BEIJING, Feb. 10, 2022 – Panshengzi (NASDAQ: GTH) today announced a cooperation agreement with Hehuang Pharmaceutical (China) Co., Ltd. ("Hehuang Pharma") (NASDAQ/LSE: HCM; HKEX: 13) to jointly develop companion diagnostic kits for Orpathys ®® (generic name: severolitinib/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 panshengzi "one-step method", and was approved for marketing by the State Drug Administration of China (hereinafter referred to as the "State Food and Drug Administration") 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: "We are 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." ”
Wang Sizhen, co-founder and CEO of Fanshengzi, said: "Voressa ® provides an important treatment path for NSCLC patients in China, and as a partner with Huang 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." ”
Resources
[1] Vuong HG, et al. Clinicopathological implications of MET exon 14 mutations in non-small cell lung cancer – A systematic review and meta-analysis. Lung Cancer 2018; 123: 76-82. doi: 10.1016/j.lungcan.2018.07.006.
[2] World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed June 2021.
[3] World Health Organization. International Agency for Research on Cancer. Globocan China Fact Sheet 2020. Available at http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed June 2021.
[4] Liu X, et al. Next-generation sequencing of pulmonary sarcomatoid carcinoma reveals high frequency of actionable MET gene mutations. J Clin Oncol 2016; 34: 794-802. doi: 10.1200/JCO.2015.62.0674.
[5] Lu S, et al. Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. 2021 Jun 21:S2213-2600(21)00084-9. doi: 10.1016/S2213-2600(21)00084-9.
More about Voreşa ® (severitinib)
Volesa ® is a potent, highly selective oral MET tyrosine kinase inhibitor that exhibits clinical activity in advanced solid tumors. Volesa ® blocks abnormal activation of the MET receptor tyrosine kinase signaling pathway due to mutations (e.g., MET exon 14-jump mutations) or gene amplification.
Varesea ® was conditionally approved for marketing in China for the treatment of patients with THE MET exon 14-jump mutation who had progressed to disease after systemic therapy or who were unable to undergo chemotherapy. In 2011, Hehuang Pharma entered into a global licensing agreement with AstraZeneca to jointly develop and commercialize sivotinib. Hehuang Pharma is responsible for the marketing, production and supply of sivatinib in China, while AstraZeneca is responsible for commercializing sivotinib in China and around the world. Currently, Voressa ® is being developed as a monotherapy or as a combination therapy with other drugs to treat multiple tumor types, including lung, kidney and stomach cancers.
About the lung cancer 8 gene kit and the "one-step" patented technology
The Panshengzi Human 8 Gene Mutation Joint Detection Kit (Semiconductor Sequencing Method) (National Machinery Injection 20203400072, referred to as the "Lung Cancer 8 Gene Kit") is equipped with the Panshengzi patented technology "One-step Method for Rapidly Constructing an Amplicon Library" (Chinese Invention Patent ZL201710218529.4, referred to as the "One-Step Method" Patent Technology), which has been applied to the "Establishment and Clinical Application of Key Technologies for Early and Accurate Diagnosis of Lung Cancer" project of in-depth cooperation between Panshengzi and West China Hospital of Sichuan University. And won the second prize of the National Science and Technology Progress Award. The Lung Cancer 8 Gene Kit detects eight gene mutations and fusions that are closely related to targeted therapy in NSCLC patients (including mutations in EGFR, BRAF, KRAS, HER2, and PIK3CA, translocations of ALK and ROS1, and jump mutations in MET exon 14, seven of which are biomarkers recommended by the 2018 NCN guidelines for NSCLC patients), providing patients with a range of services such as medication guidance, molecular typing, prognosis assessment, and more. At present, it has been approved for the concomitant diagnosis of NSCLC-targeted drugs such as gefitinib, Icotinib, Osimertinib, and Crizotinib.
The patented "one-step method" technology can complete the library building process in only one reaction step, thereby reducing manual operation and effectively reducing the risk of pollution in the library building process. Lung Cancer 8 Gene Kit has the advantages of fast and convenient, equipped with the pan-oxon gene sequencer GENETRON S5 (National Machinery Injection 20193220820) and the automatic dosing system GENETRON Chef (Yu Machinery Injection 20192220364), which can issue a report in two days, suitable for hospitals to independently carry out testing.
About Hehuang Medicine
Hehuang Pharma (NASDAQ/LSE: HCM; HKEX: 13) is an innovative biopharmaceutical company in the commercialization phase, dedicated to the discovery, global development and commercialization of targeted drugs and immunotherapies for the treatment of cancer and immune diseases. The Group's companies employ more than 4,600 people, including a team of approximately 1,500 in the core oncology/immunology business. Since its inception, Hehuang Pharmaceutical has promoted 12 independently discovered cancer drug candidates to conduct clinical research around the world, of which the first three innovative oncology drugs have now been approved for marketing. For more details, please visit: www.hutch-med.com or follow the Enterprise LinkedIn page.
About Ubiquinoa
Panshengzi (NASDAQ: GTH) is a global leading precision medicine company for cancer, focusing on cancer genomics research and applications, and is committed to changing the way cancer is diagnosed and treated with advanced molecular biology and big data analysis capabilities. Panshengzi has created a rich product and service pipeline, covering the whole cycle of cancer from early screening to diagnosis and treatment recommendations, to monitoring and prognosis management, and actively expanded more innovative application directions and scenarios of molecular detection technology with upstream and downstream partners in the industrial chain. For more company information, please visit: https://www.genetronhealth.com.
Safe Harbor Statement
This press release contains Assumptions, Plans and Forward-Looking Statements by Panshengko for the Future, which are subject to risks and uncertainties that could cause actual results to be inconsistent with the expectations described in the forward-looking statements. Such statements are made pursuant to the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements involve inherent risks, uncertainties and a number of factors that could cause actual results to differ materially from those described in any forward-looking statements. For example, our expectations for the further application of the Lung Cancer 8 Gene Kit to key hospitals in China, as well as other words and similar expressions that include "expected", "believe", "expect", "plan" are also forward-looking descriptions. More information about these and other risks and uncertainties is included in the Company's filings with the SEC. All information provided in this press release should not be construed as an opinion at any point in time after the date of this announcement. Panshengko anticipates that future events and developments will result in changes in the Company's assumptions and assumptions, but the Company undertakes no obligation to update any forward-looking descriptions, except as required by applicable law, whether new information, future events or otherwise occur.
This article originated from Grand Gateway
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