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锦波生物:关于EK1雾化剂用于治疗新型冠状病毒感染的临床试验阶段性完成并取得总结报告的公告
2024-11-20 10:37
关于EK1雾化剂用于治疗新型冠状病毒感染的临床试验阶段性完成 并取得总结报告的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记 载、误导性陈述或者重大遗漏,并对其内容的真实性、准确性和完整性承担个别 及连带法律责任。 山西锦波生物医药股份有限公司(以下简称"公司")子公司北京锦波鼎 正生物医药研究有限公司开发的国家Ⅰ类化学新药EK1雾化剂用于治疗新型冠状 病毒感染的多中心临床试验已完成并取得总结报告。现将有关内容公告如下: 一、在研项目情况 证券代码:832982 证券简称:锦波生物 公告编号:2024-096 山西锦波生物医药股份有限公司 2、次要疗效指标:试验组病毒载量呈现显著下降趋势,试验组核酸转阴时 间较安慰剂组中位数时间显著缩短;用药后第4天,试验组病毒载量对比安慰剂 组显著下降;试验组至发热和呼吸道症状持续恢复时间对比安慰剂组显著缩短; 3、同时,试验组7天内症状恢复效果显著优于安慰剂组;用药后第4天试验 组病毒载量对比安慰剂组最大下降超96%; 4、安全性:本试验中,试验组和安慰剂对照组的不良事件发生率和不良反 应发生率相当,且试验组无严重不良事件发生。 EK1雾化剂是国家 ...
锦波生物(832982) - 关于EK1雾化剂用于治疗新型冠状病毒感染的临床试验阶段性完成并取得总结报告的公告
2024-11-19 16:00
证券代码:832982 证券简称:锦波生物 公告编号:2024-096 一、在研项目情况 EK1雾化剂是国家"十三五"传染病国家重大专项课题《防治重大呼吸道病 毒感染疾病的原创生物技术产品研发及战略储备》的Ⅰ类新药研究成果,是利 用病毒进入抑制原理我国自主研制的首个治疗新型冠状病毒感染的雾化吸入制 剂。 本品采用雾化吸入给药方式,直接作用于冠状病毒。经中国科学院武汉病 毒研究所、复旦大学医学分子病毒学教育部重点实验室和复旦大学P3实验室对 新型冠状病毒及其各种突变株持续进行体内外有效性研究,发现EK1雾化剂对新 型冠状病毒野生型、Delta、Omicron及Omicron全球流行过的BA.2、BF.7、XBB 系列、BQ1.1、EG5.1、JN.1、LB.1、KP.3和KP.3.1.1等突变株均能有效抑制, 具有广谱抑制新型冠状病毒的特点。 二、项目临床研究结果 EK1雾化剂于2021年9月9日获得国家药品监督管理局下发的临床试验批准通 知书。2023年5月,广州医科大学附属第一医院作为组长单位,在全国26家临床 山西锦波生物医药股份有限公司 关于EK1雾化剂用于治疗新型冠状病毒感染的临床试验阶段性完成 并取 ...
锦波生物:重组胶原蛋白研究及产业化先行者,未来增长可期
Hua Yuan Zheng Quan· 2024-11-19 09:28
Investment Rating - The report initiates coverage on Jinbo Biotech with a "Buy" rating, citing its strong position in the recombinant collagen protein market and significant growth potential [3][7] Core Views - Jinbo Biotech specializes in the research, development, and industrialization of functional proteins, particularly recombinant collagen, with a leading advantage in this sector [2] - The company's flagship product, Weiyimei, is the only injectable recombinant collagen medical device (Class III) in China, providing a high barrier to entry and competitive advantage [7][9] - Revenue and net profit are expected to grow significantly, with projected revenue of 1.392 billion, 2.051 billion, and 2.645 billion yuan for 2024-2026, and net profit of 718 million, 1.067 billion, and 1.381 billion yuan, respectively [7][9] Business Overview - Jinbo Biotech focuses on the development and commercialization of medical devices and functional skincare products using recombinant humanized collagen as the core ingredient [2][21] - The company has a robust R&D pipeline, with ongoing projects in gynecology, urology, orthopedics, and cardiovascular fields, leveraging its expertise in recombinant collagen [21][28] Financial Performance - From 2016 to 2023, the company achieved a CAGR of 47.5% in revenue and 47.9% in net profit, with gross margins consistently exceeding 80% [2][32] - The company's profitability has improved significantly, with net margins rising from 20.0% in 2020 to 38.3% in 2023, driven by the rapid market penetration of Weiyimei [32] Market Position and Competitive Advantage - Jinbo Biotech is the first company listed on the Beijing Stock Exchange specializing in recombinant collagen, with Weiyimei being the only injectable recombinant collagen product in China [9][21] - The company has established a strong competitive edge through its "R&D + Product + Channel" strategy, with a diversified product portfolio and extensive sales network [2][9] Growth Drivers - The medical device segment, particularly Weiyimei, is expected to drive revenue growth, with projected revenue increases of 85%, 50%, and 30% for 2024-2026 [8][9] - Functional skincare products are also expected to grow, with revenue increases of 30%, 20%, and 15% for the same period, supported by the company's brand-building efforts [8][9] Valuation and Peer Comparison - The company's current valuation is attractive, with a forward PE of 28x, 19x, and 14x for 2024-2026, compared to an average PE of 34x for comparable companies in 2023 [7][9] - Comparable companies include A-share listed firms like Imeik and Bloomage BioTechnology, as well as Hong Kong-listed Giant Biogene, all of which operate in the medical aesthetics and recombinant collagen sectors [9][93]
大宗交易(京)
2024-11-13 10:37
| 日期 | 代码 | 简称 | 成交价 | 成交数量(股) | 买入营业部 | 卖出营业部 | | --- | --- | --- | --- | --- | --- | --- | | 2024-11- 13 | 832522 | 纳科诺尔 | 71.01 | 50000 | 国泰君安证券股份有 限公司广东广州东风 | 粤开证券股份有限公 司广东分公司 | | | | | | | 中路营业部 | | | 2024-11- 13 | 832982 | 锦波生物 | 173 | 19000 | 中信证券股份有限公 司山西分公司 | 山西证券股份有限公 司太原府西街证券营 | | | | | | | | 业部 | ...
锦波生物:Q3业绩再超预期,产品获海外首证看好未来发展空间
ZHONGTAI SECURITIES· 2024-11-08 05:53
Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative price increase of over 15% in the next 6 to 12 months compared to the benchmark index [6]. Core Insights - The company reported a revenue of 386 million in Q3 2024, representing a year-over-year increase of 92% and a quarter-over-quarter growth of 2%. The net profit attributable to shareholders reached 210 million, up 154% year-over-year, exceeding market expectations [1]. - For the first three quarters of 2024, the company achieved a total revenue of 990 million, a 91% increase year-over-year, with a net profit of 520 million, reflecting a 170% increase compared to the same period last year [1]. - The company’s product, Wei Yi Mei, has surpassed one million units sold since its launch, and it has established a presence in over 3,000 medical beauty terminals as of the first half of 2024 [1]. - The collagen sector remains highly prosperous, with stable pricing and a declaration from the company to not authorize online platforms or social media for sales, suggesting expected price stability [1]. - The company has received its first overseas medical device registration certificate for its subcutaneous filler in Vietnam, marking a significant step in its international expansion [4]. - The company has formed a strategic partnership with L'Oréal to incorporate recombinant human collagen into its products, further enhancing its international market presence [4]. Financial Performance Summary - The company’s revenue is projected to grow significantly, with estimates of 1.412 billion for 2024, 1.977 billion for 2025, and 2.570 billion for 2026, reflecting growth rates of 81%, 40%, and 30% respectively [3]. - The net profit attributable to shareholders is expected to reach 701 million in 2024, 1.013 billion in 2025, and 1.304 billion in 2026, with year-over-year growth rates of 134%, 44%, and 29% respectively [3]. - The gross margin for Q3 was reported at 93.6%, with a year-over-year increase of 2.3 percentage points, indicating improved profitability [3]. - The company’s overall net profit margin reached 54.6%, remaining stable compared to Q2 while improving by 13% year-over-year [3]. Market Position and Future Outlook - The company is well-positioned in the high-demand collagen market, with a strong product pipeline and ongoing research and development efforts [4]. - The report highlights the importance of monitoring the progress of new product registrations and market expansions as potential catalysts for future growth [4].
锦波生物:获得境外医疗器械注册证事件点评:首个境外医疗器械注册证获批,胶原出海未来可期
EBSCN· 2024-11-07 00:44
Investment Rating - The report maintains a "Buy" rating for the company [3][5]. Core Views - The company has received its first overseas medical device registration certificate in Vietnam, marking a significant step in its international expansion [2][3]. - Vietnam's medical device market is rapidly growing, with a projected CAGR of 9.0% from 2024 to 2033, and over 90% of medical devices are imported [2][3]. - The approved product is a D-class medical device, a subcutaneous filler containing recombinant type III human collagen, aimed at correcting dynamic facial wrinkles [3]. - The company is a leader in the recombinant collagen industry in China and has showcased its products at international exhibitions, enhancing its global recognition [3]. Financial Summary - The company forecasts net profits of 749 million, 1.098 billion, and 1.479 billion yuan for 2024, 2025, and 2026 respectively, with corresponding EPS of 8.46, 12.41, and 16.71 yuan [3][4]. - Revenue is expected to grow from 1.417 billion yuan in 2024 to 2.747 billion yuan in 2026, with a growth rate of 81.63% in 2024 [4][11]. - The company's P/E ratios are projected to decrease from 27 in 2024 to 14 in 2026, indicating potential for value appreciation [4][11].
锦波生物:获批越南医疗器械注册证,开启国际化新篇章
Soochow Securities· 2024-11-07 00:32
Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - The approval of a Class D medical device registration in Vietnam marks a significant step for the company in its international expansion, particularly in the aesthetic medicine sector [2] - The company is positioned as a leader in recombinant collagen injection products, with strong clinical results and sales feedback in China, indicating substantial growth potential in overseas markets [2] - The ongoing development of a comprehensive anti-aging treatment plan and strategic partnerships to enhance brand influence are expected to support long-term growth [3] - The company has a robust pipeline of products under development, including recombinant collagen products for gynecological use and facial volumizing gels, which are progressing well through regulatory approval [3] Financial Forecast and Valuation - The company is projected to achieve total revenue of 1,434.02 million in 2024, with a year-on-year growth of 83.79% [1] - The net profit attributable to the parent company is expected to reach 733.50 million in 2024, reflecting a year-on-year increase of 144.67% [1] - The report anticipates a continued strong performance for the company, with net profits projected at 7.3 billion, 10.1 billion, and 13.0 billion for 2024, 2025, and 2026 respectively, corresponding to P/E ratios of 28, 20, and 16 [4]
锦波生物(832982) - 关于获得境外医疗器械注册证的公告
2024-11-04 16:00
证券代码:832982 证券简称:锦波生物 公告编号:2024-095 山西锦波生物医药股份有限公司 关于获得境外医疗器械注册证的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整,没有虚假记 载、误导性陈述或者重大遗漏,并对其内容的真实性、准确性和完整性承担个别 及连带法律责任。 一、基本情况 山西锦波生物医药股份有限公司(以下简称"公司")于近日获得越南 主管当局颁发的一项D类医疗器械注册证,具体情况如下: 二、医疗器械注册证主要内容 医疗器械名称:皮下填充剂 品牌名称:Ayouth 规格:2mg/瓶,4mg/瓶,6mg/瓶,8mg/瓶,10mg/瓶。 注册证编号:2402995ĐKLH/BYT-HTTB 医疗器械分类:D类 医疗器械所有人名称:山西锦波生物医药股份有限公司 医疗器械所有人地址:山西综改示范区太原唐槐园区锦波街18号 适用范围:该产品用于面部真皮组织填充以纠正额部动力性皱纹(包括 眉间纹、额头纹和鱼尾纹)。 证书签发日期:2024年11月2日 三、对公司的影响 上述产品是公司获得的首个境外重组Ⅲ型人源化胶原蛋白注射用医疗器 械,是公司拓展海外市场取得的又一重大突破,是公司产品迈向国 ...
锦波生物:24Q3归母净利2.1亿元,继续环比提升
Tianfeng Securities· 2024-10-29 11:03
Investment Rating - The investment rating for the company is "Buy" with a target price reflecting an expected return of over 20% within the next six months [4][11]. Core Views - The company, Jinbo Biological, is a leading enterprise in the field of recombinant collagen, and 2024 is expected to be a pivotal year for its commercialization efforts. The company is focusing on enhancing its C-end marketing for the Weiyimei® brand and deepening its B-end relationships with major clients [2][4]. - The company has achieved significant revenue growth, with a year-on-year increase of 91.16% in the first three quarters of 2024, reaching a total revenue of 988 million yuan [1][2]. - The company has made substantial investments in R&D, obtaining 13 invention patents in the first half of 2024, including two international patents, and has completed key research in various medical fields [1][2]. Financial Summary - For 2024, the company is projected to achieve a net profit of 712.76 million yuan, with a year-on-year growth rate of 137.75%. The expected earnings per share (EPS) for 2024 is 8.05 yuan [3][7]. - The company's revenue is forecasted to grow to 1.49 billion yuan in 2024, reflecting a growth rate of 91% compared to the previous year [3][7]. - The company's EBITDA is expected to reach 876.76 million yuan in 2024, with a significant increase in profitability metrics such as gross margin and net margin [3][7]. Market Position and Strategy - The company is expanding its product specifications and types, which has been a key driver for its growth in the medical aesthetics sector. The Weiyimei® product line has seen innovative developments aimed at high-end channels [2][4]. - The company is also focusing on building a strong consumer brand presence and enhancing customer retention through targeted marketing strategies [2][4].