- LOGIN
- MemberShip
- 2025-12-22 14:36:56
- Company
- Will patients taking osteoporosis drugs increase?
- by Moon, sung-ho Feb 28, 2025 05:58am
- With a denosumab biosimilar expected to enter the clinical trial site in Korea in earnest, changes in the treatment market are expected. # According to industry sources on the 24th, the Ministry of Health and Welfare recently announced a preliminary administrative notice of the revision of the 'Detailed Standards and Methods for the Application of Medical Benefits' centered on the listing of the denosumab biosimilar. Unless there is a major disagreement, the revision is likely to take effect next month. The item that will be listed is the Celltrion biosimilar ‘Stoboclo prefilled syringe (hereinafter referred to as Stoboclo).’ The drug is a biosimilar version of Amgen’s Prolia that has achieved unrivaled sales in the domestic osteoporosis treatment market, and the drug is expected to compete with the original product starting next month. The Ministry of Health and Welfare plans to revise the notice to apply the same reimbursement standards as Prolia. With the notice, interest is shifting to how Stoboclo’s reimbursment listing will spark competition with the original Prolia. The industry is interested in whether Stoboclo will be able to exert its influence as a biosimilar in the domestic market, as it has in the global market. Currently, the price of Prolia is KRW 154,700 per 60 mg. Stoboclo’s price is expected to be lower than this because it is a biosimilar. For reference, the Ministry of Health and Welfare expanded the reimbursement standard for osteoporosis treatment last year. It made it possible to continue applying the reimbursement to patients who have reached the treatment goal of the T-score, which is the standard for osteoporosis treatment and covered those on the borderline. When measuring bone density using dual-energy X-ray absorptiometry (DXA), the T-score is -2.5 or less (T-score ≤ -2.5), and the patient is approved for reimbursement, the patient is approved for reimbursement for an additional year even if the T-score improves to -2.5 or more and -2.0 or less during treatment. If the T-score is above -2.5 and below -2.0 even after treatment, the drug will be granted reimbursement for an additional year. The HIRA has been conducting selective intensive reviews since last year in anticipation of an increase in claims due to the expansion of reimbursement. The biosimilar Stoboclo will also be subject to these reimbursement standards, as will Prolia. The Ministry of Health and Welfare explained, “As Stoboclo is scheduled to be newly listed, it will be applied reimbursement standards in the same way as existing denosumab injection’s standard, and ‘etc.’ has been added to the product name in the notification category.” A professor of rheumatology at a tertiary hospital in Seoul said, “Previous osteoporosis drugs had to be taken on an empty stomach in the early morning and required sitting for a long time due to concerns about esophagitis.” He said, “The dosing method was that difficult to take.” He went on to say, “The treatment paradigm has changed significantly after the introduction of Prolia from the patient's perspective, as it provides injections like vaccinations. This has rapidly restructured the osteoporosis treatment market restructuring,” and expanded the market to expand further.
- Company
- Will the SC injection be a new treatment option for IBD?
- by Son, Hyung Min Feb 28, 2025 05:58am
- The clinical accomplishments of subcutaneous formulation (SC) new drugs are being noticed in the inflammatory bowel diseases (IBD) area, including Crohn's disease and ulcerative colitis. Celltrion's Remsima SC clinical results have recently shown improved endoscopic and histologic remission rates. Janssen's Tremfya SC induction therapy also showed results similar to the intravenous (IV) formulation. Remsima SC showed clinical recapture after dose escalation According to industry sources on February 27, Celltrion unveiled its clinical results during the European Crohn´s and Colitis Organisation (ECCO) annual conference held for four days in Berlin, Germany. Remsima SC is Celltrion's in-house developed biologic medicine, changing the existing IV injection to SC formulation. Remsima is a biosimilar version of Janssen's inflammatory bowel disease medication Remicade. In November 2019, Celltrion obtained approval for Remicade's SC injection formulation, Remsima, in Europe and began challenging the market. IBD is characterized by repetitive improvement and recurring chronic inflammation in the gastrointestinal tract caused by an abnormal immune response. Ulcerative colitis and Crohn's disease are types of IBD. Repetitive gastrointestinal tract symptoms, including diarrhea, blood in stool, and abdominal pain, significantly affect daily life but treatments are lacking. Therefore, patients need new treatments. CelltrionThe recently presented phase 3 clinical trial is a study result of Remsima SC involving patients with moderate to severe ulcerative colitis (UC) and Crohn's disease (CD). The analysis was based on two years of post hoc data analysis of the LIBERTY-CD and LIBERTY-UC clinical trials, which were the basis of approval. The effects were analyzed in patients who had a loss of response during the previous treatment with Remsima SC 120 mg, and then the dose was escalated to 240 mg. The analysis results indicate that 66.0% (31/47 patients) of the CD patients and 69.4% (43/62 patients) of UC patients showed clinical recapture after dose escalation following loss of response. Ultimately, 85.1% (40/47 patients) of CD patients and 82.3% (51/62 patients) of UC patients had clinical recapture at 102 weeks. Notably, in CD patients, the early clinical recapture group had increased serum drug levels from 8.0 to 22.1 μg/mL following dose escalation, and the later clinical recapture group had increased serum levels from 11.1 to 19.8μg/mL. In UC patients, both the early clinical recapture group and later clinical response group (7.4 to 16.5 μg/mL) had increased serum drug levels. A researcher said, "The current study result confirmed that dose escalation of Remsima SC induces rapid clinical recapture in patients who experienced loss of response. Through further studies, we need to analyze factors related to the clinical recapture rate in depth. Janssen's Tremfya SC induction therapy demonstrated effectiveness Janssen unveiled its clinical results for the SC formulation of Tremfya SC at ECCO 2025. Tremfya is an autoimmune disease therapy that blocks or inhibits the interleukin (IL)-23 signaling pathway. By suppressing IL-23, a key mediator of inflammation, the treatment has shown to be effective in several chronic immune-mediated conditions, including CD, UC, psoriasis, and palmoplantar pustulosis. JanssenThe efficacy of Tremfya was previously demonstrated in the QUASAR study using an IV induction therapy followed by SC maintenance therapy. In the recent Phase 3 ASTRO trial, the effectiveness and safety of SC induction therapy were evaluated in patients with moderate-to-severe UC. Treatment for IBD is divided into induction therapy and maintenance therapy. Induction therapy aims to induce remission in patients with severe active disease. Maintenance therapy is used to sustain remission. The ASTRO study was a multinational, randomized, double-blind, placebo-controlled trial that enrolled 418 UC patients who were either unresponsive or intolerant to corticosteroids, immunosuppressants, biological agents, or Janus kinase (JAK) inhibitors or who had not previously received these treatments. The primary endpoint was clinical remission at week 12, based on clinical indices and endoscopic scores. The clinical results revealed that the Tremfya SC group achieved a clinical remission rate of 27.6%, compared with 6.5% in the placebo group. Additionally, the endoscopic and histo-endoscopic mucosal improvement rates were 37.3% and 30.5% in the Tremfya SC group, which were substantially higher than the 12.9% and 10.8% observed in the placebo group. Safety profiles were comparable between the Tremfya SC and placebo groups, with similar incidences of adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation. A researcher commented, "The ASTRO study provides important data that extends the previous Tremfya IV induction regimen results. This demonstrates that Tremfya is highly effective not only in its IV formulation but also in SC induction therapy, and it can be used in patients with moderate-to-severe UC without raising new safety concerns." Based on these clinical results, Janssen submitted a biologics license application (BLA) for Tremfya SC induction therapy to the U.S. Food and Drug Administration (FDA) in November last year.
- Company
- Will MSD’s rare cancer drug Welireg be reimbursed this time
- by Eo, Yun-Ho Feb 28, 2025 05:57am
- Attention is gathering as to whether the rare anticancer drug Welireg will succeed in its second attempt at reimbursement listing in Korea. According to industry sources, MSD Korea’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan) will be presented to the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in March this year. This drug was submitted for reimbursement in April last year and was put up for public petition in May, gaining the consent of more than 50,000 people, but it failed to overcome the CDDC review hurdle. The key to Welireg’s second reimbursement attempt will again be finances. Welireg was designated an orphan drug in Korea for the treatment of Von Hippel-Lindau disease in January last year, then formally approved in May of the same year. Specifically, the drug is indicated for the treatment of adult patients with VHL who require therapy for associated renal cell carcinoma (RCC), CNS hemangioblastoma, or pancreatic neuroendocrine tumors (pNET), that do not require immediate surgery. As a HIF-2α inhibitor, Welireg reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis, and tumor growth. The drug’s efficacy was demonstrated in the open-label Study 004 trial, which investigated 61 patients with VHL-associated RCC who were diagnosed with at least one measurable solid tumor localized to the kidney. Patients enrolled in the trial had other VHL-associated tumors including CNS hemangioblastomas and pNET. The major efficacy endpoint of the clinical trial was the overall response rate (ORR) in patients with VHL-associated RCC as measured by radiology assessment using RECIST v1.1 as assessed by an independent review committee (IRC). Additional efficacy endpoints included duration of response (DoR) and time to response (TTR). In the study, Welireg showed an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR had not yet been reached, and the DoR among responders who were still responding after at least 12 months was 56%. Median TTR was 8 months. Also, in patients with VHL-associated CNS hemangioblastomas, Welireg showed an ORR of 63%, with a complete response rate of 4% and a partial response rate of 58%. Recently, Welireg was additionally approved for a kidney cancer indication in the US. Its efficacy for the indication was confirmed in LITESPARK-005, a trial conducted on patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma (RCC) that had progressed following both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF-TKI. Results showed that Welireg improved progression-free survival (PFS) and reduced the risk of disease progression or death by 25% compared to everolimus in patients with advanced renal cell carcinoma who received a PD-1 or PD-L1 immune checkpoint inhibitor and a VEGF receptor-targeted therapy, either sequentially or in combination.
- 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.
