Hua Medicine Announces Supply Agreement with WuXi STA for Commercial Manufacturing of Dorzagliatin

February 21, 2022, Shanghai, China

Hua Medicine (the "Company", Stock Code: 2552.HK) today announces a supply agreement with WuXi STA for the commercial manufacturing of dorzagliatin, a first-in-class oral therapy for type 2 diabetes (T2D). This commercial supply agreement between Hua Medicine and WuXi STA will further enhance their current collaboration. As the long-time trusted partner of Hua Medicine, WuXi STA will provide the commercial supply of dorzagliatin, helping millions of people with diabetes in China. Dr. Li Chen, Founder, CEO and Chief Science Officer of Hua Medicine, Dr. Jin She, Chief Manufacturing Officer and Sr. VP of Hua Medicine, Mr. Yilei Fu, Chief Quality Officer and Sr. VP of Hua Medicine, Dr. Xiaoyong Fu, CTO, Head of API Business of WuXi STA and Dr. Jinling Chen, Sr. VP, Head of Drug Product Business of WuXi STA attended the signing ceremony.

▲ Hua Medicine With WuXi STA Commercialization Cooperation Signing Ceremony

2021 witnessed significant milestones in the R&D and commercialization of dorzagliatin. In March, the New Drug Application (NDA) of dorzagliatin was submitted to China National Medical Products Administration (NMPA) and accepted in April. In September, Hua Medicine and Sinopharm announced a supply chain strategic cooperation for dorzagliatin. A new manufacturing campus is expected to be built in the Lin-gang Special Area of China (Shanghai) Pilot Free Trade Zone to ensure future commercial supply. The phase III clinical study of dorzagliatin monotherapy showed 65.2% diabetes remission rate without the intervention of any glucose-lowering medication in 52 weeks, after the patients reached normal blood glucose level with dorzagliatin treatment. With this positive result, dorzagliatin provides a new option of oral treatment for T2D patients.

As one of the first participants of the Market Authorization Holders ("MAH") pilot program in China, Hua Medicine has established a series of drug safety and drug quality management systems in line with international and domestic standards. As the preferred partner, WuXi STA was the 1st CDMO Hua Medicine has ever worked with. Deeply involved in the CDMO industry for more than twenty years, WuXi STA has established an integrated CMC platform, as well as a quality system meeting the global standard. For dorzagliatin, the two companies worked closely for API process development and manufacturing involving solid dispersion technology, accelerating the first-in-class oral antidiabetic therapy to market. Last year, dorzagliatin has successfully passed the Pre-approval Inspection (PAI) by NMPA at the Shanghai Waigaoqiao site and Changzhou site of WuXi STA. With the agreement signed, Hua Medicine and WuXi STA will continue their close collaboration for API and solid dispersion R&D and commercial manufacturing.

Additionally, Hua Medicine recognized WuXi STA as the "Most Valuable Partner" to express thanks to WuXi STA's long-term contributions to the dorzagliatin project.

Dr. Li Chen, CEO of Hua Medicine, said, "WuXi STA proved to be an important partner for us during our 10-year collaboration. Going forward, we expect a closer relationship with WuXi STA in the commercial manufacturing of dorzagliatin to reach more T2D patients in China, thus addressing this major public health issue."

Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "We are pleased to enhance our partnership with Hua Medicine for dorzagliatin. We look forward to leveraging our proven integrated CMC platform, global standard quality system and vast API and solid dispersion commercial manufacturing capacity to accelerate the commercialization of dorzagliatin for diabetes patients."

About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired insulin and GLP-1 secretion of patients with Type 2 diabetes and serve as a cornerstone therapy targeting the root cause of the disease. Two Phase III registration trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin have been completed in China, as well as studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submitted its NDA to the National Medical Products Administration, so as to realize the "First in Global, Start from China" mission objective for the benefit of diabetic patients worldwide.

About Hua Medicine
Hua Medicine is an innovative drug development company in China focused on developing novel therapies for patients worldwide with unmet medical needs. Hua Medicine teams up with global high caliber people and integrates ultimate global resources to explore breakthrough technologies and products, and accelerate global innovation in diabetes care. Targeted on glucose sensor glucokinase, dorzagliatin, a novel oral diabetes drug, restoring glucose sensitivity in T2D patients, has completed SEED and DAWN registration trials and filed NDA in China. This global first-in-class glucokinase activator (GKA) has demonstrated its potential of achieving diabetes remission to help millions of diabetic patients around world.

About WuXi STA
WuXi STA (stapharma.com), a subsidiary of WuXi AppTec (wuxiapptec.com), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier contract development and manufacturing organization (CDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate.
For more information, please visit: http://www.STApharma.com

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