China & Korea Drug Approvals — March 2026
China & Korea Drug
Approvals — March 2026
China’s NMPA approved 8 drugs in March 2026 spanning diagnostics, vaccines, biosimilars, and recombinant proteins. South Korea’s MFDS approved 4 drugs, all small molecule combination products targeting diabetes, hypertension, and common cold.
8 drugs approved in China — March 2026
Spanning diagnostics, vaccines, biosimilars, recombinant proteins, and a botulinum toxin. All data from the March 2026 monthly report, Table 0.
| Drug | Target | Modality | Indication | Developer | Date |
|---|---|---|---|---|---|
| Higenamine Hydrochloride | β2-adrenergic receptor | Small molecule drug | Heart Diseases; Contrast agents | Zhuhai Rundu Pharmaceutical | Mar 31 |
| 99mTc-3PRGD2 | αvβ3 | Peptide conjugate radionuclide; Diagnostic radiopharmaceutical | Lung Cancer | Foshan Rui Diao Pharmaceutical | Mar 31 |
| Recombinant Human Hyaluronidase (BaoPharma) | Hyaluronic acid | Recombinant protein; Enzyme | Drug adjuvant | Shanghai Bao Pharmaceutical | Mar 31 |
| Adsorbed tetanus vaccine (Beijing Minhai) | — | Prophylactic vaccine | Tetanus | Beijing Minhai Biological Technology | Mar 31 |
| Recombinant Botulinum Toxin Type A (Claruvis) | SNAP25 | Toxin | Glabellar frown lines | Claruvis Pharmaceutical | Mar 25 |
| Recombinant erythropoietin stimulating protein (3SBio) | EPO receptor | Colony-stimulating factors | Anemia in chronic kidney disease | Guangdong Sansheng Pharmaceutical | Mar 17 |
| Influenza Vaccine Quadrivalent (Shenzhen Kangtai) | — | Inactivated vaccine; Prophylactic vaccine; Multivalent vaccine | Influenza, Human | Shenzhen Kangtai Biological Products | Mar 17 |
| Insulin Degludec biosimilar (Zhuhai United Laboratories) | INSR | Biosimilar; Peptide Hormone | Diabetes Mellitus, Type 2 | Zhuhai Federal Biomedical | Mar 3 |
4 drugs approved in South Korea — March 2026
All small molecule combination products: one triple diabetes combination, one dual hypertension combination, and two cold/flu multi-ingredient products.
| Drug | Target | Indication | Developer | Date |
|---|---|---|---|---|
| Metformin HCl / Lobeglitazone Sulfate / Empagliflozin L-Proline | SGLT2 · PRKAB1 · PPARγ | Diabetes Mellitus, Type 2 | Chong Kun Dang Pharmaceutical Corp. | Mar 10 |
| Acetaminophen / Chlorpheniramine / Pseudoephedrine / Methylephedrine / Dextromethorphan / Guaifenesin / Vitamin B2 | α-adrenergic · NMDA · σ1 · H1 · COXs | Common Cold | RP Bio, Inc. | Mar 9 |
| Chlortalidone / Telmisartan | NCC · AT1R | Essential Hypertension | Yuhan Corp. | Mar 5 |
| Acetaminophen / Guaifenesin / DL-Methylephedrine / Dextromethorphan / Chlorpheniramine | NMDA · H1 · adrenergic · σ1 · COXs | Common Cold | COSMAX PHARMA CO., LTD | Mar 3 |
4 signals from the China & Korea March 2026 approval data
Strategic takeaways derived from the 12 approvals in the March 2026 monthly report.
China’s March 2026 approvals span 6 distinct modalities
China’s 8 March 2026 approvals span small molecules (Higenamine Hydrochloride), diagnostic radiopharmaceuticals (99mTc-3PRGD2), recombinant proteins and enzymes (Hyaluronidase, erythropoietin stimulating protein), vaccines (tetanus, quadrivalent influenza), biosimilars (Insulin Degludec), and toxins (Botulinum Toxin Type A). This breadth reflects NMPA’s broad approval activity across therapeutic and diagnostic categories.
Insulin Degludec biosimilar: NMPA approval signals long-acting insulin access push
The approval of an Insulin Degludec biosimilar from Zhuhai Federal Biomedical Co., Ltd. on March 3, 2026, targeting INSR for Type 2 diabetes, signals continued NMPA progress in building a domestic biosimilar pipeline for high-value biologics. Insulin Degludec (Tresiba) is one of the most widely prescribed long-acting insulin analogues globally; a Chinese biosimilar creates meaningful access and pricing pressure in that segment.
South Korea’s 4 approvals: all small molecule combinations targeting chronic disease and OTC
All 4 South Korea MFDS approvals in March 2026 are small molecule combination products. The Metformin/Lobeglitazone/Empagliflozin triple combination from Chong Kun Dang (SGLT2, PRKAB1, PPARγ) and the Chlortalidone/Telmisartan dual combination from Yuhan Corp. (NCC, AT1R) target chronic cardiometabolic conditions. The two cold/flu multi-ingredient products from RP Bio and COSMAX reflect continued activity in the Korean OTC combination drug market.
99mTc-3PRGD2: αvβ3-targeted diagnostic radiopharmaceutical approved for lung cancer
99mTc-3PRGD2, a peptide conjugate radionuclide targeting αvβ3 integrin, received NMPA approval on March 31, 2026 for lung cancer diagnostics, developed by Foshan Rui Diao Pharmaceutical Co Ltd. αvβ3 integrin is overexpressed on tumour vasculature and is a validated target for tumour imaging. This approval adds a domestic targeted radiopharmaceutical diagnostic option for lung cancer, China’s most prevalent malignancy by incidence.
China & Korea drug approvals March 2026 — key questions
China’s NMPA approved 8 drugs in March 2026, including diagnostics, vaccines, biosimilars, a botulinum toxin, and a recombinant protein adjuvant.
South Korea’s MFDS approved 4 drugs in March 2026, all small molecule drugs: a triple combination for Type 2 diabetes, two cold/flu combination products, and a dual combination for essential hypertension.
China’s 8 March 2026 approvals span small molecule drugs (Higenamine Hydrochloride for heart disease), diagnostic radiopharmaceuticals (99mTc-3PRGD2 for lung cancer), recombinant proteins and enzymes (Hyaluronidase as drug adjuvant, erythropoietin stimulating protein for anemia), vaccines (tetanus and quadrivalent influenza), a biosimilar (Insulin Degludec for Type 2 diabetes), and a toxin (Botulinum Toxin Type A for glabellar lines).
Chong Kun Dang Pharmaceutical Corp. received approval in South Korea on March 10, 2026 for a triple combination of Metformin Hydrochloride, Lobeglitazone Sulfate, and Empagliflozin L-Proline for Diabetes Mellitus, Type 2, targeting SGLT2, PRKAB1, and PPARγ.
Insulin Degludec biosimilar developed by Zhuhai Federal Biomedical Co., Ltd. (Zhuhai United Laboratories) was approved in China on March 3, 2026 for Diabetes Mellitus, Type 2, targeting INSR.
99mTc-3PRGD2, a peptide conjugate radionuclide and diagnostic radiopharmaceutical targeting αvβ3, developed by Foshan Rui Diao Pharmaceutical Co Ltd, was approved in China on March 31, 2026 for Lung Cancer.
Data on this page is sourced from the PatSnap March 2026 monthly pharmaceutical report, Table 0 (drug approvals). Represents a snapshot of available records as of March 2026.