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- 2025-12-23 04:23:08
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- 13 of Keytruda’s indications await ‘redeliberation’
- by Eo, Yun-Ho Feb 01, 2024 12:38pm
- The first result for the reimbursement for the remaining 13 indications of Keytruda was ultimately a collective ‘hold.’ However, the reimbursement journey for 'Keytruda' has just begun. The Health Insurance Review and Assessment Service held its first Cancer Disease Deliberation Committee meeting of the new year on January 31st and reviewed the reimbursement of the remaining 6 indications for MSD Korea's PD-1 inhibitor immuno-oncology drug Keytruda (pembrolizumab) that were not reviewed last year, and issued another re-deliberation decision. This completes the first round of reviews for Keytruda’s 13 indications for which the company applied for reimbursement in June last year. 3 indications were presented in October, 4 in November, and 6 in the most recent CDDC meeting. At the time, MSD applied to extend reimbursement to 13 indications for its Keytruda. The indications were: ▲ early-stage triple-negative breast cancer; ▲locally recurrent or metastatic triple-negative breast cancer, ▲metastatic or with unresectable, recurrent head and neck squamous cell carcinoma, ▲ locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma, ▲adjuvant treatment of patients with renal cell carcinoma, ▲non-muscle invasive bladder cancer,▲persistent, recurrent, or metastatic cervical cancer,▲ advanced endometrial carcinoma, ▲advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ▲ unresectable or metastatic MSI-H or dMMR colorectal cancer ▲metastatic MSI-H or dMMR small bowel cancer, ▲ metastatic MSI-H or dMMR ovarian cancer, and ▲ metastatic MSI-H or dMMR pancreatic cancer A re-deliberation decision is not a rejection. It literally means that the agenda will be given a second look. MSD Korea had applied for a large-scale reimbursement expansion for its Keytruda, which was an unprecedented event in the history of Korea's insurance benefits system. Due to its large scale, the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service, which are conducting the review, also need to take their time for serious deliberation and preliminary discussions. In other words, the first re-deliberation decision was probably inevitable. It would be more accurate to say that the first review was more of a preliminary review of the medical validity and necessity of reimbursing the 13 indications. In fact, MSD appears to be quickly preparing for the redliberation process. A company official said, "Through the first round of discussions, we completed discussions on the need for the reimbursement and clinical utility of Keytruda’s 13 indications. MSD will now focus on building on the discussions made during the 3 rounds of deliberations and prepare additional measures to expand reimbursement, including a fiscal-sharing plan.”
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- MSD’s rare cancer drug Welireg first prescribed in KOR
- by Eo, Yun-Ho Jan 29, 2024 06:05am
- A rare anti-cancer drug targeting a very small number of patients, Welireg, has been prescribed in Korea. According to industry sources, the prescription code for MSD Korea’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, ‘Welireg (belzutifan),’ has been registered at the Samsung Medical Center in Seoul. Currently, SMC is the only hospital that has the drug code inserted for Welireg’s prescription in Korea, and the first patient was prescribed the drug in December last year. Welireg was designated as an orphan drug in January for the treatment of Von Hippel-Lindau disease and was officially approved in May. Specifically, the drug is indicated for the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring 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. Welireg’s efficacy was demonstrated through the open-label Study 004 trial which investigated 61 VHL-associated RCC patients diagnosed based on a VHL germline alteration and 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 trial, 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%. Meanwhile, the drug has recently been approved for renal cell carcinoma in the U.S. The drug demonstrated its efficacy in the LITESPARK-005 trial, which was conducted on 746 patients with unresectable locally advanced or metastatic clear cell 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 in advanced RCC following treatment with both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF receptor-targeted therapy compared with the everolimus, and reduced the risk of disease progression or death by 25%.
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- Vemlidy dominates stagnant 300 bil. won hepatitis B market
- by Son, Hyung-Min Jan 29, 2024 06:05am
- The market for hepatitis B treatment, worth 300 billion won annually, is currently experiencing a slowdown. While Gilead Sciences Korea’s Vemlidy is expanding its market share, Viread and Baraclude are facing a decline. In the generics market, Dong-A ST is leading the market. Prescription sales for Vemlidy has increased by 26% compared to last year, while original drugs have shown poor performance According to the drug market research agency UBIST on the 26th, the market size for hospital outpatient prescriptions last year was 284.6 billion won, a 1.2% increase compared to 281.1 billion won in 2022. Additionally, the market size for original drugs last year was 236 billion won, showing a slight increase from 229.2 billion won in 2022. The size of the hepatitis B treatment market. (Unit: KRW 100 million) Vemlidy is experiencing rapid growth in the market for treating hepatitis B. The original drug's sales have significantly decreased since Viread’s drug pricing reduction in 2018, and Vemlidy seems to be filling the void. Vemlidy entered the Korean market in 2017. In 2019, its prescription sales exceeded 10 billion won, and the sales continued to grow, with 39.3 billion won in 2021 and 49.2 billion won in 2022. The prescription sales of Vemlidy recorded 61.9 billion won last year, a 25.8% increase compared to the previous year. Vemlidy, a new hepatitis B drug developed by Gilead Sciences, is a follow-up to Viread. Despite its effectiveness in inhibiting the hepatitis B virus, Viread is known to cause side-effects such as kidney injury and low bone mineral density. If any problem arises with kidney function after receiving treatments, reimbursement standards allow Vemlidy to be replaced by Baraclude. Vemlidy overcomes Viread's adverse effects. In clinical trials, Vemlidy treatment demonstrated effectiveness in the long-term treatment of patients and observed no side effects related to kidney injury or low bone mineral density. Considering that hepatitis B cannot be cured, the safety of long-term administration is crucial to both patients and medical professionals. Gilead Sciences is switching Viread, its first marketed hepatitis B drug, with Vemlidy. Changes in prescription performance of key hepatitis B treatment drugs. (Unit: KRW 100 million) Prescription sales of Viread were 164.7 billion won in 2018, but they have been declining since then, reaching 113.1 billion won in 2019 and dropping to 90 billion won in 2020. Last year’s prescription sales amounted to 93.5 billion won, a 1.6% decrease from the previous year. Baraclude recorded prescription sales of 73 billion won last year, indicating a 2.1% decrease from 2022. The analysis suggests that the decline in Baraclude sales can be attributed to a reduction in drug pricing. BMS Pharmaceutical voluntarily reduced the price of Baraclude, which had expired patent, as part of a trade-off approach following the listing of its acute myeloid leukemia treatment Onureg and myelofibrosis treatment Inrebic for reimbursements. Prescription sales for GSK's Zeffix decreased by 13.1% from 3.8 billion won in 2022 to 3.3 billion won last year. GSK was unable to capture the market share left by Hepsera's withdrawal. Hepsera, a new drug for hepatitis B developed by GSK, recorded over 10 billion won in prescription sales in 2018. However, about a quarter of patients experienced resistance to the drug and experienced difficulties in maintaining treatment. GSK withdrew the approval for Hepsera in 2022, leading to its withdrawal from the Korean market. Changes in prescription performance of key hepatitis B treatment drugs. (Unit: KRW 100 million) Sales of treatments from domestic pharmaceutical companies were not significant. Bukwang Pharm’s Sebivo topped prescription sales of 1.2 billion won, showing a 25% decrease from the previous year. Sebivo, a Novartis drug introduced by Bukwang Pharmaceutical in 2019, saw a decline in prescription performance even after Bukwang took over sales. Il Dong's Besivo maintained its performance by generating prescription sales of 2.3 billion won last year, holding steady compared to the previous year. Besivo has not shown significant growth since its launch in 2017. Levovir, Bukwang Pharm's in-house developed hepatitis B drug, maintained its performance from 2022 by achieving sales of 800 million won last year. Levovir, the first domestically approved hepatitis B treatment, received approval in 2006. However, its prescription sales have consistently declined, recording less than 1 billion won since 2021. Generic drug growth slowed…Decreased sales of generic versions of Viread and Baraclude Last year, prescription sales for some generic drugs were reported to have decreased, just like certain original pharmaceuticals. Generic drugs for hepatitis B recorded prescription sales of 48.6 billion won last year, showing a 6.3% decrease from 51.9 billion won in 2022. During the same period, the market share of generics also slightly decreased from 23% to 21%. Yearly prescription performance of Viread and its generic versions. (Unit: KRW 100 million) Prescription sales for generic version of Viread decreased by 6.4% from 17.1 billion won in 2022 to 16 billion won last year. Viread generic drug market has steadily increased prescription sales since surpassing 10 billion won in 2019, but its growth halted after five years. Among them, Dong-A ST's Virreal, which holds the highest market share, experienced a 12.5% decrease in prescriptions, dropping from 3.2 billion won in 2022 to 2.8 billion won. During the same period, Daewoong's Virehepa decreased by 11.8%, and Jeil Pharm’s Tecavir decreased by 15.2%. Yearly prescription performance of Baraclude and its generic versions. (Unit: KRW 100 million) Prescription sales for Baraclude's generic version were recorded at 33.3 billion won last year, a 4.5% decrease compared to 2022. Although this market surpassed 30 billion won in prescription sales in 2020, it did not significantly increase its market share. Dong-A ST's Baracle recorded prescription sales of 10.5 billion won last year, becoming the only generic drug to surpass the 10 billion won mark. In this market, Dong-A ST held a 32% market share. Bukwang Pharmaceutical's Bukwang entecavir recorded 3.2 billion won last year, a 29% decrease from 4.5 billion won in 2022. During the same period, Daewoong Pharmaceutical's Baracross increased from 3.3 billion won to 3 billion won, indicating a 9% decrease. The prescription sales for JW Pharmaceutical’s Entekhan decreased by 17%. Generic drug developers' next target is Vemlidy. Aside from the first generics like Dae Woong’s Vemliver, Dong-A ST’s Vemlia, and CKD Pharmaceutical’s Tenofobell-A, five other companies have received approval for generic versions of Vemlidy in the domestic market. These generics were officially launched in the last quarter of the previous year, contributing to a combined prescription amount of 800 million won for the quarter. It will be interesting to see how Vemlidy's growth might impact the expansion of the generic pharmaceuticals market. Due to issues related to reimbursement cuts, switching between hepatitis B treatments has been challenging. However, generic companies plan to increase their market share by offering lower drug prices. Currently, Vemlidy costs 3,500 won, but domestic generic companies have entered the market with prices in the 2,400 won range, approximately 70% of Vemlidy's price.
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- Will Polivy secure reimbursement approval this year?
- by Eo, Yun-Ho Jan 29, 2024 06:04am
- Roche Korea’s Polivy (polatuzumab vedotin) The question of whether ‘Polivy,’ a B-cell lymphoma treatment, will be listed for insurance reimbursements this year is garnering significant attention. According to industry sources, Roche Korea’s Polivy (polatuzumab vedotin), a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), is expected to be presented to the Health Insurance Review and Assessment Service (HIRA)’s Cancer Disease Review Committee on the 31st. Previously, in 2021, Polivy made an initial attempt to obtain reimbursement listing for its third-line treatment as a combination therapy with BR therapy (bendamustine/rituximab). However, Polivy did not receive approval from the Cancer Disease Review Committee. In the first half of last year, Roche applied for reimbursement as a first-line treatment, in combination with other pharmaceuticals, including rituximab plus cyclophosphamide, doxorubicin, and prednisone. As the first CD79b-directed antibody-drug conjugate (ADC), Polivy received approval for its indication as a first-line treatment in Korea in November 2022. This approval was granted approval based on the demonstrated efficacy in Phase 3 POLARIX clinical trial results. The POLARIX trial conducted follow-up of all patients for more than 24 months. During the 28.2-month follow-up period, patients with DLBCL treated with first-line Polivy and R-CHP combination therapy showed a 27% reduction in the risk of disease progression or death compared to those treated with R-CHOP. Among the most commonly reported adverse reactions of Polivy combination therapy, with a frequency of more than 30%, are peripheral neuropathy (52.9%), nausea (41.6%), neutropenia (38.4%), and diarrhea (30.8%). DLBCL, which is an aggressive form of blood cancer, is the most common type of non-Hodgkin lymphoma. In Korea, approximately 5000 patients are newly diagnosed with DLBCL every year. DLBCL falls into the category of aggressive lymphoma, which requires immediate treatment due to the fast progression of the disease. About half of the patients reach remission following treatment due to their positive responsiveness to the therapy. However, approximately 30-40% of the patients are still non-responsive to the standard therapy, R-CHOP, or experience remission after receiving first-line treatments. Most patients with relapsed or refractory DLBCL experience recurrence within two years, and the duration of survival after recurrence is estimated to be only six months. Despite these critical conditions, not many effective treatment options are available for patients with relapsed or refractory DLBCL.
- Company
- New CKD drug Kerendia lands in general hospitals in KOR
- by Eo, Yun-Ho Jan 26, 2024 05:51am
- The landing procedure for the new chronic kidney disease drug 'Kerendia' is in full swing in general hospitals in Korea ahead of its reimbursement listing. According to industry sources, Bayer Korea's Kerendia (finerenone) recently passed the drug committee (DC) review at Sinchon Severance Hospital. It is also undergoing a landing process at major hospitals nationwide. Kerendia, a treatment for chronic kidney disease associated with type 2 diabetes, will be listed for reimbursement next month (February). With Chong Kun Dang joining as a domestic sales partner, full-scale promotional activities are expected to unfold along with the rapid landing process. Kerendia was approved in Korea last year as a treatment for adult patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of end-stage kidney disease (ESKD) and a sustained decrease in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure. CKD is one of the most common complications of type 2 diabetes and an independent risk factor for cardiovascular disease. Although it is a progressive disease, it is difficult to detect because there are no specific symptoms until just before end-stage renal failure. In addition, when end-stage renal failure occurs, dialysis or kidney transplantation is required to maintain life, which not only imposes a significant social and economic burden but also significantly affects the patient's quality of life. Therefore, patients with type 2 diabetes need to be monitored regularly for kidney damage with kidney function tests, it is important to slow the progression of kidney disease and lower the risk of cardiovascular disease through early diagnosis and appropriate treatment. Three main factors are known contributors to kidney disease in type 2 diabetes: hemodynamic changes, metabolic abnormalities, and inflammation and fibrosis. However, current treatments primarily target hemodynamic and metabolic factors, raising the need for new therapies that target the inflammation and fibrosis factor. Kerendia is a first-in-class, selective, non-steroidal mineralocorticoid receptor antagonist(MRA) that has a novel mechanism of action that targets inflammation and fibrosis in adult chronic kidney disease with type 2 diabetes. Overactivation of the mineralocorticoid receptors can cause inflammation and fibrosis, which can lead to permanent kidney damage. By inhibiting the overactivation of the mineralocorticoid receptor, Kerendia reduces inflammation and fibrosis and inhibits kidney damage. Bayer demonstrated Kerendia’s efficacy through the Phase III trial (FIDELIO-DKD). In the study, which enrolled approximately 5,700 patients in 48 countries worldwide, Kerendia was found to reduce chronic kidney disease progression and reduce cardiovascular disease risk in adult patients with chronic kidney disease and type 2 diabetes. Patients in the study received 10 mg or 20 mg of Kerendia or placebo in addition to standard therapy. Results showed Kerendia significantly reduced the incidence of a sustained decline in eGFR of ≥ 40%, kidney failure (defined as chronic dialysis, kidney transplantation, or a sustained decrease in eGFR to < 15 mL/min/1.73 m2 ), or renal death by 18% compared with placebo. In addition, Kerendia reduced the major secondary outcome – a composite of time to first 9 occurrences of CV death, non-fatal MI, non-fatal stroke, or hospitalization for heart failure – by 14%. The overall rate of serious adverse events or acute kidney injury-related adverse events was comparable between the two groups. Meanwhile, the European Society of Cardiology (ESC) published a major revision of its 2021 guidelines for the diagnosis and treatment of acute or chronic heart failure (HF), which included Kerendia as a Class 1A recommendation in preventing hospitalization for heart failure in patients with chronic kidney disease with type 2 diabetes. In addition, the ESC recommended that patients measure their glomerular filtration rate and urinary albumin levels once a year to screen for the development of chronic kidney disease in patients with diabetes.
- Company
- Ildong Idience presents 1st interim results for Venadaparib
- by Kim, Jin-Gu Jan 25, 2024 05:50am
- On the 22nd, Idience, the new drug development subsidiary of Ildong Pharmaceutical, announced that they have presented the research findings related to 'Venadaparib' at the 2024 ASCO Gastrointestinal Cancers Symposium held from the 18th to the 20th. Venadaparib is a novel targeted anticancer candidate product with a mechanism focused on selective inhibition of ‘Poly ADP-ribose polymerase (PARP).’ Idience is currently engaged in clinical development efforts for various cancer types, including gastric cancer, breast cancer, ovarian cancer, and cancers with resistance to PARP inhibitors. Idience participated in a poster session at the symposium where they shared interim results from the Phase 1 clinical study. This study involved a combination therapy of Venadaparib and chemotherapy irinotecan in patients with gastric cancer undergoing third- or fourth-line treatments. According to the presentation, in the evaluable patient group (11 patients) who received an appropriate dosage combination of Venadaparib and irinotecan, the objective response rate (ORR) was 36.4%, with a median progression-free survival (mPFS) of 5.6 months. In the clinical trial, it was observed that among all the patients enrolled, the ORR was significantly higher at 60% in the subset of gastric cancer patients (5 patients) with homologous recombination deficiency (HRD), a marker for cancer treatment. “Considering that Lonsurf (trifluridine/tipiracil), which is used as third-line standard treatment for metastatic gastric cancer, has shown ORR at 4% and mPFS of 2.0 months, the clinical result of Venadaparib is promising,” Idience staff stated. Additionally, “Current Venadaparib study is particularly valuable because considering that human epidermal growth factor receptor 2 (HER2) expression is a marker for classifying HER2-positive gastric cancer and HER2-negative gastric cancer, Venadaparib efficacy was evaluated in patients with HER2-positive gastric cancer or HER2-negative gastric cancer, “ Idience staff emphasized. Since the current study confirmed Venadaparib's competitiveness and novelty compared to existing treatments, the company plans to speed up its development process, aiming to receive approval for the clinical entry (Phase 2/3) next year. Furthermore, the company intends to utilize the expedited assessment and approval system to accelerate its commercialization agenda. Idience is one of the subsidiaries of Ildong Holdings, formerly Ildong Pharmaceuticals. The company owns several pipelines related to anticancer drugs. Currently, Idience operates businesses, including clinical development of new candidate drugs, which includes Venadaparib, license-out, and open innovations.
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- Boehringer Ingelheim Korea appoints Ana-Maria Boie as new GM
- by Son, Hyung-Min Jan 25, 2024 05:49am
- Ana-Maria Boie, new General Manager of Boehringer Ingelheim Korea Boehringer Ingelheim Korea announced on the 24th that it had appointed Ana-Maria Boie as the General Manager and Head of Human Pharma. The new GM, Ana-Maria Boie, is a seasoned expert with 24 years of experience in the pharmaceutical industry, in various areas including management, marketing, sales, and ESG. Boie joined Boehringer Ingelheim Romania in 2009 as a marketing manager and has contributed to the company's growth ever since, serving as the national sales manager for the Romania subsidiary, the regional marketing manager for the respiratory BU in the Austria subsidiary, the GM for the Romania subsidiary, and the director of human pharma sales and commercial in the Russia subsidiary. Beyond sales performance, Boie has also made significant contributions in embedding the company's core corporate values into the organization's culture. In 2020, she participated in the development of the ‘Sustainable Development-For Generations (SD4G)’ framework, the company's global core strategy for a sustainable society. In 2021, she was appointed Business Manager for the emerging market region at the company's headquarters in Germany, where she led the development and execution of business strategies across the Mexico-Brazil-South America-India-Middle East-Africa-Turkey (IMETA) markets, and spearheaded the creation of strategies to improve treatment access for underserved populations. GM Ana-Maria Boie, said, "I am very honored to be part of the journey of improving the quality of life for people and animals through innovative therapies in Korea, one of Boehringer Ingelheim’s key markets. I look forward to working with employees and executives of Boehringer Ingelheim Korea, who live by trust, respect, and passion to fulfill the corporate value, and grow the company around Boehringer Ingelheim’s first corporate brand claim, ‘Life Forward.’”
- Company
- Samsung Biologics tops 1 trillion won in profit
- by Chon, Seung-Hyun Jan 25, 2024 05:49am
- Samsung Biologics For the first time, Samsung Biologics has surpassed a yearly operating profit of 1 trillion won among pharmaceutical companies in Korea. Due to the continued growth of CDMO services for biopharmaceuticals, the company has accumulated quarter sales exceeding 1 trillion won in consecutive quarters. According to the Financial Supervisory Service report on the 24th, Samsung Biologics saw an operating profit of 350 billion won in Q4 last year, a 11.9% YoY increase. The annuals sales for the year reached 1.735 trillion won, showing a 11.2% increase from the previous year. Additionally, in Q3 last year, Samsung Biologics became the first in Korea’s history to exceed quarter sales of 1 trillion won, and they continued to show this growth in Q4. Last year, Samsung Biologics gained an operating profit of 1.114 trillion won, a 13.2% increase compared to the previous year. Annual sales reached 3.695 trillion won, demonstrating a 23.1% increase. These figures represent the company's most significant annual sales and an operating profit since its establishment. Samsung Biologics topped annual sales of 1 trillion won for the first time in the history of pharmaceutical companies in Korea. Samsung Biologics became the first in Korea’s history to exceed annual operating profit of 1 trillion won Samsung Biologics, founded in 2011, recorded 66 billion won in an operating profit in 2017, making it the first time the company has generated a surplus. It generated 91.7 billion won in 2019; however, in 4 years it expanded 12 times. Samsung Biologics’ yearly sales figure (left) and operating profit (right) (unit: 100 million won, graph by Financial Supervisory Service). Samsung Biologics focuses primarily on Contract Manufacturing Organization (CMO) and Contract Development Organization (CDO) services for Active Pharmaceutical Ingredients (APIs) and biopharmaceuticals. Currently, the company operates a total of four biopharmaceutical manufacturing facilities. Samsung Biologics has enhanced its CMO capacity through the partial operation of these four factories, attaining the world’s largest production capacity (240,000 liters) in the category of a single manufacturing facility within 23 months of launching the factory in October 2022. “We have reached the highest quarterly sales in our history, primarily due to the revenue generated from the fourth facility’s operation, enhanced operational efficiency in the existing first to third facilities, increased sales volume at Samsung Biologics, and the launch of new products,” the company explained. In the previous year, they reported the total value of orders of 3.5 trillion won, contributing to a cumulative value of orders of approximately $12 billion. Furthermore, they have successfully secured contracts with 14 out of the top 20 global pharmaceutical companies as their customers. Samsung Biologics is actively responding to the increasing demand for biopharmaceuticals by constructing its fifth facility, which commenced in April last year and is scheduled for completion by April 2025. This fifth facility is strategically designed, incorporating the best practices from facilities 1 to 4, and will have a production capacity of 180,000 liters, successfully expanding the company's total production capacity to 780,000 liters. As part of its portfolio expansion plan, Samsung Biologics is proactively investing in Antibody-Drug Conjugate (ADC) production. The company is currently in the process of constructing manufacturing facilities for ADC production, with a target for completion within this year. Samsung Biologics has also invested in ‘AimedBio,’ a Korean company possessing advanced technology for ADC, and in the Swiss company ‘Araris Biotech’ through the ‘Life Sciences Fund’ it established with Samsung C&T. Samsung Biologics has established a business office in New Jersey, a hub for major pharmaceutical companies, to use it as a communication channel with customers. They plan to further expand into strategically important overseas locations to build a global order network and enhance their competitiveness in terms of sales capabilities. Samsung Biologics' subsidiary, Samsung Bioepis, has recorded a significant milestone by surpassing 1 trillion won in sales, reporting 1.203 trillion won, representing an 8% increase from the previous year. However, its operating profit decreased by 11%, reaching 205.4 billion won. In April 2022, Samsung Biologics incorporated Samsung Bioepis as its 100% subsidiary, and the performance of Samsung Bioepis is now reflected in Samsung Biologics' results. During that period, Samsung Biologics acquired 1,034,185,2 shares of Samsung Bioepis stock, previously owned by Biogen, for 2.7655 trillion won, officially transitioning Samsung Bioepis into a 100% subsidiary of Samsung Biologics. Currently, Samsung Bioepis sells seven biosimilars, including treatments for autoimmune diseases in the United States, such as ‘Hadlima,’ a biosimilar to ‘Humira,’ and treatments for rare blood disorders in Europe, such as ‘Epysqli,’ a biosimilar to ‘Soliris.’ Samsung Bioepis plans to focus on expanding product sales in the global market throughout this year. They plan to finalize the development of their follow-up biosimilar pipeline and prepare for a significant advancement in future businesses, such as ADC research. Samsung Biologics has projected its sales for this year to be 4.1564 trillion won.
- Company
- Sales of Esomezol ·Noltec↑ Nexium↓ in the PPI market
- by Kim, Jin-Gu Jan 25, 2024 05:49am
- Sales of major proton pump inhibitor (PPI) class of antiulcer drugs showed mixed performance last year. ‘Nexium (esomeprazole)’ saw a 4% year-on-year decline in prescriptions, while ‘Lanston LFDT (lansoprazole)’ and ‘Pariet (rabeprazole)’ also saw a decline in prescriptions. Hanmi Pharmaceutical's ‘Esomezol (esomeprazole)’ and Ilyang Pharmaceutical's ‘Noltec (ilaprazole)’ saw an increase in prescriptions last year. However, the increase has slowed down recently. This may be due to the rapid growth of its competitors such as P-CABs (potassium-competitive acid blockers). Presciptions of Esomezol·Esomezol Plus rise 3% in 1 yr…sales growth slows down Hanmi PharmaceuticalAccording to market research institution UBIST, Hanmi Pharmaceutical's ‘Esomezol‘ recorded the highest prescription sales in the domestic PPI anti-ulcer drug market last year. Esomezol prescriptions totaled KRW 61.6 billion last year, up 1% YoY. Hanmi Pharmaceutical launched Esomezol in 2008. Since then, its prescriptions have increased steadily. From 2018 to 2021, prescription sales increased by more than 20% every year. In 2021, it reached the KRW 50 billion mark for the first time and became the market leader. However, since 2022, its sales growth has slowed down. In 2022, sales increased by only 2% YoY, and in 2023, the growth rate decreased further to 1%. Hanmi Pharmaceutical launched Esomezol Plus in 2022 to make up for the slowdown in sales of Esomezol. Esomezol Plus is an immediate-release product that contains esomeprazole and magnesium hydroxide. It is characterized by a faster onset of action than the existing Esomezol. Esomezol Plus generated prescription sales of KRW 1.5 billion in 2022 and KRW 2.6 billion last year. Prescription sales of Esomezol and Esomezol Plus together increased by 3% from KRW 62.4 billion in 2022 to KRW 64.2 billion last year. The situation is not so different for Ilyang Pharmaceutical's Noltec. Noltec’s prescriptions rose 3% YoY to KRW 42.3 billion last year. From 2018 to 2020, Noltec’s prescription sales increased by more than 10% every year. In 2021, the year-on-year prescription growth rate decreased to 8% and further decreased to 3% in 2022 and 2023. Nexium KRW 33.5 billion→KRW 32.3 billion…prescriptions decreased for 3 consecutive years Other major PPIs performed poorly in the outpatient prescription market in general. AstraZeneca's Nexium posted prescription sales of KRW 32.3 billion last year. This is down 4% from the KRW 33.5 billion it had made in 2022. It was the 3 consecutive year the company saw a decline in prescriptions since 2021. Nexium’s sales grew steadily until 2020 and had long been a leader among PPI class anti-ulcer drugs, but prescriptions declined for the first time in 2021. With the decline, the company had to hand over its market lead to Hanmi Pharmaceuticals' Esomezol. In 2022, the decline was even greater. Prescription sales dropped from KRW 42 billion in 2021 to KRW 33.5 billion, dropping 20% in one year. Daewoong Pharmaceutical has concluded its copromotion agreement for Nexium (left) and is selling Nexium’s generic version, Nexierd (right) from 2022 The industry pointed to the change in domestic sales rights as one of the reasons for the decline in Nexium's prescription performance. Previously, Nexium was co-promoted and co-sold by Daewoong Pharmaceutical, but AstraZeneca and Daewoong chose to part ways at the end of 2021. Daewoong decided to focus its sales efforts on the launch of Nexium's potential competitor, Fexuclu (fexuprazan). So, Ildong Pharmaceutical took over the place of Daewoong Pharmaceutical and copromoted sales of Nexium ever since. Ildong aimed to synergize Nexium’s sales with another PPI antiulcer drug, Rabiet (rabeprazole), but both Nexium and Rabiet experienced a sales decline as a result. Daewoong decided to part ways with Nexium and launch a generic version of Nexium. Since 2022, the company started selling its Nexium generic Nexierd in 2022. At the same time, it sold Nexiquin, another generic version of Nexium, through its subsidiary Daewoong Bio. Nexierd and Nexiquin landed in the market in 2022, recording prescription sales of KRW 7.5 billion in the first year. However, sales dropped 8% to KRW 6.9 billion last year. Lanston·Pariet·Rabiet show slowdown in sales…influenced by rise in competition, including P-CAB etc. Takeda's Lanston LFDT (lansoprazole) has also seen a decline in its prescriptions for 3 consecutive years since 2021. Last year, prescription sales of Lanston LFDT were KRW 21.7 billion, down 7% YoY. The drug had made a personal new record in 2020 with KRW 32.8 billion in prescriptions, but it fell to KRW 30.8 billion the following year, and further declined to KRW 23.4 billion in 2022. Sales of Takeda's other PPI anti-ulcer drug, Dexilant DR (dexlansoprazole), have stagnated recently. Presciptions of Dexilant had increased from KRW 17.1 billion in 2020, to KRW 18.8 billion in 2021, then to KRW 20.9 billion in 2022. However, last year, it sold KRW 20.9 billion, the same as in the previous year. Eisai’s Pariet (rabeprazole) generated KRW 19.6 billion last year, down 4% YoY. Pariet’s prescription sales steadily expanded from 2018 to 2022 but saw a decline for the first time last year. Ildong Pharmaceutical's ‘Laviet’ decreased by 2% from KRW 19.4 billion in 2022 to KRW 19.1 billion last year. Sales of Daewon Pharmaceutical's Eswoamp (esomeprazole) fell 6% to KRW 18.8 billion from KRW 20 billion during the same period, and Takeda's Pantoloc (pantoprazole) fell 5% to KRW 12.1 billion from KRW 12.7 billion. The industry pointed to the rise of its competitors as one of the reasons for the sluggish sales of the major PPI class anti-ulcer drugs. P-CAB class drugs are one representative. The rapid rise in prescription sales of HK Inno.N’s ‘K-CAB (tegoprazan)’ and Daewoong Pharmaceutical's ‘Fexuclue (fexuprazan),’ had relatively slowed down sales of PPI drugs that have the same indication. K-CAB recorded prescription sales of KRW 158.2 billion last year. Since its launch in 2019, it has made strong growth, recording a 20% YoY increase in sales. Fexuclue recorded prescription sales of KRW 53.5 billion last year. After launching in July 2022 and generating sales of KRW 12.9 billion by the end of the year, its sales rose even more steeply last year. The rise of PPI+antacid combination drugs is also analyzed to have contributed to the decline of PPI single-agent drugs. The PPI+antacid market grew rapidly, recording KRW 19.8 billion in 2020, to KRW 27.6 billion in 2021, to KRW 44.2 billion in 2022, and then to KRW 53.8 billion last year.
- Company
- Potential of AVEO Oncology acquired by LG Chem
- by Jan 24, 2024 05:46am
- LG Chem's subsidiary AVEO Oncology is showing results in intractable cancers. AVEO, which was acquired by LG Chem in 2022 for about KRW 750 billion, specializes in developing new anticancer drugs and has recorded annual sales of about KRW 200 billion. AVEO owns Fotivda (tivozanib), which has been approved in the U.S. for the treatment of Stage III or higher renal cell carcinoma. In addition to Fotivda, AVEO is developing first-in-class drugs for refractory cancers such as head and neck cancer and triple-negative breast cancer through novel mechanisms of action. According to industry sources on the 23rd, AVEO’s head and neck cancer drug candidate, ficlatuzumab, recently entered Phase III clinical trials. Ficlatuzumab is a new head and neck cancer drug candidate that targets hepatocyte growth factor, or HGF, and c-MET. In the trial, AVEO is evaluating the efficacy and safety of ficlatuzumab in combination with Merck’s Erbitux(cetuximab) in patients with recurrent or metastatic (R/M) human papillomavirus(HPV)-negative head and neck squamous cell carcinoma. In the Phase II study, ficlatuzumab+Erbitux demonstrated superior efficacy compared with Erbitux monotherapy. After 2 years of follow-up in 58 patients with head and neck cancer, the ficlatuzumab plus Erbitux combination achieved a median progression-free survival (PFS) of 3.7 months and an objective response rate (ORR) of 19%. Two patients achieved a complete response (CR) and four patients achieved a partial response (PR). Overexpression of c-Met was associated with a reduced risk of disease progression in the HPV-negative arm. The efficacy of Erbitux monotherapy was not demonstrated during the same period. AVEO is also exploring the potential of ficlatuzumab in combination with chemotherapy in patients with pancreatic cancer and acute myeloid leukemia in early clinical trials. In both studies, ficlatuzumab demonstrated efficacy activity and an acceptable tolerability profile. AVEO plans to further evaluate the efficacy of ficlatuzumab in various solid tumors. AVEO develops candidate substances for intractable cancers, including triple-negative breast cancer and pancreatic cancer In addition, AVEO is also accelerating the development of its oncology pipeline. Among them, the new drug candidate in the fastest clinical stage is AV-203. AV-203 is designed to inhibit both ligand-dependent and -independent HER3 signaling. Ligand specifically binds to the receptor. HER3 is a receptor whose expression has been identified in a number of solid tumors, and to date, no new cancer drugs have been developed that target this biomarker. In addition to AV-203, Daiichi Sankyo's patritumab is currently being evaluated for HER3-mutated breast cancer. AVEO has completed a Phase Ia study of AV-203 in patients with advanced solid tumors. AV-203 was well tolerated in multiple tumor models, including breast, head and neck, lung, ovarian, and pancreatic cancers. In the trial, AV-203 demonstrated early signs of activity in HER3-responsive ligands, heregulin or neuregulin, that was consistent with those confirmed through preclinical data. Therefore, AVEO plans to continue to a Phase 1b study. AVEO is also conducting clinical trials for its AV-380. AV-380 is an innovative new drug candidate that targets growth differentiation factor 15 (GDF15). GDF15 is a pro-inflammatory cytokine whose elevated circulating levels have been correlated with cachexia in cachectic cancer patients and several animal models of cancer cachexia. Cancer cachexia is a complex metabolic syndrome characterized by malnutrition and severe involuntary weight loss due to the loss of muscle and fat tissue. 80% of cancer patients are known to suffer from cachexia. Preclinical data confirmed that inhibiting GDF15 with AV-380 can reverse the effects of cachexia. In addition, AVEO is also conducting a preclinical study for AV-353 in patients with triple-negative breast cancer in collaboration with the Mayo Clinic in Minnesota, USA. AV-353 is an inhibitory antibody specific to Notch 3, a signaling pathway that is important in cell-to-cell communication involving gene regulation mechanisms that control multiple cell differentiation processes during the entire life cycle. The Notch 3 receptor pathway has been implicated in multiple diseases, including cancer, cardiovascular diseases, and neurodegenerative conditions. AVEO is leveraging its Human Response Platform to secure its drug pipeline. All of its drug candidates in development including ficlatuzumab, AV-203, AV-380, and AV-353, were developed using AVEO's proprietary Human Response Platform.
