[Edaily Reporter KIM JI-WAN ] On the 24th, the pharmaceutical and life sciences sectors both posted strong gains on the domestic stock market.

On that day, the pharmaceutical sector rose 3.3% compared to the previous trading day. Of the 161 stocks in the sector, 116 rose, 14 remained unchanged, and 31 fell. With the number of rising stocks roughly four times that of falling ones, buying momentum appeared to be spreading across the sector.

The life sciences sector also rose 1.97%, joining the upward trend. Of the 92 stocks in the sector, 53 rose, 12 remained unchanged, and 27 fell.

Among major stocks, HanmiPharm hit the daily price limit, rising 29.96% to 540,000 won, on news that it had licensed its new obesity drug candidate “HM17321” to Genentech, a subsidiary of the Roche Group, in a deal worth up to 3.5 trillion won.

Orum Therapeutics, Inc. closed at 72,500 won, up 16.94%, on news that its antibody-drug conjugate (DAC) drug candidate “ORM-1153” received approval from the U.S. Food and Drug Administration (FDA) for its Phase 1 clinical trial plan (IND).

AbClon Inc. also rose 9.44% to 30,150 won following news that its partner, Henlius, is making steady progress in key clinical trials, including the global Phase 3 trial for “AC101 (HLX22, dulpatatug)” for stomach cancer.

As concerns over a resurgence of COVID-19 resurfaced, buying interest also surged in related stocks. ShinpoongPharmaceutical hit its daily price limit, rising 29.93% to 10,550 won, while Cellid Co., Ltd. also hit its daily price limit, climbing 29.98% to 2,285 won; Sugentech, Inc. also soared 29.94% to 5,100 won, reaching its daily price limit.

According to the Korea Disease Control and Prevention Agency, the number of COVID-19 inpatients in South Korea has increased over the past four weeks from 23 to 27 to 48 to 56, and the virus detection rate has also risen to 9.1%. While health authorities expect the peak of the outbreak to occur between the fourth week of August and the fourth week of September, they project that the maximum scale of the outbreak will be only 11–48% of last year’s levels.

HanmiPharm Hits Daily

Price

Limit on

News of

3.5 Trillion Won Technology Export Deal for Obesity

Drug

Candidate

HanmiPharm(128940)

HanmiPharm hit the daily price limit

following news that it had exported

technology

for

a new

obesity drug candidate to Genentech, a subsidiary of the global pharmaceutical company Roche Group, in a deal valued at up to 3

.

5 trillion won.

According to KG Zeroin’s MP DOCTOR (formerly Marketpoint) that day, HanmiPharm closed at 540,000 won, up 124,500 won (29.96%) from the previous trading day. After news of the technology export agreement broke that morning, buying pressure surged, sending the stock price soaring to the daily price limit.

Investors focused on the contracting party and the scale of the technology export. HanmiPharm announced that day it had signed an exclusive licensing agreement with Genentech for “HM17321 (UCN2 analog),” a new drug candidate currently under development for the treatment of metabolic diseases such as obesity, type 2 diabetes, and cardiovascular disease.

Under the agreement, Genentech secures exclusive rights to develop, manufacture, and commercialize HM17321 worldwide, excluding South Korea. HanmiPharm will retain rights in South Korea.

Under this agreement, HanmiPharm will receive an upfront payment of $190 million (approximately 285 billion won) from Genentech. The total value of the agreement, including all milestones related to future clinical development, regulatory approval, and commercialization, could reach up to approximately $2.3 billion (approximately 3.5 trillion won). Once the product is launched, HanmiPharm is also set to receive separate royalties based on sales.

HM17321 is drawing attention because it utilizes a mechanism of action different from that of the glucagon-like peptide-1 (GLP-1) class of drugs, which currently dominates the global obesity treatment market.

HM17321, developed in-house by HanmiPharm, is a non-incretin UCN2 (Urocortin-2) analog. It aims to be the first-in-class drug in its class that reduces body weight while preserving muscle mass.

Currently, GLP-1-based incretin-class obesity treatments are rapidly expanding their market share by highlighting their high weight-loss efficacy. However, one of the limitations cited is that during the weight-loss process, lean body mass can decrease along with fat mass. As the competitive focus in the obesity treatment market shifts from simple weight-loss rates to “what kind of weight is lost and by how much,” the importance of treatment strategies that preserve muscle mass is also growing.

HM17321 targets this very issue. In HanmiPharm’s preclinical studies, HM17321 was shown to promote weight loss and improve body composition not only when administered alone but also when used in combination with GLP-1 agonists.

The fact that it is a peptide-based drug is another factor that could broaden the scope of future development strategies. HanmiPharm is even considering options such as developing HM17321 in combination with incretin-based therapies like GLP-1 or as a fixed-dose combination (FDC) product.

Clinical development has already begun. Last November, HanmiPharm received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for HM17321’s Phase 1 clinical trial. The company is currently evaluating safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy adults and obese patients.

HanmiPharm plans to complete the Phase 1 trial, after which Genentech will take the lead in global development starting with Phase 2. As Genentech—which possesses global new drug development experience and commercialization capabilities—takes over clinical development, attention is focused on the pace of HM17321’s global development.

Choi In-young, Executive Vice President of HanmiPharm (Head of Future Growth Division), stated, “The paradigm of obesity treatment is evolving beyond simple weight loss to include improvements in body composition and the restoration of metabolic health.” He added, “We find it deeply meaningful that HM17321’s differentiated scientific mechanism and development potential have been recognized by the global market. “Going forward, HanmiPharm will do its utmost to develop innovative new drugs so that we can provide patients with more fundamental and differentiated therapeutic value,” he added.

Roche also plans to further expand its pipeline in the field of obesity and cardiometabolic diseases through the acquisition of HM17321.

Boris L. Zaitra, Head of Corporate Business Development at Roche, said, “Based on the expansion of our cardiometabolic disease pipeline and our outstanding diagnostic capabilities, Roche is building an innovative portfolio capable of meeting the diverse treatment needs of patients with obesity and related diseases,” and “With the acquisition of this next-generation candidate from HanmiPharm, which has the potential to be the first-in-class in its class, Roche and Genentech plan to pursue a differentiated therapeutic strategy that selectively reduces fat mass while improving muscle mass and function,” he said.

He added, “We will further accelerate the development of this candidate to address significant unmet medical needs in the fields of obesity and metabolic diseases.”

Orum Therapeutics, Inc. Soars on U.S. Phase 1 Clinical Trial Approval

#Orum Therapeutics

,

Inc.

soared

on news that its new blood cancer drug candidate, “ORM-1153,” has entered

U

.

S. Phase 1 clinical trials

. Plans to begin dosing the first patients this year for relapsed or refractory acute myeloid leukemia (AML) stimulated investor sentiment.

On that day, Orum Therapeutics, Inc. closed at 72,500 won, up 10,500 won (16.94%) from the previous trading day.

The stock price surge was driven by the U.S. Food and Drug Administration’s (FDA) approval of the Investigational New Drug (IND) application. Orum Therapeutics, Inc. announced that it had received FDA approval for the Phase 1 IND of ORM-1153, an antibody-drug conjugate (DAC) candidate.

ORM-1153 is a candidate drug that utilizes Orum Therapeutics, Inc.’s proprietary Dual-Precision Targeted Protein Degradation (TPD²) technology. Simply put, this mechanism involves an antibody first locating cancer cells and then delivering a protein-degrading drug into the cell to eliminate specific proteins necessary for the cancer cells’ survival.

The target of ORM-1153 is CD123. The antibody selectively seeks out cancer cells that express CD123 and then delivers a drug that degrades the target protein, GSPT1, into the cell. When GSPT1 is removed, the cancer cell’s normal protein synthesis and survival processes are disrupted, resulting in an anticancer effect.

Orum Therapeutics, Inc. plans to administer the first dose to patients with blood cancers, including relapsed or refractory AML, by the end of this year. The Phase 1 clinical trial is scheduled to be conducted at several medical institutions in the United States with approximately 42 participants. Depending on future development progress, the company may also consider expanding the clinical trial to other countries.

This clinical trial will prioritize confirming the safety and tolerability of ORM-1153. In addition, it will comprehensively evaluate pharmacokinetics (PK)—how the drug is absorbed, distributed, and metabolized in the body—pharmacodynamics (PD)—how the drug affects its actual targets—and initial antitumor effects.

Prior to entering the clinical phase, preclinical studies confirmed a certain level of anticancer potential.

Orum Therapeutics, Inc. presented preclinical data on ORM-1153 at the American Association for Cancer Research (AACR) Annual Meeting last April. Anticancer activity was observed in various AML models, as well as in cells derived from AML patients and TP53-related models.

In particular, the company explained that anticancer activity was observed in vivo even at low doses, and good tolerability was confirmed during repeated dosing.

The TPD² technology applied to ORM-1153 is characterized by combining the cell selectivity of an antibody with target protein degradation (TPD) technology into a single drug. Since the antibody seeks out specific cancer cells and delivers the degradative agent, the goal is to selectively eliminate the target protein inside cancer cells while reducing unnecessary drug exposure to normal cells.

While conventional antibody-drug conjugates (ADCs) transport cytotoxic drugs to cancer cells, Orum Therapeutics, Inc.’s DAC differs in that it directly degrades specific proteins within cancer cells that cause disease or are essential for their survival.

The company plans to expand its pipeline into the CD123-expressing blood cancer segment with ORM-1153. CD123 is known to be highly expressed in certain blood cancer cells, including AML, and is therefore used as a key target in the development of new blood cancer drugs.

Olaf Christensen, Chief Medical Officer at Orum Therapeutics, Inc., stated, “The approval of the clinical trial plan for ORM-1153 marks a significant milestone, bringing yet another first-in-class antibody-drug conjugate into the clinical phase and expanding our research into CD123-expressing blood cancers,” and “We believe that combining precise, cell-selective drug delivery technology with targeted protein degradation technology into a single drug has the potential to improve treatment efficacy and tolerability for patients with severe blood cancers,” he added.

AbClon Inc. Rises on News of Smooth Progress in AC101 Global Clinical Trials

AbClon Inc.(174900)

’s

stock rose more than 9% on news that the global clinical development of “AC101 (HLX22, dulpatatug),” an antibody therapy developed by its partner Henlius, is proceeding smoothly.

On that day, AbClon Inc. closed at 30,150 won, up 2,600 won (9.44%) from the previous trading day.

The stock price rise was driven by progress in AC101’s key global clinical trials. AbClon Inc. announced today that its partner, Henlius, is conducting major global clinical trials for AC101 targeting gastric and breast cancer in various countries around the world. Details were disclosed in Henlius’s first-half earnings report.

AC101 has now entered the global Phase 3 clinical trial stage for gastric cancer. Henlius is conducting the trial using a head-to-head design, directly comparing AC101 with existing first-line therapies.

Research institutions in major countries—including South Korea, the United States, China, Europe, Japan, Australia, and Latin America—have completed the first patient enrollment, and full-scale patient dosing and follow-up observations are currently underway.

A Phase 2 clinical trial targeting HER2-low breast cancer is also underway. Unlike conventional HER2-positive breast cancer, HER2-low breast cancer has relatively limited available targeted treatment options and is considered an area with high unmet medical need.

Henrius is expanding the scope of AC101 beyond monotherapy or combination with existing treatments to include combination therapy with next-generation antibody-drug conjugates (ADCs).

Currently, Henlius is conducting Phase 2 and 3 clinical trials evaluating the combination of AC101 and “HLX87,” a next-generation HER2 ADC that the company is developing in-house. The company plans to validate the efficacy of the AC101 and HLX87 combination therapy in the first-line treatment setting for breast cancer and develop it into a new standard combination treatment strategy in the future.

Henlius’s financial growth continues. Revenue for the first half of this year reached 3.5882 billion yuan (approximately 670 billion Hanwha KRW), a 27.3% increase compared to the same period last year. Net income rose 10.3% during the same period to 430.4 million yuan.

The company’s global commercialization footprint is also expanding rapidly. Henlius has secured marketing approvals for a total of 10 products in approximately 60 countries, including the United States, Europe, and China.

Furthermore, by expanding strategic partnerships with global pharmaceutical companies such as Eisai, Sandoz, and Abbott, the company is building a global business network that spans from in-house development to overseas sales.

The market is taking note of the fact that AC101 is expanding its development scope beyond the global Phase 3 clinical trial for gastric cancer to include trials for HER2-low breast cancer and ADC combination therapy. In particular, analysts note that as patient enrollment begins in earnest in major countries, the pace of AC101’s global clinical trials is being reflected in AbClon Inc.’s enterprise value.