NMPA Approved Drugs List – February 2026: 3 Innovative Drugs Approved in China
According to the National Medical Products Administration (NMPA), three innovative drugs were approved for marketing in China in February 2026. These newly added entries to the NMPA approved drugs list cover moderate-to-severe plaque psoriasis, myelofibrosis, and KRAS G12C–mutant advanced non-small cell lung cancer (NSCLC).
This round of approvals includes Class 1 innovative drugs as well as a product granted priority review with conditional approval, reflecting the continued optimization of China’s regulatory review system.
As a China pharmaceutical wholesaler closely tracking NMPA approval updates, DengYueMed provides the following structured overview of the latest additions to the NMPA approved drugs list.
NMPA Approved Drugs List – February 2026 Overview
| Drug Name | Brand Name | Applicant | Indication | Approval Date |
|---|---|---|---|---|
| Amdokitug Monoclonal Antibody Injection | Yisaituo | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Moderate-to-severe plaque psoriasis (adults) | 2026-02-13 |
| Rovadicitinib Tablets | Anxu | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | First-line treatment for intermediate-2 or high-risk myelofibrosis | 2026-02-28 |
| Sosimerasib Sulfate Tablets | Jilemei | Zhejiang Hangyu Pharmaceutical Co., Ltd. | KRAS G12C-mutant advanced NSCLC | 2026-02-28 |
Amdokitug Monoclonal Antibody Injection Approved by NMPA for Moderate-to-Severe Plaque Psoriasis
The NMPA approved Amdokitug Monoclonal Antibody Injection (brand name: Yisaituo), developed by Sunshine Guojian Pharmaceutical.
The drug is indicated for adult patients with moderate-to-severe plaque psoriasis who are eligible for systemic therapy or phototherapy.
Key Information of Amdokitug Monoclonal Antibody Injection:
- Indication: Moderate-to-severe plaque psoriasis
- Target Population: Adults requiring systemic therapy or phototherapy
- Therapeutic Area: Autoimmune disease
- Product Type: Biologic
The biologics market for psoriasis has long been dominated by multinational pharmaceutical companies. In recent years, Chinese biopharmaceutical firms have significantly strengthened their R&D capabilities in immunology and inflammatory diseases, entering higher-barrier biologics development.
This approval demonstrates China’s growing innovation maturity in autoimmune disease treatment.
Explore more psoriasis treatment options in our product portfolio.
Rovadicitinib Tablets Approved by NMPA for First-Line Treatment of Myelofibrosis
The NMPA approved Class 1 innovative drug Rovadicitinib Tablets (brand name: Anxu) for marketing.
The drug is indicated for first-line treatment of adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), and post-essential thrombocythemia myelofibrosis (PET-MF), aiming to improve splenomegaly and disease-related symptoms.
Key Information of Rovadicitinib Tablets:
- Drug Category: China Class 1 innovative drug
- Therapeutic Area: Myeloproliferative neoplasms (MPN)
- Treatment Setting: First-line therapy
- Clinical Value: Improvement of splenomegaly and related symptoms
Myelofibrosis is a rare hematologic malignancy with limited treatment options.
Its approval as a first-line therapy signals that Chinese-developed innovative drugs are moving earlier in treatment paradigms, rather than remaining limited to later-line supplementary roles. This reflects increasing R&D depth in targeted therapies for hematologic cancers.
View additional myelofibrosis treatment products for global supply.
Sosimerasib Sulfate Tablets Receive Priority Review and Conditional Approval from NMPA
The NMPA granted priority review and conditional approval to the Class 1 innovative drug Sosimerasib Sulfate Tablets (brand name: Jilemei).
The drug is indicated for adult patients with KRAS G12C–mutant advanced non-small cell lung cancer who have received at least one prior systemic therapy.
Key Information of Sosimerasib Sulfate Tablets:
- Drug Category: China Class 1 innovative drug
- Regulatory Pathway: Priority review + conditional approval
- Target: KRAS G12C
- Indication: Advanced NSCLC
KRAS G12C mutations were historically considered difficult-to-target oncogenic drivers. With advances in molecular targeting technology, this mutation has become a key focus of global lung cancer drug development.
The conditional approval highlights regulatory support for precision oncology in China and demonstrates that domestic innovation is entering highly competitive global molecular target landscapes.
Discover more targeted therapies for NSCLC in our oncology portfolio.
Trends in the NMPA Approved Drugs List in 2026
Based on NMPA approvals since early 2026, several clear trends have emerged:
1️⃣ Increasing proportion of Class 1 innovative drugs
2️⃣ Normalization of priority review and conditional approval mechanisms
3️⃣ Continued momentum in precision medicine
4️⃣ Strong activity in autoimmune and hematologic disease areas
Overall, China’s innovative drug development is progressing toward higher quality and greater differentiation, as reflected in the expanding NMPA approved drugs list.
About DengYueMed
DengYueMed is a China-based pharmaceutical wholesaler serving the global market, continuously monitoring China’s innovative drug launches and updates to the NMPA approved drugs list.
We provide monthly updates on newly approved drugs in China to support international partners with timely and professional insights into the Chinese pharmaceutical market.
For more updates on the latest NMPA approved drugs list, follow DengYueMed for ongoing regulatory and market intelligence.
FAQ about NMPA Approved Drugs List
What is NMPA in pharma?
The National Medical Products Administration (NMPA) is China’s national drug regulatory authority responsible for the review, approval, and supervision of pharmaceuticals, medical devices, and cosmetics. In pharma, it functions similarly to the U.S. FDA, overseeing drug approvals and market regulation in China.
What are approved drugs?
Approved drugs are medications that have been reviewed and authorized by a national regulatory authority—such as the National Medical Products Administration (NMPA)—after evaluating their safety, efficacy, and quality. Once approved, these drugs can be legally marketed and prescribed for specific medical indications.
What are Class 1 drugs in China?
Class 1 drugs in China are innovative medicines containing new chemical or biological entities that have not been approved anywhere in the world. Under the National Medical Products Administration (NMPA) system, they represent the highest level of drug innovation.
What is the list of approved drugs called?
The list of approved drugs is commonly referred to as the “approved drugs list” or an official drug registry maintained by a national regulatory authority. In China, it is published and managed by the National Medical Products Administration (NMPA).
