Andamertinib

BEIJING--( BUSINESS WIRE )--Beijing Avistone Biotechnology Co., Ltd. (also referred to as Avistone Biotechnology or Avistone), an innovative biotechnology company focused on precision oncology therapeutics, announced that they had recently completed their Series B financing of 1 billion Chinese yuan (~$140 million USD). The Series B financing was jointly led by SDIC CS Capital and IDG Capital, with participation from Yanchuang Capital and Cathay Capital. Existing shareholder Bain Capital continues to make additional investments. This round of financing will be used to support clinical research and development of the Avistone pipeline, including both drug monotherapy studies and internal combinations; to accelerate the screening of new molecules; to support clinical studies and expansion in the United States of America; and to support commercialization of PLB1001 (Vebreltinib) in China. In China, Avistone has established a commercial sales and marketing team covering 25 provinces, nearly 1,000 hospitals, and hundreds of commercial companies and retail outlets. Dr. Hepeng Shi, founder, chairman and CEO of Avistone Biotechnology, said: "We thank our Series B investors for trusting and investing in Avistone. This very important financing will support the commercialization of our recently approved molecule, PLB1001 (Vebreltinib), in MET Exon 14 Skipping Non-Small Cell Lung Cancer (NSCLC) and will provide funding for our pipeline. We will continue to pursue our vision to become a leading biotechnology company with a deep pipeline and focus on innovation. We aspire to be highly trusted by the patients and families that we serve along with the physicians, practitioners, and scientists that we work with.” SDIC states: “We are pleased to lead the B-round financing for Avistone. The Company has demonstrated impressive execution capabilities and has led effective translational medical work. We firmly believe that the company will continue to produce more clinically advanced innovative products in the future. We are committed to collaborating closely with the Avistone team to foster the company's growth, ultimately benefiting patients and contributing to the advancement of China's innovative pharmaceutical industry.” IDG Capital noted that, “We believe that the demand for better products is a prevailing trend in the biopharmaceutical industry, and Avistone has consistently aimed for and practiced this goal. Dr. Shi's team swiftly achieved breakthroughs from 0 to 1 in product development, showcasing strong execution and product layout capabilities. Additionally, we have high expectations for Avistone's outstanding commercialization capabilities. We believe that in the future, Avistone can achieve more innovative breakthroughs, and IDG Capital is committed to ongoing support, contributing to the advancement of the innovative pharmaceutical industry alongside Avistone.” Jonathan Zhu, Partner and Co-Head of Asia Private Equity at Bain Capital, expressed that “We are delighted to witness Avistone's breakthroughs in targeted oncology drug development, positioning itself as a leading domestic innovative pharmaceutical enterprise with successful ventures into Class 1 innovative drugs. We have observed the growth and development of Avistone and have strong confidence in the company's research and development capabilities, execution efficiency, and pipeline layout strategy. Our continued investment in Avistone underscores our belief in Dr. Shi's leadership and his team's ability to efficiently develop groundbreaking innovative biopharmaceuticals. This establishes them as a pioneering platform for tumor-targeted drug innovation rooted in China and globally oriented.” About Avistone Biotechnology Avistone Biotechnology is an oncology company focused on developing innovative therapies for patients with significant unmet medical needs globally. Avistone has an extensive portfolio and pipeline of targeted therapies. The Company’s lead asset is PLB1001 (Vebreltinib), a small-molecule inhibitor that targets MET tyrosine kinase activity. Vebreltinib recently received conditional approval from the National Medical Products Administration (NMPA) as a treatment for patients with MET exon 14 skipping non-small cell lung cancer (NSCLC) in China. The company's second asset is PLB1004, a potent inhibitor of EGFR tyrosine kinases (TKI), including aberrant activity observed with EGFR exon20 insertion (genetic) mutations in NSCLC tumors.

BEIJING--(BUSINESS WIRE)-- Avistone Biotechnology Co. Ltd. (“Avistone” or “the Company”), an innovative biotechnology company focused on precision oncology therapeutics, announced that they received conditional approval from the National Medical Products Administration (NMPA) to commercialize Vebreltinib (also referred to as PLB1001, APL-101, Bozitinib, CBT-101) to treat patients with MET exon 14 skipping non-small cell lung cancer (NSCLC) in China. The conditional approval was based on results from a pivotal Phase II KUNPENG study with an objective response rate (ORR) of 75.0% and median progression-free survival (PFS) in patients with advanced METex14 mutations to 14.1 months with a good safety pro was recently presented at the 2023 European Society for Clinical Oncology (ESMO) Congress in Madrid, Spain (Poster# 1379P). MET signaling is implicated in cell proliferation, migration, invasion, and survival. Genomic alterations in MET can manifest in driving oncogenesis in the form of MET exon 14 skipping (METex14) or other activating mutations, MET gene amplification, gene fusion and MET protein overexpression. METex14 is an independent prognostic factor associated with poorer survival rates in patients with NSCLC. "The development of drugs for indications related to MET targets has always been a difficult one. With the NMPA approval of Vebreltinib, we look forward to providing this new treatment option to patients with MET exon 14 skipping NSCLC in China” said Dr. Hepeng Shi, Chairman, CEO, and Founder of Avistone. Avistone holds the exclusive rights to Vebreltinib in China, Hong Kong and Macau. About Avistone Biotechnology Co. Ltd. Avistone is an oncology company focused on developing innovative therapies for patients with significant unmet medical needs globally. Avistone has an extensive pipeline of targeted therapies including two clinical-stage drug candidates and several ongoing programs in the pre-clinical development stage. The Company’s lead asset is PLB1001, a small-molecule inhibitor that targets MET tyrosine kinase activity, including aberrant activity observed with METexon14 skipping (genetic) alterations in NSCLC tumors and in other solid tumors. The company's second clinical asset is PLB1004, a potent inhibitor of EGFR tyrosine kinases (TKI), including aberrant activity observed with EGFR exon20 insertion (genetic) mutations in NSCLC tumors.