On April 20, Yiling Pharmaceutical responded on the "Interactive Easy" platform of the Shenzhen Stock Exchange to the problems of "Lianhua Qingpeng research and development process is only 15 days" and "Lianhua Qingpeng has not carried out double-blind experiments".
Some investors asked that the media reported that it took only 15 days from the development to the production of Lianhua Qingpeng capsules. If you want to know how many days the R&D cycle is and the correlation with the actual efficacy, do you also need to follow the review steps of clinical trials, or do Chinese medicines have their own logical basis for judging?
Yiling Pharmaceutical replied that the "research and development process of Lianhua Qingpeng only 15 days" reported in the media article was inconsistent with the facts.
Lianhua Qing plague is the innovative application of network disease theory to epidemic prevention and control, the company's founder forty years committed to network disease research, in the history of the development of traditional Chinese medicine for the first time to build a network disease theory system, the establishment of a new discipline of traditional Chinese medicine network disease, the company's scientific research team leader for the first time will be the application of network disease theory to lung disease, discuss the occurrence and development of lung disease, bring together two thousand years of traditional Chinese medicine prevention and control of epidemic disease three dynasties famous party and become lianhua qing plague group, and join the lotus aromatic wet spleen and stomach, Rhodiola rosea to improve immunity and healthy qi.
The innovative research of compound Chinese medicines needs to inherit the essence of Chinese medicines, and it needs to be completed through a complete process of "theoretical innovation - clinical practice - preclinical research - clinical research - new drug approval".
In February 2003 SARS outbreak in Guangzhou, mainland China, because influenza and SARS belong to the category of traditional Chinese medicine "plague", with similar symptoms, in the follow-up research and development process, the company's scientific research team will have carried out new drug research for the treatment of influenza LianhuaQing plague localization influenza and SARS two indications, in May 2003 completed the influenza, SARS efficacy research and toxicological research and declared clinical approval.
In May 2003, in order to promote the prevention, diagnosis and treatment of SARS drugs to be listed as soon as possible, the State Food and Drug Administration issued the "Notice on Matters Related to the Rapid Approval of Drugs for the Prevention and Treatment of Infectious ATYP", "Basic Technical Requirements for the Research of Drugs for the Prevention and Treatment of Infectious ATYP", and opened up a "green channel" to accelerate approval.
In June 2003, the company obtained the clinical approval for the treatment of influenza in Lianhua Qing plague (batch number: 2003L02071) and the clinical approval for the treatment of SARS (batch number: 2003L02292). The company actively carried out preparatory work after receiving the approval of the clinical approval, but in the process, due to the reduction of SARS clinical cases, it could not meet the requirements of clinical trials, so the clinical research only carried out clinical studies of influenza 2 and 3.
In February 2004, Lianhua Qing plague declared production.
On May 9, 2004, it was approved by the State Food and Drug Administration for the treatment of influenza and is a heat attack lung certificate (drug approval number: Z20040063).
The research and development process of new drugs of Lianhua Qingyi is the result of the rapid approval of the state and the joint efforts of R&D personnel in the special epidemic period, which is in line with the new drug research and development procedures of the national drug supervision department.
Some investors asked, why "there has been no experimental report on random double-blindness of Lianhua Qing plague?" "It is said that even Hua Qing plague has not carried out double-blind research, and the effect is not good?"
Yiling Pharmaceutical replied that Lianhua Qingpeng is an innovative patented traditional Chinese medicine developed under the guidance of the theory of network disease, is a national medical insurance catalogue (Class A) and a national essential drug list variety, has been listed more than 20 times in the National Health Commission, the Administration of Traditional Chinese Medicine issued by the National Health Commission, influenza A, influenza B, avian influenza and other diseases related to the drug recommendation, is one of the representative drugs to deal with respiratory infectious public health events.
In 2011, the "Research on the Treatment of Influenza by Chinese Medicine Lianhua Qing plague" won the second prize of the National Science and Technology Progress Award, and in 2020, the project "Research and Application of Chinese Medicine Lianhua Qing Plague in the Treatment of Novel Coronavirus Pneumonia" won the first prize of Hebei Provincial Science and Technology Progress Award.
In April 2020, the State Drug Administration approved lianhua qing plague capsules/granules to add a new indication of "mild and ordinary type of novel coronavirus pneumonia" on the basis of the original approved indications. Lianhua Qingyi has been included in the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia" jointly issued by the National Health Commission and the State Administration of Traditional Chinese Medicine (Trial Version 4/5/6/7/8/9) and the new crown pneumonia diagnosis and treatment plan of more than 20 provinces and cities, and is one of the "three parties and three drugs" of Traditional Chinese medicine to fight the epidemic.
Random double-blind multi-center, random grouping multi-center, real-world research, etc. are all recognized by the international medical community clinical evaluation methods of drugs, for different diseases, different situations, different stages, you can take any of these research methods, the results are of scientific value, Lianhua Qing plague from research and development to the market for nearly 20 years, is one of the most innovative Chinese medicines to carry out clinical evaluation research in China.
In 2003, the randomized double-blind, controlled, multi-center Phase 3 clinical trial of Lianhua Qingpeng Capsules for the Treatment of Influenza was carried out by four hospitals including Guang'anmen Hospital of the Chinese Academy of Chinese Medical Sciences, and the test process was carried out in strict accordance with the "Measures for the Administration of Drug Registration" and the requirements of GCP, and the results confirmed that Lianhua Qingpeng significantly improved influenza-like symptoms.
In 2009, the clinical study of randomized double-blind, multi-center and oseltamivir control treatment of influenza A(H1N1) was jointly completed by You'an Hospital affiliated to Capital Medical University and 8 hospitals. The test results proved that Lianhua Qingxiao was comparable to oseltamivir in terms of viral nucleic acid negative time, and the defervescence time Lianhua Qingpeng was better than oseltamivir, which significantly reduced the severity of the disease and the duration of symptoms, and the treatment cost was only equivalent to 1/8 of oseltamivir, showing the advantages of comprehensive intervention.
In 2020, Lianhua Qingpeng carried out prospective, randomized, controlled and multi-center clinical research on the treatment of new crown pneumonia. Since the outbreak of the new crown epidemic has just occurred, and its incidence, prognosis and death are not clear, the expert group discussed that double-blind, placebo control can not ensure the safety of patients, so the expert group decided to adopt a randomized, controlled, multicenter research method. The study was jointly completed by 23 hospitals in 9 provinces such as Wuhan University People's Hospital, with a third-party CRO company responsible for monitoring and quality control, and a third-party statistical unit completing data management and statistical analysis to ensure its objectivity and scientificity. The results of the study confirmed that the improvement rate of the main clinical symptoms (fever, fatigue, cough, etc.) in the Lianhua Qing plague treatment group was significantly higher than that in the control group, the duration of symptoms was significantly shortened, and the clinical cure rate was effectively improved. The paper was published in the internationally renowned botanical medicine journal Phtomedicine.
In 2021, the prospective, open-label and controlled trial of 1976 cases of close contacts of new crown pneumonia was conducted by the Second Affiliated Hospital of Hebei Medical University, and the results of the study confirmed that the positive rate of nucleic acid test in the intervention group of Lianhua Qingfeng was 0.27% significantly lower than that of the control group of 1.14% (statistically significant), and the preventive application of Lianhuaqing fever in close contact groups could reduce the positive infection rate of new crown pneumonia by 76%, and the safety was good.
In 2022, randomized, double-blind, international multi-center clinical studies on the efficacy and safety of Lianhua Qing plague in the treatment of patients with mild and moderate COVID-19 are underway, and relevant follow-up studies in China are also being carried out.
At present, the company is going all out to do a good job in scientific research, quality and quantity production, ensure market supply, and contribute to the prevention and control of the epidemic. The company calls on everyone to fight the epidemic with one heart, overcome the difficulties of the times, and rationally distinguish the false statements on the Internet about the company and Lianhua Qingyi.
The company will continue to track the development of the situation, for some defamation of the company, the release of false information, the company has retained evidence and reported to the relevant departments, through legal means to protect their legitimate rights and interests.
There are also investors who ask, the Internet said that the description of adverse reactions and contraindications in the instructions of Lianhua Qing plague drugs is not clear, is this true?
In this regard, Yiling Pharmaceutical replied: The media article said that "the description of adverse reactions and contraindications in the instructions for Lianhua Qingyi drugs has not been clear" is inconsistent with the facts.
In March 2019, the company has proposed amendments to the drug regulatory authorities for the "adverse reactions" and "contraindications" items in the instructions of Lianhua Qingpeng capsules in accordance with the provisions of the Measures for the Administration of Drug Registration and the Guiding Principles for the Writing of Non-prescription Drug Instructions for Proprietary Chinese Medicines. Among them, [adverse reactions] were revised to "post-marketing monitoring data show that this product can see the following gastrointestinal adverse reactions such as nausea, vomiting, abdominal pain, diarrhea, bloating, nausea, as well as rash, itching, dry mouth, dizziness, etc.", [Contraindications] revised to "people who are allergic to this product and the ingredients of this product should not take it".
As a proprietary Chinese medicine that has been on the market for nearly 20 years, Lianhua Qingpeng has good safety, and according to the data of the National Adverse Drug Reaction Monitoring System, the incidence of adverse reactions is less than one in 10,000, which belongs to the "very rare" level recommended by the International Committee of Medical Science Organizations (CIOMS).