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- Company
- Obesity drug craze affects global pharma subsidiaries in KOR
- by Son, Hyung Min Apr 4, 2025 05:58am
- Whether or not a new obesity drug in the glucagon-like peptide (GLP-1) family has been launched has had a significant impact on the performance of Novo Nordisk and Lilly Korea. Last year, Novo Nordisk’s sales increased by 63% upon the launch of Wegovy in the domestic market. In the case of Lilly Korea, sales decreased slightly due to the delay in the launch of the licensed Mounjaro into the market in 2023 and the sluggish sales of some other products.&160; According to the Financial Supervisory Service on the 3rd, Novo Nordisk Korea's sales increased 63% from KRW 230.2 billion in 2023 to KRW 374.7 billion last year. Operating profit increased 65% from KRW 8.3 billion to KRW 13.7 billion over the same period. Novo Nordisk’s sales growth was driven by Wegovy. According to the market research institution IQVIA, Wegovy recorded sales of KRW 60.3 billion in the same quarter since its launch in October last year. Wegovy, which was approved in Korea in April 2023, is a GLP-1 formulation composed of semaglutide, which has been confirmed to have effects on reducing weight and glycated hemoglobin. Novo Nordisk developed the obesity treatment drug Wegovy, a semaglutide that confirmed the weight loss effect of patients during the clinical trial of its GLP-1 class diabetes drug candidate and is administered once a week. Novo Nordisk’s insulin product also contributed to the growth in its sales. According to the market research institution UBIST, sales of its combination of liraglutide, a GLP-1 analogue, and the insulin degludec, Xultophy, reached KRW 15.1 billion last year, up 26% from the previous year.&160; In addition, the once-weekly insulin product Tresiba and the insulin combination product Ryzodeg also recorded sales of KRW 38 billion and KRW 31.3 billion last year, up 3% and 7%, respectively.&160; Novo Nordisk plans to further strengthen its position in the field of obesity. Currently, Novo Nordisk is conducting a global Phase III clinical trial of its new obesity drug, ‘CagriSema,' following the success of its previous drugs, Wegovy and Saxenda. CagriSema is a combination of 2.4 mg of semaglutide, the main ingredient of Wegovy, and 2.4 mg of the long-acting amylin analogue, Cagrilintide. This drug is regarded as a next-generation obesity drug. In clinical trials, CagriSema has been shown to be 23% more effective in weight loss than existing single-agent semaglutide. The expected end of clinical trials is in the first quarter of next year, after which Novo Nordisk plans to apply for approval from major regulatory agencies around the world. Lilly shows slow performance due to non-launch of Mounjaro On the other hand, the performance of Lilly Korea’s Mounjaro, which is also a GLP-1 class diabetes and obesity drug, showed a slight decline. Lilly Korea recorded sales of KRW 164.2 billion last year, down 2% from KRW 167.8 billion the previous year. Operating profit was KRW 10.3 billion, down 1% from 2023. In the case of Lilly Korea, it is analyzed that sales have not increased significantly due to the delay in the launch of Mounjaro. Mounjaro is a new diabetes drug developed by Lilly. Mounjaro acts on both the gastric inhibitory peptide (GIP) receptor and the GLP-1 receptor to promote insulin secretion, improve insulin resistance, and reduce glucagon secretion, thereby reducing blood sugar levels before and after meals. Mounjaro has the advantage of not only controlling blood sugar levels but also having an excellent weight loss effect. Mounjaro has proven its weight loss effect through the results of the Phase III SURMOUNT-1 clinical trial, which was conducted on overweight adult patients who are not diabetic, have a body mass index (BMI) of 30 kg/m2&160;or higher, or have one or more comorbidities, and who were administered Mounjaro once a week. Lilly launched the same-ingredient obesity treatment, Zepbound, in the US market in November 2023, as it has confirmed the weight loss effect in the clinical trial of the drug in the US. In Korea, the drug was approved as a treatment for diabetes in June 2023 and secured additional indications as a new obesity drug with the same product name in August last year. However, its launch in the domestic market has not yet taken place.&160; In addition, sales of Lilly Korea’s Trulicity and Cymbalta were also sluggish last year. Sales of Trulicity, a GLP-1 class diabetes drug, fell 16% from KRW 44.4 billion the previous year to KRW 37.2 billion. Sales of Cymbalta, an antidepressant, fell 52% from 2023 to KRW 5.1 billion. Lilly Korea is looking forward to the success of the SGLT-2 inhibitor Jardiance. Jardiance's sales last year rose 14% year-on-year to KRW 66.3 billion. It benefited from the withdrawal of its rival product, Forxiga, from the market last year. In addition, the company is aiming for a rebound by launching Ebglyss, a new atopic dermatitis drug, in January this year.&160; Lilly is also preparing a next-generation diabetes and obesity drug. Retatrutide, which is being developed by Lilly, is a next-generation diabetes and obesity drug that acts on three receptors: GLP-1, GIP, and GCG (glucagon). To date, no new obesity drugs have been commercialized using this mechanism. In the Phase II clinical trial, Retatrutide demonstrated a weight loss effect of 22.8% and 24.2% when administered at 8 mg and 12 mg at week 48, respectively. This is a higher weight loss effect than the 20.2% of the existing GLP-1 and GIP targeting Mounjaro. Currently, Lilly is confirming the potential of retatrutide not only in obesity but also in various chronic diseases such as diabetes and liver disease.
- Company
- New drug 'Niktimvo' for cGVHD receives ODD in Korea
- by Eo, Yun-Ho Apr 4, 2025 05:58am
- 'Niktimvo,' a new drug for the treatment of chronic graft-versus-host disease (cGVHD), has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety (MFDS) announced this on the notifications of Orphan Drug Designation (ODD). Niktimvo (axatilimab)'s basis for ODD indication is for the treatment of 'adults and pediatric patients over 40 kg with chronic graft-versus-host disease (cGVHD) after failure of two or more systemic therapy.' In August last year, Niktimvo secured the U.S. Food and Drug Administration (FDA) approval It is a cGVHD treatment jointly developed by Incyte Corporation and Syndax Pharmaceuticals, a company in Massachusetts specializing in developing anticancer agents, through the exclusive agreement for global joint-development&8231;launching. GvHD is a serious complication that often occurs after allogeneic hematopoietic stem cell transplant (allo-SCT). Donor T cells from the transplanted graft recognize the recipient’s normal cells as foreign and attack them, affecting multiple organs, including the skin, gastrointestinal tract, liver, and lungs. Since symptoms can manifest throughout the body, GvHD causes additional challenges for patients who have survived allo-SCT, significantly impacting their quality of life. Corticosteroids are used as the first-line treatment; however, approximately 50% of patients fail to respond. In such cases, with no established standard therapy available, there has been an unmet need for effective treatment options. Regarding this, Niktimvo has emerged as a promising new therapeutic option with a novel mechanism of action to address the severe complications in chronic GVHD patients after previous treatments. In South Korea, Novartis Korea's 'Jakavi (ruxolitinib)' was listed on the reimbursement list in November 2023. Sanfi Korea's 'Rezurock (belumosudi)' is in the reimbursement process. The efficacy of Niktimvo was demonstrated through the AGAVE-201 study, which enrolled 241 children and adult patients with refractory and chronic GvHD who received two prior systemic therapies. Clinical results showed that the primary endpoint was met in every cohort treated with Niktimvo, with sustained responses observed across all organ systems and patient subgroups. Among patients receiving the approved dose of 0.3 mg/kg every two weeks, 75% achieved an objective response (ORR) within the first six months of treatment, with a median time to response of 1.5 months. Additionally, 60% of patients maintained their response after 12months of treatment.
- Policy
- COVID-19 Vaccine Damage Compensation Act passes NA
- by Lee, Jeong-Hwan Apr 4, 2025 05:58am
- A special law that compensates and supports patients who have suffered damage after COVID-19 vaccination was passed at the plenary session of the National Assembly on the afternoon of the 2nd. Also, a partial amendment to the Framework Act on Health and Medical Services, which includes the establishment of a Health and Medical Manforce Planning Estimation Committee under the direct control of the Minister of Health and Welfare, passed the plenary session along with the special act. The National Assembly passed the 'Special Act on Compensation for Damage Caused by COVID-19 Vaccination' with 263 in favor and 2 abstentions out of 265 members present. The Act on the Medical&160;Manpower&160;Planning Committee&160;was passed at the plenary session with 247 in favor, 11 against, and 8 abstentions out of 266 members present. The Special Act expands the scope of vaccine damage compensation, such as by presuming that there is a causal relationship if the temporal correlation between COVID-19 vaccination and the disease occurrence is proven. The government has been administering vaccinations and providing state compensation in accordance with the current Infectious Disease Control and Prevention Act. However, the need for the Special Act was raised as there were indications that the damage caused by COVID-19 vaccination was not being properly compensated, due to limited causality of the damage being accepted. The Special Act, which passed the plenary session, was passed by the National Assembly Health and Welfare Committee in January with consensus from the ruling and opposition parties. The Medical&160;Manpower&160;Planning Committee&160;Act, which will deliberate the number of medical school enrollees from 2027, has also passed the National Assembly, but it is unlikely to serve as a clue to resolve the conflict between the government and the medical community in Korea. The amendment proposes the establishment of the Medical&160;Manpower&160;Planning Committee, an independent deliberation body under the direct control of the MOHW, to deliberate on the estimation of medical personnel by job type. The committee members will consist of no more than 15 experts recommended by medical provider representative organizations, consumer representative organizations, and relevant academic societies, with the majority of the members recommended by providers, such as the Korean Medical Association (KMA), and the chairman of the committee will be elected from among the members recommended by the academic community. In addition, the revised act ensures the independence of the committee and ensures transparency by disclosing the minutes and reference materials, and the appointment of a Medical&160;Manpower&160;Planning center to ensure the professionalism of the planning work. When the committee estimates the size of the medical personnel required, the Health and Medical Services Policy Deliberation Committee, chaired by the Minister of MOHW, will then determine the number of medical school students.
- Company
- US postpones 'Drug Tariffs', but industry eyes the situation
- by Kim, Jin-Gu Apr 4, 2025 05:57am
- The US Trump administration announced reciprocal tariffs against the entire world, but “postponed” the application of tariffs on pharmaceuticals, because it is “considering separate industry-specific tariffs” on semiconductors, key minerals, and pharmaceuticals. The domestic pharmaceutical and bio industry is relieved for now but is keeping a close eye on the White House's next move. As the U.S. has been the largest exporter of pharmaceuticals for 3 consecutive years, the specific tariff rates and items subject to the tariffs are expected to have a significant impact on the profits and losses of companies. US President Donald Trump announced on the 2nd (local time) that he would impose a 25% reciprocal tariff on South Korea. However, pharmaceuticals were excluded from this measure. The White House explained that it would impose separate tariffs on pharmaceuticals. The White House said in a separate briefing after President Trump's announcement of tariffs that “this measure does not apply to items already subject to tariffs such as automobiles, steel, aluminum, and lumber under Section 232 of the Trade Expansion Act.” It went on to explain that “President Trump is also considering separate industry-specific tariffs on semiconductors, pharmaceuticals, and key minerals, so these items are also not included in the reciprocal tariffs.” The domestic pharmaceutical and biopharmaceutical industry expressed relief for the time being because the companies have bought time to respond to the US drug tariff, at least temporarily. There are various ways for the pharmaceutical and biopharmaceutical industry to respond to the US drug tariff. In the short term, the method of moving stockpiles to the US in advance can be used. In the mid-to-long term, the industry is also considering producing products directly in the US or outsourcing manufacturing to US companies. Celltrion has secured sufficient inventories of biosimilars that can be procured locally until the third quarter of 2025. In addition, if tariffs are actually applied, the company plans to focus on exporting APIs, which are subject to lower tariffs, rather than finished drugs, which are subject to relatively higher tariffs. Furthermore, in the mid-to-long term, the company is also considering securing manufacturing facilities in the United States. SK Biopharmaceuticals, which sells the new epilepsy drug ‘Xcopri (cenobamate)’ in the United States, has a structure in which it manufactures active pharmaceutical ingredients in Korea, packs them in Canada, and then exports them to the United States. SK Biopharmaceuticals has been promoting this local production strategy in the United States for several years to stabilize its supply chain, and after transferring production technology and completing the verification procedures, it received approval from the US FDA in the second half of last year. Samsung Bioepis, which exports biosimilars to the US, is already cooperating with several contract manufacturing organizations (CMOs) overseas, so it is expected to be able to quickly adjust its strategy if a tariff is imposed. However, as the possibility of imposing tariffs on pharmaceuticals remains high, the pharmaceutical and biopharmaceutical industry is paying close attention to the specific tariff rates for pharmaceuticals and the items subject to tariffs. In this regard, President Trump announced at a press conference on the 18th of last month that the tariff on pharmaceuticals would be “25% or higher.” Some predict that basic and essential drugs will be exempted from tariffs. They note that public opinion in the United States is negative about imposing tariffs on basic and essential drugs. In the case of Huons, it exports lidocaine injections to the United States. This product is a basic drug that is in short supply in the United States and is said to have only one or two local manufacturers. So even if tariffs are imposed on pharmaceuticals, such basic drugs are expected to not be subject to them. The same is true for GC Biopharma. GC Biopharma exports the blood product Alyglo to the United States. Blood products are essential medicines in the United States, and there has been a shortage of supply in the country for several years. The company expects that blood products, including Alyglo, will not be subject to tariffs. In the United States, there is ongoing criticism that tariffs should not be imposed on basic and essential medicines. The Association for Accessible Medicines (AAM), a US generic drug lobby group, has expressed concern that if tariffs are imposed on medicines, the number of medicines in short supply, currently at 127, will surge to 215. The Kaiser Family Foundation, a US non-profit health organization, has warned that imposing tariffs on pharmaceuticals could cause the US healthcare spending growth rate to jump from the current 5% to as much as 60%. The United States has been Korea's largest pharmaceutical export destination for 3 consecutive years since 2022. Last year, pharmaceuticals exported from Korea to the United States amounted to USD 1.35809 billion (about KRW 2 trillion). This is an 18% increase compared to USD 903.3 million in 2023. However, the pharmaceutical trade balance with the United States has been in the red. The trade deficit with the United States was USD 1.1317 billion in 2022, USD 955.54 million in 2023, and USD 292.07 million last year.
- Company
- Qarziba may be prescribed in general hospitals in KOR
- by Eo, Yun-Ho Apr 3, 2025 05:55am
- Qarziba, an immunotherapy drug that targets neuroblastoma, may now be prescribed at general hospitals in Korea. According to industry sources, Recordati Korea's immunotherapy drug for high-risk, recurrent, and refractory neuroblastoma, Qarziba Inj (dinutuximab beta), has passed the drug committees (DCs) of the ‘Big 5 general hospitals’ in Korea, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Severance Hospital. The company has been expanding the drug’s prescription in Korea since receiving reimbursement listing in December last year. As the first drug covered through the approval-evaluation-negotiation linkage system, the drug was approved only 13 months after it was approved in Korea. According to the Ministry of Health and Welfare notice, children from 12 months or older to less than 20 who have not received anti-GD2(disialoganglioside2) antibody treatment before with ▲high-risk neuroblastoma (INSS stage 4 disease or stage 2-3 and have MYCN gene amplification’ and have shown partial or better response to induction chemotherapy and have had hematopoietic stem cell transplant and initiated within 6 months of the transplant, and ▲recurrent or refractory neuroblastoma may receive Qarziba with reimbursement. The drug demonstrated its effect through major pivotal studies, including the Phase III APN311-302 trial. Main results showed that the 5-year event-free survival (EFS) rate for the Qarziba treatment group (378 patients) among high-risk neuroblastoma patients recieivng maintenance therapy was 57%, and the five-year overall survival (OS) rate was 64%, which was statistically significantly higher than that of the control group (466 patients) that did not receive Qarziba immunotherapy., which was 42% and 50%, respectively. Ji-won Lee, a professor of the Department of Pediatric Hematology-Oncology at Samsung Medical Center, said, “This disease has a particularly poor prognosis and a large disease burden, so it is very important to implement an appropriate maintenance therapy that can minimize minimal residual disease (MRD) to prevent recurrence when treating neuroblastoma. Qarziba has significantly improved the survival of patients with high-risk neuroblastoma as maintenance therapy compared to those that did not receive maintenance immunotherapy, shifting the treatment paradigm.” “Major overseas guidelines, such as the International Society of Pediatric Oncology Europe Neuroblastoma (SIOPEN) and the National Comprehensive Cancer Network (NCCN), have already recommended anti-GD2 antibodies such as Qarziba as standard maintenance immunotherapy for high-risk neuroblastoma,” said Jung-yoon Choi, Professor of the Department of Pediatrics at Seoul National University Children's Hospital. ”With the Korean patients also able to receive the global standard of care, I believe this will change the treatment environment in Korea.”
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