(Stock Code: 9989)
(Shenzhen Hepalink Pharmaceutical Group Co., Ltd.)
(A company limited by shares incorporated in the People's Republic of China)
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This announcement is voluntarily published by Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (the "Company", together with its subsidiaries referred to as the "Group") to inform the shareholders and potential investors of the Company about the latest developments in the Group's business.
The Board of Directors of the Company (the "Board") is pleased to announce that on 23 June 2021, shenzhen Ruidi Biopharmaceutical Co., Ltd., its holding subsidiary, has approved the treatment of AR-301 as an antibiotic for the treatment of respiratory-associated pneumonia caused by Staphylococcus aureus
The Phase III Greater China Drug Clinical Trial (the Group's all-human monoclonal antibody drug) ("AR-301-002") has completed the first patient administration. The pivotal greater China trial is expected to enroll 30 patients from a total of 26 clinical sites.
The Phase III clinical trial, titled AR-301-002, was a randomized, double-blind, placebo-controlled, multicenter clinical study to evaluate the efficacy and safety of AR-301-002 as a combination of antibiotics for the treatment of Staphylococcus aureus ventilator-associated pneumonia (VAP). The primary clinical efficacy objective of this study was to assess the difference in clinical cure rates between SOC alone and combination SOC and AR-301-002 treatment at day 21. Together with clinical experts in the field, the company defines strict clinical cure criteria.
Details of AR-301-002
AR-301-002 is a fully human monoclonal monoclonal IgG1 antibody (mAb) specifically against α toxins released by Staphylococcus aureus,
By aridis Pharmaceuticals, Inc., a subsidiary of the Company, listed on the NASDAQ (stock code: ARDS)
of the company) research and development. The drug is used in combination with antibiotic standard therapy to treat patients with respiratory-associated pneumonia (VAP) caused by Staphylococcus aureus. The results of a phase I/II trial that has been completed in the US earlier show that patients treated with AR-301-002 consistently confirmed to take less time on mechanical ventilation and eradicate Staphylococcus aureus at a higher rate than those treated with antibiotics alone. AR-301-002 has been granted FDA-granted Rapid Review Channel qualification and EMA-granted orphan drug status.
This is hereby announced.
Undertake the orders of the Board of Directors
Shenzhen Hepalink Pharmaceutical Group Co., Ltd
Chairman
Li Li
Shenzhen, China
June 23, 2021
As at the date of this announcement, the executive directors of the Company are Mr. Li Li, Ms. Li Tan, Mr. Shan Yu and Mr. Zhang Bin, and the independent non-executive directors of the Company are Dr. Lu Chuan, Mr. Chen Junfa and Mr. Wang Zhaohui.