Core Insights - The pharmaceutical industry is accelerating its transformation towards innovation-driven development, with R&D capabilities becoming a key competitive metric for companies [1] - Zhendong Pharmaceutical is focusing on innovation, with its subsidiary Guangdong Longchuang's new drug application for "Vaginal Lactobacillus Dual Live Bacteria Capsules" being accepted by the National Medical Products Administration (NMPA), marking a significant milestone in the company's innovation strategy [1][2] - The product addresses bacterial vaginosis through a novel treatment concept, utilizing a combination of Lactobacillus gasseri and Lactobacillus rhamnosus to restore vaginal microecological balance, thus overcoming issues related to antibiotic resistance and dysbiosis [1][2] R&D Progress - The project has undergone years of technical development, completing comprehensive preclinical studies and Phase III clinical trials, demonstrating a significantly higher cure rate compared to the control group and excellent safety profiles [2] - The acceptance of the NDA marks a critical step towards market approval, bringing the product closer to serving patients and filling a gap in the domestic market for natural and safe gynecological treatment options [2] Market Outlook - The demand in the female health sector is continuously increasing, particularly for vaginal microecological products, with the private care market in China projected to grow from 52 billion yuan in 2019 to 83 billion yuan by 2025, reflecting a compound annual growth rate of 10.2% [2] - Zhendong Pharmaceutical's innovative formulation is expected to capture market opportunities in this billion-dollar sector, contributing to the company's new growth trajectory [2] Strategic Support - The company emphasizes R&D innovation as a core strategy, planning to establish a new drug creation center in Shanghai by 2024, focusing on oncology, dermatology, digestion, and urology, while building a diversified product matrix of innovative drugs, generics, and traditional Chinese medicine [3] - Zhendong Pharmaceutical is advancing steadily in the high-quality development wave of the pharmaceutical industry, with multiple projects in the innovative drug sector progressing well, creating a synergistic development pattern across various tracks [3] - As innovative products like the Vaginal Lactobacillus Dual Live Bacteria Capsules are launched and R&D pipelines continue to expand, the company aims to strengthen its core competitiveness and provide high-quality treatment options for patients, thereby creating greater value for investors and society [3]

Policy Developments - The National Healthcare Security Administration (NHSA) explained the "dual catalog" for the 2025 medical insurance drug list, adding 114 new drugs, including 105 negotiated new drugs, 7 competitive bidding drugs, and 2 directly transferred from national procurement [1] - Among the new drugs, 111 are newly launched within the last five years, accounting for nearly 98%, with 50 being Class 1 new drugs, marking a historical high in both proportion and quantity [1] - The new drugs cover key treatment areas such as oncology, anti-infection, chronic diseases, rare diseases, and mental illnesses [1] - The NHSA also released the first commercial insurance innovative drug catalog, including 19 innovative drugs from 18 companies, with 9 being Class 1 new drugs, approximately 50% of the total [1] Drug and Device Approvals - Fuan Pharmaceutical's subsidiary received a drug registration certificate for injectable isavuconazole, indicated for treating invasive aspergillosis and mucormycosis in adult patients [2] - Zhendong Pharmaceutical's investee company, Longchuang Pharmaceutical, had its new drug application for a vaginal probiotic capsule accepted by the National Medical Products Administration [3] Capital Markets - Mingji Hospital Group passed the listing hearing on the Hong Kong Stock Exchange, with CICC and Citigroup as joint sponsors [4] - Yifang Bio announced plans to issue H-shares and apply for listing on the Hong Kong Stock Exchange [5] - Insilico Medicine received approval from the China Securities Regulatory Commission for its overseas IPO, planning to issue up to 108,894,000 shares [6] - Huatai Medical plans to repurchase shares with a total amount between 200 million and 250 million yuan, with a buyback price not exceeding 315 yuan per share [8] Industry Developments - Nanjing Pharmaceutical's subsidiary plans to invest 398 million yuan in a modern pharmaceutical logistics expansion project, with a construction period of approximately 35 months [9] - Buchang Pharmaceutical's subsidiary plans to establish a new company with a registered capital of 1 million yuan, aimed at expanding its business scope [10] - Fosun Pharma's subsidiary, Yaoyou Pharmaceutical, signed a licensing agreement with Pfizer for a GLP-1 receptor agonist, with potential payments totaling up to 158.5 million dollars based on sales milestones [11] Public Opinion Alerts - Rhein Biotech is planning a change in control and intends to acquire at least 80% of Beijing Jinkangpu's equity, with the stock expected to be suspended for up to 10 trading days starting December 10, 2025 [12]

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]