扬帆出海！东曜药业与科兴制药就朴欣汀®海外市场商业化许可达成协议
非常高兴与科兴制药达成朴欣汀®的海外市场商业化许可合作。科兴制药是中国药企出海的标杆型企业，通过本次合作，东曜药业将联同科兴制药将朴欣汀®推向快速发展中的新兴国家市场，这是朴欣汀®进军国际市场的关键一步，也是紧跟国家号召、顺应“一带一路”战略的重要举措，为新兴国家癌症患者提供高质量且可负担的好药，为民族医药发展贡献一份力量，为人类命运共同体尽一份责任。
我们对于本次合作充满信心，东曜药业的商业化生产能力和成本优势非常明显，为朴欣汀®的后续生产提供了有力保障；同时科兴制药在新兴国家的商业化渠道也日趋完善，相信借助彼此优势，我们可以加速推进朴欣汀®的海外市场布局，推动中国高品质生物药走出国门，早日惠及更多患者。
朴欣汀®（贝伐珠单抗注射液）是由东曜药业自主开发的抗体药物，已经获得中国国家药品监督管理局的上市批准，用于治疗晚期、转移性或复发性非鳞状非小细胞肺癌和转移性结直肠癌。朴欣汀®是安维汀®（Avastin®）的生物类似药，后者在中国已获批用于治疗转移性结直肠癌、非小细胞肺癌、胶质母细胞瘤、肝细胞癌、卵巢癌、宫颈癌。
科兴制药是一家主要从事重组蛋白药物和微生态制剂的研发、生产、销售一体化的创新型生物制药企业，专注于抗病毒、肿瘤与免疫、血液、消化、退行性疾病等治疗领域，目前在新型蛋白、新型抗体、核酸药物等技术方向进行研发布局，致力于用生物技术服务全球患者，成为高品质生物药领导者。
近年来，科兴制药业务持续高速增长，已成为重组蛋白药物的领军企业。核心产品稳居国内同类品种前列，覆盖全国各省市地区18000多家终端，其中等级医院6500余家，并通过巴西、菲律宾、印度尼西亚等全球30多个国家的市场准入并实现销售。
东曜药业专注于创新型抗肿瘤药物及疗法的开发及商业化，致力于打造患者及其家属、医疗专业人士信赖的肿瘤治疗领先品牌。
公司已经建成具有国际竞争力的创新药商业化生产基地，其中包含单抗原液和制剂车间，以及集ADC原液和冻干制剂生产于一体的ADC商业化生产车间。预计到2022年上半年，生物药商业化生产基地产能达到约20,000升，可以实现创新药物的高质量商业化生产。
凭借研发和生产优势，公司研究开发了多个系列、多个品种的抗肿瘤药物，形成了高水平、多元化的药物产品链。在自主创新开发药物的同时，东曜药业与国内外制药公司开展多元的战略合作，提供从研发、工艺开发、临床试验、注册申报到商业化生产的一站式CDMO解决方案，秉持“以品质 助创新 共成长”的服务理念，加速化药、生物药特别是ADC药物的开发和生产，赋能合作伙伴，造福广大病患。
Setting Sail! TOT BIOPHARM and Kexing Biopharm Sign Commercialization License and Cooperation Agreement on Pusintin® Overseas Market
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 (including 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) of China 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, Philippinesand Indonesia.
About TOT BIOPHARM International Company Limited(Stock Code: 1875.HK)
TOT BIOPHARM is dedicated to developing and commercializing innovative anti-tumor drugs and therapies, striving to build a leading oncology treatments brand worthy of the trust of patients and their family members, and medical professionals.
The Company has set up an internationally competitive innovative drugs commercial production base equipped with including antibody drug substance and formulation production facility, as well as an integrated ADC commercial production facility capable of putting out both ADC drug substance and freeze-dried formulation. By the first half of 2022, the production capacity for biological drugs of the base is expected to reach approximately 20,000 liters, realizing quality commercial production of innovative drugs.
Given its competitiveness in R&D andproduction, TOT BIOPHARM has developed many series and varieties of oncology drugs, forming a high standard and comprehensive pharmaceutical product chain.In addition to innovating in developing its own drugs, it also has strategic partners in domestic and overseas pharmaceutical corporations to provide one-stop CDMO services from R&D, crafts development, clinical trials, registration and application to commercial production. Upholding its “facilitating innovation and mutual growth with a focus on quality” service concept, the Company is committed to hastening development and production of chemical drugs and biological drugs, especially ADC drugs, and to empowering its partners to the ultimate end of benefiting patients.