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- 2026-05-08 18:35:30
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- Policy
- Inheritance of drug price ceiling to be blocked in transfers
- by Jung, Heung-Jun May 08, 2026 01:15pm
- Changes are expected to the current rules that allow drug price ceilings to be inherited during product transfers. The system is likely to revert to past regulations that apply the lower of the new calculated price and the price at the time of transfer.As a result, acquiring high-priced generics to avoid the impact of drug pricing reform will no longer be viable.According to industry sources on the 6th, a working-level consultative body comprising the Ministry of Health and Welfare and industry representatives recently discussed changes to the transfer regulations that were not brought before the Health Insurance Policy Deliberation Committee in March.The rules governing price ceilings in transfers have changed multiple times. Until 2020, prices were set based on the lower of the final ceiling price of the transferred product and the newly calculated price.However, following the stepwise pricing reform, industry backlash arose as transfers were treated as new listings, leading to significant price drops.In response, the government allowed inheritance of the existing ceiling price starting during transfers in 2021.Now, the government plans to revert to the previous rule, applying the lower of the existing ceiling and the new calculated price.Even if a high-priced generic is acquired, the newly calculated price at the moment of transfer is applied, effectively enforcing a lowest price rule.Pharmaceutical companies that had considered acquiring high-priced generics to avoid pricing reform will lose this option.With the reform, the generic pricing rate has been reduced to 45%, and the reduction rate for products failing to meet the baseline requirements has been strengthened from 85% to 85%. Combined with multi-listing management rules, prices could fall to as low as 30.6% within one year if bioequivalence studies are not conducted.Previously, companies might have chosen to acquire products with higher maintained prices.However, if prices are reset based on the calculation price at the time of transfer, transfers that take existing drug prices into account become meaningless.
- Company
- Hunter syndrome drug Hunterase ICV approved in Peru
- by Lee, Seok-Jun May 08, 2026 01:15pm
- GC Biopharma announced on the 6th that its intracerebroventricular (ICV) Hunter syndrome treatment, ‘Hunterase ICV’, has received marketing approval from Peru’s regulatory authority, General Directorate of Medicines, Supplies and Drugs (DIGEMID).This marks the third overseas approval following Japan and Russia. The company plans to expand into additional countries using its Latin America entry as a foothold.Hunter syndrome is a rare inherited disease caused by a deficiency of the IDS (Iduronate-2-sulfatase) enzyme, leading to the accumulation of glycosaminoglycans (GAGs). It presents with skeletal abnormalities, joint deformities, respiratory and cardiac dysfunction, and cognitive impairment. It is known to occur in approximately 1 in every 100,000 to 150,000 male infants.About two-thirds of patients develop severe forms involving central nervous system damage. As the disease progresses, cognitive decline and behavioral abnormalities emerge, affecting patients’ quality of life and prognosis.Hunterase ICV is administered directly into the brain ventricles once a month. In Japanese clinical trials, it significantly reduced heparan sulfate, a key factor in CNS damage.The company also reported stabilization or improvement in cognitive and developmental functions, with sustained efficacy confirmed in long-term follow-up.Jae-woo Lee, head of R&D at GC Biopharma, said, “Based on long-term clinical data, we will focus on addressing the unmet medical needs of patients with severe Hunter syndrome.”
- Company
- SK bioscience's successful M&A
- by Chon, Seung-Hyun May 08, 2026 01:15pm
- The sales share of SK bioscience’s German contract development and manufacturing organization (CDMO) subsidiary has reached nearly 80%. By deploying funds secured during the COVID-19 pandemic into mergers and acquisitions (M&A), the company has strengthened its financial position and improved its defense against market pressures.According to SK bioscience, on the 7th, IDT Biologika’s first-quarter sales reached KRW 128.3 billion, an 8.5% increase from the same period last year.IDT Biologika is a German biotech company acquired by SK bioscience in 2024. SK bioscience purchased a 60% stake in IDT Biologika, previously held by the German biopharmaceutical firm Klocke Gruppe, through a wholly owned German subsidiary. The total acquisition price for IDT Biologika amounted to KRW 370.0 billion. SK bioscience decided to allocate paid-in capital to a third party, issuing 1,519,543 new shares worth KRW 75.7 billion to the Klocke Gruppe. Consequently, the total cash invested by SK bioscience in the acquisition of IDT Biologika is KRW 294.3 billion.Sales of SK bioscience and IDT Biologika (unit: KRW 100 million, source: SK bioscience) BLUE: SK bioscience, GREEN: IDT BiologikaFounded in 1921, IDT Biologika is a major biotech company operating CDMO businesses in Germany and the United States. It has a track record recognized by more than 10 core drug regulatory agencies, including those in the U.S. and Europe. The company develops processes and analytical methods while producing drug substances (DS) and drug products (DP) across the entire vaccine and biotech spectrum from clinical to commercial stages, employing approximately 1,800 people.IDT Biologika’s performance began to be reflected in SK bioscience’s consolidated financial statements starting from the fourth quarter of 2024. Revenue from IDT Biologika of KRW 111.2 billion was recognized in Q4 2024, and last year it recorded revenue of KRW 465.7 billion.With the inclusion of IDT Biologika’s results, SK bioscience’s revenue surged. In the first quarter of this year, SK bioscience’s revenue expanded more than sevenfold compared to the first quarter of 2024.SK bioscience faced significant fluctuations in performance throughout the COVID-19 pandemic.In 2020, SK bioscience signed a contract manufacturing agreement with AstraZeneca to produce and supply COVID-19 vaccine drug substances and finished products. In the same year, SK bioscience signed a tripartite agreement with the Ministry of Health and Welfare and Novavax to supply the COVID-19 vaccine 'NVX-CoV2373,' beginning full-scale contract manufacturing and supply in 2021.SK bioscience’s sales in the first quarter of 2020 was only KRW 22.7 billion. Then, it jumped nearly fivefold over the year to KRW 112.7 billion in the first quarter of 2021, and then rose to KRW 450.9 billion in the fourth quarter of 2021.However, as the contract manufacturing performance for COVID-19 vaccines dissipated, sales dropped. In the first quarter of 2023, SK bioscience’s sales amounted to KRW 20.6 billion, a 95.4% reduction compared to the fourth quarter of 2021.While sales fell sharply after the end of the pandemic, the M&A strategy successfully minimized the sales gap. In the first quarter of this year, IDT Biologika accounted for 76.1% of SK bioscience’s total sales. IDT Biologika’s sales were more than three times higher than SK bioscience’s separate sales of KRW 40.3 billion.From the fourth quarter of 2024 to the first quarter of this year, IDT Biologika’s cumulative sales reached KRW 705.2 billion, accounting for 72.2% of the parent company's sales.
- Policy
- Innovative pharmas need permanent pricing incentives
- by Lee, Jeong-Hwan May 08, 2026 01:15pm
- Rep. In-soon Nam of the Democratic Party of Korea has drawn attention by stating that permanent pricing incentives for innovative pharmaceutical companies should be institutionalized in order to advance Korea into a pharmaceutical and biotech powerhouse and create blockbuster new drugs.Rep. Nam criticized the Ministry of Health and Welfare, noting that while the ministry recently formalized a differential drug pricing system between innovative and non-innovative pharmaceutical companies through a resolution by the Health Insurance Policy Deliberation Committee, the inclusion of preferential pricing for innovative pharmaceutical companies only as a temporary provision left some gaps.Regarding legislation to introduce limited international nonproprietary name (INN) prescribing, Rep. Nam also expressed the view that it would be reasonable to either remove penalty provisions for doctors who fail to comply with mandatory INN prescribing regulations or to downgrade and relax these penalties to administrative fines.Her point is that policy and legislation should be pursued with a focus on ensuring that the public can access frequently out-of-stock and essential medicines without barriers, setting aside conflicts between specific professions such as doctors and pharmacists.Having officially announced her candidacy for Deputy Speaker of the second half of the 22nd National Assembly, Rep. Nam In-soon promised that, if elected, she would strive to create a national environment that advances the pharmaceutical and biotech industry and enhances public access to essential medicines.On the 7th, Rep. Nam held a meeting with the press corps and stated, “As the Jae-myung Lee administration has adopted a national agenda to transform Korea into a leader in digital health and the pharma-biotech industry, I will consider various ways to support this goal as Deputy Speaker.”“Pharma-biotech lost priority under Yoon administration… will restore momentum”Rep Nam assessed that while fostering the pharma-biotech industry has always been a priority across administrations, interest declined under the former Yoon, weakening growth momentum.In contrast, she noted that the Lee administration has set a goal of becoming one of the world’s top 5 pharma powerhouses and developing domestic blockbuster drugs, raising expectations for policy reforms across related ministries, including the Ministry of Health and Welfare.She therefore argued for the need to permanently extend preferential drug pricing for innovative pharmaceutical companies with the goal of fostering blockbuster new drugs.Rep Nam stated, “I have consistently advocated for differential pricing between innovative and general pharmaceutical companies, and I welcome its inclusion in the recent reform. However, making the incentive temporary limits its impact on new drug R&D investment.”“The government’s goal is to improve the domestic pharmaceutical industry’s structure using the funds secured through drug price cuts. If we want innovative new drugs and blockbusters to emerge in Korea, preferential treatment for innovative pharmaceutical companies cannot be temporary. Instead of offering temporary preferential treatment to innovative companies, we must remove the ‘temporary’ qualifier to allow for active support.”Rep Nam also noted that the Health and Welfare Minister Eun-Kyeong Jeong has shown a strong commitment to fostering domestic new drug development.She said, “The Lee administration has declared its intention to nurture blockbuster drug companies and has merged the Bio Committee and Bio-Health Innovation Committee. Previously, the Ministry of Health and Welfare did not appear to take a leading role, but after speaking with Minister Jeong Eun-kyung following the integration of the innovation committees, it appears the Ministry intends to take the initiative and carry out its duties. The atmosphere will change going forward.”He noted, “Currently, South Korea lags behind advanced countries in terms of pharmaceutical technology, new drug development, and medical AI, so we must catch up quickly. Since I enacted the Special Act on the Promotion of the Pharmaceutical Industry, preferential measures have been stalled for several years. If elected Deputy Speaker, I will prioritize this area in my legislative work.”“Let’s carry out limited INN prescribing focused on patients, without provisions punishing doctors”Regarding the limited INN prescribing bill currently pending in the National Assembly’s Health and Welfare Committee, Rep Nam expressed the view that even if provisions punishing doctors who violate the mandatory generic prescribing requirement are removed, a legislative environment must be created that ensures patients can access essential medicines without inconvenience.She emphasized that, since limited INN prescribing is a key policy agenda item of the current administration, efforts should focus on addressing resistance from the medical community and ensuring smooth institutional adoption.The current bill mandates INN prescribing for selected drugs designated by the Ministry of Health and Welfare following a government committee review, and stipulates penalties of up to one year in prison or a fine of up to KRW 10 million for violations.Rep Nam clearly stated that these penalty provisions should either be removed entirely or downgraded to administrative fines.She also noted the need to carefully consider concerns raised by the Korean Medical Association regarding the scope of bioequivalence testing and trust in substitution and INN prescribing.Rep Nam said, “The KMA is opposing the measure, raising concerns about the broad scope of bioequivalence testing, and their arguments should be taken seriously. We need further discussion on how to incorporate these concerns into policy. For now, it seems there is a lack of objective data or research on generic substitution and INN prescribing, so we need to accumulate more data.”She added, “Gradual implementation of INN prescribing for out-of-stock and essential medicines could serve as a middle ground between physicians and pharmacists. “Public awareness of generic substitution and INN prescribing has significantly increased during the COVID-19 pandemic, as more people have experienced receiving alternative drugs with the same active ingredient.”Nam emphasized, “We should activate systems such as post-notification of substitution and build more research data to support future legislative discussions. But imposing criminal penalties for INN prescribing violations is inappropriate. A more reasonable approach would be to remove penalties or reduce them to administrative fines, prioritize patient-centered legislation, and consider enforcement measures in stages.”“Warehouse pharmacy regulations need to prevent misuse”The recent amendment to the Pharmaceutical Affairs Act, which strengthens regulations on warehouse-style pharmacy advertising, is also one of Nam’s achievements.She explained that the ultimate goal of the regulation is to prevent excessive consumption and misuse of medicines that could lead to adverse effects.The provision in the Pharmaceutical Affairs Act prohibits expressions that may encourage misuse and delegates authority to the Ministry of Health and Welfare to specify concrete and unique expressions that cannot be used in pharmacy names or promotional slogans through subordinate regulations, prioritizing public safety above all else.Rep Nam said, “We also brought forward the implementation date from six months to three months after the government’s promulgation, and added a supplementary provision allowing public health centers to provide administrative guidance to pharmacists opening new pharmacies before the law takes effect. I was the one who codified the provision for pharmacists to provide medication guidance within the Pharmaceutical Affairs Act. At first, pharmacists weren’t very fond of it, but today, medication guidance has become a crucial system and phrase for ensuring public medication safety.”She continued, “When I look at warehouse-style pharmacies, I'm sorry whether pharmacists can actually provide proper medication guidance to patients. We must prevent the public from perceiving medications as mere commodities. Even after my election as Deputy Speaker, I will engage in policy monitoring to curb the misuse of medications by the public by regulating warehouse-style pharmacies.”
- Company
- Cochrane review on ineffectiveness of Alzheimer’s drug sparks backlash
- by Eo, Yun-Ho May 07, 2026 10:29am
- “Anti-amyloid Alzheimer’s drugs show no clinically meaningful effect.”The backlash is as fierce as the message itself. Last April, the Cochrane Database published the results of a systematic review and meta-analysis covering anti-amyloid targeted therapies.The study concluded that these drugs, as a whole, failed to demonstrate clinically meaningful benefits in inhibiting cognitive and functional decline and raised significant safety concerns, such as amyloid-related imaging abnormalities (ARIA).Cochrane is a nonprofit health research organization with over 11,000 experts from more than 190 countries worldwide, providing evidence to inform healthcare decision-making. Such an announcement in a prestigious academic journal naturally had a significant impact.However, before assessing the value and validity of the study, the academic community has come forward to directly refute the results of the Cochrane meta-analysis.It is true that the conclusions of a meta-analysis can vary completely depending on “how the data is pooled.”Medical professionals argue that the core of the controversy surrounding this review lies in the fatal “methodological limitations” inherent in the study design.Because the study produced results that fundamentally overturn the current landscape of clinical practice, it is also true that any misinterpretation could cause significant turmoil for patients with early-stage Alzheimer’s disease, whether they are about to begin treatment or are already undergoing it, as well as their families.Integration of drugs with different development stages and regulatory statusThe main criticism is this: the review analyzed in a single pool four drugs that failed to meet clinical endpoints (e.g., ‘bapineuzumab’), ‘aducanumab (withdrawn due to safety concerns),’ and currently approved ‘lecanemab’ and ‘donanemab.’The argument is that grouping drugs with fundamentally different levels of development maturity, regulatory status, and mechanisms of action with equal weighting is scientifically inappropriate.Furthermore, the review is criticized for indiscriminately combining exploratory early-stage clinical trials (Phase 2) with large-scale confirmatory trials (Phase 3). Small-scale Phase 2 data with low statistical power were treated on par with Phase 3 results involving thousands of participants, leading to a severe distortion of the overall effect estimate. As a result, positive signals from drugs like lecanemab or donanemab, whose efficacy was clearly demonstrated in individual clinical trials, were diluted by the vast amount of noise from drugs that had failed in the past.Ji-won Seo, planning secretary of the Korean Dementia Association (Dongguk University Ilsan Hospital), stated, “If drugs at different development stages and regulatory statuses are combined, results will inevitably be diluted by the majority of data from failed drugs. It is not scientific to group successful drugs, failed candidates, and even those whose approvals have been revoked into the same basket and conclude that ‘the efficacy of this class is unclear.’”Regulatory approvals are based on independent dataGlobal regulatory authorities worldwide evaluate new drugs based on the specific clinical data unique to each drug, rather than on a generalized impression of the entire class.For example, lecanemab has been approved in over 50 countries worldwide, including the US FDA (July 2023), Japan PMDA (September 2023), China NMPA (January 2024), Korea MFDS (May 2024), UK MHRA (August 2024), and the European Commission (April 2025).Donanemab has also received sequential marketing authorization in over 40 major countries worldwide, including the US (July 2024), Japan (September 2024), China (December 2024), and Europe (September 2025).This global wave of approvals was made possible by thorough and independent reviews by regulatory agencies in each country, which evaluated the clinical evidence supporting these drugs’ ability to inhibit cognitive and functional decline, as well as the manageability of side effects such as ARIA. This means that, unlike the results of the Cochrane Review’s overly broad meta-analysis, their actual clinical value has already been validated worldwide.The Cochrane review cited ARIA as a major safety concern. ARIA is divided into cerebral edema (ARIA-E) and microbleeds (ARIA-H). While these are side effects that require careful management in the ATT class, the majority are asymptomatic or mild and can be adequately managed through regular MRI monitoring.These safety profiles have already been thoroughly reviewed during regulatory approval processes and are reflected in labeling and prescribing information.Alzheimer’s disease is ultimately a fatal, progressive neurodegenerative disorder. Now that evidence has been established that intervention during the early symptomatic stage can slow disease progression, unfounded misconceptions can lead to negative outcomes, causing patients to miss the “golden window” for treatment.Seo added, “With new treatments emerging in a field that previously had limited options, expectations for early diagnosis and treatment are increasing. However, following recent reports of research findings that were misinterpreted, many patients are expressing anxiety in the clinic or experiencing confusion when deciding on a treatment plan.”Seo emphasized, “We must remember that each drug has been approved by regulatory authorities based on clear scientific evidence. If the optimal window for treatment is missed due to misunderstandings, it could later result in far greater burdens for patients and their families.”
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