Workflow
REMEGEN(688331)
icon
Search documents
荣昌生物(688331) - 荣昌生物关于公司核心药品专利获得期限补偿的提示性公告
2025-06-13 09:00
| 证券代码:688331 | 证券简称:荣昌生物 | 公告编号:2025-033 | | --- | --- | --- | | 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 关于公司核心药品专利获得期限补偿的提示性公告 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。 近日,荣昌生物制药(烟台)有限公司(以下简称"公司"或"荣昌生物")收到 国家知识产权局下发的《药品专利权期限补偿审批决定》,现将相关情况公告如下: 一、 涉及药品专利基本情况 专利号:ZL200710111162.2 专利名称:优化的 TACI-Fc 融合蛋白 专利申请日:2007 年 6 月 15 日 涉及药品:注射用泰它西普 二、 药品专利权期限补偿审批决定主要内容 按照中国专利法及其实施细则相关规定,决定给予该专利药品专利权期限补偿,补 偿天数 1827 天,原专利权期满终止日 2027 年 6 月 15 日,现专利权期满终止日 2032 年 6 月 15 日。药品专利权期限补偿期间,其保护范围限于国务院药品监 ...
荣昌生物(09995.HK)6月12日收盘上涨20.1%,成交16.05亿港元
Jin Rong Jie· 2025-06-12 08:39
机构评级方面,中泰国际证券有限公司给予"增持"评级,目标价51.3港元。 行业估值方面,药品及生物科技行业市盈率(TTM)平均值为4.2倍,行业中值6.01倍。荣昌生物市盈 率-18.33倍,行业排名第107位;其他大健康国际(02211.HK)为0.56倍、精优药业(00858.HK)为0.68 倍、金斯瑞生物科技(01548.HK)为1.6倍、东瑞制药(02348.HK)为3.08倍、正大企业国际 (03839.HK)为3.16倍。 6月12日,截至港股收盘,恒生指数下跌1.36%,报24035.38点。荣昌生物(09995.HK)收报57.65港元/ 股,上涨20.1%,成交量2884.28万股,成交额16.05亿港元,振幅25.73%。 最近一个月来,荣昌生物累计涨幅28.17%,今年来累计涨幅233.33%,跑赢恒生指数21.47%的涨幅。 财务数据显示,截至2025年3月31日,荣昌生物实现营业总收入5.26亿元,同比增长59.17%;归母净利 润-2.54亿元,同比增长27.16%;毛利率83.26%,资产负债率66.62%。 本文源自:金融界 作者:行情君 资料显示,荣昌生物制药(烟台)股份有 ...
港股创新药概念午后走强 荣昌生物、中国生物制药涨超15%
快讯· 2025-06-12 05:18
无需港股通,A股账户就能T+0买港股>> 港股创新药概念午后走强,荣昌生物、中国生物制药涨超15%,君实生物、昭衍新药(603127)、百济 神州、凯莱英(002821)等多股涨超5%。 ...
荣昌生物(688331) - 荣昌生物关于完成发行H股的公告
2025-05-29 09:15
| 证券代码:688331 | 证券简称:荣昌生物 公告编号:2025-032 | | --- | --- | | 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 关于完成发行 H 股的公告 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。 荣昌生物制药(烟台)股份有限公司(以下简称"本公司")于2025年5月22 日发布了《荣昌生物制药(烟台)股份有限公司关于根据一般授权发行H股的公告》 (公告编号:2025-025),内容有关配售本公司19,000,000股新H股(以下简称"本 次配售")。除另有界定外,本公告所用词汇与该公告所定义者具有相同含义。 二、配售事项完成后的股本变动 因发行配售股份,本公司已发行股份总数由544,608,243股增加至563,608,243 股。本次配售完成后,本公司已发行H股总数由189,581,239股H股增加至 208,581,239股H股,而A股数目维持不变,仍为355,027,004股A股。 董事会欣然宣布,配售协议中规定的所有先决条件均已达成(包括取 ...
荣昌生物:以42.44港元/股的价格成功配发及发行1900万股新H股
快讯· 2025-05-29 09:06
Core Viewpoint - Rongchang Biologics (688331.SH) successfully issued a total of 19 million new H-shares at a placement price of HKD 42.44 per share, raising approximately HKD 806.36 million in total proceeds [1] Group 1 - The new H-shares represent about 9.11% of the enlarged total issued H-shares after the placement [1] - The total issued shares after the placement will increase by approximately 3.37% [1] - The net proceeds from the placement, after deducting commissions and estimated expenses, will amount to approximately HKD 796 million [1]
荣昌生物: H股公告
Zheng Quan Zhi Xing· 2025-05-27 09:14
Core Viewpoint - RemeGen Co., Ltd. has received approval from the National Medical Products Administration (NMPA) in China for the marketing of Taitizumab (brand name: Tai'ai®) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are positive for acetylcholine receptor (AChR) antibodies [1][2]. Group 1: Product Approval and Clinical Benefits - Taitizumab has shown significant clinical benefits in gMG patients, with 98.1% of patients in the Taitizumab group improving their Myasthenia Gravis Activities of Daily Living (MG-ADL) score by at least 3 points after 24 weeks, compared to only 12.0% in the placebo group [2]. - The Taitizumab group experienced a reduction in MG-ADL scores by 5.74 points from baseline, while the placebo group saw a reduction of only 0.91 points [2]. - In terms of Quantitative Myasthenia Gravis (QMG) scores, 87.0% of patients in the Taitizumab group improved by at least 5 points, compared to 16.0% in the placebo group, with a reduction of 8.66 points from baseline in the Taitizumab group versus 2.27 points in the placebo group [2]. Group 2: Market Potential and Unmet Needs - There is a significant unmet clinical need for gMG treatments, with approximately 120 million patients globally, including around 220,000 patients in China, of which 80%-85% are AChR antibody positive [3]. - The approval of Taitizumab in China is expected to benefit a larger population of gMG patients and help achieve better treatment outcomes in long-term disease management [2][3]. - Taitizumab is also being investigated in global multicenter Phase III trials for its efficacy and safety in a broader patient population [2]. Group 3: Mechanism of Action - Taitizumab targets the pathogenic antibody production at the source by simultaneously acting on B-cell activating factor (BLyS) and proliferation-inducing ligand (APRIL), which are crucial in the activation of B cells and plasma cells [3]. - In addition to gMG, Taitizumab has also been approved for the treatment of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) in China [3].
荣昌生物(688331) - H股公告
2025-05-27 09:00
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 RemeGen Co., Ltd.* 榮 昌 生 物 製 藥( 煙 台 )股 份 有 限 公 司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:9995) 自願公告 國家藥品監督管理局批准泰它西普(商品名:泰愛®) 用於治療全身型重症肌無力在中國上市 中華人民共和國,煙台 2025年5月27日 1 重症肌無力(Myasthenia Gravis, MG)是一種由神經肌肉接頭(NMJ)傳遞障礙引發的 自身免疫性疾病,以波動性肌肉無力和易疲勞性為核心特徵,治療周期較長且易 復發。約80%-85%重症肌無力患者為AChR抗體陽性患者,超過85%的患者在發 病後24個月內會發展為全身型重症肌無力(gMG)。據弗若斯特沙利文報告,全球 重症肌無力患者約120萬人,其中中國患者約22萬人,存在巨大未滿足臨床需求。 泰它西普由人跨膜激活劑及鈣調親環素配體相互作用因子(TACI)受體的胞外域以 及人免疫球蛋白 ...
荣昌生物(09995.HK):用于治疗全身型重症肌无力药物泰它西普获批在中国上市
Ge Long Hui A P P· 2025-05-27 08:39
Core Viewpoint - Rongchang Biologics' drug Tai'taxip has received approval from the NMPA for the treatment of adult generalized myasthenia gravis (gMG) patients with AChR antibody positivity in China [1][2]. Group 1: Drug Approval and Clinical Data - Tai'taxip has shown significant clinical benefits and good safety in gMG patients, with 98.1% of patients in the treatment group improving their MG-ADL score by ≥3 points after 24 weeks, compared to 12.0% in the placebo group [1]. - The treatment group saw a reduction in MG-ADL scores by 5.74 points from baseline, while the placebo group saw a reduction of only 0.91 points [1]. - In terms of the quantitative myasthenia gravis score (QMG), 87.0% of patients in the Tai'taxip group improved by ≥5 points, compared to 16.0% in the placebo group, with a reduction of 8.66 points from baseline in the treatment group versus 2.27 points in the placebo group [1]. Group 2: Market Potential and Patient Demographics - Approximately 80%-85% of myasthenia gravis patients are AChR antibody positive, with over 85% of these patients developing gMG within 24 months of onset [2]. - There are about 1.2 million myasthenia gravis patients globally, with around 220,000 in China, indicating a significant unmet clinical need [2]. - The approval of Tai'taxip in China is expected to benefit more domestic myasthenia gravis patients and achieve better treatment outcomes in long-term disease management [2]. Group 3: Additional Indications - Besides gMG, Tai'taxip has also been approved for the treatment of systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) in China [3].
荣昌生物制药(烟台)股份有限公司关于变更公司注册资本、取消监事会、修订《公司章程》及部分内部管理制度的公告
Core Viewpoint - Rongchang Biopharmaceutical (Yantai) Co., Ltd. has announced changes to its registered capital, the cancellation of its supervisory board, and revisions to its articles of association and internal management systems [1][2][3] Group 1: Changes in Registered Capital - The company completed the registration of shares from the 2022 A-share restricted stock incentive plan, resulting in an increase in total shares from 544,332,083 to 544,608,243 shares and registered capital from RMB 544,332,083 to RMB 544,608,243 [1] Group 2: Cancellation of Supervisory Board and Revisions to Articles of Association - The supervisory board will be abolished, with its powers transferred to the board's audit committee, and relevant rules will be repealed [2] - The articles of association will be revised to reflect these changes, including the removal of references to the supervisory board and adjustments to the powers of the shareholders' meeting and board of directors [3] Group 3: Revisions to Internal Management Systems - The company plans to revise several internal management systems to enhance operational compliance, with specific rules such as the shareholders' meeting rules and independent directors' work system pending approval from the shareholders' meeting [4]
荣昌生物(688331) - 荣昌生物董事会薪酬与考核委员会工作规则
2025-05-26 10:16
荣昌生物制药(烟台)股份有限公司 董事会薪酬与考核委员会工作规则 第一章 总则 第一条 为进一步建立荣昌生物制药(烟台)股份有限公司(以下简称公司,连同 其附属公司,统称集团)健全的薪酬管理制度,完善公司治理结构,根据《中华人民共 和国公司法》(以下简称《公司法》)、《中华人民共和国证券法》(以下简称《证券 法》)、《上市公司章程指引》、《上市公司治理准则》、公司股票上市地证券监管机 构的规定和上市规则等相关法律、法规以及《荣昌生物制药(烟台)股份有限公司章程》 (以下简称《公司章程》)的规定,特设立董事会薪酬与考核委员会,并制定本工作规 则。 第二条 薪酬与考核委员会是董事会下设的专门工作机构,主要负责研究董事及高级 管理人员的薪酬策略和政策、绩效评估及激励机制及其他与薪酬相关的事宜,并向董事会 提出建议。经董事会通过后,提呈股东会决议。 第三条 本工作规则所称的高级管理人员是指公司的总经理、首席财务官和董事会秘 书以及《公司章程》规定的其他高级管理人员。 第二章 组成 第四条 薪酬与考核委员会由三名或以上董事组成,直接由董事会委任,独立非执行 董事占大多数,主席由独立非执行董事担任。 第七条 薪酬与考核委 ...