultaneously, the drug name naturally becomes central to shaping disease awareness.The shift does have positive aspects. When innovative treatments emerge for diseases with limited therapeutic options, they inherently attract patient and clinician attention, serving as catalysts for heightened disease awareness. Indeed, for some conditions, social awareness of diagnosis and treatment has increased significantly following the introduction of such drugs.However, there are also concerns. If the structure where drug names become known before the disease itself solidifies, there is a risk that awareness could center around specific treatments rather than fostering a deeper understanding of the disease itself. While medicine inherently evolves through diverse treatment strategies and multiple options, public perception can be simplified around a single brand name.The influence of new drugs continues to grow. At the same time, the role of the pharmaceutical industry is expanding beyond developing therapies to shaping disease awareness itself. This means companies are becoming entities that shape disease perception, going beyond just treatment developers.Consequently, the social responsibility that the pharmaceutical industry must shoulder is also growing. As the influence of new drugs expands, so does the need to examine how this power operates and what its implications mean for the healthcare environment and patients. Now that pharmaceutical innovation can reshape disease awareness itself, the industry must consider its public responsibility towards patients and society, alongside its private corporate interests.
- Policy
- Entering into RSA contracts is the key to high-cost drugs
- by Jung, Heung-Jun Mar 10, 2026 08:55am
- As the number of ultra-high-cost new drugs seeking insurance coverage grows, more medications are entering double or triple Risk-Sharing Agreement (RSA) contracts.There is a growing trend of triple RSA contracts that combine the standard RSA Refund model with Expenditure Caps and Patient-Level Outcome-Based Refunds.AI-generated imageAccording to industry sources on the 5th, ultra-high-cost drugs recently listed are entering the reimbursement bracket through contracts that combine existing Refund and Expenditure Cap models with Outcome-Based Refunds.The government is strengthening these safety measures to manage financial risks while ensuring access to new drugs; in effect, these hybrid models have become an essential option for crossing the reimbursement threshold.A majority of the new drugs listed or granted expanded coverage this month involved hybrid contracts. Antengene's Xpovio (selinexor) and AstraZeneca Korea's Imjudo and Imfinzi were all subject to both Refund and Expenditure Cap models.For Xpovio, the additional financial requirement due to expanded coverage was estimated at KRW 11.6 billion. However, the government determined that the actual financial impact would be lower when applying two types of RSA.GC Biopharma's Livmarli (maralixibat), a treatment for pruritus in Alagille syndrome, was subject to a triple contract: a Refund, an Expenditure Cap, and a Patient-Level Outcome-Based Refund.The Patient-Level Outcome-Based Refund model tracks treatment results; if pre-agreed targets are not met, the pharmaceutical company must refund a certain amount. It is reported that Livmarli passed the Drug Benefit Evaluation Committee and the Health Insurance Policy Deliberation Committee because GC Biopharma submitted a risk-sharing plan that included this outcome-based refund.Ipsen Korea's Bylvay (odevixibat), a treatment for pruritus in patients with cholestatic liver disease listed last October, is another case of a triple contract.During its cost-effectiveness evaluation, Bylvay was found to have higher annual costs than alternative treatments. However, it was able to clear the listing threshold through the risk-sharing types proposed by the pharmaceutical company. At the time, the estimated annual claim amount was KRW 118.4 billion, but the financial burden was deemed lower through the RSA.As the listing and expansion of reimbursement for immuno-oncology drugs and high-cost new drugs continue to increase, pharmaceutical companies are actively using combinations of Refund, Expenditure Cap, and Outcome-Based Refund models to obtain National Health Insurance coverage.
