Chinese Innovative Drug Developers See Breakthrough Therapy Designations Surge in May: Hansoh, Innovent Among Recipients

　　【Pharmaceutical Network Industry DynamicsSince 2026, China's innovative drugs have made significant progress in Breakthrough Therapy Designation (BTD). Public information in May showed that several companies, including Hansoh Pharma and Innovent Bio, have successively received new designations.
 

On May 11, Innovent Bio announced that IBI363, the world’s first PD-1/IL-2α-bias bispecific fusion protein, was granted the third Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The drug will be used in combination with bevacizumab for patients with advanced microsatellite-stable or mismatch repair-proficient (MSS/pMMR) colorectal cancer who have failed ≥2 prior lines of standard treatment. The Phase III clinical trial for this indication is planned to start soon in China.
 

NHWD-870 HCI Receives Breakthrough Therapy Designation
 

On May 9, HS-20093, a B7-H3-targeted antibody-drug conjugate self-developed by Hansoh Pharma, was approved by the National Medical Products Administration (NMPA) and designated as a breakthrough therapy drug. The indication is for unresectable locally advanced or metastatic esophageal squamous cell carcinoma that has failed prior first-line treatment with platinum-based chemotherapy and immune checkpoint inhibitors.
 

This product is one of the company's key innovative pipelines in the oncology field. It is designed based on the clinical characteristic of high B7-H3 expression in esophageal squamous cell carcinoma, offering a differentiated competitive advantage. Its inclusion in the breakthrough therapy designation will further strengthen the company’s R&D capabilities in the field of anti-tumor biologics and enrich its product pipeline.
 

On May 8, NHWD-870 HCI, a novel oral BET inhibitor independently developed by Ningbo Wenda Pharma, officially received the Breakthrough Therapy Designation from the National Medical Products Administration (NMPA), with the proposed indication for advanced NUT midline carcinoma that has failed prior chemotherapy.
 

Ningbo Wenda Pharma is committed to the research and development of cutting-edge, innovative, and high-quality novel drugs, with a strategic focus on the fields of oncology, immunology, and neurodegenerative diseases. The recent designation of NHWD-870 HCI as a breakthrough therapy is primarily based on the significant efficacy and survival benefits demonstrated in its Phase II clinical study.
 

On May 6, the CDE website showed that the Zorevunersen Injection submitted by IQVIA Pharmaceuticals was proposed to be included in the breakthrough therapy category for the treatment of Dravet Syndrome.
 

Previously, Zorevunersen had received orphan drug designation from both the FDA and EMA. Additionally, the FDA granted the drug Rare Pediatric Disease Designation and Breakthrough Therapy Designation for the treatment of Dravet syndrome associated with confirmed non-functional or loss-of-function mutations in the SCN1A gene.
 

Overall, from Hansoh Pharma's B7-H3 ADC to Innovent Bio's PD-1/IL-2 dual-mechanism fusion protein, it is evident that China's pharmaceutical innovation is transitioning from "rapid following" to a new stage of "differentiated competition" with greater originality and clinical value. At the same time, drugs granted Breakthrough Therapy designation in China are showing trends of increasingly differentiated targets, expanding from "popular target following" into broader disease areas, as well as leading companies achieving "multiple designations."
 

　　Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.