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China Accelerates Innovation: 11 Novel Drugs Approved in 2026

Mar 30, 2026 10:36 CST Updated 10:36
GSK

Pharmaceutical R&D Manufacturer

  【Pharmaceutical Network Industry DynamicsAccording to a March 27 announcement by the National Medical Products Administration (NMPA), the NMPA has approved the listing of GlaxoSmithKline's (GSK) Demogokimab Injection (brand name: Easly), which is indicated for the maintenance treatment of severe eosinophilic asthma in adults and adolescents aged 12 years and above.
 
The newly approved Dermoquimab is a biologic targeting the specific subtype of severe eosinophilic asthma. This disease is characterized by eosinophil infiltration in the airways, and patients often face issues such as recurrent acute exacerbations and progressive decline in lung function, with clinical treatment needs remaining largely unmet over the long term.
 
Data shows that Dermoqimab, a new generation anti-Interleukin-5 (IL-5) monoclonal antibody developed by GSK, has a longer half-life, high binding affinity, and high potency, requiring only once every six months of injection. By targeting and regulating the eosinophil-related inflammatory pathway, it can effectively control airway inflammation and reduce the risk of acute exacerbations, providing a new precise treatment option for clinical practice. Previously, the first-generation IL-5 monoclonal antibody Mepolizumab (brand name: Nucala), also developed by GSK, was approved for marketing in the United States in November 2015 as a once-a-month formulation.
 
Currently, multiple biologics targeting the eosinophilic phenotype of asthma have been launched in China, including drugs targeting anti-IL-5/IL-5R, anti-IL-4/IL-13, etc. The addition of Demokizumab will further enrich clinical treatment options.
 
In recent years, with the support of favorable national policies, China's innovative drugs have been emerging one after another. According to statistics, since 2026, 11 innovative drugs have been approved for marketing.
 
In addition to the above products, the Epoetin Alfa Injection (brand name: Xinbiao) applied for by Guangdong Sunsheng Pharmaceutical Co., Ltd. was approved for marketing on March 19. This product is used to treat anemia caused by chronic kidney disease in hemodialysis patients who are receiving erythropoietin therapy.
 
Anemia is a common complication of chronic kidney disease (CKD). Since endogenous erythropoietin (EPO) is primarily produced in the kidneys, the progressive destruction of kidney tissue during the development of chronic renal failure leads to insufficient secretion of endogenous EPO, thereby causing renal anemia. The incidence of anemia increases gradually with the decline of kidney function. When patients with chronic kidney disease progress to stage 5, also known as end-stage renal disease (ESRD), the prevalence of anemia reaches 98.2%. Data shows that Rosetropoetin α is a highly glycosylated, long-acting recombinant protein product that retains its original biological activity while offering greater stability and a longer half-life, reducing the frequency of administration and enhancing clinical convenience.
 
In addition, the Class 1 innovative drug Sotorasib Mesylate Tablets (brand name: Jilemei), applied for by Zhejiang Hangyu Pharmaceutical Co., Ltd., was approved for marketing this year. It is suitable for adult patients with advanced non-small cell lung cancer (NSCLC) harboring the mouse sarcoma virus oncogene (KRAS) G12C mutation who have received at least one systemic treatment.
 
Zhengda Tianqing Pharmaceutical Group Co., Ltd.'s Class 1 innovative drug Rovacitinib Tablets (brand name: Anxu) has been approved for marketing. This medicine is indicated for the first-line treatment of adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF), addressing disease-related splenomegaly or disease-related symptoms.
 
The application for Anmuchitumab Injection (brand name: Yisaituo) submitted by 3SBio Inc. (Shanghai) has also been approved for marketing in China. It is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
 
Xianweida Bio-Tech (Hangzhou) Co., Ltd.'s Enoxaglutide Injection (Brand Name: Xianyida) has been approved for marketing in China, indicated for glycemic control in adult patients with type 2 diabetes.
 
Huahui Anjian (Beijing) Biotechnology Co., Ltd.'s application for the listing of Libevirtamab Injection (trade name: Huayounuo) has been approved for marketing. It is used to treat adult patients with chronic hepatitis D virus (HDV) infection, with or without compensated cirrhosis.
 
Yichang Dongyangguang Changjiang Pharmaceutical Co., Ltd.'s申报的1类创新药奥洛格列净胶囊 (商品名:东泽安) has been approved for上市,适用于改善成人2型糖尿病患者的血糖控制。
 
Suzhou Shengdiya Biopharmaceutical Co., Ltd.'s Relatlimab Alpha Injection (trade name: Aizeli) has been approved for marketing. This product, in combination with fluorouracil and platinum-based drugs, is used for the first-line treatment of locally advanced unresectable, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma that is PD-L1 positive (CPS≥1) as assessed by a fully validated test.
 
Arrowhead Pharmaceuticals, Inc.'s Class 1 innovative drug, Roledip (generic name: volanesorsen sodium injection), has been approved for marketing in China. On the basis of dietary control, this drug is used to reduce triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS).
 
BeiGene (Suzhou) Biotechnology Co., Ltd. has announced the market launch of its Class 1 innovative drug, Zotoclax Tablets (brand name: Baiyue Da). The drug is indicated for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously undergone at least one systemic treatment regimen including a Bruton's tyrosine kinase (BTK) inhibitor, as well as for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior systemic therapies (including a Bruton's tyrosine kinase [BTK] inhibitor).
 
The密集 approval of these innovative drugs is inseparable from the strong support of favorable national policies. In recent years, a series of policy measures, ranging from R&D innovation support, industrialization landing assistance, to medical insurance system support and clinical application promotion, have provided robust protection for the pharmaceutical industry’s development. This has accelerated the speed of innovative drug R&D and improved listing efficiency. The implementation of innovative drugs ultimately benefits a large number of patients. In the future, with continued policy support and the continuous enhancement of corporate innovation capabilities, it is believed that more innovative drugs will enter clinical use, bringing health hopes to countless patients.
 
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