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  • h ttps://www.slideshare.net/MarcusEvansPharma/discovering-key-regulatory-reforms-to-enable-accelerated-drug-development-and-approval-in-china-dr-ye-hua

  • h ttps://www.cnppa.org/index.php/Home/News/show/id/874/sortid/18.html
    h ttp://www.nmpa.gov.cn/WS04/CL2056/357685.html

  • >>No. 9086

    英語のままで申し訳ございませんが。。。下記参考になるかと存じます。

    [总局关于鼓励药品创新实行优先审评审批的意见] 2017-12-28
    Opinions of the General Administration on Encouraging Drug Innovation to Implement Priority Review and Approval
    http://samr.cfda.gov.cn/WS01/CL0844/220706.html

    First, the scope of priority review and approval
    (1) Application for registration of a drug with obvious clinical value and one of the following conditions: 
      1. Application for registration of innovative drugs not listed and sold in China. 

    7. Included in the National Science and Technology Major Project, the National Key R&D Program, and the application for registration of new drugs approved by the National Center for Clinical Medical Research and approved by the Central Management Department.
      Drug registration application (b) controlling the following diseases with obvious clinical advantages: 
  1. AIDS; 
  2. tuberculosis; 
  3. viral hepatitis; 
  4. rare disease; 
  5. malignancies; 
  6 children with drugs; 
  7. elderly Endemic and multiple diseases.


    Second, the process of priority review and approval
    …After the completion of Phase I and Phase II clinical trials, the applicant submits the trial results and the next clinical trial protocol in a timely manner. The drug review center arranges communication with the applicant within 30 days after receiving the information. If no safety problems are found, they can be transferred to the next clinical trial after communicating with the drug trial center. For the results of the trials showing no better than the trend of the listed drugs, no priority will be given. 
      For rare diseases or other special diseases, you can apply for a reduction in the number of clinical trial cases or exemption from clinical trials when applying for clinical trials. The drug review center makes a decision on whether to approve the application based on the technical review needs and the actual situation of the Chinese patient. 

    …4. For the treatment of serious life-threatening diseases, there is no effective treatment, and new drugs that are of great significance for solving clinical needs. Applicants can submit an application for face-to-face communication with the drug testing center at any time after preparation. The reviewers should Schedule a meeting to exchange views within 10 days. In the clinical trial phase, the drug trial center should maintain communication with the applicant to guide and promote the development of new drug clinical trials; if based on early clinical trial data, it can reasonably predict or judge its clinical benefit and is more obvious than existing treatment methods. The advantage allows for conditional approval of the market prior to completion of the Phase III confirmatory clinical trial.

    参考(英語):
    https://www.fdanews.com/IPRM0325162
    https://www.slideshare.net/MarcusEvansPharma/discovering-key-regulatory-reforms-to-enable-accelerated-drug-development-and-approval-in-china-dr-ye-hua

  • NMPA (CDE)とのコミュニケーション方法等は、ガイドラインによって規定されています。

  • 药品研发与技术审评沟通交流办法
    Drug development and technical review communication methods
    Chapter I General Provisions 

    Article 1 regulates the communication between the applicant and the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as the Drug Evaluation Center). 

    …Article 3 The forms of communication include: face-to-face meetings, video conferences, teleconferences or written responses.

    …Article 5 Communication is the process of interaction between the applicant and the reviewer on technical issues. The two parties can fully elaborate their respective views on the discussion issues during the communication process, and the resulting consensus can be used as an important basis for R&D and evaluation. 


    Chapter II Types of Communication Meetings

    Article 6 Communication meetings are divided into Class I, Class II and Class III meetings. 
    …(2) Class II meetings refer to meetings held for the key stages of drug development, including the following:
    …3. Pre-application meeting for new drug listing. To discuss whether the existing research data meets the data requirements for the new drug listing review, discuss, but not limited to, the following questions: Whether the existing research data supports the data requirements for the review of the new drug listing application. After the discussion meets the requirements, or meets the requirements after supplementation and improvement, the application for new drug listing can be submitted to the State Drug Administration. 

    参照(原文中国語): h ttp://www.cde.org.cn/policy.do?method=view&id=397

  • [2017年12月期第3四半期 決算説明会資料] 2017-11-14
    3. 医薬品及び医療機器の承認プロセスの短期化
    - 緊急性を要する新薬及び希少疾患の新薬について、条件付きの販売開始を認める。
    - 希少疾患の新薬については、臨床試験の実施回数の削減対象となりうる。
    - 中国政府支給の研究開発補助金により開発された革新的な医薬品及び医療機器は、優先審査の対象となりうる。

    [总局关于鼓励药品创新实行优先审评审批的意见] 2017-12-28
    Opinions of the General Administration on Encouraging Drug Innovation to Implement Priority Review and Approval
    h ttp://samr.cfda.gov.cn/WS01/CL0844/220706.html

    First, the scope of priority review and approval
    (1) Application for registration of a drug with obvious clinical value and one of the following conditions: 
      1. Application for registration of innovative drugs not listed and sold in China. 

    7. Included in the National Science and Technology Major Project, the National Key R&D Program, and the application for registration of new drugs approved by the National Center for Clinical Medical Research and approved by the Central Management Department.
      Drug registration application (b) controlling the following diseases with obvious clinical advantages: 
  1. AIDS; 
  2. tuberculosis; 
  3. viral hepatitis; 
  4. rare disease; 
  5. malignancies; 
  6 children with drugs; 
  7. elderly Endemic and multiple diseases.


    Second, the process of priority review and approval
    …For rare diseases or other special diseases, you can apply for a reduction in the number of clinical trial cases or exemption from clinical trials when applying for clinical trials. The drug review center makes a decision on whether to approve the application based on the technical review needs and the actual situation of the Chinese patient. 

    …4. For the treatment of serious life-threatening diseases, there is no effective treatment, and new drugs that are of great significance for solving clinical needs. Applicants can submit an application for face-to-face communication with the drug testing center at any time after preparation. The reviewers should Schedule a meeting to exchange views within 10 days. In the clinical trial phase, the drug trial center should maintain communication with the applicant to guide and promote the development of new drug clinical trials; if based on early clinical trial data, it can reasonably predict or judge its clinical benefit and is more obvious than existing treatment methods. The advantage allows for conditional approval of the market prior to completion of the Phase III confirmatory clinical trial.

    参考(英語):
    h ttps://www.fdanews.com/IPRM0325162
    h ttps://www.slideshare.net/MarcusEvansPharma/discovering-key-regulatory-reforms-to-enable-accelerated-drug-development-and-approval-in-china-dr-ye-hua

    [会社説明会資料] 2018-03-29
    2018年第2四半期に独立 データモニタリング委員会に よる中間解析が行われ、中間 解析結果を以て第3相に進む かどうか判断される見込み

    [中国における F351 第2相臨床試験中間解析において良好な結果を報告] 2018-09-25
    …新規被験者登録を停止すべきとの同委員会からの勧告は、当社グループ、当社の株主の皆 様そして肝線維症に苦しむ患者様方にとって素晴らしく重要な進展であります。同委員会の 勧告に従い、中国における当第2相臨床試験は 2019 年夏頃に終了し、その後、当試験の最 終結果は国際学会の場で発表される予定です。その間、当社グループは中国における F351 の第3相臨床試験の準備と、今年第4四半期に予定されております米国における第1相臨床 試験の最終結果の解析を進めます。


    [CTR20182273] 2018-12-05
    羟尼酮胶囊BE研究
    Bioequivalence test of oxycodone capsules in the hollow abdominal state of Chinese healthy volunteers
    已完成 completed
    试验目的: 比较上海睿星基因技术有限公司研制的羟尼酮胶囊(规格:30mg/粒,受试制剂)与其自身参比制剂羟尼酮胶囊(规格:15mg/粒)在中国健康男性受试者中空腹状态下吸收程度和速度的差异。通过主要药代动力学参数及相对生物利用度,评价两者是否具有生物等效性,为受试制剂的注册申请提供依据。
    Test Purpose: Compare the oxynithone capsules (specification: 30mg/granule, test preparation) developed by Shanghai Ruixing Gene Technology Co., Ltd. with its own reference preparation, oxyniquanone capsule (Specification: 15mg/granule) in Chinese healthy male subjects The difference in absorption and speed in the state. Through the main pharmacokinetic parameters and relative bioavailability, whether the two are bioequivalent is provided, and the basis for the registration of the test preparation is provided.

  • [当社グループの事業進捗について ] 2019-01-30
    …2019 年 8 月末までに試験が完了される予定です。
    上述の第 2 相臨床試験に関する良好な結果と安全性情報、さらに治験終了時期が近付いていることを 考慮して、当社グループは、患者様を用いた生物学的同等性データ及び薬物動態データを準備しておりま す。これは、2019 年後半までに国家薬品監督管理局(NMPA)(旧 CFDA)とのコミュニケーションを開始し、この重要な医薬候補品の承認に向けたアドバイスを NMPA に求めるためです。
    F351 が NMPA の承認を得た場合、北京コンチネント薬業有限公司(北京コンチネント)の新工場で 製造される予定です。


    [CTR20190379] 2019-05-05
    羟尼酮患者及特殊人群PK研究
    PK study of patients with oxycodone and special population
    进行中(尚未招募)In progress (not yet recruited)
    试验目的: 1、评价羟尼酮胶囊在目标适应症患者(慢性乙型病毒性肝炎伴肝纤维化患者)及特殊人群(轻度肝功能不全患者)中的药代动力学(PK)特征。2、评价口服羟尼酮胶囊对慢性乙型病毒性肝炎伴肝纤维化合并轻度肝功能不全患者QT/QTc的影响。3、评价慢性乙型病毒性肝炎伴肝纤维化合并轻度肝功能不全患者口服羟尼酮胶囊的安全性。
    Test Purpose: 1. To evaluate the pharmacokinetic (PK) characteristics of oxycodone capsules in patients with target indications (chronic hepatitis B with liver fibrosis) and special population (patients with mild hepatic insufficiency). 2. To evaluate the effect of oral oxynitone capsules on QT/QTc in patients with chronic hepatitis B with hepatic fibrosis and mild hepatic insufficiency. 3. To evaluate the safety of oral progesterone capsules in patients with chronic hepatitis B with liver fibrosis and mild hepatic insufficiency.


    [CTR20190867] 2019-05-07
    羟尼酮胶囊和恩替卡韦胶囊的相互作用研究
    Study on the interaction between oxycodone capsules and entecavir capsules
    进行中(招募完成)In progress (recruitment completed)
    试验目的: 1、评价羟尼酮胶囊和恩替卡韦胶囊在健康受试者中的药代动力学相互作用,为羟尼酮胶囊后续临床研究提供依据。2、评价健康受试者口服羟尼酮胶囊和恩替卡韦胶囊的安全性和耐受性。
    Test Purpose: 1. To evaluate the pharmacokinetic interaction of oxycodone capsules and entecavir capsules in healthy subjects, and to provide evidence for subsequent clinical studies of oxycodone capsules. 2. Evaluation of the safety and tolerability of oral administration of oxycodone capsules and entecavir capsules in healthy subjects.


    [2019年12月期第1四半期報告書] 2019-05-15
    …この重要な医薬候補品の承認 に至る過程で必要だとNMPAからアドバイスされた内容に従って、患者様を用いた生物学的同等性データ 及び薬物動態データを準備しております。


    [CTR20191392] 2019-07-11
    羟尼酮胶囊在中国健康受试者中的临床药代动力学试验(Ic)
    Pharmacokinetic test of oxycodone capsules in healthy subjects
    进行中(尚未招募)In progress (not yet recruited)
    试验目的: 评价羟尼酮胶囊(规格:30mg/粒)在健康受试者中的药代动力学特征以及进食对药代动力学的影响,为II/III期临床试验方案提供依据。
    Test Purpose: To evaluate the pharmacokinetic characteristics of oxycodone capsules (specification: 30 mg/particle) in healthy subjects and the effect of feeding on pharmacokinetics, provide a basis for Phase II/III clinical trial protocols.


    [2019年12月期第2四半期報告書] 2019-08-14
    …当第2四半期に、異なる製剤に対する生物学的同等性試験 (biological equivalence study;BE試験)、特別な患者グループに対する薬物動態試験、ならびに NMPAのガイドライン等に沿ったCMC(※)試験を完了しました。 当社グループは、この重要な医薬候補品の承認の基準について、第3相臨床試験の実施方法や早めに承認を得られるかどうかなども含めて、 NMPAと連絡を取る予定です。 (※Chemistry,Manufacturing and Controlの各頭文字を取った略語)

  • Anti-fibrotic effects of pirfenidone by interference with the hedgehog signalling pathway in patients with systemic sclerosis-associated interstitial lung disease

    Results
    Hh pathway activation was increased in the lung tissue of SSc-ILD patients and was decreased by pirfenidone, Sufu was upregulated in lung fibroblasts isolated from SSc-ILD patients after pirfenidone challenge, and pirfenidone inhibited the phosphorylation of GSK-3β signalling.

    Conclusion
    Pirfenidone has anti-fibrotic effects in SSc-ILD patients by interfering with both the Hh signalling pathway and the GSK-3β signalling pathway via the regulation of Sufu expression. These results might promote its use in other Hh driven lung diseases such as idiopathic pulmonary fibrosis and especially the interstitial lung disease associated with connective tissue diseases.

    h ttp://onlinelibrary.wiley.com/doi/10.1111/1756-185X.13247/full

  • Pirfenidone for the Treatment of Connective Tissue Diseases Associated Interstitial Lung Disease: A Report of Three Cases and Review of Literature

    No serious adverse events were evident during the whole treatment. Conclusion Based on our experience on pirfenidone for the management CTD associated ILD and the review of current literature,we herein can conclude that pirfenidone may be of some value in patients with CTD-ILD,especially for those with progressive respiratory dysfunction after adequate treatment of glucocorticoid and immunosuppressant.

    h ttp://oversea.cnki.net/kcms/detail/detail.aspx?filename=OZHL201701002&dbcode=CJFD&dbname=CJFDTEMP

  • ZSP1603是众生与药明康德共同研发,国内同靶点第一个获批临床用于治疗IPF(特发性肺纤维化)和恶性肿瘤的小分子创新药物。目前,能够有效治疗IPF的药物全球仅有两项获批,分别是罗氏的吡非尼酮和勃林格殷格翰的尼达尼布,且临床需求远未得到满足,国内尚无产品获批。

    h ttp://news.pharmnet.com.cn/news/2017/11/30/485057.html

  • Clinical Experience with Pirfenidone in Connective Tissue Diseases Related Interstitial Lung Diseases

    Our study has additional limitations. This was an open, prospective, single-center study. Further randomized clinical studies are needed to evaluate effect of pirfenidone on CTD-ILD. To date, controlled treatment trials have not been performed in different entities of CTD-ILDs and it is not clear that such trials are truly feasible, given the low patient numbers, multiple options of combined immunosuppressive therapies.

    In conclusion, we found that pirfenidone treatment should be considered as it achieved a clinical and laboratory significant improvement. Pirfenidone administration was generally safe and may attenuate inflammation and improve lung function at an earlier phase of CTD-ILD.

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