Sanggen Biopharma Submits Sci-Tech Innovation Board IPO Prospectus with Two Marketed Antibody Drugs

VCBeat (WeChat ID: vcbeat) has learned that on October 31, 2019, Guojian Pharmaceutical applied for a listing on the STAR Market. The company plans to issue a maximum of 61.621142 million shares, with expected proceeds of RMB 3.183 billion.

Guojian Pharmaceutical, established in 2002, is one of China’s first innovative biopharmaceutical companies dedicated to antibody therapeutics. It is currently the only domestic pharmaceutical company with two marketed therapeutic antibody drugs, and has evolved into a leading Chinese antibody drug enterprise with integrated capabilities in independent R&D, industrialization, and commercialization.

Since its establishment, Guojian Pharmaceutical has consistently focused its research and development efforts on key international therapeutic areas for antibody drugs. The company has proactively established multiple technology platforms for innovative antibody therapeutics, possessing a systematic innovation capability that spans drug discovery, preclinical studies, pilot-scale process development, quality research, clinical trials, and commercialization.

The company’s primary source of revenue is “Recombinant Human Tumor Necrosis Factor Receptor II-Antibody Fusion Protein” (brand name: Etanercept, marketed as “Yisaipu”), available in two specifications: 12.5 mg/vial and 25 mg/vial. Yisaipu is the first fully human antibody-based drug launched in China, the first tumor necrosis factor-alpha (TNF-α) inhibitor approved for marketing in the field of rheumatology in China, and the first biologic agent introduced to the Chinese rheumatology market. Through continuous and professional academic education, it has improved the treatment modalities for rheumatic disease patients in China, filling the gap where no biologic agents were previously available in this therapeutic area.

The former China Food and Drug Administration (CFDA) has approved three indications: rheumatoid arthritis, ankylosing spondylitis, and psoriasis. In 2017, the drug was included in Category B of the Western medicines section of the National Reimbursement Drug List. Since its market launch, it has benefited hundreds of thousands of patients with ankylosing spondylitis and rheumatoid arthritis.

In addition to the company’s flagship product, Etanercept (Yisaipu), the company has independently developed “Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection” (brand name: Jianbupai/Genicept), which is currently the only humanized anti-CD25 monoclonal antibody approved for marketing in China. It received the Pharmaceutical GMP Certificate issued by the National Medical Products Administration in June 2019 and was launched for commercial sales in October 2019. This product is indicated for the prevention of acute rejection following kidney transplantation and can be used in combination with conventional immunosuppressive regimens, significantly improving graft survival rates and enhancing patients’ quality of life.

Other Clinical Product Pipelines of Guojian Pharmaceutical

Guojian Pharmaceutical: Key Financial Data

As an innovative biopharmaceutical company specializing in antibody-based drugs, Guojian Pharmaceutical operates the National Engineering Research Center for Antibody Drugs. The company has consistently prioritized the development of its R&D system and technology platforms, as well as the strategic layout of its R&D pipeline, maintaining sustained high levels of R&D investment. Cumulative R&D expenditures have accounted for nearly 18% of its revenue. In 2018, Guojian Pharmaceutical reported total revenue of RMB 114 million and net profit of RMB 35.8 million. The company’s primary revenue and profits are derived from domestic and international sales of its flagship proprietary product, “Recombinant Human Type II Tumor Necrosis Factor Receptor-Antibody Fusion Protein” (brand name: Yisaipu). Yisaipu is indicated for the treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriasis. As China’s first fully human antibody-based drug to reach the market, it was also the first tumor necrosis factor-alpha (TNF-α) inhibitor launched in the field of rheumatology in China, filling the gap among domestic enterprises in fully human therapeutic antibody drugs. Since 2006, Yisaipu has maintained a leading position in the domestic market share. According to Frost & Sullivan, Yisaipu held approximately 52.3% of the domestic TNF-α inhibitor market in 2018 and was also the leader in the domestic large-molecule drug market for autoimmune diseases, with a market share of approximately 48.7%.