LEPU BIO(02157)
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全球首个EGFR ADC附条件获批上市,由中国企业自主研发;拥有2万只实验猴的鼎泰药研递表港交所 | 掘金创新药
Mei Ri Jing Ji Xin Wen· 2025-11-05 11:32
每经记者:金喆 每经编辑:魏官红 资本眼 一周行情 10月27日至10月31日,医药生物指数下跌2.81%,跑输上证指数2个百分点,连续六周跑输上证指数。 创新药(BK1106)周内上涨3.61%,连续两周上涨。恒生医疗保健业指数(HSCICH)周下跌0.08%, 虽较上周幅度收窄,但仍处于下行趋势;港股创新药ETF(513120)周内上涨2.38%。 一周IPO动向 鼎泰药研递表港交所 拥有超过2万只实验猴 10月31日,江苏鼎泰药物研究(集团)股份有限公司(以下简称"鼎泰药研")在港交所递交招股书,拟 在香港主板上市。公司曾于2016年到2021年在新三板挂牌,2023年一度计划在A股上市,但最终因综合 评估IPO(首次公开募股)环境而调整战略,转而寻求港股上市路径。 鼎泰药研成立于2008年,创始股东之一为江苏省药物研究所。2022年到2024年,鼎泰药研营收规模在7 亿元以上,2025年上半年收入约为3.76亿元,其中非临床研究服务、临床试验服务和销售研究动物三大 业务收入分别为2.81亿元、0.90亿元及521.9万元。盈利方面,连续亏损两年后,鼎泰药研在2025年上半 年扭亏为盈,净利润为0.65 ...
乐普生物(02157) - 截至二零二五年十月三十一日止月份之股份发行人的证券变动月报表
2025-11-05 09:52
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10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: 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) 呈交日期: 2025年11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) | 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 RMB | | 1,804,439,838 | 本月底法定 ...
2025 年度三季报业绩总结:创新与出海主线逻辑不变
Great Wall Glory Securities· 2025-11-03 11:17
Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Views - The investment logic in the pharmaceutical sector is shifting from policy pressure to innovation-driven growth, with the "14th Five-Year Plan" directly supporting the development of innovative drugs and medical devices [8][26] - The industry is witnessing a transition from rapid following to original innovation, as demonstrated by Chinese companies showcasing their global competitiveness and pipeline value at the 2025 ESMO conference [8][26] - The recent approval of innovative drugs and the successful listing of companies on the STAR Market indicate a supportive capital market for innovative pharmaceutical enterprises [8][26] Industry Review - The pharmaceutical and biotechnology industry index increased by 1.89%, ranking 20th among 31 primary industries, underperforming the CSI 300 index which rose by 2.80% [5][16] - The sub-industries of medical research outsourcing and vaccines showed the highest gains, with increases of 5.26% and 4.19% respectively, while medical devices and traditional Chinese medicine experienced declines of 1.21% and 0.56% [5][16] - As of October 31, 2025, the industry’s PE (TTM, excluding negative values) was 30.67x, up from 30.08x in the previous period, indicating an upward valuation trend but still below the average [21] Company Dynamics - A total of 36 listed companies in the pharmaceutical and biotechnology sector experienced a net reduction in shareholder holdings amounting to 805 million yuan, with 4 companies increasing holdings by 120 million yuan and 32 companies reducing holdings by 925 million yuan [5][6] - Among the 501 tracked companies, 499 have disclosed their performance for the first three quarters of 2025, with 53 companies reporting a net profit growth of 100% or more, and 69 companies reporting growth between 30% and 100% [6] Investment Recommendations - Focus on companies with strong positions in innovative drugs and cutting-edge technology platforms, particularly those involved in ADC, bispecific/multispecific antibodies, and cell therapy, which can provide high potential for international market expansion [8] - Pay attention to the CXO industry, which is expected to see increased demand due to the recovery of innovative drug development and commercialization, especially for leading companies with strong service capabilities in new technology areas [8]
CAR-T药物有望进入商保;绿谷医药违规推广被罚
Mei Ri Jing Ji Xin Wen· 2025-11-02 23:20
Group 1 - WuXi AppTec's CAR-T drug, Rikeolunase injection, is expected to be included in the commercial health insurance innovation drug directory, marking a significant step in China's multi-tiered medical security system [1] - The drug is the first domestically approved Class 1 CAR-T therapy, with a pricing of 1.29 million yuan per injection, which aims to alleviate the pressure on basic medical insurance [1] - This breakthrough not only facilitates the realization of cutting-edge technology value but also promotes the formation of a complete closed loop from R&D to commercialization in the biopharmaceutical industry [1] Group 2 - Green Valley Pharmaceutical was fined 400,000 yuan for illegal promotion of the drug Ganluotena capsules (brand name: Jiuqi Yi), which has been controversial regarding its efficacy since approval [2] - The fine serves as a significant warning for pharmaceutical companies, especially for new drugs with low public awareness, emphasizing the importance of compliance in marketing practices [2] Group 3 - Libang Pharmaceutical has submitted its prospectus for an IPO on the Hong Kong Stock Exchange, focusing on the kidney disease sector as a global leading biopharmaceutical company [3] - The company has established a vertically integrated platform covering R&D, production, and commercialization, creating a core competitive advantage in a market with approximately 850 million kidney disease patients [3] Group 4 - Aidi Pharmaceutical's ADC118 tablets, a Class 1 new drug for HIV-1 treatment, have received clinical approval, marking the first domestically developed integrase inhibitor combination therapy to enter clinical trials in China [4] - This development represents a significant breakthrough in the research and development of new drugs for AIDS in China, potentially providing high-quality domestic treatment options for HIV patients [4] Group 5 - Lepu Biopharma's MRG003 (Vebecotuzumab) has been approved for marketing by NMPA, aimed at treating recurrent/metastatic nasopharyngeal carcinoma patients who have failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitors [5] - MRG003 is the world's first approved EGFR ADC new drug, marking a new milestone for domestic ADC products [5]
乐普生物-B(02157.HK):杨明拟退任监事
Ge Long Hui· 2025-10-31 11:48
Core Points - LePu Biotech-B (02157.HK) announced the resignation of Yang Ming from the position of supervisor due to retirement [1] - Yang Ming will no longer hold any position within the company after the resignation takes effect [1] - The resignation will be effective upon the approval of a new supervisor at the upcoming shareholders' meeting [1]
乐普生物-B:杨明辞任监事
Zhi Tong Cai Jing· 2025-10-31 11:47
Core Points - The company Lepu Biopharma-B (02157) announced that Yang Ming has resigned from his position as a supervisor due to retirement [1] - Following the resignation, Yang Ming will no longer hold any position within the company [1]
乐普生物-B(02157):杨明辞任监事
智通财经网· 2025-10-31 11:43
Core Viewpoint - Lepu Biopharma-B (02157) announced the resignation of Yang Ming from the position of supervisor due to retirement, effective immediately, and he will no longer hold any position within the company [1] Group 1 - Yang Ming has retired and resigned from his supervisory role at Lepu Biopharma-B [1] - Following the resignation, Yang Ming will not hold any positions within the company [1]
乐普生物(02157) - 监事辞任
2025-10-31 11:36
(股份代號:2157) 監事辭任 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,並明確表示概不會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。 LEPU BIOPHARMA CO., LTD. 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) 樂普生物科技股份有限公司(「本公司」)董事(「董事」)會(「董事會」)謹此宣佈, 楊明先生(「楊先生」)因退休已辭任本公司監事職務。辭任生效後,楊先生將不再 於本公司擔任任何職務。 楊先生辭任監事將於擬舉行的本公司股東大會上獲本公司股東(「股東」)批准委任 新監事後生效。在此之前,楊先生將繼續根據法律、行政法規及公司章程的規定 履行監事職責。 楊先生已確認,彼與董事會並無任何意見分歧,亦無與其辭任有關之事宜須敦請 股東或香港聯合交易所有限公司垂注。 董事會謹此向楊先生在任期間作出的貢獻表示衷心感謝。 承董事會命 樂普生物科技股份有限公司 董事長兼執行董事 蒲忠傑博士 中國,上海 2025年10月31日 於本公告日期,董事會包括執行董事蒲忠傑博士(董事長 ...
东曜药业祝贺合作伙伴乐普生物EGFR ADC新药获NMPA批准上市
Xin Lang Cai Jing· 2025-10-31 10:26
Core Insights - Dongyao Pharmaceutical celebrates the conditional approval of its partner Lepu Biopharma's innovative drug, Vebekotamab, marking a significant milestone in the commercialization of ADCs in China [1][3] - The successful collaboration between Dongyao and Lepu demonstrates the company's capabilities in complex molecule production and quality control, essential for ADC manufacturing [1][2] Company Overview - Dongyao Pharmaceutical (stock code: 1875.HK) is a leading global CDMO specializing in biopharmaceuticals, providing comprehensive services from early development to commercial production [8] - The company has extensive experience in large-scale biopharmaceutical production compliant with GMP standards, with certifications from multiple countries including China, Brazil, and Japan [2][8] Product Details - Vebekotamab is an EGFR-targeted ADC designed for treating recurrent or metastatic nasopharyngeal carcinoma (R/M NPC), representing the first approved EGFR-targeted ADC in China [5] - The drug combines a monoclonal antibody targeting EGFR with a potent payload, leading to tumor cell death through a specific mechanism [5] Industry Context - The approval of Vebekotamab highlights the growing importance of ADCs in targeted cancer therapies, providing new treatment options for patients with limited alternatives [3][4] - The collaboration between Dongyao and Lepu sets a precedent for effective partnerships in the biopharmaceutical industry, emphasizing the need for high-quality production and regulatory compliance [2][4]
乐普生物-B高开逾7% 注射用维贝柯妥塔单抗国内获批上市
Zhi Tong Cai Jing· 2025-10-31 01:31
Core Viewpoint - Lepu Biopharma-B (02157) experienced a significant increase in stock price, rising by 7.34% to HKD 6.87, with a trading volume of HKD 13.97 million following the approval of its drug Meiyouheng (injectable Vebrecatinib) by the National Medical Products Administration in China [1] Group 1 - The National Medical Products Administration has approved Meiyouheng (injectable Vebrecatinib) for market entry in China, marking it as the first approved EGFR-targeted antibody-drug conjugate (ADC) in the country [1] - Meiyouheng is designed for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC), representing a significant advancement in targeted cancer therapy [1] - The approval of Meiyouheng is considered a major milestone for the company, enhancing treatment efficacy for patients and paving the way for the expansion of its indications and commercial potential [1]