[Edaily Reporter NA EUN-KYUNG ] On the 27th, the domestic stock market rebounded for the first time in a while, but it was a “Black Tuesday” for major biotech stocks. The KOSPI closed at 5,638.34, up 3.09% from the previous trading day, while the KOSDAQ closed at 743.83, up 2.29%. The KOSPI even triggered an intraday buy-side circuit breaker.

In contrast, #G2GBIO, Inc. and CMG Pharmaceutical Co., Ltd.(058820)fell 12.94% and 11.39%, respectively. VUNO, Inc.(338220), which had hit the daily price limit the previous day, also showed weakness from the start of the session and closed the regular session down 8.46% at 7,030 won. Olix Pharmaceuticals, Inc.(226950)has fallen for four consecutive trading days; it was confirmed that the company has resubmitted, with revisions, the clinical trial application documents for OLX301A—a candidate drug for age-related macular degeneration that was recently rejected—to New Zealand.

Reflecting Ethics Committee’s Requests… Resuming Subsequent Development Procedures

According to KG Zeroin MP Doctor (MP DOCTOR, formerly Marketpoint) on that day, Olix Pharmaceuticals, Inc. closed regular trading at 90,600 won, down 5.72% from the previous trading day. Compared to the closing price of 106,900 won on the 21st, the stock has fallen 15.25% in just four trading days.

Amid the stock’s decline, the company completed the process of resubmitting the clinical trial application for OLX301A in New Zealand. An Olix Pharmaceuticals, Inc. official told E-Daily, “The IND application for OLX301A was rejected because there were administrative requirements that needed to be addressed, and the local ethics committee recommended corrections,” adding, “We recently completed the resubmission.”

OLX301A is a small interfering RNA (siRNA)-based candidate drug for the treatment of age-related macular degeneration (AMD). It has completed a Phase 1 clinical trial in the U.S., and in the subsequent Phase 2a trial, the company plans to evaluate its efficacy and safety in patients with AMD accompanied by geographic atrophy (GA), a condition in which retinal tissue atrophies in a map-like pattern.

Previously, Olix Pharmaceuticals, Inc. announced on the 12th that it had been notified by New Zealand’s Health and Disability Ethics Committee (HDEC) that its Phase 2a clinical trial application had been rejected. The reason given was that the submitted documents did not meet local ethical standards and relevant regulations. The company has explained that this is a matter pertaining to the ethical review stage, which is distinct from the review conducted by Medsafe, the drug regulatory agency. Having completed the necessary revisions to the documents with this resubmission, Olix Pharmaceuticals, Inc. is now awaiting the local ethics committee’s decision on approval.

In addition, OLX702A—a candidate drug for metabolic dysfunction-associated steatohepatitis (MASH) and obesity that was licensed to Eli Lilly—is also awaiting the Clinical Study Report (CSR) from the Phase 1 clinical trial in Australia conducted by Olix Pharmaceuticals, Inc. The Phase 1 clinical trial for OLX702A completed the final patient visit for the multiple-dose study last May. A company official stated, “We expect to receive the CSR within the year, and as of now, there are no plans to change the schedule.”

Previously released interim clinical results for OLX702A showed signs of reduced hepatic fat. According to the first-quarter report this year, in the single-dose group of patients with metabolic abnormal fatty liver disease (MASLD), one subject’s hepatic fat content decreased by more than 70%. In some patients, liver fat content dropped to 5% or below—within the normal range—just one to two months after administration. However, as these are interim analysis results rather than final topline data, the efficacy across the entire patient population and the results of repeated dosing must be confirmed in the future.

Under the contract, Olix Pharmaceuticals, Inc. is responsible for completing the Phase 1 clinical trial, after which Lilly will take over research, development, and commercialization. Therefore, the subsequent Phase 2 trial falls under the development phase led by Lilly.

However, the company did not disclose specific details regarding whether the decision to proceed with Lilly’s Phase 2 clinical trial of OLX702A will be made after receiving the CSR, or whether follow-up plans—including a combination trial with tirzepatide—have been agreed upon. An Olix Pharmaceuticals, Inc. representative stated, “The specific timing of the agreement or decision is confidential under the contract,” adding, “We are in ongoing communication with Lilly regarding this matter.”

G2GBIO, Inc.: “UBT Agreement Is the First Step in Verifying Technological Suitability”

G2GBIO, Inc. closed regular trading on the 27th at 39,350 won, down 12.94% from the previous trading day. The stock price trended downward following media reports that the agreement with UBT is an evaluation phase preceding the main technology export contract and that there had been no separate disclosure from the counterparty’s parent company.

In response, G2GBIO, Inc. explained the nature of the contract and the company’s position through its social media (SNS) investor relations (IR) channel. The company stated, “This contract is an evaluation agreement serving as a preliminary verification stage for technology transfer,” adding, “It is distinct from the formal technology transfer agreement. While a successful evaluation could lead to a follow-up agreement in the future, it has not yet been confirmed whether such an agreement will be signed at this point.”

The agreement, disclosed on the 19th, involves evaluating the development potential of applying G2GBIO, Inc.’s long-acting injectable platform, “InnoLAMP,” to a specific candidate compound from UBT. The contract term runs until the earlier of the completion of the research or 12 months from the contract date. The target compound and the contract amount remain undisclosed.

The company explained, “The purpose of this disclosure is to provide investors with information regarding the signed agreement,” adding, “We believe that verifying the applicability of our platform to the substance in question holds significant importance from both a research and development and a business perspective.” However, it added, “This assessment of importance does not imply the success of the evaluation or the signing of a subsequent technology transfer agreement.”

In response to the observation that the other party has not issued a separate announcement, the company stated, “Whether the contracting party and its parent company disclose information is determined in accordance with the regulations of the relevant country and the internal standards of each individual company,” and clarified, “The fact that the other party has not issued a separate announcement does not undermine the substance of this agreement or the sincerity of the research collaboration between the two companies.”

However, it is difficult to downplay the significance of the agreement solely based on the fact that the overseas partner has not issued a separate announcement. In fact, while domestic companies announced the technology export agreements between #Rznomics Inc. and Eli Lilly, as well as between #Orum Therapeutics, Inc. and Vertex, no separate press releases in the counterparties’ names have been confirmed. For domestic biotech companies, such agreements represent major business achievements, whereas for global pharmaceutical companies managing numerous R&D projects, they may be relatively small-scale transactions, which can lead to differences in how the two parties assess the need for disclosure and publicity.

Meanwhile, whether an evaluation agreement will lead to a full-fledged contract is a separate issue. Previously, Peptron, Inc.(087010)saw its market capitalization swell to as much as 9 trillion won on expectations of a technology export deal after signing a platform evaluation agreement with Eli Lilly in October 2024. However, this month—approximately two years later—the evaluation concluded without a formal agreement, causing its market capitalization to drop to the 2.4 trillion won range. Given this precedent, it is believed that G2GBIO, Inc. also saw a wave of sell-offs as investors focused on the uncertainty surrounding the success of its technology export deal.

In response, G2GBIO, Inc. explained, “While there is always a risk that an evaluation agreement may not lead to a formal contract,” it added, “Since each evaluation agreement differs in terms of the applicable technology, target compounds, and evaluation conditions, we cannot prejudge the outcome of our project based on past cases involving other companies.”

The company added, “Should any major events occur—such as the termination or suspension of research—that could influence investment decisions, we will provide timely and transparent updates in compliance with relevant regulations and confidentiality obligations.”

Hanmi and Beijing Hanmi See After-Hours Volatility Amid Weak Performance… Losses Recovered Following

Announcement

of Treasury Stock Cancellation

HanmiPharm(128940)’s stock price fluctuated in after-hours trading on the 27th following the release of its earnings report. Although the stock price fell to 345,000 won during after-hours trading, it rebounded after the company announced its decision

to cancel treasury stock, recovering

to the previous day’s closing price.

HanmiPharm announced on the same day that it recorded consolidated third-quarter revenue of 377.4 billion won and operating profit of 37.8 billion won. While revenue increased by 4.2% year-over-year, operating profit decreased by 31.3%. Weak performance at its Chinese subsidiary, Beijing Hanmi Pharmaceutical, weighed on consolidated profitability.

Beijing HanmiPharm’s third-quarter revenue was 79.3 billion won, down 15.8% from the same period last year, while operating profit fell 75.1% to approximately 5.9 billion won. In its investor relations materials, the company explained that over-the-counter (OTC) sales declined as it strengthened internal controls based on the “payment in advance, shipment after receipt” principle regarding uncollected receivables. Restricting new shipments until sales proceeds were collected from customers also impacted short-term performance.

Previously, HanmiPharm faced issues with receivables management and internal controls due to delayed collection of sales proceeds from transactions with local distributors such as Runmeikang. HanmiPharm suspended new transactions with the business partners in question until the receivables were collected and strengthened its management system by establishing a Chief Risk Officer (CRO) position. The company also accepted requests from some institutional investors for a special audit and, on the 8th, began an investigation with external accounting and legal firms, aiming to present the results by the end of this month.

The factor that shifted investor sentiment following the earnings announcement was the cancellation of treasury shares. At a board meeting held that day, HanmiPharm decided to cancel 85,316 shares of treasury stock it had previously acquired. This represents approximately 0.67% of the total issued shares, and the cancellation is scheduled for November 2. The estimated cancellation amount stated in the disclosure is approximately 28.3 billion won based on book value, and the cancellation will be carried out by canceling existing holdings without purchasing new treasury shares.