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医药健康企业融资谈判过程中需要创始人注意的两三事（上篇）
近两年，因为生物医药类企业IPO承压...
Beijing Jincheng Tongda & Neal Law Firm
China: Healthcare
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Article
Understanding The EU's International Procurement Instrument
Earlier this year, the Commission relied for the first time on the EU's International Procurement Instrument in order to take measures against China for its failure to ensure reciprocal access to public...
Crowell & Moring LLP
Article
汉坤 • 观点 | 《药品管理法实施条例》（修订草案）重点快评
2022年5月9日，国家药监局发布《药品管理法实施条例（修订草案征求意见稿）》（简称"《征求意见稿》"），向社会公开征求意见，征求意见反馈截止
Han Kun Law Offices
Article
汉坤 • 观点 | 中国药品年度报告制度简析
2022年4月11日，国家药品监督管理局（" 国家药监局"）发布了《药品年度报告管理规定》以及相应的报告模板（以下合称" 《年报规定》"）...
Han Kun Law Offices
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汉坤 • 观点 | 简评新版《医疗器械临床试验质量管理规范（GCP）》
Han Kun Law Offices
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Han Kun • Opinion | Interpretation Of The "Detailed Rules For The Supervision Of Internet Diagnosis And Treatment (Trial)"
Han Kun Law Offices
Article
Han Kun • Opinion | Research On Urban Customized Commercial Medical Insurance
Han Kun Law Offices
Article
汉坤 • 观点 | 医药BD项目如何友好"分手"？
Han Kun Law Offices
Article
How Digital Therapeutics (DTx) Products Are Regulated In China?
Han Kun Law Offices
Article
2024 Data Analytics: China Life Sciences NewCo & Licensing Terms
Han Kun Law Offices
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Han Kun • Opinion | The New Ethical Review Regulations Focus On Quick Comments
Han Kun Law Offices
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Han Kun • Opinion | Hainan Boao Lecheng Clinical Urgently Needs A Review Of The Highlights Of The New Regulations On The Management Of Imported Drugs And Devices
Han Kun Law Offices
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Han Kun • Opinion | Brief Review Of The Measures For The Review Of Science And Technology Ethics (Trial) (Draft For Comments)
Han Kun Law Offices
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汉坤 • 观点 | CAR-T/NK监管路在何方 — 体细胞临床研究工作指引（征求意见稿）要点解读
Han Kun Law Offices
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China's Major Escalation Of Export Control Measures Has Profoundly Impacted The Global Supply Chain
King & Wood Mallesons
Article
Critical Insecurity – How Critical Minerals Policies Are Impacting Global Markets And Supply Chains
King & Wood Mallesons
Article
我国自动辅助驾驶侵权责任的探讨 ——从特斯拉自动辅助驾驶天价赔偿案和我国法院入库案例谈起
AnJie Broad Law Firm
Article
Beyond Stay Or Leave: How MNCs Are Recalibrating Their China Strategy (Video)
Alvarez & Marsal
Article
股权投资视角下的新公司法司法解释草案解读
Beijing Jincheng Tongda & Neal Law Firm
Article
Han Kun • Opinion | Implementation And Regulation Of DCT (Decentralized Clinical Trials) In China
The concept of "patient-centered" has become the core guiding ideology of current drug development. "Patient-centered" drug development refers to the process...
Han Kun Law Offices
Article
汉坤 • 观点 | LDT试点新规解读
近年来，我国不断探索对LDT的监管。随着一系列新规的出台，有众多优秀的跨国及本土公司均参与到该领域的研究中...
Han Kun Law Offices
Article
Han Kun • Opinion | The Spring Of Traditional Chinese Medicine? From The "Special Provisions On The Registration And Administration Of Traditional Chinese Medicines", The Characteristic Marketing Evaluation System Of Traditional Chinese Medicine
In recent years, our country has been vigorously supporting the inheritance, innovation and development of traditional Chinese medicine. In 2019...
Han Kun Law Offices
Article
药企出海新热点：管线分拆"SON"模式的实践解读
近期，医药行业正掀起一股"管线分拆项目"（"Spin off-NewCo"，或称"SON"模式）的热潮。短短两个月，笔者即接手了近十起管线分拆项目。
Han Kun Law Offices
Article
Han Kun Opinion | Breaking News: 10 Questions And Answers On Pharmaceutical Anti-Corruption In 2023
Han Kun Law Offices
Article
Han Kun Opinion | CAR-T/NK Regulatory Decisions — Interpreting The "Guidelines For Somatic Cell Clinical Research (Trial)"
Han Kun Law Offices
Article
汉坤 • 观点 | 从药械产品全生命周期视角解读License-in/out许可交易项目合作条款要点
Han Kun Law Offices
Article
汉坤 • 观点 | 企业或需自设伦理委员会：《科技伦理审查办法（试行）》正式出台
Han Kun Law Offices
Article
Han Kun • Opinion | Interpret The New Regulations For The Inspection Of Drug Clinical Trial Institutions In The Post-"722 Storm" Era
Han Kun Law Offices
Article
Han Kun • Opinion | 2023 Life Sciences Regulatory Compliance Annual Summary
Han Kun Law Offices
Article
Han Kun • Opinion | Quick Review Of The New Regulations: Interpret The Latest Questions And Answers Of The Ministry Of Science And Technology
Han Kun Law Offices
Article
Han Kun • Quick Comment | Is The Transmission Of Cross-border Genomic Data Between China And The United States Blocked? Biden Data Executive Order Quick Review
Han Kun Law Offices
Article
Han Kun • Opinion | Analysis Of Key Points Of License-In/out Contract Disputes In The Life Sciences Industry (1): Joint Steering Committee, Reasonable Commercial Efforts, Confidentiality Obligations
Han Kun Law Offices
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Hankun • Quick Comment | The Regulations On Human Genetic Resources Management Are Revised Again
Han Kun Law Offices
Article
Han Kun • Opinion | Quick Review Of The New Regulations: Interpret The Latest Questions And Answers Of The Ministry Of Science And Technology
On September 8, 2023, the China Biotechnology Development Center directly under the Ministry of Science and Technology of the People's Republic of China...
Han Kun Law Offices
Article
Han Kun • Quick Comment | Is The Transmission Of Cross-border Genomic Data Between China And The United States Blocked? Biden Data Executive Order Quick Review
Recently, U.S. President Joe Biden signed the Executive Order on Preventing Access to Americans' Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern) ("Executive Order").
Han Kun Law Offices
Article
Han Kun • Opinion | Analysis Of Key Points Of License-In/out Contract Disputes In The Life Sciences Industry (1): Joint Steering Committee, Reasonable Commercial Efforts, Confidentiality Obligations
License-in/out is a common transaction model in the pharmaceutical field in recent years, that is, the licensor licensees the relevant R&D technology and patents...
Han Kun Law Offices
Article
Hankun • Quick Comment | The Regulations On Human Genetic Resources Management Are Revised Again
On March 15, the website of the Central People's Government released State Order No. 777 "Decision of the State Council on Amending and Abolishing Certain Administrative Regulations" ("Decision")...
Han Kun Law Offices
Article
2022-2023 China Medical Device License-In/Out Project Core Clause Data Analysis
Han Kun Law Offices
Article
观点 | 生命科学行业License-In/Out合同争议要点分析（二）：适应症变更、监管要求变更、合同变更或解除
被许可方认为，适应症变更会在很大程度上浪费先前在适应症X上的研发投入。适应症变更后，许多临床前研究需要重做，也需要重新进行IND申
Han Kun Law Offices
Article
Insights Into China Biotech's New Approach: Spin-Off-NewCo Model
China's pharmaceutical industry is witnessing a notable surge in "pipeline spin-off projects", a model commonly referred to as the "Spin-off-NewCo" or "SON"...
Han Kun Law Offices
Article
汉坤 • 观点 | 细胞与基因治疗领域又一利好：研究者发起的临床研究（IIT）管理办法正式落地
近日，国家卫生健康委员会（下称"国家卫健委"）、国家中医药局和国家疾控局三部委联合发布了...
Han Kun Law Offices
Article
汉坤 • 观点 | 解读2024年版《赫尔辛基宣言》最新亮点 — 全球医学研究伦理准则系统性更新
2024年10月19日，第75届世界医学会全体大会审议通过了《世界医学协会赫尔辛基宣言...
Han Kun Law Offices
Article
观点 | 《医疗器械管理法（草案）》十大亮点快评
Han Kun Law Offices
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China Released Draft Medical Device Law For Comments
Han Kun Law Offices
Article
China Pilots Lifting Restrictions On Foreign Investment In Stem Cell, Gene Therapy, And Genetic Diagnosis Sectors In Four Free Trade Zones
Han Kun Law Offices
Article
2024年NewCo与药械License-in/out项目核心条款数据分析与对比
Han Kun Law Offices
Article
速评《美国优先投资政策备忘录》对中国生物医药行业的潜在影响
Han Kun Law Offices
Article
China Newsletter | Q2 2025/Issue No. 64
Greenberg Traurig, LLP
Article
Chinese Regulators Continue Enforcement Actions Against Medical Insurance Fraud
Arnold & Porter
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Industry Observation｜China Life Sciences And Healthcare Weekly Report No. 30
SGLA Law Firm
Article
Pharma Remains An Enforcement Focus In China – SAMR Orders Unwinding Of A Completed Pharma Deal
Herbert Smith Freehills Kramer LLP
Article
What Are The Contract Essentials For China-related Life Sciences Collaboration Agreements?
Gowling WLG
Article
China On The Move: China's Healthcare And Life Sciences Regulatory Evolution In 2025
Greenberg Traurig, LLP
Article
China Compliance Update – Summer 2025
Arnold & Porter
Article
The Regulatory Data Protection Regime In China (Draft For Comments)
Fangda Partners
Article
China Compliance Update: Life Sciences — Summer 2025
Arnold & Porter
Article
Growth and Opportunities in China's Medical Device Market.
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