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- 2026-03-11 16:33:51
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- Reimb status of Keytruda for breast cancer treatment
- by Moon, sung-ho Feb 13, 2025 05:59am
- As Keytruda passed the Drug Reimbursement Evaluation Committee (DREC) review after another attempt, it is expected to be reimbursed within the first half of the year. According to the pharmaceutical industry on February 10, the Health Insurance Review and Assessment Service (HIRA) held the 2nd DREC for 2025 and approved reimbursement appropriateness for Gilead Sciences Korea's Trodelvy (sacituzumab govitecan). Product photos of Trodelvy and KeytrudaTrodelvy is an antibody-drug conjugate (ADC) that binds to Trop-2 protein, highly expressed in various cancer types, including breast cancer, and releases medication inside the tumor cells. It minimally affects healthy cells, and it can destroy not only tumor cells but also the tumor microenvironment (TME). Consequently, clinical practices in South Korea can now use the drug as a non-reimbursed treatment for triple-negative breast cancer (TNBC). However, using the drug without reimbursement costs over KRW 10 million per cycle (three weeks). Due to this cost burden, reimbursement is needed to improve patient access and more uses in clinical practices. Furthermore, Trodelvy is the only treatment approved by the MFDS as a second-line treatment for patients with metastatic TNBC, regardless of existing genetic mutation or biomarkers. Patients have high hopes for reimbursement of this medication. In response, the HIRA recognized the necessity of Trodelvy, which was reviewed for reimbursement appropriateness. HIRA stated that Trodelvy is the first case of a new drug being recognized for innovativeness. Last year, HIRA revised the details of the criteria for drugs submitted for negotiations and determined to offer new drugs a benefit from the government based on their ICER value. Innovative drugs are to meet the criteria of ▲If no products or therapy that can be replaced or have therapeutic equivalence ▲Final result index, such as overall survival extension, indicates significant clinical improvements ▲New drugs granted expedited review according to Article 35-4 Clause 2 of the Pharmaceutical Affairs Act or medicine determined to have equivalent value as determined by the committee. HIRA stated, "Trodelvy is the first case for which a revised system aimed at improving patient access to new drugs with innovativeness." Following this decision, Trodelvy is now closer to being reimbursed as the second new ADC drug, following Enhertu. If the company agrees to the drug price negotiations with the National Health Insurance Service (NHIS) without further issue, reimbursement can be applied within the first half of the year. Obtaining reimbursement will positively impact Gilead Sciences, which launched its oncology business division when launching Trodelvy in South Korea, to expand its presence in clinical practices. However, the status of Keytruda (pembrolizumab), used as a first-line treatment in combination with chemotherapy, is concerning as it remains non-reimbursed. Since Trodelvy is used as a second-line treatment, reimbursement approval of Keytruda is essential for use in clinical practices. MSD Korea has also applied for setting reimbursement criteria for Keytruda for up to 17 indications to treat cancers, including TNBC. Now, for metastatic TNBC treatments in clinical practices, chemotherapy, Keytruda or Tecentriq (atezolizumab) is used as first-line treatments, the PARP inhibitor Lynparza (olaparib) is used as a second-line treatment, and Trodevly is used after the second-line treatment. Professor Joohyuk Sohn at Yonsei Cancer Hospital (Department of Oncology) said, "Keytruda is not actually competing against Trodelvy. We hope reimbursement will be provided for drugs benefiting all patients." Sohn added, "Trodelvy extended the progression-free survival (PFS) by five months compared to chemotherapy. Five months is a significant time for patients. And, data indicate that patients who respond well to the treatment can extend up to 10-15 months, so the drug is clinically significant." Meanwhile, HIRA's DREC determined reimbursement appropriateness for Adempas (riociguat, Bayer Korea), a treatment for arterial pulmonary hypertension, in addition to Trodelvy during the second meeting. The committee determined that the plaque psoriasis treatment Bimzelx Autoinjector (bimekizumab, UCB Korea) and Ebglyss Autoinjector inj (lebrikizumab, Lily Korea) would be appropriate for expanded reimbursement scope if the companies accepted the drug price below the evaluated amount. Additionally, the committee determined that Cabometyx tab (cabozantinib, Ipsen Korea), a treatment for renal cell carcinoma (RCC), would be appropriate for expanded reimbursement scope if the company accepted the drug price below the evaluated amount.
- Company
- "Paradigm shift in follicular lymphoma treatment: CAR-T"
- by Whang, byung-woo Feb 13, 2025 05:58am
- "Although CAR-T cell therapy or bispecific antibody respectively offers an advantage for treating follicular lymphoma, CAR-T data demonstrating positive results over 10 years in 60% of patients indicate that it is an effective treatment option." As various treatment options are introduced to treat relapsed/refractory follicular lymphoma (FL) with a poor prognosis, how these treatments can be utilized is of great interest. In South Korea, Kymriah (tisagenlecleucel), which is known as the chief CAR-T therapy, was approved for expanded indications in 2023 to treat patients with relapsed/refractory FL who had previously undergone two or more treatments. After that, doctors are gaining treatment experiences with the drug. Dr. Stephen J. Schuster, Professor of the Department of Hematology/Oncology at the University of Pennsylvania Abramson Cancer CenterDuring a meeting with Daily Pharm, Dr. Stephen J. Schuster, Professor of the Department of Hematology/Oncology at the University of Pennsylvania Abramson Cancer Center, who has years of prescription experience in the United States, emphasized the necessity of CAR-T therapy for treating follicular lymphoma. Follicular lymphoma (hereafter, FL) is a type of non-Hodgkin Lymphoma (NHL) that occurs when cells in the lymph system turn malignant. Because the symptoms of the disease progress slowly, about 80% of the cases are identified at stage III or Stage IV after the disease progresses. The prognosis for patients who relapse is poor. Dr. Schuster said, "The prevalence of FL seems to be increasing in Asia." He added, "As FL progresses in various ways, clinical characteristics significantly vary by patient." Dr. Schuster explains that considering the characteristics of FL, characterized by low-risk disease cases and slow disease progression, most diseases can be managed through proactive treatments. The disease becomes problematic if a disease has a poor prognosis requiring more than one treatment due to relapses. According to Dr. Schuster, data from patients with FL who need more than one treatment indicate that the remission period shortens as patients repeatedly receive treatment. "About 20% of the patients with FL relapse after two years following the initial treatment. Even after further treatment, the remission period shortens, and patients have a poor prognosis, thereby needing strong treatments, including CAR-T cell therapy," Dr. Schuster said. "Despite increased overall survival, patients repeatedly need treatments, and the disease can become fatal, ultimately leading to death." There are several treatment options for FL, but Dr. Schuster highlights the clinical benefits of CAR-T cell therapy because CAR-T cell therapy does not require further treatment after the initial therapy. The clinical effect of Kymriah (tisagenlecleucel) has been proven through the ELARA clinical study regarding relapsed/refractory FL. The four-year long-term follow-up results of the study were presented at the American Society of Hematology (ASH) conference held in December 2024. The four-year long-term assessment results of the ELARA study (median follow-up period at 53 months) showed that patients with relapsed/refractory FL treated with Kymriah had consistent treatment response over 4 years and a favorable safety profile. The median progression-free survival (PFS) of all patients was 53.3 months. At 48 months, 50% PFS was reported in all patients, and 66% of patients were reported to have gained complete remission (CR). "The follow-up on patients who participated in the 2014 study has been about 10 years, and the data indicate that the overall response rate (ORR) is about 80%, similar to the recently presented ELARA clinical study result," Dr. Schuster said. "In contrast to FL requiring repeated blood tests, various scans, and drug administration for additional therapy, CAR-T cell therapy can lessen the physical and mental burden." Will the introduction of bispecific antibody change the treatment paradigm?..."CAR-T cell therapy's advantage" Kymriah received expanded indication in April 2023 in South Korea to treat FL, broadening treatment options. (모네투주맙)However, there are even more options available at clinical practices. For instance, the bispecific antibody Lunsumio (mosunetuzumab) has been introduced. Regarding this, Dr. Schuster acknowledges the role of bispecific antibodies but favors CAR-T cell therapy, which demonstrates positive long-term results over 10 years. "Each CAR-T cell therapy and bispecific antibody has an advantage, and there are no concrete answers to the treatment sequence. The CAR-T data demonstrating positive results over 10 years in 60% of patients is unbeatable," Dr. Schuster said. In particular, Dr. Schuster highlights that antigen can be easily lost during the treatment course of bispecific treatments, like MabThera or mosunetuzumab, that target CD20. "The biopsy results from patients treated with bispecific antibody drugs showed that 5.5-6% of patients had losses of CD20. However, CD19-targeting CAR-T cell therapy rarely led to losses of CD19," Dr. Schuster remarked. Dr. Schuster views that bispecific antibody drugs are important but may not replace CAR-T cell therapy. Long-term follow-up data on the remission period and response rate are needed for bispecific antibody treatment outcomes. Dr. Schuster mentions that drug tolerance is an advantage for Kymriah. The most common adverse event (AE) of CAR-T cell therapy is cytokine release syndrome (CRS). Kymriah has a relatively low AE rate and low severity. Dr. Schuster also emphasized, "In the past, there have been cases where FL patients received therapies repeatedly, but ultimately, the disease led to death. However, Kymriah offers a single treatment that can help maintain a remission state. It is also a cost-effective treatment option compared to previous therapies." Lastly, Dr. Schuster said, "Even if FL patients experience relapse after treatments, they may receive CAR-T cell therapy and maintain remission state for about 10 years, as well as having improved quality of life." He added, "Because an index for predicting survival varies by disease and disease shows characteristics, making a treatment choice through clinical follow-up assessment is important."
- Company
- Celltrion wins, Samsung loses Eylea patent trial
- by Kim, Jin-Gu Feb 13, 2025 05:58am
- Companies have seen mixed results regarding the preliminary injunction applications over the biosimilar version of the macular degeneration drug Eylea (aflibercept). While Samsung Bioepis lost the preliminary injunction application for patent infringement filed by Bayer, Celltrion won its case. The conflicting results have also led to conflicting reports on whether or not the Eylea biosimilar will be sold in Korea. Sales of Samsung Bioepis and Samil Pharmaceutical's Afilivu will be discontinued in Korea after the existing inventory. On the other hand, Celltrion and Kukje Pharm will be able to continue selling Eydenzelt as before. According to industry sources on the 12th, the Seoul Central District Court's 60th Civil Division recently reached conflicting conclusions in the preliminary injunction applications for patent infringement filed by Bayer and Regeneron against Samsung Bioepis and Celltrion. On July 30, 2019, Bayer filed a petition with the court for a preliminary injunction against Samsung Biologics, Samsung Bioepis, and Samil Pharmaceutical for infringement of the patent on the composition of Eylea along with Regeneron. On the same day, Bayer also filed a petition with the court for a preliminary injunction against Celltrion and Kukje Pharm. Their request was to discontinue sales of Samsung Bioepis and Celltrion’s Eyelea generics as they infringe on Eylea’s unlisted patents. On the 7th, the court made a decision. It decided to “acknowledge” Bayer's claims in the petition for a preliminary injunction against Samsung Bioepis. On the other hand, it decided to “dismiss” the petition for a preliminary injunction against Celltrion. The conflicting court decisions have rendered sales of the two companies biosimilars in Korea in opposite positions. Furthermore, Samil Pharmaceutical and Kukje Pharm, which have signed joint sales contracts with the two companies, are also experiencing mixed fortunes. Samsung Bioepis has been jointly selling Afilivu with Samil Pharmaceutical. Celltrion has been jointly selling Eydenzelt with Kukje Pharm. Due to the court’s decision, sales of Samsung Bioepis and Samil Pharmaceutical's Afilivu will be discontinued. Samsung Bioepis received approval for Afilivu in February last year and began joint sales with Samil Pharmaceutical in May. However, the company explained that the remaining stock can be prescribed to patients. “We will file an objection to the preliminary injunction,” said an official at Samsung Bioepis. ‘We cannot carry out any additional sales activities, but the stock that is already in circulation in the market can be prescribed to patients.’ On the other hand, Celltrion and Kukje’s Eydenzelt from Kukje Pharmaceutical can continue to be sold. Celltrion received approval for Eydenzelt in May last year. Kukje Pharm signed a joint sales agreement with Celltrion in April last year. It then began full-scale sales in September last year. The industry estimates that Samsung Bioepis and Samil Pharmaceutical, which launched their products one step ahead, have gained an advantage in the competition. However, the court's decision to grant a preliminary injunction is expected to accelerate the pace of the latecomers, Celltrion and Kukje Pharm’s product, in their pursuit.
- Company
- Officially launched Vantive Korea targets renal care market
- by Whang, byung-woo Feb 13, 2025 05:58am
- As Baxter's 'Renal Care and Acute Therapies Businesses' launches as an independent global company completes, it has begun officially operating under a new company name. Vantive LogoAccording to medical devices industry on February 5, a fund managed by global investment firm the Carlyle Group has completed the acquisition of Baxter International’s Renal Care business, finalizing the spin-off of the division. As a result, the 'Renal Care and Acute Therapies Businesses' newly launched as Vantive, a company specializing in Vital Organ Therapy. The decision to spin off the business aims to enhance agility in responding to rapidly evolving healthcare needs, establish more precise business strategies, and focus on innovation within each company's specialized division. Vantive has set its mission as 'Extending Life, Expanding Possibilities.' The company plans to set its business strategy based upon its 70-year legacy of pioneering innovations in renal care. As the company's spin-off is completed globally, the spin-off process has also been finalized in South Korea. While business registration updates remain completed, Baxter and Vantive have already been operating as separate entities. Before the launch of Vantive Korea, Baxter relocated its office to the Samil Building on Cheonggyecheon-ro last year. The move was a strategic decision to create a more efficient work environment in the heart of Cheonggyecheon. The global renal care market is currently valued at US$ 15 billion, with an anticipated annual growth rate of 3–4% over the next three years. As of 2021, the 'Renal Care and Acute Therapies Businesses,' which has now been spun off into Vantive, generated approximately US$ 5 billion (KRW 6.4895 trillion) in sales under Baxter, holding a significant share of the company's business. Based on the audit report, Baxter's sales for the past four years were reported to be ▲KRW 242.6 billion for 2020 ▲KRW 244.9 billion for 2021 ▲KRW 192.7 billion for 2022 ▲KRW 188.1 billion for 2023. During the same period, operating profits were reported as ▲KRW 11.9 billion for 2020 ▲KRW 12 billion in 2021 ▲KRW 5.8 billion in 2022 ▲KRW 5.6 billion in 2023. Baxter Korea Apart from the spinoff, the company already needed a turnaround opportunity to rebound its revenue. Following the separation, Vantive Korea is expected to focus on maintaining and expanding its domestic market presence. In December 2023, during a general meeting of shareholders, the company established Baxter Korea as a new entity through a corporate spinoff. As a result, Baxter Korea will now handle pharmaceutical imports and distribution, excluding the renal business. Vantive will remain the surviving company, responsible for all remaining business segments, including the renal care division. High hopes for Vantive Korea's future directions after a parallel company shift Vantive's 'Renal Care and Acute Therapies Businesses' aims to strengthen leadership in renal disease and vital organ therapy. Even regarding employee distribution, Vantive remains the primary entity after spinoff. According to Baxter Korea's 2023 audit report, the company had 267 employees. After the spinoff, Vantive Korea retained approximately 200 employees, while Baxter Korea downsized to about 50 employees. Based on its 70-year legacy, Vantive Korea plans to differentiate itself by integrating innovative technology and digital connectivity services. At the end of last year, before the launch of Vantive Korea, Baxter relocated its office to the Samil Building on Cheonggyecheon-ro. The move was a strategic decision to create a more efficient work environment in the heart of Cheonggyecheon. During announcing the company name Vantive, Lim Kwang-hyuk, CEO of Baxter Korea, said, "The renal care expertise accumulated over the past 70 years will be further expanded under Vantive. We will continue investing in innovative treatments and vital organ therapy to extend and improve patient lives." The company's logo also reflects its future strategy. The "V" in Vantive's logo is divided into three sections, representing innovative therapies, digital solutions, and advanced services. As peritoneal dialysis and home dialysis are encouraged, the 'digital patient management platform' is becoming increasingly significant. Vantive is expected to enhance its market share by integrating digital innovations into dialysis equipment. Kieran Gallagher, Chairman of Vantive's Board, said, "The launch of Vantive will be a significant milestone in the ongoing advancement of renal care and life-sustaining vital organ therapy. Vantive is committed to providing enhanced connectivity, visibility, and insights across the entire patient treatment journey."
- Company
- ‘Employees work long-term at Daiichi Sankyo for a reason'
- by Eo, Yun-Ho Feb 13, 2025 05:58am
- To survive and develop, we need to change and adapt to change. This is easy to say, but never easy to do. Daiichi Sankyo is a master of adaptation. The company has established itself in the domestic market by supplying drugs for chronic diseases, mainly cardiovascular diseases. Starting with hypertension drugs such as Olmetec, Sevikar, and Sevikar HCT, the company has launched the antiplatelet drug Effient and anticoagulant Lixiana and has achieved continuous growth by launching new leading products in crisis, such as patent expiry. Maybe it's the products, but it's also the strategy. The story of how Daiichi Sankyo stopped promoting its antibiotic Kravit independently when Olmetec’s patent expired and focused on its circulatory system pipeline through co-promotion with a Korean company is still much talked about. Now, Daiichi Sankyo is looking to take a new leap forward with its oncology business. Last year, Enhertu, an antibody-drug conjugate (ADC) that was listed for reimbursement in Korea, began to gain popularity in the anticancer field, supported by its excellent clinical results. With an average annual growth rate of 15% from 2014 to date, Dailypharm sought to learn more about the talents behind the company's growth. Daily Pharm met with Mr. Hyundong Ryu (50), Managing Director of Management Headquarters at Daiichi Sankyo to learn more about the people behind the company’s growth. Hyundong Ryu, Managing Director of Management Headquarters, Daiichi Sankyo Korea-Tell us about the company's organizational structure. What does the Management Headquarters do? Daiichi Sankyo Korea has 4 headquarters. The Primary Business Unit, responsible for chronic diseases and specialty drugs; the Oncology Business Unit, is responsible for anti-cancer drugs; the Development Medical Headquarters, which is responsible for clinical development, licensing, and follow-up; and the Business Management Headquarters, which is responsible for the overall management and operation of the company. I am currently in charge of the entire Business Management Headquarters, which includes human resources, general affairs, finance, distribution, IT, business planning, and external relations. -Daiichi Sankyo is very good at coming up with products that are needed at the time and achieving good results with those products. This cannot be done without the right “people.” Daiichi Sankyo is known for its job longevity, especially in the industry. What is the secret behind this? We have our own management philosophy and values with regard to human resources, on how to develop talent and treat them at Daiichi Sankyo. We don't just run a company for business, for sales, but for people to come together and work together. The mindset of not using people as tools is something that has been passed down as part of our culture. I think the sincerity of the management in valuing talent and caring to not make employees feel like they are being used as a tool is one of the important reasons behind our employees’ job longevity. -Regarding the new Oncology BU, it’s not easy to create a business unit that didn't exist before, get it up and running, and then have it drive the company's future strategy. What did you focus on and what difficulties did you face in creating the Oncology BU? When you create a new business unit (BU), you're bringing in new people, and the success of the business depends on them. We've been through this process twice in the past where new people come in, intertwine with existing employees, and grow. The company has learned from these experiences how to integrate and resolve cultural conflicts that can arise when bringing in new businesses and bringing in a lot of new talent. We believe that it is best to provide as many opportunities for communication as possible to help people understand the value of the organization's values of 'together' and 'togetherness' rather than trying to artificially seal conflicts. #SB-You seem to have a good internal mindset to deal with change. What does Daiichi Sankyo look for in its employees? Daiichi Sankyo Korea has created new business units and recruited new talents, so in Korea, since the 2020s, we have emphasized and valued “Collaborate & Trust” the most. We don't look at a candidate's experience or specifications but rather how they want to contribute to our organization. For example, we try to select candidates who value work and take responsibility for their work, rather than candidates who emphasize the resonance of “I did it” or “I am the best” or those who want to prioritize their career path. - Interest in multinational pharmaceutical companies has been rising these days. There aren't many new hires at each company, but in the overall framework of multinational companies, this seems to be happening to some extent. Does Daiichi Sankyo have any procedures or requirements for hiring new employees? We hire new employees on a case-by-case basis. It's not a regular program, but we have an intern program that has been up and running for more than 10 years. We hire people who have a good work attitude and understand the value of “working together” as marketing representatives (MRs). We don't look for any specific qualifications. Unless we need a pharmacy professional, we look for a 4-year graduate with some language level, etc., and their attitude towards work and contribution to the team and organization's goals is important. -What programs do you offer to foster talent after they join the company? In terms of fostering talent, the company has a systemic roadmap in place for overall talent growth and support. When you first join the company, we spend 2-3 days training you on the company's systems and other things you need to learn. At the one-year mark, we have a week-long training session at a separate location with other new hires and experienced employees. This is called the first-year onboarding training, which focuses on improving your understanding of the company's mission, values, and culture. In the second year, we hold a reminder training (vision training) where employees reflect on the goals and visions they set in the first year and what they want to achieve within the company. In the third year, you go to the headquarters in Japan for a week of training. When it comes to work-level job training, some parts cannot be fully covered in-house, so we offer training support without a specific budget limit for all training needs. Individuals can request individualized competency training, which they discuss with their manager and then receive support from the company. At the manager level, we offer an annual 360-degree, multi-faceted assessment to identify strengths and weaknesses and provide one-on-one coaching on how to overcome them. Key talent, such as potential next-generation leaders, is developed separately by HR. For example, we support MBA and pharmacy-related graduate programs. There is also a program called STDP (Short-Term Development Program) to help employees gain a global perspective. This program is mainly offered at our Japanese headquarters but has recently been expanded to include offices in the ASCA region (Asia and South America). -Is there a system in place that encourages employees to move between departments? Many programs in the pharmaceutical industry allow people to experience different roles. We have a very active job posting program. When we have a vacancy, we encourage job posting, preferably among existing employees. It is difficult to verify the potential and capabilities of people who have specialized experience from outside the company. On the other hand, we have expectations that people with sufficient internal potential can perform well if they are given time to develop their careers, and this has proven to be true in many cases. -How are employees and executives evaluated? We perform two main types of evaluations: Performance Evaluation and Competency Evaluation. First, in performance evaluation, the basic framework is performance-based relative evaluation for sales and absolute evaluation for internal employees. However, for both sales and internal employees, we make sure that the attitude and effort in the process of performance are fully reflected, not just the arithmetic results. After setting goals, we conduct feedback interviews about four times a year. Midterm feedback is used to correct the direction and track the process of achieving goals. -I'm also curious about the company’s reward system such as incentives. There are two types of performance pay: individual performance pay and management performance pay. Individual performance pay is based on the achievement of individual or team goals. For the base salary, many multinational companies adopt the merit increase system and set the increase rate according to performance, but Daiichi Sankyo does not differentiate the base salary increase rate by performance. We set the same base salary increase for all employees, reflecting the inflation rate of the previous year, and top it up with a performance bonus based on the performance of the organization. This is because cross-functional collaboration between teams and departments is of utmost importance. -Do you have annual longevity awards in addition to incentives? There are 5-yearly awards for 10, 15, 20, and 25 years of service. No one has reached 30 years of service yet, but there will be rewards when they do. For 10 years of service, you get a 10-day sabbatical. It's a valuable reward for contributing to the growth and development of the company over a long period of time, and in fact, long-term service is not uncommon in our company compared to other foreign companies. - The slogan “Cooperation” seems to be at the core of the company's foundation. That's right. At Daiichi Sankyo, individual achievement is important, but the performance of the underlying organization is also important, and this permeates the entire company as a corporate culture. The company takes its time and encourages individuals to develop their capabilities over time. The company focuses on “steadiness” rather than chasing short-term goals. We are creating a corporate culture where each person is not engrossed in their own role but rather has a company-wide perspective, that naturally leads to cooperation and trust.
- Company
- Will 'Verzenio' be reimb for early breast cancer in 2025?
- by Eo, Yun-Ho Feb 12, 2025 06:13am
- Product photo of Verzenio The industry eyes whether 'Verzenio,' with expanding reimbursement challenges, will obtain results this year. According to sources, Lilly Korea's CDK4/6 inhibitor Verzenio (abemaciclib) is expected to be considered for the upcoming Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) for its indication for early breast cancer. Verzenio faced challenges in the first attempt at the CDRC review for its indication to treat early breast cancer. Despite submitting the application and waiting for six months, Verzenio was presented to the committee in May 2023, but the result was 'reimbursement standards non-established.' After five months, Verzenio re-submitted its reimbursement application to the HIRA in October. Then, the drug was considered for the CDRC, but the result was the same as before. Patients have high hopes for reimbursement approval of Verzenio for early breast cancer. In fact, the public petition yielded over 50,000 votes. The efficacy of the drug was demonstrated again through the five-year outcomes from the monarchE study, which was presented at the 2023 European Society for Medical Oncology (ESMO) Congress. The data used for the follow-up research were based on the four-year data presented at the 2022 San Antonio Breast Cancer Symposium held in December and an article published in The Lancet Oncology. The primary endpoints, which were invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), showed clinically significant differences between the Verzenio treatment group and the control group (endocrine therapy alone) that was even more pronounced in five-year data compared to the four-year data. In year 5, the primary endpoint invasive disease-free survival (IDFS) demonstrated an approximately 8% difference. Verzenio appears to have a potential carry-over effect through the fifth year, even after completing the two-year treatment period. Besides the endocrine therapy letrozole generic, Verzenio is the only treatment option available in HR+/HER2- type early-stage breast cancer. On November 18, 2022, Verzenio was approved for expanded use in combination with endocrine therapy in the adjuvant treatment of patients with HR+/HER2- high-risk early-stage breast cancer and who have lymph node-positive recurrence. The following are specific indications: ▲Four or more lymph node metastases, ▲1-3 lymph node metastases with a tumor size of 5 cm or larger, ▲Histological grade 3 limited recurrent high-risk patients. Professor Keun Seok Lee, Professor at National Cancer Center's Center for Breast Cancer Korea, said, "The use of Verzenio in combination with endocrine therapy is recommended by the Korean and international chief guidelines as a post-surgical adjuvant therapy for relapsed and high-risk patients, based on significant evidence. Since the drug's clinical usefulness has been confirmed through clinical studies and chief academic reviews, we need improvements to patient treatment access through reimbursement to increase the survivability of patients who qualify as relapsed and high-risk conditions."
- Company
- 'Lorviqua' accepts DREC condition…negotiations to start
- by Eo, Yun-Ho Feb 11, 2025 06:02am
- Product photo to Lorviqua The final review process is about to begin for expanded reimbursement of the non-small cell lunger cancer treatment 'Lorviqua' as a first-line treatment. According to industry sources, Pfizer Korea accepted the condition of 'accepting the drug price below the evaluated amount' suggested by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) in January regarding the ALK anticancer drug, Lorviqua (lorlatinib). The company will soon undergo drug price negotiations with the National Health Insurance Service (NHIS). The Ministry of Health and Welfare (MOHW) has recently issued a green light for negotiations, and they will begin the process this month. As the company terminated the Risk Sharing Agreement (RSA) for Lorviqua, switching it to general medicine reimbursement, it is proceeding with the expanded reimbursement for first-line treatment. After the breakdown of the drug price negotiations with the NHIS in June, Pfizer immediately filed for general medicine reimbursement, which passed the last HIRA's DREC for 2024. Even after reapplication, the reimbursement process has been slow. Analysis suggests that the government postponed the decision because Lorviqua was initially contracted as a total expenditure-capped RSA, then switched to a general medicine reimbursement. The industry is to closely watch whether Lorviqua will finish the drug price negotiations without additional hurdles and obtain expanded reimbursement. Meanwhile, Lorviqua is a drug developed to penetrate the blood-brain barrier (BBB). The clinical value of the drug has been assessed as significant based on the long-term follow-up results of the CROWN study, which was recently presented at the ASCO. The study results showed that Lorviqua reduced the disease progression and death risk by 81% compared to crizotinib, and 60% of treated patients were alive without disease progression after five years. The risk of brain metastasis was reduced in 94% of the treated patients, with only 4 out of 114 patients who did not previously had brain metastasis developing it after being treated with Lorviqua.
- Company
- Mitsubishi Tanabe Pharma sold to private equity fund
- by Whang, byung-woo Feb 11, 2025 06:02am
- The sale of Japanese pharmaceutical company Mitsubishi Tanabe Pharma to a global private equity firm is expected to bring changes to its Korean branch as well. Although the company is being sold, it is not being sold by business unit, so its effect on the overall market is expected to be small. Rather, the sales are expected to increase support for the company and add strength to its market expansion activities. According to industry sources on the 11th, global private equity firm Bain Capital signed an agreement with Mitsubishi Chemical, the parent company of Mitsubishi Tanabe Pharma, to acquire Mitsubishi Tanabe Pharma. The transaction is valued at approximately ¥510 billion (KRW 4.9 trillion) and will be in a carve-out transaction from its parent Mitsubishi Chemical Group. Carve-out deals typically involve a company evaluating and selling off a specific business unit to raise capital and improve operational efficiency. This involves creating a structure that allows the business unit to operate independently and then selling it off. The advantage for investors is that a standalone business unit has greater growth potential and offers the opportunity to become more competitive in the market. In fact, this transaction was reportedly decided by parent company Mitsubishi Chemical Group to improve management efficiency and focus on its core business. Mitsubishi Chemical Group decided to exit its pharmaceuticals division as part of a reorganization of its business portfolio due to deteriorating profitability in recent years. As the pharmaceutical division requires long-term investment due to its high research and development (R&D) costs, the group has reportedly decided to prioritize and focus on its core chemicals business. Mitsubishi Tanabe Pharma has garnered attention for its successful sales of ALS drug Radicava in the U.S. market, but the limited exclusivity period in the U.S. until 2029 has raised concerns about the company’s long-term growth. As a result, the company needed new investments and strategies to develop additional new drugs and expand its global reach. However, there are predictions that the acquisition will not drive major change as it is not a spin-off. Instead, the company’s focus will be on market expansion as a standalone company. In this regard, Bain Capital has stated that it will acquire Mitsubishi Tanabe Pharma and strengthen the company's R&D capabilities, and support its global market expansion strategy. “We will actively support Mitsubishi Tanabe Pharma to continue its innovation as an independent company and explore new growth opportunities,” said Bain Capital. However, the sale is expected to have some impact on the Korean market. Mitsubishi Tanabe Pharma Korea has been supplying various treatments in Korea and generated about KRW 70 billion in sales last year. Pic of Uplizna The company took active steps last year to secure new growth engines, such as starting the domestic marketing authorization process for the ALS (Amyotrophic Lateral Sclerosis) drug Radicava (edaravone) and initiating the insurance reimbursement process for the optic neuromyelitis drug Uprisna. However, the sale may result in adjustments to its product supply schedule and new drug launch strategy in Korea. Bain Capital and Mitsubishi Chemical plan to finalize the process in the third quarter. Even if Mitsubishi Tanabe Pharma Korea’s business remains intact, there is a possibility of delays in approval and reimbursement discussions, given the administrative procedures. “All the details that were shared internally, including the sales of the business division, were not much different from the global announcement. So although the company’s name will change, I don't think there will be any major changes,” said an industry official. He added, “However, as Bain Capital has expressed its intention to make aggressive investments in the pharmaceutical division, which has been suffering due to funding difficulties of its parent company, there are some positive expectations as well."
- Company
- OliX licenses out RNA-based MASH drug technology to Lilly
- by Feb 10, 2025 05:50am
- OliX, a company developing RNA-based new drugs, has transferred its metabolic dysfunction-associated steatohepatitis (MASH) and obesity drug candidate to the multinational pharmaceutical company Eli Lilly. On the 7th, OliX announced that it had signed a joint development and technology export agreement with Lilly for its MASH and obesity drug candidate 'OLX75016 (OLX702A)'. The total contract size is USD 630 million (about KRW 911.7 billion). The amount is the sum of the upfront payment and the development and commercialization milestones based on clinical progress. Details such as the proportion of the upfront payment were not disclosed. Under the agreement, OliX will continue with the Phase 1 clinical trial of OLX75016. Lilly will be responsible for other research, development, and commercialization. The agreement includes a provision that, upon signing, OliX will grant an exclusive license to Lilly. Specifically, if OliX develops a treatment that targets the 'MARC1' gene and one or more other genes involved in MASH simultaneously, Lilly will have priority rights to that treatment. The company explained that the total size of the contract could increase or exclusive negotiations could be conducted according to the clinical progress. OLX75016 is a candidate for the treatment of obesity and MASH, which is based on double-stranded small interfering RNAs (siRNA) technology. OLX702A is being developed as a subcutaneous injection formulation for the treatment of obesity that is administered once every 3 months. Results of OLX702A in obese animal model (Source: OliX) OliX is currently conducting a Phase I trial in Australia for OLX75016. It began administering the first patient for the Phase I trial in February last year. In May of the same year, it completed a change in the clinical trial protocol to add patients with nonalcoholic fatty liver disease (NAFLD) to the trial subjects to ensure safety and preliminary efficacy. The company aims to complete the first phase of clinical trials this year. OliX previously confirmed the effects of OLX702A on improving fatty liver and liver fibrosis and weight loss in preclinical studies. OliX also confirmed the weight loss synergistic effect when OLX702A in combination with Lilly's ‘Zepbound’ in a high-fat diet obesity mouse model. Zepbound is a dual agonist that simultaneously activates the glucagon-like peptide-1 (GLP-1) receptor and the Glucose-dependent insulinotropic polypeptide (GIP) receptor.
- Company
- Bayer Korea marks 70th year, preparing for 100-yr milestone
- by Whang, byung-woo Feb 10, 2025 05:50am
- Bayer Korea, celebrating its 70th year in business in the Korean market, is preparing for the next leap toward the 100th year. The company plans to enhance the capacity of treatments already launched in the market and its new growth driver pipeline, aiming for long-term and continuous business growth. Additionally, as the importance of the ESG business has been stressed, the company pursues sustainable business by setting specific directions. Bayer launched in South Korea after the Korean war…Bayer known for Aspirin Bayer Korea, the South Korean subsidiary of the global life sciences company Bayer, entered the Korean market in 1955, starting with its crop protection business. In the 1950s, during the post-Korean War period when food shortages were severe, Bayer Korea collaborated with Dongbu Farm Hannong (previously, Korean Agricultural Association) to enhance agricultural productivity. The company’s primary focus was providing various crop protection products to improve crop yields. In the 1960s, Bayer products began manufacturing in South Korea through a technology partnership with Hanil Pharmaceutical. This period marks the introduction of Bayer products into the Korean market. The representative product at the time was aspirin, a widely used pain reliever with over 120 years of history. Historical records also indicate that Bayer contraceptives were distributed to public health centers in South Korea. Bayer's full-scale business expansion took place in 1972 with the establishment of Bayer Pharmaceuticals Korea. The company acquired 30 locally produced products from Hanil Pharmaceutical, including Bayer Aspirin, extending its business into the healthcare sector. In 1989, Bayer Korea was officially established as a corporation. Entering the 2000s, the company expanded its portfolio through successive mergers and acquisitions, including Aventis CropScience, Roche's OTC division, Schering Korea, MSD Consumer Care, and Monsanto. These acquisitions solidified Bayer Korea's position as a leading global life sciences company with a broader and more advanced product lineup. Bayer As of February 2025, Bayer Korea holds a total of 62 pharmaceutical products, including prescription and over-the-counter (OTC) medications. One of Bayer Korea's key products in recent years is Eylea (aflibercept), a treatment for age-related macular degeneration (AMD). In 2023, Eylea is a blockbuster medication that generated KRW 96.8 billion in sales in South Korea. However, the company faces increasing competition from next-generation therapies and biosimilars that challenge Eylea's market dominance. Expanding sales growth remains one of Bayer Korea's concerns. Based on the company report, Bayer's sales for the past four years amounted to ▲ KRW 332.6 billion in 2020 ▲ KRW 340.1 billion in 2021 ▲KRW 358.0 billion in 2022 ▲ KRW 347.6 billion in 2023. Bayer Korea entered the Korean market in 1955 and its current corporation was established in 1989 Bayer in need of a new growth driver…prepares for a new generation of pharmaceuticals As the pharmaceutical landscape continues to evolve rapidly, Bayer has been transitioning into a more agile organization since last year to adapt to environmental changes quickly. An agile organization breaks down departmental barriers, forming multifunctional teams integrating marketing·sales·operations within the same division. This structure enables greater flexibility and responsiveness to meet the demands of a fast-changing market environment. A Bayer Korea representative said, "Bayer Korea has been focusing on strengthening the foundation for collaboration among employees to build a better future together." One of the most significant changes for Bayer Korea is the appointment of JinA Lee as the company’s first Korean CEO since its entry into the Korean market. Lee's appointment highlights the increasing importance of the Korean market and its strong R&D ecosystem, including early- and late-stage clinical trials and real-world data (RWD) studies. Bayer Korea A notable achievement under Lee's leadership is Kerendia, ranked second in outpatient prescription sales among products that received reimbursement in 2024, making a strong debut in its first year as a reimbursed drug. Additionally, high-dose Eylea (8mg), which extends dosing intervals to 20 weeks, entered the reimbursement list earlier than expected in October last year, helping Bayer maintain its influence in the retinal disease market. Also, Verquvo, a heart failure treatment, is established as part of a new generation of therapies, securing Bayer's future growth. This year, Bayer Korea plans to address unmet medical needs in the Korean market and improve patient access to innovative drugs, such as Nubeqa, which has strong market potential. A Bayer Korea representative stated, "In the healthcare sector, Bayer is committed to delivering innovative products and services through research and development that spans disease diagnosis to prevention and treatment. We are strengthening our expertise in cardiovascular, renal, and oncology treatments while expanding into new therapeutic areas with novel treatment options to ensure continuous growth." Bayer Korea aims for the next leap, focusing on 'sustainable mangagement' Bayer Korea, as it celebrates its 70th anniversary, focuses on 'sustainability' for long-term success. In addition to corporate social responsibility activities, the company is committed to sustainable organizational growth, driven by employee-led campaigns. According to Bayer Korea’s report released in December, the company is actively engaged in activities aligned with its four sustainable development goals: ▲Ending hunger ▲Healthcare ▲Climate change response ▲Gender equality and diversity. For instance, the company pursues hunger relief efforts through a partnership with World Vision, supporting underprivileged children through the "Love Lunchbox" volunteer program. This initiative has been expanded into a year-long challenge, where a team of seven employees participates monthly in preparing meal ingredients, cooking, packaging, and cleaning up. Bayer Korea Additionally, volunteer activities such as an art contest for individuals with developmental disabilities, the Unity Marathon with visually impaired participants, and the Proper Disposal of Expired Medicines Campaign were conducted last year. Lee stated, "Bayer Korea's sustainability report holds the greatest significance not in the scale of its outcomes but in our employees' voluntary and active participation. Through this initiative, we have collectively shared Bayer's vision and goals across the company, systematically organized our achievements, and laid the groundwork for developing more advanced strategies in the future." Lee added, "Bayer Korea is undergoing a transitional phase as we introduce a new generation of pipeline products. We aim to successfully establish these new treatments in the market to improve patients' lives while building a strong foundation to develop further innovative therapies."
