According to the CDE official website, two new traditional Chinese medicines have obtained implicit permission for clinical trials. They are the Category 2.3 new drug "Xuesaitong Soft Capsules" from China Resources Shenghuo and the Category 1.1 new drug "Jiuwei Zhengxiao" from the Institute of Clinical Basic Medicine of the China Academy of Chinese Medical Sciences. Particles".

Xuesaitong soft capsule:
carotid atherosclerosis

Xuesaitong soft capsule has the functions of activating blood circulation, removing blood stasis, unblocking meridians and activating meridians, and its main component is total saponins of Panax notoginseng. Currently, this drug has been approved for use in the meridian recovery period of ischemic stroke (cerebral infarction) caused by blood stasis blockage. Symptoms include hemiplegia, numbness on one side of the body, crooked mouth and tongue, and slurred speech.

This time, China Resources Shenghuo's Class 2.3 new Chinese medicine "Xuesetong Soft Capsule" has obtained another implied clinical trial license, which is intended for carotid atherosclerosis. It is understood that the carotid artery is a common site for systemic atherosclerosis, which is an important sign of systemic atherosclerosis and an important risk factor for cerebral infarction. Early detection and standardized treatment of carotid atherosclerosis are of extremely important value in the prevention and treatment of cerebral infarction and systemic atherosclerosis. The Xuesetong series of products are also the core

products of Kunming Pharmaceutical Group. According to the 2023 annual report of Kunming Pharmaceutical Group, Kunming Pharmaceutical Group achieved revenue of 7.703 billion yuan, a year-on-year decrease of 6.99%, and net profit of 445 million yuan, a year-on-year increase of 16.05%. Among them, the revenue of Kunming Pharmaceutical Group in the cardiovascular and cerebrovascular field was 2.078 billion yuan, a year-on-year increase of 13.67%, and the Xuesetong series of products were the main growth factor.

At the beginning of this year, Kunming Pharmaceutical Group announced that it plans to sign an equity transfer agreement with its affiliated company China Resources Sanjiu to acquire 51% of Kunming China Resources Shenghuo's equity held by China Resources Sanjiu with RMB 1.791 billion of self-owned or self-raised funds. This also means that the market structure of Xuesetong series products will change further, and the volume of Xuesetong soft capsules of Kunming Pharmaceutical Group and China Resources Shenghuo is expected to grow again.

Jiuwei Zhengxiao Granules:
advanced liver cancer

my country is a high-incidence area for primary liver cancer, with young onset age and rapid disease progression. Due to the high malignancy of primary liver cancer, rapid progression of the disease, and intrahepatic dissemination in the early stage, it is often in the middle and late stages by the time of diagnosis. In addition, most patients have cirrhosis, and only 15% to 20% of cases can be treated with surgery. . Although the treatment of liver cancer has made significant progress over the past decades, the overall relative 5-year survival rate of liver cancer is still low.

According to relevant reports, traditional Chinese medicine has made great progress in clinical and experimental research on liver cancer and has become one of the main means of treating liver cancer in my country. Jiuwei Zhengxiao Granules is a new Chinese medicine Category 1.1 drug applied by the Institute of Clinical Basic Medicine of the Chinese Academy of Chinese Medical Sciences. The indication for this clinical trial that has been implicitly approved for clinical trials is advanced primary liver cancer with syndrome of positive and negative toxins.

Upon inquiry, the Institute of Clinical Basic Medicine of the Chinese Academy of Chinese Medical Sciences has registered two patents, namely "a traditional Chinese medicine composition for primary liver cancer and its application" (CN111603501A, CN111603501B) and "a traditional Chinese medicine composition for late stage liver cancer". Chinese medicinal compositions and their applications for recurrent liver cancer” (CN118806832A).

Among them, the Chinese medicine composition described in patent CN118806832A includes 1-50 parts of ginkgo, 1-35 parts of emblica, 1-30 parts of scutellaria, 1-30 parts of artemisia annua, 1-35 parts of dried tangerine peel, 1-35 parts of immature orange, 1-20 parts of tangerine peel, 1-30 parts of green tangerine peel, and 1-35 parts of fructus aurantii. This invention provides a new option for the clinical treatment of patients with advanced primary liver cancer.

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