AsymBio

We are pleased to invite you to a webinar on September 24th at 10 AM EST: Navigating Antibody & ADC Advancements: Expert Perspectives and Industry Trends. This event will feature esteemed experts who will discuss the most recent advancements in antibody therapeutics and Antibody-Drug Conjugates (ADCs). Don't miss this opportunity to enhance your understanding of this rapidly evolving field. Register now to secure your spot! #biotech #antibody #Asymbio #Asymchem #ADC #therapeutics #Webinar #medicovestor #AntibodySociety

If you are a innovator in ADC/NDC field looking for a reliable partner for drug product development from bench to launch, AsymBio is your first choice. IMPACT Platform owns the technical expertise in formulation and process development to support clinical and commercial supply. We take your molecules to IND, BLA and beyond! #ADC #IND #BLA #CMC #CDMO #clinical #commercial #formulation #AsymBio #process_development

a. Shanghai Huaota announced that National Medical Products Administration (NMPA) granted IND approval for HB0052, a type of CD73 targeting ADC. Phase I trial will be initiated in China in Sep 2024 for advanced solid tumors, which makes HB0052 the 2nd CD73-ADC candidate to enter clinical trials globally. b. European Commission (EC) has approved KEYTRUDA in combination with Padcev (an antibody-drug conjugate) for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. The decision follows the adoption of the European Society for Medical Oncology and European Association of Urology clinical guidelines. Source: official announcement Contact AsymBio for leading ADC CDMO solutions! https://www.asymbio.com/ #ADC #EU #NMPA #IND #Clinical #cancer #carcinoma #KEYTRUDA #Padcev

At AsymBio, we provide top-notch drug product development solutions from bench to BLA to drive innovations for multiple modalities, such as ADCs, antibodies, recombinant proteins etc. We take pride in our deep technical expertise in formulation and process development to support clinical and commercial supply. If you are looking for the right CDMO partner for your molecules, check out our IMPACT platform for the customized services that fit your needs. The platform features: a.   Developability evaluation b.   Lyo DP development c.   Clinical in-use evaluation d.   High concentration DP development e.   Photosensitive ADC DP development Visit our website for more information! https://www.asymbio.com/ #ADC #DP #formulation #biologics #proteins #antibody #photosensitive #clinical #developability #BLA #IND #research

Doma announced that FDA has approved the company's IND application for bispecific ADC, DM005. This milestone paves the way for Phase 1 clinical trials of DM005 in subjects with advanced solid tumor in the United States. The clearance of this IND application marks a significant milestone for Doma as the company continues to advance its pipeline of novel therapeutic candidates into clinical development. Previously in Doma's 1st bispecific ADC was authorized by FDA for clinical trials in July 2024. Source: official announcement AsymBio is a leading ADC CDMO solutions provider. Click for more details. https://www.asymbio.com/ #ADC #FDA #clinical #cancer #tumor #CDMO #IND #milestone

At AsymBio, we provide top-notch drug product development solutions from bench to BLA to drive innovations for multiple modalities, such as ADCs, antibodies, recombinant proteins etc. We take pride in our deep technical expertise in formulation and process development to support clinical and commercial supply. If you are looking for the right CDMO partner for your molecules, check out our IMPACT platform for the customized services that fit your needs. The platform features: a.   Developability evaluation b.   Lyo DP development c.   Clinical in-use evaluation d.   High concentration DP development e.   Photosensitive ADC DP development Visit our website for more information! https://www.asymbio.com/ #ADC #DP #formulation #biologics #proteins #antibody #photosensitive #clinical #developability #BLA #IND #research

a. Mabwell announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for "a randomized, controlled, open-label, multicenter Phase III clinical study of 9MW2821 in combination with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer" has been approved. The corresponding Phase III clinical study has been initiated and is currently in the enrollment stage. 9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell, which has been approved for three pivotal clinical trials. b. Fudan Zhangjiang announced first patients have just been included in the innovative and promising clinical study for FDA018. It is a type of novel anti-Trop2 ADC for triple-negative breast cancer (TNBC). Source: official announcement of Mabwell & Fudan Zhangjiang Check out integrated ADC CDMO solutions by AsymBio ! https://www.asymbio.com/ #ADC #TNBC #NMPA #CDE #clinical #patients #innovation #novel #CDMO #

Don't miss our upcoming #webinar on Aug 31 at 9-10 pm EDT! Dr. Shujing Wang, Senior Director of AsymBio Center of Technology and Innovation, will give a talk on "Challenges and Strategies on Drug Product Development of Antibody Drug Conjugates (ADC)". ADC development and production are an efficient coordination of diverse modules including the payload-linkers, antibodies, ADC drug substance and ADC drug product. Combined with the payload-linker synthesis capabilities of Asymchem, Asymbio provides one-stop CMC service for ADCs, through the fluent cohesion between process modules, comprehensive quality system and advanced project management, to realize optimum control and balance on quality assurance, cost reduction, risk mitigation and timeline compression for our customers. Register now! https://lnkd.in/eScH4KuE To learn more about AsymBio, please visit: https://www.asymbio.com/ #adc #webinar #asymbio #antibodydrugconjugate #bioconjugates #conjugates #drugsubstance #drugproduct #cmc #payloadlinker #payload #linker

Multitude Therapeutics, a strategic partner of AsymBio, announced National Medical Products Administration (NMPA) has accepted the company’s IND application for AMT-676, an anti-CDH17 antibody-drug conjugate (ADC). AsymBio, the leading CDMO solutions provider, warmly extends congratulations on this major milestone achievement. With this IND approval, Multitude Therapeutics will be able to conduct phase 1 clinical trials in China for patients with advanced solid tumors, which will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AMT-676. We look forward to continuing our collaboration to advance their clinical trials to solve unmet medical needs for patients worldwide.

China currently holds the 𝗹𝗮𝗿𝗴𝗲𝘀𝘁 share of the global ADC pipeline at 43.8% with a total of 519 ADC drug candidates, 155 of which are currently in clinical trials. Chinese pharmaceutical companies have emerged as leading players in global ADC research and development, especially for molecules targeting CLDN18.2, CD73, CD444v9, MUC18, etc. (Source: Insight database) AsymBio’s ONE total solutions for ADCs are designed to streamline complex processes, alleviate challenges, and propel your ADCs towards successful commercialization. By combining our expertise, we are committed to redefining the possibilities within bioconjugate landscape, offering a seamless and comprehensive approach from inception to manufacturing. #ADC #CD73 #CD444v9 #MUC18 #China #clinical #bioconjugate #manufacturing #Multitude #Syndivia #Sotio #LaNova #Innovent #Lepu #KeyMed