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Hua Medicine Announces 2019 Interim Results

– 2019-08-16

Updated pipeline expands dorzagliatin-driven portfolio
Cash position of approximately RMB 1,246.4 million

August 16, 2019 - Hong Kong

Hua Medicine (“Hua” or the “Company”, Stock Code: 2552.HK), as a pre-revenue drug development company, today announced its interim results for the six months ended June 30, 2019 (the “Review Period”).

“Hua Medicine’s strategic goal is to become a global diabetes care company,” said Dr. Li Chen, Chief Executive Officer of Hua Medicine. “We will continue to advance the development of dorzagliatin as a global first-in-class medicine launched first in China, and we plan to expand our market access globally through the strength of our drug development platform.

“In order to implement the Company’s strategy, our scientific platform focuses on the remodeling of glucose homeostasis by employing dorzagliatin as a cornerstone therapy for diabetes – either as monotherapy or in combination with other currently approved antidiabetic medicines, as well as other popular medicines commonly taken by diabetes patients. ”

Business Highlights of Hua Medicine during the Review Period:

In the development of dorzagliatin:

The Company has made excellent progress advancing its two Phase III trials for dorzagliatin in China, with a total randomized enrollment of 1,181 patients as of July 31, 2019.
  o The enrollment for the Company’s monotherapy Phase III trial (HMM0301) for dorzagliatin was completed on February 28, 2019.
  o 718 patients have enrolled for the combination with metformin Phase III trial (HMM0302) for dorzagliatin, as of July 31, 2019.
In January 2019, the China National Intellectual Property Administration (CNIPA) issued to the Company a patent on a controlled release formulation of dorzagliatin, in which this new patent would extend the exclusivity of dorzagliatin to 2037 in China.
The Company has started two Phase I trials in the United States, DPP-4 combination trial (HMM0111) and SGLT-2 combination trial (HMM0112), which the Company has dosed its first patients for the trials in January 2019 and April 2019, respectively.
The Company continues to advance its development of fixed-dose combination drug candidates with dorzagliatin, with six programs in development, and for which the Company filed a patent in May 2019.。
The Company announced an updated pipeline in June 2019, which expands the dorzagliatin-driven portfolio in the diabetes care market.
The Company continues to advance development of fixed-dose combinations of dorzagliatin with currently approved oral antidiabetic medicines.

Financial Highlights:

Total expenditures incurred by the Company was approximately RMB240.9 million, of which approximately RMB166.5 million was attributable to research and development expenses.
As of June 30, 2019, the Company’s cash position was approximately RMB1,246.4 million.
Research and development expenses increased by approximately RMB70.8 million or 74% to approximately RMB166.5 million.
Loss and total comprehensive expense for the period decreased by approximately RMB1,271.4 million or 84.4% to approximately RMB235.5 million.

Looking forward to the next 12 months, the Company expects to:

continue to advance the development of its dorzagliatin-driven pipeline by initiating or conducting clinical trials in China or the United States.
announce top-line 24-week data for both of its Phase III trials in China, 52-week data for its monotherapy Phase III trial, and also the results of its two Phase I combination PK/PD trials in the United States.
upon receipt of positive Phase III data, partner with international pharmaceutical companies to make dorzagliatin available to patients outside of China,
  o this will include partnerships for conducting clinical trials and navigating the drug approval process;
  o as well as for the marketing and commercialization of dorzagliatin outside of China.
prepare for filing of NDA submission upon completion of both Phase III trials.
expand its commercial strategy and marketing team in anticipation of China launch of dorzagliatin.
incur additional and significant expenses relating to establishing its manufacturing facilities in China.
expand and grow its collaborations with global experts in diabetes to further understand the potential of dorzagliatin, as part of its strategy to establish dorzagliatin as a cornerstone therapy for the treatment of diabetes globally.

About Hua Medicine

Hua Medicine is a pre-revenue China-based drug development company currently focused on developing dorzagliatin, a first-in-class oral drug for the treatment of Type 2 diabetes. Founded by an experienced group of entrepreneurs and international investment firms, Hua advanced a first-in-class oral drug for the treatment of Type 2 Diabetes into NDA enabling stage and is conducting two Phase III trials in China. The Company also has initiated product life-cycle management studies of this novel diabetes drug, and advanced the knowledge in personalized diabetes care. Hua's strategy is to leverage the cost-efficient and high-quality drug development capabilities available in China, while working very closely with disease experts and regulatory agencies in China and rest of the world to advance diabetes care solutions for global patients.

For further information, please contact:
Hua Medicine
Emily Yeh

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