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]

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]

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]

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]

（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 ...

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]

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]

Core Insights - The National Medical Products Administration of China has approved the listing application for the candidate drug Meiyouheng® (Injection Vebecotamab) developed by the company, which is an innovative antibody-drug conjugate targeting the epidermal growth factor receptor (EGFR) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/MNPC) [1] Group 1: Drug Development and Approval - Meiyouheng® is an ADC composed of an EGFR-targeting monoclonal antibody linked to a potent microtubule inhibitor, demonstrating high specificity for tumor cells expressing EGFR, which is prevalent in various malignancies [1] - The drug targets EGFR, which is expressed in 89% of advanced nasopharyngeal carcinoma cases, making it a significant target for cancer treatment [1] Group 2: Clinical Efficacy and Safety - Meiyouheng® has shown clinically meaningful efficacy advantages in patients who have failed second-line systemic chemotherapy and PD-(L)1 inhibitors, with manageable safety profiles [2] - In a Phase II clinical trial, the combination therapy of Meiyouheng® with Putiheng (Injection Putilizumab) achieved the highest confirmed objective response rate (cORR) of 73.3% and the longest median progression-free survival (mPFS) of 10.9 months in patients who failed immunotherapy and platinum-based chemotherapy [2]

Core Viewpoint - Lepu Biopharma-B (02157) has received approval from the National Medical Products Administration for its candidate drug Meiyouheng (injectable Vebrecatinib), marking a significant milestone for the company in the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) [1] Group 1 - Meiyouheng (injectable Vebrecatinib) is the first EGFR-targeted antibody-drug conjugate (ADC) approved in China, representing a pioneering achievement in this category [1] - The approval of Meiyouheng is expected to enhance treatment outcomes for patients suffering from R/M NPC [1] - The company plans to expand the indications for Meiyouheng based on this approval, aiming to accelerate the realization of its commercial potential [1]

Core Insights - The National Medical Products Administration of China has approved the listing application for the candidate drug Meiyouheng (injectable Vebecotuzumab) developed by the company, which is an innovative antibody-drug conjugate targeting epidermal growth factor receptor (EGFR) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/MNPC) [1][2] Company Overview - Meiyouheng is an ADC composed of an EGFR-targeting monoclonal antibody linked to a potent microtubule inhibitor, demonstrating high affinity for tumor cells expressing EGFR, which is a significant target in cancer therapy [1] - The drug targets EGFR, which is highly expressed in various malignancies, including colorectal cancer, lung cancer, and head and neck cancer, with 89% of advanced NPC cases showing EGFR expression [1] Clinical Efficacy - Meiyouheng has shown clinically meaningful efficacy in patients who have failed second-line or higher systemic chemotherapy and PD-(L)1 inhibitors, with controllable safety [2] - Key registration clinical trial results for Meiyouheng in treating R/MNPC will be presented as a "late-breaking abstract" at the 2025 American Society of Clinical Oncology annual meeting [2] - The combination therapy of Meiyouheng with Puyouheng (putilizumab injection) has demonstrated significant and durable clinical benefits, achieving the highest confirmed objective response rate (cORR) of 73.3% and the longest median progression-free survival (mPFS) of 10.9 months in patients who failed immunotherapy and platinum-based chemotherapy [2]