InnoCare’s Next-Generation TRK Inhibitor Zurletrectinib Granted Priority Review by China’s NMPA for NTRK Fusion-Positive Tumors
A prominent biopharmaceutical company dedicated to the development of innovative therapies for cancer and autoimmune diseases, announced a major regulatory milestone today. The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted priority review designation to the company’s next-generation pan-TRK inhibitor, zurletrectinib (also known by its investigational code ICP-723). The priority review status follows the recent acceptance of the company’s New Drug Application (NDA) for zurletrectinib, targeting the treatment of patients with advanced solid tumors harboring NTRK gene fusions.
This development marks a significant step forward in InnoCare’s mission to bring targeted cancer therapies to patients with high unmet medical needs. By obtaining priority review, zurletrectinib is now positioned to undergo an expedited evaluation process by the Chinese regulatory authorities, significantly shortening the timeline for potential market approval.
What Priority Review Means for Patients and Drug Development in China
Priority review is a regulatory mechanism established by China’s CDE to accelerate the approval process for drugs that offer substantial clinical value. Such drugs are typically designated for conditions with no or few effective treatment options, or for those that demonstrate clear advantages over existing therapies in terms of efficacy, safety, or patient outcomes. For a drug like zurletrectinib, which targets a rare and genomically defined subset of cancers, the designation not only underscores its therapeutic promise but also reflects the growing recognition of precision oncology within China’s healthcare system.
“Receiving priority review status is a key validation of our science and the potential clinical impact of zurletrectinib,” said Dr. Jasmine Cui, co-founder, chairwoman, and CEO of InnoCare. “We are delighted by this decision from the NMPA and are optimistic that zurletrectinib will soon become a valuable treatment option for patients suffering from NTRK fusion-positive solid tumors. The drug’s performance in clinical trials has been impressive, and we are committed to bringing it to patients as swiftly and safely as possible.”
Understanding TRK Fusion and Its Role in Cancer
NTRK gene fusions are rare genetic alterations that occur when one of the three neurotrophic tyrosine receptor kinase (NTRK1, NTRK2, or NTRK3) genes fuses with an unrelated gene. This fusion leads to the formation of a chimeric TRK fusion protein with constitutive kinase activity, which drives cancer cell proliferation and survival. These fusions can occur in a wide array of adult and pediatric cancers, making TRK inhibitors a unique example of tumor-agnostic therapy.
Although the overall incidence of NTRK fusion across all cancers is relatively low—estimated at less than 1%—the fusion can be highly prevalent in certain rare tumor types. For instance, more than 90% of patients with secretory breast carcinoma, infantile fibrosarcoma, and salivary gland secretory carcinoma harbor NTRK gene fusions. In China, it is estimated that approximately 6,500 new cases of NTRK fusion-positive solid tumors are diagnosed each year. Given the scarcity of effective targeted treatments for these patients, a novel, highly selective TRK inhibitor like zurletrectinib could meet a crucial medical need.
Zurletrectinib: A New-Generation TRK Inhibitor with Improved Resistance Profile
Zurletrectinib (ICP-723) represents a new generation of pan-TRK inhibitors designed to overcome limitations of first-generation agents. While initial TRK inhibitors such as larotrectinib and entrectinib have shown strong efficacy, many patients develop resistance through acquired mutations in the kinase domain of the TRK proteins. These resistance mutations can render first-generation therapies ineffective.
Zurletrectinib has been engineered to maintain high potency against both wild-type TRK proteins and those with resistance mutations. It has also demonstrated strong intracranial activity, an important feature given that brain metastases are common in many cancers and a major site of progression on earlier TRK inhibitors.
A paper published in the British Journal of Cancer, a journal within the Nature Publishing Group, highlighted zurletrectinib’s preclinical and early clinical performance. The study, titled “Zurletrectinib is a next-generation TRK inhibitor with strong intracranial activity against NTRK fusion-positive tumors with on-target resistance to first-generation agents,” provided detailed data on the compound’s ability to overcome common resistance mutations, including solvent-front and xDFG mutations.
The registrational clinical trial conducted in China evaluated zurletrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumors. The study demonstrated robust efficacy across tumor types, with durable responses and a manageable safety profile. Although detailed results have not yet been publicly disclosed, early data suggest that the drug may significantly improve outcomes for patients who have progressed on or are ineligible for existing therapies.
Growing Interest in Tumor-Agnostic Approvals and Precision Oncology in China
The priority review of zurletrectinib by China’s NMPA is part of a broader trend toward embracing precision oncology and tumor-agnostic treatment strategies. In recent years, regulatory authorities in China have taken important steps to support innovative therapies, including the introduction of fast-track pathways, conditional approvals, and the incorporation of genomic biomarkers into treatment guidelines.
Drugs targeting NTRK gene fusions were among the first to receive tumor-agnostic approvals globally. The FDA and EMA have both approved larotrectinib and entrectinib for tumors harboring NTRK fusions, regardless of the cancer’s tissue of origin. China has been relatively cautious in this area, but the priority review of zurletrectinib suggests a growing openness to such approaches, especially when supported by strong clinical evidence and biomarker-driven trial designs.
InnoCare’s Broader Pipeline and Strategic Vision
Founded in 2015, InnoCare Pharma has quickly risen to prominence within China’s biotech ecosystem. With a robust pipeline that includes therapies for hematologic malignancies, solid tumors, and autoimmune diseases, the company is focused on addressing areas of high unmet medical need through innovative drug discovery and development.
In addition to zurletrectinib, InnoCare’s portfolio includes orelabrutinib, a BTK inhibitor approved in China for the treatment of B-cell malignancies; ICP-488, a TYK2 inhibitor under development for autoimmune conditions; and other investigational agents targeting key oncogenic pathways.
By advancing zurletrectinib, InnoCare continues to demonstrate its commitment to pushing the boundaries of precision medicine and bringing transformative therapies to patients in China and beyond. The company is also exploring potential global expansion and out-licensing opportunities for key assets, positioning itself as a serious contender on the international biopharma stage.
The priority review designation for zurletrectinib marks an important regulatory milestone for InnoCare and offers renewed hope for patients living with NTRK fusion-positive cancers. If approved, zurletrectinib would become one of the first next-generation TRK inhibitors available in China, and potentially one of the first globally to demonstrate broad efficacy against resistance mutations in a real-world population.
With the review process now officially underway, InnoCare is preparing for potential commercial launch and expanding its efforts to increase awareness and access to TRK fusion testing across China. The company is also collaborating with leading hospitals and diagnostic laboratories to ensure that eligible patients can be rapidly identified and enrolled in future studies or treatment programs.
As precision oncology continues to evolve, drugs like zurletrectinib offer a glimpse into the future of cancer treatment—one where therapies are tailored not to the location of a tumor, but to its unique genetic drivers. For InnoCare and the patients it serves, that future may be closer than ever.
