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- 2026-04-28 07:38:30
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- Wegovy vs Mounjaro in KOR…who's the winner?
- by Moon, sung-ho Jan 09, 2025 05:56am
- As more people are living with obesity in the world, obesity treatment is gaining popularity. According to the World Obesity Federation report, more than half of the world's population in 2035, 10 years from now, will be categorized as overweight or obese. South Korea is projected to have a similar rate. At the end of last year, Novo Nordisk's obesity drug 'Wegovy (semaglutide),' which gained popularity and was in short supply in the global market, was finally introduced to clinical practices in South Korea. After that, new drugs with significant weight-loss effects are being introduced into South Korea, indicating a shift in the paradigm of obesity treatment. The companies have applied for expanded indications for these drugs, influencing clinical areas. Prodouct photo of According to pharmaceutical industry sources on January 6, Novo Nordisk Korea has been supplying 'Wegovy Prefilled Pen Inj' to clinical practices since mid-October last year. Wegovy received domestic marketing authorization in April with indications to aid weight-loss overweight patients who have a Body Mass Index (hereafter referred to as BMI) of 30kg/m2 or higher or those who are overweight with early BMI of 27kg/m2 or higher and below 30kg/m2 and having one or more weight-related accompanying diseases. Additionally, in July 2024, Wegovy also receive approval for the indication to reduce risks of major cardiovascular events (death from cardiovascular diseses, non-fatal cardial infarction, or non-fatal cerebral strok) in overweight or obese patients with early BMI of 27 kg/m² or higher with cardiovascular diseases. Upon the launch of Wegovy, Novo Nordisk Korea actively worked to secure market dominance in the Korean obesity treatment market, using about 80 sales and marketing employees. As a result, Wegovy is currently being used in medical clinics as a non-reimbursable drug. Patients pay an average cost of KRW 700,000-800,000 per month for treatment. "Japan's drug price seems to be the world's lowest, but it is covered by insurance. It has been launched as the lowest price globally among non-reimbursed drugs," Chul Jin Lee, President of the Korean Society for the Study of Obesity (Joeun Family Health Clinic), said. "It is likely that the company has considered the potential launch of Mounjaro (tirzepatide) in Korean clinical practices." Wegovy's company seems to be attempting to dominate the market by entering the domestic clinical field ahead of Mounjaro. The industry's interest is now on the launching date of 'Mounjaro,' known as Wegovy's rival. Lily Korea plans to introduce the drug to clinical practices in South Korea this year. In addition to Mounjaro's approval for type 2 diabetes, Lily Korea received extended approval for the drug as an adjuvant therapy for chronic weight control, which is similar to Wegovy. Although it is being sold in the market for obesity treatment as the product name 'Zepbound,' Mounjaro will be used for treating diabetes and obesity in South Korea. Regarding this, Lily's recent announcement of the top-line results of the open-label SURMOUNT-5 Phase 3 clinical trial draws attention. This study directly compared the effects of Mounjaro to Wegovy. According to the results presented, patients treated with Mounjaro had greater weight loss effects compared to those treated with Wegovy. This finding indicates that Mounjaro is superior in a one-on-one comparison to Wegovy. In the clinical study involving 751 patients who are obese or overweight without diabetes, patients treated with Mounjaro for 72 weeks had a weight loss of 22.67kg, which is an average loss of 20.2% of the body weight. During the same period, patients treated with Wegovy had a weight loss of 13.7% (14.96kg). When the weight loss range was compared, Zepbound showed about 47% superior effects than Wegovy. Consequently, when Mounjaro becomes available in the Korean market, Wegovy will likely face a short-lived 'popularity.' "Mounjaro in the form of vial is under consideration of domestic approval," Lee said. "Mounjaro's yearly cost is about KRW 3 million less than what Wegovy costs. Moreover, the drug price of vial formation saw a 50% reduction in the United States. When it launches in South Korea after obtaining approval, Mounjaro will likely priced significantly less. For this reason, clinical practices are closely watching Mounjaro." "When vial formation becomes available, doctors prefer using those than pen types," Lee added. "A weekly vial package treatment regimen would be optimal." Due to Wegovy and Mounjaro's success, GLP-1 emerged as the R&D trend in the domestic and foreign pharmaceutical and biotech industries. Recently, the FDA granted approval for Zepbound, containing a similar active ingredient to Mounjaro, for sleep apnea. In addition to its diabetes and obesity indications, the extended indication of sleep apnea suggests an increased volume of usage. Also, an extended indication is likely approved in South Korea. Companies witnessing these successes are evaluating the possibility of metabolic dysfunction-associated steatohepatitis (MASH) treatment since GLP-1 improves insulin secretion and sensitivity, improving blood glucose control. Because MASH is caused by fat buildup in the liver of people who consume little or no alcohol, weight loss can have a positive effect on patients. For this reason, pharmaceutical companies have determined that GLP-1 can be a treatment for MASH, alongside diabetes and obesity, and are currently conducting clinical trials. The same goes for Wegovy and Mounjaro's active ingredients, semaglutide and tirzepatide. Novo Nordisk and Lily are assessing the clinical utility of those drugs in patients with MASH, conducting phase 2 and phase 3 clinical trials, respectively. The industry is anticipating potential extended indications. Additionally, survodutide, under development by Boehringer Ingelheim, demonstrated clinical utility in a phase 2 trial, emerging as a new drug candidate for MASH. The biotech industry in South Korea is also considering the possibility of new GLP-1 drugs. Many companies have begun clinical studies. The outstanding companies are ProGen and D&D Pharmatech. ProGen is gaining attention for its new drug development in diabetes and obesity fields. The company is developing 'PG-102,' which works bi-specifically by binding GLP-1·GLP-2. ProGen's new drug candidate received approval from the Ministry of Food and Drug Safety (MFDS) for conducting a domestic phase 2 trial. ProGen aims to maximize the effects, such as improving intestine function, glucose uptake in adipose tissue, and alleviating chronic inflammation by targeting both GLP-1 and GLP-2. Kun-Ho Yoon, Chief Medical Officer of Progen (Endocrinology Specialist), says the significance of the study is that "Since there have been no new drug candidates that simultaneously target both GLP-1 and GLP-2, ProGen's 'PG-102' can be a first-in-class candidate treatment." D&D Pharmatech is conducting clinical trials for its GLP-1 agent for various fields, including MASH, Parkinson's disease, and dementia. Last year, the company initiated a Phase 2 trial after receiving the FDA approval of its Phase 2 trial Investigational New Drug (IND) application. The Phase 2 trial is being conducted in 10 clinical trial centers, and the trial involves 68 patients who are overweight or obese with accompanying MASH. The Korean clinical practices are closely watching the D&D Pharmatech's achievements. "D&D Pharmatech has GLP-1 and GLP-2 bi-specific agents and amylin-based products," Lee said. "The company has a competitive edge, especially having a proprietary platform for switching an agent to oral formation alongside having injectable." "Regarding developing a GLP-1 formation, the key to success is which company could diversify with lesser cost," Lee remarked. "The success in the market competition will be determined by providing various clinical benefits at lower prices for injectable, vial, and oral formations," Lee projected.
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- Sales of Flu drug Tamiflu did not fare so well last year
- by Nho, Byung Chul Jan 08, 2025 05:53am
- The oseltamivir-based flu treatment market, commonly represented by Tamiflu, is on a vertical decline after peaking in sales in 2023. The market for related preparations was valued at KRW 35.6 billion in 2023, the largest in 5 years. By 3Q 2024, the oseltamivir market posted sales of KRW 6.2 billion; even when the sales of the fourth quarter are combined, it will be difficult to realize the KRW 10 billion mark. However, given how flu alerts were issued from December last year to January this year, a spike in the drug’s sales is expected during the period. The overall market for related ingredients has remained at the level of KRW 23.1 billion in 2019, and after reaching a low of KRW 10.5 billion in 2020 and KRW 339 million in 2021. The market recovered to KRW 20.9 billion in 2022 and reached KRW 35.6 billion in 2023. The market for related therapeutics shrank significantly during the peak of the pandemic due to the impact of COVID-19 vaccination and strict personal hygiene such as wearing masks and disinfecting hands. Oseltamivir is one of more than 20 products competing in the market for the treatment of influenza A-B virus infections. Roche's Tamiflu is the undisputed leader in the market, with sales of about KRW 2.6 billion through the third quarter of last year. That's down sharply from 2023 when it generated KRW 15.3 billion in sales. Tamiflu's performance in 2019-2020-2021-2022 had been KRW 7.4 billion-4 billion-137 million-14.1 billion, respectively. In second place is Hanmiflu Cap, which sold KRW 1.6 billion by the third quarter of 2024, a sharp drop from KRW 7.7 billion in 2023. Hanmiflu's performance in 2019-2020-2021-2022 is in the range of KRW 4.8 billion-KRW 1.7 billion-KRW 29 million-KRW 2.4 billion. Yuhan Corp’s Yuhan N-flu and Chong Kun Dang’s Tamivir ranked third and fourth with sales of KRW 490 million to KRW 470 million through the third quarter of 2024, respectively. Comyflu (Kolon Pharmaceutical), Seltaflu (Vivozon Pharm), and Oseltawon Cap (Daewon Pharmaceutical) followed, with sales in the range of KRW 100-400 million in the same period, down sharply from the KRW 1.2-1.8 billion in 2023. Kuhnflu (Kuhnil Biophamr), Hanaflu Cap (Hana Pharm), and Shinpoong Flu (Shin Poong Pharm) have been generating sales between KRW 30 million and KRW 80 million until the third quarter of last year. Oseltamivir is taken twice a day for five days within two days of symptom onset, regardless of food intake. The treatment is available for newborns starting at 2 weeks of age, with a recommended dose of 3 mg per kg for children under 1 year of age. Prophylaxis is approved for persons 1 year of age and older and is taken once daily for 10 days at a dose as directed by a physician within 2 days of contact with an infected person. Common adverse reactions include nausea, vomiting, and headache (>10%); if a gastrointestinal disorder occurs, taking it with food could be helpful. Patients should not discontinue the medication at their discretion and should receive guidance to fully take the medication as prescribed. NSAIDs and acetaminophen do not affect the effectiveness of anti-influenza antivirals and may be taken together. However, aspirin should be avoided if a child is infected with influenza and has a fever. Aspirin can cause Reye's Syndrome, a condition that can cause severe vomiting, convulsions, acute encephalopathy, fatty degeneration, and death in children with the virus.
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- J.P. Morgan selects ADC and obesity as big deal keywords
- by Moon, sung-ho Jan 08, 2025 05:53am
- With the opening of the 'J.P. Morgan Healthcare Conference', which attracted much attention last year with domestic pharmaceutical and biotech companies announcing the achievement of 'big deals,’ approaching, attention is gathering on what results will be announced this year. The keywords of this year's event are glucagon-like peptide-1 (GLP-1)--based obesity drugs and antibody-drug conjugates (ADCs), which have risen as hot topics in the global pharmaceutical and bio market. At the event, domestic pharmaceutical and biotech companies will be presenting their portfolios and holding face-to-face meetings. #According to industry sources on the 6th, the 43rd JP Morgan Healthcare Conference is scheduled to be held in San Francisco, U.S., from January 13 to 16 (local time). The event, which celebrates its 43rd event this year, has served as an opportunity for about 600 domestic and large multinational pharmaceutical companies to share their new R&D achievements and status and discuss the future development of the pharmaceutical and bio industry. Above all, it is an opportunity for domestic pharmaceutical and biotech companies to fulfill their main objectives of ”technology exports” and “forging partnerships.” In particular, at this year's event, in addition to the conference regular Samsung Biologics, Lotte Biologics, and Celltrion will unveil their contract development manufacturing Organization (CDMO) facilities and major business strategies. Among them, Samsung Biologics has always participated in the event since the 2020s and unveiled its major business strategies in the Main Track. This year, the company's CEO John Rim will be the main track presenter and will present its manufacturing facilities (5-8 plants) and antibody-drug conjugate (ADC) portfolio. Celltrion will also participate in the event to showcase its drug development achievements, including its ADC anti-cancer pipeline, as well as its CDMO vision. Celltrion is developing 3 ADC drugs and 3 multi-antibody drugs with the goal of commercializing its first product in 2029. Lotte Biologics, which has set its sights on becoming a CDMO specialist, is expected to announce its plans for the CDMO business and the expansion of its Syracuse ADC production facility under its newly appointed CEO James Park. Lotte Biologics previously announced that it will invest KRW 4.6 trillion by 2030 to own the capability as a global-level biopharmaceutical manufacturing competitor. At the same time, the Syracuse Bio Campus has disclosed plans to invest in ADC production facilities and begin full-scale production this year. Along with domestic CDMOs, bio companies that are challenging new drug development also registered and put their names on the event lineup. Among them, Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical, which launched the P-CAB class gastroesophageal reflux disease drug Zaqbo (zastaprazan) last year, will also participate in the event. Onconic Therapeutics will use the JP Morgan Healthcare Conference to focus on strategic meetings with global pharmaceutical companies and investors. In particular, the company plans to accelerate the global market entry of its targeted anti-cancer drug Nesuparib with Zaqbo. “The JP Morgan Healthcare Conference will be an important opportunity to showcase our new drug pipeline and technology to the global market and create new collaboration opportunities,” said a representative from Onconic Therapeutics. “As we excluded the market value of Nesuparib from the public offering price during the KOSDAQ listing process, leaving new shareholders’ interests untouched, we look forward to a full-scale reassessment and valuation of the company through this event.” Bridge Biotherapeutics has been officially invited to make a corporate presentation. The presentation will highlight the company's growth strategy, including BBT-877, its lead candidate for idiopathic pulmonary fibrosis. BBT-877 is in the later stages of a global Phase 2 clinical trial, with top-line data expected next April. To date, 98 patients, representing more than 75% of the total patients, have completed the 24-week dosing process, and data from all patients in the trial will be finalized within the first quarter of next year. In addition, domestic companies that are developing not only anti-cancer drugs but also obesity drugs, a global drug development trend, will also participate in the event. D&D Pharmatech will present its glucagon-like peptide (GLP-1) based obesity treatment. In November last year, D&D Pharmatech started clinical trials for DD02, an oral GLP-1-based obesity treatment, through its U.S. partner Metsera. Also, Dx&Vx will also be participating in the event to share the progress of its own oral GLP-1 obesity drug currently in development. “As global pharmaceutical companies compete to develop oral GLP-1 therapeutics, interest in our technology is growing,” said a representative from Dx&Vx. ”We look forward to strengthening our global presence at the J.P. Morgan Healthcare Conference and collaborating with various partners to bring better treatment options to patients.”
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- Expansion of NIP needed for 20-valent pneumococcal vaccine
- by Whang, byung-woo Jan 08, 2025 05:53am
- "Invasive pneumococcal disease remains the most common invasive infection and poses a significant burden. Pneumococcal diseases, such as pneumonia or ear infection, pose significant burden. The new vaccine must cover conventional serotypes as well as newly introduced serotypes to manage the invasive pneumococcal infection and expect an additional reduction." The introduction of the pneumococcal vaccine with the most serotypes in South Korea has brought attention to its preventive effects against pneumococcus and unmet needs for vaccines. Given the availability of vaccines in the National Immunization Program (NIP), there is a heightened interest in the preventive effects of added serotypes. Dr. Ki Wook Yun, Professor of the Department of Pediatrics and Adolescent Medicine at Seoul National University College of MedicineDr. Ki Wook Yun, Professor of the Department of Pediatrics and Adolescent Medicine at Seoul National University College of Medicine, emphasizes the importance of seeking ways to improve preventive effects in terms of society, given the additional effects of newly introduced drugs. According to Dr. Yun, unlike viral infection, bacterial infection cannot be recovered by relying on immunity, requiring antibiotic treatment. Mortality in children has decreased compared to the past, but bacterial infection still needs considerable attention. "Bacterial infection is one of the most burdening diseases in children. The prevalence decreased over time due to vaccine development and environmental improvement. Yet, the disease prevalence is higher than other diseases," Yun explained. "Not only children with immature immunity but seniors are prone to respiratory infections. Consequently, children and seniors are the primary patients for respiratory prevention and treatment." Dr. Yun comments that given these factors, it is crucial to prevent infection through vaccination and to stop it from transitioning to severe stages. Invasive pneumococcal disease remains the most common invasive infection and poses a high disease burden, so the importance of vaccination has been stressed. "Bacterial identification is challenging for infections related to pneumococcus, leading to frequent use of antibiotics. Consequently, patients may experience aftermaths of the treatment," Dr. Yun stated. "Vaccines can prevent these issues and may alleviate antibiotic tolerance by reducing the volume of antibiotic use." The government has included 13-valent and 15-valent pneumococcal vaccines in the NIP for children. From a different view, it remains to be seen what impact of Prevenar 20, a recently approved vaccine containing 20 serotypes, will have. Dr. Yun focuses on newly identified serotypes not included in the 13-valent vaccine as primary causes of infection. "13-valent vaccine alone cannot prevent all serotypes, so vaccines that contain new serotypes may be necessary," Dr. Yun said. "New vaccine must cover conventional serotypes as well as newly introduced serotypes to manage invasive pneumococcal infection and expect additional reduction." "Because Prevenar 20 also met non-inferiority to 13-valent vaccines, and it met immunogenicity requirements set by WHO at the fourth immunization, using the vaccine will likely be similar to the conventional vaccine," Dr. Yun added. "Additional serotypes can also offer disease prevention, so clinical benefits are expected." "The 20-valent pneumococcal vaccine has established sufficient validity for the NIP…establishing mass immunity must be considered" The remaining issue is whether the vaccine will be included in the NIP. While it offers broader prophylaxis than conventional vaccines, its introduction faces cost concerns due to the existing conventional vaccines already being part of the NIP. Dr. Yun analyzes that considering foreign cases, disease burden, and as drug price increases, Prevenar 20 has established sufficient validity for the NIP. "The 20-valent vaccine includes seven additional serotypes compared to conventional vaccines, potentially providing about 40-50% additional prevention against invasive pneumococcal infections. This suggests that the vaccine is more effective than existing ones," Dr. Yun said. "About 70-80% of non-vaccine serotypes causing infections in South Korea are not included in existing vaccines," Dr. Yun stated. "About half of these are serotypes included in the 20-valent vaccine. Consequently, it may be inadequate to keep using existing vaccines." Dr. Yun particularly emphasizes that to maximize the effects of the pneumococcal vaccine, increasing the vaccination rate for mass immunity must be considered. The 13-valent conjugate vaccine previously achieved high vaccination rates and demonstrative high effectiveness. However, a drop in vaccination rates due to new vaccines not being included in the NIP may lead to an increase in invasive infections and pneumonia. "Rather than expecting protection from individual vaccination, we must consider approaches generating society-wise preventive effects. Considering these views, there must be active measures to increase the vaccination rate with new vaccines such as Prevenar 20," Dr. Yun said. Finally, Dr. Yun remarked, "Despite the significant burden of pneumococcal diseases, such as pneumonia or ear infection, a surveillance system has not been established in South Korea." Adding, "The Korea Disease Control and Prevention Agency (KDCA) must address these aspects and implement systematic improvements so that invasive pneumococcal diseases are not overlooked."
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- New drug 'Truqap' for HER2- breast cancer Rx available
- by Son, Hyung Min Jan 08, 2025 05:53am
- Product photo of AstraZeneca Korea'Truqap,' an oral anticancer drug that targets AKT gene mutation, is now available for prescription at general hospitals. According to industry sources, AstraZeneca Korea's Truqap (capivasertib), a treatment for hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center and Seoul National University Hospital, and medical centers, including Gachon University Gil Medical center, Gangnam Severance Hospital, Korea University ANAM Hospital, Seoul National University Bundang Hospital, and Cha University Bungdang Medical Center. Domestically approved in March 2024, Truqap was launched as a non-reimbursable drug in September of the same year. This drug can be prescribed for combination therapy with fulvestrant following progression on or after an endocrine therapy or recurrence within 12 months after adjuvant therapy. The introduction of Truqap is significant because it offers more second-line treatment options following first-line treatment of HR-positive/HER2-negative breast cancer where there have been unmet needs. HR-positive/HER2-negative breast cancer accounts for 70% of the total breast cancer patients. This drug was demonstrated to be efficacious based on the CAPItello-291 Phase 3 study. The results showed that Truqap improved the median progression-free survival (mPFS) by approximately 2.5-fold compared to fulvestrant alone in patients who failed the first-line treatment following endocrine therapy (ET)±CDK4/6 inhibitor therapy. In detail, the Truqap+fulvestrant combination group had a mPFS of 7.3 months, which is more than double the 3.1 months with fulvestant alone. "Patients with PIK3CA/AKT1/PTEN mutations, accounting for about 50% of patients with HR-positive/HER2-negative breast cancer, may have faster disease progression; therefore, there has been a consistent need for second-line treatment for metastatic breast cancer targeting these mutations," Dr. Kywong Hwa Park, Professor of the Division of Oncology at Korea University ANAM Hospital, explained. "In metastatic breast cancer, patients who achieve complete recovery with a first-line treatment is rare, and most patients fail treatments, leading to the second-line treatments or more. The mutation targeted by Truqap commonly metastasizes to various organs, so we anticipate a positive outlook with this medication," Dr. Park said.
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- Twice yearly HIV drug 'lenacapavir' receives ODD
- by Eo, Yun-Ho Jan 07, 2025 06:05am
- Product photo of Sunlenca Twice yearly injectable 'lenacapavir' for HIV prevention has been designated as an orphan drug in South Korea. The Ministry of Food and Drug Safety (MFDS) recently announced this through the new year's first orphan drug designation notification. The drug is indicated 'In combination with other antiretroviral therapy, for treatment of patients with multidrug-resistant HIV-1 infection for whom cannot be treated with antiretrovirals.' This drug, marketed under the product name as 'Sunlenca,' is a first-in-class long-acting HIV-1 capsid inhibitor that is subcutaneously administered every six months. It was approved in the United States and Europe in 2022 and has been prescribed. The current HIV treatment regimen requires daily oral administration of antiretrovirals. As long-acting agents become available, the treatment frequency has been extended to two or six months. Sunlenca offers not only HIV treatment but also 'prevention.' In September 2024, this drug's developer, Gilead Sciences, announced the second interim result of lenacapavir's Phase 3 PURPOSE2 trial. The result has shown that lenacapavir reduced HIV infection by 96% compared to baseline HIV prevalence (HIV). Only two cases occurred among 2180 study participants, suggesting that 99.9% of the participants in the lenacapavir-treated group had not been infected with HIV. The PURPOSE 2 study is the second key Phase 3 trial evaluating the efficacy of twice-yearly lenacapavir as a pre-exposure prophylaxis (PrEP) used to prevent HIV. In June 2024, Gilead Sciences concluded the double-blind trial conducted in Sub-Saharan Africa early after meeting the key endpoints. This PURPOSE1 clinical trial evaluated lenacapavir as a PrEP among cisgender women. Science, the academic journal and outlet for scientific news, has named lenacapavir as 'Breakthrough of the Year' based on these study results.
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- AstraZeneca Korea recertified Innovative Pharma Company
- by Whang, byung-woo Jan 07, 2025 06:05am
- AstraZeneca Korea announced today that it has successfully extended its certification as a 2024 Innovative Pharmaceutical Company by the Ministry of Health and Welfare. This marks the third consecutive recertification since the company was first certified in 2018, and recognizes the company's steady R&D investments and achievements made through global collaborations. With the extension, AstraZeneca Korea will be maintaining its status as an Innovative Pharmaceutical Company for another three years, until 2027. The Innovative Pharmaceutical Company certification system, which is organized by the Ministry of Health and Welfare, is based on the ‘Special Act on Fostering and Supporting the Pharmaceutical Industry,’ which reviews companies with high R&D investment ratios and excellent performance in developing new drugs. Certified companies can receive various support, including points for R&D support, preferential drug pricing, and tax benefits. Through its Open Innovation strategy, AstraZeneca Korea has been strengthening its collaboration with local researchers and companies to contribute to the development of the Korean pharmaceutical industry. In particular, the approval of durvalumab for the first-line treatment of biliary tract cancer in 2022 resulted from clinical trials led by local researchers and is considered a successful global collaboration model. Also, AstraZeneca Korea was recognized for its rapid response to the health crisis during the COVID-19 pandemic. The company invests around 20% of its annual revenue in clinical research, with more than 180 clinical studies underway in Korea. In addition, the company has continued to invest in R&D by conducting clinical trials on next-generation innovative drugs such as antibody-drug conjugates (ADCs), radioconjugates, and cell gene therapies in Korea. “The extension of the Innovative Pharmaceutical Company certification is an achievement of our long-standing collaboration with the Korean healthcare industry,” said Sehwan Chon, Country President of AstraZeneca Korea. ”We will continue to work closely with Korean research institutes and companies to create a patient-focused healthcare ecosystem and expand our innovative pipeline.” Chon added, “We look forward to further collaborating with the government, academia, and industry to raise the global profile of Korea's healthcare industry.”
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- 1st RSV preventive inj 'Beyfortus' can be prescribed
- by Eo, Yun-Ho Jan 06, 2025 05:56am
- Product photo of Beyfortus The first injectable antibody drug approved in South Korea to prevent respiratory syncytial virus (RSV), 'Beyfortus,' is now available for prescription at general hospitals. According to industry sources, Sanofi Korea's Beyfortus (nirsevimab) has passed the drug committees (DC) of medical centers, including Seoul National University Hospital, Cha University Gangnam Medical Center, Korea University Anam Hospital, Korea University Ansan Hospital, Cha University Bundang Medical Center, and Pusan National University Yangsan Hospital. Beyfortus was approved by the Ministry of Food and Drug Safety (MFDS) in May as an injectable antibody to prevent RSV. It can be administered to all newborns and infants during their first RSV season. Beyfortus can also be given to infants under 24 months who are at high risk for severe RSV disease during their second RSV season. The Phase 3 MELODY study, which was the basis of Beyfortus approval, showed that the lower respiratory infection by RSV was reduced by 74.5% in the Beyfortus-treated group. This study evaluated the effectiveness of Beyfortus in 3012 infants born after 35 weeks during their first RSV season. The effectiveness in preventing RSV infections requiring medical attention was assessed until 150 days after the Beyfortus administration. Based on the Beyfortus real-world evidence demonstrated in the interim results from the national immunization program in Galicia, Spain, infants six months or younger who were administered Beyfortus had an 82% reduction in hospitalization due to RSC compared to non-administered infants. "Individuals of all ages can be contracted with RSV, but 90% of infants under 2 years old become infected. When infected, a mild cold symptom can advance to lung infections, possibly leading to hospitalization," Ki Wook Yun, Professor of Seoul National University College of Medicine, explained. "When infants without completely developed bronchial tubes contract RSV, symptoms can be worse. It could result in socioeconomic loss in addition to affecting family members." Yun added, "Since taking care of one's hygiene was the only RSV prevention available, there were unmet needs for RSV prevention. With the availability of injectable antibody drug, active RSV prevention is expected to be possible."
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- Balversa may be prescribed at general hospitals in Korea
- by Eo, Yun-Ho Jan 06, 2025 05:56am
- The new bladder cancer drug Balversa may now be prescribed in Korea’s Big 5 tertiary hospitals in Korea. According to industry sources, Janssen Korea's FGFR-inhibiting urothelial carcinoma (bladder cancer) drug Balversa (erdafitinib) recently passed the drug committees (DCs) of tertiary hospitals including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital. In addition, the drug’s prescription codes have been generated at major medical institutions across the country, including Kangnam Sacred Heart Hospital, GangNeung Asan Hospital, Hallym University Kangnam Sacred Heart Hospital, National Cancer Center, Keimyung National University Hospital, Ulsan National University Hospital, Korea Cancer Center Hospital, and Chonnam National University Hwasun Hospital. Balversa was approved by the Ministry of Food and Drug Safety in January 2022, but it is still not reimbursed in Korea. But expectations have been rising since Janssen submitted a reimbursement application for Balversa at the end of last year. As such, it remains to be seen if Balversa will be reimbursed by the end of the year and become a viable treatment option in Korea. Specifically, the drug is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with FGFR2 or FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy, which includes platinum-based chemotherapy, or whose disease has progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. However, the approval of PD-1 and PD-L1-directed immuno-oncology agents in the first- and second-line settings that followed Balversa’s approval led to the need for Balversa to demonstrate efficacy in patients who previously received these agents. The situation was addressed with the publication of Balversa’s Phase III THOR trial study, which demonstrated a prolonged overall survival (OS) benefit with Balversa over chemotherapy in patients with metastatic urothelial carcinoma with FGFR3/2 gene alterations whose disease progressed after first-line treatment with immuno-oncology agents. In the study, Balversa prolonged overall survival (OS) compared with chemotherapy in patients with metastatic urothelial carcinoma. Results showed that over a median follow-up of 15.9 months, the mOS was 12.1 months in the Balversa arm, reducing the risk of death by 36% compared with the 7.8 months in the chemotherapy arm. Based on these findings, the U.S. Food and Drug Administration granted Balversa formal approval in January, but with a more restricted indication than originally approved. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) also recently recommended expanding Balversa’s indication. Janssen Korea has additionally submitted the results from the THOR study to Korea’s Ministry of Food and Drug Safety. Therefore, the company may start the reimbursement progress in earnest for Balversa in the second half of the year. Therefore, it remains to be seen whether Balversa will be able to go beyond landing in medical institutions and gain insurance reimbursement in Korea. Meanwhile, bladder cancer is one major cancer that has lacked a targeted therapy option. Balversa is the first targeted anti-cancer drug for bladder cancer with a novel mechanism of action that inhibits fibroblast growth factor receptor (FGFR). FGFR is a biomarker involved in cancer cell growth that is associated with various cancers. FGFR mutations are particularly common in bladder cancer, with 20 to 30% of patients carrying mutations.
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- Lily's 'Jaypirca' launches in KOR
- by Whang, byung-woo Jan 03, 2025 06:28am
- Product photo of Jaypirca Lily Korea announced on January 2 that Jaypirca (ingredient name: pirtobrutinib), a treatment for mantle cell lymphoma (MCL), was launched in South Korea on December 26. To date, Jaypirca is the first reversible Bruton's tyrosine kinase (BTK) inhibitor of any kind. Jaypirca was approved by the Ministry of Food and Drug Saftey (MFDS) in August 2024 for its efficacy and effects as a 'monotherapy for adult patients with relapsed or refractory MCL previously received at least two treatments.' Before the approval of Jaypirca, there was no drug approved in South Korea for patients with relapsed or refractory MCL whose symptoms advanced after previously receiving a BTK inhibitor. Jaypirca is the first reversible BTK inhibitor to demonstrate clinical significance in patients with relapsed or refractory MCL who have undergone one or more BTK treatments. It selectively inhibits BTK with a 300-fold greater selectivity than any other kinases (98%) in a preclinical study. The basis for approval was the BRUIN Phase 1/2 clinical trials, which evaluated the effectiveness and safety of Jaypirca in patients with relapsed or refractory MCL who had previously received one or more BTK inhibitors. The primary analysis set (PAS), involving 90 patients who had previously been treated with one or more BTK inhibitors, had an overall response rate (ORR) of 56.7% and a duration of response (DoR) of 17.6 months. The most common adverse reactions after the Jaypirca treatment were fatigue (26.3%), decreased neutrophil count (22.8%), diarrhea (22.1%), and bruising (21%). The rate of discontinued treatment due to adverse reactions was 1.2%. The rate of reduced volume of treatment due to adverse reactions was 3.3%. Previously, Jaypirca was approved under the FDA's Accelerated Approval in January 2024 based on the response rate results. In South Korea, in June 2024, it was designated an orphan drug as the monotherapy for patients with relapsed or refractory MCL previously treated with BTK inhibitors. Last month, Jaypirca was the only drug considered for the reimbursement review by the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) to receive a reimbursement criteria decision. The remaining steps are the Drug Reimbursement Evaluation Committee (DREC) review, drug price negotiations with the National Health Insurance Service (NHIS), and a review from the Health Insurance Policy Review Committee. "The launch of Jaypirca is expected to expand the treatment opportunity for patients with MCL who couldn't continue treatment because there has been no alternative medication after the disease progressed after previous therapies," Mira Kyon, Head of Lily Korea Oncology Division, stated. "Lily will continue to put efforts into providing better patient treatment opportunities and suggesting new paradigms to blood cancer therapies."
