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华领医药(00865.HK):糖尿病创新药物的新兴开发平台

Hualing Pharmaceutical (00865.HK): An Emerging Development Platform for Innovative Diabetes Drugs

興業證券 ·  Jul 20, 2018 00:00  · Researches

  Development platform for innovative drugs for diabetes: Hualing Pharmaceutical is a Chinese drug development company currently working to develop the world's first innovative drug, oral drug Dorzagliatin, or HMS5552, for the treatment of type 2 diabetes. The company uses the “VC (capital) +IP (technology) +CRO” VIC operating model for drug development, and the first-class R&D team performs quality control and supervision of project screening, operation management and clinical practice. The current product pipeline includes two GKA drugs under development, Dorzagliatin and mGluR5, which are used to treat levodopa-induced movement disorders in type 2 diabetes and Parkinson's disease, respectively.

Traditional medicine dominates the market, and the penetration rate of innovative drugs needs to be increased. China's antidiabetic drug market is expected to grow from RMB 512 billion in 2017 to RMB 97.8 billion in 2022, with a compound annual growth rate of 13.8%. In addition to insulin, the anti-diabetic drug market in China is dominated by traditional drugs such as alpha-glucoglyase inhibitors and metformin, the biguanide metformin, and sales revenue of innovative drugs such as DPP-4, GLP-1, and SGLT-2 inhibitors is low. Currently, more than 20 drugs targeting 8 types of targets are being developed, and the penetration rate of innovative drugs is expected to continue to increase.

The GKA drug phase III was approved for the first time in clinical trials and is expected to be marketed in 2020. Dorzagliatin has two major advantages: (1) The efficacy is superior to existing oral medications. The clinical phase II data for Dorzagliatin is superior to the best available oral drug sitagliptin. (2) The side effects of previous GKA drugs have been overcome in terms of safety. Due to the good tolerability and low side effects shown in clinical trials, Dorzagliatin is the first GKA drug to enter clinical phase III. It is expected to be marketed in 2020 and will become the first-line standard treatment for type 2 diabetes in China in the future.

World-renowned venture capitals continue to be optimistic, raising more than 200 million US dollars in 5 years. The company continues to be favored by many world-renowned venture capitalists, receiving a total investment of about 200 million US dollars. On March 27, 2018, $117.4 million of Series D and Series E financing was completed. The company's shareholding structure is scattered. The highest shareholding ratio is ARCH Venture Partners, which focuses on investing in early-stage life technology companies, Venrock, a famous American venture capital fund, and Fidelity Capital and F-Prime Fund, which hold 15.07%, 12.46%, 6.74%, and 6.23% of the shares respectively. In addition, Li Ge, the founder of Pharmaceutical Ming Kangde, and Li Gechi, 30% of Wuxi Healthcare Ventures hold 3.37% and 8.92% respectively. The family of Dr. Chen Li, the founder of the company, owns 4.95%

Risk warning: risks associated with limited operating history, past losses and reliance on key executives, risks associated with successful development, obtaining regulatory approval and commercialization of drugs, risks related to intellectual property, etc.

The translation is provided by third-party software.


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