South Korea Drug Approvals — April 2026
South Korea Drug
Approvals — April 2026
South Korea’s MFDS approved 5 drugs in April 2026, leading all regions globally with the most approvals in the month. The cohort spans a triple-checkpoint CAR-T for lymphoma, a PSMA diagnostic for prostate cancer, a triple-combination for hypertension, and two multi-ingredient combination products for cold and bowel preparation.
5 drugs approved in South Korea — April 2026
All data from the April 2026 monthly report, Table 1. Sorted by approval date (latest first).
| Drug | Target | Modality | Indication | Developer | Date |
|---|---|---|---|---|---|
| [F-18]Florastamin | PSMA | Small molecule drug; Diagnostic radiopharmaceutical | Recurrent or Metastatic Prostate Carcinoma | FutureChem Co., Ltd. | Apr 30 |
| Anbalcabtagene autoleucel | TIGIT · CD19 · PD-1 | Autologous CAR-T cell therapy | Primary mediastinal LBCL (R/R); DLBCL (R/R) | Curocell, Inc. | Apr 29 |
| Sodium Picosulfate / Potassium Sulfate / Magnesium Sulfate / Simethicone | — | Small molecule drug | Intestinal preparation | Vivozon Pharmaceutical Inc. | Apr 29 |
| Amlodipine Besylate / Valsartan / Indapamide | NCC · AT1R · L-type calcium channel | Small molecule drug | Essential Hypertension | AHN-GOOK PHARMACEUTICAL CO., LTD. | Apr 28 |
| Acetaminophen / Guaifenesin / Dextromethorphan / DL-Methylephedrine / Bromhexine | adrenergic · COXs · σ1 · NMDA | Small molecule drug | Common Cold | Chong Kun Dang Pharmaceutical | Apr 23 |
Two innovative approvals profiled
Anbalcabtagene autoleucel — triple-checkpoint CAR-T for lymphoma
Anbalcabtagene autoleucel is an autologous CAR-T therapy targeting TIGIT, CD19, and PD-1, developed by Curocell, Inc. It was approved by South Korea’s MFDS on April 29, 2026 for relapsed or refractory primary mediastinal large B-cell lymphoma and relapsed or refractory diffuse large B-cell lymphoma. Its simultaneous targeting of three immune checkpoints — CD19 (tumour antigen), TIGIT (immune checkpoint), and PD-1 (immune checkpoint) — within a single autologous CAR-T construct represents a mechanistically advanced approach to lymphoma cell therapy.
TIGIT · CD19 · PD-1 · CAR-T · DLBCL · Curocell[F-18]Florastamin — PSMA PET diagnostic for prostate cancer
[F-18]Florastamin is a small molecule PSMA-targeting PET diagnostic radiopharmaceutical developed by FutureChem Co., Ltd. It was approved by South Korea’s MFDS on April 30, 2026 for Recurrent or Metastatic Prostate Carcinoma. PSMA (prostate-specific membrane antigen) is overexpressed on prostate cancer cells and their vasculature, making it a well-validated diagnostic target for PET imaging across the metastatic and recurrent prostate cancer setting.
PSMA · PET diagnostic · Prostate cancer · FutureChem3 signals from South Korea’s April 2026 approval data
Strategic takeaways from 5 MFDS approvals in the April 2026 monthly report.
South Korea leads April 2026 global approvals with 5 — spanning CAR-T, diagnostics, and combination drugs
South Korea’s MFDS granted 5 of the 12 total April 2026 global drug approvals — more than any other region. The 5 approvals span modality breadth from an autologous CAR-T (Anbalcabtagene autoleucel, lymphoma) and a PSMA PET diagnostic ([F-18]Florastamin, prostate cancer) to three small molecule combination products covering hypertension, common cold, and bowel preparation. This breadth reflects MFDS’s active approval activity across innovative oncology and established therapeutic categories.
Anbalcabtagene: Curocell achieves landmark MFDS approval for a domestically developed triple-checkpoint CAR-T
Anbalcabtagene autoleucel’s approval marks a milestone for Curocell, Inc. as a South Korean-headquartered biopharmaceutical company achieving domestic MFDS approval for an autologous CAR-T — a cell therapy modality historically dominated by US and European developers. The construct’s simultaneous targeting of TIGIT, CD19, and PD-1 is designed to combine direct tumour cell killing (CD19) with dual immune checkpoint reinvigoration (TIGIT, PD-1) in the tumour microenvironment.
[F-18]Florastamin: domestic PSMA PET agent adds to Korea’s precision oncology diagnostic infrastructure
[F-18]Florastamin’s MFDS approval for PSMA-targeted PET imaging in recurrent or metastatic prostate cancer — developed by domestic company FutureChem Co., Ltd. — adds a locally developed diagnostic radiopharmaceutical option to South Korea’s precision oncology infrastructure. PSMA PET imaging has become the standard-of-care staging and restaging tool for prostate cancer in major markets; this domestic approval reduces dependence on imported agents such as PSMA-11 and DCFPyL.
Triple combination hypertension: Amlodipine/Valsartan/Indapamide covers CCB, ARB, and thiazide in one tablet
AHN-GOOK PHARMACEUTICAL’s triple combination of Amlodipine Besylate (L-type calcium channel blocker), Valsartan (AT1R antagonist), and Indapamide (NCC inhibitor/thiazide-like diuretic) covers three distinct antihypertensive mechanisms in a single tablet. This class of fixed-dose triple combination products — targeting blood pressure reduction through complementary mechanisms — reflects South Korea’s active fixed-dose combination drug development market, which produces multiple approvals per year across cardiometabolic indications.
South Korea drug approvals April 2026 — key questions
South Korea’s MFDS approved 5 drugs in April 2026: Anbalcabtagene autoleucel (TIGIT/CD19/PD-1 autologous CAR-T for lymphoma), [F-18]Florastamin (PSMA diagnostic radiopharmaceutical for prostate cancer), Sodium Picosulfate combination (intestinal preparation), Amlodipine/Valsartan/Indapamide triple combination (essential hypertension), and Acetaminophen multi-ingredient combination (common cold).
Anbalcabtagene autoleucel is an autologous CAR-T therapy targeting TIGIT, CD19, and PD-1, developed by Curocell, Inc. It was approved by South Korea’s MFDS on April 29, 2026 for relapsed or refractory primary mediastinal large B-cell lymphoma and relapsed or refractory diffuse large B-cell lymphoma.
[F-18]Florastamin, a small molecule diagnostic radiopharmaceutical targeting PSMA, developed by FutureChem Co., Ltd., was approved by South Korea’s MFDS on April 30, 2026 for Recurrent or Metastatic Prostate Carcinoma.
A triple combination of Amlodipine Besylate, Valsartan, and Indapamide targeting NCC, AT1R, and L-type calcium channel, developed by AHN-GOOK PHARMACEUTICAL CO., LTD., was approved in South Korea on April 28, 2026 for Essential Hypertension.
Anbalcabtagene autoleucel was developed by Curocell, Inc., a South Korean biopharmaceutical company.
Data on this page is sourced from the PatSnap April 2026 monthly pharmaceutical report, Table 1 (drug approvals). Represents a snapshot of available records as of April 2026.