Yifan Pharmaceutical's wholly-owned subsidiary, cross-linked sodium hyaluronate injection received the notification of drug registration acceptance

On July 23, Yifan Pharmaceutical issued an announcement stating that its wholly-owned subsidiary, Beijing Xinyan Road, received on July 21 an overseas production of cross-linked sodium hyaluronate injection (trade name: Hyruan ONE®) issued by the National Medical Products Administration.
The "Notice of Acceptance" for drug registration and marketing authorization applications is used to treat knee osteoarthritis
.

Hyruan ONE® is the original product of LG Chem, Ltd.
, which is a single-dose preparation for the treatment of knee osteoarthritis.
It was approved for the first time in Korea in October 2013 and subsequently registered and marketed in more than 16 countries and regions.

.
The viscoelasticity of this product is close to that of normal adult joint synovial fluid.

In December 2017, Yifan International Pharmaceutical Co.
, Ltd.
, a wholly-owned subsidiary of the company, signed a product licensing agreement with LG Chem, Ltd.
to obtain the exclusive rights and interests of Hyruan ONE® in China and Australia, and is responsible for product registration and clinical trials required for registration According to the research, the agreement is valid for 10 years from the start of the first business year after the product is approved
.
The company obtained the "Drug Clinical Trial Approval" in October 2018, and completed the domestic phase III clinical trial study in August 2020, and reached the primary efficacy endpoint

       According to IQVIA sample data, the global market size of sodium hyaluronate injection in 2020 is about 7.
53 billion yuan, of which cross-linked sodium hyaluronate injection is 1.
59 billion yuan
.
According to the sample data from Minai.

       According to the relevant laws and regulations of the State Drug Registration, the above-mentioned drugs will be reviewed by the Drug Evaluation Center of the State Drug Administration and approved by the State Drug Administration after receiving the application for registration and marketing authorization of the State Drug Administration