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- 2026-04-03 12:18:28
- Company
- Lotte-Axcelead-Kanaph signs MOU for joint ADC development
- by Kim, Jin-Gu Jun 17, 2025 05:58am
- Lotte Biologics announced on the 16th that it has signed a three-party memorandum of understanding (MOU) with global new drug development company Axcelead and innovative new drug development company Kanaph Therapeutics to establish an ‘ADC Toolbox’ for the development of antibody-drug conjugates (ADC). Under the agreement, the three companies will collaborate on joint research and development of linkers and payload technologies, which are key for the development of antibody-drug conjugates, which are regarded as next-generation anticancer drugs. Axcelead is a global contract research organization (CRO) spun off from Takeda Pharmaceutical in Japan. It will utilize Takeda's library of over 1.2 million compounds and more than 1,000 new drug development data to identify novel payload candidates that have not been applied to existing ADCs. Kanaph Therapeutics will focus on building an innovative platform that overcomes the limitations of existing linkers and payloads in ADC development. The developed linkers, payloads, and other results will be transferred to Lotte Biologics, based on which the company will strengthen the competitiveness of its ADC platform, including SoluFlex Link. Through the collaboration, Lotte Biologics plans to provide an ADC toolbox service that allows customers to select and utilize various technologies according to their needs. This is expected to further strengthen its one-stop platform service, which covers everything from research and development to GMP production for ADC modalities. A Lotte Biologics representative said, “The agreement marks another step forward in establishing a differentiated ADC platform and toolbox. We will continue to strengthen our partnership with both companies to enhance our ADC competitiveness in the global market and provide patients with more innovative treatments.” An Axcelead representative said, “We are very pleased to be able to forge a strategic partnership for the development and advancement of ADC platform technology and services. Based on our proprietary new drug development platform, we will contribute to the development of innovative treatments.” A Kanaph Therapeutics representative added, “Through this collaboration, we will strive to build a diverse toolbox of linkers and payloads that can overcome the limitations of existing ADC drugs and accelerate the development of innovative new drugs.”
- Opinion
- [Reporter's View] GMP standards for sterile products
- by Lee, Hye-Kyung Jun 17, 2025 05:58am
- The Ministry of Food and Drug Safety (MFDS) is devising measures to reduce the burden on the pharmaceutical industry ahead of the implementation of the 'Revised PIC/S Good Manufacturing Practices (GMP) Guide for Sterile Medicinal Products (guidelines on manufacturing and quality control of medicines)' in December. Following the administrative announcement of revised guidelines in 2023, the MFDS has granted a two-year grace period. Therefore, the MFDS has planned a solution to lessen the burden, rather than an extended grace period as requested by several pharmaceutical companies. Strengthened GMP standards for sterile medicinal products include ▲systemic establishment·implementation of contaminant management methods for sterile medicinal products ▲establishment of separate GMP for cutting-edge technology biotechnology medicines ▲specifying detailed formulation and selection process·methods for products meeting GMP standards. Establishing contamination-control strategies is most important, but establishing a strategy for each lot number requires substantial manpower and investment. Approximately 100 companies in South Korea are reportedly manufacturing sterile products. In fact, since late last year, news of sterile production halts has been circulating, primarily among some manufacturers. For instance, Ildong Pharmaceutical's 'Ativan,' which had experienced years of supply halt and re-production, recently announced a final halt to both supply and production. According to the MFDS, this is due to the company's internal circumstances. It is also rumored that the decision to withdraw was made due to a combination of existing supply concerns, such as the cost-effectiveness of reinvesting in facilities, given the strengthened GMP standards. MFDS's consistent response when asked has been 'no further grace period.' Then, on the 11th, the MFDS Quality Management Division proactively requested a meeting with reporters. The MFDS explained that they had met with factory managers from approximately 20 manufacturers of sterile products last month. The reason they couldn't hold a press briefing immediately was their desire to jointly explain the ongoing 'Research on the GMP Guide for Sterile Products Implementation Plan' with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. MFDS has been conducting research jointly with the association since last year to alleviate the industry's burden related to the strengthened management of GMP for sterile products, aiming for standard relaxation. They are already in the mid-phase of research with three companies, HK inno.N, JW Pharmaceutical, and Daehan Pharmaceutical, which produce over 90% of large-volume intravenous fluids. If this research is successful, standards for large-volume intravenous fluids are expected to be relaxed first. From a quality perspective, they were preparing technical support measures to alleviate the industry's burden resulting from the actual implementation of the strengthened standard. However, a question arises here. While technical and regulatory support measures are being prepared to apply GMP standards at the same level as PIC/S member countries to domestic sterile product preparation manufacturers, has an alternative plan been prepared for cases where smaller companies, facing difficulties in facility and personnel investment despite this support, decide to abandon sterile product preparations? The disappointing part was the Quality Management Division's ambiguous response, suggesting that the Biopharmaceutical Management Support Team might handle supply-related issues rather than the Quality Management Division. It sounded like, 'GMP standards are our division's responsibility, but supply is another division's responsibility, so we don't know.' MFDS expresses concern that it might appear as if companies are abandoning the supply of sterile products, such as injectables, solely due to the strengthening of GMP standards. However, these two issues are inseparable. Many sterile product preparations are designated as shortage prevention drugs (SPD) or national essential medicines. This designation implies that the government intends to manage them because they are not profitable. Now, a situation has arisen where companies must invest anywhere from several billion to tens of billions of KRW in facilities and manpower for sterile product preparations that yield almost no profit. Consequently, it's inevitable that cases will emerge where companies decide to withdraw products after weighing investment costs against profitability. Therefore, instead of considering the issues of standards and supply separately, we hope that they will be addressed together, and solutions will be devised to reduce the burden on the pharmaceutical industry and alleviate public anxiety caused by supply instability.
- Company
- New RNAi drug 'Rivfloza' gets ODD in KOR
- by Eo, Yun-Ho Jun 16, 2025 06:04am
- The rare genetic disorder treatment 'Rivfloza' has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety recently announced this on its notification board. Rivfloza (nedosiran) is indicated to treat children over 9 years of age and above and adults with 'primary hyperoxaluria type 1 (PH1)' and relatively preserved kidney function. Rivfloza was approved by the U.S. Food and Drug Administration (FDA) in October 2023. It is the first RNAi-based rug developed using Novo Nordisk's GalXC RNAi technology platform. The efficacy of Rivfloza was demonstrated through the results obtained from the Phase 2 PHYOXTM 2 study and the interim analysis data from the Phase 3 PHYOXTM 3 extension study. In the PHYOXTM 2 study, the Rivfloza-treated group showed a significantly lower 24-hour urinary oxalate (Uox) excretion rate at 90-180 days compared with the start of the administration. The study measured the changes in the 24-hour Uox excretion rate from the starting date using the area under the curve (AUC) analysis method. The results have shown that the average linear squares (LS) difference in 24-hour Uox excretion rate between the patient group treated with Rivfloza for 90 days and the control group was 4976. Furthermore, the interim results of the PHYOX3 extension study confirmed that reduced 24-h Uox excretion was maintained in 13 patients who received additional treatment of Rivfloza for 6 months. Meanwhile, PH1 is a rare genetic disorder causing oxalate overproduction in the liverm with an estimated prevalence of 1 in 38,600 people in the world. PH1 is the most common clinically out of three types of primary hyperoxaluria (approximately 80%). It is a metabolic disorder primarily affecting the kidney and may cause progression of kidney damage.
- Policy
- Atopic dermatitis drug Ebglyss reimbursed from next month
- by Lee, Tak-Sun Jun 16, 2025 06:03am
- With pricing negotiations between the National Health Insurance Service and the manufacturer of the new atopic dermatitis drug ‘Ebglyss Autoinjector (Lebrikizumab, Lilly Korea)’ complete, the drug is expected to be listed for reimbursement next month in Korea. Once listed, the number of biological agents available for atopic dermatitis will increase from two—Dupixent (dupilumab) and Adtralza (tralokinumab)—to three. According to industry sources on the 13th, the NHIS recently updated its website with news of the agreement made on Ebglyss Autoinjector. In August 2024, the Ministry of Food and Drug Safety approved this drug as a treatment for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older (weighing at least 40 kilograms) who are inadequately controlled by topical therapies or for whom such treatments are not recommended. In February, the drug’s reimbursement application was approved by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service. At the time, the condition was attached that the adequacy of its reimbursement would be recognized if the company accepted the price below the initially assessed value. Lilly Korea accepted such a price and began negotiations with the National Health Insurance Service in March." It is highly likely that Ebglyss waived drug price negotiations as it accepted a price below the weighted average price of existing atopic dermatitis drugs covered by the national health insurance, and would only have negotiated the estimated claims amount with the NHIS. Ebglyss demonstrated its clinical efficacy and safety profile in a pivotal Phase III clinical trial and is expected to become a first-line treatment option for patients with atopic dermatitis in Korea. The clinical studies on which the approval was based on are the Phase III ADvocate-1, ADvocate-2 and ADhere trials. The trials evaluated the clinical efficacy and safety of Ebglyss in 1062 adults and adolescents with moderate-to-severe atopic dermatitis. In ADvocate-1 and ADvocate-2, which evaluated Ebglyss as a monotherapy, Ebglyss improved outcomes, with 58.8% and 52.1% (16.2% and 18.1%, respectively in the placebo arm) achieving Eczema Area and Severity Index (EASI) 75; and 38.3% and 30.7% (9% and 9.5%, respectively in the placebo arm) achieving EASI 90 during the induction period (weeks 0-16) compared to placebo. Also, after one year of maintenance therapy (Week 52), 81.7% of the Ebglyss arm achieved EASI 75 (vs. 66.4% in the placebo arm) and 66.4% achieved EASI 90 (vs. 41.9% in the placebo arm), demonstrating significant symptom improvement in the long term. The most commonly reported adverse events following treatment with Ebglyss were conjunctivitis (6.9%), injection site reactions (2.6%), allergic conjunctivitis (1.8%), and dry eye (1.4%), with the majority of adverse events being mild or moderate and not leading to treatment discontinuation. Recently, the government has applied reimbursement for cross-administration of biological agents and JAK inhibitors used to treat severe atopic dermatitis, and Ebglyss is expected to benefit from this as well. Patients are also expected to benefit from the increased biological agent options and lower drug prices.
- Policy
- Roche’s SMA drug Evrysdi Tab approved in Korea
- by Lee, Hye-Kyung Jun 16, 2025 06:03am
- The table formulation of Roche's blockbuster drug for spinal muscular atrophy (SMA), Evrysdi (risdiplam), has received marketing authorization in Korea. On the 13th, the Ministry of Food and Drug Safety approved Roche Korea's ‘Evrysdi 5 mg (risdiplam).’ With the approval, SMA patients in Korea may now be prescribed the 5 mg tablet formulation in addition to the existing liquid oral solution, enabling easier intake. Evrysdi is the first oral treatment for SMA and has the advantage of self-administering without location restrictions. In addition, the newly approved Evrysdi Tab is the first tablet formulation for SMA treatment. The 5mg tablets can be swallowed whole or dispersed in water and may be stored at room temperature. The existing liquid solution will continue to be available, and patients weighing 20 kg or more and aged 2 years or older are eligible to take the tablet formulation. Spinal Muscular Atrophy (SMA) is a systemic disorder caused by a deficiency of the Survival Motor Neuron (SMN) protein, which is essential for motor function. The disease affects not only neuromuscular systems but also respiratory muscles, cardiac rhythm, skeletal muscles, joints, and the autonomic nervous system. Evrysdi is a splicing modifier that binds to the immature pre-mRNA of the SMN2 gene, increasing and maintaining the levels of Survival Motor Neuron (SMN) protein throughout the patient's body. It can cross the blood-brain barrier, allowing for even distribution across the entire body, including the central nervous system. In February, the U.S. FDA approved Evrysdi based on the results of a bioequivalence study. In the trial, Evrysdi 5 mg Tab and the existing liquid formulation demonstrated equivalent absorption of the active ingredient risdiplam. Meanwhile, in Korea, Evrysdi Dry Syrup 0.75 mg/mL (risdiplam) was approved in 2020 and has been reimbursed since October 2023, three years later. Evrysdi is currently reimbursed for the treatment of 5q Spinal Muscular Atrophy in patients who received a genetic diagnosis of 5q SMN-1 deficiency or mutation that ▲ have 3 or fewer copies of SMN2 even before the onset of symptoms, and are less than 6 months old at the time of treatment initiation; or ▲ have SMA types 1-3 with clinical symptoms and signs related to SMA and are not on permanent ventilation.
- Company
- Anti-PD-1 immunotherapy 'Zynyz' gets ODD in KOR
- by Eo, Yun-Ho Jun 16, 2025 06:02am
- Product photo of Zynyz (retifanlimab) The checkpoint inhibitor immunotherapy 'Zynyz' has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety (MFDS) has recently announced this through its notification board. It is indicated to treat relapsed or metastatic locally advanced Merkel cell carcinoma (MCC). Zynyz (retifanlimab) obtained U.S. approval in 2023 through the FDA's expedited approval program. MCC is associated with fast cancer cell growth and high metastatic rate, thus known for poor prognosis. Therefore, a first-line treatment option that can bring about a continuous response in metastatic MCC patients is necessary. The basis of accelerated approval of Zynyz is the Phase 2 PODIUM-201 study involving 65 patients with relapsed or metastatic locally advanced MCC who have not received prior systematic therapy. The study participants were treated with 500 mg Zynyz every 4 weeks for 24 weeks until they experienced progression of disease or non-tolerable toxicity level. The study's primary goal was set as the overall response rate (ORR) assessed by an independent review committee according to the RECIST guidelines (version 1.1). The secondary goals included the duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS), and safety. The study results showed that the ORR of Zynyz was 52.2% (95% CI 40~65). In patients who showed responses, 18% of those had complete remission, and 34% had partial remission. The range of DOR was 1.1~24.9 months. 76% of the patients had DOR lasting over 6 months, and 62% had DOR lasting over 12 months. Meanwhile, Zynyz was recently approved by the FDA for additional indication to treat anal squamous cell carcinoma. It was the first immunotherapy to be approved. The basis of approval was the Phase 3 POD1UM-303 and the Phase 2 POD1UM-202 studies.
- Company
- Denosumab’s reimbursement denials increase due to stricter
- by Moon, sung-ho Jun 16, 2025 06:02am
- Although the government extended the reimbursed period for denosumab-based osteoporosis treatments last year, concerns about reimbursement denials continue in practice. Major medical societies, such as the Korean Endocrinology Society, have reached the point where they have issued guidelines to prevent insurance reimbursement cuts when prescribing treatments, raising awareness of the issue. According to the medical community on the 11th, the Korea Endocrine Society recently analyzed cases of insurance reimbursement cuts for denosumab prescriptions and issued guidelines to prevent such cuts to frontline healthcare providers. Previously, in May of last year, the Ministry of Health and Welfare expanded the reimbursement criteria for denosumab-based osteoporosis treatments, including Amgen's Prolia. The key change was that patients who had reached the treatment goal for osteoporosis—defined by their T-score—but remained at the borderline threshold, would continue to be eligible for reimbursement under the revised guidelines. Under the revision, a patient who was initially eligible for reimbursement based on a bone mineral density (BMD) T-score of ≤ -2.5 and shows improvement during treatment to a T-score between -2.5 and -2.0, can receive continued reimbursement for an additional year—up to a maximum of two years. The issue, however, lies in the increasingly strict reviews by the Health Insurance Review and Assessment Service (HIRA), which has led to a rise in reimbursement denials. In fact, HIRA has introduced new review guidelines following the Ministry of Health and Welfare’s extension of the reimbursement criteria in 2023. These include specific principles regarding the use of osteoporosis drugs, particularly focusing on the interpretation of lumbar spine BMD results. HIRA clarified the evaluation method for ‘central bone’ in DXA (dual-energy X-ray absorptiometry) scans and established new review criteria for early denosumab administration. The move appears to show the authorities’ intention to minimize confusion in reimbursement claims arising from the expanded coverage by providing more precise review standards to clinical practitioners. The guidelines issued by the Korean Endocrine Society also closely align with these principles set by HIRA. Specifically, the society emphasized in its preventive guidance that: ▲Selecting only two areas with the lowest T-scores is no longer acceptable, ▲ All measurable lumbar vertebrae from L1 to L4 must be included in the assessment. Also, ▲the Exclusion of a specific vertebra requires a clear medical rationale, supported by radiographic evidence, and, ▲ clinicians must fully understand both the diagnostic criteria based on BMD interpretation and the insurance reimbursement requirements for prescribed treatments. A representative from the Korean Endocrine Society stated, “Osteoporosis treatments are now being prescribed at local clinics and small hospitals, leading to a gradual increase in reimbursement cuts. Selecting only two vertebrae with the lowest T-scores for osteoporosis diagnosis is no longer acceptable. Unless there is a clear justification—such as a difference of more than 1.0 in T-scores compared to surrounding vertebrae, structural abnormalities, implants, or degenerative changes confirmed by radiographic imaging—all measurable lumbar vertebrae must be included in the bone density evaluation.” They further explained, “Denosumab should be administered on a 180-day (6-month) schedule, and early administration is only permitted within 2 weeks of the due date. Follow-up BMD testing must be conducted at exact 365-day intervals, and if testing is performed earlier, reimbursement will generally not be allowed. In cases where early testing within 4 weeks is unavoidable, the reason must be clearly documented in the medical record. Otherwise, it may be subject to reimbursement denial.” Meanwhile, following the expiration of Amgen's substance patent for its original denosumab-based therapy Prolia, biosimilar versions of the drug have entered the domestic clinical market. The first denosumab biosimilar, Stoboclo, has received reimbursement approval and is being co-marketed by Celltrion Pharm and Daewoong Pharmaceutical. Samsung Bioepis is also set to enter the Korean denosumab market, preparing to launch its biosimilar Obodence in partnership with Hanmi Pharmaceutical. As a result, intense competition in sales and marketing is expected between Amgen and its Korean partner Chong Kun Dang, Celltrion Pharm (with Daewoong), and Samsung Bioepis (with Hanmi), all vying for market share in the osteoporosis treatment market.
- Company
- Latecomer psoriasis drug Bimzelx enters competition in KOR
- by Whang, byung-woo Jun 13, 2025 06:03am
- The new psoriasis treatment Bimzelx (bimekizumab) has cleared the reimbursement hurdle and is now officially entering Korea’s market competition. With numerous psoriasis treatment options already on the market, the drug is expected to target new patients based on its relatively low drug price. On the 12th, UCB Korea held a press conference to celebrate the launch of Bimzelx in Korea and highlighted the product's competitiveness. ▲ (From left) Jeong-Eun Kim, Department of Dermatology, Hanyang University Hospital; Stevan Shaw, Head of Research at UCB UK Bimzelx is the first plaque psoriasis treatment that dually inhibits interleukin-17A and 17F (IL-17A and 17F). IL-17A and IL-17F are key cytokines that trigger the inflammatory process in psoriasis, and Bimzelx selectively and directly targets and inhibits both simultaneously. In the BE READY trial, the global Phase 3 clinical study that became the basis for the approval, 90.8% of patients in the Bimzelx group achieved PASI 90 at Week 16, and 68.2% of patients achieved PASI 100. In a clinical trial that compared Bimzelx with another biological agent, there was a clear difference in the percentage of patients who achieved complete clearance of skin lesions at Week 16, which is referred to as 'PASI 100'. Specifically, ▲BE VIVID: Bimzelx 59%, ustekinumab (Stelara) 21% ▲BE SURE: Bimzelx 60%. 8%, adalimumab (Humira) 23.9% ▲BE RADIANT: Bimzelx 61.7%, secukinumab (Cosentyx) 48.9%, etc. The introduction of Bimzelx as a new psoriasis treatment option is significant because of its dual inhibiting mechanism of action that blocks IL-17A and IL-17F. Dr. Stevan Shaw, Head of Research at UCB UK and developer of Bimzelx, said, "Bimzelx’s dual inhibition of interleukin-17A and interleukin-17F showed a higher skin lesion improvement rate in psoriasis patients compared to secukinumab, which only inhibits interleukin-17A.” He further explained, “The dosing regimen, which involves administration every 8 weeks for maintenance therapy, also enhances patient convenience, representing a significant advantage over existing interleukin-17A inhibitors.” In addition, Professor Jeong-Eun Kim of Hanyang University Hospital's Department of Dermatology said, “Even in a meta-analysis conducted over a long period of 52 weeks, Bimzelx showed better efficacy than other drugs in terms of the cumulative number of days achieving PASI 100. No new safety issues were reported during long-term treatment that continued for over three years, with no special events reported overall.” In other words, despite the emergence of various psoriasis treatments, there is still unmet demand due to resistance and other factors, for which Bimzelx is considered to be competitive. The reimbursement price for Bimzelx, which has been covered by health insurance since June, is KRW 801,332. In order to compare the specific drug prices with existing treatments, it is necessary to consider the dosage and administration, and Bimzelx does not have a significant advantage in terms of cost competitiveness, which is a strategy often chosen by later entrants. Bimzelx is administered subcutaneously at 320 mg (two 160 mg doses) at 0, 4, 8, 12, and 16 weeks, and then every 8 weeks thereafter. Considering that competing treatments have administration schedules ranging from 4 weeks to 12 weeks, Bimzelx has a moderate dosing schedule. Regarding this, Professor Kim stated that prescriptions will be tailored to individual patient characteristics and the doctors’ discretion. He added, “While consideration should be given to the patient's comorbidities and prior treatment history, there is no guideline on which drug must be used as the first or last option based on efficacy. However, as more treatment options become available, the therapeutic paradigm for psoriasis is expected to shift and become more segmented.” Finally, Professor Kim added, “Personally, I think Bimzelx should be considered first for patients who do not respond well to biological agents.”
- Company
- New ADC drug Padcev seeks reimb again in Korea
- by Eo, Yun-Ho Jun 13, 2025 06:03am
- The ADC bladder cancer drug Padcev is once again attempting reimbursement listing in Korea. According to Dailypharm coverage, Astellas Pharma Korea recently submitted a reimbursement application for its antibody-drug conjugate (ADC) Padcev (enfortumab vedotin). Accordingly, it will be interesting to see whether the company will be able to make progress in the discussion on insurance reimbursement for Padcev as a monotherapy and combination therapy. This is the company’s third attempt at reimbursement listing. Padcev was first approved in Korea in March 2023, and has remained non-reimbursed for over 2 years since. The monotherapy option passed the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee review in February this year, but the application was rejected after the government and pharmaceutical companies failed to agree on the cost-effectiveness after the company completed the pharmacoeconomic evaluation. At the end of last year, Astellas Pharma applied for Padcev’s reimbursement as a monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have previously received PD-1 or PD-L1 inhibitors and platinum-based chemotherapy, and as first-line therapy for advanced metastatic urothelial carcinoma in combination with the PD-1 inhibitor ‘Keytruda (pembrolizumab)’ However, the applications were also rejected by the Cancer Disease Deliberation Committee in February. Astellas Pharma plans to supplement the relevant data and reapply for reimbursement. The drug is recommended as Category 1 in the National Comprehensive Cancer Network (NCCN) guidelines. It is a new treatment option for urothelial cancer patients whose cancer has progressed or recurred even after receiving treatment with immunotherapy drugs and platinum-based chemotherapy. The drug was approved in March in Korea for the treatment of patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy, then was approved in combination with Keytruda in July. Padcev’s efficacy as a monotherapy was demonstrated through the EV-301 study, an open-label, Phase III trial that was conducted on 608 patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors. Study results showed that Padcev reduced the risk of death by 30% compared to chemotherapy. The median overall survival (OS) of the Padcev group was 12.9 months, demonstrating a significant improvement in survival compared to chemotherapy's 9.0 months. In addition, Padcev significantly improved progression-free survival (PFS) with a 38% reduction in disease progression or death risk, with the median progression-free survival (PFS) for Padcev being 5.6 months and 3.7 months for the control group. In the case of the Keytruda-Padcev combination, its efficacy was demonstrated through the randomized Phase III EV-302 trial that was presented at the European Society for Medical Oncology Annual Meeting (ESMO 2023). The trial evaluated Padcev+Keytruda versus conventional chemotherapy in 886 patients in 25 countries. Trial results showed, that at a median follow-up of 17.2 months, the median overall survival in the Padcev combination therapy group was 31.5 months, approximately twice as long as the 16.1 months in the platinum-based chemotherapy group, reducing the risk of death by 53%.
- Company
- Pharma-distributor 'margin war' heats up again
- by Son, Hyung Min Jun 13, 2025 06:03am
- The pharmaceutical industry and distribution industry are in conflict over profit margins. Janssen Korea reportedly notified its training companies of a 2%p reduction in margins and continuing negotiations with individual companies. Some domestic pharmaceutical companies are implementing margin reductions starting this year. Pharmaceutical companies are citing sluggish sales, drug price reductions, and increasing debt ratios as background for these margin cuts. However, the distribution industry is showing strong resistance, claiming that if they bear labor costs, delivery fees, and other commissions, they will incur losses with every transaction. Domestic and foreign pharmaceutical companies announce margin reductions According to industry sources on June 13, VivaCell Biotechnology recently officially informed its distributors of a plan to lower sales discount rates. According to the official letter, the company will reduce the sales discount rate from the current 4% to 3% of the cash collection starting in July. The pharmaceutical distribution industry interprets this as a strategy to cut margins. The distribution industry is expressing concern that numerous pharmaceutical companies are implementing margin reductions this year. Indeed, Korea Pharma, Kolon Pharm, and Ahn-Gook Pharmaceutical have also announced plans to lower their distribution margins this year. Recently, the global pharmaceutical company Janssen Korea joined in. Janssen Korea notified its trading partners that it would pursue a 2%p reduction from existing margins. The distribution industry asserts that while some pharmaceuticalcompanies have attempted margin adjustments of around 1%p due to declining profitability, it's rare for a company like Janssen to pursue a reduction as significant as 2%p. The distribution industry has expressed strong objection, particularly because this measure was announced without prior discussion or consultation with the distribution industry. The distribution industry immediately began to protest, demanding negotiations through their association. They assert that if Janssen Korea negotiates with individual companies, it's highly likely to result in a mere notification. However, Janssen Korea maintains that negotiations with individual companies are appropriate, given the varying contract terms and scale of trading partners, rather than with the association. In this regard, Janssen Korea is reportedly conducting individual negotiations with companies starting this week. Industry leaders, including Korea Pharmaceutical Distributors Association Chairman Park Ho-young, are expressing a strong commitment to respond, stating, "The association will reflect on its member companies and strive to eliminate factors threatening the pharmaceutical distribution industry." Margin narrowing and conflict increasing...the endless tug-of-war between pharma-distribution Margin rate reductions are ongoing conflict issue between the pharmaceutical and distribution industries. Pharmaceutical companies push for lower margins, while distributors try to prevent them. The recent decision by Janssen Korea to cut margins, in particular, signals a potential escalation of this conflict, as the distribution industry mounts a strong backlash. The association recently agreed that Janssen's margin cut threatens the very existence of the distribution industry. In fact, this is the first time in several years that the issue of pharmaceutical companies' distribution margins has been formally placed on the association's agenda, highlighting the severity of the current situation. The distribution industry began direct confrontation, including demonstrations against pharmaceutical companies, years ago. In 2013, the association held collective protests, including one-person demonstrations against Handok, demanding an increase in distribution margin rates. At the time, the association emphasized that a 5% margin, as proposed by Handok, made distribution unfeasible and strongly advocated for additional margins. In 2014, the distribution industry requested a margin increase from GSK, citing deteriorating business conditions, leading to another conflict. They stressed the necessity of a margin increase to cover credit card fees and labor costs, among other expenses, and threatened to refuse to handle GSK products if their request was not met. However, the conflict was temporarily resolved in October of the same year when the Korea Pharmaceutical Distributors Association and GSK agreed on a margin increase. Since then, the distribution industry has engaged in discussions and negotiations with pharmaceutical companies regarding margin reductions, aiming for mutual growth. However, in the case of Janssen Korea's recent margin cut, they are adopting strong opposing stance. The distribution industry refutes the pharmaceutical companies' calls for mutual growth, asserting that their very survival is at stake. Indeed, the gross margin rate for the pharmaceutical distribution industry has been on a continuous decline. The gross margin rate is a key indicator used to measure distributors' profitability before deducting all expenses, including labor costs and selling, general, and administrative expenses. While the exact margin pharmaceutical distributors earn from purchasing drugs from manufacturers is not precisely known, they generally consider gross profit, the opposite of cost of goods sold, as their margin. A comparison of the gross margin rates of 55 pharmaceutical distribution companies with over KRW 100 billion in sales last year showed an average of 6.2%. The margin rate, which was 7.1% in 2020, recorded 7.0% in 2021 before entering a downward trend. A closer look by sales bracket reveals that companies with annual sales of over 500 billion KRW had an average margin rate of 6.6% last year. The highest margin rate recorded in the last five years was 6.8% in 2023, failing to exceed 7%. Companies with sales between KRW 200 billion and KRW 500 billion also saw their margin rates decline. Their average margin rate last year was 7.4%, the lowest in the past five years. Notably, excluding Korea Medix, which operates under a CSO (Contract Sales Organization) model and had a margin rate of 43.9%, the average for this group sharply drops to 5.8% based on last year's figures. The average margin rate for companies with annual sales between KRW 100 billion and KRW 200 billion has also been decreasing each year. Their average margin rate last year was 6.4%, a 0.2 percentage point increase from 2023, but it has remained at an average of 6.3% over the past five years. The pharmaceutical distribution industry believes that current margin rates make survival difficult, considering credit card fees, labor costs, delivery fees, and returns. An official from the pharmaceutical distribution industry said, "The continuous decrease in margin rates is attributable to the pharmaceutical companies' declining sales. Pharmaceutical companies are responding to losses incurred from drug price reductions by reducing margins for pharmaceutical distributors. If margins continue to decrease, small and medium-sized distributors simply cannot survive." Adding, "It's a situation where pharmaceutical companies advocate for mutual growth while the distribution industry asserts its right to survival. A compromise needs to be found, but relationships between trading partners must also be considered. The proliferation of distributors and CSO companies has intensified competition, making excessive return orders and aggressive labor cost expenditures issues that also need careful consideration. However, it is an undeniable fact that operating businesses is not easy with the current margin rates."
