本报讯(记者李雯珊)9月22日，康哲药业控股有限公司(以下简称"康哲药业")与重庆智翔金泰生物制药股 份有限公司(以下简称"智翔金泰")签订独家合作协议，获得两款1类治疗用生物制品唯康度塔单抗 (GR2001)注射液和斯乐韦米单抗(GR1801)注射液在中国大陆的独家商业化权与除中国大陆之外的亚太 地区及中东、北非的独家许可权。 唯康度塔单抗是一款安全性佳，且优效于破伤风人免疫球蛋白(HTIG)，可为患者提供快速且持久保护 的破伤风被动免疫制剂。产品中国Ⅲ期临床试验达到了主要疗效终点。2024年5月，产品被国家药品监 督管理局(NMPA)药品审评中心(CDE)纳入突破性治疗品种名单，其新药上市申请(NDA)已于2025年5月 获得CDE受理，有望成为中国第二个获批的破伤风被动免疫单抗。 斯乐韦米单抗是全球首款针对狂犬病毒糖蛋白表位Ⅰ和/或Ⅲ的重组全人源抗狂犬病病毒(RABV)双特异 性抗体，符合世界卫生组织(WHO)建议开发的针对不同抗原位点的"鸡尾酒式"疗法，可大规模标准化稳 定生产，并且中和谱广、免疫原性低、对疫苗主动免疫干扰小、成本可控。2025年1月14日，其用于成 人疑似狂犬病病毒暴露后的被动免疫适 ...

2025年9月22日，康哲药业控股有限公司("康哲药业"，00867)通过其附属公司与重庆智翔金泰生物制药 股份有限公司("智翔金泰")就两款用于感染性疾病防控领域的创新生物制剂签订独家合作协议，获得产 品在中国大陆的独家商业化权与除中国大陆之外的亚太地区及中东、北非的独家许可权。两款产品均属 于1类治疗用生物制品并处于中国NDA审评阶段，其中唯康度塔单抗(GR2001)注射液用于破伤风的被动 免疫适应症，而斯乐韦米单抗(GR1801)注射液用于疑似狂犬病病毒暴露后的被动免疫适应症。 唯康度塔单抗注射液是一款安全性佳，且优效于破伤风人免疫球蛋白(HTIG)的重组人源化抗破伤风毒 素的单克隆抗体，可为患者提供快速且持久的保护。产品作用靶点为TeNT的重链C端(TeNT-Hc)。TeNT 是一条约150kDa的单链蛋白，经过翻译后修饰，形成由重链和轻链组成的活性毒素，产品能特异性结 合TeNT-Hc，阻断其进入神经元细胞，起到被动免疫作用。唯康度塔单抗注射液用于破伤风的被动免疫 适应症的Ⅲ期临床试验达到了主要疗效终点。2024年5月，唯康度塔单抗注射液被国家药品监督管理局 (NMPA)药品审评中心(CDE)纳入突 ...

Company Overview - Hunan Maijizhi Biotechnology Co., Ltd. (Maijizhi) has submitted a listing application to the Hong Kong Stock Exchange, with CICC as the sole sponsor [1] - The company is a clinical-stage biopharmaceutical firm focused on discovering, developing, and commercializing innovative biologics to address unmet medical needs in allergic and autoimmune diseases [3] Product Pipeline - Since its establishment in 2016, Maijizhi has developed a robust pipeline of eight innovative candidate products, including core product MG-K10, key products MG-014 and MG-013, all of which are next-generation long-acting antibodies discovered and developed through the company's proprietary technology platform [3] - MG-K10 is a potential best-in-class, self-developed long-acting anti-IL-4Rα antibody currently undergoing clinical trials for eight indications, including atopic dermatitis and asthma, showing promising safety and efficacy data [3] Market Potential - The global market for allergic disease drugs is projected to grow from $61.8 billion in 2023 to $122.2 billion by 2032, with a compound annual growth rate (CAGR) of 7.9% [4] - The Chinese market for allergic disease drugs is expected to grow from $7.2 billion in 2023 to $31 billion by 2032, with a CAGR of 17.5% [4] - The global market for autoimmune disease drugs is anticipated to increase from $133.8 billion in 2023 to $192.3 billion by 2032, with a CAGR of 4.1% [4] - The Chinese autoimmune disease market is expected to grow significantly, from $3.8 billion in 2023 to $26.6 billion by 2032, with a CAGR of 24% [4] Financial Performance - For the fiscal year 2023, Maijizhi reported revenues of RMB 8.722 million, with total losses of approximately RMB 252.942 million [6][7] - In 2024, the company expects revenues to increase to RMB 24,000, while losses are projected to be around RMB 178.308 million [6][7] - The company has no approved or commercialized products yet but is advancing multiple candidates towards the BLA application stage [5]