LM-302目前正在中国开展Ⅲ期临床试验，用于治疗经二线及以上系统治疗后进展的CLDN18.2阳性局部 晚期或转移性胃及胃食管交界部腺癌。此次纳入突破性治疗药物程序，有望加速LM-302的上市进程， 尽早为更多CLDN18.2阳性胃癌患者带来创新治疗选择。 2025年美国临床肿瘤学会(ASCO)年会上，礼新医药公布了LM-302联合PD-1单抗治疗胃癌的最新研究数 据：在41例疗效可评估的患者中，ORR为65.9%，DCR为85.4%。CLDN18.2≥25%的患者32例，ORR为 71.9%，DCR为96.9%。研究结果显示，LM-302联合方案在CLDN18.2阳性患者中具有良好的抗肿瘤活 性且安全性可控[1]。 格隆汇8月19日丨中国生物制药(01177.HK)公告，集团全资附属公司礼新医药科技(上海)有限公司("礼新 医药")自主研发的创新药LM-302"CLDN18.2ADC"已被中国国家药品监督管理局药品审评中心(CDE)纳 入突破性治疗药物程序(BTD)，用于联合PD-1单抗一线治疗CLDN18.2阳性的局部晚期或转移性胃及胃 食管交界部腺癌。 LM-302是一款潜在同类首创(first-in- ...

Core Viewpoint - The company has received formal acceptance of its clinical trial application for the injectable 7MW4911 from the National Medical Products Administration (NMPA) and an IND Acknowledgement Letter from the FDA, indicating progress in its drug development process [1] Group 1: Regulatory Approvals - The company announced that it has received a "Notice of Acceptance" from the NMPA for its clinical trial application for 7MW4911 [1] - The FDA has acknowledged receipt of the IND application for 7MW4911, confirming the company's compliance with regulatory requirements [1] Group 2: Product Development - 7MW4911 is an innovative antibody-drug conjugate (ADC) targeting cadherin 17 (CDH17), developed based on the company's proprietary IDDC™ antibody conjugation technology platform [1]

Group 1 - Core product Lukanasatuzumab (SAC-TMT) received breakthrough therapy designation from China's National Medical Products Administration (NMPA) for treating locally advanced or metastatic non-squamous non-small cell lung cancer without driver gene mutations [1] - This is the fifth breakthrough therapy designation for Lukanasatuzumab, which is an innovative antibody-drug conjugate (ADC) targeting advanced solid tumors such as non-small cell lung cancer, breast cancer, gastric cancer, and gynecological tumors [1][2] - Lukanasatuzumab has two approved indications in China, including treatment for unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and EGFR mutation-positive non-small cell lung cancer after platinum-based chemotherapy [2] Group 2 - The company plans to place 5.918 million H-shares at a price of HKD 331.8 per share, raising approximately HKD 1.943 billion, marking the largest new share placement in the Hong Kong biopharmaceutical sector this year [3] - Proceeds from the placement will be used for product research and development, clinical trials, regulatory filings, manufacturing, and commercialization, aiming to enhance R&D capabilities and expand the product pipeline [3] - The company has seen a cumulative stock price increase of 110.04% this year, reflecting strong market interest in innovative drug concepts [3]

Core Insights - The China National Medical Products Administration (NMPA) has announced that the injection of Trastuzumab Deruxtecan (T-DXd, DS-8201a) developed by Daiichi Sankyo is proposed for priority review for treating adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received one treatment regimen [1][2] - Trastuzumab Deruxtecan is a targeted HER2 antibody-drug conjugate (ADC) that has already received approval for four indications in China, including HER2-positive advanced breast cancer and HER2 (ERBB2) activating mutation non-small cell lung cancer [1] - The DESTINY-Gastric04 study, the first Phase 3 trial for Trastuzumab Deruxtecan in HER2-positive advanced gastric cancer, demonstrated significant overall survival (OS) improvement compared to standard treatments [2] Summary by Sections Drug Approval and Indications - Trastuzumab Deruxtecan is under priority review for treating HER2-positive gastric cancer in patients who have received prior treatment [1] - The drug has previously been approved for multiple indications in China, including advanced breast cancer and non-small cell lung cancer [1] Clinical Study Results - The DESTINY-Gastric04 study showed that Trastuzumab Deruxtecan significantly improved median overall survival to 14.7 months, extending it by 3.3 months compared to the standard treatment of 11.4 months [2] - The study indicated a 30% reduction in the risk of death for patients treated with Trastuzumab Deruxtecan compared to standard therapies [2] - The safety profile of Trastuzumab Deruxtecan was deemed manageable, with low-grade adverse events, although attention is needed for the risk of interstitial lung disease [2]

Group 1 - The core point of the article is that CSP301, a novel EGFR antibody-drug conjugate developed by the company, has received its third Fast Track designation from the FDA for treating advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) patients without EGFR mutations or other driver gene alterations who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy [1][2] - CPO301 has previously received two Fast Track designations from the FDA, the first in June 2023 for treating EGFR-mutant metastatic NSCLC patients who have relapsed or are refractory after EGFR-targeted therapy, and the second in September 2024 for treating recurrent or metastatic squamous NSCLC patients with EGFR overexpression who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy [1][2] - Lung cancer is the most prevalent and deadliest cancer globally, with approximately 2.5 million new cases and 1.8 million deaths annually, driven by activated EGFR gene mutations and overexpression of the EGFR protein [2] Group 2 - CPO301's Fast Track designations are based on encouraging clinical efficacy data, indicating its potential for greater activity compared to existing NSCLC and other cancer treatment options [2] - CPO301 is a humanized monoclonal antibody optimized from cetuximab and conjugated with topoisomerase I inhibitors, currently undergoing clinical studies in both China and the United States [2] - The Fast Track designation from the FDA will facilitate the development and registration process of CPO301 in the U.S. and globally [2]

Core Viewpoint - The company announced promising preclinical results for its novel FGFR2b-targeted antibody-drug conjugate (ADC) TST105, which demonstrates enhanced anti-tumor activity compared to existing ADCs in models of gastric and colorectal cancers [1][2]. Group 1: Clinical Research Findings - TST105 utilizes a site-specific conjugation technology and a novel topoisomerase I inhibitor as its payload, showing significantly improved anti-tumor efficacy in preclinical gastric and colorectal cancer models compared to ADCs using MMAE as a payload [1]. - In vitro studies indicate that TST105 exhibits specific cytotoxic effects on gastric and colorectal cancer cells, with an efficacy range of 0.3 nM to 0.4 nM, and demonstrates a stronger bystander effect compared to MMAE-based ADCs [2]. - In vivo pharmacological studies reveal that TST105 achieves a tumor growth inhibition (TGI) rate of 91.25% at a dose of 3 mg/kg in gastric cancer models, compared to 48.32% for Bema-MMAE, with an overall response rate (ORR) of 70% for TST105 versus 0% for Bema-MMAE [2]. Group 2: Industry Context and Future Prospects - The company expressed excitement about the transformative potential of TST105 in treating FGFR2b-overexpressing tumors, emphasizing its commitment to advancing this promising candidate into clinical development [3]. - The AACR 2025 conference, scheduled for April 25-30, 2025, in Chicago, serves as a significant platform for sharing advancements in cancer research, bringing together scientists, clinicians, and advocates to discuss the latest breakthroughs in oncology [3].

Core Viewpoint - Kanghong Pharmaceutical's subsidiary, Kanghong Biotech, has received approval from the National Medical Products Administration for the clinical trial application of its injectable KH815, a novel antibody-drug conjugate targeting TROP2 for advanced solid tumors [1] Group 1 - Kanghong Biotech's KH815 is a self-developed drug with potential anti-resistance properties [1] - The drug is specifically designed for the treatment of advanced solid tumors [1]

Core Viewpoint - The company, Innovent Biologics, has successfully transitioned from a "domestic ADC dark horse" to a "star player in the Hong Kong 18A sector," achieving the largest fundraising scale in the biotech sector since 2022 and leading the IPO first-day gain rankings for 2025 in Hong Kong [1][2]. Fundraising and IPO Performance - Innovent Biologics' IPO price was set at HKD 94.60 per share, raising approximately USD 211 million (around RMB 1.54 billion), with the total amount potentially increasing to USD 243 million upon full exercise of the greenshoe option, marking the largest IPO in the Hong Kong 18A sector in nearly four years [1]. - On its first trading day, the stock surged by 116.7%, reaching a peak price of HKD 222, a significant increase of 134.67% from the IPO price, with total trading volume exceeding HKD 2 billion, reflecting strong market confidence in the company [1]. Investment Interest and Strategic Partnerships - Prior to the IPO, Innovent Biologics attracted significant interest from investors, securing commitments from 15 cornerstone investors totaling USD 65 million (approximately HKD 505 million), including prominent firms like BioNTech SE and Eli Lilly, as well as top domestic funds [2]. - The company is positioned as a key player in the ADC field, focusing on developing innovative ADC drugs for cancer and autoimmune diseases, which is crucial for long-term investment considerations [2]. R&D Capabilities and Product Pipeline - The core value of ADC innovation companies lies in platform and drug value, and Innovent Biologics boasts a strong technical team with over 20 years of experience, having developed four next-generation ADC technology platforms and a differentiated pipeline of 13 self-developed ADC candidates [3]. - The company has received recognition from international authorities for its core technologies and pipeline, with three products, including DB-1303 and DB-1311, having received FDA fast track designations, and DB-1303 also recognized as a breakthrough therapy [3]. Market Position and Future Outlook - Innovent Biologics has established itself as a leader in ADC drug innovation, securing over USD 6 billion in total value from multiple business development transactions with top global pharmaceutical companies since 2023 [4]. - The company is transitioning its growing innovation potential into commercial momentum, with a clear path to revenue generation and cash flow from clinical development, setting the stage for further valuation growth as core products reach the market [4].

近期，外部环境震荡加剧，并蔓延至医药板块。4月9日，在传出"美国将对药品征收关税"的消息后，恒生医疗保健指数(800804)早盘跌幅一度超过7%，但随 后指数并未持续下探而是一路走高并于午后翻红。 并且研究结果还显示出来持续改善趋势，即随时间推移，泰它西普组MG-ADL和QMG评分持续下降，并在第24周改善幅度达峰值。 而从安全性来看，泰它西普治疗期间整体安全耐受，总体不良事件(AE)发生率与安慰剂组相当，感染类AE发生率低于安慰剂组(45.6%vs 59.6%)。 其中医药板块情绪的带动者之一，便是早盘半小时内拉升超15个点的荣昌生物(09995)。 智通财经APP观察到，虽然4月9日开盘时受到整个市场负面情绪影响，荣昌生物深水低开，开盘10分钟内两度探底，最大跌幅达到10.23%，但在触底后，荣 昌生物股价先于指数快速反弹，20分钟便将股价从深水拉至0轴，并在接下来10分钟后将股价强势拉升至最高5.33%。 虽然后续在市场震荡影响下，荣昌生物的场内筹码分歧扩大，股价再度走低，但午后荣昌生物股价再度于水下强势拉升，并在20分钟内再度将涨幅从0轴拉 升至最高11.19%。 荣昌生物之所以能逆市实现资金合力上攻 ...

Core Viewpoint - The company, Yingensheng Bio-B (09606), is set to launch an initial public offering (IPO) from April 7 to April 10, 2025, aiming to globally offer 15.0716 million shares, with a price range of HKD 94.6 to HKD 103.2 per share, and expects trading to commence on April 15, 2025 [1][2]. Company Overview - Established in 2019, the company is a key leader in the field of antibody-drug conjugates (ADC), focusing on developing innovative ADC drugs for cancer and autoimmune diseases [1]. - The company has two core products: DB-1303/BNT323, targeting cancers such as endometrial cancer and breast cancer, and DB-1311/BNT324, targeting small cell lung cancer and other cancers [1][2]. Product Pipeline - In addition to core products, the company has developed five other clinical-stage ADCs and two bispecific ADCs expected to enter clinical stages between 2025 and 2026 [2]. - The company currently has no commercially approved products and has recorded losses of RMB 357.5 million and RMB 1.0504 billion for the years ending December 31, 2023, and 2024, respectively, primarily due to R&D expenses [2]. Financial Performance - The company reported revenues of RMB 1.787 billion and RMB 1.941 billion for the years ending December 31, 2023, and 2024, respectively, mainly from licensing and collaboration agreements [2]. - The company anticipates significant expenditures in the coming years as it continues clinical research and prepares for the commercialization of its candidate drugs [3]. Investment and Funding - The company has entered cornerstone investment agreements with several investors, including BioNTech SE and various funds, agreeing to subscribe for shares totaling approximately USD 65 million (about HKD 505 million) [3]. - The cornerstone placement is expected to provide reliable commitments and enhance market confidence in the company’s prospects [3]. Use of Proceeds - Assuming a share price of HKD 98.90, the estimated net proceeds from the global offering would be approximately HKD 1.37 billion, with allocations planned for R&D, commercialization of core products, and operational funding [4].