Announcement from Joincare Pharmaceutical Group Co., Ltd. on Obtaining the Approval Notice for Drug Clinical Trials
Announcement from Joincare Pharmaceutical Group on Obtaining the Approval Notice for Drug Clinical Trials
Securities code: 600380 Securities abbreviation: Jiancareyuan Announcement number: Lin 2025-082
Joincare Pharmaceutical Group Co., Ltd.
Announcement on Obtaining Drug Clinical Trial Approval Notice
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.
Recently, Livzon Pharmaceutical Factory of Livzon Group (hereinafter referred to as Livzon Pharmaceutical Factory), a subsidiary of Livzon Pharmaceutical Group Co., Ltd., a subsidiary of Joincare Pharmaceutical Group Co., Ltd. (hereinafter referred to as the Company), received the "Drug Clinical Trial Approval Notice" (notice number: 2025LP03436, 2025LP03437) for NS-041 tablets for the new indication of "treatment of depression" approved and issued by the State Food and Drug Administration, and agreed to NS-041 Conduct clinical trials for new indications. The relevant details are now announced as follows:
1. Basic information on drugs
Drug name: NS-041 tablets
Dosage form: tablet
Registration classification: Chemical drugs Class 1
Indications for application: depression
Approval conclusion: According to the "Drug Administration Law of the People's Republic of China" and relevant regulations, after review, the NS-041 tablets accepted on October 13, 2025 met the relevant requirements for drug registration, and it was agreed to carry out clinical trials for depression.
2. Drug research and development and related situations
NS-041 tablets are a new type of highly selective KCNQ2/3 agonist, targeted for the treatment of neuropsychiatric diseases such as epilepsy and depression. It is currently the only KCNQ2/3-targeted drug in China that has been approved for clinical research on epilepsy and depression at the same time. On December 27, 2023, NS-041 tablets were approved to conduct clinical trials for the "epilepsy" indication. This indication is currently undergoing Phase II clinical research.
The newly approved clinical trial indication for NS-041 tablets this time is "treatment of depression." Research shows that KCNQ2/3 channel activators can regulate the excitability of dopamine neurons in the ventral tegmental area of the midbrain, thereby improving related depression symptoms. In preclinical studies for this indication, NS-041 tablets were used to treat classic acute and chronic depression in mice.
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Announcement from Joincare Pharmaceutical Group on Obtaining the Approval Notice for Drug Clinical Trials
In depression models, they all showed good antidepressant effects; their target selectivity was higher than that of drugs under development for the same target, and no potential risk of eye toxicity was found.
NS-041 tablets were introduced under a license agreement signed by Livzon Pharmaceutical Factory and New Ocean Pharmaceuticals (Shanghai) Co., Ltd. in 2024. Livzon Pharmaceutical Factory exclusively enjoys all rights and interests of the drug in Greater China.
As of the disclosure date of this announcement, the cumulative direct investment in research and development expenses for NS-041 tablets is approximately RMB 58.5394 million.
3. Market situation of drugs
According to the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, as of the date of this announcement, there are no new generation drugs targeting KCNQ2/3 on the market in China.
4. 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. Due to the particularity of drug research and development, the cycle from clinical trials to production and launch is long and has many links, which are easily affected by many unpredictable factors. There are many uncertainties in the progress and results of clinical trials and the future product market competition situation. The company will fulfill its information disclosure obligations in a timely manner based on the progress of research and development. Investors are advised to pay attention to investment risks. Announcement is hereby made.
Joincare Pharmaceutical Group Co., Ltd. December 22, 2025
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