-- Announcement on Obtaining Notice of Approval for Drug Clinical Trials by A Holding Subsidiary for Traditional Chinese Medicine Innovative Drug Research Project
Hunan Nansheng Pharmaceutical Co., Ltd.
HUNANFANGSHENGPHARMACEUTICALCO.,LTD.
Securities code: 603998 Securities abbreviation: Fangsheng Pharmaceutical Announcement number: 2025-079
Hunan Nansheng Pharmaceutical Co., Ltd.
Announcement on Obtaining Approval Notice for Drug Clinical Trial for the Traditional Chinese Medicine Innovative Drug Research and Development Project of the Holding Subsidiary
The company's board of directors and all directors guarantee that the contents of this announcement do not contain any false records, misleading statements or major omissions, and assume legal responsibility for the authenticity, accuracy and completeness of its contents.
On September 3, 2025, Guangdong Dongsheng Rongke Pharmaceutical Co., Ltd. (hereinafter referred to as "Fangsheng Rongke"), a holding subsidiary of Hunan Nansheng Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company" or "Fangsheng Pharmaceutical"), received the "Drug Clinical Trial Approval Notice" approved and issued by the National Medical Products Administration for its innovative traditional Chinese medicine research and development project Gynecological Hemostasis and Xiaotong Granules. The relevant information is now announced as follows:
1. Basic information about drugs
Drug name: Gynecological Hemostasis and Xiaotong Granules
Dosage form: granules
Registration classification: Traditional Chinese Medicine Category 1.1
Application Matters: Clinical Trial
Acceptance number: CXZL2500039
Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, the Fuke Zhihe Xiaotong Granules accepted on June 12, 2025 met the relevant requirements for drug registration. On the basis of further improving the clinical trial plan, it was agreed to carry out Phase II and III clinical trials of this product.
2. Related information about new drugs
Gynecological Zhixue Xiaotong Granules are composed of the fourth batch of national veteran Chinese medicine experts’ academic experience inheritance instructors, national-level famous veteran Chinese medicine experts, experts enjoying special government allowances from the State Council, former president of Hunan University of Traditional Chinese Medicine, and key subjects of the National Administration of Traditional Chinese Medicine.
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Hunan Nansheng Pharmaceutical Co., Ltd.
HUNANFANGSHENGPHARMACEUTICALCO.,LTD.
Professor You Zhaoling, a scientific and academic leader, combined with many years of clinical diagnosis and treatment practice, developed a clinically effective prescription for postpartum lochia (Qi deficiency and blood stasis syndrome), which is characterized by persistent lochia, pain in the lower abdomen that refuses to be pressed, excessive lochia or dripping and stagnant, purple and dark color, fatigue, lack of breath and laziness, spontaneous sweating, low back pain, and lower abdominal distension.
This prescription is based on the pathogenesis of multiple deficiencies and blood stasis after childbirth, with deficiency in the root and excess in the end, with qi deficiency and kidney deficiency as the basis, blood stasis as the standard, and emphasizing both symptoms and root causes. It is based on replenishing qi and blood, removing blood stasis and relieving pain. It has the characteristics of treating both the symptoms and the root cause, emphasizing on tonifying the kidneys, and is suitable for patients with qi deficiency and blood stasis syndrome who have persistent lochia after delivery. This prescription is as effective as treating patients with postpartum irregular vaginal bleeding, abdominal pain, and syndrome diagnosis of qi deficiency and blood stasis. Its legislation, drug selection, and prescription are in line with the theory of traditional Chinese medicine and the etiology and pathogenesis of the disease. It has obvious characteristics among similar products. This prescription won the national invention patent (CN117482158A) in July 2025.
As of the date of this announcement, the cumulative R&D investment in this drug project is approximately RMB 4.89 million (unaudited).
3. Market situation of similar drugs
Gynecological Zhixue Xiaotong Granules is a category 1.1 innovative traditional Chinese medicine independently developed by Fangsheng Rongke. As of the date of this announcement, this product has not yet been launched domestically or overseas.
Gynecological diseases are common and frequently-occurring diseases in women, and Chinese patent medicines play an important role in the treatment of gynecological diseases. According to Minai.com data, in the first quarter of 2025, the sales of gynecological proprietary Chinese medicines in my country's three major terminals and six major markets were approximately 4.9 billion yuan. Sales of proprietary Chinese gynecological drugs at retail pharmacies in my country will remain at around 5.7 billion yuan from 2020 to 2023, with a growth rate of 3.38% in the first three quarters of 2024, showing an overall steady growth trend.
Currently, the main Chinese patent medicines on the market for treating postpartum lochia include compound motherwort capsules, Shanfuxin granules, motherwort ointment/granules/dispersible tablets/tablets/capsules/soft capsules, Xinhua granules/tablets, Yigong granules, Angongzhixue granules, etc. According to data from Moran Entropy Pharmaceuticals, the sales of motherwort ointment/granules/dispersible tablets/tablets/capsules/soft capsules in all terminal hospitals in 2024 will be 289 million yuan, and the sales in physical pharmacies in the first half of 2025 will be 103 million yuan; Xinhua
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Hunan Nansheng Pharmaceutical Co., Ltd.
HUNANFANGSHENGPHARMACEUTICALCO.,LTD.
The sales of granules/tablets in all terminal hospitals in 2024 will be 220 million yuan.
4. Approval procedures that need to be completed before the product is put on the market
After receiving the approval notice for the clinical trial of Fuke Zhixue Xiaotong Granules, Fangsheng Rongke will conduct and complete the clinical trial in accordance with the notice and the requirements of new drug development and drug registration regulations, and then integrate the application materials to apply for product listing.
5. Risk warning
According to the laws and regulations related to drug registration in my country, after a drug obtains a drug clinical trial approval notice, it still needs to conduct clinical trials and undergo review and approval by the State Food and Drug Administration before it can be produced and marketed.
The cycle from drug development, clinical trial approval to production is long and involves many steps. Drug research and development to launch are easily affected by some uncertain factors. Investors are advised to make prudent decisions and pay attention to guarding against investment risks. The company will actively promote the above-mentioned research and development projects in accordance with relevant national regulations and fulfill its information disclosure obligations on the subsequent progress of the projects in a timely manner.
Announcement hereby
Board of Directors of Hunan Nansheng Pharmaceutical Co., Ltd. September 4, 2025
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