[Featured Stock] Appclon, Leading New Drug for First-Line Gastric Cancer Up... Expected to Surpass Efficacy of Keytruda + Herceptin

[Asia Economy Reporter Hyungsoo Park] Appclon is showing strong performance. The fact that a biotech company with a market capitalization under 300 billion KRW possesses a Best-In-Class anticancer drug candidate pipeline within its group, which has announced successful Phase 2 results and is about to enter Phase 3, in addition to chimeric antigen receptor T-cell (CAR-T) therapy, appears to be an attractive investment point influencing the stock price, according to securities firm analysis.

As of 9:28 AM on the 30th, Appclon is trading at 18,800 KRW, up 12.57% from the previous day.

Kyobo Securities expects Appclon to disclose positive interim results from the Phase 1 clinical trial of its CAR-T therapy, followed by Phase 2 results of its antibody therapy in October.

Researcher Jeonghyun Kim of Kyobo Securities explained, "Appclon's AC101 is a HER2-targeted antibody therapy," adding, "It aims to be the best-in-class drug for HER2-positive gastric cancer treatment."

He continued, "According to the revised NCCN guidelines this year, the current first-line standard treatments for HER2-positive gastric cancer are combination therapies of Trastuzumab (hereafter T) + Pembrolizumab (P) + Chemotherapy (C) or T + C."

He emphasized, "Until last year, the T + C combination therapy was used, but based on the Keynote-811 study (ORR in treatment group 74% vs placebo group 52%), the T + P + C combination therapy was also approved by the FDA."

Researcher Kim analyzed, "Appclon's partner, Shanghai Henlius, aims to surpass the efficacy of T + P + C through the combination of its T biosimilar and AC101 (HLX22). At the end of last month, Henlius first announced that an ORR of over 85% is expected in the Phase 2 trial (AC101 + Herceptin + Chemo combination)."

He added, "This estimate is based on efficacy data from the entire dosing group before unblinding the double-blind trial (ORR 77.3%) and partially disclosed low-dose group (ORR 100%). Henlius plans to release data after unblinding the Phase 2 trial in October this year."

Researcher Kim further stated, "Based on this, they plan to enter the global Phase 3 trial next year," and added, "Since Henlius' Herceptin biosimilar is its top-selling product, they aim to grow biosimilar sales and simultaneously develop new drugs based on AC101."

Appclon successfully raised 22 billion KRW in capital from institutional investors at the end of July. Concerns about additional capital raising over the next two years have been eliminated. Appclon's annual cash burn is in the 10 billion KRW range, which is relatively low compared to other biotechs. Researcher Kim judged that Appclon's light scale and sound financial management will significantly reduce unexpected risks for investors. The smaller market capitalization compared to Bacsell Bio (1.1 trillion KRW), GC Cell (890 billion KRW), and NKMax (650 billion KRW) was also cited as an investment attraction for Appclon.

This content was produced with the assistance of AI translation services.