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- 2026-05-04 19:44:16
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- Organon introduces JADA system for postpartum hemorrhage
- by Hwang, Byung-woo Jul 18, 2024 05:48am
- Organon, which emphasizes its focus on women's health after spinning off from MSD, has launched its first product in Korea. The JADA system (JADA), a medical device for the control and treatment of postpartum hemorrhage, is the first product the company released in Korea since Organon officially launched its Korean subsidiary in June 2021. JADA, which can be used for intrauterine negative pressure hemostasis, was recognized as a safe and effective new health technology by the National Evidence-based Healthcare Collaborating Agency (NECA) late last month. For Organon, the approval of JADA is significant because it is the first new product the company has introduced in Korea since the spin-off. Since its launch, the company has been differentiating itself by providing solutions focused on women's health, and the JADA aligns with the company’s purpose. Among Organon's many solutions at the global level, the company chose to first introduce the JADA system to Korea to address the unmet need for postpartum hemorrhage. According to Organon, postpartum hemorrhage is one of the most common birth complications, but can even result in maternal death. According to a national survey conducted from 2009 to 2014, about one-fifth of all mothers experience postpartum hemorrhage. In other words, the introduction of the JADA system has significance because it provides a new treatment option that can quickly and accurately control postpartum hemorrhage, which is of high concern amid the declining birthrate and rising interest in maternal health. "JADA is the first fruit born through Organon's efforts to deliver new treatment options for unmet needs in women's health since its inception," said So Eun Kim, Managing Director of Organon Korea. "We will continue to lead the way in providing various innovative medicines and solutions that address the health challenges that women may face throughout their lifecycles." Product photo of the JADA system and a schematic diagram of its mechanism of action JADA is the first new technology introduced in 15 years since the introduction of the intrauterine balloon tamponade and compression suture. While conventional intrauterine balloon tamponade systems achieved hemostasis by applying direct pressure to the lining of the uterus for 12 to 24 hours, JADA creates a negative pressure state in the uterus within minutes and applies pressure (up to 90 mmHg) to induce physiologic contractions. In the PEARLE study, bleeding was controlled successfully with JADA in 94% of the participants without requiring further interventions, with a median time to control bleeding of 3 minutes. Since its U.S. Food and Drug Administration (FDA) approval in August 2020, JADA has been expanding its reach in Asia including Hong Kong and Singapore, as well as parts of the Middle East and South America. "As the risk of postpartum hemorrhage increases in line with an increase in the mother's age, the importance of controlling postpartum hemorrhage for healthy births will continue to increase," said an Organon representative. "We are working to launch JADA in Korea, but the official launch date has not been set yet." The representative added, “Organon Korea has identified a number of unmet needs in women's health and will continue to strive to provide a range of innovative medicines and solutions for various health issues that women may experience throughout their lifecycle."
- Company
- ProGen expands bi-specific antibody R&D with Korean partners
- by Son, Hyung-Min Jul 17, 2024 05:50am
- ProGen's R&D competitiveness in developing bi-specific antibodies expands to various fields, including immunotherapy, diabetes drugs, and new drugs for obesity. ProGen has started joint research with Yuhan Corp. to develop immunotherapy, and the company has also entered phase 2 trials for in-house developed drugs for diabetes and new drugs for obesity. Furthermore, ProGen has signed a business agreement with AbTis, a subsidiary of Dong-A ST, to develop bi-specific antibody-drug conjugates (ADC). Sources said on July 16th that earlier this month, ProGen signed a comprehensive R&D collaboration agreement with Yuhan Corp. to develop innovative new drug candidates. These companies have established a new drug development committee comprising new drug development experts, and they are set to develop next-generation new drugs and strengthen global market competitiveness. Under this agreement, ProGen and Yuhan Corp. plan to develop bi-specific antibody-mediated immunotherapy. These companies are currently developing PG-208, which is in the candidate product search stage. ProGen specializes in developing bi-specific antibodies, and the company has a proprietary 'NTIG' platform, which is a long-term fusion protein technology. The NTIG platform has the advantage of improving the half-life of proteins in various forms and administration intervals. The NTIG is optimized for the development of anti-cancer and immune disease treatments with multi-targeting and long-term durability. ProGen Progen also has another platform called 'Cyt-NTIG,' which combines NTIF platform technology and proprietary engineered cytokine. This platform targets cytokines that induce immune overactivation, overcoming systemic side effects of cytokines. Cytokines are proteins involved in immunity and inflammation, including the cell's proliferation, cell division, cell death, and wound healing. ProGen is investigating various possibilities with this bi-specific platform technology. In addition to developing immunotherapy, the company is investigating the potential of bi-specific antibodies in treating ADC, obesity, and diabetes. In April, ProGen signed a collaboration agreement with AbTis, a subsidiary of Dong-A ST, to develop bi-specific antibody-mediated ADC. AbTis plans to develop bi-specific antibody-mediated ADC by combining its third-generation ADC linker technology, 'AbClick,' which overcomes conventional ADC limitations, with ProGen's NTIG technology. ProGen and AbTis aim to develop new drugs for autoimmune diseases by working on new bi-specific antibody-drug conjugates (BsADC) for immune diseases. ProGen Developing bi-specific antibodies for diabetes and obesity ProGen is also developing bi-specific antibodies for diabetes and obesity. ProGen is developing PG-102, an obesity treatment that targets GLP-1 and GLP-2 bi-specifically. The Ministry of Food and Drug Safety (MFDS) recently approved a phase 2 trial in South Korea for this new drug candidate. The phase 2 trial will evaluate the safety and efficacy of PG-102 and placebo in patients with diabetes and obesity. GLP-1 is the incretin hormone secreted from the intestine, increasing glucose-induced insulin secretion. It is known to play an important role in regulating weight control. ProGen aims to maximize the effects, such as improving intestine function, glucose uptake in adipose tissue, and alleviating chronic inflammation, by targeting both GLP-1 and GLP-2. In a preclinical trial, PG-102 demonstrated more significant weight loss effects than tirzepatitide, the ingredient used in Zepbound. In detail, PG-102 improved the metabolic function in a mouse model of diabetes and obesity and demonstrated effective weight loss results in adipose cells. In the phase 1a trial involving healthy individuals, PG-102's safety and drug tolerance have been confirmed. When the effects of PG-102 on blood glucose and weight loss are confirmed through local phase 2 trials, ProGen aims to enter global phase 2 trials next year. Additionally, ProGen is collaborating with Rani Therapeutics, a United States-based company, to jointly develop the oral obesity drug, RPG-102. RPG-102 contains PG-102 in Rani Therapeutics' oral RaniPill capsule. The recently disclosed phase 1a trial results confirm RPG-102's drug tolerance and safety results. ProGen and Rani Therapeutics plan to develop RPG-102 as a once-weekly oral therapy.
- Company
- Botulinum toxin exports in 1H rise 17%
- by Kim, Jin-Gu Jul 17, 2024 05:50am
- Korea's botulinum toxin exports increased by 17% year-on-year in the first half of this year. This is the highest half-yearly export performance recorded ever. The increase in exports to the United States, China, and Japan is analyzed to have driven the increase in overall botulinum toxin exports. According to the Korea Customs Service on July 16, the amount of domestic botulinum toxin exports from January to June this year was USD 194.21 million (about KRW 270 billion). Compared to the USD 166.39 million recorded in the first half of last year, the amount has increased by 17% in just one year. This is the highest half-year export record ever. In the last three years, botulinum toxin exports have steadily increased, since recording USD 122.1 million in the first half of 2021 and USD 127.91 million in the second half; USD 131.41 million in the first half of 2022, and USD 164.9 million in second half; USD 166.39 million in the first half of 2023 and USD 186.62 million in the second half; and USD 194.21 million in the first half of this year. The industry is expecting to exceed the USD 200 million mark in the second half of the year. Semiannual exports of Korean botulinum toxins (Unit: USD 1 million, Source: Korea Customs Service) By country, exports to the United States, China, and Japan increased significantly. In the first half of the year, exports to the U.S. totaled at KRW 35.64 million, up 55% from the USD 23.01 million in the same period last year. Exports to China increased 53% from USD 23.55 million to USD 35.92 million. Exports to Japan increased 45% from USD 10.52 million to USD 15.27 million. Thailand and Brazil, which had been 2 of the leading exporting countries for domestically produced botulinum toxin, saw a slowdown. Exports to Thailand increased only 3%, from USD 14.01 million to USD 14.37 million. Brazil's exports dropped 25% from USD 21.07 million to USD 15.81 million. The industry expects a further increase in exports of domestic botulinum toxin products to the US and China markets in the future. In the US, Daewoong Pharmaceutical's Jubo (domestic product name: Nabota) has entered the market. The company has been selling its product through its local partner Evolus. Last year, Daewoong Pharmaceutical's botulinum toxin exports were estimated to be KRW 109.9 billion, with most coming from the US. 대웅제약 주보(좌), 휴젤 레티보 제품사진. Hugel is also preparing to enter the US market. In March this year, the company received the U.S. Food and Drug Administration's (FDA) approval for Retivo (domestic product name: Botulax). It is the second domestic botulinum toxin after Daewoong Pharmaceutical's ZuboJubo to receive marketing authorization in the US. In June, the company won a strain dispute with Medytox and overcame the biggest obstacle to entering the US market. The U.S. International Trade Commission (ITC) issued a preliminary ruling that Hugel did not infringe on Medytox's intellectual property rights. If this preliminary ruling leads to a final ruling in October, it is expected to accelerate Retivo's entry into the U.S. market. Hugel’s Retivo entered first in the Chinese market. Hugel received marketing authorization for Retivo in China in October 2020. Since then, it has reportedly been steadily increasing exports. Daewoong Pharmaceutical is also accelerating its entry into China with Nabota. Daewoong has applied for Nabota’s approval in China. Daewoong plans to launch Nabota in China early next year after receiving marketing authorization within the year. In addition to Daewoong, Huons is also in the process of applying for marketing authorization for its product to enter the Chinese market.
- Company
- Ultomiris gets expanded indication for neuromyelitis optica
- by Hwang, Byung-woo Jul 17, 2024 05:50am
- Ultomiris (ravulizumab) has strengthened its position in the market for neuromyelitis optica after obtaining approval for expanded indication. Product photo of UltomirisOn July 11th, the Ministry of Food and Drug Safety (MFDS) granted approval of expanded indication for Ultomiris, a C5 complement inhibitor, for the treatment of adults aged 18 years and above with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP-4) antibody-positive. The approval of NMOSD indication was based on data from the external placebo-controlled, multi-center, open-label phase 3 CHAMPION-NMOSD trial, which evaluated the treatment effect and safety of Ultomiris. The placebo used in the control group was the placebo from Soliris’ phase 3 PREVENT trial for NMOSD, considering that NMOSD is a rare disease and Ultomiris and Soliris are similar treatment types. The data from the 73-week (median treatment period) clinical trial demonstrated that patients who received Ultomiris were recurrence-free and had a 98.7% reduction in the risk of recurrence compared to those who received placebo. Furthermore, the research confirmed a significant improvement in the secondary endpoints, annual recurrence rate (APR) and the Hauser Ambulatory Index (HAI). During the clinical trial, there were no cases with recurrence when treated with Ultomiris, recording 0.000 APR. It was reported that the rate of patients who experienced worsened HAI in Ultomiris was 3.4% (2 out of 58), whereas those who received placebo had a 23.4% HAI (11 out of 47). Additionally, the trial had three severe adverse cases after the start of treatment. Two patients had meningococcal infections but continued treatments after recovery without any side effects. Ho Jin Kim, Professor of the Neurology department at the National Cancer Center, said, “Ultomiris demonstrated no recurrences in NMOSD patients for 73.5 weeks. It is a treatment option with improved convenience of treatment, as it extends the duration interval from 2 weeks to 8 weeks.” Ultomiris is the next-generation C5 complement inhibitor, as it extended its half-life by four times compared to Soliris. Soliris required administration every two weeks, whereas Ultomiris improved the convenience of treatment by extending the interval to 8 weeks. “The interval of treatment not only reduces the number of hospital visits, but also saves the physical strength of patients with difficulties in walking and vision. It also reduces other costs related to hospital visits,” Kim added. “Improvements of convenience alleviate the burden of treatment and help improve patients’ quality of life and treatment compliance,” Kim explained. With the current indication approval, Ultomiris can be used to treat four rare diseases, including ▲paroxysmal nocturnal hemoglobinuria (PNH) ▲atypical hemolytic uremic syndrome (aHUS), and ▲generalized myasthenia gravis (gMG). Chul Woong Kim, Lead for Rare Diseases at AstraZeneca Korea, said, “After obtaining reimbursement approval for Soliris, we are pleased to contribute to the improvement of NMOSD treatment in South Korea with the expanded indication for Ultomiris.” Kim added, “We will strive to enhance treatment options so that more NMOSD patients can receive treatments without fear of recurrence and continue with their daily lives.”
- Company
- Will Eylea K-biosimilar overcome evergreening in the U.S.?
- by Hwang, Byung-woo Jul 16, 2024 05:48am
- The expiration of the U.S. substance patent for the blockbuster biopharmaceutical Eylea (aflibercept) is expected to spark competition in the biosimilar market. Samsung Bioepis, which preemptively received marketing authorization for an Eylea biosimilar, is stuck in a patent dispute with Regeneron, which owns the original Eylea. It is expected that other latecomers will also face a tough time entering the market depending on Regeneron’s patent response. Pic of Eylea Eylea is a treatment for eye diseases such as macular degeneration that binds to vascular endothelial growth factor (VEGF) and inhibits neovascularization. The drug generated global market sales of KRW 13 trillion. Of these, the U.S. market accounts for USD 5.719 billion in sales, accounting for a 62% share. Currently, Eylea’s patent has expired in Korea and its biosimilar has been launched into the market, and the patent is scheduled to expire in May 2025 in Europe. In the U.S., the product patent expired in June of this year, but the other patents will expire as follows: ▲formulation patent in 2027, ▲ regimen patent in 2032, ▲purification and batch patent in 2040 The difference between biosimilar entry in Korea and the United States is in the existence of patent disputes. In Korea, Bayer, which sells Eylea, did not file a patent suit, so there was no problem with the launch of Eylea biosimilars. However, in the U.S., Regeneron filed a patent infringement lawsuit against Celltrion and Samsung Bioepis in November last year. Regeneron patent defense remains a hurdle in the Eylea market...launch timing remains in question Samsung Bioepis is the company facing an immediate issue due to the patent suit. In May, the U.S. Food and Drug Administration (FDA) approved Samsung Bioepis' Eylea biosimilar, Opuviz, along with India's Biocon Biologics' Yesafili, as the first biosimilars. However, on June 15, the U.S. District Court for the Northern District of West Virginia granted Regeneron's motion for a preliminary injunction against Samsung Bioepis, which prevents Opuviz from launching in the United States. Samsung Bioepis immediately filed an appeal against the preliminary injunction, but the appeal is expected to take 6 months to a year. A Samsung Bioepis official said, “We have no position on the patent dispute that we can disclose at this time.” While it is difficult to predict the outcome of the patent dispute, the general consensus is that the ruling aligns with Regeneron’s intent as the request for a preliminary injunction has been granted. "In the current situation where the product patent has already expired, it is important to determine whether the formulation patent is infringed, and Samsung Bioepis or Celltrion must prove that the patent has not been infringed," said an official from the Korean Intellectual Property Office. "Regeneron's strategy will be to delay the launch of the similar by claiming patent infringement." "In addition to the remaining formulation patent, Regeneron's dosing regimen patent expires in 2032, among others, so the company has an evergreen strategy in place and does not need to hasten the process. The Korean company can appeal to the federal court, but that will also take time, so the originator has an advantage." Considering this, it is difficult to gauge the exact timing of Opuviz’slaunch as its launch is banned until the end of the patent dispute. Given the nature of biosimilars, where multiple competitors enter the market at the same time, it is important to arrive first into the market. However, in this situation, it is unclear whether the biosimilar companies will be able to enjoy the advantage of first approval. The industry believes this is a red flag for Celltrion as well, as the company has also completed applying for U.S. FDA marketing authorization for its biosimilar. However, the result may differ, as there have been cases like Humira where the original and generic companies discussed royalty payments to enable earlier market launch of the generics. AbbVie had delayed the launch of Humira biosimilars beyond the product patent term by building a patent barrier, but Amgen agreed to pay royalties on the remaining patents and released the first Humira generic. "At the time, the industry expected Humira’s generic release to be a long battle as well, but discussions were dramatically held, allowing for the generic’s launch last year,” said an industry official. "If the company feels that it has been extended Eylea’s patent long enough, there is a possibility that the timing of the launch of its generics could be coordinated through similar discussions.”
- Company
- Bladder cancer drug Balversa lands in KOR 1.5yr after apvl
- by Eo, Yun-Ho Jul 15, 2024 05:47am
- The new bladder cancer drug Balversa may now be prescribed, one year and a half after being approved in Korea. According to industry sources, Janssen Korea’s FGFR targeting urothelial carcinoma (bladder cancer) drug Balversa (erdafitinib) recently passed Seoul Asan Medical Center’s drug committee (DC) review. Balversa was approved by the Ministry of Food and Drug Safety in January 2022. Specifically, the drug is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with FGFR2 or FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy, which includes platinum-based chemotherapy, or whose disease has progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. However, the approval of PD-1 and PD-L1-directed immuno-oncology agents in the first- and second-line settings that followed Balversa’s approval led to the need for Balversa todemonstrate efficacy in patients who previously received these agents. The situation was addressed with the publication of Balversa’s Phase III THOR trial study, which demonstrated a prolonged overall survival (OS) benefit with Balversa over chemotherapy in patients with metastatic urothelial carcinoma with FGFR3/2 gene alterations whose disease progressed after first-line treatment with immuno-oncology agents. In the study, Balversa prolonged overall survival (OS) compared with chemotherapy in patients with metastatic urothelial carcinoma. Results showed that over a median follow-up of 15.9 months, the mOS was 12.1 months in the Balversa arm, reducing the risk of death by 36% compared with the 7.8 months in the chemotherapy arm. Based on these findings, the U.S. Food and Drug Administration (FDA) granted Balversa formal approval in January, but with a more restricted indication than originally approved, and the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended expanded indications for Balversa. Janssen Korea has also additional submitted results from the THOR study to Korea’s Ministry of Food and Drug Safety. Therefore, the company well may launch Balversa in earnest in the second half of the year. It remains to be seen whether Balversa will be able to go beyond landing in medical institutions and gain insurance coverage in Korea. Meanwhile, bladder cancer is one major cancer that has lacked a targeted therapy option. Balversa is the first targeted anti-cancer drug for bladder cancer with a novel mechanism of action that inhibits fibroblast growth factor receptor (FGFR). FGFR is a biomarker involved in cancer cell growth that is associated with various cancers. FGFR mutations are particularly common in bladder cancer, with 20 to 30% of patients carrying mutations.
- Company
- Severe asthma drug 'Fasenra' lands in general hospitals
- by Eo, Yun-Ho Jul 15, 2024 05:47am
- AstraZeneca Korea’s Fasenra (benralizumab) has passed the drug committees (DC) of tertiary general hospitals. ‘Fasenra,’ a severe asthma treatment, has been listed for insurance reimbursement this month and is now available for prescriptions at general hospitals. Industry sources said that AstraZeneca Korea’s Fasenra (benralizumab) has passed the drug committees (DC) of tertiary general hospitals, including Samsung Medical Center in Seoul, Seoul National University, Seoul Asan Hospital, and Seoul St. Mary’s Hospital, and medical institutions, including Kyungpook National University Hospital, Pusan National University Hospital, Seoul National University Bundang Hospital, Ajou University Hospital, Chonnam National University Hospital, and Chungnam National University Hospital. Since July 1st, Fasenra has been approved for reimbursement. Severe eosinophilic asthma accounts for most of the cases of severe asthma. The basis of Fasenra’s approval was improvements in patients with severe eosinophilic asthma: up to 87% of the patients treated with Fasenra no longer had advanced asthma. The drug can be reimbursed when treating patients with severe eosinophilic asthma who are inadequately controlled despite treatment with high-dose inhaled corticosteroid-long-acting beta-agonist (ICS/LABA) and long-acting muscarinic antagonist (LAMA). In detail, the following criteria should be met: ▲Within the year before starting treatment, the eosinophil count in the blood was 300 cells/㎕ or higher, and within the first year of treatment, systemic oral corticosteroids (OCS) were required for acute exacerbations four or more times, or within 6 months before starting therapy, systemic oral corticosteroids were continuously administered, or ▲The eosinophil count in the blood was 400 cells/㎕ or higher within the year before starting treatment. Systemic corticosteroids were required for acute exacerbations three or more times within the first year of treatment. Severe eosinophilic asthma accounts for approximately 84% of severe asthma cases. It involves frequent exacerbations and may lead to reduced quality of life despite treatment with high-dose inhaled corticosteroids and other conventional therapies. In particular, when symptoms are not controlled, even with asthma controllers, oral steroids may be necessary. However, long-term use of these medications is associated with systemic side effects such as osteoporosis, hypertension, and diabetes. Therefore, biological agents are recommended to reduce the dosage of these treatments. Fasenra is a targeted biologic agent that binds directly to interleukin-5 receptor alpha (IL-5Rα) expressed on eosinophils' surface, inducing cell apoptosis. It has been demonstrated to reduce blood eosinophil counts rapidly within one day of administration. In the global Phase 3 SIROCCO clinical study, enrolling 1205 severe eosinophilic asthma patients worldwide, including Korea, Fasenra administered at 8-week intervals showed a 51% reduction in annual asthma exacerbation rates compared to placebo after 48 weeks of treatment. In the CALIMA study, Fasenra treatment also resulted in a 28% reduction in annual asthma exacerbation rates compared to placebo.
- Company
- K-Bios make progress in new rare lung cancer drug dev
- by Son, Hyung-Min Jul 15, 2024 05:47am
- The c-MET-mutation-targeted NSCLC drugs that are being developed by Korean pharma and biotech companies have been recognized for their potential. Recently, Abion Bio signed an agreement with Janssen to receive Leclaza (lasertinib) free of charge. This agreement will allow Abion Bio to commercialize the combination of its in-development vabametkib and Leclaza for the treatment of lung cancer. InnoCure Therapeutics’s targeted therapy has been recognized for its value by being selected as a national new drug development project According to industry sources on the 13th, Johnson & Johnson’s subsidiary Janssen will provide domestic biotech Abion Bio free lasertinib for its EGFR-positive non-small cell lung cancer (NSCLC) clinical trial. Abion Bio’s NSCLC drug candidate in development is vabametkib, which targets the c-MET mutation. c-MET is a protein expressed by the mesenchymal-epithelial transition (MET) gene. It is one of the proteins that transmit signals to cells and is considered a typical oncogene and is associated with the development of various solid cancers, including lung, colon, stomach, and liver cancers. It is estimated that 6% of patients with non-small cell lung cancer harbor a c-MET mutation. Janssen will be testing lasertinib’s potential in EGFR-positive NSCLC in combination with Abion Bio’s vabametkib. Approximately 30-40% of patients with EGFR-mutated NSCLC develop a c-MET mutation after receiving a prior EGFR targeting therapy. In clinical results, vabametkib demonstrated an objective response rate (ORR) of 52.9% in patients with c-MET-mutated NSCLC who failed prior treatment. In previously untreated patients, the ORR was 75%. In terms of safety, vabametkib’s incidence of grade 3 or higher treatment-related adverse events (TRAE) was 10%. This was lower than the TRAE rates of 38% and 28% identified with Novartis' Tabrecta and Merck's Tepmetko. Abion is aiming to develop vabametkib as a treatment for EGFR-mutant NSCLC in combination with Leclaza and as monotherapy for MET-mutant NSCLC. InnoCure develops c-MET-mutated lung cancer treatment with target protein degrader InnoCure Therapeutics has also made progress in the development of c-MET lung cancer therapies. Recently, the company's new drug candidate was selected as an R&D project to support the establishment of a new drug ecosystem that is being organized by the Korea Drug Development Fund. InnoCure develops new drugs with next-generation target protein degrader (TPD) technology. The company is focused on the development of new drugs for non-small cell lung cancer by utilizing its main technologies, ELKBIL, NEOELKBIL platform, and its oral formulation platform MILPROTAC. InnoCure Based on its TPD technology, Innocure has been developing a c-MET targeted inhibitor for the treatment of NSCLC. With the selection of this new drug development project, the company plans to derive new drug candidates and conduct research to enter clinical trials. While there is a treatment available for MET exon 14 deletion among c-MET mutations, no other targeted therapies are available on the market. InnoCure Therapeutics aims to address this unmet need by degrading the c-MET target protein.
- Company
- K-Bio speeds up novel drug development to treat MASH
- by Son, Hyung-Min Jul 15, 2024 05:47am
- The biotech industry in South Korea has made notable achievements in treating MASH. Many pharmaceutical companies have failed in clinical trials to develop a treatment for MASH due to its complex pathogenesis. As the first treatment for MASH has been approved, the industry draws attention to the success of the commercialization of other new drug candidates of various pharmaceutical companies that entered clinical trials in South Korea. On July 11th, the current trend in the MASH treatment development was discussed during the Bioplus-Interphex Korea 2024 (BIX 2024), sponsored by the Korea Biotechnology Industry Organization (Korea Bio) and RX Korea. MASH was previously known as Non-Alcoholic Steatohepatitis (NASH). International academic associations, such as the American Association for the Study of Liver Diseases (AASLD), agreed upon the use of the term Metabolic dysfunction-associated steatohepatitis (MASH). Developing treatment for MASH has been challenging until now. However, the first novel drug to treat MASH in March became available after the U.S.-based Madrigal Pharmaceuticals’ Rezdiffra was approved. The late-comers eye on the opportunity to develop the second potential novel drug development through various mechanisms. Lee Seul-ki, D&D pharmatech CEO D&D pharmatech has entered a phase 2 trial in the United States. The company has recently received approval for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA). DD01’s phase 2 trial will be conducted across 10 institutions in the United States, enrolling 68 patients with MASH-accompanying overweight and obesity. DD01 is an agent targeting both GLP-1 and glucagon. In preclinical trials, D&D pharmatech’s DD01, an agent targeting both GLP-1 and glucagon, has shown a significant decrease in liver fat and a weigh loss effect. DD01’s effect has been maintained in a phase 1 trial. The phase 1 trial evaluated the drug tolerance and safety of DD01 and placebo in patients with MASH accompanied by obesity instead of in healthy adults. The clinical results demonstrated that a 4-week DD01 treatment reduced liver fat by 52%. These results were similar to those of the 1-year treatment with semaglutide (57% reduction) or Tirzepatide (47% reduction). High-dose (80 mg) DD01 treatment reduced liver fat by 30% in all patients. In contrast, the placebo’s reduction effect was shown in 8% of all patients. Lee Seul-ki, D&D pharmatech’s CEO, said, “We believe that glucagon plays an important role because many obesity patients also have MASH. Clinical studies reported that glucagon therapy reduces liver fibrosis by 50-80%.” Lee added that “DD01 is formulated with GLP-1 and glucagon in a ratio of 10:1. In a preclinical study, DD01 demonstrated to maintain the effect of GLP-1 as well as the effect of glucagon.” “We need a drug that effectively regulates blood glucose and weight to treat MASH. GLP-1 drugs that can quickly elevate blood glucose have adverse reactions, such as dizziness and vomiting. For DD01, we confirmed that it is more slowly released into the blood than other therapies. Additionally, we received approval of an IND application for a new protein therapy targeting collagen synthesis and investigating the potential of various novel drugs,” Lee commented. OliX Pharmaceuticals is developing a new drug candidate, OLX75016, to treat MASH. OLX75016 works by inhibiting MARC1 expression, which is related to the pathogenesis of MASH and reducing liver fat. June Hyun Park, OliX Pharmaceuticals Director OliX Pharmaceuticals has recently entered a phase 1 trial for OLX75016 in Australia and started the first patient administration. Notably, OliX Pharmaceuticals is investigating the possibility of using OLX75016 in combination with novel drugs targeting GLP-1 and glucagon. Since most MASH treatments target GLP-1, OliX Pharmaceuticals plans to develop treatments that have distinguished mechanisms and improve synergistic effects with GLP-1 agents. In a preclinical trial, OLX702A demonstrated effects in reducing liver fat and reversing liver fibrosis. June Hyun Park, OliX Pharmaceuticals Director, said, “Fibrosis contributes to deaths associated with liver. We are confirming the role of MARC1 in liver fibrosis. As we confirm MARC1 as an important factor in fibrosis, we are exploring the potential of novel drug development.”
- Company
- Protein C deficiency drug 'Ceprotin' begins negotiations
- by Eo, Yun-Ho Jul 12, 2024 05:48am
- Takeda Pharmaceuticals Korea 'Ceprotin' has entered the last stage of obtaininig reimbursement listing. According to our investigation, Takeda Pharmaceuticals Korea has started to negotiate drug pricing with the National Health Insurance Service (NHIS) for Ceprotin (Human potein C), a novel drug for the treatment of congenital protein C deficiency. ‘Human protein C deficiency’ is a type of thrombotic disease that causes blood clotting and it was first reported in 1981. 'Severe congenital protein C deficiency,' a type of protein C deficiency, is an extremely rare disease that occurs in one in every 4 million. In South Korea, there have been reported cases of 13 patients to date (according to 2019 KOSIS statistics). Congenital protein C deficiency is a hereditary disorder that occurs when the body lacks ‘protein c,’ a naturally occurring thrombolytic agent in the body, due to genetic abnormalities. On average, healthy individuals have a 'protein C' level of around 100 ng/dL. However, patients with severe congenital protein C deficiency are known to have less than 1% of normal levels (less than 1 ng/dL), disrupting the balance between blood clotting and anticoagulation. This imbalance results in frequent thrombosis, recurrent venous thrombosis, venous stasis ulcers, and pulmonary embolism. These symptoms can lead to high-risk conditions such as myocardial infarction or stroke. Additionally, it occurs when blood vessels become blocked due to thrombosis, causing bleeding throughout the body, the most common manifestation is large, purplish patches resembling bruises on the skin. Currently, there is no known drug therapy that can prevent or fully control venous thrombosis and purpura fulminans (PF) in patients with severe congenital protein C deficiency. Ceprotin is a concentrated solution of human protein C made from human protein C. It received the Orphan Drug Designation from the Ministry of Food and Drug Safety (MFDS) in March 2021. Based on an early phase clinical study, enrolling 18 patients with severe congenital protein C deficiency, Ceprotin was demonstrated to be effective in treating purpura fulminans (PF) or other thrombotic events compared to the histological control group. In the study, 18 patients with purpura fulminans (PF) (6 severe, 11 moderate, and 1 mild) were treated with Ceprotin. 17 patients (94.4%) were assessed as 'effective,' 1 patient (5.6%) as 'effective with complications.' There were no reports of 'ineffective' outcomes. This result demonstrated more effective treatment outcomes than a control group (21 patients), which received traditional therapies such as fresh frozen plasma or traditional anticoagulants. In the secondary efficacy rating of Ceprotin, out of 18 cases of purpura fulminans (PF), 13 cases (72.2%) were evaluated as 'excellent,' 4 cases (22.2%) as 'good,' and 1 case (5.6%) of severe purpura fulminans (PF) was assessed as 'fair.' Additionally, out of the 5 cases of venous thrombosis, 4 cases (80%) were evaluated as 'excellent' and 1 case (20%) as 'good'. Furthermore, Ceprotin effectively reduced the size and number of skin lesions. Non-necrotic skin lesions were treated within a maximum of 12 days (median 4 days), while necrotic skin lesions were treated within a maximum of 52 days (median 11 days) with this drug.
