Hainan Poly Pharm.Co.Ltd(300630) iodophor was approved to be listed in the Netherlands and entered the 10 billion contrast agent market

\u3000\u30 Chongqing Baiya Sanitary Products Co.Ltd(003006) 30 Hainan Poly Pharm.Co.Ltd(300630) )

Performance review

Recently, the company has received the listing permission from the Dutch drug evaluation committee, which indicates that Hainan Poly Pharm.Co.Ltd(300630) has the qualification to sell iodophor injection in the Netherlands, and also indicates that Hainan Poly Pharm.Co.Ltd(300630) has successfully entered the field of contrast agents, which will have a positive impact on the company’s market expansion.

Business analysis

Broad market space for contrast agents: according to the data of Grandview research, the global contrast agent market in 2021 was US $4.04 billion, of which the United States accounted for 41.6%; According to the data of public hospitals in key provinces and cities of Intranet, the sales volume of sample hospitals of contrast agent injection in China in 2021 was 4.95 billion yuan, of which iodopanol accounted for 5.58%. Iopamidol was first developed by Bracco as a non-ionic, low permeability iodized contrast agent. It is widely used in various diagnostic fields such as lumbar and cervical myelography, CT and CT enhancement. Iodophor injection was first approved for listing in France in May 1981. Since then, it has been approved for listing in other European countries, including Italy, Germany, the Netherlands and the United Kingdom. It was approved for listing in the United States in December 1985 and in China in July 2002.

The company has submitted the application for registration of generic drugs in China, Europe and the United States respectively: the first generic contrast agent developed by the company. The company has received marketing permission from the Dutch drug evaluation committee and will be used in neuroradiology, including lumbar spine, thoracic spine and cervical spine, as well as CT myelography. After the successful research and development of generic drugs for iodophor injection, the company has submitted generic drug registration applications in China, Europe and the United States respectively, which belongs to a common line product. The approval of iopanol in the Netherlands also marks that Hainan Poly Pharm.Co.Ltd(300630) successfully entered the field of contrast agents. With the subsequent approval of other markets, it will have a positive impact on the company’s market expansion.

Investment advice

It is estimated that the net profit of the company from 2021e to 2023e will be 530 / 714 / 970 million yuan, the corresponding EPS will be 1.21/1.63/2.22 yuan, and the corresponding PE will be 15 / 11 / 9 times respectively, maintaining the “overweight” rating of the company.

Risk tips

Generic drug R & D risk, innovative drug R & D risk, drug quality risk, exchange rate fluctuation risk, restricted stock lifting risk, other regulatory risks, etc.

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