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[IT뉴스]Hanmi Signs $2.3B Obesity Drug Deal With Roche[K-Bio Pulse]

온카뱅크관리자

2026-08-26 08:27:25

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 This article was released as Pharm Edaily Premium Content on August 25, 2026, at 8:15 AM.
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 [Jiwan Kim, Edaily Reporter] On Aug. 24, South Korea’s pharmaceutical and life sciences sectors both posted strong gains.
 The pharmaceutical sector rose 3.3% from the previous session. Among 161 stocks, 116 advanced, 14 were unchanged and 31 declined, showing broad-based buying across the sector.
 The life sciences sector also gained 1.97%. Of 92 stocks, 53 rose, 12 remained flat and 27 fell.
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 Among major movers, Hanmi Pharmaceutical surged to the daily upper limit after announcing a licensing deal worth up to KRW 3.5 trillion for its obesity drug candidate HM17321. Orum Therapeutics climbed 16.94% following U.S. FDA clearance for a Phase 1 trial of ORM-1153, while AbClon gained 9.44% on continued progress in global clinical development of AC101.
 COVID-19-related stocks also rallied amid renewed concerns over a potential resurgence. Shin Poong Pharmaceutical, Cellid and Sugentech all hit the daily upper price limit.
 According to the Korea Disease Control and Prevention Agency, the number of hospitalized COVID-19 patients rose from 23 to 27, 48 and 56 over the past four weeks, while the virus detection rate increased to 9.1%. Health authorities expect the current wave to peak between late August and late September, although the overall scale is projected to remain below last year’s level.
 Hanmi Pharma Lands $2.3 Billion Roche Deal
 Hanmi Pharmaceutical soared to the daily upper limit after licensing its obesity drug candidate HM17321 to Genentech, a Roche Group company, in a deal worth up to KRW 3.5 trillion.
 According to KG Zeroin’s MP DOCTOR, formerly MarketPoint, Hanmi Pharmaceutical closed at KRW 540,000, up KRW 124,500, or 29.96%, from the previous session. Shares jumped to the price ceiling after the licensing agreement was announced earlier in the day.
 Under the agreement, Genentech will obtain exclusive rights to develop, manufacture and commercialize HM17321 worldwide, excluding South Korea, while Hanmi will retain domestic rights.
 Hanmi will receive an upfront payment of $190 million, or approximately KRW 285 billion. Including clinical development, regulatory approval and commercialization milestones, the total deal value could reach approximately $2.3 billion, or KRW 3.5 trillion. Hanmi is also entitled to separate royalties following commercialization.
 HM17321 is a non-incretin UCN2, or Urocortin-2, analogue independently developed by Hanmi. It is being developed as a potential first-in-class therapy designed to reduce body weight while preserving muscle mass.
 This differentiates HM17321 from existing GLP-1-based incretin obesity drugs. While GLP-1 therapies have demonstrated significant weight-loss efficacy, reduction in lean body mass during treatment has emerged as one of their limitations.
 As competition in the obesity market shifts from simply achieving greater weight loss toward improving the quality of weight reduction and overall body composition, muscle preservation has become an increasingly important treatment goal.
 In preclinical studies, HM17321 showed favorable effects on both weight reduction and body composition when administered alone as well as in combination with GLP-1-based therapies.
 The drug is also being developed as a peptide-based therapy, which could allow future development as a fixed-dose combination with incretin drugs or as part of broader combination treatment strategies.
 Clinical development is already underway. Hanmi received U.S. FDA clearance for a Phase 1 investigational new drug application in November 2025 and is currently evaluating HM17321 in healthy adults and patients with obesity.
 The Phase 1 study is assessing safety, tolerability, pharmacokinetics and pharmacodynamics. Hanmi plans to complete the Phase 1 trial, after which Genentech is expected to take over global development beginning with Phase 2.
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 <img alt="Hanmi Pharmaceutical headquarters. (Photo=Hanmi Pharmaceutical)" class="thumb_g_article" data-org-src="https://t1.daumcdn.net/news/202608/26/Edaily/20260826081842921bpid.png" data-org-width="1132" dmcf-mid="xIOWxnXSsL" dmcf-mtype="image" height="auto" src="https://img1.daumcdn.net/thumb/R658x0.q70/?fname=https://t1.daumcdn.net/news/202608/26/Edaily/20260826081842921bpid.png" width="658">
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 Hanmi Pharmaceutical headquarters. (Photo=Hanmi Pharmaceutical)
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 Choi In-young, vice president and head of future growth at Hanmi Pharmaceutical, said, “The obesity treatment paradigm is evolving beyond simple weight loss toward improving body composition and restoring metabolic health.”
 He added, “We are very pleased that the differentiated scientific mechanism and development potential of HM17321 have been recognized globally. Hanmi Pharmaceutical will continue to focus on developing innovative drugs that can provide more fundamental and differentiated treatment value for patients.”
 Roche also plans to expand its obesity and cardiometabolic pipeline through the acquisition of HM17321.
 Boris L. Zaïtra, head of Roche Corporate Business Development, said Roche was building an innovative portfolio to address the diverse needs of patients with obesity and related diseases by combining its expanding cardiometabolic pipeline with its diagnostic capabilities.
 He said the addition of Hanmi’s potential first-in-class candidate would allow Roche and Genentech to pursue a differentiated strategy aimed at selectively reducing fat mass while improving muscle mass and function.
 Orum Therapeutics jumps on U.S. Phase 1 approval
 Orum Therapeutics surged after receiving U.S. FDA clearance to begin a Phase 1 clinical trial of ORM-1153, an antibody-degrader conjugate being developed for relapsed or refractory acute myeloid leukemia and other hematologic malignancies.
 Shares closed at KRW 72,500, up KRW 10,500, or 16.94%, from the previous session.
 ORM-1153 applies Orum’s dual-precision targeted protein degradation, or TPD², technology. The drug uses an antibody to selectively identify CD123-expressing cancer cells and deliver a protein degrader into those cells.
 Once inside the cancer cell, the drug is designed to degrade GSPT1, a protein involved in cancer-cell survival and protein synthesis.
 Orum plans to begin first-in-human dosing by the end of this year in patients with relapsed or refractory AML and other blood cancers. The initial U.S. Phase 1 trial is expected to enroll approximately 42 patients across multiple medical centers, with potential expansion into additional regions later.
 The study will evaluate safety and tolerability as its primary objectives, while also assessing pharmacokinetics, pharmacodynamics and preliminary antitumor activity.
 Orum previously presented preclinical data for ORM-1153 at the American Association for Cancer Research annual meeting in April. The candidate demonstrated antitumor activity across multiple AML models, including AML patient-derived cells and TP53-related models.
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 <img alt="Hanmi Signs $2.3B Obesity Drug Deal With Roche[K-Bio Pulse]" class="thumb_g_article" data-org-src="https://t1.daumcdn.net/news/202608/26/Edaily/20260826081844208qljm.png" data-org-width="220" dmcf-mid="yUkFokUZrn" dmcf-mtype="image" height="auto" src="https://img4.daumcdn.net/thumb/R658x0.q70/?fname=https://t1.daumcdn.net/news/202608/26/Edaily/20260826081844208qljm.png" width="220">
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 Hanmi Signs $2.3B Obesity Drug Deal With Roche[K-Bio Pulse]
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 The company also reported in vivo activity at relatively low doses and favorable tolerability following repeated administration.
 The key feature of Orum’s TPD² platform is the combination of antibody-based cell selectivity with targeted protein degradation. Unlike conventional antibody-drug conjugates, or ADCs, which typically deliver cytotoxic payloads, Orum’s DAC approach delivers a degrader designed to eliminate a specific intracellular protein.
 Through ORM-1153, Orum is expanding its research and development efforts into CD123-expressing hematologic malignancies. CD123 is highly expressed in certain blood cancers, including AML, and has emerged as an important therapeutic target.
 Olaf Christensen, chief medical officer of Orum Therapeutics, said, “The IND clearance for ORM-1153 marks an important milestone in advancing another potential first-in-class antibody-degrader conjugate into the clinic and expanding our research into CD123-expressing hematologic malignancies.”
 He added that combining precise cell-selective drug delivery with targeted protein degradation in a single drug could potentially improve both efficacy and tolerability for patients with serious blood cancers.
 AbClon gains as AC101 global trials advance
 AbClon rose sharply after its partner Henlius reported continued progress in the global clinical development of AC101, also known as HLX22 or dulpatatug.
 AbClon closed at KRW 30,150, up KRW 2,600, or 9.44%, from the previous session.
 The update was disclosed through Henlius’ first-half earnings announcement.
 AC101 is currently being evaluated in a global Phase 3 trial for gastric cancer. Henlius is conducting a head-to-head study against a first-line treatment, with first patient enrollment completed at major research centers across South Korea, the U.S., China, Europe, Japan, Australia and Latin America.
 Patient dosing and follow-up are now underway across the participating regions.
 A separate Phase 2 trial is also progressing in patients with HER2-low breast cancer, an area with substantial unmet medical needs and relatively limited targeted treatment options compared with HER2-positive disease.
 Henlius is also expanding AC101 into combination therapy with its next-generation HER2 antibody-drug conjugate, HLX87.
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 <img alt="Hanmi Signs $2.3B Obesity Drug Deal With Roche[K-Bio Pulse]" class="thumb_g_article" data-org-src="https://t1.daumcdn.net/news/202608/26/Edaily/20260826081845422wavz.jpg" data-org-width="745" dmcf-mid="Wej5ij3Gsi" dmcf-mtype="image" height="auto" src="https://img3.daumcdn.net/thumb/R658x0.q70/?fname=https://t1.daumcdn.net/news/202608/26/Edaily/20260826081845422wavz.jpg" width="658">
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 Hanmi Signs $2.3B Obesity Drug Deal With Roche[K-Bio Pulse]
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 A Phase 2/3 trial is currently evaluating the AC101-HLX87 combination in the first-line breast cancer setting, with the aim of developing a potential next-generation standard combination regimen.
 Henlius also reported solid first-half financial performance. Revenue reached RMB 3.588 billion, or approximately KRW 670 billion, up 27.3% year on year. Net profit increased 10.3% to RMB 430.4 million.
 The company has also expanded its global commercialization network. Henlius currently has 10 approved products across more than 60 countries, including the U.S., Europe and China.
 Through strategic partnerships with global pharmaceutical companies including Eisai, Sandoz and Abbott, Henlius has been strengthening its international commercialization capabilities.
 Investors are paying particular attention to the broadening development strategy for AC101, which now spans a global Phase 3 gastric cancer program, a HER2-low breast cancer study and combination trials with a next-generation ADC.
 김지완 (2pac@edaily.co.kr) 
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