Hua Medicine Announces the Commercialization Cooperation with Raybow Pharmaceutical

Hua Medicine
Dec 17, 2020
4513

December 17, 2020, Shanghai, China

Hua Medicine (the"Company", Stock Code: 2552.HK) today announces that it has entered into a commercial supply agreement with Zhejiang Raybow Pharmaceutical Co., Ltd. ("Raybow Pharmaceutical"). As a future major supplier of dorzagliatin, the global first-in-class oral drug for the treatment of Type 2 diabetes, Raybow Pharmaceutical will supply Hua Medicine with active pharmaceutical ingredients ("API") after the commercial launch of dorzagliatin in China.

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▲ Hua Medicine and Raybow Pharmaceutical Signing Ceremony

In 2020, Hua Medicine made significant progress in accelerating the new drug application ("NDA") preparation process and commercialization of dorzagliatin. On August 17, 2020, Hua Medicine and global biopharmaceutical company, Bayer AG, established a strategic partnership to commercialize dorzagliatin in China. Hua Medicine received an upfront payment of RMB 300 million, and additional milestone payments could reach up to RMB 4.18 billion. In September 2020, the Company obtained the drug manufacturing permit for dorzagliatin and completed the requisite work for commercial launch, laying a solid foundation for the product launch and escalation of future production capacity. The Company plans to submit the NDA to the National Medical Products Administration ("NMPA") early next year.

As one of the first participants of the Market Authorization Holders ("MAH") pilot enterprises in China, Hua Medicine has established a series of drug safety and drug quality management systems in line with international and domestic standards, and has worked closely with many top CDMO companies, such as STA Pharmaceutical and Desano, in production process research, industrial production technology development and the commercialization of dorzagliatin.

This partnership with Raybow Pharmaceutical further expands Hua Medicine's commercialization preparations, increasing dorzagliatin's commercial production potential to address global demand.Raybow Pharmaceutical, a wholly-owned subsidiary of Zhejiang Jiuzhou Pharmaceutical (603456.SS), has become an important partner of Hua Medicine over the past few years in clinical drug development and production. This cooperation represents another strong and win-win alliance based on long-term cooperation and trust between both parties. According to the agreement, Raybow Pharmaceutical will equip Hua Medicine with special plants and production equipment to ensure dorzagliatin's API supply.

"We are glad to have the opportunity to work with Raybow Pharmaceutical to serve patients globally. This year, Hua Medicine has achieved multiple milestones in clinical research and development, completing several NDA required clinical trials and achieving excellent results. I believe that with the concerted efforts of Hua Medicine and its partners, this first-in-class drug will certainly benefit more diabetic patients as soon as possible," said Dr. Li Chen, CEO and Founder of Hua Medicine.

Mr. Wang Bin, CEO of Raybow Life Technology, said, "Hua Medicine is a leading innovative drug development company in China, and we are honored to be Hua Medicine's long-term strategic partner to jointly promote the comprehensive commercialization of dorzagliatin and the advancement of China's healthcare ecosystem.

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 glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs. Two Phase III registration trials for dorzagliatin have been completed in China. The Company has obtained the “Drug manufacturing permit” of dorzagliatin issued by the Shanghai Drug Administration, and plans to submit NDA to the National Medical Products Administration, so as to realize the " First in Global, Start from China” for the benefit of the majority of diabetic patients.

About Hua Medicine
Hua Medicine is a leading, clinical-stage innovative drug development company in China focused on developing novel therapies for the treatment of diabetes. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA-enabling stage and it has currently completed two Phase III registration trials for Dorzagliatin. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.

About Raybow
Raybow is a subsidiary of Jiuzhou Pharma. It is committed to providing"One-Stop Service" to global partners, covering the stages from new drug preclinical research all the way to commercial production. Raybow has two production sites (Raybow Suzhou, Raybow Taizhou) and three R&D centers (Raybow Taizhou, Raybow Hangzhou, Raybow US), and more than 1500 global employees.
Raybow is committed to the research and development of new pharmaceutical technology, especially in the area of high-end fluorine chemistry, asymmetric synthesis, glycosides, high potency synthesis, and biological enzyme technology. This reflects Raybow's high level of technical research and development strength. The company has passed official audits of the FDA, NMPA and AIFA/PMDA many times and passed EHS audits by multinational companies on a regular basis. As part of the global pharmaceutical industry, Raybow is focused on the research and development of innovative drugs that are both life changing and life saving for people worldwide.

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Website: www.huamedicine.com

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