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- 2026-07-23 18:45:21
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- 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.
- InterView
- [Reporter’s View] When intent doesn’t meet reality
- by Hwang, byoung woo Jul 22, 2026 08:50am
- While covering the issue of disinfectants used at pharmaceutical plants, the first thing that came to mind was the distance between regulatory necessity and real-world application.In the wake of South Korea’s deadly humidifier disinfectant scandal, few would dispute the need for tighter controls on chemicals and biocidal products. The intent of the system, which is to manage potentially hazardous substances in advance and establish clear standards for their use, is necessary.However, just because a system is designed with the right intentions does not mean it translates seamlessly into the field. Particularly in spaces like pharmaceutical manufacturing, where rigorous quality control systems are already in place, even minor changes in standards can lead to compounding procedural and validation burdens.On the surface, the issue appears straightforward. A biocidal product management system has been introduced, and pharmaceutical plants simply need to use disinfectants and sterilizing agents that meet the applicable standards. Yet, at pharmaceutical manufacturing sites, switching even a single disinfectant goes far beyond a simple change in procurement.This issue is unrelated to the ingredients or safety of the manufactured vaccines themselves, as the biocidal substances are not entering the vaccine drug substance or being mixed into finished products. The issue involves products used to disinfect manufacturing environments, including work areas, cleanrooms, and controlled areas at pharmaceutical plants.At pharmaceutical plants, disinfectants used to maintain aseptic conditions in work areas and cleanrooms are managed under Good Manufacturing Practice (GMP) standards. In the case of products such as vaccines and injectables, where aseptic control is particularly important, the manufacturing environment itself forms part of quality control.Therefore, every single disinfectant is managed according to the area and method of use, the amount applied, the replacement cycle, and relevant quality documentation. Before switching to a new product, manufacturers must verify that it provides the same disinfecting efficacy as the existing one and assess whether it may cause corrosion or reactivity issues with equipment or materials. Where necessary, cleaning and disinfection procedures, environmental monitoring standards, and standard operating procedures may also need to be revised.Nor can a product be used immediately at a GMP manufacturing site simply because it has received regulatory approval. A product that meets environmental safety standards is not necessarily the same as one suitable for maintaining an aseptic environment at a pharmaceutical plant.This is where gaps between the regulatory systems of different ministries become apparent. Products applied directly to the human body are regulated by the Ministry of Food and Drug Safety, while disinfectants used in manufacturing environments fall under the Ministry of Climate, Energy and Environment regulations. While the division of roles seems reasonable, the two domains do not neatly divide within the space of a pharmaceutical manufacturing site.From the Ministry of Climate, Energy and Environment’s perspective, such a product would be a biocidal product used at a workplace. From the Ministry of Food and Drug Safety’s perspective, however, it is a GMP-controlled element used to maintain the pharmaceutical manufacturing environment. The same product is viewed through two conflicting regulatory frameworks.This does not mean that safety regulations should be eased in any way, as the lessons of the humidifier disinfectant tragedy are clear. Rather, the application of safety regulations must be refined so that they do not give rise to new supply risks.For products such as influenza vaccines, which must be supplied during a specific period, even a minor change can become a burden. Replacing and validating a disinfectant takes time, and this may also create risks for production and release schedules.What is needed now is not a dispute over responsibility. The government should preserve the purpose of the regulations while establishing implementation standards that reflect the unique GMP requirements of pharmaceutical manufacturing sites. The industry, for its part, should not merely ask for grace periods, but should review the products in use and put systems in place to respond to the regulations.Regulations are becoming more stringent, yet sites that fall across ministerial boundaries are often left in regulatory blind spots. The issue of disinfectants used at pharmaceutical plants is one such example.It is time for the system to acknowledge the realities of the field and why changing a single disinfectant requires months of validation and paperwork.
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