One-stop CDMO service platform Yantai MacBerry International Biomedical Co., Ltd. (hereinafter referred to as "Macbriam") congratulates partner Pioneering Pharmaceutical Co., Ltd. (stock code: 9939. HK, or "Pioneering Pharmaceuticals") PD-L1/TGF-β dual-target antibody (GT90008) was approved for clinical trials by the State Drug Administration of China (NMPA) on 21 October 2021.
Since September 30, 2020, the two parties have established a cooperative relationship on the GT90008 project, pioneered the pharmaceutical industry to formulate an efficient project plan and actively cooperated with the Macbria team to complete the preparation of toxicological batch samples within 3 months, and the project was approved for clinical trials 13 months after its launch, and Macbriam's excellent one-stop CDMO service platform has been once again proved.
Dr. Tong Youzhi, founder, chairman and CEO of Pioneering Pharmaceuticals, said: "We are very pleased to have been approved by NMPA to carry out the clinical trial of PD-L1/TGF-β dual-target antibodies, GT90008 is the second new antibody drug in the clinical trial stage of Pioneering Pharmaceuticals, from the introduction to the clinical license, the speed of promotion is rapid, which fully reflects the work efficiency and execution of the team. Although the clinical effect of this dual target has recently been questioned, our goal is to actively explore clinical strategies for the treatment of advanced tumors with combined ALK-1 monoclonal antibodies, and we expect that the combination of GT90008 and GT90001 can bring new hope to patients with advanced tumors. Thanks to the Macbury team for their efforts.
Dr. Li Xinfang, President of Macbury, said: "We are very pleased to be able to provide our professional and efficient services for the GT90008 project to help explore the pharmaceutical industry's exploration of advanced tumor treatment; the R&D, production and quality team of nearly 500 people on The McBly one-stop CDMO service platform is a reliable backing for the research and development of new drugs for customers, and we are willing to help the new drug development process of customers around the world with compliant and efficient solutions. I wish the GT90008 project a smooth clinical trial of new drugs and benefit the majority of patients with advanced tumors.
About the development of the pharmaceutical industry
Founded in 2009, Pioneer Pharmaceuticals focuses on the development and industrialization of potential "best-in-class" and "first-in-class" innovative drugs, and strives to become a leader in the research, development and commercialization of innovative therapies. Pioneering Pharmaceuticals has prospectively laid out a diversified product pipeline including small molecule innovative drugs, bio-innovative drugs and combination therapies, including five new drug projects undergoing clinical research, androgen receptor (AR) antagonists, ALK-1 monoclonal antibodies, mTOR kinase targeted inhibitors and Hedgehog/SMO inhibitors, as well as PD-L1/TGF-β dual-target antibodies, AR-Degrader and c-Myc inhibitors that are undergoing preclinical research. The company has more than 60 patents that have been obtained and applied for in the world, and a number of projects have been listed as the "major new drug creation" special projects of the 12th and 13th Five-Year Plans of the country. On May 22, 2020, Pioneering Pharmaceutical was officially listed on the main board of The Stock Exchange of Hong Kong Limited, stock code: 9939. HK。 Welcome to the company's website: www.kintor.com.cn
About Macbury
Macbury's mature CHO cell large-scale culture and ADC technology platform can provide customers with one-stop and customized services for innovative biological drugs and biosimilars such as monoclonal antibodies, double antibodies, fusion proteins, and ADCs, from cell line construction and process development to clinical sample production and even commercial production. It is one of the few CDMO companies in the world that can provide ADC drug full-process services from research and development to commercial production. Macbury has reached cooperation with dozens of customers in China, the United States, Europe and other countries, undertaking 65 comprehensive projects, 25 projects have obtained FDA, NMPA, TGA clinical trial approvals, 1 customer uses samples provided by Macbury to carry out Phase III clinical trials in the United States, and 6 customers use samples provided by Macbury to carry out Phase II clinical trials in the United States. Welcome to the company's website: www.mabplex.com
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