| 证券代码：300406 | 证券简称：九强生物 公告编号：2026-015 | | --- | --- | | 债券代码：123150 | 债券简称：九强转债 | 北京九强生物技术股份有限公司 关于完成第一类医疗器械备案的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有 虚假记载、误导性陈述或重大遗漏。 北京九强生物技术股份有限公司（以下简称"公司"）于近日在北京市海淀 区市场监督管理局完成了第一类医疗器械的备案，具体情况如下： | 序号 | 产品名称 | | 备案号 | 备案日期 | 备案证 | 注册 | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | | 有效期 | 类别 | | | | 全自动样品处理系统 | | 京海械备 | 2026.03.31 | 长期 | Ⅰ | 用于检测前样本的离心，进 | | 1 | （型号：GLA | 1000） | 20260056 | | | | 行分析前后的处理及加工。 | 上述产品取得备案，丰富了公司在体外诊断仪器产品线的品种，有利于进一 步提升公司的核心竞 ...

| 证券代码：300406 | 证券简称：九强生物 公告编号：2026-014 | | --- | --- | | 债券代码：123150 | 债券简称：九强转债 | 北京九强生物技术股份有限公司 关于全资子公司取得医疗器械注册证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有 虚假记载、误导性陈述或重大遗漏。 北京九强生物技术股份有限公司（以下简称"公司"）的全资子公司福 州迈新生物技术开发有限公司于近日收到国家药品监督管理局颁发的《医疗 器械注册证》，具体情况如下： | 序号 | 产品名称 | 注册证编号 | 注册 类别 | 注册证有效期 | | | 预期用途 本产品用于体外定性检 | | --- | --- | --- | --- | --- | --- | --- | --- | | | 抗体试剂（免 HER2 | 国械注准 | | 自批准之日起有效期 | | | 测经 10%中性缓冲福尔 马林固定石蜡包埋乳腺 | | 1 | 疫组织化学法） | 20263400630 | Ⅲ | 至 年 月 2031 26 | 03 | 日 | 癌组织切片中的 HER2 | | | | | ...

| 证券代码：300406 | 证券简称：九强生物 | 公告编号：2026-013 | | --- | --- | --- | | 债券代码：123150 | 债券简称：九强转债 | | 北京九强生物技术股份有限公司 关于公司获得发明专利证书的公告 | 序号 | 专利号 | 专利名称 | 专利权人 | 专利类型 | 申请日期 | 授权日期 | | 证书号 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1 | ZL202211 400677.5 | 酶标记物的 制备方法 | 九强生物 | 发明 | 2019.10.30 | 2026.03.10 | 第 | 8762691 | 号 | | 2 | ZL202310 453290.4 | 他克莫司检 测试剂盒 | 九强生物 | 发明 | 2020.01.06 | 2026.03.10 | 第 | 8760513 | 号 | 上述发明专利证书的取得不会对公司近期生产经营产生重大影响，但有利于 发挥公司的知识产权优势，促进技术创新，提升公司的核心竞争力，并形成持续 创新机制。 一 ...

Investment Rating - The overall industry rating is neutral, indicating that the expected return over the next six months will be between -5% and 5% relative to the CSI 300 index [6][7]. Core Insights - The pharmaceutical sector experienced a decline of 1.12% on March 4, 2025, outperforming the CSI 300 index by 0.02 percentage points, ranking 26th among 31 sub-industries in the Shenwan classification [3]. - Notable performers in the sector included Yahui Pharmaceutical (+20.02%), Ailis (+11.17%), and Rundou Co. (+6.99%), while the worst performers were Kanghui Co. (-6.26%), Changshan Pharmaceutical (-5.89%), and Hualan Biological (-4.75%) [3]. - Priovant announced that the FDA has accepted its new drug application for Brepocitinib, granting it priority review status based on positive results from the Phase 3 VALOR study, which showed significant clinical improvement in myositis total improvement score (TIS) for the 30mg dose group [4]. Summary by Sections Market Performance - On March 4, 2025, the pharmaceutical sector's performance was -1.12%, with various sub-industries showing mixed results, including in vitro diagnostics (-0.62%) and hospitals (-0.72%) performing better than blood products (-2.16%) and offline pharmacies (-2.10%) [3]. Industry News - The FDA has accepted Priovant's application for Brepocitinib, a selective TYK2 and JAK1 dual inhibitor, which could become the first targeted therapy approved for dermatomyositis if successful [4]. - Sanyou Medical announced that its SWINGO-3D Lumbar Cage System received FDA 510(K) certification [4]. Company News - Cap Bio's subsidiary received a medical device registration certificate for its chromosome multi-STR genotyping kit [5]. - Jiukang Bio announced the approval of its blood type identification and irregular antibody screening quality control product by the National Medical Products Administration [5]. - Dongya Pharmaceutical received approval for its fumaric acid valproate tablets from the National Medical Products Administration [5].

特此公告。 北京九强生物技术股份有限公司 北京九强生物技术股份有限公司（以下简称"公司"）于近日收到国家 药品监督管理局颁发的《医疗器械注册证》，具体情况如下： | 注册 | 序号 | 产品名称 | 注册证编号 | 注册证有效期 | 预期用途 | 类别 | | | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 本产品用于北京九强生 | 物技术股份有限公司生 | | | | | | | | | | | | | | | | | | | | 产 | 的 | ABO | 正 | 反 | 定 | 型 | 及 | RhD | 血型检测卡（微柱凝 | | | | | | | | | | | | 胶法）、ABO正定型及RhD | 血型复检卡（微柱凝胶 | | | | | | | | | | | | | | | | | | | | 血型鉴定及不规则 | 国 | 械 | 注 | 准 | ...

| 证券代码：300406 | 证券简称：九强生物 公告编号：2026-011 | | --- | --- | | 债券代码：123150 | 债券简称：九强转债 | 北京九强生物技术股份有限公司 关于取得医疗器械注册证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有 虚假记载、误导性陈述或重大遗漏。 北京九强生物技术股份有限公司（以下简称"公司"）于近日收到北京 市药品监督管理局颁发的《医疗器械注册证》，具体情况如下： | 序号 | 产品名称 | 注册证编号 | | 注册 类别 | 注册证有效期 | 预期用途 | | --- | --- | --- | --- | --- | --- | --- | | 1 | 总蛋白测定试剂盒 （双缩脲法） | 京 械 注 20262400061 | 准 | Ⅱ | 自批准之日起有效期 至 2031 年 02 月 27 日 | 本试剂盒用于体外定量 测定人血清或血浆中总 蛋白（TP）的含量。 | 上述产品医疗器械注册证的取得，丰富了公司在体外诊断生化细分领域 产品线的品种，有利于进一步提升公司的核心竞争力和市场拓展能力，对公 司未来的经营将产生积极 ...

证券代码：300406 证券简称：九强生物 公告编号：2026-010 债券代码：123150 债券简称：九强转债 北京九强生物技术股份有限公司 关于持股5%以上股东减持股份计划期限届满的公告 持股5%以上的自然人股东ZHOU XIAOYAN女士保证向本公司提供的信息内容真实、 准确、完整，没有虚假记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提供的信息一致。 北京九强生物技术股份有限公司(以下简称"公司"或"九强生物")于 2025年11月11日披露了《关于持股5%以上股东减持股份计划预披露公告》（公 告编号：2025-102）持有公司股份30,769,636股（占当时公司总股本比例为 5.25%，占当时剔除公司回购账户股份后总股本比例为5.28%，）的自然人股 东ZHOU XIAOYAN女士计划自上述预披露公告披露之日起十五个交易日后的三 个月内（即2025年12月3日至2026年3月2日）以集中竞价和/或大宗交易方式 减持本公司股份，计划减持数量不超过2,214,173股（占当时公司总股本比 例为0.38%，占当时剔除公司回购账户股份后总股本比例为0.38%）。 上述减 ...

Regulatory Updates - In 2025, the National Medical Products Administration (NMPA) received 457 special approval applications for innovative medical devices, with 104 approved for special review and 38 priority applications, of which 26 were granted priority approval [1] - By the end of 2025, 475 traditional Chinese medicine production bases passed inspections, covering nearly 1.24 million acres and providing 101 types of Chinese medicinal materials for 215 production enterprises [2] Company Announcements - Shanghai Pharmaceuticals announced that its pregabalin capsules received a drug registration certificate from the Philippines, with a total sales amount of $13.37 million for three specifications [2] - Jiukang Bio received a medical device registration certificate for its albumin assay kit, valid until February 12, 2031 [3] Clinical Research - Eli Lilly's orforglipron demonstrated superior efficacy in glycemic control and weight loss compared to oral semaglutide in a head-to-head study involving 1,698 participants [4][5] - The study results were published in The Lancet, indicating significant improvements in A1C and weight reduction with orforglipron [5] Financial Performance - Baili Tianheng reported a net loss of 1.051 billion yuan for 2025, a significant decline from the previous year, with total revenue of 2.520 billion yuan, down 56.72% [8] - Junshi Biosciences achieved a total revenue of 2.498 billion yuan in 2025, a year-on-year increase of 28.23%, but reported a net loss of 874 million yuan [8] - Yifang Bio reported a net loss of 317 million yuan for 2025, with total revenue of 37.3253 million yuan, down 77.89% [9] - Nanmo Bio's total revenue for 2025 was 421.2586 million yuan, up 10.50%, with a net profit increase of 399.29% to 32.4313 million yuan [10]

| 证券代码：300406 | 证券简称：九强生物 公告编号：2026-009 | | --- | --- | | 债券代码：123150 | 债券简称：九强转债 | 2026年2月27日 | 序号 | 产品名称 | 注册证编号 | 注册 类别 | 注册证有效期 | 预期用途 | | --- | --- | --- | --- | --- | --- | | 1 | 白蛋白测定试剂盒 （溴甲酚绿法） | 京 械 注 准 20262400050 | Ⅱ | 自批准之日起有效期 至 2031 年 02 月 12 日 | 本试剂盒用于体外定量 测定人血清和血浆中的 白蛋白（ALB）含量。 | 上述产品医疗器械注册证的取得，丰富了公司在体外诊断生化细分领域 产品线的品种，有利于进一步提升公司的核心竞争力和市场拓展能力，对公 司未来的经营将产生积极影响。上述产品实际销售情况取决于未来市场推广 效果，公司目前尚无法预测其对公司未来业绩的影响，敬请投资者注意投资 风险。 特此公告。 北京九强生物技术股份有限公司 董事会 北京九强生物技术股份有限公司 关于取得医疗器械注册证书的公告 本公司及董事会全体成员保证信息披露的内容真 ...

Group 1 - The core viewpoint of the news is that Jiukang Bio has experienced a decline in both revenue and net profit for the first nine months of 2025, with a significant drop of 18.24% in revenue and 27.03% in net profit year-on-year [2] - As of February 25, Jiukang Bio's financing balance reached 2.08 billion yuan, with a net financing outflow of 137.65 million yuan on that day, indicating a high level of financing activity [1] - The company has a diverse revenue structure, with 95.09% of its income coming from in vitro diagnostic reagents, while other segments contribute significantly less [1] Group 2 - As of September 30, 2025, Jiukang Bio had 18,100 shareholders, a decrease of 2.48% from the previous period, while the average number of circulating shares per person increased by 2.54% to 23,502 shares [2] - The company has distributed a total of 1.33 billion yuan in dividends since its A-share listing, with 701 million yuan distributed over the past three years [3] - Among the top ten circulating shareholders, Huabao Zhongzheng Medical ETF holds 8.3446 million shares, having reduced its holdings by 1.4085 million shares compared to the previous period [3]