Last week, we joined forces with Guangdong-Hong Kong-Macao Greater Bay Area Center for Drug Evaluation and Inspection (GBACDEI) to co-host the inaugural training seminar for Investigational New Drug Application in Hong Kong. Organized by our dedicated Ecosystem Development Division, this event drew around 200 experts, scholars, researchers, and pharmaceutical representatives from Hong Kong and beyond. During the seminar, speakers from GBACDEI provided a comprehensive overview of the clinical trial application process for new drugs in Mainland China, detailing pharmaceutical technical requirements and case studies. This information was invaluable for industry stakeholders looking to register new drugs, enhancing their capability and efficiency in navigating the complexities of clinical trials. The seminar also opened doors for new drugs in Hong Kong to access the vast Mainland China market, boosting the value chain of Hong Kong's biopharmaceutical industry! A standout moment was the dynamic panel discussion on “How HSITP’s Life Science Ecosystem Supports Clinical Trials for New Drugs.” Our Associate Director, Ecosystem Development (Life Science)- Alex Kwong shared valuable insights alongside esteemed panelists Prof. Raven- Kin-Hang Kok (Associate Professor – University of Hong Kong) and Sabrina, so kuen Chan (Senior Executive Director - The Hong Kong Association of the Pharmaceutical Industry). The conversation centered on the critical role of our ecosystem in fostering collaboration and driving innovation in clinical trials for new drugs. A huge thank you to our CEO-Vincent and our Ecosystem team, including Anita, Alex, Eddie, and everyone else who contributed to making this event a resounding success! #innovation #technology #crossboundary #sustainability #green #development #sustainabledevelopment #greeninitiatives #environmentallyfriendly #education #environmentalprotection #economicgrowth #hongkongshenzheninnovationandtechnologypark #hk #hongkong #Shenzhen #Innovation #Technology #GreaterBayArea #Leadership #GreenBuilding #lifesciences #ecosystemdevelopment #innovators #sciences #starup #sustainability #cybersecurity #FlyAsia2024 #StartupEcosystem #Innovation #GBACDEI #Pharmaceuticals #Clinicaltrials
HSITP Hong Kong-Shenzhen Innovation and Technology Park的动态
最相关的动态
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UPDATE ? To all PHARMA, BIOTECH & MEDICAL DEVICE companies interested in the Hong Kong and/or Greater Bay Area (GBA) marketplace. As of November 1, 2024, a New Hong Kong SAR Policy was announced regarding new drugs, new vaccines, new advanced therapies and new medical devices. Under the "1+ mechanism", once a new drug, a new vaccine, a new advanced therapy product and a new medical device are approved and registered in Hong Kong and in-use at Hong Kong public hospitals, these new drugs, new therapies and new medical devices shall have a 'Green Channel' to access the 86 million population residing in the Greater Bay Area {GBA = Guangdong Province}. #2024policyaddress #InvestHK #HongKong https://lnkd.in/gUDAAab7 https://lnkd.in/g4n855Fu Hong Kong Where Business Goes to Grow!
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?? We're excited to announce that we'll be part of the Biotech Business Mission in Japan 2024! The biotech mission to Japan from 7-11 October 2024 offers an exclusive opportunity for European SMEs and clusters to present themselves in the Japanese biotech, pharmaceutical and healthcare sector and to explore new business opportunities. The mission includes participation in the EU-Japan Biotech & Pharma Partnering Conference in Osaka and a visit to BioJapan 2024 in Yokohama. The latter is considered the largest trade fair for biotechnology in Japan. The programme is aimed at SMEs and clusters that are active in the following sectors: ? Drug discovery ? Drug discovery support including AI-assisted drug development ? Regenerative medicine ? Digital therapeutics such as drug-device combinations, non-pharmacological therapy systems ? Interested parties who are active in the above-mentioned areas should apply by 6 june 2024 at the latest. Further information on the event, programme, conditions and the application form can be found here: https://lnkd.in/eiVi5TN4 #EENCanHelp #Biotech #SME
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UPDATE ? To all PHARMA, BIOTECH & MEDICAL DEVICE companies interested in the Hong Kong and/or Greater Bay Area (GBA) marketplace. As of November 1, 2024, a New Hong Kong SAR Policy was announced regarding new drugs, new vaccines, new advanced therapies and new medical devices. Under the "1+ mechanism", once a new drug, a new vaccine, a new advanced therapy product and a new medical device are approved and registered in Hong Kong and in-use at Hong Kong public hospitals, these new drugs, new therapies and new medical devices shall have a 'Green Channel' to access the 86 million population residing in the Greater Bay Area {GBA = Guangdong Province}. #2024policyaddress #InvestHK #HongKong https://lnkd.in/g7hViW32 https://lnkd.in/gtCPkD46 Hong Kong Where Business Goes to Grow!
"1+" mechanism for approval of new drugs to commence on November 1
info.gov.hk
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Increased spending on public health in China is likely to boost pharmaceutical companies like Dr. Reddy’s Laboratories Ltd, which operates via a joint venture and a wholly-owned subsidiary in the Dragon Nation. With over 20 years of experience in China, the company is gearing up to tap into the opportunity with a more focused approach. The company’s Chief Executive Officer for Branded Markets (India and Emerging Markets), M.V. Ramana, shared his thoughts with Informist on market opportunities, regulatory challenges, product filings, and the launch pipeline. Read more at Informist: https://lnkd.in/g6Ygcb5S #InformistExclusives #PharmaceuticalIndustry #ChinaMarket #HealthcareInvestment #DrReddys #MarketOpportunities?
Dr Reddy's preps to tap post-COVID pharma boom in China, says Ramana
informistmedia.com
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UPDATE ? To all PHARMA, BIOTECH & MEDICAL DEVICE companies interested in the Hong Kong and/or Greater Bay Area (GBA) marketplace. As of November 1, 2024, a New Hong Kong SAR Policy was announced regarding new drugs, new vaccines, new advanced therapies and new medical devices. Under the "1+ mechanism", once a new drug, a new vaccine, a new advanced therapy product and a new medical device are approved and registered in Hong Kong and in-use at Hong Kong public hospitals, these new drugs, new therapies and new medical devices shall have a 'Green Channel' to access the 86 million population residing in the Greater Bay Area {GBA = Guangdong Province}. https://lnkd.in/gUDAAab7 https://lnkd.in/g4n855Fu Hong Kong Where Business Goes to Grow! #2024policyaddress #InvestHK #HongKong
"1+" mechanism for approval of new drugs to commence on November 1
info.gov.hk
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Global Pharma’s Strategic Expansion into China’s Booming Biotech Sector China's biotech industry is thriving, drawing significant investment from global pharmaceutical companies. Driven by a robust national sector, international players are increasingly collaborating with local biotech firms to capitalize on innovation and expand their reach in the growing Chinese market. This surge reflects China’s strategic position as a key player in the future of global healthcare. #PharmaInChina #BiotechGrowth #HealthcareInnovation #GlobalExpansion #ChinaBiotech #PharmaceuticalInvestments #BiotechCollaboration #EmergingMarkets #PharmaTrends
Global pharma invests in China on the strength of a booming national biotech sector
https://www.imd.org/ibyimd
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Pharmaceutical #research and development in Europe is losing ground as the United States and China surge ahead. New data shows that while Europe's private R&D spending has grown steadily, it has been overtaken by faster growth in the #US and explosive investment in #China. With China now overtaking #Europe in drug discovery, the findings highlight the urgent need for policy reforms and strategic action to safeguard Europe's #competitiveness in this critical sector. ?? Read more: https://lnkd.in/exqYsYvM
Growth in European pharma R&D spending outpaced by US and China
sciencebusiness.net
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?? Take a look at our President and Co-founder Lin Jin engaging at the Swiss Chinese Life Science Forum 2024! ?? -->???????? ?????? ???????????????? ?????????? ! We've been captivated by a series of interesting talks and discussions, which focused on China's role in the global pharmaceutical industry. ?? Key challenges such as entering the European market, New modality innovative drug development in China, and the importance of involving the Chinese population to support global drug development were central topics of yesterday’s forum. ?? Over the past decade, China has clearly shifted towards the development of novel therapeutic strategies and to high-quality standards in compliance with the recently reformed authority, NMPA. Our Co-Founder shared insights on the growing trends of Life Science licensing deals in China, highlighting the recent acquisition of Gracell, a CAR-T oriented Chinese-based clinical-stage biopharma, by AstraZeneca for 1.2 billion ??. CAR-T therapy development is a rising trend, positioning China in the first position for the number of clinical trials since 2017. This is no coincidence, as China offers an ideal ecosystem for therapies such as CAR-T, with over 3 thousand hospital facilities qualified for cell-based therapies. ?? Why is China now leading in this sector? **Strong government and regulatory support ??? **Expedited clinical data collection ?? **Various collaborations and partnerships ?? **Significant capital inflow ?? To know more about us and our services ?? -->Website ??: https://catug.bio/ #LifeScience #Pharmaceuticals #GlobalHealth #ChinaHealthcare #Innovation #DrugDevelopment #CAR-T #ClinicalTrials #SwissChineseForum #Biopharma #Collaboration #NMPA #BioTech #HealthcareTrends #TherapeuticStrategies #ClinicalResearch #MedicalAdvancements #HealthcareLeadership
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Drug Development Costs Predicted to Soar as BIOSECURE Act Gains Momentum ???? As US-China trade relations face new challenges due to the BIOSECURE Act, pharmaceutical companies exploring Contract Development and Manufacturing Organizations (CDMOs) outside China might need to brace for increased drug development and manufacturing costs. ?? Since its introduction in January, the BIOSECURE Act has sent shockwaves across the pharmaceutical sector. ?? The Act, which restricts federal funding for "biotechnology equipment or services" from companies deemed "biotechnology companies of concern," primarily targets Chinese firms like WuXi AppTec and WuXi Biologics. This has raised significant concerns about the future of collaborations with these companies, especially since many pharmaceutical companies rely heavily on federal grants to finance their clinical programs. Key Points to Consider: ?? Definition and Impact: The Act does not enforce a blanket prohibition but restricts federal funding for equipment or services from certain foreign companies, including those in China. ?? Alternatives to Chinese CDMOs: With the Act pushing for reduced dependence on Chinese CDMOs, India emerges as a notable alternative. Indian CDMOs like Syngene International Limited, Cipla, and AUROBINDO PHARMA LTD are gaining attention, alongside US-based options such as the Center for Breakthrough Medicines and Catalent Pharma Solutions. However, shifting to new CDMOs can be costly and complex. Cost Implications: Switching from Chinese to US or European CDMOs is likely to increase drug development costs. Although India offers cost-effective alternatives, it will take time for its CDMO market to mature to the level of China's. ?? Impact on Drug Approval Process: The Act might not significantly affect drug approvals in the short term but could pose challenges for companies starting new trials as the 2032 deadline approaches. ? Mitigation Strategies: Companies need to establish termination rights and technology transfer provisions with their Chinese partners. It's crucial to have multiple vendors and backup plans to ensure a smooth transition if needed. ?? ?? In Conclusion: The BIOSECURE Act represents a significant shift in the pharmaceutical landscape, compelling companies to reconsider their reliance on Chinese CDMOs. Early planning and strategic partnerships will be key in navigating this new terrain successfully. #Pharma #BIOSECUREAct #DrugDevelopment #CDMO #Biotech #China #India #USPharma #WuXiAppTec #Manufacturing #ClinicalTrials #FederalFunding #PharmaceuticalIndustry #Biotechnology #Healthcare #DrugApproval #SupplyChain #PharmaIndustry #Innovation #CostManagement #GlobalTrade #TradeRelations #Biopharma #HealthcarePolicy #FDA #NIH #PharmaNews #IndustryInsights #RegulatoryCompliance #TechTransfer #PharmaceuticalResearch
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? Thrilled to be speaking at BIOPLUS-INTERPHEX KOREA (BIX) in Seoul this July! I look forward to discussing with the panel on Europe’s regulatory landscape for clinical trials, how new regulations are shaping the industry, and the opportunities in the region.? Let’s connect at BIX to explore regulatory strategies together!?? #BIXKorea2024 #ClinicalTrialsEurope #RegulatoryAffairs?
??Exciting News! Biomapas CEO, János Filakovsky, is attending and presenting at BIOPLUS-INTERPHEX KOREA (BIX) this July in Seoul! Janos will speak on the panel, ‘Regulatory Affairs for Clinical Trials in Europe’, covering Europe’s regulatory advantages, and new regulations introduced, aiming to further streamline clinical trials approval/authorisation process within the EU market.?? The panel will discuss how Europe’s advanced clinical trial infrastructure and reasonable costs are making it an ideal destination for clinical trials. The session will explore the impact of new regulations, the competitive advantages Europe offers, and the financial incentives available.?? BIX is a premier biopharmaceutical exhibition offering keynote sessions, conferences, and networking opportunities. Janos brings his extensive expertise in clinical research, regulatory compliance, and strategic growth into this dynamic event. Join Janos for a dive into the future of clinical trials in Europe. Don't miss the chance to connect and gain valuable insights! ?Learn more about the session here: https://bit.ly/3RJ3mYU #BIXKorea2024 #Biopharmaceuticals #RegulatoryAffairs #LithuaniaCRO #KoreaBIO?
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