First case of bridging associated diagnosis in China丨Panzoite's “human PDGFRA gene D842V mutation detection kit” was approved by NMPA

Recently, the “Human PDGFRA Gene D842V Mutation Detection Kit” registered by Pansion was approved by the National Drug Administration (NMPA). It became the first companion diagnostic kit developed by the NMPA by the NMPA after the introduction of guidelines for accompanying diagnostic reagents in China. The kit was developed jointly by Panzotron and Cornerstone Pharmaceutical. It can detect PDGFRA gene mutations in gastrointestinal stromal tumors (GIST) patients and be used for accompanying diagnosis with tajihua (generic name: avatinib) drugs.

The launch of this kit has also achieved a number of “firsts”: a domestically produced companion diagnostic kit approved for marketing based on pharmacodynamics data in China and abroad; an accompanying kit marketed on a complete bridging path after the publication of the “Guiding Principles for Clinical Trial Registration and Review of Non-original Research Accompanying Diagnostic Reagents for Antineoplastic Drugs” and the “Guiding Principles for Clinical Trial Registration and Review of Original Research Accompanying Diagnostic Reagents Developed Simultaneously with Antineoplastic Drugs” and “Guiding Principles for Clinical Trial Registration and Review of Original Research Accompanying Diagnostic Reagents Developed Simultaneously with Antineoplastic Drugs”; Accompanying kits marketed on a complete bridging path; both drugs and devices received priority review by NMPA.

GIST patients with PDGFRA gene D842V mutation have always lacked effective treatment drugs, and Taijihua showed excellent anti-tumor activity in Chinese patients with unresectable or metastatic GIST with PDGFRA gene exon 18 mutation (including D842V mutation), and is safe and well tolerated. It is the first drug approved for precise treatment of this disease in China. This companion diagnostic kit is the first domestic kit for the D842V mutation in the human PDGFRA gene. It is supported by scientific and effective clinical data, patients are screened more accurately, and treatment is matched with Taijihua, so that patients can obtain more accurate and greater survival benefits.

The data for the entire approval process of the kit was sufficient and rigorous, and finally the approval was implemented within three years. In response, Wang Sizhen, co-founder, chairman and CEO of Panshengzi, said, “In line with the attitude of being responsible for patients, Panshengzi and Cornerstone Pharmaceutical adhere to the same strict standards of quality and efficiency. We can provide pharmaceutical customers with efficient companion diagnostic services, help shorten drug development cycles, and promote efficient approval. In the process of collaborating with partners to promote the certification and application of innovative products, we are more hopeful to work together to promote a more standardized and standardized industry, so that compliant precision medicine can benefit more patients.”

Dr. Xie Yizhao, Chief Scientific Officer of Cornerstone Pharmaceutical, said, “Precision medicine is one of Cornerstone's core strategies. The approval of the Taijihua® companion diagnostic kit demonstrates our capabilities in developing companion diagnostics for precision medicine in China. The success of this case is due to the joint efforts of Cornerstone Pharmaceuticals and our experienced diagnostic partner Pansiang, as well as Blueprint Medicines. I believe this, along with the approval and commercialization of diagnostic kits, will enable more GIST patients in China to benefit from Taijihua® treatment.”

Taijihua was discovered by Cornerstone Pharmaceutical's partner Blueprint Medicines as an effective, selective, and orally administered PDGFRA and KIT mutant kinase inhibitor. Cornerstone Pharmaceuticals and Blueprint Medicines have signed an exclusive collaboration and licensing agreement to develop and commercialize Taijihua in mainland China, Hong Kong, Macau and Taiwan.

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