于推进IND的同时，SM17目前正完成由静脉注射转为皮下注射剂型的桥接研究，预计最早于本年第一 季度完成。公司预计最早于本年第二季度启动针对AD的II期临床试验。公司认为，将SM17的适应症从 AD扩展到IBD，是解决这一具有重大临床和商业价值领域未满足医疗需求的重要机遇。 消息面上，中国抗体-B发布公告，于2026年2月24日，公司同类首创(FIC)治疗产品SM17用于治疗炎症 性肠病(IBD)患者的新药临床试验申请(IND)已获中国国家药品监督管理局(NMPA)批准。该IND批准代 表着SM17治疗范围从特应性皮炎(AD)拓展至IBD的重要里程碑，涵盖克罗恩病(CD)及溃疡性结肠炎 (UC)等慢性、衰竭性疾病，这些疾病存在显著未满足的医疗需求。公司已完成针对使用SM17皮下注射 剂型的健康志愿者I期桥接实验的随访。有关研究数据将用作支持IBD适应症的进展直接推进II期临床开 发。 中国抗体-B(03681)午前涨超5%，截至发稿，涨4.48%，报2.1港元，成交额952.99万港元。 ...

本集团已于2023年在中国开始CBT-199的药物发现过程。CBT-199已自2023年6月起于临床前动物研究中 进行安全性和耐受性评估，有关研究预期将有助于未来的临床试验。 本公司认为，由于CBT-199的临床试验现被认为可安全推进，标志着CBT-199临床开发的关键里程碑， 且本集团已正式获授权启动第2阶段临床试验。本集团将持续密切关注审评进度，并适时另行刊发公 告，以知会本公司股东及潜在投资者有关本集团业务的最新发展。 智通财经APP讯，拨康视云-B(02592)发布公告，本公司于美利坚合众国(美国)特拉华州注册成立的全资 附属公司 ADS Therapeutics LLC (ADS USA)，已完成有关于2025年12月12日向美国食品及药物管理局 (美国药管局)提交的CBT-199(一种由本集团开发的潜在同类最佳眼科候选药物)新药临床试验申请(新药 临床试验申请)的审查期。由于美国药管局未发出任何临床试验暂停令，新药临床试验申请现已生效， 临床试验被认定为可安全推进。 CBT-199是一种新型局部眼用乳液，适用于治疗老花眼，而老花眼为常见的年龄相关性病症，患者眼内 晶状体逐渐增厚且失去弹性，导致聚焦 ...

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced the acceptance of its new drug clinical trial application for JSKN033, a combination therapy for advanced cervical cancer, by the National Medical Products Administration (NMPA) [1] Group 1: Clinical Trial Details - JSKN033 is a high-concentration subcutaneous compound formulation consisting of a bispecific antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) and a programmed death ligand 1 (PDL1) immune checkpoint inhibitor [1] - The clinical trial, identified as JSKN033-202, is an open-label, multicenter, Phase II study aimed at evaluating the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with advanced cervical cancer [1] - All participants will receive treatment with JSKN033 in combination with either cisplatin or carboplatin, and the choice of platinum drug and the inclusion of bevacizumab will be determined by the researchers based on individual patient circumstances [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has announced the acceptance of its new drug clinical trial application for JSKN033, a combination therapy for advanced cervical cancer, by the National Medical Products Administration (NMPA) [1] Group 1: Clinical Trial Details - JSKN033 is a high-concentration subcutaneous compound formulation consisting of a bispecific antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) and a programmed death ligand 1 (PDL1) immune checkpoint inhibitor [1] - The clinical trial, identified as JSKN033-202, is an open-label, multicenter, Phase II study aimed at evaluating the safety, efficacy, and pharmacokinetic/pharmacodynamic characteristics of JSKN033 in combination with platinum-based chemotherapy, with or without bevacizumab, for treating patients with advanced cervical cancer [1] - All participants will receive treatment with JSKN033 in combination with either cisplatin or carboplatin, and the choice of platinum drug and the inclusion of bevacizumab will be determined by the researchers based on individual patient circumstances [1]

Core Viewpoint - Deutsche Bank reiterated its "Hold" rating on Neurocrine Biosciences (NBIX.US) and maintained a target price of $152, believing that investor expectations for the clinical results were low, thus the impact on the stock price will be minimal [1] Group 1: Clinical Trial Results - Neurocrine Biosciences reported that the Phase III KINECT-DCP trial for valbenazine (Ingrezza) in treating Dystonic Cerebral Palsy (DCP) failed, eliminating the opportunity for Ingrezza to expand its indications beyond tardive dyskinesia (TD) and Huntington's disease (HD) [1] - The failure of the DCP indication for Ingrezza was not included in Deutsche Bank's valuation model, meaning it will not alter the company's valuation [1] Group 2: Sales Estimates and Market Focus - Deutsche Bank estimates the peak sales for Ingrezza to be approximately $2.821 billion, compared to consensus expectations of about $2.998 billion, which includes around $2.585 billion from TD sales and approximately $236 million from HD sales [2] - In the absence of label expansion, Deutsche Bank expects management to focus on increasing Ingrezza prescriptions, supported by an expanded sales team, while the TD market is anticipated to grow despite currently low penetration [2]

Core Viewpoint - The company announced that its subsidiary, Shanghai Heyu Biopharmaceutical Technology Co., Ltd., has received approval from the National Medical Products Administration (NMPA) in China for the clinical trial (IND) application of its oral, highly active, and selective small molecule KRAS G12D inhibitor, ABSK141, aimed at treating patients with advanced solid tumors carrying the KRAS G12D mutation [1] Group 1 - The clinical trial application for ABSK141 has been approved by the NMPA [1] - ABSK141 is designed to target advanced solid tumors with the KRAS G12D mutation [1] - The drug is characterized as an oral, highly active, and highly selective small molecule inhibitor [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration (NMPA) in China for its new drug clinical trial application for the oral, highly active, and selective small molecule KRAS G12D inhibitor ABSK141, aimed at treating patients with advanced solid tumors carrying the KRAS G12D mutation [1] Group 1 - The subsidiary involved is Shanghai Heyu Biopharmaceutical Technology Co., Ltd. [1] - The drug ABSK141 targets a specific mutation (KRAS G12D) associated with advanced solid tumors [1] - The approval marks a significant step in the development of targeted therapies for cancer treatment [1]

Core Viewpoint - The company has completed the enrollment for the Phase III clinical trial AFFIRM-205, evaluating the combination therapy of LAE002 (afuresertib) and fulvestrant for treating HR+/HER2- locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN gene alterations [1] Group 1 - The Phase III clinical trial AFFIRM-205 is a multicenter, randomized, double-blind, placebo-controlled study aimed at assessing the antitumor efficacy and safety of the combination therapy [1] - The company aims to announce the top-line data from this critical Phase III study in the first half of 2026 [1] - A new drug application will be submitted to the National Medical Products Administration of China later in 2026 [1] Group 2 - The company has signed an exclusive licensing agreement with Qilu Pharmaceutical Co., Ltd. on November 12, 2025 [1] - Under the licensing agreement, Qilu Pharmaceutical has obtained exclusive rights for the research, development, and commercialization of LAE002 (afuresertib) in the Chinese region, including mainland China, Hong Kong, Macau, and Taiwan [1]

Core Viewpoint - The company has completed the enrollment for the Phase III clinical trial AFFIRM-205, evaluating the efficacy and safety of LAE 002 (afuresertib) in combination with Fulvestrant for treating HR+/HER2- locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN gene alterations [1] Group 1 - The Phase III clinical trial AFFIRM-205 is a multicenter, randomized, double-blind, placebo-controlled study [1] - The company aims to announce the topline data from this key Phase III study in the first half of 2026 [1] - A new drug application will be submitted to the National Medical Products Administration of China later in 2026 [1] Group 2 - The company has signed an exclusive licensing agreement with Qilu Pharmaceutical Co., Ltd. on November 12, 2025 [1] - Under the licensing agreement, Qilu Pharmaceutical has obtained exclusive rights for research, development, and commercialization of LAE 002 (afuresertib) in the Greater China region, including mainland China, Hong Kong, Macau, and Taiwan [1]

Core Insights - The launch of the first international standard clinical trial for new drugs in Macau marks a historic step, establishing the capability to conduct clinical trials and completing the clinical research network in the Greater Bay Area [1][2] Group 1: Clinical Trial Details - The FIBRONEER™-SARD trial is a global multicenter Phase IIIb clinical trial initiated by Boehringer Ingelheim, focusing on the efficacy and safety of nerandomilast in patients with Systemic Autoimmune Disease-related Interstitial Lung Disease (SARD-ILD) [1] - The trial will be conducted in approximately 15 countries and regions worldwide, with the Macau University of Science and Technology Clinical Trial Center (MUST-CTC) as the implementing site and Hong Kong University Clinical Trial Center (HKU-CTC) providing strategic support [1] Group 2: Drug Information - Nerandomilast, a PDE4B selective inhibitor developed by Boehringer Ingelheim, has shown good efficacy and safety in Phase III studies for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) [2] - The drug has received "Breakthrough Therapy" designation from the FDA and priority review qualifications in multiple regions, including the US and Europe [2] Group 3: Strategic Collaborations - Boehringer Ingelheim signed a strategic cooperation agreement with MUST-CTC, indicating the HOPE project has achieved full coverage in the Greater Bay Area [2] - This collaboration aims to enhance regional synergy, capacity building, and the transformation of research outcomes, ultimately creating more value for patients [2]