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Announcement on the Acceptance of Clinical Trial Application for Drugs by Joincare Pharmaceutical Group Industry Co., Ltd.
Published Time：
2020-02-18
Securities Code: 600380 Securities Abbreviation: Jiankang Yuan Announcement No.: 2020-013
Joincare Pharmaceutical Group Industry Co., Ltd.
Announcement on the Acceptance of Clinical Trial Application for Drugs
The board of directors and all directors of this company guarantee that the content of this announcement does not contain any false records, misleading statements or major omissions, and assume individual and joint and several liability for the authenticity, accuracy and completeness of its content.
Recently, Joincare Pharmaceutical Group Industry Co., Ltd. (hereinafter referred to as the "Company")'s holding subsidiary, Lizhu Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Lizhu Group"), wholly-owned subsidiary, Zhuhai Lizhu Microsphere Technology Co., Ltd. (hereinafter referred to as "Lizhu Microsphere"), received the "Acceptance Notification" issued and approved by the National Medical Products Administration (hereinafter referred to as the "NMPA"). The clinical trial application for Aripiprazole Microspheres for Injection, submitted by Lizhu Microsphere, has been accepted. The details are announced as follows:
I. Main Content of the Acceptance Notification
Drug Name: Aripiprazole Microspheres for Injection
English Name: Aripiprazole Microspheres for Injection
Dosage Form: Injection
Specification: 300mg, 400mg
Application Item: New Drug Application
Registration Category: Chemical Drug Category 2.2
Applicant: Zhuhai Lizhu Microsphere Technology Co., Ltd.
According to Article 32 of the "Administrative License Law of the People's Republic of China", after review, it is decided to accept it. Acceptance Number: CXHL2000058, CXHL2000059
II. Drug R&D and Related Situations
"Aripiprazole Microspheres for Injection" has undergone 5 years of R&D, and the clinical trial application was accepted on February 13, 2020.
"Aripiprazole Microspheres for Injection" is a long-acting sustained-release preparation of aripiprazole, injected once a month, which can reduce the frequency of administration and thus improve patient medication compliance. It is mainly used to treat adult schizophrenia.
As of the date of this announcement, the cumulative direct R&D expenditure for "Aripiprazole Microspheres for Injection" is approximately RMB 10.2884 million.
III. Market Situation of the Drug
According to the NMPA's official website database, currently, no such product has been approved for marketing in China, no manufacturer has been approved for clinical trials, and no other manufacturer has applied for clinical trials.
IV. Approval Procedures Still to be Followed for Product Listing
The clinical trial application for this product has been accepted. Within 60 days from the date of acceptance and payment, if no negative or questioning response is received from the Center for Drug Evaluation of the National Medical Products Administration, the clinical trial can be carried out according to the submitted plan. Production and marketing can only begin after the completion of clinical trials and approval by the NMPA.
V. Risk Warning
Due to the particularity of drug R&D, the cycle from clinical application to production and marketing is long and involves many links, and is easily affected by many unpredictable factors. There is uncertainty as to whether clinical approval will be obtained. The company will fulfill its information disclosure obligations in a timely manner based on subsequent progress. Investors are advised to pay attention to investment risks.
This announcement.
Joincare Pharmaceutical Group Industry Co., Ltd.
February 18, 2020
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