| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号：2025-034 | | --- | --- | --- | | 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 自愿披露关于泰它西普获欧盟孤儿药资格认定的公告 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： 近日，荣昌生物制药（烟台）股份有限公司（以下简称"公司"或"荣昌生物"） 的产品泰它西普（商品名：泰爱®，研发代号：RC18）获得欧盟委员会（EC）授予的孤 儿药资格认定（Orphan Drug Designation,ODD），用于治疗重症肌无力，现将具体情况 公告如下： 一、 药品相关情况 重症肌无力（Myasthenia Gravis, MG）是一种由自身抗体介导、获得性神经肌肉 接头传递障碍的罕见自身免疫性疾病。据国际重症肌无力基金会（MGFA）及研究数据显 示，全球 MG 患病率约为每 10 万人 15-25 例，在欧盟符合罕见病（患病率低于万分之五） 定义。尽管现有治疗（如胆碱酯酶抑制剂、 ...

荣昌生物制药（烟台）股份有限公司 股东大会会议资料 荣昌生物制药（烟台）股份有限公司 2024 年年度股东大会、 2025 年第一次 A 股类别股东大会及 2025 年第一次 H 股类别股东大会 会议资料 股票简称：荣昌生物 股票代码：688331 2025 年 6 月 1 荣昌生物制药（烟台）股份有限公司 股东大会会议资料 荣昌生物制药（烟台）股份有限公司 会议资料目录 三、会议议案 （一）2024 年年度股东大会 10、议案十：《关于变更公司注册资本、取消监事会、修订<公司章程>的 议案》 11、议案十一：《关于修订<股东会议事规则>的议案》 12、议案十二：《关于修订<董事会议事规则>的议案》 13、议案十三：《关于修订<独立董事工作制度>的议案》 （二）2025 年第一次 A 股类别股东大会 1、议案一：《关于变更公司注册资本、取消监事会、修订<公司章程>的 议案》 2、议案二：《关于修订<股东会议事规则>的议案》 （三）2025 年第一次 H 股类别股东大会 1、议案一：《关于变更公司注册资本、取消监事会、修订<公司章程>的 2 一、会议须知 二、会议议程 1、议案一：《关于公司<2024 年度董事 ...

Core Viewpoint - The focus of investment has shifted from AI to innovative pharmaceuticals, with significant interest and funding directed towards the latter, as evidenced by attendance at recent strategy meetings and substantial capital inflows into the sector [1][4]. Group 1: Market Trends - Innovative pharmaceuticals have seen a surge in investment, with southbound funds increasing their holdings by 55.14 billion, three times more than new consumer sectors [4]. - The healthcare sector's share of Hong Kong stock trading volume has risen from less than 5% a year ago to 15% [4]. - The top ten public funds this year are dominated by innovative pharmaceutical funds, indicating a shift in market sentiment and investment strategies [4][5]. Group 2: Fund Manager Insights - Fund manager Zhou Sicong has noted a correlation between the performance of innovative pharmaceuticals and AI, suggesting that when one sector performs well, the other may not [2][3]. - Zhou has observed that TMT fund managers are increasingly involved in innovative pharmaceuticals, indicating a broader interest in the sector [3]. - The current market dynamics have led to a new generation of fund managers emerging as leaders in the innovative pharmaceutical space, while traditional managers have struggled [5][21]. Group 3: Investment Opportunities - The introduction of ADC (Antibody-Drug Conjugates) has proven the value of innovative pharmaceuticals, leading to significant licensing deals and collaborations with major global pharmaceutical companies [10][11]. - The potential for licensing out agreements is projected to account for nearly 30% of global sales in the coming years, highlighting a key growth area for innovative pharmaceuticals [11]. - The market is increasingly recognizing the strength of Chinese innovative pharmaceuticals, with a shift in how these assets are valued and perceived globally [12][21]. Group 4: Valuation and Market Sentiment - The traditional valuation methods for innovative pharmaceuticals are being challenged, with new metrics emerging that reflect the changing landscape of the industry [17][18]. - The current excitement around innovative pharmaceuticals is contrasted with previous market downturns, suggesting a more optimistic outlook for the sector moving forward [21][22]. - Despite concerns about potential bubbles in the market, there is a growing belief in the long-term potential of Chinese innovative pharmaceuticals to surpass their global counterparts [21][22].

Investment Rating - The report provides a neutral (N) rating for RemeGen and Junshi Biosciences, with price targets of Rmb 63 and Rmb 35 respectively [20][24]. Core Insights - The recent stock price rallies of RemeGen and Junshi are attributed to their developments in PD-1xVEGF bispecific antibodies (bsAbs), with RemeGen's stock jumping approximately 18% and Junshi's by about 6% on June 12, 2025 [2]. - RemeGen's potential out-licensing deal for telitacicept and ongoing trials for RC178 are key drivers of investor interest, while Junshi's JS207 is undergoing multiple Phase 2 trials, indicating strong market expectations for both companies [5][6]. Summary by Sections RemeGen - RemeGen's stock performance is driven by expectations of a telitacicept out-licensing deal and positive clinical data presentations at the ERA Congress 2025 [5]. - The company is advancing its Phase 3 trial for telitacicept in IgAN, with potential approval in China anticipated [5]. - RemeGen has initiated a Phase 1 trial for RC178, a PD-1xVEGF bsAb, with over 100 patients enrolled and ongoing Phase 2 trials in NSCLC [5][6]. Junshi Biosciences - Junshi's stock sentiment is influenced by the ongoing trials of its PD-1xVEGF bsAb, JS207, which is in several Phase 2 trials [6]. - Management suggests that JS207 has shown comparable efficacy to other bsAbs and may have a better safety profile based on Phase 1 data [6]. - Junshi is exploring a broader range of indications in its Phase 2 trials compared to RemeGen, with potential registrational trials for JS207 expected in late 2025 or early 2026 [6]. Comparative Analysis - Both RemeGen and Junshi are developing PD-1xVEGF bsAbs, with market expectations for out-licensing opportunities [6]. - RemeGen may have slightly more clinical data available than Junshi, but Junshi is exploring a wider range of indications in its trials [6]. - The business development potential for both companies will largely depend on the clinical efficacy and safety of their respective products [6].

Group 1 - Heptagon Pharma announced the latest progress in its core patent rights protection, with the National Intellectual Property Administration maintaining the validity of its "combination molecule" patent, which involves the use of transgenic animals to produce fully human heavy chain antibodies (HCAb) [1] - The "combination molecule" patent is central to Heptagon Pharma's Harbour Mice® platform, which has established collaborations with several well-known pharmaceutical companies globally, indicating significant commercial value [1] Group 2 - Yunnan Baiyao's JZ-14 capsule, a first-in-class small molecule immunomodulator developed by its subsidiary, has received clinical trial approval, showing significant immunomodulatory and anti-proliferative activity in ulcerative colitis and various tumor models [2] - Successful clinical translation of JZ-14 could fill a gap in the immunomodulation field and expand Yunnan Baiyao's presence in chemical drug innovation [2] Group 3 - Rongchang Bio's product, Taihetai (RC18), has received orphan drug designation from the European Commission for the treatment of myasthenia gravis, which provides various policy supports including scientific advice on development plans and a ten-year market exclusivity post-approval [3] Group 4 - Merck's Clesrovimab (MK-1654) injection application is proposed for priority review by the National Medical Products Administration, aimed at preventing lower respiratory tract infections caused by RSV in newborns and infants entering or born during the RSV season [4] - Clesrovimab's long-acting protective characteristics may alter the current RSV prevention landscape, necessitating attention to its competitive differentiation from vaccines and pricing strategies [4]

Economic Indicators - Multiple economic indicators showed improvement in May, with a significant rebound in consumption growth [1][11] - The market is experiencing rapid rotation among sectors, indicating clear structural opportunities despite a background of reduced trading volume [1][11] Stock Market Performance - US stock markets experienced a decline, with major indices falling: Dow Jones down 299.29 points (-0.7%), S&P 500 down 50.39 points (-0.84%), and Nasdaq down 180.12 points (-0.91%) [4][3] - Technology stocks faced pressure, with Tesla leading the decline at nearly 4%, and other major companies like Apple, Microsoft, and Amazon also experiencing losses [4] Foreign Exchange Market - In May, the foreign exchange market in China remained stable, with a net inflow of $33 billion from non-bank sectors [5] - The demand for foreign exchange decreased, while the willingness to settle foreign exchange remained stable, indicating a rational and orderly market [5] Commodity Market - Oil prices rebounded significantly due to risks in the Middle East, with WTI crude oil futures rising 4.3% to $73.27 per barrel and Brent crude oil increasing 4.4% to $76.45 [4] - Gold prices faced a slight decline, with COMEX gold futures down 0.3% to $3406.9 per ounce [4] Corporate Developments - BOE announced plans to acquire a 30% stake in Rainbow Optoelectronics for a base price of 4.849 billion yuan, aiming to enhance competitiveness [8] - Guoxin Technology successfully tested a new quantum-resistant encryption card, indicating advancements in information security products [9] - Rongchang Bio's drug, Tai Itasip, received orphan drug designation from the EU, which will provide policy support for its development [10]

Group 1: Stock Performance and Risks - Huayang New Materials (600281.SH) has experienced significant stock price fluctuations, with a cumulative increase that deviates from the industry average, indicating potential irrational speculation risks [1] - The company clarified that its main business does not involve rare earth permanent magnets, focusing instead on precious metal recovery and processing, which is facing rising raw material costs due to increasing precious metal prices [1] - Jinniu Chemical (600722.SH) reported that its methanol sales prices have not changed significantly despite a 20% increase in stock price over three trading days, indicating stable market conditions [4] Group 2: New Product Developments - Guoxin Technology (688262.SH) successfully tested its new quantum-resistant password card, CCUPHPQ01, and has sent samples to multiple clients for application development [2] - Rongchang Biopharmaceutical (688331.SH) received orphan drug designation from the EU for its product Tai Itasip, which is the first dual-target fusion protein drug for treating myasthenia gravis, providing policy support for its development in the EU [8] Group 3: Corporate Actions and Financial Updates - Lakala (300773.SZ) is in discussions regarding its H-share listing, which faces significant uncertainty in approval and regulatory processes [3] - Dematech (688360.SH) entered a strategic cooperation agreement with Shanghai Zhiyuan New Technology to explore innovative applications of embodied intelligent robots in logistics [9] - Yashi Chuangneng (603378.SH) announced a potential forced reduction of 3% of its shares due to a margin call affecting its major shareholder [10] - Siwei Technology (688213.SH) reported a decrease in the shareholding ratio of its major shareholder, the National Integrated Circuit Industry Investment Fund II, from 7.35% to 6.99% [11] - Jingyi Equipment expects a revenue increase of 36.54% to 42.48% year-on-year for the first half of 2025, projecting revenue between 690 million to 720 million yuan [12]

Core Points - The company is holding its annual general meeting to discuss various proposals, including financial reports and governance changes [1][3][19] - The meeting will take place on June 26, 2025, at 14:00 in Yantai, China, with both on-site and online voting options available [4][5][6] Meeting Procedures - Attendees must register and verify their identity to participate in the meeting [1][2] - Shareholders have the right to speak, ask questions, and vote on proposals, but must adhere to the meeting's agenda and time limits [2][3] - The meeting will be conducted in an orderly manner, with the chairman having the authority to manage discussions and responses to questions [2][3][4] Agenda Items - The meeting will review and vote on several key proposals, including: - The 2024 annual board report [8][10] - The 2024 annual supervisory report [10] - The 2024 financial settlement report, which has been audited and approved [11] - The 2024 annual report and its summary [12] - A proposal for profit distribution, indicating no distribution for 2024 [13] - The reappointment of accounting firms for 2025 [13] - Confirmation of director and supervisor remuneration for 2024 [14][18] - A proposal for general authorization to issue new shares [15][16] - Changes to the company's registered capital and governance structure, including the abolition of the supervisory board [17][21] - Amendments to the company's articles of association and meeting rules [19][20][22] Financial Performance - The company reported significant sales growth, particularly from its products, with a revenue of 1.699 billion yuan from one of its drugs [24] - The company is focused on maintaining high R&D investment while reducing net losses compared to previous years [24]

华福证券认为，港股创新药（含Pharma）为医药板块中最强势的板块，其次为创新药产业链CRO板 块，创新药已成为市场认可的主线之一，个股方面从主流一二线标的，行情亦在向有创新药布局或BD 预期的中药或仿制药标的扩展。短期创新药建议积极拥抱龙头和一线标的。 （本文机构观点来自持牌证券机构，不构成任何投资建议，亦不代表平台观点，请投资人独立判断和决 策。） 消息面上，据央视新闻，6月13日国务院常务会议召开研究优化药品和耗材集采有关举措。会议指出， 要加强药品和耗材集采政策评估，总结经验、补齐短板，推动集采工作规范化制度化常态化开展。要更 好促进"三医"协同发展和治理，完善公立医院补偿机制，支持医药企业提高创新能力，更好满足群众多 元化就医用药需求。要加强对药品和耗材生产、流通、使用全链条质量监管，扎实推进仿制药质量和疗 效一致性评价，让人民群众用药放心安心。 东吴证券指出，创新药BD推动及优秀临床数据下，看好的医药子行业排序分别为：创新药>CXO>中药 >医疗器械>药店>医药商业等。具体标的选择思路：从成长性角度选股，主要集中创新药领域；从左侧 角度选股，主要集中在CXO、医疗器械。 6月16日，创新药概念小幅 ...

Core Insights - The pharmaceutical-themed funds are dominating the performance rankings for the first half of the year, with nine out of the top ten funds being pharmaceutical-focused, led by Huatai-PineBridge Hong Kong Advantage Select A, which achieved a 103.67% return [1][2] - The strong performance of these funds is driven by multiple factors, including breakthroughs in innovative drug development, recovery of liquidity in the Hong Kong stock market, and restructuring of valuation systems through cross-border business development transactions [1][2] Fund Performance - The average return of the top ten actively managed equity funds exceeds 69%, with notable performances from Changcheng Pharmaceutical Industry Select A and Yongying Pharmaceutical Innovation Smart Select A, achieving returns of 87.73% and 79.79% respectively [2] - Huatai-PineBridge Hong Kong Advantage Select A is highlighted as a "doubling fund" for the year, marking a significant achievement in the market [2] Market Dynamics - The pharmaceutical sector is experiencing a "double hit" in profitability and valuation in 2025, with the Hang Seng Hong Kong Stock Connect Innovative Drug Index showing a year-to-date increase of 70.09% [3] - The performance of pharmaceutical funds is significantly influenced by their exposure to Hong Kong stocks, with the Hang Seng Healthcare Index rising by 54.59%, outperforming the A-share innovative drug index, which increased by 24.15% [3] Investment Strategy - Huatai-PineBridge Hong Kong Advantage Select A has benefited from investments in leading companies in the Hong Kong innovative drug and medical device sectors, capitalizing on improved overseas liquidity and favorable industry policies [4] - The introduction of financing channels for unprofitable biotech companies in Hong Kong has allowed competitive biotech firms to enter the market, with many now in advanced stages of research and commercialization [4] Future Outlook - The pharmaceutical industry is expected to maintain long-term investment value driven by demographic aging, consumption upgrades, and technological innovation, although caution is advised regarding potential overvaluation of certain stocks [6] - The current market for innovative drugs is characterized by high valuations and volatility, with expectations for a rebalancing between these factors in the near future [6][7] - The valuation of leading companies and key stocks is anticipated to be reassessed, with a focus on the long-term potential of authorized products and revenue realization from commercial partnerships [7]