在此前开展的Ⅰ期临床研究中，50余例入组患者在80-1200μg/kg剂量下均显示出良好的安全性和有效 性，尤其在高剂量中表现出类似于CAR-T的疗效，且未带来额外安全性风险。值得关注的是，伴髓外瘤 患者同样表现出显著疗效和良好安全性，微小残留病灶(MRD)阴性率也明显高于目前标准治疗。 LBL-034是一款全球独创2:1结构设计的GPRC5D/CD3双特异性抗体，通过优化抗CD3亲和力和空间位阻 作用，显著降低了对T细胞的非特异性激活的风险，同时保持高效的T细胞条件激活能力，从而兼具强 大抗肿瘤活性和更佳安全性，具备同类最佳潜力。 8月25日，维立志博-B(09887)宣布，公司自主研发的GPRC5D/CD3双特异性抗体顺利完成Ⅱ期临床研究 (CTR20232974)首例患者入组，有望成为首个国产靶向GPRC5D的TCE疗法。该研究是一项多中心、单 臂、多队列Ⅱ期临床试验，由北京大学人民医院路瑾教授牵头，全国20余家医院共同参与，旨在评价 LBL-034在多种复发/难治的浆细胞肿瘤患者中的疗效和安全性。 ...

Financial Data and Key Metrics Changes - The company reported a revenue of RMB 950 million for the first half of 2025, with over RMB 300 million coming from commercialized drugs, marking a significant achievement in its first year of commercialization [52][53] - Gross profit was RMB 660 million, comparable to the previous year, while the net loss for the first half was RMB 145 million, with an adjusted loss of RMB 69 million after one-off budget adjustments [54][55] - Cash and financial assets totaled RMB 4.5 billion, indicating a healthy financial status to support upcoming R&D and innovation [58] Business Line Data and Key Metrics Changes - The company has three main products ready for the market, with significant progress in approvals and commercialization efforts [15][32] - The commercialization team has expanded to nearly 400 personnel to support the increasing number of products ready for market [14] Market Data and Key Metrics Changes - The company has successfully covered over 30 provinces, 300 cities, and 1,000 hospitals across China, with partnerships established with over 400 pharmacies [32][34] - The company is actively working towards gaining medical insurance coverage for its products, which is expected to enhance market access and sales [36][81] Company Strategy and Development Direction - The company aims to advance differentiated pipelines targeting significant medical needs, optimizing payload linker strategies, and exploring applications in non-oncology areas [30] - The focus is on expanding global partnerships and strengthening strategic collaborations to maximize the value of its pipelines [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future income from sales revenue, anticipating continued cash flow generation from commercialized drugs [53] - The company is preparing for the implementation of new medical insurance policies, which are expected to impact product sales positively [100] Other Important Information - The company completed a follow-on financing of USD 250 million and is included in major global equity indexes, enhancing its market presence [29] - The company has initiated several pivotal trials globally, including for various cancer indications, which are expected to drive future growth [25][26] Q&A Session Summary Question: What is the breakdown of sales revenue for breast cancer and lung cancer? - Lung cancer is the biggest contributor to sales revenue, consistent with patient numbers and indications [64] Question: What is the focus for R&D going into the next stage? - The focus is on developing differentiated products targeting clinical demands, with an emphasis on bispecific targets and new payload strategies [70][72] Question: Can you provide guidelines on the sales trend for Q3? - The company expects quarter-over-quarter growth, with significant sales anticipated from lung cancer indications [76] Question: What is the strategy for going into the medical insurance catalog? - The strategy prioritizes entering the medical insurance catalog to enhance market access and sales volume [100] Question: Can you address the IP disputes mentioned? - The company has initiated a lawsuit against several founders related to IP disputes, which is currently under review by the Sichuan Provincial High Court [103]

Summary of Merus (MRUS) FY Conference Call - August 13, 2025 Company Overview - Merus is an oncology-focused biotechnology company with a portfolio of clinical assets, including collaborations with partners like Insight, Loxo, and Gilead [4][3] - The company specializes in bispecific and multispecific antibodies, leveraging over a decade of experience in monoclonal antibody development [4][5] Key Product: Pitocetimab - **Pitocetimab** is a bispecific antibody targeting EGFR and LGR5, designed to enhance cancer cell targeting and improve therapeutic efficacy [8][9] - The mechanism of action involves internalization and degradation of EGFR, enhancing the immune response against cancer cells [10][11] Clinical Data Highlights - At ASCO 2025, Merus reported a **63% response rate** in a cohort of 43 patients with recurrent metastatic head and neck cancer treated with pitocetimab in combination with pembrolizumab [13] - The median progression-free survival (PFS) was **9 months**, significantly longer than the **3 months** typically seen with pembrolizumab alone [14] - **Overall survival** data showed that **80%** of patients were alive at 12 months, indicating a substantial improvement over existing therapies [16][34] Regulatory Strategy - Merus plans to pursue **accelerated approval** for pitocetimab in both first-line and second-line settings based on early endpoints like overall response rate (ORR) [17][24] - The company is in discussions with the FDA regarding the Project Front Runner paradigm, which allows for potential approval based on early clinical endpoints [18][22] Future Trials and Enrollment - A randomized trial for second and third-line treatment is ongoing, comparing pitocetimab to investigator's choice therapies, with expected near-complete enrollment by the end of 2025 [20][21] - The first-line trial will randomize pitocetimab plus pembrolizumab against pembrolizumab alone, following successful precedents [24][25] Colorectal Cancer Development - Merus is also exploring pitocetimab in colorectal cancer, with plans to report data in the second half of 2025 [36] - The focus is on genetically wild-type metastatic colorectal cancer, with ongoing cohorts evaluating the drug's efficacy in first, second, and third-line settings [42][44] Market Context - Current therapies for head and neck cancer show response rates of **19-21%** for pembrolizumab alone, and **34-35%** when combined with chemotherapy, highlighting the potential competitive advantage of pitocetimab [15][33] - The company aims to provide broad access to its therapies globally, emphasizing the importance of international registration strategies [45] Conclusion - Merus is positioned as a promising player in the oncology space, with innovative bispecific antibody therapies showing significant clinical efficacy and a strategic approach to regulatory approval and global market access [4][16][45]

Financial Data and Key Metrics Changes - The company ended Q2 2025 with $101 million in cash, providing a runway into 2027 for executing on various programs [34] - The overall response rate for the lead program, Tivesimig, was reported at 17.1%, significantly higher than the control arm [9][10] Business Line Data and Key Metrics Changes - Tivesimig showed a tripling of the overall response rate compared to the control arm, with a p-value of 0.031 [9] - CTX-8371, the PD-1/PD-L1 bispecific antibody, reported two deep partial responses in early cohorts, indicating promising early efficacy [6][19] Market Data and Key Metrics Changes - The ongoing randomized trial for Tivesimig in patients with advanced biliary tract cancer has fewer total deaths than projected, suggesting better-than-expected survival outcomes [11][12] - The company plans to initiate cohort expansions for CTX-8371 in non-small cell lung cancer and triple-negative breast cancer later this year [33] Company Strategy and Development Direction - The company aims to file a license application for Tivesimig in 2026, following a robust interaction with the FDA [31][106] - Future studies will explore indications where both VEGF targeting and PD-1 targeting have shown effectiveness, such as renal cell and gastric cancer [79] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of Tivesimig to extend overall survival in patients, despite the current lower-than-expected mortality rate [40][14] - The company is focused on advancing its pipeline, with multiple milestones expected over the next six quarters [30][31] Other Important Information - The company has fast track designation for Tivesimig, which may lead to priority review upon filing [31] - Preclinical data for CTX-10,726 showed superior tumor control compared to leading drug candidates in its class [27][29] Q&A Session Summary Question: Is there a chance that decreased deaths in the study reflect performance due to drug crossover? - Management confirmed that about half of the patients in the control arm crossed over after progression, and statistical methods will adjust for this in the overall survival analysis [39][40] Question: Can you clarify the timeline for PFS analysis? - Management indicated that the 80% event threshold will not be reached until Q1 2026, and they expect to present a priority dataset at that time [48][50] Question: What is the status of the BLA submission process? - The company is on track with its CMC process and does not foresee it being a limiting factor for BLA submission [55] Question: How confident is the company in the demographics of the study? - Management stated that randomization was stratified by key prognostic variables, which should balance demographics across treatment arms [73] Question: What are the plans for the dose expansion cohorts for CTX-8371? - The company plans a small randomized study of approximately 50 patients to explore different doses in the expansion cohorts [102]

Financial Performance & Partnerships - Recognized approximately $75 million in 2025, including around $45 million from partnership-related cash milestones and option exercise fees, which significantly reduced net operating cash burn in the first half of 2025 compared to the first half of 2024[12] - Milestone, option exercise, and related deferred revenue of $45.8 million recognized in 2Q 2025 from BeOne and BMS[16, 17] - Potential future milestone payments from existing partnerships could reach up to $6.1278 billion, with royalty rates varying from low single-digit percentages to 20% depending on the partner and therapeutic indication[13] - Cash, cash equivalents, and marketable securities totaled $324.2 million in 2Q 2025, an increase of $9.2 million year-to-date, benefiting from milestone revenues and favorable working capital movements[16, 17] Clinical Development Updates - Investigational New Drug (IND) application cleared for ZW251, with first-in-human studies planned to start in 2025[11, 12, 47] - Phase 2 trial initiated to evaluate zanidatamab in HER2+ neoadjuvant and adjuvant breast cancer[12] - Bristol Myers Squibb collaboration progresses with a $7.5 million option exercise payment to Zymeworks[12] - ZW171: Global Phase 1 study in MSLN-Expressing Solid Tumors (NCT06523803) is an open-label, FIH, dose-escalation study (N~160)[19] - ZW191: Global Phase 1 Study in FRα-Expressing Solid Tumors (NCT06555744) is an open-label, FIH, dose-escalation study (N~145)[24] Zanidatamab Regulatory & Clinical Progress - NMPA granted BeOne conditional approval of zanidatamab in China for BTC, resulting in a $20 million payment to Zymeworks[12] - EMA granted conditional marketing approval of zanidatamab in Europe for BTC, expanding patient access and potential future royalties payable to Zymeworks[12, 47] - Jazz presented encouraging overall survival (OS) data for zanidatamab in 1L HER2+ GEA at the ASCO Annual Congress, showing a median OS of 36.5 months[12]

Core Viewpoint - Zhejiang Huahai Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of its drug HB0043, which targets pyogenic hidradenitis [1][2]. Drug Basic Information - Drug Name: Injectable HB0043 - Indication: Pyogenic Hidradenitis - Dosage Form: Injectable Sterile Powder - Application: Clinical Trial - Applicants: Shanghai Huatai Biopharmaceutical Co., Ltd. and Huabo Biopharmaceutical Technology (Shanghai) Co., Ltd. [1] Additional Drug Information - In May 2025, Huatai received approval from New Zealand's Medicines and Medical Devices Safety Authority to conduct Phase I clinical trials for HB0043 in New Zealand [1]. - The total R&D investment in the project has reached approximately RMB 69.09 million [3]. Drug Mechanism and Advantages - HB0043 is a recombinant humanized IgG1 bispecific antibody that targets both IL-17A and IL-36R, demonstrating high binding and blocking activity [3]. - Compared to monoclonal antibodies, HB0043 shows stronger efficacy in inhibiting cytokine-induced inflammation and fibrosis through dual blockade of IL-17A and IL-36R [3]. - It has proven superior efficacy in various animal disease models, including atopic dermatitis, idiopathic pulmonary fibrosis, diabetic nephropathy, and neutrophilic asthma [3]. - HB0043 is the first bispecific drug targeting IL-17A and IL-36R globally, potentially overcoming the limitations of existing single-target therapies [4].

Summary of Maiwei Biotech Conference Call Company Overview - Maiwei Biotech, established in 2017, focuses on oncology and age-related diseases with a pipeline of 16 projects, including 4 already on the market [3][6] - The company utilizes three main technology platforms: efficient molecular discovery, ADC (Antibody-Drug Conjugate), and TCE (Tandem Bispecific Antibody) [2][3] Key Developments in ADC and TCE - In the ADC field, Maiwei's UC (Urothelial Carcinoma) drug is in Phase II clinical trials with an overall efficacy rate of approximately 40% [2][5] - The cervical cancer drug has entered Phase III trials, and the esophageal cancer drug targets the PD-1 plus chemotherapy market [2][5] - The MF6 toxin platform shows high activity and non-PGP substrate characteristics, advantageous for treating multi-drug resistant tumors, particularly in gastrointestinal cancers [2][11] Clinical Trials and Market Potential - Maiwei plans to complete Phase III trials for UC and cervical cancer this year and aims for rolling submissions next year, which could significantly enhance its market position [2][6] - The iron regulatory monoclonal antibody is the only one globally that supports monthly dosing, with a peak sales potential in the U.S. estimated at $2 billion [4][21] - The TCE platform's first pipeline, targeting AML (Acute Myeloid Leukemia) and MM (Multiple Myeloma), is expected to enter clinical trials in mid-2026, with market sizes of $17 billion and $27 billion respectively [4][23] Competitive Advantages - Maiwei's ADC technology employs a site-specific conjugation process that enhances drug stability and concentration within tumors, improving efficacy and reducing side effects [12][26] - The MF6 toxin is designed to overcome traditional ADC limitations due to high expression of PGP proteins, making it suitable for high PGP-expressing gastrointestinal tumors [28][40] Future Strategies - The company aims to strengthen collaborations with academia and industry to accelerate drug development and enhance recognition through high-impact publications [6][18] - Maiwei is focusing on five key pipelines this year, including TMC top, cervical cancer, and UC projects, with plans to introduce additional TCE pipelines in the future [25][31] Research and Development Insights - Maiwei has made significant progress in the field of white介11 (W11) with promising results in anti-aging and scar treatment, with clinical trials expected to yield results within 3 to 6 months [19][20][39] - The company is also exploring innovative oral therapies for osteoarthritis, which could fill a significant market gap if proven effective [22] Conclusion - Maiwei Biotech is positioned as a leader in innovative cancer therapies with a robust pipeline and strategic focus on overcoming existing treatment limitations, particularly in multi-drug resistant cancers and age-related diseases [2][6][31]

Group 1 - The core agreement between the company and Pfizer regarding the PD-1/VEGF bispecific antibody (SSGJ-707) has been established, with the license agreement effective from July 24, 2025 [1] - The company will receive a total of up to $150 million in non-refundable and non-offsettable option and exercise fees under the option agreement with Pfizer [1] - Pfizer has conditionally agreed to subscribe for 31.14 million shares at a price of HKD 25.2055 per share, totaling approximately HKD 785.0 million, which represents about 1.30% of the existing issued share capital [1] Group 2 - The net proceeds from the subscription will be approximately HKD 785.0 million, with around HKD 628.0 million (80% of the net proceeds) allocated for global research and development of clinical and preclinical projects, and improving production facilities [2] - Approximately HKD 157.0 million (20% of the net proceeds) will be used for other general corporate purposes [2] - The subscription is seen as an opportunity to raise additional funds and enhance the company's shareholder base with Pfizer as a strategic investor, supporting business growth and pipeline development [2]

Group 1: Company Overview - Company, Anmai Biotech, is preparing for an IPO in Hong Kong, having completed multiple rounds of financing with notable investors, achieving a post-money valuation of $492 million in its last funding round in 2022 [1] - The company specializes in developing T-cell engagers for cancer and autoimmune diseases, currently in the clinical stage with no commercialized products yet [3][6] - Anmai Biotech reported projected revenue of approximately 459 million RMB for 2024, with a profit of 47.7 million RMB, marking a turnaround from previous losses [3][4] Group 2: Financial Performance - The company experienced a significant drop in R&D spending from 185 million RMB in 2023 to 123 million RMB in 2024, with R&D expenses constituting 78.8% and 74.1% of total expenses respectively [5] - As of April 30, 2025, the company has cash and cash equivalents of 327 million RMB, sufficient to maintain financial stability for the next 12 months [5] - The total accumulated loss of the company reached 2.355 billion RMB by the end of 2024 [3] Group 3: Product Pipeline and Market Potential - Anmai Biotech's lead product, EMB-01, is the first dual-specific antibody targeting EGFR/cMET for colorectal cancer, currently in Phase II clinical trials [6][12] - The global market for colorectal cancer drugs is projected to grow from $3.1 billion to $7.4 billion by 2034, with over 2 million new cases expected globally in 2024 [8][9] - The company has established a strong international collaboration network, with total transaction values exceeding $2.1 billion in licensing agreements [14] Group 4: Industry Trends and Competitive Landscape - The innovative drug sector, particularly in T-cell engagers, has seen significant growth, with the Hong Kong innovation drug index rising by 65.5% year-to-date [2] - Anmai Biotech ranks second globally in international collaboration transaction volume within the T-cell engager field, indicating strong market positioning [14] - The TCE market is competitive, with 10 TCE therapies approved globally, and Anmai Biotech's unique technology platforms may provide a competitive edge [15]

Core Viewpoint - The rise of domestic innovative drugs in China since 2025 is significantly driven by Business Development (BD) strategies, allowing companies to monetize their research through partnerships with multinational pharmaceutical firms [1][2]. Company Overview - A notable player in this space is Anmai Biotech, which is preparing for an IPO in Hong Kong and has gained attention for its BD transactions, accumulating over $2.1 billion in deal value since the end of 2023, ranking second globally in the TCE bispecific antibody sector [1][3]. - The founder, Wu Chenbing, previously served as the Chief Scientific Officer at 3SBio, indicating a strong lineage of expertise and a shift in Chinese biotech from "following" to "leading" in innovation [1][3]. Financial Performance - As of the end of 2024, Anmai Biotech's cash and equivalents are sufficient for only 12 months of operations, highlighting the importance of clinical progress and commercialization capabilities for its transition from a "transaction star" to a "profit benchmark" [2][8]. - The company reported a revenue of 459 million yuan in 2024, with a net profit of 47.7 million yuan, following a loss of 595 million yuan in 2023 primarily due to R&D expenses [7]. Product Pipeline - Anmai Biotech's lead product, EMB-01, is a bispecific antibody targeting EGFR/cMET, which is among the first to enter Phase II trials for colorectal cancer, with a market potential driven by the increasing incidence of the disease [6][7]. - The global bispecific antibody market is projected to grow from $13.4 billion in 2024 to over $220 billion by 2034, with a compound annual growth rate of 32.4% [6]. Strategic Partnerships - The company has engaged in multiple licensing agreements, including a significant deal with Vignette Bio valued at $635 million for EMB-06, and a recent global licensing agreement with Juri for KLK2/CD3 TCE with a potential value of $210 million [7]. Leadership and Expertise - The leadership team includes Dr. Zhu Yonghong, who brings extensive international clinical development experience, complementing Wu Chenbing's background in drug development [4]. - Anmai Biotech's FIT-Ig technology platform, patented in the U.S. in 2018, is a key competitive advantage, addressing stability issues in traditional bispecific antibodies [4][5].