11 January 2022, TOT BIOPHARM International Company Limited (TOT BIOPHARM, 1875.HK) announced the signing of an exclusive commercialization license cooperation agreement for Pusintin®’s overseas markets with Kexing BIOPHARM Co., Ltd. (Kexing Biopharm, 688136.SH). The signing ceremony adopted the method of "cloud signing". Dr. Liu Jun, CEO of TOT BIOPHARM, and Zhao Yanqing, General Manager of Kexing Biopharm, attended the ceremony.
According to the cooperation agreement, Kexing Biopharm is granted an exclusive license to commercialize 朴欣汀® (bevacizumab injection, intended English trade name: Pusintin®) in all countries and regions in the world except China (excluding Hong Kong, Macau and Taiwan regions), the European Union (based on its member states in 2021), the United Kingdom, the United States and Japan (the “Cooperation Area”). TOT BIOPHARM is entitled to receive from Kexing Biopharm an upfront payment of RMB 30 million and R&D milestone payments, a sales milestone payment of up to RMB 380 million, and an agreed proportion of net sales commission in the cooperation area. Kexing Biopharm will be responsible for the marketing application and commercialization activities of Pusintin® in the cooperation area.
Bevacizumab is an anti-vascular endothelial growth factor monoclonal antibody (anti-VEGF mAb). As a broad-spectrum anti-tumor drug, bevacizumab injection has become a globally recommended standard therapy in the treatment guidelines for a variety of malignant tumors, with abundant real-world evidence of its efficacy and safety since its entry into the market. The originator drug has been approved for 8 indications globally.
Pusintin® has obtained the marketing approval from the National Medical Products Administration (NMPA) on November 30, 2021 and is used for the treatment of advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC) and metastatic colorectal cancer (mCRC), and supplementary applications for four other indications have been submitted (three are being processed).
TOT BIOPHARM has established large-scale commercial production base that meets international standards, covering an area of 50,000 square meters with a capacity of monoclonal antibodies to reach 20,000L until the first half of 2022 and continuing to increase. Moreover, relying on its self-developed Perfusion-batch mixed culture technology (PB-Hybrid® Technology) for commercial production, the company can simplify the process and reduce production costs, thus ensuring the high-quality and stable supply of Pusintin®.
Dr. Liu Jun, CEO of TOT BIOPHARM, said, “We are very pleased to enter into the license and cooperation agreement with Kexing Biopharm, which is a domestic benchmarking enterprise to expand overseas markets. We aim to quickly introduce Pusintin® into the fast-growing emerging market through close collaboration between TOT BIOPHARM and Kexing Biopharm. This is not only a critical step for Pusintin® to enter the international market, but also a significant momentum to closely follow the national call and comply with “the Belt and Road” strategic initiative, as well as providing high-quality and affordable oncology drugs to cancer patients in emerging countries, contributing to the national medicine’s development and fulfilling our responsibility to the shared future of mankind as a whole.”
Zhao Yanqing, General Manager of Kexing Biopharm, said, “We are full of confidence in this cooperation. TOT BIOPHARM has outstanding advantages on commercial production capacity and cost control, which will continuously empower the subsequent commercial production of Pusintin®. As for Kexing Biopharm, its commercialization channels in emerging countries are maturing and becoming more and more sophisticated. We believe that this marriage of strengths will allow us to speed up overseas market deployment of Pusintin®, empower China's high-quality biological drugs to go globalization, thereby benefit more patients earlier.”
About Pusintin®
Pusintin® (bevacizumab injection) is a biological antibody drug self-developed by TOT Biopharm, which has obtained the marketing approval from the National Medical Products Administration (NMPA) of China recently and is used for the treatment of advanced, metastatic or recurrent non-squamous non-small-cell lung cancer (nsNSCLC) and metastatic colorectal cancer (mCRC). Pusintin® is a biosimilar to Avastin®, which has been approved for the treatment of nsNSCLC, mCRC, glioblastoma multiforme (GBM), hepatocellular carcinoma (HCC), ovarian cancer and cervical cancer in China.
About Kexing BIOPHARM Co., Ltd. (Stock Code: 688136.SH)
Kexing Biopharm is an innovative biopharmaceutical enterprise mainly engaged in the R&D, production and sales of recombinant protein therapeutics and microecological agents. We focus on pharmaceutical research in the therapeutic fields of antiviral, oncology, immunology, hematology, digestion and degenerative diseases.
In recent years, we have achieved continued and rapid growth in its business, becoming a leader in the recombinant protein therapeutics industry. Our core products, remained at the forefront of similar varieties in China, have been adopted by over 18,000 sales terminals, including over 6500 hospitals in the provinces, municipalities and regions across China, and accessed into and sold in over 30 countries, including Brazil, Philippines and Indonesia.