前沿生物药业(南京)股份有限公司

About 前沿生物药业(南京)股份有限公司

Frontage BioPharmaceuticals (Nanjing) Co., Ltd. (Stock Code: 688221.SH), established in 2013, is a globally competitive, innovative biopharmaceutical company based in China. We are dedicated to the research, development, production, and sale of innovative drugs addressing significant unmet clinical needs. Our company possesses advanced long-acting polypeptide technology platforms and novel transdermal patch formulation technology platforms. Leveraging the long-acting polypeptide platform, we have independently developed a series of innovative drug products in the anti-HIV field, including the first-class national new drug Acoini® (generic name: Ibalizumab), which is already on the market, and the investigational product FB1002, which is undergoing clinical trials in China and the US for multiple HIV indications. Our polypeptide R&D platform also supports several pipeline projects for long-acting polypeptides. Utilizing the novel transdermal patch formulation technology platform, our investigational product FB3001, a novel transdermal analgesic patch, is intended for the treatment of muscle, bone, and joint pain. Furthermore, building on our years of experience in antiviral drug research and development, we continue to delve into new drug research in other antiviral fields. Our investigational product FB2001 focuses on the anti-COVID-19 field and has initiated Phase I clinical trials in both China and the US. The company was co-founded by three renowned experts: Dong Xie, Changjin Wang, and Rongjian Lu. We are a leading enterprise in China for new AIDS drugs and were recognized among the top ten emerging innovative forces in China's pharmaceutical industry in 2020. Since its inception, the company has focused on the R&D of new long-acting polypeptide drugs, addressing unmet clinical and patient needs with a strategy of differentiated product development. Our core product is Acoini®, a first-class national new drug, China's first original new drug for AIDS treatment, and the world's first long-acting HIV fusion inhibitor. It received approval for production and marketing from the National Medical Products Administration in May 2018 and began sales in China in August 2018. In December 2020, as an exclusive patented product, it was included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2020) through negotiation. We have also commenced work on drug listing and registration in overseas markets. The launch of Acoini® and its broad market prospects provide a solid foundation for further enhancing our core competitiveness and new drug R&D capabilities. Frontage BioPharmaceuticals (Nanjing) Co., Ltd. has established a complete new drug R&D system over more than a decade of accumulated research, forming core competitiveness in innovative drug R&D. This includes drug molecule design and discovery, clinical trial design and implementation, registration and approval of marketed drugs in regulatory markets, and process scale-up and quality control across all core aspects. The company has built the broadest and deepest marketing system covering medical institutions in its domestic field, while also actively expanding global market channels for its innovative anti-HIV drug products. Driven by high standards for manufacturing processes and quality control, we are constructing international manufacturing bases for formulations and active pharmaceutical ingredients in Nanjing Jiangning, Sichuan Jintang, and Shandong Qihe, compliant with certifications from the US FDA, EU EMA, and China NMPA. Frontage Bio has been deeply involved in the anti-HIV drug field for over ten years, focusing on unmet clinical needs in anti-HIV new drug R&D, addressing the limitations of existing therapies, and emphasizing a differentiated product development strategy. Our operations cover the entire value chain from innovative drug discovery, preclinical R&D, global clinical development, to production and sales. We possess global competitiveness in the sub-fields of long-acting HIV treatment and immunotherapy, striving to develop innovative anti-HIV drugs with unique characteristics and competitive advantages.