On August 8, 2021, Rongchang Biotechnology (09995. HK) reached a global exclusive licensing agreement with internationally renowned biopharmaceutical company Seagen Inc. (SGEN) to develop and commercialize its ADC new drug, vidiximab.
It is reported that Rongchang Biotechnology will generate a total potential revenue of up to 2.6 billion US dollars from this transaction, including a down payment of 200 million US dollars and a milestone payment of up to 2.4 billion US dollars. At the same time, Rongchang Biotechnology will receive a gradient sales commission from high single digits to more than 10% of net sales of vidiximab in the Seattle gene region. Seattle Gene has obtained the rights of global development and commercialization of vidicizumab outside Rongchang Biological Region, and Rongchang Biological will reserve the rights of clinical development and commercialization in Asia (except Japan and Singapore). This transaction amount has set a new record for single variety overseas authorization transactions by Chinese pharmaceutical companies.
Vidiximab is a novel ADC drug targeting HER2, with high affinity for HER2 and intracellular endocytosis efficiency. As a single drug treatment, vidicizumab has shown clinical anti-tumor activity in urothelium cancer, gastric cancer, breast cancer and other tumors with HER2 expression, and has obtained world leading clinical data, especially in tumor patients with low HER2 expression, it has also achieved good therapeutic effects. In addition, the combined treatment effect of this drug and PD-1 drug has also been confirmed in the clinical trials of urothelium carcinoma. Because the clinical efficacy is significantly better than the existing treatment methods, the indication of vidicizumab for urothelium cancer has been recognized by the US FDA and the State Food and Drug Administration for breakthrough treatment, and the indication for advanced breast cancer has been recognized by the State Food and Drug Administration for breakthrough treatment. So far, it is the only domestic ADC drug that has been recognized by the US FDA for breakthrough treatment. This drug has been conditionally approved for marketing in China for the treatment of locally advanced metastatic gastric cancer. On July 14, the State Drug Administration accepted its application for the marketing of new drugs for locally advanced or metastatic urothelium cancer.
Vidiximab has shown strong anti-tumor effects in various advanced cancers that lack effective treatment methods, "said Dr. Jianmin Fang, co-founder, CEO, and Chief Scientific Officer of Rongchang Biotechnology, Seattle Genomics is an internationally renowned biopharmaceutical company widely recognized in the field of tumors and ADC. We are pleased to collaborate with Seattle Genomics to maximize the potential of vidiximab and benefit patients worldwide. The signing of this contract fully reflects the advanced technology and enormous commercial value of vidiximab, highlighting the important position of Rongchang Biotechnology in the global ADC field. It is Rongchang Biotechnology that has transformed itself from a local Chinese company An important milestone in the company's transformation into an international biopharmaceutical company.
As a leading biopharmaceutical company in the global oncology and ADC fields, Seattle Gene is optimistic about the advanced technology and huge market potential of this Chinese original ADC new drug. Dr. Clay Siegall, President and CEO of Seattle Genetics, stated: Vidiximab is a late stage clinical product with multiple development opportunities. As a monotherapy or in combination with PD-1 inhibitors, it fully demonstrates the potential for differentiated ADC in various solid tumors with different HER2 expression levels. It can further expand and enrich the depth and diversity of the Seattle gene product pipeline, which is strategically beneficial for us to continue expanding global space and providing meaningful treatment to patients everywhere
Rongchang Biotechnology was established in 2008 and has set multiple records in China's biopharmaceutical field. As early as ten years ago, Rongchang Biotechnology Company proactively determined that ADC drugs were a key direction for the development of anti-tumor drugs, and focused on the layout of ADC. It established an ADC platform with integrated independent innovation capabilities, covering the entire process of ADC research, development, and production, thereby leading the ADC race in China. In addition to vidiximab, there are three ADC drugs in its development pipeline that have already entered the clinical stage. In terms of other innovative drugs, in March of this year, Rongchang Biotechnology independently developed the world's first dual target therapy for systemic lupus erythematosus, the biopharmaceutical Tataxipu, which was approved for sale in China. This "sea voyage" of Viticizumab demonstrates that Rongchang Biological's independent research and development strength has been recognized by well-known international pharmaceutical companies.
About Rongchang Biology
Rongchang Biopharmaceutical (Yantai) Co., Ltd. is a leading innovative biopharmaceutical company in China, headquartered in the Yantai Economic and Technological Development Zone, with research and development centers and branches in Beijing, Shanghai, California, and Maryland. The company is committed to discovering, developing, producing, and commercializing original biopharmaceuticals with independent intellectual property rights, and has created a batch of new biopharmaceuticals with significant clinical value for major diseases such as autoimmune, oncology, and ophthalmology. Currently, more than 20 candidate biopharmaceutical products are being developed, and more than 20 indications for 7 products are undergoing clinical trials or have entered the commercialization stage. Among them, the world's first innovative drug for dual target treatment of systemic lupus erythematosus, Tataxipu, was approved for sale in March 9th; The first domestically produced antibody conjugated (ADC) drug in China, Vidiximab, was approved for sale on June 8th. On November 9, 2020, Rongchang Biotechnology was listed on the Hong Kong Stock Exchange, raising a total of 590 million US dollars, setting a record for the world's largest biotechnology IPO that year.
Seagen is a global biotechnology company dedicated to discovering, developing, and commercializing innovative cancer drugs that have a meaningful impact on human life. Seagen is headquartered in the Seattle area of Washington, USA and has branches in California, Canada, Switzerland, and the European Union.
Vidicizumab is China's first original antibody coupled (ADC) drug developed by Rongchang Biology. It targets HER2 protein on the tumor surface, and can accurately identify and kill tumor cells. It has obtained global leading clinical data in clinical trials of treating gastric cancer, urothelium cancer, breast cancer and other tumors. It is the first ADC drug in China that has been recognized by the US FDA and the State Drug Administration for breakthrough treatment. On June 9, 2021, the indication for gastric cancer of this drug was approved for sale by the National Drug Administration; On July 14, the application for listing urothelium cancer indications was accepted by the State Drug Administration. Currently, advanced clinical trials of the drug targeting multiple solid tumors are underway.