BioRay Pharmaceutical

BioRay Pharmaceutical operates as a commercial-stage biopharmaceutical company in China, with a focus on medicines for immune-mediated diseases and cancer. The company's history is rooted in its former parent company, Zhejiang Hisun Pharmaceutical, which entered biologics R&D in 2003. BioRay was officially established as a separate entity in 2019 following a major strategic investment. In a significant transaction, PAG, an Asia-focused private equity firm, acquired a 58% controlling stake for approximately $540 million, marking one of the largest private equity investments in China's biotechnology sector at the time. Zhejiang Hisun retains a 42% ownership stake. This pivotal event established BioRay as an independent company, with Dr. Haibin Wang as CEO. In January 2023, the company secured an additional strategic financing round of over $218 million at a pre-money valuation of $1.9 billion, attracting a foreign sovereign wealth fund and domestic investment funds.

The company's business model is fully integrated, covering the entire value chain from drug discovery and clinical development to manufacturing and commercialization. It generates revenue through the sale of its marketed pharmaceutical products. In 2022, BioRay reported over RMB900 million (approximately $131 million) in revenue, demonstrating a compound annual growth rate of over 50% from 2019 to 2022. The company's operations are supported by over 1,600 employees and four R&D and manufacturing centers in Taizhou, Hangzhou, Shanghai, and San Diego, USA. BioRay serves patients in China with autoimmune diseases and cancer.

BioRay's product portfolio includes seven marketed products. A key product is Anbainuo®, a biosimilar for etanercept used to treat autoimmune disorders like rheumatoid arthritis and psoriasis, which received its first approval in 2015. Another product, Anjianning®, is one of China's first adalimumab biosimilars. In May 2023, the company gained approval for its independently developed drug, Zuberitamab Injection, for lymphoma treatment. Beyond its commercialized drugs, the firm has a robust pipeline with more than 10 assets in clinical trials and over 20 in the preclinical stage. The pipeline features diverse therapeutic modalities, including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and bi-specific antibodies. One notable candidate is BR111, an ADC targeting dual epitopes of ROR1 for treating hematological malignancies and solid tumors, which has received clinical trial approval from China's NMPA.

Keywords: biopharmaceutical, immunology, oncology, autoimmune diseases, monoclonal antibodies, antibody-drug conjugate, biosimilar, China pharmaceutical market, clinical trials, drug development, biologics manufacturing, Zhejiang Hisun, PAG, Zuberitamab, Anbainuo, ROR1 ADC, etanercept biosimilar, adalimumab biosimilar, cancer therapy, rheumatoid arthritis treatment