Health & Beauty

On the evening of May 25, Hengrui pharmaceutical announced that the company's brief new drug application for iodixanol injection (anda, the US generic drug application) was approved by the US Food and Drug Administration (FDA).

According to the data, in 2021, the global sales of iodixanol related dosage forms were about USD 873million. Previously, there was no generic drug product of iodixanol approved for marketing abroad. This means that according to the US competitive generic drug therapy act, the first generic drug of Hengrui pharmaceutical, iodixanol, will obtain a 180 day market monopoly period.

It is worth noting that due to the impact of the epidemic in GE Medical Shanghai factory, the contrast agent in the U.S. market has been obviously out of stock. At this time, FDA approved Hengrui's contrast agent products, or there are also considerations to relieve the market supply pressure in time. Hengrui medicine replied to the interface news on May 26 that the company has been actively promoting the marketing of the drug.

Iodixanol injection is an X-ray contrast agent (contrast agent), which was listed in the United States and China in 1996 and 2001 respectively. According to the data of Intranet, in 2019, the terminal sales of iodixanol injection in China's public medical institutions exceeded 3.5 billion yuan, of which Hengrui pharmaceutical accounted for about 50% of the market share.

However, in the fifth batch of national drug procurement in June 2021, iodixanol, as a large variety of Hengrui, offered 6057 yuan / bottle, which was accidentally lost, which immediately caused market shock.

At that time, the company also lost its bid for gronbromium. The total sales of these two products in the first quarter of 2020 and 2021 respectively accounted for 1.873 billion yuan and 491million yuan, accounting for 6.75% and 7.09% of the current revenue respectively. In this regard, Hengrui pharmaceutical said that the failure of the two products to win the bid would affect the product sales to a certain extent, but would not have a significant impact on the production and operation of the company. However, according to the annual report of 2021, the revenue of Hengrui pharmaceutical contrast agent section was RMB 3.270 billion, a year-on-year decrease of 9.93%, falling back to the level of 2019.

Subsequently, Hengrui pharmaceutical's share price began to enter a downward period. In the first half of 2021, although the company's sales revenue of innovative drugs increased by 43.80% year-on-year, the sales of traditional generic drugs declined due to the impact of national and local volume procurement.

However, facing the painful period of transformation, Hengrui medicine began to vigorously promote its "scientific and technological innovation" and "internationalization" strategies.

From 2018 to 2021, the R & D investment of the company was 2.670 billion yuan, 3.896 billion yuan, 4.989 billion yuan and 5.943 billion yuan respectively, accounting for 15.33%, 16.73%, 17.99% and 22.94% of the current operating revenue. Among them, the overseas R & D investment in 2021 was 1.236 billion yuan, accounting for 19.93% of the total R & D investment.

However, compared with the innovative pharmaceutical enterprises such as Baiji Shenzhou and Junshi biology, the internationalization of Hengrui pharmaceutical was considered to be slightly slow. From 2018 to 2021, the company's foreign operating revenue was RMB 651million, RMB 632million, RMB 758million and RMB 617million respectively, accounting for about 2% of the total revenue. The gross profit margin decreased from 75.07% in 2018 to 55.72% in 2021, far below the domestic gross profit margin of about 87%. Unlike the above-mentioned innovative pharmaceutical companies, which seek to cooperate with multinational large pharmaceutical companies when exploring overseas markets, Hengrui pharmaceutical is more inclined to "do it yourself" in the past two years.

Up to now, Hengrui pharmaceutical has established a complete clinical R & D team in the United States and Europe, fully launched the global product development team work mode, and the overseas R & D team has reached more than 170 people.

In 2021, Hengrui pharmaceutical also introduced a number of foreign executives, appointed Mr. Scott filosi as the CEO of Hengrui pharmaceutical in the United States / Europe, and appointed josephe, an expert in the medical field Dr. Eid served as the chief medical officer of Hengrui in the United States / Europe, and Dr. Mike Lee and Dr. Kiyoshi hashigami were appointed as the deputy general manager of clinical research and development of Hengrui Australia and Hengrui Japan respectively.

On May 18 this year, Hengrui pharmaceutical established a wholly-owned subsidiary luzsana biotechnology overseas. According to the report of American Medical Media endpoints news, Scott filosi, CEO of luzsana, said that luzsana was established to put Hengrui's drugs into the international market. With the launch of the company, luzsana will develop 11 clinical projects in the fields of cancer, cancer support care and metabolism.

In response to this choice, Hengrui medicine replied to the news on the interface that the establishment of a localized R & D team is conducive to strengthening communication and cooperation with local regulators, medical and scientific research institutions, experts and scholars, improving R & D efficiency and promoting clinical research progress. At present, the company has carried out nearly 20 international clinical trials, including 7 International multi center phase III projects, and more than 10 studies are in the preparation stage.

On May 12 this year, the international multicenter phase III clinical trial of the combination of carrelizumab, a PD-1 inhibitor of Hengrui medicine, and apatinib reached the main end point., This is the fastest progress project of Hengrui pharmaceutical at present. The company also plans to submit a communication and exchange application for the listing of new drugs to FDA in the near future.