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- 2025-12-22 15:15:14
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- 20-valent pneumococcal conjugate vaccine to enter market
- by Whang, byung-woo Nov 08, 2024 05:47am
- The pneumococcal vaccine market, which has shifted with the introduction of a 15-valent vaccine this year, is expected to again face fierce competition with the approval of a new 20-valent vaccine. Pfizer, which is about to launch a new product, plans to replace the share of its existing product, Prevenar 13 with its new product, Prevenar 20. In the process, MSD, which has been gaining market share since the launch of Vaxneuvance, will also be facing increasing challenges to secure its sales. (From the left) Product photos of Vaxneuvance and Prevenar 20 According to industry sources on the 7th, the Ministry of Food and Drug Safety recently approved Pfizer's ‘Prevenar 20 Prefilled Syringe' (Prevenar 20). Prevenar 20 is Pfizer's first new pneumococcal vaccine in 14 years, which adds 7 serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F) to the existing Prevenar 13 vaccine. It can be used to vaccinate infants, children, and adolescents aged 6 weeks to 18 years and adults aged 18 years and older. Prevenar 20 is expected to be released in the first half of next year, given that Vaxneuvance was approved a year ago on Oct. 31, 2023, and then released to market in April the following year. A Pfizer spokesperson said, “We are currently working with multiple stakeholders to expedite all processes to accelerate the launch of Prevenar 20. We will share more details as soon as we have a specific launch timeline.” Prevenar 13 was sold in partnership with Chong Kun Dang for adults and Korea Vaccine for pediatric use. Industry insiders believe that these two companies will have priority in discussing the distribution of Prevenar 20. If there is one variable in terms of timing, its entry into the National Immunization Program (NIP) would likely be the variable. Currently, pediatric pneumococcal vaccines are included in the NIP, and both Prevenar 13 and Vaxneuvance are available through the program. Last year, Vaxneuvance passed the Korea Disease Control and Prevention Agency’s Korea Expert Committee on Immunization Practices within a month of its approval, expanding its market influence by applying the pediatric NIP upon its launch. In fact, Jae-Yong Cho, executive director of vaccine business at MSD Korea, said at a recent media seminar that “Both the initial vaccination cases using Vaxneuvance for infants and young children under the NIP, as well as cross-dosing cases where subjects are switching from the existing 13-valent vaccine to Vaxneuvance, have been increasing.” Pfizer is also reportedly in discussions with the KDCA about applying pediatric NIP to Prevenar 20 to gain competitiveness. “Pediatric pneumococcal vaccination covered by the NIP, so Pfizer has no choice but to enter the NIP to make Prevenar 20 competitive,” said a vaccine industry insider. ”We understand that they are currently in discussions with the KDCA, but whether the drug will be included in the NIP will depend on how Pfizer sets the price.” The industry's view is that if the discussions between the KCDA and Pfizer go smoothly, it could lead to a quick launch, but if there is a big disagreement on the price, the pharmacoeconomic evaluation process will be inevitable, changing Pfizer's prompt introduction strategy. Prevenar 13 and Vaxneuvance compete in clinics in Korea “We are making our best efforts to promptly introduce Prevenar 20 into the National Immunization Program. We are working closely with relevant departments to prepare the necessary procedures,” said a Pfizer representative. Apart from the pediatric NIP entry, pricing is also expected to be a key issue in the adult market, as a non-reimbursed launch is certain in the area. In the current market, Vaxneuvance is only slightly more than Prevenar 13. The successor to Prevenar 13, Prevenar 20, is expected to be a little more expensive. Upon its launch, the company had been running TV commercials to build brand awareness for Vaxneuvance. The company has also been emphasizing immunogenicity, which is as important to the vaccine's effectiveness as the scope of protection.
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- Optivo's clinical results for Koreans with gastric cancer
- by Son, Hyung Min Nov 08, 2024 05:47am
- Product photo of the immunotherapy Optivo. Optivo, an immunotherapy used to treat certain types of cancer, showed a positive result in gastric cancer clinical trials that involved Koreans. The study demonstrated a 47% reduction in the disease progression and death risk compared to conventional therapies. According to industry sources on November 6th, Bristol Myers Squibb (BMS) and Ono Pharmaceutical have recently presented the subgroup analysis results from Phase 3 'ATTRACTION-4,' evaluating Optivo as a treatment for East Asian patients. The clinical trial involved 724 patients with HER2-negative gastric cancer, including 291 Korean patients. The study evaluated Optivo in combination with platinum-based chemotherapy as a first-line treatment for patients compared to a combination therapy of placebo plus platinum-based chemotherapy. Based on the clinical result, Optivo combination therapy's benefit of improving progression-free survival (PFS) was prominent in the Korean patient group compared to those from other countries. In detail, the Korean subgroup's median PFS was 14.8 months for Optivo combination therapy and 8.3 months for placebo, showing 47% lower disease progression and death risk with Optivo combination therapy. The objective response rate (ORR) was 54.7% for the Optivo combination therapy group, which was higher than the placebo group's. The median duration of response (DOR) was 16.0 months for the Optivo combination therapy group, which was longer than the 9.9 months for the placebo group. In the total patient group, about 80% of the patients who showed complete response (CR) in the Optivo combination therapy group survived over three years. New safety-related adverse reactions associated with Optivo combination therapy had not been reported. In a retrospective clinical analysis conducted in Asan Medical Center involving patients with advanced gastric cancer who also have advanced deficient mismatch repair (dMMR), patients treated with Optivo combination therapy had a 12-month PFS of 69.4%, which was longer than 20.6% for the placebo group. "The subgroup analysis from the ATTRACTION-4 study, which enrolled many Koreans, showed that Optivo combination therapy yielded positive data during about three years of follow-up. This study results support the treatment effects of Optivo combination therapy, currently listed as a reimbursable first-line treatment for HER2-negative advanced or metastatic gastric cancer," Hyung-Don Kim, a Professor of the Department of Oncology at Asan Medical Center in Seoul, said. Optivo is the only reimbursable drug among immunotherapies…has been established as a standard therapy In South Korea, Optivo was approved in June 2021 as a first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma. It was listed for reimbursement last year. The average OS was below 1 year for HER2-negative patients, about 80% of advanced·metastatic cancer, who received conventional chemotherapy as a first-line treatment. Compared to immunotherapy for cancer, several targeted therapies used in clinical trials as a first-line treatment had not shown significant clinical benefits. The treatment practices for HER2-negative advanced gastric cancer started to change following the introduction of a treatment strategy of using an immunotherapy agent in combination with conventional chemotherapy. Optivo is now established as a standard therapy after becoming the first immunotherapy to win approval for the indication to treat advanced·metastatic gastric cancer as a first-line treatment in combination with chemotherapy. The basis for Optivo combination therapy used as a first-line treatment of advanced gastric cancer was the Phase 3 CheckMate-649 study, which showed relatively high ORR and longer DRR compared to single chemotherapy in all patient groups, including patients with below PD-L1 CPS 5. Such treatment benefits were repeated in the fourth-year follow-up results presented at the ASCO Gastrointestinal (GI) Cancers Symposium (ASCO GI), held in January. The clinical results showed that the Optivo combination therapy group's below CPS 5 patient group had an ORR of 55%. Optivo combination therapy provided an OS benefit for the patient group accompanying microsatellite instability-high (MSI-H) regardless of the PD-L1 expression rate. "Gastric cancer is a type of cancer with the highest prevalence in South Korea, but Korean patients faced difficulties because of limited treatment option availability," Professor Kim said. "As Optivo combination therapy has demonstrated OS extension in HER2-negative gastric cancer as the first first-line combination therapy, it is meaningful because it provides a treatment option with long-term survival goal." "With reimbursement listing, many patients could benefit from Optivo combination therapy over a year. It might have brought positive changes to the survival rate of advanced or metastatic gastric cancer," Professor Kim added.
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- Geo-Young and UBC Korea sign MOU to distribute Bimzelx
- by Son, Hyung Min Nov 08, 2024 05:47am
- (from the left) Sujin Hwang, General Manager of UBC Pharm, Sun-Hae Cho, Chairwoman of Geo-Young. Geo-Young announced today that it has signed a Memorandum of Understanding with UBC Korea to distribute Bimzelx. Under the agreement, Geo-Young will carry out the entire distribution process from storage to supply of Bimzelx. Bimzelx is a treatment for plaque psoriasis that simultaneously and directly targets and inhibits interleukin 17A and 17F (IL-17A·IL-17F), protein immunomodulators that drive inflammation in psoriatic disease. On August 29, Bimzelx the Ministry of Food and Drug Safety approved Bimzelx as a treatment for adult patients with moderate-to-severe psoriasis who require phototherapy or systemic therapy. Through this distribution agreement, Geo-Young plans to commit itself to ensuring a stable supply of Bimzelx in Korea. In multiple clinical trials, including in South Korea, Bimzelx demonstrated higher levels of Psoriasis Area and Severity Index (PASI) 100 achievement rates than existing biologics. PASI, which stands for Psoriasis Area and Severity Index, is a key efficacy endpoint for psoriasis treatments, and Bimzelx’s PASI 100 achievement rate was maintained at a high level for three years in an open-label extension study. “As the leading drug distributor in Korea, we will do our best to provide prompt and accurate supply of Bimzelx and contribute to the treatment of psoriasis patients,” said Sun-Hae Cho, Chairwoman of Geo-Young. ”We will continue to take initiative in improving public health through the active distribution of excellent medicines.” “We are very pleased to take the first step towards the launch of Bimzelx with Geo-young, following the approval of Bimzelx by the MFDS in August,” said Sujin Hwang, General Manager of UBC Pharm. ”We hope that the stable supply of Bimzelx will help many psoriasis patients in Korea experience the therapeutic benefits of Bimzelx.”
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- Novo Nordisk tops KRW 14T in sales, thanks to Wegovy
- by Whang, byung-woo Nov 08, 2024 05:46am
- Novo Nordisk has recorded a strong sales performance in Q3, driven by the steady growth of its major products, including Wegovy and Ozempic. According to Novo Nordisk's business reports on November 6th (local time), they recorded US$10.267 billion (KRW 14.3378 trillion) in Q3 sales, up 21% from the previous year. Its operating profit amounted to US$4.877 billion (KRW 6.8112 trillion), up 26% from 2023, and it recorded US$3.9325 billion (KRW 5.4921 trillion) in net revenues, up 21% from 2023. By region, the sales rose by 22% to US$3.85297 billion (KRW 5.4861) in the North American market and by 21% to US$2.59707 billion (KRW 3.6275 trillion) in the global market, excluding the North American market. It recorded cumulative sales of US$29.483 billion (KRW 41.1818 trillion) up to Q3 2024. Sales growth of 23-27% and an operating profit increase of 21-27% for the fiscal year 2024 are forecasted. The company analyzed increased sales across the entire portfolio contributed positively to the sales growth in Q3. By products, entire GLP-1 agents recorded sales of US$446.59 million (KRW 623.5 billion), up 14%. Among these, GLP-1 drugs for obesity showed a growth rate of 55%, and GLP-1 drugs diabetes showed a growth rate of 15%. During the same period, rare disease treatments and insulin agents recorded sales growth of 17% (KRW 577.7 billion) and 10% (KRW 1.5805 trillion), respectively. Also, its key product Wegovy (semaglutide), an obesity drug, generated US$2.4997 billion (KRW 3.49 trillion), which rose 79% from US$873 million (KRW 1.2194 trillion) from year-over-year (YoY). The diabetes drug Ozempic generated sales of US$7.82581 billion (KRW 10.9287 trillion) in Q3, up 32% YoY. In contrast, Saxenda (liraglutide), an obesity drug, recorded sales of US$135.45 million (KRW 189.1 billion), down 43% YoY, due to Wegovy's success. Victoza, a diabetes drug, also recorded a negative growth of -41%. "We have achieved significant sales growth due to the rising demand for GLP-1 treatment targeting diabetes and obesity," Lars Fruergaard Jørgensen, CEO of Novo Nordisk, said. Meanwhile, Novo Nordisk announced they have confirmed Wegovy's effect in patients with metabolic dysfunction-associated steatohepatitis (MASH) through the latest ESSENCE study. Based on these clinical trial results, the company will file for approval from the United States and EU in the first half of 2025.
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- Oral psoriasis drug 'Sotyktu' lands at Big 5 hospitals
- by Son, Hyung Min Nov 08, 2024 05:46am
- Product photo of Oral psoriasis drug 'Sotyktu' is now available for prescription at tertiary general hospitals. According to industry sources, BMS Korea’s TYK2 inhibitor, Sotyktu (deucravacitinib), has passed the drug committees of the 'Big 5' tertiary hospitals, including Samsung Medical Center, Seoul University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. Prescription code is also available in major hospitals nationwide, including Gangnam Severance Hospital, Konyang University Hospital, Soonchunghyang University Bucheon Hospital, Seoul National University Bundang Hospital, Soonchunghyang University Hospital Seoul, Ewha Womans University Medical Center, Chosun University Hospital, and Soonchunghyang University Cheonan Hospital. Since being added to the reimbursement list in April, this drug is increasingly available in hospitals. Sotyktu is the first TYK2 inhibitor approved for adults with moderate-to-severe plaque psoriasis. It was approved in August 2023 in South Korea to treat adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy. The insurance coverage was made available eight months after receiving approval. It is covered by insurance reimbursement for the treatment of patients over 18 with chronic severe plaque psoriasis who have symptoms lasting over six months. Coverage requirements include ▲Plaque psoriasis with over 10% of the total skin areas ▲Patients who have Psoriasis Area and Severity Index (PASI) score of over 10 ▲Patients who have undergone methotrexate or cyclosporine for over 3 months but cannot continue the treatment due to no response or side effects ▲Patients who have undergone light therapy or UPV photo therapy for over 3 months but cannot continue the treatment due to no response or side effects. Clinical efficacy of Sotyktu was demonstrated in Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical studies, which compared the drug with placebo or Otezla in 1,684 adult patients 18 years or above with plaque psoriasis. POETYK PSO-1 studies have shown that the Sotyktu treatment group had a PASI 75 response rate of 58.4% at week 16, which was significantly higher than the apremilast group's 35.1% and the placebo group's 12.7%. Furthermore, 53.6% of the Sotyktu treatment group achieved sPGA score of 0 or 1, higher than 32.1% in the apremilast group and 7.2% in the placebo group. In POETYK PSO-2 study, the Sotyktu treatment group had a PASI 75 response rate of 53.0% at week 16, which was significantly higher than the apremilast group's 39.8% and the placebo group's 9.4%. Additionally, 49.5% of the Sotyktu treatment group achieved sPGA score of 0 or 1, higher than the apremilast group's 33.9% and the placebo group's 8.6%. Sotyktu’s high response was maintained for up to 52 weeks. "Previously, patients who did not respond to or have had side effects when treated with conventional treatments, such as systemic therapy or light therapy, had biological agents as their only option. Sotyktu, which offers the convenience of once-daily oral administration, is expected to meet the unmet needs of psoriasis patients," Choe Yong-beom, President of the Korean Society for Psoriasis, said.
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- Reimb discussions discontinued for NMOSD drug Uplizna
- by Eo, Yun-Ho Nov 07, 2024 05:47am
- Uplizna, a new drug for neuromyelitis optica spectrum disorder (NMOSD) that is administered twice a year, has failed to pass the final gateway to reimbursement in Korea. According to Dailypharm coverage, Mitsubishi Tanabe Pharma Korea’s pricing negotiations with the National Health Insurance Service (NHIS) for Uplizna (inebilizumab), a treatment used to treat adult patients with for neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-Aquaporin-4 (AQP4) antibodies, has been discontinued recently. The company had accepted the “below the evaluated amount” condition set by the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee for the reimbursement of Uplizna (inebilizumab) in August but was unable to reach an agreement. NMOSD occurs when AQP4 autoantibodies, a disease-specific biomarker produced by B cells, bind to AQP4, a target antigen present on glial cells in the central nervous system, and activate the immune responses, causing nerve damage. Uplizna is an anti-CD19 human monoclonal antibody that selectively binds to CD19, a B cell-specific surface antigen, depleting B cells that produce AQP4 antibodies, thereby preventing disease relapse. The safety and efficacy of Uplizna were demonstrated in the N-MOmentum study, which evaluated the use of Uplizna monotherapy in 230 patients without the use of concomitant immunosuppressive agents. Study results showed that 89% of patients treated with Uplizna did not experience a relapse during 197 days of follow-up, resulting in a 77.3% reduction in the risk of relapse compared to placebo. Safety evaluations Uplizna also showed comparable rates of adverse events to the placebo group. Also, in an extension study, Uplizna continued to reduce the risk of relapse for at least 4 years, with an 87.7% relapse-free rate. In terms of long-term safety profile, Uplizna was generally well tolerated, with no increase in infection rates due to B-cell depletion. NMOSD is a serious autoimmune disease in which most patients experience persistent relapses and incomplete recovery, resulting in accumulated nerve damage that can cause vision loss, gait disturbances, and even death from respiratory failure.
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- 20-valent pneumococcal conjugate vaccine set to launch
- by Moon, sung-ho Nov 06, 2024 05:52am
- Attention has been drawn to another competitor set to launch in the market for the 'pneumococcal vaccine.' This year, the pneumococcal vaccine market has been fiercely competitive with newly released products. As the 20-valent vaccine is likely to come out right after the 15-valent conjugate vaccine has entered the market after 13 years, competition between global pharmaceutical companies to take the market share is becoming intense. As clinical practices draw attention to the next generation of vaccines, they expect that 'price' will be a determining factor in the non-reimbursed market. According to pharmaceutical industry sources, the Ministry of Food and Drug Safety (MFDS) granted approval of Pfizer Korea's 'Prevenar 20 Prefilled Syringe (hereafter, Prevenar 20).' Prevenar 20 is Pfizer Korea's next-generation product that follows 'Prevenar 13,' which currently dominates the Korean market for pneumococcal vaccines. In addition to serotype components in the 13-valent vaccine, Prevenar 20 contains seven additional serotypes, including 8, 10A, 11A, 12F, 15B, 22F, and 33F. The MFDS has approved the drug's indication to prevent invasive pneumococcal disease, pneumonia, and acute otitis media caused by pneumococcus in infants, children, and adolescents aged six weeks and below 18 years old. It is also used to prevent invasive pneumococcal disease and pneumonia caused by pneumococcus in adults 18 years of age and above. As Prevenar 20 has been officially approved, Pfizer Korea will prepare to launch the product. Pfizer Korea will likely aim to launch the product in the first half of 2025. Analysis suggests that an official launch is possible when Prevenar 20 is included in the vaccine guidelines of major medical sciences organizations and the National Immunization Program (NIP). The process is similar to that of MSD's 15-valent vaccine, 'Vaxneuvance,' which has been officially launched into the clinical practices. MSD Korea received the official approval of Vaxneuvance from the MFDS on October 31, 2023. Considering Pfizer Korea's Prevenar 20 was approved on October 31, 2024, Vaxneuvance was approved precisely a year before. After the approval, Vaxneuvance was included in the Korean Society of Infectious Diseases (KSID)'s '2024 Updated Guidelines for Adult Immunization' that "KSID recommends use of the 15-valent pneumococcal conjugate vaccine (PCV15, MSD's Vaxneuvance) over the 13-valent pneumococcal conjugate vaccine (PCV13, Pfizer's Prevenar 13) for individuals subjected to adult pneumococcal conjugate vaccine (PCV) immunization." MSD launched the vaccine in April this year soon after its inclusion in the NIP, and Pfizer Korea is likely to follow a similar launching schedule. "We have been trying to receive Prevenar 20's approval. The specific schedule for launch has not been decided," a representative from Pfizer Korea said. "We will prepare for the launch next year." "We have yet to confirm our Korean partner for Prevenar 20," a representative from Pfizer Korea said. "We are in a partnership with Chong Kung Dang for Prevenar 13 for adults, and we have an agreement with 'Koreavaccine' for Prevenar 13 for young children." The industry draws attention to the competition in the pneumococcal vaccine market for the clinical practice. The question is who will dominate the market, given the competition between two global pharmaceutical companies. Following the withdrawal of the 10-valent PCV vaccine (Synflorix, GSK) from the Korean market, the 13-valent vaccine Prevenar 13 and the 15-valent vaccine Vaxneuvance are currently competing in the clinical practice. In particular, MSD Korea chose Boryung Biopharma as its Korean partner. Upon launching Vaxneuvance, MSD Korea actively engaged in sales‧marketing by hiring Paik Jong Won, a businessman, TV celebrity, and CEO of TheBorn Korea, as its commercial model. According to a pharmaceutical market research firm UBIST, the number of NIP and non-reimbursed immunizations for adults in nationwide hospital‧private clinics is rising after Vaxneuvance launched in April. In detail, based on UBIST, the cumulative number of PCV vaccine immunizations from April to June this year is 994 counts. Among these, 809 immunizations were with Prevenar 13. 185 Vaxneuvance immunization was made. After MSD Korea launched Vaxneuvance in April this year, they chose Paik Jong Won, TheBorn Korea CEO, as their commercial model, putting efforts into raising awareness. To the right is the product photo of Prevenar 20, Pfizer Korea's pneumococcal vaccine, which is expected to launch in the first half of 2025. The number of immunizations with Prevenar 20 is below that of market dominating Prevenar 13, but the number is rising. Based on the assumption that Vaxneuvance has been well established in clinical practice as a new vaccine, the number of immunizations were likely increased. In fact, a director of the pediatrics and adolescent clinic said, "When we used Prevenar 13 for immunizations, we had several inquiries if it's possible to switch to Vaxneuvance. Since medication switching is possible during the immunization course, we answer patient inquiries." And added, "If patients have not completed the immunization schedule, medication switching is possible. We had several cases of switching after inquiries." Considering changes brought by the Vaxneuvance launch this year, Prevenar 20 will likely bring changes to clinical practices such as the department of internal medicine and the department of pediatrics and adolescents. Sang Hyuk Ma, a Director of Pediatrics and Adolescents at Changwon Fatima Hospital, said, "Following Prevenar 13, Vaxneuvance and the 15-valent vaccine have been introduced to South Korea. We must consider clinically if a vaccine with more serotypes is appropriate for South Korea. Pneumococcal serotypes tend not to mix, and serotypes common in South Korea must be accounted for vaccination." Ma added, "In other words, the vaccines were developed towards what's needed in the United States. We must look into common serotypes in South Korea and discuss whether the latest vaccines are necessary for immunizations in Korean citizens, including infants and children." Gwak Kyung-Keun, the President of Seoul Physicians' Association, said, "In my opinion, there is no difference between the 15-valent and the 20-valent vaccines. There is no basis for which one is more superior." Gwak anticipated, "In the end, it will be the sales‧marketing competition between companies. One would argue that the 20-valent vaccine has more serotypes but will be a marketing fight without a comparison basis."
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- Roche seeks digital solutions for its healthcare ecosystem
- by Whang, byung-woo Nov 06, 2024 05:52am
- With the importance of personalized healthcare being emphasized more than ever with the emergence of innovative new drugs, Roche Diagnostics Korea is aiming to lead the market by focusing on digital solutions. The company plans to lead the healthcare sector through digital transformation in line with the paradigm shift in treatment, from early diagnosis and precision medicine to predictive medicine. (From the left) Tae-Hyun Um (Director of Insurance Policy Affairs, KSLM), Yeo-Min Yun, Director of Scientific Affairs, KSLM), Sail Chun (CEO&Chaiarman, KSLM), Kit Tang (General Manager of Roche Diagnostics Korea), Muhwan Yun (head of Digital Insights, Roche Diagnostics Korea), Sungho Cho (Head of Core Lab & POC, Roche Diagnostics Korea) On the 5th, Roche Diagnostics Korea held a press conference on the theme of “Future Healthcare and Innovation Presented by Diagnostic Tests” and emphasized the importance and opportunities of digital transformation in the healthcare sector. With the launch of the Digital Insights division, the company has been focusing on providing data-driven insights and marking a new turning point in personalized medicine. “Digital transformation in healthcare is the new normal, and we have already entered the era of artificial intelligence (AI) transformation beyond digital transformation,” said Muhwan Yun, head of Digital Insights at Roche Diagnostics Korea. ”Roche Diagnostics has set its own ethical standards for applying AI to healthcare, and is aiming to expand and innovate its digital portfolio, including continuous R&D investment and collaboration.” One representative project is Smart Lab, a digital transformation of diagnostic laboratories. The goal is to make existing laboratory operations more efficient, flexible, and data secure, to ultimately increase insight from analyzing data. For this, Roche Diagnostics has been emphasizing 'digital solutions' and building an enabling ecosystem. It focuses on incorporating significant data of a certain scale, advanced analytics, and digital technologies to support medical decisions and improve the treatment experience. The company’s representative technology, NAVIFY, is a cloud-based data platform that analyzes vast amounts of healthcare data in a standardized format to enable precision medicine. “In practice, we have seen significant improvements in time, manpower, and cost metrics for testing and analysis after implementing Roche Diagnostics Digital Insight Solution’s NAVIFY portfolio,” said Yun, ”and the satisfaction rate among healthcare providers who have used them is over 90%.” “With South Korea set to enter a super-aged society next year, the role of diagnostic test data for efficient and effective treatment is expected to increase further,” said Kit Tang, General Manager of Roche Diagnostics Korea. ”Roche Diagnostics Korea will continue to strive to contribute to an efficient healthcare system and improved patient outcomes with innovative diagnostic solutions covering a wide range of disease areas.” The hurdle to building a digital ecosystem for diagnostic tests is in the “maturity” of the digital transformation In the long run, digital transformation in diagnostics is essential, but there are hurdles. Not only are institutional improvements required for the digital transformation of the existing system, but the nature of healthcare is such that it is important to integrate the different perspectives of each stakeholder, including hospitals, manufacturers, patients, and academic societies. Yeo-Min Yun (Director of Scientific Affairs, KSLM)In response to this, Yeo-Min Yun, Director of Scientific Affairs at KSLM of the Korean Society for Laboratory Medicine (Konkuk University Hospital), emphasized that the emergence of technology should be supported by measures that can encourage their use in practice, such as by assigning service fees. “If you look at imaging, the technology that analyzes the images through AI technology is being applied and utilized to create values that have never existed before,” said Director Yun. ”Referring to this precedent, I think that efforts should be made to apply a service fee for such diagnostic tests and recognize their value in clinical practice.” Ultimately, Roche Diagnostics' challenge is to collect and utilize fragmented data. To this end, the company expects the newly launched division to serve as a base to build the ecosystem. “In Korea, data compatibility is relatively poor, so we are striving to collect and utilize data well,” said Director Yun, adding, ”As the implementation of digital ecosystems is not fully mature yet, it will be important for each component, including the company, to be integrated.”
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- CKD’s CKD-508 receives approval to initiate P1T in the U.S.
- by Son, Hyung Min Nov 06, 2024 05:52am
- Chong Kun Dang announced on the 4th that it has received approval from the U.S. Food and Drug Administration (FDA) for the Phase I clinical trial of CKD-508, its new drug candidate for dyslipidemia. In the trial, Chong Kun Dang will confirm the safety and lipid-improving effects of CKD-508 and explore the optimal dose for a Phase II trial. CKD-508 is a treatment for dyslipidemia that works by inhibiting the activity of cholesteryl ester transfer protein (CETP), which facilitates the transport of cholesteryl esters (CE) and triglycerides (TG) between lipoproteins in the blood, thereby lowering low-density cholesterol (LDL-C) levels and increasing high-density cholesterol (HDL-C) levels. In a non-clinical efficacy trial conducted by Hyosung Research Center, Chong Kun Dang confirmed the LDL-C-lowering and HDL-C-raising effects of CKD-508 and demonstrated a significant reduction in apolipoprotein (Apo-B), a key marker of dyslipidemia. “CKD-508 is an innovative drug that is expected to be effective at low doses by solving the problems of previous CETP inhibitors that were discontinued due to drug accumulation and blood pressure increase based on its strong binding to CETP,” said Chong Kun Dang. ”If successful, it is expected to become a new treatment option for patients with statin-resistant dyslipidemia that cannot be controlled with statins.”
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- Amgen's Prolia·Evenity generate KRW 2T in quarterly sales
- by Son, Hyung Min Nov 06, 2024 05:52am
- Amgen Amgen's Prolia and Evenity for the treatment of osteoporosis continue to show sales growth. Prolia and Evenity led Amgen's performance, generating sales of KRW 2 trillion in Q3. Analysis suggests that sequential therapy, using Evenity followed by Prolia for the treatment of osteoporosis with high-risk fractures, has been widely used, and it has led to continued increases in sales. Sources said on November 6th, Amgen's sales in Q3 were US$ 8.50 billion (approximately KRW 11.72 trillion), up 23.1% year-over-year (YoY). Operating profit for the same period was US$ 2.047 billion, up 1.3% from 2022. Prolia generated the highest sales among Amgen's products. Prolia's sales in Q3 were US$1.045 billion (approximately KRW 1.44 trillion), up 6.0% YoY. Prolia recorded US$3.20 billion (approximately KRW 4.42 billion) for the nine months this year, up 9.1%. Last year, Prolia's annual sales were US$40.48 billion. Developed by Amgen, Prolia is a treatment for osteoporosis. It was approved in the United States, and after that, Amgen successfully received Prolia's approval in major countries, including South Korea, Europe, and Japan. Prolia sales nearly doubled to US$352 million in Q1 of 2016 in two years from US$196 million (approximately KRW 270 billion) in Q1 of 2014. Prolia's sales continue to grow, generating US$852 million (approximately 1.2 trillion) in Q1 of 2022. In Q2 of 2023, its quarterly sales topped US$1 billion. In Q1 of this year, it dropped to US$9.99 billion, but then successfully rebounded in Q2, recording US$1.165 billion. Prolia's strength lies in having secured real-world data. Based on its FREEDOM and FREEDOM Extension clinical studies spanning 10 years, Prolia effectively reduced the risk of fractures than the conventional osteoporosis treatment, Alendronate. Unlike other medications, Prolia continues to increase bone density. Prolia is categorized as a medication that can be administered for long-term. As a result, pharmaceutical companies are developing Prolia biosimilars. Earlier this year, U.S.-based Sandoz received approval for a biosimilar of Prolia and Korean pharmaceutical companies such as Celltrion and Samsung Bioepis also plan to complete clinical trials and prepare for approval. Prolia's patent is set to expire in 2025. Quaterly sales performance of Prolia (green) and Evenity (oranage) in 2023 and 2024 (unit: US$1 million). Evenity records KRW 550 billion in Q3 sales…continues to increase The success of the osteoporosis treatment Evenity has contributed to Amgen's sales performance. Evenity's Q3 sales amounted to US$399 million (approximately KRW 550 billion), up 30.0% from US$307 million in 2022. Evenity is a bone-forming agent that provides dual effects of promoting bone formation and inhibiting bone absoption. It was approved in the United States in 2019. Evenity recorded sales of US$100 million for the first time in Q1 2020, and it continues to grow. In Q3 2022, Evenity recorded sales of US$200 million, more than doubling its initial launch. In Q3 of Last year, Evenity surpassed US$300 million and showed steady growth, reaching sales of US$400 million in Q3 of this year. Evenity's increase in sales is mainly due to its osteoporosis treatment strategy. As part of its marketing strategy, Amgen has strategized a sequential therapy of using the bone-forming agent Evenity followed by the bone resorption inhibitor, Prolia. Based on their approved indications, Bone-forming agents have a maximum duration of use of 2 years. Therefore, after a certain period of treatment, switching to bone resorption inhibitors such as Prolia or bisphosphonate agents are mainly used. According to Evenity's ARCH study or a study comparing teriparatide and risedronate, a sequential therapy using bone-forming agents first followed by bone resorption agents is more effective in preventing the risk of bone fractures in patients. Korea-based or overseas guidelines for osteoporosis treatment recommend bone-forming agents, such as Evenity, as first-line treatments for high-risk individuals.
