China Fund News reporter Nanshen
From Wang Sicong's "anger" lianhua Qing plague, to the continuous fall and stop of Yiling Pharmaceutical, to Wang Sicong's Weibo being banned, the incident continued to ferment...
At the beginning of these two days, the argument that "Lianhua Qingpeng research and development only took 15 days" was very popular, and after Yiling Pharmaceutical stopped yesterday and struggled to pull up and turn red, it fell sharply again this morning, down 9% at one point, and from the high point more than a week ago, the pullback was more than 30%.
At noon on the 20th, Yiling Pharmaceutical responded urgently to the above statement, saying that "the research and development process of Lianhua Qingpeng is only 15 days" is inconsistent with the facts, and details the entire research and development process of Lianhua Qingpeng in the case of the SARS outbreak in 2003. "The research and development process of lianhua qingyi new drugs 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," Yiling Pharmaceutical said.
Investor: Only 15 days of R&D?
Since the 18th, investors have continuously asked on the interactive platform of the Shenzhen Stock Exchange whether the research and development of Lianhua Qingpeng really only took 15 days? It is hoped that the company will clarify and explain the actual R&D cycle, the degree of correlation with the efficacy, and the R&D process.
The reporter of China Fund News checked it, and this statement should be derived from an article in the 2168th issue of China Traditional Chinese Medicine News on June 30, 2004 - "Blooming the Flower of Science and Technology in the Baptism of Blood and Fire - Documentary on the Research and Development of Lianhua Qing plague capsules". In this article, there are the following statements:
They tackled the problem day and night, and completed the research work on the production process and quality standards of the extraction, concentration, drying, molding and other production processes and quality standards of "Lianhua Qingpeng Capsules" in just 15 days, and continuously improved them to meet the production requirements of high standards. ”
"It took only one month for Lianhua Qingpeng capsules to be developed to obtain the batch number of the Provincial Food and Drug Administration, and then to enter the fast-track approval channel of the State Food and Drug Administration, which is indeed a miracle."
Yiling Pharmaceutical: In line with the new drug development process
Yiling Pharmaceutical responded that the statement that "the research and development process of Lianhua Qingpeng is only 15 days" is inconsistent with the facts.
The company said that Lianhua Qing plague is the innovative application of the theory of network disease to the prevention and control of epidemic diseases, the founder of the company forty years is committed to the study of network disease, for the first time in the history of the development of traditional Chinese medicine to build a theoretical system of network disease, the creation 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 diseases, explore the occurrence and development of lung disease, bring together two thousand years of traditional Chinese medicine to prevent and control the epidemic of the three dynasties and become the Lianhua Qing plague group, and add the 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 its response, the company detailed the development process of Lianhua Qing plague.
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.
Clinical research on COVID-19 continues
From the above-mentioned reply of Yiling Pharmaceutical, it can be seen that in 2003, due to the reduction of clinical cases of SARS, it was impossible to meet the requirements of clinical trials, and Lianhua Qingpeng only conducted clinical studies of influenza 2 and 3. In this case, for the treatment of new crown pneumonia, is there any definite efficacy and safety data for Lianhua Qingpeng?
Yiling Pharmaceutical said that 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 Qingpeng from the development and listing of nearly 20 years, is one of the most innovative Chinese medicines in the country to carry out clinical evaluation research.
The company said that 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 issue of botanical medicine 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 multicenter clinical studies on the efficacy and safety of LianhuaQing 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.
"The rate of adverse reactions is less than 1 in 10,000"
There are also investors who are concerned about adverse reactions and contraindications, whether the description is inaccurate.
In response, Yiling Pharmaceutical said that the media article said that "the description of adverse reactions and contraindications in the instructions for Lianhua Qingpeng drugs has not been clear" is inconsistent with the facts. The company said that in March 2019, in accordance with the provisions of the Measures for the Administration of Drug Registration and the Guiding Principles for the Writing of Prescriptions for Proprietary Chinese Medicines, the "adverse reactions" and "contraindications" items in the instructions of Lianhua Qingyi capsules were revised to the drug regulatory authorities.
Among them, [adverse reactions] was 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".
According to the company, 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).
In the early trading of April 20, After the sharp low opening of Ling Pharmaceutical, it fell by 9% at one point, and the early closing decline was still nearly 8%, and from the high point of 43.12 yuan more than a week ago, the decline has reached 31%.
EDIT: Captain