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- 2026-05-03 21:03:12
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- "Breast cancer treatments received positive reviews"
- by Son, Hyung-Min Jun 07, 2024 05:50am
- Major antibody-drug conjugates (ADC) have secured positive clinical results in treating breast cancer. ADCs under development by global pharmaceutical companies have shown to be effective in various types of breast cancer, including triple-negative breast cancer, hormone-positive (HR+)/HER2-negative breast cancer. With these results, latecomers have established a foundation to secure indications for breast cancer, following the cases of Kadcyla, Enhertu, and Trodelvy. According to industry sources on June 4th, clinical achievements of several ADCs, including Padcev, datopotamab deruxtecan, and sacituzumab tirumotecan, were presented at the American Society of Clinical Oncology (ASCO 2024) annual meeting, which started on May 31st. Astellas and Seagen have presented clinical outcomes of their ADC Padcev. Padcev, an ADC anticancer agent targeting the cell surface protein nectin-4, has been approved worldwide for urothelial carcinoma. During this meeting, the results of the phase 2 EV-202 clinical study, confirming its potential in breast cancer, were disclosed. Both companies are exploring possibilities not only in urothelial carcinoma but also in breast cancer, gastric cancer, and non-small cell lung cancer, as nectin-4 protein is expressed in various solid tumors. On June 2, the Phase 2 study results of Padcev, a nectin-4-targeting ADC, were presented at ASCO 2024 (source: snapshot of ASCO 2024 lecture presentation). EV-202 clinical study evaluated Padcev’s effectiveness and safety in patients with triple-negative breast cancer and hormone (HR) positive·HER2-negative breast cancer who have been treated with chemotherapy before. The primary endpoint was objective response rate (ORR), and the secondary endpoints were duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and and safety/drug tolerance. The clinical results showed that the Padcev treatment group had an ORR of 19.0% for triple-negative breast cancer, while the DRR, an index measuring the percentage of patients with no disease progression during or after the treatment, was 57.1%. Such results were consistent with the outcomes for HR+/HER2- breast cancer. The Padcev treatment group recorded an ORR of 15.6%, while the DCR was 51.1%. The treatment-related adverse events (TRAE) of over Grade 3 for Padcev were decreased neutrophil counts (7%), decreased white blood cell counts (5%), and increased aspartate aminotransferase (5%). Adverse reactions identified in two cohorts were manageable and consistent with previously disclosed safety data. Currently, for triple-negative breast cancer, there is no ADC approved after Trodevly. All eyes are on whether Padcev would secure an indication for treating triple-negative breast cancer through follow-up clinical results. A TROP2-targeting ADC demonstrated additional effects on breast cancer On June 2, the clinical results of datopotamab deruxtecan, under development by Daiichi Sankyo and AstraZeneca, and MSD’s sacituzumab tirumotecan were disclosed. These two drugs are ADCs targeting TROP2 protein, an intracellular calcium signal transducer regulating cell proliferation and survival. TROP2 protein is expressed in healthy cells but commonly overexpressed in cancer cells. The protein is also associated with drug resistance. Gilead Sciences’ Trodelvy is the only available drug with a similar mechanism that succeeded in commercialization. Datopotamab is under clinical trials to confirm its potential for breast cancer and non-small cell lung cancer. The TROPION-BREAST01 study showed that datopotamab improved PFS for HR+/HER2- breast cancer. This time, the report detailing the study’s patient reported outcome (PRO) was disclosed. The TROPION-BREAST01 study increased the likelihood of datopotamab securing an indication to treat breast cancer (source: snapshot of ASCO 2024 lecture presentation). The clinical study involved 732 patients with inoperable or metastatic HR+/HER2- breast cancer previously treated with at least one chemotherapy. The patients were randomly assigned to either the datopotamab group or investigator’s choice of chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) with a 1:1 allocation. The PRO included (GGS), quality of life (QoL), and time to deterioration (TTD) evaluated by EORTC QLQ-C30, a questionnaire to assess the quality of life of cancer patients. The clinical results showed that the TTD for QOL in the datopotamab group was 3.4 months, compared to 2.1 months in the chemotherapy group. TTD for the datopotamab group was confirmed to be delayed in terms of physical function, pain, and most other symptoms and functioning scales. MSD’s sacituzumab tirumotecan was shown to be effective in triple-negative breast cancer. In 2022, MSD licensed the ADC candidate sacituzumab from China-based Sichuan Kelun-Biotech. Results from the phase 3 OptiTROP-Breast01 study compared sacituzumab to investigator’s choice chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) in patients with locally recurrent or metastatic breast cancer. The primary endpoint was PFS, assessed by blinded independent central review (BICR). Interim analysis results for PFS showed that the sacituzumab group recorded a PFS of 5.7 months, which was longer than the 2.3 months in the chemotherapy group. PFS at 6 months was 43.4% for the sacituzumab group and 11.1% for the chemotherapy group. Sacituzumab reduced the disease progression and mortality risk by 69%. OS was significantly favorable for Sacituzumab treatment. “Sacituzumab monotherapy demonstrated clinically meaningful PFS and OS benefits compared to chemotherapies,” an investigator stated. “Moreover, it demonstrated a manageable safety profile for treating triple-negative breast cancer, which has limited treatment options.”
- Company
- ‘Fully utilize the various IBD treatment options available'
- by Eo, Yun-Ho Jun 07, 2024 05:50am
- Professor Hong Sub Lee. Busan Paik Hospital, Inje university. Incidence of Inflammatory bowel disease (IBD), which had been regarded as a condition typically associated with Westerners, is now rising amongst Asian populations as well, including Koreans. According to the IBD fact sheet published by the Korean Association for the Study of Intestinal Diseases, the number of patients with ulcerative colitis and Crohn's disease has more than doubled in 10 years, to 37,000 and 18,000, respectively, by 2019. At the same time, treatments that can be used as a "weapon" by doctors are being introduced competitively to the market are being launched competitively. In an interview with Dailypharm, Professor Hong Sub Lee (Department of Gastroenterology) of Busan Paik Hospital, Inje University, assessed the importance of 'sequencing' the existing and new drugs and preparing an IBD treatment strategy customized for each patient. In recent years, appropriate drug selection has emerged as a key issue in the treatment of IBD in clinical practice in Korea, as treatment options have diversified to include Janus kinase (JAK) inhibitors in addition to conventional biologics. While it is not always possible to immediately switch to another drug when the therapeutic effect of a drug is inadequate, the availability of several prescribable options has created a dilemma of which drugs to use and in what order. Professor Lee explained, "We divide patients into low-risk and high-risk groups according to the presence and severity of symptoms, and then develop a treatment strategy and select drugs accordingly.” Lee added, "High-risk patients are those who are younger, have lesions that invade the entire large intestine and have deep ulcers. They are considered high-risk patients according to IBD metrics, in which case they are judged to be candidates for biologics or small molecule drugs that have recently been introduced in Korea." "We approach patients with fewer symptoms with the usual treatment strategy. But high-risk patients need to start a treatment sequence in line with the health insurance reimbursement system as quickly as possible." Adding to the dilemma for clinicians is the recent increase in the use of JAK inhibitors as a mainstream treatment option for ulcerative colitis and Crohn's disease. "Recently, JAK inhibitors have also been increasingly used to treat IBD. For example, filgotinib is the only JAK inhibitor that can be prescribed directly after azathioprine. According to clinical trials, upadacitinib has shown a high effect. However, to prescribe other JAK inhibitors, you need to first take patients off azathioprine, which is problematic for doctors because they have to remove a drug that they believe is effective for their patients." Therefore, Professor Lee believes that Korea’s reimbursement standards need to be improved to allow for more freedom of choice in clinical practice. "I would like to be able to quickly prescribe the increasing number of drug options to patients who really need them. We don't need to wield a big knife for patients with mild symptoms, but we need to improve the reimbursement standards so that we can approach each patient especially those at high risk with a personalized treatment strategy so that we can actively use necessary drugs.” "In addition to drugs, fecal microbiota transplantation (FMT), which utilizes the gut microbiome to treat IBD, is a major therapeutic option. I opened an inflammatory bowel disease clinic last November and am looking to start a gut microbiota transplantation company and pursue its research. I want to research and develop therapies using FMT to help treat IBD in practice."
- Policy
- Latuda·Dupixent enter negotiations with the NHIS
- by Lee, Tak-Sun Jun 07, 2024 05:50am
- (from the top) 'Latuda (lurasidone),' a medication used to treat schizophrenia and imported and distributed by Bukwang Pharmaceutical, and 'Dupixent (dupilumab),' which aims to expand reimbursement for young children, have entered negotiations with the National Health Insurance Service (NHIS). When an agreement with the National Health Insurance Service (NHIS) is completed, reimbursement coverage is possible following reporting to the Health Insurance Policy Review Committee According to the NHIS on June 5, Latuda 20, 40, 60, 80, 120mg and Dupixent Prefilled Inj 200 mg and 300 mg entered negotiations this month. These two drugs have cleared the review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) held in May. At the time, Latuda received a decision that it could receive reimbursement if accepted below-evaluated amount. It appears that Bukwang Pharmaceutical accepted the DREC’s suggested below-evaluated amount. When a company agrees with an amount below the standard to be exempted from the drug pricing negotiations, it will only negotiate the expected claim amount. Latuda, developed by Japan's Sumitomo Pharma, is an atypical antipsychotic medication used in the treatment of schizophrenia and type 1 bipolar disorder. It works by binding to dopamine and serotonin receptors in the central nervous system, blocking the action of neurotransmitters in the brain. Bukwang Pharmaceutical acquired the exclusive development·license of Latuda for South Korea in 2017. Latuda is reported to have generated US$1.465 billion (about KRW 1 trillion) in sales in the United States in 2022. Dupixent has applied for expanded reimbursement for treating patients with severe atopic dermatitis in children aged 6 months to younger than 6 years. In May, the DREC decided that the expanded reimbursement criteria were appropriate. When the negotiations for expanded usage are completed, Dupixent will be reimbursed for patients with severe atopic dermatitis from 6 months to adulthood. In the LIBERTY AD PRESCHOOL Phase 3 trial, Dupixent showed significant improvement in skin lesions in young children. At 16 weeks, 28% of patients treated with Dupixent in combination with topical corticosteroids (TCS) showed a score of 0 or 1 point in the Investigator's Global Assessment PN-Stage (IGA PN-S), demonstrating a significant improvement in atopic dermatitis compared to 4% of the placebo group. Consequently, it met the primary efficacy endpoint. Its indication for young children was approved in South Korea in November 2022.
- Company
- ADC·immunotherapy competitiveness↑…K-bio gains attention
- by Son, Hyung-Min Jun 07, 2024 05:50am
- The American Society of Clinical Oncology (ASCO 2024) annual meeting started on May 31st lasting five days in Chicago, U.S. Korea-based biopharmaceutical companies have confirmed clinical achievements in globally trending R&D areas, including antibody-drug conjugates (ADC), immunotherapy for cancer, and bispecific antibodies. LigaChem Biosciences presented clinical data of LCB14, a human epidermal growth factor receptor 2 (HER2)- targeting ADC candidate. LBC14 has been shown to improve primary assessment indexes. ABL Bio confirmed efficacy in various solid cancers and blood cancers, including diffuse large B-cell lymphoma (DLBCL), Hodgkin lymphoma, non-small cell lung cancer (NSCLC), and pancreatic cancer. Additionally, the Korea-based biopharmaceutical industry’s immunotherapy for cancer with a new mechanism of action have shown potential at early stages of clinical trials. It has also shown synergistic effect with bispecific antibodies. LigaChem Biosciences’ ADC shows comparable efficacy to Enhertu At ASCO 2024, LigaChem Biosciences presented the Phase 2 clinical trial result of LCB14, a HER2-targeting ADC candidate. LCB14 is linked via a monomethyl auristatin F (MMAF) agent, unlike most ADC drugs employing topoisomerase inhibitors. MMAF is an anti-tubulin inhibitor that kills cancer cells by inhibiting microtubule formation. Currently, Roche’s Kadcyla Daiichi Sankyo·AstraZeneca’s Enhertu have emerged as HER2-targeting ADCs. These two were approved for the treatment of breast cancer, but only Enhertu was approved gastric cancer. LigaChem Biosciences is confirming the market potential of its candidate for one of Enhertu’s indications, metastatic gastric cancer or gastroesophageal junction cancer. The clinical trial evaluated LCB14’s efficacy in patients with gastric cancer who had received at least two or more previous treatments (16 patients, cohort 1) and who had received at least one treatment (19 patients, cohort 2). Cohort 1 treated with LCB14 had an objective response rate (ORR) of 37.5%, a median progression-free survival (PFS) value of 4.3 months, and an overall survival (OS) of 10.0 months. This result was comparable to the clinical result of DESTINY-Gastric06, evaluating Enhertu’s efficacy, with an ORR of 35.6%, a PFS of 5.7 months, and an OS of 10.2 months. Cohort 2 treated with LCB14 recorded an ORR of 52.6%, a mPFS of 4.4 months, and an OS of 14.6 months. Since LCB14 has shown comparable efficacy to Enhertu in a phase 2 clinical trial, LigaChem Biosciences expects its potential use in treating patients with recurrent solid cancer. ABL Bio has confirmed the efficacy of CS5001, a ROR1-targeting ADC, in a phase 1 clinical trial. ROR1 is strongly expressed during fetal development. The clinical trial analyzed the efficacy, pharmacokinetics (PK), and antitumor activity of CS5001 in patients with solid cancer and lymphoma. As of January 15, 2024, the drug tolerance and safety of eight doses of CS5001 were analyzed in 17 lymphoma patients and 32 solid cancer patients. In the first eight dose groups of CS5001, no dose-limiting toxicities (DLT) were observed. Superior safety and expected pharmacokinetics property were reported, with the maximum tolerated dose (MTD) not being reached. Their investigator said, “CS50001 treatment has shown modest drug tolerance without experiencing DLT. Additionally, we observed favorable anticancer activities in various advanced solid cancers and lymphoma.” Achievements in clinical trials of immunotherapy for cancer·bispecific antibodies GI Innovation has confirmed the effectiveness of GI-102, a candidate immunotherapy for cancer. This company is developing GI-102, which acts on CD80 and interleukin (IL)-2. IL-2 is involved in immune cell proliferation and activation, and CD80 blocks CTLA-4, a receptor preventing immune cells from attacking cancer cells. The presented clinical trial results evaluated the safety, drug tolerance, and antitumor activities of GI-102. Korea-based biopharmaceutical companies participated in poster sessions at ASCO 2024, which commenced on May 31. An ORR of 17.4% was observed in 23 patients (7 skin melanoma patients, 4 NSCLC patients, and 3 ovarian cancer patients). The reported overall ORR was 42.9%, and the disease control rate (DCR) was 85.7%, including three cases of partial response (cPR) confirmed in patients with metastatic skin melanoma who had previously experienced ICB. GI Innovation aims to obtain conditional approval for its GI-102 and is assessing the potential for technology transport. They are also examining the potential of using GI-102 in combination with NK cell therapy, as well as GI-102 monotherapy. The company’s clinical trial results are receiving attention as they strive to make the technology transfer of an immunotherapy candidate by the end of this year. TiumBio presented the interim result of a phase 1b trial involving TU2218, which is under development as bispecific antibodies. TU2218’s underlying mechanism of action involves simultaneously inhibiting transforming growth factor beta (TGF-ß) and vascular endothelial growth factor (VEGF) pathway, which are known to interfere with immunotherapy activation in the body. TiumBio is conducting clinical trials in three clinical institutes in the United States to evaluate the efficacy and safety of TU2218 in combination with the immunotherapy Keytruda in patients with advanced solid cancer. The clinical results showed that out of five patients treated with a daily recommended dose of TU1228 195 mg, two patients had PR, and three patients had SD. The DCR of all treatment groups was 66.7%. The treatment-related adverse events (TRAE) of over Grade 3 were fatigue, increased gamma-glutamyl transpeptidase, and pneumonia. TRAE of Grades 4-5 was not reported.
- Opinion
- [Reporter's View] Expectations for new Alzheimer's drugs
- by Son, Hyung-Min Jun 05, 2024 05:47am
- Last month, a new drug for Alzheimer's disease, Leqembi, was approved in Korea. Leqembi, which was developed by Eisai and Biogen, targets the amyloid beta (Aβ) protein in the brain, which is considered one of the most likely causes of Alzheimer's disease. The industry welcomed Leqembi’s arrival because there had been no promising new drugs to treat Alzheimer's disease until now. Until now, donepezil, galantamine, rivastigmine, and memantine were used for Alzheimer's, but all were only able to relieve symptoms such as cognitive impairment and do not fundamentally treat dementia. Since then, a number of brain function improvement drugs have been introduced to prevent Alzheimer's disease but failed to prove their effectiveness. In 2022, acetyl-L-carnitine, which was used as a brain function enhancer, failed to prove its efficacy during clinical reevaluations, which led to its indication being removed. Oxiracetam also failed to prove its efficacy during clinical reevaluations last year and was removed from the market. Choline alfoscerate formulations also remain mired in controversy. The reason for the market exit of these drugs that had been used to improve brain function is lack of efficacy. The main problem with these drugs is that they have a jagged effect, which means that they may or may not improve the patient’s condition, depending on how the patient is feeling that day. Side effects have also slowed the development of Alzheimer's disease treatments. Alzheimer's is one of the leading causes of dementia, and it is believed that abnormal proteins such as amyloid beta protein and tau protein build up in the brain, causing nerve cells to die slowly. However, in the case of amyloid-targeted therapies, amyloid-related imaging abnormalities(ARIA), which are abnormal signals such as brain edema or microhemorrhage observed on MRI scans, may occur with their use. Aduhelm, which came close to commercialization before Leqembi also failed due to high rates of side effects in addition to its lack of efficacy. The good news is that other treatments have emerged that have shown promise in early Alzheimer's disease, including Leqembi and Lilly's donanemab. Both treatments target the amyloid beta protein, which is responsible for the development of dementia, and have shown efficacy in clinical trials with manageable side effects. In clinical trials, Leqembi improved a composite measure of cognitive function. This allowed patients with mild cognitive impairment to return to daily life to conduct day-to-day activities. Just as it is meaningful to extend the number of survival days of cancer patients by administering chemotherapy drugs, administering Leqembi is expected to have a similar effect. As we severely lack treatment options for Alzheimer's disease, new drugs are needed to expand treatment opportunities for patients. After the history of failures recorded in the development of Alzheimer's disease treatments, it would be interesting to see if the new Alzheimer's drugs can reverse the fate. It is the reporter’s hope the new drugs will be able to address the dire unmet needs of Alzheimer's patients in Korea.
- Opinion
- [Reporter’s View] An open talk on improving the GMP system
- by Lee, Hye-Kyung Jun 05, 2024 05:47am
- Last month, CEOs of biopharmaceutical companies submitted a statement to the Ministry of Food and Drug Safety (MFDS) requesting an improvement to the 'Cancellation of the GMP compliance decision (GMP One strike-out).' They asked that if non-compliance with GMP has been unintentional, a different set of measures be applied instead of one strike-out. On December 11, 2022, the MFDS initiated a GMP One strike-out act. According to this act, when a company is found to be in violation of the Good Manufacturing Practices (GMP) for medicinal products, their GMP compliance approval may be revoked. This measure has been established due to past incidents in which more than ten companies, including Binex, Vivozon Pharmaceutical, Hanall Biopharma, Dongindang Pharmaceutical, Hansol Pharm, Samsung Pharm, and Medica Korea, altered ingredients without authorization, falsified documents, and provided false information on approval documents. The GMP One strike-out act states that if a company violates GMP compliance, such as obtaining GMP compliance decisions based on false information or illegally and repeatedly falsifying GMP records, action will be taken. This year, there was a case of canceling the GMP compliance decision, and some items will soon be withdrawn. When a company receives a GMP One strike-out, manufacturing the offended item and the same formulation will be stopped. The system was implemented one year and six months ago. During this period, Hutecs Korea Pharmaceutical received a disposition and is pursuing a trial. The companies expecting a disposition may not readily accept the MFDS’s disposition. Consequently, there should be an opportunity to hear the opinions of biopharmaceutical companies CEOs regarding their statement for revising the GMP One-strike out system. The MFDS has reviewed the CEO’s statement regarding the GMP One-strike out system. However, the MFDS has not publicly discussed this matter or announced its official opinion. The MFDS may open a session with the CEOs if the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), which represents biopharmaceutical companies in South Korea, officially submits a statement. However, the MFDS prefers to discuss this matter unofficially. The GMP One-strike out system has been implemented as part of revising the Pharmaceutical Affairs Act Article 38-2 (Standards of Manufacture and quality control). Since this system was established by the National Assembly, the MFDS, an administrative agency, feels certain pressure to discuss measures for revision. However, this policy has been implemented over one year and six months ago. There is a need to conduct a public review of the system. If the KPBMA proposes a clear agenda regarding this system, the MFDS official should provide an opportunity for official discussion.
- Company
- ‘Hemlibra is the most advanced hemophilia A drug availble'
- by Nho, Byung Chul Jun 05, 2024 05:47am
- Dr. Midori Shima, Professor at Nara Medical University is explaining the therapeutic benefits of Hemlibra "Hemlibra has the potential to become the standard of care for hemophilia A, and is considered the most advanced treatment available." Dr. Midori Shima, professor of pediatric hematology-oncology at Nara Medical University in Japan, said so at a media session to mark the 1st anniversary of Hemlibra's insurance reimbursement extension at the InterContinental Seoul COEX. In the Phase III HOHOEMI trial, pediatric participants under the age of 12 saw significant joint health benefits and improved quality of life after taking Hemlibra. Professor Shima said, "Most people with hemophilia undergo knee and hip surgery in their 30s and 40s due to bleeding. Although long-term follow-up is required, our current results suggest that starting Hemlibra in childhood can help maintain knee joint health well into middle age.” Also, the 3-year interim analysis results of the AOZORA study showed that the annualized bleed rate (ABR) reductions seen in the HOHOEMI study were maintained. The mean ABR decreased from 0.4 (0.00-4.55) to 0.2 (0.00-4.04) before and after treatment with Hemlibra, respectively, and 40% of participants (12) had no bleeds. The AOZORA study will continue to track patients' MRI data through Week 313 and is expected to show that Hemlibra is effective in maintaining and improving joint health in pediatric hemophilia A patients. In addition, Hemlibra has 8 years of post-marketing surveillance data, including exposure data from 22,000 patients worldwide, demonstrating its safety and efficacy. For example, the Canadian registry study has efficacy and safety data from 553 patients of various lifestyles and ages. The study confirmed efficacy in preventing long-term bleeding, with 72.9% of patients with severe hemophilia A experiencing no bleeding. In addition, patient-to-patient comparisons showed a reduction in mean ABR. The mean ABR before treatment with Hemlibra was 1.22, and the mean ABR after treatment was 0.50. These data demonstrate that Hemlibra can safely and effectively prevent bleeding over the long term in a diverse patient population. Dr. Seema explained that Hemlibra prophylaxis offers multiple benefits for each patient group by age and lifestyle.. First, in pediatric patients, all previous prophylaxis treatments to reduce bleeding have required 2-3 intravenous injections per week, but Hemlibra can be administered as a subcutaneous injection once a week, once every two weeks, up to once every four weeks. This extended duration and convenience in administration means that patients can start prophylaxis at a younger age, which can have a significant impact on quality of life. "By starting prophylaxis early and maintaining regular prophylaxis, pediatric patients can maintain healthy joints without bleeding problems and prevent or minimize the impact of future arthropathies," said Dr. Shima. Hemlibra may also improve the patient’s ability to participate in academic and professional activities by reducing bleeding rates. The bruising and scarring of blood vessels that can occur with intravenous infusions may be eliminated by switching to subcutaneous infusions, improving the quality of life during this important developmental stage of a patient's life, including the ability to form social relationships. It is also notable that the risk of bleeding complications is significantly reduced in patients receiving Hemlibra, which may improve surgical outcomes. Most minor surgeries (e.g., dental procedures) can be performed without the need for additional clotting factor infusions. Therefore, the use of Hemlibra may minimize the need for transfusions of clotting factor concentrates or other blood products during and after surgery. This means that potential complications associated with transfusions can be avoided, contributing to a faster recovery period and shorter hospital stay, which would allow patients to return to their daily activities sooner. Meanwhile, JW Pharmaceutical's Hemlibra is an innovative new drug that works by mimicking the function of Factor VIII, a blood clotting factor that is deficient in the body of hemophilia A patients. Bispecific antibody technology was applied to the drug to simultaneously bind to factor IXa and factor X. Hemlibra is the only hemophilia A treatment that can be used in patients with and without antibodies who are resistant to existing factor VIII agents. It provides long-lasting bleed prevention with subcutaneous injections once every up to four weeks.
- Company
- More data on Leclaza·Lorviqua showcased
- by Son, Hyung-Min Jun 05, 2024 05:47am
- Positive clinical results for targeted therapies, such as EGFR and ALK, were featured at the international conference. Clinical achievements of major targeted therapies for non-small cell lung cancer (NSCLC), including Leclaza, Rybrevant, and Lorviqua, were presented at the American Society of Clinical Oncology (ASCO 2024) annual meeting in Chicago, U.S., on May 31. For Leclaza, subcutaneous (SC) Rybrevant combined with Leclaza was found to be effective as well as intravenous (IV) Rybrevant combined Leclaza. Leclaza plus Rybrevant combination therapy has been submitted for U.S. Food and Drug Administration (FDA) approval as a first-line treatment of EGFR-positive NSCLC. Pfizer’s Lorviqua, a targeted drug used to treat ALK-positive NSCLC, demonstrated clinical benefit in patients who had no treatment experience. Based on these clinical results, Lorviqua garners attention for use as a first-line treatment compared to its competitors, such as Alecensa and Alunbrig. Leclaza combined with SC Rybrevant injection offers benefit The clinical results of Leclaza plus SC Rybrevant combination therapy were presented during ASCO 2024 on May 31st. This combination therapy is undergoing trials for potential use as a first-line treatment for EGFR-positive NSCLC, and the developer plans to secure ease of administration as well. 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. PALOMA-3 Phase 3 study design to evalute the efficacy of Leclaza plus SC Rybrevant inj (source: snapshot of ASCO 2024 lecture presentation). The Phase 3 PALOMA-3 study has evaluated the efficacy and safety of Leclaza plus SC Rybrevant combination therapy compared to Leclaza plus IV Rybrevant combination therapy in patients with EGFR-positive NSCLC who have failed previous treatments. The study enrolled 418 patients with advanced or metastatic NSCLC who have EGFR exon 19 deletions or exon 21 mutations. The primary endpoint of the study was the non-inferiority assessment of Leclaza and SC Rybrevant combination therapy in pharmacokinetics aspect. The secondary endpoints included objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR), patient satisfaction, and safety. At a median follow-up of 7 months, Leclaza plus SC Rybrevant combination therapy showed non-inferiority compared to Leclaza plus IV Rybrevant combination therapy. Leclaza plus SC Rybrevant combination therapy had an 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 in terms of PFS. For infusion-related reactions (IRR), Leclaza plus SC Rybrevant combination therapy had 13% of IRR, which was significantly lower than the 66% of IRR for Leclaza plus IV Rybrevant combination therapy. Whether the SC formulation therapy would overcome the IRR adverse reactions observed in the MARIPOSA study, which evaluated the efficacy of Leclaza plus IV Rybrevant combination therapy is to be watched. Five-year follow-up data of Lorviqua have been disclosed…60% of patients had PFS Dr. Benjamin J. Solomon presented the CROWN clinical study results, which confirmed Lorviqua’s five-year survival benefit as the third-generation targeted therapy for ALK-positive cancer (source: snapshot of ASCO 2024 lecture presentation). On May 31st, the five-year follow-up clinical data of Lorviqua, a targeted drug for the treatment of ALK-positive NSCLC, were disclosed at ASCO 2024. The CROWN Phase 3 study compared the efficacy of Lorviqua to Xalkori for the first-line treatment of ALK-positive NSCLC. Lorviqua is Pfizer’s third-generation targeted drug for the treatment of ALK-positive NSCLC. Along with Lorviqua, Takeda’s second-generation Alunbrig and Roche’s Alecensa compete in the market for targeted drugs for treating ALK-positive NSCLC. As Lorviqua’s effectiveness has been confirmed in five-year long-term data, all eyes in the industry are on whether it will take the lead in the competition among first-line treatments. The clinical trial involved 296 patients with ALk-positive NSCLC who had no prior treatment experience. The patients were randomly assigned to the Lorviqua treatment group and the Xalkori treatment group by a 1:1 ratio. According to the clinical result, during the follow-up period of 60.2 months, the Lorviqua treatment group did not reach the median PFS value. The Xalkori treatment group recorded 9.1 months of PFS during the follow-up for 55.1 months. For the five-year PFS rate, 60% of the Lorviqua treatment group reached the PFS, whereas 8% of the Xalkori treatment group reached the PFS. Furthermore, 77% of the Lorviqua treatment group had Grade 3-4 adverse reactions (AE), whereas 57% of the Xalkori treatment group had Grade 3-4 AE. The safety profile was aligned with that observed in the previous analysis. Dr. Benjamin J. Solomon, Professor of Peter MacCallum Cancer Centre in Australia, said, “Based on the results of the five-year follow-up data of Lorviqua and Xalkori treatment groups, the Lorviqua treatment group’s media PFS value has not been reached. This is the longest reported PFS among advanced NSCLC.” He added, “Without any additional safety issues, this will be the unprecedented outcome among ALK-positive NSCLC clinical results.”
- Policy
- Gov’t will maintain criteria for KIPC recertifications
- by Lee, Jeong-Hwan Jun 05, 2024 05:47am
- The government has decided to maintain the recertification process and criteria for Korea Innovative Pharmaceutical Companies. Therefore, the government decided not to accept the demands of some in the pharmaceutical industry on easing the decertification regulations, ‘2 or more rebate detections and administrative disposition’, and the 'total rebate amount that exceeds KRW 5 million’ regulations. Based on the maintained regulations, pharmaceutical companies that fall under the current disqualification criteria for innovative pharmaceutical companies, such as the rebate detection regulation, are expected to fail recertifications. On the 3rd, an official from the Ministry of Health and Welfare explained, "We will proceed according to the current regulations, and will not accept complaints from the pharmaceutical industry about easing the decertification criteria." This month, the recertification process will be carried out for Korea Innovative Pharmaceutical Companies certified on June 20, 2021, based on the Special Act on Fostering and Supporting the Pharmaceutical Industry. Currently, the 28 companies include ▲GC Biopharma, ▲Daewoong Pharmaceutical, ▲Daewon Pharm, ▲Daehwa Pharm, ▲Medytox, ▲Helixmith, ▲Boryung Pharmaceutical, ▲Bukwang Pharmaceutical, ▲BC World Pharm, ▲Samyang Holdings, ▲Celltrion, ▲Shin Poong Pharmaceutical, ▲ST Pharm, ▲Yuhan Corp, ▲Isu Absix, ▲Chong Kun Dang, ▲Crystal Genomics, ▲Taejoon Pharm, ▲Korea Otsuka Pharmaceutical, ▲Korea United Pharm, ▲Genuone Sciences, ▲Handok, ▲Hanlim Pharm, ▲Hanmi Pharmacuetical, ▲Hyundai Pharm, ▲HK Inno.N, ▲LG Chem, and▲SK Chemical. The companies reportedly submitted the written evaluation materials required for the recertification last month and completed an interview evaluation. Specifically, the written evaluation consists of 25 criteria, including excellence in R&D resource input, innovation in R&D activities, excellence in technological and economic performance, and corporate social responsibility, ethics, and management transparency. The interview evaluation consists of 5 criteria on innovation in R&D activities such as R&D vision, mid- to long-term promotion strategy, and the company’s social responsibility and ethics. Several pharmaceutical companies that submitted documents to extend their certification claimed that it was unfair to revoke the innovative pharmaceutical company status, which is certified based on the percentage of investment in R&D for new drugs, for illegal drug rebates, which is an individual deviant behavior. They also raised the need to ease the rebate criteria for decertifying innovative pharmaceutical companies. They requested that the 2 two administrative dispositions on rebates and the total amount of rebates paid that exceed KRW 5 million thresholds should be eased. However, the MOHW has decided not to accept these complaints from the pharmaceutical industry this time. The reasoning is that there are already companies that have been decertified under the current regulations, so it would be unfair to change the criteria, and there is no consensus within or outside the MOHW on the feasibility of easing the rebate criteria. A MOHW official said, "If any of the 28 pharmaceutical companies whose innovative pharmaceutical company certification period expires apply for recertification, they will be judged according to the current criteria without changing the criteria such as disqualification reasons. We are not considering the pharmaceutical industry's request to ease the criteria for decertification.” As such, the 28 pharmaceutical companies whose certification was extended in 2021 and expires in June this year will be evaluated on whether to be granted recertification as innovative pharmaceutical companies based on the current criteria, including whether or not they are subject to administrative dispositions for illegal rebates. The MOHW plans to confirm and notify the recertification decision within this month after deliberations by the Pharmaceutical Industry Development and Support Committee earlier this month.
- Company
- Sprycel patent to expire soon…market shift worth KRW 40 bil
- by Nho, Byung Chul Jun 04, 2024 05:48am
- Sprycel’s compound patent for its protein tyrosine kinase inhibitor expired in March. Following the patent expiration for blockbuster medicines in the United States this year, generics are expected to enter the market. Likewise, market shifts are expected with the development and launch of generics in South Korea. According to an overseas research agency, the top 10 blockbuster medicines with patents expiring in 2024 include Sprycel, Tysabri, Myrbetriq, Victoza, Sandostatin LAR, Dulera, Oxtellar XR, and Venofer. Among these, Sprycel has the highest sales, with prescription sales totaling over KRW 2 trillion in the United States. Tysabri and Myrbetriq recorded sales totaling approximately KRW 1.3 trillion and KRW 870 billion, respectively. Victoza and Emflaza have also recorded sales of KRW 710 billion and KRW 340 billion, respectively. Dulera, Sandostatin LAR, and Oxtellar XR have reached significant external growth, with sales of KRW 260 billion, KRW 160 billion, and 150 billion, respectively. They are showing solid sales in the United States. However, the sales performance of these drugs in South Korea is quite different from the positions in the United States. Following the expiration of patents in the United States, medicines that are expected to launch in South Korea are likely limited to BMS’ Sprycel (dasatinib), a leukemia treatment, Novartis’ Sandostatin LAR (octreotide acetate), used to treat cancer, due to non-reimbursement issues. According to the pharmaceuticals market report, Sprycel sales in South Korea for the past five years (2019-2013) amounted to KRW 29.6 billion, KRW 34.1 billion, KRW 390 billion, and KRW 40.1 billion. The Sandostatin LAR inj sales in 2019, 2020, 2021, 2022, and 2023 amounted to KRW 9.6 billion, KRW 9.3 billion, KRW 9.3 billion, KRW 8.9 billion, and KRW 8.6 billion, respectively. South Korea sales performance of medicines with U.S. patents expiring in 2024. (from the top) Venoferrum, Victoza, Sandostatin LAR, Sprycel, and Tysabri. Sprycel, which received FDA approval in 2006, has been indicated for the second-line treatment of patients who do not respond to other medicines, such as Gleevec and Tasigna. Subsequently, it has been prescribed as the first-line treatment since 2010. Sprycel’s compound patent for its protein tyrosine kinase inhibitor expired in March, so generics are expected to launch starting in November due to agreements made with other companies, including Apotex, ahead of the patent expiry. Xspray Pharma also initially planned to release the incrementally modified drug (IMD) Dasynoc within the second half of 2023. Yet, it is expected to be released in Q3 this year due to monitoring several issues. Three-types of patents protect Sprycel. Its substance and use patents have expired in April 2021 and March 2024. The crystalline form patent will remain until February next year. In South Korea, Boryung is actively pursuing Sprycel generics, filing claims to confirm the scope of a right and challenging substance patent through invalidation trial. Although the Sandostatin LAR patent has already expired in Europe and Japan, its generic version has not been released due to the delicate manufacturing process. However, Viatris is likely challenging the original product. JW Pharmaceutical’s iron therapy, Venoferrum Inj (Ferric Hydroxide Sucrose Complex), and Novo Nordisk’s diabetes drug, Victoza inj (liraglutide), have been launched in South Korea. Since these drugs generated KRW 3.2 billion and KRW 170 million, respectively, last year, generic entries would not experience much growth expansion. Eisei’s Tysabri Inj (natalizumab), a multiple sclerosis therapy, generated sales ranging between KRW 30 million and KRW 60 million, but did not experience significant external growth.
