Chinese Innovative Drugs Surge Toward FDA Approvals Amid Global Expansion Push

Apr 02, 2026 06:55 CST Updated 06:55

Drug Farm

Innovative Therapies Researcher for Infectious and Immune Diseases

Kexing Biopharm

Developer, Manufacturer, and Marketer of Recombinant Protein Drugs and Microecological Preparations

InventisBio

Innovative Drug Developer

Since 2026, the enthusiasm for Chinese-produced innovative drugs to pass through the FDA has continued to rise. It is reported that in late March, a large number of pharmaceutical companies such as Drug Farm, Kexing Biopharm, and Yooking Pharmaceutical announced that their products had received U.S. FDA clinical or marketing approval, covering cutting-edge circular RNA technology, high-end complex formulations, innovative small molecules, and other fields.

Recently, Drug Farm announced that the U.S. FDA has granted Orphan Drug Designation to its ALPK1-targeted inhibitor DF-003 for the treatment of patients with ROSAH syndrome.

Public data shows that ROSAH syndrome is a rare autosomal dominant hereditary autoinflammatory disease caused by activating mutations in the ALPK1 gene. The name of the disease is derived from its main clinical features: retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and headache. DF-003, a First-in-class original innovative drug developed by Drug Farm, can potently and selectively inhibit ALPK1 as well as the activity of ALPK1 mutants that cause ROSAH syndrome.

News on March 30, Kexing Biopharm announced that its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., received a notification from the U.S. FDA,The clinical trial application for GB19 Injection, an innovative drug independently developed by Shenzhen Kexing Biopharm, has been approved by the FDA, allowing clinical trials to be conducted in the United States for the treatment of Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE).

On March 24, Yikang Pharmaceuticals announced that its wholly-owned subsidiary, Yikang Sci-Tech Innovation, had recently received approval from the U.S. FDA.Approval has been granted for the clinical trial (IND No.: 180432) of YKYY018 inhalation solution for the treatment and prevention of human metapneumovirus infection. This product is a membrane fusion inhibitor independently developed by the company using its AI platform. It was previously approved for clinical trials related to respiratory syncytial virus. Preclinical studies have shown that it has significant inhibitory effects on both human metapneumovirus and respiratory syncytial virus, with good safety.

On March 18, INNORNA announced that the U.S. FDA had approved the Investigational New Drug (IND) application for its mRNA candidate drug, IN026.IN026 is an investigational mRNA therapy for refractory gout. Following the IND approval, the company will systematically evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IN026 in this patient population with unmet treatment needs during the Phase 1 clinical trial.

On the same day, InventisBio announced that the company's application for a Phase II clinical trial to the U.S. FDA regarding D-2570 monotherapy for psoriasis has been approved.D-2570 is a novel oral selective inhibitor independently developed by the company, targeting tyrosine kinase 2 (TYK2), aimed at treating autoimmune diseases such as psoriasis. Previously, the company completed a Phase II clinical trial of D-2570 for psoriasis conducted in China. The results showed that the drug demonstrated significant efficacy in clearing skin lesions and improving disease severity, with overall good safety and tolerability.

Overall, the current approval of Chinese-produced drugs by the U.S. FDA has shown a dual-driven pattern of "frontier technology breakthroughs + high-end formulations going global." This confirms that China's pharmaceutical industry is accelerating its transformation from "generic exports" to "innovation-led" and from "product output" to "technology platform output." The industry expects that as more domestically innovated drugs enter the FDA review process, 2026 could become a "bumper year" for Chinese innovative drugs to hit the global market.

Reference: PharmaNet

↓⭐Follow PharmNews to gain insights into industry trends ↓
Submission/Corporate Cooperation/Content Communication:
Editor-in-Chief of PharmaTong Society—Huá Jí Měirén (Ww_150525)
*Please indicate remarks and intentions when adding.