证券代码：688076 证券简称：ST诺泰 公告编号：2025-071 江苏诺泰澳赛诺生物制药股份有限公司 关于自愿披露醋酸阿托西班注射液获得 药品注册证书的公告 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容的 真实性、准确性和完整性依法承担法律责任。 规格：0.9ml：6.75mg、5ml：37.5mg（按C43H67N11O12S2计） 申请事项：药品注册（境内生产） 注册分类：化学药品4类 药品有效期：18个月 包装规格：2瓶/盒、4瓶/盒 上市许可持有人：江苏诺泰澳赛诺生物制药股份有限公司 生产企业：江苏诺泰澳赛诺生物制药股份有限公司 江苏诺泰澳赛诺生物制药股份有限公司（以下简称"公司"或"诺泰生物"）于近日收到国家药品监督管理 局核准签发的醋酸阿托西班注射液的《药品注册证书》（证书编号：2025S03644、2025S03645），现 将相关情况公告如下： 一、《药品注册证书》的主要内容 药品名称：醋酸阿托西班注射液 剂型：注射剂 二、药品相关情况 醋酸阿托西班注射液是一种选择性缩宫素受体拮抗剂，可以竞争性结合子宫肌层缩宫素受体，适用于有 早产指征的妊娠妇 ...

Core Viewpoint - Jingze Biopharma is preparing for an IPO, focusing on high-growth areas of assisted reproduction and ophthalmic drugs, with a pre-IPO valuation of 3.09 billion RMB after completing multiple funding rounds [1][2]. Company Overview - Jingze Biopharma specializes in assisted reproduction and ophthalmic drugs, having developed a comprehensive R&D system and commercial-scale production capabilities [2]. - The company has eight candidate drugs, with its first core product expected to generate revenue by 2026 [2][7]. Product Pipeline - The core product JZB30, a recombinant human follicle-stimulating hormone (rhFSH) lyophilized injection, is crucial in assisted reproduction and has received NDA approval [4][7]. - Another key product, JZB05, is an anti-VEGF intravitreal injection aimed at treating wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), with expectations for commercialization by 2026 [5][6]. Market Potential - The assisted reproduction market is expanding due to relaxed fertility policies, with an estimated 59.2 million couples affected by infertility in China by 2024, projected to grow to 68.4 million by 2030 [8]. - The ophthalmic drug market is also growing, with a projected increase from 29.5 billion RMB in 2024 to 53.7 billion RMB by 2030, driven by rising rates of blindness-related eye diseases [12][13]. Financial Outlook - Jingze Biopharma is currently not profitable, with projected losses of 246 million RMB and 243 million RMB for 2023 and 2024, respectively [7]. - The company anticipates revenue generation starting in 2026 with the commercialization of JZB30, while R&D costs will continue to be a significant expense [7].

Core Viewpoint - Jingze Biopharmaceutical (Hefei) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with CICC and Guoyuan International as joint sponsors [1] Company Overview - Jingze Biopharmaceutical focuses on high-growth sectors of assisted reproductive drugs and ophthalmic drugs, establishing a comprehensive R&D system and commercial-scale production capabilities [4] - The company has developed multiple product pipelines and advanced several high-tech barrier drugs to late clinical and commercialization stages [4] - As of June 20, 2025, Jingze is one of the leading companies in China for clinical-stage macromolecular drugs in the fields of assisted reproduction and ophthalmology [4] Product Pipeline - The company has a rich product pipeline with eight candidate drugs, three of which are in late-stage development, including one that has received NDA approval and another that has submitted NDA [5] - JZB30, the first commercialized product in assisted reproduction, is a recombinant human follicle-stimulating hormone (rhFSH) lyophilized powder injection, targeting the global ovulation induction market [5][6] - JZB05, an anti-VEGF intravitreal injection, is expected to be the first commercialized product in the ophthalmic field, with ongoing Phase III clinical trials [6] Financial Overview - Research and development expenses for 2023 and 2024 are approximately RMB 122.2 million and RMB 133.3 million, respectively [6] - The total loss for the years 2023 and 2024 is approximately RMB 246.2 million and RMB 242.7 million, respectively [7] - Other income and gains for 2023 and 2024 are RMB 9.8 million and RMB 12.4 million, respectively [7]