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]

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].