Workflow
REMEGEN(688331)
icon
Search documents
荣昌生物(688331) - 华泰联合证券有限责任公司关于荣昌生物制药(烟台)股份有限公司2024年度持续督导现场检查报告
2025-04-25 09:42
经中国证券监督管理委员会《关于同意荣昌生物制药(烟台)股份有限公司 首次公开发行股票注册的批复》(证监许可〔2022〕62 号)批复,荣昌生物制药 (烟台)股份有限公司(以下简称"荣昌生物"、"上市公司"、"公司")首次公 开发行人民币普通股(A 股)股票 54,426,301 股,每股面值人民币 1 元,每股发 行价格人民币 48.00 元,募集资金总额为人民币 2,612,462,448.00 元,扣除发行 费用后,实际募集资金净额为人民币 2,505,945,496.76 元。本次发行证券已于 2022 年 3 月 31 日在上海证券交易所上市。华泰联合证券有限责任公司(以下简称"华 泰联合"、"保荐机构")担任其持续督导保荐机构,持续督导期间为 2022 年 3 月 31 日至 2025 年 12 月 31 日。 持续督导现场检查报告 华泰联合证券有限责任公司 关于荣昌生物制药(烟台)股份有限公司 2024年度持续督导现场检查报告 上海证券交易所: 根据中国证监会《证券发行上市保荐业务管理办法》和《上海证券交易所科 创板上市公司自律监管指引第 1 号——规范运作》《上海证券交易所上市公司自 律监管指引 ...
荣昌生物(688331) - 荣昌生物关于参加2024年度科创板创新药行业集体业绩说明会的公告
2025-04-25 08:46
| 证券代码:688331 | 证券简称:荣昌生物 | 公告编号:2025-018 | | --- | --- | --- | | 港股代码:09995 | 港股简称:榮昌生物 | | 荣昌生物制药(烟台)股份有限公司 关于参加 2024 年度科创板创新药行业 集体业绩说明会的公告 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、准确性和完整性承担法律责任。 重要内容提示: 投资者可于 2025 年 4 月 28 日(星期一)至 5 月 7 日(星期三)16:00 前 登录上证路演中心网站首页,点击"提问预征集"栏目或通过荣昌生物制药(烟 台)股份有限公司(以下简称"公司")邮箱 ir@remegen.com 进行提问。公司将 在说明会上对投资者普遍关注的问题进行回答。 公司已于 2025 年 3 月 28 日发布公司 2024 年年度报告,为便于广大投资者 更全面深入地了解公司 2024 年度经营成果、财务状况,公司计划于 2025 年 05 月 08 日(星期四)15:00-17:00 参加由上海证券交易所主办的 2024 年度科创板 创新药行业集体业 ...
4月24日汇添富医疗服务灵活配置混合A净值增长1.25%,近3个月累计上涨30.6%
Sou Hu Cai Jing· 2025-04-24 11:13
金融界2025年4月24日消息,汇添富医疗服务灵活配置混合A(001417) 最新净值1.5450元,增长1.25%。 该基金近1个月收益率18.21%,同类排名2|8;近3个月收益率30.60%,同类排名1|8;今年来收益率 28.32%,同类排名1|8。 汇添富医疗服务灵活配置混合A股票持仓前十占比合计64.17%,分别为:恒瑞医药(10.23%)、科伦药 业(9.09%)、百利天恒(8.94%)、海思科(8.27%)、信立泰(6.66%)、泽璟制药-U(6.10%)、新 诺威(4.69%)、荣昌生物(3.49%)、诺诚健华-U(3.35%)、微电生理(3.35%)。 公开资料显示,汇添富医疗服务灵活配置混合A基金成立于2015年6月18日,截至2025年3月31日,汇添 富医疗服务灵活配置混合A规模44.08亿元,基金经理为张韡。 简历显示:张韡女士:中国。康奈尔大学生物医学硕士,曾任东方证券医药助理研究员,汇添富基金医药研 究员、高级医药研究员及医药行业研究组组长。2021年9月29日起任汇添富香港优势精选混合型证券投 资基金基金经理。2022年10月21日担任汇添富达欣灵活配置混合型证券投资基金基金 ...
港股开盘,医药板块持续走强,港股通医药ETF(159776),港股创新药ETF(159567)涨超均超2%。荣昌生物,诺诚健华领涨
Xin Lang Cai Jing· 2025-04-22 02:05
Core Viewpoint - The Hong Kong Innovation Drug Index (987018) has shown a strong upward trend, indicating a positive market sentiment towards biotech companies in the region, particularly in the innovative drug sector [1] Group 1: Market Performance - As of April 22, 2025, the Hong Kong Innovation Drug Index increased by 4.45%, with notable gains from individual stocks such as Rongchang Biotech (09995) up by 10.06%, Kangzhi Pharmaceutical (00867) up by 5.58%, and Lepu Biotech-B (02157) up by 5.05% [1] - The Hong Kong Innovation Drug ETF (159567) rose by 1.94%, marking its third consecutive increase, with a latest price of 1.21 yuan [1] - Over the past two weeks, the Hong Kong Innovation Drug ETF has accumulated a total increase of 4.96% [1] - The ETF experienced a turnover rate of 5.72% during the trading session, with a transaction volume of 72.48 million yuan [1] - The average daily transaction volume for the ETF over the past week was 531 million yuan, with a scale growth of 83.05 million yuan [1] Group 2: Industry Insights - Huaxin Securities highlighted that in areas such as antibodies, ADCs, and bispecific antibodies, Chinese biotech companies have established a technological advantage from the initial stages of research and development [1] - The industry is continuously exploring new targets and combinations, leading to an increasing proportion of globally leading or optimal innovations [1] - The domestic policy environment for innovative drugs is improving, with a focus on establishing a diversified payment system and refining the pricing mechanism for innovative drugs [1] - The release of overseas clinical data and the peak of external licensing are accelerating the realization of innovative value [1] - There is a growing emphasis on collaboration and product licensing abroad, with the value of technological platforms becoming more prominent [1]
4月21日中银创新医疗混合A净值增长2.27%,近3个月累计上涨36.72%
Sou Hu Cai Jing· 2025-04-21 12:32
Group 1 - The core point of the news is the performance of the Zhongyin Innovation Medical Mixed A fund, which has shown significant growth in its net value and returns over various time frames [1] - As of April 21, 2025, the latest net value of Zhongyin Innovation Medical Mixed A is 1.6127 yuan, reflecting a growth of 2.27% [1] - The fund's one-month return is 14.21%, ranking 9th out of 4672 similar funds; the three-month return is 36.72%, ranking 18th out of 4599; and the year-to-date return is 34.02%, ranking 36th out of 4590 [1] Group 2 - The top ten stock holdings of Zhongyin Innovation Medical Mixed A account for a total of 70.60%, with significant positions in companies such as Heng Rui Pharmaceutical (9.81%), Innovent Biologics (8.55%), and others [1] - The fund was established on November 13, 2019, and as of December 31, 2024, it has a total scale of 2.02 billion yuan [1] - The fund manager, Zheng Ning, has a background in asset management and has held various positions in the industry since 2022 [2]
荣昌生物(688331) - 华泰联合证券有限责任公司关于荣昌生物制药(烟台)股份有限公司2024年度持续督导跟踪报告
2025-04-18 11:13
华泰联合证券有限责任公司 关于荣昌生物制药(烟台)股份有限公司 2024 年度持续督导跟踪报告 2024年以后年度公司存在持续亏损的风险,主要是由于公司积极布局覆盖多 项疾病治疗领域的在研产品管线,作为创新型生物制药企业,公司未来仍将维持 1 相应规模的研发投入用于在研产品进行临床前研究、全球范围内的临床试验以及 新药上市前准备等药物开发工作,且公司新药上市申请等注册工作、上市后的市 场推广等方面亦将带来高额费用,均可能导致短期内公司亏损扩大,从而对公司 日常经营、财务状况等方面造成不利影响。 综上所述,公司2024年营业收入较去年增长58.54%,但仍处于亏损状态,公 司2024年以后年度存在持续亏损的风险。 (二)整改情况 | 保荐机构名称:华泰联合证券有限责任公司 | 被保荐公司简称:荣昌生物 | | --- | --- | | 保荐代表人姓名:刘兆明 | 联系电话:025-56839300 | | 保荐代表人姓名:高元 | 联系电话:025-83387686 | 根据《证券法》《证券发行上市保荐业务管理办法》和《上海证券交易所科 创板股票上市规则》(以下简称"《上市规则》")等有关法律、法规的规定, ...
4月16日中银创新医疗混合A净值下跌2.81%,近1个月累计上涨13.3%
Sou Hu Cai Jing· 2025-04-16 12:15
Core Viewpoint - The recent performance of the Zhongyin Innovation Medical Mixed A fund shows a decline in net value but strong returns over various time frames, indicating potential resilience in the healthcare investment sector [1]. Fund Performance Summary - The latest net value of Zhongyin Innovation Medical Mixed A is 1.5786 yuan, down by 2.81% - The fund's one-month return is 13.30%, ranking 7 out of 4623 in its category - The three-month return stands at 38.74%, ranking 14 out of 4566 - Year-to-date return is 31.19%, ranking 24 out of 4559 [1]. Holdings Summary - The top ten stock holdings of Zhongyin Innovation Medical Mixed A account for a total of 70.60%, with the following key positions: - Heng Rui Pharmaceutical: 9.81% - Xinda Bio: 8.55% - Huaneng Pharmaceutical: 8.41% - Kangfang Biotech: 8.35% - Kangnuo Ya-B: 8.32% - Kelun Botai: 7.87% - BeiGene-U: 6.24% - Rongchang Bio: 5.96% - Hansoh Pharmaceutical: 3.98% - Xin Nuo Wei: 3.11% [1]. Fund Manager Background - Zheng Ning, the fund manager, has a master's degree and extensive experience in the investment sector, having previously worked at Taikang Asset Management and Zhonggeng Fund Management - Zheng joined Zhongyin Fund Management in 2022 and has managed multiple funds since then, including the Zhongyin Innovation Medical Mixed Fund [2].
荣昌生物接待181家机构调研,包括淡水泉(北京)投资、银华基金、华夏基金、浙商医药等
Jin Rong Jie· 2025-04-11 10:01
Core Viewpoint - Rongchang Biopharma disclosed its research reception announcement, indicating strong financial performance and significant progress in core pipeline development for 2024, with a focus on various therapeutic areas [1][2]. Financial Overview - The company reported a revenue of 1.717 billion yuan for 2024, representing a year-on-year growth of 58.5% [7]. - The sales expense ratio for 2024 was 55.3%, a decrease of 16.3 percentage points compared to the previous year [7]. - Research and development expenses increased to 1.54 billion yuan, up 17.9% year-on-year [7]. - The overall gross margin for 2024 was 80.4%, an increase of 3.0 percentage points from the previous year [7]. - As of the end of 2024, the company had approximately 1 billion yuan in cash and cash equivalents, with sufficient loan credit lines available [7]. Core Pipeline Development Progress 1. **RC18 in China** - Myasthenia Gravis (MG): BLA application has been accepted, with data presented at the AAN conference showing significant clinical efficacy [4]. - Primary Sjögren's Syndrome (pSS): Phase III enrollment is complete, with normal progress in medication and follow-up [4]. - IgA Nephropathy (IgAN): Phase III enrollment is complete, with normal progress in medication and follow-up [4]. 2. **RC18 Overseas** - Systemic Lupus Erythematosus (SLE): Phase III international multicenter clinical research is ready [5]. - Myasthenia Gravis (MG): Continuous enrollment in Phase III [5]. 3. **RC48 in China** - Urothelial Carcinoma (UC): Phase III for first-line combination therapy is complete, with normal progress in medication and follow-up [6]. - Gastric Cancer (GC): Phase III for first-line combination therapy has started, with patient enrollment underway [6]. 4. **Other Pipeline Developments** - RC88: Phase II clinical trial for advanced malignant solid tumors has completed enrollment [10]. - RC148: Observed good efficacy and safety in single-agent clinical exploration, with ongoing Phase II trials for advanced lung cancer [11]. - RC278: ADC drug using next-generation conjugation technology for various solid tumors [12]. - RC28: Phase III clinical trials for diabetic macular edema (DME) and wet age-related macular degeneration (wAMD) have completed enrollment [13].
荣昌生物(688331):全年业绩符合预期 泰它西普GMG三期数据读出
Xin Lang Cai Jing· 2025-04-10 07:44
Core Insights - The company reported a revenue of 1.72 billion yuan in 2024, representing a 58.5% increase, but incurred a net loss attributable to shareholders of 1.47 billion yuan, with a non-GAAP net loss of 1.51 billion yuan, aligning with expectations [1] - The company's core products continue to expand, with both the autoimmune and oncology teams gaining access to over 1,000 hospitals [1] - The drug Tai Taisip received NMPA approval in March 2021 and was included in the new national medical insurance for treating SLE in December of the same year [1] - The autoimmune commercialization team has grown to over 800 people, while the oncology team has nearly 600, both achieving access to over 1,000 hospitals [1] Clinical Data - Tai Taisip's Phase III clinical data for generalized Myasthenia Gravis (gMG) was presented at the AAN annual meeting, showing the highest MG-ADL response among peers [2] - The study included 114 gMG patients, with significant improvements in MG-ADL and QMG scores observed from week 4 [2] - At 24 weeks, the MG-ADL score decreased by 5.74 points in the Tai Taisip group compared to a 0.91 point decrease in the placebo group, with 98.1% of patients showing a ≥3 point improvement [2] - The QMG score decreased by 8.66 points in the Tai Taisip group versus a 2.27 point decrease in the placebo group, with 87% of patients showing a ≥5 point improvement [2] - The safety profile of Tai Taisip during treatment was reported to be acceptable [2] - The application for Tai Taisip's market approval for gMG was accepted in October 2024, with expectations for approval in Q2 2025 [2] Revenue Forecast - Revenue projections for the company are estimated at 2.27 billion yuan in 2025, 3.11 billion yuan in 2026, and 4.29 billion yuan in 2027, reflecting year-on-year growth rates of 32.5%, 36.8%, and 37.8% respectively [3] - The continued expansion of commercialized products, along with the potential international market entry for Tai Taisip, supports a "buy" rating [3]
港股异动 | 荣昌生物(09995)涨近10% 泰它西普gMGIII期数据优异 机构指其商业化推广策略清晰
智通财经网· 2025-04-10 03:26
消息面上,近日,荣昌生物宣布其自主研发的BLyS/APRIL双靶点融合蛋白创新药泰它西普 (telitacicept,RC18)用于治疗全身型重症肌无力(gMG)3期研究结果,以"最新突破性研究"口头报 告亮相美国神经病学学会(AAN)年会。数据显示,泰它西普治疗24周后,98.1%的患者重症肌无力日 常活动评分(MG-ADL)改善≥3分,87%的患者定量重症肌无力评分(QMG)改善≥5分,具有显著的 临床意义。目前,泰它西普用于治疗全身型重症肌无力的上市申请已于2024年10月获CDE受理,并被纳 入优先审评,预计于今年二季度在中国获批上市。 交银国际认为,泰它西普gMGIII期数据优于已上市竞品,且商业化推广策略清晰。在中国内地,泰它 西普的gMG适应症上市申请已于2024年10月获受理并纳入优先审评,公司对于该适应症的商业化策略 包括:1)增加神经免疫领域专线代表,覆盖更多目标市场(包括VYVGART的现有重点目标医院); 2)加强医生教育,重点推广泰它西普相比VYVGART的核心竞争优势;3)鼓励临床专家探索更多病 例,收集医生反馈,建立专家分享平台。基于优异的临床数据和清晰的商业化推广策略,该行看好 ...