Weekly in Asia｜Nov-1

20191110-1116

I-Mab Biopharma Receives IND Approval from NMPA to Initiate Clinical Trials for its Anti-GM-CSF Monoclonal Antibody TJM2 in China

On November 14, I-Mab Biopharma, a China and U.S.-based clinical-stage biopharmaceutical company announced that the National Medical Products Administration (NMPA) has approved its IND application for TJM2 to conduct clinical trials in patients with rheumatoid arthritis (RA).

TJM2, a humanized immunoglobulin G1 (IgG1) neutralizing antibody, is the first in-house developed drug candidate from I-Mab’s global portfolio of internally developed candidates to have entered clinical trials. Patients with autoimmune and inflammatory diseases have been recruited to the trials and the outcomes were positive.

About I-Mab

I-MAB Biopharma Co., Ltd. is a clinical-stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and autoimmune diseases. The Company produces monoclonal antibodies, immune cytokines, bispecific antibodies, tumor innovative drugs, and other products.

NEC and VAXIMM Collaborates to Advance Personalized Neoantigen Cancer Vaccines

Cancer is one of the greatest threats to human, with millions of new cases diagnosed worldwide annually. NEC Corporation, a leader in IT and network technologies, and VAXIMM, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, announced on November 12 the signing of a strategic clinical trial collaboration agreement and an equity investment agreement to develop novel personalized neoantigen cancer vaccines.

Under terms of the collaboration, NEC and VAXIMM will co-develop personalized cancer vaccines using NEC’s cutting-edge artificial intelligence (AI) technology, which is utilized in its Neoantigen Prediction System, and VAXIMM’s proprietary T-cell immunotherapy technology.

The vaccines are planned to be evaluated in a Phase I clinical trial in various solid tumors. NEC will provide funding for a Phase I clinical trial. VAXIMM will be responsible for conducting the clinical trial, which is expected to be initiated in 2020.

About NEC Corporation

Founded in 1899, Tokyo, NEC Corporation is a leader in the integration of IT and network technologies. The Company manufactures and provides computers, telecommunication equipment, electronic devices, semiconductors, and software.

About VAXIMM

VAXIMM is a privately held, clinical stage, Swiss/German biotech company that develops active immunotherapies for patients suffering from cancer.

Imagion Biosystems’ Cancer Diagnosed Patent Issued in India

According to the International Agency for Research on Cancer, in India, the number cancer diagnosed will reach 1.41 million by 2026. Much like other places on the globe, breast cancer and lung cancer are the most common cancers in the country, with nearly 60 percent of breast cancer patients being diagnosed in late stages. In markets like India where diagnosis often only occur in later stages, there is a huge opportunity to improve survival rates.

Imagion Biosystems Limited, an Australian company dedicated to early detection of cancer, has been issued a patent from the Government of India Patent Office, related to detection, measurement and imaging of cancer using targeted magnetic nanoparticles. The company is now planning to expand its business in India.

About Imagion Biosystems

Imagion Biosystems Ltd. manufactures and supplies medical equipment. The Company offers a bio-imaging detection technology that uses disease specific targeting nanoparticles and highly sensitive detectors to locate tumors and other diseased cells by their molecular signature.

Adimmune’ Quadrivalent Flu Vaccine Recieve Thai FDA Approval

Taiwanese vaccine maker Adimmune corporation announced that the production of the quadrivalent flu vaccine ADIMFLU TETRA has been approved by the Thai FDA in October this year. The drug is expected to be available for sale in Thailand next year, opening up the Southeast Asian market for Taiwan’s biologics industry.

About Adimmune

Founded in 1965, Adimmune Corporation (ADIM) is the only influenza vaccine manufacturer with both EU GMP and US FDA certification in Asia, as well as the only PIC/S GMP manufacturer of human vaccines in Taiwan.

BeiGenes’ BRUKINSA™ (zanubrutinib) receives FDA approval

BeiGene, Ltd., a Chinese commercial-stage biopharmaceutical company, announced on November 18 receiving the approval from the U.S. Food and Drug Administration (FDA) for BRUKINSA™ (zanubrutinib), as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.

BRUKINSA™ is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that was designed to maximize target occupancy and minimize off-target binding. It is currently being evaluated globally in a broad pivotal clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

About BeiGene

BeiGene, Ltd. is a commercial stage biopharmaceutical company focusing on the discovery, development, and commercialization of immuno-oncology drugs for the treatment of cancer.

References:

1. http://www.i-mabbiopharma.com/en/article-389.aspx
2. https://www.nec.com/en/press/201911/global_20191112_01.html
3. https://imagionbiosystems.com/imagion-biosystems-patent-issued-in-india/
4. https://www.chinatimes.com/realtimenews/20191113000408-260206?chdtv
5. http://ir.beigene.com/news-releases/news-release-details/us-fda-grants-beigenes-brukinsatm-zanubrutinib-accelerated

Author

GeneOnline