Avistone Biotech Secures RMB 1 Billion Series B Funding to Advance Commercialization of Vebreltinib and Oncology Pipeline

VCBeat has learned at the earliest opportunity,December 28, 2023, Beijing—Beijing Avistone Biotechnology Co., Ltd. (hereinafter referred to as “Avistone Biotechnology” or “Avistone”), a promising Chinese innovative oncology drug company,Announced the completion of a RMB 1 billion Series B financing round in recent days. This round of financing was led bySDIC MerchantsandIDG CapitalCo-lead investor,Yanchuang Group, Cathay CapitalCo-investment, existing shareholdersBain CapitalContinue to inject additional investment. The funds raised in this round will be used to advance the clinical studies within Avistone Biotechnology’s pipeline, expand the broad application scenarios of the dual-target combination of bozitinib and anatinib, actively promote the dual filing process in China and the United States, accelerate the screening of potential compounds and their development into drug candidates, and support drug launches and commercialization strategies.

Dr. Shi Hepeng, Founder, Chairman, and CEO of Avistonestated: “We thank the Series B investors for their trust in and investment in Avistone. With Wanbirui”^®(The approval of Bozitinib Enteric-coated Capsules for market launch and commercial supply will help Avistone advance from a Biotech to a Biopharma company. This round of financing will facilitate the IPO of Avistone Biotechnology.)New Drug Vanbryl^®the commercialization of (Borutinib Enteric-coated Capsules), the approval for indications such as glioma, and the research and development of other oncology drugs including Andatinib (PLB1004).“We have always upheld the vision of ‘becoming a trusted biopharmaceutical company and serving human health through continuous innovation,’ deeply cultivating our pipeline and fostering innovation.”

SDIC Merchants Life Sciences Teamstated: “SDIC Merchants is pleased to lead the Series B financing round of Avistone Biotechnology. The company’s team has demonstrated impressive execution capabilities and led highly effective translational medicine efforts. We firmly believe that the company will continue to deliver more innovative products with clinical advancement in the future. SDIC Merchants will work hand in hand with the Avistone team to drive the company’s growth, benefiting patients while supporting the development of China’s innovative pharmaceutical industry.”

IDG Capitalstated, “We believe that the demand for superior products is a major trend in the biopharmaceutical industry, and Avistone has consistently made this its goal and put it into practice. The team led by Dr. Shi Hepeng rapidly achieved a breakthrough from 0 to 1 in product development, fully demonstrating the team’s strong execution capabilities and strategic product portfolio planning. Furthermore, we have high expectations for Avistone’s outstanding commercialization capabilities. We are confident that Avistone will achieve more innovative breakthroughs in the future, and IDG Capital will continue to work alongside Avistone to drive progress in the innovative drug industry.”

Jia Zhu, Partner and Co-Head of Asia Private Equity at Bain Capitalstated: “We are delighted to witness Avistone Biotechnology’s breakthrough achievements in the R&D of targeted oncology therapeutics, establishing it as a leading innovative pharmaceutical company in China with proven success in developing Class 1 novel drugs. We have closely followed Avistone’s growth and remain firmly confident in its R&D capabilities, operational efficiency, and pipeline strategy. Our continued co-investment in Avistone Biotechnology underscores our strong confidence that Dr. Shi’s team can efficiently develop breakthrough innovative biologics, building Avistone into a China-rooted, globally oriented innovation platform for targeted oncology therapies.”

Avistone Biotechnology is an innovative pharmaceutical company in China, dedicated to the research and development of novel anti-tumor drugs. With a robust R&D pipeline, the company has established a strategic presence in multiple oncology therapeutic areas, including lung cancer and glioma. Avistone Biotechnology is committed to exploring unmet clinical needs and serving patients, thereby realizing its vision of advancing human health through continuous innovation.

Avistone Biotechnology has established a commercialization team composed of business elites from leading pharmaceutical companies both in China and abroad. The team’s coverage extends across 25 provinces in China, nearly 1,000 hospitals, as well as hundreds of commercial distributors and retail outlets. It is committed to providing academic services and specialized disease management solutions in the field of MET-abnormality-related disorders to thousands of healthcare professionals in oncology, thereby taking concrete actions to meet clinical needs and prolong patient survival. Based on evidence-based data published in the fields of lung cancer and glioma, Bozitinib Enteric-Coated Capsules have been included as a recommended therapy in the 2022 Edition of the CACA Guidelines for the Diagnosis and Treatment of Glioma and the 2023 Expert Consensus on Targeted Therapy for NSCLC with MET Exon 14 Skipping Mutations.

Figure 1. Vanbry, a marketed product of Beijing Purunao Biotechnology Co., Ltd., a wholly-owned subsidiary of Avistone^®(Bozitinib Enteric-coated Capsules)

As the company's first commercialized product, Wanbirui^®(Bozitinib Enteric-Coated Capsules) is a highly selective oral small-molecule MET inhibitor indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations. Results from the pivotal Phase II registration clinical study showed that the overall objective response rate (ORR), as assessed by the Blinded Independent Review Committee (BIRC), was 75.0%, with a median duration of response (mDoR) of 15.9 months, a median progression-free survival (mPFS) of 14.1 months, and a median overall survival (mOS) of 20.7 months.

The New Drug Application (NDA) for the second indication of Bozitinib Enteric-coated Capsules was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China in October 2023 and included in the priority review program. The drug is intended for adult patients with isocitrate dehydrogenase (IDH)-mutant WHO grade 4 astrocytoma or glioblastoma (GBM) with a history of lower-grade disease, who harbor the PTPRZ1-MET (ZM) fusion gene and have experienced recurrence or intolerance following radiotherapy and temozolomide (TMZ) treatment. Results from the pivotal Phase II/III registration clinical study showed that, in the full analysis set population, Bozitinib Enteric-coated Capsules reduced the risk of death by 48% (P=0.009) compared to the chemotherapy control group, demonstrating significant survival benefits for patients in the bozitinib group.

Furthermore, MET amplification and overexpression constitute mechanisms of resistance to EGFR TKIs. The Company is actively conducting Phase Ib/II combination trials of bozitinib with an EGFR TKI (andatinib) to address this unmet clinical need.

Andatinib is a small-molecule epidermal growth factor receptor (EGFR) inhibitor independently developed in China with global intellectual property rights. Phase I clinical trial data have demonstrated that the drug exhibits favorable efficacy and safety,Meanwhile, more than 60% of patients with lung cancer brain metastases can benefit.The company is conducting a Phase II clinical study (pivotal registration trial) in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. Meanwhile, a Phase I clinical trial is also underway in the United States.

ANS01 is a Type II MET inhibitor with the potential to overcome resistance following monotherapy with Type I MET inhibitors. ANS01 has received clinical trial approvals in both China and the United States, and Phase I clinical trials are currently being conducted simultaneously in both countries.

Disclaimer: The content of this article is for corporate information display purposes only and does not constitute disease diagnosis or prescription medication recommendations. Avistone Biotechnology does not recommend the use of any unapproved drugs/indications.