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[IT뉴스]DreamCIS Soars on 19% Weight Loss…Reyon Cuts Injection Burden 89%[K-Bio Pulse]

온카뱅크관리자

2026-05-11 08:17:29

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 This article was released as Pharm Edaily Premium Content on May 8, 2026, at 11:40 AM.
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 [Jiwan Kim, Edaily Reporter] Korean pharmaceutical and biotech shares moved sharply higher on May 7 as companies announced positive global clinical data and U.S. FDA-related developments across obesity, ophthalmology, and oncology sectors. Investors responded strongly to signs that several domestic firms are moving beyond early-stage R&amp;D into global commercialization and licensing discussions.
 DreamCIS hit the daily upper limit after its partner reported successful global Phase 3 results for an obesity treatment candidate. Reyon Pharmaceutical surged on long-term efficacy data for a wet age-related macular degeneration (wAMD) gene therapy, while PolarisAI Pharma gained after investee Alpha Tau Medical obtained FDA approval to expand a pancreatic cancer clinical trial.
 DreamCIS Soars on Global Phase 3 Success of Obesity Drug Candidate
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 DreamCIS closed up 29.8% at 6,250 won after Brightgene Bio-Medical announced that its GLP-1/GIP dual agonist obesity drug candidate “BGM0504” achieved primary endpoints in a global Phase 3 study.
 The randomized, double-blind, placebo-controlled trial enrolled 652 overweight and obese patients across 41 clinical sites in China. Participants had an average baseline body weight of 96.2 kg and a mean BMI of 33.9 kg/m².
 According to the company, BGM0504 achieved an average 19.3% weight reduction at 52 weeks. In addition to weight loss, the drug demonstrated broad cardiometabolic benefits. Among patients with hypertension, 92.9% reportedly returned to normal blood pressure ranges. Hip bone density increased by an average of 3.9% despite substantial weight reduction, and no hypoglycemia cases were reported during the study.
 Safety data also attracted attention. The discontinuation rate due to adverse events in the high-dose 15mg group was only 0.7%, suggesting potentially improved tolerability compared with existing GLP-1 therapies, which are often associated with gastrointestinal side effects and treatment dropouts.
 The global obesity drug market is currently dominated by Eli Lilly’s Mounjaro/Zepbound and Novo Nordisk’s Wegovy. Market observers are now watching whether BGM0504 can differentiate itself through both weight reduction and broader metabolic benefits.
 DreamCIS said it has independently submitted an IND application for domestic Phase 3 trials in Korea and is seeking exclusive commercialization and distribution rights for the Korean market.
 Reyon Pharmaceutical Climbs on Long-Term Gene Therapy Data
 Reyon Pharmaceutical rose 9.02% to close at 11,240 won after announcing 52-week follow-up data for “NG101,” a gene therapy targeting wet age-related macular degeneration co-developed with Elysigen.
 The data were presented at ARVO 2026, one of the world’s largest ophthalmology conferences, held this year in Denver.
 According to the presentation, patients in the low-dose cohort required an average of 9.8 anti-VEGF injections during the year prior to treatment. After receiving NG101, the average number of injections fell to 1.1 during the 52-week follow-up period, representing an approximately 89% reduction in injection burden.
 The durability profile also appeared encouraging. Five out of six patients maintained vision with one or fewer additional injections over one year, while three patients required no supplementary anti-VEGF injections at all during the observation period.
 No serious adverse events (SAE) or dose-limiting toxicities (DLT) were observed during the study.
 Reyon Pharmaceutical and Elysigen completed dosing for all 20 patients enrolled in the Phase 1/2a study and plan to secure interim data in the third quarter of 2026 before advancing into global Phase 2b trials and licensing negotiations.
 Reyon Pharmaceutical secured exclusive global manufacturing and supply rights for NG101 under a 2020 co-development agreement with Elysigen. The company’s smart factory in Chungju is expected to serve as a future production hub for commercialization.
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 Reyon Pharmaceutical’s Chungju Bio Plant. (Photo=Reyon Pharmaceutical)
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 PolarisAI Pharma Gains on FDA Approval for Alpha Tau Trial Expansion
 PolarisAI Pharma climbed 8.02% to 7,540 won after Alpha Tau Medical received FDA approval for an IDE supplement related to its pancreatic cancer program.
 The approval allows Alpha Tau to expand enrollment in its U.S. multicenter IMPACT pilot study by adding a gemcitabine/nab-paclitaxel combination arm alongside the existing mFOLFIRINOX cohort.
 As a result, the total study size will increase from 30 to 40 patients, including newly diagnosed unresectable locally advanced and metastatic pancreatic cancer patients.
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 <img alt="Alpha Tau Expands U.S. Pancreatic Cancer Trial After FDA Approves IDE Supplement. (Source: Alpha Tau)" class="thumb_g_article" data-org-src="https://t1.daumcdn.net/news/202605/11/Edaily/20260511081421416ufxf.png" data-org-width="800" dmcf-mid="2V110ADgDw" dmcf-mtype="image" height="auto" src="https://img1.daumcdn.net/thumb/R658x0.q70/?fname=https://t1.daumcdn.net/news/202605/11/Edaily/20260511081421416ufxf.png" width="658">
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 Alpha Tau Expands U.S. Pancreatic Cancer Trial After FDA Approves IDE Supplement. (Source: Alpha Tau)
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 The study is evaluating “Alpha DaRT,” a localized radiation platform based on radium-224. The technology is designed to emit high-energy alpha particles directly inside tumors while minimizing damage to surrounding healthy tissues due to the short travel distance of alpha radiation.
 Alpha Tau CEO Uzi Sofer described the FDA decision as an important step toward developing new treatment options for one of the deadliest cancers. The company expects patient enrollment to be completed in the third quarter of 2026.
 Chief Medical Officer Robert Den said the expanded design would allow Alpha Tau to evaluate Alpha DaRT across both major first-line standard-of-care regimens for pancreatic cancer, strengthening the company’s development pathway.
 김지완 (2pac@edaily.co.kr) 
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