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- 2026-04-21 15:18:30
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- Dayvigo targets Zolpidem dominance…Korean commercial launch imminent
- by Eo, Yun-Ho Mar 19, 2026 12:39pm
- An insomnia treatment with a new mechanism of action, ‘Dayvigo,’ is soon to be commercialized in Korea.According to industry sources, Eisai Korea is currently undergoing the approval process with the Ministry of Food and Drug Safety (MFDS) for Dayvigo (lemborexant), a dual orexin receptor antagonist (DORA). Formal approval is anticipated around mid-year.Mechanistically, Dayvigo is classified as an orexin/hypocretin receptor antagonist. It works by inhibiting orexin, which promotes sleep. It is important to note that orexin itself is a neuropeptide in the brain that promotes wakefulness.The drug demonstrated efficacy through two Phase III clinical trials, including the SUNRISE I study.The trials involved 1,006 adult patients from 67 medical institutions in the U.S. and Europe, who were divided into 4 treatment groups. These included 266 patients in the Davigo 5 mg treatment group, 269 in the Davigo 10 mg treatment group, 263 in the zolpidem CR Tab (6.25 mg) treatment group, and 208 in the placebo group. The average age of the patients participating in the study was 63, and 86% were female.Key results showed that most patients in the Dayvigo groups fell asleep within 20 minutes, demonstrating improved sleep onset. In addition, nighttime sleep maintenance time increased by more than 60 minutes compared to baseline.Furthermore, both the low-dose and high-dose groups demonstrated superiority over the placebo group in terms of sleep onset and sleep maintenance. These improvements were particularly pronounced in the Dayvigo 10mg treatment group.Dayvigo received FDA approval in 2019 and is currently prescribed in markets including Europe and Japan.
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- Jeil's subsidiary, Onconic licensing transactions total KRW 10B
- by Chon, Seung-Hyun Mar 19, 2026 12:39pm
- Jeil Pharmaceutical has reached the cumulative technology licensing fees revenue of KRW 10 billion from its R&D subsidiary, Onconic Therapeutics. This steady influx of technology licensing fee stems from the completion of domestic clinical trials, the approval of the new drug Jaqbo, and its successful entry into the Chinese market. Additionally, Jeil Pharmaceutical's revenue surged to KRW 67.1 billion last year as it ramped up sales of Jaqbo.According to the Financial Supervisory Service (FSS) on the 18th, Jeil Pharmaceutical received a total of KRW 1.8 billion in technology licensing fees from Onconic Therapeutics last year. Specifically, the company received KRW 600 million in February, followed by KRW 300 million and KRW 900 million in May and October, respectively.Yearly Cumulative Technology Licensing Fees of Jeil Pharmaceutical's subsidiary Onconic Therapeutics (unit: KRW 1 million, source: Financial Supervisory Service)These payments stem from the settlement of technology export milestones for Jaqbo, which Jeil Pharmaceutical originally out-licensed to Onconic Therapeutics. In March 2023, Onconic Therapeutics signed a technology export deal with the Chinese firm Livzon Pharmaceutical Group for Jaqbo, valued at up to $127.5 million. Under the terms, Onconic received a non-refundable upfront payment of $150 million and is expected to receive up to $112.5 million in milestone payments based on development, regulatory approval, and commercialization stages.In January of last year, Onconic Therapeutics received a $3 million milestone from Livzon following the first patient dosing in China's Phase 3 clinical trial. In March, it billed an additional $1.5 million after completing the transfer of production technology to Livzon.By August, Onconic billed and received a $5 million development milestone within 30 business days. This was achieved by the successful conclusion of Phase 3 trials in China and the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA). A portion of these fees received from Livzon is redistributed to Jeil Pharmaceutical as milestones.Jaqbo is a P-CAB (Potassium-Competitive Acid Blocker) drug, approved in April 2024 as the 37th Korea-developed new drug. P-CAB anti-ulcer agents work by competitively binding with potassium ions to the proton pump, the final stage of acid secretion in gastric parietal cells, thereby inhibiting gastric acid secretion.Jeil Pharmaceutical's revenue history from Jaqbo includes two non-refundable payments of KRW 150 million each in December 2020 and May 2021. In 2022, it received KRW 1 billion in February and another KRW 1 billion in December as Phase 3 clinical milestones. In April 2023, the company received KRW 2.7 billion as a settlement from Onconic’s upfront payment from Livzon (representing 13.5% of the $15 million). In 2024, an additional KRW 600 million was paid over four installments. As of last year, Jeil's cumulative technology licensing fees for Jaqbo totaled KRW 7.58 billion.Jeil Pharmaceutical has also consistently generated revenue from an oncology drug out-licensed to Onconic. For the dual-target anticancer agent JPI-547, the company has secured a total of KRW 2.5 billion. This includes upfront payments of KRW 750 million each in December 2020 and May 2021, plus a KRW 1 billion development milestone received in December 2022. The total amount Jeil Pharmaceutical has collected from Onconic Therapeutics for both Jaqbo and JPI-547 amounted to KRW 10.08 billion.Through Jaqbo domestic sales, Jeil Pharmaceutical achieved expanded sales effects. Jaqbo entered the prescription market in last October after receiving National Health Insurance coverage. Jeil Pharmaceutical and Dong-A ST collaborate on leading marketing and sales. Jaqbo's revenue for Jeil expanded from KRW 8.3 billion in 2024 to KRW 67.1 billion last year.
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- Multi-indication anti-cancer drugs, 'Tevimbra' offers alternative
- by Eo, Yun-Ho Mar 18, 2026 09:12am
- Product photo of 'Tevimbra (tislelizumab)' As advanced oncology treatments surge, discussions are in full swing to bridge the gap between the financial burden and improved patient access.The government recently presented the enhancement of coverage for rare cancers as a core task through the 5th Comprehensive Cancer Control Plan (2026–2030), and the need to re-examine the overall financial structure of oncology reimbursement is gaining attention.Related to this, the Korean Society of Medical Oncology has also emphasized the need to expand the scope of reimbursement for rare cancer treatments, calling for a balance between coverage expansion and fiscal sustainability.The background to these policy discussions is the rapid expansion of approved uses for multi-indication oncology drugs, such as immune checkpoint inhibitors, antibody-drug conjugates, and bispecific antibodies, which could accelerate the pace of expenditure growth.The recent regulatory and expanded reimbursement of the immunotherapy 'Tevimbra (tislelizumab)' is garnering significant attention. It is being interpreted as a case study demonstrating how realistic alternatives can be implemented amidst spending on multi-indication oncology drugs is skyrocketing.Tevimbra entered the Korean market in April last year, becoming the first immunotherapy to successfully secure reimbursement for the first-line treatment of esophageal cancer in combination with chemotherapy. Within just two months, it expanded its approved indications to a total of five, including esophageal cancer, gastric cancer, and first- and second-line treatment of non-small cell lung cancer.In December of the same year, an unusual record for Tevimbra was set when all five of these indications passed the Cancer Drug Review Committee in a single session. After that, it secured additional indications in perioperative adjuvant therapy for non-small cell lung cancer, extensive-stage small-cell lung cancer, and nasopharyngeal cancer. This drug's scope was expanded from major to rare cancers with limited existing treatment options in a short period. However, the expanded reimbursement for major indications remains ongoing.Despite concerns in the medical community that regulatory and reimbursement hurdles are rising, Tevimbra's rapid achievement is raising expectations, largely due to a strategy that combines proven clinical equivalence with a rational pricing model. By demonstrating clinical utility equivalent to first-in-class agents while offering a pricing structure that reduces the financial burden relative to competitors, the drug has navigated the approval and reimbursement processes swiftly. Experts evaluate Tevimbra as a symbolic case that tests the consistency of the reimbursement review process.Both clinicians and National Health Insurance subscribers are also welcoming Tevimbra as an expansion of treatment options. Clinicians appreciate the increased choices within the same efficacy profile, allowing for prescriptions tailored to patient characteristics. At the same time, payers view the situation positively as price competition between drugs with equivalent clinical effects can lead to significant cost savings.Providing options for rare cancers like nasopharyngeal cancer, or for areas like perioperative non-small cell lung cancer and esophageal cancer where reimbursed treatment options were previously lacking, aligns with the government's goal of expanding reimbursement coverage.In a situation where the reimbursement system is becoming restricted due to spending being concentrated on specific immunotherapies, a drug that successfully enters the reimbursement list by presenting a new price structure based on clinical similarity is expected to set a favorable precedent.Professor Ji-Youn Han of the Hematology-Oncology Department at the National Cancer Center said, "Tevimbra demonstrated an efficacy and safety profile equivalent to that of existing immunotherapies across various studies. In certain patient subgroups, it has shown clear relative advantages." Professor Han added, "As clinical evidence for Tevimbra grows, it is an option that can broaden the scope of treatment selection and improve clinical benefits and access. We hope for rapid reimbursement expansion so that patients can receive benefits."
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- 'Nubeqa' reimb progress…changes to prostate cancer trt strategies
- by Son, Hyung Min Mar 18, 2026 09:11am
- Prostate cancer treatment 'Nubeqa' The prostate cancer treatment 'Nubeqa' is under reviews for final insurance reimbursement hurdle.As the competing drug 'Erleada' faced setbacks in price negotiations and the patent expiration of Xtandi approaches, a total shift in the competitive landscape among Androgen Receptor Pathway Inhibitors (ARPI) is expected.According to industry sources, Bayer Korea is set to enter price negotiations with the National Health Insurance Service for Nubeqa (darolutamide). Nubeqa passed the Drug Benefit Evaluation Committee earlier this month, advancing to the final stage of coverage.The indications that passed the reimbursement evaluation include ▲high-risk non-metastatic castration-resistant prostate cancer ▲hormone-sensitive metastatic prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) ▲mHSPC in combination with docetaxel and ADT.Among these, the hormone-sensitive combination therapies were approved as suitable for reimbursement on the condition that a price below the evaluated amount be accepted.Once reimbursement discussions are finalized, Nubeqa will be available for practical clinical use in both triplet and doublet therapies. The strength of this drug lies in its differentiated treatment strategies, depending on whether docetaxel is co-administered, allowing for customized treatment tailored to the patient's condition.Doctors evaluate that this will expand treatment options, as triplet therapy (Nubeqa+ADT+docetaxel) can be used for patients who require aggressive early treatment. In contrast, doublet therapy (Nubeqa+ADT) can be considered for elderly patients or those with high chemotherapy burdens due to comorbidities.Clinical evidence for Nubeqa continues to accumulate, with the ARANOTE study targeting mHSPC patients showing that the Nubeqa + ADT doublet therapy significantly improved outcomes, reducing the risk of radiological progression or death by 46% compared to placebo.It also delayed the time to progression and PSA progression, showing consistent results across secondary endpoints. A post-monitoring analysis confirmed delay in time to deterioration of quality-of-life and pain progression.Furthermore, the ARASENS study showed that the triplet combination of Nubeqa + ADT + docetaxel significantly improved overall survival, reducing the risk of death by 32.5%.Competition among ARPIs intensifies…the market is closely watching variables such as reimbursement and patentsCurrently, the prostate cancer treatment landscape is centered on androgen receptor inhibitors.Major treatment options include Janssen's 'Zytiga (abiraterone),' 'Erleada (apalutamide),' and 'Xtandi (enzalutamide)' serving as major options alongside Nubeqa.However, several variables surround the market environment. Competing drug Erleada reportedly failed to reach an agreement during recent price negotiations with the National Health Insurance Service on expanding reimbursement for its high-risk non-metastatic indication.Prostate cancer treatment 'Xtandi'Analysis suggests that the adjustment of the Risk-Sharing Agreements (RSA) rate following the expansion of the target population is a key point of contention.Furthermore, the patent for Xtandi, which has led the market, is set to expire in major countries, starting with the U.S., in 2027. As Xtandi is a blockbuster with annual sales of approximately $6 billion, the possibility of structural market changes due to generic entry is being discussed in the mid- to long-term.Ultimately, Nubeqa's reimbursement progress, beyond a new listing, is evaluated as a variable that will influence the overall competitive landscape.As treatment options with clinical use as both doublet and triplet combination strategies are made available, depending on reimbursement status, the paradigm of prostate cancer treatment in Korea is increasingly likely to be restructured toward more patient-centered care.
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- Adjuvant immunotherapies shift gastric cancer trt paradigm
- by Son, Hyung Min Mar 17, 2026 09:22am
- Cancer immunotherapy 'Imfinzi'Major immune checkpoint inhibitors have demonstrated effects in pre- and post-operative adjuvant therapy. A paradigm shift in the treatment of gastric cancer is expected.According to industry sources on the 17th, the addition of an indication for the immunotherapy 'Imfinzi (durvalumab)' in advanced gastric cancer is imminent. AstraZeneca Korea anticipates approval within this month.While East Asia is notable for excellent early diagnosis and surgical outcomes, the risk of recurrence due to residual micrometastases remains high for patients with Stage 2–3 locally advanced disease. A perioperative treatment strategy, administering anticancer drugs both before and after surgery, has emerged as a solution to improve clinical outcomes.According to the final analysis of the Phase 3 MATTERHORN trial presented at the European Society for Medical Oncology (ESMO 2025) in Berlin last October, Imfinzi's perioperative adjuvant therapy significantly improved overall survival (OS) with statistical significance. Furthermore, clinical results for Asian patients, including South Koreans, were introduced at ESMO ASIA 2025.A total of 180 Asian patients participated in this analysis. The Asian cohort had a higher proportion of high-risk patients, with a greater frequency of T4 staging and lymph node positivity compared to the overall study population.Despite this, the Imfinzi combination therapy showed positive results, reducing the risk of disease progression by 26% in the event-free survival (EFS) endpoint compared with the placebo combination group. The 24-month EFS rate was 72.1% for the Imfinzi group, higher than the 64.2% in the placebo group. As the median EFS has not yet been reached in either group, the treatment benefit may become even more pronounced during long-term follow-up. The OS benefits were also consistent with the previous global clinical data.A particularly striking result was the pathological complete response (pCR). In the Asian cohort, the Imfinzi combination increased the proportion of patients whose tumors completely disappeared at the time of surgery to 18.9%, more than triple the 5.6% recorded in the placebo group. This level is similar to the overall analysis results, demonstrating that Imfinzi can significantly enhance tumor shrinkage effects during the preoperative phase.Safety was also confirmed to be at a manageable level, with no specific increase in toxicity compared to the standard FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) regimen. There was no significant difference in Grade 3 or higher adverse events between the two groups, and treatment discontinuation rates were similar, indicating no new safety concerns arising from the addition of Imfinzi. Given that FLOT itself is an intensive regimen, this is interpreted as an important finding.Based on these clinical results, the U.S. Food and Drug Administration (FDA) last month approved Imfinzi monotherapy as maintenance treatment following FLOT combination therapy in adult patients with resectable gastric and gastroesophageal junction adenocarcinoma.While surgery remains the cornerstone of curative treatment for gastric cancer, there is a growing global consensus, including in Asia, that surgery alone is often insufficient for a full cure. The MATTERHORN study has shown that administering immunotherapy in combination with FLOT before surgery, followed by radical resection and subsequent treatment, can meaningfully improve long-term outcomes.Clinical trials of major immunotherapies in perioperative adjuvant therapyCancer immunotherapy 'Keytruda'The attempt to integrate immunotherapy into perioperative care is not limited to Imfinzi. Various studies combining different immunotherapies with chemotherapy are confirming the potential for expanding gastric cancer treatment strategies.For example, improvements in preoperative pathological response rates have been reported in several studies, including studies involving avelumab + FLOT (MONEO), sintilimab + FLOT, toripalimab + SOX, and tislelizumab + SOX. Some studies are also exploring strategies that combine immunotherapy with anti-angiogenic agents or radiation therapy.Recently, the potential to improve tumor response rates has also been identified in preoperative adjuvant strategies involving the PD-1 inhibitor Tevimbra (tislelizumab), further raising the possibility of expanding preoperative immunotherapy.However, not all immunotherapies have achieved the same level of success.MSD's Keytruda (pembrolizumab) demonstrated improved pCR in the Phase 3 KEYNOTE-585 study evaluating a perioperative adjuvant strategy but failed to improve EFS, thus failing to meet its primary endpoints.
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- Facing the era of low-priced generics…diabetes drug competition
- by Chon, Seung-Hyun Mar 16, 2026 09:25am
- Dong-A ST is adding two more combination therapies that utilize its in-house-developed diabetes drug, Suganon. Having completed the development of these new combinations, the company has entered the regulatory approval stage. Once these two combination drugs are approved, six types of Suganon lineups will be secured.Chong Kun Dang has also expanded its Duvie line, new diabetes drugs, to six products. While competing drugs are seeing stagnant growth due to overheated market competition from hundreds of generics, Chong Kun Dang has strengthened its competitiveness by securing new growth engines through the concentration of its research and development (R&D) capabilities. Analysis suggests that establishing new, incrementally modified drugs (IMDs) will be a powerful driving force for profitability in preparation for the upcoming era of low-priced generics.Dong-A ST files for two Suganon combination drugs...establishing new growth engines amid slow growth in over-saturated marketAccording to the Financial Supervisory Service (FSS) on the 16th, Dong-A ST submitted applications for the marketing authorizations of “Sugaempa” and “Suganova SR” to the Ministry of Food and Drug Safety on the 13th. Both “Sugaempa” and “Suganova” are combination drugs made using Dong-A ST's diabetes drug, Suganon.Suganon, approved in October 2015 as the 26th Korea-developed new drug, is a DPP-4 inhibitor diabetes treatment. Suganon has an outstanding blood glucose-lowering effect even at low doses due to its high selectivity for the DPP-4 enzyme. It has a low impact on the metabolism of other drugs, resulting in high medication convenience and compliance for patients with chronic diseases who must take multiple medications. Furthermore, it can be used without dose adjustment, even in patients with decreased renal function."Sugaempa" is a combination drug that joins Suganon with empagliflozin, an SGLT-2 class diabetes drug. The original drug for the empagliflozin component is Jardiance. "Suganova" is a triple combination drug consisting of Suganon, empagliflozin, and metformin.Yearly outpatient prescriptions for Suganon products (unit: KRW 100 million, source: UBIST)If Dong-A ST receives approval for "Sugaempa" and "Suganova," the Suganon family lineup will expand to six types.In July 2016, Dong-A ST launched Sugamet, a combination containing Suganon and metformin. In May 2023, it released Sugadapa, combining Suganon with the SGLT-2 inhibitor dapagliflozin, and in January 2024, it added a triple combination drug comprising Suganon, dapagliflozin, and metformin.By combining two different SGLT-2 inhibitor components, Dong-A ST will offer two types of Suganon + SGLT-2 inhibitor combinations and two types of Suganon + SGLT-2 inhibitor + metformin combinations. This strategy aims to equip the maximum number of combinations possible so that patients taking individual component drugs separately can utilize a Suganon combination drug. The Suganon family is evaluated to have successfully settled into the prescription market, recording annual sales of approximately KRW 30 billion.According to the pharmaceutical research organization UBIST, the four types in the Suganon family recorded KRW 31.5 billion last year. Sugamet and Suganon recorded prescription amounts of KRW 17.4 billion and KRW 11.1 billion, respectively. Sugatree and Sugadapa recorded KRW 1.6 billion and KRW 1.4 billion, respectively.However, recent growth has been slow. Last year's prescription amount for Sugamet decreased by 3.5% compared to the previous year, and Suganon decreased by 7.7%. Sugamet recorded prescription sales of KRW 20.6 billion in 2022, but they have decreased by 15.6% over the last three years. Suganon has shown a downward trend for three consecutive years, following KRW 14.1 billion in 2022, a 20.9% decline. While Suganon and Sugamet combined for KRW 34.7 billion in 2022, the prescription amount for the four Suganon family products, including Sugatree and Sugadapa, decreased by 9.0% compared to three years ago.With both the DPP-4 inhibitor and SGLT-2 inhibitor markets in Korea entering a state of oversaturation due to the entry of generics, it is a difficult environment to sustain growth. While most domestic pharmaceutical companies compete by offering generics, Dong-A ST's move is to strengthen its competitiveness in the oversaturated market by investing in its self-developed new drugs and additional R&D capabilities. 174 subjects participated in the clinical trials for Dong-A ST's "Sugaempa" and "Suganova."Chong Kun Dang establishes 6 Duvie lineup... Securing profitability weapon against low-priced generic eraChong Kun Dang is also strengthening its competitiveness in a stagnant market by steadily adding to its self-developed diabetes drug Duvie lineup.On the 11th, Chong Kun Dang received marketing authorization approval from the Ministry of Food and Drug Safety for Duviempol XR. Duviempol XR is a triple combination drug comprising lobeglitazone, empagliflozin, and metformin. Lobeglitazone is the main component of Duvie, the diabetes drug independently developed by Chong Kun Dang.Chong Kun Dang stated, "We expect to increase administration convenience by providing a new treatment therapy with the fixed-dose combination of lobeglitazone, empagliflozin, and metformin for type 2 diabetes patients whose blood sugar is not appropriately controlled by the dual therapy of empagliflozin and metformin."Duviempol XR is the sixth lineup developed based on Duvie. Approved in 2013 as the 20th Korea-developed new drug, Duvie is a thiazolidinedione (TZD) class diabetes treatment.Starting with Duvie, Chong Kun Dang currently sells four Duvie lineups: Duviemet SR, Duviemet S, and Duet S. Duviemet SR, approved in 2016, is a combination drug combining Duvie and metformin.Duviemet S, approved in May 2023, is a combination drug containing Duviemet and the DPP-4 inhibitor sitagliptin. The original drug for sitagliptin is Januvia. In June 2023, Chong Kun Dang received additional approval for Duet S, a dual combination drug joining lobeglitazone and sitagliptin.In January, it equipped its fifth lineup by receiving approval for Duviempa, which joins Duvie and empagliflozin. Duviempa can be used for adult type 2 diabetes patients for whom the concomitant administration of lobeglitazone and empagliflozin is appropriate.For Chong Kun Dang, the strategy is to maximize synergy in the prescription market by presenting new treatment alternatives to medical staff and patients through the introduction of various combination drugs centered on Duvie.Annual outpatient prescriptions for Suganon family (unit: KRW 100 million, source: UBIST)The market situation for Duvie is also not easy. Last year, outpatient prescription costs for the four types in the Duvie family totaled KRW 20.3 billion, a 3.9% decrease from the previous year. Duvie's prescription volume was KRW 18.3 billion, accounting for about 90%, while the remaining products were not significantly prominent. In 2022, Duvie and Duviemet combined for KRW 25.4 billion. Last year, the combined prescription amount of the four products decreased by 20.2% compared to three years ago.As with Suganon, it is a difficult environment for Duvie to sustain growth as pharmaceutical companies indiscriminately release generics for diabetes drugs like SGLT-2 inhibitors. However, the company is moving to equip itself with additional growth engines by steadily releasing combination drugs developed through its R&D capabilities. It is viewed that combination drugs developed by a pharmaceutical company's proprietary new drugs can become a driving force for future profitability, especially as the government continues its attempts to lower generic drug prices.In November last year, the Ministry of Health and Welfare (MOHW) reported to the Health Insurance Policy Deliberation Committee a plan to improve the drug pricing system, which includes lowering the price calculation rate for generics and off-patent drugs from 53.55% to the 40% range. It is reported that on the 11th, the MOHW held a sub-committee of the Health Insurance Policy Deliberation Committee and suggested a generic drug price calculation rate in the low-to-mid 40% range. If the generic drug price standard is lowered from 53.55% to 43%, the calculation shows the maximum generic price will be reduced by 19.7%.In the reorganization plan reported by the MOHW last November, it was specified that, while maintaining the maximum price requirements applied since 2020, the reduction rate for unmet requirements would be expanded from 15% to 20%. This means that the prices of generics that do not meet the maximum price requirements will drop even further.Under the drug pricing system reform since July 2020, a generic product can receive the maximum price only if it meets both requirements: performing a bioequivalence study and using registered drug master file ingredients. Every time one requirement is not met, the upper limit price drops by 15%. If both requirements are not met, the structure results in a 27.75% reduction. Applying a 15% reduction rate, the generic maximum price calculation standard of 53.55% drops to 45.52% if one requirement is unmet, and to 38.69% if two requirements are unmet.If the generic calculation standard is set at 43%, a generic that fails to meet one maximum price requirement will be lowered to 34.40%, and a generic that fails to meet two requirements will be lowered to 27.52%. In this case, the price of a generic failing to meet one requirement is reduced by 24.4% compared to the current level, and the reduction rate for failing two requirements is 28.9%. It is mathematically possible to calculate that the reduction in generic drug prices will approach 30%.This is the background for which pharmaceutical companies are complaining that performance pressure could intensify due to the generic drug price cuts. An industry official stated, "Due to the government's policy on lowering drug prices, the market may find it difficult to expect profits from generics in the future. Equipping new drugs or IMDs that can receive high drug prices will greatly help future performance strength."
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- Evolving HIV treatment strategies… new treatment options emerge
- by Son, Hyung Min Mar 16, 2026 09:25am
- The paradigm of HIV treatment is expanding beyond simple viral suppression toward a “lifecycle management” strategy that considers the entire lifespan of people living with HIV.Within the current HIV treatment landscape, a variety of options have emerged, ranging from oral dual-drug regimens that reduce the medication burden during the initial treatment phase to long-acting injectables that prioritize quality of life during long-term treatment. Consequently, treatment strategies are becoming increasingly multifaceted.HIV had long been perceived as a fatal infectious disease characterized by rapid disease progression and high mortality. However, with advances in antiretroviral therapy (ART), the life expectancy of people living with HIV has increased to approximately 78 years, reaching a level not significantly different from that of the general population.At the same time, the U=U (Undetectable = Untransmittable) concept—which states that the virus cannot be transmitted to others once the viral load in the blood becomes undetectable— has positioned HIV treatment as a core pillar of public health strategy, moving beyond individual care.Accordingly, HIV treatment is shifting from a question of survival to ‘how to manage the disease for a long time and in good health.’ In actual clinical practice, the number of patients newly diagnosed in their 20s and 30s is increasing, alongside those in their 60s and 70s who have been on treatment for decades, underscoring the growing importance of long-term treatment management strategies.Amid these changes, there is an emphasis on an approach that considers the entire treatment journey, from the initial treatment phase through long-term management. Among the leading treatment options are GSK’s oral two-drug regimen ‘Dovato (dolutegravir and lamivudine)’ and the combination therapy of the long-acting injectable combination therapy ‘Vocabria (cabotegravir) + Rekambys (rilpivirine).’Two-drug regimen ‘Dovato’ emerges as an initial treatment strategy…effective viral suppression with minimal drug burdenHIV treatment drug ’Dovato.’More than half (approximately 66.7%) of newly diagnosed HIV infections in Korea are diagnosed in people in their 20s and 30s. Since lifelong treatment is required from the time of diagnosis, the importance of strategies to minimize the medication burden during the initial treatment stage is increasing.Dovato, a two-drug oral regimen, is characterized by its ability to reduce drug exposure while demonstrating viral suppression efficacy non-inferior to existing three-drug regimens.In the GEMINI I and II studies, Dovato demonstrated non-inferiority in viral suppression compared with the dolutegravir (DTG) + tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)-based three-drug regimen, and the TANGO study reported positive results regarding bone and renal biomarkers and lipid changes compared to TAF-based therapy. The risk of weight gain was also found to be relatively lower.Thermore, the PASO-DOBLE study, which directly compared the regimen to the existing three-drug regimen of bictegravir (BIC), FTC, and TAF, confirmed non-inferiority in viral suppression rates at week 48, and reported relatively lower risks of weight gain and metabolic side effects.The DOLCE study, conducted in a high-risk group of treatment-naïve HIV-infected individuals with low CD4 counts and high viral loads, and the ATTEND study, which focused on late-diagnosed individuals, also confirmed similar viral suppression effects compared to triple therapy.Based on these study results, guidelines from the Spanish AIDS Research Group GeSIDA (Grupo de Estudio de SIDA), as well as those in Norway, Sweden, and other countries, recommend Dovato as an initial treatment option regardless of baseline viral load.Every 2 month injectable better utilized for HIV in the long term…offers greater utilization in long-term treatment stagesHIV treatment drugs ‘Vocabria’ and ‘Rekambys’As HIV treatment enters the long-term management phase, the focus of treatment has naturally shifted toward quality-of-life management.Amid this trend, the long-acting injectable combination therapy ‘Vocabria + Rekambys,’ administered once every two months, is also establishing itself as a major treatment option.In the Phase III SOLAR study, the therapy demonstrated non-inferiority in both virologic failure rates and viral suppression rates compared with the standard three-drug oral regimen (BIC/FTC/TAF).Treatment satisfaction was also high. The study found that approximately 90% of patients who switched to the long-acting injectable regimen preferred it over the existing oral regimen, citing the following main reasons: ▲ the absence of the need to take medication daily, ▲ treatment convenience, and ▲ reduced psychological burden from being repeatedly reminded of their HIV status through daily medication.The U.S. Department of Health and Human Services (DHHS) guidelines also state that switching to long-acting injectable therapies can improve treatment convenience and reduce medication-related fatigue and the burden of social stigma.In the CARES study, which reflects real-world clinical practice, the virologic success rate of the long-acting injectable therapy reached 96.9%, showing similar efficacy to the oral medication group. Treatment adherence was also found to be high, with 96% of scheduled doses administered within ±7 days.Based on these study results, the 2025 European AIDS Clinical Society (EACS) removed HIV Subtype A1, which had previously been identified as a risk factor for virologic failure and resistance in certain ethnic groups when switching to the Vocabria + Rekambys combination therapy.Currently, the Vocabria + Rekambys combination therapy is the only long-acting HIV injectable treatment available in Korea. It is being used as a switch therapy option to improve treatment convenience and quality of life in adult patients whose viral load has been stably suppressed through existing treatments.This treatment has reportedly accumulated more than 1,000 treatment cases within about one year since its launch in Korea last April.
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- Government sticks to low-40% pricing for generic drugs
- by Kim, Jin-Gu Mar 13, 2026 09:06am
- The government has reportedly decided to maintain its plan to apply a generic drug pricing ratio in the “low to mid-40% range” compared to original drugs. This position remains significantly different from the compromise proposal of about 48% suggested by the pharmaceutical industry, which had already represented a 10% reduction from the current level. Criticism is expected that the government is not demonstrating sufficient willingness to communicate with the pharmaceutical industry regarding drug pricing policy, despite industry objections.According to industry sources on the 11th, the MOHW held a subcommittee meeting of the Health Insurance Policy Deliberation Committee that day to discuss the drug pricing system reform plan. In the closed-door meeting, the MOHW reportedly presented a generic drug pricing calculation rate in the low to mid-40% range.This level is largely consistent with the direction the government presented during last month's HIPDC discussions. Last November, the MOHW reported a drug pricing system reform plan to the HIPDC. This plan included lowering the drug pricing ratio for generics and off-patent drugs from 53.55% to the 40% range.At that time, the ministry indicated that the new generic pricing calculation standard would likely be set between 40% and below 45%. When presenting the reform proposal, the ministry also outlined a schedule for adjusting the prices of already listed drugs. It stated that products currently priced at 45-50% would begin price adjustments in 2027, with reductions to the 40% range by 2029.This still shows a considerable gap from the 48% compromise level proposed by the pharmaceutical industry. The pharmaceutical industry has presented its bottom line for an acceptable calculation rate, signaling its willingness to negotiate with the government.On the 10th, the Emergency Response Committee for Drug Pricing Reform for Pharmaceutical Industry Development held a press conference and proposed joint research with the government, including analysis of price reduction impacts.At the press conference held by the ‘Emergency Response Committee for Drug Pricing Reform for Pharmaceutical Industry Development’ at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association on the 10th, the committee proposed that “considering the profitability of listed pharmaceutical companies and industry conditions, the acceptable price for generic drugs would be about 48.2% of the original drug price.”The specific pricing ratio is expected to be confirmed at the full committee meeting scheduled for the 26th. However, the key question is whether there will be a re-discussion process before the agenda is submitted to the full committee meeting.In this regard, concerns have been raised in the National Assembly that the drug pricing reform plan is being pushed forward without sufficient discussion.Representative Sunmin Kim of the Rebuilding Korea Party pointed out during the National Assembly Health and Welfare Committee plenary meeting on the 10th that the Ministry of Health and Welfare had attempted to ‘pass NA’ by proceeding with the HIPDC subcommittee and plenary meeting schedules in March without including the drug pricing reform plan in its annual report to the National Assembly.Representative Joo-min Park of the Democratic Party of Korea, who chairs the Health and Welfare Committee, agreed that a separate briefing on the reform plan is necessary. He told Health and Welfare Minister Eun-Kyoung Jeong, “Since this is an extremely important matter, it would be appropriate to provide an additional report at the plenary session after discussions on the reform plan are completed.”As a result, the ministry is increasingly likely to provide a separate briefing on the direction of the drug pricing reform plan to the National Assembly before the HIPDC plenary vote.Currently, the MOHW plans to vote on the drug pricing system reform plan at the HIPDC plenary meeting on the 26th. This plan includes lowering the pricing ratio for already-listed generic drugs from the current 53.55% to the 40% range.The generic pricing ratio is the key issue in the current drug pricing reform debate. Currently, domestic generic drug prices are set at 53.55% of the original drug price. The government is pushing to reduce this ratio to the 40% range.In response, the pharmaceutical industry has raised concerns that an excessive price reduction could lead to deteriorating corporate profitability, reduced investment in research and development, and employment instability. As an alternative, the industry proposed a moderated reduction with a pricing ratio of around 48%.
- Company
- New RSV prophylaxis is entering KOR…expanded infant protection
- by Son, Hyung Min Mar 13, 2026 09:06am
- The prevention strategy for infant respiratory syncytial virus (RSV) is expected to expand rapidly in South Korea.As global pharmaceutical companies are proceeding with regulatory approval processes for maternal vaccines and new antibody injectables, a new competitive landscape is beginning to take shape. RSV vaccine 'Abrysvo'According to industry sources on the 13th, Pfizer Korea has summitted application for the approval of 'Abrysvo,' its RSV vaccine. Approval is anticipated within the first half of this year.Abrysvo is a vaccine that targets the F protein, a major surface protein of RSV. It is specifically designed based on the pre-fusion (pre-F) form of the F protein, which the virus uses to penetrate cells.The pre-F protein is known to be the most effective antigen for inducing neutralizing antibodies, as it represents the viral structure just before cell binding and entry. Abrysvo induces an immune response using a protein that stabilizes this specific structure.Designed as a bivalent vaccine targeting both major RSV subtypes (A and B), Abrysvo uses a maternal immunization strategy. In this approach, antibodies generated by the mother following vaccination are transferred through the placenta to protect the infant after birth.RSV is a leading respiratory virus causing pneumonia and bronchiolitis. While it can infect individuals of all ages, infection rates are particularly high in infants. Globally, approximately 90% of children are infected with RSV before age two. For some, it progresses to severe lower respiratory tract disease, making it a primary cause of infant hospitalizations.Clinical evidence for Abrysvo was secured through the Phase 3 MATISSE study. The results showed that maternal vaccination during late pregnancy significantly reduced the risk of severe RSV-related lower respiratory tract disease in infants within six months of birth.Regarding safety, commonly reported adverse reactions included injection site pain, headache, myalgia, and nausea.Abrysvo is established as a preventive option in major overseas markets. In the U.S., it was approved in 2023 for the prevention of RSV-LRTD in infants via maternal vaccination (32–36 weeks) and for adults aged 60 and older. Last year, the indication was expanded to include adults aged 18 and older.Upcoming competition in RSV prevention strategy for children: Vaccines vs. Antibody InjectionsAntibody therapy, 'Enflonsia (clersrovimab),' for RSV prevention MSD has also entered the infant RSV prevention market.MSD Korea recently submitted an approval application to the Ministry of Food and Drug Safety (MFDS) for 'Enflonsia (clersrovimab),' an RSV preventive antibody injection for neonates and infants. The company anticipates approval by the second half of this year.Unlike vaccines, antibody injections deliver antibodies directly into the body, providing immediate protective effects following administration.Enflonsia is a long-acting monoclonal antibody targeting the F protein. It is designed to maintain preventive efficacy for approximately five months with a single dose, covering the typical RSV season from autumn to the following spring.Notably, Enflonsia was developed as a fixed-dose (105mg) treatment regardless of body weight, which is evaluated as a feature that increases convenience for pediatric prevention programs.In the Phase 2b/3 CLEVER study, a single administration of Enflonsia reduced the incidence of RSV-related LRTD by 60.5% and the risk of RSV-related hospitalization by 84.3%.Furthermore, the Phase 3 SMART study involving high-risk infants confirmed its preventive efficacy and a safety profile similar to 'Synagis (palivizumab),' the existing RSV preventive antibody.Antibody therapy 'Beyfortus' for RSV preventionIf Abrysvo and Enflonsia are approved, they are expected to compete with other long-acting RSV preventive antibodies.Currently, 'Beyfortus (nirsevimab),' an RSV preventive antibody developed by Sanofi, has already entered the infant market.Beyfortus is launching in Korea this year and is garnering attention as a major infant RSV prevention option.Previously, AstraZeneca's Synagis was used for RSV prevention, but its short half-life necessitated multiple doses during the RSV season. In contrast, Beyfortus is a long-acting antibody with an extended half-life, allowing for full-season protection with a single administration.Recent international studies have also compared the effectiveness of these different prevention strategies. A large-scale population-based study in France comparing maternal vaccines and infant antibody strategies found that the Beyfortus group had a lower risk of RSV-related hospitalization.Additionally, a surveillance study conducted in the U.S. showed that Beyfortus was 81% effective in preventing RSV-related hospitalizations, with efficacy maintained for approximately 4 to 7 months. Researchers found that while both strategies reduce RSV-related hospitalizations, antibody-based prophylaxis provided greater protection against severe disease.
- Company
- Leclaza launches in Germany, accelerates Europe entry
- by Cha, Ji-Hyun Mar 13, 2026 09:06am
- Photo of Yuhan Corp’s Leclaza (source: Yuhan Corp)Leclaza, a lung cancer drug developed by Yuhan Corporation, has successfully entered the health insurance reimbursement system in Germany, the largest pharmaceutical market in Europe. This listing is expected to accelerate Leclaza’s entry into other European countries.According to the biotech industry on the 12th, Germany’s Federal Joint Committee (G-BA), responsible for evaluating health insurance reimbursement in Germany, assigned billing codes 761990MO and 761990MP to Leclaza 80 mg and 240 mg, respectively, starting this month. Billing codes are assigned after drug price negotiations are finalized, enabling hospitals to bill health insurance for the medication after prescribing it.Leclaza is a third-generation treatment for non-small cell lung cancer (NSCLC) targeting epidermal growth factor receptor (EGFR) mutations. It received approval in Korea in January 2021 as the country's 31st domestically developed new drug. The combination therapy of Leclaza and Rybrevant received approval from the U.S. Food and Drug Administration (FDA) in August 2024 as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed EGFR exon 19 deletion or exon 21 L858R substitution mutation.Later, at the end of 2024, the European Commission (EC) also approved the Lecelaza and Johnson and Johnson’s Rybrevant combination therapy as a first-line treatment for EGFR-mutated NSCLC. Subsequently, in July of last year, the G-BA determined that the combination therapy had sufficient clinical value to qualify for health insurance reimbursement.Under Germany’s Social Code Book V (SGB V), new drugs can enter the market immediately after receiving marketing authorization. Within approximately 6 months, the G-BA evaluates the drug’s clinical benefit, after which price negotiations with health insurers begin. Negotiations typically conclude within another 6 months, after which hospital billing codes are assigned.The G-BA ultimately determined that the combination therapy of Leclaza and Rybrevant positively impacts survival rates for lung cancer patients. It particularly noted a relatively pronounced survival benefit in the patient group aged 65 and under. The G-BA estimated the annual number of patients expected to receive treatment in Germany to be between 1,250 and 3,025.Germany is widely regarded as one of the most stringent countries in Europe in terms of drug pricing decisions. However, Lazertinib entered the reimbursement system relatively smoothly, being recognized for its clinical value. Once prescriptions gain traction in the German market, it is expected to positively influence drug pricing negotiations and insurance listings in other European countries as well.Once sales expand in major European countries, Yuhan Corporation is expected to receive additional licensing fees. Yuhan has not yet received the USD 30 million milestone payment for Leclaza’s approval in Europe. In addition, if sales grow in the European market, the company will receive royalties based on a certain percentage of sales according to the licensing agreement.Yuhan Corporation's total licensing revenue over the 7 years from 2019 to last year amounted to KRW 460 billion. Of this amount, cumulative licensing revenue from Lazertinib technology transfer alone has reached approximately USD 275 million, including upfront payments and development and regulatory milestones.Yuhan Corporation received a non-refundable upfront payment of USD 50 million when it licensed Leclaza to Janssen Biotech, a Johnson & Johnson subsidiary, in November 2018. Subsequently, a USD 35 million milestone was paid in 2020 when the clinical trial for the combination therapy of Rybrevant and Leclaza began. The company received an additional USD 65 million the same year when patient enrollment for the clinical trial began.The company continued to generate milestone revenues thereafter based on progress in development and regulatory approvals. A USD 60 million milestone was triggered by the 2024 U.S. Food and Drug Administration (FDA) approval. Last year, the company received additional milestone payments of USD 15 million for Japanese approval and USD 45 million for Chinese approval.
