3. 武田银屑病新药试验告捷，2026 年冲刺 FDA 获批 武田制药的口服 TYK2 抑制剂 zasocitinib（一款有望对标百时美施贵宝 Sotyktu 的药物），在中重度斑 块状银屑病的两项 III 期试验中表现优异。用药 16 周后，该药在医生整体评估达标率、银屑病面积严重 程度改善 75% 以上两项关键指标上，均显著优于安慰剂。武田计划 2026 年向 FDA 提交获批申请。 （来源：抗体圈） 2025 年 12 月 19 日，《亚洲医药快报》（Fierce Pharma Asia）发布年度最后一期行业周报，聚焦制药 领域关键进展：第一三共（Daiichi Sankyo）两款抗体偶联药物（ADC）迎来一喜一忧，武田 （Takeda）银屑病新药试验成功，同时行业并购、跨国合作及政策变动多点开花。以下是核心信息的通 俗解读： 1. 乳腺癌新药组合获批，十年首破治疗格局 阿斯利康与第一三共合作的 Enhertu，联合罗氏的 Perjeta，获美国 FDA 批准成为 HER2 阳性转移性乳腺 癌的一线新疗法 —— 这是该领域十多年来首个新一线治疗方案。临床试验显示，该组合比传统 THP 疗 法降低 44 ...

Core Viewpoint - The European Commission has approved a new indication for Sugli monoclonal antibody, expanding its treatment options for adult patients with advanced non-small cell lung cancer (NSCLC) [1] Company Summary - 基石药业-B's stock price increased by 4.61% to 5.90 HKD with a trading volume of 12.15 million HKD [1] - The approval allows Sugli to be used as a monotherapy for adult patients with unresectable stage III NSCLC who have PD-L1 expression ≥1%, no EGFR sensitive mutations, or ALK/ROS1 genomic alterations, and have not shown disease progression after platinum-based chemoradiotherapy [1] - The CEO, Dr. Yang Jianxin, highlighted that this new indication approval marks a significant milestone, providing comprehensive treatment coverage from stage III to IV NSCLC in Europe within just one year of the initial approval for metastatic NSCLC [1]

Group 1 - The core point of the article is that Sihuan Pharmaceutical Group (02005.HK) has received approval from the National Medical Products Administration of China for its Metronidazole, allowing it to be used as an active pharmaceutical ingredient in marketed formulations [1] Group 2 - Metronidazole is a nitroimidazole antibiotic primarily used for treating anaerobic bacterial infections such as appendicitis and pelvic inflammatory disease [1]

Core Insights - Novo Nordisk's Wegovy obesity drug received accelerated approval from the U.S. FDA to treat metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis [2] - Following the announcement, Novo Nordisk's shares increased by approximately 5% [1][2] Company Developments - The FDA approval is contingent upon the use of Wegovy in conjunction with a reduced calorie diet and increased physical activity [2] - The stock price of Novo Nordisk rose by 5.05% by 9:59 a.m. London time, indicating positive market reaction to the news [2]

Investment Rating - The report maintains a "Buy" rating for 康方生物 (9926 HK) with a target price of HKD 115, indicating a potential upside of 16.3% from the current price of HKD 98.90 [7]. Core Insights - 康方生物's application for the PD-L1 positive NSCLC indication for its drug 依沃西 has been approved in mainland China earlier than expected, just 9 months after submission [1]. - The initial overall survival (OS) interim analysis from the HARMONi-2 study shows a hazard ratio (HR) of 0.777, indicating a 22.3% reduction in the risk of death, although it has not yet reached statistical significance [1]. - The report expresses optimism regarding the overseas development of 依沃西, particularly the ongoing HARMONi-7 study, which is expected to have a higher probability of achieving significant results due to a larger sample size and a focus on patients with higher PD-L1 expression [1]. Summary by Sections Approval and Clinical Data - The approval of 依沃西 for PD-L1 positive NSCLC in mainland China reflects regulatory confidence in the clinical benefits observed [1]. - The interim analysis of the HARMONi-2 study is based on a sample size of 398, with a low alpha allocation value of 0.0001, suggesting that the results may improve as more data matures [1][2]. Market Potential - The report forecasts peak sales of 61 billion RMB in mainland China and 5.7 billion USD overseas for 依沃西, highlighting its significant commercial potential [1]. - The upcoming data readout from the global Phase III HARMONi study for 2L EGFR+ NSCLC is anticipated to be a key event for investors [1]. Pipeline Developments - The report notes that the first clinical-stage antibody-drug conjugate (ADC) targeting HER3 has commenced enrollment in Australia, and a second ADC targeting TROP-2/Nectin-4 has received FDA clinical approval [1].