Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanbang, has submitted a drug registration application for a new indication of a drug targeting ALK-positive non-small cell lung cancer, which has been accepted by the National Medical Products Administration [1] Group 1 - Fosun Pharma announced that its subsidiary Fosun Wanbang has received acceptance for a drug registration application for Dihydroartemisinin-Ruxolitinib capsules [1] - The application is specifically for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who are positive for anaplastic lymphoma kinase (ALK) [1]

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Wanbang, has submitted a drug registration application for a new drug, SAF-189, which targets ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients [1] Group 1 - The drug SAF-189 is classified as a Class 1 chemical drug [1] - The application has been accepted by the National Medical Products Administration of China [1] - The indication for the new drug is specifically for patients with ALK-positive locally advanced or metastatic NSCLC [1]

Core Viewpoint - The company has received acceptance from NMPA for the marketing authorization application of Ensartinib capsules for postoperative adjuvant therapy in ALK-positive non-small cell lung cancer (NSCLC) patients [1] Group 1: Product Development - Ensartinib is a new generation ALK inhibitor that is highly selective and potent [1] - The drug was previously approved by NMPA in November 2020 for the treatment of ALK-positive locally advanced or metastatic NSCLC patients who progressed after or are intolerant to Crizotinib [1] Group 2: Clinical Data - Mid-term results of postoperative adjuvant therapy with Ensartinib will be disclosed at the 2025 European Society for Medical Oncology (ESMO) annual meeting [1] - The 2-year disease-free survival (DFS) rate for patients receiving postoperative adjuvant therapy with Ensartinib is reported to be 86.4% [1] - The risk ratio for 2-year DFS is 0.20, indicating an 80% reduction in the risk of recurrence, significantly lowering the likelihood of disease relapse [1]

Core Viewpoint - The announcement indicates that the company has received acceptance from the National Medical Products Administration (NMPA) for its application of a new drug, which is a significant step towards potential market entry for the treatment of specific lung cancer patients [1] Group 1: Company Information - The company, Betta Pharmaceuticals (stock code: 300558), has announced that it received an acceptance notice from the NMPA for its application of the drug, Enasidenib Hydrochloride Capsules (brand name: Baimena®) [1] - The drug is intended for postoperative adjuvant therapy in patients with ALK-positive non-small cell lung cancer (NSCLC) at stages IB to IIIB, who have previously undergone surgical resection [1] - The decision for patients to receive or not receive adjuvant chemotherapy will be made by their physicians [1] Group 2: Industry Context - The acceptance of the drug application by NMPA represents a crucial regulatory milestone in the pharmaceutical industry, particularly for oncology treatments [1] - The focus on ALK-positive NSCLC highlights the ongoing advancements and targeted therapies being developed within the cancer treatment sector [1]

Core Viewpoint - TianTan Bio (600161.SH) announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. has submitted a marketing authorization application for "Recombinant Human Coagulation Factor VIIa for Injection" to the National Medical Products Administration (NMPA) in January 2025, and has received the acceptance notice [1] Group 1 - The product's marketing authorization application has been accepted by the NMPA, with acceptance number CXSS2500005 [1] - Chengdu Rongsheng is actively conducting work to support the review process since the acceptance of the application [1] - The NMPA has requested additional clinical trial data for the pediatric population (under 12 years old), leading Chengdu Rongsheng to withdraw the drug registration application [1] Group 2 - Chengdu Rongsheng plans to supplement and improve the relevant clinical data before resubmitting the marketing authorization application [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Chaohui Pharmaceutical Co., Ltd., has had its drug registration application for Compound Polyethylene Glycol (3350) Electrolyte Powder accepted by the National Medical Products Administration of China, indicating progress in the commercialization of this product for chronic constipation treatment [1][1]. Group 1: Company Developments - The drug is intended for the treatment of chronic constipation, excluding constipation caused by organic diseases [1]. - As of October 2025, the total R&D investment for the series of Compound Polyethylene Glycol Electrolyte Powder products, including this drug, is approximately RMB 6.21 million (unaudited) [1]. - The acceptance of the drug registration application is not expected to have a significant impact on the company's current performance [1]. Group 2: Market Potential - According to the latest data from IQVIA CHPA, the sales revenue of Compound Polyethylene Glycol Electrolyte Powder in mainland China (excluding Hong Kong, Macau, and Taiwan) is projected to be approximately RMB 873 million in 2024 [1].