Core Viewpoint - Shares of Sanofi experienced a decline following the announcement that the U.S. regulatory review of its multiple-sclerosis drug will not be completed by the end of the year [1] Group 1: Company Updates - Sanofi's multiple-sclerosis drug is facing delays in the U.S. regulatory review process, which is now expected to extend beyond the end of the year [1] - The company also indicated that a trial for a different form of treatment is ongoing, but specific details were not provided [1]

A California jury awarded $40 million to two women on Friday, 12 December, who claimed they developed ovarian cancer after long-term use of Johnson & Johnson’s baby powder.Both California residents testified that they had used J&J's baby powder after bathing for about 40 years. They also stated that their ovarian cancer treatments required major surgeries and many rounds of chemotherapy.The healthcare giant, meanwhile, plans to appeal the jury's decision on both the liability verdict and the compensatory da ...

Eli Lilly shares have climbed in the double digits this year.Generally, investors turn to pharmaceutical stocks to add an element of safety to their portfolios. These stocks aren't known for rapid growth, but instead, for steady growth that you can count on over time -- this reliability is due to the fact that patients need their medicines, and that supports drugmakers' revenue through any economic environment.But in recent years, one pharma stock in particular has been behaving like a growth stock -- in fa ...

Core Insights - Ascletis Pharma Inc. announced positive topline results from a Phase I clinical trial for ASC50, an oral small molecule inhibitor targeting IL-17, indicating favorable safety, tolerability, and pharmacokinetics [3][5][7] Group 1: Clinical Trial Results - The Phase I clinical trial was randomized, double-blind, and placebo-controlled, involving 46 healthy participants who received varying doses of ASC50 [3] - ASC50 demonstrated a dose-proportional pharmacokinetic profile from 10 mg to 600 mg, with an elimination half-life ranging from 43 to 104 hours depending on the dose [1][2][8] - All adverse events reported were mild and transient, with no serious adverse events or discontinuations noted during the study [8] Group 2: Target Engagement and Efficacy - Strong target engagement was observed with elevated plasma IL-17A levels persisting until day 7 for higher doses of ASC50 [1][8] - The drug showed higher absolute oral bioavailability and longer half-life compared to another IL-17 inhibitor currently in clinical development [8] Group 3: Future Development - Based on the positive results, ASC50 is advancing to the next phase of clinical development, focusing on multiple ascending doses in participants with mild to moderate plaque psoriasis [5] - ASC50 is positioned as a potential best-in-class oral small molecule IL-17 inhibitor, developed using Artificial Intelligence-assisted Structure-Based Drug Discovery technology [6][7]

Core Viewpoint - The U.S. Food and Drug Administration's decision on Sanofi's investigative drug for multiple sclerosis is expected to be delayed until the first quarter of 2026, moving from the previously communicated date of December 28 [1] Company Summary - Sanofi is a French pharmaceutical group that is currently awaiting a decision from the U.S. FDA regarding its drug for treating multiple sclerosis [1]

近期送达的一审判决书表示，驳回杭州中美华东制药有限公司的全部诉讼请求。案件受理费598,732 元，由杭州中美华东制药有限公司负担。涉案的金额：111,386,405元（较首次披露暂计金额增加10,600 元） 近日，华东医药（000963）发布公告称，因侵害发明专利权纠纷，中美华东将青海珠峰冬虫夏草原料有 限公司、青海珠峰冬虫夏草药业有限公司、杭州华东武林大药房有限公司三名被告诉至浙江省高级人民 法院。 ...

Core Viewpoint - The company, Xingqi Eye Medicine, has received a new Drug Production License from the Liaoning Provincial Drug Administration, which will replace its existing license expiring on December 22, 2025. The new license has reduced the scope of production for certain products [1]. Group 1 - The existing Drug Production License of the company will expire on December 22, 2025 [1] - The company has received a new Drug Production License from the Liaoning Provincial Drug Administration [1] - The new license has reduced the production scope to exclude "solution dosage forms (ophthalmic), inhalation preparations (workshop 101 production area 2 line), and large-volume injections" [1]

通化金马药业集团股份有限公司 投资者关系活动记录表 | | 专业队伍，打造创新营销模式，保证公司在新药销售的主 | | --- | --- | | | 导性、可控性，充分平衡药品的利润空间和患者可及性， | | | 做好新药上市的定价工作；结合市场的广泛需求，制定精 | | | 准营销策略。同时，现有生产体系已做好充分准备，设计 | | | 产能可满足阿尔茨海默病患者的用药需求，确保新药获批 | | | 后能够快速投入市场，为广大患者提供新的优质治疗选 | | | 择。 | | 关于本次活动是否涉 | 否 | | 及应披露重大信息的 | | | 说明 | | | 活动过程中所使用的 | 无 | | 演示文稿、提供的文 | | | 档等附件（如有，可 | | | 作为附件） | | | 投资者关系活动类别 | √特定对象调研 □分析师会议 | | --- | --- | | | □媒体采访 □业绩说明会 | | | □新闻发布会 □路演活动 | | | □现场参观 | | | □其他（请文字说明其他活动内容） 申万宏源证券：张静含、仰佳佳 | | | 建信基金：马牧青 | | | 上市公司： | | 活动参与人 ...

A U.S. regulatory decision on tolebrutinib will again be delayed while a late-stage trial of the drug for a different form of the disease didn't hit its main goal. ...

Core Insights - Sanofi's tolebrutinib did not meet its primary endpoint in the PERSEUS phase 3 study for primary progressive multiple sclerosis (PPMS), leading the company to decide against pursuing regulatory registration for this indication [1][8][10] Company Updates - Sanofi expressed disappointment over the study results but emphasized the importance of these findings in enhancing the understanding of multiple sclerosis biology [2] - The safety profile of tolebrutinib was consistent with previous studies, with drug-induced liver injury (DILI) identified as a risk, necessitating strict liver monitoring [2][4] - Tolebrutinib was provisionally approved in the UAE for non-relapsing secondary progressive multiple sclerosis and is under regulatory review in the EU and other regions [3] Financial Considerations - Sanofi will conduct an impairment test on the intangible asset value of tolebrutinib, with results expected in January 2026, but this will not impact the business net income or financial guidance for 2025 [4] Industry Context - Multiple sclerosis (MS) is characterized by progressive disability, with PPMS representing about 10% of the overall MS patient population [1][5] - There is a significant unmet need in addressing disability accumulation in MS, particularly for secondary progressive multiple sclerosis [6]