Core Viewpoint - The company TianKang (301263.SZ) has received a notice of acceptance for the drug registration application of Safinamide Mesylate Tablets from the National Medical Products Administration (NMPA) in China, indicating progress in its drug approval process [1] Group 1: Company Developments - TianKang's wholly-owned subsidiary, Anhui TianKang Pharmaceutical Co., Ltd., has recently received the acceptance notice for the drug registration application [1] - The acceptance of the application is based on the review conducted by the NMPA according to Article 32 of the Administrative Licensing Law of the People's Republic of China [1] Group 2: Product Information - Safinamide Mesylate Tablets are a selective inhibitor of monoamine oxidase B (MAO-B) and are primarily used for treating adult patients with idiopathic Parkinson's disease (PD) [1] - The drug serves as an adjunct therapy to stable doses of Levodopa (L-dopa) alone or in combination with other PD treatments for patients experiencing mid to late-stage fluctuations [1]

人民财讯9月18日电，泰恩康（301263）9月18日晚间公告，全资子公司安徽泰恩康制药有限公司于近日 收到国家药品监督管理局签发的甲磺酸沙非胺片境内生产药品注册上市许可申请《受理通知书》。甲磺 酸沙非胺片是一种选择性抑制B型单胺氧化酶(MAO-B)抑制剂，主要用于治疗成年特发性帕金森氏病 (PD)患者，作为稳定剂量的左旋多巴(L-dopa)单独或与其他PD治疗联合的附加疗法，用于中晚期波动患 者。 ...

格隆汇9月18日丨泰恩康(301263.SZ)公布，全资子公司安徽泰恩康制药有限公司于近日收到国家药品监 督管理局（简称"国家药监局"）签发的甲磺酸沙非胺片境内生产药品注册上市许可申请《受理通知 书》，国家药监局根据《中华人民共和国行政许可法》第三十二条的规定，对上述药品的药品注册上市 许可申请进行了审查，决定予以受理。甲磺酸沙非胺片是一种选择性抑制B型单胺氧化酶（MAO-B）抑 制剂，主要用于治疗成年特发性帕金森氏病（PD）患者，作为稳定剂量的左旋多巴（L-dopa）单独或 与其他PD治疗联合的附加疗法，用于中晚期波动患者。 ...

Core Viewpoint - The company TianKang (301263.SZ) has received a notice of acceptance for the drug registration application of Safinamide Mesylate Tablets from the National Medical Products Administration (NMPA) in China, indicating progress in its product development for treating Parkinson's disease [1] Group 1: Company Developments - TianKang's wholly-owned subsidiary, Anhui TianKang Pharmaceutical Co., Ltd., has recently received the acceptance notice for the drug registration application [1] - The drug, Safinamide Mesylate Tablets, is a selective MAO-B inhibitor intended for the treatment of adult patients with idiopathic Parkinson's disease [1] - The drug is designed to be used as an adjunct therapy with stable doses of Levodopa, either alone or in combination with other Parkinson's disease treatments, particularly for patients experiencing mid to late-stage fluctuations [1]

Core Viewpoint - The article discusses the complexities and challenges associated with diagnosing and treating Parkinson's disease, highlighting the increasing prevalence due to aging populations and the limitations of current treatment options [2][6][11]. Diagnosis Challenges - Parkinson's disease diagnosis lacks a "gold standard," relying on clinical assessments rather than specific biomarkers [3][4]. - Key diagnostic criteria include the presence of at least two core motor symptoms, with the requirement of bradykinesia [3][4]. - Non-motor symptoms such as olfactory dysfunction and sleep disturbances can also aid in diagnosis, but early-stage symptoms may not be recognized [4][5]. Treatment Difficulties - Current treatment strategies emphasize a multidisciplinary approach, with medication as the primary method, but there is no "one-size-fits-all" prescription [6][7]. - The treatment landscape includes six major classes of drugs, with dosages tailored to individual patient needs [6][7]. - The phenomenon of "treatment window crisis" arises as the disease progresses, complicating medication management and leading to fluctuating symptoms [7][11]. New Drug Developments - New medications, such as the third-generation MAO-B inhibitor, have emerged, but challenges remain, including the persistent feeling of drug shortages and the inability of current treatments to halt neuronal death [11][12]. - The need for "disease-modifying therapies" that not only alleviate symptoms but also repair neurons and slow disease progression is emphasized as a critical area for future research [11].