Last updated: 2026/01/07
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- Remote-Controlled Synthetic Cells Offer Breakthrough in PrecisRemote-Controlled Synthetic Cells Offer Breakthrough in Precision Cancer Therapyion Cancer Therapy
- Prof. Raju Kucherlapati at Puxin: CAR-T Therapy's Prospects & Challenges in Precision Medicine Era
- Innovation Source, Health Everlasting | 2024 Biopharmaceutical and Synthetic Biology Expert Exchange Conference
- Connecting China and Building Dreams for the Future
- ''Diving Deeper - A New Track and Platform for Immune Cell Therapy'' IGC Satellite Conference Organized by Hillgene
- Live丨Writing a New Chapter for Cellular and Gene Therapies, Paving the Road to an Innovatively Developed and Industrialized Future
- Hillgene Reached a Strategic Cooperation with Biotheus in Climbing to New Heights in China for CAB-T Cell Therapy Products
- Contributing to the “Wuzhong Highland” in Biopharmaceutical Industry丨Hillgene Joined the “Innovative Pharmaceutical CXO Alliance in the Yangtze River Delta Region”
- Good News | Hillgene Won the Title of “Star of Tomorrow” among the China Biopharmaceutical CDMO Companies in Star Awards-2021 BPID
- Another Award | Hillgene Was Awarded the TOP 5 Annual Pharmaceutical CXO Companies
- Leading Enterprise of Professional and Dedicated CDMO for Cellular Therapy Products - Hillgene Completed the Pre-A Round Funding up to Hundreds of Millions of Dollars
- Establishment of the Judge Workshop at the Industrial Park, Bridging the Court and the Enterprises
- Hillgene Completed the Pre-A+ Round Funding up to Tens of Millions of Dollars Again Constant Enhancing the Capability of CQDMO Services in the Industry of Cellular Therapy Product
- Hillgene Reached a Strategic Cooperation with T-Maximum in Accelerating the innovation and Breakthrough of Universal Cells
- Official Operation of Hillgene R&D Center, Boosting the Innovation of the Biopharmaceutical Industry in Wuzhong District
- Innovative and Breakthrough CGT, Best Opportunity and Perfect Timing at Dongtai Hu Lake: CGT Industrialization Summit and First Anniversary Celebration of Hillgene
- Hillgene Reached a Strategic Cooperation with HighthinkMed in Exploring One-Stop Whole-Process Innovative Service Mode for Cellular Therapy Products
- MAH System Stimulates the Vitality of Innovation - Hillgene Empowers the Cellular Therapy Products with CQDMO Services
- Hillgene Was Awarded the TOP 10 Most Promising CXO Companies of [China Biopharmaceutical Industry in 2022]
- Hillgene Won the BioCon Awards [Annual CDMO Excellence Award]
- Breaking | Hillgene Was Accepted as a Candidate of the “Unicorn” Enterprises Fostering Program
- Congratulations!! Released Globally! ICH Guideline E19, with Academician Zhang Dan as a Working Expert, Was Formally Released and Reached Step 5
- Academician Zhang Dan of Hillgene Was Invited to Attend and Make His Presentation at the 22nd Taihu Economic and Trade Cooperation Meeting of Wuzhong District
- Hillgene Was Awarded the Most Promising and Innovative CXO Company of the Top Value Innovative Companies in the Biomedical Science and Technology Industry of China in 2022
- FDA Removes REMS Requirements for CAR-T Therapies, Paving the Way for Broader Patient Access
- European Commission Grants Approval for Lentiviral Vector–Based CAR-T Therapy
- Breakthrough in NK Cell Expansion: Novel K562 Feeder Line Enhances Yield and Purity
- Global Lentiviral Vector CDMO Market to Grow at ~8% CAGR by 2030
- Global Cell and Gene Therapy Market Projected to Reach $39.6 Billion by 2034
- Study Confirms Safety and Efficiency of Optimized K562 Feeder Cells for NK Cell Expansion
- Bayer Advances Parkinson’s Stem Cell Therapy into Phase III Clinical Trial
- French Biotech Allogenica Secures €2.5M Grant to Advance Universal CAR-T Therapy Industrialization
- AstraZeneca and Algen Biotechnologies Forge $555 Million Gene Therapy Collaboration
- Hillgene Takes Note of FDA New Guidelines: Interpreting the Latest Developments and Industry Opportunities in Cross-Border Genetic Data Research
- EU Issues First-Ever GMP Annex on Artificial Intelligence: 10 Key Compliance Requirements for Pharmaceutical AI
- FDA Adds Boxed Warning to Johnson & Johnson and Legend Biotech’s CAR-T Therapy Carvykti
- Experimental Gene Therapy Restores Immune Systems in Children with Deadly Disorder
- McKesson Report: Cell and Gene Therapies Grow Rapidly, but Cost and Access Gaps Persist
- Eli Lilly Expands Gene Therapy Portfolio with $262 Million Acquisition of Adverum Biotechnologies
- MIT Researchers Develop Tunable Gene Expression System for Synthetic Biology and Therapeutic Applications
- UMass Chan Launches Global Gene and Cell Therapy Training Program to Advance HIV Cure Research
- Landmark UCL Study Confirms Long-Term Safety and Efficacy of Gene Therapy for ADA-SCID
- Kelonia Therapeutics and Johnson & Johnson Form Strategic Collaboration to Develop Next-Generation In Vivo CAR-T Therapies
- FDA Introduces “Plausible Mechanism” Pathway to Accelerate Approval of Ultra-Rare and Personalized Gene Therapies
- FDA Issues Strongest Safety Warning for Sarepta’s Gene Therapy Elevidys After Two Fatal Liver Injury Cases
- Cellex Symposium 2025 Highlights the Next Phase of Cell and Gene Therapy Industry Development
- Avantor Unveils Next-Generation Sterile Sampling Platform to Strengthen Quality Control in CGT Manufacturing
- FDA Approves Novartis Gene Therapy Itvisma for Expanded SMA Patient Population
- Oncolytic Virus CDMO Market Enters Rapid Growth Phase, Expected to Surpass USD 1.7 Billion by 2035
- Genentech to Present 46 Hematology Abstracts at ASH 2025, Including New AAV Gene Therapy and Oncology Data
- Regeneron and Tessera Therapeutics Partner to Develop in-Vivo Gene Editing Therapy TSRA-196 for Alpha-1 Antitrypsin Deficiency
- Capricor Reports Positive Phase 3 HOPE-3 Results: Deramiocel Demonstrates Skeletal and Cardiac Benefits in Duchenne Muscular Dystrophy
- Vertex’s Gene Therapy Casgevy Shows Strong Efficacy in Younger Children with Blood Disorders
- FDA Approves First Gene Therapy for Rare Immune Disorder Wiskott-Aldrich Syndrome, Expanding Treatment to Patients Aged 6 Months and Older
- FDA Approves BioCryst’s Oral Pellet Form of Orladeyo, First Oral Prophylactic Therapy for Children Aged 2–11 with HAE
- Sanofi Signs Up to $1.04 Billion Alzheimer’s Drug Development Deal with South Korea’s ADEL
- UAE Becomes Second Country to Approve Gene Therapy Itvisma for Spinal Muscular Atrophy
- FDA Approves Omeros’ Yartemlea as First Treatment for Transplant-Associated Thrombotic Microangiopathy
- First-of-Its-Kind Fentanyl Vaccine Prepares to Enter Human Clinical Trials
- Industry News
- Opinions of the State Council on the Reform of the Review & Approval System for Drugs and Medical Devices
- The NPC Standing Committee’s Decision on Authorizing the State Council to Carry out the Pilot Drug Marketing Authorization Holder System in Some Places and Related Issues
- Notice of the General Office of the State Council on Issuing the “Pilot Plan on Drug Marketing Authorization Holder System”
- Announcement Notification of “Regulations on the Quality Management of Cell Bank Establishment”
- The Comprehensive Affairs Department of NMPA Issued the Announcement on “Technical Guideline for the Pharmaceutical Study and Evaluation of Cellular Therapy Products” (No. 216, 2017)
- The Comprehensive Affairs Department of NMPA Issued the “Announcement on the Direct Reporting of Adverse Reactions by Marketing Authorization Holders (Draft for Comments)”
- Considerations on “IND Application Studies and Application Materials for Cellular Therapy Products”
- Notification of “CAR-T Cell Quality Control Testing Research and Non-clinical Study Considerations”
- Announcement of “Regulations on Manufacturing Quality Management for Chimeric Antigen Receptor T Cell (CAR-T cell)-based Drug Products”
- The General Office of the National Health Commission issued the Letter of Opinion on “Administrative Measures for the Clinical Research and Translational Use of Somatic Cell Therapy (Interim)
- Proclamation of the “General Instructions on Human Gene Therapy Products (Draft)”
- Full text of the new “Drug Administration Law of the People's Republic of China”
- NMPA (formerly CFDA) Solicits Public Comments on “Good Manufacturing Practice (GMP) – Appendix for Cellular Therapy Drugs” (Draft for Comments)
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Inspection Procedures of Drug Product MAHs (Draft for Comments)”
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Key Points for Inspection of Drug Product MAHs (Draft for Comments)”
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Guidelines for Quality Agreement on Drug Consignment Production (Draft for Comments)”
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Reference Template for Quality Agreement on Drug Consignment Production (Draft for Comments)”
- Newly Revised “Provisions for Supervision and Administration of Drug Manufacturing”
- Newly Revised “Provisions for Drug Registration”
- Notification of Public Comment Soliciting on “Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-based Immunotherapy Products (Draft for Comments)”
- Notification of Public Comment Soliciting on “Technical Guideline for the Pharmaceutical Study and Evaluation of Gene Therapy Products (Draft for Comments)”
- [IIT] Announcement on Public Comment Soliciting on the “Administrative Measures for Investigator Initiated Clinical Trials by Medical and Health Institutions (Draft for Comments)”
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Clinical Trial of Cell-based Immunotherapy Products (Interim)” (No. 14, 2021)
- NMPA issued the “Measures for the Administration of Drug Inspection (Interim)”, and abolished the original drug administrative measures for GMP and GSP certification!
- European Medicines Agency updates Reflection Paper on GMP Responsibilities of MAHs
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Good Manufacturing Practice (GMP) – Appendix for Cellular Therapy Drugs (Draft for Comments)”
- Cell Therapy CDMO — New Track in Pharmaceutical CXO Industry, the Untapped Area
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Good Manufacturing Practice (GMP) – Appendix for Investigational Drugs (Draft for Comments)”
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Clinical Risk Management Plan for Marketing Application of Chimeric Antigen Receptor T cell (CAR-T) Therapy Pro
- Who will become the leading “water supplier” during the “gold rush” of the cellular therapy industry?
- The Comprehensive Affairs Department of NMPA Solicits Public Comments on “Key Points for Inspection of Drug Product MAHs (Draft for Comments)”
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Evaluation of Immune-related Adverse Events in Antitumor Therapy” (No. 25, 2022)
- Hillgene Winning the Bid on the First Contract Manufacturing Order for Commercial CAR-T Cell Therapy in China
- [GMP revised] Appendix for “Investigational Drugs (Interim)” issued and taking effect as of July 1!
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Ex-vivo Genetic Modification System (Interim)” (No. 29, 2022)
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Cell-based Immunotherapy Products (Interim)” (No. 30, 2022)
- Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of In-vivo Gene Therapy Products (Interim)” (No. 31, 2022)
- CDE issued “Guidelines on Clinical Trial Statistics of Drug Products for Rare Diseases (Interim)”
- Important Report from CDE! The Annual Report on Progress of Clinical Trials for New Drug Registration in China (2021)
- CDE: Notification of Public Comment Soliciting on “Technical Guideline for the Clinical Research and Development of New Drug Products for Chronic Lymphocytic Leukemia (Draft for Comments)”
- Big News: FDA issued the finalized version of guidance “Comparability Protocols for Post-approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA”
- Big News: Newly released “Good Manufacturing Practice for Cellular Therapy Products (Interim)”!
- MAH issued“Provisions for Supervision and Administration of Drug Quality (Interim)”
- NMPA issued the Announcement on “Implementing Electronic Application of Drug Registration”
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