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[IT뉴스]Graphy Jumps on Overhang Relief, Vigencell Soars on Phase 2 Win[K-Bio Pulse]

온카뱅크관리자

2025-12-04 10:27:29

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 This article was released as Pharm Edaily Premium Content on November 27, 2025, at 8:00 AM.
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 [NA Eun-kyung, Edaily Reporter] Three Korean pharma, biotech and healthcare stocks, Vigencell, Graphy and Samyang Biopharm closed at the daily upper limit on Nov. 26. Samyang Biopharm which was spun off from Samyang Holdings, the holding company of Samyang Group has now hit the limit-up for three straight sessions since its KOSPI debut on Nov. 24.
 Graphy which listed on the KOSDAQ on Aug. 25, surged to its daily limit after concerns over an overhang were eased and news spread that the U.S. Food and Drug Administration had cleared a denture material used in its products for sale in North America, the world’s largest market. Vigencell soared to the limit from the opening bell after the company said the previous evening that its lead pipeline achieved statistical significance in a Phase 2 trial.
 The day’s biggest decliner in the sector was Caregen. On worries that the release of Phase 1 data for its macular degeneration drug might be delayed again the stock gave back three days of gains in a single session.
 Overhang risk clears, Graphy takes off
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 <img alt="Dentures made using Graphy’s THD (TERA HARZ Hard Denture) dental resin for 3D printers (Source: Graphy)." class="thumb_g_article" data-org-src="https://t1.daumcdn.net/news/202512/04/Edaily/20251204102547475tbkk.jpg" data-org-width="584" dmcf-mid="WYk5OOEoI8" dmcf-mtype="image" height="auto" src="https://img4.daumcdn.net/thumb/R658x0.q70/?fname=https://t1.daumcdn.net/news/202512/04/Edaily/20251204102547475tbkk.jpg" width="658">
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 Dentures made using Graphy’s THD (TERA HARZ Hard Denture) dental resin for 3D printers (Source: Graphy).
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 According to KG Zeroin’s MP Doctor service, formerly MarketPoint, shares of 3D printing based clear aligner specialist Graphy closed at 17,530 won up 29.9 percent from the previous session. The company said the easing of overhang pressure was the main driver of the rally.
 A three month IPO lock up expired the previous day releasing 1,212,260 shares into the market equal to 10.98 percent of total outstanding shares. On the morning of Nov. 25 when the free float jumped to 69.84 percent of total shares trading volume spiked to 10.41 million shares and the stock briefly hit its intraday limit of 16,510 won. The average daily volume over the prior five sessions had been around 450,000 shares meaning more than 23 times that amount changed hands on Nov. 25. The heavy trading continued into the 26th, with volume reaching 8.35 million shares.
 “Because a large amount of stock changed hands on the 25th, the market appears to have judged that the overhang issue was resolved, which we believe had a positive impact on the share price,” a Graphy official said.
 News of U.S. regulatory clearance, announced on Nov. 25, also added fuel to the rally. Graphy said eight products in its THD (TERA HARZ Hard Denture) line, a group of dental resins for 3D printers mainly used to make dentures, received 510(k) clearance from the FDA. The company expects the launch of the line to significantly raise its profile and credibility in the United States.
 “After 510(k) clearance, it usually takes two to three weeks to complete product registration and other procedures, and we are preparing to launch the THD line in the U.S. market immediately after that,” the official said. “Our main products are clear aligners, and this clearance should enhance trust in Graphy’s materials, creating a synergy by lifting sales of existing products such as clear aligners.”
 The global clear-aligner market is projected to grow from about 25 trillion won in 2023, or 27.6 percent of the broader market to 60 trillion won in 2030 or 40 percent according to industry forecasts. North America accounts for about 45 percent of the global clear-aligner market and is the largest single region.
 Big win at a critical time, can Vigencell finally turn a corner?
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 <img alt="Vigencell announced on the evening of Nov. 25 that a Phase 2 trial of its NK/T cell lymphoma treatment VT-EBV-N had succeeded. The stock immediately hit the upper price limit at the opening on Nov. 26 and set a new 52-week high of 4,555 won. (Source: KG Zeroin MP Doctor)" class="thumb_g_article" data-org-src="https://t1.daumcdn.net/news/202512/04/Edaily/20251204102548729cfld.jpg" data-org-width="637" dmcf-mid="YXKqGGSrD4" dmcf-mtype="image" height="auto" src="https://img2.daumcdn.net/thumb/R658x0.q70/?fname=https://t1.daumcdn.net/news/202512/04/Edaily/20251204102548729cfld.jpg" width="658">
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 Vigencell announced on the evening of Nov. 25 that a Phase 2 trial of its NK/T cell lymphoma treatment VT-EBV-N had succeeded. The stock immediately hit the upper price limit at the opening on Nov. 26 and set a new 52-week high of 4,555 won. (Source: KG Zeroin MP Doctor)
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 Vigencell closed at the upper limit of 4,555 won after immediately locking at the top of the daily band at the open. The move came after the company announced after the market close on Nov. 25 that a Phase 2 trial of its lymphoma treatment VT-EBV-N had succeeded.
 VT-EBV-N is a natural killer/T cell lymphoma therapy. Its competitors include Atara Biotherapeutics’ Ebvallo, or Tab-cel.
 Vigencell listed on the KOSDAQ in 2021 via a special technology listing. It posted no revenue through 2023 and generated its first sales last year of about 300 million won. At the time of listing, the company told investors in its securities registration statement that it expected to generate 23.8 billion won in 2024, mainly from license-out revenue tied to VT-EBV-N. So far, however, its only related deal is a 3.5 billion won domestic exclusive marketing agreement for VT-EBV-N signed with Boryung in 2020, before the IPO.
 The Phase 2 success comes at an especially important moment. A grace period for avoiding designation as a low-revenue management-risk stock is scheduled to end at the close of this year, based on full-year sales. Investors are now watching to see whether Vigencell can generate more than 3 billion won a year from VT-EBV-N starting next year and thus avoid being placed on the Korea Exchange watchlist.
 “Based on the Phase 2 results for VT-EBV-N, we plan to seek fast-track review status and pursue conditional approval,” a Vigencell official said. “We will present more detailed business plans around VT-EBV-N at an investor relations session on Dec. 2.”
 If the Ministry of Food and Drug Safety grants conditional approval for VT-EBV-N, Boryung will handle domestic sales under the earlier agreement. Vigencell also plans to seek global licensing deals with overseas pharmaceutical partners.
 Caregen says there will be no further delay to Phase 1 data
 Caregen fell 11.41 percent to close at 73,700 won as concerns mounted in the market over a possible delay in releasing Phase 1 results for its lead pipeline.
 The company had previously pledged to publish the clinical study report for CG-P5, its treatment for wet age related macular degeneration, or wAMD, by the end of this month. On that expectation, the stock had been on a steady run up since mid month climbing from 62,500 won on Oct. 30 to 83,600 won on Nov. 25.
 When no announcement had appeared by Nov. 26 investors began to fear that the CG-P5 Phase 1 readout would again be pushed back. The projected completion date for the Phase 1 trial was originally Dec. 31, 2024 but was later revised to June 30, 2025 then to Oct. 31, 2025 and again to Nov. 30 this year for a total of three postponements.
 In response the company posted a notice on its official website, saying the timing for receiving the clinical study report had been fixed for Nov. 28, U.S. local time. Taking the time difference into account Caregen said it expects to receive the report on Nov. 29 in Korea. “As soon as we receive the CSR we will immediately complete our internal review and disclose the results without delay on Dec. 1” the company said.
 A company official said previous delays had been unavoidable because Caregen added a central reading procedure and reanalyzed the pooled data. “This time the results will be announced without further delay” the official said.
 The central reading procedure is a process of integrating data from six clinical sites to create a consistent dataset. Caregen plans to use the Phase 1 data to seek Breakthrough Therapy Designation or BTD from the FDA and said the central reading step was necessary for that filing.
 “Unlike many other Phase 1 studies, which are conducted in healthy volunteers the CG-P5 Phase 1 trial enrolled patients with severe wet age related macular degeneration and was designed to assess both safety and efficacy,” the company official said. “We expect to be able to apply for and obtain BTD based on the Phase 1 data alone.”
 A BTD label allows a sponsor to work more closely with the FDA from the early stages of development to map out a strategic development plan and can shorten review timelines. About 33 percent of drugs granted BTD ultimately win approval, giving them a relatively high success rate. Caregen plans to use the Phase 1 results to pursue out-licensing deals while preparing for a Phase 2 study.
 GlobalData estimates the global wet age-related macular degeneration treatment market at about 6.7 billion dollars or roughly 9.9 trillion won as of 2023.
 나은경 (eeee@edaily.co.kr) 
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