Workflow
REMEGEN(REGMY)
icon
Search documents
荣昌生物(09995) - (经修订) 截至二零二六年一月三十一日止月份之股份发行人的证券变动月报表
2026-02-25 08:30
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年1月31日 狀態: 重新提交 致:香港交易及結算所有限公司 公司名稱: 榮昌生物製藥(煙台)股份有限公司 呈交日期: 2026年2月25日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09995 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 208,581,239 | RMB | | 1 RMB | | 208,581,239 | | 增加 / 減少 (-) | | | | 0 | | RMB | | 0 | | 本月底結存 | | | 208,581,239 | RMB | | 1 RMB | | 208,581,239 | | 2. 股份分類 | 普通股 | 股份類別 | A ...
荣昌生物2026年临床进展与产品获批展望
Jing Ji Guan Cha Wang· 2026-02-13 01:46
Core Insights - Rongchang Biotech is expected to achieve multiple clinical advancements, product approvals, and partnership milestones by 2026 [1] Stock Performance - The overseas Phase III clinical trial for Taitasip in treating myasthenia gravis continues to enroll participants, with completion anticipated in the first half of 2026 [2] - Taitasip has received FDA fast track designation for primary Sjögren's syndrome, with a global Phase III trial likely to commence [2] - The global Phase II registration trial for Vidisizumab in second-line urothelial carcinoma has been completed, and the accelerated enrollment for the Phase III trial in first-line urothelial carcinoma is ongoing, with Pfizer expected to submit an overseas marketing application in the first half of 2026 [2] Project Progress - New indications for Vidisizumab and the ophthalmic drug RC28 are expected to receive approval in the second to third quarter of 2026 [3] - The indication for Taitasip in IgA nephropathy is anticipated to be approved in the fourth quarter [3] - Core product RC148 (PD-1/VEGF dual antibody) has three Phase III clinical trials approved, with overseas development plans being noteworthy [3] Related Transactions - An upfront payment of $650 million from the licensing agreement with AbbVie for RC148 will be reflected in the 2026 performance, with the total transaction amount reaching $5.6 billion [4] - Subsequent milestone payments from collaborations with Vor Bio and Santen Pharmaceutical may also progress [4] Product Development Progress - RC278 (targeting CDCP1 ADC) has entered Phase I/II clinical trials [5] - RC288 (bispecific ADC) is planned to initiate clinical trials in early 2026 [5]
荣昌生物:盈利拐点出现时点明显前移,维持“买入”评级-20260206
BOCOM International· 2026-02-05 10:50
Investment Rating - The report maintains a "Buy" rating for Rongchang Biologics (09995) with a target price of HKD 136 [1] Core Insights - The report is optimistic about the company's upcoming milestones, including the enrollment of MGIII for Taitasip and the initiation of SSIII, as well as the first overseas BLA submission for Vedisit and the data readout for 1LUCIII [1] - The inclusion of Taitasip's indications in the mainland's medical insurance is expected to drive significant sales growth, alongside the anticipated approvals for major indications like SS and IgAN [1] - Early-stage products (RC148, RC118, new ADCRC278) are progressing towards more indications, with data readouts likely to continue catalyzing the stock price [1] Financial Performance - Rongchang Biologics has issued a positive earnings forecast, expecting approximately RMB 3.25 billion in revenue for the previous year, representing a year-on-year growth of about 89% [1] - The net profit is projected to be around RMB 716 million, with a non-deductible net profit of approximately RMB 78.5 million, both showing a turnaround from losses year-on-year [1] - The performance significantly exceeded previous expectations from both the report and the market, with the timing of the profitability inflection point occurring earlier than previously anticipated [1] - Excluding contributions from external licensing and fair value gains, the report estimates that the company's core business achieved or approached breakeven in the fourth quarter, ahead of prior expectations [1] - With Taitasip and RC148 expanding internationally and more R&D costs being borne by overseas partners, there is optimism for further improvement in the company's profit margins this year [1]
花旗:重新予荣昌生物(09995)“买入/高风险”评级 目标价105港元
智通财经网· 2026-02-05 09:21
智通财经APP获悉,花旗发布研报称,在暂停评级一段时间后,重新给予荣昌生物(09995)"买入/高风 险"评级,目标价为105港元。因集团与艾伯维就PD-1/VEGF双特异性药物RC148达成合作,进一步拓展 其管线候选药物的全球潜力。 总体而言,花旗认为此次业务拓展合作展示了荣昌生物创新资产的高品质及其业务发展能力,但考虑到 PD-1/VEGF领域及全身型重症肌无力领域的激烈竞争,认为其全球商业化进程仍存在不确定性。花旗将 荣昌生物上述合作的6.5亿美元首付款计入今年收入,并预估RC148经风险调整后的峰值销售额为27亿 美元。 花旗认为,合作完成后,市场焦点应转移至基于临床数据和竞争格局的未来全球三期临床研究及商业化 潜力。关于泰它西普的全球开发,其治疗全身型重症肌无力的三期临床研究顶线数据或于2027年上半年 公布,而针对干燥症的三期临床试验将于今年上半年启动。泰它西普在国内的销售趋势积极,公司管理 层目标于2026年实现收支平衡。 ...
荣昌生物(09995) - 截至二零二六年一月三十一日止月份之股份发行人的证券变动月报表
2026-02-05 08:38
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年1月31日 狀態: 新提交 致:香港交易及結算所有限公司 公司名稱: 榮昌生物製藥(煙台)股份有限公司 呈交日期: 2026年2月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09995 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 208,581,239 | RMB | | 1 RMB | | 208,581,239 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 208,581,239 | RMB | | 1 RMB | | 208,581,239 | | 2. 股份分類 | 普通股 | 股份類別 | A | ...
大行评级丨花旗:重新予荣昌生物“买入/高风险”评级,目标价105港元
Ge Long Hui· 2026-02-05 06:20
花旗认为,合作完成后,市场焦点应转移至基于临床数据和竞争格局的未来全球三期临床研究及商业化 潜力。关于泰它西普的全球开发,其治疗全身型重症肌无力的三期临床研究顶线数据或于2027年上半年 公布,而针对干燥症的三期临床试验将于今年上半年启动。泰它西普在国内的销售趋势积极,公司管理 层目标于2026年实现收支平衡。 花旗发表研报指,经过一段时间暂停评级后,重新给予荣昌生物"买入/高风险"评级,目标价为105港 元。集团与AbbVie就PD-1/VEGF选药物RC148达成合作,进一步拓展其管线候选药物的全球潜力。 ...
交银国际:荣昌生物盈利拐点出现时点明显前移 维持“买入”评级
Zhi Tong Cai Jing· 2026-02-04 01:54
Core Viewpoint - The report from CMB International maintains a "Buy" rating for Rongchang Biologics (09995) with a target price of HKD 136, highlighting optimism for the company's upcoming clinical trial phases and product approvals, which are expected to drive sales growth and stock price catalysts [1] Group 1: Company Performance - Rongchang Biologics anticipates a revenue of approximately RMB 3.25 billion for the previous year, representing a year-on-year growth of about 89% [1] - The net profit is expected to be around RMB 716 million, with a non-GAAP net profit of approximately RMB 78.5 million, both showing a turnaround from losses in the previous year [1] - The performance significantly exceeded both the firm's and market's prior expectations, with the profitability inflection point occurring earlier than previously anticipated [1] Group 2: Future Prospects - The company is expected to achieve or approach breakeven in its core business during the fourth quarter of last year, ahead of earlier forecasts [1] - With the international expansion of Taitasip and RC148, along with more R&D costs being covered by overseas partners, there is optimism for further improvement in core business profit margins this year [1] - The inclusion of Taitasip in the national medical insurance in mainland China is anticipated to boost sales, alongside approvals for larger indications such as SS and IgAN [1]
交银国际:荣昌生物(09995)盈利拐点出现时点明显前移 维持“买入”评级
智通财经网· 2026-02-04 01:46
Core Viewpoint - The report from CMB International maintains a "Buy" rating for Rongchang Biologics (09995) with a target price of HKD 136, highlighting optimism regarding the company's upcoming clinical trials and product approvals, which are expected to drive sales growth and stock price catalysts [1] Group 1: Company Performance - Rongchang Biologics anticipates a revenue of approximately RMB 3.25 billion for the previous year, representing a year-on-year growth of about 89% [1] - The net profit is expected to be around RMB 716 million, with a non-GAAP net profit of approximately RMB 78.5 million, both showing a turnaround from losses in the previous year [1] - The performance significantly exceeded both the firm's and market's prior expectations, with the profitability inflection point occurring earlier than previously anticipated [1] Group 2: Future Prospects - The company is expected to achieve or approach breakeven in its core business during the fourth quarter of the previous year, ahead of earlier forecasts [1] - With the international expansion of Taitasip and RC148, and more R&D costs being borne by overseas partners, there is optimism for further improvement in the core business profit margin this year [1] - The inclusion of Taitasip in the National Medical Insurance in mainland China is anticipated to lead to significant sales growth, alongside approvals for major indications such as SS and IgAN [1]
交银国际:维持荣昌生物买入评级 维持目标价136港元
Zhi Tong Cai Jing· 2026-02-03 08:02
交银国际发布研报称,维持荣昌生物(09995)136港元目标价,维持买入评级。剔除BD和公允价值收益 对利润的贡献,预计4Q25公司主营业务已实现或接近盈亏平衡,早于该行此前的预期。随着泰它西普 和RC148出海后、更多研发费用由海外合作伙伴承担,该行看好2026年主业利润率进一步改善的空间。 随着关键产品相继BD出海,2026年该行看好 1)泰它西普和维迪西妥在海外注册研究上的进展,包括泰它西普MGIII期入组(预计1H26完成入组、 1H27读出)和SSIII期启动(1H26)、维迪西妥实现首个海外BLA申报(1H26,2LUC)和1LUCIII期数据的读 出;2)中国内地泰它西普MG适应症纳入医保后的销售放量,以及SS、IgAN等更多大适应症的获批;3) 早期品种(包括RC148、RC118、新型ADCRC278等)在更多适应症上的推进,相关数据读出有望持续催 化股价。 2026年1月30日,公司发布2025年年度业绩预告,预计全年实现营业收入约32.5亿元(人民币,下同),同 比增长约89%;预计实现净利润约7.16亿元,扣非净利润约7,850万元,均实现同比扭亏为盈。本次业绩 表现显著超出该行及市场 ...
交银国际:维持荣昌生物(09995)买入评级 维持目标价136港元
智通财经网· 2026-02-03 07:57
智通财经APP获悉,交银国际发布研报称,维持荣昌生物(09995)136港元目标价,维持买入评级。剔除 BD和公允价值收益对利润的贡献,预计4Q25公司主营业务已实现或接近盈亏平衡,早于该行此前的预 期。随着泰它西普和RC148出海后、更多研发费用由海外合作伙伴承担,该行看好2026年主业利润率进 一步改善的空间。 交银国际主要观点如下: 核心产品放量叠加BD兑现,驱动2025年扭亏为盈 2026年1月30日,公司发布2025年年度业绩预告,预计全年实现营业收入约32.5亿元(人民币,下 同),同比增长约89%;预计实现净利润约7.16亿元,扣非净利润约7,850万元,均实现同比扭亏为盈。 本次业绩表现显著超出该行及市场此前预期,且盈利拐点出现时点亦较此前判断明显前移。 根据公告,公司业绩高增长的主要由三方面驱动 1)核心产品商业化持续放量:泰它西普和维迪西妥单抗在中国内地市场的销售快速放量,持续贡献业 绩核心增量;2)BD收入确认显著增厚利润端:2025年公司分别与Vor Biopharma就泰它西普海外权益 达成授权、与参天制药就眼科创新药RC-28E注射液达成大中华及亚洲地区授权,获得的首付款及潜在 股 ...