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荣昌生物(09995) - 2025 Q1 - 季度业绩
2025-04-28 11:20
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的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不對因本公告全部或任何部份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。 承董事會命 榮昌生物製藥(煙台)股份有限公司 董事長兼執行董事 王威東先生 (股份代號:9995) 2025年第一季度報告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.09(2)(a)條及第13.10B 條規則及《證券及期貨條例》(香港法例第571章)第XIVA部之內幕消息條例作出。 茲載列榮昌生物製藥(煙台)股份有限公司(「本公司」)在上海證券交易所網站刊發之 《榮昌生物製藥(煙台)股份有限公司2025年第一季度報告》,僅供參閱。以下為本公 司2025年第一季度報告,僅供參考。如有任何歧義,概以中文版本為準。 本公司董事會(「董事會」)提醒本公司股東及潛在投資者,本公告所載信息及財務 數據未經審計,已經本公司審核委員會審閱但未經獨立核數師審閱。 本公告所載2025年第一季度報告內的未經審計財務數據乃根據中華人民共和國會 計原則而非國際財務報告準則編製,並且僅根據上海證券交易所科創板的要求編 製 ...
荣昌生物(09995) - 2024 - 年度财报
2025-04-28 09:06
(於中華人民共和國註冊成立的股份有限公司) 股份代號 : 9995 2024 年度報告 * 僅供識別 目錄 2 公司資料 4 董事長報告 6 管理層討論及分析 23 董事、監事及高級管理層履歷 30 企業管治報告 49 董事會報告 87 獨立核數師報告 93 綜合損益表 94 綜合全面收益表 95 綜合財務狀況表 97 綜合權益變動表 99 綜合現金流量表 101 財務報表附註 195 財務概要 196 釋義及詞彙 榮昌生物製藥(煙台)股份有限公司 ╱ 二零二四年年報 2 公司資料 執行董事 榮昌生物製藥(煙台)股份有限公司 RemeGen Co., Ltd.* 王威東先生 (董事長) 房健民博士 林健先生 何如意博士 (自2025 年2 月 6日起辭任) 溫慶凱先生 (自2025 年4 月 2日起獲委任) 非執行董事 王荔強博士 蘇曉迪博士 獨立非執行董事 郝先經先生 陳雲金先生 黃國濱先生 (自2025 年 1 月10日起獲委任) 馬蘭博士 (自2025 年 1 月10日起辭任) 監事 任廣科先生 (主席) 李宇鵬先生 李壯林先生 審核委員會 郝先經先生 (主席) 王荔強博士 陳雲金先生 薪酬與考核委員會 ...
荣昌生物:泰它西普gMGIII期数据公布,差异化竞争优势明显,维持买入-20250410
交银国际· 2025-04-10 06:15
交银国际研究 消息快报 荣昌生物 (9995 HK) 泰它西普 gMG III 期数据公布,差异化竞争优势明显,维持买入 此报告最后部分的分析师披露、商业关系披露和免责声明为报告的一部分,必须阅读。 下载本公司之研究报告,可从彭博信息:BOCM 或 https://research.bocomgroup.com Ethan.Ding@bocomgroup.com (852) 3766 1834 诸葛乐懿 Gloria.Zhuge@bocomgroup.com (852) 3766 1845 丁政宁 医药 2025 年 4 月 10 日 泰它西普 gMG III 期数据优于已上市竞品:公司在美国神经病学会年会 (AAN 2025)上公布了泰它西普治疗重症肌无力(gMG)的中国内地III 期 研究结果。研究招募 114 例基线 MG-ADL 评分≥6、QMG 评分≥8 的 gMG 患 者,其中泰它西普组(皮下给药 240mg QW)和安慰剂组各 57 例,中位 MG-ADL 评分和 QMG 评分分别为 10 分/18-19 分,高于 VYVGART® III 期 ADAPT 研究中的 9 分/16 分(即泰它西普 ...
荣昌生物(09995):泰它西普gMGIII期数据公布,差异化竞争优势明显,维持买入
交银国际· 2025-04-10 05:39
交银国际研究 消息快报 荣昌生物 (9995 HK) 泰它西普 gMG III 期数据公布,差异化竞争优势明显,维持买入 此报告最后部分的分析师披露、商业关系披露和免责声明为报告的一部分,必须阅读。 下载本公司之研究报告,可从彭博信息:BOCM 或 https://research.bocomgroup.com 丁政宁 Ethan.Ding@bocomgroup.com (852) 3766 1834 诸葛乐懿 Gloria.Zhuge@bocomgroup.com (852) 3766 1845 医药 2025 年 4 月 10 日 泰它西普 gMG III 期数据优于已上市竞品:公司在美国神经病学会年会 (AAN 2025)上公布了泰它西普治疗重症肌无力(gMG)的中国内地III 期 研究结果。研究招募 114 例基线 MG-ADL 评分≥6、QMG 评分≥8 的 gMG 患 者,其中泰它西普组(皮下给药 240mg QW)和安慰剂组各 57 例,中位 MG-ADL 评分和 QMG 评分分别为 10 分/18-19 分,高于 VYVGART® III 期 ADAPT 研究中的 9 分/16 分(即泰它西普 ...
荣昌生物(09995) - 2024 - 年度业绩
2025-03-27 12:16
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的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部份內容而產生或因倚 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) 截至2024年12月31日止年度 年度業績公告 董事會欣然宣佈本公司截至2024年12月31日止年度的綜合業績,連同截至2023年 12月31日止年度的比較數字。 業務摘要 過去一年,本公司於推進商業化、產品管線及業務運營方面取得重大進展: 商業化 - 本公司截至2024年12月31日止年度的產品銷售收益約為人民幣1,699.1百萬 元,較去年同期的人民幣1,049.2百萬元增長61.9%,主要得益於自身免疫 類商業化產品泰它西普(RC18,商品名:泰愛®)及抗腫瘤類商業化產品維 迪西妥單抗(RC48,商品名:愛地希®)的強勁銷售增長帶動。 1 產品管線 泰它西普(RC18,商品名:泰愛®) 2 - 2024年3月,FDA授予泰它西普快速通 ...
荣昌生物:收入将快速增加,股东净亏损将逐年缩小
中泰国际证券· 2025-01-22 14:23
Investment Rating - The report maintains a "Buy" rating for Rongchang Biologics with a target price adjusted to HKD 19.00 from HKD 21.80 [4][5][14]. Core Insights - The company is expected to see a significant increase in revenue, with a forecasted sales revenue of approximately RMB 1.715 billion for 2024, representing a year-on-year growth of nearly 60% [1]. - Shareholder net losses are projected to decrease by about RMB 410 million to approximately RMB 1.47 billion compared to the previous year [1]. - The main product, Taitasip, is anticipated to drive high revenue growth in 2024, particularly in indications such as lupus [1][2]. Revenue and Loss Forecast - Revenue forecasts for 2024-2026 have been raised by 6.1%, 2.6%, and 1.1% respectively, reflecting the company's strong sales performance [3]. - Despite an increase in sales expense forecasts, shareholder net losses are still expected to narrow year-on-year [3]. Product Development and Approvals - The company is making progress in the approval and development of new indications for its main products, Taitasip and Vidisizumab, with potential approvals expected in 2025 for several new indications [2]. - New product applications are anticipated to be submitted within the year, aligning with the company's development timeline [2]. Financial Data Summary - The financial data indicates a significant recovery trajectory, with total revenue expected to grow from RMB 768 million in 2022 to RMB 3.084 billion by 2026 [12]. - Shareholder net losses are projected to decrease from RMB 999 million in 2022 to RMB 438 million by 2026, indicating a substantial improvement in financial health [12].
荣昌生物:费用管控成效显著,集中资源加速重点管线推进
第一上海证券· 2024-11-29 03:27
Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 23.95, indicating a potential upside of 40.7% from the current price [4]. Core Insights - The company has demonstrated significant revenue growth, achieving Q3 revenue of CNY 467 million, a year-on-year increase of 34.6% and a quarter-on-quarter increase of 13.6%. Cumulatively, revenue for the first three quarters grew by 57.1% [1]. - Cost control measures have led to a notable reduction in losses, with Q3 net loss narrowing by 32.6% to CNY 291 million. The gross margin for Q3 improved to 82.1%, up 4.1 percentage points from the previous quarter [1]. - The company is focusing resources on key pipelines, with several clinical trials progressing well, including the completion of patient enrollment for various Phase III trials [3]. Financial Performance - The company reported a cash and cash equivalents balance of CNY 1.12 billion as of September 30, with a loan credit line of CNY 2.8 billion [1]. - The sales revenue for the product 泰它西普 reached approximately CNY 270 million in Q3, reflecting a year-on-year growth of about 43% [2]. - The projected revenues for the company for the years 2024, 2025, and 2026 are CNY 1.624 billion, CNY 2.411 billion, and CNY 3.243 billion, respectively [4].
荣昌生物:厚积薄发的ADC与融合蛋白领域明星
中泰国际证券· 2024-11-21 11:23
Investment Rating - The report initiates coverage with a "Buy" rating and sets a target price of HKD 21.80 [81][85]. Core Insights - Rongchang Biopharmaceutical (9995 HK) is a leading domestic manufacturer in the ADC and fusion protein sectors, with a strong R&D pipeline [6][15]. - The company's core products, including the first domestic ADC, Vadisizumab (爱地希), and the dual-target biological drug, Taisip (泰爱), are expected to see rapid revenue growth [7][21]. - The revenue forecast for Vadisizumab is projected to increase from RMB 530 million in 2023 to RMB 1.31 billion by 2026, with a CAGR of 35.3% [29][30]. - Taisip is anticipated to benefit from the strong demand for systemic lupus erythematosus treatments, with revenue expected to grow from RMB 520 million in 2023 to RMB 1.71 billion by 2026, reflecting a CAGR of 48.8% [41][53]. Summary by Sections Company Overview - Rongchang Biopharmaceutical was established in 2008 and went public in Hong Kong in 2020, focusing on R&D and production in oncology, autoimmune diseases, and ophthalmology [15][19]. - The company has established three major technology platforms: ADCs, fusion proteins, and bispecific antibodies, with six additional products in the pipeline [15][19]. Product Pipeline - The company has a robust pipeline with six investigational drugs in oncology and ophthalmology, including RC28 and RC88, which are expected to have significant market potential [2][67]. - RC28 is in Phase III clinical trials targeting age-related macular degeneration and diabetic macular edema, while RC88 is in Phase II trials for MSLN-positive solid tumors [2][67][71]. Financial Performance - Revenue is projected to grow from RMB 1.08 billion in 2023 to RMB 3.05 billion by 2026, with a CAGR of 41.5% [75]. - The company is expected to reduce shareholder net losses gradually, with a forecasted loss of RMB 432 million by 2026 [76]. Market Position and Competitive Advantage - Vadisizumab is the only approved domestic ADC in China, benefiting from increasing market demand for ADCs [29][30]. - Taisip's clinical data shows superior efficacy compared to its main competitor, Benlysta, which positions it favorably in the market for systemic lupus erythematosus [41][47]. Valuation and Investment Thesis - The report uses a DCF model to price the stock, indicating a target price of HKD 21.80, suggesting significant upside potential based on current valuations [86]. - The company’s current stock price reflects a lower valuation compared to peers, indicating room for growth as the market recognizes its product pipeline and revenue potential [81][85].
荣昌生物三季报点评:盈利能力持续向好,海内外研发齐头并进
中泰证券· 2024-11-06 11:15
Investment Rating - The investment rating for Rongchang Biologics is "Accumulate" (maintained) [1] Core Views - The company's revenue for the third quarter reached 4.7 billion yuan, representing a year-on-year growth of 34.6% [1] - The total revenue for the first nine months of 2024 was 12.1 billion yuan, with a year-on-year increase of 57.1% [1] - The net loss for the third quarter was 2.9 billion yuan, which is a decrease in loss by 32.6% compared to the previous quarter [1] - The company continues to see robust growth in revenue, aligning with expectations, and maintains strong profitability [1] Financial Summary - **Revenue Forecasts**: - 2022A: 772 million yuan - 2023A: 1,083 million yuan - 2024E: 1,608 million yuan - 2025E: 2,167 million yuan - 2026E: 2,880 million yuan - Year-on-year growth rates: 2023A: 40%, 2024E: 48%, 2025E: 35%, 2026E: 33% [1][2] - **Net Profit Forecasts**: - 2022A: -999 million yuan - 2023A: -1,511 million yuan - 2024E: -1,025 million yuan - 2025E: -776 million yuan - 2026E: -587 million yuan - Year-on-year growth rates: 2023A: -51%, 2024E: 32%, 2025E: 24%, 2026E: 24% [1][2] - **Earnings Per Share (EPS)**: - 2022A: -1.83 yuan - 2023A: -2.78 yuan - 2024E: -1.88 yuan - 2025E: -1.43 yuan - 2026E: -1.08 yuan [1][2] - **Cash Flow**: - Operating cash flow for 2023A: -1,502 million yuan - Net profit for 2023A: -1,511 million yuan [3] Research and Development - The company is advancing its international research and development efforts, with significant clinical trials ongoing for key products such as Taitasip and Vidisizumab [1] - The early pipeline aligns with industry development trends and demonstrates differentiation [1]
荣昌生物2024Q3点评:商业化略超预期,聚焦后期价值管线
国泰君安· 2024-11-03 04:19
Investment Rating - The report maintains a rating of "Buy" for Rongchang Biopharmaceuticals [2][4]. Core Views - The company achieved a revenue of 470 million RMB in Q3 2024, representing a year-on-year growth of 34.6%, with a net loss of 290 million RMB, which is a reduction of 40 million RMB compared to the previous year [3][4]. - The gross margin improved to 82.1%, an increase of 5.8 percentage points, due to enhanced product processes and increased sales scale [4]. - The company is focusing on late-stage pipelines and controlling R&D expenses, with an R&D expense ratio of 74.3%, down by 17.2 percentage points [4]. - Revenue forecasts for 2024-2026 are maintained at 1.647 billion, 2.504 billion, and 3.319 billion RMB respectively [4]. Financial Summary - Revenue for 2022A was not provided, but for 2023A it is projected at 1,083 million RMB, with a significant increase to 1,647 million RMB in 2024E, and further growth to 2,504 million RMB in 2025E and 3,319 million RMB in 2026E [1]. - The net profit figures indicate a loss of 999 million RMB in 2024E, with losses decreasing to 856 million RMB in 2025E and 299 million RMB in 2026E [1]. - The PE ratio is projected to improve from -28.33 in 2024E to -6.68 in 2026E, while the PB ratio is expected to rise from 5.82 in 2024E to 11.81 in 2026E [1].