（於中華人民共和國註冊成立的股份有限公司） 股份代號 : 2157 2025 中期報告 目錄 | 2 | 公司資料 | | --- | --- | | 4 | 財務概要 | | 5 | 管理層討論及分析 | | 23 | 其他資料 | | 29 | 中期財務資料的審閱報告 | | 30 | 中期簡明綜合損益及其他全面收益表 | | 31 | 中期簡明綜合財務狀況表 | | 33 | 中期簡明綜合權益變動表 | | 34 | 中期簡明綜合現金流量表 | | 35 | 中期簡明綜合財務資料附註 | | 55 | 釋義及技術詞彙 | 樂普生物科技股份有限公司 二零二五年中報 2 公司資料 執行董事 蒲忠傑博士 （董事長） 隋滋野博士 （總經理） 非執行董事 蒲珏女士 秦怡然女士 （自2025年6月27日起獲委任） 楊紅冰先生 （自2025年6月27日起退任） 獨立非執行董事 周德敏先生 楊海峰先生 華風茂先生 監事 徐揚先生 楊明先生 趙力萱女士 審計委員會 華風茂先生 （主席） 楊海峰先生 蒲珏女士 薪酬及考核委員會 楊海峰先生 （主席） 華風茂先生 蒲忠傑博士 提名委員會 周德敏先生 （主席） 楊海峰先生 蒲珏 ...

Core Viewpoint - The pharmaceutical sector is experiencing a rebound, with significant stock price increases for several companies following regulatory support for innovative drug clinical trial approvals [1] Group 1: Stock Performance - Several pharmaceutical stocks have seen notable gains, including: - Hutchison China MediTech (00013) up 11.04% to HKD 27.96 - Innovent Biologics (09969) up 10.76% to HKD 18.63 - Zai Lab (09688) up 7.84% to HKD 26.14 - Lepu Biopharma-B (02157) up 7.3% to HKD 8.53 - CanSino Biologics (09926) up 6.5% to HKD 136 [1] Group 2: Regulatory Developments - The National Medical Products Administration (NMPA) has proposed to optimize the review and approval process for innovative drug clinical trials, aiming to complete reviews within 30 working days for eligible applications [1] - This initiative supports key national R&D projects and encourages global early-stage synchronized development and international multi-center clinical trials [1] Group 3: Market Sentiment and Challenges - There are concerns regarding potential restrictions on Chinese innovative drugs in the U.S. market, but many pharmaceutical companies believe these rumors will not significantly impact the prospects for Chinese drugs abroad [1] - HSBC notes that the short-term emotional impact of these rumors may be greater than the actual damage, as prohibiting patent transactions is technically challenging [1] - Global pharmaceutical companies are facing a "patent cliff" risk and are in need of high-quality Chinese assets to strengthen their product pipelines, leading to lobbying against such administrative orders [1]

Core Viewpoint - Pharmaceutical stocks experienced a rebound today, with significant gains observed in several companies following regulatory news from the National Medical Products Administration (NMPA) regarding the optimization of clinical trial review and approval processes for innovative drugs [1] Group 1: Stock Performance - Hutchison China MediTech (00013) rose by 11.04%, trading at HKD 27.96 [1] - Innovent Biologics (09969) increased by 10.76%, trading at HKD 18.63 [1] - Zai Lab (09688) saw a rise of 7.84%, trading at HKD 26.14 [1] - Lepu Biopharma-B (02157) gained 7.3%, trading at HKD 8.53 [1] - CanSino Biologics (09926) increased by 6.5%, trading at HKD 136 [1] Group 2: Regulatory Developments - The NMPA announced a plan to further optimize the review and approval process for clinical trials of innovative drugs, aiming to complete reviews within 30 working days for eligible applications [1] - This initiative supports key national R&D projects and encourages global early-stage synchronized development and international multi-center clinical trials [1] Group 3: Market Sentiment and Risks - Recent negative rumors regarding potential restrictions on Chinese innovative drugs entering the U.S. market have been noted, but several pharmaceutical companies believe these rumors do not currently impact the expectations for Chinese innovative drugs abroad [1] - HSBC indicated that the short-term emotional impact of these rumors may be greater than the actual damage, as prohibiting patent transactions is technically challenging [1] - Global pharmaceutical companies are facing a "patent cliff" risk and are in need of high-quality Chinese assets to strengthen their product pipelines, leading to lobbying against such administrative orders [1]

Core Viewpoint - After a significant drop, Hong Kong's innovative drug concept stocks rebounded across the board, indicating market resilience and potential recovery in the sector [1] Group 1: Market Performance - As of the report, Kangning Jereh Pharmaceutical-B surged over 14%, Hutchison China MediTech rose more than 6%, Zai Lab and Lepu Biopharma B increased over 5%, and Akeso-B climbed over 4% [1] Group 2: Industry Sentiment - Several pharmaceutical companies have acknowledged rumors regarding potential restrictions from the U.S. on innovative drugs from China, but they believe these rumors do not currently impact the expectations for Chinese innovative drugs entering international markets [1] Group 3: Future Outlook - Market analysts predict that leading biotech companies such as BeiGene and Innovent Biologics are expected to reach a profitability inflection point by 2025, with a strong growth trajectory anticipated thereafter [1] - With improvements in industrial capabilities and product line expansions, it is expected that more biotech firms will enter a profitability cycle in the future [1]

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: 2025年8月31日 狀態: 新提交 公司名稱: 樂普生物科技股份有限公司(於中華人民共和國註冊成立的股份有限公司) 第 1 頁 共 10 頁 v 1.1.1 FF301 II. 已發行股份及/或庫存股份變動 呈交日期: 2025年9月4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) | 02157 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,804,439,838 | RMB | | 1 RMB | | 1,804,439,838 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 1,804,439,838 | RMB | | 1 ...

Group 1 - The Hong Kong biotechnology stocks experienced a collective decline, with notable drops in several companies [1] - WuXi AppTec (02126) saw a decrease of 12.95%, closing at 4.840 [2] - BioNTech (06952) fell by 12.53%, with a latest price of 13.750 [2] Group 2 - Other companies such as Valiant (09887) and Beihai Kangcheng (01228) also reported significant declines of 9.93% and 9.75% respectively [2] - The decline extended to companies like Saint Noble (02257) and MIRXES (02629), which dropped by 9.64% and 8.43% [2] - Overall, the biotechnology sector is facing downward pressure, impacting multiple firms [1]

2025 年 08 月 27 日 乐普生物-B(02157.HK) EGFR ADC 获批上市值得期待，多个管 线产品快速推进中 事件：公司发布 2025 年中期业绩，报告期内公司实现营业收入 4.66 亿元，实现归母净利润 0.42 亿元。 本报告版权属于国投证券股份有限公司，各项声明请参见报告尾页。 1 EGFR ADC 获批上市值得期待，多个数据即将在 ESMO 学术会议 披露。公司 EGFR ADC MRG003 鼻咽癌适应症已在 NDA 上市审核阶 段，后续获批上市值得期待，此外联用 PD-1 的 R/M 鼻咽癌适应症 正在进行 3 期临床，单药治疗二线及以上头颈癌适应症正在进行 3 期临床。数据披露方面，公司预计在 ESMO 2025 年会上披露 MRG003 联合 PD-1 的头颈癌 2 期数据以及联合 PD-1 的鼻咽癌 2 期 数据，相关数据披露值得期待。 其他多个管线产品快速推进中，已达成多个对外授权合作。其 他产品管线方面， TF ADC MRG004A 已在 2025 年 8 月进入 3 期注 册临床阶段，预计将在 ESMO 2025 年会上披露胰腺癌 1b 期数据； 溶瘤病毒 CG0 ...

作者：行情君 8月22日，乐普生物-B(02157)盘中上涨6.16%，截至11:47，报10.17元/股，成交2.0亿元。 乐普生物科技股份有限公司主要市场在中国，专注于肿瘤治疗领域的生物制药研发，特别在靶向治疗及 免疫治疗上有创新成果。该公司拥有完整的药物发现、临床开发、CMC及GMP合规生产的端到端能 力，并已经建立了专业的销售和营销团队，旨在满足临床需求，提供优化和创新的药物解决方案。 截至2025年中报，乐普生物-B营业总收入4.66亿元、净利润4174.5万元。 8月20日，2025财年中报归属股东应占溢利4175万人民币，同比增长121.69%，基本每股收益0.02人民 币。 本文源自：金融界 ...

每经AI快讯，8月21日，港股创新药概念午后走高，乐普生物(02157.HK)涨超9%，复宏汉霖(02696.HK) 涨超5%，君实生物(01877.HK)、荣昌生物(09995.HK)等个股跟涨。 （文章来源：每日经济新闻） ...

Group 1 - The Hong Kong stock market opened slightly higher on August 21, with the Hang Seng Index at 25,216 points, up 0.20%, while the Hang Seng Tech Index was at 5,528 points, down 0.23% [1] - Hong Kong Exchanges and Clearing (HKEX) reported record high revenue and net profit for the first half of 2025, with total revenue of HKD 14.076 billion, a year-on-year increase of 33%, and net profit of HKD 8.519 billion, up 39% [3] - The increase in trading volume in the cash market, derivatives market, and Stock Connect was attributed to the recovery of the Hong Kong stock market and growing global investor interest in non-USD assets [3] Group 2 - HKEX CEO Charles Li indicated that the exchange will explore a 24-hour trading mechanism, which positively impacted the stock price, reaching a high of HKD 447, up 1.31% [4] - Domestic brokerage stocks saw a significant rise, with Guotai Junan International up over 5% and Guotai Haitong up over 2%, while other firms like Zhongzhou Securities and China Galaxy also experienced gains [4] - Various cross-border ETFs, including the Hong Kong Stock Connect Innovative Drug ETF and Hong Kong Securities ETF, showed strong performance, with increases of over 1% [5]