Chinese Innovative Drugs Secure Dual FDA and NMPA Approvals: Yuesai Bio, Tianda Qing, Huadong Medicine Among Recent Success Stories

　　【Pharmaceutical Network Industry DynamicsRecently, it was reported that the refractory epilepsy iPSC-derived allogeneic cell therapy independently developed by Shanghai Yuesai Biotechnology has successively received clinical trial approvals from the U.S. Food and Drug Administration (FDA) and China's National Medical Products Administration Center for Drug Evaluation (CDE) within a month.
 

It is reported that Yuese Biotech has been deeply engaged in the iPSC field for many years. Its self-developed UX-GIP001 injection can achieve neural circuit repair and functional reconstruction by directing the differentiation of iPSCs into inhibitory neural progenitor cells with specific functional characteristics, breaking through the limitations of traditional symptomatic treatments. After receiving approval from the CDE on April 8, the first patient will be enrolled soon, with Phase I registration clinical trials expected to be completed next year before moving into Phase II.
 

Notably, recently, domestically produced innovative drugs have been intensively obtaining dual approvals from both China and the U.S. (FDA and NMPA/CDE clinical trial permits). For instance, on April 4, TQB3205, the "Pan-KRAS inhibitor" independently developed by CHIATAI TIANQING, received the Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for advanced malignant tumors.
 

TQB3205 Capsule is an oral Pan-KRAS inhibitor that achieves high-affinity binding with various KRAS mutant proteins, locking the KRAS protein in an inactive state. This blocks downstream signaling pathways (such as the MAPK pathway and the PI3K-AKT pathway), effectively inhibiting the proliferation of multiple KRAS mutant tumor cells, and precisely exerting anti-tumor effects at the target level. On March 12 this year, the drug received clinical trial approval by default from the National Medical Products Administration (NMPA) and is intended for the treatment of advanced malignant tumors.
 

On March 26, Huadong Medicine Co., Ltd. announced that its wholly-owned subsidiary, Huadong Medicine Co., Ltd., had received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration. The clinical trial application for HDM2024 Injection, a Class 1 therapeutic biological product, was approved, with the indication being advanced solid tumors.
 

Injectable HDM2024 is a novel Class 1 biologic developed by Huadong Medicine with global intellectual property rights. It is also a new bispecific antibody-drug conjugate targeting the epidermal growth factor receptor and human epidermal receptor. Preclinical studies have shown that it exhibits excellent anti-tumor activity, drug-like properties, and safety. In February 2026, Huadong Medicine completed the submission of the clinical trial application for injectable HDM2024 to the U.S. FDA, and on March 10, the drug received approval for Phase I clinical trials in the United States.
 

In March, the IND application for Leman Biotech's metabolic-enhanced CD19 CAR-T injection META 10-19 targeting relapsed or refractory CD19-positive B-cell hematological tumors was successfully approved by the U.S. FDA. Leman Biotech is a clinical-stage immunometabolism innovation drug research and development company. Based on innovative technologies of immunometabolic reprogramming combined with cutting-edge artificial intelligence (AI), the company focuses on developing metabolic-enhanced cancer immunotherapy drugs.
 

META 10-19 is one of its products with faster development progress. Previously, the drug has successfully completed the first dosing of a systemic lupus erythematosus subject at the First Affiliated Hospital of Zhejiang University School of Medicine. In addition, the IIT clinical study of this therapy has also successfully included pediatric patients.
 

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The industry believes that the dense landing of China-produced innovative drugs in both China and the US in 2026 is the result of the combined effects of technology, policy, market, and capital. In the future, this will accelerate the promotion of China's pharmaceutical industry to complete a major leap from "catching up" to "leading".
 

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