基石药业9月15日公告，公司自身免疫与炎症领域管线之一CS2015（OX40L/TSLP双特异性抗体）入选 2025年美国过敏、哮喘和免疫学会（ACAAI）年度科学会议。CS2015是一款同时靶向OX40L和TSLP的 潜在同类首创/同类最佳双特异性抗体，通过双重抑制Th2介导炎症反应的关键调控因子，为特应性皮炎 （AD）、哮喘、慢性阻塞性肺病（COPD）等2型炎症性疾病提供新治疗策略。 ...

人民财讯9月15日电，基石药业9月15日在港交所公告，公司自身免疫与炎症领域管线之一 CS2015(OX40L/TSLP双特异性抗体)入选2025年美国过敏，哮喘和免疫学会(ACAAI)年度科学会议，并 将以"电子壁报演示+现场口头汇报"的形式展出。本次大会将于11月6日至10日在美国奥兰多举行。 CS2015是一款同时靶向OX40L和TSLP的潜在同类首创/同类最佳双特异性抗体，通过双重抑制Th2介导 炎症反应的关键调控因子，为特应性皮炎(AD)、哮喘、慢性阻塞性肺病(COPD)等2型炎症性疾病提供新 治疗策略。 ...

Core Viewpoint - Company announced that its pipeline asset CS2015, a dual-specific antibody targeting OX40L and TSLP, has been selected for presentation at the 2025 American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting, scheduled for November 6-10 in Orlando, USA [1] Group 1: Product Development - CS2015 is a potential first-in-class/best-in-class dual-specific antibody that targets both OX40L and TSLP [1] - The antibody aims to provide new treatment strategies for type 2 inflammatory diseases such as atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD) by dual inhibition of key regulatory factors involved in Th2-mediated inflammatory responses [1]

Core Viewpoint - Company’s CS2015, a dual-specific antibody targeting OX40L and TSLP, has been selected for presentation at the 2025 ACAAI Annual Scientific Meeting, highlighting its potential in treating type 2 inflammatory diseases [1] Group 1: Product Development - CS2015 is a potential first-in-class/best-in-class dual-specific antibody that targets both OX40L and TSLP [1] - The antibody aims to provide new treatment strategies for atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD) by dual inhibition of key regulatory factors in Th2-mediated inflammatory responses [1] Group 2: Conference Participation - The ACAAI Annual Scientific Meeting will take place from November 6 to 10 in Orlando, USA, where CS2015 will be showcased through an electronic poster presentation and live oral presentation [1]

Core Viewpoint - Company Basilea Pharmaceutica has announced that its pipeline candidate CS2015 has been selected for presentation at the 2025 ACAAI Annual Scientific Meeting, highlighting its potential in treating type 2 inflammatory diseases [1] Group 1: Product Development - CS2015 is a dual-specific antibody targeting both OX40L and TSLP, representing a potential first-in-class or best-in-class therapy [1] - The drug aims to provide new treatment strategies for atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD) by dual inhibition of key regulatory factors in Th2-mediated inflammatory responses [1] Group 2: Event Participation - The ACAAI Annual Scientific Meeting will take place from November 6 to 10 in Orlando, USA, where CS2015 will be showcased through an electronic poster presentation and live oral presentation [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]