The new drug "Compound Sanhuang Capsule" is the first AIDS drug project in Yunnan Province that has been approved by the State Food and Drug Administration to enter and complete clinical trials. However, a few days ago, this new drug, which has been supported by people from all walks of life and allowed many people to fight for it for eight years, has been “gunned†by the State Food and Drug Administration.
When he saw the results of the spot check against the results of more than a year's testing conducted by dozens of experts in six large hospitals in Beijing, Chen Dagang, the drug inventor, had a little “drum†and immediately asked the Registration Department to review the blood samples.
In the absence of any reply, the registration department issued a notice “Don’t approve the registrationâ€. This result made all insiders almost desperate.
Yesterday, Kunming Hansen Biotechnology Co., Ltd. held the "Compound Sanhuang Capsule" registration briefing and questioned the registration department's "disapproval of registration" administrative license, and submitted a lawsuit request to Beijing No. 1 Intermediate People's Court. The State Food and Drug Administration will once again face corporate litigation.
8 years in Yunnan to create a new drug
Yesterday’s briefings, the Provincial Science and Technology Department, the Provincial Health Department and other relevant leaders and experts in the treatment of AIDS in many hospitals in Kunming were all heavy faces. In fact, since the "San Huang San Capsule" was researched and developed in 2000, it has been supported by many departments in Yunnan Province, and it has come to the present day.
Relevant data show that "Compound Sanhuang Capsule" is the first AIDS new drug project in Yunnan Province that has been approved by the State Food and Drug Administration to enter and complete clinical trials, and is also the first Chinese medicine drug to treat AIDS in China, the first to complete a standardized clinical trial. . The project has become the National Science and Technology Department's Science and Technology Support Program and the Yunnan Science and Technology Agency's Scientific and Technological Assistance Program Support Project. It has received funding support from projects in many countries and provinces.
"Compound Sanhuang Capsule" has been researched and developed by the project team led by drug inventor Chen Dagang since 2000. November 2001 and July 2005 were respectively approved by the Yunnan Food and Drug Administration AIDS hospital preparation approval. January 2006 won the national patent certificate.
According to Chen Dagang, after this, the drug completed the formalities for the new drug application and approval for the clinical research of the drug by the State Food and Drug Administration, and it officially entered the clinical trial according to the GCP standard on December 28, 2005. Capital Medical University Youan Hospital, People's Liberation Army 302 Hospital, Capital Medical University Beijing Ditan Hospital, China Academy of Chinese Medical Sciences Beijing Guanganmen Hospital, Chinese Academy of Medical Sciences Peking Union Medical College Hospital, Beijing University First Hospital to undertake clinical trials and clinical trials statistics, testing. The entire clinical trial was officially concluded in December 2006.
It is understood that in the course of the entire clinical trial of "Compound Sanhuang Capsule", none of the 198 subjects died because of worsening conditions. All subjects returned to normal life and work ability; more than 90% of patients were now able to participate in heavy physical work. The conclusion of the clinical trial is that the use of "Compound Sanhuang Capsule" for the treatment of AIDS patients has played a role in suppressing the replication of HIV virus, enhancing the immune function of the body, and improving the patient's symptoms; the drug also has a certain therapeutic effect on HIV-infected people in the short-term and long-term. The long-term efficacy remains to be observed; the variety is easy to take, and the subject has fewer adverse reactions and good compliance after taking it. No obvious adverse reactions were seen during the entire clinical trial.
In this clinical trial, according to the functional characteristics of traditional Chinese medicines such as “revitalizing pathogenic factors, promoting blood circulation, clearing away heat and detoxification, and tonicating spleen and kidneyâ€, it has a good clinical therapeutic effect on AIDS (HIV/AIDS); The reproduction and elevation of CD4 cell counts are consistent with the results of the preclinical pharmacology of this species and can be reported for registration.