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- 2026-05-01 11:20:50
- Company
- Domestic approval application filed for 'Voranigo' in KOR
- by Eo, Yun-Ho Feb 27, 2025 05:57am
- Product photo of Voranigo New drug 'Voranigo' for malignant brain tumors has entered domestic approval procedure. According to the industry sources, Servier Korea has recently submitted approval application to the Ministry of Food and Drug Safety (MFDS) for Voranigo (vorasidenib). In Sepetember last year, this drug was designated an orphan drug in South Korea. Voranigo is indicated for the treatment of diffuse gliomas with an isocitrate dehydrogenase (IDH) mutation. Voranigo targets patients with low-grade gliomas who are vulnerable to IDH1 or IDH2 mutations. This drug is a bispecific inhibitor of IDH1/2, developed by multinational pharmaceutical company Servier. It targets glioma (astrocytoma or oligodendroglioma), a type of brain tumor that is difficult to treat. Voranigo received the final approval from the U.S. Food and Drug Administration (FDA) in August 2024 and is in the process of getting approved in countries worldwide, including Europe. The efficacy of Voranigo was demonstrated through the Phase 3 INDIGO study. The study results were presented at last year's American Society of Clinical Oncology (ASCO) Annual Meeting. The study results showed that in patients with glioma who have IDH mutation, the drug significantly reduced the tumor progression or death risk by 61% compared to the placebo. Voranigo also reduced the risk of requiring further treatments by 74%. The study participants had no history of undergoing treatments other than surgery. Voranigo also showed favorable drug tolerance. Its safety profile was similar to the Phase 1 clinical trial case results. Meanwhile, glioma is the most common type of primary malignant brain tumor in adults, and almost all adult patients (grade 2 diffuse gliomas) are likely to have IDH1 or IDH2 mutation. These patients are currently treated with off-label (medicines approved for other uses) instead of officially approved medicines. In addition to Voranigo monotherapy, Servier is currently conducting clinical trials for concurrent use of the drug with MSD's immune checkpoint inhibitor, 'Keytruda (ingredient: pembrolizumab),' in patients with relapsed and advanced gliomas who have IDH1 mutation. The company already has 'Tibsovo (IDH1 inhibitor)' and a 'IDH2 inhibitor' in its IDH inhibitor pipeline.
- Company
- Nexium challenged by P-CAB…attempts at regaining sales
- by Whang, byung-woo Feb 27, 2025 05:57am
- Proton pump inhibitors (PPIs) are being challenged by emerging P-CAB drugs. Therefore, Nexium's company is strengthening strategic partnerships to maintain Nexium's market position. The company continues partnering with Ildong Pharmaceutical and plans to continue collaboration based on its years of prescription experience. (from left) Ji-Young Kim, executive director of AstraZeneca Korea, Hwoon-Yong Jung, Professor in the Department of Gastroenterology at Asan Medical Center in Seoul, and Sang Gyun Kim, Professor in the Department of Gastroenterology at Seoul National University Hospital. AstraZeneca Korea announced this on February 20 at the press conference celebrating its 25-year anniversary of the South Korea launch of gastroesophageal reflux disease (GERD) treatment Nexium (esomeprazole magnesium trihydrate). Launched in 2000, Nexium is one of the major PPI treatments that works by suppressing gastric acid secretion. It has six indications, including GERD, and has the most indications among domestically approved PPIs. After 25 years since the launch of this drug, the effects on superior acid control and the improvement of GERD, as well as the effectiveness and safety profile of long-term administration, have been confirmed through various clinical practices. Nexium has been recorded as No.1 in accumulative prescription volume for 10 years in the global GERD treatment market, including PPI and P-CAB. Dr. Hwoon-Yong Jung, Professor in the Department of Gastroenterology at Asan Medical Center in Seoul, said, "Nexium is a s-isomer-based PPI with a superior treatment rate in 98.9% of patients with GERD. It has established a firm position in the market." Dr. Jung added, "It secured various indications, including maintenance therapy following intravenous injection to prevent rebleeding related to gastric ulcer. It is now known to provide a wide variety of treatment options." However, as the growth rate of PPI monotherapy has been decreasing, the company has deep concerns. According to market research firm UBIST, last year's outpatient prescription sales in the PPI monotherapy market were KRW 636.2 billion. The PPI monotherapy market steeply rose until 2021. After that, the growth rate significantly decreased. The prescription sales of PPI monotherapy in 2019 were KRW 461.7 billion and then increased by 19% to KRW 550.1 billion the following year. In 2021, the sales increased by 9% to KRW 600.4 billion. In 2022, the sales increased by only 2%, with KRW 614.3 billion. In 2023, it increased by 2% with KRW 624.5 billion. Last year, it rose by 2% compared to the previous year. After 2022, it grew 2% in three consecutive years. Analysis suggests that the introduction of P-CAB drugs has contributed to this sales trend. P-CAB drugs have a longer duration of drug action compared to PPI drugs, so they are also effective for managing night-time gastric acid secretion. They also have the advantage of combining with other medications because it is less likely to interact with other drugs. The total prescription sales of P-CAB drugs show a high growth rate: ▲2019, KRW 30.4 billion▲2020, KRW 77.1 billion ▲2021, KRW 110. 7 billion ▲2022, KRW 146.3 billion ▲2023, KRW 217.2 billion ▲2024, KRW 286.4 billion. Despite defending the market position, Nexium is seeing decreasing sales. The recent sales of Nexium indicate that its sales have been decreasing after recording the highest sales in 2020, with KRW 45.6 billion: ▲2021, KRW 42.0 billion ▲2022, KRW 33.5 billion ▲2023, KRW 32.3 billion ▲2024, KRW 29.1 billion. Despite this trend, experts view that Nexium will maintain its market position. Apart from the P-CAB drugs' effect, the long-term trend can be closely watched. Dr. Jung said, "New drug releases attract attention and can lead to increased usage, but existing drugs still have advantages and remain in use." Dr. Jung added, "P-CAB development has provided an additional treatment option that can enhance drug action in patients who are experiencing a decrease in the drug effectiveness." Dr. Sang Gyun Kim, Professor in the Department of Gastroenterology at Seoul National University Hospital, said, "The degree of symptom improvement experienced by patients are not significantly different between PPI and P-CAB. If a disease is effectively managed by PPI, there is no need to change the medication." Dr. Kim added. "We have to wait to see which medication will benefit patients more. Given that P-CAB has not been in the market for so long, we still need to monitor its long-term usage." Bae Yong-Chan, Executive Director of Ildong Pharmaceutical Along with this, AstraZeneca and Ildong Pharmaceutical plan to maintain their influence on the market by strengthening their partnership. Bae Yong-Chan, Executive Director of Ildong Pharmaceutical's ETC division, said, "Besides the gastroenterology area, we are strengthening partnerships to pave the way for cardiovascular diseases area. Also, Nexium's long-term maintenance therapy will still be its advantage." Bae added, "Nexium is a trusted medication that has contributed to improving patient quality of life. Ildong Pharmaceutical, in collaboration with AstraZeneca, is expanding Nexium's value. We will strive to create the best treatment settings through continued collaboration."
- Company
- Chong Kun Dang strengthens its oncology business
- by Kim, Jin-Gu Feb 27, 2025 05:57am
- Chong Kun Dang is tightening the reins on its oncology business. It recently acquired the right for the liver cancer drugs ‘Nexavar (sorafenib)' and ‘Stivarga (regorafenib)' and neutropenia drug ‘Neulapeg (pegfilgrastim)' in the recent month. The company expects the drugs to create synergy with its existing pipeline of anti-cancer drugs centered on the in-house developed drug Camtobell (belotecan). The company expects sales related to its Oncology business are also expected to increase to twice the existing level. Neulapeg in addition to Nexavar and Stivarga… acquired 3 types of oncology drugs in one month Chong Kun Dang announced on the 26th that it has signed a partnership agreement with GC Biopharma to jointly market Neulapeg. GC Biopharma will jointly conduct domestic sales and marketing, and Chong Kun Dang will exclusively distribute Neulapeg in Korea. Neulapeg is a second-generation neutropenia treatment developed by GC Biopharma in 2015 with its own technology. It is a drug that prevents hematologic side effects when the patients' immunity is reduced due to decreased neutrophil levels during chemotherapy, which increases the risk of infection. The company applied its PEGylation technology, which increases the half-life of the drug and enhances its stability compared to existing treatments. Compared to the first-generation treatment, which required four to six doses per cycle, the drug is said to provide the same effect with only one dose per cycle, greatly improving patient convenience. On the 6th of this month, the company signed an exclusive domestic sales agreement with Bayer Korea for the liver cancer treatment Nexavar and Stivarga. Chong Kun Dang will be in charge of exclusive distribution, sales, and marketing of Nexavar and Stivaga in domestic hospitals from this month. Nexavar and Stivarga are targeted therapies for liver cancer. Nexavar is used for the first-line treatment of liver cancer and Stivarga is used for the second-line treatment. When used together, Nexavar and Stivarga can offer sequential treatment for liver cancer. #Synergies with existing products such as Camtobell expected... Expected to double sales in the anti-cancer business With the recent acquisition of Nexavar, Stivaga, and now Neulapeg, Chong Kun Dang has expanded its lineup of anti-cancer drugs and adjuvants. The company expects the newly acquired products to synergize with its existing anticancer drugs. (from the left) Nexavar, Stivarga, Neulapeg Chong Kun Dang previously owned 12 anti-cancer drugs, including its in-house-developed drug, Camtobell. Camtobell is a camptothecin-based anticancer drug developed by Chong Kun Dang in 2004 with its technology. It is Chong Kun Dang’s first new drug and the third new anti-cancer drug in Korea. It is used for recurrent ovarian cancer and small-cell lung cancer. In addition, ▲Lenaloma Cap (lenalidomide) and Tezobel (bortezomib) for multiple myeloma ▲ Leukeevec (imatinib) for chronic myeloid leukemia ▲Belotaxel (docetaxel), a cytotoxic anticancer drug used for breast cancer and non-small cell lung cancer ▲Beloxa (oxaliplatin) for metastatic colon and rectal cancer ▲Eloceta (elotinib) and Iretinib (gefitinib), targeted therapies for non-small cell lung cancer, ▲Gemtan (gemcitabine) and Pemecine (pemetrexed), cytotoxic anticancer drugs for prostate cancer, Calutami (bicalutamide), and ▲Caelyx (doxorubicin) for metastatic breast cancer. These products generate annual sales of around KRW 40 billion. According to drug market research institution IQVIA, the combined sales of Chong Kun Dang’s 12 existing anti-cancer drugs as of 2023 was KRW 39.6 billion. If new items worth around KRW 35 billion are added to this, Chong Kun Dang’s anticancer sales are expected to double. Nexavar and Stivarga will jointly generate sales of KRW 14.2 billion in 2023. Neulapeg generated sales of KRW 19.3 billion. In addition to introducing new products, the company is also strengthening its internal oncology business. At the time of the introduction of Nexavar and Stivarga, CEO Young-Zu Kim explained, “Chong Kun Dang has recently strengthened its expertise in the oncology drug sector by establishing a dedicated oncology drug organization.” 'ADC anti-cancer drugs'-'shRNA anti-cancer drugs' are being developed in-house...“to expand its oncology drug portfolio” In the mid-to-long term, it is also expecting synergy with its own anti-cancer drug under development. In February 2023, Chong Kun Dang signed a contract with the Dutch company Synaffix to introduce antibody-drug conjugate (ADC) technology and secured the rights to use 3 ADC platform technologies to develop ADC anticancer drugs. In April of last year, it signed a license agreement with Curigin, a company developing RNAi-based gene therapy, for its bispecific shRNA candidate substance 'CA102.' Chong Kun Dang plans to secure global rights to Curigin’s anticancer drug candidate substance 'CA102' and conduct exclusive research and development and commercialization with superficial bladder cancer as its first indication. In addition to this, the company is planning to introduce the Keytruda (pembrolizumab) biosimilar in Korea. In 2022, Chong Kun Dang signed an exclusive supply and sales contract with Singapore's Favorex for the Keytruda biosimilar in Korea. “Chong Kun Dang has sales power and expertise in the field of anticancer drugs, including Camtobell, which was developed with the company’s proprietary technology,” said a Chong Kun Dang official. ”We will expand our anticancer drug portfolio to further expand our presence in the domestic anticancer drug market.”
- Company
- LigaChem Bio expands partnership with Wuxi XDC
- by Cha, Jihyun Feb 27, 2025 05:57am
- LigaChem Biosciences announced on the 26th that it has signed an expanded memorandum of understanding (MOU) with Wuxi XDC to develop a next-generation antibody-drug conjugate (ADC) drug. This agreement expands the collaboration from clinical sample production to research and development in addition to the 2021 agreement that had been made between the two companies. Through this collaboration, LigaChem Biosciences aims to accelerate its development pipeline that applies the ADC platform. By leveraging Wuxi XDC's research talent and infrastructure, LigaChem Biosciences aims to reduce the time to discover potential drug candidates. In line with its VISION 2030 Early Achievement Strategy, LigaChem Biosciences aims to identify 3-5 new ADC candidates per year and rapidly advance them to the next clinical stage. The company is aggressively pursuing this strategy by acquiring technologies from domestic and foreign biotechs and signing new antibody discovery agreements with several CROs. Young-Zu Kim, CEO of LigaChem Biosciences said, “We are pleased to strengthen our collaboration with Wuxi XDC, with whom we have had a long-standing partnership. We expect to shorten the time to discover candidates that took around 3 years by over 1 year through this collaboration.” Jimmy Lee, CEO of Wuxi XDC said, “Our expansion of our collaboration with LigaChem Biosciences further strengthens our long-standing partnership. We look forward to leveraging Wuxi XDC's one-stop service of research, development, and manufacturing to support LigaChem Biosciences’s rapid development of its next-generation ADC candidates.”
- Policy
- NA starts Special Act to support the pharma and bio industry
- by Lee, Jeong-Hwan Feb 27, 2025 05:56am
- The National Assembly is pushing for the enactment of a special law to bring together the capabilities at the national level to promote and foster the biopharmaceutical industry. The policy agenda includes the establishment of a basic plan every 5 years, the establishment of a Pharmaceutical Biohealth Innovation Committee, and the provision of policy support such as research and development facilities, tax incentives for bio special zones, and practical support such as substantial budget support and tax cuts. On the 24th, Rep. Il-Young Jung, a member of the National Assembly's Strategy and Finance Committee, and the Democratic Party of Korea, proposed the ‘Special Act on the Promotion of the Pharmaceutical Biohealth Industry and Strengthening of Competence (Bio Special Act).’ As the bio industry is a core industry with strategic value in health, medicine, society, economy, and security, the need for support for biotechnology development and the industry as a whole has been raised. In particular, after the COVID-19 pandemic has passed, the bio industry has established itself as a national strategic industry that has a significant impact not only on the health of the people but also on the national economy and security, and there has been a growing demand to foster the industry at the national level. In response, Rep Il-Young Jung proposed the Bio Special Act to enable the government to provide comprehensive support and foster the bio industry in a timely manner, and establish a legal basis for supporting the bio industry. The bill includes ▲the establishment and implementation of a five-year basic plan, ▲the establishment and operation of the Pharmaceutical Bio-Health Innovation Committee, ▲budget support for R&D and infrastructure construction, ▲designation of bio-special zones, and the ▲provision of special exemptions such as tax support for special zones and exemption from preliminary feasibility studies and regulatory improvements. In addition, the plan includes ▲tax and financial support for foreign-invested companies and companies returning to Korea, ▲the creation of a bio-industry fund, and ▲support for the training of professionals and vocational training. Among these, the tax support is intended to reduce taxes on pharmaceutical and bio-health companies in accordance with the relevant tax laws, such as the Act On Restriction On Special Cases Concerning Taxation and Act On Restriction On Special Cases Concerning Local Taxation, to promote investment in the pharmaceutical and bio-health industry and revitalize special zones. “The current Korean economy is facing a difficult situation with a growth rate of just over 1%, and this economic difficulty is largely due to structural problems in the Korean industrial structure, rather than a temporary phenomenon,” said Rep. Il-Young Jung. He also pointed out that ”The trade environment is deteriorating further due to domestic political instability and the tariff war that began under the Trump administration in the United States, which will significantly hurt the semiconductor and automobile industries, which have driven the Korean economy.” “The need for new growth industries has been continuously raised to overcome the difficulties of the Korean economy, and the bio industry is the most in the spotlight,” said Jung, ”It is necessary to intensively foster the bio industry and quickly develop it into a major industry that will lead the Korean economy.” “The global bio industry market will grow to about USD 3.3 trillion by 2027. We will establish a legal and institutional foundation for the promotion of the bio industry through the Bio Special Act so that the Korean bio industry can become globally competitive and serve as a new economic engine for Korea, to succeed the semiconductors and automobile industry.”
- Company
- Dongwha makes record sales record for 4 consecutive years
- by Kim, Jin-Gu Feb 26, 2025 06:30am
- Dongwha Pharmaceutical has broken its sales record for 4 consecutive years. The company's active overseas investment and entry into new businesses are cited as the driving forces behind the record sales streak. In particular, the Vietnamese pharmacy chain it acquired in 2023 has contributed greatly to the expansion of the company's business. Vietnam's Trung Son Pharma recorded sales of more than KRW 100 billion last year. The company plans to fully promote its business in Vietnam this year and expects its performance to improve further in the process. According to the Financial Supervisory Service on the 26th, Dongwha Pharmaceutical recorded sales of KRW 464.9 billion last year, up 28.7% from the previous year. Sales have increased for 4 consecutive years. Dongwha Pharmaceutical's sales have steadily increased from KRW 272.1 billion in 2020 to KRW 293 billion in 2021, KRW 340.4 billion in 2022, and KRW 361.1 billion in 2023. Compared to 2020, the sales volume has increased by more than 70% in four years. In particular, sales growth was remarkable last year. This is in contrast to the 10% annual average increase it had made from 2020 to 2023. By growth rate alone, it is three times than that of previous years. Dongwha Pharmaceutical The analysis is that the Vietnamese pharmacy chain that the company acquired led to the expansion of its external appearance. Dongwha Pharmaceutical acquired Trung Son Pharma in Vietnam in August 2023. It purchased a 51% stake in Trung Son Pharma for a total of KRW 39.1 billion. Trung Son Pharma generated KRW 101.1 billion in sales last year alone. With the addition of sales of KRW 100 billion, Dongwha Pharmaceutical's consolidated sales exceeded KRW 400 billion for the first time. Other sales, excluding Trung Son Pharma’s sales, have also increased year-on-year. Dongwha Pharmaceutical's separate sales last year were KRW 363.8 billion, an 8.6% increase from KRW 335.1 billion in 2023. However, Trung Son Pharma had a negative impact on Dongwha Pharmaceutical's operating profit. Dongwha Pharmaceutical's consolidated operating profit fell 28.7% from KRW 18.8 billion in 2023 to KRW 13.4 billion last year. Dongwha Pharmaceutical explained that the “operating profit decreased due to the recording of consolidated income and expenses in the Vietnamese pharmaceutical distribution chain.” Dongwha Pharmaceutical expects its Vietnam business to be in full swing this year, with Trung Son Pharma at the center and said that sales and operating profit are expected to improve further once the related businesses go on track. “After the acquisition of Trung Son Pharma, the company has been focusing on post-merger integration (PMI) and is now in the stage of full-scale business promotion,” said a Dongwha Pharmaceutical official. ”Once the time-consuming drug approval issues are resolved, we expect Trung Son Pharma’s sales and operating profit to improve further.”
- Opinion
- [Reporter's View] Gov't OKs JAK inhibitor drug switching
- by Eo, Yun-Ho Feb 26, 2025 06:30am
- It has been a flexible and swift measure. Drug-switching between JAK inhibitors and biological agents for the treatment of severe atopic dermatitis will be reimbursed starting in March. The Ministry of Health and Welfare (MOHW) issued an administration notice of a partial revision draft of the pharmaceutical long-term care reimbursement requirement standard. In this administrative notice, the MOHW improved the standard so that despite previous treatment with biological agents, when a patient does not adequately respond or has no tolerability, drug switching to JAK inhibitors will be covered by reimbursement. Also, when a patient does not benefit from JAK inhibitors or cannot continue treatment due to side effects (the switched drug is recommended to be administered for at least 6 months), one can switch to biological agents. Reimbursement is not provided when a patient switches to another drug more than once. Concerns have been raised often regarding drug switching not being covered by reimbursement in South Korea. At the end of last year, an issue in one area was resolved. The MOHW decided to approve drug switching for rheumatoid arthritis patients when tumor necrosis factors (TNF) or JAK inhibitors are not effective or cannot continue treatment due to side effects. Of course, there is still room for improvement regarding expanded reimbursement for atopic dermatitis medicines. Drug switching between the same class medicines has been excluded from the reimbursement list. We must acknowledge that this is the first step. The current expanded reimbursement is a result of the government's swift response. Until now, the government has been hesitant to reimburse JAK inhibitor drug switching due to insufficient clinical evidence. For atopic dermatitis, reimbursement was no longer provided when a patient used biological agents, such as interleukin, or oral agents, like JAK inhibitors, and then switched to another medicine. Despite experiencing side effects after the initial treatment or ineffectiveness, patients were not easily switched to another medicine. Academics have consistently provided opinions. However, the government faced difficulty revising the system without documents showing clear evidence. It was reviewed multiple times but did not result in expanded reimbursement. Amid this situation, the Korean Atopic Dermatitis Association submitted a statement that drug switching must be allowed for the atopic dermatitis area. Furthermore, the association stated that after the revision of the guidelines after nine years, there were no therapeutic differences between biological agents and oral agents. The government responded again to multiple requests. At the end of last year, a review was started again regarding drug switching for atopic dermatitis. Soon after, the government responded to requests swiftly. Clear communication can provide another opportunity. The effective communication between the health and welfare authority and clinical practices deserves praise.
- Company
- SK Bioscience will start a global trial for its mRNA vaccine
- by Cha, Jihyun Feb 26, 2025 06:29am
- SK Bioscience's messenger ribonucleic acid (mRNA) vaccine has entered full-scale clinical trials. SK Bioscience announced on the 25th that it has begun Phase I/II global clinical trials of GBP560, a Japanese encephalitis mRNA vaccine candidate. The Phase I/II clinical trial will involve 402 healthy adults living in Australia and New Zealand. It will be conducted to evaluate the immunogenicity and safety of the vaccine after vaccination. In the first stage, the tolerability and immunogenicity of the subjects will be checked after administering low, medium, high, or control doses twice at 28-day intervals. In the second stage, the dosage and administration method will be set based on the results of the first stage, and the immunogenicity and safety will be evaluated by comparing it with the control group. SK Bioscience plans to secure interim results from the GBP 560 Phase I/II clinical trial next year. Previously, SK Bioscience confirmed the safety and immunogenicity of the candidate substance through repeated dose toxicity tests, safety pharmacology tests, animal efficacy tests, and immune-mediated attack tests in the GBP 560 non-clinical trial. The development of the Japanese encephalitis vaccine is part of the '100-day Mission' project to prepare for the next pandemic, which SK Bioscience is conducting with international organizations to establish an mRNA vaccine platform. The 100-day Mission aims to develop and mass-produce a vaccine within 100 days of the outbreak of an unknown infectious disease (Disease-X) to respond to the pandemic within 100 days. SK Bioscience signed an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) in 2022 to receive an initial research and development grant of USD 40 million and launched the project. When it enters the later development stage, CEPI will provide SK Bioscience with up to an additional USD 100 million. Through this project, SK Bioscience aims to secure mRNA vaccine platform technology that can respond to pandemics and various diseases, and establish a new pipeline to gain global competitiveness. Jae-Yong Ahn, President and Chief Executive Officer of SK Bioscience, said, “If the technology is expanded with the mRNA platform, we will be able to respond quickly to unknown diseases and ensure fair access to vaccines and sufficient supply. We will conduct clinical trials successfully to contribute to global public health and solidify our position as a vaccine R&D leader.”
- Company
- Celltrion tops KRW 1T in 2024 sales
- by Chon, Seung-Hyun Feb 26, 2025 06:29am
- Celltrion's sales and operating profit are reported to be the highest in history due to expanded sales of biosimilars. Its sales exceeded KRW 1 trillion in both North American and European markets. According to the Financial Supervisory Service (FSS), Celltrion's operating profit for last year was KRW 1.2110 trillion, up 89.7% from the previous year. The sales amounted to KRW 3.7092 trillion, up 98.0%. Both sales and operating profit are the largest in history. The company explained, "Existing products, including Remsima, Truxima, and Herzuma, have shown stable growth, and new products, including Remsima SC, Yuflyma, and Vegzelma, have generated a record high annual sales." Celltrion recorded KRW 1.0636 trillion in Q4 sales, up 178.0% Year-over-Year (YoY). The company's quarterly sales exceeded KRW 1 trillion for the first time. Celltrion's biological drug sales last year in both the North American market and the European market topped KRW 1 trillion for the first time. Celltrion Celltrion's sales of biological drugs in the North American market reached KRW 1.0453 trillion, a 66.1% increase from the previous year. Inflectra showed steady performance, and Truxima, Yuflyma, Zymfentra, and Vegzelma also showed sales growth. Biological drug sales in the European market increased from KRW 986 billion in 2023 to KRW 1.5468 trillion last year, an expansion of 56.9%. As the expansion of new drug sales accelerated, sales rose significantly. Annual sales of the intravenous (IV) formulation Remsima, a biosimilar to Remicade, alone exceeded KRW 1 trillion for the first time in history. According to market research firm IQVIA, Remsima's European market share is reported to be 62% as of Q3 of last year. Including Remsima SC, it showed high market share in major European countries: 88.8% in the U.K., 80% in France, 75.8% in Spain, and 73.8% in Germany. Guided by a pharmacy benefit manager (PBM), Remsima SC, sold as a new drug in the United States, has been listed on approximately 90% of formularies in the U.S. insurance market, and the production continues to increase significantly. Truxima, a biosimilar to the anticancer drug MabThera, is recording a market share of 30% range in Europe and the United States. Herzuma, a biosimilar to anticancer drug Herceptin, shows market share of 72% in Japan. Biosimilar version of autoimmune diseases treatment Humira is expanding its market share in both Europe and the United States. Last year's sales more than doubled compare to the previous year, recording KRW 349.1 billion. The 2024 global sales of Vegzelma, a biosimilar to the anticancer drug Avastin, expanded more than four-fold compared to the previous year, with KRW 221.2 billion. Based on the company's direct-sales marketing network and competitive production cost, Vegzelma showed fast growth, recording a market share of 29% in Euope and reaching No.1 in the list. Celltrion employee said, "This year, we will ensure the internal stability of the company by launching a new portfolio, improving production cost, and generating cost-effectiveness. We plan to continue company growth quantity-wise and quality-wise." He said, "This year's production cost rate will be improved quickly by depleting the remaining stock with high production costs, expanding Plant 3 production, and terminating compensation for the development cost of existing products.
- Company
- Samsung Bioepis launches Stelara biosimilar Pyzchiva in US
- by Whang, byung-woo Feb 26, 2025 06:29am
- Pic of Pyzchiva Samsung Bioepis announced on the 25th that its autoimmune disease treatment Pyzchiva (ustekinumab) has been launched in the US through its marketing partner Sandoz. Stelara’s biosimilar Pyzchiva is Janssen’s treatment for autoimmune diseases such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Stelara’s annual global sales are about KRW 15 trillion (USD 10.361 billion), and its sales in the United States are about KRW 10 trillion (USD 6.72 billion). Pyzchiva is an autoimmune disease treatment that inhibits the activity of interleukin (IL)-12,23, a type of inflammatory cytokine involved in immune responses. With the launch of Pyzchiva, Samsung Bioepis has expanded its portfolio in the US market with the launch of its third autoimmune disease treatment, an interleukin inhibitor, following the launch of two existing autoimmune disease treatments that are tumor necrosis factor-alpha (TNF-a) inhibitors. This is the company's fifth product in the US market, including anticancer drugs and ophthalmic disease treatments. “With the launch of Pyzchiva in the US, we will be able to provide a variety of treatment options for patients with autoimmune diseases,“ said Linda Y. MacDonald, Executive Vice President and Head of Global Commercial Division at Samsung Bioepis. “Expanding treatment options will reduce medical costs and ultimately contribute to the establishment of a sustainable healthcare system.” ”We will continue to work to address unmet needs in the US pharmaceutical market,” she added. Meanwhile, Samsung Bioepis is also selling Pyzchiva through Sandoz in Europe and is ranked first in the biosimilar market with a 43% share of the European Stelara biosimilar market. In addition, in South Korea, Epyztek (the domestic brand name for Samsung Bioepis’s Stelara biosimilar) was launched and sold in July last year through a direct sales system at about 40% lower price than the original drug.
