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- 2025-12-23 05:15:50
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- Ryvrevant to lead market with Exkivity’s market withdrawal
- by Son, Hyung-Min May 14, 2024 05:48am
- Takeda Exkivity, a treatment for non-small-cell lung cancer patients with EGFR exon 20 insertion mutation, is being withdrawn from the market. The highly anticipated oral treatment failed to demonstrate efficacy in a confirmatory clinical trial, leading to its market withdrawal. With no competition, Rybrevant is expected to remain the market leader for the foreseeable future. According to industry sources on April 4, Takeda withdrew the market approval for Exkivity as of the first of this month. Takeda’s Exkivity was approved in Korea in July 2022 to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutation. However, Exkivity was withdrawn from the Korean market after nearly 2 years due to the failure of the confirmatory trial that was required to maintain the license. While there are many targeted therapies for EGFR-positive lung cancer that target exon 19 and exon 21, such as Tagrisso and Leclaza, targeted therapies for EGFR exon 20 insertion mutations have been difficult to develop. The exon 20 insertion variant is known to have many subtypes, making it difficult to target. Hanmi Pharmaceutical's poziotinib also failed to demonstrate efficacy in a Phase II trial. Takeda received approval for Exkivity based on efficacy results of the Phase I/II AP32788-15-101 trial which enrolled 114 patients with EGFR Exon20 insertion mutation-positive NSCLC. In the trial, patients treated with Exkivity showed an objective response rate (ORR) of 28%. Also, as an oral drug, Exkivity owned the advantage of being easier to administer compared to competing products. However, Exkivity failed to demonstrate efficacy in the Phase III trial. The Phase III EXCLAIM-2 trial compared the efficacy and safety of Exkivity with platinum-based chemotherapy in treatment-naïve patients with EGFR exon 20 insertion mutation-positive locally advanced or metastatic NSCLC. Results showed that Exkivity did not improve progression-free survival (PFS), the primary endpoint, compared to platinum-based chemotherapy. As a result, Takeda has decided to withdraw Exkivity from the global market, including in Korea. Rybrevant becomes the only treatment to target exon 20 insertion mutation Janssen With the voluntary withdrawal of Exkivity from the market, Janssen's Rybrevant will become the only treatment available for EGFR exon20 insertion mutation-positive NSCLC. Ryvrevant was approved in February 2022 for the treatment of patients with locally advanced or metastatic NSCLC whose disease progressed during or after treatment with platinum-based chemotherapy. Although Rybrevant was approved as a second-line treatment, there is a high likelihood that the drug will additionally be approved as a first-line treatment in Korea. The U.S. Food and Drug Administration (FDA) recently approved Rybrevant plus platinum-based chemotherapy as a first-line treatment, and the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the combination as a first-line treatment in Europe as well. Rybrevant demonstrated its efficacy in the Phase III PAPILLON study. The study enrolled 308 patients with previously untreated EGFR exon20 insertion mutation-positive advanced NSCLC. The study also included patients with a history of brain metastases. Results showed that Rybrevant plus platinum-based chemotherapy (carboplatin+pemetrexed) reduced the risk of disease progression or death by 61% compared to chemotherapy alone. The ORR was 73% in the Rybrevant combination arm and 47% in the chemotherapy arm. Adding on to its list of strengths, Rybrevant also has Leclaza. The target therapy combination of Rybrevant, which targets EGFR exon 20, with Leclaza, which targets exons 19 and 21, has demonstrated efficacy recently. In the MARIPOSA trial, Leclaza plus Rybrevant met the primary endpoint and demonstrated efficacy compared with Tagrisso. In addition to MARIPOSA, which evaluated the efficacy of the combination therapy, the PALOMA study is evaluating the efficacy and safety of the subcutaneous Rybrevant combination and Leclaza. To date, clinical results that have been published have shown that the subcutaneous formulation of Rybrevant is well tolerated compared to the intravenous infusion. The Rybrevant subcutaneous injection can be administered in 7 minutes. This is why attention is rising on whether the combination therapy will address the concerns of infusion-related reactions (IRRs) reported in the MARIOSA study with the use of the Rybrevant SC formulation.
- Company
- AbbVie’s Aquipta becomes the first oral CGRP migraine drug
- by Son, Hyung-Min May 13, 2024 05:52am
- Professor Byung-Kun Kim (Department of Neurology, Nowon Eulji Medical Center) For the first time, an oral CGRP drug has been introduced for the treatment of migraine. AbbVie’s Aquipta has shown positive results as a preventive treatment for chronic migraine as well as episodic migraine in patients who have failed up to 4 prior oral preventive treatments. Experts believe that the benefits of being an oral formulation would allow Aquipta to become a viable new treatment option that can meet the unmet needs of migraine patients in Korea. On the 10th, AbbVie Korea held a press conference to celebrate the launch of Aquipta, its oral calcitonin gene-related peptide (GRRP) receptor agonist, in Korea. Aquipta was approved in Korea last November for migraines in adults. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2021 as a prophylaxis of adult episodic migraine and chronic migraine and in August last year in Europe for the prevention of migraine in adult patients with 4 or more migraine days per month. The domestic approval was based on the Phase III PROGRESS, ADVANCE, and ELEVATE studies. The PROGRESS trial compared the efficacy and safety of Aquipta with placebo in the prevention of chronic migraine. The study enrolled 521 adult patients with a history of chronic migraine (15 or more migraine days per month and at least 8 migraine days per month) for at least 1 year, who were randomized 1:1 to either the Aquipta or placebo arm. The primary endpoint was the change from baseline in the mean migraine days per month during the 12-week treatment period. Results showed a 6.9-day reduction in mean migraine days per month from baseline in the Aquipta arm, compared to 5.1 days in the placebo arm. The ADVANCE trial evaluated the efficacy of Aquipta versus placebo in the prevention of episodic migraine. The study enrolled 458 adult patients with a history of episodic migraine, defined as 4 to 14 migraine days per month. Results showed that the mean number of migraine days per month was reduced by 4.2 days from baseline in the Aquipta arm and 2.5 days in the placebo arm. Also, in the ELEVATE study, which evaluated the prevention of episodic migraine in patients who had failed prior preventive treatments, Aquipta achieved a greater reduction in mean monthly migraine days compared to placebo. Professor Byung-Kun Kim (Department of Neurology, Nowon Eulji Medical Center) said, “The introduction of CGRP receptor antagonists has shown great effect in preventing migraines. However, existing drugs are injectables that require monthly visits to the clinic. So the introduction of an oral option has broadened the pool of treatment options for our patients." “Migraine waxes and wanes over time, so it is very difficult to prove the effectiveness of a new drug over placebo in the area. The fact that Aquipta has demonstrated efficacy in more than 500 patients is meaningful. Clinical trials do not take into account whether migraine patients can conduct their daily lives. With the use of CGRP receptor agonists, we received feedback from patients that they can go about their daily lives. This is an important factor to consider." Migraine severely impacts daily life...' reimbursement standards need to be improved’ Professor Min Kyung Chu (Department of Neurology, Severance Hospital and Chair of the Korean Headache Society) According to the World Health Organization (WHO), migraine is one of the top 10 conditions that reduce quality of life. According to the 2019 Global Burden of Disease Study, migraine was the second leading cause of disability and the first leading cause of death among women under 50 years of age. In fact, the number of migraine patients is on a constant rise. According to the Health Insurance Review and Assessment Service, the number of migraine patients in Korea increased by 10.5% from 545,607 in 2018 to 602,906 in 2022. While some patients with mild headaches can go about their daily lives, others suffer from symptoms such as nausea, photophobia, phonophobia, and osmophobia. Also, their condition is often accompanied by pain in the eye area, and the migraine attacks may last for more than a day. Professor Min Kyung Chu (Department of Neurology, Severance Hospital) said, “If you have over 3-4 migraine attacks a month, or develop 1-2 migraine attacks a month, you need aggressive preventive treatment. Although costly, CGRP-targeted therapies have changed the landscape of migraine treatment, bringing great benefits to the patients.” Professor Chu added, “Due to strict reimbursement standards set for the use of CGRP treatments in migraines in Korea, more than 90% of the existing CGRP drugs are prescribed without reimbursement. If one drug fails, we need to switch to a different drug, but Korea’s current reimbursement standards do not allow switching between CGRP drugs. Many areas are in need of improvement, and we plan to continue to raise this issue at the academic level as well."
- Company
- BeiGene reapplies for Tevimbra’s reimb in esophageal cancer
- by Eo, Yun-Ho May 13, 2024 05:52am
- BeiGene is again attempting reimbursement for its immunotherapy, ‘Tevimbra (tislelizumab)’ in Korea. According to industry sources, BeiGene Korea recently submitted an application for the reimbursement of its Tevimbra (tiselizumab) and is waiting for the Health Insurance Review and Assessment Service's Cancer Disease Review Committee’s deliberation. Tevimbra had previously received the ‘reimbursement standards not set' decision by the CDDC in March. Therefore, the industry’s eyes are on whether the company’s second attempt for Tevimbra's reimbursement will be successful. Tevimbra (tiselizumab), which was approved in Korea last November, is an immuno-oncology drug indicated as a monotherapy for patients with unresectable, relapsed, locally advanced, or metastatic oesophageal squamous cell carcinoma who are unable to continue platinum-based chemotherapy or who have relapsed or progressed after receiving prior platinum-based chemotherapy. In the global Phase III RATIONALE-302 trial, Tevimbra prolonged median overall survival (OS) by 2.3 months compared to chemotherapy (8.6 months vs. 6.3 months), with a statistically significant 30% reduction in the risk of death, and did not show any crossover, unlike existing immuno-oncology monotherapies in the OS graph. In the trial, Tevimbra’s OS improvement was consistent across predefined subgroups, including baseline PD-L1 status, region, and race. Compared to chemotherapy, Tevimbra resulted in more than twice as many patients responding to treatment (20% vs. 10%), and showed an improvement in the median duration of response of approximately 3 months, from 4.0 months to 7.1 months, with sustained responses and a reduction in tumor size, which is directly related to quality of life for esophageal cancer patients. Furthermore, Tevimbra was associated with a 17% lower risk of disease progression or death in progression-free survival (PFS) (HR=0.83, 95% CI 0.67-1.01) and improved health-related quality of life (HRQoL) compared to chemotherapy. In April, the U.S. National Comprehensive Cancer Network (NCCN) revised its guidelines to recommend Tevimbra as a Category 1, preferred option for second-line treatment of esophageal squamous cell carcinoma.
- Company
- MM drug Tecvayli can be prescribed in tertiary hospitals
- by Eo, Yun-Ho May 13, 2024 05:52am
- The new multiple myeloma drug ‘Tecvayli’ can now be prescribed in tertiary hospitals in Korea. According to industry sources, Janssen Korea’s multiple myeloma drug Tecvayli (teclistamab) has passed the drug committee (DC) review of top tertiary hospitals in Korea, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Seoul Asan Medical Center. After being approved in Korea in July last year, Tecvayli may be prescribed to treat patients with relapsed or refractory multiple myeloma who have received at least three previous lines of treatment, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. Tecvayli is the first bispecific antibody that induces apoptosis, by binding to 2 receptors commonly found on multiple myeloma cells. Multiple myeloma is a blood cancer caused by the abnormal differentiation and proliferation of B cells (plasma cells), a type of white blood cell responsible for the immune system located in the bone marrow. It is the second most common blood cancer, with most patients experiencing relapses. Tecvayli binds to the B-cell maturation antigen (BCMA) on myeloma cells, and CD3 on T-cells. Tecvayli binds to BCMA and CD3 and induces myeloma cell death via redirection of T cells. Tecvayli was approved based on results from the Phase 1/2 MajesTEC-1 study. In the trial which evaluated the efficacy and safety of the drug in a total of 165 patients, Tecvayli achieved an overall response rate (ORR) of 63% in patients with relapsed or refractory multiple myeloma (RRMM) who have received three or more therapies, including triple-class exposure to a proteasome inhibitor (PI), an immunomodulatory drug and an anti-CD38 monoclonal antibody. Also, 32.7% of the patients achieved a stringent complete response (sCR). Also, 6.7% and 19.4% of patients showed a complete response (CR) and very good partial response (VGPR), respectively. The median time to first response was 1.2 months, and the duration of response (DOR) was analyzed to be 18.4 months (14.9-not estimable). Ki-Hyun Kim, Chairman of the Multiple Myeloma Research Committee at the Korean Society of Hematology (Hematology-Oncology, Samsung Medical Center), said, “Based on the high response rate and the convenience of being an off-the-shelf, patient-administered formulation, we believe that the bispecific antibody Tecvayli may provide significant clinical benefit and hope for patients with multiple myeloma.”
- Company
- Pharma companies showcase their R&D achievements
- by Son, Hyung-Min May 13, 2024 05:52am
- ProGen’s CEO Jong Gyun-Kim Pharmaceutical companies have disclosed the development outcomes of the obesity treatments, which have now become the trending R&D. As obesity treatments of the GLP-1 class, such as those of Novo Nordisk and Lilly, become blockbuster new drugs globally, the development of latecomers is on the rise. Major companies plan to develop the next-generation obesity treatments related to GLP-1/GLP-2 and microneedle. At BIO KOREA 2024, held on May 8th at Coex, Seoul, the session titled ‘Advancements and Strategic Directions in the Diabetes-Obesity Treatment Market‘ was held. During the session, ProGen and Daewoong Therapeutics showcased their next-generation obesity treatments. Global pharmaceutical companies’ obesity treatments, such as Novo Nordisk's Wegovy and Saxenda and Eli Lilly’s Zepbound, have demonstrated game-changing weight loss effects. Because of the advantage of effective weight loss with injection, the use of obesity treatments has significantly increased. Korean pharmaceutical companies are developing distinguished obesity treatments with various mechanisms of action and formulations. ProGen·Daewoong Therapeutics, developing obesity treatments with mechanisms of action of dual agonist·microneedle ProGen is developing GLP-1/GIP-2 dual agonist for the treatment of diabetes and obesity. The company has an in-house NTIG platform, which is a multi-specific fusion protein technology. The NTIG platform has the advantage of improving drug efficacy and administration duration of various proteins. ProGen’s PG-102, a new candidate product for obesity, is under development using this platform. In preclinical trials, PG-102 has shown a greater effect on weight loss than Zepbound’s active ingredient, tirzepatitide. Specifically, PG-102 has improved metabolic health in an obesity mouse model and it demonstrated effective weight loss in fat cells. ProGen’s CEO Jong Gyun-Kim said, “Our goal for indications is monthly administration for diabetes and weekly administration for obesity. We are confident that it is more effective in reducing glycosylated hemoglobin and weight loss than other drugs.” He added, “It is also expected to prevent comorbidities such as cardiovascular diseases." Kim analyzed the cost of obesity treatment and the long-term administration data to play an important role in the future commercialization of treatments. Non-reimbursed obesity treatments are not covered by insurance reimbursement except for about nine countries. If the treatment is not reimbursed, it costs over US$15,000 annually. "The analysis suggests that pricing and insurance reimbursement policies will greatly influence the future development of obesity treatments," Kim said. "The weight loss effect of obesity drugs is approximately 20-40%. In the future, the quality of weight loss will become more important. The developers of obesity drugs should consider the phenomenon of more than two-thirds of patients regaining weight after weight loss as a significant issue," Kim added. Daewoong Therapeutics is developing an obesity treatment with a microneedle formulation. Microneedle is a drug delivery technology that utilizes patch-like devices with needles thinner than hair follicles to help absorb medication into the body. In precise quantities, microneedle can deliver various drugs, such as vaccines, toxins, and antibodies. The core processes are conducted at low temperatures, preventing degradation of biopharmaceuticals. It can reduce injection site pain and allow storage at room temperature, resulting in cost savings for storage and distribution. Although this technology has typically been used in skincare procedures and cosmetics, the pharmaceutical industry is trying to replace injections or oral formulations with new administration routes for treating dementia and diabetes. According to Daewoong Pharmaceutical, the microneedle obesity treatment patch they are developing requires only once-weekly application on areas with thin skin layers, such as the arms and abdomen. Currently marketed injectables require daily or weekly administration. The microneedle patch could serve as an alternative for patients resistant to injections or those with poor medication adherence. Daewoong Therapeutics plans to compare the efficacy of microneedle patch formulation with subcutaneous (SC) injections of semaglutide compounds such as Ozempic, Wegovy, and Rybelsus from Novo Nordisk. The company is conducting clinical trial comparing its microneedle formulation of 1mm with SC injections. Daewoong Pharmaceutical’s DDS department team leader Lee Buyong Daewoong Pharmaceutical’s DDS department team leader Lee Buyong said, “We are developing a microneedle patch formulation that can be administered once a week and stored at room temperature. If successful, we believe we can tap into a niche market. We are progressing with the development, anticipating that the patch containing 1.5-2 mm of semaglutide will have equivalent efficacy to the current 1 mg semaglutide injection." "Currently marketed GLP-1 formulations are all administered via injection, which can be difficult for patients with needle phobia and may result in low adherence rates. Microneedle patch could serve as an alternative," Lee emphasized. "While major obesity treatments require refrigerated storage, microneedle formulations can be stored at room temperature, offering significant manufacturing advantages," Lee added. "The current microneedle formulation does not have a classification of being sterile or non-sterile. We have started building manufacturing facilities for mass production, assuming that it will become a sterile formulation in the future. The facility's completion in 2026 will enable us to proceed with phase 2/3 clinical trials."
- Company
- Hanmi’s 2 new accounts of the pipeline enter clinical trial
- by Son, Hyung-Min May 13, 2024 05:51am
- Hanmi Pharm is accelerating the development of new obesity drugs. Following efpeglenatide, which has entered the Phase 3 trial in South Korea, Hanmi Pharm’s other new drug candidate has entered the full-scale clinical trial. Furthermore, Hanmi Pharm plans to establish various pipelines, including an oral agent, digital therapy related to obesity prevention and management, and eating disorder treatment. According to Hanmi Pharm on May 13, the U.S. Food & Drug Administration (FDA) has granted approval for a Phase 1 study of HM15275. HM15275 is a new drug candidate that simultaneously targets glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP)/glucagon for the treatment of obesity. Hanmi Pharm plans to maximize drug’s effect by simultaneously targeting GLP-1, GIP, and glucagon. GLP-1 and GIP are the active ingredients of Saxenda and Wegovy. Patients with diabetes and obesity typically have reduced incretin, and the disorders are associated with a reduction in GLP-1 secretion and decreased GIP-mediated stimulation of insulin secretion. GLP-1 and GIP are hormones responsible for 2/3 of the post-meal insulin response. Currently, Zepbound is available in the market as a dual agonist of GLP-1·GIP. However, a triple agonist that also includes glucagon has not been made available in the market. Hanmi Pharm aims to launch a first-in-class drug in this field. Hanmi Pharm’s pipeline efpeglenatide and HM15275 have entered clinical trials. The clinical trials will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics profile in healthy adults and patients with obesity. Furthermore, Hanmi will disclose four accounts of preclinical trial results related to HM15275 at the American Diabetes Association 2024 (ADA 2024) meeting. The company anticipates that HM15275 will be as effective as surgical therapy’s weight loss outcome (about 25%). Efpeglenatide proceeded to a Phase 3 trial…other pipeline underway To focus on developing novel obesity drugs, Hanmi Pharm has launched H.O.P. project. The company aims to secure various pipelines, including digital therapy and obesity drugs to improve feeding disorders. Hanmi Pharm Efpeglenatide, which has entered the Phase 3 trial, is the closest among these to be marketed. In October of last year, the Ministry of Food and Drug Safety (MFDS) granted approval for a Phase 3 trial of Hanmi’s obesity drug of GLP-1 class, efpeglenatide. The Phase 3 trial, being conducted in university hospitals in South Korea, will evaluate the efficacy of efpeglenatide. It will be a randomized, double-blind, placebo-controlled, parallel-group comparison study, enrolling 420 adult patients with obesity without diabetes. Efpeglenatide is a new candidate product that initially struck a licensing agreement with Sanofi in 2015 but returned to Hanmi Pharm in 2020. Sanofi was developing efpeglenatide but returned the right after the company changed its business strategy. Hanmi Pharm plans to develop efpeglenatide as an optimized GLP-1 class obesity treatment for Koreans. In a global trial, efpeglenatide was effective in weight loss and adjusting blood sugar. Because global companies have developed GLP-1 obesity treatments based on the standard of westerners with severe obesity, Hanmi Pharm has set a goal to develop a treatment optimized to the Korean obesity standard, which considers a body mass index (BMI) of 25kg/㎡. Efpeglenatide has been developed as a once-weekly dosing of injection. It is expected to have the same competitiveness as Wegovy (ingredient: semaglutide) and Zepbound (ingredient: tirzepatitide). Saxenda (liraglutide) is formulated for once-daily administration. Additionally, Hanmi Pharm plans to develop obesity treatments that minimize muscle loss and inhibit weight regain. In fact, previous research results show that two-thirds of the patients gain weight after they stop taking obesity treatments. Therefore, the quality of weight loss is an important factor for latecomers. Hanmi Pharm plans to develop treatments that overcome this issue. The company is currently seeking candidate products. Hanmi Pharm plans to develop an oral GLP-1 treatment for obesity. Most current GLP-1 treatments for obesity are administered as once-daily or once-weekly injections, but an oral treatment would provide more convenience to patients. Furthermore, Hanmi Pharm plans to develop a new biological drug that can improve eating disorders, such as binging, and a digital therapy that can be used for preventative measures of obesity through making adjustments to daily habits.
- Company
- HSF therapy 'Altuviiio' receives Orphan Drug designation
- by Eo, Yun-Ho May 10, 2024 04:33pm
- 'Altuviiio,' a once-weekly administered hemophilia A new drug, has been designated as Korea’s Orphan Drug. The Ministry of Food and Drug Safety (MFDS) announced this in a recent posting. Sanofi-Aventis Korea’s Altuviiio (efanesoctocog alfa) is a first-in-class high sustained factor (HSF) therapy for hemophilia A. With once-weekly treatment, Altuviio keeps hemophilia factor activity levels at over 40%, and helps provide patients with a near to normal life. Altuviiio provides bleed protection through a once-weekly treatment and delivers the longest sustained protection as a factor-based therapy, except for non-factor agents. When designated as Orphan Drug, drugs receive benefits such as accelerated approval review and exemption from GMP facility inspection. Sanofi is preparing for Altuviiio’s application for commercialization approval in South Korea. It is the first to receive MFDS’ orphan drug designation as a hemophilia therapy other than a non-factor agent, which received the designation three years ago. Meanwhile, XTEND-1 global Phase 3 study demonstrated the efficacy of Altuviiio. The study results demonstrated that the Altuviiio-administered group had a significant reduction of 77% in annualized bleeding rates (ABR) compared to a group with prior factor VIII prophylaxis. Altuviiio-administered group’s average weekly factor VIII activity was over 40 IU/dL and had levels of 15 IU/dL at 7 days. Furthermore, Altuviiio demonstrated superior drug tolerance, and antibody occurrence was not reported in the Altuviio-administered group. The most common side effects of Altuviiio were headache, arthralgia, falling, and backache.
- Company
- Dong-A ST will exclusively supply surgical robot Versius
- by Son, Hyung-Min May 10, 2024 05:47am
- Dong-A ST announced on the 8th that it has signed an agreement with CMR Surgical for the exclusive supply and distribution of the surgical robot ‘Versius’ in Korea. Versius was developed by CMR Surgical, a British company specializing in surgical robots. It has the advantage of having small, modular, and portable robot arms. It can be flexibly deployed according to the surgical method and operating room environment, being highly useful in operating rooms with space constraints. In particular, the company recently launched an indocyanine green (ICG) contrast imaging system that visualizes areas that cannot be seen with the naked eye with 3D HD technology, dramatically increasing the safety and precision of its operations. The market for Versius grew significantly in Europe. The robot has performed more than 20,000 surgeries across Latin America, Asia Pacific, and the Middle East. CMR Surgical has been continuously working to expand Versius’ geographic footprint. Driven by the success of Versius, the company has received investments from global companies such as SoftBank and Tencent since its inception in 2014. Dong-A ST plans to expedite the regulatory procedure for its globally verified Versius, and promptly introduce a new option to Korea’s robot-assisted laparoscopic surgery market. An official from Dong-A ST said, “Versius is a surgical robot that owns excellent technology, convenience, and proven safety. The product is expected to further enhance the efficiency and precision of surgeries for the medical staff.” Dong-A ST has been accelerating its medical device business expansion around the surgical sector. It expressed plans to create synergies by selling an endoscopic automatic suturing device this year and has secured new surgical products.
- Company
- 98% relapse-free Soliris is reimbursed for NMOSD in Korea
- by Son, Hyung-Min May 10, 2024 05:47am
- Ho Jin Kim, Head of Department of Neurology & Division of Clinical Research, National Cancer Center A new treatment option has been introduced for patients with neuromyelitis optica spectrum disorder (NMOSD), a disease that has over a 90% relapse rate. Soliris became fully reimbursable for NMOSD last month, recording a 98% relapse-free rate. However, there are concerns that the stringent reimbursement requirements for Soliris may reduce patient access to the treatment. On May 7, AstraZeneca Korea held a press conference at the Conrad Hotel in Seoul to celebrate the reimbursement of Soliris for NMOSD in Korea. Soliris is a C5 complement inhibitor developed by AstraZeneca. It binds to the C5 protein and prevents the activation of a complement terminal complex, which has been shown to be effective for several autoimmune diseases. Soliris is currently approved for paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD). In Korea, its approval for the NMOSD indication was extended in 2021. AstraZeneca Korea succeeded in securing reimbursement for the indication in Korea approximately 3 years after expanding its indication. NMOSD is a rare autoimmune disease characterized by unpredictable, recurrent episodes of optic neuritis and myelitis. It can cause severe disability, including optic neuritis resulting in blindness and paraplegia. 7 out of 10 NMOSD patients are positive for anti-quantiporin-4 (AQP-4) antibodies, which can activate the complement cascade and cause necrosis of the optic nerve and spinal cord. 90% of the patients suffer relapses, and each relapse is characterized by worsening symptoms, increasing the likelihood of blindness, paralysis, and premature death. Soliris has gained attention for showing effects in patients with relapsing NMOSD. In the PREVENT study, at 48 weeks of treatment, 98% of patients in the Soliris treatment arm were relapse-free, compared to 63% in the placebo arm. These relapse prevention benefits were sustained over the 144-week treatment period. The PREVENT extension study confirmed Soliris’s relapse-free rate of 94.4% 197 weeks after treatment. The study also confirmed the drug’s long-term sustained relapse prevention effect. However, some have expressed concerns on how the reimbursement requirements may limit patient access. The drug is currently reimbursed for adult patients with NMOSD who are 18 years of age or older who are AQP-4 antibody-positive and have an Expanded Disability Status Scale (EDSS) scores of 7 or below at the time of Soliris administration and at least 2 symptomatic relapses within the past year or at least 3 symptomatic relapses within the past 2 years (including one within the past year). The issue is that patients have to have multiple relapses to qualify for Soliris’ use. Specifically, patients who are receiving rituximab, an existing treatment for NMOSD, off-label, are ineligible for Soliris’ reimbursement. Patients would have to experience worsening of their disease to receive reimbursement. Enspryng, which was approved for NMOSD prior to Soliris, also has strict reimbursement requirements that prevent many patients from receiving its benefits. Professor Ho-Jin Kim from the Department of Neurology at the National Cancer Center said, “Even a single relapse of NMOSD can cause permanent disability. Active relapse prevention treatment is essential in the acute phase to prevent permanent disability in patients.” He added, “New high-priced treatments that are highly effective in preventing relapses have emerged, but the current reimbursement conditions limit their use in Korea. The expensive drugs should be used when they are most beneficial, rather than in a predetermined order. There is still a lot of work to be done to ensure the most efficient use of these good drugs for our patients." Chul Woong Kim, Director of the Rare Disease Business Unit at AstraZeneca, said, “The reimbursement of Soliris will allow patients with NMOSD to receive treatment for rapid relapse prevention. We will work to improve patient access so that more patients can enjoy Soliris' benefits."
- Company
- Korean AI-driven drug discovery speeds up
- by Nho, Byung Chul May 10, 2024 05:46am
- Ministry of Health and Welfare (MOHW) and the Ministry of Science and ICT will allocate KRW 34.8 billion in AI-driven new drug discovery. AI-driven new drug discovery through data collaboration among the biopharmaceutical industry, medical institutions, research institutions, universities, and public institutions has accelerated and gained significant attention. Previously, individual biopharmaceutical companies in South Korea conducted AI-driven new drug discovery through their in-house protocol, and the process was kept confidential. Starting with the recently organized business group called K-MELLODDY (Machine Learning Orchestration for Drug Discovery), a new system is expected to be implemented within the first half of the year to build upon a system to utilize sources and information related to various clinical and substance owned by 20 institutions. An individual company’s AI-driven new drug discovery could predict a new drug candidate’s ADMET (Absorption, Distribution, Metabolism, Excretion, Toxicity) value via in-vitro studies. However, these test results were insufficient to ensure the drug would pass in-vivo (pre-clinical) or clinical trials. Furthermore, ADMET prediction for clinical trial outcomes requires learning from clinical trial (in-human) data, but not enough clinical or in vivo data makes implementation extremely difficult. Furthermore, beyond predicting ADMET for a single drug molecule, solutions were needed that could expand to include interactions with specific targets, drug-drug interactions, responses based on user types, and various toxicity predictions. Therefore, optimized models based on federated learning have been considered for AI-driven drug development. K-MELLODDY aims to utilize new drug development data without leaking internal data to the outside world. In other words, federated learning and blockchain, which securely maintain companies' intellectual property data while leveraging AI, are evaluated as the core technologies of this project. The project’s characteristics and advantage are differentiated by 'Obtaining reliability of AI-driven new drug discovery,' 'High expandability of platform,' 'Securing ownership of data utilizing technology,' and 'Reducing new drug development cost.' Upon completion of the platform, utilizing AI predictions for the candidate product's metabolism and toxicity experiment results could reduce the number of experiments by half, leading to more than 50% cost savings. “K-MELLODDY project aims to build a federated learning-based AI drug development platform by utilizing the power of data held by Korea's academia, industry, and research institutes related to drug development. It aims to derive successful AI case studies in the drug discovery stage,” Hong Sungeun, Senior Researcher at the Convergence AI Institute for Drug Discovery (CAIID), stated. He added, “A budget of KRW 34.8 billion will be allocated over the next five years to complete the development of a Korean federated learning-based AI new drug discovery model.” Meanwhile, K-MELLODDY is described as a Korean AI new drug platform project that has been improved to suit the needs of the Korean situation while benchmarking the EU-MELLODDY project. EU-MELLODDY is an initiative for data collaboration among 10 pharmaceutical companies, first implemented in the EU. The initial business goal was to prove that data-based cooperation is possible between competing pharmaceutical companies and spread technological safety. Based on the results of EU-MELLODDY, which was conducted in 2019 for three years with KRW 25.6 billion put into, it was observed that the machine learning-based cooperative ADME/Tox prediction model was learned without leaking pharmaceutical companies’ confidential information. In addition, it outperformed the single model formulated by individual institutions without data leakage.
