Core Insights - The company Beihai Kangcheng-B (01228) announced that its domestically developed enzyme replacement therapy CAN103 has been included in China's first version of the "Commercial Insurance Innovative Drug Directory," which will be implemented starting January 1, 2026 [1] Group 1: Product Development - CAN103 was approved for market launch on May 13, 2025, making it the first domestically developed enzyme replacement therapy for adolescents aged 12 and older, as well as adults with Type I and Type III Gaucher disease in China [1] - On July 2, 2025, CAN103 was officially prescribed at Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, marking its entry into clinical application [1] Group 2: Market Impact - The inclusion of CAN103 in the insurance directory is considered a milestone achievement for the company, as it ensures that Gaucher disease patients will have access to safe and effective domestic enzyme replacement therapy, providing broader and more comprehensive treatment coverage [1]

Financial Performance - Revenue increased by RMB 225 million, a 184% year-over-year increase, primarily due to the commercialization of Nerlynx® in Taiwan in December 2020 and Hunterase® in mainland China in May 2021[134, 145] - R&D expenses decreased by RMB 1165 million, a 424% year-over-year decrease, mainly due to decreased payments to licensing partners[135, 145] - Cash balance increased by RMB 385 million, a 368% year-over-year increase, primarily attributed to the initial public offering in 2H 2021[133, 160] - Administrative expenses increased by RMB 27 million, a 50% year-over-year increase, primarily due to increased administrative employee costs and office expenses[145, 160] - The company's loss for the period was RMB 249 million in 1H 2022[146] Pipeline and Clinical Development - CANbridge identified 539 MPS II patients, and Hunterase has entered into 47 commercial insurance programs[37, 44, 135] - CAN108 NDA has been filed in mainland China and Taiwan for ALGS[41, 62] - The first patient was dosed in the Phase 1/2 trial for CAN103 in adult and adolescent patients with Gaucher disease in July 2022[47, 104] - CAN106 Phase 1 SAD study showed complete blockade of complement function, encouraging further studies in patients with PNH[70, 82] Strategic Initiatives - CANbridge opened a US-based Gene Therapy R&D center in Burlington, MA[47] - CANbridge formed a Complement Disease Scientific Advisory Board[47, 87]