APAC Drug Approvals: China and South Korea, February 2026

Updated on March 20,2026|Written by Patsnap Team

China and South Korea together accounted for 13 of the 19 global drug approvals in February 2026 — making APAC the most active regulatory zone worldwide this month. China’s NMPA approved 6 drugs, with oncology and immunology featuring prominently. South Korea’s MFDS approved 7 drugs, predominantly combination small molecules for cardiovascular, metabolic, and symptomatic indications.

All data is sourced from Patsnap Synapse, an AI-powered drug intelligence platform with real-time NMPA, MFDS, PMDA, and global regulatory coverage.

China NMPA Approvals — February 2026

1. Sosimerasib (Zhejiang Hangyu Pharmaceutical) — KRAS G12C+ NSCLC

Approval date: February 25, 2026
Drug type: Small molecule
Target: KRAS G12C
Indication: KRAS G12C-mutant non-small cell lung cancer (NSCLC)

Sosimerasib is China’s first domestically developed KRAS G12C inhibitor to receive approval. The KRAS G12C mutation is found in approximately 13% of NSCLC adenocarcinomas and drives uncontrolled cell proliferation via persistent RAS–RAF–MEK–ERK signalling. Globally, sotorasib (Amgen, FDA 2021) and adagrasib (BMS, FDA 2022) established the clinical proof of concept for covalent KRAS G12C inhibitors; fulzerasib became China’s first KRAS G12C approval in 2024. Sosimerasib — domestically developed — marks a further maturation of China’s innovative oncology pipeline.

For the foundational pharmacology of KRAS G12C inhibition, the FDA approval summary of sotorasib (PMC) provides a thorough mechanistic and clinical context. For current resistance biology and next-generation inhibitor strategies, see this Nature review of KRAS G12C inhibitors and brain metastases.

Sosimerasib also received Conditional Marketing Approval status simultaneously — NMPA’s expedited pathway for drugs addressing unmet clinical need — reflecting the high burden of lung cancer in China, where approximately 900,000 new cases are diagnosed annually.

Monitoring China’s oncology pipeline across KRAS, EGFR, HER2, and beyond? Patsnap Synapse provides real-time NMPA filing intelligence, clinical trial tracking, and patent landscaping for every major oncology target. Explore China oncology pipeline data on Synapse →

→ Deep dive: KRAS G12C/G12D — three agents approved or designated in February 2026

2. Rovadicitinib (Chia Tai Tianqing) — Myelofibrosis

Approval date: February 25, 2026
Drug type: Small molecule
Targets: JAK2; JAK1; ROCK1; ROCK2
Indications: Primary myelofibrosis, post-polycythemia vera myelofibrosis, post-essential thrombocythemia myelofibrosis

Rovadicitinib is a dual JAK/ROCK inhibitor — a mechanistic approach that combines established JAK2 pathway suppression with ROCK inhibition to address not just cytokine-driven symptoms but potentially the underlying bone marrow fibrosis. Existing JAK inhibitors (ruxolitinib, fedratinib, pacritinib, momelotinib) improve spleen volume and symptoms but do not consistently reverse fibrosis. ROCK1/2 inhibition targets downstream fibrotic remodelling pathways, and the dual mechanism hypothesis is that combining both in a single molecule may produce deeper clinical responses than JAK inhibition alone.

Want to track the full competitive landscape, patent estate, and clinical pipeline for this target? Search this target on Patsnap Synapse →

3. Amdokitug (Sunshine Guojian) — Plaque Psoriasis

Approval date: February 10, 2026
Drug type: Monoclonal antibody
Target: IL-17A
Indication: Plaque psoriasis

Amdokitug is a domestically developed IL-17A monoclonal antibody for moderate-to-severe plaque psoriasis — an indication where IL-17A inhibition with secukinumab (Novartis) and ixekizumab (Eli Lilly) has established high efficacy benchmarks, with PASI 90+ responses in clinical trials. This approval reflects the broader domestication trend in China’s biologics landscape, with multiple home-grown IL-17A, IL-23, and TNF-α antibodies now competing alongside originator products.

4. Obinutuzumab β (Beijing Mabworks) — AQP4-IgG+ NMOSD

Approval date: February 10, 2026
Drug type: Monoclonal antibody (glycoengineered)
Target: CD20
Indication: AQP4-IgG-positive neuromyelitis optica spectrum disorder (NMOSD)

NMOSD is a rare autoimmune condition affecting the optic nerves and spinal cord, driven by AQP4-IgG autoantibodies that trigger complement-mediated astrocyte destruction. The condition carries high relapse-associated disability risk. Approved NMOSD therapies include inebilizumab (anti-CD19), eculizumab and ravulizumab (complement pathway), and satralizumab (IL-6 receptor). Anti-CD20 approaches (rituximab and now obinutuzumab β) target the B-cell compartment responsible for autoantibody production. This China-originated anti-CD20 approval in a rare neurological disease represents a meaningful expansion of domestic biologics capability.

5. Pertuzumab Biosimilar (Betta Pharmaceuticals) — HER2+ Breast Cancer

Approval date: February 2, 2026
Drug type: Biosimilar monoclonal antibody
Target: HER2
Indications: Early-stage and metastatic HER2-positive breast cancer

Betta Pharmaceuticals’ pertuzumab biosimilar references Roche’s Perjeta, which binds domain II of HER2 to block receptor dimerisation — a complementary mechanism to trastuzumab (domain IV binding). Pertuzumab is used in combination with trastuzumab as the standard neoadjuvant and metastatic regimen for HER2-positive breast cancer. HER2 positivity occurs in approximately 20–25% of breast cancers. Biosimilar entry reduces costs substantially, which is particularly significant in China where originator trastuzumab and pertuzumab access has historically been limited by pricing.

6. Rabies Vaccine (Chengda Biotechnology Benxi) — Rabies Prophylaxis

Approval date: February 10, 2026
Drug type: Prophylactic vaccine
Indication: Rabies

China remains one of the countries with the highest global rabies burden, with tens of thousands of post-exposure prophylaxis courses administered annually. This approval adds another domestically manufactured option to the supply base.

China NMPA February 2026: Summary

South Korea MFDS Approvals — February 2026

South Korea’s 7 approvals were concentrated in fixed-dose combination small molecules — a pattern consistent with the MFDS’s long-running approval profile. Combination products that consolidate two or more established mechanisms into a single pill generate a high proportion of Korean approvals each month.

Cardiovascular and metabolic

Ezetimibe/Fimasartan/Atorvastatin (Boryung Corp.) — A triple-combination targeting cholesterol absorption (NPC1L1), blood pressure (AT1R), and cholesterol synthesis (HMGCR) in a single tablet. Approved February 27 for combined hypertension and hypercholesterolemia.

Pitavastatin/Choline Fenofibrate (Daewon Pharmaceutical) — Dual lipid-lowering combination targeting HMGCR (statin) and PPARα (fibrate). Approved February 25 for coronary disease.

Gastrointestinal

Berberine Tannate/Scopolia Extract/Ursodeoxycholic Acid/Bismuth Subnitrate (Hanmi Pharmaceutical) — A four-component combination for functional GI indications including gastralgia, dyspepsia, and diarrhea. Approved February 27.

Topical analgesic / anti-pruritic

Glycol Salicylate/L-Menthol/Vanillyl Nonylamide (Sinsin Pharmaceutical) — A topical combination targeting TRPA1, TRPM8, and κ-opioid receptors for pruritus, insect bites, and pain. Approved February 23.

Vaccines and symptomatic

Kovax (Korea Vaccine Co.) — Inactivated influenza A/B vaccine. Approved February 20.

Chlorpheniramine/Scopolamine (Firson Co.) — Antihistamine/anticholinergic combination for motion sickness. Approved February 9.

Acetaminophen/Chlorpheniramine (COSMAX PHARMA) — OTC analgesic/antihistamine combination for common cold symptoms. Approved February 9.

South Korea MFDS February 2026: Summary

APAC Regulatory Trends: What February Signals

China’s domestic oncology pipeline is maturing. Sosimerasib and rovadicitinib are both domestically developed by Chinese companies — not licensed-in originator products. This continues a structural shift in China’s approval mix, increasingly toward innovative domestic origination rather than import and biosimilar-heavy activity.

South Korea’s fixed-dose combination strategy is consistent and commercially pragmatic. The MFDS has a well-established pathway for combination reformulations that simplify patient regimens in high-prevalence conditions — cardiovascular, metabolic, and GI. For companies targeting the Korean market, this pattern creates predictable launch opportunities.

Biosimilars are improving biologic access in China at scale. The pertuzumab biosimilar approval is part of a broader NMPA strategy to reduce treatment costs for HER2-positive cancers — a high-priority oncology segment in China’s public health system.

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Further Reading

• Global drug approvals roundup — February 2026
• US & EU drug approvals — February 2026
• Japan iPSC cell therapy approvals — February 2026
• KRAS G12C/G12D inhibitor pipeline — 2026

Data sourced from Patsnap Synapse. Regulatory classifications reflect filings as of February 2026. This post is for informational purposes only.