重组生物制药
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宝济药业通过港交所聆讯 中信证券、国泰海通为联席保荐人
Zheng Quan Shi Bao Wang· 2025-11-27 00:57
Core Insights - Baoyi Pharmaceutical has passed the main board listing hearing on the Hong Kong Stock Exchange, with CITIC Securities and Guotai Junan acting as joint sponsors [1] - The company's core product, SJ02 (Shengnuowa®), is a long-acting recombinant human follicle-stimulating hormone carboxy-terminal peptide fusion protein for assisted reproduction, which received NDA approval from the National Medical Products Administration in August 2025 [1] - Two other core products, KJ103 (an innovative recombinant immunoglobulin G (IgG) degrading enzyme in Phase III development) and KJ017 (a recombinant hyaluronidase in NDA stage), are in late-stage trials or NDA registration in China [1] - The company's strategy focuses on four key areas: large-volume subcutaneous delivery, antibody-mediated autoimmune diseases, assisted reproduction, and recombinant biopharmaceuticals [1] - According to Frost & Sullivan, the total clinical addressable market size for the company's four strategic therapeutic areas in China is expected to reach approximately RMB 50 billion by 2033 [1]
宝济药业通过港交所聆讯 核心产品SJ02已获得国家药监局的NDA批准
Zhi Tong Cai Jing· 2025-11-26 23:17
Core Insights - Shanghai Baoji Pharmaceutical Co., Ltd. is preparing for its main board listing on the Hong Kong Stock Exchange, with CITIC Securities and Guotai Junan as joint sponsors [1] - The company focuses on four strategic therapeutic areas: large-volume subcutaneous delivery, antibody-mediated autoimmune diseases, assisted reproduction, and recombinant biopharmaceuticals [3] - The company's core products include SJ02, KJ017, and KJ103, with SJ02 having received NDA approval from the National Medical Products Administration in August 2025 [3][6] Product Pipeline - The company has a pipeline of 12 self-developed products, including three core products (KJ017, KJ103, and SJ02), four other clinical-stage candidates, and five preclinical assets [3] - SJ02 is a long-acting recombinant human follicle-stimulating hormone CTP fusion protein for assisted reproduction, while KJ017 is a recombinant hyaluronidase for large-volume subcutaneous delivery [5] - KJ103 is an innovative recombinant immunoglobulin G (IgG) degrading enzyme aimed at treating various autoimmune diseases [5][6] Market Potential - According to Frost & Sullivan, the clinical addressable market for the company's four strategic therapeutic areas in China is projected to reach approximately RMB 50 billion by 2033 [4] - The market segments include large-volume subcutaneous delivery (approximately RMB 7 billion), antibody-mediated autoimmune diseases (approximately RMB 26.7 billion), assisted reproduction (approximately RMB 14.9 billion), and recombinant biopharmaceuticals (over RMB 5.3 billion) [4] Financial Overview - The company's revenue for the six months ending June 30, 2023, was RMB 6.93 million, with projected revenues of RMB 61.6 million for 2024 and RMB 419.9 million for 2025 [7] - Research and development expenses for the same periods were approximately RMB 133 million, RMB 251 million, and RMB 111 million respectively [7] - The company has established commercial-scale production capabilities to support cost-effective and standardized production [6]