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- 2026-07-25 03:58:12
- Company
- Invossa still mired in legal battles 7 years after license revocation
- by Kim, Jin-Gu Jul 24, 2026 08:21am
- Kolon TissueGene's knee osteoarthritis candidate TG-C failed to demonstrate improvements in pain and physical function in its U.S. Phase III trial. The clinical setback is expected to have a significant impact on the ongoing litigation involving Invossa Invossa-K Inj (Invossa), which is being pursued against Kolon TissueGene and Kolon Life Science. The two companies are currently involved in a total of 55 Invossa-related lawsuits with claims exceeding KRW 100 billion.Kolon TissueGene and Kolon Life Science in 55 damages lawsuits worth KRW 104.1 billionAccording to Korea's Financial Supervisory Service on July 23, Kolon TissueGene and Kolon Life Science are currently involved in 55 lawsuits related to Invossa—32 involving Kolon Life Science and 23 involving Kolon TissueGene. Most are claims seeking damages related to Invossa, with the total amount in dispute near KRW 104.1 billion.The plaintiffs who filed the lawsuit claim that they suffered physical and financial damages due to the change in Invossa's main cell line, which was revealed in 2019.Invossa drew global attention after receiving approval from Korea's Ministry of Food and Drug Safety (MFDS) in July 2017 as the world's first gene therapy for knee osteoarthritis. TG-C is the product's US development name.However, during the US Phase III trial in March 2019, it was discovered that one of the product's principal components, originally described as cartilage-derived cells, had in fact been replaced with kidney-derived cells that carry tumorigenic potential. The MFDS revoked Invossa's marketing authorization in April 2019, while the US Food and Drug Administration (FDA) placed the clinical trial on hold. The FDA later lifted the clinical hold in April 2020.Kolon TissueGene is currently facing 16 shareholder lawsuits seeking damages for investment losses. A total of 2,048 shareholders are participating in these cases, with claims amounting to KRW 55.5 billion. In addition, 931 patients who received Invossa have filed 6 damages lawsuits against Kolon TissueGene for KRW 12.2 billion.Kolon Life Science is also engaged in large-scale litigation with both shareholders and patients. Shareholders have filed 21 lawsuits seeking KRW 24.1 billion in damages, while 941 patients have filed 10 lawsuits seeking KRW 12.4 billion. The company is also being sued by multiple domestic insurers seeking reimbursement through subrogation claims.Industry and legal experts expect the latest US Phase III results to have little direct impact on the outcome of the damages lawsuits. However, they say the failed trial could increase the companies' financial and legal burdens when courts determine damages or during settlement negotiations.Most cases still await first-instance rulings at 7 years…Kolon loses first patient lawsuitAlthough more than 7 years have passed since the first wave of litigation began, the vast majority of cases have yet to receive even a first-instance ruling.A recent damages lawsuit filed by Invossa patients, however, resulted in the first trial court decision. On July 9, the Seoul Central District Court ruled entirely in favor of 139 patients who sued Kolon TissueGene and Kolon Life Science for damages.The court found that Invossa had been manufactured using kidney-derived cells rather than the cartilage-derived cells identified in the original marketing application, recognizing this as a “manufacturing defect.” It also concluded that marketing and selling the product while labeling it as containing cartilage-derived cells violated both the Pharmaceutical Affairs Act and the Act on Fair Labeling and Advertising. Accordingly, the court held the companies liable for both economic damages and emotional distress suffered by the patients. It rejected Kolon's argument that the defect could not have been identified based on the scientific knowledge available at the time of manufacture.Despite prevailing at trial, it will take more time for patients to receive compensation, as Kolon has appealed the ruling to the Seoul High Court. In addition, Kolon has blocked enforcement actions such as the seizure and collection of claims by patients by filing for a stay of execution.Most shareholder lawsuits likewise remain at the first instance stage. Three lawsuits against Kolon TissueGene have already concluded after plaintiffs withdrew their claims or courts recommended settlement. In 4 of the company's 16 shareholder lawsuits, however, trial courts ruled in favor of Kolon. The plaintiffs have appealed, with those cases now before the appellate court.By contrast, the dispute with Mitsubishi Tanabe Pharma over the return of upfront payments and damages arising from the terminated licensing agreement was resolved early on. In 2016, Kolon Life Science signed a technology licensing agreement with Mitsubishi Tanabe worth up to JPY 50 billion and received an upfront payment of JPY 2.5 billion. Mitsubishi Tanabe terminated the agreement in December 2017 and filed arbitration with the International Chamber of Commerce (ICC) the following April. After the changed cell line issue emerged in May 2019, it was added as an additional ground for termination. Ultimately, Kolon returned the JPY 2.5 billion upfront payment along with JPY 134 million in damages in April 2021.Administrative appeal over ‘Invossa license revocation’ still pending before Supreme CourtKolon Life Science is also pursuing administrative litigation in addition to the civil lawsuits. After the Ministry of Food and Drug Safety (MFDS) revoked Invossa's marketing authorization in 2019, the company filed an administrative lawsuit challenging the decision.Both the Seoul Administrative Court (first instance) in February 2021 and the Seoul High Court (second instance) in February 2024 ruled in favor of the MFDS. The courts found that the discrepancy between the cell component described in the marketing authorization application and the one actually detected constituted a material defect, dismissing Kolon's claims. Kolon subsequently appealed to the Supreme Court, where the case remains pending.In addition to the lawsuit over the revocation of Invossa's marketing authorization, Kolon Life Science also filed lawsuits seeking to ▲overturn the MFDS Commissioner's revocation of its clinical trial authorization, ▲ invalidate the Daejeon Regional Office of Food and Drug Safety's order to recall and dispose of Invossa, and ▲cancel the Ministry of Health and Welfare's and the Ministry of Science and ICT's orders to recover government research funding.Among these, the lawsuits challenging the revocation of the clinical trial authorization and the recall and disposal order were voluntarily withdrawn by Kolon Life Science. Meanwhile, the lawsuit seeking to overturn the government's recovery of research funding ultimately ended in Kolon's favor after reaching the Supreme Court. The company had received KRW 1.25 billion in government funding during the development of Invossa.Executives including former Chairman Woong-yeol Lee and CEO Woosok Lee were acquitted in criminal casesCriminal proceedings against Honorary Chairman Woong-yeol Lee, former CEO Lee Woo-seok, and other Kolon Life Science executives concluded with acquittals.Honorary Chairman Woong-yeol Lee and former CEO Lee Woo-seok were indicted on charges including violations of the Capital Markets Act and the Pharmaceutical Affairs Act. Prosecutors alleged that they concealed the US Food and Drug Administration's clinical hold order, attracted investment through the company's listing, manipulated the share price, and made false disclosures in violation of capital markets regulations.Both the first- and second-instance courts acquitted the defendants. The trial court found that the evidence presented was insufficient to conclude that the defendants knowingly concealed the cell line change or intentionally made false disclosures to attract investment.The appellate court (second instance) ruling was also handed down in February of this year. The Seoul High Court also upheld the acquittals. The appellate court ruled that the misunderstanding regarding the origin of the cells was recognized only after the product had already been manufactured and marketed, characterizing it as an error made during the development process rather than a deliberate cover-up. The acquittals became final after prosecutors decided not to appeal to the Supreme Court.The former head of Kolon Life Science's Bio New Drug Research Center and its former medical team leader were also acquitted by the Supreme Court. They had been charged with obstruction of official duties by fraudulent means, fraud under the Act on the Aggravated Punishment of Specific Economic Crimes, and violations of the Subsidies Management Act.The trial court ruled that there was insufficient evidence to conclude that they had interfered with the MFDS's review process or fraudulently obtained government R&D subsidies by deceiving government evaluators. However, the former medical team leader was found guilty of providing entertainment to an MFDS official and was fined KRW 10 million. The appellate court likewise found no evidence of intentional submission of false data or subsidy fraud, and the Supreme Court upheld those findings by dismissing the prosecution's appeal. The bribery conviction, however, was ultimately upheld, leaving the fine in place.
- Policy
- “Division of industry within the MOHW”…fostering pharma biotech
- by Lee, Jeong-Hwan Jul 24, 2026 08:21am
- Sung-il Oh, the Head of the Division of Pharmaceutical and Biotech Industry"I consider the Division of Pharmaceutical and Biotech Industry as the Division of Industry within the Ministry of Health and Welfare. While the traditional duties of the Office for Healthcare Policy on regulatory laws under the Medical Services Act and the Pharmaceutical Affairs Act, the primary mission of the Division of Pharmaceutical and Biotech Industry is fundamentally to promote and foster technology, markets, and the industry. My priority is to listen extensively and meet as frequently as possible with pharma companies, biotech firms, and healthcare sector stakeholders to build an environment where the industry can perform at its best."Core mission of the Division of Pharmaceutical and Biotech Industry under the Ministry of Health and Welfare (MOHW) include fostering domestic blockbuster novel drugs, providing policy support for the pharmaceutical and biotech sectors to address supply instabilities of essential medicines, modernizing the Innovative Pharmaceutical Company certification system, and nurturing the global pharmaceutical and biotech industry.Sung-il Oh, newly appointed as the Head of the Division of Pharmaceutical and Biotech Industry on July 22, clearly understood the aim of the division and its key responsibilities, despite returning to healthcare administration after a hiatus.Meeting with the press that day, Oh explained that while the current government, including the MOHW, considers strengthening public access to healthcare and enhancing patient convenience a major pillar of healthcare policy, it also recognizes the promotion and development of the pharmaceutical and biotech industry as a vital task to achieve.In outlining his aspirations as the new division head, Oh pledged to "listen as much as possible and meet as many people as possible." As the administration has defined the pharmaceutical and biotech industry as a key growth driver for the nation's future and signaled regulatory rationalization for its fostering and promotion, his commitment signifies an intention to directly observe and hear what regulatory improvements and policies the market actually requires.Oh highlighted, "The current government has a very keen interest in promoting the pharmaceutical and biotech industry, something I observed during my previous role as the Regulatory Reform and Legal Affairs Officer," and added, "Unlike the previous administration where the Regulatory Reform Committee functioned under the Prime Minister, the current administration's Regulatory Rationalization Committee is chaired directly by the President. Biotech has consistently been a major agenda item at presidential meetings."Oh continued, "The advice from senior officials was to listen first. I am personally experiencing that the pharmaceutical and biotech industry has many factors distinct from general healthcare administration, and I am studying various issues extensively." He stated, "I maintain an open-minded approach toward everyone who comes to visit. For now, my focus will be on properly executing well-crafted existing policies, such as the reform plan for the Innovative Pharmaceutical Company criteria."Oh concluded by stating, "Government interest in regulatory rationalization is high, and as the government believes that promoting the pharmaceutical and biotech industry will expand the nation's future growth engines, there seems to be deep deliberation at the top," and added, "While general healthcare administration primarily deals with occupational disputes and conflict mediation, and national health insurance focuses on fee adjustments, the Division of Pharmaceutical and Biotech Industry is a unit built to promote and foster. Perspective needs to shift significantly. I intend to learn thoroughly right from the basics."
- Policy
- Ban on succession of price caps deferred until next year
- by Jung, Heung-Jun Jul 24, 2026 08:21am
- The government will postpone implementation of a new rule blocking the succession of reimbursement price caps during pharmaceutical product transfers and acquisitions until next year, following a grace period through the second half of this year.The change regarding price cap succession in product transfers was not included in the drug pricing reform agenda reviewed by the Health Insurance Policy Deliberation Committee (HIPDC) in March. The government has likely decided to delay implementation in consideration of on-site acceptability.Discussions on improving the implementation of the revised drug transfer and acquisition rules took place during a public-private consultative meeting involving the Ministry of Health and Welfare, the Health Insurance Review and Assessment Service (HIRA), the National Health Insurance Service (NHIS), and industry representatives on July 22.AI-generated imageThe revision to the drug product transfer and acquisition system was included in the Ministry’s May amendment to the 'Standards for Drug Pricing Decisions and Adjustments.' Until now, for products transferred between companies, the same reimbursement price ceiling as before the transfer was applied.Under the revised system, however, products acquired through transfers will instead receive whichever is lower—the newly calculated reimbursement price or the existing price ceiling—to prevent companies from using transfers to circumvent the revised drug pricing system.Because the generic drug pricing rate will change under the new pricing framework, transferred products will effectively be subject to the newly calculated reimbursement price rather than retaining the previous reimbursement ceiling.The rules governing pharmaceutical product transfers have undergone several revisions over the years. Since 2021, however, transferred products have generally been allowed to inherit the existing reimbursement price ceiling.Because the Ministry had initially planned to implement the revised notification on Aug. 1 following its administrative notice in May, the timeline was considered too tight, prompting agreement to introduce a grace period.With implementation now postponed until January next year, products currently under transfer negotiations are expected to proceed without disruption.A wave of last-minute product transfers is expected as companies reorganize their product portfolios in the second half of the year in response to the broader drug pricing reform,Since this will be the final grace period during which acquiring companies can still inherit the existing reimbursement price ceiling, transfer activity is expected to become more active than usual.
- Policy
- Post-listing price cuts to be made every April and October
- by Jung, Heung-Jun Jul 24, 2026 08:20am
- The government is expected to exclude reimbursement expansion-related price cuts from its routine post-listing price cuts, which will take effect next year. The decision reflects concerns that patients could face delays in benefiting from lower drug costs, as well as the administrative complexity of refund procedures.At a public-private consultative meeting on drug pricing reform held on July 22, government and industry representatives discussed measures to improve the standardization of post-listing price cuts.In March, the Health Insurance Policy Deliberation Committee (HIPDC) agreed to align the timing of price cuts under various post-listing management mechanisms to April and October to improve the predictability of reimbursement price reductions.The routine post-listing price cut measure was approved by the HIPDC in March. Price cuts resulting from reimbursement expansions are expected to be excluded.Until now, reimbursement prices have been adjusted whenever a new indication was approved, or reimbursement coverage was expanded. The government sought to reduce these post-listing price cuts to two scheduled adjustments each year—in the first and second half of the year—to improve predictability for the industry.Under the original proposal, reimbursement expansions themselves would still take effect immediately. However, the resulting reimbursement price reduction was set to be deferred until the next scheduled adjustment, with pharmaceutical companies later refunding the difference.For example, if reimbursement coverage were expanded in January and the reimbursement price was therefore subject to a reduction, the amount corresponding to the delayed price cut until the April adjustment would be refunded afterward by the pharmaceutical company.However, this approach raised concerns that patients would not immediately benefit from lower drug costs at the time of reimbursement expansion.In addition, implementing the refund mechanism was expected to create a substantial and unnecessary administrative burden for both pharmaceutical companies and the National Health Insurance Service. As a result, the government has largely decided to exclude reimbursement expansion-related price cuts from the routine post-listing price adjustment schedule.Meanwhile, the government had previously planned to abolish actual transaction price-based price cuts after expanding incentives for lower-price drug purchasing but has decided to maintain the current system due to concerns about potential drawbacks. Reimbursement re-evaluations will also continue to be conducted when warranted rather than on an annual basis. The timing of price adjustments under these mechanisms will likely be brought into line with the new routine schedule.
- Product
- Novartis·Boehringer reportedly restructureing sales rights for blockbuster items
- by Kim JiEun Jul 24, 2026 08:20am
- AI-generated imageAs reports emerge that Novartis and Boehringer Ingelheim are pursuing business reorganizations to transfer the sales rights of major products in South Korea to local pharmaceutical companies or change their distribution partners, the pharmaceutical distribution industry is closely monitoring.It is reported that new distributors have been selected for certain products, or that negotiations are in their final stages, with the expectation that sales rights will transition sequentially as current contracts expire. However, the companies have yet to issue official statements.According to distribution industry sources on July 23, Novartis is reviewing measures to reorganize its sales strategies for several prescription drugs.Following its co-promotion of Gleevec with Yuhan, co-promotion models with domestic companies are also reportedly under consideration for products such as the lung cancer treatment Tasigna, the immune thrombocytopenia treatment Revolade, and the iron overload treatment Exjade.Recently, Novartis also signed a partnership agreement transferring the promotional and supply rights for its cardiovascular products, Diovan and Exforge, to DKSH Korea.Multiple industry sources said, "We understand that directions have already been set to some extent for certain items, while various candidate companies are being reviewed for the remaining products."It is being reported in the industry that Boehringer Ingelheim is pursuing a similar reorganization of its sales strategy.Industry reports indicate that for some products currently co-promoted with Yuhan, discussions are underway to transfer sales rights to other distributors upon contract expiration, with direction already effectively finalized for certain items.In particular, new distributors have reportedly been selected for around five items, including the inhaler Atrovent, and it has been raised that some items currently distributed by Yuhan will also undergo sequential distributor changes as contracts expire.In some quarters, the possibility of structural changes in sales for the diabetes treatment Jardiance is also being discussed.Wholesalers "closely monitoring margin changes"... Pharmacies "return issues could recur"The wholesale industry is reacting most sensitively to these rumored transfers of sales rights. This is because a change in distributor frequently accompanies changes not only to transaction terms, but also to margin structures and return criteria.Given that Novartis and Boehringer Ingelheim hold numerous high-volume products in the domestic market, business partners are closely monitoring potential changes in contract terms.Pharmacies are also expected to face difficulties in managing existing inventory if suppliers change. In the past, pharmacies experienced confusion during sales rights transitions as outgoing and incoming distributors repeatedly shifted responsibility for inventory returns to each other.However, industry analysts suggest that since most of the items involved are high-volume, frequently prescribed products with fast inventory turnover at pharmacies, the actual impact on the field could be limited.The industry views this rights reorganization as having a significant impact on distribution structures and commercial terms beyond a simple change of sales partners. As both Novartis and Boehringer Ingelheim hold substantial market share in major products in the domestic prescription market, wholesalers and pharmacies alike are closely watching for official announcements and contract progress.An industry insider stated, "When sales rights change, the distribution structure ultimately changes as well. The most sensitive aspects are margins and commercial terms from the wholesalers' perspective, and existing inventory management and return standards from the pharmacies' perspective. Although official announcements have not been made yet, the entire industry is keeping a close eye on these developments because the products involved hold such significant influence."Another industry official anticipated, "Because these products have high turnover rates, major chaos at pharmacies may not result. However, if inventory return standards or supply criteria change during the transfer of rights, both distributors and pharmacies could be considerably affected, making the final contract details crucial."
- Company
- HIV treatment evolving beyond 'once-daily'
- by Son, Hyung Min Jul 23, 2026 09:09am
- Competition in human immunodeficiency virus (HIV) treatment development is shifting from viral suppression efficacy toward enhancing patient dosing convenience.As once-daily oral therapy has become the standard of care, clinical outcomes for once-weekly oral treatments and twice-yearly preventive injections are being disclosed, demonstrating shifts in both therapeutic and preventive strategies.According to industry sources on July 23, major global pharmaceutical companies are scheduled to present research results on long-acting treatment strategies, including once-weekly HIV therapies and twice-yearly pre-exposure prophylaxis (PrEP), at the 26th International AIDS Conference (AIDS 2026) starting on July 26 in Rio de Janeiro, Brazil.First Phase 3 success for a once-weekly oral treatmentThe most highlighted result is the Phase 3 clinical trial results of an oral combination therapy combining Gilead's lenacapavir and MSD's islatravir.Lenacapavir is a long-acting agent that inhibits viral replication by targeting the HIV capsid. Islatravir is a nucleoside reverse transcriptase translocation inhibitor (NRTTI) with a mechanism distinct from conventional reverse transcriptase inhibitors, acting to block viral replication.Gilead is expanding its long-acting strategy in both treatment and prevention based on lenacapavir. Following the launch of 'Sunlenca' as a therapeutic agent, the company applied a separate product name, 'Yeztugo,' for its preventive indication.Until now, long-acting HIV treatment has centered on injectable agents administered up to once every two months or once-daily oral regimens. To achieve injectable-level dosing convenience with an oral formulation, both companies have been developing a once-weekly oral therapy combining the long-acting agent lenacapavir with the novel-mechanism islatravir.The global Phase 3 trials, designated ISLEND-1 and ISLEND-2, evaluated the efficacy and safety of switching from conventional daily oral therapy to once-weekly treatment (lenacapavir + islatravir) in virologically suppressed people living with HIV. Both studies demonstrated non-inferiority in viral suppression efficacy at 48 weeks compared to existing daily oral regimens.ISLEND-1 is a study comparing maintenance therapy with Gilead's 'Biktarvy' (bictegravir + emtricitabine + tenofovir alafenamide) against switching to lenacapavir + islatravir following Biktarvy administration.Among 607 patients evaluated, none in the lenacapavir + islatravir arm failed to maintain viral suppression at week 48, compared with 1 patient (0.3%) in the Biktarvy maintenance arm.Similar results were confirmed in ISLEND-2, which enrolled patients maintaining various daily oral regimens. At week 48, the proportion of patients with HIV RNA at or above 50 copies/mL (the threshold for viral suppression) was 1 patient (0.3%) in the lenacapavir + islatravir group and 4 patients (1.3%) in the baseline regimen group.Safety profiles were also comparable to existing therapies. Concerns regarding decreases in lymphocyte and CD4+ T-cell counts, previously raised during high-dose development, were not observed in these trials.If approved by regulatory authorities, lenacapavir + islatravir will become the world's first once-weekly oral HIV treatment.Twice-yearly era for prevention… Expanding long-acting strategiesGilead 'Yeztugo'In addition to HIV treatment, long-acting strategies are expanding into pre-exposure prophylaxis (PrEP) to prevent infection.Gilead will also present long-term follow-up data for its twice-yearly HIV prevention injection, Yeztugo. This study evaluated post-approval long-term preventive efficacy and real-world persistence, focusing on confirming the clinical value of long-acting PrEP.n the PURPOSE 1 trial, 95% of eligible participants chose to continue with Yeztugo in the open-label extension, with zero incident HIV cases reported during the 52-week follow-up period.In PURPOSE 2 as well, 95% of participants selected Yeztugo administration, maintaining adherence rates above 90%.The twice-yearly administration regimen is recognized as a strategy that reduces pill burden and improves persistence compared to daily oral PrEP.Beyond efficacy into a 'dosing interval' competitionGSK 'Cabenuva'In addition to Gilead, GSK's injectable 'Cabenuva' (cabotegravir + rilpivirine), administered once monthly or once every two months, holds an established position in the long-acting HIV treatment market.Gilead is also pursuing the development of next-generation long-acting therapeutics, including once-weekly oral treatments, twice-yearly preventive injections, and combinations of lenacapavir with broadly neutralizing antibodies (bNAbs).MSD also recently secured FDA approval for its once-daily islatravir-based combination tablet, 'Idvynso,' while concurrently advancing the development of a once-monthly oral PrEP candidate (MK-8527) and a once-weekly oral treatment.Currently, daily oral medication is the standard of care in HIV treatment. As development progresses from long-acting injectables to once-weekly oral therapeutics, options personalized to patients' lifestyles and treatment preferences are expected to become increasingly diverse.
- Company
- Pyderin’s choice as PDRN is trending
- by Hwang, byoung woo Jul 23, 2026 09:08am
- Pyderin symposium landscapeAmid the rapid rise in PDRN products, Pyderin is demonstrating distinction in the market, highlighting its raw-material technology and studies on human application.Rather than expanding its product lineup by riding trends, the company's strategy is to establish a trustworthy benchmark for pharmacists and consumers by scientifically validating PDRN's origin, purity, molecular size, and skin-delivery capacity.On July 21, Pyderin held the 'REDEFINE SYMPOSIUM' at Josun Palace in Seoul, unveiling the PDRN raw material technology and research findings applied to its products."Not all PDRN Is created equal…raw material specifications are the starting point"First, CEO Hye Won Lim of Shebah Biotech described PDRN as a DNA-based biopolymer, emphasizing that the required characteristics of the raw material vary by application, including cosmetics, medical devices, and pharmaceuticals.PDRN is utilized across various sectors, including cosmetics, medical devices, and pharmaceuticals, based on its mechanisms of action, which involve anti-inflammation, cell and tissue regeneration, and angiogenesis. However, Lim explained that because required functionalities and applicable regulations differ by industry, it is difficult to apply a single raw material specification to all products uniformly.Cosmetics require a relatively small molecular size to facilitate skin delivery. Conversely, medical devices must also consider physical properties such as viscosity and skin retention time. This implies that technology engineered to tailor PDRN's molecular size to the product's intended use is essential.Under these circumstances, Pyderin used PDRN raw materials with molecular sizes specifically tailored for cosmetic applications. Rather than simply formulating the PDRN ingredient, the company engineered the size and specifications right from the raw material stage centering on skin delivery.During the symposium, Pyderin highlighted the differentiation of the PDRN raw materials used in its products through a symposium booth.CEO Lim stated, "PDRN for cosmetics must be designed in relatively smaller sizes for absorption, while PDRN for medical devices requires larger sizes for retention and viscosity," adding, "Technology that can adjust the raw material size according to the industry and product purpose is crucial."The raw material used in Pyderin products is also verified to confirm its biological species. After receiving the raw materials, Sheba Biotech verifies the salmonid species through genetic analysis, then purifies and adjusts the molecular size of the raw material for use in Pyderin products.CEO Lim emphasized, "We utilize genetic analysis methods to distinguish whether the raw materials actually originate from salmon," and added, "Once the origin of the raw material is confirmed, we extract the DNA and process it according to the intended use of the product."Human application studies confirm changes in skin metricsIn the subsequent presentation, Dr. Ki Su Sung of Chungdam Jeunex Clinic (Director of the Korean Society for Obesity and Aesthetic Medicine) presented the results of a human application study evaluating the feasibility of applying PDRN formulations to the skin.The research team created micro-channels in the skin using a fractional laser and then applied the PDRN formulation. Subsequently, the treatment was repeated at set intervals, and changes in skin condition were evaluated.The study went beyond simple visual assessment to measure skin-related parameters such as wrinkle depth and pigmented area. Participant satisfaction and any adverse sensations or discomfort experienced during product use were also monitored.Dr. Sung explained that major skin metrics improved after application of the PDRN formulation, and the improvement trend continued during follow-up. He added that virtually no distinct adverse reactions were reported during the study.A key feature of this study was the application of PDRN after creating skin delivery pathways via laser treatment. It explored the potential to overcome the skin-delivery limitations of large-molecule PDRN and to utilize it for post-dermatological-procedure recovery and care.Dr. Sung explained that combining dermatological procedures with PDRN formulations and applying the product repeatedly could also assist in post-procedure skin management.(From left) Hye Won Lim, CEO of Shebah Biotech; Dr. Ki Su Sung of Chungdam Jeunex Clinic; Jung Bin Kim, Chief Medical Director of Chungdam Jeunex ClinicDosage alone cannot judge topical PDRNJung Bin Kim, Chief Medical Director of Chungdam Jeunex Clinic, noted that while PDRN has emerged as a mainstream ingredient in the cosmetics market, the quality of the raw material and its skin-delivery efficacy can vary from product to product.This means that for topical PDRN to function effectively on the skin, it is not enough to simply blend the ingredient. Raw material purification, molecular size, application concentration, and delivery mechanism must all be scientifically engineered.Dr. Kim stated, "Topical PDRN is effective, but on one condition," adding that, "It must be purified and properly manufactured based on solid science. Simply producing it haphazardly will not yield results."PDRN has a relatively larger molecular size compared to general cosmetic ingredients like vitamin C. It is difficult to assume that a sufficient amount is delivered merely by applying it onto the skin surface; thus, the molecular size and formulation must be designed specifically for optimal skin absorption.Even if a product contains a high concentration of PDRN, if the actual percentage delivered into the skin is low, it is difficult to achieve the expected results. This is why product efficacy should be evaluated by examining the molecule size, concentration, and delivery system that can actually reach the skin, rather than judging by raw material content alone.Dr. Kim said, "The core criteria for selecting a good PDRN product come down to two factors: purity and molecular size," and highlighted, "Designing a smaller molecular size to enhance skin delivery and purifying the DNA raw material to high purity are where the true technological capabilities lie."Pyderin was designed by increasing the purity of the PDRN raw materials and reducing their molecular size to suit cosmetic applications. During the presentation, it was also explained that Pyderin's raw material was engineered with a smaller molecular size than conventional PDRN raw materials.In particular, Dr. Kim evaluated this raw material engineering as the key driver in enhancing the skin delivery capacity of Pyderin's PDRN formulation.He also introduced cases of Pyderin product use after dermatological laser and injection procedures. This approach manages skin dryness and irritation that may occur immediately after a procedure and supports the recovery of damaged skin through repeated applications thereafter.Accordingly, it was explained that this can serve as a rationale not only for post-procedure care at clinics but also for pharmacists to recommend appropriate products based on a consumer's skin condition and procedure history."Validation, Not Trends"... Targeting global markets on a foundation of pharmacy trustPyderin structured this symposium not merely as a product launch event but as a platform for disclosing raw material technology and research evidence.Min-Geon Kim, CEO of Pyderin, defined the brand's starting point as "validation, not trends." He explained that establishing a steadfast standard over time by confirming the product's value through scientific evidence and data was the reason for launching Pyderin.Min-Geon Kim, CEO of PyderinCommunity pharmacies were selcted for Pyderin as its initial distribution channel in November last year. According to CEO Kim, the products entered over 2,000 pharmacies nationwide within just eight months of launch.The company currently collaborates with Baekje Pharmaceutical, a domestic pharmaceutical distributor, to supply products to pharmacies.CEO Kim viewed this not merely as a count of store placements, but as the accumulated result of trust built with pharmacists who gave a new brand an opportunity.Furthermore, Pyderin disclosed that while it expanded into the Shinsegae Duty Free Myeongdong store in April this year to gauge consumer feedback, it withdrew just 45 days after entry due to concerns that expanding distribution channels might undermine the trust established with its existing pharmacy network.CEO Kim stated, "We believed that expanding into new channels should not compromise the value and trust of our existing network," adding, "Rather than focusing simply on selling more, we aim to become a brand that our partners can trust over the long term."He added, "We will build a brand that pharmacists can confidently recommend as experts, and one where domestic and international partners can grow together believing in Pyderin's values and principles. We will prove our product capabilities in the global market."Amid intensifying competition in the PDRN market, Pyderin presented the origin and specifications of its raw materials, skin delivery efficiency, and human application evidence as its key differentiators.In the future, how Pyderin specifically accumulates raw material test results and human application data, and connects them into actionable rationale for pharmacy settings, is expected to determine the success of its validation strategy.
- Policy
- Novartis to build ₩140 Billion RLT Plant in Korea
- by Lee, Jeong-Hwan Jul 23, 2026 09:08am
- The multinational pharmaceutical company Novartis will make a major investment of approximately KRW 140 billion to foster a radioligand therapy ecosystem in Korea.The investment is expected not only to establish a domestic production base for the company, but also to significantly improve access to treatment.The fact that investment in Korea by Novartis and other global pharmaceutical companies is expanding beyond clinical trials, research and development, and open innovation into the construction of manufacturing facilities is also significant.On the 21st, the Ministry of Health and Welfare (Eun-Kyeong Jeong, Minister) signed a memorandum of understanding with Novartis (Judith Love, President of Asia Pacific, Middle East and Africa) on the creation of an ecosystem for radioligand therapy in Korea at Novotel Ambassador Seoul Yongsan.Radioligand therapy combines a radioactive isotope with a ligand that binds to a target protein on cells. It is an innovative advanced biotherapeutic technology that kills cancer cells by directly breaking their DNA. One representative example is Novartis’ ‘Pluvicto Inj,’ which received approval from the Ministry of Food and Drug Safety in 2024 and has since been administered to patients in Korea.Under the agreement, Novartis plans to invest approximately KRW 140 billion to substantially strengthen Korea’s radiopharmaceutical industry capabilities.Specifically, Novartis will build an RLT manufacturing facility in Korea and establish an advanced cold-chain logistics network. It will also expand the number of hospitals capable of administering RLT from the current 10 to 30.Furthermore, the company will focus investment in building the broader RLT ecosystem, including the training of domestic specialist researchers to global standards.Novartis has invested in and collaborated with Korean pharmaceutical companies in various areas, including technology transfer and clinical research. Its latest investment in an RLT production facility, which expands these collaborative achievements into the advanced biopharmaceutical field, is expected to strengthen Korea’s research, development and manufacturing capabilities in radiopharmaceuticals.Minister Jeong said, “We sincerely welcome Novartis's decision to make a large-scale manufacturing investment in Korea. It is meaningful that a global leader in the pharmaceutical and biotechnology market has shown confidence in Korea's outstanding technological capabilities and potential. This agreement will serve as a significant turning point in providing innovative treatment options to patients in Korea.”Judith Love, President of Novartis APMA, added, “This agreement represents an important step in accelerating the advancement of Korea’s RLT ecosystem and strengthening the country’s role in future healthcare innovation. We will work closely with the Korean government and healthcare stakeholders to benefit more patients with our innovative cancer treatments.”
- Company
- Government-Industry clash over price-cut base date
- by Kim, Jin-Gu Jul 23, 2026 09:08am
- With the revised drug pricing system set to take effect in just over a month, the base date used to determine the extent of price cuts for already-listed generics has emerged as a key variable.The government maintains that the 45% pricing rate should be applied based on drug prices at the time the revised system takes effect. The pharmaceutical industry, however, argues that the base should be the prices in place at the time of the across-the-board drug price cuts in 2012, given that prices have since been reduced several times afterwards.As the difference in the base date could result in additional losses amounting to hundreds of billions of won, industry anxiety is rising.September 2026 vs April 2012…Disagreement over base date used for pricing rateAccording to the industry sources on July 22, the core of the reform is to lower the generic drug pricing rate from the current 53.55% to 45%. On the surface, this appears to be a reduction of 8.55 percentage points, but the actual size of the cut can vary significantly depending on which point in time is used to determine the original price to which the rate is applied.The government plans to regard the price in place at the time of the September 2026 pricing reform as 53.55% of the original drug price and apply the new 45% pricing rate on that The pharmaceutical industry, by contrast, argues that the base should be the price in April 2012, when the 53.55% standard was first introduced, or in January 2014, when the system had become established. The industry submitted this position during the recent public comment period for the drug pricing reform proposal.Repeated price cuts made through Price-Volume Agreements and Actual Transaction Pricing…Concerns over “double cuts”The pharmaceutical industry points out that reimbursed drug prices have continued to decline under the government’s post-listing management measures, including the price-volume agreement system and actual transaction price-based reductions.It also notes that many products have had their prices cut through generic drug price reevaluations, reimbursement and clinical reevaluations, or voluntary price reductions. The industry therefore argues that using the current point in time (September 2026) as the base amounts to double regulation.An industry official said, “Drug prices have already been reduced several times under the government’s various post-listing management measures. The government’s proposal would cut these already-lowered prices once again, effectively disregarding previous reductions and imposing regulation twice.”“The 53.55% rate itself was created in conjunction with the across-the-board drug price cuts in 2012. It would therefore be reasonable to apply the 45% generic pricing rate based on prices at the time of implementation.”Plavitor price cut 7.5% over 14 Years…may incur an additional KRW 5.7 billion loss depending on the base dateThe impact of the base-date difference on projected pharmaceutical sales is clearly illustrated by Samjin Pharmaceutical’s clopidogrel antiplatelet drug ‘Platless.’ Even when the price is reduced to the same 45% level, selecting a different base date results in an additional annual loss of KRW 5.7 billion.Immediately after the across-the-board price cuts in April 2012, Platless was priced at KRW 1,164 per tablet. Its current price is KRW 1,077, representing a 7.5% decline over 14 years.Under the government proposal, which uses 2026 as the base, dividing the current price of KRW 1,077 by 0.5355 produces an original drug price equivalent to KRW 2,011. Under the industry proposal, which uses 2012 as the base, the then-price of KRW 1,164 produces an original price of KRW 2,174.In other words, using the current price, which has already been reduced through mechanisms such as the price-volume agreement system, means beginning with an original-price equivalent that is KRW 163 lower.Applying the government’s new 45% pricing rate to the converted original price would be 45% of KRW 2,011, resulting in a final price of KRW 905. This is KRW 172 below the current price of KRW 1,077, representing an effective price cut of 16.0%.Applying 45% to KRW 2,173 under the industry’s proposed method would produce a price of KRW 978. This is KRW 99 below the current price of KRW 1,077, representing an effective reduction of around 9.2%. As a result, using the current price rather than the 2012 price as the base creates a 6.8-percentage-point difference in the effective reduction, at 16.0% versus 9.2%.Applying these reduction rates to Platless prescription sales last year produces a clear difference in the projected decline in sales.Under the government method, a 16.0% reduction would result in annual prescription sales losses of KRW 13.4 billion. Under the industry’s requested method, a 9.2% reduction would result in annual losses of around KRW 7.7 billion. A change in the base date alone would therefore cost Samjin Pharmaceutical an additional KRW 5.7 billion in losses annually from a single product.Additional loss near KRW 27 billion across all clopidogrel productsThe difference is not limited to one product. Other clopidogrel generics have undergone almost the same drug price reduction mechanisms as Platless.The current outpatient prescription market for clopidogrel antiplatelet drugs is estimated at approximately KRW 530 billion. Excluding the original product Plavix (KRW 130 billion), the generic market totals approximately KRW 400 billion.Applying the difference between the government’s and industry’s reduction rates to the entire clopidogrel generic market produces a gap of KRW 27 billion. Under the government method, total losses across generics would amount to approximately KRW 63.9 billion, compared with KRW 36.7 billion under the industry’s proposed method.Korea’s generic drug market includes numerous large-volume ingredients with annual sales in the hundreds of billions of won, including valsartan, amlodipine and atorvastatin. If the same calculation is extended across the entire market, the annual loss gap for the domestic pharmaceutical industry could expand into the hundreds of billions of won, depending on which base date is selected.
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- Will Blenrep be reimbursed in the second half of this year?
- by Eo, Yun-Ho Jul 23, 2026 09:08am
- Attention is turning to whether the reimbursement listing process for Blenrep, a new antibody-drug conjugate (ADC) treatment for multiple myeloma, will finally make progress.According to DailyPharm’s reporting, Blenrep (belantamab mafodotin), GSK Korea’s first-in-class anti-BCMA antibody-drug conjugate (ADC) targeting B-cell maturation antigen (BCMA), is expected to be placed on the agenda of an upcoming meeting of the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee.Blenrep was designated under Korea’s Global Innovative Products on Fast Track, or GIFT, program. It received domestic approval in December last year and was launched without reimbursement in April.Therefore, it remains to be seen whether Blenrep will secure reimbursement and establish itself as a viable prescribing option.Specifically, Blenrep is indicated ▲ in combination with bortezomib and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy; and ▲ in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy, including lenalidomide.Blenrep demonstrated efficacy in the open-label Phase III DREAMM-7 and DREAMM-8 trials.In DREAMM-7, median progression-free survival was 36.6 months in the Blenrep combination group (BVd: belantamab mafodotin, bortezomib, dexamethasone), showing a statistically significant improvement compared with 13.4 months in the control group (DVd: daratumumab, bortezomib, dexamethasone). At a median follow-up of 39.4 months, overall survival was also significantly improved, with a 42% reduction in the risk of death.Interim analysis results of DREAMM-8 (median follow-up: 21.8 months) showed that median progression-free survival had not been reached in the Blenrep combination group. The regimen demonstrated a statistically significant improvement in progression-free survival, with a median of 12.7 months in the control group.Multiple myeloma is a blood cancer in which malignant plasma cells proliferate excessively in the bone marrow and replace normal plasma cells. These malignant plasma cells produce an abnormal protein known as M-protein, which can cause bone lesions accompanied by pain as well as anemia. In Korea, approximately 1,961 new cases of multiple myeloma are reported annually, accounting for around 0.7% of all cancer cases(2022, Korea Central Cancer Registry).
