[Edaily Reporter Hong Ju-yeon ] On the 16th, the domestic pharmaceutical and biotech sector saw mixed performance across individual stocks. #SAMIK PHARM. Co., LTD. hit the daily price limit, driven by its long-acting injectable platform technology, and #Onconic Therapeutics Inc. also surged on positive preclinical data for a new anticancer drug. In contrast, Kolon TissueGene, Inc.(950160)and LEMON COMPANY LIMITED both traded lower due to uncertainty surrounding clinical results and the fallout from controversy, respectively.

SAMIK PHARM.

Co

.,

LTD.

Rises on Long-Acting Injectable Platform Technology and Hair Loss Theme 'Up'

According to KG Zeroin’s MP Doctor (formerly Marketpoint), SAMIK PHARM. Co.

,

LTD. closed at 5,570 won—up 1,280 won (29.84%) from the previous day—hitting the daily price limit. This is interpreted as a result of the market’s attention on the company’s long-acting injectable platform technology for hair loss treatments. Earlier this year, SAMIK PHARM. Co., LTD. registered a patent for “technology for manufacturing polymer microparticles using cyclodextrin-encapsulated compounds,” which enables the development of a long-acting, once-monthly injectable version of baricitinib—a JAK inhibitor used to treat alopecia areata.

This is also supported by its revenue performance. SAMIK PHARM. Co., LTD.’s consolidated revenue for the first quarter of this year reached 15.5 billion won, a 10.4% increase compared to the same period last year. The company is maintaining steady growth centered on its prescription drug and CMO businesses and currently holds a portfolio of 117 pharmaceutical products. Securities analysts assessed that “the company is expanding its business into various therapeutic areas by leveraging its long-acting injectable platform,” adding that “this will serve as a meaningful growth driver in terms of strengthening new drug development capabilities and diversifying the business portfolio.”

SAMIK PHARM. Co., LTD. official stated, “We view today’s stock price increase as being driven by fluctuations in supply and demand rather than any specific event,” adding, “The long-acting injectable platform is currently in the early stages of development, and we expect to secure additional R&D patents later this year.”

Onconic Therapeutics Inc. Rises 20.33% on Positive Preclinical Data for Nesuparib in Endometrial Cancer

Onconic Therapeutics Inc. closed regular trading at 14,500 won, up 2,450 won (20.33%) from the previous day. At one point during the session, the stock reached 15,150 won. The stock price rose on news that a research paper confirming the excellent tumor growth inhibition effects of “Nesuparib,” a next-generation synthetic lethal anticancer drug candidate, in a preclinical model of PTEN-deficient endometrial cancer was published in the SCI-indexed international journal *JCMM*.

Nesuparib is a dual inhibitor that simultaneously inhibits PARP 1/2, which is involved in DNA damage repair, and Tankyrase 1/2, which regulates cancer cell growth signaling. In this study, it demonstrated stronger tumor growth inhibition than existing PARP monotherapy inhibitors such as olaparib, niraparib, and talazoparib. Its market potential is also drawing attention because it targets PTEN deficiency, which is present in up to 80% of endometrial cancer patients. The global endometrial cancer treatment market is projected to grow to approximately 26.4 trillion won by 2033.

The publication of this paper also strengthens the development rationale for Onconic Therapeutics Inc.’s ongoing Phase 2 “PENELOPE” clinical trial for endometrial cancer. PENELOPE is a randomized Phase 2 clinical trial evaluating the efficacy and safety of the combination therapy of nesuparib and pembrolizumab (Keytruda) in patients with advanced or recurrent pMMR endometrial cancer.

An Onconic Therapeutics Inc. official stated, “This study provides important evidence demonstrating that nesuparib’s dual PARP-Tankyrase inhibition mechanism can exhibit differentiated anticancer activity,” adding, “Given the high level of interest shown by global pharmaceutical companies at Bio USA in the nesuparib-pembrolizumab combination trial and its differentiated dual inhibition mechanism, we will continue to expand its global development potential.”

Kolon TissueGene, Inc. Sees Increased Volatility Amid Anticipation for Phase 3 Topline Results… Down 20.28%

Kolon TissueGene, Inc. closed the regular session at 62,100 won, down 15,800 won (20.28%) from the previous day. The stock exhibited extreme volatility, fluctuating between an intraday high of 81,100 won and a low of 55,400 won. This is interpreted as the result of both anticipation and uncertainty, as the announcement of topline results from the U.S. Phase 3 clinical trial of “TG-C,” a cell-gene therapy for osteoarthritis, is scheduled for later this month.

TG-C is scheduled to release its first topline results this month following a two-year long-term follow-up and data analysis after completing dosing in 1,066 patients in the U.S. If the results are positive, the company plans to submit a Biologics License Application (BLA) to the FDA in the first quarter of next year and launch the product on the U.S. market in 2028. The key issue in this Phase 3 trial is whether the drug can demonstrate efficacy as a “disease-modifying osteoarthritis drug (DMOAD)” that prevents structural degeneration of the knee joint, going beyond simply alleviating pain.

Legal risks are also effectively being resolved. Executives at KOLON LIFE SCIENCE Inc., who had been accused of mislabeling ingredients, received a final not-guilty verdict from the Supreme Court, and on the 3rd of this month, the court’s recommendation for a settlement in a 6.8 billion won damages lawsuit filed by shareholders was finalized.

Some observers have raised the possibility of a preemptive leak of TG-C clinical data. In response, the company stated, “The fact that our U.S. headquarters has received the clinical data and is analyzing it is not particularly new, as the entire two-year follow-up period is part of the analysis process,” adding, “The clinical results have not yet been released, and no schedule for their announcement has been set.”

LEMON COMPANY LIMITED Down 21.11% Amid Fallout from Sewol Ferry Date Controversy

LEMON COMPANY LIMITED closed the main session at 5,380 won

,

down 1,440 won (21.11%) from the previous day. The controversy that erupted the previous day on online communities and elsewhere contributed to the stock’s decline. Critics pointed out that “April 16, 2014” was displayed as an example for entering a date of birth in a mobile app developed by Lemon Healthcare for patients at certain university hospitals, which evoked memories of the Sewol Ferry disaster; the example has since been corrected.

Hong Byung-jin, CEO of Lemon Healthcare, issued an apology on the company’s website, stating, “After investigating the circumstances, we confirmed that the phrase in question was originally created during the app’s development process and had been copied and reused without verification even after subsequent screen redesigns.” He added, “Regardless of the circumstances, it is entirely our company’s fault that we failed to filter out the display of a date that represents a source of pain for all citizens on our service screen.”

LEMON COMPANY LIMITED is a newcomer that listed on KOSDAQ on the 6th. The company operates “LDB” (LEMON DIGITAL BRIDGE), a two-way medical data intermediary platform that connects participants in the medical data ecosystem—including hospitals, patients, insurance companies, and pharmaceutical firms—in real time. The service is currently used by more than 130 major hospitals, including Seoul National University Hospital, Severance Hospital, and Asan Medical Center. To date, LEMON COMPANY LIMITED has not yet demonstrated profitability. Last year, it reported revenue of 15.9 billion won and an operating loss of 600 million won. The company has outlined a strategy to invest the funds raised through its IPO into the development of medical AI technology for disease prediction, aiming to secure a leading position in the personalized medicine market. For this year—the year of its IPO—the company has projected revenue of 24.1 billion won and an operating profit of 6.5 billion won, anticipating a return to profitability.