Recently, according to the official website of CDE, two Class 1 new drugs of Hengrui Medicine have obtained implicit approval for clinical trials, namely HRS-5632 injection and HRS-6208 capsule. The former is intended to treat lipoprotein disorders, and the latter targets solid tumors.

Lipoprotein disorders

Lipoprotein disorder refers to the abnormal metabolism of plasma lipoproteins. Studies have shown that it may lead to abnormal transport and distribution of lipids in the blood, thus causing a series of health problems. At present, lipoprotein disorder has been confirmed to be an independent risk factor for atherosclerotic cardiovascular disease (ASCVD), and there is no specific drug to treat it. It is reported that cardiovascular diseases, mainly ASCVD, are the leading cause of death among urban and rural residents in China, accounting for more than 45% of the causes of death.

In response to lipoprotein disorder, Hengrui Medicine has deployed a small molecule drug "HRS-5346 tablets". It is understood that HRS-5346 has shown the effectiveness and safety of improving lipoprotein disorder in preclinical studies. In May 2024, the clinical trial application of HRS-5346 was approved by CDE, and Phase I clinical research has been started, with 80 patients to be enrolled. HRS-5632 is another drug that Hengrui Medicine has deployed in the cardiovascular field. The clinical indication approved this time is also lipoprotein disorder.

In addition to the above two drugs, Hengrui Medicine has a number of other drugs in the cardiovascular field that have entered clinical trials, covering targets such as PCSK9, FXIa, and ANGPTL3, involving indications such as hypercholesterolemia and myocardial hypertrophy.
The clinical trial application for HRS-5632 was successfully approved, and Hengrui Medicine may start further research on it.

HRS-6208
Solid Tumors

It is estimated that the number of new cancer cases in China will reach 4.825 million in 2022, a year-on-year increase of 2.9%; the market size of China's anti-tumor drug industry is expected to reach 559 billion yuan in 2029, with a compound growth rate of about 19% from 2024 to 2029.

In the field of anti-tumor, Hengrui Medicine has established a comprehensive and rich pipeline of research and development, among which the clinical research of many drugs has made new progress in 2024. According to statistics, as of now in 2024, Hengrui Medicine has updated the research progress of more than 30 Class 1 anti-tumor new drugs, including a number of drugs approved for clinical trials for the first time, and projects with new indications approved for clinical trials.
HRS-6208 is another anti-tumor drug approved by Hengrui Medicine for clinical trials by CDE. Its registration classification is a Class 1 new chemical drug, and Hengrui Medicine may start further research on it.

Conclusion

In 2024, Hengrui Medicine's drug development progress will be further accelerated, and a number of drugs will be approved for clinical trials in China, not only in the anti-tumor and cardiovascular fields, but also in skin diseases, ophthalmic diseases and other sectors. By accelerating the progress of innovative research and development of various drugs, Hengrui Medicine is expected to further enrich its product layout.

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