格隆汇8月19日丨石四药集团(02005.HK)公布，集团的吗啉硝唑已获中国国家药品监督管理局批准登记 成为在上市制剂使用的原料药。吗啉硝唑是一种硝基咪唑类抗生素，主要用於治疗厌氧性细菌引起的阑 尾炎和盆腔炎。 ...

Novo Nordisk shares were up 5.05% by 9:59 a.m. London time (4:45 a.m. E.T.). This is a developing story. Please check back for updates. Shares of Novo Nordisk climbed almost 5% Monday after the company's blockbuster Wegovy obesity drug received accelerated approval from the U.S. Food and Drug Administration to treat a serious liver disease. The company on Friday said that it was granted the approval for the treatment of metabolic dysfunction- associated steatohepatitis (MASH) in adults with moderate to adva ...

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].