科兴制药(688136.SH)：针对GDF15靶点的创新型药 物GB18注射液临床试验注册申请获受理 智通财经APP讯，科兴制药(688136.SH)发布公告，近日，公司全资子公司深圳科兴药业有限公司("深圳 科兴")收到国家药品监督管理局("国家药监局")行政许可文书《受理通知书》，深圳科兴申报的"GB18 注射液"临床试验申请已获得受理。 据悉，GB18是一种针对GDF15(生长分化因子15)靶点的创新型药物，专门用于治疗肿瘤恶病质。该分 子采用了独特的Fc融合纳米抗体结构设计，不仅提高了药物的稳定性和生物利用度，还显著增强了其在 抑制信号通路传递中的表现。 公司GB18对标全球领先同靶点同适应症，临床前数据显示，GB18具有明显的差异化优势。体内实验表 明，通过阻断GDF15信号通路，GB18能够有效逆转肿瘤恶病质导致的体重减轻;能显著提高模型动物的 肌肉和脂肪重量，改善肌肉纤维的质量。实验结果显示，接受GB18治疗的恶病质动物比对照组表现出 更强的运动能力，以及和正常动物相近的机体能量代谢指标。此外，基于临床前药代动力学(PK)数据， GB18预计可实现每3~4周/次的皮下注射频率，大幅减少患者的用药 ...

本公司董事会、全体董事保证本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。 科兴生物制药股份有限公司（以下简称"公司"） 董事会于 2025 年 3 月 14 日收到公司实际控制人、董事长邓学勤先生《关于提议科兴生物制药股份有限公 司回购公司股份的函》。邓学勤先生提议公司以自有资金和回购专项贷款通过上 海证券交易所交易系统以集中竞价交易方式回购公司股份，具体内容如下： 证券代码：688136 证券简称：科兴制药 公告编号：2025-005 科兴生物制药股份有限公司 关于公司实际控制人兼董事长提议回购公司股份的公告 一、提议人的基本情况及提议时间 1、提议人：公司实际控制人、董事长邓学勤先生 2、提议时间：2025 年 3 月 14 日 二、提议人提议回购股份的原因和目的 基于对公司未来发展的信心和对公司价值的认可，为了进一步建立、健全公 司长效激励机制，吸引和留住优秀人才，充分调动公司员工的积极性和创造性， 并增强投资者对公司的投资信心，紧密结合公司利益、股东利益与员工利益，促 进公司健康可持续发展，结合公司经营情况及财务状况等因素，邓学勤先生提议 ...

证券代码：688136 证券简称：科兴制药 公告编号：2025-006 科兴生物制药股份有限公司 关于以集中竞价交易方式回购公司股份方案的公告 本公司董事会及全体董事保证本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。 重要内容提示： ● 回购股份价格：不超过人民币 29.77 元/股（含）， 该价格不高于公司董事会通 过回购决议前 30 个交易日公司股票交易均价的 150%。 ● 相关股东是否存在减持计划：截至回购预案披露日，公司董事、监事、高级管 理人员、控股股东、实际控制人、回购股份提议人、持股 5%以上的股东在未来 3 个月、未来 6 个月内暂不存在减持公司股份的计划。若未来拟实施股份减持计划， 将严格按照中国证监会、上海证券交易所有关法律、法规及规范性文件的相关规 定及时告知公司并履行相关信息披露义务。 ● 相关风险提示： 1、本次回购股份存在回购期限内公司股票价格持续超出回购价格上限，导致 回购方案无法实施或只能部分实施的风险； 2、若公司在实施回购股份期间，受外部环境变化、公司临时经营需要、投资 等因素影响，致使本次回购股份所需资金未能 ...

证券代码：688136 证券简称：科兴制药 公告编号：2025-004 科兴生物制药股份有限公司 第二届董事会第二十一次会议决议公告 本公司董事会及全体董事保证本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。 一、董事会会议召开情况 科兴生物制药股份有限公司 董事会 经各位董事认真审议，会议形成了如下决议： （一）审议通过《关于以集中竞价交易方式回购公司股份方案的议案》 经审议，董事会同意公司使用自有资金和回购专项贷款通过集中竞价交易方 式回购公司已发行的部分人民币普通股（A 股）股票。本次回购股份在未来适宜 时机用于股权激励或员工持股计划，回购价格不超过 29.77 元/股（含），回购资 金总额不低于人民币 3,000 万元（含），不超过人民币 6,000 万元（含），具体回 购资金总额以实际使用的资金总额为准。同时，为顺利、高效完成公司本次回购 股份事项的相关工作，董事会授权公司管理层在法律法规、《公司章程》允许的 范围内办理本次回购股份的相关事宜。根据相关法律法规及《公司章程》的有关 规定，本次回购股份方案无需提交公司股东大会审议。 具体内容详 ...

Financial Performance - The company achieved total operating revenue of 140,675.89 million yuan, representing a year-on-year increase of 11.73%[3]. - The net profit attributable to the parent company was 3,153.15 million yuan, a significant turnaround from a loss of 19,029.03 million yuan in the previous year[3]. - The basic earnings per share increased to 0.16 yuan from a loss of 0.96 yuan in the previous year[3]. - The weighted average return on net assets improved to 1.94%, an increase of 13.05 percentage points compared to the previous year[3]. - Total assets at the end of the reporting period were 316,190.03 million yuan, up 4.32% from the beginning of the period[3]. Cost Management - The company effectively controlled operating costs, leading to a decrease in sales, research and development, and production costs[7]. Revenue Sources - The significant growth in overseas revenue was driven by sales of paclitaxel albumin in the EU region[7]. Non-Recurring Gains and Losses - Non-recurring gains and losses were positively impacted by government subsidies and changes in the fair value of private equity funds held by the company[8]. - The company is currently awaiting the audit report and final valuation of its private equity fund, which may affect its non-recurring gains and losses for 2024[9]. Financial Reporting - The financial data presented is preliminary and subject to final confirmation in the annual report[2].

Group 1 - The core point of the article is the strategic cooperation between Sinovac Biotech and Zhejiang Jiuying Technology, a wholly-owned subsidiary of Baicheng Pharmaceutical, focusing on innovative drug development and overseas commercialization [1] Group 2 - The signing ceremony for the strategic cooperation took place on February 24 in Shenzhen [1] - The collaboration presents opportunities for both companies to establish deep and diversified strategic partnerships in multiple fields [1]

证券代码：688136 证券简称：科兴制药 公告编号：2025-002 科兴生物制药股份有限公司 自愿披露关于人干扰素α1b 吸入溶液 获得美国 FDA 新药临床试验许可的公告 本公司董事会及全体董事保证本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。 近日，科兴生物制药股份有限公司（以下简称"公司"）全资子公司深圳科 兴药业有限公司（以下简称"深圳科兴"）收到美国食品药品监督管理局（以下 简称"FDA"）的通知，深圳科兴自主研发的人干扰素α1b吸入溶液药品临床试 验申请已获得FDA批准，可在美国开展临床试验，适应症为小儿呼吸道合胞病毒 性下呼吸道感染（肺炎、毛细支气管炎）。现将相关情况公告如下： 一、许可基本情况 药品名称：人干扰素α1b吸入溶液 公司人干扰素α1b吸入溶液适应症为小儿呼吸道合胞病毒性下呼吸道感染 （肺炎、毛细支气管炎）。呼吸道合胞病毒（RSV）是引起婴幼儿急性呼吸道感 染最常见的病毒病原，5岁以下儿童为易感人群，特别是婴幼儿或有基础疾病的 患儿，感染后容易发展为重症肺炎，WHO关于儿童急性呼吸道感染的病因学研究 1 表明，RSV感 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [4] Core Views - The company is expected to turn profitable in 2024, with a projected revenue growth of over 10% year-on-year and a net profit of approximately 30 million yuan [4] - The overseas revenue is anticipated to grow by over 60% year-on-year, driven by the approval of albumin paclitaxel in the EU, which has opened and deepened the EU market [4][5] - The company is focusing on cost reduction and efficiency improvement, with decreases in sales, R&D, and production costs compared to 2024 [4] - Long-term growth is expected as the company continues to introduce products and expand its overseas business [4] Financial Summary - Revenue is projected to increase from 1,316 million yuan in 2022 to 2,412 million yuan in 2026, reflecting a compound annual growth rate (CAGR) of approximately 31.3% [6] - The net profit is expected to recover from a loss of 90 million yuan in 2022 to a profit of 228 million yuan in 2026 [6] - The earnings per share (EPS) is forecasted to rise from -0.45 yuan in 2022 to 1.14 yuan in 2026 [6] - The price-to-earnings (P/E) ratio is projected to decrease from -37.8 in 2022 to 15.0 in 2026, indicating improved valuation as profitability returns [6]

Financial Performance - The company expects to achieve a net profit of approximately 30 million yuan for 2024, a turnaround from a net loss of 190.29 million yuan in the same period last year[3]. - The net profit attributable to the parent company, excluding non-recurring gains and losses, is projected to be around 33 million yuan, compared to a loss of 201.21 million yuan last year[3]. - Revenue is expected to grow by over 10% compared to the previous year, with overseas sales increasing by over 60% due to the commercialization strategy in the EU market[5][6]. Market Strategy - The company has successfully launched paclitaxel in the EU, significantly enhancing its market presence[5]. - Domestic market revenue is showing steady growth, supported by refined management and targeted marketing strategies[6]. Cost Management - Sales, research and development expenses, and production costs have all decreased compared to the previous year, contributing to improved profitability[6]. Non-Recurring Items - The company received government subsidies and experienced changes in the fair value of its private equity fund holdings, impacting non-recurring gains and losses[6]. Financial Reporting - The financial data provided is preliminary and has not yet been audited by external accountants, which may affect the final reported figures[7][8]. - The company emphasizes the importance of monitoring investment risks related to the preliminary financial data[8].

Group 1 - The core viewpoint of the news is that Kexing Pharmaceutical is making significant progress in overseas commercialization, with multiple product approvals and collaborations announced in December 2025, indicating a strong push into international markets [1] - Kexing Pharmaceutical has entered into a partnership with Jiangxi Kairui Pharmaceutical, a subsidiary of Qingfeng Pharmaceutical Group, to introduce Enzalutamide Soft Capsules in 11 countries and regions, including Brazil, Argentina, and Colombia [1][2] - The collaboration on Enzalutamide Soft Capsules marks the second product partnership between Kexing and Qingfeng, following the earlier agreement on Olaparib tablets in April 2024 [1] Group 2 - Enzalutamide is a drug targeting advanced prostate cancer, particularly for high-risk non-metastatic castration-resistant prostate cancer (NM-CRPC) and symptomatic metastatic castration-resistant prostate cancer (CRPC) patients [2] - In 2022, there were 1.467 million new cases of prostate cancer globally, making it the second most common cancer among men, with incidence rates increasing with age [2] - The global incidence of prostate cancer increased by 42% from 2007 to 2017, with Brazil reporting 62 new cases per 100,000 men [2] Group 3 - Enzalutamide is recognized as a new generation treatment for prostate cancer, with significant efficacy and safety, and it is the most comprehensive androgen receptor inhibitor for prostate cancer indications [3] - The global sales of Enzalutamide exceeded $5 billion in 2023, indicating a substantial market demand [3] - The partnership between Kexing and Qingfeng aims to leverage their strengths for mutual growth and to benefit more patients, enhancing Kexing's product line in oncology [3]