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    Home > Active Ingredient News > Drugs Articles > Mah's first order is delivered, and the first approved new Chinese medicine is listed under the system of listing Permit Holder

    Mah's first order is delivered, and the first approved new Chinese medicine is listed under the system of listing Permit Holder

    • Last Update: 2017-09-12
    • Source: Internet
    • Author: User
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    Source: the introduction of medical geography 2017-09-12 is accompanied by the listing of a traditional Chinese medicine variety and the official landing of a new deal in an industry, which is of epoch-making significance

    This variety is "Danlong oral liquid", which is the first approved Chinese herbal medicine variety since the pilot implementation of China's drug marketing license holder system (MAH) in CFDA pilot

    Since then, a large number of people or institutions in the pharmaceutical circle have officially stepped into the new era of "having drug approval"

    Through entrusted production, drugs can be put into the market, which is of great significance to the growth of the pharmaceutical industry

    Kant Pharmaceutical Co., Ltd

    won the first order recently

    The reporter learned from the pharmaceutical registration department of the State Food and drug administration that recently the General Administration has approved the application of the listing license holder of "Danlong oral liquid" submitted by Zhejiang Kant Pharmaceutical Group Co., Ltd

    (hereinafter referred to as Kant pharmaceutical) and agreed to produce the product by itself

    The drug is a new drug of 6 kinds and the monitoring period is 4 years

    Kant Pharmaceutical Co., Ltd

    held the "Danlong oral liquid launch conference" for the first time

    The reporter learned at the conference that the drug is also a classic case of the industrialization development of preparations in traditional Chinese medicine hospital

    Danlong oral liquid is a clinical experience formula summarized by Professor Xu Dejin, a famous expert in respiratory department of Jiangsu People's Hospital, through years of dedicated research and clinical practice

    As a hospital preparation of Jiangsu People's Hospital, Danlong oral liquid has been in clinical use for many years

    In fact, with the continuous improvement of the standards of traditional Chinese medicine, it has become more and more difficult to apply for approval of proprietary Chinese medicine in recent years

    In particular, the traditional Chinese medicine compound preparation is composed of many kinds of medicinal materials, and the composition analysis is more complicated than that of a single kind of medicine, so it is more difficult to apply for registration and approval for listing

    According to the 2016 annual report of drug review, in 2016, the drug review center completed 84 ind applications of traditional Chinese medicine recommended for clinical trials and submitted them to the General Administration for approval, with a maximum of 18 respiratory drugs

    According to Hu Zengren, general manager of Kant pharmaceutical, Danlong oral liquid can be successfully approved for listing mainly based on four points: first, the drug has independent intellectual property rights and obtained national invention patents; second, there is a major breakthrough in the theory of traditional Chinese medicine for asthma treatment, which is the first Chinese patent medicine to treat asthma with Salvia miltiorrhiza as the king medicine; third, it is safe and effective, modern preparation process production and quality Stable; fourth, MAH pilot since the approval of the first new Chinese medicine

    Rigorous clinical trials, clinical trial data verification, production site inspection

    Mah is of great significance to the industry MAH is of great significance to the industry! What's the opinion of experts in the industry about MAH and the first order implemented by the state? Niu Zhengqian, executive vice president of China Pharmaceutical Enterprise Management Association, told reporters that with the further promotion of the pilot work of the drug listing license holder system by the State Administration, the pilot varieties to be commissioned for production in the pilot provinces will be listed, and those that meet the conditions will be included in the priority review and approval, which will connect the pilot varieties with the priority approval channels, and accelerate the research results of high-quality innovative drugs Transformation

    Kant pharmaceutical is one of the first enterprises to benefit from this policy

    At the same time, according to the relevant documents, the drug production enterprise group company can centralize the drug approval number of each holding subsidiary to the group company and become the holder

    The group company has the approval holder of the subsidiary company, and the group production enterprise can effectively improve the concentration of the pharmaceutical industry by integrating the resources of the subsidiary company

    In his view, MAH also brings new changes to the pharmaceutical commercial circulation industry

    Within the framework of pilot drug marketing license holder system, some pharmaceutical trading enterprises can actively transform themselves into drug marketing license holders, cooperate with R & D institutions and production enterprises through technology transfer, merger and acquisition, equity participation and other forms, and form "strategic alliance" by taking advantage of their respective advantages, so as to make pharmaceutical distribution enterprises change their position in the competition from passive to active, relying on drug circulation The natural advantages of enterprises in grasping market trends and future trends and finding the most promising drugs make it possible for businesses to extend upstream

    Promoting blood circulation and removing blood stasis is superior to the same kind According to Liu Min, Professor of respiratory medicine in the First Affiliated Hospital of Tianjin University of traditional Chinese medicine, 480 patients with mild or moderate asthma in acute attack (Heat Asthma Syndrome) were enrolled in the phase III clinical trial of Danlong oral liquid supplement

    They were randomly divided into the experimental group and the control group according to the ratio of 3:1

    Both groups maintained the original western medicine treatment

    The experimental group was given Danlong oral liquid and the control group was given Kechuanning oral liquid 10 ml / time, 3 times / day, 7 days after treatment

    The results showed that, compared with the efficacy of asthma symptoms, the control and display rate test group was higher than the control group; compared with the efficacy of lung function, the control and display rate test group was higher than the control group; compared with the difference before and after the treatment of TCM syndrome score, the test group was better than the control group; compared with the difference before and after the treatment of TCM syndrome score, the test group was better than the control group, the difference was statistically significant

    The incidence of adverse reactions was only 1.73% in the experimental group and 10.17% in the control group

    Liu Min, Professor of respiratory medicine in the First Affiliated Hospital of Tianjin University of traditional Chinese medicine, said: "from the experimental results, western medicine combined with Danlong oral liquid is better than Kechuanning oral liquid in the treatment of mild and moderate acute attack of bronchial asthma."

    Liu Min pointed out that the clinical trial was approved by the ethics committee of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine

    There was no significant difference between the two groups in demographic data, vital signs, course, degree of illness, pulmonary function and TCM syndrome score (P > 0.05)

    Danlong oral liquid supplement phase III clinical trial research organization lineup is also very strong

    The First Affiliated Hospital of Tianjin University of traditional Chinese medicine is the main unit in charge

    Eight authoritative medical institutions, including the Affiliated Hospital of Jiangxi University of traditional Chinese medicine, the Affiliated Hospital of Liaoning University of traditional Chinese medicine, Jilin integrated hospital of traditional Chinese and Western medicine, West China Hospital of Sichuan University, Subei people's Hospital of Jiangsu Province, the first hospital of Shanxi Medical University and the Affiliated Hospital of Inner Mongolia Medical College, participated in the experimental study

    What is the biggest advantage of Danlong oral liquid in clinical application? Liu Guiying, director of respiratory department of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine, believes that Danlong oral liquid may make up for the deficiency of modern medicine in the treatment of acute attack of bronchial asthma

    Liu Guiying, director of respiratory department of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine, explained that Danlong oral liquid consists of Danshen, Scutellaria, ephedra, paeony, Dilong, Fangfeng, Fritillaria thunbergii, liquorice and Pinellia ternata

    Among them, Radix Salviae Miltiorrhizae and Radix Paeoniae Alba can promote blood circulation and remove blood stasis; ephedra, Scutellaria, Fangfeng, jiebiao and Quxie; ephedra and earthworm can relieve spasm and asthma; Pinellia ternata and Fritillaria can relieve cough and phlegm

    Compared with the control medicine, the medicine pays more attention to clearing phlegm, removing blood stasis and eliminating pathogenic factors on the basis of the symptomatic treatment of reducing lung qi, relieving cough and asthma, and takes into account the pathological basis and inducing factors of asthma attack such as phlegm, blood stasis and pathogenic factors

    The treatment of "removing blood stasis and asthma, clearing heat and phlegm" which is represented by it comprehensively considers all aspects of the acute attack of asthma, so its effect of relieving asthma and cough is more prominent

    Select the appropriate clinical entry point At the meeting, the reporter learned that although the newly issued "Chinese medicine law" encourages the transformation of hospital preparations to industrial development, with the continuous improvement of Chinese medicine standards, most enterprises have lost the enthusiasm to carry out hospital preparations

    The approval and listing of Danlong oral liquid not only improves the enthusiasm of Chinese Medicine enterprises to speed up the development of hospital preparations, but also provides one for the increasingly high incidence of asthma patients A new safe and effective treatment is of great significance to improve the quality of life of patients

    According to Hu Zengren, the reason why Danlong oral liquid successfully completed the transformation from hospital preparation to industrial production is mainly based on two points: first, the persistence and continuous investment of the enterprise

    When choosing products, Kant pharmaceutical industry has gone through the joint efforts of several generations

    In particular, in recent years, because of the increasing haze and weather, the incidence rate of respiratory diseases is increasing

    We believe in the market value of this product

    Now we have invested more than 1000 yuan in the research and industrialization of entrance liquid, and second, we need to increase R & D in enterprises

    Kant pharmaceutical is a national high-tech enterprise, which attaches great importance to the research and development of new products

    It has invested nearly 100 million yuan in innovative drug research, established a sound research and development system, has a high-quality new drug research team, and hired many famous scientists with high academic status in the field of new drug research at home and abroad, including Dr

    Xu Huaqiang, a special expert of "Guoqian", and Mr

    Xi zhijianbo The company has established a research and development base of innovative drugs in Zhangjiang science and Technology Park, Shanghai

    It has obtained a number of national invention patents and several independent innovative drugs are under research

    "In fact, it is very difficult to complete the transformation of a hospital preparation into a product."

    Hu zenghen said frankly that enterprises need to consider new drug research and development from the perspective of safety, effectiveness, stability and controllability, resource guarantee and reasonable cost

    As for the preparation of Chinese patent medicine products, the quality problem is the most difficult to control, especially because of the different sources of Chinese patent medicine, the homogeneity of Chinese patent medicine products has always been a problem, and Danlong oral liquid can not be easily approved

    In addition, according to Liu Guiying, there are four key factors for the success of Danlong oral liquid in terms of research and development: first, the acute attack period of asthma is accurately selected as the research entry point; second, the theoretical formula of activating blood circulation and removing blood stasis is superior to the same kind of drugs; third, the clinical application of Danlong oral liquid has a high maturity for many years, and it has the conditions to turn into industrial production; fourth, the dosage form is properly selected, and the mouth is suitable Compared with pill, powder, paste and other dosage forms, it has the highest similarity

    During the interview, the reporter also learned that at present, the Danlong oral liquid of Kant Pharmaceutical Co., Ltd

    is actively completing the safety sampling work before the listing, and it is expected to be officially sold in November this year

    In addition, in order to ensure the safety and effectiveness of the product, Kant pharmaceutical will simultaneously start phase IV clinical trials, carry out the clinical evaluation of Danlong oral liquid, and further prove the clinical application value of Danlong oral liquid.
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