[Edaily Reporter Minji Son ] On the 29th, the domestic pharmaceutical, biotech, and healthcare stock market rose, driven by individual catalysts such as clinical data, expanded indications, and new product launches. #Cellbion Co., Ltd rose as existing clinical results for its prostate cancer treatment candidate came back into focus, and ROKIT HEALTHCARE Inc. surged on news of an application to expand its indication for cartilage treatment in Europe. HanmiPharm(128940)also rebounded on expectations of sales following the start of prescriptions for the domestically developed obesity treatment “Epe.”

Cellbion Co.,

Ltd

47.4% ORR in the measurable lesion group highlighted

, Ltd

According to KG Zeroin MP Doctor (MP DOCTOR, formerly Marketpoint), Cellbion Co., Ltd closed at 12,720 won on the KOSDAQ market today, up 6.53% (780 won) from the previous trading day. During the session, the stock rose as high as 12,850 won.

This is believed to have had a positive effect on investor sentiment as existing clinical data for Cellbion Co., Ltd.’s prostate cancer drug candidate, “Pocubotide Satetrasetate” (Lu-177-DGUL), came under renewed scrutiny. Although no new clinical results were released, interest grew as the market identified additional variations in response rates depending on the analysis criteria.

Previously, Cellbion Co., Ltd announced an objective response rate (ORR) of 35.9% based on data from 78 patients in the domestic Phase 2 clinical trial of Pocubotide who were eligible for an overall efficacy assessment. The ORR refers to the percentage of patients whose tumors completely disappeared or shrank beyond a certain threshold as determined by imaging tests.

Subsequently, based on the Clinical Study Report (CSR), the company separately disclosed the response rate for the measurable lesion group. The ORR, calculated by analyzing only the group of patients with lesions whose size could be measured via imaging, was recorded at 47.4%. The difference in the figures resulted from variations in the composition of the overall evaluation group and the measurable lesion group.

Cellbion Co., Ltd’s ORR for this patient subgroup is higher than that of FutureChem’s prostate cancer radiotherapy drug “FC705,” which was announced the previous day. FutureChem recently announced that in the U.S. Phase 2a clinical trial of FC705, the objective response rate (ORR)—the percentage of patients whose tumors shrank beyond a certain threshold or disappeared—was 38.9%.

Meanwhile, Cellbion Co., Ltd.’s recent investor relations (IR) sessions with institutional investors, such as securities firms and asset management companies, are also believed to have contributed to the stock price increase. A Cellbion Co., Ltd. official stated, “We explained the clinical results and evaluation criteria to institutional investors, and this communication likely influenced today’s stock price movement.”

ROKIT HEALTHCARE Inc. Rises on Application to Expand Indications for Cartilage Treatment in Europe

ROKIT HEALTHCARE Inc. closed at 19,450 won, up 21.79% (3,480 won). This rise is believed to have been driven by the company’s announcement that day that it had completed an application to amend its existing medical device certification to include an indication for knee cartilage defects.

ROKIT HEALTHCARE Inc. announced that it completed an application last month to amend its European Medical Device Regulation (CE MDR) certification to add the indication for knee cartilage defects to its artificial intelligence (AI) cartilage regeneration platform, the “Dr. INVIVO AI Regen KIT.”

The company expects the review results between late this year and early next year. If approved, it plans to launch full-scale marketing and sales targeting local European medical institutions in the first quarter of next year and push forward with its entry into the European market.

This announcement is part of the process to expand the scope of the existing certification. Furthermore, as the review by the certification body is currently underway, the company’s projected timeline for review results and commercialization schedule—as well as its market entry—are expected to depend on the final outcome.

ROKIT HEALTHCARE Inc. presented long-term follow-up clinical data collected over four years in Egypt as the basis for this application to add new indications. According to the company, histological examinations revealed tissue resembling hyaline cartilage—similar to normal articular cartilage—and improvements were confirmed in pain and joint function assessments.

However, some analysts suggest that these long-term follow-up results warrant further scrutiny. A related Egyptian study published in an academic journal in 2023 was a single-arm, open-label study that followed 10 patients for 12 months. Some analysts point out that the lack of a control group limits the ability to accurately assess the treatment’s efficacy.

An industry insider stated, “Since approval has not yet been decided, it is difficult to assess the application for expanded indications as positive news on its own,” adding, “Even after approval, we need to monitor whether it leads to actual adoption and sales in the European healthcare market.”

HanmiPharm Rebounds as ‘Epe’ Prescriptions Begin

HanmiPharm closed at 388,500 won on the KOSPI market today, up 5.14% (19,000 won) from the previous trading day.

This is interpreted as investor sentiment being positively influenced by expectations for strong sales performance following the start of prescriptions for the domestically developed obesity treatment “Epe” today. Given that the stock price had undergone a significant correction following product approval, it appears that bargain-hunting buying also flowed in on the back of the launch.

Epe received domestic marketing approval on the 7th. In a Phase 3 clinical trial involving 448 Korean patients with obesity, the drug demonstrated a 9.02% weight loss compared to the placebo group after 40 weeks of treatment. Whether the drug can establish itself in the market will depend on the extent to which medical institutions adopt it and prescriptions to patients expand following its launch.

A key point to watch is price competitiveness. Since obesity treatment requires continuous medication over a certain period, the cost borne by patients can influence product selection and whether they continue treatment.

One of the key factors to watch is price competitiveness. Since obesity treatment requires continuous medication for a certain period, the cost borne by patients—along with treatment efficacy—can influence product selection and whether patients continue treatment.

The price for the first four-week supply of Epe has been set at 129,800 won. This is expected to lower the initial cost burden and improve accessibility for patients looking to begin treatment. However, the price for the maintenance dose of 10 mg is 299,200 won. Since costs vary depending on dosage increases, some analysts suggest it is necessary to evaluate both the perceived effectiveness and the actual costs experienced during the course of treatment.

Another strength of Epe is that its weight-loss efficacy was confirmed in clinical trials involving Korean patients with obesity. With the entry into the market of a domestically developed treatment backed by data from Korean patients, treatment options for both patients and healthcare providers have expanded.

A HanmiPharm official stated, “To ensure a successful establishment in the domestic market, we will enhance patients’ access to treatment based on rigorous quality control and a reasonable pricing structure,” adding, “We will do our utmost to contribute to the public’s healthy weight loss and comprehensive management of metabolic diseases, and ultimately to significantly improve the quality of life for patients with obesity.”