Recently, Hubei Tianshu Pharmaceutical Co., Ltd. (Tianshu Pharmaceutical) received the official approval notice for the marketing application of Eratrectinib API issued by the NMPA. This approval entitles Tianshu Pharmaceutical to conduct commercial manufacturing and market supply of this novel anti-tumor drug’s API. It further enriches the company’s high-end API product portfolio and fuels the independent and controllable development of the domestic innovative drug industrial chain.
Eratrectinib (brand name: VELMARTO®) is a new-generation TRK inhibitor independently developed by Vcare PharmaTech. As a Class 1 small-molecule targeted anti-tumor innovative drug, it is indicated for adult and adolescent patients aged 12 years and older suffering from solid tumors harboring NTRK gene fusions. The drug targets NTRK and precisely inhibits TRKA, TRKB and TRKC signaling pathways to block the proliferation, differentiation and metastasis of tumor cells. As a tissue-agnostic broad-spectrum anti-cancer agent, Eratrectinib is applicable to more than 45 types of cancers including lung cancer, colorectal cancer and breast cancer, regardless of primary tumor location. Registrational clinical trials have verified its outstanding efficacy and safety profiles. Moreover, it effectively addresses the common drug resistance issues associated with first-generation TRK inhibitors, delivering a brand-new high-quality therapeutic option for domestic patients with NTRK fusion-positive solid tumors.
On June 4, NMPA granted conditional marketing approval for Eratrectinib Capsules (finished dosage form) under the priority review pathway. As the core upstream raw material for finished formulation manufacturing, stable large-scale supply of API constitutes a critical prerequisite for the commercial launch of innovative drugs. The successful approval of Eratrectinib API for Tianshu Pharmaceutical serves as a vital driving force for the full industrialization and steady market supply of Vcare PharmaTech’s first innovative drug.
For years, Tianshu Pharmaceutical has focused on custom manufacturing of pharmaceutical intermediates and APIs, consistently advancing its green manufacturing platform and building core technological capabilities centered on synthetic biology and continuous production technologies. Meanwhile, the company has established a comprehensive quality management system and high-standard production platforms, with multiple API varieties submitted for marketing approval. The marketing clearance of Eratrectinib API marks a major milestone for Tianshu Pharmaceutical in the field of APIs for novel anti-tumor drugs. Tianshu Pharmaceutical will swiftly advance the commercial production of this product. Leveraging its robust production capacity, the company will provide Vcare PharmaTech with high-quality, stable and sufficient API supply, jointly accelerating the delivery of this innovative drug to benefit a broad patient population at an early date.
