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- 2026-06-06 11:22:09
- Policy
- Government support for the next Leclaza discovery continues
- by Lee, Jeong-Hwan May 06, 2026 03:29pm
- Kang-seop Lim, Director of the Pharmaceutical Bio Industry Division, MOHW“A new drug candidate from the biotech venture Genosco was licensed out to Johnson & Johnson in the U.S. via the mid-sized pharmaceutical company Yuhan Corporation, leading to the creation of Leclaza. This is a prime example of a successful pharmaceutical and biotech startup from Korea. We plan to continue pushing forward with government policies this year to provide full support until the end, ensuring that more startup models emerge, with policies that support the commercialization of such early-stage discoveries.”The Ministry of Health and Welfare is unveiling a specialized startup fostering roadmap for the pharmaceutical and biotech sector for the first time in history, aiming to create domestic blockbuster drugs like a “second Leclaza” from the venture stage.The plan will provide full-cycle support to ensure promising drug candidates are not lost, linking technologies from universities, hospitals, and research institutes to startups, scaling them up, and supporting global expansion.On the 3rd, Kang-seop Lim, Director of the Pharmaceutical Bio Industry Division, stated that a startup support plan will be developed jointly with the Ministry of SMEs and Startups (MSS) and announced by June or July.With the newly established division within MOHW and Director Lim dedicating his full efforts as its first head, there is a growing momentum to develop multifaceted policies for the promotion of the pharmaceutical and biotechnology industry.This initiative follows President Jae-myung Lee’s ‘Startup Nation’ strategy announced in January.At that time, President Lee instructed all government ministries to build a startup ecosystem where anyone, including young people, regional entrepreneurs, and deep-tech startups, can pursue entrepreneurship.The MOHW is joining forces with the MSS on the plan, following their earlier announcement of collaborative measures for pharmaceutical and biotech industry policies.This amounts to establishing specific policy measures to promote and foster startups in the pharmaceutical and biotech industry, with the revitalization of startups in this sector serving as the policy goal and overarching framework.Director Lim pointed to research institutes within universities, medical institution research centers, including those in university hospitals, and government-funded research institutes as the specific targets of this policy.This administrative initiative aims to increase the number of cases where new drug candidates currently being researched by professors, doctors, and scholars are brought to the forefront through government-supported startups, commercialized and productized through processes such as licensing out, and then expanded beyond the domestic market into the global market.Director Lim cited Leclaza as a representative example. He explained that this is a policy in which the MOHW and MSS joined forces to ensure that a highly marketable domestic new drug, capable of succeeding in both domestic and overseas markets, was developed through the Genosco-Yuhan Corporation-Johnson & Johnson track.Director Lim stated, “Lecraza is a representative success case in which an early-stage drug candidate developed by Genosco was licensed by the mid-sized pharmaceutical company Yuhan, and later out-licensed to Johnson & Johnson for commercialization in overseas markets. This is a prime example of a successful pharmaceutical and biotech startup, and the government plans to support more cases like this.”He added, “In Korea, pharma-biotech startups typically emerge through several routes, including ventures founded by professors and researchers in university labs, physicians in hospitals, and researchers at government-funded institutes. A significant number of new drug candidates are likely to originate at the researcher or academic stage. The policy focus is on how the government can support these efforts when they transition into pharma-biotech startups.”Lim continued, “Given the limited size of the domestic market, global expansion is inevitable. We will support pharma-biotech startups not only in scaling up after their establishment, but also through to global expansion and commercialization.”He further stated, “This is the first time the Ministry of Health and Welfare has introduced a policy specifically targeting pharma-biotech venture startups. While we are still working through the details and identifying actionable support measures, we plan to finalize and announce the startup support plan by July. Ultimately, our goal is to establish a Ministry of Health and Welfare policy that identifies and supports startups that will serve as the seeds for large-scale innovative drug development.”
- Policy
- Remote delivery of medical supplies for rare disease patients allowed
- by Lee, Jeong-Hwan May 06, 2026 03:29pm
- Minister Eun-kyeong Jeong ㅆhe Ministry of Health and Welfare announced that starting on the 4th, it will implement a “non-face-to-face direct delivery service for medical products” targeting rare disease patients, patients with severe intractable diseases, and severely ill children.This is to ensure stable access to medical products for patients with rare diseases who are facing difficulties in securing necessary medical supplies due to the prolonged Middle East conflict.Target conditions include short bowel syndrome, Cornelia de Lange syndrome, Pompe disease, and biliary atresia. Medical products (including pharmaceuticals and medical devices) in high demand for each disease group, such as syringes and IV lines, are included in the remote delivery program.The Ministry will provide one-stop support through the telemedicine platform ‘Soldoc,’ which allows patients to consult with representatives via chat and make product purchases and delivery after patients and caregivers go through the verification process.In the future, the model will expand to include customized in-person and remote care, collaboration between large and local hospitals, and delivery of pharmaceuticals and medical supplies.On the 3rd, Minister Eun-kyeong Jeong held a roundtable meeting at Seoul National University Hospital Rare Disease Center with representatives from the Korean Organization for Rare Diseases, SNUH medical staff, and the Soldoc platform to discuss the initiative.During the meeting, participants shared challenges faced by rare disease patients due to the Middle East conflict, and decided to immediately launch a direct delivery service for medical supplies in collaboration with the telemedicine platform Soldoc.Patients with rare diseases are defined as those suffering from rare conditions affecting 20,000 people or fewer, as stipulated by the Rare Disease Management Act. Among these patients, those who must manage their conditions at home using medical supplies such as syringes and IV sets are facing difficulties due to rising prices and shortages of medical supplies caused by the war in the Middle East.In fact, Mr. A, a caregiver for a patient with short bowel syndrome, expressed his anxiety, saying, “I was worried because the IV sets I used to buy online were often out of stock due to the situation in the Middle East.”Ms. B, who cares for a child with Cornelia de Lange syndrome, also said, “Syringes and disposable vials are essential for the children’s nutritional support (enteral feeding) and medication administration, so I was worried I wouldn’t be able to obtain the supplies I usually buy from online shopping sites.”Ultimately, the difficulties in securing medical supplies purchased through online shopping sites due to the fallout from the Middle East conflict led to a partnership between the Ministry of Health and Welfare and the telemedicine platform SolDoc.Unlike general online shopping sites, Soldoc has a system in place to verify eligibility, being linked with medical institutions to confirm whether a patient has a rare disease.Through this system, when a patient with a rare disease or their caregiver submits a purchase request via the internet or app, eligibility verification is easily conducted through the National Health Insurance Service system.Once verified, they can purchase products and receive delivery, paying out-of-pocket for non-reimbursed items.For items covered under medical expense reimbursement that require prescriptions, patients can consult doctors via telemedicine before purchase. Claims are handled by the provider, and patients only pay their coinsured share.Items available include syringes, infusion sets, suction tips, suction catheters, sterile saline, and disinfectant swabs.The Ministry plans to expand the program to include patients with severe intractable diseases and children receiving medical expense support, if necessary.Additionally, the Ministry is considering pharmaceutical delivery for urgent cases.Telemedicine will be formally implemented in December, following revisions to the Medical Service Act. The revised law allows telemedicine for rare disease patients.In particular, patients with rare diseases can receive telemedicine services even at hospital-level or higher medical institutions, and the delivery of drugs and supplies is also permitted. The Ministry plans to strengthen services focused on those requiring essential medical services through telemedicine before the law takes effect.Minister Eun-kyeong Jeong promised, “The state and society will take responsibility to ensure that patients are not marginalized or left in anxiety simply because their diseases are rare. We will provide financial support for the cost of medical supplies if needed after reviewing the burden of medical supply costs.”Meanwhile, on the same day, Minister Jeong, Soon-heon Kwak, Director General of Health and Medical Policy, Jin-hyang Jeong, Secretary General of the Korean Organization for Rare Diseases, seven patients, and six medical staff members, including Joong-shin Park, Vice President for Medical Services at Seoul National University Hospital, held a staff meeting at Seoul National University Hospital in Jongno-gu, Seoul, after the roundtable meeting.
- Company
- A year after Leclaza securing European approval…Yuhan
- by Chon, Seung-Hyun May 06, 2026 03:28pm
- Yuhan expects to receive a $30 million technology fee payment for the European market entry of its new anticancer drug, Leclaza, soon.During the recent Q1 business performance presentation, Yuhan stated, “We expect to receive the $30 million milestone associated with the European launch of the lazertinib combination therapy soon,” and added, “The business plan established early this year is progressing smoothly.”Lazertinib, the active pharmaceutical ingredient of Leclaza, is a new anticancer drug developed by Yuhan. Leclaza is a non-small cell lung cancer (NSCLC) treatment that was approved in January 2021 as the 31st domestically developed new drug in Korea.In December 2024, the European Commission (EC) approved the combination therapy of Leclaza + Rybrevant as a first-line treatment for adult patients with locally advanced or metastatic NSCLC harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.While the $30 million (approx. KRW 44 billion) milestone was met with Leclaza's entry into the European market, the payment has not yet been received, despite 17 months having passed. According to the company, the milestone will be transferred once sales of Leclaza begin in major European countries. Since the beginning of this year, Leclaza has been listed for health insurance in countries such as the UK, Switzerland, Italy, and Germany, and sales have begun. Securities analysts anticipate the European technology fee will be received within the first half of the year.Yuhan recorded KRW 5 billion in technology fee revenue in the first quarter. This is a 23.7% increase from the KRW 4 billion recorded in Q1 of last year, but significantly lower than the KRW 70.3 billion recorded in the previous quarter. Technology fee revenue inherently fluctuates, as it is generated from new drug licensing agreements or the advancement of development stages for licensed-out drugs.Last year, Yuhan received KRW 104.1 billion in technology fee revenue, with milestones from approvals in Japan and China accounting for a large portion.In May of last year, as the Japanese Ministry of Health, Labor and Welfare approved the Leclaza + amivantamab combination therapy, the requirement for an additional $15 million milestone was met, resulting in KRW 25 billion in technology fee revenue in Q2 of that year.In Q4 of last year, KRW 70.3 billion in technology fees were received. In August last year, China's National Medical Products Administration (NMPA) approved Leclaza as a combination therapy with Rybrevant, and Yuhan received a $45 million (KRW 69 billion) milestone from its partner, Janssen Biotech, for achieving the step-by-step milestone for Leclaza.Yuhan's Q1 technology fee revenue includes royalties from Janssen's sales of Leclaza. In 2024, the Leclaza and Rybrevant combination therapy received U.S. FDA approval, and sales in the U.S. began. According to Johnson & Johnson's performance data, Q1 sales of the Leclaza-Rybrevant combination therapy reached $257 million (approx. KRW 300 billion), an 82.7% increase year-on-year.Yuhan stated, “Prescription of the Leclaza combination therapy is expanding in major markets such as the U.S. and Europe, and we have secured a foundation for full-scale revenue growth through its listing as a 'Preferred Treatment' in the NCCN guidelines and the approval of the Rybrevant SC formulation.”In the 2026 National Comprehensive Cancer Network (NCCN) guidelines for NSCLC, the Leclaza + Rybrevant combination therapy was included as a 'Preferred Treatment' for first-line treatment. Leclaza is the first domestically developed new drug to be incorporated into the NCCN Category 1 first-line treatment.Yuhan received a steady inflow of technology fee revenue since 2018, when it began licensing new drug technologies.In July 2018, Yuhan licensed the technology for the degenerative disc disease treatment YH14618 to Spine BioPharma in the U.S. It received an upfront payment of $650,000 and was guaranteed $217.5 million in step-by-step milestones based on development, approval, and sales.In November 2018, Yuhan licensed out the anticancer drug Leclaza to Janssen Biotech. The total contract size, including a non-refundable $50 million upfront payment, is up to $1.205 billion.In January 2019, Yuhan signed a license and co-development agreement with Gilead Sciences for a new drug candidate targeting two drug targets for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The terms included a $15 million upfront payment and $777 million in milestones based on development, approval, and sales.In July 2019, Yuhan signed a technology transfer agreement for YH25724 with Boehringer Ingelheim. YH25724 is a dual-agonist targeting the GLP-1 protein and FGF21 factor simultaneously, with the technology transfer agreement signed during the preclinical stage. For this contract, Yuhan received a non-refundable upfront payment of $40 million. An additional $10 million milestone was generated for YH25724 in November 2021 upon entering Phase 1 clinical trials.In August 2020, Yuhan signed a technology transfer agreement with Processa Pharmaceuticals in the U.S. for YH12852, a treatment candidate for functional gastrointestinal disorders, in which Yuhan received a non-refundable $2 million upfront payment in the form of stock. Yuhan recognized the upfront payments and milestones received from the other four companies excluding Processa, which paid in stock, in installments. Yuhan received total technology fee revenue in 2019 until the first quarter of this year is amounted to be KRW 465 billion. Of the Leclaza technology fee revenue secured by Yuhan, 40% is paid to the original developer, Oscotec. In 2016, Yuhan acquired the development rights for Leclaza at the preclinical stage from Oscotec and its subsidiary Genosco. The total contract size for that acquisition was KRW 1.5 billion.
- Policy
- Incrementally modified drugs unaffected by price reform
- by Jung, Heung-Jun May 06, 2026 03:28pm
- Under the government’s drug pricing system reform, the insurance pricing premium rates for incrementally modified drugs and their combination products are expected to remain unchanged. Only some conditions related to the duration of the premium are likely to be adjusted.As the pricing calculation rate for generics is set to drop to 45%, domestic companies are expected to show greater interest in developing incrementally modified drugs.According to industry sources on the 6th, during working-level discussions between the government and the pharmaceutical industry, a consensus was reached not to lower the premium for incrementally modified new drugs.Although maintaining the current premium was discussed at the Health Insurance Policy Deliberation Committee (HIPDC) in November last year, the point was excluded from the reform plan approved by the HIPDC in March this year.This led to concerns within the industry that the premium might also be reduced along with the lower pricing calculation rate. There were concerns that lowering the premium could eliminate incentives for R&D investment.Under the current pricing system, incrementally modified drugs receive a premium on a base pricing rate of 53.55%, resulting in a final price of 70%. For new dosage or administration forms, a 58.9% premium is applied, resulting in a price of 77%.For incrementally modified combination drugs, pricing is calculated as the sum of pre-patent-expiry prices of each component. Innovative pharmaceutical companies receive 68% of that sum, while general pharmaceutical companies receive 59.5%.The government is not expected to significantly adjust these premium rates. Instead, it is reported that the preferential premium rate for combination drugs by general pharmaceutical companies—currently a 59.5% sum—will be slightly adjusted to a 60% sum.As the generic pricing rate is reduced from 53.55% to 45% while the incrementally modified drug premium remains unchanged, the price gap between generics and modified drugs is expected to widen further.The conditions for the premium duration are expected to be simplified. Previously, a one-year premium could be extended in two-year increments through conditional approvals and reviews.Going forward, a basic one-year premium will be granted, with an additional three-year extension if domestic manufacturing criteria are met. If no follow-on generics are listed thereafter, the premium may continue.Modified drugs and their combination products that are domestically produced and face no market competition will be able to maintain their premium drug prices for a long time.
- Opinion
- [Reporter's View] Contradiction of "K-passing" and a new drug powerhouse
- by Lee, Jeong-Hwan May 06, 2026 03:28pm
- The President Lee Jae Myung administration is promoting the growth of the pharmaceutical and biotech industry with goals of 'Rising as a leading country in global pharmaceuticals,' 'Strengthening treatment accessibility for patients with severe and rare/intractable diseases,' and 'Expanding fair value compensation for innovative new drugs.'The government's stance on the end goal of the drug pricing system reform plan, which recently passed the Health Insurance Policy Review Committee, is to transform the inherent nature of Korea's pharmaceutical and biotech industry, aiming to 'develop new drugs·stably supply essential medicines·expand patient accessibility to reimbursement.'Despite the government's policy vision, South Korea is facing "New Drug Korea-Passing." The South Korean government is not immune to the phenomenon in which pharmaceutical companies that have developed innovative new drugs delay or abandon their launches in the Korean market.While "New Drug Korea-Passing" has long been practiced primarily by global pharmaceutical companies, the rapid improvement in domestic firms' drug development capabilities suggests a future in which Korean deciding to bypass Korea. One of these examples is Cenobamate (brand name Xcopri), a new epilepsy drug developed by SK Biopharmaceuticals and Dong-A ST.It is a contradiction that South Korea, while seeking to become a global pharmaceutical powerhouse, must now worry about the availability of patient treatment, given the "Korea-Passing" phenomenon.The bigger issue is that it is difficult to find any serious deliberation at the government level to establish a solution.The cause of "New Drug Korea-Passing" is "low National Health Insurance (NHI) reimbursement prices for new drugs." Criticism follows that Korea's maximum reimbursement prices for new drugs are only half the OECD average and about 1/30 of those in the United States.When pharmaceutical companies accept Korea's low drug prices, other countries may use them as a reference, leading companies to abandon the relatively small Korean market. Ultimately, the victims of these decisions are the patients who must bear the full burden.The reason the South Korean government tries to set new drug prices as low as possible is not entirely incomprehensible. Since they attempt to set prices using the NHI fund, composed of citizen contributions, as the sole source of financing, it is inevitably difficult to determine a price that fully reflects the value of an innovative drug.Ultimately, the conclusion is reached that to realize a pharmaceutical and biotech powerhouse and solve the "New Drug Korea-Passing" problem, substantial financial resources are required to set prices that reflect the proper value of new drugs.This means that government efforts to secure separate financial resources outside of the NHI fund to determine new drug prices are needed immediately. The solution to achieving both the conflicting tasks of securing the sustainability and soundness of NHI finances while strengthening patient access to medicines also involves breaking away from the single-source NHI funding structure.The consequence of failing to manage the national task and securing separate funds has consistently manifested as a reduction in pharmaceutical spending through generic drug price cuts, repeated in the same pattern every time. This is why criticism arises that, while intense strategic posturing continues between the Ministry of Health and Welfare (MOHW), global pharmaceutical companies, domestic pharmaceutical companies, and patient groups over how to distribute limited resources, only innocent generic companies are hit.Unless the structure that relies entirely on the NHI fund to expand innovative drug reimbursement, amid an era of super-aging and the increasing launch of ultra-expensive new drugs, is reformed, there is no place for the MOHW, the domestic pharmaceutical industry, or patients.Various methods for creating separate funds beyond the NHI can be discussed. These include establishing funds dedicated to ultra-expensive medicines, similar to the UK's Cancer Drugs Fund, or implementing policies that allow a portion of tobacco taxes or lottery proceeds to be used for innovative drug reimbursement.Legislative bills for such policies have been proposed in the National Assembly for over a decade. The key is the government's will. Responsibility should not be placed solely on the MOHW. It requires a policy decision from the Ministry of Economy and Finance, the Ministry of Planning and Budget. Furthermore, the Prime Minister and the President. Are they not the drivers who set the policy goals of leaping into a pharmaceutical and bio-tech powerhouse and strengthening patient access to new drugs?In the National Assembly, policy seminars calling for the rapid reimbursement of innovative new drugs and the expansion of reimbursed indications are held daily, and the heavy responsibility for solving the problem is habitually returned to the Bureau of Health Insurance Policy of the MOHW. Can we continue to demand a solution for the expansion of new drug reimbursement and the "Korea-Passing" problem from the MOHW alone?It is time for the fiscal authorities, besides the MOHW, to take the lead with proactive measures to solve the task of securing separate funds through social consensus, and to immediately resolve the contradiction where being a 'new drug powerhouse' and "Korea-Passing" coexist. The President's political slogan, "I'll do it," should not be an exception when it comes to strengthening access to innovative drug reimbursement and expanding financial resources.
- Policy
- What's the reason behind domestically developed CAR-T 'Rimqarto' obtaining Phase 3 waiver?
- by Lee, Tak-Sun May 04, 2026 10:33am
- CAR-T therapy Rimqarto (source: Curocell)Rimqarto (anbalcabtagene autoleucel, Curocell), the first domestically developed CAR-T therapy to be approved in South Korea, has been granted a waiver for Phase 3 clinical trials.This decision is interpreted as the result of a comprehensive consideration of the unique characteristics of the drug as a third-line treatment for lymphoma, as well as the ethical dilemmas associated with comparative clinical trials against existing therapies.According to the results of the Ministry of Food and Drug Safety (MFDS)'s Central Pharmaceutical Affairs Advisory Committee (CPAC) meeting held on April 2, it was concluded that it is appropriate to waive the Phase 3 clinical trial for the new CAR-T (Chimeric Antigen Receptor T-cell) therapy 'Rimqarto' and replace it with post-marketing surveillance.CPAC members highlighted that while Rimqarto has the same basic mechanism as existing CAR-T agents, it introduces a novel mechanism that simultaneously inhibits PD-1 and TIGIT to prevent T-cell exhaustion.According to a recently disclosed meeting report, one member highly evaluated the product's efficacy, stating, "The response rates were better than the clinical results of previously approved therapies, particularly with a high proportion of patients achieving complete remission (CR) and encouraging long-term survival results."Regarding safety, no specific issues were found besides the adverse events typically reported in similar agents (such as CRS and ICANS), and deaths during the trial were judged to have a low correlation with the drug.On the highly debated issue of giving a 'conditional pass for Phase 3 clinical trials,' the committee reached a consensus that it is "practically impossible." First, they viewed it as lacking ethical validity. Given that already-proven CAR-T products are approved and in use, administering a less effective control drug to patients was deemed unethical.The difficulty of patient recruitment was also considered. The patient population in the third-line lymphoma treatment phase has a low survival rate and a small number of candidates, making it extremely difficult to conduct large-scale confirmatory trials that include a control group. Consequently, the CPAC concluded that it is more rational to continuously verify safety and efficacy using Real-World Data (RWD) collected in clinical settings or Post-Marketing Surveillance (PMS), rather than mandating a Phase 3 trial.Based on this CPAC advisory, the MFDS finalized the approval conditions for Rimqarto. The committee agreed that the "product approval is appropriate, given that it is a third-line lymphoma treatment," and decided to disclose the meeting report anonymously.This decision served as a stepping stone toward the rapid supply of an independently developed domestic CAR-T therapy to the field. It is expected to provide new treatment opportunities for patients with severe hematologic cancers who do not respond to existing treatments.Meanwhile, 'Rimqarto Inj' is an orphan drug for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) that is relapsed or refractory after two or more systemic therapies.Rimqarto works by inserting genetic information into the patient's immune cells (T-cells) to enable them to recognize CD19, a surface antigen on B-cells, and then re-injecting these cells into the patient's body to identify and destroy cancer cells expressing CD19. It is designed to inhibit the expression of immune checkpoint receptors PD-1 and TIGIT, thereby blocking cancer cells' immune evasion and inducing enhanced, sustained T-cell responses to increase anti-tumor effects.
- Company
- Why are generic firms rechallenging Precedex's patent?
- by Kim, Jin-Gu May 04, 2026 10:33am
- An invalidation trial has been filed against the premix formulation patent of Pfizer’s sedative ‘Precedex (dexmedetomidine).’ What is interesting is that generic drug manufacturers had already succeeded in circumventing this patent back in 2020. In this context, some interpret this move as the generic companies’ attempt to launch a premix formulation and glass vial product containing the same active ingredient.According to industry sources on the 1st, Ilsung IS recently filed an invalidation trial against Hospira regarding the Precedex premix formulation patent.Precedex, approved in June 2010, is used for ‘sedation of patients who are intubated early under intensive care and receiving mechanical ventilation.’ Pfizer acquired the product through its acquisition of Hospira in 2015. Subsequently, Pfizer Korea received additional approval for the premix formulation in 2017.There are two patents related to Precedex. The substance patent expired in January 2013, leaving the formulation patent, which is set to expire in June 2032, as the current target of generic challenges.Generics were launched sequentially following the expiration of the substance patent. Companies including Ilsung IS, Hanlim Pharm, Penmix, Kyongbo Pharmaceutical, Pharmbio Korea, Hana Pharm, and Jeil Pharmaceutical obtained approvals. However, due to the active premix formulation patent, products were released in ampoule form, requiring mixing the dexmedetomidine-containing drug into a basic intravenous solution.In 2020, JW Life Science and Dai Han Pharm attempted to circumvent the premix formulation patent. JW argued that its proprietary container did not fall within the patent scope of Pfizer’s Precedex and won both first and second trials. It subsequently launched premix generics with its partners Hanlim and Hana Pharm. However, these products used special plastic infusion containers rather than the original glass vial.What is notable this time is that Ilsung IS chose to file an invalidation trial rather than a circumvention trial, as JW had filed. Given that circumvention trials generally have higher chances of success at first instance, Ilsung appears to have chosen a more difficult path.This is interpreted as an attempt to secure not only the premix formulation but also the glass vial packaging format.The premix formulation patent describes a ‘ready-to-use liquid pharmaceutical composition containing dexmedetomidine or its pharmaceutically acceptable salt thereof, placed in a sealed glass container for parenteral administration.’ Since the patent explicitly specifies a “sealed glass container,” its circumvention allows the sale of premix formulations but not in glass vials, as doing so would risk patent infringement.Glass vials and plastic infusion bags each have clear advantages and disadvantages. Plastic IV bags have the advantage of a relatively lower risk of breakage. Their light weight, which facilitates transportation, is also cited as an advantage. However, compared to glass vials, there is a greater risk of drug molecule leaching or adsorption. Additionally, reduced stability during long-term storage is pointed out as a drawback.On the other hand, glass vials prevent the drug from reacting with the packaging material, allowing it to maintain its purity for a long time. They also remain stable during long-term distribution and storage. This is why glass vials are the standard for pharmaceuticals that require long-term stability, despite the higher risk of breakage.The domestic market size for dexmedetomidine-based sedatives is estimated at around KRW 19 billion annually. According to the Ministry of Food and Drug Safety, domestic production and import volumes increased from KRW 16 billion in 2022 to KRW 19 billion in 2023, but declined back to KRW 16 billion in 2024 due to reduced usage amid the healthcare crisis. Pfizer’s two products account for about 40% of the total supply as of 2024.
- Policy
- US tests pay-for-performance to address fee-for-service limits
- by Jung, Heung-Jun May 04, 2026 10:33am
- To address the issues of an aging population and rising healthcare costs, the U.S. will launch a pilot program for a pay-for-performance system nationwide starting this July.This model links payments to the achievement of chronic disease management metrics and represents an attempt to overcome the limitations of the traditional fee-for-service (FFS) system.On the 30th, Soo-min Kwon, a senior researcher at the Health Insurance Review and Assessment Service (HIRA) Benefits Policy Research Division, published the policy implications of “The US’s New Performance-Based Payment Model for Chronic Disease Management” through an HIRA Issue report.The US Centers for Medicare & Medicaid Services (CMS) will pilot the ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) model from July this year through June 2036. This model combines performance-based payment systems with technology-enabled healthcare delivery.All Medicare Part B providers across all states are eligible. Patients are categorized into four groups;▲ those with at least two of hypertension, dyslipidemia, obesity/overweight, or prediabetes, ▲ those with at least one of diabetes (DM), chronic kidney disease (CKD), or atherosclerotic cardiovascular disease (ASCVD); ▲ chronic musculoskeletal pain; ▲ those with at least one of depression or anxiety disordersParticipating institutions provide integrated services including clinical consultations, lifestyle interventions, education, and medication management. They also conduct clinical improvement activities, collecting outcome data through remote monitoring tools and implementing interventions using digital health platforms.Final control and minimum improvement targets are set for each evaluation metric, with targets adjusted annually over the treatment period.Institutions receive payments for managing patients over a one-year period. During the initial six months of treatment, they receive 50% of the annual payment in monthly installments, while the remaining 50% is paid based on whether performance targets were met and whether the patient received services for the same condition from other healthcare providers.The payment structure differs between the initial treatment year and subsequent management phases to incentivize early achievement of clinical outcomes.Kwon explained, “This represents a shift from service-based to performance-based payment systems, redesigning reimbursement criteria around clinical results rather than service quantity.”She added, “In line with global trends in payment system reform, this could serve as a reference model for designing integrated chronic disease payment systems in Korea and ensuring the sustainability of the national health insurance finances.”
- Company
- ‘Zipalertinib’ targets the Exon 20 lung cancer mkt…presenting new trt option
- by Son, Hyung Min May 04, 2026 10:33am
- While treatment options for EGFR exon 20 insertion mutation non-small cell lung cancer (NSCLC) remain limited, the potential for a change in the therapeutic environment is being proposed as the oral targeted therapy ‘zipalertinib’ enters the U.S. regulatory approval process.With consistent efficacy confirmed in global clinical trials and analysis of Asian patient populations amid limited existing treatments, zipalertinib is garnering attention as a competing product to ‘Rybrevant (amivantamab),’ the only approved medicine in this space.According to industry sources on the 4th, the U.S. Food and Drug Administration (FDA) recently accepted a New Drug Application (NDA) for zipalertinib. The drug’s target population includes patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed following platinum-based chemotherapy. The goal review date under the Prescription Drug User Fee Act (PDUFA) is February 27, 2027.Zipalertinib is a next-generation irreversible EGFR tyrosine kinase inhibitor (TKI) being co-developed by Taiho Pharmaceutical of Japan and Cullinan Therapeutics of the U.S. This drug is designed to selectively inhibit mutant EGFR while minimizing impact on wild-type (normal) EGFR.The NDA is based on results from Part 2b of the Phase 1/2 REZILIENT1 study.The REZILIENT1 study included 176 patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations as the primary efficacy evaluation group. The study evaluated the clinical efficacy of zipalertinib in patients whose disease progressed after platinum-based chemotherapy.Notably, 51 of the total patients had prior experience with Rybrevant, confirming zipalertinib’s potential as a subsequent treatment option after existing targeted therapies. Patients received 100 mg of zipalertinib orally twice daily, with objective response rate (ORR) and duration of response (DOR) analyzed as primary endpoints.Clinical results showed an ORR of 35.2% in the Zipalertinib group, with a median DOR of 8.8 months. It is noteworthy that responses were also confirmed in patients with prior Rybrevant treatment. In that specific patient group, the ORR was 30%, suggesting its viability as a follow-up treatment option.Zipalertinib results were presented at ESMO Asia 2025, held in Singapore last year.The efficacy in Asian patients did not differ significantly from that in the global patients.According to a subgroup analysis presented at the ESMO Asia 2025, the ORR for the Asian patient group was 33%, similar to the 37% observed in the non-Asian group. The duration of response (DOR) was 8.3 months and 10.5 months, respectively, while progression-free survival (PFS) showed almost identical patterns at 9.5 months and 9.0 months.In terms of overall survival (OS), the median has not yet been reached in the Asian patient group, whereas it was 24 months in the non-Asian group.Regarding safety, the primary adverse events included paronychia, rash, dry skin, diarrhea, and stomatitis, most of which were Grades 1–2 and manageable.Limited treatment environment…”Oral drug option is highly significant”Janssen’s RybrevantThe development of treatments for NSCLC with an EGFR exon 20 insertion mutation has faced significant challenges. Unlike treatments targeting Exon 19 deletions or Exon 21 L858R mutations, Exon 20 insertion mutations have diverse subtypes, making drug design structurally difficult.Takeda’s Exkivity, which garnered high expectations as an oral targeted therapy, received conditional approval based on a 28% ORR in early trials. However, it was withdrawn from the global market after failing to prove PFS improvement in the confirmatory Phase 3 trial (EXCLAIM-2).Poziotinib, previously developed, was also suspended after failing to meet efficacy expectations and experiencing toxicity issues in Phase 2 trials.As a result, Janssen’s Rybrevant is now the only treatment approved in this therapeutic area. However, as an intravenous-based therapy, it has been noted for limitations regarding administration convenience and treatment persistence.Given such a treatment gap, zipalertinib, which can be administered orally, is being evaluated as a new alternative because it offers manageable safety while increasing mutation selectivity compared to previous agents. The industry is focusing on the possibility that the Exon 20 mutation treatment landscape will transition from a monotherapy-centered environment to a more competitive one, depending on future approvals.Professor Ross Soo of the National Cancer Centre Singapore explained, “Zipalertinib demonstrated efficacy in Asian patients equivalent to that of the global patient population,” and added, “Because it is an oral drug, it is significant in terms of patient accessibility and treatment persistence.”
- Policy
- Kwangdong secures first generic exclusivity for Tagrisso
- by Lee, Tak-Sun May 04, 2026 10:33am
- Domestic pharmaceutical companies are intensifying their push into the KRW 110 billion non-small cell lung cancer (NSCLC) treatment market centered on Tagrisso (osimertinib). Following Chong Kun Dang’s first generic approval in January, Kwangdong Pharmaceutical has also joined the ranks of companies obtaining first generic exclusivity, marking the start of a full-scale race to capture the market.Kwangdong Pharmaceutical’s ‘Ktinib Tab’ Approved… Second after Chong Kun DangAccording to the Ministry of Food and Drug Safety, Kwangdong Pharmaceutical obtained first generic exclusivity on April 30 for its osimertinib mesylate product ‘Ktinib Tab (40mg, 80mg).’ This is the second such approval following Chong Kun Dang’s ‘Otinib Tab,’ which received approval on January 27.The drug’s indications include, as a monotherapy: ▲Adjuvant treatment following complete resection in patients with NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations ▲Treatment of patients with unresectable locally advanced (Stage III) NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations whose disease has not progressed during or after platinum-based chemoradiotherapy ▲First-line treatment of patients with locally advanced or metastatic NSCLC harboring an EGFR exon 19 deletion or exon 21 (L858R) substitution mutation ▲Treatment of patients with EGFR T790M-positive locally advanced or metastatic NSCLC who have previously been treated with an EGFR-TKI.Additionally, as a combination therapy, it is indicated for the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitutions, in combination with pemetrexed and platinum-based chemotherapy. These indications are identical to the original Tagrisso.Like Chong Kun Dang, Kwangdong succeeded in circumventing Tagrisso’s formulation patent (set to expire January 2035), thereby securing first generic exclusivity. As a result, both companies will hold a roughly 9-month market exclusivity period starting from the expiry of the substance patent.First, generic exclusivity is granted when a company successfully challenges a patent and meets the criteria of being among the first to file for approval. Both companies achieved patent circumvention in September last year by winning a passive scope confirmation trial regarding the formulation patent. AstraZeneca has since appealed, and a lawsuit to cancel the ruling is currently ongoing at the Intellectual Property High Court.The approval applications were also submitted simultaneously to the MFDS, meaning both companies met the requirements for exclusivity.The exclusivity period for Ktinib (during which sales of identical drugs are restricted) is set from December 28, 2033, to September 27, 2034.Since the original drug Tagrisso’s substance patent remains valid until 2033, immediate market entry is not possible. However, both companies plan to enter the market immediately upon patent expiry, block latecomers, and capture the KRW 110 billion market.Tagrisso vs. Leclaza… generics join the competitionCurrently, the domestic NSCLC treatment market is dominated by AstraZeneca’s original drug Tagrisso and Yuhan’s domestic new drug Leclaza, which are competing fiercely for market share. With Chong Kun Dang and Kwangdong preparing to launch generics, the market landscape is expected to become even more complex.A pharmaceutical industry insider analyzed, “Given the high commercial potential of the product, generic companies are continuing to challenge the patents. With Chong Kun Dang and Kwangdong securing generic exclusivity, the generic market is highly likely to evolve into an initial two-horse race starting in 2033
