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亿胜生物科技不含防腐剂单剂量贝复舒滴眼液成功获批商业化

Yisheng Biotech successfully approved commercialization of preservative-free single-dose beifusu eye drops

香港智远 ·  Dec 30, 2019 14:01

Hong Kong,2019YeartwelveMonthtwenty-sevenDay

Yisheng Biotechnology Co., Ltd. ("Yisheng Biology" or "Group"-Stock Code: 1061) is pleased to announce that Zhuhai Yisheng Biopharmaceutical Co., Ltd., an indirect wholly-owned subsidiary of the Group, has been approved by the State Drug Administration (SDA). The registration and commercialization of a single dose of recombinant bovine basic fibroblast growth factor eye drops without preservatives (single dose Bei Fu Shu eye drops) was carried out in the people's Republic of China.

As of the date of this announcement, the approved product is the group's fourth single dose of preservative-free eye drops approved by the State Drug Administration. Three other preservative-free single-dose eye drops-tobramycin, levofloxacin and sodium hyaluronate-were approved by the SFDA in April 2017 (March 2018), June 2018 and July 2018, respectively.

The board of directors said that the successful approval of a single dose of Bei Fu Shu eye drops will, on the one hand, provide more choices for patients using Bei Fu Shu series products to achieve the best therapeutic effect. on the other hand, it will further strengthen the group's competitive advantage and market position in the field of ophthalmic growth factor drugs.

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About Recombinant Bovine basic Fibroblast growth Factor Eye Drops (Beifushu Eye Drops)

Recombinant bovine basic fibroblast growth factor eye drops (Bei Fu Shu eye drops) is a new kind of national genetic engineering drug developed and commercialized by the group since 1999. Its active ingredient is recombinant bovine basic fibroblast growth factor. It can promote a variety of tissue repair and regeneration, treat corneal injury, keratitis, xerophthalmia caused by various causes, and be used for corneal repair after corneal surgery.

In addition, Bei Fu Shu series products (Bei Fu Shu Eye Drops and Bei Fu Shu Eye Gel) have been listed in the new national medical insurance catalogue in 2019, and their sales are in the forefront of ophthalmic drugs. According to Mine.com, the market share of Bei Fushu series of ophthalmic growth factor drugs (in terms of sales) in the sample hospital in 2018 was about 59.3%.

About "blowing-filling-sealing" single-dose platform

As one of the group's core R & D platforms, Yisheng "blow-pour-seal" single-dose platform is an advanced manufacturing platform for the development and production of a series of preservative-free single-dose drugs, especially ophthalmic drugs. In addition to the approved single-dose preservative-free tobramycin, levofloxacin, sodium hyaluronate and recombinant bovine basic fibroblast growth factor eye drops, a number of single-dose products are still in different stages of research and development. used to treat eye injuries, eye infections, eye fatigue, xerophthalmia and respiratory diseases.

About Yisheng creature

Yisheng Biotechnology Co., Ltd. is a biopharmaceutical company specializing in the research, development, production and sale of genetic engineering drug rb-bFGF (recombinant bovine basic fibroblast growth factor, also known as FGF-2). Since 1998, five innovative biopharmaceuticals have been on the market in China.

The company's products are mainly used in wound repair and disease treatment in the field of ophthalmology and dermatology prescription drugs. at present, with 42 sales and promotion offices in major cities in China, it has successfully covered more than 6900 hospitals in China.

Based on the internal R & D platform of growth factors and antibodies, the company currently has a series of research pipelines at all clinical stages, covering a wide range of disease treatment areas.

The translation is provided by third-party software.


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