Wuxi

Alzheon to Present Biomarker, Brain Preservation, and Clinical Results from Pivotal Program of Oral ALZ-801/Valiltramiprosate at International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders

Retrieved on: 
Tuesday, February 27, 2024

“The new treatment landscape for Alzheimer’s disease is beginning to take shape, and Alzheon’s simplified approach has an opportunity to transform the standard of care and improve access to treatment for Alzheimer’s patients.

Key Points: 
  • “The new treatment landscape for Alzheimer’s disease is beginning to take shape, and Alzheon’s simplified approach has an opportunity to transform the standard of care and improve access to treatment for Alzheimer’s patients.
  • ALZ-801’s efficacy data and favorable safety profile, showing no increased risk of vasogenic edema, underscore the differentiated clinical profile of our treatment,” said Martin Tolar, MD, PhD, Founder, President, and CEO of Alzheon.
  • Results from our pivotal APOLLOE4 Phase 3 trial will set the stage for the potential NDA filing this year and commercial launch in 2025.”
    Alzheon presentations include two posters and two symposium presentations.
  • If the results of our study are positive, we will be moving quickly to bring an oral option to Alzheimer’s patients and their families,” said John Hey, PhD, Chief Scientific Officer.

WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance's AMTAGVI™ (lifileucel) for Advanced Melanoma

Retrieved on: 
Tuesday, February 20, 2024

PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ -- WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.

Key Points: 
  • AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • AMTAGVI is also the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • "We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma.
  • "Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.

WuXi Advanced Therapies Receives FDA Approval to Manufacture Iovance's AMTAGVI™ (lifileucel) for Advanced Melanoma

Retrieved on: 
Tuesday, February 20, 2024

PHILADELPHIA, Feb. 20, 2024 /PRNewswire/ -- WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced that the U.S. Food and Drug Administration (FDA) has approved its Philadelphia site to begin the analytical testing and manufacturing of AMTAGVI for Iovance, which received FDA accelerated approval of its Biologics License Application (BLA) on February 16, 2024.

Key Points: 
  • AMTAGVI is the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • AMTAGVI is also the first and only one-time, individualized T cell therapy to receive U.S. FDA approval for a solid tumor cancer.
  • "We congratulate Iovance on this major milestone in their quest to address unmet patient needs in the treatment of advanced melanoma.
  • "Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.

Global Genome Editing Market Research Report 2023-2035: Pharmaceutical Giants Expand Capabilities - WuXi AppTec and Ensoma Lead Acquisitions - ResearchAndMarkets.com

Retrieved on: 
Monday, February 12, 2024

The "Global Genome Editing Market, 2023-2035: Focus on Technology, Industry Trends and Forecasts" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Genome Editing Market, 2023-2035: Focus on Technology, Industry Trends and Forecasts" report has been added to ResearchAndMarkets.com's offering.
  • The report features an extensive study of the current market landscape, market size and future opportunities associated with the genome editing market, during the given forecast period.
  • Further, the genome editing market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry.
  • The genome editing market landscape is concentrated with the presence of over 110 genome editing companies (very large, large, mid-sized and small companies).

Genome Editing Market Report 2024: Technology Licensing Deals are Driving the Overall Partnership Activity - Global Industry Trends and Forecasts 2023-2035

Retrieved on: 
Wednesday, February 7, 2024

DUBLIN, Feb. 7, 2024 /PRNewswire/ -- The "Global Genome Editing Market, 2023-2035: Focus on Technology, Industry Trends and Forecasts" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Feb. 7, 2024 /PRNewswire/ -- The "Global Genome Editing Market, 2023-2035: Focus on Technology, Industry Trends and Forecasts" report has been added to ResearchAndMarkets.com's offering.
  • The report features an extensive study of the current market landscape, market size and future opportunities associated with the genome editing market, during the given forecast period.
  • Further, the genome editing market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry.
  • The genome editing market landscape is concentrated with the presence of over 110 genome editing companies (very large, large, mid-sized and small companies).

WuXi XDC Enters into Partnership with Multitude Therapeutics and HySlink Therapeutics, Novel Linker-Payload Technology Enabling Clients to Accelerate ADC Discovery and Development

Retrieved on: 
Wednesday, January 31, 2024

WuXi XDC signed a Memorandum of Understanding (MOU) with HySlink on the same day.

Key Points: 
  • WuXi XDC signed a Memorandum of Understanding (MOU) with HySlink on the same day.
  • WuXi XDC will provide a fully integrated, one-stop bioconjugate platform and end-to-end CRDMO services.
  • As WuXi XDC's strategic partner, Multitude Therapeutics will provide proprietary T-Moiety linker technologies, co-developed with HySlink.
  • Multitude and HySlink, stated, "WuXi XDC has exceptional capability as a leading global CRDMO.

WuXi XDC and Celltrion Sign MOU for Integrated Services for Antibody-Drug Conjugates (ADCs)

Retrieved on: 
Wednesday, January 24, 2024

Under the collaboration, Celltrion will delegate WuXi XDC as primary service provider on each of the integrated projects, from process development to GMP manufacturing, within the global territory.

Key Points: 
  • Under the collaboration, Celltrion will delegate WuXi XDC as primary service provider on each of the integrated projects, from process development to GMP manufacturing, within the global territory.
  • WuXi XDC is an ideal partner for Celltrion given their advanced platform and broad expertise in ADC development and manufacturing.
  • Collaborating with WuXi XDC provides an exciting opportunity for us to further accelerate our innovative pipeline development and benefit patients worldwide."
  • Dr. Jimmy Li, CEO of WuXi XDC, commented, "We are very pleased to partner with Celltrion to accelerate their innovative pipeline.

WuXi AppTec Triples Peptide Manufacturing Capacity and Launches the New Taixing API Manufacturing Site

Retrieved on: 
Monday, January 8, 2024

SHANGHAI, Jan. 8, 2024 /PRNewswire/ -- WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries to advance discoveries and deliver groundbreaking treatments to patients, announced the commissioning of its two new peptide manufacturing plants, one at its Changzhou facility and another at the new Taixing site in China. This significant expansion has increased the company's Solid-Phase Peptide Synthesis (SPPS) total reactor volume to 32,000 liters, addressing the surging global demand for peptide therapeutics.

Key Points: 
  • The other newly commissioned peptide plant is situated at the company's Taixing site.
  • Commissioning the peptide plant at the Taixing site marks its official launch as the newest and largest of WuXi AppTec's five API production sites.
  • Dr. Minzhang Chen, Co-CEO of WuXi AppTec, commented: "The launch of our new peptide manufacturing plants and the development of the new Taixing site are important milestones for WuXi AppTec.
  • WuXi AppTec will continue to focus on enhancing our capability and capacity, accelerating innovative therapies to patients globally."

WuXi XDC Enters into Partnership Agreement with IntoCell, Enabling Clients to Accelerate ADC Discovery and Development

Retrieved on: 
Wednesday, January 3, 2024

Under the agreement, IntoCell will provide proprietary drug-linker technologies using their Ortho-Hydroxy Protected Aryl Sulfate (OHPASTM) Linker and novel Camptothecin drugs called NexatecansTM, a new class of OHPAS-able Camptothecins.

Key Points: 
  • Under the agreement, IntoCell will provide proprietary drug-linker technologies using their Ortho-Hydroxy Protected Aryl Sulfate (OHPASTM) Linker and novel Camptothecin drugs called NexatecansTM, a new class of OHPAS-able Camptothecins.
  • WuXi XDC will provide fully integrated, one-stop bioconjugate platform and end-to-end CRDMO services.
  • This synergy will empower clients of both parties to accelerate PCC (Pre-clinical candidates) selection further, develop more next-generation ADCs and other bioconjugates, and expedite the CMC development process.
  • It demonstrates WuXi XDC's platform development strategy, namely to grow continually and evolve to help our clients to accelerate and transform the discovery, development and manufacturing of ADCs and other bioconjugates. "

Myricx Bio Enters into an Exclusive Antibody License Agreement with WuXi Biologics

Retrieved on: 
Tuesday, November 21, 2023

Myricx intends to progress the ADC through preclinical and clinical development for difficult-to-treat solid tumours.

Key Points: 
  • Myricx intends to progress the ADC through preclinical and clinical development for difficult-to-treat solid tumours.
  • WuXi Bio will receive an upfront payment and will be eligible for development and commercialisation milestone payments, as well as royalties on net sales.
  • This is the second antibody license agreement that Myricx has entered into with a global company in the past few months as the Company builds out its pipeline of NMTi-ADCs.
  • Myricx CEO Dr Robin Carr said, “We are delighted to have reached this agreement with WuXi Bio, one of the top biologics CRDMOs globally.