- LOGIN
- MemberShip
- 2025-12-22 02:12:25
- Company
- Korea is a strategic key R&D site for Boehringer Ingelheim
- by Whang, byung-woo Apr 01, 2025 05:52am
- Boehringer Ingelheim, which has proposed integrated management of cardiovascular-kidney-metabolic syndrome (CRM) with Jardiance at the forefront, has been drawing on innovation through research and development (R&D) investment. Boehringer Ingelheim has already invested more than EUR 5 billion (KRW 7.9666 trillion) in R&D in 2022 globally and has been steadily increasing its R&D ratio, with a 14.2% increase to EUR 5.8 billion (KRW 9.2412 trillion) in 2023. In particular, the company has been continuing to forge active partnerships with the establishment of a new Business Development & Licensing (BD&L) department in Korea. Ana-Maria Boie, General Manager and Head of Human Pharma at Boehringer Ingelheim Korea Daily Pharm met with Ana-Maria Boie, General Manager and Head of Human Pharma at Boehringer Ingelheim Korea, who is celebrating her first anniversary in office, to hear about her thoughts on the past year and the company's plans for the future. Since entering the pharmaceutical industry after obtaining a medical license in Romania, Boie is a seasoned professional who has accumulated experience in various countries, including Europe, Latin America, the Middle East, Africa, and Asia, for 25 years. After working in marketing at AstraZeneca and Pfizer, Boie joined Boehringer Ingelheim in 2009 and took on roles in various areas including marketing, sales, and ESG. Since her appointment, Boehringer Ingelheim Korea has focused on three areas: ▲R&D, ▲organizational culture, and ▲pipeline expansion. “We are focusing on R&D to develop breakthrough treatments in therapeutic areas with unmet needs,” said Boie, ”We have 33 ongoing clinical studies in Korea, and with the establishment of the BD&L department, we have been actively promoting collaboration and open innovation with domestic pharmaceutical companies and biotech companies.” The company has been evaluated to have shown its determination to expand R&D by adding South Korea to the two existing innovation hubs it had in Japan and China. Boie explained that Korea is an important country in terms of strategic priorities at Boehringer Ingelheim and that the company is willing to develop the Innovation Landscape together based on its interest in Korea's innovative capability. In the future, the company plans to actively explore new opportunities through active support based on the newly established BD&L department in Korea. “In the last few years, Korea has emerged as a 'New Kid on the Block' in the biotech sector, becoming a country that is attracting attention on the global stage. In terms of R&D, Korea has established itself as one of the top 5 countries in the world, and so we at Boehringer Ingelheim have set a strategic goal to further expand our R&D in Korea,” said Boie. “The ultimate goal of the BD&L department is to discover and explore innovative new substances with Korean researchers and strengthen collaboration with Korean companies,” said Boie. “Its main role is to support and promote the discovery of new candidate substances in collaboration with Korean companies, conduct R&D, and support their global entry.” “Korea has limited access to new drugs compared to other countries, limitations in pharmaceutical industry’s innovation exist” From Boie’s perspective, South Korea is a country that leads the development of the pharmaceutical industry in Asia, owning the 4th largest pharmaceutical industry in the Asia-Pacific region and a top-tier medical system. She also positively evaluated Korea’s national health insurance system, which is a single-payer system that covers the entire population. However, Boie also mentioned that the single-payer system limits innovation in the pharmaceutical industry as it is affected by the limited national budget. Boie said, “Despite the fact that Korea has one of the best healthcare systems in the world, Korea is relatively slow in terms of introducing and gaining access to innovative drugs. The reason for this is that the innovativeness of innovative drugs is not given enough value.” She also cited the existence of various drug price reduction regulations post-approval and reimbursement as one of the factors limiting access to innovative drugs. “In terms of the drug life cycle, which goes from domestic approval to reimbursement approval and patent expiry, there is very limited time available to provide the drug to patients in Korea (especially when the drug supply is delayed),” said Boie. ”According to 2022 data, Korea is at least one to one and a half years behind other countries in launching new drugs.” In particular, only 33% of the 460 new innovative drugs developed and launched between 2012 and 2021 have been successfully launched in Korea. This is even lower than that of Germany (61%) and the UK (59%). She emphasized, “To address this issue, I am working with the KRPIA board of directors, the chairman of the Healthcare Committee of the European Chamber of Commerce in Korea, and other stakeholders, and discussing with the Korean government agencies, including the MFDS, HIRA, and the NHIS.” Boehringer Ingelheim selects Korea as a strategic key country... accelerates new drug introduction As the company is focusing on innovation through R&D, it is also focusing on expanding its influence in the domestic market through new drugs. According to Boie, the company plans to launch at least 20 new drugs or indications in several countries, including South Korea, within the next seven years. Among them, South Korea is one of the top 10 strategic countries for Boehringer Ingelheim, and the company has shown a strong willingness to actively introduce innovative treatment options to the South Korean market. Currently, the Human Pharma division of Boehringer Ingelheim focuses on the following areas: Cardio-Renal-Metabolic (CRM), Pulmonary Fibrosis, and Oncology. "We are looking to introduce two major new drugs that are currently undergoing clinical trials in Korea as soon as possible,” said Boie. The first is survodutide, a GLP-1/glucagon dual agonist, which has yielded positive research in treating fatty liver and metabolic-syndrome-associated fatty liver (MASH). We are receiving a review from the MFDS for the domestic approval of metalyse (tenecteplase), a next-generation thrombolytic agent for the treatment of acute ischemic stroke (AIS). In addition, Ofev (nintedanib), a drug for treating pulmonary fibrosis, which is expected to be approved for reimbursement as final discussions are underway, is also one product the company has high expectations for this year. In addition, nerandomilast, a follow-up drug to Ofev that has been designated as a Breakthrough Therapy by the US Food and Drug Administration (FDA), and the HER2 inhibitor zongertinib for the treatment of non-small cell lung cancer (NSCLC) are expected to be launched in Korea in the long term. “Boehringer Ingelheim does not settle; we have been continuing to develop new drugs and innovative treatment solutions to gradually replace the existing portfolio,” said Boie. ”The fact that we are reinvesting more than 20% of our sales in R&D means that we are focusing on developing and introducing innovative new drugs, rather than on existing products whose patents have expired.” Finally, Boie added, “All of our efforts at Boehringer Ingelheim are focused on developing innovative new drugs and improving patients‘ access to treatment. I to be remembered as a ’reliable and trustworthy person.' when I complete my work here.”
- Company
- Tepmetko granted reimb for METex14+ NSCLC
- by Whang, byung-woo Apr 01, 2025 05:52am
- Pic of Tepmetko On the 31st, Merck Korea announced that its Tepmetko (ingredient name: tepotinib), a treatment for MET-ex14 deletion-mutated non-small cell lung cancer, will be reimbursed as of the 1st of next month. Accordingly, Tepmetko is now covered by reimbursement for patients with locally advanced or metastatic non-small cell lung cancer with MET exon 14 deletion, regardless of the treatment line (first or later line). As a result, patients with MET exon 14 deletions may now use Tepmetko as a first-line treatment and receive reimbursement. MET mutations, which occur in 1.8-3.1% of NSCLC patients in Korea, are very rare. They cause resistance to other anticancer treatments and have a high rate of metastasis to bones and the brain, which leads to poor patient prognosis. In addition, most patients are elderly and have a low response rate to immune checkpoint inhibitors, and most patients relapse within 5 months. Tepmetko’s reimbursement is based on the Phase II VISION study in patients with MET-mutated NSCLC. In the 32.6-month follow-up of 313 patients diagnosed by liquid biopsy or tissue biopsy, Tepmetko showed an objective response rate (ORR) of 58.6%, median progression-free survival (PFS) of 15.9 months, median overall survival (OS) of 29.7 months, and median duration of response (DoR) of 46.4 months in patients diagnosed by tissue biopsy and with no previous treatment experience. These results were consistent regardless of treatment line, biopsy method, etc., and showed consistent efficacy in Asian patients, including Koreans. In a subgroup analysis of 106 Asian patients, the ORR of patients who were initially treated with Tepmetko was 64%, with a median PFS of 16.5 months, a median OS of 32.7 months, and a median DoR of 20.7. “Patients with MET mutations have a poor prognosis, with many being elderly patients dying within a year, and there are limitations to existing reimbursement options such as chemotherapy or immunotherapy, so domestic and international guidelines recommend first using TKIs that target the right mutations,” explained Jin Seok Ahn, Professor of Hematology-Oncology at Samsung Medical Center. “Tepmetko is a useful treatment that can prevent disease progression compared to the current standard of care in the first line,” said Professor Ahn. ”With the reimbursement approval greatly improving access to treatment, we should actively utilize next-generation sequencing that has a short average test time to provide effective treatment options for patients with MET mutations and provide personalized treatment for patients with MET mutations.”
- Company
- AbbVie Korea seeks to grow to ₩KRW 300B with biodrugs
- by Whang, byung-woo Mar 31, 2025 05:59am
- AbbVie Korea, which successfully passed on the risk of Humira (adalimumab) with its later products is aiming to make another leap forward with its innovative pipeline. The company is working to improve its capabilities by balancing the 3 key factors - sales growth, R&D, and social contribution. AbbVie Korea was established in 2013 as the Korean affiliate of AbbVie, headquartered in North Chicago, Illinois, USA. Its major business units include ▲the Immunology Business Unit (rheumatoid diseases, psoriasis, atopic dermatitis, inflammatory bowel diseases, etc.), ▲the Specialty Business Unit (hepatitis C, chronic migraine, etc.), and ▲the Oncology Business Unit, each of which has a solid portfolio. AbbVie eliminates the risk of Humira... Skyrizi and Rinvoq shows shared growth AbbVie’s representative product has long been Humira, a blockbuster immune disease treatment. It was a highly symbolic product as it has been the global No. 1 specialty drug in the market for the past 10 years. However, in recent years, Humira has also been AbbVie’s biggest concern as well. With the looming entry of Humira biosimilars upon the expiration of its patent, there were doubts about whether the company would be able to address Humira’s expected sales gap. In fact, when competition with biosimilar products intensified upon the expiry of Humira's North American patent in 2023, there were concerns about the company’s sales recovery, as sales fell by USD 5.4 billion (about KRW 7 trillion) year-on-year. To conclude, the company has eliminated Humira’s sales risk. Although sales of Humira were inevitably reduced, the loss was quickly made up due to the growth of the company’s follow-up drugs, next-generation immune disease treatments ‘Rinvoq’ (Upadacitinib) and ‘Skyrizi’ (Risankizumab). According to the 2024 Global Pharmaceutical Sales Rankings, Skzrizi recorded sales of USD 11.72 billion (KRW17.2237 trillion), a 50.9% increase from the previous year, ranking seventh among all products. This year, Skyrizi’s sales are expected to reach USD 13.72 billion (KRW 20.162.9 trillion) Rinvoq’s sales target is also up to USD 2 billion (about KRW 2.9 trillion) for this year and 2026, the success of these two follow-up drugs is demonstrating AbbVie’s strong foothold in the field of immune diseases. Thanks to the growth of Skyrizi and Rinvoq, AbbVie recorded USD 54.5 billion in sales in 2024, ranking second in the global pharmaceutical industry in terms of sales. The stock price also reflected this expectation of sales, recording a high growth of over 34% as of March 1, 2025, compared to two years ago, March 1, 2023. In response to this, Robert Michael, CEO of AbbVie, said, “We expect net profit to exceed the previous high, in just 2 years after the expiration of the Humira patent in the United States.” Unlike how other pharmaceutical companies usually take 9-11 years to recover sales after the expiration of their blockbuster patents, AbbVie’s sales are expected to recover in just two years, successfully turning the crisis of patent expiration into an opportunity. The company’s new drugs still lack influence in Korea... The cross-administration reimbursement approval for atopic dermatitis drugs expected to be beneficial Even in the domestic market, the sales fluctuations of Humira have decreased, while sales of Rinvoq and Skyrizi grew rapidly. According to the market research institution IQVIA, Humira recorded sales of KRW 104 billion in 2020 and surpassed the KRW 100 billion mark, but saw its sales drop to KRW 91.2 billion in 2021. This is the combined result of the drug price cuts and market competition following the launch of biosimilars in Korea in June 2021. Since then, Humira has recorded sales of KRW 85.8 billion in 2022 and KRW 86.6 billion in 2023 and entered a stable sales period. In this situation, Skyrizi recorded sales of KRW 27.9 billion in 2023, an increase of KRW 11.4 billion from KRW 16.5 billion in 2022, while Rinvoq also recorded sales of KRW 20.7 billion, an increase of KRW 9.2 billion from KRW 1.1 billion in 2022. Although the overall scale of the drugs’ sales is still small compared to Humira's, when considering that the sales of ‘Rinvoq+Skyrizi’ have reached half the level of Humira's, rising from KRW 28 billion in 2022 to KRW 48.6 billion in 2023, there is a good chance that it will overtake Humira's sales within a few years. In particular, there are high expectations on Rinvoq’s growth , as reimbursement for cross-administration between biological drugs and JAK inhibitors is now granted for severe atopic dermatitis in Korea. The reimbursement approval for cross-administration of the drugs is expected to change the monopoly made by the biological drugs that entered the market the earliest. Many predict that Rinvoq will be the biggest beneficiary, and the drug is expected to continue its strong growth. However, the company is concerned that the overall sales growth of AbbVie Korea is not as large as expected. According to the audit report disclosed on the Data Analysis, Retrieval, and Transfer System, DART, AbbVie Korea's posted KRW 234.7 billion in sales in 2023. Its operating profit was KRW 11.5 billion. This is an increase of about KRW 80 billion compared to KRW 154.6 billion in 2022, but this is no major change, considering its absorption merger with Allergan Korea last year. As such, the audit report released in early April is expected to be an indicator of whether the sales of Humira, which entered a stable period in 2024 and the growth of new drugs will be able to create synergies. AbbVie expands its portfolio... Strengthening global competitiveness Nevertheless, the reason why the industry has high expectations for the future of AbbVie is because it is expanding its pipeline along with its strong position in the field of immunology. Following the launch of Venclexta, a treatment for acute myeloid leukemia and chronic lymphocytic leukemia, the company is working to get Epkinly, a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) it received approval last year, reimbursed in Korea. In addition, Elahere (mirvetuximab soravtansine), for which the company recently announced the results of a global Phase III clinical study, is also attracting attention as the first-in-class drug. Ovarian cancer is mostly detected in the late stages, and platinum-based chemotherapy is considered as its first-line treatment. However, there is no other available treatment option if resistance develops during the first treatment, so Elahere is expected to play an important role in the treatment of platinum-resistant ovarian cancer in the future. In addition, the company has signed a license agreement with the Danish company Gubra to develop a new drug for the treatment of obesity and secured GUB014295, a long-acting amylin analogue, which is regarded as the next generation of obesity treatment. AbbVie Korea Meanwhile, since its foundation, AbbVie Korea has been steadily practicing sharing and volunteer activities for patients with rare and intractable diseases and the underprivileged, striving to fulfill its corporate social responsibility. The company’s representative social contribution program is the “Week of Possibilities,” which has been participated in by employees around the world since its founding in 2013. Specifically, the company has been carrying out various activities, including pop art portraits that brightly depict patients with rare and incurable diseases whose self-esteem has been lowered due to a long period of illness, a mosaic of air-purifying plants (scandia moss) for climate-vulnerable groups, and tree planting to reduce global warming and create healthy forests together. In addition, A-Walk, which was launched in 2016, is a walking campaign by employees to help patients and has been praised for contributing to the improvement of employees' health and strengthening teamwork through innovative ideas. Under the program, when employees achieve their target number of steps, matching donations are made for patients. Last year, the event was expanded to include employees from 8 Asian countries who participated in A+Walk and donated to patient organizations in each country.
- Company
- Handok closer to commercialize new innovative drugs for BTC
- by Nho, Byung Chul Mar 31, 2025 05:59am
- Biliary tract cancer (BTC) is known for being difficult to treat. The five-year survival rate is 29.4%, which is the second lowest of all cancer types. Early diagnosis of BTC is difficult, and treatment for BTC is extremely limiting despite of the high risk. Fortunately, the situation is changing. New treatments are being approved in South Korea and new drugs are being developed actively. For instance, Handok's pharmaceuticals are showing potential for treating BTC. Currently, standardized second-line treatments are not available for BTC when the first-line treatment fails. Due to difficulties in early diagnosis, only 25% of the patients are operable at the diagnosis, and patients show a high recurrence rate of about 60%. The second-line treatment for BTC has been limited to chemotherapy in combination with a first-line treatment, used regardless of the patient's condition. Even if patients undergo second-line treatment, patients have poor prognosis due to low response rates and life expectancy. In 2023, Handok obtained the domestic approval of Pemazyre, which can be used as a second-line treatment for BTC. Pemazyre is indicated for patients with 'locally advanced or metastatic BTC who have FGFR2 gene fusions.' Pemazyre is the first BTC-targeted treatment approved in South Korea. Pemazyre demonstrated significant data based on the Phase 2 FIGHT-202 clinical trial. The primary endpoint, the combination therapy's Overall Response Rate (ORR), was 37%. Although the study involved patients with advanced disease after first-line treatment or above, the drug showed favorable effects. Pemazyre has been used in the U.S., Europe, and Japan. It is expected to be reimbursed this year. Handok has been putting efforts into introducing its new BTC treatment, HDB001A. In 2019, Handok entered into a strategic partnership with ABL Bio, the original developer of HDB001A, and secured domestic commercialization rights for the product. Subsequently, Handok made a US$ 5 million equity investment in the American biotech venture TRIGR Therapeutics, which had obtained global commercialization rights (excluding Korea and China) from ABL Bio in 2018. In 2021, TRIGR Therapeutics was merged into Compass Therapeutics. Handok and Compass Therapeutics are collaborating to develop HDB001A for BTC indication. Handok conducted a Phase 2 clinical trial in South Korea in 2021 involving BTC patients and secured significant data. The efficacy evaluation of this Phase 2 study showed that the ORR for patients receiving a combination of HDB001A and paclitaxel was 37.5% in second- and third-line treatments and a 63.6% ORR in second-line treatment. These results were presented at the 2023 ASCO GI Symposium. A view of Handok Future Complex, an integrated R&D center located in Magok district in Seoul. Building on the significant Phase 2 results of HDB001A (Compass Therapeutics project name: CTX-009) led by Handok, Compass Therapeutics has been conducting the U.S.-based Phase 2/3 trial COMPANION-002 to evaluate HDB001A (CTX-009) as a second-line treatment for BTC. COMPANION-002 is designed to compare the combination therapy of HDB001A (CTX-009) with paclitaxel against paclitaxel monotherapy in 150 patients with metastatic or recurrent BTC, with top-line results expected to be announced later this month. HDB001A (CTX-009) development is progressing rapidly. Handok has swiftly advanced its Phase 2 clinical trial in South Korea through close collaboration with researchers, providing the clinical protocol and data that enabled Compass Therapeutics to secure global Phase 2/3 approval from the FDA quickly. In addition, HDB001A (CTX-009) received Fast Track designation from the FDA in 2024, further accelerating its development. Handok plans to use the results from the COMPANION-002 study as clinical data for domestic approval of HDB001A (CTX-009) and launch it as Handok's proprietary anticancer therapy within two years. Handok also collaborates with global companies such as Jazz Pharmaceuticals and Incyte to introduce anticancer treatments in areas with unmet needs. Currently, it exclusively supplies the domestic market with its therapies for hepatic vein occlusion 'Defitellio,' high-risk acute myeloid leukemia 'Vyxeos,' intrahepatic cholangiocarcinoma 'Pemazyre,' and diffuse large B-cell lymphoma 'Minjuvi.' In addition, Handok is strengthening its internal research capabilities and developing new anticancer agents using its dual-targeting platform and targeted protein degradation platform. In April 2024, the company presented poster data on its new lung cancer therapeutic, 'HDBNJ-2812,' at the American Association for Cancer Research (AACR 2024). In April, another poster presentation on its in-house new drug development is scheduled for AACR 2025. Moreover, in March 2024, Handok launched collaborative research on next-generation innovative new drugs with partners Genexine and ToolGen.
- Company
- Novartis' 'Leqvio' for dyslipidemia lands at Big 5 hospitals
- by Eo, Yun-Ho Mar 31, 2025 05:58am
- Product photo of LeqvioThe new drug Leqvio, a twice-yearly treatment for dyslipidemia, is now available for prescriptions at tertiary general hospitals. According to industry sources, Novartis Korea's siRNA drug Leqvio (inclisiran) passed the drug committees (DC) of the 'Big 5' hospitals, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center in Seoul, and Sinchon Severance Hospital. Considering that the drug was approved in June last year, prescription settings are relatively established stably. The remaining issue is the drug's reimbursement status. Novartis applied for reimbursement listing immediately after obtaining approval for Leqvio. However, the company has shown a difference in opinion against the government regarding reimbursement criteria during the review process. The main issue under discussion for setting reimbursement criteria is whether the drug's indication to 'reduce cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD)' would be approved. The competing product 'Repatha (evolocumab)' has already been reimbursed, so the government may not see expediting Leqvio's reimbursement as an urgent agenda. Repatha is currently approved in 41 countries, and Leqvio in 39 countries. Notably, Leqvio can be administered by healthcare professionals in hospitals twice a year. This reduces the number of required injections and ensures professional administration instead of self-injection. In fact, among patients (including those with atherosclerotic cardiovascular disease, ASCVD) who have received Leqvio for up to 6.8 years, 78.4% have reached their target LDL-C levels. A U.S. real-world study found that ASCVD patients with high drug adherence (fully adherent) experienced a 27% lower risk of major adverse cardiovascular events (MACE) compared to those with lower adherence. Moreover, the high-adherence group incurred lower annual healthcare costs than the low-adherence group, indicating that the dosing convenience provided by Leqvio not only reduces the risk of recurrent cardiovascular events but also alleviates the economic burden on ASCVD patients. If the reimbursement criteria for Leqvio in ASCVD are not set, official approval would eventually have to await the results of a cardiovascular outcome trial (CVOT), a process that could take several years. For instance, the market for statin-ezetimibe combination products alone is estimated at around KRW 1 trillion, and when combined with the funding allocated for statins and PCSK9 inhibitors, the total expenditure on LDL-C lowering could range from KRW 1.5 trillion to 2 trillion. Yet, only 24% of ASCVD patients in Korea are currently achieving their LDL-C targets. Professor Suh Jon of the Department of Cardiology at Soonchunhyang University Bucheon Hospital said, "For high-risk patients, drug adherence in lipid-lowering therapy is crucial. In reality, adherence to current treatment options is low, with only about 3 out of 10 patients reaching their LDL-C targets. It clearly shows an unmet need for a new treatment option in lipid-lowering therapy."
- Company
- Ono Pharma Korea appoints Kan Sato as new CEO
- by Eo, Yun-Ho Mar 31, 2025 05:58am
- Ono Pharma Korea has appointed a new leader. According to the related industry, Ono Pharma Korea recently appointed Sato Kano as its new CEO following the resignation of former CEO, Ho-jin Choi. Choi, who led the company for four and a half years since his appointment in October 2020, has stepped down. Choi joined Ono Pharmaceutical in 2014 as the head of sales and marketing and contributed to the launch and reimbursement of the PD-1 inhibitor immuno-oncology drug 'Opdivo' in Korea. He previously worked at J&J Korea, AstraZeneca Korea, and Allergan Korea, and completed an MBA at Thunderbird School of Global Management in the United States. Kan Sato, the newly appointed head of the Korean subsidiary, is a graduate of the Glovis University Graduate School of Management in Japan. He has previously worked as a manager in the International Business Department of Ono Pharmaceutical's Taiwan subsidiary and as a manager of the International Business Department at the company's headquarters, and has now taken on the role of leading the Korean subsidiary. With the appointment, Ono Pharmaceutical Korea has transitioned to a Japanese head system for the first time in about 6 years since the appointment of Min-yeol Yang as CEO in July 2019.
- Company
- Lotte Biologics’ CMO business makes smooth progress
- by Chon, Seung-Hyun Mar 28, 2025 06:38am
- Lotte Biologics has been making smooth progress, building a new plant since its launch. Three years after its launch, it has received a total of KRW 800 billion from its parent company and is speeding up the construction of its Songdo plant. The US plant, which was acquired 3 years ago, also generated more than KRW 200 billion in sales every year. On the 27th, according to the Financial Supervisory Service, Lotte Biologics decided on the 26th to issue KRW 210 billion in paid-in capital to its shareholders. The new shares will be issued to Lotte Biologics shareholders in the form of 3,231,000 shares. The new shares to be issued will account for 35.8% of the total number of shares issued before the capital increase, which is 9,017,500 shares. The issue price of new shares is KRW 65,000 per share. Lotte Biologics, which was launched in June 2022, is owned by Lotte Corporation and Lotte Holdings, which have 80% and 20% stakes, respectively. Lotte Corporation and Lotte Holdings are estimated to have invested KRW168 billion and KRW 42 billion, respectively, in this paid-in capital increase. Lotte Corporation said, “We will invest KRW 168 billion to maintain control over Lotte Biologics and enhance its business competitiveness.” Lotte Biologics Lotte Corporation entered the biopharmaceutical industry in May 2022 by acquiring the BMS plant in eastern New York for USD 160 million (about KRW 200 billion). The BMS plant is a production facility dedicated to biopharmaceuticals, with an annual production capacity of 35,000 liters. Lotte also signed a USD 220 million Contract Manufacturing Organization (CMO) contract with BMS for biopharmaceutical production. In June 2022, Lotte Holdings officially entered the biopharmaceutical business by launching Lotte Biologics. Lotte Biologics will use the funds it has raised this time to build a factory in the Songdo Bio Campus. Lotte Biologics signed a memorandum of understanding (MOU) with the Incheon Metropolitan City and the Incheon Free Economic Zone in June 2023 to build a mega plant in Songdo, Incheon. Lotte Biologics plans to build 3 mega plants with a total capacity of 360,000 liters by 2030. Lotte Biologics began construction of Plant 1 in the Bio Campus in Songdo, Incheon, in March last year, and aims to obtain GMP approval by the second half of 2026 and start operations in 2027. This is the fourth paid-in capital increase made since Lotte Biologics' launch. Lotte Biologics conducted a paid-in capital increase through allocation to shareholders of KRW 210.6 billion in December 2022. In March 2023, it raised KRW 212.5 billion through a paid-in capital increase. Lotte Biologics also decided to conduct a paid-in capital increase of KRW 150.1 billion in June last year. When this capital increase is completed, Lotte Biologics will have raised a total of KRW 783.2 billion from its parent company through 4 paid-in capital increases since its launch. Lotte Biologics was launched with a capital of KRW 13 billion and has received a total of KRW 796.2 billion in investment from its parent company. The company has been generating steady profits from the BMS plant it acquired at the time of its launch. Lotte Biologics inherited the existing CDMO contract when it acquired the BMS plant. The drugs that BMS was producing will continue to be produced for the next three years after Lotte acquired the plant. It is reported that the BMS's immuno-oncology drugs 'Opdivo' and 'Yervoy', the kidney transplant immunosuppressant ‘Nulojix,’ and the multiple myeloma treatment ‘Empliciti’ were produced at the Syracuse plant. Lotte Biologics has set a goal of achieving sales of KRW 1.5 trillion by 2030. Lotte Biologics recorded sales of KRW 234.4 billion and an operating loss of KRW 66.3 billion last year. Lotte Biologics generated its first sales of KRW 228.6 billion in 2023. The cumulative sales of Lotte Biologics since its launch have been tallied at KRW 463 billion. Lotte Biologics announced its CDMO business vision at the JP Morgan Healthcare Conference in January. CEO James Park presented the successful CDMO transformation of the Syracuse Bio Campus in New York and the blueprint for the Songdo Bio Campus. He expressed an ambition to accelerate Lotte Biologics’ leap into the global CDMO market, unveiling its innovative proprietary ADC platform SoluFlex Link, and announcing plans to provide an ADC one-stop service in collaboration with finished drug product partners in North America. SoluFlex Link is an ADC platform that uses a unique linker technology jointly developed by Lotte Biologics and Kanaph Therapeutics, a drug fusion technology bioventure. The company believes SoluFlex Link improves instability, which is a major drawback of antibody-drug conjugates (ADCs) and can be used with various antibodies and payloads. “New ADC drug developers can conduct various research and development with this technology,” said Lotte Biologics. “We believe that can offer an optimized solution for the development and production of next-generation ADCs because it can increase production yield and treatment efficiency.”
- Company
- Shaperon discusses licensing out Nugel technology to Europe
- by Lee, Seok-Jun Mar 28, 2025 06:38am
- On the 27th, Shaperon announced that it has recently entered into discussions with global pharmaceutical companies about licensing out its next-generation atopic dermatitis treatment, NuGel, at Bio Europe Spring 2025, which was held in Europe. The company emphasized that it is accelerating the process of securing the company’s fiscal soundness by generating revenue through the commercialization of its technology, especially since it has made considerable progress during discussions with some large pharmaceutical companies. Shaperon held partnering meetings with a total of 27 companies, including large global pharmaceutical companies and global leaders in the field of dermatology at Bio Europe. Discussions were made around Nugel, the company's core pipeline. The large European pharmaceutical companies that had first meetings at this event also showed interest in Nugel and Shaperon’s major pipelines, including its preclinical alopecia areata treatment and treatment for idiopathic pulmonary fibrosis. Through this conference, Shaperon received requests from a number of global pharmaceutical companies that it had previously been in contact with and received on-site inspection requests on Nugel’s technical data, moving past the confidentiality agreement stage. The company explained that its interest in Nugel has increased considerably since the results of Part 1 of the Phase IIb clinical trial, which was recently completed in the United States, were positively received by many pharmaceutical companies. Europe is a key market that accounts for about 28% of the global atopic dermatitis treatment market. Many of the companies leading the development of atopic dermatitis treatments are based in Europe. “As several companies have expressed interest and are actively discussing the matter, we expect to see tangible commercialization results in the near future,” said a Shapreon official. “We plan to further accelerate the commercialization of Nugel through follow-up discussions with the pharmaceutical companies that are currently in talks.” Nugel is a treatment for atopic dermatitis that targets the ‘GPCR19 receptor’. It is characterized by its superior efficacy and safety compared to existing treatments through the inflammatory complex modulating mechanism of action that encompasses innate and adaptive immunity. Shapreon has begun recruiting patients for Part 2 of the Phase IIb trial in the United States, which is currently being conducted on 177 atopic dermatitis patients and is expected to receive the final report on Phase IIb in the first half of next year.
- Company
- LigaChem Biosciences invests ₩36.6B in its UK partner
- by Cha, Jihyun Mar 27, 2025 05:54am
- LigaChem Biosciences announced on the 21st that it will invest USD 25 million (about KRW 36.6 billion) in its partner, UK-based Iksuda Therapeutics, to participate in management. The first USD 15 million was invested in the fourth quarter of last year. The additional USD 10 million will be invested in the middle of this year. After the investment is completed, LigaChem Biosciences will secure a 26.6% stake in Iksuda. In addition to this equity investment, LigaChem Biosciences has also secured the right to purchase the shares of Iksuda’s existing major investors and the actual rights to the Iksuda pipeline. LigaChem Biosciences has signed an agreement with existing major investors so that the company can purchase the investors’ shares within 3 years at the investment principal. This will enable LigaChem Biosciences to secure up to 73.9% of Iksuda’s shares. This means that LigaChem Biosciences will be able to substantially lead the management of Iksuda and the development of its pipeline. Based on this investment, LigaChem Biosciences plans to accelerate the clinical development of Iksuda's ADC pipeline to bring it to the global market sooner. In particular, the company plans to speed up the technology transfer of HER2-ADC and expand and conduct additional multinational clinical trials targeting patients resistant to existing ADC competitors in the market to increase the value of the pipeline. Iksuda has introduced technologies for multiple substances from LigaChem Biosciences. It has a number of pipelines, including LCB14 (HER2-ADC), LCB73 (CD19-ADC), and IKS04 (CanAg-ADC) and IKS012 (FRα-ADC) acquired through platform technology transfers. Iksuda is working to license out a number of programs in their clinical stages, including LCB14 and LCB73, which were developed by LigaChem Biosciences, to global pharmaceutical companies. “Through this investment, we plan to focus on early clinical development and commercialization of the pipelines of both companies by utilizing the abundant clinical development capabilities of Iksuda with its specialty in the ADC field,” said Yong-Zu Kim, CEO of LigaChem Biosciences. “In addition to this investment, we plan to further strengthen open innovation to secure future growth engines to achieve VISION 2030 sooner.”
- Company
- ADC mkt leader Daiichi-Sankyo's R&D drive
- by Whang, byung-woo Mar 27, 2025 05:54am
- Daiichi-Sankyo, a company leading the antibody-drug conjugate (ADC) market, is expanding its R&D capacity through the 'Expand & Extend'-based strategy. Daiichi-Sankyo plans to focus on expanding and strengthening access through the DXd-ADC platform, which is a basis for the company's chief pipeline. Daiichi-Sankyo's chief ADC drug is Enhertu (ingredient: trastuzumab deruxtecan). Currently, Enhertu is approved in most countries for the treatment of HER2-positive breast cancer, gastric cancer, and non-small cell lung cancer (NSCLC). Recently, Enhertu received an expanded indication from the U.S. Food and Drug Administration (FDA) for the treatment of patients with 'HER2-low metastatic breast cancer who have been treated with one or more endocrine therapy sessions' and expanded its market impact. The DXd-ADC platform has been the basis of this achievement. Daiichi-Sankyo, launched after a merger between Daiichi and Sankyo, strengthened ADC technology based on a synergy between Sankyo's monoclonal antibody (mAb) technology and Daiichi's anticancer agent payload and linker technology. Previously, conventional ADCs have been limited in therapeutic effects due to ▲Lack of payload diversity ▲Heterogeneity in drug conjugation sites ▲Linker instability ▲Restrictions on the number of drugs that can be conjugated. The DXd-ADC platform gained attention because it offered improved anticancer effects and overcame existing ADC limitations. The DXd-ADC platform has been used to expand the pipeline in addition to Enhertu based on seven technological strengths, including ▲High-potency payloads ▲High drug-to-antibody conjugation ratios ▲Uniform binding between the drug and antibody. Enhertu, jointly-developed by Daiichi-Sankyo and AstraZeneca, secured the most indications and ranked the top among new ADC drugs. Enhertu recorded the highest sales in the U.S. market last year, with U.S. sales reaching 282.4 billion yen, a 36.0% increase year-over-year, and the U.S. market is expected to account for 49.0% of Enhertu's total sales in 2024. In South Korea, Daiichi-Sankyo Korea recorded sales of KRW 274 billion in 2023, the highest among Japanese pharmaceutical companies operating in South Korea. Given Enhertu's growth, its overall sales are projected to exceed KRW 300 billion in 2024. Global Sales of Major ADCs in 2023 and 2024 (unit: KRW 100 million) Daiichi-Sankyo is preparing for a new drug that is Enhertu's follow-up…focusing on expanding the pipeline Daiichi-Sankyo has been employing a '5 DXd-ADC & Next Wave' strategy, focusing its R&D capacity on five ADCs in the oncology sector and the 'Next Wave' pipeline, including products for rare diseases and vaccines. Daiichi-Sankyo's chief pipeline includes ▲TROP2-directed Dato-DXd (datopotamab deruxtecan) ▲HER3-directed HER3-DXd (patritumab deruxtecan) ▲B7-H3-directed I-DXd (ifinatamab deruxtecan) ▲CDH6-directed R-DXd (raludotatug deruxtecan). A Trop-2-directed antibody drug, Datroway, is Enhertu's follow-up drug, and it was approved by the Food and Drug Administration (FDA) in January as a breast cancer medication. Datroway is soon to be launched. Datroway can be used as a treatment for hormone receptor (HR)-positive and human epidermal growth factor 2 (HER)-negative breast cancer. Furthermore, patritumab deruxtecan is a drug candidate that is expected to receive approval this year. Clinical trials of patritumab and ifinatamab are being conducted involving patients with lung cancer and ovarian cancer, respectively. In addition, Daiichi-Sankyo is focusing on securing next-generation growth drivers by developing innovative therapies in the specialty drug and vaccine sectors, leveraging its proprietary modality technology. Jeong-tae Kim, CEO of Daiichi-Sankyo KoreaDaiichi-Sankyo has unveiled its 'Expand & Extend' strategy to provide the DXd-ADC pipeline to patients quickly. The 'Expand' strategy aims to establish a DXd-ADC treatment approach for breast and lung cancers and subsequently expand its indications to earlier treatment stages and a broader range of cancer types. Meanwhile, the 'Extend' strategy encompasses the development of next-generation ADCs and new modalities that maximize platform effects through combination therapies and formulation changes. Thus ultimately providing additional treatment options beyond DXd-ADC therapy. Jeong-tae Kim, CEO of Daiichi-Sankyo Korea, stated, "As of 2024, over 40 of our global clinical studies have been conducted in South Korea, and two Korean medical institutions have been selected among 15 Phase 1 clinical sites across eight countries, contributing from the earliest stages of clinical research." "We plan to launch four ADCs and targeted cancer agents and have substantially prepared and put efforts into leaping as a leader in the oncology sector. For instance, providing treatment options to more patients," Kim added, "In addition to distributing pharmaceuticals, we will provide pragmatic hope by leading innovations in collaboration with Korean medical communities and acting as a bridge with the headquarters."
