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Joincare Pharmaceutical Group Industry Co., Ltd. Announcement on Obtaining Drug Acceptance Notice
Published Time：
2020-02-18
Securities Code: 600380 Securities Abbreviation: Health Yuan Announcement No.: 2020-012
Joincare Pharmaceutical Group Industry Co., Ltd.
Announcement on Obtaining Drug Acceptance Notification
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"), its holding subsidiary, Lizhu Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Lizhu Group"), its wholly-owned subsidiary, Zhuhai Lizhu Microsphere Technology Co., Ltd. (hereinafter referred to as "Lizhu Microsphere"), and Lizhu Pharmaceutical Factory (hereinafter referred to as "Lizhu Pharmaceutical Factory") received the Acceptance Notification issued by the National Medical Products Administration (hereinafter referred to as the "NMPA"). The application for registration of Octreotide Acetate Microspheres for Injection submitted by Lizhu Microsphere and Lizhu Pharmaceutical Factory has been accepted. The details are announced as follows:
I. Main Content of the Acceptance Notification
Drug Name: Octreotide Acetate Microspheres for Injection
English Name: Octreotide Acetate Microspheres for Injection
Dosage Form: Injection
Specification: 10mg, 20mg, 30mg
Application Item: Application for existing national standard drugs
Registration Category: Chemical Drug Category 4
Applicant: Zhuhai Lizhu Microsphere Technology Co., Ltd., Lizhu Pharmaceutical Factory of Lizhu Group
According to Article 32 of the Administrative License Law of the People's Republic of China, after review, it was decided to accept the application. Acceptance Numbers: CYHS2000095, CYHS2000096, CYHS2000097
II. Drug R&D and Related Information
"Octreotide Acetate Microspheres for Injection" has undergone 5 years of R&D, and this registration application was accepted on January 20, 2020.
"Octreotide Acetate Microspheres for Injection" is a long-acting sustained-release preparation, injected once a month, and can be used for:
1. Treatment of the following acromegaly patients:
—Subcutaneous injection of octreotide acetate injection has fully controlled the condition.
—Patients unsuitable for surgery, radiotherapy, or ineffective treatment, or patients in the potential response phase before radiotherapy fully takes effect.
2. Patients with functional gastrointestinal pancreatic endocrine tumors and related symptoms, who have been fully controlled by subcutaneous injection of octreotide acetate injection.
—Carcinoid with carcinoid syndrome characteristics.
—Vasactive intestinal peptide tumor.
—Glucagonoma.
—Gastrinoma/Zollinger-Ellison syndrome.
—Insulinoma (for pre-operative hypoglycemia control and maintenance therapy).
—Growth hormone-releasing factor adenoma.
As of the date of this announcement, the cumulative direct R&D investment in "Octreotide Acetate Microspheres for Injection" is approximately RMB 19.596 million.
III. Market Situation of the Drug
According to the NMPA's official website database, currently one company in China has been approved to market this product. According to IQVIA's sample statistics and estimated data, the domestic terminal sales of "Octreotide Acetate Microspheres for Injection" in 2018 were approximately RMB 109 million, and the domestic terminal sales in the first three quarters of 2019 were approximately RMB 116 million. Another company has been approved for clinical trials, and no other manufacturers have submitted applications.
IV. Approval Procedures Still to be Completed for Product Launch
The Company still needs to obtain the clinical trial notification for "Octreotide Acetate Microspheres for Injection", conduct clinical research according to the notification content, and finally obtain approval from the NMPA before it can be marketed.
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 it is easily affected by many unpredictable factors. There is uncertainty about whether clinical approval can 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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