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- 2026-05-04 13:48:22
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- Bosulif, 2nd-generation leukemia drug available in Big 5
- by Eo, Yun-Ho Aug 05, 2024 07:50am
- Product photos of Pfizer Korea The second-generation leukemia drug, 'Bosulif,' has landed in 'Big 5' general hospitals. According to industry sources, Pfizer Korea's chronic myelogenous leukemia (CML) drug, Bosulif, has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. It is now available for prescription at 21 nationwide medical centers. After making the insurance reimbursement list in January, it has quickly become available for prescription. However, some patients are expressing disappointment regarding the reimbursement criteria. Bosulif's reimbursement criteria are set as 'the second-line treatment of patients over ages of 18 years old with chronic phase, accelerated phase, or blast phase Philadelphia chromosome-positive CML (Ph+ CML) who have previously demonstrated resistance or intolerance to neoadjuvant therapy, including Gleevec (imatinib).' However, since the indication for the basis of approval does not include age limits and the drug can be prescribed beginning from the first-line treatment, patients are pointing out the problem of the narrow reimbursement standard. Therefore, all eyes are on whether the issues related to the reimbursement criteria of the latecomer, new CML drug Bosulif will be solved. Bosulif is a second-generation, targeted anticancer drug alongside Novartis Korea's 'Tasigna (nilotinib),' BMS Korea's 'Sprycel (dasatinib),' and Il-Yang Pharmaceutical's 'Supect (radotinib).' The efficacy and safety of Bosulif have been confirmed in the Phase 3 NCT02130557 study, which enrolled newly diagnosed CML patients. The primary endpoint of Bosulif was a major molecular response (MMR) by 12 months. Patients treated with Bosulif had an MMR of 47%. Patients treated with the control drug, first-generation drug Gleevec (imatinib), had an MMR of 36%. MMR at month 60 was 74% for Bosulif versus 66% for Gleevec. After 60 months of follow-up, the median time to MMR in responders was 9.0 months for bosutinib and 11.9 months for Gleevec. Additionally, Bosulif has recently shown potential to treat Lou Gehrig's disease, also known as amyotrophic lateral sclerosis (ALS). In a Phase 2 study conducted by a research team including, the Center for iPS Cell Research and Application (CiRA) at Kyoto University, 26 ALS patients were treated with the CML drug Bosulif. Based on the result, Bosulif has been demonstrated to suppress the progression of motor dysfunction in almost half of the patients.
- Company
- Fresenius Kabi launches 2 Ntense amino acid solutions
- by Eo, Yun-Ho Aug 02, 2024 05:52am
- On the 1st, Fresenius Kabi Korea (CEO&President: Noah Park) announced the launch of its high-strength amino acid nutritional solutions ‘Ntense’ and ‘Ntense EF’ in Korea. Ntense, which stands for “Nitrogen Intensify,” is a three-chamber bag product that provides ▲nutritional treatment for critically ill patients with a high risk of muscle loss even with short-term hospitalization and ▲the 'protein: calorie ratio (1.5g:20kcal)' required by critically ill patients. The name comes from nitrogen, which is a component of amino acids. In addition, the Ntense EF version does not contain electrolytes and is the only 3-chamber bag product licensed in Korea that is approved for Intradialytic Parenteral Nutrition (IDPN) during hemodialysis. According to the international guidelines on nutritional support for severe patients, high protein and moderate energy are recommended for critically ill adult patients requiring nutritional therapy. The U.S. National Kidney Foundation’s Kidney Disease Outcome Quality Initiative International Guidelines (KDOQI) and European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines recommend IDPN as a treatment option to maintain or improve the nutritional status of hemodialysis patients. "Ntense is an original nutritional fluid already being used globally since its initial launch in Europe, Ntense provides a high protein and adequate calorie option for critically ill patients,” said Noah Park, CEO & President of Fresenius Kabi Korea. “We believe Ntense EF will improve malnutrition in patients with electrolyte imbalance and hemodialysis patients.” Meanwhile, Ntense comes in 4 sizes - 506ml, 1012ml, 1518ml, and 2025ml. The Ntense EF version comes in 2 sizes - 506ml and 1012ml. The amount can be customized according to the patient's malnutrition status and calorie requirements. The insurance price of Ntense and Ntense EF 1012ml is KRW 40,197 each, while the 506ml and 1518ml sizes are KRW 26,798 and KRW 50,246, respectively, as announced on August 1.
- Company
- GC·Hanmi submit IND apl. for new 'Fabry disease' drug
- by Son, Hyung-Min Aug 02, 2024 05:52am
- GC Biopharma and Hanmi Pharmaceutical announced on July 1st that they have submitted Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Phase 1/2 clinical trials of ‘(LA-GLA),’ a treatment for Fabry disease that they are co-developing. LA-GLA is an innovative new drug to treat Fabry disease. GC Biopharma and Hanmi Pharmaceutical are co-developing it as the 'world's first once-monthly subcutaneous dosing.' Fabry disease is a rare disease inherited in an X-chromosome and is a type of lysosomal storage disease (LSD). It occurs when 'alpha-galactosidase A,' the enzyme needed to break down the glycolipid in the lysosome. It is a progressive, rare, incurable disease caused by unbroken glycolipid building up in the body, resulting in cell toxicity and inflammatory response. It can damage many organs, and severe complications lead to death. Currently, patients with Fabry disease are treated with enzyme replacement therapy (ERT), an intravenous infusion of enzymes created using recombinant DNA technology. This therapy requires receiving inconvenient and burdensome intravenous injection every two weeks at the hospital. There are limitations regarding the efficacy in suppressing the progressive kidney disease. LA-GLA is a 'next-generation long-acting ERT' with improvements to such limitations of existing treatments. During the non-clinical development phase, it received an Orphan Drug Designation (ODD) from the U.S. FDA in May based on superior efficacy in improving kidney function, vascular disease, and peripheral neuropathy compared to conventional therapies. GC Biopharma and Hanmi Pharmaceutical official said, "Commencing in the United States, we also plan to conduct Korean and global clinical trials." He added, "Based on our experiences, knowledge, and skills in developing lysosomal storage disease treatments, we will strive to develop new drugs and provide new treatment options to patients suffering from Fabry disease."
- Company
- Next Biomedical seeks IPO…knocks on global GI mkt
- by Hwang, Byung-woo Aug 02, 2024 05:52am
- Next Biomedical will seek KOSDAQ listing in August based on its achievements in the GI field. The company has been collaborating with the global company Medtronic to expand into the endoscopic hemostatic agent market with its flagship product. Based on the revenue growth, the company plans to establish the drug as a standard-of-care in the global market. Don-Haeng Lee, CEO of Next Biomedical, is making a presentation Established in 2014, Next Biomedical is an innovative bio-solution company that develops therapeutic materials based on its polymer and drug delivery system technologies. Its main products include an endoscopic hemostatic powder (Nexpowder), an endovascular embolization microsphere (Nexsphere), and an arthritis pain embolization treatment (Nexsphere-F). Of these, the product that generates significant sales is the endoscopic hemostatic powder Nexpowder, which is a powder-type hemostatic treatment that can be used through endoscopes to hemorrhage bleeding sites and prevent rebleeding in the event of gastrointestinal bleeding. In particular, Next Biomedical signed a global licensing agreement (excluding Korea, Japan, and Greater China) with Medtronic in 2020 to sell its products in 29 countries including the United States, Canada, and Europe. The company's prominence in the digestive field can be attributed to CEO Lee's background as a professor of gastroenterology at Inha University Hospital. Based on Lee’s clinical experience, the company was able to build a consortium of academic and university hospital collaborations and secure a network of key stakeholders in the GI field in Korea and abroad. "The rise in endoscopic procedures has also led to the rise in GI bleeding amongst patients, rendering hemostasis and rebleeding prevention an important task for all surgeons including gastroenterologists,” said Lee. "After feeling the need while performing endoscopic procedures in the field, we developed a product, which is being exported to the US and Europe." The company has succeeded in rapidly commercializing the finished product of the therapeutic material in Korea and abroad, which has shown results in terms of sales and exports. Excerpt from Next Biomedical Last year, Next Biomedical posted sales of KRW 4.8 billion, which was nearly double the KRW 2.7 billion it had posted in 2022. In Q1 this year, sales were KRW 2.3 billion and are expected to exceed KRW 10 billion. However, the company is still recording an operating loss due to an increase in SG&A expenses caused by the increase in R&D expenses. However, this is expected to turn into a profit after the IPO, supported by the growth in overseas sales in the U.S. and Europe, which accounted for 88% of sales last year. "We estimate sales of about KRW 12 billion this year and consider the operating profit break-even point to be KRW 15 billion,” said Lee. "We don't have much cost burden because Dong-A ST is in charge of sales and marketing in Korea and Medtronic is in charge overseas, so we think we will able to record a surplus next year." Will seek to enter the U.S. guidelines as a standard of care...is conducting post-marketing clinical trials In particular, the company is conducting post-marketing clinical trials to enter the endoscopic hemostasis guidelines as a standard of care with its Nexpowder. It plans to build clinical evidence with 278 patients in 10 hospitals in the U.S., Canada, and Europe. Don-Haeng Lee, CEO of Next Biomedical The trial is being led by Dr. Loren Laine, Past President of the American Gastroenterological Association (AGA) and Professor of Medicine at Yale University School of Medicine, and sponsored by Medtronic. The company believes the number of patients in the trial is sufficient to build evidence for its use as a hemostatic agent after endoscopic bleeding. "We aim to be listed as a standard of care by utilizing the clinical evidence obtained from the clinical trial,” said Lee. "If the guidelines include the use of Nexpowder as a first-line treatment, the demand for the product is expected to increase significantly due to its differentiated competitiveness." In addition, the company is focusing on occupying the market with Nexsphere-F, a fast-resorbable hydrophilic gelatin-based embolic microsphere for endovascular embolization. The drug reduces pain without side effects by embolizing abnormal blood vessels that cause arthritis pain with fast-acting microspheres that break down within a short period of time (2 to 6 hours). Post-marketing clinical trials are already underway for the drug in Korea for a new health technology application, and post-marketing clinical trials are also soon to begin in Europe. In addition, the company recently completed filing an Investigational Device Exemption application to the U.S. FDA to confirm the efficacy and safety of Nexsphere-F, with plans to receive approval by 2026. "Based on our rapid product commercialization experience and abundant clinical evidence, we will take the initiative to open and preoccupy new markets by listing all our products as the global standard of care,” said Lee. “We will successfully enter the US market by completing the ongoing clinical trials and KOSDAQ listing."
- Company
- Mounjaro bids into Korea's obesity treatment market
- by Hwang, Byung-woo Aug 02, 2024 05:51am
- Mounjaro brand logo Lilly Korea announced on the 1st that its GIP/GLP-1 dual-acting agent, Mounjaro (tirzepatide), has received approval from the Ministry of Food and Drug Safety (MFDS) as an adjunct for chronic weight management. Mounjaro is the first and, to date, the only (as of July 2024) GIP/GLP-1 dual receptor agonist available. It selectively binds to and activates both GIP and GLP-1 receptors, the targets of endogenous GIP and GLP-1, to lower fasting and postprandial blood glucose concentrations and reduce body weight and body fat. GIP and GLP-1 are two primary incretin hormones that stimulate insulin secretion, improve insulin sensitivity, reduce glucagon secretion, regulate appetite, and maintain satiety. The approval authorizes the use of Mounjaro as a once-weekly subcutaneous injection as an adjunct to a reduced-calorie diet and exercise regimen for chronic weight management in adult patients. It is indicated for ▲ obese adult patients with an initial body mass index (BMI) of 30kg/m² or greater, or ▲overweight patients with an initial BMI of 27kg/m² or greater but less than 30kg/m² with one or more weight-related comorbidities (e.g., hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease). In June 2023, Mounjaro was first approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval was based on the Phase III SURMOUNT-1 and SURMOUNT-2 clinical trials. SURMOUNT-1 was a 72-week study that evaluated the efficacy and safety of Mounjaro in 2,539 adults with obesity (BMI≥30 kg/m²) or overweight (27kg/m²≤BMI
- Company
- New oHCM drug 'Camzyos' is under review for reimb list
- by Eo, Yun-Ho Aug 02, 2024 05:51am
- Product photo of BMS Korea The new drug for obstructive hypertrophic cardiomyopathy (oHCM), 'Camzyos,' has entered the last stage for reimbursement listing. Sources said that the Ministry of Health and Welfare (MOHW) ordered the National Health Insurance Service (NHIS) to initiate a drug price negotiation for Bristol Myers Squibb Korea's Camzyos (mavacamten), a treatment for obstructive hypertrophic cardiomyopathy (oHCM). The company encountered several hurdles with Camzyos during the review process; for instance, the drug received a re-assessment status during the Health Insurance Review and Assessment Service (HIRA) review. Therefore, all eyes are on whether Camzyos will be approved for the reimbursement list. After clearing the Economic Evaluation Committee of Health Insurance Review, it was rapidly considered for the Drug Reimbursement Evaluation Committee (DREC) review. Camzyos is the only drug that selectively inhibits cardiac myosin-actin cross-bridge formation, which is the cause of oHCM. Camzyos' mechanism involves dissociating myosin from actin, relaxing overstimulated heart muscle, and thereby improving left ventricular outflow tract (LVOT) structure and LVOT outflow obstruction. Because no treatments have been available to treat oHCM for a long time, Off-label medications were used to manage symptoms. Because of Camzyos, the European Society of Cardiology (ESC) updated its guidelines for managing cardiomyopathy for the first time in about nine years. Previously, the guidelines for HCM were based on evidence limited to small-scale monitoring data, retrospective analysis results, and consensus opinion. However, Camzyos has completely changed this situation. Two large-scale, phase 3 clinical trials conducted as randomized controlled trial (RCT) have confirmed the significant effect of Camzyos. Consequently, ESC guidelines recommend Camzyos with the highest evidence level A for the first time in treatment options. American College of Cardiology (ACC) and the American Heart Association (AHA) are preparing to update their guidelines. Furthermore, based on this phase 3 trial evidence, the U.S. FDA granted Camzyos Breakthrough Therapy Designation (BTD) and approval. Considering these factors, Camzyos appears to have met the criteria of an innovative new drug, announced by the government last year: ▲There are no alternative products, therapeutically equivalent products, or therapies available ▲Extending the survival period significantly and showing clinically meaningful improvements ▲Has been approved for MFDS’ GIFT (priority review designation), U.S. FDA’s BTD, or Europe’s EMA expedited review (PRIME). Meanwhile, the efficacy of Camzyos was demonstrated through the Phase 3 EXPLORER-HCM trials. In this trial, Camzyos improved primary endpoints, which were the patient’s symptoms (NYHA classification) and exercise capacity measured with peak oxygen uptake (pVO2), more than twofold compared to the placebo. 20% of the patients treated with Caymzyos met the NYHA classification and pVO2 improvements. It also reduced the LVOT outflow obstruction index by four-fold after exercise. 7 out of 10 patients who received Camzyos treatment had improved indexes and ended up not considering surgery, and they maintained the effects for 30 weeks.
- Company
- VUNO knocks on the U.S. market to generate operating profit
- by Hwang, Byung-woo Aug 01, 2024 05:48am
- Medical artificial intelligence (AI) company VUNO has launched an AI-based brain quantification device in the United States market. Whether the company will use this as a stepping stone for sales expansion garners attention. VUNO's strategy is to quickly turn around by increasing the sales performance of its major product and entering the overseas market. At the same time, improving negative indicators for operating profit and net profit would take time. VUNO officially launched its product to the U.S. market on July 28th, seeking to expand sales. VUNO's consolidation sales last year were KRW 13.3 billion, the highest sales in the company's history. The company achieved a 60% increase from the sales of KRW 8.2 billion in 2022. Quarterly report also showed an increasing trend. VUNO's quarterly sales last year were ▲KRW 1.7 billion in Q1, ▲KRW 3 billion in Q2, ▲KRW 3.5 billion in Q3, and ▲KRW 4.9 billion in Q4. This year's Q1 sales were KRW 5.5 billion. The analysis suggests that VUNO's rising performance has been led by the growth of VUNO's major product, DeepCARS, an AI-based cardiac arrest prediction software, increased domestic and international sales of medical image products, and successful business-to-consumer (B2C) commerce. Notably, VUNO's DeepCARS entered the market as the first drug to be deferred from the 'New Health Technology Assessment,' which was in effect in August 2022. After that, the company likely established a stable sales structure and rather than generating temporary sales. The remaining issue is negative indicators for operating profit and net profit. Vuno's quarterly operating profit and loss last year resulted in a ▲loss of KRW 4 billion for Q1, ▲loss of KRW 5.3 billion for Q2, ▲loss of KRW 1.8 billion for Q3, and ▲loss of KRW 2.5 billion for Q4. In Q1 this year, VUNO also recorded an operating loss of KRW 3.4 billion and a net loss of KRW 3.4 billion. The total operating loss last year was KRW 13.7 billion. This year, a similar loss is expected when calculating based on Q1 loss. However, a sales turnaround may be possible after entering the U.S. market. The company recently attended the Alzheimer's Association International Conference (AAIC) and officially launched its AI-based brain quantification medical device, VUNO Med®–DeepCARS™, in the U.S. market. VUNO Med®–DeepCARS™ is an AI medical device receiving approval from the U.S. Food and Drug Administration (FDA) in October 2023. VUNO plans to build its sales network by increasing interactions with key stakeholders (KOL) to accelerate market penetration. In June, the company participated in its U.S. subsidiary's paid-in capital increase by investing KRW 3 billion to enter the North American market. As the company aims to penetrate the U.S. market, VUNO protects its key technology by registering patents. VUNO announced on July 30th that it has decided to register two patents associated with VUNO Med®–DeepCARS™. The company plans to gradually seek sales expansion opportunity following an increase in demand for early The company will need to reach a specific revenue level to address the main causes of operating losses: selling, general, and administrative expenses. Therefore, VUNO is expected to intensify its efforts to target the U.S. market. Yeha Lee, the CEO of VUNO, said, "Two patents that we have registered is an AI-based key technology with various potential uses in clinical practices. It increases the efficiency of brain MRAI analysis." Lee added, "We will make a strategic approach to successfully enter the U.S. market, of which early entry is crucial. We will strive to help address dementia with the product."
- Company
- Celltrion’s Steqeyma approved in CAN…targets Stelara mkt
- by Hwang, Byung-woo Aug 01, 2024 05:48am
- On the 31st, Celltrion announced that it had received New Drug Application (NDS) approval for its Stelara biosimilar Steqeyma from Health Canada. With the approval, Celltrion may now sell Steqeyma in Canada for plaque psoriasis, psoriatic arthritis, and Crohn's disease. The Canadian approval supports the company’s plan to settle into the global ustekinumab market starting with North America, the largest pharmaceutical market. According to IQVIA, the global ustekinumab market was valued at around USD 20.4 billion (KRW 26.52 trillion) last year, with the Canadian market recording USD 663 million (KRW 861.9 billion). When including the U.S. market, the total North American market is about $16.375 billion (KRW 21.285 trillion), accounting for more than 80 percent of the global market. Celltrion previously received approval for Steqeyma in Korea in June and a positive opinion for marketing authorization from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). When approved, the European approval will further accelerate Celltrion's expansion into the global ustekinumab market. The approval will also expand Celltrion's autoimmune disease treatment portfolio in North America, adding an interleukin (IL) inhibitor to its existing tumor necrosis factor (TNF)-α inhibitor product line, expanding the target patient population. "Canada has pro-biosimilar policies in place that actively encourage the prescription of biosimilars, which will help Celltrion gain presence in the country," said a Celltrion official. "North America is the world's largest market for ustekinumab, and we expect the approval of Steqeyma in Canada to be the beginning of our expansion into the North American market." Meanwhile, Celltrion plans to secure a portfolio of 11 biosimilars by 2025, with the goal of strengthening its presence in the global market and increasing revenue.
- Company
- Will the cardiomyopathy drug Vyndamax be reimb this time?
- by Eo, Yun-Ho Aug 01, 2024 05:48am
- The reimbursement listing process for ‘Vyndamax,’ Pfizer’s treatment for transthyretin amyloid cardiomyopathy (ATTR-CM), is gaining attention in Korea. According to industry sources, discussions for the reimbursement of Pfizer Korea’s Vyndamax (tafamidis 61mg) for Transthyretin amyloid cardiomyopathy (ATTR-CM) have again begun. Once again, the key players will be the Pharmacoconomic Evaluation Subcommittee and the Reimbursement Standard Subcommittee. Vyndamax failed its first reimbursement attempt in early 2021. The company then made its second attempt in the first half of the same year after conducting a pharmacoeconomic evaluation and preparing a risk-sharing agreement (RSA) but saw the same results. Then, in April 2022, the drug failed to pass the Health Insurance Reimbursement and Assessment Service’s reimbursement subcommittee’s threshold again, then passed the threshold in July of the same year, but was again rejected by the Drug Reimbursement Evaluation Committee after 9 months. At the time, it was believed that the authorities failed to close the gap with the pharmaceutical company on the terms of the RSA. Therefore, it remains to be seen whether Vyndamax will be able to pass the DREC review and move on to the drug pricing negotiation stage this time. Vyndamax is virtually the only treatment option available for ATTR-CM. ATTR-CM is a fatal condition with a poor treatment outcome due to a lack of specific treatment and is often mistaken for simple heart failure If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. In this area with a dire need, Vyndamax demonstrated a reduction of cardiovascular events in ATTR-CM patients and improvement in their functional athletic ability in the six-minute walk through the Phase III ATTR-ACT study. Based on these results, healthcare professionals in Korea have been insisting on the need to prescribe Vyndamax. “The approval of Vyndamax last year has greatly advanced Korea’s ATTR-CM treatment landscape, bringing substantial survival benefits for patients with ATTR-CM,” said Jung-Woo Son, Professor of Cardiology at Wonju Severance Christian Hospital. “However, the drug is still not reimbursed in Korea, and patients are left unable to start treatment even after diagnosis.”
- Company
- Kim Sang-pyo, appointed as Moderna Korea's new GM
- by Eo, Yun-Ho Aug 01, 2024 05:47am
- Kim Sang-pyo, appointed as the new General Manager of Moderna Korea. Moderna Korea appointed Kim Sang-pyo, the former head of AstraZeneca Korea, as the new General Manager. Moderna announced the appointment of Kim Sang-pyo as the new General Manager, effective on August 1st. Kim will head Moderna's subsidiary in South Korea, succeeding Sohn Ji-young, who led the company's establishment in the Korean market and overall business operations since 2021. Kim stated, "South Korea is an important market for Moderna's global management strategy. I am deeply responsible for further strengthening Moderna's leadership in mRNA technology. Furthermore, I will realize Moderna's mission, which is to bring out the potential of mRNA medicines, and strive to contribute to the nation's healthcare." Kim is an expert who has accumulated experience and achievements working in the pharmaceutical industry for over 20 years. He has been the head of AstraZeneca from 2018 until recently, achieving the goals of promoting management efficiency and growth, maximizing new product launch opportunities, and developing global business projects, such as COVID-19 vaccine distribution. Before AstraZeneca, he held leadership positions in various domestic and global business sectors, including oncology general manager and business unit director at MSD. Kim led business growth and innovation, earning recognition for his role and leadership. Patrick Bergstedt, Senior Vice President of Asia and Emerging Markets at Moderna, said, "We welcome Kim's appointment as the new GM. With his extensive experience and deep insights into the healthcare industry, we look forward to having Kim lead Moderna Korea." Since its official launch in June 2021, Moderna Korea has contributed to overcoming the pandemic by introducing the COVID-19 vaccine to South Korea. The company has also established partnerships with the Korean government and research institutes and will use the mRNA platform technology to help solve various healthcare issues. This fall, Moderna Korea will supply updated COVID-19 vaccines in alliance with the government's plan to protect the nation from COVID-19 mutations.
