Core Insights - The European Medicines Agency (EMA) has provided positive recommendations for new drug approvals from Sanofi (SNY.US) and Insmed (INSM.US) during its recent meeting [1][2] - Sanofi's drug Wayrilz (rilzabrutinib) has been recommended for the treatment of immune thrombocytopenia, while Insmed's Brinsupri is supported for treating non-cystic fibrosis bronchiectasis in patients aged 12 and older [1][2] - Sanofi's application for Rezurock for chronic graft-versus-host disease (cGVHD) was not positively reviewed, prompting the company to seek a re-evaluation [2] Sanofi - Wayrilz has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) based on the successful LUNA Phase 3 clinical trial [1] - The company expressed disappointment over the negative opinion for Rezurock, which is already available in several countries including the U.S. [2] - Sanofi's executive vice president stated the commitment to work closely with EMA to bring the therapy to EU patients [2] Insmed - Brinsupri, an oral therapy, is poised to become the first approved treatment for non-cystic fibrosis bronchiectasis in the EU if the European Commission approves the CHMP recommendation [1] Other Companies - Roche (RHHBY.US) and Biogen (BIIB.US) received CHMP support for Gazyva (Gazyvaro) for treating specific types of lupus nephritis [2] - Regeneron Pharmaceuticals (REGN.US) is expected to gain EU approval for Libtayo as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma [2] - Agios (AGIO.US) received a positive opinion for Pyrukynd (mitapivat) for treating anemia related to adult α or β thalassemia [3] - Other companies with supported indication expansions include Bristol-Myers Squibb (BMY.US), Pfizer (PFE.US), Johnson & Johnson (JNJ.US), and Novartis (NVS.US) [3]

金十数据6月9日讯，常山药业6月9日公告，股票连续两个交易日收盘价格涨幅偏离值累计超过30%，根 据深圳证券交易所的相关规定，属于股票交易异常波动的情况。自2025年5月6日至6月9日期间，公司股 价累计涨幅达147.69%，已经严重偏离同行业和创业板综合指数增长幅度。公司艾本那肽注射液用于治 疗2型糖尿病的上市许可申请已经获得国家药监局受理，目前处于专业审评阶段，艾本那肽注射液上市 审评后续环节仍然较多，艾本那肽最终能否获批上市及获批时间仍存在不确定性。公司艾本那肽注射液 拟用于减重适应症的临床试验申请已经获得国家药监局受理，目前处于审评阶段，能否获得临床试验批 准通知书存在不确定性。 常山药业：艾本那肽注射液处于审评阶段，能否获批存在不确定性 ...