[Hong Ju-yeon, Edaily Reporter] South Korean pharmaceutical and biotech stocks posted mixed results on Wednesday. Samick Pharm surged to the daily limit as investors focused on its long-acting injectable platform technology, while Onconic Therapeutics jumped on positive preclinical data for a cancer drug. In contrast, Kolon TissueGene and Lemon Healthcare declined due to clinical uncertainty and controversy, respectively.

Samick Pharm Hits Daily Limit as Long-Acting Injectable Platform Draws Attention

According to KG Zeroin MP Doctor (formerly MarketPoint), Samick Pharm closed at the daily upper limit of 5,570 won, up 1,280 won, or 29.84%, from the previous session.

The rally was attributed to growing investor interest in the company’s long-acting injectable platform technology for hair loss treatment. Earlier this year, Samick Pharm registered a patent for “polymeric microsphere manufacturing technology using cyclodextrin inclusion compounds,” which enables the development of a once-monthly long-acting injectable formulation of the JAK inhibitor baricitinib, used to treat alopecia areata.

The company’s earnings have also bolstered investor sentiment. Consolidated revenue for the first quarter rose 10.4% year-over-year to 15.5 billion won. Samick Pharm has maintained steady growth centered on its prescription drug and contract manufacturing (CMO) businesses and currently markets 117 pharmaceutical products.

Brokerage firms noted that the company is expanding into various therapeutic areas through its long-acting injectable platform, adding that the technology could become a significant growth driver by strengthening its new drug development capabilities and diversifying its business portfolio.

A Samick Pharm official said the stock’s rise appeared to be driven mainly by changes in market supply and demand rather than any specific event.

"The long-acting injectable platform is still in the early stages of development, and we expect to secure additional R&D-related patents within this year," the official said.

Onconic Therapeutics Jumps 20.33% on Nesuparib Endometrial Cancer Data

Onconic Therapeutics closed at 14,500 won, up 2,450 won, or 20.33%, from the previous day. The stock climbed as high as 15,150 won during the session.

The rally followed news that a research paper demonstrating strong tumor growth inhibition by the company’s next-generation synthetic lethality anticancer candidate, Nesuparib, in a PTEN-deficient endometrial cancer preclinical model was published in the SCI-indexed international journal *Journal of Cellular and Molecular Medicine (JCMM)*.

Nesuparib is a dual inhibitor that targets both PARP 1/2, which are involved in DNA damage repair, and Tankyrase 1/2, which regulate cancer cell growth signaling. The study demonstrated stronger tumor growth inhibition than existing PARP-only inhibitors, including olaparib, niraparib, and talazoparib.

The drug’s market potential has also drawn attention because it targets PTEN deficiency, which is found in up to 80% of endometrial cancer patients. The global endometrial cancer treatment market is projected to reach approximately 26.4 trillion won by 2033.

The publication also strengthens the scientific rationale for PENELOPE, Onconic Therapeutics’ ongoing Phase 2 clinical trial for endometrial cancer. The randomized Phase 2 study is evaluating the efficacy and safety of Nesuparib in combination with pembrolizumab (Keytruda) in patients with advanced or recurrent pMMR endometrial cancer.

"This study provides important evidence that Nesuparib’s dual PARP-Tankyrase inhibition mechanism can deliver differentiated anticancer activity," a company official said.

"At BIO USA, global pharmaceutical companies also showed strong interest in both the Nesuparib-pembrolizumab combination trial and its differentiated dual inhibition mechanism. We will continue to expand its global development potential," the official added.

Kolon TissueGene Falls 20.28% Amid Heightened Volatility Ahead of Phase 3 Topline

Kolon TissueGene closed at 62,100 won, down 15,800 won, or 20.28%, from the previous session.

The stock experienced extreme intraday volatility, trading between a high of 81,100 won and a low of 55,400 won, as investor expectations and uncertainty surrounding the upcoming U.S. Phase 3 topline results for TG-C, a cell and gene therapy for osteoarthritis, weighed on sentiment.

After completing dosing in 1,066 patients in the United States, TG-C has undergone two years of long-term follow-up and data analysis. The company plans to announce its first topline results later this month.

If the results are positive, Kolon TissueGene plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of next year and pursue commercialization in the U.S. market in 2028.

The key question is whether the Phase 3 study can demonstrate not only pain relief but also disease-modifying osteoarthritis drug (DMOAD) efficacy by preventing structural degeneration of the knee joint.

The company’s legal risks are also nearing resolution. Executives of Kolon Life Science, who had been accused of mislabeling the product’s ingredients, were acquitted by the Supreme Court, and on July 3, a court-approved settlement recommendation became final in a shareholder lawsuit seeking 6.8 billion won in damages.

Some market participants also raised the possibility that TG-C clinical data had been leaked in advance.

In response, the company stated, “The fact that our U.S. headquarters has received the clinical data and is analyzing it is not new, as the entire two-year follow-up period is part of the analysis process.” “The clinical results have not yet been finalized, and no schedule has been set for announcing the results,” it added.

Lemon Healthcare Drops 21.11% Following Sewol Ferry Date Controversy

Lemon Healthcare closed at 5,380 won, down 1,440 won, or 21.11%, from the previous day.

The decline followed controversy that emerged on online communities the previous day. Critics pointed out that some mobile applications developed by Lemon Healthcare for university hospital patients used April 16, 2014, as an example birth date entry, drawing associations with 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. “Our investigation found that the phrase was first created during the app’s initial development and was repeatedly copied and reused without verification during subsequent interface revisions,” Hong said.

“Regardless of how it happened, it is entirely our company’s fault that we failed to filter out a date associated with the pain of the entire nation before it appeared on our service screen,” he added.

Lemon Healthcare debuted on the KOSDAQ on July 6. The company operates LDB (Lemon Digital Bridge), a two-way healthcare data brokerage platform that connects hospitals, patients, insurers, and pharmaceutical companies in real time. The platform is used by more than 130 major hospitals, including Seoul National University Hospital, Severance Hospital, and Asan Medical Center.

The company has yet to demonstrate sustained profitability. It reported revenue of 15.9 billion won and an operating loss of 600 million won last year. Lemon Healthcare plans to use the funds raised through its listing to develop medical AI technology for disease prediction and expand into the personalized healthcare market. The company has forecast revenue of 24.1 billion won and an operating profit of 6.5 billion won this year, expecting to return to operating profitability.