Avistone Pharmaceuticals

Avistone Pharmaceuticals, established in 2018, is a clinical-stage biopharmaceutical company with a strategic focus on precision oncology therapeutics. Headquartered in Beijing, China, the company directs its resources toward developing treatments for patient populations with substantial unmet medical needs across the globe. The company was founded by Dr. Hepeng Shi, who also serves as Chairman and CEO. Dr. Shi, who holds a Ph.D. from Peking Union Medical College, has a notable background in the pharmaceutical industry, including leading the successful turnaround of a subsidiary of the Yangtze River Pharmaceutical Group.

Avistone's business model is centered on the research, clinical development, and eventual commercialization of targeted cancer therapies. A significant milestone occurred in December 2021 when the company raised over \$200 million in a Series A funding round led by Vivo Capital, with participation from Bain Capital and Primavera Capital. This financing supported the combination of Avistone with Pearl Biotechnology, creating a more integrated oncology platform. Subsequently, in late 2023, the company secured an additional \$140 million in a Series B round, co-led by IDG Capital and SDIC, to further advance its pipeline and commercialization efforts. This funding has supported the company's expansion, including clinical trial activities in the United States and Canada. The company's revenue generation is anticipated from the sale of its approved drug products, with a commercial sales and marketing team already established in China, covering nearly 1,000 hospitals.

The company's lead asset is Vebreltinib (PLB1001), a small-molecule inhibitor targeting MET tyrosine kinase activity. This drug has received conditional approval from China's National Medical Products Administration (NMPA) for treating patients with non-small cell lung cancer (NSCLC) characterized by MET exon 14 skipping genetic alterations. Vebreltinib works by selectively inhibiting the MET signaling pathway, which, when irregularly activated, can drive tumor cell proliferation, invasion, and metastasis. Avistone's second primary clinical asset is PLB1004 (Andamertinib), a potent inhibitor of EGFR tyrosine kinases, designed to target EGFR exon20 insertion mutations in NSCLC tumors. This drug is designed as an oral, irreversible, and selective EGFR-TKI that also demonstrates the ability to penetrate the blood-brain barrier. The pipeline includes several other therapeutic candidates in pre-clinical and IND-enabling stages, underscoring a commitment to addressing various molecular drivers of cancer.

Keywords: precision oncology, biopharmaceutical, clinical-stage, cancer therapies, targeted therapy, non-small cell lung cancer, NSCLC, MET inhibitor, EGFR inhibitor, Vebreltinib, PLB1001, Andamertinib, PLB1004, tyrosine kinase inhibitor, molecular drivers of cancer, MET exon 14 skipping, EGFR exon 20 insertion, clinical trials, drug development, oncology pipeline, China biotechnology, global clinical development, cancer treatment