Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Ascentage Pharma, announced a multifaceted strategic collaboration. This collaboration includes: i) the joint commercialization of HQP1351 (olverembatinib) in China; ii) the collaborative clinical development of Bcl-2 inhibitor APG-2575 (lisaftoclax) with the anti-CD20 monoclonal antibody HALPRYZA® (rituximab biosimilar injection) and the anti-CD47 monoclonal antibody letaplimab (IBI188); and iii) the equity investment in Ascentage Pharma.
HQP1351, the core drug candidate of Ascentage Pharma, is the first China-developed third-generation BCR-ABL TKI targeting drug-resistant chronic myeloid leukemia (CML). At present, an NDA for HQP1351 has been submitted and subsequently granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) in China. According to the agreement, Innovent and Ascentage Pharma will be jointly responsible for the subsequent R&D of HQP1351 in China. Upon being granted a New Drug Application (NDA) approval, the two companies will jointly commercialize HQP1351 in China and equally split the profit generated by the joint commercialization. Innovent will leverage its advantage of broad commercial channel and experienced oncology commercial team to roll out HQP1351 to hospitals and pharmacies at various tiers, in aims to make this novel therapeutic available to the cancer patients in China.
After signing the agreement, Ascentage Pharma will receive an upfront payment of US$30 million from Innovent. Upon achieving certain pre-specified milestones in development, registration and annual sales performance of HQP-1351, Ascentage Pharma is eligible to receive up to US$115 million in milestone payments.
In addition, the two companies agree to jointly explore the possibility of developing the Bcl-2 TKI APG-2575 with the anti-CD20 monoclonal antibody HALPRYZA® (rituximab biosimilar injection) and the anti-CD47 monoclonal antibody letaplimab (IBI188), in certain indications.
Furthermore, Innovent will subscribe to Ascentage Pharma's common shares for a total consideration of US$50 million at HK$44.0 per share, and be granted stock warrants that will allow it to acquire additional Ascentage Pharma's common shares for a total consideration of US$50 million at subscription price of HK$57.2 per share within the next two years.
Dr. Michael Yu, Founder, Chairman and CEO of Innovent Biologics, stated, "We are excited to form this strategic collaboration with Ascentage Pharma, a pioneer in the field of innovative R&D of apoptosis-targeted therapies. Innovent is deeply engaged in the oncology area having built up a robust oncology pipeline of nearly 20 clinical stage assets, an industry-leading medical operations and regulatory affairs team, a broad commercial channel and a professional commercial team of over 2000 people. The collaboration with Ascentage pharma adds another near-to-launch innovative medicine HQP1351 to our pipeline, and we will leverage our advantage in the joint commercialization after the drug is approved. In addition, this collaboration creates potential synergy with our oncology pipeline such as CD47 and CD20 antibodies. Meanwhile, we are impressed with Ascentage Pharma's strong R&D capability and rich pipeline, and we hope to join in our partner's growth potential realization through the strategic equity investment. We look forward to partnering with Ascentage Pharma and bringing the innovative therapies of both parties to patients as soon as possible.
The strategic collaboration represents a new model for China biopharmaceutical companies and medical supplies manufacturers to work together to bring additional benefit to patients. Innovent has been exploring diversified and innovative strategic partnership models with outstanding pharmaceutical companies globally with the aim to make more innovative therapies available. This collaboration proves once again that Innovent is an ideal partner to help expand pipeline development and product commercialization."
Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, stated, "Innovent is a l...
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