Core Insights - The company, Beihai Kangcheng, has established itself as a global biopharmaceutical firm focused on rare diseases, with three approved products and seven in development [1][2] - The founder, Xue Qun, emphasizes the unmet clinical needs in the rare disease sector as a significant opportunity for growth and innovation [4] Company Development - Beihai Kangcheng was founded in 2012 after Xue Qun's decade-long experience in the rare disease field, initially focusing on oncology due to funding challenges [1] - A pivotal moment for the company was in 2018 when the Chinese government released a rare disease directory, leading to strategic partnerships and significant funding [1][3] Product Portfolio - The company has three marketed products that address clinical gaps in conditions such as MPS II and ALGS, with the first domestically developed enzyme replacement therapy for Gaucher disease, Gorenin, expected to be approved by May 2025 [2][4] Policy Support - Government policies have played a crucial role in alleviating challenges in rare disease drug development, particularly through the segmented production pilot policy that supports innovative biopharmaceuticals [3][5] - Gorenin's successful development benefited from this policy, allowing for a segmented production model that meets clinical needs while navigating regulatory hurdles [3][5] Market Strategy - The company is entering a 3.0 development phase, implementing a "dual-core drive" strategy to solidify its leadership in the domestic rare disease market while expanding internationally [7] - A strategic partnership with Baiyang Pharmaceutical aims to enhance commercialization efforts and leverage each other's strengths in the rare disease sector [7][8] Future Outlook - The company anticipates a significant market expansion for rare disease drugs, particularly with the inclusion of Gorenin in the first commercial insurance innovation drug directory set to take effect in January 2026 [5][6] - Xue Qun envisions a collaborative ecosystem that integrates diagnostics and patient education to improve awareness and treatment of rare diseases [8]
北海康成董事长薛群：深耕罕见病创新药“蓝海” 双核驱动迈向全球创新