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- 2026-03-09 23:20:51
- Policy
- Pharma, preparing for the future…generic launch in 2030s
- by Lee, Tak-Sun Feb 03, 2026 06:24am
- Product photos of Tagrisso (left) and K-CAB (right).Are they already preparing for the future? The Korean pharmaceutical industry is preparing for generics that would be launched five years later. They are also fiercely competing to secure priority marketing authorization by filing patent applications and seeking approvals.According to the Ministry of Food and Drug Safety (MFDS), 'Otinib tablet (Chong Kun Dang),' a generic version of the non-small cell lung cancer treatment Tagrisso (osimertinib), was approved on the 27th and also secured the priority marketing authorization. When assigned a priority marketing authorization, the drug receives an exclusive sales period of 9 months, during which the sale of generics containing the same active ingredient is banned.However, the effective date of the priority marketing authorization is not approaching soon. It is set to begin on December 28, 2023, and terminate on September 27, 2034. Approximately 8 years remain until the product launch. This is because the Tagrisso patent is set to expire on the specified date.Generic versions of K-CAB (tegoprazan), a P-CAB for gastroesophageal reflux disease (GERD), are increasingly receiving approvals. Yet, the priority marketing authorization is scheduled to take effect after August 26, 2031.Until now, pharmaceutical companies that received K-CAB generic approvals include GC Cross, Withus Pharm, Genuonesciences, Korea Drug, Ildong Pharmaceutical, KyungDong Pharm, and Hutecs Korea.As K-CAB is a mega-blockbuster item generating over KRW 200 billion in annual sales, numerous companies are competing for approvals to gain pre-occupancy in the generic market.Generics to Daiichi Sankyo's neuropathic pain treatment Taleaje (mirogabalin besilate) can be launched on or after 2031.Five pharmaceutical companies have applied for approval of their products containing mirogabalin besilate. Several companies have started patent challenges, excluding substance patents. Huons, Daewoong Pharm, Dong-A ST, JW Pharmaceutical, KyungDong Pharmaceutical, and Samjin Pharm.Five pharmaceutical companies that successfully challenged patents would be leading candidates to obtain priority marketing authorization. Despite this advantage, more than 5 years remain until the launch of generics, as the patent on the active ingredient is set to expire on June 4, 2031.Taleaje is still a non-reimbursed drug, and its sales cannot be estimated yet. Despite this circumstance, Korean generic companies have anticipated the bright future of the Taleaje market and have entered the race to secure a generic position.
- Company
- HK inno.N’s GLP-1 drug approved in China for diabetes
- by Cha, Ji-Hyun Feb 03, 2026 06:24am
- HK Inno.N's GLP-1 class obesity and diabetes treatment, ecnoglutide (XW003), currently undergoing Phase III clinical trials in Korea, has received its first product approval in China. Its original developer, Saiwind Biosciences, obtained new drug approval for the type 2 diabetes indication from Chinese authorities, which is expected to bolster HK Inno.N’s domestic development strategy.According to the biotech industry on the 2nd, Sciwind received approval from China’s National Medical Products Administration (NMPA) on the 30th of last month (local time) for the injectable formulation of ecnoglutide indicated for glycemic control in adult patients with type 2 diabetes.Previously, Sciwind had submitted marketing authorization applications to the NMPA for ecnoglutide for type 2 diabetes and obesity indications in November and December 2024, respectively. The obesity indication is currently under NMPA review in China.Ecnoglutide's cAMP-biased GLP-1 receptor agonist mechanism (Source: Sciwind Biosciences)Ecnoglutide is the world’s first cAMP-biased GLP-1 receptor agonist. Compared with conventional GLP-1 therapies, it enhances signaling selectivity, resulting in prolonged efficacy and improved metabolic effects.The approval was based on results from the Phase III EECOH-1 and EECOH-2 clinical trials conducted in China by Sciwind. In the EECOH-1 study, patients with type 2 diabetes inadequately controlled by diet and exercise achieved a reduction in HbA1c of up to 2.43% after 24 weeks of treatment. In the EECOH-2 study, ecnoglutide demonstrated superior glucose-lowering efficacy compared with dulaglutide, an existing GLP-1 therapy, in patients receiving concomitant metformin. In both studies, sustained efficacy and safety were confirmed through 52 weeks of treatment.Upon the approval, attention is turning to the pace of development and future approval strategy for HK Inno.N’s obesity and diabetes pipeline currently undergoing Phase III clinical trials in Korea. HK Inno.N signed a licensing agreement with Sciwind in May 2024 to secure exclusive domestic development and commercialization rights for ecnoglutide. Under the agreement, Under the agreement, HK inno.N paid an upfront payment, milestone payments tied to development stages, and royalties based on post-launch sales.HK Inno.N is currently conducting a Phase III clinical trial for ecnoglutide targeting the obesity indication. Recruitment for the domestic Phase III trial was completed last January, and the trial has now entered the dosing phase. HK Inno.N received Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety in May last year. After enrolling the first patient in September, HK inno.N completed recruitment of a total of 313 participants in approximately four months.The Phase 3 study is being conducted at 24 medical institutions, including Kangbuk Samsung Hospital, and targets adult Korean patients who are obese or overweight without diabetes. Participants receive once-weekly subcutaneous injections of either ecnoglutide or placebo to evaluate efficacy and safety. The primary endpoints are the percentage change in body weight from baseline at week 40 and the proportion of participants achieving at least a 5% reduction in body weight.
- Policy
- Korea’s Innovative Pharmaceutical Company certification overhaul
- by Lee, Jeong-Hwan Feb 03, 2026 06:24am
- Director Kang-seop LimAttention is focused on how much the domestic pharmaceutical industry's request for rationalization of the ‘one-strike-out’ rebate regulation will be reflected in the reform plan for the Korea Innovative Pharmaceutical Company certification system, for which a legislative notice is being prepared by the Ministry of Health and Welfare within February.The MOHW has gathered extensive industry feedback on the current rule mandating the immediate revocation of innovative certification for companies found guilty of illegal rebates. Based on this input, the ministry plans to partially modernize regulations that could excessively hinder innovation in the pharmaceutical industry.However, regarding the previously discussed proposal to shift from immediate revocation to a points-based penalty system for rebate violations, the MOHW said it remains cautious and has not yet reached a decision.On the 1st, Director Kang-seop Lim of the Pharmaceutical and Bio-Industry Division met with the Ministry of Health and Welfare's press corps and explained, “We will announce the legislative notice for the enforcement decrees, enforcement rules, and notices related to innovative pharmaceutical companies by February at the latest.”The overhaul of the Korea Innovative Pharmaceutical Company certification system has emerged as a key issue for the industry, as it will operate in line with the drug pricing reform scheduled for implementation this year.Under the proposed drug pricing reform, price premiums would be applied depending on whether a company is certified as an innovative pharmaceutical company and the proportion of R&D investment in new drugs within such companies.Regarding the industry’s primary demand of converting the immediate revocation of innovative certification for rebate violations to a points-based system, Lim said, “This is still under discussion, and no decision has been made.”However, Lim explained that the ministry is preparing the reform plan in full consideration of the industry's persistent demand that the current penalty, where innovative certification is immediately revoked upon confirmation of a rebate incident, is excessively harsh for pharmaceutical companies dedicated to innovation, including new drug development.As the importance of the certification system has grown significantly with the upcoming drug pricing system reform, Lim explained that the ministry is particularly examining the feasibility of introducing several of the improvement measures requested by pharmaceutical companies.Overall, the MOHW is expected to pursue an administrative approach that maintains a certain level of penalties for unfair pharmaceutical trade resulting from illegal rebates, while improving regulations that excessively revoke or withdraw innovative certification based on overly stringent standards.According to industry sources, discussions are underway on rationalizing elements such as the period of application for penalties imposed on companies involved in rebate violations within the legislative and administrative notice.Lim said, “Pharmaceutical companies have repeatedly requested that the criteria for revoking innovative certification due to rebate violations be made more reasonable than they are now. We are internally reviewing measures that can both partially accommodate industry demands while continuing to regulate illegal rebates.”He added, “The decision on whether to adopt a points-based system is still under discussion. Currently, a rebate violation immediately renders a company ineligible as an innovative pharmaceutical company, leading to automatic revocation of certification. We are considering various options to improve this framework in a more rational way. By early February, we must simultaneously announce draft amendments to the enforcement decree, enforcement rules, and public notices. We will prepare a revised innovative certification scheme that enhances predictability for pharmaceutical companies.
- Company
- Bylvay may be prescribed at Big 5 Hospitals in Korea
- by Eo, Yun-Ho Feb 03, 2026 06:24am
- Bylvay, the first drug approved under Korea’s parallel approval–assessment–negotiation linkage pathway, has successfully secured prescribing access at major tertiary hospitals.According to industry sources, Ipsen Korea’s Bylvay (odevixibat), a treatment for pruritus in patients aged three months and older with progressive familial intrahepatic cholestasis (PFIC), has been approved by the Drug Committees (DCs) of Korea’s “Big 5” hospitals, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Severance Hospital.Since its inclusion in the national health insurance reimbursement list in October last year, Bylvay has rapidly expanded its prescribing environment.Bylvay is the world’s first oral therapy indicated for the treatment of PFIC-related symptoms. It offers a non-invasive and sustainable treatment option for patients who previously had few alternatives other than high-risk procedures such as liver transplantation.Following its initial approval in the US and Europe in 2021, it has received authorization in major countries. In Korea, it was selected as the first drug under the Ministry of Health and Welfare's ‘Parallel Approval-Evaluation-Negotiation Pilot Program’ in 2023.PFIC is a rare, inherited disease that typically manifests in childhood and causes severe pruritus, growth impairment, and liver failure. Patients and their families endure suffering across all aspects of daily life, including sleep deprivation, interrupted education, and social isolation. Bylvay is a treatment that alleviates this diminished quality of life and opens the possibility for patients to return to their daily routines.Meanwhile, Bylvay demonstrated its efficacy through the Phase III ASSERT study conducted in pediatric and adolescent patients aged 17 years and younger.Study results showed that Bylvay met its primary endpoint by significantly reducing pruritus compared with placebo. It also statistically significantly improved the key secondary endpoint, mean serum bile acid levels at weeks 20 and 24 of treatment, compared to placebo. These therapeutic effects were sustained through 24 weeks of treatment.Professor Seak-hee Oh of the Department of Pediatrics at Asan Medical Center said, “Liver transplantation was a treatment option that had to be chosen as a last resort, despite an average failure rate exceeding 10% and the risk of serious complications. In a situation where there were virtually no alternatives other than transplantation, Bylvay could establish itself as an important alternative that can protect patients without the need for liver transplantation.”
- InterView
- [Desk View] Is all anticancer adjuvant therapy on a losing streak?
- by Eo, Yun-Ho Feb 02, 2026 02:17pm
- Anticancer drugs are on a losing streak in their quest for insurance reimbursement in the adjuvant therapy category. Reimbursement is deemed necessary, but meeting the agreement is not easy.The concept of continued medication administration as 'prophylaxis' is not new. In the field of chronic disorders, medicines have been used as part of a 'management' regimen rather than as a treatment. For example, anticoagulants have been designed as a prophylaxis.The issue emerged as prophylaxis field expanded to include high-cost, cutting-edge anticancer drugs. Various new anticancer drugs are securing peri-operative prophylaxis indications and being researched. Adjuvant therapies for numerous numbers of cutting-edge new drugs, including immune checkpoint anticancer agents, targeted anticancer drugs, and antibody-drug conjugates (ADC), are now one of the expanding indications. We are seeing flood of indications. The subject of adjuvant therapy raises concerns. The cost issue is one of them. While it is well known, recurrence of cancer is terrifying even after remission. AlthoughHowever, prescribing anticancer drugs as adjuvant therapy and applying insurance reimbursement is posing a burden on the Health Ministry. In fact, there have been only a few cases in Korea where adjuvant therapies have received reimbursement expansion.CDK4/6 inhibitors, for instance. Both Eli Lilly’s 'Verzenio (abemaciclib)' and Novartis's 'Kisqali (ribociclib)' have obtained indications in Korea for adjuvant therapy in early-stage breast cancer.Verzenio has been at the forefront of the reimbursement challenge, yet the result has been three rejections by the Cancer Disease Review Committee (CDRC). Verzenio struggled to even get on the CDRC list from its very first attempt. After a long six-month wait following the initial submission, it was finally tabled in May 2023, only to result in "failure to establish reimbursement criteria." Five months later, Lilly resubmitted the application to the Health Insurance Review and Assessment Service (HIRA) in October. While it was considered at the CDRC in March and July of last year, the outcome remained unchanged.Recently, the company reapplied for Kisqali. As it awaits its turn on the CDRC agenda, attention is focused on whether it can achieve a different result.What remains clear is that the benefits of adjuvant therapy are garnering significant attention from the academic community. Adjuvant therapies are already appearing in the guidelines of leading global societies, often receiving high recommendation grades.It is time for full consideration. We must meticulously weigh the necessity of oncology adjuvant therapies for each medication and prioritize practical benefits over vague "financial burdens." Administering treatment only after a patient has relapsed may actually prove to be less cost-effective. Recurrence and metastasis are fatal factors that increase cancer mortality rates. Since there is no single correct answer, the pros and cons must be carefully balanced. We cannot neglect the growing list of adjuvant therapies.
- Policy
- Expanding indications…TAVI reimb still limited
- by Hwang, byoung woo Feb 02, 2026 02:17pm
- While TAVI (Transcatheter Aortic Valve Implantation) is becoming the standard for aortic valve replacement globally, in Korea, it remains tied to reimbursement criteria of '80 years old and inoperable.'While technology is advancing, the system remains in place.In the global market, TAVI has surpassed surgical aortic valve replacement (SAVR). According to U.S. Medicare claims data, since the number of TAVI procedures overtook SAVR starting in 2016, the gap has continued to widen.The biggest problem is the reimbursement criteria, which are out of step with global trends. The U.S. (65 and older) and Europe (70 and older) already recommend TAVI as standard treatment, significantly lowering age and risk thresholds. In contrast, Korea still divides reimbursement benefits (5% patient co-payment) based on age 80.For this reason, although TAVI procedures increased rapidly after the 5% co-payment reimbursement was introduced in May 2022, most of the increase was among elderly patients aged 80 and older. The patient group in their 70s appears relatively unchanged.Currently, for a patient in their 70s to receive TAVI, they must either bear costs totaling tens of millions of won, even with selective reimbursement, or receive an "inoperable" determination from two thoracic surgeons.The fact that the procedure fee for TAVI, which requires a high level of concentration from medical staff and cooperation from a multidisciplinary team, is only about one-third that of a general stent insertion (PCI) is also a factor hindering market growth.Presentation materials from the Insurance Committee session of the Korean Society of Interventional Cardiology (KSIC) 2026 Conference in Winter, reorganized by DailyPharm.Currently, the TAVI reimbursed fee is around KRW 540,000. This is significantly lower than PCI (about KRW 1.5 million) or pediatric pulmonary valve implantation (about KRW 2 million). In contrast, the U.S. reflects complexity through a co-surgeon extra-charge structure.Particularly, during a TAVI procedure, an 'integrated heart medical team,' a so-called Heart Team consisting of thoracic surgery personnel, anesthesiology, and radiology, is mandatory.Experts point out that, given labor costs, such a Heart Team has a structure in which the hospital loses money the more procedures it performs. Under the current 'low fee structure,' it inevitably reduces the incentive for medical institutions to actively expand the procedure. Ultimately, advances in technology and the limitations of the system are leading to longer wait times for patients and reduced access to treatment.However, another hurdle, namely the leadership between medical departments, is also mentioned as a limitation to the expansion of reimbursement. Under current law, to decide whether to perform a TAVI procedure, 'unanimous agreement' from an integrated medical team, including two thoracic surgeons, is required.In reality, the procedure is fundamentally impossible in small-to-medium-sized hospitals where only one thoracic surgeon is stationed. For these reasons, concerns are raised that it may serve as a threshold for entering reimbursement rather than as a consultative body to discuss treatment methods.The government stated it would accelerate system improvements by conducting public opinion surveys in the first half of 2026.정부는 2026년 상반기 의견수렴을 통해 제도 개선에 속도를 내겠다고 밝혔다On the one hand, given the need for long-term survival rate research and valve durability, some view the expansion of TAVI reimbursement for low-risk groups as premature.Conversely, it is argued that consideration is needed to select the best treatment for the patient rather than simply applying it uniformly by age.Because of this, the current discussion on expanding TAVI reimbursement can be seen as a conflict between exercising a veto to protect the number of surgeries rather than for the patient's benefit, and concerns about the abuse of procedures whose long-term safety has not been verified.The government signaled visible institutional changes within the first half of 2026. Yoo Jung-min, director of the Division of Health Insurance Benefits at the Ministry of Health and Welfare (MOHW), who spoke at the Insurance Committee session of the recently held the Korean Society of Interventional Cardiology (KSIC) 2026 Conference in Winter, emphasized three major principles: ▲reflecting international trends ▲respecting medical judgment ▲ expanding patient treatment choice.The policy is to restructure the system so that the integrated medical team can discuss "the best treatment" rather than "inoperability."However, industry experts agree that "simple modification of wording is not enough." The opinion is that the distorted growth of the TAVI market can only be corrected if complex factors such as ▲a rational lowering of the age criteria (to age 75, etc.) ▲the realization of fees matching the difficulty of the procedure ▲the incentivization of formal Heart Team operations are considered in the reimbursement discussion.Yoo stated, "We will speed up discussions on system improvement by broadly collecting opinions from various expert groups, such as related academic societies and patient organizations, during the first half of this year," and added, "The Ministry will strive to bring changes that can be made across the overall TAVI reimbursement criteria."
- Company
- Pharmaceutical union joins drug price reform battle
- by Cha, Ji-Hyun Feb 02, 2026 02:16pm
- Tensions surrounding the government’s drug pricing system reform are increasingly shifting from a policy dispute to a matter of employment security. While opposition had previously been led by pharmaceutical industry associations and emergency response committees, labor unions on the ground that are concerned about potential restructuring have now begun to take direct action, significantly heightening the level of tensions. With even foreign-affiliated pharmaceutical sales unions joining the hardline response, observers predict the conflict could escalate into large-scale protests and coordinated collective action.According to industry sources on the 30th, the Korea Democratic Pharmaceutical Unions (KDPU) held a placard protest on the 29th in front of the Health Insurance Review and Assessment Service (HIRA) headquarters in Seocho-gu, Seoul, formally declaring its opposition to the government’s proposed drug pricing reform.The KDPU argued that the policy direction focuses solely on lowering drug prices without sufficiently reflecting the pharmaceutical industry's employment structure and unique characteristics. They also protested, stating that such reforms could lead to job insecurity, a decline in research and development (R&D), and disruptions in the supply of essential medicines.The KDPU is an industry-wide labor union affiliated with the Federation of Korean Chemical Workers' Unions (FKCU) under the Federation of Korean Trade Unions (FKTU). Its membership is largely composed of sales organization employees at multinational pharmaceutical companies, including Allergan, Takeda, Mundipharma, and AbbVie. Kolon Pharmaceutical is the only Korean company included.The KDPU held a picket protest on the 29th in front of the Health Insurance Review and Assessment Service headquarters in Seocho-dong, Seoul, opposing the government's proposed drug pricing system reform plan.This issue was triggered when the government reported a drug pricing system reform plan to the Health Insurance Policy Deliberation Committee last November. The plan proposes lowering the drug pricing calculation standard for generics and off-patent drugs from the current 53% to around 40%.The Ministry of Health and Welfare envisions reducing unnecessary drug expenditure by gradually lowering generic drug prices and adjusting the drug pricing calculation method. It plans to reinvest the secured funds into new drugs and innovative medicines to foster a new drug development ecosystem. In response, the pharmaceutical industry has repeatedly voiced opposition, citing concerns over sharp revenue declines, weakened R&D investment, and instability in the supply of essential medicines.Gi-il Park, chair of the KDPU, whom reporters met at the protest site, cited employment instability as the most critical issue in the government’s proposed reform.Park said, “The pharmaceutical industry already experienced large-scale restructuring at each company during the forced drug price cuts in 2012. For mid-sized and small pharmaceutical firms with limited profit margins, additional price cuts would render restructuring inevitable.”Park also strongly questioned the government's argument that drug price cuts would lead to increased research and development (R&D) investment. He pointed out, “Companies can only increase R&D spending if they generate sales and profits. Forcing drug prices down leaves companies with no choice but to cut costs. Ultimately, drugs that become unprofitable will cease production, potentially leading to disruptions in the supply of essential medicines. Actual stakeholders, like pharmaceutical companies and workers, are excluded from drug pricing policy discussions. A consultative body involving labor, management, government, and experts is necessary.”This marks the first time a pharmaceutical company union has staged a public protest directly targeting the drug pricing system reform.Previously, opposition to the reform had been led primarily by industry associations and emergency response committees. Since the government unveiled the reform proposal, groups such as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and the Emergency Countermeasure Committee on Drug Pricing Reform have called for revisions and a postponement of implementation through press conferences and official statements.More recently, the center of gravity in the debate has shifted toward the industry’s front lines. On the 22nd, a labor–management forum involving pharmaceutical companies and labor representatives was held at the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi Province. Representatives from the FKCU Pharmaceutical and Cosmetics Division and labor–management delegates from tenant companies jointly called for an end to unilateral drug price cuts.On the 22nd, the Emergency Committee on Drug Pricing Reform for the Development of the Pharmaceutical and Biotech Industry convened a labor–management meeting at the Hyangnam Pharmaceutical Complex in Hwaseong, Gyeonggi Province, urging the suspension of the drug price cut reform.At the forum, labor representatives from the FKCU Pharmaceutical and Cosmetics Division presented numerical estimates warning of an impending “employment shock.” They estimated that if the reform is implemented, annual revenue losses across the pharmaceutical and biotech sector would total KRW 1.2144 trillion, averaging KRW 23.3 billion per company. Operating profits could decline by an average of 52%, potentially wiping out more than half of industry earnings. Such profitability shocks, they argued, would inevitably push companies to prioritize labor cost reductions, leading to restructuring pressure across production, sales, and R&D functions.A contraction in R&D and investment is also expected. The division forecasted that if drug price cuts are implemented, pharmaceutical and biotech companies' R&D expenses would decrease by an average of 25%, and facility investments by 32%. For small and medium-sized pharmaceutical companies, the investment reduction could reach as high as 52%. The subcommittee explained that this investment contraction could directly lead to workforce reductions of 1,691 employees (9%) out of the current 39,170 pharmaceutical industry workers, with mid-sized companies facing workforce reductions of up to 12%.Sang-joon Oh, chair of the Gyeonggi South branch of FKCU, said, “Unstable employment makes it impossible to produce good drugs,” highlighting growing confusion on the ground. Deok-hee Lee, union chair at Ildong Pharmaceutical, warned, “Drug price cuts could ultimately lead to the conversion of regular employees to non-regular status and layoffs, threatening the very survival of the industry.” Given the concentration of small and mid-sized firms in the Hyangnam complex, concerns are mounting that the impact of price cuts could spread to a contraction of the local economy.On the 27th, the Emergency Committee on Drug Pricing Reform for the Development of the Pharmaceutical and Biotech Industry visited the FKTU and met with its president, Dongmyeong Kim. This meeting further underscored the expansion of a joint labor–management response to the reform.On the 27th, the Emergency Committee on Drug Pricing Reform for the Development of the Pharmaceutical and Biotech Industry visited the FKTU and met with its president, Dongmyeong Kim to convey the domestic pharmaceutical and bio-pharmaceutical industry's position and concerns regarding the proposed drug pricing system reform.During the meeting, the emergency committee explained the potential impact of drug pricing reform on industrial competitiveness and employment stability. Both sides agreed that discussions on price cuts should not proceed in isolation from industry and labor considerations, and agreed to maintain close communication and cooperation in future response efforts.Following these labor–management engagements, the labor movement’s response became more explicit. On the same day the KDPU held its protest, the FKTU released an official statement opposing the reform, marking the union’s first official stance at the central level regarding the reform, and the escalation in its level of response.In its statement, the FKTU warned that “an approach aimed at short-term fiscal savings through drug price cuts is a dangerous one that could lead to job insecurity and restructuring. The government should take seriously the lessons of past drug pricing policies, which led to confusion on the ground and weakened the industrial base. The basis for reforming the drug pricing system and its fiscal effects must be transparently disclosed, and a social discussion framework where stakeholders' opinions are substantively reflected must be immediately established.”Observations suggest that if this trend continues, the labor-management conflict surrounding the drug pricing system reform could escalate into a more confrontational phase.The KDPU stated it is reviewing phased countermeasures, including joint responses with the FKCU Pharmaceutical and Cosmetics Division and the FKTU, or additional protests, depending on the progress of future policy discussions and the schedule of the National Health Insurance Policy Deliberation Committee.Should demands for a social consensus mechanism go unmet, the possibility of extreme actions such as collective strikes has also been raised.The FKTU warned, “We will fulfill our responsibility to ensure that the interests of health insurance subscribers and the survival rights of workers are harmoniously reflected in future discussions on drug pricing reform. We will not tolerate any attempt to use this policy as a pretext for deteriorating labor conditions or undermining employment stability.”
- Company
- Sanofi 'deprioritizes' Parkinson's drug ABL301
- by Cha, Ji-Hyun Feb 02, 2026 02:16pm
- The multinational pharmaceutical company Sanofi has adjusted the development priority of a Parkinson’s disease treatment candidate it had licensed from ABL Bio. Regarding the adjustment, ABL Bio stressed that “this does not constitute a suspension of clinical development, nor a termination or cancellation of the licensing agreement.”ABL Bio officially addressed concerns on the 30th regarding the development of ‘ABL301’, a bispecific antibody for treating Parkinson's disease and other neurodegenerative disorders.Previously, on the 29th (local time), Sanofi classified some of its Phase I pipeline assets as “deprioritised” in its fourth-quarter earnings and pipeline update materials. Included in this list was ABL301 (Sanofi code: SAR446159), which ABL Bio licensed out to Sanofi in 2022.Following the news, ABL Bio’s share price opened at KRW 213,500, down about 13% from the previous day’s closing price of KRW 245,500. As of 10:20 a.m., the stock was trading at 207,500 won, down roughly 15% from the prior close.ABL Bio stated that it immediately communicated with Sanofi following the earnings announcement. According to ABL Bio, Sanofi is developing a more meticulous clinical strategy to maximize the clinical success potential of ABL301 amid intensifying competition in the Parkinson's disease treatment development landscape. ABL Bio explained that the specific timeline for subsequent clinical trials has not yet been finalized, which has led Sanofi to use the term “priority adjustment” in its earnings materials.ABL Bio added, “While details of the clinical strategy cannot be disclosed due to competitive considerations, the adjustment is unrelated to ABL Bio’s proprietary platform technology, Grabody-B. Rather, it reflects a strategic approach related to alpha-synuclein, which is considered a potential pathogenic factor of Parkinson’s disease.”The company further added, “Sanofi is still meticulously preparing for the subsequent clinical development of ABL301. Following this clinical strategy will significantly shorten the overall new drug development timeline, enable efficient use of time and resources, and substantially increase the likelihood of success.”ABL Bio repeatedly emphasized that the clinical development of ABL301 has not been halted or terminated. The company stressed, “ABL301 remains a pipeline asset of Sanofi. Sanofi’s commitment to developing ABL301 remains firm, and communication between the two companies is ongoing and active.”
- Company
- Companies prepare measures to cut costs ahead drug price cuts
- by Lee, Seok-Jun Feb 02, 2026 02:16pm
- Warnings of an upcoming drug price cut are shaking pharmaceutical companies from within. Even before the government’s official announcement, internal directives to reduce costs are already being implemented.Some companies have instructed all departments to revise their plans with budget cuts of up to 30%. No division is exempt. R&D, sales, marketing, and HR are all subject to austerity measures. With core departments simultaneously targeted for austerity, tension is rising across the entire organization. Voices are emerging that operations are grinding to a halt.According to industry sources, the atmosphere on the ground has changed dramatically since the government's drug price cut announcement.An executive at a mid-sized pharmaceutical company said, “Because the exact scale of the price cuts has not yet been finalized, companies are acting even more conservatively. Management has decided to assume an immediate revenue decline and prioritize cash preservation.” Another industry insider reported, “With budget execution frozen, discussions on new projects are stalling. Meetings that used to focus on growth strategies have recently shifted to cost control.”The R&D sector is also feeling the impact. New project launches are being put on hold, and external outsourcing contracts are under review. Clinical development plans are being divided into stages or delayed. One R&D executive said, “Approval for long-term projects has become much more difficult. The timing of investments is being recalculated.” Delays in internal approvals are also cited as narrowing the operational flexibility of research teams.Sales and marketing organizations are no exception. Sponsorship of academic conferences and advertising are decreasing, and the scale of promotional material orders is also shrinking. Some companies have effectively halted recruitment plans.The advertising sector is also seeing cases where execution timelines are delayed or contract terms are re-evaluated. A marketing executive stated, “We’ve been instructed to readjust annual advertising budgets. Maintaining brand awareness is important, but cost control is clearly the priority right now.”Sales teams report noticeably slower approval processes. A sales director said, “Sales targets remain unchanged, but support is being reduced. The burden of defending revenue has become heavier. Compared to R&D, the blade is falling more sharply on sales departments.”HR and management support divisions are also included in the austerity drive. Training budgets and welfare benefits are being adjusted, and performance bonus criteria are under further review. Some companies are even discussing the possibility of organizational downsizing. An HR official explained, “Managing fixed costs, including labor expenses, is the top priority. Aggressive investment is difficult until uncertainty is resolved.”The core of the government's proposed reform plan is to lower the pricing benchmark for generic drugs from the current 53.55% of the original drug price to around 40%. While the exact impact will vary by product depending on the detailed implementation method, an adjustment to the unit sales price is inevitable. If the sales base is shaken, it becomes difficult to simultaneously maintain both R&D and sales expenses. This is the background behind some pharmaceutical companies’ preemptive implementation of austerity measures.A sense of crisis is also evident across the industry. Recently, a labor-management meeting was held at the Hyangnam Pharmaceutical Industrial Complex in Hwaseong, Gyeonggi Province, attended by pharmaceutical companies and labor unions. The FKTU’s Pharmaceutical and Cosmetics Division and labor-management representatives of tenant companies urged a halt to the drug price reduction reform.Labor groups presented numerical estimates of the potential shock. If the reform is implemented, annual revenue losses across the pharmaceutical and biotech industry are estimated at KRW 1.2144 trillion, with an average loss of KRW 23.3 billion per company. Operating profits could decline by an average of 52%, according to their analysis. They argue that deteriorating profitability could lead to labor cost reductions and restructuring pressure across production, sales, and R&D personnel.Concerns over contracted R&D and investment were also raised. Implementation of drug price cuts is estimated to reduce R&D expenses by an average of 25% and facility investments by 32%. Analysis suggests investment reductions for small and medium-sized pharmaceutical companies could exceed 50%. A warning followed that approximately 9% of the industry's current workforce of around 39,000 could face layoffs.A senior industry executive stated, “The fact that some pharmaceutical companies have already initiated company-wide austerity measures even before the official announcement demonstrates the intensity of the crisis. Cost reduction is not merely efficiency, it represents a shift in strategic priorities. On the ground, the talk is repeatedly about survival rather than growth. The fact that corporate management stances are already turning conservative internally, even before the drug price cuts are finalized, indicates significant repercussions.”
- Policy
- ‘INN prescribing can hinder high-quality drug development’
- by Lee, Jeong-Hwan Jan 30, 2026 11:00am
- Rep. Jia Han (middle) hosted an NA forum on ingredient-name prescribing for drugs with unstable supply, together with the Seoul Medical Association.Amid diverse causes of drug supply instability, such as API shortages, export restrictions at the national and global level, quality issues leading to GMP violation sanctions, and pharmaceutical companies exiting markets due to deteriorating profitability, the medical community has argued that the “limited international nonproprietary name (INN) prescribing” policy adopted as a national agenda by President Jae-myung Lee may be ineffective or even be counterproductive.Critics further pointed out that because pharmacies cannot stock every medication, and as combination drugs for conditions such as hypertension and diabetes cannot be simply substituted, INN prescribing could lead to a “pharmacy hopping” situation in which patients must visit multiple pharmacies to find one stocking the specific drug listed on their prescription.The medical community also reiterated that even drugs with proven bioequivalence are not identical medications.Under INN prescribing, patients may receive generics from different manufacturers depending on which pharmacy they visit or on each pharmacy’s inventory situation, but equivalence among generics is not fully guaranteed.These views were presented on the 29th at a National Assembly forum titled “INN Prescribing for Drugs with Unstable Supply,” hosted by Rep. Ji-ah Han of the People Power Party and organized by the Seoul Medical Association. The presentation was delivered by Chung-gi Kim, Policy Director of the Korean Medical Association.Director Kim explained that drug supply instability arises from multiple causes.He explained that supply disruption arises from a multifaceted combination of structural causes, such as reduced global supply, manufacturing/quality issues, or pharmaceutical companies voluntarily withdrawing product approvals due to drug price/market conflicts, as well as logistical causes stemming from regional/temporal imbalances in distribution.Kim argued that attempting to resolve such multifactorial supply instability through INN prescribing is unreasonable.He cited several limitations of INN prescribing, including the potential to trigger “pharmacy hopping,” the fact that even bioequivalent generics cannot be regarded as identical drugs, and the possibility of discouraging qualitative advancement and formulation innovation in pharmaceuticals.Specifically, he diagnosed that INN prescribing is ineffective because it operates on the premise that a generic substitute exists when production or supply is restricted due to API shortages or quality issues like GMP violations.In cases where pharmaceutical companies voluntarily exit the market due to the low profitability of low-priced essential medicines, INN prescribing could further intensify price competition and accelerate market withdrawal by manufacturers.Even in situations of temporary supply instability caused by logistics imbalances, where certain pharmacies or time periods experience stockouts, INN prescribing offers little benefit, and issues could instead be addressed through direct supply management by medical institutions or adjustments in physicians’ prescribing practices.Director Kim specifically pointed out that, on average, a single pharmacy stocks over 2,000 to 3,000 types of drugs, highlighting the physical limitations of resolving supply instability through INN prescribing.Considering the inherent mismatch where pharmacies cannot stock every drug, and the fact that combination drugs for conditions like hypertension and diabetes, with their varied ingredients and dosages, cannot be simply substituted, INN prescribing risks creating a “pharmacy hopping” problem. This forces patients to search for a pharmacy that stocks all the drugs listed on their prescription.Kim further argued that when INN prescribing leads to substitution of originator drugs with generics, or substitution among generics, the ‘trap of bioequivalence’ may place patients in a situation where they cannot take the exact medicine prescribed by their physician.Furthermore, he argued that INN prescribing could act as a mechanism that discourages pharmaceutical companies from advancing the quality of drugs or pursuing formulation innovations.If ingredient-name prescribing is implemented, manufacturers may be discouraged from investing in high-quality medicines, such as reducing tablet size for patients with dysphagia, improving moisture resistance and stability for better storage and efficacy, masking unpleasant tastes, or optimizing drug release profiles.Kim stated, “Drug supply instability is a matter of national security. The current shortage is a structural phenomenon that has become chronic. This instability stems from dependence on global supply chains, low drug pricing and bidding structures, and weak quality and production incentives.”He elaborated, “The structure that maintains unsustainable prices causes pharmaceutical companies to abandon manufacturing and exit the market, leading to repeated shortages and the collapse of treatment continuity. The solution lies in securing resilience through demand management, including predictive early warning systems, appropriate drug price compensation, supply-chain diversification, and the introduction of alternative treatments.”Kim concluded, “We must shift the policy paradigm from individual drug-centered approaches to treatment-continuity-centered policies, and shift the focus from administrative convenience to clinical impact and patient safety. What is needed is not fragmented or temporary INN prescribing, but an integrated, cross-ministerial governance r framework.”
