HLX37是集团自主研发的重组人源化抗PD-L1与抗VEGF双特异性抗体，拟用于治疗晚期/转移性实体 瘤。截至目前的临床前研究表明，HLX37能够抑制肿瘤生长，且具有良好的安全性。 智通财经APP讯，复星医药(600196.SH)发布公告，近日，公司控股子公司上海复宏汉霖生物技术股份 有限公司及其控股子公司(合称"复宏汉霖")收到国家药品监督管理局关于同意HLX37注射液(即重组人源 化抗PD-L1与抗VEGF双特异性抗体注射液;简称"HLX37")用于治疗晚期/转移性实体瘤患者开展临床试 验的批准。复宏汉霖拟于条件具备后于中国境内开展HLX37的Ⅰ期临床试验。 ...

HLX37是集团自主研发的重组人源化抗PD-L1与抗VEGF双特异性抗体，拟用于治疗晚期/转移性实体 瘤。截至目前的临床前研究表明，HLX37能够抑制肿瘤生长，且具有良好的安全性。 复星医药（600196）(600196.SH)发布公告，近日，公司控股子公司上海复宏汉霖生物技术股份有限公 司及其控股子公司(合称"复宏汉霖")收到国家药品监督管理局关于同意HLX37注射液(即重组人源化抗 PD-L1与抗VEGF双特异性抗体注射液;简称"HLX37")用于治疗晚期/转移性实体瘤患者开展临床试验的 批准。复宏汉霖拟于条件具备后于中国境内开展HLX37的Ⅰ期临床试验。 ...

Aclaris Therapeutics Conference Call Summary Company Overview - Aclaris Therapeutics is a clinical stage biotech company with three assets in the clinic and another in development, supported by a robust R&D group focused on both new asset discovery and preclinical sciences [1][2] - The company has expertise in kinase inhibition, with a history stemming from Pfizer, and has expanded its portfolio through acquisitions, including a deal with BioShen [2][3] Key Assets and Pipeline - Aclaris is developing both small and large molecule platforms targeting important unmet medical needs [1][2] - The acquisition of BioShen's assets has allowed Aclaris to explore both dermatological and immunological indications, particularly in respiratory and gastrointestinal areas [3] Bosakitug (TSLP Antibody) - Bosakitug is a TSLP antibody in phase two trials, noted for its potency, being 70 times more potent than Tezopelumab [5][9] - It has a long residence time of 400 hours on TSLP compared to 3-20 hours for competitors, which enhances its therapeutic potential [7] - Phase 2A results showed a 94% EASI75 response and an 88% IGA01 response in atopic dermatitis, with sustained effects observed 12 weeks post-treatment [8][12] Phase 2B Study - Aclaris is confident in the phase 2B study due to the robust data from phase 2A, focusing on a well-defined patient population to minimize placebo effects [11][12] - The dosing regimen remains consistent with phase 2A, aiming for a competitive response rate compared to existing treatments [15] Future Directions - Aclaris plans to explore the potential of Bosakitug in both dermatological and respiratory indications, with a focus on dermatology for the current asset [19] - The company is also developing a bispecific antibody (052) targeting TSLP and IL-4R, which has shown promising preclinical results [20][21] ITK Platform and 2138 - 2138 is the lead compound in Aclaris's ITK franchise, demonstrating dual pharmacology by inhibiting ITK and JAK3, with a focus on atopic dermatitis and potential expansion into lichen planus [31][36] - The compound has shown significant potency and a favorable safety profile, with plans to move into clinical trials for lichen planus due to its mechanistic fit and unmet medical need [36][38] Financial Position and Future Outlook - Aclaris has a strong cash position that extends its runway into the second half of 2028, allowing for continued development of its pipeline without immediate capital raises [42] - The company anticipates multiple data readouts and milestones in 2026, which could significantly impact investor interest and market positioning [41][42] Conclusion - Aclaris Therapeutics is positioned for significant growth with a diverse pipeline targeting critical areas in dermatology and immunology, backed by a solid financial foundation and promising clinical data [41][42]

Financial Data and Key Metrics Changes - In Q3 2025, net product revenues were $15.8 million, down from $18 million in Q3 2024, reflecting variability in customer ordering patterns [17][19] - Total operating expenses were $45 million on a non-GAAP basis, a 12.1% decrease year-over-year, primarily due to lower R&D expenses [18] - The net loss for Q3 2025 was $41 million, or $0.30 per share, compared to a net loss of $44 million, or $0.42 per share, in Q3 2024 [19] - Cash and cash equivalents at the end of Q3 2025 were $234.7 million, down from $250.9 million at the end of 2024, but increased to approximately $292.3 million post a $60 million financing [20] Business Line Data and Key Metrics Changes - Xelanta continues to be positioned as a differentiated treatment option for third-line plus DLBCL patients, with ongoing trials expected to yield additional data [5][6] - The company is advancing its PSMA-targeting ADC, with IND-enabling activities on track for completion by year-end [6] Market Data and Key Metrics Changes - The treatment landscape for DLBCL is evolving, with a 60/40 split between complex therapies and broadly accessible therapies [11] - The company anticipates that Xelanta could achieve peak annual revenues of $600 million to $1 billion in the U.S. by expanding into earlier lines of therapy [9][10] Company Strategy and Development Direction - The company aims to expand Xelanta's use into earlier lines of therapy for DLBCL and into indolent lymphomas, with a focus on maintaining a competitive edge in the market [8][10] - The strategy includes leveraging data from ongoing trials (LOTIS-5 and LOTIS-7) to support regulatory submissions and enhance market penetration [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to invest further in Xelanta, anticipating advancements into earlier lines of therapy and additional indications [8][23] - The management highlighted the potential for Xelanta to transform the treatment paradigm for lymphoma, particularly with promising data from ongoing trials [10][14] Other Important Information - The company secured a $60 million private placement, extending its cash runway to at least 2028, which supports its strategic initiatives [7][20] - The company plans to provide updates on key trials and data catalysts throughout 2025 and 2026 [20][21] Q&A Session Summary Question: Can you frame how many patients we might get later this quarter? - The company is still targeting approximately 100 patients for enrollment, which is expected to occur quicker than originally anticipated [24][25] Question: When should we expect to see an inflection point for Xelanta sales? - The company expects to share interim data for LOTIS-7 later this year and top-line results for LOTIS-5 in the first half of 2026, with revenue ramp-up anticipated post-approval in the first half of 2027 [28][29][30] Question: Would you consider pursuing Xelanta in the front-line DLBCL setting? - The company is monitoring the front-line setting closely but does not plan to fund a phase three study independently [32][33] Question: How do you view the split of community and academic therapies? - The company does not see a strict division between community and academic settings, as both can administer complex therapies depending on patient suitability [36][37][40] Question: How would an increase in penetration in the second or third line setting affect Xelanta revenues? - The company estimates that maintaining a 10% share in the second line could increase revenues from a $70 million run rate to over $200 million [42][44]

Core Viewpoint - The announcement by Valiant Biopharma-B (09887) regarding the successful administration of the first patient in the Phase II clinical trial of LBL-024 for first-line treatment of hepatocellular carcinoma marks significant progress in expanding the indications for this core product [1] Group 1: Clinical Trial Details - The Phase II clinical study is an open-label, multi-center trial led by Professor Zhou Jian from Zhongshan Hospital affiliated with Fudan University, currently being conducted in multiple hospitals across the country [1] - The trial aims to evaluate the efficacy and safety of the combination therapy using Opalizumab (PD-L1/4-1BB bispecific antibody LBL-024) for patients with hepatocellular carcinoma [1] Group 2: Product Information - LBL-024 is a bispecific antibody targeting both PD-L1 and 4-1BB, representing the first targeted therapy for the 4-1BB receptor to reach the registered clinical stage for treating extra-pulmonary neuroendocrine carcinoma [1] - LBL-024 is expected to become the first approved drug for the treatment of advanced extra-pulmonary neuroendocrine carcinoma [1] - Utilizing the proprietary X-body platform, LBL-024 features an optimal 2:2 structural design that can relieve PD-1/L1 immune suppression and enhance 4-1BB-mediated T cell activation, achieving a synergistic effect in tumor elimination, demonstrating greater potential for broad-spectrum cancer treatment compared to PD-1/L1 inhibitors [1]

Core Viewpoint - The announcement by Weili Zhibo-B (09887) highlights the successful administration of Opalizumab (PD-L1/4-1BB bispecific antibody LBL-024) to the first patient in a Phase II clinical trial for first-line treatment of hepatocellular carcinoma, indicating significant progress in expanding the indication for this core product [1] Group 1: Clinical Research - The Phase II clinical trial is an open-label, multicenter study led by Professor Zhou Jian from Zhongshan Hospital affiliated with Fudan University, currently being conducted in multiple hospitals across the country [1] - The trial aims to evaluate the efficacy and safety of Opalizumab in combination therapy for patients with hepatocellular carcinoma [1] Group 2: Product Information - LBL-024 is a bispecific antibody targeting both PD-L1 and 4-1BB, representing the first targeted therapy for the 4-1BB receptor to reach the registered clinical stage for treating extra-pulmonary neuroendocrine carcinoma globally [1] - LBL-024 is expected to become the first approved drug for treating advanced extra-pulmonary neuroendocrine carcinoma [1] - Utilizing the proprietary X-body platform, LBL-024 features an optimal 2:2 structural design that can relieve PD-1/L1 immune suppression and enhance 4-1BB-mediated T cell activation, achieving a synergistic effect in tumor eradication, with greater cancer treatment potential compared to PD-1/L1 inhibitors [1]

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於一線治療肝細胞癌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）用 於一線治療肝細胞癌的II期 臨 床 研 究 首 例 患 者 已 成 功 用 藥，標 誌 著 該 核 心 產 品 適 應 症 拓 展 ...

Core Insights - Crystal Tech Holdings (02228.HK) announced a strategic partnership with Eli Lilly to accelerate the discovery and development of bispecific antibodies for various diseases [1] - The partnership grants Eli Lilly access to Ailux's AI-driven bispecific antibody engineering platform, which integrates advanced structural modeling, generative design, and developmental analysis technologies [1] - The collaboration includes upfront and milestone payments totaling several tens of millions of USD, with potential total milestone payments reaching up to $345 million [1] Company Overview - Ailux Shanghai, a wholly-owned subsidiary of Crystal Tech Holdings, focuses on developing advanced biotherapies using AI-driven solutions [2] - The company has assembled a global team of over 100 members and actively collaborates with leading biopharmaceutical companies to translate cutting-edge scientific achievements into transformative drugs [2] - Crystal Tech Holdings was founded in 2015 by three MIT physicists and operates as an innovative R&D platform leveraging quantum physics, AI, and robotics [2] Financial Performance - In the first half of the year, Crystal Tech Holdings reported a revenue increase of 404% year-on-year, reaching 517 million RMB, with an adjusted net profit of 141 million RMB [3] - Historical revenue figures for Crystal Tech show 62.8 million RMB in 2021, 133 million RMB in 2022, and 80 million RMB in 2023, while net losses were 2.137 billion RMB, 1.439 billion RMB, and 1.906 billion RMB respectively during the same period [3] - The company has raised over 5 billion RMB through eight rounds of financing prior to its IPO, with notable investors including Tencent, Sequoia China, and SoftBank Vision Fund [3] Market Performance - Crystal Tech Holdings has a current market capitalization of 46.26 billion HKD, with a year-to-date increase of nearly 80% [4]

Group 1 - The rise of targeted and immunotherapy has fundamentally reshaped the treatment landscape for lung cancer, with new therapies such as antibody-drug conjugates (ADC), bispecific antibodies, T-cell engagers (TCE), and tumor vaccines emerging rapidly [1] - Fuhong Hanhlin has successfully launched 9 products in the lung cancer field, benefiting over 900,000 patients globally, including the world's first approved PD-1 monoclonal antibody for first-line treatment of small cell lung cancer, which is now available in nearly 40 countries [1] - The company plans to advance at least 8 Phase III clinical studies focused on lung cancer for its product HLX43, which combines the effects of PD-1 and ADC, and aims to expand into other cancers such as cervical, esophageal squamous cell, and colorectal cancers [1] Group 2 - HLX43, as the second ADC targeting PD-L1 globally, has shown promising treatment effects in advanced non-small cell lung cancer (NSCLC), with objective response rates (ORR) of 33.3% in previously treated squamous cell carcinoma patients and 47.4% in EGFR wild-type non-squamous NSCLC patients [2] - The drug demonstrated an ORR of 30% in patients with brain metastases and a disease control rate (DCR) of 90%, indicating its potential effectiveness across various patient subgroups [2] - Safety data for HLX43 indicates low hematological toxicity, providing a solid foundation for subsequent large-scale clinical studies [2]

Group 1 - The 2025 International Lung Cancer Frontier and Innovation Forum was held in Shanghai, focusing on key topics such as clinical prevention and control of lung cancer, breakthroughs in non-small cell lung cancer (NSCLC), and new advancements in immunotherapy for small cell lung cancer (SCLC) [1] - The rise of targeted and immunotherapy has fundamentally reshaped the treatment landscape for lung cancer, with new therapies like antibody-drug conjugates (ADC), bispecific antibodies, T-cell engagers (TCE), and tumor vaccines emerging rapidly [1] - The global incidence of lung cancer remains the highest among malignant tumors, with the company having launched 9 products that benefit over 900,000 patients worldwide, including the first approved PD-1 monoclonal antibody for first-line treatment of SCLC [1] Group 2 - The company's R&D strategy focuses on antibodies and their derivatives, including monoclonal antibodies, bispecific antibodies, multi-specific antibodies, and ADCs, supported by three core technology engines [2] - High-value projects such as HLX3901 and HLX48 are prioritized for future development, while the company continues to build a robust pipeline [2] - Local innovative enterprises have made significant progress over the past decade, providing effective "Chinese solutions" for clinical challenges, emphasizing the need for international collaboration and continuous innovation in tackling lung cancer [2]