此外，翰宇药业通过CRDMO业务布局积极开拓增长第二曲线，依托多国GMP认证资质和全产业链能 力。公司已与碳云智肽、博瑞医药等企业深化合作，项目覆盖抗菌肽、多肽偶联药物、口服多肽等管 线，成功将技术积累转化为系统性的服务输出能力。 业绩预告显示，报告期内，公司国际制剂与原料药业务协同发力，成为营收增长核心引擎，CRDMO业 务落地推进，同时持续加大以创新药HY3003为首的研发投入力度，提高核心产品的竞争力。 翰宇药业始终坚持以创新驱动发展，连续多年保持高研发投入，聚焦多肽创新药、复杂制剂及前沿技术 平台建设，三靶点创新药HY3003、司美格鲁肽等多项在研项目取得显著进展，进一步巩固了技术壁 垒，为国际化拓展与CRDMO、小核酸等业务孵化提供持续动力。 本报讯(记者刘晓一)1月28日晚间，深圳翰宇药业（300199）股份有限公司(以下简称"翰宇药业")发布 2025年度业绩预告，2025年，公司预计营业收入9.5亿元至9.8亿元，较上年同期增长60.96%至66.05%， 归属于上市公司股东的净利润达到4000万元至5000万元，较上年同期扭亏为盈。 ...

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has announced additional requirements for the overseas listing application of Macao, focusing on the legality and compliance of its capital increases and share transfers, as well as the verification of its major shareholders and their investment structures [1][3] Group 1: Regulatory Requirements - CSRC requires Macao to provide detailed explanations regarding past capital increases and share transfer pricing, including the basis for pricing and fairness, as well as compliance with capital contribution obligations [1] - The company must also clarify the legality of its establishment and historical share changes, supported by conclusive legal opinions from lawyers [1] - Additional scrutiny is required on the investment structures of major shareholders, including the identification of ultimate beneficial owners and any potential legal restrictions on shareholding [1][2] Group 2: Business Operations - Macao's subsidiaries are required to report on the progress of land delivery and registration of state-owned land use rights [2] - The company must detail its business scope, including medical research, clinical trial services, and cell technology development, confirming whether it has obtained necessary qualifications and permits [2] - The company is also required to ensure compliance with foreign investment regulations before and after the proposed public offering [2] Group 3: Product Development - Macao is positioned as a platform biotechnology company focused on the innovation and development of next-generation bispecific/multispecific peptide drugs, with its core product MT1013 being a pioneering dual-target receptor agonist peptide drug [3] - MT1013 is primarily developed for the treatment of secondary hyperparathyroidism (SHPT) and is planned to expand its indications to include conditions like chronic kidney disease-mineral and bone disorder (CKD-MBD) with osteoporosis [4] - As of September 22, 2025, MT1013 has completed its Phase II clinical trial for SHPT and has entered a Phase III clinical trial using cinacalcet as a positive control [4]

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has requested additional documentation from Maike Auto regarding its overseas listing application, focusing on capital contributions, share transfers, and compliance with regulations [1][2] Group 1: Regulatory Requirements - CSRC requires Maike Auto to clarify the pricing and fairness of past capital increases and share transfers, as well as confirm whether capital contributions have been fully paid and if there are any breaches of capital obligations [1] - The company must provide legal opinions on the ownership structure of major shareholders and whether any entities are prohibited from holding shares under relevant laws [1][2] Group 2: Company Overview - Maike Auto is a platform-based biotechnology company focused on the innovation and development of next-generation bispecific/multispecific peptide drugs, with its core product MT1013 being the world's first dual-target receptor agonist peptide drug [3] - MT1013 is primarily developed for the treatment of secondary hyperparathyroidism (SHPT) and plans to expand its indications to include conditions like chronic kidney disease-mineral and bone disorder (CKD-MBD) with osteoporosis [3] - As of September 22, 2025, MT1013 has completed its Phase II clinical trial for SHPT and is currently in a Phase III trial using cinacalcet as a positive control [3]

Core Viewpoint - Hanyu Pharmaceutical has signed strategic investment and cooperation agreements with Shenzhen Carbon Cloud Peptide Pharmaceutical Technology Co., Ltd to enhance collaboration in peptide drug development and industrialization [1][2] Group 1: Agreements and Collaborations - The agreements include a strategic investment in Carbon Cloud Peptide and a strategic cooperation for CRDMO services in innovative drugs [1] - Previous collaboration began with a framework agreement in 2024, focusing on leveraging Hanyu's capabilities in peptide drug industrialization and Carbon Cloud's advanced technology in peptide screening using AI [1][2] - A joint development agreement for a GLP-1R/GIPR/GCGR triple agonist innovative drug project was established in May 2025, laying a solid foundation for further cooperation [1] Group 2: Project Development and Support - Hanyu Pharmaceutical will utilize its CRDMO technical platform and industrialization advantages to support multiple innovative drug projects under Carbon Cloud, including PDC peptide conjugated drugs and AI antibacterial peptides [2] - The cooperation encompasses the entire process from preclinical research to commercialization, covering key aspects such as active pharmaceutical ingredient process optimization, formulation development, quality research, registration, and large-scale production [2] - Industry analysts believe this collaboration will strengthen Hanyu's industrial synergy in the peptide CRDMO service chain and accelerate the commercialization of innovative products for Carbon Cloud, achieving resource sharing and complementary advantages [2]