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- 2026-03-12 11:15:47
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- Korean and global pharmas in race for lung cancer drugs
- by Son, Hyung-Min Apr 09, 2024 05:50am
- Pharmaceutical and biotechnology companies in South Korea are conducting clinical trials to overcome drug resistance in conventional non-small cell lung cancer (NSCLC) therapy. These companies are developing 4th-generation lung cancer treatments that have proven effective in patients with drug resistance after the use of 1st-to-3rd-generation targeted therapies. Conventional EGFR-positive NSCLC therapies are categorized into 1st-generation AstraZeneca’s Iressa (gefitinib) and Roche’s Tarceva (erlotinib), 2nd-generation Boehringer Ingelheim’s Giotrif and Pfizer’s Vizimpro (dacomitinib), and 3rd-generation Yuhan Pharmaceutical’s Leclaza (lazertinib) and AstraZeneca’s Tagrisso (osimertinib). However, drug resistance can still occur when using targeted therapies with proven effectiveness. The C797S mutation is the most common mutation in EGFR-positive targeted therapies. Treatment options following the targeted therapies are limited. Patients with resistance to targeted therapies have the option of using anticancer chemotherapy, docetaxel, or cancer immunotherapy. However, these drugs do not significantly improve response rates. Latecomer companies target a C797S mutation that causes resistance after the conventional 1st-to-3rd-generation targeted therapies, aiming to seek commercialization opportunities. The analysis is that these drugs compete against antibody-drug conjugates (ADC), which have proven effective in patients resistant to targeted therapies, for commercialization. The K-Bio industry is conducting clinical trials targeting C797S mutation According to industry sources on April 6, domestic biotech venture J INTS BIO presented clinical phase 1/2 results on its 4th-generation EGFR-positive candidate JIN-A02. Byoung Chul Cho (Director of the Lung Cancer Center at Yonsei Cancer Hospital), who is also in charge of Leclaza and Rybrevant, leads the clinical stage of JIN-A02. JIN-A02, a 4th-generation EGFR tyrosine kinase inhibitor (TKI), has an underlying mechanism of action that selectively binds to C797S, which causes resistance to 3rd-generation NSCLC treatment. In the clinical study, JIN-A02 confirmed a partial response (PR) in one patient and stable disease (SD). J INTS BIO explained that among 4th-generation EGFR-TKI treatments, it is the first instance of PR in patients with the C797S mutation. Bridge Biotherapeutics is developing BBT-207, a 4th-generation EGFR-positive lung cancer treatment. A phase 1/2 trial of BBT-207 is currently being conducted, enrolling 90 patients with EFGR-positive NSCLC in South Korea and the United States. Bridge Biotherapeutics plans to understand data on different mutations in patients acquired through liquid biopsy. In a preclinical trial, BBT-207 demonstrated anti-tumor effectiveness in various EGFR mutations, including the C797S mutation. Therapex has received approval from the Ministry of Food and Drug Safety (MFDS) for a phase 1/2 TRX-221 trial last month. Therapex plans to determine the recommended dose in Phase 1 and assess effectiveness in Phase 2a. The company aims to obtain approval for the indication in advanced NSCLC with EGFR C797S mutation. Previously, Therapex demonstrated the drug’s dose-dependent anticancer efficacy and blood-brain barrier (BBB) permeability in a Tagrisso-resistant brain tumor mouse model. Voronoi has obtained approval for a phase 1 trial in South Korea and is conducting the clinical trial. Voronoi also targets EGFR C797S. Through this phase 1 trial, the company plans to evaluate the drug’s effectiveness against the C797S-resistant mechanism of action. HK inno.N is conducting research on IN-119873, a 4th-generation targeted anticancer treatment, for patients who have shown resistance in the first-line treatment of NSCLC or have an L858R mutation. Unlike conventional treatments that target the binding site of adenosine triphosphate (ATP), an energy source of cancer cells, IN-119873 targets the allosteric binding site (one of the protein binding sites) of the EGFR, providing a significant advantage. Korean and overseas companies are developing fourth-generation EGFR-positive targeted lung cancer treatments. For overseas pharmaceutical companies, Black Diamond Therapeutics leads the clinical race…Will it surpass ADC Overseas pharmaceutical companies, as well as Korean biotechnology companies, are actively conducting clinical trials on 4th-generation lung cancer treatments. Black Diamond Therapeutics confirmed the highest number of partial responses (PR) in their phase 1/2 clinical trial. They are repurposing their existing brain tumor treatment, BDTX-1535, as a 4th-generation lung cancer targeted therapy. In a clinical trial targeting NSCLC patients with acquired resistance to targeted therapy, Black Diamond Therapeutics's 4th-generation EGFR-TKI treatment, BDTX-1535, yielded results of five patients with partial response (PR) and six patients with stable disease (SD) out of a total of twelve. In contrast, the U.S.-based Blueprint Medicines faces difficulties in drug development as it failed to confirm efficacy in Phase 1 clinical trials. The company faced setbacks with its 4th-generation targeted therapy candidate, BLU-945 monotherapy. However, the company is currently exploring the possibility of commercializing it as a combination therapy with Tagrisso. Blueprint Medicines plans to target exon 21 L858R mutations rather than the C797S mutation in Tagrisso-resistant patients. However, the commercialization of these targeted therapies faces a challenge in surpassing ADC clinical results. Currently, Daiichi Sankyo and MSD are jointly developing an ADC that has shown effectiveness in Tagrisso-resistant patients, and their data are being disclosed. Daiichi Sankyo and MSD’s Patritumab deruxtecan, which targets human epidermal growth factor receptor 3 (HER3), has shown effectiveness in EGFR-TKI patients compared to platinum-based chemotherapy in the phase 2 HERTHENA-Lung01 study. In the clinical trial, patritumab demonstrated complete responses (CR) and confirmed 66 partial responses (PR). The objective response rate (ORR) was observed at 29.8%. Currently, this treatment is designated as a priority review drug by the U.S. Food and Drug Administration (FDA), with approval expected to be finalized in June of this year.
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- Ilaris reimb passes DREC review, but again with a condition
- by Eo, Yun-Ho Apr 09, 2024 05:50am
- The orphan drug 'Ilaris' has again received a conditional reimbursement decision in Korea. Ilaris (canakinumab), Novartis Korea’s treatment for hereditary periodic fever syndrome, was quickly resubmitted to the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee on the 4th after receiving a conditional reimbursement decision at the same level in February but faced the same results. However, whether the scope of additional data requested by the government was reduced compared to before remains key to the drug’s road to reimbursement. Novartis was unable to accept the conditions set by the DREC in February. However, it is unlikely that DREC would have set the same level of additional documentation requirements in its second conditional reimbursement decision. In other words, what the government took into consideration this time and whether the drugmaker accepts the new terms will determine the future fate of Ilaris. Since being approved in 2015, Ilaris has already failed two reimbursement attempts. With patients waiting more than 8 years, it will be interesting to see if the government and the pharmaceutical company can reach an agreement and move toward expanding coverage. Ilaris is indicated in Korea to treat ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲ Familial Mediterranean Fever (FMF), and ▲ Systemic juvenile idiopathic arthritis (JIA). Among the indications, CAPS is further categorized into ▲Familial Cold Autoinflammatory Syndrome (FCAS)/Familial Cold Urticaria (FCU), ▲Merkle-Wells Syndrome (MWS), and ▲Neonatal Onset Multisystem Inflammatory Disease (NOMID)/Chronic Infantile Neurological Cutaneous Articular Syndrome (CINCA). With such a small patient population and complex indications, reimbursement discussions for the drug have not been easy. The number of patients for the many indications of Ilaris’ is extremely small. Some indications for Ilaris don't even have disease codes or have only recently been registered. Dr. Dae-Cheol Jeong, President of the Korean College of Pediatric Clinical Immunology (Department of Pediatrics, St. Mary's Hospital, Seoul, Korea), said, "There are many challenges to reimbursing Ilaris because due to its very specific indications and the very small number of patients each. The current situation is regrettable as some patients are even considering emigrating to countries where Ilaris can be prescribed with reimbursement."
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- Two new CML drugs were granted reimbursement in one year
- by Eo, Yun-Ho Apr 08, 2024 05:46am
- (Upper picture)Scemblix, Bosulif The chronic myelogenous leukemia (CML) treatment market is starting to show activity again. According to industry sources, treatment options for CML have been expanded with the reimbursement of Novartis Korea's 4th generation CML treatment ‘Scemblix (asciminib) in July last year, and Pfizer Korea’s 2nd generation drug 'Bosulif (bosutinib)’ this year. Scemblix, a next-generation drug, made headlines when it finalized its reimbursement listing process within a year of its application. Although it is a fourth-generation drug, its estimated cost was comparable to its third-generation alternative, Korea Otsuka Pharmaceutical’s ‘Iclusig (ponatinib),’ and was listed without drug pricing negotiations by accepting a price less than 100% of the weighted average price (WAP) of its alternative. The reimbursement process for Bosulif was not so slow either. Bosulif, which was approved in Korea in January last year, is a 2nd generation-targeted anticancer therapy like Novartis Korea’s ’ ‘Tasigna (nilotinib),’ BMS Korea’s ‘Sprycel (dasatinib),’ Il-Yang Pharmaceutical’s ‘Supect (ladotinib)’. The drug, which was approved in January, has been commercialized later in Korea than in other countries as it was approved by the U.S. FDA in 2012 but submitted reimbursement applications immediately after receiving marketing authorization and smoothly became listed for reimbursement in January this year. However, the reimbursement standard for Bosulif is under controversy. The reimbursement standard for Bosulif was set as "second-line or later treatment for patients with Philadelphia chromosome-positive chronic myeloid leukemia aged 18 years or older in chronic phase, accelerated phase, or blast phase who are resistant or intolerant to prior therapy that contained imatinib,” which is narrower than the indication it was granted for by the MFDS. In response, the Korea Leukemia Patients Organization issued a statement calling for Bosulif’s reimbursement in the first-line and for pediatric patients. Pfizer is also known to be considering expanding reimbursement to those indications. Meanwhile, Scemblix was approved as a treatment for adult patients with Ph+ CML in the chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs) after demonstrating its safety and efficacy through the Phase III ASCEMBL trial. Study results showed that Scemblix improved the rate of major molecular response (MMR) compared to its comparator bosutinib by 2 times. Also, the rate of treatment discontinuation due to adverse reactions in the Scemblix group was 5.8%, about one-fourth of the control group's 21.1%, confirming its overall safety profile. Bosulif’s safety and efficacy were verified through the Phase III NCT02130557 trial that was conducted on patients with newly diagnosed Ph+ CML. The major efficacy outcome measure was the major molecular response (MMR) at 12 months. Results showed that MMR at 12 months was 47% in the Bosulif arm and 36% in the Glivec (imatinib) arm. MMR at 60 months was 74% in the Bosulif arm and 66% in the Glivec arm. The median time to MMR in respondents after 60 weeks of follow-up was 9.0 months in the Bosulif arm and 11.9 months in the Glivec arm.
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- Early breast cancer treatments fail to get reimb in KOR
- by Eo, Yun-Ho Apr 08, 2024 05:46am
- It seems unlikely that a new reimbursed option will be introduced to the early breast cancer environment anytime soon. First, Lilly Korea again failed to overcome the barrier of the Health Insurance Review and Assessment Service's Cancer Disease Review Committee for its CDK4/6 inhibitor Verzenio (abemaciclib). This was the company’s second failed attempt to receive reimbursement for the drug in Korea. Verzenio was the only new drug available for HR+/HER2- breast cancer other than the endocrine therapy letrozole generic. In the field of early-stage breast cancer, Lilly Korea faced challenges in presenting Verzenio’s reimbursement to be deliberated by the Drug Reimbursement Evaluation Committee from its initial attempt. Verzenio’s reimbursement was presented as an agenda in May last year, 6 months after submitting its application, but received a 'no reimbursement standard established' result. The company resubmitted its to HIRA 5 months later in October. Following Verzenio's reapplication, a petition titled "Request for Reimbursement of Verzenio, a targeted therapy for early breast cancer," was posted on the Cheong Wa Dae National Petition Board the same month. Lilly added the 5-year monarchE data presented at the 2023 European Society for Medical Oncology (ESMO) Congress to reinforce its evidence but failed its second attempt as well. This makes Verzenio's reimbursement unlikely for the foreseeable future in Korea. There is another drug pending in the early breast cancer space that is seeking reimbursement in Korea as well. Bixlink Therapeutics' Nerlynx (neratinib maleate) is also struggling to reach the reimbursement stage. Nerlynx is used for HER2+ early breast cancer, just like Verzenio is used for HER2- breast cancer. Nerlynx is indicated for the extended adjuvant treatment of patients with early-stage hormone receptor-positive HER2-positive breast cancer and who completed adjuvant ‘trastuzumab-based therapy’ less than 1 year ago. However, reimbursement for Nerlynx has been pending after failing the first attempt in February last year and the reattempt in December of the same year, and no news of its reimbursement progress has been heard of since. However, in March 2023, the U.S. National Comprehensive Cancer Network (NCCN) treatment guidelines raised the level of evidence for Verzenio+endocrine therapy to Category 1 from Category 2A for adjuvant therapy in HR+/HER2- high-risk breast cancer patients. Nerlynx is also recommended in the NCCN guidelines as a treatment for early-stage and metastatic breast cancer.
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- Sanofi’s Dupixent sales skyrocket after expanded indication
- by Nho, Byung Chul Apr 08, 2024 05:46am
- Cinqair, Dupixent, Xolair, and Fasenra (clockwise from top-left). Sanofi-aventis Korea’s Dupixent (dupilumab) has accomplished outstanding external growth in the market for asthma biologic treatments. Based on pharmaceutical drug sales performance, Dupixent generated sales of KRW 143.1 billion last year. It has been ranked as the top-selling drug for the past five years. Dupixent sales were around KRW 8 billion in 2019 but have grown 1688% in four years. Dupixent secured its position as the leading product in the market by having a wider range of indications than its competitors. It has been approved for efficacy and effectiveness in type 2 inflammatory asthma, severe eosinophilic asthma, corticosteroid-dependent asthma, and atopic dermatitis. Among biologic asthma therapies, it offers the most treatment options. Notably, prurigo nodularis is related to type 2 inflammatory diseases, including atopy and asthma, and almost half of the patients with prurigo nodularis also have atopic diseases. Dupixent is the only biologic to target this disease. Novartis’ Xolair (omalizumab) ranked second and generated KRW 5.0 billion, KRW 6.1 billion, KRW 11.6 billion, KRW 15.7 billion, and KRW 21.1 in the last five years. Xolair has also consistently shown an upward trend in the sales curve. According to analysis, it is due to Xolair’s wide range of approved indications, such as allergic asthma, chronic sinusitis, and chronic idiopathic urticaria. Cinqair (reslizumab), which followed Xolair, generated approximately KRW 1.6 billion in sales last year. GSK’s Nucala (mepolizumab) and AstraZeneca’s Fasenra (benralizumab) have each shown performances in 2023, approximately KRW 700 million and KRW 400 million, respectively. Currently, Cinqair, Nucala, and Fasenra have indications for severe eosinophilic asthma only. Asthma treatment sales performances in the market (Nucala, Dupixent, Cinqair, Xolair, and Fasenra). According to South Korea’s asthma treatment guidelines, low-dose inhaled corticosteroids (ICS) and formoterol are recommended as the first-line asthma treatment. When short-acting beta agonists (SABA) are used as an alternative strategy, low-dose ICS is combined. Therapies recommended in second-to-fourth-line treatment include ICS plus leukotriene receptor antagonist or ICS plus beta 2 agonist. Fifth-line treatment involves tiotropium, anti-IgE agents (omalizumab), anti-IL/5R agents (mepolizumab, reslizumab, benralizumab), or anti-IL-4R agents (dupilumab). However, reimbursement does not cover combination therapies using biologics, such as Xolair, Nucala, and Cinqair, in treating severe asthma patients.
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- High dose Eylea approved in KOR… extends dosing interval
- by Son, Hyung-Min Apr 05, 2024 05:43am
- Bayer Korea announced that its Eylea 8mg, a treatment for macular degeneration, was approved in Korea on the 3rd. Eylea 8mg was developed to maintain the effective drug concentration in the eye longer than the already approved Eylea 2mg product, allowing for longer dosing intervals and fewer injections. Eylea is an intravitreal injection used to treat major retinal diseases, including vision impairment caused by neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). Eylea 8mg is injected once monthly for the first 3 months, after which the dosing interval may be extended to up to 16 weeks based on the physician’s judgment of visual and/or anatomic examination results. Thereafter, the dosing interval may be extended to up to 20 weeks with a treat-and-extend dosing regimen with stable visual and/or anatomic findings. The approval of Eylea 8 mg is based on the results of the PULSAR trial, in patients with neovascular (wet) age-related macular degeneration, and the PHOTON trial, in patients with diabetic macular edema (DME). The PULSAR trial, which was conducted on 1,009 patients with nAMD, showed that Eylea 8mg administered every 12 and 16 weeks was non-inferior to Eylea 2mg administered every 8 weeks in terms of best corrected visual acuity (BCVA) changes. Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 6.7 letters from baseline for its 12-week dosing regimen and 6.2 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 7.6 letters Eylea 2mg achieved at a fixed 8-week treatment interval. In the PHOTON study, which included 658 patients with DME, both dosing regimens of Eylea 8 mg achieved comparable visual improvement to Eylea 2 mg every 8 weeks. Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 8.8 letters from baseline for its 12-week dosing regimen and 7.9 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 9.2 letters Eylea 2mg achieved at a fixed 8-week treatment interval. In terms of dosing intervals, 93% of patients receiving Eylea 8 mg maintained a dosing interval of 12 weeks or longer at Week 48. Sangok Seo, Head of the Specialty Medicine BU at Bayer said, “We are very pleased that this approval establishes Eylea as the only anti-vascular endothelial growth factor (VEGF) on the market that can offer an extended dosing interval of up to 20 weeks. Building on the efficacy and safety that we have established over the past decade and an improved dosing interval, we hope to improve long-term treatment adherence and help patients maintain a better quality of life with Eylea 8mg.”
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- AbbVie Korea, 52% increase in sales last year…
- by Kim, Jin-Gu Apr 05, 2024 05:43am
- AbbVie Korea’s major performances, including sales and operating profit, have increased by about 50% in a year. The analysis attributes this to the integration with Korea’s Allergan. AbbVie headquarters initiated the integration process between both companies in June 2019. The analysis suggests that the company’s total assets have expanded due to the completion of the integration process between the Korean subsidiaries last year. According to AbbVie Korea’s audit report on April 4, the company generated sales of KRW 234.7 billion last year, up 52% in a year compared to KRW 154.6 billion in 2022. The operating profit of the same period increased from KRW 7.8 billion to KRW 11.5 billion, up 49%. AbbVie Korea reported consistently generating sales within the range of KRW 150 billion for the past five years, with KRW 157.3 billion in 2019, KRW 146.7 billion in 2020, KRW 140.4 billion in 2021, and KRW 154.6 billion in 2022. The operating profits were KRW 7.4 billion in 2020, KRW 7.1 billion in 2021, and KRW 7.8 billion in 2022, without significant changes. Notably, sales and operating profit increased by about 50%. The analysis attributes this to the integration of AbbVie Korea with Korea’s Allergan. Trends in AbbVie Korea’s sales & operating profits (Unit: KRW 100 million, Source: Financial Supervisory Service). On February 1, AbbVie Korea acquired 100% of the shares of Korea’s Allergan. Subsequently, it completed the merger with Allergan. As of the following day, the performance of existing Allergan began to be reflected in AbbVie Korea. AbbVie Korea’s total assets increased by 98% in one year, from KRW 89.9 billion in 2022 to KRW 177.7 billion last year. Similarly, the company’s payroll expenses rose from KRW 20.2 billion to KRW 32.7 billion, up 62%. Additionally, selling and administrative expenses, including payroll, increased from KRW 43.1 billion to KRW 70.4 billion, up 63%. The headquarters completed the acquisition in 2019. On June 25, 2019, AbbVie acquired Allergan for $63 billion (approximately KRW 73 trillion). The major products of AbbVie Kore are Humira, Mavyret, Rinvoq, and Skyrizi. Humira’s sales are seeing a decreasing trend due to patent expiration. Rinvoq and Skyrizi, which are follow-up drugs to Humira, are filling the gap of Humira. Korea’s Allergan had been selling Botox, a botulinum toxin.
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- Boryung speeds up Lenvima patent challenge
- by Heo sung-kyu Apr 04, 2024 06:00am
- Boryung's challenge against Eisai’s blockbuster anticancer drug Lenvima is gathering pace. As the only domestic pharmaceutical company to continue the patent challenge, Boryung’s journey has passed the 70% mark. With only one patent remaining, expectations of the company’s launch of the Lenvima generic in 2025 are rising. According to industry sources on the 1st, the Intellectual Property Trial and Appeal Board ruled in favor of Boryung that it had filed to invalidate Eisai’s anticancer drug Lenvima (lenvatinib)’s patent for "high purity quinoline derivatives and methods of manufacturing the same.” #The patent that had been in question was registered by Eisai in June 2023 for Lenvima and was set to expire on August 26, 2035. The IPTAB’s ruling is noteworthy because it marks the nearing end of Boryung's ongoing patent hurdle clearings for Lenvima. In fact, in addition to the patent in question, Lenvima also has a patent for ▲"nitrogen-containing aromatic derivatives" (expiring April 4, 2025), ▲"antitumor agent for thyroid cancer" (expiring March 4, 2028), ▲"Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinoli- necarboxamide or the solvate of the salt and a process for preparing the same” (expiring June 7, 2028), and ▲“High-purity quinoline derivative and method for manufacturing same” (expiring on March 19, 2031). Boryung is the only domestic company to challenge all these patents and independently develop a generic version of the original drug. Daewoong Pharmaceutical had challenged 3 patents together with Boryung, except for the last registered patent, but later chose to withdraw all of them. In the end, only Boryung challenged all 4 patents except for the one that expires in 2025, cleared 3 of the patent barriers, and is raising expectations of its generic’s launch in Korea. In fact, Boryung won all of its trials to confirm the passive scope of rights that preceded the patent invalidation trial. First, it received a favorable ruling in June of last year for the patent "Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinoli- necarboxamide or the solvate of the salt and a process for preparing the same” (which expires on June 7, 2028) and in August of last year for the patent ▲“High-purity quinoline derivative and method for manufacturing same” (which expires on March 19, 2031). In particular, in the case of the patent being invalidated this time, Boryung et al. have conquered one more barrier of Lenvima’s that had been built by the Eisai, in less than a year since its patent registration. However, Boryung has filed another invalidation trial for the “Antitumor agent for thyroid cancer” patent, which expires on March 4, 2028, and is awaiting for its results. If the remaining patent is also invalidated, the company will be able to launch its drug after April 4, 2025, when the last “Nitrogen-containing aromatic derivatives” patent expires. Ultimately, Boryung’s decision not to challenge the last patent suggests that it expects to launch its generic version in 2025. Therefore, it remains to be seen whether the company will be able to overcome the last remaining patent barrier and succeed in launching its generic drug in 2025.
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- Enhertu lands in general hospitals in KOR after reimb
- by Eo, Yun-Ho Apr 04, 2024 06:00am
- Hospitals in Korea are busy preparing a prescription environment for the reimbursed Enhertu. According to industry sources, Daiichi Sankyo and AstraZeneca Korea’s antibody-drug conjugate (ADC) for HER2-positive breast cancer, Enhertu (trastuzumab deruxtecan) has passed the drug committee (DC) review of 46 medical institutions in Korea, including the ‘Big 5’ tertiary hospitals in Korea - Samsung Medical Center, Seoul National University Hospital, Seoul St.Mary’s Hospital, Asan Medical Center, and Sinchon Severance Hospital. After receiving approval for Enhertu in Korea in September 2022, the companies submitted a reimbursement application for the drug in December of the same year, and the agenda passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in February. The same month, the company began negotiating drug prices with the National Health Insurance Service and concluded the negotiations at an unprecedented speed and was listed on the reimbursement list this month (April). With 50,000 people signing the petition and the government being questioned on the reimbursement progress repeatedly by the National Assembly, both the government and the company would have had to carry a significant burden during reimbursement discussions. When considering the limited scope of freedom the company has with regard to the drug price, the fact that Enhertu’s reimbursement passed the DREC review this time implies that the government has set the ICER threshold at least KRW 50 million. With the listing, Enhertu is reimbursed for patients with HER2-positive unresectable or metastatic breast cancer that has failed treatment with both trastuzumab and taxanes (including recurrence while receiving adjuvant therapy after surgery or within 6 months of completion of therapy). Also, patients with locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who failed two or more prior therapies, including trastuzumab +(fluorouracil or capecitabine) +cisplatin; or have HER2 overexpressive (IHC 3+, or 'IHC 2+ and FISH positive or SISH positive') metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; and have an ECOG performance status (PS) of 0 or 1, are eligible to receive reimbursement. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of overall survival (OS), the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1
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- AbTis-Progen signs MOU to develop bispecific antibody ADC
- by Son, Hyung-Min Apr 03, 2024 05:51am
- AbTis, Dong-A ST’s affiliate specializing in ADC, announced on April 1 that it has signed a memorandum of understanding (MOU) with Progen to develop a bispecific antibody-drug conjugate (BsADC) to treat autoimmune diseases. The MOU will leverage the two companies’ proprietary platform technologies - AbTis’ AbClick and Progen's NTIG. AbTis’ AbClick linker platform technology is a 3rd-generation linker technology that overcomes the limitations of existing ADCs, allowing selective drug delivery to desired areas, eliminating the need for mutant antibody production, and ensuring uniform production quality by controlling the drug-to-antibody ratio (DAR). Lonza, a Swiss global CDMO (Contract Development and Manufacturing Organization), recognized the superiority of AbClick linker platform technology and signed an ADC platform collaboration agreement in December 2022. AbTis is currently developing various new drugs with its AbClick technology, including an ADC for gastric cancer targeting Claudin18.2. Progen's proprietary NTIG platform technology can extend the blood half-life of proteins, making it scalable for developing two or more multi-target fusion proteins for various diseases. PG-102, which Progen is developing as a treatment for global obesity and diabetes, is a 2-to-4-week injectable that simultaneously targets GLP-1 and GLP-2 using the NTIG® technology. The drug candidate is in Phase Ib clinical trials. Tae Dong Han, CEO of AbTis, said, "Through synergy with Progen's NTIG® technology, we aim to demonstrate the differentiated excellence of our AbClick® platform and make the best efforts to develop new modality drugs that can succeed in the global ADC market.” Jong-Gyun Kim, CEO of Progen, said "We plan to extend the excellence of NTIG® technology to the field of ADC with the MOU. Based on Progen's long experience in immune disease research, we will challenge the development of new immune disease BsADC therapeutics through close collaboration with AbTis, which owns the 3rd-generation linker technology platform AbClick®.”
