Panshengzi and Huang Pharmaceutical have reached a cooperation agreement with Huang Pharmaceutical on the concomitant diagnosis of Verisa for non-small cell lung cancer

On February 10, Fanshengzi announced that it has reached a cooperation agreement with Hehuang Pharmaceutical (China) Co., Ltd. to jointly develop companion diagnostic kits for Orpathys (generic name: sefolitinib/savolitinib) in the Chinese market.

Under the agreement, the parties plan to verify and register the accompanying diagnosis of Voressa based on the approved Lung Cancer 8 Gene Kit. The lung cancer 8 gene kit is based on the patented technology development of the "one-step method" of panshengzi, and was approved for listing by the State Drug Administration of China in 2020. The kit is the first approved NGS product in China to detect met exon 14-jump variant based on RNA levels, and the indication is non-small cell lung cancer (NSCLC). The lung cancer 8 gene kit has been applied in domestic hospitals and obtained the EU CE qualification in 2021.

Volesa is a potent, highly selective, oral MET tyrosine kinase inhibitor that exhibits clinical activity in advanced solid tumors and blocks abnormal activation of the MET receptor tyrosine kinase signaling pathway due to genetic mutations (e.g., MET exon 14-jump mutations) or gene amplification. In June 2021, the State Food and Drug Administration announced that it had conditionally approved the listing of Voressa through the priority review and approval process.

It is understood that the number of lung cancer patients in China exceeds one-third of the total number of lung cancer patients in the world, and the MET exon 14 jump mutation, as a targeted mutation of the MET gene, occurs in NSCLC at an incidence of about 2%-3% [1-3]. This mutation is common (13% to 22 percent) in lung sarcoma-like carcinoma, a rare and aggressive subtype of NSCLC that is insensitive to conventional chemotherapy [4-5].

Dr. Su Weiguo, Executive Director and Chief Scientific Officer of Hehuang Pharmaceutical, said, "I am delighted to be working with Panshengzi, a leading cancer precision medicine company in China. In the course of Theoresha clinical application, concomitant diagnostic tests are essential for patients with NSCLC with the MET exon 14-jump mutation. We look forward to working with Ubionic to develop a companion diagnostic protocol that will allow patients to benefit from innovative treatment options as much as possible." ”

Sizhen Wang, co-founder and CEO of Fanshengzi, said, "Voressa provides an important treatment path for NSCLC patients in China, and as a partner of Hehuang Pharma, we are delighted that our Lung Cancer 8 Gene Kit (Tissue Edition) can become Voressa's first RNA-based NGS companion diagnostic product. This is another important collaboration between Panshengzi in the field of companion diagnostic services, which will help promote the clinical application of the lung cancer 8 gene kit in key hospitals in China. With the increasing attention of precision medicine and targeted therapy in China, the field of companion diagnosis is also developing and following up, and the prospects are promising. In the future, concomitant diagnostic services will continue to be the focus of Panshengko's business, and we will continue to explore practices to promote the application of innovative products to benefit more patients." (Li Gongsheng)