湖南方盛制药股份有限公司 HUNANFANGSHENGPHARMACEUTICALCO.,LTD. 证券代码：603998 证券简称：方盛制药 公告编号：2025-096 湖南方盛制药股份有限公司 关于公司《药品生产许可证》变更的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 一、《药品生产许可证》的变更内容 1、在生产地址湖南省长沙市麓松路789号，综合固体二车间 新增丸剂生产范围（仅用于注册申报），所在车间生产线为综合 固体二车间丸剂生产线1，上述剂型及车间生产线通过药品GMP 符合性检查后方可生产上市； 2、在生产地址湖南望城经济开发区铜官镇循环经济工业基 地内黄龙路368号的原料药车间（101车间）新增"原料药（雷美 替胺、非奈利酮、达普司他）（仅用于注册申报）"，车间生产 线为原料药车间（101车间）雷美替胺生产线、非奈利酮生产线、 达普司他生产线，上述品种转A并通过药品GMP符合性检查后方 可生产上市； 第 1页，共 3页 3、接受湖南湘雅制药有限公司委托生产黄藤素分散片（国 药准字Z20150032）、金刚 ...

Core Viewpoint - Fangsheng Pharmaceutical (603998.SH) announced that its subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd., has successfully negotiated to include its proprietary product, Yao Xue Qu Feng Zhi Tong Granules, in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog for 2025, which is expected to positively impact the product's market promotion and sales scale [1] Group 1 - The product Yao Xue Qu Feng Zhi Tong Granules is an innovative traditional Chinese medicine developed by the company [1] - This is the first time the product has been included in the 2025 Medical Insurance Catalog, which will facilitate its market access and hospital entry [1] - The inclusion is anticipated to have a positive effect on the company's future operating performance and market share, although it will not significantly impact short-term financial results [1]

Core Viewpoint - Fangsheng Pharmaceutical's subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd., has successfully negotiated to include its exclusive product, Yao Xue Qu Feng Zhi Tong Granules, in the 2025 Medical Insurance Directory, which is expected to positively impact the company's future performance and market share, although the short-term effects will be limited [1] Summary by Categories Product Information - Yao Xue Qu Feng Zhi Tong Granules is classified as a Category 1.1 innovative traditional Chinese medicine and was approved for market launch on June 9, 2025 [1] - The payment standard for the product is set at 7 yuan per bag (8g), with an effective period until December 31, 2027 [1] Market Impact - The inclusion in the medical insurance directory is anticipated to have a positive effect on the company's future performance and market share [1] - There are no changes in the status of other major products, with no exits or additions reported [1]

Core Viewpoint - Fangsheng Pharmaceutical (603998.SH) announced that its subsidiary, Guangdong Fangsheng Jianmeng Pharmaceutical Co., Ltd., has successfully negotiated to include its proprietary product, Yao Xue Qu Feng Zhi Tong Granules, in the National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog for 2025, which is expected to positively impact the product's market promotion and sales scale [1] Group 1 - The product Yao Xue Qu Feng Zhi Tong Granules is an innovative traditional Chinese medicine developed by the company [1] - The inclusion in the 2025 Medical Insurance Catalog will enhance the product's market access and sales potential [1] - The company anticipates a positive impact on future operating performance and market share, although no significant short-term effects on operating results are expected [1]

Group 1 - The core viewpoint of the news highlights the performance of the Traditional Chinese Medicine (TCM) sector, with the Zhongzheng TCM Index experiencing a slight decline of 0.28% as of December 8, 2025, while individual stocks showed mixed results, with Kangyuan Pharmaceutical leading with a gain of 1.71% [1] - The recent release of the new National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, along with the first Commercial Health Insurance Innovative Drug Catalog (2025), marks the 8th adjustment since the establishment of the National Medical Insurance Bureau, adding 114 new drugs, including 6 TCM products [1] - The Zhongzheng TCM Index includes companies involved in TCM production and sales, reflecting the overall performance of TCM-related listed companies [2] Group 2 - Huafu Securities recommends focusing on innovative drugs, particularly those with revenue and commercialization capabilities, as well as exploring potential big business development opportunities in the biotech and pharmaceutical sectors [2] - The medical device sector is expected to experience a policy turning point, with stock prices, valuations, and configurations at a low point, indicating a potential fundamental turnaround [2] - The TCM ETF closely tracks the Zhongzheng TCM Index, with the top ten weighted stocks accounting for 54.79% of the index, including notable companies such as Yunnan Baiyao and Tongrentang [2]

Core Viewpoint - The National Healthcare Security Administration (NHSA) has released the new basic medical insurance drug list for 2025, which will take effect on January 1, 2026, leading to a significant increase in the success rate of new drug negotiations, particularly for innovative drugs with high clinical value [1][2]. Group 1: New Drug Negotiation Success - The success rate for new drug negotiations in 2025 has significantly improved to 88%, up from 76% in 2024, with 114 new drugs added to the national medical insurance drug list, including 50 Class 1 innovative drugs [2][3]. - The total number of drugs in the national medical insurance drug list has increased to 3,253, enhancing coverage for critical areas such as cancer, chronic diseases, mental health, rare diseases, and pediatric medications [2]. Group 2: Unique Drug Inclusion - Among the 114 newly added drugs, 105 are unique varieties, representing 92.11% of the total, including 98 Western medicines and 7 traditional Chinese medicines [3]. - The inclusion of unique traditional Chinese medicines from companies like China Resources Sanjiu, Yiling Pharmaceutical, and others indicates a balanced representation in the new drug list [3]. Group 3: Market Potential and Growth - The inclusion of 116 drugs in the latest negotiation, particularly 11 new drugs from Heng Rui Medicine and others, is expected to lead to rapid market share growth and product volume increase due to their entry into the medical insurance directory [4][5]. - The negotiation also included new mechanism drugs, such as antibody-drug conjugates and small nucleic acid siRNA drugs, which are anticipated to drive market penetration and accessibility [5]. Group 4: Commercial Health Insurance Directory - The first commercial health insurance innovative drug directory saw intense competition, with 121 candidates but only 24 entering negotiations, resulting in 19 drugs being successfully included [6]. - The directory covers critical diseases such as Alzheimer's and multiple myeloma, with a balanced mix of imported and domestic drugs [6]. Group 5: Investment Recommendations - Companies with a significant number of innovative drugs included in the new medical insurance directory, such as Heng Rui Medicine, BeiGene, and others, are recommended for investment [9]. - Potential growth in traditional Chinese medicine products included in the new directory, such as those from China Resources Sanjiu and Yiling Pharmaceutical, is also highlighted [9].

Group 1: Flu Season Overview - The flu season in China has entered a high incidence period, with flu-like cases in southern and northern provinces reaching 10.3% and 9.1% of total emergency visits, respectively, both higher than the previous week [1] - The demand for flu prevention and control has surged, prompting pharmaceutical companies to increase inventory and supply across all segments, including vaccines, diagnostics, treatments, and drug distribution [1] Group 2: Prevention Efforts - Hualan Biological Engineering Co., Ltd. has reported a significant increase in public awareness regarding flu vaccination, leading to a rise in demand orders from disease control centers compared to the same period last year [1] - The company has efficiently utilized its cold chain logistics to meet the vaccination needs across the country [1] Group 3: Diagnostic Solutions - Shengxiang Biotechnology Co., Ltd. has developed a rapid nucleic acid testing solution for respiratory infections, covering various pathogens and is suitable for outpatient, emergency, and inpatient settings [1] - The company has seen an increase in shipments of respiratory products since October and is well-prepared to meet the testing demand during the flu season [1] Group 4: Treatment Options - The industry is witnessing a collaborative approach in flu treatment, combining Western and traditional Chinese medicine [2] - Beijing Shuanglu Pharmaceutical Co., Ltd. has reported an increase in orders for its flu medications, including Oseltamivir and immune enhancers [2] - Hunan Fangsheng Pharmaceutical Co., Ltd. has noted a significant improvement in sales of respiratory products in the fourth quarter, although overall sales for the year still require monitoring [2] Group 5: Drug Distribution - From November, the sales of flu medications, particularly Oseltamivir and Mabalaoshuai (Sufuda), have seen significant growth at the pharmacy chain, Lao Bai Xing [3] - The company has initiated supply assurance plans ahead of the respiratory disease peak season, ensuring stable market supply through predictive measures and increased inventory [3] - The overall pharmaceutical industry is responding to the flu season by ramping up production and inventory, which not only meets public medication needs but also drives company performance [3]

吉林省推动人参产业高质量发展工作专班班长、吉林省科学技术协会党组书记、副主席陈耀辉介绍，本 届长春健博会将专门设置吉林长白山野山参馆，系统讲述野山参的历史文化和千年传承。展区同时设 置"吉字号"精品馆，重点展示人参、梅花鹿、林蛙、食（药）用菌的最新科研成果和创新产品。修正药 业、同仁堂、胡庆余堂、云岭野山参等多家吉林省内外领军企业设置专门展区，搭建中医药领域展示展 销、专业采购、商贸交流对接平台。 据悉，长春健博会将于12月7日至9日举办，主会场设在东北亚国际博览中心，已有33个国家和地区的 534户企业确认参展参会，期间将举办活动近30场，各界来宾近2000人出席，包括院士专家、院长校 长、知名企业家等300多位重要嘉宾。 （文章来源：新华财经） 新华财经长春12月2日电（记者王晓林）记者从12月2日召开的2025长春国际医药健康产业博览会暨长白 山人参产业高质量发展大会（简称"长春健博会"）新闻发布会了解到，吉林省人参产业综合产值今年全 年将达到年初预定目标，突破千亿级大关，同比增长30%以上。 长白山地区是全国人参的主要产销区，吉林省林下参和园参产量国内领先，人参交易量居全国首位。 ...

Investment Strategy Overview - The core investment strategy for the pharmaceutical sector in 2026 emphasizes innovation and the recovery of profitability within the industry, as the sector has shown signs of stabilization after a period of volatility [4][30]. Innovative Drug Industry Chain - The domestic innovative drug sector is gaining global recognition, with a significant increase in the attention from multinational corporations (MNCs) towards domestic assets. The demand for new products is strong, driven by the approaching patent cliffs for MNCs and favorable policies for domestic drugs entering international markets [5][44]. - The market for PD-(L)1/VEGF bispecific antibodies is experiencing heightened interest, with complementary mechanisms to antibody-drug conjugates (ADCs) expected to drive synergy and growth [5][51]. - The demand for new therapeutic modalities such as peptides, ADCs, small nucleic acids, and cell and gene therapies (CGT) is projected to maintain high growth rates, supported by a recovering outsourcing demand during the overseas interest rate decline [6][43]. Non-Pharmaceutical Sector - The medical device sector is showing signs of recovery, with some companies reporting improved performance in Q3 2025. The bidding for medical equipment is expected to continue recovering, leading to better performance in 2026 [6][7]. - The traditional Chinese medicine sector is anticipated to benefit from ongoing adjustments to the essential drug list, with opportunities for price increases and improved profit margins for leading companies [6][7]. Retail Pharmacy Sector - The retail pharmacy industry is undergoing accelerated consolidation, with leading pharmacies optimizing their store structures to alleviate profit pressures. This is expected to result in a noticeable improvement in profit margins in 2026 [7]. Market Performance and Valuation - The pharmaceutical sector has shown a rebound since early 2025, with a notable increase in the market index, outperforming the broader market indices. As of November 21, 2025, the CITIC Pharmaceutical Index had risen by 14.68% [15][30]. - The valuation of the pharmaceutical sector is at a historical median since 2010, with a price-to-earnings (PE) ratio of 48.38X, indicating a high premium compared to the broader market [17][30]. - The scale of pharmaceutical funds reached a record high of 226 billion yuan by Q3 2025, although the market capitalization of pharmaceutical stocks remains below historical peaks, suggesting potential for growth [20][24]. Financial Performance - The pharmaceutical sector's revenue for the first three quarters of 2025 was 185.46 billion yuan, reflecting a year-on-year decline of 1.34%. However, Q3 2025 showed a revenue increase of 1.18% compared to the previous quarter, indicating signs of recovery [30][31]. - The net profit attributable to shareholders for the pharmaceutical sector in the first three quarters of 2025 was 14.06 billion yuan, down 1.69% year-on-year, but with a positive growth of 3.61% in Q3 2025 compared to the previous quarter [30][31].

Core Viewpoint - The article highlights the rising demand for flu vaccines, antiviral medications, and related testing services due to the increasing flu activity across various regions in China as winter approaches [2][6][8]. Group 1: Flu Vaccine and Antiviral Demand - The flu season is expected to drive significant growth in demand for flu vaccines, respiratory testing, and antiviral medications [2][6]. - Recent data indicates a notable increase in flu vaccine appointments and antiviral drug purchases, with some areas reporting over 500% growth in the number of buyers for antiviral medications [7][8]. - Specific antiviral drugs like Marbofloxacin have seen a remarkable increase in demand, with purchases rising over 600% in recent weeks [7]. Group 2: Market Opportunities - Analysts suggest that the current flu outbreak may lead to heightened public and market interest, creating investment opportunities in flu vaccines, virus testing, and cold medications [8]. - The demand for flu-related products is expected to surge, particularly for antiviral medications such as Oseltamivir and Marbofloxacin, as well as traditional Chinese medicine for flu treatment [8]. - The increase in flu cases is likely to boost the need for diagnostic testing, both in hospitals and for home monitoring, indicating a potential market expansion for testing products [8].