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 對 因 本 公 告 全部或任何部份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。 Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 （於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司） （股 份 代 號：9887） 自願公告 LBL-024於奧帕替蘇米單抗黑色素瘤IB/II期試驗的首例患者用藥 本公告由 南京維立 志博生物科技股份有限公司（「本公司」，連 同 其 附 屬 公 司 統 稱「本集團」）自 願 作 出，以 告 知 本 公 司 股 東 及 潛 在 投 資 者 有 關 本 公 司 的 最 新 業 務 發 展 情 況。 本 公 司 欣 然 宣 布，評 價 奧 帕 替 蘇 米 單 抗（PD-L1/4-1BB雙特異性抗體LBL-024）單 藥 或聯合其他藥劑用於一線治療晚期黑色素瘤的Ib/Ⅱ期臨床試驗（NCT07099430） 首 例 患 者 已 成 功 用 ...

Market Performance - The pharmaceutical sector experienced a decline of -1.91% on September 9, 2025, underperforming the CSI 300 index by 1.21 percentage points, ranking 28th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, pharmaceutical distribution (-0.52%), blood products (-0.62%), and in vitro diagnostics (-0.73%) performed relatively better, while medical R&D outsourcing (-3.63%), medical devices (-2.47%), and medical consumables (-2.06%) lagged behind [1] - Top three gainers included Rongchang Bio (+11.92%), Hehua Co. (+10.07%), and Zhend Medical (+10.00%), while the largest decliners were Yifang Bio (-11.74%), Huahai Pharmaceutical (-10.00%), and Chenxin Pharmaceutical (-8.42%) [1] Industry News - BMS announced positive results from the Phase II clinical trial of Pumitamig, a bispecific antibody developed in collaboration with BioNTech for the treatment of extensive-stage small cell lung cancer (ES-SCLC), showing a confirmed objective response rate (cORR) of 76.3% and a disease control rate (DCR) of 100% [2] - Pumitamig targets PD-L1 and VEGF-A, designed to restore the function of effector T cells in the tumor microenvironment while locally neutralizing the effects of VEGF-A [2] Company News - Heng Rui Medicine (600276) announced that its subsidiary Chengdu Shengdi Pharmaceutical received approval from the National Medical Products Administration for its product, Eicosapentaenoic Acid Ethyl Ester Soft Capsules, to lower triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) [3] - Taiji Group (600129) reported that its subsidiary Fuling Pharmaceutical Factory received a clinical trial approval notice for Semaglutide injection for the treatment of type 2 diabetes [3] - Huahai Pharmaceutical (600521) disclosed that its subsidiary Huahai Jiancheng underwent a pre-approval inspection by the FDA from July 14 to 18, 2025, covering the overall quality management system and the active pharmaceutical ingredient Gabapentin, which met the CGMP requirements [3] - Dongfang Bio (688298) announced that its subsidiary Laihe Bio obtained a Class III medical device registration certificate for its influenza virus antigen detection kit (colloidal gold method), enhancing the company's product portfolio in the respiratory joint detection field [3]

Core Insights - 康方生物 has successfully raised nearly 3.5 billion HKD through a new share placement, marking its third fundraising round in two years, totaling over 6.5 billion HKD [2][20] - The company is under dual pressure of commercial scaling and high clinical investment, with seven self-developed products already on the market and a robust pipeline in development [2][24] - 康方生物's market capitalization reached 142.5 billion HKD, reflecting a 155% increase since the beginning of the year [2] Financial Performance - For the first half of the year, 康方生物 reported commercial sales revenue of 1.401 billion CNY, a nearly 50% year-on-year increase, averaging over 7 million CNY in daily sales [4] - The revenue primarily comes from two globally innovative drugs, 卡度尼利 and 依沃西, which are rapidly gaining market traction [6] Product Development - 依沃西 has shown superior clinical efficacy in head-to-head trials against leading drugs, indicating its potential to outperform established competitors [7][9] - 高盛 predicts that 依沃西 could achieve peak sales of 53 billion USD by 2041, equivalent to approximately 378 billion CNY [10] - 康方生物 is advancing its global strategy with 23 registration/Phase III clinical studies and nearly 20 Phase II studies across various tumor types [15] Research and Development - The latest fundraising will allocate approximately 80% towards global and domestic R&D for innovative pipelines and technology platforms, with the remaining 20% for commercialization of approved products [20] - The company has invested heavily in R&D, with expenditures reaching 731 million CNY in the first half of the year, accounting for over half of total revenue [24] Strategic Vision - 康方生物 aims to enhance its global footprint and accelerate the commercialization of 依沃西 in China while collaborating with Summit for global clinical development [16] - The company has established a unique drug research and development platform, integrating cutting-edge technologies to efficiently advance drug candidates [23] Team and Leadership - 康方生物 was founded by a team of four PhD graduates with over 20 years of experience in biopharmaceuticals, demonstrating a strong foundation in the industry [21][22] - The company has expanded its commercialization team significantly, from 844 to 1,221 members, to support its growth ambitions [27]

Aclaris Therapeutics Conference Call Summary Company Overview - Aclaris Therapeutics is a clinical stage biopharmaceutical company focused on developing large and small molecule therapeutics with a strong research operation based in St. Louis [2][4] Key Assets and Development Pipeline - Aclaris is currently working on four assets: 1. A TSLP monoclonal antibody for atopic dermatitis, with top-line data expected in 2026 [3] 2. A bispecific antibody (ATI-52) targeting TSLP and IL4R, with readouts expected by the end of 2025 [3][4] 3. An oral ITKJAK3 small molecule inhibitor (2138) for atopic dermatitis, moving into alopecia areata later this year [4] 4. A next-generation ITK program expected to enter IND in 2026 [4] Bispecific Antibody Development - ATI-52 targets both IL-4 and IL-13, aiming for a broader therapeutic response across respiratory and dermatological indications [5][6] - The bispecific is designed for high affinity and long residence time (up to 400 hours) against both targets [7][8] - Preclinical work shows independent saturation of binding sites, enhancing the potential for success [9][10] Clinical Trials and Data - The Phase 1 SAD and MAD trials for ATI-52 are expected to report safety, tolerability, and pharmacokinetics data by the end of the year [13][14] - The ongoing Phase 2a trial for ADI-45 showed a 94% response rate in EASI-75, with significant activity observed even after treatment cessation [21][22] - Aclaris is implementing rigorous patient selection criteria to manage placebo response rates in clinical trials [36][38] Competitive Landscape - Aclaris believes that its TSLP antibody (ADI-45) has a competitive edge over existing therapies due to its potency and long residence time [20][28] - The company is aware of the crowded TSLP space but is confident in the differentiation of its products based on clinical data [19][28] Financial Position and Future Plans - Aclaris has approximately $181 million in cash, expected to last until mid-2028, allowing for the completion of key trials [62] - The company is exploring non-dilutive financing options, including monetizing royalty streams from partnerships [63][64] Long-term Strategy - Aclaris is considering partnerships for its respiratory indications while maintaining a focus on atopic dermatitis as a key area for growth [51][52] - The next-generation ITK compounds are expected to enter clinical trials in 2026, with improved potency and selectivity [59][61] Conclusion - Aclaris Therapeutics is positioned to leverage its innovative pipeline and strong clinical data to capture market opportunities in the biopharmaceutical space, particularly in dermatological and respiratory indications [2][4][62]

Core Viewpoint - The company Valiant Biopharma-B (09887) has successfully completed the Phase II clinical study of its self-developed GPRC5D/CD3 bispecific antibody, marking a significant milestone in the development of targeted T-cell engagers (TCE) therapy in China [1] Group 1: Clinical Study Details - The Phase II clinical trial (CTR20232974) is a multicenter, single-arm, and multi-cohort study led by Professor Lu Jin from Peking University People's Hospital, involving over 20 hospitals nationwide [1] - The study aims to evaluate the efficacy and safety of LBL-034 in patients with various relapsed/refractory plasma cell tumors [1] Group 2: Product Characteristics - LBL-034 features a unique 2:1 structural design for the GPRC5D/CD3 bispecific antibody, which optimizes anti-CD3 affinity and spatial steric hindrance, significantly reducing the risk of non-specific T-cell activation while maintaining effective T-cell conditional activation [1] - The product demonstrates strong anti-tumor activity and improved safety, positioning it as a potential best-in-class therapy [1] Group 3: Previous Clinical Research Findings - In the previously conducted Phase I clinical study, over 50 enrolled patients showed good safety and efficacy across doses ranging from 80 to 1200 μg/kg, particularly at high doses where it exhibited CAR-T-like efficacy without additional safety risks [1] - Notably, patients with extramedullary tumors also showed significant efficacy and good safety, with a minimal residual disease (MRD) negative rate notably higher than current standard treatments [1]

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].