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- 2026-04-21 10:52:50
- Policy
- Approval of HER2-bispecific Ab 'zanidatamab' in KOR imminent
- by Lee, Tak-Sun Mar 16, 2026 09:25am
- BeOne Medicines' 'zanidatamab (product name: Ziihera 300mg),' a HER2-targeted bispecific antibody, is likely to be approved soon.Zanidatamab is the first HER2-targeted therapy for biliary tract cancer (BTC) approved by the U.S. FDA. Once it is introduced to the Korean market, this drug is expected to improve treatment outcomes for local patients significantly.According to industry sources on the 12th, the Ministry of Food and Drug Safety (MFDS) recently completed the safety and efficacy evaluation for zanidatamab. Once a "suitable" decision is made from this review, only the final administrative granting of the license remains. Furthermore, under the "Approval-Reimbursement Linkage System," the company can apply for insurance coverage through the Health Insurance Review and Assessment Service (HIRA) immediately following the completion of the safety/efficacy review.In November 2024, the U.S. FDA granted accelerated approval of zanidatamab for patients with previously treated HER2-positive advanced or metastatic BTC. There has been a high unmet medical need in HER2-positive BTC patients.Treatment options for HER2-positive BTC have been extremely limited. BTC is known for its poor prognosis, with a 5-year survival rate of less than 5% once metastasized. In the pivotal HERIZON-BTC-01 clinical trial, the zanidatamab group showed an objective response rate (ORR) of approximately 52%, and a median duration of response (DOR) of approximately 14.9 months.Following its FDA approval, launch in Korea was expedited after the drug was selected for the Global Innovative products Fast Track (GIFT) program in December 2024. In Korea, the specific indication was submitted for approval for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive (IHC 3+) biliary tract cancer.Unlike conventional monoclonal antibodies, zanidatamab is a bispecific antibody that binds simultaneously to two distinct sites on the HER2 (Human Epidermal Growth Factor Receptor 2) protein. This dual-binding mechanism allows for more potent inhibition of cancer cell growth.Beyond BTC, clinical development is currently expanding into gastric and gastroesophageal junction (GEJ) adenocarcinomas.BeOne Medicines underwent a global corporate rebranding last year. Beigene Korea was originally a China-based oncology developer; the company later changed its name to BeOne Medicines and moved its legal registration to Switzerland. In Korea, the company already supplies innovative oncology drugs, including Brukinsa (zanubrutinib) and Tevimbra (tislelizumab).Ziihera is a new drug originally developed by Jazz Pharmaceuticals. BeOne Medicines holds the commercialization rights for the Asia-Pacific region.
- Policy
- Bill proposed to apply 5% coinsurance for follow-up tests
- by Lee, Jeong-Hwan Mar 16, 2026 09:25am
- An amendment to the National Health Insurance Act is being proposed to reduce the patient coinsurance rate to 5% for follow-up examinations for patients with cancer, rare diseases, and severe or intractable illnesses.A bill to amend the Patient Safety Act has also been introduced in the National Assembly. It imposes an obligation on doctors to fully explain the details and circumstances of medical accidents to patients, while stipulating that expressions of consolation, empathy, or regret made by doctors during this process cannot be used as evidence of the doctor’s liability or to their disadvantage in medical malpractice lawsuits.On the 13th, Rep. Kyo-heung Kim of the Democratic Party and Representative Cheol-soo Ahn of the People Power Party each introduced a bill to amend the National Health Insurance Act and the Patient Safety Act, respectively, containing these provisions.Bill to reduce patient coinsurance for follow-up tests for serious diseases to 5%Representative Kim’s bill proposes reducing the patient coinsurance rate to 5% for follow-up examinations for cancer, rare diseases, and severe or intractable diseases that have a high risk of recurrence.Under the current law, insured individuals and their dependents are required to bear part of the cost of medical services when receiving healthcare benefits.For certain diseases with high treatment costs, a special calculation system is applied in which the patient’s share of medical costs is reduced to 5–10% of the total medical benefit costs for a specified period.Rep. Kim pointed out that while cancer, rare diseases, and severe or intractable diseases carry a high risk of recurrence even after treatment, making continuous monitoring and follow-up examinations essential, patients face high testing costs once the special calculation exception ends after the disease is cured.He argued that this creates a problem where patients are unable to receive proper follow-up examinations due to such a financial burden.To address this, accordingly, Representative Kim introduced a bill that reduces the patient cost-sharing rate to 5% when cancer patients, rare disease patients, or patients with severe or intractable diseases undergo follow-up examinations for their respective conditions.Bill preventing doctors’ expressions of sympathy after medical accidents from being used as evidence in lawsuitsRepresentative Cheol-soo Ahn introduced a bill requiring heads of healthcare institutions or healthcare professionals to make efforts to sufficiently explain the details and circumstances of patient safety incidents. The bill also stipulates that expressions of consolation, empathy, or regret made by doctors during this process cannot be used as evidence regarding the doctor’s liability in medical malpractice lawsuits or other legal proceedings.Under the current law, there is no separate provision requiring doctors to explain the details or circumstances of patient safety incidents.In particular, doctors sometimes avoid providing explanations or maintain a defensive stance regarding patient safety incidents, as expressions of humanitarian regret or explanations could later be used as evidence of the healthcare institution’s or healthcare professional’s liability in future trials related to the incident.Representative Ahn expressed concern that the information gap and lack of communication between doctors and patients deepen distrust among patients and their guardians toward healthcare institutions, turning simple incidents into complex legal disputes.He also noted that this situation creates excessive psychological pressure and litigation burdens on healthcare professionals, contributing to instability in the medical environment.The proposed bill would therefore require doctors to provide detailed explanations about medical accidents, while explicitly stating that expressions of sympathy, empathy, or regret cannot be used as evidence of liability in medical lawsuits.Rep. Ahn explained, “This bill aims to restore trust between healthcare professionals and patients and minimize unnecessary social costs, such as those arising from litigation.”
- Company
- Facing the era of low-priced generics…diabetes drug competition
- by Chon, Seung-Hyun Mar 16, 2026 09:25am
- Dong-A ST is adding two more combination therapies that utilize its in-house-developed diabetes drug, Suganon. Having completed the development of these new combinations, the company has entered the regulatory approval stage. Once these two combination drugs are approved, six types of Suganon lineups will be secured.Chong Kun Dang has also expanded its Duvie line, new diabetes drugs, to six products. While competing drugs are seeing stagnant growth due to overheated market competition from hundreds of generics, Chong Kun Dang has strengthened its competitiveness by securing new growth engines through the concentration of its research and development (R&D) capabilities. Analysis suggests that establishing new, incrementally modified drugs (IMDs) will be a powerful driving force for profitability in preparation for the upcoming era of low-priced generics.Dong-A ST files for two Suganon combination drugs...establishing new growth engines amid slow growth in over-saturated marketAccording to the Financial Supervisory Service (FSS) on the 16th, Dong-A ST submitted applications for the marketing authorizations of “Sugaempa” and “Suganova SR” to the Ministry of Food and Drug Safety on the 13th. Both “Sugaempa” and “Suganova” are combination drugs made using Dong-A ST's diabetes drug, Suganon.Suganon, approved in October 2015 as the 26th Korea-developed new drug, is a DPP-4 inhibitor diabetes treatment. Suganon has an outstanding blood glucose-lowering effect even at low doses due to its high selectivity for the DPP-4 enzyme. It has a low impact on the metabolism of other drugs, resulting in high medication convenience and compliance for patients with chronic diseases who must take multiple medications. Furthermore, it can be used without dose adjustment, even in patients with decreased renal function."Sugaempa" is a combination drug that joins Suganon with empagliflozin, an SGLT-2 class diabetes drug. The original drug for the empagliflozin component is Jardiance. "Suganova" is a triple combination drug consisting of Suganon, empagliflozin, and metformin.Yearly outpatient prescriptions for Suganon products (unit: KRW 100 million, source: UBIST)If Dong-A ST receives approval for "Sugaempa" and "Suganova," the Suganon family lineup will expand to six types.In July 2016, Dong-A ST launched Sugamet, a combination containing Suganon and metformin. In May 2023, it released Sugadapa, combining Suganon with the SGLT-2 inhibitor dapagliflozin, and in January 2024, it added a triple combination drug comprising Suganon, dapagliflozin, and metformin.By combining two different SGLT-2 inhibitor components, Dong-A ST will offer two types of Suganon + SGLT-2 inhibitor combinations and two types of Suganon + SGLT-2 inhibitor + metformin combinations. This strategy aims to equip the maximum number of combinations possible so that patients taking individual component drugs separately can utilize a Suganon combination drug. The Suganon family is evaluated to have successfully settled into the prescription market, recording annual sales of approximately KRW 30 billion.According to the pharmaceutical research organization UBIST, the four types in the Suganon family recorded KRW 31.5 billion last year. Sugamet and Suganon recorded prescription amounts of KRW 17.4 billion and KRW 11.1 billion, respectively. Sugatree and Sugadapa recorded KRW 1.6 billion and KRW 1.4 billion, respectively.However, recent growth has been slow. Last year's prescription amount for Sugamet decreased by 3.5% compared to the previous year, and Suganon decreased by 7.7%. Sugamet recorded prescription sales of KRW 20.6 billion in 2022, but they have decreased by 15.6% over the last three years. Suganon has shown a downward trend for three consecutive years, following KRW 14.1 billion in 2022, a 20.9% decline. While Suganon and Sugamet combined for KRW 34.7 billion in 2022, the prescription amount for the four Suganon family products, including Sugatree and Sugadapa, decreased by 9.0% compared to three years ago.With both the DPP-4 inhibitor and SGLT-2 inhibitor markets in Korea entering a state of oversaturation due to the entry of generics, it is a difficult environment to sustain growth. While most domestic pharmaceutical companies compete by offering generics, Dong-A ST's move is to strengthen its competitiveness in the oversaturated market by investing in its self-developed new drugs and additional R&D capabilities. 174 subjects participated in the clinical trials for Dong-A ST's "Sugaempa" and "Suganova."Chong Kun Dang establishes 6 Duvie lineup... Securing profitability weapon against low-priced generic eraChong Kun Dang is also strengthening its competitiveness in a stagnant market by steadily adding to its self-developed diabetes drug Duvie lineup.On the 11th, Chong Kun Dang received marketing authorization approval from the Ministry of Food and Drug Safety for Duviempol XR. Duviempol XR is a triple combination drug comprising lobeglitazone, empagliflozin, and metformin. Lobeglitazone is the main component of Duvie, the diabetes drug independently developed by Chong Kun Dang.Chong Kun Dang stated, "We expect to increase administration convenience by providing a new treatment therapy with the fixed-dose combination of lobeglitazone, empagliflozin, and metformin for type 2 diabetes patients whose blood sugar is not appropriately controlled by the dual therapy of empagliflozin and metformin."Duviempol XR is the sixth lineup developed based on Duvie. Approved in 2013 as the 20th Korea-developed new drug, Duvie is a thiazolidinedione (TZD) class diabetes treatment.Starting with Duvie, Chong Kun Dang currently sells four Duvie lineups: Duviemet SR, Duviemet S, and Duet S. Duviemet SR, approved in 2016, is a combination drug combining Duvie and metformin.Duviemet S, approved in May 2023, is a combination drug containing Duviemet and the DPP-4 inhibitor sitagliptin. The original drug for sitagliptin is Januvia. In June 2023, Chong Kun Dang received additional approval for Duet S, a dual combination drug joining lobeglitazone and sitagliptin.In January, it equipped its fifth lineup by receiving approval for Duviempa, which joins Duvie and empagliflozin. Duviempa can be used for adult type 2 diabetes patients for whom the concomitant administration of lobeglitazone and empagliflozin is appropriate.For Chong Kun Dang, the strategy is to maximize synergy in the prescription market by presenting new treatment alternatives to medical staff and patients through the introduction of various combination drugs centered on Duvie.Annual outpatient prescriptions for Suganon family (unit: KRW 100 million, source: UBIST)The market situation for Duvie is also not easy. Last year, outpatient prescription costs for the four types in the Duvie family totaled KRW 20.3 billion, a 3.9% decrease from the previous year. Duvie's prescription volume was KRW 18.3 billion, accounting for about 90%, while the remaining products were not significantly prominent. In 2022, Duvie and Duviemet combined for KRW 25.4 billion. Last year, the combined prescription amount of the four products decreased by 20.2% compared to three years ago.As with Suganon, it is a difficult environment for Duvie to sustain growth as pharmaceutical companies indiscriminately release generics for diabetes drugs like SGLT-2 inhibitors. However, the company is moving to equip itself with additional growth engines by steadily releasing combination drugs developed through its R&D capabilities. It is viewed that combination drugs developed by a pharmaceutical company's proprietary new drugs can become a driving force for future profitability, especially as the government continues its attempts to lower generic drug prices.In November last year, the Ministry of Health and Welfare (MOHW) reported to the Health Insurance Policy Deliberation Committee a plan to improve the drug pricing system, which includes lowering the price calculation rate for generics and off-patent drugs from 53.55% to the 40% range. It is reported that on the 11th, the MOHW held a sub-committee of the Health Insurance Policy Deliberation Committee and suggested a generic drug price calculation rate in the low-to-mid 40% range. If the generic drug price standard is lowered from 53.55% to 43%, the calculation shows the maximum generic price will be reduced by 19.7%.In the reorganization plan reported by the MOHW last November, it was specified that, while maintaining the maximum price requirements applied since 2020, the reduction rate for unmet requirements would be expanded from 15% to 20%. This means that the prices of generics that do not meet the maximum price requirements will drop even further.Under the drug pricing system reform since July 2020, a generic product can receive the maximum price only if it meets both requirements: performing a bioequivalence study and using registered drug master file ingredients. Every time one requirement is not met, the upper limit price drops by 15%. If both requirements are not met, the structure results in a 27.75% reduction. Applying a 15% reduction rate, the generic maximum price calculation standard of 53.55% drops to 45.52% if one requirement is unmet, and to 38.69% if two requirements are unmet.If the generic calculation standard is set at 43%, a generic that fails to meet one maximum price requirement will be lowered to 34.40%, and a generic that fails to meet two requirements will be lowered to 27.52%. In this case, the price of a generic failing to meet one requirement is reduced by 24.4% compared to the current level, and the reduction rate for failing two requirements is 28.9%. It is mathematically possible to calculate that the reduction in generic drug prices will approach 30%.This is the background for which pharmaceutical companies are complaining that performance pressure could intensify due to the generic drug price cuts. An industry official stated, "Due to the government's policy on lowering drug prices, the market may find it difficult to expect profits from generics in the future. Equipping new drugs or IMDs that can receive high drug prices will greatly help future performance strength."
- Company
- Evolving HIV treatment strategies… new treatment options emerge
- by Son, Hyung Min Mar 16, 2026 09:25am
- The paradigm of HIV treatment is expanding beyond simple viral suppression toward a “lifecycle management” strategy that considers the entire lifespan of people living with HIV.Within the current HIV treatment landscape, a variety of options have emerged, ranging from oral dual-drug regimens that reduce the medication burden during the initial treatment phase to long-acting injectables that prioritize quality of life during long-term treatment. Consequently, treatment strategies are becoming increasingly multifaceted.HIV had long been perceived as a fatal infectious disease characterized by rapid disease progression and high mortality. However, with advances in antiretroviral therapy (ART), the life expectancy of people living with HIV has increased to approximately 78 years, reaching a level not significantly different from that of the general population.At the same time, the U=U (Undetectable = Untransmittable) concept—which states that the virus cannot be transmitted to others once the viral load in the blood becomes undetectable— has positioned HIV treatment as a core pillar of public health strategy, moving beyond individual care.Accordingly, HIV treatment is shifting from a question of survival to ‘how to manage the disease for a long time and in good health.’ In actual clinical practice, the number of patients newly diagnosed in their 20s and 30s is increasing, alongside those in their 60s and 70s who have been on treatment for decades, underscoring the growing importance of long-term treatment management strategies.Amid these changes, there is an emphasis on an approach that considers the entire treatment journey, from the initial treatment phase through long-term management. Among the leading treatment options are GSK’s oral two-drug regimen ‘Dovato (dolutegravir and lamivudine)’ and the combination therapy of the long-acting injectable combination therapy ‘Vocabria (cabotegravir) + Rekambys (rilpivirine).’Two-drug regimen ‘Dovato’ emerges as an initial treatment strategy…effective viral suppression with minimal drug burdenHIV treatment drug ’Dovato.’More than half (approximately 66.7%) of newly diagnosed HIV infections in Korea are diagnosed in people in their 20s and 30s. Since lifelong treatment is required from the time of diagnosis, the importance of strategies to minimize the medication burden during the initial treatment stage is increasing.Dovato, a two-drug oral regimen, is characterized by its ability to reduce drug exposure while demonstrating viral suppression efficacy non-inferior to existing three-drug regimens.In the GEMINI I and II studies, Dovato demonstrated non-inferiority in viral suppression compared with the dolutegravir (DTG) + tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)-based three-drug regimen, and the TANGO study reported positive results regarding bone and renal biomarkers and lipid changes compared to TAF-based therapy. The risk of weight gain was also found to be relatively lower.Thermore, the PASO-DOBLE study, which directly compared the regimen to the existing three-drug regimen of bictegravir (BIC), FTC, and TAF, confirmed non-inferiority in viral suppression rates at week 48, and reported relatively lower risks of weight gain and metabolic side effects.The DOLCE study, conducted in a high-risk group of treatment-naïve HIV-infected individuals with low CD4 counts and high viral loads, and the ATTEND study, which focused on late-diagnosed individuals, also confirmed similar viral suppression effects compared to triple therapy.Based on these study results, guidelines from the Spanish AIDS Research Group GeSIDA (Grupo de Estudio de SIDA), as well as those in Norway, Sweden, and other countries, recommend Dovato as an initial treatment option regardless of baseline viral load.Every 2 month injectable better utilized for HIV in the long term…offers greater utilization in long-term treatment stagesHIV treatment drugs ‘Vocabria’ and ‘Rekambys’As HIV treatment enters the long-term management phase, the focus of treatment has naturally shifted toward quality-of-life management.Amid this trend, the long-acting injectable combination therapy ‘Vocabria + Rekambys,’ administered once every two months, is also establishing itself as a major treatment option.In the Phase III SOLAR study, the therapy demonstrated non-inferiority in both virologic failure rates and viral suppression rates compared with the standard three-drug oral regimen (BIC/FTC/TAF).Treatment satisfaction was also high. The study found that approximately 90% of patients who switched to the long-acting injectable regimen preferred it over the existing oral regimen, citing the following main reasons: ▲ the absence of the need to take medication daily, ▲ treatment convenience, and ▲ reduced psychological burden from being repeatedly reminded of their HIV status through daily medication.The U.S. Department of Health and Human Services (DHHS) guidelines also state that switching to long-acting injectable therapies can improve treatment convenience and reduce medication-related fatigue and the burden of social stigma.In the CARES study, which reflects real-world clinical practice, the virologic success rate of the long-acting injectable therapy reached 96.9%, showing similar efficacy to the oral medication group. Treatment adherence was also found to be high, with 96% of scheduled doses administered within ±7 days.Based on these study results, the 2025 European AIDS Clinical Society (EACS) removed HIV Subtype A1, which had previously been identified as a risk factor for virologic failure and resistance in certain ethnic groups when switching to the Vocabria + Rekambys combination therapy.Currently, the Vocabria + Rekambys combination therapy is the only long-acting HIV injectable treatment available in Korea. It is being used as a switch therapy option to improve treatment convenience and quality of life in adult patients whose viral load has been stably suppressed through existing treatments.This treatment has reportedly accumulated more than 1,000 treatment cases within about one year since its launch in Korea last April.
- Policy
- Pace of expanding low-priced purchase incentive has been adjusted
- by Jung, Heung-Jun Mar 16, 2026 09:25am
- The government is expected to adjust the schedule of its implementation policy, considering the potential side effects of expanding low-priced purchase incentives for medical institutions.While the original plan was to increase the incentive for low-priced purchases from 20% to 50%, officials are now reviewing a plan to lower the target to 35%.According to industry sources on the 16th, the government's fundamental policy direction of transitioning market price reductions into a 'market-linked, transaction-based price system' remains unchanged.However, given the potential negative consequences of a rapid expansion of incentives, the Health Insurance Policy Deliberation Committee is expected to lower the planned increase rate at its meeting this month.The low-price purchase incentive is a system that provides a portion of the savings as a grant to medical institutions when they purchase medicines at a transaction price below the maximum reimbursement limit. Under the current standards notified by the Ministry of Health and Welfare (MOHW), approximately 20% to 30% of the price difference is paid to these institutions.The reform plan released last November included a proposal to expand the incentive payout rate to a maximum of 50%. It is intended to lower actual transaction prices through market competition without relying on government-mandated price cuts.Since the announcement, there have been persistent concerns about overheated price competition and chaos in the distribution order. Critics have pointed out that the side effects of damaging the industry ecosystem could outweigh the benefits of reduced pharmaceutical expenditures.During a recent National Assembly debate on the drug pricing system, specific concerns were raised regarding the potential for rebates following the expansion of these incentives.Hong Seok-hwan, the Policy Director of the Korean Confederation of Trade Unions, criticized the move by stating that rather than the government directly removing the price bubble, the policy induces pharmaceutical companies and hospitals to enter into side agreements at prices lower than the officially notified price, effectively legalizing rebates by guaranteeing the price difference as profit.The government is adjusting the rate of increase in incentives downward to address these concerns. The proposed 35% rate is currently under discussion, and the final payout rate will be decided at this month's Health Insurance Policy Deliberation Committee meeting.Meanwhile, this expansion of low-price purchase incentives applies only to private tertiary general hospitals, general hospitals, clinics, and pharmacies. National and public hospitals are expected to maintain the current 20% rate.
- Policy
- Stepwise price reduction applied from 13th listed product
- by Jung, Heung-Jun Mar 16, 2026 09:25am
- The government, which had planned to implement stepwise drug price reductions of 5 percentage points starting from the 11th listed product, has decided to revise both the criteria for listing items and the reduction method.The new direction under discussion is to apply stepwise reductions starting from the 13th listed product, while maintaining the current method of applying 85% of the previous lowest price as the new price.According to industry sources on the 16th, the government’s drug pricing system reform proposal discussed at the recent Health Insurance Policy Deliberation Committee (HIPDC) subcommittee differs from the proposal announced in November last year.The stepwise drug price reduction reform plan is expected to undergo partial changes. AI-generated imageThe reform plan from last November included a method whereby “the price of the first generic would be reduced by 5 percentage points starting from the 11th product listing of the same formulation.” This represented a significant strengthening of the current product reduction system, which is applied starting from the 21st listed product.Additionally, the plan stipulated that if there were 10 or more initially listed generics, the price would be uniformly set at the 11th product’s level one year later.At this HIPDC subcommittee meeting, a proposal to apply the stepwise reduction starting from the 13th product was discussed. While the method of reducing the price by 5 percentage points each time would be removed, discussions are focused on maintaining the approach of applying a price set at 85% of the lowest price for subsequent listings. This effectively means maintaining the current reduction rate of 15% applied from the 21st product onward.Products listed at the point where stepwise reductions begin will have their prices adjusted to 85% of the lowest price after one year.For example, if there were 10 products this month and the number exceeds 13 with next month’s listings, the price for the newly listed products will be set at 85% one year later. However, if additional items are listed the following month, their prices would be further reduced by an additional 85% on top of the 85% already applied.Although the threshold number of products used as the basis for stepwise reductions has been slightly relaxed, the system still effectively results in an additional 15% reduction following the initial 15% reduction, depending on the listing timing.However, the details currently under discussion are not yet finalized. There is a possibility that the application method or specific figures could change at the HIPDC meeting on the 26th.Additionally, since the generic drug pricing rate is not clearly defined as being in the “mid-to-high 40% range,” the exact drug price calculations under stepwise reductions will likely be possible only after the HIPDC decision is finalized.
- Company
- Government sticks to low-40% pricing for generic drugs
- by Kim, Jin-Gu Mar 13, 2026 09:06am
- The government has reportedly decided to maintain its plan to apply a generic drug pricing ratio in the “low to mid-40% range” compared to original drugs. This position remains significantly different from the compromise proposal of about 48% suggested by the pharmaceutical industry, which had already represented a 10% reduction from the current level. Criticism is expected that the government is not demonstrating sufficient willingness to communicate with the pharmaceutical industry regarding drug pricing policy, despite industry objections.According to industry sources on the 11th, the MOHW held a subcommittee meeting of the Health Insurance Policy Deliberation Committee that day to discuss the drug pricing system reform plan. In the closed-door meeting, the MOHW reportedly presented a generic drug pricing calculation rate in the low to mid-40% range.This level is largely consistent with the direction the government presented during last month's HIPDC discussions. Last November, the MOHW reported a drug pricing system reform plan to the HIPDC. This plan included lowering the drug pricing ratio for generics and off-patent drugs from 53.55% to the 40% range.At that time, the ministry indicated that the new generic pricing calculation standard would likely be set between 40% and below 45%. When presenting the reform proposal, the ministry also outlined a schedule for adjusting the prices of already listed drugs. It stated that products currently priced at 45-50% would begin price adjustments in 2027, with reductions to the 40% range by 2029.This still shows a considerable gap from the 48% compromise level proposed by the pharmaceutical industry. The pharmaceutical industry has presented its bottom line for an acceptable calculation rate, signaling its willingness to negotiate with the government.On the 10th, the Emergency Response Committee for Drug Pricing Reform for Pharmaceutical Industry Development held a press conference and proposed joint research with the government, including analysis of price reduction impacts.At the press conference held by the ‘Emergency Response Committee for Drug Pricing Reform for Pharmaceutical Industry Development’ at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association on the 10th, the committee proposed that “considering the profitability of listed pharmaceutical companies and industry conditions, the acceptable price for generic drugs would be about 48.2% of the original drug price.”The specific pricing ratio is expected to be confirmed at the full committee meeting scheduled for the 26th. However, the key question is whether there will be a re-discussion process before the agenda is submitted to the full committee meeting.In this regard, concerns have been raised in the National Assembly that the drug pricing reform plan is being pushed forward without sufficient discussion.Representative Sunmin Kim of the Rebuilding Korea Party pointed out during the National Assembly Health and Welfare Committee plenary meeting on the 10th that the Ministry of Health and Welfare had attempted to ‘pass NA’ by proceeding with the HIPDC subcommittee and plenary meeting schedules in March without including the drug pricing reform plan in its annual report to the National Assembly.Representative Joo-min Park of the Democratic Party of Korea, who chairs the Health and Welfare Committee, agreed that a separate briefing on the reform plan is necessary. He told Health and Welfare Minister Eun-Kyoung Jeong, “Since this is an extremely important matter, it would be appropriate to provide an additional report at the plenary session after discussions on the reform plan are completed.”As a result, the ministry is increasingly likely to provide a separate briefing on the direction of the drug pricing reform plan to the National Assembly before the HIPDC plenary vote.Currently, the MOHW plans to vote on the drug pricing system reform plan at the HIPDC plenary meeting on the 26th. This plan includes lowering the pricing ratio for already-listed generic drugs from the current 53.55% to the 40% range.The generic pricing ratio is the key issue in the current drug pricing reform debate. Currently, domestic generic drug prices are set at 53.55% of the original drug price. The government is pushing to reduce this ratio to the 40% range.In response, the pharmaceutical industry has raised concerns that an excessive price reduction could lead to deteriorating corporate profitability, reduced investment in research and development, and employment instability. As an alternative, the industry proposed a moderated reduction with a pricing ratio of around 48%.
- Company
- New RSV prophylaxis is entering KOR…expanded infant protection
- by Son, Hyung Min Mar 13, 2026 09:06am
- The prevention strategy for infant respiratory syncytial virus (RSV) is expected to expand rapidly in South Korea.As global pharmaceutical companies are proceeding with regulatory approval processes for maternal vaccines and new antibody injectables, a new competitive landscape is beginning to take shape. RSV vaccine 'Abrysvo'According to industry sources on the 13th, Pfizer Korea has summitted application for the approval of 'Abrysvo,' its RSV vaccine. Approval is anticipated within the first half of this year.Abrysvo is a vaccine that targets the F protein, a major surface protein of RSV. It is specifically designed based on the pre-fusion (pre-F) form of the F protein, which the virus uses to penetrate cells.The pre-F protein is known to be the most effective antigen for inducing neutralizing antibodies, as it represents the viral structure just before cell binding and entry. Abrysvo induces an immune response using a protein that stabilizes this specific structure.Designed as a bivalent vaccine targeting both major RSV subtypes (A and B), Abrysvo uses a maternal immunization strategy. In this approach, antibodies generated by the mother following vaccination are transferred through the placenta to protect the infant after birth.RSV is a leading respiratory virus causing pneumonia and bronchiolitis. While it can infect individuals of all ages, infection rates are particularly high in infants. Globally, approximately 90% of children are infected with RSV before age two. For some, it progresses to severe lower respiratory tract disease, making it a primary cause of infant hospitalizations.Clinical evidence for Abrysvo was secured through the Phase 3 MATISSE study. The results showed that maternal vaccination during late pregnancy significantly reduced the risk of severe RSV-related lower respiratory tract disease in infants within six months of birth.Regarding safety, commonly reported adverse reactions included injection site pain, headache, myalgia, and nausea.Abrysvo is established as a preventive option in major overseas markets. In the U.S., it was approved in 2023 for the prevention of RSV-LRTD in infants via maternal vaccination (32–36 weeks) and for adults aged 60 and older. Last year, the indication was expanded to include adults aged 18 and older.Upcoming competition in RSV prevention strategy for children: Vaccines vs. Antibody InjectionsAntibody therapy, 'Enflonsia (clersrovimab),' for RSV prevention MSD has also entered the infant RSV prevention market.MSD Korea recently submitted an approval application to the Ministry of Food and Drug Safety (MFDS) for 'Enflonsia (clersrovimab),' an RSV preventive antibody injection for neonates and infants. The company anticipates approval by the second half of this year.Unlike vaccines, antibody injections deliver antibodies directly into the body, providing immediate protective effects following administration.Enflonsia is a long-acting monoclonal antibody targeting the F protein. It is designed to maintain preventive efficacy for approximately five months with a single dose, covering the typical RSV season from autumn to the following spring.Notably, Enflonsia was developed as a fixed-dose (105mg) treatment regardless of body weight, which is evaluated as a feature that increases convenience for pediatric prevention programs.In the Phase 2b/3 CLEVER study, a single administration of Enflonsia reduced the incidence of RSV-related LRTD by 60.5% and the risk of RSV-related hospitalization by 84.3%.Furthermore, the Phase 3 SMART study involving high-risk infants confirmed its preventive efficacy and a safety profile similar to 'Synagis (palivizumab),' the existing RSV preventive antibody.Antibody therapy 'Beyfortus' for RSV preventionIf Abrysvo and Enflonsia are approved, they are expected to compete with other long-acting RSV preventive antibodies.Currently, 'Beyfortus (nirsevimab),' an RSV preventive antibody developed by Sanofi, has already entered the infant market.Beyfortus is launching in Korea this year and is garnering attention as a major infant RSV prevention option.Previously, AstraZeneca's Synagis was used for RSV prevention, but its short half-life necessitated multiple doses during the RSV season. In contrast, Beyfortus is a long-acting antibody with an extended half-life, allowing for full-season protection with a single administration.Recent international studies have also compared the effectiveness of these different prevention strategies. A large-scale population-based study in France comparing maternal vaccines and infant antibody strategies found that the Beyfortus group had a lower risk of RSV-related hospitalization.Additionally, a surveillance study conducted in the U.S. showed that Beyfortus was 81% effective in preventing RSV-related hospitalizations, with efficacy maintained for approximately 4 to 7 months. Researchers found that while both strategies reduce RSV-related hospitalizations, antibody-based prophylaxis provided greater protection against severe disease.
- Company
- Leclaza launches in Germany, accelerates Europe entry
- by Cha, Ji-Hyun Mar 13, 2026 09:06am
- Photo of Yuhan Corp’s Leclaza (source: Yuhan Corp)Leclaza, a lung cancer drug developed by Yuhan Corporation, has successfully entered the health insurance reimbursement system in Germany, the largest pharmaceutical market in Europe. This listing is expected to accelerate Leclaza’s entry into other European countries.According to the biotech industry on the 12th, Germany’s Federal Joint Committee (G-BA), responsible for evaluating health insurance reimbursement in Germany, assigned billing codes 761990MO and 761990MP to Leclaza 80 mg and 240 mg, respectively, starting this month. Billing codes are assigned after drug price negotiations are finalized, enabling hospitals to bill health insurance for the medication after prescribing it.Leclaza is a third-generation treatment for non-small cell lung cancer (NSCLC) targeting epidermal growth factor receptor (EGFR) mutations. It received approval in Korea in January 2021 as the country's 31st domestically developed new drug. The combination therapy of Leclaza and Rybrevant received approval from the U.S. Food and Drug Administration (FDA) in August 2024 as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed EGFR exon 19 deletion or exon 21 L858R substitution mutation.Later, at the end of 2024, the European Commission (EC) also approved the Lecelaza and Johnson and Johnson’s Rybrevant combination therapy as a first-line treatment for EGFR-mutated NSCLC. Subsequently, in July of last year, the G-BA determined that the combination therapy had sufficient clinical value to qualify for health insurance reimbursement.Under Germany’s Social Code Book V (SGB V), new drugs can enter the market immediately after receiving marketing authorization. Within approximately 6 months, the G-BA evaluates the drug’s clinical benefit, after which price negotiations with health insurers begin. Negotiations typically conclude within another 6 months, after which hospital billing codes are assigned.The G-BA ultimately determined that the combination therapy of Leclaza and Rybrevant positively impacts survival rates for lung cancer patients. It particularly noted a relatively pronounced survival benefit in the patient group aged 65 and under. The G-BA estimated the annual number of patients expected to receive treatment in Germany to be between 1,250 and 3,025.Germany is widely regarded as one of the most stringent countries in Europe in terms of drug pricing decisions. However, Lazertinib entered the reimbursement system relatively smoothly, being recognized for its clinical value. Once prescriptions gain traction in the German market, it is expected to positively influence drug pricing negotiations and insurance listings in other European countries as well.Once sales expand in major European countries, Yuhan Corporation is expected to receive additional licensing fees. Yuhan has not yet received the USD 30 million milestone payment for Leclaza’s approval in Europe. In addition, if sales grow in the European market, the company will receive royalties based on a certain percentage of sales according to the licensing agreement.Yuhan Corporation's total licensing revenue over the 7 years from 2019 to last year amounted to KRW 460 billion. Of this amount, cumulative licensing revenue from Lazertinib technology transfer alone has reached approximately USD 275 million, including upfront payments and development and regulatory milestones.Yuhan Corporation received a non-refundable upfront payment of USD 50 million when it licensed Leclaza to Janssen Biotech, a Johnson & Johnson subsidiary, in November 2018. Subsequently, a USD 35 million milestone was paid in 2020 when the clinical trial for the combination therapy of Rybrevant and Leclaza began. The company received an additional USD 65 million the same year when patient enrollment for the clinical trial began.The company continued to generate milestone revenues thereafter based on progress in development and regulatory approvals. A USD 60 million milestone was triggered by the 2024 U.S. Food and Drug Administration (FDA) approval. Last year, the company received additional milestone payments of USD 15 million for Japanese approval and USD 45 million for Chinese approval.
- Company
- Polivy makes 3rd bid for reimbursement…DREC review imminent
- by Eo, Yun-Ho Mar 13, 2026 09:06am
- Attention is focused on whether Polivy, the first new first-line treatment for diffuse large B-cell lymphoma (DLBCL) in 20 years, will succeed on its third attempt to obtain reimbursement listing in Korea.According to industry sources, Roche Korea's Polivy (polatuzumab vedotin), a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), is expected to be submitted to the Health Insurance Review and Assessement Service's Drug Reimbursement Evaluation Committee next month (April).It remains to be seen whether progress can be made approximately 8 months after passing the Cancer Disease Deliberation Committee last July.Originally, Polivy sought reimbursement in 2021 for its first approved indication as a third-line therapy, in combination with the BR regimen (bendamustine + rituximab), but the application failed to pass CDDC review at that time.Later, in the first half of 2023, Roche submitted a reimbursement application for first-line therapy using Polivy in combination with R-CHOP therapy (rituximab, cyclophosphamide, doxorubicin, and prednisone). However, this application also failed to pass the Cancer Disease Deliberation Committee in February 2024.Expectations are high for Polivy's latest reimbursement attempt. Roche has submitted additional follow-up analysis results with a 60.9-month follow-up period from the POLARIX study, which evaluated the effectiveness of Polivy in combination with Pola-R-CHP as a first-line treatment for DLBCL.The study, presented at the American Society of Hematology (ASH 2024) annual meeting, has been regarded as the first clinical trial in 20 years to expand the standard first-line treatment for DLBCL. Key results show patients receiving Polivy combination therapy demonstrated a clear improvement in overall survival (OS) compared with those treated with the existing standard therapy, R-CHOP.The lymphoma-related mortality rate was 9.0% in the Polivy combination therapy group and 11.4% in the R-CHOP control group. At approximately 5 years after treatment initiation, the mortality risk in the Polivy combination therapy group decreased by 15%, an improvement over the previous 3-year follow-up result (6% risk reduction).In addition, patients receiving the Polivy combination therapy (38.7%) required follow-up treatments (radiation therapy, systemic chemotherapy, or CAR-T cell therapy) about 25% less frequently than those in the R-CHOP control group (61.7%).Meanwhile, diffuse large B-cell lymphoma (DLBCL) is an aggressive type of blood cancer and the most common form of non-Hodgkin lymphoma. In South Korea, the number of new patients diagnosed with DLBCL is estimated to reach 5,000 each year.Accounting for the highest proportion of non-Hodgkin lymphomas, diffuse large B-cell lymphoma is an aggressive lymphoma requiring immediate treatment due to its rapid progression. Although more than half of patients respond well to treatment and achieve remission, 30–40% of patients either fail to respond to the standard therapy R-CHOP or experience relapse after first-line treatment.Despite the fact that most patients experience relapse within two years and that survival is only about six months upon relapse, making it a highly lethal disease, relapsed/refractory diffuse large B-cell lymphoma remains an area with limited effective treatment options.
