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Suzhou Kintor Teams up with CMAB Biopharma Inc. for the Development and Production of ALK-1 Monoclonal Antibody

  • Time of issue:2019-08-19

(Summary description)[Suzhou, August 19, 2019]Suzhou Kintor Pharmaceuticals, Inc. (“Suzhou Kintor") and CMAB Biopharma (Suzhou) Inc. ("CMAB") announced together a comprehensive strategic cooperation agreement on the development and production of ALK-1 monoclonal antibody in Suzhou Biopharma Industrial Park (BioBAY).

Suzhou Kintor Teams up with CMAB Biopharma Inc. for the Development and Production of ALK-1 Monoclonal Antibody

(Summary description)[Suzhou, August 19, 2019]Suzhou Kintor Pharmaceuticals, Inc. (“Suzhou Kintor") and CMAB Biopharma (Suzhou) Inc. ("CMAB") announced together a comprehensive strategic cooperation agreement on the development and production of ALK-1 monoclonal antibody in Suzhou Biopharma Industrial Park (BioBAY).

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  • Time of issue:2019-08-19 15:23
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[Suzhou, August 19, 2019]Suzhou Kintor Pharmaceuticals, Inc. (“Suzhou Kintor") and CMAB Biopharma (Suzhou) Inc. ("CMAB") announced together a comprehensive strategic cooperation agreement on the development and production of ALK-1 monoclonal antibody in Suzhou Biopharma Industrial Park (BioBAY).
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Opening up the signing ceremony of strategic cooperation between pharmaceutical industry and Suqiao biology
Signing ceremony of the strategic cooperation agreement between Kintor and CMAB Two phase I clinical trials of ALK-1 (Activin receptor-like kinase-1) monoclonal antibody as a reference listed drug of Pfizer were completed in the United States, Italy, South Korea, and Japan between 2007 and 2014, and good safety was demonstrated in these trials which enrolled more than 100 patients with advanced solid tumors. Therefore it was considered as a potential “first-in-class” drug. The Group was granted the exclusive rights by Pfizer to develop, produce and commercialize the drug globally in January 2018, and was the first company which conducted a phase II clinical trials in Taiwan for liver cancer in combination with PD-1 (Nivolumab). This drug is expected to emerge as the first therapeutic drug of fully human monoclonal antibody against the ALK-1 worldwide. According to the agreement, CMAB will provide all services related to CMC research and clinical sample production for the development of ALK-1 monoclonal antibody from Kintor to meet the requirements of the Sino-US IND application. This strategic cooperation will leverage a high-level CMC process development and production platform from CMAB, R&D team with rich experience in Sino-US IND application, and a sound product quality system to advance the development and marketing of ALK-1 monoclonal antibody.
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Photo of signing ceremony of both parties
Photo of the signing ceremony between two parties Dr. Youzhi Tong, the Group's Chairman and CEO said, "Detailed inspection and intensive project discussion have done much to reassure our confidence in choosing CMAB as a long-term partner of the Group. CMAB has embraced the world-class production equipment and facilities, excellent technical integration capabilities, and mature CDMO technology. Meanwhile, it has a core technical team with extensive experience in Sino-US IND application and a sophisticated intellectual property protection system. We believe that the cooperation between the two parties will reinforce the successful Sino-US IND application of our ALK-1 monoclonal antibody, and help cancer patients in China and even the world to have access to more and better therapeutic regimen as soon as possible.”
"We are honored to have the opportunity to reach a comprehensive strategic cooperation agreement with Suzhou Kintor. Through a decade of development, Suzhou Kintor, as an enterprise specializing in innovative drugs against tumors in China, has brought together more than a dozen high-level leading talents as returnees, focusing on the treatment of prostate cancer, breast cancer, liver cancer and hair lost and building a rich product pipeline. Several product pipelines have been included into the pre-clinical to clinical phase III clinical trials. Among these drugs, ALK-1 monoclonal antibody, a blockbuster bio-macromolecular candidate in the world, has entered a key R&D stage.” “CMAB will not merely provide professional CMC technology and production services for Suzhou Kintor, but also make the utmost of team experience in Sino-US IND application to offer high-quality products and services in compliance with the requirements of international drug regulators, thereby contributing to the rapid advancement of the ALK-1 monoclonal antibody from Suzhou Kintor into clinical trials and commercial production so as to accelerate the successful launch of the product.”, said Dr. Wang Yongzhong, CEO of CMAB.
Founded in 2009, Suzhou Kintor is an innovative enterprise and industrialized platform committed to the development of “best-in-class” and “first-in-class” drugs. The Group's products are Class 1 novel drugs covering the prostate cancer, breast cancer, liver cancer and hair loss. Many projects have been listed as the National Special Project for "Significant Novel Drugs Development" during the 12th and 13th Five-Year Plan period. Its major product, Proxalutamide, is undergoing clinical trials in China and the United States concurrently. Clinical trials of this product are conducted as a second-line therapy and a first-line therapy for mCRPC in the phase III in China and as a second-line therapy for mCRPC in the phase II in the United States. Phase I / Ib clinical trials have been completed in China for metastatic breast cancer, and Phase Ic clinical trials for combined drugs are ongoing for breast cancer; Phase I clinical trials of KX-826 for androgenetic alopecia has been completed in China and the United States, and phase II clinical trials are ready to be carried out in China and the United States; We hold an exclusive global license from Pfizer to develop and commercialise ALK-1. Two phase I clinical trials have been completed in the U.S. and other regions. A phase II clinical trials is currently being conducted in Taiwan for ALK-1 monoclonal antibody combined with PD-1 (Nivolumab) for the treatment of liver cancer. The R&D pipeline also includes selective inhibitor against mTOR kinase, Hedgehog / SMO inhibitors, cMyc inhibitors and AR-Degrader. Suzhou Kintor was selected as the "Unicorn Cultivation Enterprise" in Suzhou City and Suzhou Industrial Park in 2018, respectively.
[About CMAB]
Established in 2017, CMAB Biopharma Inc. (CMAB) is located in Suzhou Biopharma Industrial Park, covering an area of 10,500 square meters. The total amount of financing has exceeded RMB600 millionwithin two years since its incorporation. It is currently the fastest growing bio-macromolecule CDMO company in China. Our core team members come mostly from top biopharma companies across the globe and have extensive experience in the biopharmaceutical industry. The production base is designed based on international first-class standards, and it conforms to domestic and foreign GMP standards; it is equipped with mainstream facilities compatible with multiple production process platforms used by top biopharma companies at home and abroad. Up to now, CMAB's capabilities include high-level production process development, technology transfer, project management, production and quality management, and IP protection system. Its production system is designed on the basis of advanced one-stop production technology, offering GMP - conformed production capacities of 3, 15, 50, 200, 500, 1000 and 2000 liters, and full integrated services for international contract R&D and production. CMAB offers a wide range of operational capabilities, including DNA sequence, biopharmaceutical products, process development, large-scale production, drug testing, quality assurance, provision of leading project management experience, excellent services of drug registration and strict protection system of customer intellectual property. Throughout CMAB's comprehensive footprints, CMAB always aims to ensure that we provide customers with the highest level services of biopharmaceutical development and production.
 

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