China's Pharmaceutical Innovation Thrives as New Drugs Gain Breakthrough Therapy Designations

　　【Pharmaceutical Network Industry DynamicsIn recent years, domestic policy resources have been clearly tilting towards "source innovation," encouraging companies to shift from "rapid followers" to tackling more cutting-edge targets and mechanisms. Against this backdrop, an increasing number of drugs with "global new" potential have begun to receive breakthrough therapy designations.
 

On January 5, 2026, Kelun Pharmaceutical announced that the antibody-drug conjugate (ADC) Luskansa Monoclonal Antibody targeting human trophoblast cell surface antigen 2 (TROP2), developed by its holding subsidiary Sichuan Kelun Biotech, in combination with Merck's anti-programmed cell death protein 1 (PD-1) monoclonal antibody Pembrolizumab for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%, epidermal growth factor receptor (EGFR) gene mutation-negative, and anaplastic lymphoma kinase (ALK)-negative, has recently received Breakthrough Therapy Designation.
 

To date, Lucantisumab has received five breakthrough therapy designations, with three indications approved for marketing in China, and the first two have been included in the medical insurance.
 

On January 4, 2026, the CDE announced that DR10624 Injection, a Class 1 new drug submitted by Daor Biologics, a holding subsidiary of Huadong Medicine, is proposed to be included in the breakthrough therapy designation for the treatment of severe hypertriglyceridemia.
 

DR10624 is a globally first-in-class tri-target long-acting agonist targeting FGF21R, GCGR, and GLP-1R developed by Daor Biotech based on its proprietary MultipleBody platform technology. By simultaneously modulating the signaling pathways mediated by these three receptors, it exerts a synergistic effect to achieve the reduction of blood glucose, weight loss, and lipid-lowering effects. Clinical results show that DR10624 has demonstrated significant comprehensive metabolic improvement efficacy in patients with SHTG.
 

On January 2, 2026, Hengrui Pharma announced that its self-developed antibody-drug conjugate (ADC) targeting Claudin18.2 (CLDN18.2) — SHR-A1904 for injection — has been officially included in the list of breakthrough therapies by the Center for Drug Evaluation of the National Medical Products Administration. The drug is intended for the treatment of patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who are CLDN18.2-positive and have received at least one prior line of systemic therapy. The inclusion in the breakthrough therapy program is based on the drug’s potential clinical value for specific indications.
 

According to reports, in 2025, the Center for Drug Evaluation under the National Medical Products Administration will include over 40 China-produced new drugs in the "Breakthrough Therapy Drugs" list. The vast majority (approximately 80%) of these drugs are concentrated in the field of cancer treatment, involving cutting-edge targets such as HER2, EGFR, and KRAS G12C. Among them, leading companies with strong R&D capabilities like CHIATAI TIANQING, Hansoh Pharma, and Innovent Biologics have been granted more breakthrough therapy designations. Only in the first half of the year, CHIATAI TIANQING had five products included; followed by Hansoh and Innovent, each with four; and Limin, Hengrui Pharma, and Cenovus each with three.
 

The industry believes that the designation of breakthrough therapies has become one of the core engines driving China's pharmaceutical industry from "manufacturing" to "creation" and from "local" to "global." Looking ahead, as policies continue to deepen, it is expected that more drugs with "global new" potential will receive breakthrough therapy designation. However, it should be noted that challenges will also arise, such as popular targets potentially still attracting overcrowded research and development, and the commercial insurance payment system needing improvement.
 

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