Core Viewpoint - Inhibrx Biosciences, Inc. announced positive primary results from the ChonDRAgon clinical study, evaluating the efficacy of ozekibart (INBRX-109) in patients with advanced or metastatic, unresectable chondrosarcoma compared to placebo [1] Group 1: Clinical Study Results - The ChonDRAgon study involved 206 participants and demonstrated significant improvement in progression-free survival (PFS) for chondrosarcoma patients treated with ozekibart [1] - Ozekibart is the first investigational drug to show a significant improvement in PFS in a randomized controlled trial for this patient population [1] Group 2: Regulatory and Market Implications - Inhibrx plans to submit a New Drug Application (NDA) to the U.S. regulatory authorities for ozekibart's chondrosarcoma indication by the end of June 2026 [1] - The company holds exclusive development and commercialization rights for ozekibart in mainland China, Hong Kong, Macau, and Taiwan through its wholly-owned subsidiary, HJB [1] Group 3: Market Context - Currently, there are no approved systemic treatment options for chondrosarcoma, highlighting the potential market value of ozekibart for global patients and in the regions where the company has exclusive rights [1]

本公告由創勝集團醫藥有限公司（「本公司」）自願作出，旨在告知本公司股東及潛 在投資者有關最新業務進展。本公告所用但並無另行界定的詞彙應與本公司日期 為2021年9月14日的招股章程中所賦予該等詞彙的涵義相同。 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。 Transcenta Holding Limited 創勝集團醫藥有限公司 （以存續方式於開曼群島註冊的有限公司） （股份代號：6628） 自願公告 有關創勝集團合作夥伴Inhibrx公佈ozekibart治療軟骨肉瘤的 II期臨床試驗積極結果，計劃於2026年遞交BLA的業績進展 創勝集團醫藥有限公司 本公司董事會（「董事會」）欣然公佈，合作夥伴Inhibrx Biosciences, Inc. （「Inhibrx」，納斯達克代碼：INBX）公佈了註冊性臨床研究ChonDRAgon （n=206）的積極主要結果。該研究評估了ozekibart(INBRX-109)單藥相較安慰劑在 晚期或轉移性、 ...

Financial Data and Key Metrics Changes - In Q3 2025, revenue grew by 54% compared to Q3 2024, driven by key products [6][9] - Gross margin as a percentage of revenue was 83.6%, an increase of 1.4 percentage points year-over-year [9] - Earnings per share increased to $7.02, compared to $1.18 in Q3 2024 [10] Business Line Data and Key Metrics Changes - Revenue from key products accounted for $12 billion in the quarter, with significant contributions from immunology, oncology, and cardiometabolic health [11][12] - EBGLYSS prescriptions increased by 41% in Q3 2025 compared to Q2 2025 [11] - Mounjaro's total prescriptions grew by over 60% in the U.S. [14] Market Data and Key Metrics Changes - U.S. revenue increased by 45%, with strong volume growth from Zepbound and Mounjaro, despite a 15% decline in price [10] - International revenue increased by over 100% in constant currency, reflecting strong uptake of Mounjaro [10] - Japan, China, and the rest of the world saw constant currency revenue growth of 24%, 22%, and 51%, respectively [10] Company Strategy and Development Direction - The company is focused on expanding its manufacturing footprint and has announced plans for new facilities in the U.S. [7][8] - Lilly aims to leverage its robust pipeline and R&D investments to maintain a competitive edge in the market [51][53] - The company is pursuing an "all of the above" strategy to expedite the launch of orforglipron [39] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong performance and market share gains in the incretin analogs market [6][9] - The company raised its revenue and earnings per share guidance for the year based on strong financial performance [6][15] - Management acknowledged the competitive landscape but emphasized confidence in their portfolio and execution strategy [51][53] Other Important Information - The company distributed $1.3 billion in dividends and executed approximately $700 million in share repurchases during the quarter [8] - Lilly achieved several key milestones, including FDA approvals and positive trial results for multiple products [7][26] Q&A Session Summary Question: Comments on orforglipron and its market launch - Management indicated a focus on getting orforglipron to patients quickly and is pursuing various strategies to expedite its launch [39] Question: Insights on Mounjaro's international ramp - Management noted strong performance in new markets and emphasized the importance of patient activation for obesity treatment [46] Question: Market dynamics and competitor behavior - Management expressed confidence in their competitive position and highlighted ongoing investments in R&D and execution [51][53] Question: Pricing and volume dynamics for orforglipron - Management discussed the importance of understanding price elasticity and the potential for significant market expansion with orforglipron [85]

Summary of Tectonic Therapeutic (NasdaqGM:TECX) Conference Call on TX45 Phase 1B Part B Results Company Overview - **Company**: Tectonic Therapeutic - **Product**: TX45 - **Focus**: Treatment for pulmonary hypertension associated with reduced ejection fraction heart failure (PHFREF) Key Points from the Conference Call Clinical Trial Results - **Trial Design**: Phase 1B clinical trial evaluated safety and hemodynamic effects of TX45 in 14 patients with PHFREF [2][3] - **Primary Endpoint**: Mean change from baseline in pulmonary vascular resistance (PVR) for patients with PVR ≥ 3 WU [4] - **Results**: TX45 was well tolerated, showing improvements in all hemodynamic measurements evaluated [3][12] - **Wedge Pressure**: Decreased by over 6 mmHg, translating to a 29% reduction from baseline [13] - **PVR Reduction**: Approximately 20% reduction in PVR for patients with PVR ≥ 3 WU [14] - **Cardiac Output**: Increased by approximately 17% [16] - **Mean Pulmonary Artery Pressure**: Decreased by 19% [16] - **Ejection Fraction Improvement**: Left ventricular ejection fraction improved from 34% at baseline to 40.3% at day 29, representing a 19% increase [17] Market Potential - **Patient Population**: Approximately 1.1 million people in the U.S. with PHFREF, with around 300,000 having CPCPH and PVR ≥ 3 [6] - **Need for Treatment**: Significant need for new treatments due to worse exercise capacity and increased mortality in patients with pulmonary hypertension [5] Future Clinical Trials - **APEX Phase 2 Trial**: Ongoing trial with over 50% enrollment, focusing on patients with PVR ≥ 3 WU [21] - **Upcoming Studies**: Plans to initiate a study for TX45 in pulmonary hypertension associated with interstitial lung disease (PHILD) [22] - **Financial Health**: Company has a financial runway into Q4 2028 [22] Safety and Tolerability - **Adverse Events**: No serious or severe adverse events reported; only mild to moderate procedure-related back pain observed [12] - **Vital Signs**: No clinically significant changes in vital signs, ECG, or lab values [12] Discussion Points - **Correlation with Exercise Capacity**: Data suggests that improvements in hemodynamics may correlate with increased exercise tolerance, although exact predictions for 6-minute walk tests remain uncertain [20] - **Data Consistency**: Consistency of results across different patient populations was noted, reinforcing confidence in TX45's efficacy [23][26] Regulatory and Development Considerations - **Future Steps**: Potential for a Phase 2/3 trial for HFREF, depending on APEX trial results and regulatory alignment [57] Additional Insights - **Echocardiographic Data**: Persistent improvements in left ventricular function and pulmonary hemodynamics observed up to 29 days post-dose [17][19] - **Outlier Impact**: Discussion on the impact of an outlier patient on mean and median hemodynamic results, highlighting variability in small sample sizes [33][34] This summary encapsulates the critical findings and future directions for Tectonic Therapeutic's TX45, emphasizing its potential impact on treating PHFREF and the company's strategic plans moving forward.

Core Insights - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of injection-use Ruikang Trastuzumab [1] Group 1: Clinical Trial Details - The clinical trial will focus on Ruikang Trastuzumab as a monotherapy compared to Docetaxel + Carboplatin + Trastuzumab + Pertuzumab for neoadjuvant treatment of early-stage or locally advanced HER2-positive breast cancer [1] - This study is a randomized, open-label, multi-center Phase III clinical trial [1] Group 2: Product Approval and Indications - Injection-use Ruikang Trastuzumab has already been approved for use in China, specifically for adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 activation mutations and have previously received at least one systemic treatment [1]

Core Viewpoint - The company has officially launched a Phase III clinical trial for its proprietary product, Keguan Liyan Oral Solution, aimed at treating acute pharyngitis caused by external wind-heat syndrome [1] Group 1: Product Information - Keguan Liyan Oral Solution received its new drug certificate and production approval in 1997, making it a unique product of Wanglaoji Pharmaceutical [1] - The product is included in the 2025 edition of the Pharmacopoeia of the People's Republic of China and is known for its effects of dispelling wind, clearing heat, and detoxifying, primarily used for colds associated with external wind-heat invasion [1] Group 2: Clinical Trial Details - Wanglaoji Pharmaceutical obtained the clinical trial approval notice from the National Medical Products Administration in February 2024, allowing the company to conduct confirmatory clinical trials for acute pharyngitis [1] - The Phase III clinical trial has recently been officially initiated by Wanglaoji Pharmaceutical [1]

该药物剂型为注射液，用法用量按方案规定使用。本次试验主要目的为评估SHR - 1905注射液在中重度 特应性皮炎患者中的有效性指标；次要目的为评估其他有效性指标及安全性；探索性目的为评估药代动 力学、免疫原性特征及对生物标志物的影响。 药物临床试验登记与信息公示平台数据显示，广东恒瑞医药有限公司的评价SHR - 1905注射液在中重度 特应性皮炎患者中有效性和安全性的随机、双盲、安慰剂对照的IIa期研究已启动。临床试验登记号为 CTR20253993，首次公示信息日期为2025年10月15日。 目前，该实验状态为进行中（尚未招募），目标入组人数20人。 风险提示：市场有风险，投资需谨慎。本文为AI大模型基于第三方数据库自动发布，任何在本文出现 的信息（包括但不限于个股、评论、预测、图表、指标、理论、任何形式的表述等）均只作为参考，不 构成个人投资建议。受限于第三方数据库质量等问题，我们无法对数据的真实性及完整性进行分辨或核 验，因此本文内容可能出现不准确、不完整、误导性的内容或信息，具体以公司公告为准。如有疑问， 请联系biz@staff.sina.com.cn。 责任编辑：小浪快报 SHR - 1905注射 ...

Core Viewpoint - Heng Rui Medicine's subsidiary received approval from the National Medical Products Administration for clinical trials of SHR-1905 injection, a monoclonal antibody targeting TSLP, aimed at improving inflammation and controlling disease progression [1] Group 1: Product Development - SHR-1905 injection is designed to block the release of inflammatory cytokines and inhibit downstream inflammatory signaling [1] - The global market has a similar product, Tezepelumab, which is projected to generate approximately $1.22 billion in sales in 2024 [1] - The cumulative R&D investment for SHR-1905 injection has reached approximately 209.62 million yuan [1]

Core Viewpoint - Heng Rui Medicine announced the approval of clinical trials for SHR-1905 injection by the National Medical Products Administration, indicating a significant step in the development of a new therapeutic option targeting inflammation [1] Group 1: Company Developments - The subsidiary Guangdong Heng Rui Medicine Co., Ltd. received the clinical trial approval notice for SHR-1905 injection [1] - SHR-1905 is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), which plays a role in blocking the release of inflammatory cytokines [1] Group 2: Product Information - SHR-1905 injection aims to inhibit downstream inflammatory signaling pathways, ultimately improving inflammatory conditions and controlling disease progression [1]

格隆汇10月13日丨恒瑞医药(600276.SH)公布，公司子公司广东恒瑞医药有限公司收到国家药品监督管 理局核准签发关于SHR-1905注射液的《药物临床试验批准通知书》，将于近期开展临床试验。SHR- 1905注射液是胸腺基质淋巴细胞生成素（TSLP）单克隆抗体，可以阻断炎症细胞因子的释放，抑制下 游炎症信号的传导，最终改善炎症状态并控制疾病进展。 ...