November 14, 2024 — Qingdao Baheal Medical INC. (“Baheal Medical”, stock code: 301015.SZ) announced that its wholly-owned subsidiary, Beijing Baheal ZHIHE Medical Achievement Transformation Service Co., Ltd., has signed a marketing cooperation agreement with Beijing Biostar Biopharmaceutical Co., Ltd. (“Biostar”, stock code: 2563.HK). Under the agreement, Baheal Medical will obtain exclusive marketing rights in mainland China for Biostar’s independently developed Class 1 innovative drug, Utidelone Injection (brand name: UTIDE®). Baheal Medical will make a non-refundable upfront payment of RMB 50 million to Biostar, and additional milestone payments based on development and sales progress. In return, Biostar will pay Baheal Pharma a tiered promotion service fee based on annual terminal sales.

Utidelone stands as the only microtubule inhibitor Class 1 innovative drug independently developed by a domestic company and the first new anti-tumor drug with a novel molecular structure approved globally since 2010. It is initially approved for the treatment of recurrent or metastatic advanced breast cancer, the leading malignant tumor among women. Despite advances in clinical treatments, breast cancer patients still face a significant risk of recurrence or metastasis, with a five-year survival rate of just 28%1 for advanced cases. Clinical studies have demonstrated that Utidelone significantly improves both progression-free survival (PFS) and overall survival (OS) in patients with advanced breast cancer, while offering a favorable safety profile. The introduction of Utidelone provides a promising new therapeutic option and renewed hope for patients battling advanced breast cancer.

Utidelone is the world’s first chemotherapeutic drug developed using synthetic biology technology. As a next-generation microtubule stabilizer, it delivers several key benefits, including enhanced efficacy, improved safety, a broader anti-cancer spectrum, reduced likelihood of resistance, and the capability to cross the blood-brain barrier2. These attributes address the clinical need for treatments that prioritize both efficacy and safety. Utidelone received approval from the National Medical Products Administration (NMPA) in March 2021 and was included in the National Reimbursement Drug List in March 2023, bridging a significant gap in the national insurance catalog for domestically innovated microtubule inhibitor chemotherapy drugs.

In the context of an aging population and a rising number of cancer cases, combined with the continuous expansion of health insurance coverage, Utidelone presents vast market potential due to its significant advantages over taxane-based drugs.

Commenting on the collaboration, Tang Li, Chairman of Biostar, said, "As a biopharmaceutical company driven by synthetic biology technology, Biostar is committed to developing innovative oncology drugs. Having recently listed on the Hong Kong Stock Exchange, we are thrilled to partner with Baheal Pharma, a company with exceptional commercialization capabilities, to bring Utidelone to a broader patient population."

Fu Gang, Chairman of Baheal Medical, stated, " Baheal Medical is committed to bringing products to market that can truly improve clinical outcomes. As a strategic partner and cornerstone investor in Biostar’s IPO, we are thrilled to join forces to promote this groundbreaking product, bringing new hope and better treatment options to more patients."

This collaboration significantly expands Baheal Medical 's oncology portfolio. As a platform dedicated to supporting pharmaceutical innovation, Baheal Medical leverages its strengths to collaborate with leading pharmaceutical companies. Additionally, with backing from its major shareholders, Baheal Medical continues to introduce innovative products with proprietary intellectual property. Driven by both external partnerships and internal innovation, Baheal Medical aims to enhance its competitive edge in the market, fueling strong growth momentum.

Sources:

1. Kimberly D CA, June 2022

2. Xu B, et al. Annals of Oncology, November 2020