乐普生物 20250710 摘要 乐普生物的 EGFR ADC（MRG003）针对鼻咽癌适应症预计 2025 年底 至 2026 年初获批上市，头颈鳞癌适应症预计 2027 年内获批。注册性 临床数据在 ASCO 会议上获得积极反馈，商业化策略已在讨论中。 TFADC（MRG004A）靶向组织因子，在胰腺导管腺癌方面显示良好信 号，已完成国内扩组实验，并计划在 ASCO 大会上公布数据。公司已向 中国 CDE 提交注册性临床沟通交流申请，寻求一线治疗方案。 GPC3 ADC（MRG006A）针对肝癌，具有全球首创潜力，目前正在进 行一期临床试验。预计 2026 年分享一期临床数据，并寻求海外合作机 会，肝癌市场潜力巨大。 Claudin 18.2 ADC（CMG901）由乐普生物与康诺亚共同开发，已授 权给阿斯利康，目前处于全球注册性三期临床阶段，预计 2026 年底提 交 NDA 申报。 CDH17 ADC（MRG007）针对结直肠癌，已授权给美国 Biotech Avent，获得国内 IND 批件，即将启动临床试验。总交易金额包括 4,700 万美元首付款及超过 12 亿美元里程碑付款。 Q&A 乐普生物 ...

[Table_Invest]买入 创新+消费共振，心血管平台加速多元化转型 [Table_Summary] 聚乳酸面部填充剂国内第 7 证，公司正式进入医美领域。聚左旋乳酸微 粒真皮组织填充剂是再生类医美产品，刺激胶原蛋白生成，具有优异的 生物相容性、可降解性和安全性。根据弗若斯特沙利文预测，我国基于 聚左旋乳酸的皮肤填充剂在 2024 年的出厂端市场规模预计约 11 亿元、 2030 年有望增长至约 38 亿元，年复合增长率接近 23%。截至公告日， 我国 NMPA 已批准包括乐普医疗在内的 7 张聚乳酸面部填充剂注册证； 公司另有多种玻尿酸产品已申报注册申请，快速丰富消费医疗产品矩阵。 持股乐普生物，PD-1 商业化&ADC 管线研发快速推进。乐普医疗持有 同一实控人旗下乐普生物 13.17%股份，乐普生物作为国内 ADC 领域的 领军企业，旗下首个商业化产品 PD-1 普特利单抗销售快速放量贡献现 金流，针对消化道癌的 ADC 产品 MRG007 已实现海外 BD 合作、交易 金额最高达 12 亿美元，针对二线及以上晚期鼻咽癌的 EGFR ADC 产品 MRG003 的 NDA 申请已获得 CDE 受理 ...

2025ASCO：中国创新，闪耀全球 20250606 摘要 中国创新药在 ASCO 会议上的数据占比创新高，口头报告 73 项，LBA 报告 11 项，表明中国药企创新能力显著提升，尤其在双抗、ADC 和小 分子疗法领域。 信达生物的二代 IO 产品 IBI363 通过增强 IL-2 功能并降低毒性，在黑色 素瘤、结直肠癌和肺癌中显示出潜力，尤其在非小细胞肺癌后线治疗中， 低剂量组总生存期超过 15 个月。 IBI363 在结直肠癌四线治疗中，1 毫克剂量组 OS 达 17.5 个月，接近 一线治疗水平，联合贝伐珠单抗后 ORR 接近 20%，DCR 超过 60%， 显著延长患者总生存期。 康方生物卡度尼利单抗一线治疗宫颈癌亚组分析显示，PD-L1 低表达患 者 PFS 达 12 个月，CPS>10%患者 PFS 达 11.1 个月，验证了其在宫 颈癌治疗中的优势。 博泰公司的 ADC 药物 264 在 HER2 突变耐药及 TNBC 中表现突出， HER2 突变耐药患者 ORR 达 45.1%，PFS 达 6.9 个月；一线 TNBC 患 者 ORR 达 71%，PFS 达 13.4 个月。 Q&A 近年 ...

港股创新药上涨，石药集团拉升涨超13%，乐普生物-b涨9%，金斯瑞生物科技涨超5%，带动港股医药 ETF上涨。 广发港股创新药ETF、汇添富港股通创新药ETF、万家港股创新药ETF基金、银华港股创新药ETF涨超 2%；汇添富恒生生物科技ETF、富国恒生医疗ETF、南方恒生生物科技ETF、银华港股通医药ETF、博 时恒生医疗ETF、平安港股医药ETF、鹏华恒生生物科技ETF、易方达港股通医药ETF涨超1.5%。 消息面上，6月5日，石药集团发布公告，集团开发的腺苷钴胺胶囊(0.5mg)("该产品")已获得中国国家药 品监督管理局颁发的药品注册批件，并视同通过仿制药质量和疗效一致性评价。 | | 港股创新药ETF涨幅- | | | | --- | --- | --- | --- | | 证券代码 | 11 字间称 | 当日涨跌%。 | 基金管理人 | | 513120.SH | 港股创新药ETF | 2.27 | 广发基金 | | 159570.SZ | 港股通创新药ETF | 2.25 | 汇添富基金 | | 520700.SH | 港股创新药ETF基金 | 2.15 | 万家基金 | | 159567.SZ ...

Core Viewpoint - The announcement highlights the promising results of the candidate drug MRG003, an innovative antibody-drug conjugate targeting epidermal growth factor receptor, for the treatment of recurrent or metastatic nasopharyngeal carcinoma, with key clinical trial results to be presented at the 2025 ASCO annual meeting [1] Group 1: Clinical Trial Results - The objective response rate (ORR) for the MRG003 group was 30.2%, compared to 11.5% for the chemotherapy group, with a statistically significant p-value of 0.0025 [1] - Progression-free survival (PFS) was significantly improved in the MRG003 group, with a hazard ratio (HR) of 0.63 and a median PFS of 5.8 months, compared to the chemotherapy group [1] - The median overall survival (OS) for the MRG003 group was 17.1 months, while the chemotherapy group had a median OS of 12 months, with an HR of 0.73 [1]

Core Insights - The 2025 ASCO Annual Meeting will take place from May 30 to June 3 in Chicago, showcasing significant advancements in innovative drug development from Chinese pharmaceutical companies [1][5] - Multiple drugs with "first-in-class" or "best-in-class" potential have been selected for oral presentations, highlighting the R&D capabilities of Chinese biotech firms [1] Group 1: Company Highlights - Innovent Biologics has seven studies selected for oral presentations, including IBI363 (PD1xIL2 bispecific antibody) with clinical data on non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and malignant pleural mesothelioma (MLN) [1] - China Biologic Products has twelve studies selected, with four classified as "latest breakthrough abstracts" (LBA), notably the combination of bemarituzumab and anlotinib for first-line treatment of NSCLC [1] - Kelun-Biotech will present six research outcomes, focusing on SKB264 (TROP2 ADC), A167 (PD-L1 monoclonal antibody), and A400 (RET inhibitor) [2] Group 2: Drug Development Focus - Antibody-drug conjugates (ADCs) are a major focus for domestic pharmaceutical companies at this year's meeting, with several companies showcasing their ADC products [2] - Baiyuntianheng's bispecific ADC BL-B01D1 (EGFRxHER3) will present Phase I clinical data for small cell lung cancer (SCLC) and NSCLC [3] - Zai Lab's ZG006 (DLL3xCD3 tri-antibody) will release Phase II dose expansion data for SCLC patients, along with updates on other dual-target antibodies [3] Group 3: Key Clinical Data - The combination therapy of vidutolimab and trastuzumab for HER2-positive gastric cancer will be presented in a rapid oral report [4] - The c-MET ADC RC108 will also update its progress during the meeting [4] - The ASCO 2025 meeting is positioned as a crucial platform for Chinese innovative drug companies to showcase their breakthroughs in key indications, further promoting the internationalization of domestic innovations [5]

Core Viewpoint - Lepu Biopharma-B (02157) has regained market attention due to significant progress in its ADC pipeline, leading to a stock price increase of nearly 78% year-to-date, despite a previous decline since its IPO in 2022 [1][18]. Group 1: Company Overview - Lepu Biopharma was established in 2018 and has built its pipeline through acquisitions and partnerships, including PD-1 antibodies and ADC drugs [1]. - The company focuses on integrating PD-1 as a cornerstone for cancer treatment while developing ADCs and other therapies for enhanced clinical outcomes [1][12]. Group 2: Financial Performance - In 2024, Lepu Biopharma is projected to achieve revenue of 368 million RMB, a year-on-year increase of 63.21%, driven by the commercialization of PD-1 [4]. - Despite revenue growth, the company reported a loss of 424 million RMB in the same year, with cash reserves remaining stable at 401 million RMB [4]. Group 3: Pipeline Development - The core drug in Lepu's pipeline is MRG003, an EGFR-targeting ADC, which has shown promising results in clinical trials for nasopharyngeal carcinoma (NPC) and head and neck squamous cell carcinoma (HNSCC) [4][10]. - MRG003 has received breakthrough therapy designation from both the CDE and FDA, indicating its potential in treating difficult-to-manage cancers [10]. Group 4: Competitive Landscape - The global market for EGFR-targeting ADCs is competitive, with several companies, including Rakuten Medical and Systimmune, also developing similar therapies [6][7]. - Lepu's MRG003 has demonstrated superior efficacy compared to existing treatments, with an overall response rate (ORR) of 47.4% in NPC patients, significantly higher than the typical 20-30% ORR for second-line therapies [7][10]. Group 5: Future Prospects - The company is actively exploring combination therapies, such as MRG003 with PD-1, which has shown an ORR of 66.7% in early trials [12]. - Lepu is also advancing its CG0070 oncolytic virus therapy, which has shown promising results in treating non-muscle invasive bladder cancer (NMIBC) and has received breakthrough therapy designation from the FDA [14][15]. Group 6: Challenges Ahead - Despite the positive developments, Lepu Biopharma's reliance on external acquisitions for its pipeline raises questions about its internal R&D capabilities [18]. - The company faces challenges related to ongoing losses and the need for substantial funding to support its numerous clinical trials [18].

Group 1 - The core viewpoint is that the Hong Kong stock market is experiencing a technical bull market, leading to a revaluation of innovative pharmaceutical companies, driven by improved liquidity and policy expectations [1][17] - The Hang Seng Index has risen over 20% this year, while the Hang Seng Healthcare Index has increased by over 40%, indicating strong market performance [1] - The revaluation of the innovative drug sector is attributed to global capital reassessing the long-term logic of China's innovative drug industry [1][19] Group 2 - AI medical technology breakthroughs, comprehensive policy support, and enhanced commercialization capabilities are expected to provide greater valuation expansion potential for Hong Kong's innovative drug sector compared to A-shares [4] - Companies with differentiated innovative pipelines and commercialization potential are becoming market focal points, entering a phase of valuation expansion [4][21] - Lepu Biopharma's 2024 financial report validates this logic, showcasing rapid commercialization and differentiated advantages in its three major pipelines [4][21] Group 3 - Lepu Biopharma achieved approximately 368 million yuan in revenue for 2024, with its main product, Pu You Heng®, generating around 300 million yuan, marking a threefold increase from the previous year's 100 million yuan [6] - The company has established a complete commercialization loop through a specialized marketing team, enhancing its market penetration and professional trust [6][7] - Lepu Biopharma has completed access to procurement platforms in 27 provinces and covers approximately 81 key cities with its sales channels [6] Group 4 - Lepu Biopharma's R&D pipeline focuses on three major areas: ADC, cancer immunotherapy, and oncolytic viruses, which collectively build competitive barriers [9][16] - The ADC pipeline, particularly the core product MRG003, demonstrates significant clinical potential and has received priority review from NMPA and orphan drug designation from FDA [11][13] - The company is also advancing other ADC candidates, such as MRG004A and MRG006A, which show promising clinical results and potential for broad application across various cancers [13][14] Group 5 - The supportive policy environment and recovering capital market are expected to accelerate industry growth and enhance valuation recovery [19][21] - The global healthcare financing activities are rebounding, with an estimated total of $58.2 billion in 2024, indicating a positive trend after two years of decline [19] - Lepu Biopharma is positioned at a critical point for performance and valuation growth, driven by strengthened commercialization capabilities and breakthroughs in its pipeline [21]