08.23.19
CMAB Biopharma (Suzhou) Inc., a pure-play CDMO business in biologics, and Suzhou Kintor Pharmaceuticals, Inc., an innovative biopharmaceutical enterprise, have formed a strategic cooperation agreement for the development and manufacturing of Kintor's ALK-1 mAb.
ALK-1 mAb has been studied in two Phase-I clinical trials in the U.S., Italy, South Korea and Japan from 2007 to 2014. In these two clinical studies, ALK-1 mAb demonstrated favorable PK and safety profile and reasonable clinical benefits, which suggest that this novel therapeutic antibody has a potential to be a first-in-class in targeting ALK-1, an angiogenesis target. Kintor has been granted the exclusive and worldwide rights to develop, manufacture and commercialize this novel anti-angiogenic drug, and has initiated a Phase II clinical trial in combination with nivolumab in patients with hepatocellular carcinoma (HCC) in Taiwan. This is the first time Pfizer has licensed a Chinese company to develop a new antibody drug for oncology indications, which is expected to become the first fully human therapeutic monoclonal antibody that targets ALK-1 in the world.
According to the agreement, CMAB will provide a full range of CMC research and manufacturing services that meet the IND application requirements of China and the U.S. This strategic cooperation will support the clinical development of ALK-1 antibody worldwide by Kintor. This collaboration is based upon CMAB's sophisticated CMC process development and manufacturing platform, experienced R&D team in IND applications in both China and the U.S., and an advanced product quality system.
"We are delighted and greatly honored that a comprehensive strategic cooperation agreement can be launched with Kintor. Kintor has been an outstanding player for the development of innovative anti-tumor drugs in China and recruited a top leadership team with drug discovery experience from multinational pharmaceutical companies,” said Dr. Yongzhong Wang, chief executive officer, CMAB. “This well recognized innovative drug discovery company has delivered a strong portfolio across pre-clinical development to Phase-III clinical trials. ALK-1 MONOCLONAL ANTIBODY, a blockbuster large molecule clinical asset, is now in a critical stage of clinical development. To support Kintor's clinical development plan, CMAB will not only provide professional CMC technology and manufacturing services for Kintor, but also make full use of its team's expertise in IND application both in China and the U.S.”
Dr. Youzhi Tong, president and chief executive officer, Kintor, said, "During the discussion of this collaboration agreement, we have been very impressed with the expertise of CMAB's biotechnology team, the world-class production equipment and facilities and the customer-centered attitude toward cooperation. We, therefore, have decided to work together for the development manufacturing of ALK-1 antibody with CMAB. With the extensive and comprehensive discussions about this collaboration project, we have felt very confident in choosing CMAB as our long-term partner.”
CMAB Biopharma is a flexible full-service CDMO dedicated to providing bespoke development and manufacturing services of antibodies and biologics for clients in China and across the globe.
ALK-1 mAb has been studied in two Phase-I clinical trials in the U.S., Italy, South Korea and Japan from 2007 to 2014. In these two clinical studies, ALK-1 mAb demonstrated favorable PK and safety profile and reasonable clinical benefits, which suggest that this novel therapeutic antibody has a potential to be a first-in-class in targeting ALK-1, an angiogenesis target. Kintor has been granted the exclusive and worldwide rights to develop, manufacture and commercialize this novel anti-angiogenic drug, and has initiated a Phase II clinical trial in combination with nivolumab in patients with hepatocellular carcinoma (HCC) in Taiwan. This is the first time Pfizer has licensed a Chinese company to develop a new antibody drug for oncology indications, which is expected to become the first fully human therapeutic monoclonal antibody that targets ALK-1 in the world.
According to the agreement, CMAB will provide a full range of CMC research and manufacturing services that meet the IND application requirements of China and the U.S. This strategic cooperation will support the clinical development of ALK-1 antibody worldwide by Kintor. This collaboration is based upon CMAB's sophisticated CMC process development and manufacturing platform, experienced R&D team in IND applications in both China and the U.S., and an advanced product quality system.
"We are delighted and greatly honored that a comprehensive strategic cooperation agreement can be launched with Kintor. Kintor has been an outstanding player for the development of innovative anti-tumor drugs in China and recruited a top leadership team with drug discovery experience from multinational pharmaceutical companies,” said Dr. Yongzhong Wang, chief executive officer, CMAB. “This well recognized innovative drug discovery company has delivered a strong portfolio across pre-clinical development to Phase-III clinical trials. ALK-1 MONOCLONAL ANTIBODY, a blockbuster large molecule clinical asset, is now in a critical stage of clinical development. To support Kintor's clinical development plan, CMAB will not only provide professional CMC technology and manufacturing services for Kintor, but also make full use of its team's expertise in IND application both in China and the U.S.”
Dr. Youzhi Tong, president and chief executive officer, Kintor, said, "During the discussion of this collaboration agreement, we have been very impressed with the expertise of CMAB's biotechnology team, the world-class production equipment and facilities and the customer-centered attitude toward cooperation. We, therefore, have decided to work together for the development manufacturing of ALK-1 antibody with CMAB. With the extensive and comprehensive discussions about this collaboration project, we have felt very confident in choosing CMAB as our long-term partner.”
CMAB Biopharma is a flexible full-service CDMO dedicated to providing bespoke development and manufacturing services of antibodies and biologics for clients in China and across the globe.
