Securities code: 000963 securities abbreviation: Huadong Medicine Co.Ltd(000963) Announcement No.: 2022-001
Huadong Medicine Co.Ltd(000963)
Announcement on the holding subsidiary’s obtaining the notice of approval for drug clinical trial
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
On January 18, 2022, Huadong Medicine Co.Ltd(000963) (hereinafter referred to as “the company”) holding subsidiary Zhejiang Doyle Biotechnology Co., Ltd. (hereinafter referred to as “Doyle biotechnology”) received the notice of approval for drug clinical trial (Notice No.: 2022lp00075) approved and issued by the State Drug Administration (nmpa), The phase I clinical trial application of dr30303 for injection of class 1 new biological products declared by Doyle biology was approved to evaluate humanized claudin18 2 safety, tolerance, pharmacokinetics and preliminary efficacy of monoclonal antibody dr30303 in the treatment of advanced solid tumors. The details are hereby announced as follows:
1、 Basic information content of the drug
Drug name: dr30303 for injection
Dosage form: injection
Specification: 100mg / bottle
Indications: claudin18 2 positive advanced solid tumors
Treatment field: tumor
Application item: registered clinical trial of domestically produced drugs
Registration classification: Class 1 biological products for treatment
Applicant: Zhejiang Doyle Biotechnology Co., Ltd
Acceptance No.: cxsl2101424
Notice No.: 2022lp00075
Approval conclusion: according to the drug administration law of the people’s Republic of China and relevant regulations, the dr30303 for injection accepted on November 15, 2021 meets the relevant requirements of drug registration, and it is agreed to carry out the clinical trial of advanced solid tumor according to the submitted scheme.
2、 Development and registration of the drug
On April 26, 2021, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of the company, acquired 75% equity of Doyle bio. Dr30303 for injection is one of the key new drugs developed by Doyle bio. For details, please refer to the announcement on acquisition of shares of Doyle Biology (Announcement No.: 2021-036) disclosed by the company on April 28, 2021.
In November 2021, Doyle biology submitted a clinical trial application for dr30303 for injection to nmpa. Dr30303 is a targeted claudin18 2. The humanized IgG1 (immunoglobulin G1) monoclonal antibody modified by FC engineering can specifically bind and express claudin18 2 and induce tumor cell death through antibody dependent cell-mediated cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC).
Claudins is a kind of integrin membrane protein existing in epithelial and endothelial tight junction. It is an important part of tight junction. Human claudin18 gene can produce claudin18 2 protein subtype, many studies pointed out that claudin18 2 protein is not expressed in other normal tissues other than differentiated gastric epithelial cells, and is abnormal in gastric cancer, pancreatic cancer, gastroesophageal junction cancer and ovarian cancer. CLDN18. 2 has become an important research and development target in the field of tumor.
At present, there is no anti claudin18 in the world Class 2 drugs are listed. This time, it has obtained the approval notice of clinical trial of dr30303 drugs for injection. It is the first approved clinical trial application of Doyle biology, which will enrich the company’s product reserves in the field of tumor treatment, increase the company’s drug coverage in the field of innovative drugs and tumor disease treatment, and accelerate the company’s integration into the global innovative pharmaceutical industry, Further enhance the company’s comprehensive competitiveness.
According to the requirements of laws and regulations related to drug registration in China, after the drug has obtained the notice of approval for clinical trial, it still needs to carry out clinical trial and be reviewed and approved by the State Drug Administration before it can be produced and put on the market.
3、 Impact on listed companies and risk tips
This time, Doyle bio obtained the approval notice of clinical trial of dr30303 for injection, which is an important progress in the R & D process of this new drug. It will not have a significant impact on the company’s current performance. In the long run, it is conducive to promoting the progress of product research and development and listing, and further improving the company’s core competitiveness.
New drug R & D has the characteristics of large investment, long cycle and high risk. There are many uncertainties in the progress and results of clinical trials and the market competition situation of future products. Drugs will be affected by many factors such as technology, approval and policies from clinical trials to putting into operation. The company will actively promote the progress of drug R & D in accordance with relevant national regulations, And timely fulfill the obligation of information disclosure according to the progress of R & D. please pay attention to the investment risks.
It is hereby announced.
Huadong Medicine Co.Ltd(000963) board of directors January 19, 2022
