| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号：2025-021 | | --- | --- | --- | | 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 自愿披露关于抗体偶联药物 RC278 获得药物临床试验申请 受理通知书的公告 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。 一、 药品基本情况 由于医药产品具有高科技、高风险、高附加值的特点，药品的前期研发以及产品从 研制、临床试验报批到投产的周期长、环节多，容易受到一些不确定性因素的影响。敬 请广大投资者谨慎决策，注意防范投资风险。 审批结论：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、 药品的其他相关情况 RC278 是由荣昌生物自主研发的一款具有 First-in-Class/Best-in-Class 潜质的 ADC 分子，该分子能特异识别一个新型肿瘤靶点，并具有创新的连接子—毒素系统，在 临床前研究中展现出广谱抗肿瘤活性、良好的安全性和药代动力学特征，将为晚期实体 ...

Summary of the Conference Call Industry Focus - The report focuses on the pharmaceutical industry, specifically highlighting innovative drugs and contract research organizations (CXO) Core Insights and Arguments - Continuous recommendation of innovative drugs with positive growth outlook, including: - 恒瑞医药 (Hengrui Medicine) - 华东医药 (East China Pharmaceutical) - 翰森制药 (Hansoh Pharmaceutical) - 贝达药业 (Betta Pharmaceuticals) - 信立泰 (Sinopharm) - 科伦药业 (Kelun Pharmaceutical) - 百利天恒 (Baili Tianheng) - 荣昌生物 (Rongchang Biopharmaceutical) - 科伦博泰生物 (Kelun Biotech) - 石药集团 (Shijiazhuang Pharmaceutical Group) [1][1][1] - Recommendation of CXOs showing signs of profit growth turning points, including: - 药明生物 (WuXi Biologics) - 药明康德 (WuXi AppTec) [1][1] - Positive outlook on domestic replacement of innovative medical devices, specifically: - 惠泰医疗 (Huitai Medical) [1] - Anticipation of recovery in consumer healthcare, particularly: - 爱尔眼科 (Aier Eye Hospital) [1] Other Important Points - The report emphasizes the ongoing trend of recommending companies that are positioned well within the pharmaceutical sector, particularly those that are expected to benefit from market dynamics and growth opportunities - The focus on innovative drugs and CXOs indicates a strategic approach to capitalize on emerging trends in the healthcare market - The mention of domestic replacements in medical devices suggests a shift towards local production and innovation, which could impact market competition and supply chains - The recovery in consumer healthcare points to potential growth areas as the market stabilizes post-pandemic

Investment Rating - The report maintains a rating of "Buy" for the pharmaceutical and biotechnology industry [1]. Core Insights - GLP-1 drugs have emerged as leading products, with recommendations to focus on companies such as BoRui Pharmaceutical, Innovent Biologics, and Federated Pharmaceutical [1][15]. - The global GIP-1 market shows significant potential, with Q1 2025 sales surpassing PD-1 antibodies. The WHO is developing guidelines for the use of GLP-1 in adult obesity, expected to be released in August-September 2025 [1][15]. - The report highlights a shift in R&D trends from single-target to multi-target drugs, with a focus on oral formulations and both peptide and small molecule drugs [1][16]. Summary by Sections Industry Performance - The A-share pharmaceutical index has increased by 1.0% this week and 1.2% year-to-date, underperforming the CSI 300 by 1.0% and outperforming by 3.4% respectively [9]. - The H-share biotechnology index has decreased by 4% this week but increased by 27% year-to-date, outperforming the Hang Seng Technology Index by 19% and 29% respectively [9]. GLP-1 Drug Market - Sales of semaglutide reached 78.64 billion USD in Q1 2025, surpassing Keytruda's 72.05 billion USD [15]. - The WHO is expected to finalize guidelines for GLP-1 RA use in obesity treatment by late 2025, which could significantly boost sales [15]. R&D Trends - The report notes a transition from single-target to multi-target drug development, with multi-target drugs showing superior clinical efficacy [16][17]. - Clinical data indicates that semaglutide and dual-target drugs like tirzepatide are leading in weight loss efficacy, with ongoing trials for multi-target drugs showing promising results [17]. Investment Recommendations - The report ranks preferred sub-sectors as follows: innovative drugs > CXO > traditional Chinese medicine > medical devices > pharmacies > pharmaceutical commerce [10]. - Specific stock recommendations include BoRui Pharmaceutical, Innovent Biologics, Federated Pharmaceutical, and others based on growth potential and valuation metrics [10].

1 關於維迪西妥單抗（RC48，商品名：愛地希®） 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。 RemeGenCo. , 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注射用維迪西妥單抗 （商品名：愛地希®）用於治療HER2陽性且存在肝轉移的 晚期乳腺癌在中國上市 本公告由榮昌生物製藥（煙台）股份有限公司（「本公司」）自願作出。 本公司董事會（「董事會」）欣然宣佈，注射用維迪西妥單抗（商品名：愛地希®）正 式獲得中國國家藥品監督管理局（「NMPA」）在中國上市的批准，用於治療HER2 陽性且存在肝轉移的晚期乳腺癌的患者。 本適應症獲得批准是基於RC48-C006 III期臨床研究，詳細數據在2024年12月的 聖安東尼奧乳腺癌研討會(SABCS)公布，結果顯示：相比拉帕替尼聯合卡培他濱 組，維迪西妥單抗組顯著延長了無進展生 ...

Group 1 - The Hong Kong stock market opened lower on May 8, with the Hang Seng Index down 0.45% and the Hang Seng Tech Index down 0.28%, while the Hong Kong Innovation Drug Index rose by 0.18% [1] - The Hong Kong Innovation Drug ETF (159567) opened higher and increased by 1.16%, with notable gains in component stocks such as Ascentage Pharma-B up over 3% and Lepu Biopharma-B up over 2% [1] - The Hong Kong Innovation Drug ETF closely tracks the Hong Kong Innovation Drug Index, which reflects the performance characteristics of biotechnology companies listed under the Hong Kong Stock Connect [1] Group 2 - According to Everbright Securities, the commercialization of domestic weight-loss drugs is imminent, and sales capabilities will be a significant factor in assessing future competitive advantages for companies [2] - China Galaxy Securities noted that the pharmaceutical sector has experienced a prolonged adjustment, with overall valuations at low levels and public fund holdings underweight, suggesting a potential recovery in the pharmaceutical market in 2025 [2] - Cinda Securities anticipates that the second quarter of 2025 may see catalysts for innovative drugs, including expected negotiations for medical insurance and the implementation of the Class B medical insurance directory [2]

Core Viewpoint - Rongchang Biologics (688331.SH) has experienced a significant decline in stock price, closing at 46.28 yuan with a drop of 6.92%, indicating a state of breaking the issue [1] Group 1: Company Overview - Rongchang Biologics was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on March 31, 2022, with an initial offering price of 48.00 yuan per share and a total issuance of 54.4263 million shares [2] - The total funds raised from the initial public offering amounted to 2.612 billion yuan, with a net amount of 2.506 billion yuan after expenses [2] Group 2: Financial Performance - The company reported net profits attributable to shareholders of -999.9 million yuan in 2022, -1.511 billion yuan in 2023, and -1.468 billion yuan in 2024 [3] - The revenue for 2024 was approximately 1.717 billion yuan, reflecting a year-on-year increase of 58.54% compared to 2023 [4] - The net cash flow from operating activities was -1.114 billion yuan in 2024, showing a decrease from -1.503 billion yuan in 2023 [4] Group 3: Future Plans - Rongchang Biologics plans to raise up to 1.952 billion yuan through a specific issuance of A-shares, with the net proceeds intended for new drug research and development projects [3]

Core Viewpoint - CICC maintains the profit forecast for Rongchang Biologics (09995) at a loss of 9.15 billion yuan for 2025 and a loss of 3.33 billion yuan for 2026, while raising the target price by 40.6% to 45 HKD, indicating a potential upside of 21.8% from the current stock price due to positive data from the gMG trial of Taitasip [1] Group 1 - The company's Q1 2025 performance met expectations, with revenue of 526 million yuan, a year-on-year increase of 59.17%, and a net profit loss of 254 million yuan, which is a nearly 1 billion yuan reduction in loss compared to the previous year [2] - Product revenue showed strong year-on-year growth, with operating cash flow improving significantly; the company reported a net cash outflow of 188 million yuan in Q1 2025, an improvement of 238 million yuan year-on-year, mainly due to increased sales collections [3] Group 2 - Taitasip's Phase III clinical trial data for treating generalized myasthenia gravis (gMG) showed excellent results, with 98.1% of patients improving their MG-ADL score by at least 3 points after 24 weeks, compared to 12% in the placebo group; the overall score decreased by 5.74 points [4] - The safety profile of Taitasip was comparable to the placebo group, with a lower incidence of infection-related adverse events (45.6% vs. 59.6%); the drug's market application for gMG is expected to be approved in the second quarter of this year [4]

证券代码：688331 证券简称：荣昌生物 公告编号：2025-020 荣昌生物制药（烟台）股份有限公司 2022 年 A 股限制性股票激励计划之 本次股票上市类型为股权激励股份；股票认购方式为网下，上市股数为 276,160股。 A 类权益第二个及 B 类权益首次授予第一个归属期 第一次归属结果暨股份上市公告 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、准确性和完整性依法承担法律责任。 重要内容提示： 本次股票上市流通总数为276,160股。 本次股票上市流通日期为2025 年 5 月 8 日。 一、本次限制性股票归属的决策程序及相关信息披露 1、2022 年 10 月 16 日，公司召开第一届董事会第二十四次会议，会议审议通 过了《关于<荣昌生物制药（烟台）股份有限公司 2022 年 A 股限制性股票激励计 划（草案）>及其摘要的议案》《关于<荣昌生物制药（烟台）股份有限公司 2022 年 A 股限制性股票激励计划实施考核管理办法>的议案》以及《关于提请股东大会 授权董事会办理公司 2022 年 A 股限制性股票激励计划相关事宜的议案》。公司独 立 ...

Investment Rating - The investment rating for the company is "Buy" [7] Core Views - The company has achieved continuous loss reduction for three consecutive quarters, driven by the commercialization of Tai'tasip and Vidi'sitom, with expectations for profitability improvement [1][2] - The company reported a revenue of 526 million yuan in Q1 2025, a year-on-year increase of 59.17%, primarily driven by the sales of Tai'tasip and Vidi'sitom [2] - The company is optimistic about the ongoing clinical trials and market potential of Tai'tasip for generalized Myasthenia Gravis (gMG) and other indications [3][4] Financial Performance - In Q1 2025, the company reported a net loss of 254 million yuan, a reduction of 95 million yuan year-on-year, indicating a trend of continuous loss reduction [2] - The R&D expense ratio decreased by 37.7 percentage points to 62.53%, while the sales and management expense ratios also saw significant declines, contributing to the loss reduction [2] - Revenue projections for 2025-2027 are estimated at 2.407 billion, 3.269 billion, and 4.185 billion yuan respectively, with expectations of continued loss reduction in 2025-2026 and profitability in 2027 [5][12] Pipeline and Market Potential - Tai'tasip has received breakthrough therapy designation in China and orphan drug status in the US, indicating strong market potential [3] - The company is advancing multiple products through clinical trials, with several indications expected to enter commercialization, supporting revenue growth [4] - The company is optimistic about the commercialization prospects of Tai'tasip in both domestic and international markets, particularly in the US [3][4]

Investment Rating - The investment rating for the company is "Buy-A" with a 6-month target price of 60.01 CNY [4]. Core Insights - The company reported a revenue of 526 million CNY for Q1 2025, representing a year-on-year growth of 59.17%. However, it incurred a net loss of 254 million CNY during the same period [1]. - The clinical data for the drug Taitasip in treating Myasthenia Gravis (MG) is promising, with 98.1% of patients showing improvement in daily activity scores after 24 weeks of treatment. The overseas Phase 3 trials are currently in the enrollment stage [1][2]. - The company has multiple product approvals expected in 2025, including Taitasip for MG and IgA nephropathy, as well as Vedisizumab for HER2-positive breast cancer [2]. Financial Projections - Revenue projections for the company are estimated at 2.30 billion CNY in 2025, 3.29 billion CNY in 2026, and 4.23 billion CNY in 2027. Net profits are expected to be -1.03 billion CNY in 2025, -385 million CNY in 2026, and a profit of 263 million CNY in 2027 [2][10]. - The earnings per share (EPS) are projected to be -1.90 CNY in 2025, -0.71 CNY in 2026, and 0.48 CNY in 2027 [2][10]. Market Performance - The company's stock price was 55.98 CNY as of April 28, 2025, with a market capitalization of approximately 30.47 billion CNY [4]. - The stock has shown a relative return of 41.8% over the past month and 101.9% over the past three months [6].