Eratrectinib, the next-generation TRK inhibitor independently developed by Vcare PharmaTech, has received marketing approval

　　NTRK gene fusions have been identified as oncogenic drivers in adult and pediatric patients with pan-solid tumors. A fusion gene is typically formed by the combination of an NTRK gene containing a kinase domain and its fusion partner gene. To date, more than 229 fusion partner genes have been discovered, giving rise to 358 unique fusion-tumor pairings. Patients harboring such fusions generally have a poor prognosis. For advanced solid tumor patients who do not receive targeted therapy, the median overall survival ranges from 10.2 to 12.7 months, and these patients are also at a higher risk of brain metastasis. Meanwhile, the loss of the extracellular domain in NTRK fusions renders antibody-based therapies ineffective. Currently, treatment primarily relies on small-molecule TRK inhibitors that target the kinase domain.^1-3

　　In terms of tumor type distribution, NTRK fusions are characterized by rare mutations with broad tumor spectrum distribution. On one hand, the incidence of NTRK fusions reaches up to 90% in rare malignancies such as secretory breast carcinoma and infantile fibrosarcoma, and ranges from 5% to 25% in papillary thyroid carcinoma and Spitzoid melanoma. On the other hand, real-world data from approximately 295,000 solid tumor patients worldwide indicate that NTRK fusion-positive cases account for a larger absolute number of patients among common cancer types. Collectively, NTRK fusion-positive patients with non-small cell lung cancer, breast cancer, soft tissue sarcoma and colorectal cancer make up nearly 50% of all affected cases, representing the key population requiring close clinical attention. In addition, the prevalence of NTRK fusions is higher in East Asian populations, with an overall incidence of approximately 0.4% among Chinese patients. It is estimated that more than 15,000 new cases of NTRK fusion-positive solid tumors are diagnosed in China each year.^4-5

　　Nat Rev Clin Oncol. 2018 Dec;15(12):731-747.

　　Breaking News: Domestic Next-Generation Tumor-Agnostic Targeted Drug Eratrectinib Approved

　　On June 4, the official website of the NMPA announced that Vcare PharmaTech’s Class 1 new drug, Eratrectinib (VELMARTO^®), has been approved for marketing in China. It is indicated for adult and adolescent patients with advanced solid tumors harboring NTRK gene fusions.

　　Efficacy Breakthrough: Eratrectinib Delivers Comprehensive Clinical Benefits

　　Eratrectinib (VELMARTO^®) is a next-generation TRK inhibitor independently developed by Jiangsu Vcare PharmaTech Co.,Ltd.. In pivotal registration clinical trials for patients with NTRK fusion-positive solid tumors, this pan-tumor anticancer agent has demonstrated outstanding efficacy and safety.

　　Registration study results showed an ORR of 68.5% and a DCR of 85.2%. Among patients followed up for more than 6 months, the ORR reached 89.7% and the DCR was 100%, with a mOS of 40.7 months.⁶

　　In terms of long-term clinical benefits, Eratrectinib also achieved impressive results in PFS and DOR. The 2-year PFS rate stood at 75.7% and the 2-year DOR rate hit 85.5%, fully proving that the drug can deliver sustained disease control and long-term remission for patients.

　　Furthermore, for patients with baseline brain metastases, the ORR was as high as 87.5%. For patients previously treated with TRK-TKIs, the ORR reached 47.4%, reflecting robust therapeutic efficacy across these patient groups.

　　New Hope for Patients with NTRK Fusion Resistance

　　As a next-generation TRK inhibitor independently developed in China, Eratrectinib delivers durable and deep tumor remission, with potent brain penetration and a favorable overall safety profile. Different from the linear structure of first-generation TRK inhibitors, Eratrectinib features a cyclic molecular structure. Structural optimization reduces off-target risks and effectively prevents the emergence of drug-resistant mutations, endowing the agent with the anti-resistance mechanisms characteristic of second-generation TRK inhibitors.

　　About Vcare PharmaTech

　　Jiangsu Vcare PharmaTech Co., Ltd. (Vcare PharmaTech) was co-founded in 2010 by professors from China Pharmaceutical University and overseas returnee experts. As a commercial-stage innovative biopharmaceutical enterprise empowered by AI for differentiated de novo drug design, the Company is dedicated to the development of novel medicines and cutting-edge therapeutics, and has been accredited as a National Key Specialized, Refined, Differential and Innovative "Little Giant" Enterprise.

　　Headquartered in the Biotech and Pharmaceutical Valleyof Nanjing Jiangbei New Area, Vcare PharmaTech owns an intelligent R&D headquarters spanning 21,000 square meters. It has built a full-chain innovation system covering independent new drug R&D and industrialization, ranging from AI-powered differentiated target initiation at the early discovery stage, preclinical candidate identification, integrated collaborative pharmaceutical development to green manufacturing. Boasting a robust talent pipeline, the Company employs over 900 staff members, among whom technical professionals account for more than 84%, including over 200 master’s and doctoral degree holders. Such a highly educated, specialized and innovation-driven core R&D workforce underpins the Company’s sustained technological breakthroughs and product upgrading.

　　Having engaged in pharmaceutical innovation for 16 years, Vcare PharmaTech adheres to the core strategy of indigenous R&D and innovation, targeting unmet clinical needs via differentiated therapeutic approaches. Centered on addressing treatment resistance, overcoming drug resistance and improving target selectivity, the Company has established a high-quality, diversified and tiered innovative drug pipeline covering major chronic illnesses including cardiovascular and cerebrovascular diseases, inflammatory autoimmune disorders and oncology, with its novel pharmaceutical discoveries positioned for global commercialization.

　　The Company’s core pipeline candidates feature prominent competitive edges and promising commercial prospects. Eratrectinib (VC004), a next-generation TRK inhibitor and small-molecule targeted anti-tumor agent indicated for solid tumors driven by NTRK gene fusions, delivers tumor-agnostic therapeutic benefits across a broad spectrum of indications and has obtained marketing approval in China. Sumecigrel Capsule, a novel oral P2Y12 receptor antagonist selected four times for China’s National Major Science and Technology Projects, precisely inhibits platelet activation and aggregation to block thrombosis for the prevention and treatment of cardiovascular, cerebrovascular and arterial circulatory disorders; its pivotal confirmatory clinical trials are well underway domestically. VC005, a new-generation highly selective JAK1 inhibitor, is being developed via both oral and topical formulations for full-population treatment of atopic dermatitis with all indications in Phase III clinical trials. The asset is also under clinical development for ankylosing spondylitis, vitiligo, alopecia areata and other autoimmune diseases, with robust efficacy and safety data accelerating its clinical progression.

　　Backed by years of technological accumulation, the Company strives to integrate AI capabilities across the entire value chain from early R&D to manufacturing, establishing an AI-enabled premium innovative drug development system and specialized technical platforms. Its R&D platforms have been officially accredited as Nanjing Key Laboratory for AI-Assisted Drug Design and Nanjing Engineering Research Center for Synthetic Biology & Flow Chemistry; its AI-directed site-specific enzyme mutation technology has been recognized as Advanced Cleaner Production Technology by Nanjing authorities. Over the past five years, the Company has secured aggregate financing exceeding RMB 1.2 billion, earning strong recognition from the capital market.

　　Moving forward, abiding by its founding mission of "The better Care, The better Medicines", Vcare PharmaTech will keep advancing AI-driven original innovation and cutting-edge pharmaceutical technologies while expanding its footprint across domestic and overseas markets. Leveraging robust R&D strengths to build a differentiated novel drug portfolio, the company commits to delivering superior therapeutic options for patients worldwide and evolving into a globally influential innovative pharmaceutical enterprise.

References:

1.Nguyen MA, et al. Pathology. 2023 Aug;55(5):596-609.

2.Jiang T, et al. Acta Pharm Sin B. 2021 Feb;11(2):355-372.

3.Cocco E, et al. Nat Rev Clin Oncol. 2018 Dec;15(12):731-747.

4.O'Haire S, et al. Sci Rep. 2023 Mar 13;13(1):4116.

5.Qi C, et al. Int J Cancer. 2023 Dec 1;153(11):1916-1927.

6.Vcare Pharma. Phase II Clinical Study Data of Eratrectinib[R]