北海康成-B(01228)公布，该集团的国内首个本土自主研发生产的酶替代疗法一类创新药CAN103已成功 纳入中国第一版"商保创新药目录"，该目录于2026年1月1日起正式实施。 公司认为，CAN103纳入该目录为集团的里程碑成就，乃由于此举将确保戈谢病患者用得上、用得起安 全有效的国产酶替代疗法，获得更广泛更全面的治疗保障。 CAN103于2025年5月13日获批上市，是中国首个本土自主研发生产适用于12岁及以上青少年和成人I型 和Ⅲ型戈谢病患者的长期酶替代疗法，亦为中国首个通过生物制品分段生产检查的创新生物药。于2025 年7月2日，CAN103在上海交通大学医学院附属新华医院开出首方，标志着该药物正式进入临床应用， 未来将大大提升国内患者用药可及。 ...

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]