Antrogen Nears Approval in Japan [K-Bio Pulse]

[Kim Jiwan, Edaily Reporter] Antrogen surged as its drug, which was license-out 10 years ago, is now nearing regulatory approval in Japan.

Kolon TissueGene also saw a sharp rise ahead of the TG-C clinical trial results. Although TG-C faced challenges after its domestic approval was revoked, it is increasing its chances of obtaining regulatory approval in the U.S.

TG-C. (Photo=Kolon TissueGene)

OliX, which has recently gained recognition for its technology exports, continued its upward trend as its new pipeline (a hair loss treatment) entered the next phase of clinical trials.

According to KG Zeroin MP Doctor (formerly MarketPoint) on the 12th, Antrogen closed at 18,680 KRW, up 7.36% (1,280 KRW) from the previous day.

Kolon TissueGene rose 9.64% (4,050 KRW) to close at 46,050 KRW, while OliX climbed 5.10% (2,250 KRW) to reach a closing price of 46,350 KRW on the 11th.

◇Antrogen, nears approval in Japan.

Antrogen garnered market attention as its proprietary therapy nears regulatory approval in Japan.

According to industry sources, Japan‘s I’rom Pharmaceutical is scheduled to hold a pre-New Drug Application (pre-NDA) meeting with the Pharmaceuticals and Medical Devices Agency (PMDA) on April 16 for its dystrophic epidermolysis bullosa (DEB) treatment candidate, ALLO-ASC-EB.

Previously, in July 2015, I‘rom Pharmaceutical acquired the technology license for ALLO-ASC-EB from Antrogen, securing the development and commercialization rights for Japan and Taiwan.

Dystrophic epidermolysis bullosa (DEB) is a rare genetic disorder that causes the skin‘s epidermis to blister and peel due to a genetic defect. In Japan, approximately 500 patients are officially registered, while estimates suggest the total number, including unregistered cases, could be around 2,000.

The pre-NDA (New Drug Application) meeting is a procedural step conducted before the official NDA submission. One month before the meeting, I’rom Pharmaceutical must submit comprehensive documentation to the Pharmaceuticals and Medical Devices Agency (PMDA), including Phase 3 clinical trial results, manufacturing processes (CMC), preclinical data (toxicology, pharmacology, and pharmacokinetics), clinical summaries, dosage and administration (including maximum usage), drug pricing, and potential side effects.

I‘rom Pharmaceutical is responsible for clinical development and regulatory approval, while Antrogen will handle the manufacturing of the therapy.

Earlier, on March 10, Antrogen announced that it had received Foreign Manufacturer Accreditation (FMA) from the PMDA for its cell therapy manufacturing facilities. This certification allows production sites in Gasan and Magok, South Korea, to manufacture and export the treatment to Japan. The therapy is expected to be supplied immediately upon regulatory approval.

An Antrogen representative stated, “Dystrophic epidermolysis bullosa (DEB) is a life-threatening genetic disorder with a significant unmet medical need, as there are currently no effective treatments available.” They added, “Since ALLO-ASC-SHEET was designated as an orphan drug by the Japanese Ministry of Health based on its Phase 1/2 clinical trial results, we anticipate an expedited regulatory review process for its approval.”

The representative further explained, “This therapy will be manufactured by Antrogen and supplied to the Japanese market as a fully finished product.” They also noted, “The expected approval date is March 2026, approximately nine months after the NDA submission.”

◇Kolon TissueGene, TG-C Revival

Kolon TissueGene saw a sharp rise in its stock price as the announcement of Phase 2 clinical trial results for TG-C approaches.

According to industry sources, Kolon TissueGene plans to present follow-up data from its Phase 2 clinical trial of TG-C at the upcoming World Congress on Osteoarthritis (OARSI), which will be held from April 24 to 27 at Songdo Convensia, Incheon.

TG-C is the world’s first gene therapy-based osteoarthritis treatment developed by Kolon TissueGene. It was approved in South Korea in 2017, but in 2019, a controversy arose regarding changes in its cell composition, leading the Ministry of Food and Drug Safety (MFDS) to revoke its approval.

As a result, the U.S. Food and Drug Administration (FDA) halted the ongoing Phase 3 trial in 2019. However, after further investigation, TG-C was determined to have a low risk of safety issues, and the clinical trial was resumed. The U.S. trial is now progressing smoothly, with Kolon TissueGene aiming to submit a Biologics License Application (BLA) to the FDA by 2027.

Kolon TissueGene completed patient dosing for its Phase 3 trial in July 2023 and is currently conducting follow-up observations. The Phase 3 clinical data is expected to be released in 2026.

With the upcoming announcement of Phase 2 follow-up results, industry experts believe the data could serve as an indicator of potential Phase 3 outcomes.

Wi Hae-joo, a researcher at Korea Investment & Securities, stated:“According to long-term follow-up data presented at the 2023 International Cartilage Regeneration & Joint Preservation Society (ICRS), 79% of patients who received TG-C treatment remained without the need for total knee replacement surgery for 15 years. If the upcoming follow-up results at OARSI reaffirm this, it will further strengthen the efficacy and safety profile of TG-C.”

A Kolon TissueGene representative commented: “We update the Phase 2 follow-up data for TG-C annually. Our primary focus is on completing the remaining clinical trials to obtain FDA approval.”

◇OliX Gains Momentum with New Pipeline

OliX Pharmaceuticals experienced a surge in its stock price after its alopecia (hair loss) treatment entered a Phase 1b/2a clinical trial.

OliX announced that it has submitted an Investigational New Drug (IND) application for its hair loss treatment candidate, OLX104C (OLX72021), to the Bellberry Human Research Ethics Committee (Bellberry HREC) in Australia.

Lee Dong-ki, CEO of OliX.

This Phase 1b/2a trial will evaluate the safety and efficacy of OLX104C in healthy male patients with androgenic alopecia (male pattern baldness). The trial will be conducted across approximately 10 clinical sites in Australia, enrolling 120 participants, and is expected to last around 30 months.

The trial consists of two parts:

Phase 1b: Evaluates the safety and tolerability of OLX104C, including its potential effects on sexual function.

Phase 2a: Assesses the drug’s human proof-of-concept (PoC) through multiple intradermal injections.

Androgenic alopecia accounts for over 90% of hair loss cases in South Korea. OLX104C works by reducing androgen receptor expression and is developed as a topical treatment. Unlike traditional oral medications that affect the entire body and may cause side effects such as sexual dysfunction and depression, OLX104C is applied directly to the scalp, minimizing systemic exposure and adverse effects.

Lee Dong-ki, CEO of OliX, stated, “Unlike conventional oral treatments that require daily intake, OLX104C is a topical treatment administered once a month, enhancing patient convenience. We expect it to offer superior efficacy with fewer side effects than existing treatments.”

He further revealed, “We are in the final stages of discussions for a joint research and development partnership with a global pharmaceutical company based on our expertise in skin and hair-related therapeutics. Following our recent technology transfer deal with Eli Lilly, we anticipate additional milestones soon.”

Previously, OliX confirmed the safety of OLX104C in a Phase 1 clinical trial in Australia.