China's Pharma Innovation Ecosystem Continues to Evolve as Zorevunersen Nears Breakthrough Therapy Designation

　　【Pharmaceutical Network Industry DynamicsIn May, another innovative drug is proposed to be included in the breakthrough therapy category. On May 6, the Zorevunersen Injection submitted by IQVIA was proposed by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to be included in the breakthrough therapy category for the treatment of Dravet Syndrome. This news follows the proposal on April 28 to include eight innovative drugs in the breakthrough therapy category, demonstrating the vigorous vitality of China's innovative drug research and development and serving as a vivid epitome of the continuous optimization of China's pharmaceutical innovation ecosystem.
 

Dravet syndrome is a severe developmental and epileptic encephalopathy (DEE). Data shows that Zorevunersen is an investigational antisense oligonucleotide designed to treat the underlying cause of Dravet syndrome by increasing the production of functional NaV1.1 protein in brain cells from the unaffected (wild-type) copy of the SCN1A gene. This highly differentiated mechanism of action aims to reduce seizure frequency beyond what can be achieved with antiepileptic drugs and improve patients' neurodevelopment, cognition, and behavior.
 

In March 2026, the research data on zorevunersen was published in The New England Journal of Medicine (NEJM), including results from two completed Phase I/IIa studies and an ongoing open-label extension (OLE) study, for the first time demonstrating its potential disease-modifying effects in patients with Dravet syndrome. It has been reported that Zorevunersen has shown disease-modifying potential and has been granted orphan drug designation by both the FDA and EMA.
 

In addition to Zorevunersen, on April 28, the Center for Drug Evaluation (CDE) proposed to include eight innovative drugs in the breakthrough therapy category. Among them, Allist Pharmaceuticals' AST24082 capsule (JAB-3312 capsule) is proposed for inclusion in the breakthrough therapy designation, with a proposed indication of using Citrate Golaresec tablets in combination with AST24082 capsules (JAB-3312 capsules) for the first-line treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer carrying the KRAS G12C mutation and PD-L1<50%. Innovent Bio's IBI363 is proposed for inclusion in the breakthrough therapy designation, with a proposed indication of being used in combination with Bevacizumab for the treatment of advanced microsatellite stable or mismatch repair proficient (MSS/pMMR) colorectal cancer that has failed ≥2 prior lines of standard treatment. CSPC's SYS6010 is proposed for inclusion in the breakthrough therapy designation, with a proposed indication of treating unresectable locally advanced or metastatic esophageal squamous cell carcinoma after failure of prior first-line platinum-based chemotherapy and immune checkpoint inhibitor (ICI) treatment. Hansoh Pharma's HS-20093 for injection is also proposed for inclusion in the breakthrough therapy designation, with an indication for use in unresectable locally advanced or metastatic esophageal squamous cell carcinoma after failure of prior first-line platinum-based chemotherapy and immune checkpoint inhibitor (ICI) treatment. Wenda Pharmaceutical's NHWD-870 HCl tablets are proposed for inclusion in the breakthrough therapy designation, with a proposed indication for use in advanced NUT midline carcinoma that has failed prior chemotherapy. Connoymab's CM336 injection is proposed for inclusion in the breakthrough therapy designation, with a proposed indication of... Eli Lilly's Selpercatinib capsules are proposed for inclusion in the breakthrough therapy designation, with a proposed indication of adjuvant treatment after curative local treatment for IB to IIIA stage non-small cell lung cancer (NSCLC) patients who are RET gene fusion-positive. Bristol Myers Squibb's Mezigdomide (CC-92480) capsules are proposed for inclusion in the breakthrough therapy designation, with a proposed indication of being used in combination with Carfilzomib and Dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received Lenalidomide and anti-CD38 monoclonal antibody treatment.
 

Data show that SYS6010, developed by CSPC's Jushi Bio, is an antibody-drug conjugate (ADC) targeting EGFR. It is composed of a humanized anti-EGFR monoclonal antibody linked to a topoisomerase I inhibitor payload via a cleavable linker. The product can specifically bind to EGFR receptors on the surface of tumor cells and, after internalization, release cytotoxic payloads within the cells to exert its anti-tumor effects. Innovent Bio’s IBI363 features a unique differentiated design in its molecular structure; the IL-2 retains affinity for IL-2Rα while reducing the activity of IL-2Rβγ. By activating CD8 T cells in tumor tissues, it works synergistically with PD-1 antibodies to enhance anti-tumor activity while effectively controlling toxic side effects.
 

The emergence of these innovative achievements will not only bring hope to patients but also drive the innovative transformation of China's pharmaceutical industry. With the continuous expansion of breakthrough therapies, an increasing number of high-quality innovative drugs will enter clinical use, meeting the growing health needs of the population. In the future, with policy support, corporate efforts, and capital assistance, China's pharmaceutical innovation ecosystem will continue to improve, potentially giving rise to more innovative drugs.
 

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