[Edaily Reporter SONG YOUNG-DOO ] Olix Pharmaceuticals, Inc. plummeted more than 14% as the rejection of its application for a clinical trial in New Zealand for a potential treatment for age-related macular degeneration coincided with a broader downturn in the KOSDAQ market. ROKIT HEALTHCARE Inc., which has recently seen a string of weak stock performance, hit a new 52-week low during trading.

Olix Pharmaceuticals, Inc.: “Rejection by Ethics Committee, Not Regulatory Authority… Not a Clinical Failure”

According to KG Zeroin MP Doctor on the 13th, Olix Pharmaceuticals, Inc.(226950)closed at 91,000 won, down 14.31% (15,200 won) from the previous trading day. During the session, the stock fell as low as 89,200 won.

The apparent reason for the decline in investor sentiment toward Olix Pharmaceuticals, Inc. was the rejection of its application for approval of a Phase 2a clinical trial in New Zealand for “OLX301A” (chemical name OLX10212), a candidate drug for age-related macular degeneration (AMD). Olix Pharmaceuticals, Inc. announced on the 12th that it had been notified of the rejection of the application by the Northern B Health and Disability Ethics Committee (HDEC) in New Zealand.

This clinical trial is designed to evaluate the efficacy and safety of OLX10212 in patients with age-related macular degeneration (AMD) accompanied by geographic atrophy (GA) in both eyes. The drug is injected into the vitreous cavity, and the trial is designed to randomly assign patients across multiple clinical sites for comparison with a sham treatment group.

According to the announcement, the ethics committee determined that the submitted application did not meet New Zealand’s ethical standards and relevant regulations.

In a statement to shareholders, Olix Pharmaceuticals, Inc. explained that this rejection is distinct from a decision by Medsafe, the drug regulatory authority. To conduct a clinical trial in New Zealand, regulatory approval from Medsafe and ethical approval from the HDEC must be obtained separately; this rejection pertains specifically to the HDEC’s decision.

The company stated, “We do not believe this issue stems from a fundamental problem with the clinical trial protocol design itself,” adding, “We plan to supplement the necessary data and resubmit the application in October.” The company intends to proceed with the follow-up process based on its prior experience of obtaining Medsafe approval for the Phase 2a clinical trial plan in New Zealand for “OLX104C,” a treatment for male pattern baldness.

An Olix Pharmaceuticals, Inc. official said, “It seems the decline may have been exacerbated by the generally weak market conditions,” adding, “Since this isn’t a case of clinical failure, it appears the stock price has overreacted to the situation.”

There are also cases where development continued after a clinical trial application was rejected

Along with supplementing its New Zealand application, Olix Pharmaceuticals, Inc. is simultaneously preparing for clinical trials in other countries. The company completed its application for approval of the Phase 2a clinical trial plan for OLX301A in Australia on September 16.

The company stated, “We will swiftly implement follow-up measures in response to the rejection of the New Zealand application while simultaneously preparing for clinical trials in other countries to ensure there are no delays in the overall development schedule for the global Phase 2a clinical trial.”

In particular, industry experts agree that the rejection of a clinical trial application is not an event that significantly impacts a company’s value. In fact, there are cases where domestic companies have addressed the issues raised after a rejection, obtained approval, and achieved successful development outcomes. A prime example is “Efamynurad,” a gout treatment candidate developed by JWPHARMACEUTICAL(001060).

In March 2023, the Phase 3 clinical trial application for Efaminurad was rejected in Taiwan. According to the company’s explanation at the time, Taiwanese authorities did not recognize the domestic product “Febuxostat” submitted as the comparator drug. JWPHARMACEUTICAL resubmitted the application after changing the comparator drug to one recognized by local regulatory authorities and received approval in August of the same year.

Subsequently, the company conducted a multinational Phase 3 clinical trial across five Asian countries. In August of this year, JWPHARMACEUTICAL announced that the 6 mg dose of Efaminurad—the primary development dose—demonstrated statistical superiority over 40 mg of Febuxostat in the primary efficacy endpoint. However, the higher 9 mg dose failed to meet the non-inferiority criteria when compared to 80 mg of Febuxostat.

This case demonstrates that a rejection at the clinical trial application stage does not necessarily determine the outcome of the drug evaluation. However, since Olix Pharmaceuticals, Inc.’s specific points of concern have not been disclosed, it remains to be seen how the scope of the required revisions and the time required for re-review will affect the clinical trial schedule.

ROKIT HEALTHCARE Inc. Falls for Fourth Consecutive Trading Day... Hits 52-Week Low During Trading Session

#ROKIT HEALTHCARE Inc. closed at 23,050 won today, down 6.49% (1,600 won). Notably, the stock fell as low as 22,200 won during the session, dipping below its previous 52-week low of 24,200 won. This marks the fourth consecutive trading day of declines since the 7th of this month.

The downward trend has continued since its U.S. subsidiary, Rokit America, withdrew its application for a Nasdaq listing. On July 28, when the company announced the withdrawal of its Nasdaq listing application, the closing price was 39,150 won. The next day, it plummeted 24.65% to 29,500 won; although it rebounded to 36,050 won on August 5, it was unable to sustain the upward momentum. Today’s closing price is 41.12% lower than the level on the day the withdrawal was announced.

Since the delisting announcement, the company has released a series of updates regarding earnings growth, new products, patents, and overseas expansion. In August, it reported first-half revenue of 16.275 billion won, a 67.6% increase year-over-year. However, the operating loss for the same period was approximately 15.8 billion won; the company explained that this was due to a concentration of upfront costs related to major clinical trials, research and development, and the expansion of its U.S. operations.

On August 27, the company announced a research platform for artificial skin capable of applying cells tailored to specific individuals and ethnicities, as well as the supply of the “Epitem-2 Creator Kit” and the filing of a patent application. Subsequently, on September 2, it announced the decision to register a patent in Singapore for an autologous dermal regeneration patch, and on September 3, it disclosed the preclinical results of a kidney regeneration patch developed in collaboration with researchers from Harvard Medical School, along with plans to present the findings at the American Society of Nephrology.

The company also emphasized its expansion of overseas operations. On September 10, it announced the signing of a three-year non-exclusive distribution agreement for its skin regeneration platform with Guoren, a Chinese medical company. It also set a goal to begin the first patient surgeries within four months, following local regulatory approvals and hospital adoption procedures.

In a media interview, CEO Yoo Seok-hwan revealed plans to pursue clinical trials for cartilage regeneration in the U.S. with Harvard Medical School researchers, as well as his vision for business expansion in China, the U.S., the Middle East, and North Africa. He explained that in Shanghai, the company would pursue the establishment of a joint venture involving local medical and research institutions, pharmaceutical companies, and investors.

On September 28, the company announced that in the second phase of animal testing for its hair-growth candidate compound, hair weight increased by up to 65% compared to the control group. On the 7th, it also announced plans to present its technology and showcase its platform at the American Society of Nephrology and the International Society for Diabetic Foot, highlighting the theme “AI Regenerative Technology Made in Korea Lands in the U.S.”

While the stock price reacted on the days of these announcements, the rebound was short-lived. The closing price at the end of September fell to 26,800 won, and on this day, it dropped further to 23,050 won. Compared to the closing price on the 28th of last month, this represents a 20.38% decline.

While the company is presenting growth prospects, the market continues to demand validation of its technology and business performance.