Financial Data and Key Metrics Changes - The company has achieved significant growth, reaching over 3.4 million patients treated globally with its oncology medicines, supported by strong commercial execution [56] - Keytruda is approved in 56 indications in the US, 44 in the EU, and 41 in Japan, showcasing its leadership in immuno-oncology [56][59] Business Line Data and Key Metrics Changes - The oncology portfolio has yielded 35 phase three trials with statistically significant overall survival and 56 FDA approved indications [7] - The development of subcutaneous pembrolizumab with barahyaluronidase alfa has shown comparability to IV Keytruda, with a median injection time of two minutes [17][19] Market Data and Key Metrics Changes - The company is focusing on expanding its presence in earlier stage diseases, particularly in head and neck cancer, where there is a significant unmet medical need [60] - The anticipated peak uptake of subcutaneous pembrolizumab in the US is expected to reach between 30-40% within 18 to 24 months [62] Company Strategy and Development Direction - The company aims to diversify its oncology portfolio beyond Keytruda, focusing on additional therapeutic areas such as HIV vaccines, immunology, cardiovascular, and ophthalmology [6] - The strategy includes leveraging the proven track record of Keytruda to sustain leadership in oncology beyond its loss of exclusivity in 2028 [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing development of innovative therapies and the potential for significant impact on cancer care through a diversified pipeline [55] - The company is committed to maximizing patient access and improving outcomes through its robust commercial engine and innovative product offerings [63] Other Important Information - The company has a strong focus on biomarker development, which is crucial for patient selection and optimizing treatment outcomes [36] - There are ongoing phase III studies for various agents, including MK1084 and Sac TMT, which are expected to read out in the near future [53][64] Q&A Session Summary Question: What is the company's perspective on the evolving market for PD-1, PD-L1, and VEGF bispecifics? - Management highlighted the consistent improvements in progression-free survival across multiple indications and expressed optimism about the ongoing trials in China, with plans to expand to the US [75][78] Question: How does the company view the market opportunity for head and neck cancer treatments? - Management clarified that patients receiving preoperative Keytruda did not lose the opportunity for surgery, and emphasized the safety and efficacy of the treatment [79]

开源证券股份有限公司余汝意,余克清,刘艺近期对华东医药（000963）进行研究并发布了研究报告《公司深度报 告：创新转型再出发，多产品步入收获期》，给予华东医药买入评级。 公司聚焦肿瘤、内分泌及自免三大核心领域，差异化布局ADC和PROTAC技术，ROR1ADC以及HPK1PROTAC已 经进入临床阶段；治疗消化道肿瘤的自研Cpd3-ADC均计划2025Q2/Q3递交中国和美国的IND申请。公司降糖减重 管线布局口服小分子GLP-1药物HDM1002；GLP-1R/GIPR双靶点的HDM1005，其肥胖适应症已在2025年4月完成 全部受试者入组，2型糖尿病于2025年4月完成首例患者入组；FGF21R/GCGR/GLP-1R激动剂DR10624，预计 2025Q3获得重度高甘油三酯血症的2期顶线结果。公司有望在更多适应症上实现布局。 华东医药 创新转型再出发，多产品步入收获期，维持"买入"评级 医药工业经营趋势稳健，医美多产品矩阵有望保证公司长周期向上 风险提示：临床研发失败风险、竞争格局恶化风险、销售不及预期风险等。 最新盈利预测明细如下： 公司聚焦慢病、肿瘤以及免疫等领域，覆盖医药工业、医药商业、医美、 ...

Financial Data and Key Metrics Changes - The company reported a confirmed overall response rate (ORR) of 68% and a disease control rate of 93% across all dose levels in the ongoing clinical trial for ZL1310 [12][21] - The median follow-up for the efficacy evaluable patients was 3.4 months, with some patients remaining in response for over 9 months [22][43] Business Line Data and Key Metrics Changes - ZL1310, the investigational DLL3 targeted antibody-drug conjugate, demonstrated promising clinical activity in patients with relapsed or refractory extensive stage small cell lung cancer [6][19] - The safety profile of ZL1310 was reported as manageable, with only 16% of patients in the low-dose group requiring dose interruptions [10][19] Market Data and Key Metrics Changes - Small cell lung cancer accounts for approximately 15% of all lung cancers, affecting around 372,000 patients worldwide, with a poor prognosis and a median overall survival of about 13 months [6][19] - The estimated global prevalence of DLL3 expressing neuroendocrine carcinomas is roughly 350,000 to 400,000 patients, indicating a significant market opportunity for ZL1310 [26] Company Strategy and Development Direction - The company plans to initiate a registrational study in second-line small cell lung cancer later this year, with overall survival as the primary endpoint [22][23] - There is a strategy to expand ZL1310 into first-line small cell lung cancer and other DLL3 expressing solid tumors, aiming to reduce treatment burden for patients [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for accelerated approval based on the promising data and ongoing discussions with the FDA [56][57] - The company is optimistic about the efficacy of ZL1310 in the competitive landscape, particularly in comparison to existing therapies [48][49] Other Important Information - The company is exploring combination therapies with ZL1310, including carboplatin and atezolizumab, to enhance treatment efficacy [38][39] - The company has received fast track designation from the FDA, which may facilitate the development process [32] Q&A Session Summary Question: Can you comment on the therapeutic window and confidence in the selected dose for pivotal studies? - Management indicated that the 1.6 mg/kg dose shows a good balance of efficacy and safety, with a slight attrition in response at higher doses [29][30] Question: What is the dosing strategy and safety consideration for the combination trial? - The company is methodically exploring combinations with existing chemotherapy regimens and is confident in the competitive activity of ZL1310 [37][38] Question: How does the durability of ZL1310 compare to competitors in refractory small cell lung cancer? - Management noted that the durability of response is clinically meaningful, with a median follow-up of 6.9 months for the most mature data set [42][43] Question: What gives confidence in potential accelerated approval for ZL1310? - Ongoing discussions with the FDA suggest that accelerated approval is a viable option, contingent on the results of the randomized trial [56][57] Question: What are the remaining items to align with the FDA before initiating the pivotal study? - The main focus is to finalize the dosing strategy and ensure alignment on study design with the FDA [65][66]

Media ReleaseCOPENHAGEN, Denmark; June 2, 2025 New data showed that rinatabart sesutecan (Rina-S®) 100 mg/m2 led to a confirmed objective response rate (ORR) of 50.0 percent, including two complete responses (CR), and median duration of response (mDOR) was not reached after a median follow-up of 7.7 monthsContinued evaluation of single-agent Rina-S 100 mg/m2 in patients with advanced endometrial cancer (EC) is ongoing in the Phase 2 RAINFOL™-01 trial and will be further evaluated in a planned Phase 3 trial ...

Core Insights - Merck (MRK) announced positive data from the dose confirmation phase of the phase II/III waveLINE-003 study for zilovertamab vedotin, an antibody drug conjugate (ADC) targeting relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [1][2] Study Results - The waveLINE-003 study showed a 56.3% objective response rate (ORR) for zilovertamab vedotin (1.75 mg/kg) in combination with standard-of-care rituximab and gemcitabine-oxaliplatin (R-GemOx), with eight patients achieving complete response (CR) and one partial response [2][6] - The phase II portion of the study indicated a promising response rate and manageable safety profile for zilovertamab vedotin in combination with standard care [3] Development Activities - Zilovertamab vedotin is a first-in-class ADC targeting ROR1, a protein overexpressed in various hematologic malignancies, representing a potential innovation in cancer treatment [4] - The ADC is being evaluated in additional mid-to-late-stage studies for DLBCL, including phase III waveLINE-010 and phase II waveLINE-007 studies for previously untreated DLBCL patients [7] - A new phase II waveLINE-011 study has been initiated to compare zilovertamab vedotin plus rituximab and R-CHP against polatuzumab vedotin with R-CHP for DLBCL treatment [8] Other Developments - Merck also reported data from the phase I KANDLELIT-001 study for its KRAS G12C inhibitor candidate, MK-1084, showing manageable safety and antitumor activity in advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) patients [9][10] - The phase III KANDLELIT-012 study is evaluating MK-1084 in combination with cetuximab and mFOLFOX6 for first-line treatment of KRAS G12C-mutant CRC, while the phase III KANDLELIT-004 study is investigating its use with Keytruda for metastatic NSCLC [11]

Summary of Zai Lab (ZLAB) Update / Briefing June 02, 2025 Company and Industry Overview - **Company**: Zai Lab (ZLAB) - **Industry**: Oncology, specifically focusing on small cell lung cancer (SCLC) and DLL3 targeted therapies Key Points and Arguments Clinical Data and Efficacy - **ZL1310**: Investigational DLL3 targeted antibody-drug conjugate (ADC) showing promising clinical activity in patients with recurrent SCLC [4][8] - **Patient Demographics**: 89 patients enrolled in the trial, with 47% having one prior line of therapy and 53% having failed at least two prior lines [10] - **Efficacy Results**: - Confirmed overall response rate (ORR) of 68% and disease control rate (DCR) of 93% across all dose levels [14] - In second-line patients, ORR remains robust at 67% with a DCR of 97% [15] - Notably, the 1.6 mg/kg dose arm achieved an unconfirmed ORR of 79% and a 100% DCR [16] - **Intracranial Activity**: 68% ORR in patients with brain metastases, with 86% response in those without prior cranial radiation [21] Safety Profile - **Safety Analysis**: ZL1310 demonstrated a well-tolerated safety profile, with only 16% of patients in the low-dose group requiring dose interruptions [12] - **Adverse Events**: Most common treatment-related adverse events included anemia (40%), neutropenia (30%), and nausea (26%) [13] - **High-Grade Adverse Events**: Only 6% experienced grade three or greater toxicity in the lower dose group [12] Future Development Plans - **Phase III Trial**: A registrational study in second-line SCLC is planned to start later this year, comparing ZL1310 against investigator's choice of therapy [24][25] - **Combination Studies**: Exploring combinations with checkpoint inhibitors and chemotherapy, aiming to demonstrate competitive efficacy [40] - **Expansion into Other Tumors**: Plans to pursue opportunities in first-line SCLC and neuroendocrine carcinoma, targeting DLL3 expressing tumors [27] Regulatory Considerations - **Accelerated Approval**: Discussions with the FDA indicate potential for accelerated approval based on response rates in the randomized trial [58] - **Study Design**: The pivotal study will include patients with extensive stage SCLC who have progressed after first-line platinum-based therapy [25][66] Additional Important Insights - **Therapeutic Window**: The 1.6 mg/kg dose shows a promising balance of efficacy and tolerability, with ongoing discussions about dose optimization [33][34] - **Durability of Response**: Median follow-up for responders is 6.9 months, with a significant number of patients remaining in response [44] - **Comparison with Competitors**: ZL1310 is positioned as a more easily administered outpatient option compared to other therapies like pirilatumab, which may have logistical challenges [52] This summary encapsulates the critical findings and future directions for Zai Lab's ZL1310 program, highlighting its potential impact on the treatment landscape for small cell lung cancer.

31% confirmed ORR (8 responses in 26 evaluable patients) across B7-H4 high tumors at intermediate doses 44% confirmed ORR (7 responses in 16 evaluable patients) in the subset of patients with ≤4 prior lines of therapy CAMBRIDGE, Mass., June 02, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced additional interim Pha ...

Core Insights - Eli Lilly and Company announced promising Phase 1 data for its folate receptor alpha (FRα) antibody-drug conjugate (ADC) LY4170156, showing a preliminary overall objective response rate (ORR) of 55% in women with heavily pre-treated platinum-resistant ovarian cancer [1][2][3] Group 1: Clinical Data and Efficacy - The study enrolled 95 participants with high-grade serous ovarian cancer, with a median of five prior systemic regimens [2][3] - Among the 95 patients, 51% had tumors with FRα expression less than 75%, while 34% had expression of 75% or higher [2] - The ORR was 45% in 58 efficacy-evaluable patients, with a disease control rate of 74% [3] Group 2: Safety Profile - The most common treatment-emergent adverse events included nausea (64%), anemia (40%), fatigue (32%), vomiting (32%), diarrhea (28%), and neutropenia (27%) [3] - No maximum tolerated dose has been established, and treatment-emergent neuropathy and ocular toxicity have not been observed to date [3] Group 3: Future Directions - Based on the results, the company aims to advance LY4170156 into registrational Phase 3 clinical trials [4] - The ADC is designed to target FRα across expression levels with an improved therapeutic index, potentially benefiting a larger number of ovarian cancer patients [5]

ZL-1310 ASCO 2025 Highlights June 2, 2025 NASDAQ:ZLAB | HKEX:9688 © 2024. Zai Lab. All Rights Reserved. Associate Director of Drug Development, Sarah Cannon Research Institute Forward-Looking Statements This presentation contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding product candidates in our pipeline including ZL-1310 and related clinical trials and preclinical studies, the potential benefits and safety an ...

Core Insights - Defence Therapeutics Inc. has opened its first U.S. laboratory in the Boston-Cambridge area, marking its initial physical presence in the United States and reinforcing its commitment to advanced research and development in biotechnology [1][2][3] Company Expansion - The new laboratory is located at Cambridge Scientific Labs in Watertown, which will facilitate the development and optimization of the company's proprietary Accum® technology for antibody-drug conjugates (ADCs) [2] - Establishing a presence in the Boston-Cambridge area provides access to top-tier scientific resources and collaboration opportunities within the region's renowned biotech ecosystem [2] Strategic Importance - The CEO of Defence Therapeutics emphasized that this expansion is a significant milestone, positioning the company at the heart of the global biotech community and supporting its mission to advance the Accum® platform for next-generation ADCs [3] - The Cambridge Scientific Labs location will serve as a short-term base while the company evaluates options for a long-term facility in the area [2][3] Company Overview - Defence Therapeutics is a publicly-traded clinical-stage biotechnology company focused on developing next-generation radio-immuno-conjugate and ADC products using its proprietary ACCUM® technology, which enables precision delivery to target cells, enhancing efficacy against cancer [3]