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- 2025-12-22 13:30:52
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- Keytruda and Vyloy to transform gastric cancer treatment
- by Moon, sung-ho Dec 17, 2024 05:51am
- Metastatic gastric cancer has long been labeled as a drug-barren area on site. Various clinical studies have been conducted to develop new therapies for the area, but most have been unsuccessful. This is due to the tumor's heterogeneity, which makes it difficult to prove the efficacy of treatments. However, the recent introduction of immuno-oncology drugs and targeted therapies has changed the treatment strategy in clinical practice. # The treatment paradigm for gastric cancer has now reached a state where the use of anticancer drugs is indispensable. However, due to obstacles in the domestic health insurance system, such as reimbursement and companion diagnostics, the use of these drugs in clinical practice is still limited. And pharmaceutical companies that are well aware of the situation have been scrambling to solve the problem. According to industry sources on the 13th, several drugs from global pharmaceutical companies have been approved in Korea for metastatic gastric cancer this year and are now available for clinical use. One representative drug is MSD Korea’s Keytruda (pembrolizumab). Keytruda was approved for the first-line treatment of metastatic HER2-positive gastric cancer, and in March this year, the indication was expanded to include HER2-negative gastric cancer. This makes Keytruda the first immuno-oncology option approved for both HER2-positive and HER2-negative gastric cancer. In the case of metastatic HER2-positive gastric cancer, the new indication was based on KEYNOTE-811, which was presented at the European Society for Medical Oncology’s ESMO Congress 2023. Specifically, after a median follow-up of 28.4 months, the Keytruda-trastuzumab-chemotherapy combination (10.0 months) reduced the risk of disease progression or death by 28% compared to trastuzumab-chemotherapy (8.1 months), resulting in a statistically significant improvement in PFS in the advanced HER2-positive gastric cancer ITT(intention to treat) population. The KEYNOTE-811 study, in particular, was expanded to a global clinical trial based on a trial led by Professor Sun Young Rha (Medical Oncology) at Yonsei Cancer Hospital. In addition, Keytruda was approved in March this year for the first-line treatment of HER2-negative gastric cancer, demonstrating clinical utility over chemotherapy regardless of the patient’s PD-L1 expression. Results from the KEYNOTE-859 trial, which became the basis of the drug’s approval for the indication, showed that at a median follow-up of 31 months, the median overall survival (OS) of the Keytruda-antineoplastic chemotherapy combination was 12.9 months, compared to 11.5 months with chemotherapy alone, and the risk of death was reduced by 22%. If Keytruda has changed the landscape of gastric cancer treatment as an immuno-oncology agent, Astellas' Vyloy (zolbetuximab) is the representative targeted therapy option. Vyloy is the first globally approved Claudin 18.2-targeted treatment, an immunoglobulin monoclonal antibody that binds to Claudin 18.2, a protein expressed and exposed in the stomach. Its approval in Korea allows Vyloy to be used in combination with fluoropyrimidine and platinum-based chemotherapy as a first-line treatment for patients with Claudin 18.2-positive, HER2-negative, unresectable locally advanced or metastatic gastric adenocarcinoma or gastro-oesophageal junction adenocarcinoma. The approval of Vyloy was based on two Phase 3 trials in patients with Claudin 18.2-positive and HER2-negative unresectable, locally advanced or metastatic gastric adenocarcinoma or gastro-oesophageal junction adenocarcinoma, the SPOTLIGHT and GLOW studies. In SPOTLIGHT, the median progression-free survival (PFS) in the Vyloy arm was 10.61 months, compared to 8.67 months in the control arm, reducing the risk of disease progression or death by approximately 25%. The secondary endpoint, median OS, was significantly higher in the Vyloy arm at 18.23 months versus 15.54 months in the placebo arm. Professor Sun Young Rha (Medical Oncology, Yonsei Cancer Hospital), Chairman of the Korean Cancer Association, said, “With an estimated prevalence of more than 100,000 patients with Stage IV gastric cancer in Korea, the approval of the first Claudin 18.2-targeted therapy will provide a breakthrough in the treatment of metastatic gastric cancer, an area that had limited options. In addition to expanding treatment options, the significant improvement in mOS compared to conventional chemotherapy, as Vyloy reduced the risk of disease progression or death by approximately 25%, is very encouraging in the treatment of metastatic gastric cancer due to its stagnant survival rate.” Keytruda’s expanded indication and the introduction of Vyloy have changed the treatment strategy for metastatic gastric cancer in Korea, but institutional obstacles have been obstructing its full use on-site. In the case of Keytruda, it has been difficult to cross the threshold of the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee. It has applied for reimbursement for 17 indications but is being held up by the CDDC because it would require a significant investment in health insurance finances. As of August, the company has applied for insurance reimbursement benefits to the CDDC for a total of 17 indications, upon being granted marketing authorization for 33 indications in 17 cancers. After applying for reimbursement for 13 indications last year, the company added four more indications to the application this year, including MSI-H gastric cancer, MSI-H biliary tract cancer, HER2-positive gastric cancer, and HER2-negative gastric cancer. In addition, MSD Korea submitted a new reimbursement proposal in October to expand the reimbursement standard for 17 indications, including gastric cancer and is making every effort to set reimbursement standards this year. For reference, HIRA’s last CDDC meeting this year is scheduled for the 18th. However, it has been reported that there has not been a proper discussion made on the gastric cancer indication yet. If it fails to pass this year's CDDC review, Keytruda's application will enter its third year of deliberations. An MSD Korea official said, “Patients with gastric cancer, triple-negative breast cancer, and head and neck cancer, for which there are no current therapies available, are longing for the opportunity to be treated with Keytruda, which has demonstrated sufficient clinical utility. This reimbursement submission also includes the gastric cancer indication for which we applied for additional reimbursement expansion earlier this year. We hope it will be included in the final CDDC review.” Vyloy’s situation is different, but similar to Keytruda's. Companion diagnostics are required to use the drug, but this restriction is holding the drug’s use back. This is because HIRA is reportedly considering whether Roche Diagnostics' companion diagnostic test for Claudin 18.2, immunohistochemistry (IHC), should be evaluated as a new health technology in the reimbursement review process. If it is subject to a new health technology assessment, it would be difficult to utilize Vyloy in clinical practice during the review period, apart from its reimbursement. “If the companion diagnostic test method for Vyloy is subject to new health technology assessments, the introduction of the treatment in Korea may be delayed for up to a year,” said Rha. Targeted anticancer drugs and companion diagnostics inevitably go hand in hand, but the current system has structural limitations that do not support this, and patients are left to suffer the consequences. The KCA will continue to advocate for policy changes.”
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- Soaring exchange rate causes pharma asset value to fluctuate
- by Kim, Jin-Gu Dec 16, 2024 05:53am
- The sharp rise in the won-dollar exchange rate in the aftermath of the impeachment and martial law has had a significant impact on the asset value of pharmaceutical and biotech companies. Companies with much foreign currency assets held in dollars have shown a significant increase in their asset value due to the high exchange rate, such as Samsung Biologics and SK Biopharm, which have a large share of overseas business. On the other hand, companies with large foreign currency liabilities held in dollars experienced a decrease in asset value due to the rise in the exchange rate. #SB 'High exchange rate' gains for firms with large dollar assets...Samsung Biologics’ asset value rises to KRW 112.9 billion when the exchange rate rises by 10% According to industry sources, the won-dollar exchange rate closed at KRW 1,432.80 on the Seoul foreign exchange market on the 14th, up 1.00 won from the previous trading day. The won-dollar exchange rate has recently remained above KRW 1430 in the aftermath of the declaration of emergency martial law and failed the impeachment vote. In Q3, the average won-dollar exchange rate was KRW 1,358.55. In the 3 months since it has risen to over KRW 1430, an increase of over 5%. Compared to last year, the increase is even greater. In Q4 last year, the average exchange rate was KRW 1321.24, which rose more than 8% in a year. Some analysts predict that if the current turmoil continues, the won-dollar exchange rate could reach KRW 1,500. Changes in the won-dollar exchange rate The rise in the exchange rate can have a modest impact on the asset value of pharma-bio companies. In particular, companies with a large proportion of overseas business are greatly affected by the exchange rate due to the assets and liabilities they hold in foreign currencies. If the company owns much foreign currency assets in dollars, the asset value will increase due to the rise in the exchange rate, and conversely, if there are many financial liabilities borrowed in dollars, the asset value will decrease. In its latest quarterly report, Samsung Biologics explained that every 10% rise in the won-dollar exchange rate increases its net income before corporate taxes by KRW 112.9 billion. Considering that the current KRW-dollar exchange rate has risen by about 5% compared to the average exchange rate in the third quarter, the time of the quarterly report, it is calculated that the recent rise in the exchange rate has increased the corporate’s asset value by about KRW 50 billion. In the case of SK Biopharmaceuticals, every 10% rise in the exchange rate increases the value of its assets by KRW 7.8 billion. Chong Kun Dang’s asset value increased by KRW 1 billion. The analysis is that companies that own more assets than liabilities held in dollars would show an increase in asset value. #SB Cashable assets of Samsung Biologics, Celltrion, Dong-A ST, increase due to exchange rate fluctuations The rise in exchange rates will especially affect the cash and cashable assets of major pharmaceutical and biotech companies. They have already increased their cash and cash equivalents by hundreds of millions of won to tens of billions of won in the third quarter due to the rise in the exchange rate. If the current high exchange rate continues to the fourth quarter, it is expected that the companies’ cash and cashable assets will increase even further. Samsung Biologics reported cash and cash equivalents of KRW 540.2 billion at the end of the third quarter, an increase of KRW 172.3 billion from the KRW 367.9 billion at the end of the second quarter. The increase in cash and cash equivalents was partly driven by a rise in the exchange rate. The company explained that the effect of foreign exchange rate fluctuations on cash and cash equivalents amounted to KRW 19.9 billion. Approximately 9% of the increase in cash and cash equivalents in the third quarter (KRW 172.3 billion) was attributable to foreign exchange rate changes. During the same period, Celltrion's cash and cash equivalents increased by KRW 408.1 billion, up from KRW 564.6 billion to 972.7 billion, of which KRW 4.1 billion was attributable to foreign exchange rate changes. Dong-A ST's cash and cash equivalents increased from KRW 212.8 billion to KRW 301.3 billion. Of this, the increase in cash and cash equivalents due to exchange rate fluctuations amounted to KRW 700 million. In the case of SK Biopharm, cash and cash equivalents increased from KRW 239.7 billion to KRW 266.0 billion, with the effect of exchange rate fluctuations amounting to nearly KRW 200 million. In the case of Chong Kun Dang, Hanmi Pharmaceutical, and Daewoong Pharmaceutical, the companies’ cash and cash equivalents decreased in the third quarter compared to the second quarter, but cash and cash equivalents ultimately increased due to the effect of exchange rate changes. Exchange rate changes partially offset the decrease in cash and cash equivalents. At Chong Kun Dang, cash and cash equivalents decreased from KRW 219.6 billion at the end of the second quarter to KRW 203.1 billion at the end of the third quarter. However, it increased by KRW 1.3 billion due to exchange rate changes. If the exchange rate had not risen, the decrease in cash and cash equivalents would have been even greater. Hanmi Pharmaceutical's cash and cash equivalents decreased from KRW 55 billion to KRW 48.2 billion. However, it increased by KRW 1.6 billion due to the effect of exchange rate fluctuations. Daewoong Pharmaceutical saw a decrease in cash and cash equivalents from KRW 111.5 billion to KRW 94.6 billion, with an increase of KRW 1.1 billion due to the effect of exchange rate changes. If the current high exchange rate continues, the effect of the exchange rate fluctuations is expected to contribute more significantly to the overall increase in cash and cash equivalents of corporations. At Yuhan Corp, cash and cash equivalents decreased from KRW 299.3 billion at the end of the second quarter to KRW 229.9 billion at the end of the third quarter, with a decrease of KRW 500 million in cash and cash equivalents due to exchange rate fluctuations over the same period. The decrease in cash and cash equivalents is attributed to the exchange rate rise, as the companies had more financial liabilities in dollars than financial assets.
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- Daiichi Sankyo appoints Sunjin Lee to head Enhertu BU
- by Eo, Yun-Ho Dec 16, 2024 05:52am
- Sunjin Lee, head of Enhertu BU, Daiichi Sankyo Korea Daiichi Sankyo Korea has appointed Sunjin Lee (47), a former executive director of Takeda Pharmaceuticals Korea, as the new head of Daiichi Sankyo. According to industry sources, Daiichi Sankyo recently made the appointment. Lee will succeed Mr. Hyun-Joo Lee (48), who has left to head ZP Therapeutics Korea. After working at Baxter Korea and Boehringer Ingelheim Korea, Lee joined Takeda in 2017 as the Marketing Manager of Takeda's Hemophilia Business Unit, where she developed creative marketing strategies. At the company, Lee was recognized for her leadership skills, playing a pivotal role in improving access and awareness of Takeda's hemophilia business. Later, as the Launch & Digital Excellence Lead for the company’s Asia Pacific (APAC) region, she led product launches in the market and successfully executed projects, including providing vision and direction for the execution of digital transformation in APAC countries. Since 2022, Lee has led Takeda's Oncology Business Unit, where she has been responsible for promotional activities for anti-cancer drugs such as Zejula and Alunbrig. Meanwhile, Daiichi Sankyo's Oncology Business Unit, represented by the antibody drug conjugate (ADC) Enhertu, is an integrated business unit that involves the company’s licensing, drug pricing, and medical departments. Daiichi Sankyo seeks to become a global player in Oncology by 2025, and Enhertu is currently reimbursed in Korea.
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- New PAH drug Winrevair to land in KOR next year
- by Eo, Yun-Ho Dec 13, 2024 05:52am
- The new pulmonary arterial hypertension drug ‘Winrevair’ is expected to be commercialized in Korea soon. According to industry sources, MSD Korea's Winrevair (sotatercept), the world's first symptomatic treatment for pulmonary arterial hypertension, recently passed the second approval-reimbursement linkage evaluations. The drug’s formal approval is expected in 2025. Winrevair had been designated as an orphan drug by the Ministry of Food and Drug Safety in January, then designated as a Global Innovative products on Fast Track (GIFT) in April this year. In March, the US FDA approved Winrevair for the treatment of pulmonary arterial hypertension as a subcutaneous injection administered once every three weeks. Winrevair is a combination of the protein complex activin with the transforming growth factor TGF-β. It works by blocking abnormal signaling between pulmonary vascular cells to reverse disease progression. Pulmonary arterial hypertension is a condition in which the blood vessels in the lungs narrow, causing high pulmonary blood pressure, which leads to heart failure. In Korea, about half of patients die within 5 years. More than 10 drugs have been approved in the area, including phosphodiesterase-5 inhibitors and endothelin receptor antagonists, but many patients suffer from severe symptoms despite using 2 to 3 drug combinations. In Phase III STELLAR study, sotatercept demonstrated efficacy over placebo. In the trial, patients were randomized 1:1 to sotatercept or placebo to assess the efficacy and safety of the drug. Results showed that sotatercept increased the 6-minute walk distance (6MWD), the primary endpoint, by 40.1 meters compared to a 1.4-meter decrease found with placebo over the same period. 38.9% of patients that used sotatercept met the secondary composite endpoint, which included an improvement of 30 meters or more in the 6-minute walking test. This was 4 times longer than that of the 10.1% in the placebo group.
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- "Confirmed long-term Tx effects of Camzyos…new oHCM Tx"
- by Son, Hyung Min Dec 13, 2024 05:51am
- Dr. Neal K. Lakdawala, Professor at Brigham and Women "In a clinical study spanning three years, Camzyos has demonstrated consistent patient symptom management and safety in many patients with obstructive hypertrophic cardiomyopathy (oHCM). Given its proven efficacy in long-term treatment, it is expected that many patients with oHCM can significantly improve their quality of life through this treatment without the need for surgical treatment." During a recent meeting with Daily Pharm, Dr. Neal K. Lakdawala, Professor at Brigham and Women's Hospital in the United States, remarked on 'Camzyos,' a first-in-class targeted treatment option for obstructive hypertrophic cardiomyopathy (oHCM), as above oHCM is a type of hypertrophic cardiomyopathy (HCM) characterized by abnormal heart muscle thickening, primarily in the left ventricle. This condition obstructs blood flow and impairs heart function. Common symptoms include shortness of breath, chest pain, and fainting, and it can lead to complications such as heart failure, atrial fibrillation, and even sudden cardiac death. Until now, treatment methods besides surgical treatment because no treatments could directly target pathophysiological causes of oHCM. While unmet needs for oHCM have been high, the introduction of Camzyos as the first treatment targeting the pathophysiology of the disease has opened the gate for new treatment options. Camzyos is a treatment for oHCM that reduces excessive cross-bridge formation between actin and myosin in the heart muscle, which is the underlying cause of the condition. This mechanism helps relax the overly contracted heart muscle. Additionally, the therapy has demonstrated myocardial remodeling effects, improving not only the function of the heart but also its structural integrity. Camzyos can be reimbursed with the national health insurance starting this month in South Korea. Now, Korean patients with oHCM can use targeted treatment options besides the option of surgical treatment. Dr. Lakdawala remarked that Camzyos could change the treatment paradigm for oHCM since the drug's efficacy and safety were demonstrated not only in clinical trials for approval but also in long-term administration studies. Camzyos demonstrates consistent effectiveness in long-term administration studies In the EXPLORER-HCM trial, which was the basis for approval, Camzyos demonstrated significant improvement in the primary endpoint, which assessed both symptom severity (NYHA class) and exercise capacity (pVO2), compared to the placebo group. Camzyos continues to establish additional evidence for its long-term safety and efficacy. At the European Society of Cardiology annual congress (ESC 2024) in September, results from the MAVA-LTE clinical study evaluating Camzyos' long-term effects and safety were unveiled. Interim results showed that at week 180 of treatment, 66.3% of patients achieved NYHA Class I, with 46.8% demonstrating a complete response (NYHA Class I+Valsalva LVOT pressure gradient of ≤30 mmHg). The NYHA classification system, established by the New York Heart Association, evaluates the extent of symptoms and activity limitations in patients. Additionally, N-terminal pro-brain natriuretic peptide (NT-proBNP) levels decreased by 81% from baseline at week 180, with 53.8% of patients reaching normal NT-proBNP levels. NT-proBNP serves as a biomarker for assessing heart failure severity and prognosis, often elevated under conditions of excessive myocardial stress or stretch in heart failure patients. The EQ-5D-5L score, which assesses health-related quality of life, showed improvement, indicating better subjective health perceptions among patients. "Camzyos' long-term data, confirmed through the MAVA-LTE study, shows the positive potential of the drug. Patients' symptoms have been consistently maintained well during 3 years of long-term study, and the safety profile has also been consistent," Dr. Lakdawala emphasized. "In fact, the number of patients choosing to undergo surgical treatments is declining after the introduction of Camzyos. The Real-World Data of Camzyos confirmed in clinical practices show an equivalent level of effectiveness and safety profile to results demonstrated in previous clinical studies," Dr. Lakdawala added. "Although the outcomes may vary depending on individual's pathophysiology, most patients undergone Camzyos treatments also have significantly improved symptoms or show much improved responses." "Camzyos' myocardial remodeling effect, which improves cardiac function and structure, has gained most attention since the early EXPLORER-HCM study," Dr. Lakdawala stated. "The study results showed significant reductions in key indicators of cardiac hypertrophy in HCM, such as left ventricular wall thickness and left ventricular mass, following Camzyos treatment. These changes were observed as early as 24 to 30 weeks into the treatment and were sustained over the long-term treatment period," he added. Despite the introduction of targeted treatment option..undiagnozed patients↑ Despite the recent introduction of targeted treatment option, diagnosing oHCM is still challenging. According to Dr. Lakdawala, many cardiomyopathy patients often adapt to their long-standing symptoms, and they fail to recognize their condition. Typically, as symptoms gradually restrict physical activity, patients adjust to a limited lifestyle and forget that their health status is not normal. Dr. Lakdawala explained that many patients only realize that HCM caused their past symptoms after receiving a diagnosis and experiencing improvement following treatment. "The issue of undiagnosed HCM is one of the major global challenges today. To address this issue, it is crucial to educate cardiology healthcare providers through multiple channels to help them understand that patients’ symptoms may be associated with this condition," Dr. Lakdawala emphasized. "When there is a thickening of the left ventricular wall, it is important not to simply attribute it to secondary effects of hypertension or overlook the severity of the condition. Additionally, the lack of appropriate imaging diagnostics, which often leads to missed diagnoses of HCM, is another critical issue that must be resolved," he stressed. With the introduction of Camzyos, patients' left ventricular outflow obstruction and related symptoms can be improved by taking an oral drug once a day. While surgical treatment is still necessary for some patients, most are expressing satisfaction that their symptoms can be effectively managed through oral medication alone, according to Dr. Lakdawala. "Recent guidelines for HCM in the United States and Europe prioritize a patient-centered approach above all," he stated. "These guidelines focus on symptom management as the primary goal and emphasize expanding treatment options to improve symptoms. Previously, surgical treatments like septal reduction therapy (SRT) had been the primary option. Introducing Camzyos in the guidelines provided a new option, expanding patients' treatment choices." Dr. Lakdawala added, "In the past, HCM patients were often prohibited or restricted from engaging in physical activity. However, recent studies have confirmed that appropriate levels of exercise are safe for these patients. Based on this evidence, we are gradually relaxing guidelines to permit regular exercise and moderate physical activity, while continually seeking ways to enhance the quality of life for patients with HCM."
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- NeuroBiogen enters into Binding Term Sheet with US Company
- by Lee, Seok-Jun Dec 12, 2024 05:50am
- Scilex Holding Company, a Nasdaq-listed company, announced that d a binding Term Sheet had been signed between NeuroBiogen, a Korean company specializing in innovative new drugs, and Scilex Bio, a controlling interest of joint venture by Scilex Holding Company on December 10th, local time. Under the terms of the agreement, Scilex Bio will be granted an exclusive worldwide license to develop and commercialize tisolagiline (KDS2010), an oral treatment for Alzheimer's disease and obesity that is in clinical development by NeuroBiogen. The collaboration will leverage NeuroBiogen’s R&D capabilities for KDS2010 and Scilex’s commercialization expertise in the central nervous system and first-line therapy. “We are currently in the process of finalizing a term sheet with Scilex for the formal agreement, and are currently negotiating the details of the agreement,” said a NeuroBiogen representative. NeuroBiogen has successfully completed a Phase I clinical trial on KDS2010 for Alzheimer's disease and obesity and is conducting a Phase II trial. Meanwhile, Scilex, which was founded in 2011, is a leading research and development company for CNS-related therapies, including FDA-approved treatments for gout, migraine, and non-opioid painkillers.
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- 'Effective in Asian patients' Leclaza vs Tagrisso comb
- by Son, Hyung Min Dec 12, 2024 05:49am
- Leclaza plus Rybrevant and Tagrisso plus platinum-based chemotherapy have shown consistent effects in Asian patients. The effects of the combination therapy of Leclaza and Tagrisso, which are non-small cell lung cancer (NSCLC) treatments, have been unveiled at the European Society for Medical Oncology (ESMO) Asia Congress 2024. ESMO Asia Congress 2024 took place over three days, starting on December 6, in Singapore. The concurrent use of Leclaza with Rybrevant subcutaneous (SC) formulation showed non-inferior results compared to the conventional Rybrevant intravenous (IV) injection. Tagrisso plus platinum-based chemotherapy has consistently improved overall survival compared to Tagrisso monotherapy in Asian patients. Leclaza plus Rybrevant SC formulation, injection-related adverse reactions sixfold↓in the PALOMA-3 study Combination therapy of YuhanAccording to industry sources on December 10, Janssen unveiled the result of the PALOMA-3 clinical trial, which was to investigate the potential of Leclaza plus Rybrevant SC formulation, treatments for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Previously, in this clinical study, Leclaza plus Rybrevant SC showed non-inferiority compared to Leclaza plus Rybrevant IV. Leclaza plus SC Rybrevant combination therapy had an objective response rate (ORR) of 30.1%, whereas Leclaza plus IV Rybrevant combination therapy had an ORR of 32.5%, meeting the non-inferiority requirement. Leclaza plus SC Rybrevant combination therapy showed a positive trend regarding progression-free survival (PFS). PFS refers to a duration during which a patient's disease does not worsen. Unlike the oral formulation of Leclaza, Rybrevant was developed as an IV injection. For Rybrevant IV inj, patients have the inconvenience of visiting the hospital once every 2-3 weeks, and the administration takes more than an hour. Janssen plans to develop an SC formulation to offer ease of administration and reduce concern regarding adverse reactions related to injection. SC formulation is expected to improve patient convenience since it can significantly reduce the administration duration to within 10 minutes. The latest presentation is a follow-up clinical result where the efficacy and safety of the drug were evaluated in 255 Asian patients out of the total 418 study participants. Patients had previous treatment history of receiving AstraZeneca's targeted therapy Tagrisso and platinum-based chemotherapy. During the first 4 months of the treatment, 74% of the Leclaza+Rybrevant SC group and 75% of the Leclaza+Rybrevant IV group received anticoagulant agents to prevent venous thromboembolism (VTE). The key endpoints included disease control rate (DCR), duration of response (DOR), PFS, overall survival (OS), and safety. Clinical results showed that the Leclaza+Rybrevant SC group had a DCR of 80.2%, and the Leclaza+Rybrevant IV group had a DCR of 72.9%. DCR refers to a percentage of delaying the disease progression to extend patient survival. For PFS, Leclaza+Rybrevant SC group showed a favorable trend. At 12 months, 77% of the patients treated with Leclaza+Rybrevant SC survived. It was 61% for those treated with Leclaza+Rybrevant IV. DOR and PFS could not be estimated. For injection-related response (IRR), the Leclaza+Rybrevant SC group had an IRR sixfold less than the Leclaza+Rybrevant IV group. Most responses were mild, Grade 1-2. For the VTE occurrence rate, 11% of the Leclaza+Rybrevant SC group treated with anticoagulant had VTE, and it was 12% for the Leclaza+Rybrevant IV group. It was 18% and 22% for those who did not receive anticoagulants, respectively. The safety profile of Asian patients corresponded to those in other countries. The effectiveness of Tagrisso+platinum-based chemotherapy as a first-line treatment has been reconfirmed AstraZenecaAstraZeneca unveiled the study results of the FLAURA2 cohort study, which involved Tagrisso+platinum-based chemotherapy in Asian patients. Previous results of this clinical study showed that Tagrisso+platinum-based chemotherapy demonstrates a statistically significant improvement in PFS compared to Tagrisso monotherapy. Patients had not previously received treatment, and they were randomly assigned 1:1 to Tagrisso plus pemetrexed (product name: Alimta) plus cisplatin/carboplatin group and Tagrisso monotherapy group. Participants were categorized into Chinese Asian/non-Chinese Asian/non-Asian. The primary endpoint included PFS, and the secondary endpoints included OS, ORR, DOR, and safety. The clinical results showed that the PFS of the Tagrisso combination therapy group was 25.5 months, which was over six months older than the 19.4 months in the Tagrisso monotherapy group. The median OS was 40.5 months for the Tagrisso combination therapy group and 38.3 months for the Tagrisso monotherapy group. The safety profile showed that the adverse event rates over Grade 3 in the Tagrisso combination therapy group were 67%, higher than in the Tagrisso monotherapy group. The adverse event rates due to discontinued use of Tagrisso were 10% for the Tagrisso combination group and 7% for the monotherapy group. "Tagrisso+platinum-based chemotherapy showed consistent benefits in Asian patients similar to the previous clinical results. Such clinical results demonstrate the potential of the therapy as a first-line treatment of Asian patients with EGFR-positive advanced NSCLC," a researcher remarked.
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- Merck Biopharma Korea and LG Chem will comarket Glucophage
- by Whang, byung-woo Dec 12, 2024 05:49am
- (from the left) In-Kyum Hwang, Head of the Diabetes and Cardiovascular Business Unit at Merck Biopharma Korea; In-Cheol Hwang, Senior Vice President of LG Chem’s Primary Care Business Division Merck Biopharma Korea announced on the 11th that it has signed a partnership agreement with LG Chem to jointly sell Glucophage (metformin hydrochloride), a treatment for type 2 diabetes, in Korea. Under the agreement, LG Chem will distribute Glucophage to healthcare providers in Korea starting January 1, 2025. Merck Biopharma Korea will continue to hold the marketing authorization. Glucophage is a treatment for type 2 diabetes, a condition in which the body becomes resistant to insulin, resulting in relatively impaired insulin secretion and elevated blood sugar. Since being first used in the clinic in 1957, it has been in use for more than 60 years and is recommended as a first-line treatment in the world's leading type 2 diabetes treatment guidelines, including the American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD) and the American Association of Clinical Endocrinology (AACE). The companies entered into the partnership agreement to expand their presence in the Korean diabetes market through the synergy of Merck's global quality management capabilities and LG Chem's strong marketing and sales capabilities. While LG Chem's Zemiglo product line holds a leading position in the domestic DPP-4 inhibitor market with a 23.8% share (according to UBIST, Q3 2024), the company's strategy is to further strengthen its presence in the diabetes treatment market through the sale of Glucophage. “Based on our close partnership with Merck, we will provide effective diabetes treatment solutions to our customers and further strengthen our market leadership position by continuously expanding our diabetes treatment portfolio,” said In-Cheol Hwang, Senior Vice President of LG Chem’s Primary Care Business Division. “Through our collaboration with LG Chem, we look forward to providing stable and reliable treatment options for diabetes patients in Korea,” said In-Kyum Hwang, Head of the Diabetes and Cardiovascular Business Unit at Merck Biopharma Korea. “Based on our corporate philosophy, ‘As One for Patients,’ we will continue to pursue patient-centric innovation and will continue our endeavors to improve the quality of life for people with type 2 diabetes.”
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- 'Lalaola' wins 2024 Pharma Industry ad grand prize
- by Son, Hyung Min Dec 11, 2024 05:54am
- The winner of the 2024 pharmaceutical and biotechnology industry advertising·PR awards has been announced. Yuhan's 'Lalaola' won the Grand Prize in the advertising category, and Amgen Korea's 'Blue Wish campaign' won the Grand Prize in the PR category. On December 10, Dailypharm (Publisher: Lee Jeong Seok) hosted the '2024 Korean Pharmaceutical & Biotech Industry Advertising·PR Awards Ceremony' at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KBPMA)'s K-Room. This year, the awards ceremony marked 12 years, and 66 contents in the advertising and PR categories were submitted to compete. On December 10, Dailypharm (Publisher: Lee Jeong Seok) hosted the 12th The awards were categorized into the advertising and PR sectors. In the advertising category, a grand prize, three best prizes, and seven excellence awards have been selected. In the PR category a grand prize, two best prizes, and three excellence awards have been awarded. The awards were presented in the advertising category by the following sections: ▲TV·CF ▲Prints·Radio▲Internet·SNS, in the PR category: ▲Social Contribution·Disease Awareness Campaigns ▲Corporate·Product Promotion. Yuhan's 'Lalaola' won the Grand Prize in the advertising cateogry. The winner was presented with a plaque and a cash prize of KRW 5 million. Yuhan won the Grand Prize in the advertising category. The award recipient Kim Jong-won, Director of External Affairs at Yuhan, stated, "Lalaola was launched in South Korea in July 2023, and this year, we have made efforts to promote the product. We hope Lalaola will grow in the market for high-dose arginine, similar to Mag-B. We look forward to participating in the ceremony next year again." In the TV·CF category, Johnson & Johnson Korea's 'Tylenol' and Iksu Pharmaceutical's 'Iksu Kongjin-dan' were awarded the best prize, receiving plaques and a cash prize of KRW 3 million. Handok's 'Ketotop,' Chong Kun Dang's 'Braining Cap,' Reckitt Korea's 'Gaviscon,' and Daewon Pharm's 'Coldaewon Kids' won the excellence awards. In the Internet·SNS category, Jeil Health Science's 'Jeil Cool Pap' was awarded the best price. Excellence awards were given to Dongkook Pharmaceutical's 'Cencia' and Kyung Nam Pharm's 'PM-Zol-Q series,' each receiving trophies and a cash prize of KRW 2 million. Dongsung Bio Pharm's 'Loxo-N Gel' won the excellence award in the Prints·Radio category. In the PR category, entries that delivered meaningful messages to society, particularly those focusing on social contributions and ESG activities, were awarded. This year's grand prize in the PR category went to Amgen Korea's 'Blue Wish campaign,' a social contribution initiative fulfilling the wishes of children with rare diseases. The award included a plaque and a cash prize of KRW 5 million. Seohyun Kim, Director of External Affairs at Amgen Korea, said, "We are pleased to receive such an honorable award. Three weeks ago, we decorated a room for a child who has been battling leukemia for a long time. The child's dream was to have a newly decorated room, and fulfilling that dream was deeply moving. I'll be joining the volunteers tonight, and I intend to dedicate this award to them. I will also donate the prize money." In the PR subcategory for Social Contribution·Disease Awareness Campaigns, the best awards went to Novartis Korea's 'Shine a Light on HS (Hidradenitis Suppurativa)' campaign. Sanofi's 'Helping Hands' campaign received the excellence award. In the Corporate·Product Promotion category, the best prize was awarded to HK Inno. N's corporate promotion program, which received a plaque and a cash prize of KRW 3 million. JW Pharmaceutical's 'JW R&D Insight' and Shinshin Pharmaceutical's 'Short Form' campaign won excellence awards. Korean Pharmaceutical & Biotech Industry Advertising·PR Awards were established in 2013 to encourage advertising and PR professionals who bring new value to the pharmaceutical industry and medicines and promote the creation of advertisements that resonate with pharmacists, the primary target of pharmaceutical advertising. In his opening remarks, In-ho Ga, Head of the Dailypharm's Press Department, stated, "I believe the fresh and creative ideas of advertising and PR professionals have made significant contributions to pharmaceutical branding. I sincerely congratulate the winning companies." This year's contest was judged by a panel led by Daechun Ahn, the former President of the Korean Advertising Society (Professor at Korea University), along with Jae Hoon Cheong, Professor at Sahmyook University College of Pharmacy, and Jae-Kook Lee, Senior Vice President of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA). "We evaluated whether the strategy and messaging were clear and effectively conveyed in the advertising category. In the PR category, we focused on the campaigns' authenticity, consistency, and sustainability. Many excellent works that met the judging criteria were submitted," Ahn explained. "This event is meaningful in recognizing the hard work of advertising and PR professionals in the pharmaceutical and biotech industry over the past year. Next year, many PR professionals are expected to continue to play a pivotal role," Jae-Kook Lee, Senior Vice President of KPBMA remarked. Youngshin Lee, the CEO of the Korean Research-Based Pharma Industry Association (KRPIA), said in a video message, "The importance of precise pharmaceutical information has been emphasized, and the media environment is changing. Delivering accurate medication information is essential for helping patients and their families return to their daily routines. I extend my gratitude and encouragement to the advertising and PR professionals who design sincere campaigns to promote pharmaceuticals. I hope this advertising award acts as a meaningful platform that enhances the pride of PR professionals in the industry."
- Company
- Lilly will directly distribute Trulicity in Korea next year
- by Lee, Tak-Sun Dec 11, 2024 05:54am
- Pic of Trulicity Lilly, who holds the marketing authorization for the diabetes drug ‘Trulicity (dulaglutide),’ which has been distributed by Boryung since 2016, will directly distribute the drug in Korea from next year. With the launch of the diabetes and obesity drug Mounjaro (tirzepatide) expected next year, it is expected that this change of distributors will have an impact. According to industry sources on the 9th, Lilly Korea told its customers that the distributor for Trulicity 0.75mg/0.5ml and 1.5mg/0.5ml disposable pens will be changed from Boryung to Lilly from next year. Boryung and Lilly signed a joint sales agreement in June 2016 to market and sell Trulicity in Korea. Under the agreement, Boryung has been the exclusive distributor of Trulicity in Korea. Trulicity is a GLP-1 receptor antagonist class diabetes drug. GLP-1 analogs are developed using the hormone glucagon-like peptide-1 (GLP-1), which is involved in the regulation of blood sugar in the body. GLP-1 analogs stimulate insulin secretion but are less likely to cause hypoglycemia, therefore has the advantage of lowering the risk of hypoglycemia compared to conventional insulin. It is also used to treat obesity because it suppresses appetite and supports weight loss. In particular, Trulicity has almost monopolized the domestic GLP-1 analog diabetes treatment market with its convenience of once-weekly administration to control blood sugar. Based on IQVIA, domestic sales were KRW 41.8 billion in 2020, KRW 49.9 billion in 2021, KRW 59.5 billion in 2022, and KRW 54.5 billion in 2023. However, the drug has been struggling with domestic supply due to increasing global demand. With Trulicity’s distributor changing from Boryung to Lilly, attention is also focused on the domestic supply of Mounjaro, which is expected to become the next-generation GLP-1 product. In addition to diabetes, Mounjaro gained an indication for obesity last year and has been regarded as a viable rival to Wegovy (semaglutide, Novo Nordisk). Given Lilly's relationship with Boryung, which had been tied by Trulicy, many in the industry had expected Boryung to distribute Mounjaro. However, with Lilly taking over direct distribution from next year, it is expected that Mounjaro will be supplied by Lilly itself or a third domestic pharmaceutical company. An industry insider explained, “It is difficult to predict a drug’s copromotors because there are many interested parties involved. The company said it will distribute Trulicity directly next year, but we don't know how the situation will change.”
