CStone has received approval from China's NMPA for the manufacturing of AYVAKIT® (avapritinib tablets, 100 mg)
Monday, August 19, 2024
CStone Pharmaceuticals focused on developing innovative anti-cancer therapies, has announced that the China National Medical Products Administration (NMPA) has approved the manufacturing localization registration for the 100 mg strength of AYVAKIT® (avapritinib tablets).
AYVAKIT is a targeted therapy approved by the NMPA for the treatment of adults with unresectable or metastatic GIST with a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. It is also approved by the health authorities in Hong Kong and Taiwan for similar indications.
AYVAKIT received approval from the NMPA in March 2021 for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) carrying the PDGFRA exon 18 mutation, including the PDGFRA D842V mutation.
As the world’s first precision therapy for GIST based on a driver gene, AYVAKIT has shown significant efficacy in multiple clinical trials. Its inclusion in the National Reimbursement Drug List (NRDL) has further improved its accessibility and affordability.
AYVAKIT is recommended in several domestic and international guidelines, including the 2023 CSCO Guidelines for Gastrointestinal Stromal Tumor Diagnosis and Treatment, and the 2023 NCCN Guidelines for Gastrointestinal Stromal Tumors and Systemic Mastocytosis.
AYVAKIT was discovered by Blueprint Medicines, with whom CStone has an exclusive collaboration and licensing agreement for its development and commercialization in the Greater China region, including mainland China, Hong Kong, Macau, and Taiwan.
This approval follows the earlier approval of the 300 mg strength in June 2024. The introduction of both strengths will offer greater treatment flexibility and is expected to replace the currently imported versions, with domestic supply anticipated to begin by late 2024 or early 2025.
The approval for both the 100 mg and 300 mg strengths of AYVAKIT® will better address the needs of diverse patient groups and enhance convenience. It also strengthens the accessibility and market competitiveness of AYVAKIT® in China.
Additionally, manufacturing localization application for GAVRETO® (pralsetinib capsules) is currently under review by the NMPA’s Center for Drug Evaluation, following its submission in April this year. It remain dedicated to delivering high-quality medicines to patients in China through advanced manufacturing and stringent quality management.
In the United States, AYVAKIT is approved by the FDA for the treatment of three conditions: adults with unresectable or metastatic GIST with a PDGFRA exon 18 mutation, including PDGFRA D842V mutations; adults with advanced systemic mastocytosis (ASM, SM with an associated haematological neoplasm, and mast cell leukaemia); and adults with indolent systemic mastocytosis (ISM). In Europe, AYVAKIT (marketed as AYVAKYT®) is approved for the treatment of similar conditions, including adults with ASM, SM-AHN, or MCL after previous systemic therapy, and adults with ISM with moderate to severe symptoms that are inadequately controlled on symptomatic treatment.
In July 2024, CStone entered an agreement with Hengrui, granting them exclusive promotion rights for AYVAKIT in mainland China. CStone retains all other rights under its agreement with Blueprint Medicines, including development, registration, manufacturing, and distribution.
Source: cstonepharma.com
