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我武生物:关于获得屋尘螨膜剂临床试验申请受理通知书的公告
2024-09-26 09:51
证券代码:300357 证券简称:我武生物 公告编号:2024-025 号 浙江我武生物科技股份有限公司 关于获得屋尘螨膜剂临床试验申请受理通知书的公告 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。 日前,浙江我武生物科技股份有限公司(以下简称"公司")获得国家药品 监督管理局发出的《受理通知书》,由公司提交的"屋尘螨膜剂"(以下简称"本 品")药物临床试验申请已获得正式受理。现将有关内容公告如下: 一、基本情况 注册分类:治疗用生物制品1类 申请事项:境内生产药品注册临床试验 剂型:膜剂 适应症:作为特异性免疫治疗方式,用于尘螨致敏相关的变应性鼻炎(伴或 不伴过敏性结膜炎、过敏性哮喘)的成人患者。 药品注册申请人:浙江我武生物科技股份有限公司 根据《中华人民共和国行政许可法》第三十二条的规定,经审查,决定予以 受理。 二、后续流程 根据《药品注册管理办法》的规定,国家药品监督管理局药品审评中心(以 下简称"药品审评中心")将对已受理的药物临床试验申请进行审评,对药物临 床试验申请应当自受理之日起六十日内决定是否同意开展,并通过药品审评中心 网站通知申请人审 ...
我武生物:营收稳健增长,新品销售持续放量
Tebon Securities· 2024-09-17 04:03
[Table_Main] 证券研究报告 | 公司点评 我武生物(300357.SZ) 2024 年 09 月 16 日 买入(维持) 所属行业:医药生物/生物制品 当前价格(元):16.78 证券分析师 周新明 资格编号:S0120524060001 邮箱:zhouxm@tebon.com.cn 吴明华 资格编号:S0120524050002 邮箱:wumh3@tebon.com.cn 市场表现 -57% -46% -34% -23% -11% 0% 11% 2023-09 2024-01 2024-05 我武生物 沪深300 | --- | --- | --- | --- | |--------------------------------|--------|--------|--------| | 沪深 300 对比 | 1M | 2M | 3M | | 绝对涨幅 (%) | -13.24 | -12.05 | -22.85 | | 相对涨幅 (%) | -7.77 | -2.94 | -12.05 | | 资料来源:德邦研究所,聚源数据 | | | | 相关研究 1.《 我武生物(300357.SZ) ...
我武生物:关于公司涉及诉讼事项的进展公告
2024-09-09 09:37
证券代码:300357 证券简称:我武生物 公告编号:2024-024 号 浙江我武生物科技股份有限公司 关于公司涉及诉讼事项的进展公告 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。 重要内容提示: 1、案件所处的诉讼阶段:一审立案,尚未开庭 2、上市公司所处的当事人地位:原告 3、涉案的金额:10,961,305.35 元及利息 3,215,093.51 元(暂计) 4、对上市公司损益产生的影响:因本次诉讼尚未开庭审理,本次诉讼事项 对公司本期利润或期后利润的影响尚具有不确定性。 浙江我武生物科技股份有限公司(以下简称"公司"或"原告")已就上海 利合股权投资合伙企业(有限合伙)违反承诺减持公司股票事项向上海市浦东新 区人民法院(以下简称"法院")提起诉讼,并于 2024 年 7 月 5 日收到法院发 出的立诉前调解案号为(2024)沪 0115 民诉前调 66428 号的通知,详见公司于 2024 年 7 月 8 日披露的《关于公司涉及诉讼的公告》(公告编号:2024-017 号)。 近日,公司收到法院发出的案号为(2024)沪 0115 民初 8171 ...
我武生物:关于联营公司在研产品获得临床试验总结报告的公告
2024-08-30 07:58
证券代码:300357 证券简称:我武生物 公告编号:2024-023 号 日前,浙江我武生物科技股份有限公司(以下简称"公司")的联营公司上 海凯屹医药科技有限公司(以下简称"凯屹医药")研发的"吸入用苦丁皂苷 A 溶液"完成了"单/多次给药在中重度慢性阻塞性肺疾病患者中的开放、安全性 和药效学研究",并形成了临床试验总结报告。现将有关内容公告如下: 一、基本情况 浙江我武生物科技股份有限公司 关于联营公司在研产品获得临床试验总结报告的公告 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。 药物名称:吸入用苦丁皂苷A溶液 注册分类:化学药品第1类 剂型:吸入溶液 适应症:慢性阻塞性肺疾病 临床试验批准通知书编号:2021LP00320 临床试验分期:Ib期临床试验 研究方法:开放、单/多次给药、多中心 申办方:上海凯屹医药科技有限公司 研究组长单位:上海市第一人民医院 二、试验结果 的4小时达到FEV1峰值。同时,作为一种全新机制治疗COPD的药物,本研究周 期短,尚不足以充分观察本品在非临床研究中体现出的抗炎效果。 根据以上结果,支持吸入用苦丁皂苷A溶液在人 ...
我武生物:粉尘螨滴剂稳健增长,下半年为粉尘螨发病旺季,环比有望增长
GOLDEN SUN SECURITIES· 2024-08-28 13:13
证券研究报告 | 半年报点评 gszqdatemark 2024 08 28 年 月 日 我武生物(300357.SZ) 粉尘螨滴剂稳健增长,下半年为粉尘螨发病旺季,环比有望增长 事件:公司发布 2024 年半年报。2024H1,公司收入 4.29 亿元,同比 +11.12%;实现归母净利润 1.49 亿元,同比+0.42%;扣非后归母净利润 1.42 亿元,同比-0.69%。 2024Q2,公司收入 2.13 亿元,同比+4.85%,环比-1.5%;归母净利润 0.72 亿元,同比-7.81%,环比-6.71%。 拆分看,粉尘螨滴剂稳健增长,黄花蒿粉滴剂新品导入迅速放量。公司上 半年分版块看:1)粉尘螨滴剂收入 4.11 亿元,同比+9.36%,下半年为 粉尘螨发病旺季,环比有望增长;2)黄花蒿粉滴剂收入 0.12 亿元,同比 +103.74%,放量迅猛。 公司核心产品粉尘螨滴剂上半年稳健增长,考虑粉尘螨过敏具有一定季节 性,预计下半年会环比增长。上半年粉尘螨滴剂收入 4.11 亿元,同比稳 健增长。粉尘螨滴剂用于粉尘螨过敏引起的过敏性鼻炎和过敏性哮喘的脱 敏治疗。粉尘螨适宜的生存条件是温度 20℃-30℃ ...
我武生物(300357) - 我武生物投资者关系管理信息
2024-08-25 09:18
证券代码:300357 证券简称:我武生物 浙江我武生物科技股份有限公司投资者关系活动记录表 编号:2024-005 | --- | --- | --- | --- | |--------------|---------------|-------------------------|----------| | | □特定对象调研 | □分析师会议 | 媒体采访 | | 投资者关系活 | | | | | | □业绩说明会 □ | 新闻发布会 | 路演活动 | | 动类别 | | | | | | □现场参观 | ■其他(分析师电话会议) | | 参与单位名称 及人员姓名 共 59 家机构共计 72 名人员参加,详见附件。 时间 2024 年 8 月 23 日 15:00-15:35 地点 电话会议 上市公司接待 董事长:胡赓熙;总经理:何建明;副总经理/董事会秘书:管祯 人员姓名 玮。 一、经营情况介绍: 2024 年上半年公司经营情况处在复苏中,报告期内,公司实 现营业收入为 429,257,047.81 元,较上年同期增长 11.12%,归属 投资者关系活 于上市公司股东的净利润为 149,230,994. ...
我武生物2024半年报点评:高基数下增速放缓,关注三季度表现
Guotai Junan Securities· 2024-08-24 14:19
国泰君安版权所有发送给上海东方财富金融数据服务有限公司.东财接收研报邮箱.ybjieshou@eastmoney.com p1 股 票 研 究 公 司 更 新 报 告 证 券 研 究 报 告 ——我武生物 2024 半年报点评 股票研究 /[Table_Date] 2024.08.24 | --- | |-------------------| | | | 丁丹 ( 分析师 ) | | 0755-23976735 | | dingdan@gtjas.com | | S0880514030001 | | --- | --- | |-----------------------|-------| | | | | 谈嘉程 ( 分析师 ) | | | 021-38038429 | | | tanjiacheng@gtjas.com | | | S0880523070004 | | 本报告导读: 公司 2024Q2 受基数影响增速环比放缓,2024Q3 有望在 2023Q3 的低基数上实现复 苏,同时黄花蒿滴剂市场推广成果有望在 2024Q3 得到初步验证,维持增持评级。 投资要点: [Table_Summary] 维 ...
我武生物:监事会决议公告
2024-08-22 09:43
证券代码:300357 证券简称:我武生物 公告编号:2024-022 号 浙江我武生物科技股份有限公司 第五届监事会第六次会议决议公告 本公司及监事会全体成员保证信息披露内容的真实、准确和完整,没有虚假记 载、误导性陈述或重大遗漏。 一、监事会会议召开情况 浙江我武生物科技股份有限公司(以下简称"公司")第五届监事会第六次会议通 知于 2024 年 8 月 12 日以邮件方式发出。会议于 2024 年 8 月 22 日在公司上海分公司会 议室(上海市钦江路 333 号 40 号楼 5 楼)以现场方式召开。会议应出席监事 3 人,实 际出席监事3人。会议由监事会主席金桃女士召集并主持,公司董事会秘书列席了会议。 本次会议的召集、召开符合《中华人民共和国公司法》等有关法律、行政法规、部门规 章、规范性文件和《公司章程》的规定。 二、监事会会议审议情况 经与会监事认真审议,通过如下决议: (一)审议通过《公司 2024 年半年度报告及其摘要》 经审核,监事会认为董事会编制和审核的《公司 2024 年半年度报告》与《公司 2024 年半年度报告摘要》的程序符合法律、行政法规和中国证监会的规定,报告内容真实、 准确、 ...
我武生物:非经营性资金占用及其他关联资金往来情况汇总表(2024年6月30日)
2024-08-22 09:43
| 非经营性往头 | ┣经营性往 | 经营性往 | 非经营性往 | F经营性往 | 经营性往来 | | | | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 与用性质 | 经营性往 | | | | | | | | | | | | | | | | | | | | 经营性往头 | 非经营性占 | | | | | | | | | | | | | | | | | | | | 营性占 | | | | | | | | | | | | | | | | | | | | | F经营性占 | | | | | | | | | | | | | | | | | | | | | न | TT | 生来性 | - | 非经营性 | | 非经营性 | 17 70 | | | | | | | | | | | | | | ┣经 | | | | | | | | | | | | | | | | | | | ...
我武生物(300357) - 2024 Q2 - 季度财报
2024-08-22 09:43
Product Performance - The main product "Dust Mite Drops" significantly contributes to revenue, accounting for a large proportion of total sales[5]. - The company plans to enhance the promotion of "Artemisia Pollen Allergen Sublingual Drops" to accelerate its large-scale sales[5]. - Sales revenue from the main product, "Dust Mite Drops," was ¥411,400,335.75, up 9.36% year-on-year[32]. - Sales revenue from the "Artemisia Pollen Sublingual Drops" reached ¥12,266,312.01, marking a significant growth of 103.74% due to increased marketing efforts in northern markets[32]. - The total allergen activity for the Artemisia Pollen Sublingual Drops is reported at 16,000 BU/ml, indicating a high potency for treating related allergic conditions[27]. Financial Performance - The company's operating revenue for the reporting period was ¥429,257,047.81, representing an increase of 11.12% compared to the same period last year[14]. - The net profit attributable to shareholders was ¥149,230,994.02, showing a slight increase of 0.42% year-on-year[14]. - The net cash flow from operating activities decreased by 37.66% to ¥102,261,817.01 compared to the previous year[14]. - Total assets at the end of the reporting period reached ¥2,681,607,721.02, an increase of 4.66% from the end of the previous year[14]. - The weighted average return on equity decreased to 6.65%, down from 7.30% in the previous year[14]. Research and Development - The company is actively expanding its research and development in the field of natural drugs, particularly focusing on new antibiotics to combat multi-drug resistant bacteria, which poses a significant public health challenge globally[24]. - The company has developed a proprietary stem cell culture system and a series of core technologies, including biomimetic culture technology, to enhance the medical potential of stem cells[22]. - Research and development investment amounted to ¥61,227,252.73, accounting for 14.26% of total revenue, with a year-on-year increase of 13.52%[38][41]. - The company plans to continue clinical research for "Ragweed Pollen Skin Prick Liquid" and "Dog Dander Skin Prick Liquid" to improve their sensitivity metrics[35]. Regulatory Environment - Regulatory changes in the pharmaceutical industry are tightening, which may affect operational risks; the company will focus on compliance and risk management[3]. - The regulatory environment for the biopharmaceutical industry in China is tightening, with new policies aimed at enhancing quality management and increasing entry barriers for pharmaceutical companies[21]. - The National Medical Products Administration (NMPA) has implemented new guidelines for clinical trials and drug approval processes, aiming to complete reviews within 30 working days for innovative drugs[20]. - The NMPA has issued multiple new regulations in 2024, including guidelines for non-clinical research on human stem cell products, which will further standardize the industry[20]. Market Position and Strategy - The company maintains a leading position in the sublingual desensitization treatment market, with only its "Dust Mite Drops" and "Artemisia Pollen Sublingual Drops" approved for nationwide sale in China[22]. - The company is addressing the risk of concentrated product sales by diversifying its product offerings and strengthening market presence[5]. - The company is positioned to benefit from the expanding pharmaceutical manufacturing sector supported by government policies and rising disposable incomes[18]. - The company is expected to leverage the favorable regulatory changes to enhance its competitive edge in the biopharmaceutical market[21]. Social Responsibility and Community Engagement - The company provided a donation of up to 12,000 bottles of "Artemisia Pollen Allergen Sublingual Drops" and cash not exceeding RMB 700,040 to the Beijing Kangmeng Charity Foundation for allergy treatment assistance[84]. - In March 2024, the company signed a supplementary agreement to donate up to 24,000 bottles of the same product and cash not exceeding RMB 880,000 to assist patients in Shanxi and Shaanxi provinces[84]. - The company actively engages in social responsibility initiatives, including support for patients with allergic diseases[83]. Environmental Compliance - The company strictly adheres to multiple environmental protection laws and standards, including the Air Pollution Prevention and Control Law and the Water Pollution Prevention and Control Law[68]. - The company reported no exceedances in pollutant emissions during the reporting period[69]. - The company has established a wastewater treatment facility that meets discharge standards, with online monitoring systems in place for real-time pollution factor tracking[73]. - The company has committed to environmental responsibility and has implemented various measures to ensure compliance with environmental standards[68]. Governance and Compliance - The company has revised its board meeting rules to enhance governance and operational efficiency, approved by the board and shareholders[64]. - The company has made strategic moves to solidify its governance and compliance, ensuring transparent communication with investors[101]. - The company has not engaged in any major related party transactions during the reporting period, reflecting a focus on operational integrity[89]. - The company has not reported any penalties or corrective actions, indicating compliance with regulations[88]. Shareholder Engagement - The company has committed to distributing cash dividends exceeding 30% of the net profit attributable to shareholders annually since its listing, with a planned cash dividend of ¥1.85 per 10 shares for 2023[63]. - Cumulative cash dividends distributed to shareholders have reached nearly ¥800 million[63]. - The annual shareholders' meeting had a participation rate of 54.63%[65]. - The company reported a profit distribution of 104.72 million, indicating a focus on shareholder returns despite the overall income decline[134].