November 1, 2024 – Shanghai, China
Recently, in the "2024 Shanghai Pharmaceutical Manufacturer Comprehensive Credit Risk Assessment" authorized by the Shanghai Medical Products Administration, Hua Medicine (Shanghai) Ltd. ("Hua Shanghai") was awarded the highest credit rating of Grade A. This has been reviewed, data analyzed, and model evaluated by the third-party credit rating agencies based on information submitted by participants. It was peer-reviewed by experts from the Shanghai Pharmaceutical Quality Association, and confirmed by relevant functional departments of the Shanghai Medical Products Administration.
According to the Guidance for Credit Rating of Shanghai Pharmaceutical Manufacturer (Revised Edition 2024), assessment criteria are from four dimensions: pharmaceutical manufacturers' dishonesty and non-compliance records, drug management capabilities, social credit assessment, and market competitiveness. Hua Shanghai received full scores in both pharmaceutical manufacturer dishonesty and non-compliance records and social credit assessment, with the remaining two dimensions also ranking at the forefront of the industry.
Since the launch of the global first-in-class drug HuaTangNing (华堂宁®) in September 2022, Hua Shanghai has participated in the Shanghai Pharmaceutical Manufacturer Credit Rating Assessment for two consecutive years, receiving a Grade A rating at both times. From its inception, Hua Medicine has been enhancing the product quality and has dedicated itself to establishing a world-leading quality management system. As the marketing authorization holder (MAH), we has implemented a comprehensive drug quality management system throughout the drug lifecycle. In addition, we has organized the drug quality committee and drug safety committee to ensure the end to end lifecycle management of product quality and safety from drug research and development, production to sales.
About Hua Medicine
Hua Medicine("Company") is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine's cornerstone product HuaTangNing (华堂宁®) (dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin on hydrochloride-tolerated T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with varying degrees of renal function impairment (including end-stage renal impairment without dialysis). Hua Medicine partnered with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing (华堂宁®) in China, benefiting diabetic patients and their families.
Hua Medicine (Shanghai) Ltd. ("Hua Shanghai", 尊龙凯时医药技术(上海)有限公司),means a limited liability company incorporated under the law of the PRC on June 22, 2011, being an indirect wholly-owned subsidiary of the Company.
"Group", "Our", "We" or "Us" means the Company and its subsidiaries.
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Hua Medicine
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