这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 国家医保局详解"双目录" 12月9日，国家医保局对2025年医保药品目录进行了解读，并阐释了医保支持真创新的多维路径。 据国家医保局披露，经相应程序，本次基本医保目录新增114种药品，包括三种准入途径：105种谈判新 增（独家产品），7种竞价新增（非独家产品），2种国家集采中选药品直接调入。29种临床已被替代或 长期未生产供应的药品被调出，其中9种尚有相同治疗主成分的其他剂型在目录内，不减少目录编号。 在新增药品中，111种为5年内新上市品种，占比近98%，50种为1类新药，无论是比例还是数量都创历 年新高。从治疗领域看，新增药品涵盖了肿瘤、抗感染、慢性病、罕见病、精神疾病等重点领域。 今年国家医保局同步发布了首个商保创新药目录，包含18家企业的19款创新药，其中1类新药有9种，约 占50%。 21点评：多款创新药的快速落地有效解决了临床痛点。另外，首版商保创新药目录的同步推出，与基本 医保形成了有效互补，既保障了普通患者的基础用药需求，也为需要高价创新药的患者提供了更多支付 支持。 药械审批 福安药业：子 ...

该药品为复方制剂，主要成分为格氏乳杆菌和鼠李糖乳杆菌活菌，用于阴道菌群恢复，细菌性阴道病的 治疗。 振东制药(300158.SZ)公告，公司参股的广东龙创基药业有限公司(简称"龙创基药业")核心产品"阴道用 乳杆菌二联活菌胶囊"的新药申请(NDA)已获中国国家药品监督管理局药品审评中心(CDE)受理。 ...

格隆汇12月10日丨振东制药(300158.SZ)公布，公司参股的广东龙创基药业有限公司（简称"龙创基药 业"）核心产品"阴道用乳杆菌二联活菌胶囊"的新药申请(NDA)已获中国国家药品监督管理局药品审评 中心(CDE)受理。本品为复方制剂，主要成分为格氏乳杆菌和鼠李糖乳杆菌活菌，用于阴道菌群恢复， 细菌性阴道病的治疗。 ...

振东制药（300158）(300158.SZ)公告，公司参股的广东龙创基药业有限公司(简称"龙创基药业")核心产 品"阴道用乳杆菌二联活菌胶囊"的新药申请(NDA)已获中国国家药品监督管理局药品审评中心(CDE)受 理。 该药品为复方制剂，主要成分为格氏乳杆菌和鼠李糖乳杆菌活菌，用于阴道菌群恢复，细菌性阴道病的 治疗。 ...

人民财讯12月10日电，振东制药（300158）12月10日公告，公司参股的广东龙创基药业有限公司(简 称"龙创基药业")核心产品"阴道用乳杆菌二联活菌胶囊"的新药申请(NDA)已获中国国家药品监督管理局 药品审评中心(CDE)受理。该药品为复方制剂，主要成分为格氏乳杆菌和鼠李糖乳杆菌活菌，用于阴道 菌群恢复，细菌性阴道病的治疗。 ...

振东制药公告，公司参股的广东龙创基药业有限公司核心产品"阴道用乳杆菌二联活菌胶囊"的新药申请 (NDA)已获中国国家药品监督管理局药品审评中心(CDE)受理。该药品为复方制剂，主要成分为格氏乳 杆菌和鼠李糖乳杆菌活菌，用于阴道菌群恢复，细菌性阴道病的治疗。 ...

Group 1 - The core viewpoint of the articles highlights the significant growth and innovation in the pharmaceutical company, Zhendong Pharmaceutical, particularly in its R&D pipeline and product offerings [1][2] Group 2 - In Q3 2025, Zhendong Pharmaceutical reported a net profit attributable to shareholders of 12.43 million yuan, a year-on-year increase of 31.34%, and a non-net profit of 8.684 million yuan, up 2253.78% [1] - The company has successfully turned around its non-net profit in the first three quarters of this year [1] - Zhendong's innovative drug pipeline has made significant breakthroughs, with multiple projects showing positive progress [1] Group 3 - The "Vaginal Lactobacillus Dual Live Bacteria Capsule" has reached its primary research endpoint in Phase III clinical trials and has been accepted for Pre-NDA application by the National Medical Products Administration [1] - This innovative therapy addresses gynecological infections by restoring vaginal microecological balance, overcoming issues related to antibiotic resistance and dysbiosis [1] - The product is designed to be suitable for grassroots medical institutions and home use, aiming to cover 3,000 tertiary hospitals and 5,000 maternal and child health hospitals nationwide [1] Group 4 - Zhendong Pharmaceutical is expanding its presence in emergency medicine by introducing an innovative epinephrine nasal spray formulation, which addresses the challenges of traditional injection forms [2] - This product is designed for quick intervention in allergic shock situations and is patent-protected in major markets including China, the US, and Europe [2] Group 5 - The company is advancing its R&D pipeline in oncology and dermatology, with promising developments in treatments for gastric cancer, breast cancer bone metastasis, and atopic dermatitis [2] - In the consumer health sector, Zhendong's Minoxidil solution has captured a 43% retail market share in the hair loss treatment market, complemented by a new oral hair growth product [2] - The company is leveraging social media platforms to promote scientific awareness of hair loss prevention while enhancing its product offerings through a convenient retail network [2]

Core Viewpoint - Despite facing external challenges, the company demonstrates resilience in its operations and continues to show multi-dimensional development [1] Business Performance - In the first half of 2025, the company achieved revenue of 1.457 billion yuan, maintaining stability [2] - The revenue structure is balanced, with traditional Chinese medicine (TCM) and Western medicine each accounting for approximately half of total revenue [2] - TCM revenue reached 799 million yuan, representing 54.82% of total revenue, while Western medicine revenue was 628 million yuan, accounting for 43.10% [3][4] Product Development - The company has a diverse product pipeline with 11 exclusive products and 589 approvals, including 250 products listed in the 2024 National Medical Insurance Catalog, making up 56.69% of its offerings [1] - Key products such as Dafeixin Minoxidil and Xihuang Pills are experiencing steady sales growth, contributing significantly to overall revenue [4] - New products like hair growth tablets and Bai Granules have been launched, enhancing the product lineup and driving sales growth [5] Financial Health - The company's gross profit margin improved to 51.15% in the first half of 2025, with TCM gross margin increasing by 3.52 percentage points [6] - The overall debt ratio was low at 19.59%, down nearly 7 percentage points from the end of 2024, indicating strong financial stability [7] Research and Development - The company invested 251 million yuan in R&D in 2024, accounting for 8.44% of revenue, with a 25.27% increase from the previous year [8] - A new drug research center was established, focusing on innovative drug development, including anti-tumor drugs and TCM [8][9] Governance and Strategy - A new board of directors was appointed in November 2024, marking a shift towards a younger and more professional management team [11] - The company is adapting to industry trends by focusing on value creation rather than just scale expansion, aligning with the broader "anti-involution" strategy in the pharmaceutical sector [12]

Core Viewpoint - Zhendong Pharmaceutical has made significant progress in the development of multiple innovative drug pipelines, particularly with the "Vaginal Lactobacillus Dual Live Bacteria Capsules," which has reached the primary research endpoint in its Phase III clinical trial and has been accepted for Pre-NDA application by the National Medical Products Administration (NMPA) [1][2] Group 1: Product Development - The "Vaginal Lactobacillus Dual Live Bacteria Capsules" is a compound preparation aimed at treating bacterial vaginosis (BV) caused by microbial imbalance, utilizing a mechanism that restores vaginal microbiota balance rather than merely killing bacteria [2] - The clinical trial results indicate a significant improvement in cure rates and safety, with no risk of antibiotic resistance, addressing the limitations of traditional antibiotic treatments [1][2] Group 2: Market Demand - The prevalence of vaginitis among women of childbearing age is approximately 35% to 60%, with a recurrence rate of up to 60% within 12 months post-antibiotic treatment, highlighting a substantial market demand for safe and effective therapeutic solutions [1][2] Group 3: Research and Development Investment - In the first half of the year, Zhendong Pharmaceutical invested 91.69 million yuan in R&D, accounting for 6.29% of its operating revenue, indicating a commitment to diversifying its innovative drug pipeline and accelerating clinical progress [2]

Group 1 - The core point of the news is that Shanxi Zhendong Pharmaceutical Co., Ltd. has adjusted the upper limit of its share repurchase price from 6.00 yuan per share to 11.4 yuan per share to ensure the effective execution of the repurchase plan in the current market environment [2][3] - The initial repurchase plan announced on October 24, 2024, aimed to use a total fund of "not less than 50 million yuan and not more than 100 million yuan" to repurchase shares at a price not exceeding 6 yuan per share within 12 months after the shareholders' meeting approval [2] - The adjustment in the repurchase price was driven by the company's stock price consistently exceeding the original upper limit, necessitating a revision to facilitate the continuation of the repurchase operations [2] Group 2 - The company has already repurchased a total of 12.9167 million shares, accounting for 1.28% of the current total share capital as of the announcement date [3] - The management's decision to raise the repurchase price reflects their strong confidence in the company's future stable development and intrinsic value, aiming to protect shareholder interests [3] - In recent years, the company has been actively expanding its business layout, particularly in the innovative drug research and development sector, with product coverage in oncology, dermatology, and gynecology [2]