On December 11, 2025 Innovent Biologics (SSE: 688428; HKSE: 09969), a high-tech biopharmaceutical company, reported that its independently developed next-generation TRK inhibitor, Enoxin ( zolectretinib, ICP-723), has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult and adolescent patients aged 12 years and older with solid tumors harboring NTRK fusion genes. This marks the approval of China’s first independently developed next-generation TRK inhibitor for market launch.
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In a pivotal registrational clinical trial for patients with NTRK fusion-positive solid tumors, zoletrazinib demonstrated excellent efficacy and safety as a broad-spectrum anticancer drug regardless of tumor type. Registry results showed an overall response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, a 24-month progression-free survival (PFS) rate of 77.4%, and a 24-month overall survival (OS) rate of 90.8%.
As a new generation TRK inhibitor independently developed in China, zoletrazinib is more effective than first-generation TRK inhibitors. It not only provides long-term deep remission but also exhibits strong penetrating brain activity and good overall safety. Furthermore, data shows that it can overcome resistance to first-generation TRK inhibitors. The once-daily oral administration of two tablets also offers great convenience to patients.
Professor Zhang Yizhuo of Sun Yat-sen University Cancer Center stated, "NTRK fusion-positive tumors often progress rapidly and have limited treatment options. Zoletratinib has demonstrated remarkable efficacy, especially in adolescent patients where the overall response rate (ORR) reached 100% . Clinically, zolectratinib’s onset of action is significantly faster than traditional chemotherapy, with many patients observing significant tumor shrinkage within one to two cycles, providing a valuable treatment window for critically ill patients. Furthermore, the duration of zolectratinib’s effective response is long; the longest response we have observed clinically has exceeded 36 months, offering hope for longer survival to patients with solid tumors."
Professor Luo Zhiguo of Fudan University Cancer Hospital stated, "Most of the patients enrolled in our center are sarcoma patients. Zoletratinib achieved an overall response rate (ORR) of 89.5% in patients with soft tissue sarcoma , demonstrating excellent efficacy. Furthermore, its high selectivity significantly reduces off-target toxicity and exhibits good safety, allowing patients to use the medication long-term without affecting their quality of life. For patients with solid tumors requiring long-term treatment, the efficacy and safety advantages of zoletratinib can help them live longer and better."
Professor Wang Qiming of Henan Cancer Hospital emphasized, "Zoletratinib also demonstrates excellent efficacy in NTRK fusion-positive lung cancer patients, with an overall response rate (ORR) of 88.9%, bringing more hope to lung cancer patients. Simultaneously, zolectratinib exhibits remarkable brain-penetrating activity, achieving a 100% intracranial objective response rate (IC-ORR) and a 100% 12-month intracranial sustained response rate (IC-DOR), achieving strong control of brain lesions. From a molecular mechanism perspective, zolectratinib’s unique structure enables it to penetrate the blood-brain barrier and maintain effective therapeutic concentrations in cerebrospinal fluid, providing a new treatment option for patients with brain metastases."
Professor Chen Libo of Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University stated, " The overall response rate (ORR) for thyroid cancer patients enrolled with zoletrinib was 100% . Patients enrolled in our center have maintained continuous remission for two years, demonstrating the superior efficacy of zoletrinib compared to first-generation TRK inhibitors. Furthermore, as a new generation TRK inhibitor, zoletrinib offers new hope for resistant patients. With its excellent efficacy and good tolerability, zoletrinib can provide long-term, sustained, deep remission for patients with NTRK fusion-positive solid tumors."
Dr. Cui Jisong, co-founder, chairman, and CEO of InnoCare Pharma, said, "Zoletratinib is InnoCare Pharma’s third approved innovative drug and our first approved innovative drug in the field of solid tumors. As a broad-spectrum anticancer drug that is not limited to any type of tumor, zoletratinib has significant clinical implications for patients with NTRK fusion-positive solid tumors. We would like to express our special thanks to the doctors, patients, partners, and employees who participated in this clinical trial for their support, and also to the regulatory agencies for their professional and efficient approval process, which allows more patients with solid tumors to receive better treatment earlier. We believe that zoletratinib, as the first independently developed and approved TRK inhibitor in China, will bring new hope to patients with solid tumors in China."
Zolectretinib has been included in the "Pilot Program for Encouraging the Development of Pediatric Anti-tumor Drugs (Starlight Program)" by the China National Medical Products Administration. Innovent Biologics expects to submit an NDA application for zolectretinib for the treatment of pediatric patients (aged 2 to 12) soon.
NTRK fusion genes are present in various types of tumors and have been found in more than 26 types of solid tumors [1] . It is estimated that there are 6,500 new cases of tumors carrying NTRK fusion genes in China each year. These patients have short survival, rapid disease progression and high disability rate. However, due to the low popularity of the current gold standard detection method – next-generation sequencing (NGS), diagnosis is delayed, so there is still an unmet clinical need. The emergence of the broad-spectrum anticancer drug zoletrinib has brought new treatment options to patients.
(Press release, InnoCare Pharma, DEC 11, 2025, View Source [SID1234663149]).